Clinical trial NCT05188729
Conditions: Basal Cell Carcinoma Skin Cancer Cancer of the Skin, Basal Cell Cancer of the Skin Carcinoma
Keywords: Skin Cancer BCC Neoplasm Epithelial
Sponsor: Verrica Pharmaceuticals Inc.
Start date: 2022-02-01; Completion date: 2024-04-15
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).

The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

Detailed description:
This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, maximum tolerated dose (MTD), and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven BCC.

The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

All enrolled subjects will receive VP-315 intradermal injection on an outpatient basis into up to 2 target lesions. In all Parts of the study (1 or 2, as below), each 7-day treatment week comprises up to 3 consecutive treatment days followed by a no-treatment period of at least 4 days. Dosing will commence in a single target lesion. Once a lesion is observed to be fully necrotic (Part 1, Part 2; Cohorts 1-2 only), treatment of that lesion stops, and treatment of subsequent target lesions (up to 2 total) may continue on Day 1 of the following week. In Part 2, Cohorts 4 and 5, treatment of a second target lesion begins on W2D1 (not based on status of necrosis of target lesion 1).

Arms: arm 1: Cohort 1: Starting total daily dose of VP-315 will be 2 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 2: Cohort 2: Starting total daily dose of VP-315 will be 3 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 3 mg on Day 1, 4 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 3: Cohort 3: Starting total daily dose of VP-315 will be 4 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 4 mg on Day 1, 5 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 4: Cohort 4: Starting total daily dose of VP-315 will be 5 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 5 mg on Day 1, 6 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 5: Cohort 5: Starting total daily dose of VP-315 will be 6 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 6 mg on Day 1, 7 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 6: Cohort 6: Starting total daily dose of VP-315 will be 7 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 7 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 7: Cohort 7: Starting total daily dose of VP-315 will be 8 mg. Subjects will receive once daily doses of 8 mg for up to 3 days in a 7-day treatment week (e.g., 8 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. arm 8: VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). arm 9: VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). arm 10: VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses. arm 11: VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Interventions: intervention 1: Part 1: VP-315 3 Day Dosing/Week intervention 2: Part 2: VP-315 3 Day Dosing/Week - Loading Dose intervention 3: Part 2: VP-315 3 Day Dosing/Week - No Loading Dose intervention 4: Part 2: VP-315 2 Day Dosing/Week - Split Dose intervention 5: Part 2: VP-315 3 Day Dosing/Week - Split Dose
Intervention descriptions: intervention 1: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily. intervention 2: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment. intervention 3: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). intervention 4: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). intervention 5: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

Protocol documents:
Prot_000.pdf: 
A Phase 2, Multicenter, Open-label, Proof of-Concept Study 
with Safety Run-in to Evaluate the Safety, Pharmacokinetics, 
and Efficacy of VP-315 in Adult Subjects with Basal Cell 
Carcinoma 
 
NCT05188729 
 
Protocol Version/Date: 9.0 (Amendment 8) 13 October 2023 


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Verrica Pharmaceuticals Inc. 
Confidential
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CLINICAL STUDY PROTOCOL
A Phase 2, Multicenter, Open-label, Proof-of-Concept Study with
Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in 
Adult Subjects with Basal Cell Carcinoma
Sponsor:
Verrica Pharmaceuticals Inc.
44 West Gay Street, Suite 400
West Chester, PA 19380
Protocol Number:
VP-315-201
Phase
2
Indication:
Treatment of basal cell carcinoma
Sponsor Contact:
Cindy Willson, RN, BSN
Sr. Director Clinical Operations
Verrica Pharmaceuticals Inc.
44 West Gay Street, Suite 400
West Chester, PA 19380
(415) 823-4449
Sponsor Medical Monitor
Gary Goldenberg, MD
Chief Medical Officer
Verrica Pharmaceuticals Inc.
44 West Gay Street, Suite 400
West Chester, PA 19380
(917) 209-9940
Protocol Version/Date
Supersedes
9.0 (Amendment 8): 13 October 2023
8.0 (Amendment 7): 29 August 2023
Supersedes
Supersedes
Supersedes
7.0 (Amendment 6): 16 June 2023
6.0 (Amendment 5): 28 April 2023
5.0 (Amendment 4): 01 March 2023
Supersedes
4.0 (Amendment 3): 01 June 2022
Supersedes
3.0 (Amendment 2): 09 March 2022
Supersedes
2.0 (Amendment 1): 19 November 2021
CONFIDENTIALITY STATEMENT
This document contains confidential information of Verrica Pharmaceuticals Inc. This document must not be photocopied, 
disclosed, or transmitted to any other person or party who is not covered by a Confidential Disclosure Agreement with 


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Verrica Pharmaceuticals Inc. or its designee except that the document may be disclosed to appropriate site study staff and 
members of the institutional review board/independent ethics committee/institutional scientific review board or equivalent.
The information herein cannot be used for any purpose other than the evaluation or conduct of the clinical investigation 
without the prior written consent of Verrica Pharmaceuticals Inc. 
PROTOCOL SIGNATURE PAGE
SPONSOR APPROVAL AND ACKNOWLEDGMENT
A Phase 2, Multicenter, Open-label, Proof-of-concept Study with Safety Run-in to 
Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects with 
Basal Cell Carcinoma (VP-315-201)
This protocol was subject to critical review by Verrica Pharmaceuticals Inc. and has been 
approved by the following persons:
SPONSOR:
Cindy Willson, RN, BSN
Sr. Director of Clinical Operations
Verrica Pharmaceuticals Inc.
Date
SPONSOR MEDICAL MONITOR:
Gary Goldenberg, MD 
Chief Medical Officer
Verrica Pharmaceuticals Inc.
Date


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INVESTIGATOR AGREEMENT
This protocol is the property of Verrica Pharmaceuticals Inc. I understand that the 
information within it is confidential and is provided to me for review by myself, my staff, 
and applicable ethics committees. I understand that the protocol must be kept in a 
confidential manner and must be returned to the sponsor (Verrica Pharmaceuticals Inc.) or 
destroyed per Verrica Pharmaceuticals Inc. instructions, upon request. No part of this 
protocol may be reproduced in any form without permission from Verrica Pharmaceuticals 
Inc. By accepting this protocol, I agree that the information contained herein will not be 
disclosed to a third party without written authorization from Verrica Pharmaceuticals Inc.
I have read and understood the protocol and agree that it contains all of the necessary 
information to carry out the study.  
I agree to conduct this trial in accordance with all stipulations of the protocol and in 
accordance with the following: Good Clinical Practice (GCP) as described in International 
Council for Harmonisation (ICH) guideline E6(R2), and in 21 Code of Federal Regulations 
(CFR) parts 11, 50, 54, 56, and 312. Compliance with these regulations also constitutes 
compliance with the ethical principles described in the most recent revision of the 
Declaration of Helsinki (October 2013) that is recognized by the US Food and Drug 
Administration (FDA), the European Medicines Agency, and other regulatory agencies.
I agree that I will not modify this protocol without obtaining the prior approval of the sponsor 
and of the institutional review board or independent ethics committee, except when necessary 
to protect the safety, rights, or welfare of subjects.
Investigator’s Printed Name  
and Study Center: 
 
 
 
 
Signature
Date
 


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SUMMARY OF CHANGES TO THE CLINICAL PROTOCOL
VP-315-201 
A Phase 2, Multicenter, Open-label, Proof-of-concept Study with  
Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in 
Adult Subjects with Basal Cell Carcinoma 
Current Edition: 
9.0 (Amendment 8) 
13 October 2023 
Supersedes:
 
8.0 (Amendment 7)
7.0 (Amendment 6) 
6.0 (Amendment 5) 
5.0 (Amendment 4) 
4.0 (Amendment 3) 
3.0 (Amendment 2) 
2.0 (Amendment 1) 
29 August 2023
16 June 2023 
28 April 2023 
01 March 2023 
01 June 2022 
09 March 2022 
19 November 2021 
Major Reason(s) and Rationale for Amendment:  
The protocol has been amended to clarify the following items: 
Part 2, Cohort 5 Expansion Group has been approved by the SRC on October 11, 2023: 
 
Up to 20 additional subjects (for a total of approximately 30 subjects) will be enrolled into Cohort 5. 
 
After each treatment, the additional subjects enrolled into Cohort 5: will remain in the study center 
for up to 1-hour (reduced from 2-hours) post second injection for safety monitoring (e.g., continuous 
blood pressure, electrocardiographic and AE monitoring), an additional hour may be continued at 
the discretion of the PI. 
 
To provide clarification to Subject Exclusion Criteria (Section 5.3) #6. and 6. c.: 
 
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 
6.  Chronic medical condition such as, but not limited to: 
c. 
Subjects presenting  with a systolic BP <110 mmHg and/or diastolic BP <70 mmHg at 
Screening or Week 1 Day 1, or a history of cerebrovascular or cardiac disorders, or subjects at 
particular risk of sequelae following a short hypotensive episode. 
 
 
Changes by Section are detailed in the table that follows. 


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Comparative Changes
Previous Version: 
8.0 – Amendment 7 (29August 2023) 
Current Version: 
9.0 - Amendment 8 (13 October 2023) 
Initial Text
Added, Deleted, or Modified Text
GLOBAL
Grammatical and formatting refinements to improve readability and ease of use. 
Multiple Sections 
Initial Text: 
…surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 13
weeks (Part 2) after W1D1 injection 
Modified: 
…surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 13
14 weeks (Part 2) after W1D1 injection
Rationale: Modified excision time for EOT  window to allow for subject scheduling flexibility. 
4.1   Study Design
Initial Text:
 
Part 2 (N= 66 to 72): VP-315 once-daily dosing; will be a total daily dose of 8 mg in up 
to 5 cohorts (i.e, there were no DLTs that occurred during Part 1 of the study and the 
maximum dose of 8 mg was achieved). 
 
 
Cohort 4 (N=30 (10 initial/20 expansion): 
 
 
Cohort 5 (N=30 (10 initial/20 expansion): 
 
… For the first 10 subjects enrolled into Part 2 (Cohorts 4 and 5): after each treatment, 
subjects will remain in the study center for up to 2 hours post second injection for safety 
monitoring (e.g., continuous vital signs, electrocardiographic and AE monitoring).   
 
Cohort 4 expansion group: 
An SRC meeting was convened after the 10 subjects in Cohort 4 completed the Safety 
Assessment and approved the following: 
 
20 additional subjects (for a total of 30 subjects) will be enrolled into Cohort 
4. 
After each treatment, the additional 20 subjects enrolled into Cohort 4 
expansion: will remain in the study center for up to 1-hour (reduced from 2-
hours) post second injection for safety monitoring (e.g., continuous vital signs, 
Modified, Added, Deleted:
 
Part 2 (N=  Approximately 66 to 72): VP-315 once-daily dosing; will be a total daily 
dose of 8 mg in up to 5 cohorts (i.e, there were no DLTs that occurred during Part 1 of 
the study and the maximum dose of 8 mg was achieved). 
 
Cohort 4 (N= Approximately 30 (10 initial/up to 20 expansion): 
 
 
Cohort 5 (N= Approximately 30 (10 initial/up to 20 expansion): 
 
… For the first 10 subjects enrolled into Part 2 (Cohorts 4 and 5): after each treatment, 
subjects will remain in the study center for up to 2 hours post second injection for safety 
monitoring (e.g., continuous vital signs blood pressure, electrocardiographic and AE 
monitoring).
 
Cohort 4 expansion group: 
An SRC meeting was convened after the 10 subjects in Cohort 4 completed the Safety 
Assessment and approved the following: 
 
Up to 20 additional subjects (for a total of approximately 30 subjects) will be 
enrolled into Cohort 4. 
 
After each treatment, the additional 20 subjects enrolled into Cohort 4 
expansion: will remain in the study center for up to 1-hour (reduced from 2-


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Initial Text
Added, Deleted, or Modified Text
electrocardiographic and AE monitoring), an additional hour may be 
continued at the discretion of the PI. 
 
NOTE: An additional SRC meeting will convene after the 10 subjects in Cohort 5 have 
completed the Safety Assessment Visit to review the following topics: 
 
to review any safety signals that may have occurred that could impact further 
treatment 
 
if the 2 hours of safety monitoring can be reduced to 1-hour post second 
injection at treatment (an additional hour may be continued at the discretion of 
the PI). 
 
if enrollment can be expanded to include an additional 20 subjects for a total 
of 30 subjects in each cohort.   
If Cohort 5 is approved by the SRC for expansion; 20 additional subjects will be 
enrolled into Cohort 5. 
 
Four to 6 weeks in Part 1, and 12 to 13 weeks (Part 2) after the first injection of VP 315, 
subjects will return for all target and nontarget BCC lesions (Section 5.4) to be excised 
for histological evaluation. 
hours) post second injection for safety monitoring (e.g., continuous vital 
signsblood pressure, electrocardiographic and AE monitoring), an additional 
hour may be continued at the discretion of the PI. 
 
Cohort 5 expansion group: 
An SRC meeting was convened after the 10 subjects in Cohort 5 completed the 
Safety Assessment and approved the following:
 
Up to 20 additional subjects (for a total of approximately 30 subjects) will 
be enrolled into Cohort 5. 
 
After each treatment, the additional subjects enrolled into Cohort 5 
expansion: will remain in the study center for up to 1-hour (reduced from 
2-hours) post second injection for safety monitoring (e.g., continuous 
blood pressure, electrocardiographic and AE monitoring), an additional 
hour may be continued at the discretion of the PI. 
NOTE: An additional SRC meeting will convene after the 10 subjects in Cohort 5 have 
completed the Safety Assessment Visit to review the following topics: 
to review any safety signals that may have occurred that could impact further 
treatment
 
if the 2 hours of safety monitoring can be reduced to 1-hour post second 
injection at treatment (an additional hour may be continued at the discretion of 
the PI).
if enrollment can be expanded to include an additional 20 subjects for a total 
of 30 subjects in each cohort.   
If Cohort 5 is approved by the SRC for expansion; 20 additional subjects will be 
enrolled into Cohort 5.
Four to 6 weeks in Part 1, and 12 to 1314 weeks (Part 2) after the first injection of VP 
315, subjects will return for all target and nontarget BCC lesions (Section 5.4) to be 
excised for histological evaluation.
Rationale: To provide clarification on the updated study design following the Part 2 Cohort 5 SRC meeting.
5.3
Subject Exclusion Criteria
Initial Text:
6.
Chronic medical condition that in the judgment of the investigator(s) would 
interfere with the performance of the study or would place the subject at undue 
risk, such as, but not limited to: 
History of cerebrovascular or cardiac disorders, or subjects at particular 
risk of sequelae following a short hypotensive episode, including subjects 
Modified:
6.
Chronic medical condition that in the judgment of the investigator(s) would 
interfere with the performance of the study or would place the subject at 
undue risk, such as, but not limited to:


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Added, Deleted, or Modified Text
with systolic BP <110 mmHg and/or diastolic BP <70 mmHg at 
screening or Day 1 
c.
Subjects presenting with systolic BP <110 mmHg and/or diastolic BP 
<70 mmHg at screening or Day 1 or W1D1, or a History of 
cerebrovascular or cardiac disorders, or subjects at particular risk of 
sequelae following a short hypotensive episode., including subjects with 
systolic BP <110 mmHg and/or diastolic BP <70 mmHg at screening or 
Day 1 
Rationale: To provide clarification on blood pressure exclusion criteria 
7.3.1 
Management of Postinjection Reactions to VP-315 
Initial Text:
In Part 2, subjects will continue to be closely monitored for any safety 
signaling. If a TRAE is identified, the medical monitor will review and 
determine if treatment should be continued. 
Modified:
In Part 2, subjects will continue to be closely monitored for any safety 
signaling. If a TRAE SI is identified (Section 10.2), the medical monitor will 
review and determine if treatment should be continued. 
Rationale: To provide additional information for AEs requiring medical monitor review.
7.3.2.2
Study Part 2
Initial Text: 
 
Cohort 4 (N=30 (10 initial/20 expansion): 
 
Cohort 5 (N=30 (10 initial/20 expansion):
 
…For the first 10 subjects enrolled into Cohorts 4 and 5: after each treatment, subjects 
will remain in the study center for up to 2 hours post second injection for safety 
monitoring (e.g., continuous vital signs, electrocardiographic and AE monitoring).   
 
An SRC meeting will convene after the 10 subjects in each cohort (4 and 5) 
have completed the Safety Assessment Visit to review the following topics: 
o 
to review the safety signals that may have occurred that could 
impact further treatment 
o 
if the 2 hours of safety monitoring can be reduced to 1-hour post 2nd
injection at treatment (an additional hour may be continued at the 
discretion of the PI). 
o 
if enrollment can be expanded to include an additional 20 subjects 
for a total of 30 subjects in each cohort.   
 
If Cohorts 4 and 5 are approved by the SRC for expansion; 20 additional subjects will be 
enrolled into Cohort 4 followed by 20 subjects enrolled into Cohort 5. 
Modified: 
 
Cohort 4 (N= Approximately 30 (10 initial/up to 20 expansion): 
 
Cohort 5 (N= Approximately 30 (10 initial/up to 20 expansion):
…For the first 10 subjects enrolled into Cohorts 4 and 5: after each treatment, subjects 
will remain in the study center for up to 2 hours post second injection for safety 
monitoring (e.g., continuous blood pressurevital signs, electrocardiographic and AE 
monitoring).  
SRC Meetings 
An Two separate SRC meetings willwere convened after the 10 subjects in each initial 
cohort (4 and 5) have completed the Safety Assessment Visit to review the following 
topics:
o
to review the safety signals that may have occurred that could impact further 
treatment
o 
to determine if the 2 hours of safety monitoring could can be reduced to 1-hour 
post 2nd injection at treatment (an additional hour may be continued at the 
discretion of the PI).
o 
to determine if enrollment could can be expanded to include an additional up 
to 20 additional subjects for a total of approximately 30 subjects in each 
cohort.  


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Added, Deleted, or Modified Text
Subjects may be discontinued for AEs at any time per the discretion of the investigator.   
Subject dosing will continue until any TRAE of any grade occurs, with the exception of 
Grade 1 TRAEs indicative of local reactogenicity (injection-site pain, erythema, 
induration). Systemic reactogenic AEs (fever, myalgia, headache) and Grade 2 local 
reactogenic AEs will be considered TRAEs of special interest (Section 10.2). 
If there is a clinically significant AE or abnormal laboratory result at the EOS visit, 
follow-up (F/U) visits may be required until resolution of the abnormality, or until the 
condition is considered clinically stable. 
 
 
 
The SRC approved the following for both Cohorts 4 and 5: 
 
Up to 20 additional subjects (for a total of approximately 30 subjects) will 
be enrolled into Cohorts 4 and 5 (expansion groups) respectively. 
 
After each treatment, the additional subjects enrolled into Cohorts 4 and 
5 expansion groups: will remain in the study center for up to 1-hour 
(reduced from 2-hours) post second injection for safety monitoring 
(e.g., continuous blood pressure, electrocardiographic and AE 
monitoring), an additional hour may be continued at the discretion of the 
PI. 
 
If Cohorts 4 and 5 are approved by the SRC for expansion; 20 additional subjects will 
be enrolled into Cohort 4 followed by 20 subjects enrolled into Cohort 5.
Subjects may be discontinued for AEs at any time per the discretion of the investigator.  
Management of TRAEs (see Sections 7.3.1and 10.2)
Subject dosing will continue until any TRAE of any grade occurs, with the exception of 
Grade 1 TRAEs indicative of local reactogenicity (injection-site pain, erythema, 
induration). Systemic reactogenic AEs (fever, myalgia, headache) and Grade 2 local 
reactogenic AEs will be considered TRAEs of special interest (Section 10.2). 
If a TRAE SI is identified, the site will notify the medical monitor who will review 
and determine if treatment should be continued. 
For TRAE SIs occurring during VP-315 injections, or within 1-hour after the last 
injection, injections should stop until resolution of the reaction. If the reaction 
occurs during the first injection of the dose and resolves within 1-hour, the second 
injection of the dose may continue. 
For TRAE SIs Grade 2 (per CTCAE V5)  and higher reactions, the investigator 
must stop further injections in accordance with TRAE SI/DLT descriptions 
(Section 10.2). and Tryptase must be collected per protocol (Section 8.4.5). 
If there is a clinically significant AE or abnormal laboratory result at the EOS visit, 
follow-up (F/U) visits may be required until resolution of the abnormality, or until the 
condition is considered clinically stable. 
All AEs including TRAE SIs should be recorded on the subject’s AE Form. 
Subjects may be discontinued for AEs at any time per the discretion of the 
investigator.   


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Initial Text
Added, Deleted, or Modified Text
Rationale: To provide updated information on Study Part 2, Cohort 5 and Cohort 5 expansion group and management of TRAEs 
7.4.3.
Stopping Rules
Initial Text:
Part 2 of the study: The occurrence of a TRAE of special interest in any subject will 
result in discontinuation of VP-315 in that subject. 
In all cases, the SRC will have the authority to discontinue or modify VP-315 dosing if 
TRAEs, changes in vital signs, ECGs, or clinical laboratory results are observed and 
these changes are determined to pose a significant health risk to the subject.  
 
Modified:
Part 2 of the study: For Grade 2 TRAE SIs and higher (per CTCAE V5), the 
investigator should discontinue VP-315 treatment, collect Tryptase per protocol 
(Section 8.4.5) in that subject and the subject should return for all follow-up visits. 
The occurrence of a TRAE of special interest in any subject will result in 
discontinuation of VP-315 in that subject.
In all cases, the SRC will have the authority to discontinue or modify VP-315 dosing if 
TRAEs, changes in vital signs, ECGs, or clinical laboratory results are observed and 
these changes are determined to pose a significant health risk to the subject.  
Rationale: To provide clarification for stopping rules in Part 2.
8.1    Screening Assessments 
Initial Text:
Each subject must sign and date the ICF prior to their participation in any screening 
activities. Prospective subjects are expected to complete Screening evaluations 
(exclusive of biopsy) no more than 42 days prior to the planned date of the first study 
drug administration (Day 1).
Added:
Each subject must sign and date the ICF prior to their participation in any screening 
activities. Prospective subjects are expected to complete Screening evaluations 
(exclusive of biopsy) no more than 42 days prior to the planned date of the first study 
drug administration (Day 1). Note: Subjects with a systolic BP <110 mmHg and/or 
diastolic BP <70 mmHg at the Screening visit do not meet inclusion criteria and 
should not be enrolled into the study. 
Rationale: Added a note to highlight the blood pressure requirements at the Screening visit.
8.2     Treatment Period
Initial Text:
After each treatment, all subjects will remain in the study center for up to 2 hours for 
safety monitoring (e.g., continuous vital signs, electrocardiographic and AE monitoring) 
and plasma PK sampling (in Part 2) as detailed in Table 8-1.  After each treatment, the 
additional 20 subjects enrolled into Cohort 4 expansion: will remain in the study center 
for up to 1-hour (reduced from 2-hours) post second injection for safety monitoring 
(e.g., continuous vital signs, electrocardiographic and AE monitoring), an additional 
hour may be continued at the discretion of the PI. 
Modified: 
After each treatment, all subjects in Part 1, Part 2 – Cohort 1, Cohort 2 and Cohorts 
4 and 5 (first 10 subjects in each) will remain in the study center for up to 2 hours for 
safety monitoring (e.g., continuous vital signsblood pressure, electrocardiographic and 
AE monitoring) and plasma PK sampling (in Part 2) as detailed in Table 8-1.  After each 
treatment, the additional 20 subjects enrolled into Cohorts 4 and 5 expansion groups: 
will remain in the study center for up to 1-hour (reduced from 2-hours) post second 
injection for safety monitoring (e.g., continuous vital signsblood pressure, 
electrocardiographic and AE monitoring), an additional hour may be continued at the 


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discretion of the PI. Plasma PK sampling will be collected (in Part 2, Cohorts 4 and 
5 expansion groups) as detailed in Table 8-1. 
Rationale: To provide updated information on safety monitoring time and PK sampling.
Table 8-1  Schedule of Assessments - Footnotes


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Initial Text:
Footnote c: 
Vital signs (e.g., temperature, HR, BP) will be obtained at screening and at each 
treatment prior to application of study drug. Height and weight will be collected at 
Screening and EOS. Subjects must be supine for at least 5 minutes before BP and pulse 
rate measurements. On VP-315 dosing days, BP will be monitored serially just prior to 
injection, at 1, 3, and 5 minutes after each injection, and then every 5 minutes until 2 
hours post last injection of the day using an automated cuff system. For subjects in Part 
2 (Cohort 4 expansion group), monitoring of BP has been decreased to 1-hour by the 
SRC following their safety meetings.  An additional hour may be continued at the 
discretion of the PI. 
Modified: 
Footnote c: 
Vital signs (e.g., temperature, HR, BP) will be obtained at screening and at each 
treatment prior to application of study drug. Height and weight will be collected at 
Screening and EOS. Subjects must be supine for at least 5 minutes before BP and pulse 
rate measurements. On VP-315 dosing days, BP will be monitored serially just prior to 
injection, at 1, 3, and 5 minutes after each injection, and then every 5 minutes until 2 
hours post last injection of the day using an manual/automated cuff system. For 
subjects in Part 2 (Cohorts 4 and 5 expansion groups), monitoring of BP has been
decreased to 1-hour by the SRC following their safety meetings.  An additional hour 
may be continued at the discretion of the PI. 
Initial Text:
Footnote f:
Resting 12-lead ECGs (equipment provided by ECG Core Lab) will be recorded after 
the subject has been supine and at rest for at least 5 minutes at all visits, and prior to 
dosing on VP-315 dosing days. On VP-315 dosing days, 5-electrode Holter/telemetry 
(equipment provided by ECG Core Lab) will also be monitored continuously starting 15 
minutes prior to injection and continuing 2-hours post last injection of the day. For 
subjects in Part 2 (Cohorts 4 expansion group), Holter/telemetry monitoring has been 
decreased to 1-hour by the SRC following their safety meeting. An additional hour may 
be continued at the discretion of the PI. Note, in the event of EGC Core Lab equipment 
failure for the 12-lead ECG, sites may use their own 12-lead ECG machine and contact 
the ECG Core Lab for directions regarding upload to the study portal. 
Modified: 
Footnote f:
Resting 12-lead ECGs (equipment provided by ECG Core Lab) will be recorded after 
the subject has been supine and at rest for at least 5 minutes at all visits, and prior to 
dosing on VP-315 dosing days. On VP-315 dosing days, 5-electrode Holter/telemetry 
(equipment provided by ECG Core Lab) will also be monitored continuously starting 15 
minutes prior to injection and continuing 2-hours post last injection of the day. For 
subjects in Part 2 (Cohorts 4 and 5 expansion groups), Holter/telemetry monitoring has 
been decreased to 1-hour by the SRC following their safety meetings. An additional 
hour may be continued at the discretion of the PI. Note, in the event of EGC Core Lab 
equipment failure for the 12-lead ECG, sites may use their own 12-lead ECG machine 
and contact the ECG Core Lab for directions regarding upload to the study portal. 
Initial Text:
Footnote t (b):
Cohorts 4-5: If only 1 target lesion is treated and complete necrosis is not achieved at 
the W1 Safety Assessment Visit, subjects should return on W2D1 for further evaluation 
of the lesion for necrosis. No additional treatment will be administered. If a second 
target lesion was treated and complete necrosis is not achieved at the W2 Safety 
Assessment Visit, subjects should return on W3D1 for further evaluation of the lesion 
for necrosis. No additional treatment will be administered. 
Modified: 
Footnote t (b):
Cohorts 4-5 (including expansion groups): If only 1 target lesion is treated and 
complete necrosis is not achieved at the W1 Safety Assessment Visit, subjects should 
return on W2D1 for further evaluation of the lesion for necrosis. No additional 
treatment will be administered. If a second target lesion was treated and complete 
necrosis is not achieved at the W2 Safety Assessment Visit, subjects should return on 
W3D1 for further evaluation of the lesion for necrosis. No additional treatment will be 
administered.
Rationale:  To provide updated information on Cohort 5 expansion group.
8.4.2     Vital Signs Data


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Initial text:
On VP-315 dosing days, blood pressure will be monitored serially just prior to injection, 
at 1-, 3-, and 5-minutes after each injection, and then every 5-minutes until 2 hours after 
the last injection of the day using an automated cuff system (Table 8-1). For subjects in 
Part 2 – Cohort 4 expansion group, monitoring of BP has been decreased to 1-hour post 
treatment (an additional hour may be continued at the discretion of the PI).  
 
Modified: 
On VP-315 dosing days, blood pressure will be monitored serially (observing for 
hypotension that meets the definitions as described in Section 10.2): just prior to 
injection, at 1-, 3-, and 5-minutes after each injection, and then every 5-minutes until 2 
hours after the last injection of the day using a manual/n automated cuff system 
(Table 8-1). For subjects in Part 2 – Cohorts 4 and 5 expansion groups, monitoring of 
BP has been decreased to 1-hour post treatment (an additional hour may be continued at 
the discretion of the PI).  
Rationale: To provide updated information on the reduction in time for post treatment monitoring of blood pressure.
8.4.3    Electrocardiograms 
Initial text:
…..For subjects in Part 2 Cohort 4 expansion group, Holter/telemetry has been 
decreased to 1-hour after the last injection of the day after receipt of the second daily 
dose of VP-315 (an additional hour may be continued at the discretion of the PI).  
Modified: 
…..For subjects in Part 2 Cohorts 4 and 5 expansion groups, Holter/telemetry has been 
decreased to 1-hour after the last injection of the day after receipt of the second daily 
dose of VP-315 (an additional hour may be continued at the discretion of the PI).  
Rationale: To provide updated information on the reduction in time for post injection cardiac monitoring.
8.4.4     Clinical Laboratory Testing
Initial text:
A Clinical Laboratory Improvement Amendments certified laboratory will perform the 
clinical laboratory tests for this study as scheduled in Table 8-1. Tests are listed in 
Table 8-2 and will be performed at Screening, at each Safety Assessment Visit, at 
Unscheduled Visits and at the EOS; for subjects with excised lesions on both the face 
and the body, clinical laboratory samples will be collected only at the second EOS visit 
(i.e, at the EOS for Body). Clinical laboratory testing for hematology, serum chemistry, 
pregnancy tests, and tryptase levels will be performed in the local clinical laboratories at 
the study site.  
Modified:
A Clinical Laboratory Improvement Amendments (CLIA) certified laboratory [either 
central or local] will perform the clinical laboratory tests for this study as scheduled in 
Table 8-1. Tests are listed in Table 8-2 and will be performed at Screening, at each 
Safety Assessment Visit, at Unscheduled Visits and at the EOS; for subjects with 
excised lesions on both the face and the body, clinical laboratory samples will be 
collected only at the second EOS visit (i.e, at the EOS for Body). Clinical laboratory 
testing for hematology, serum chemistry, pregnancy tests, and tryptase levels will be 
performed in the local clinical laboratories at the study site. 
Rationale: Updated information to include central laboratory
Table 8-2
Clinical Laboratory Tests
Initial text:
Added: 
T-Cell Clonality (Central lab only)
Expansion Cohorts 4 and 5


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Serum Pharmacokinetics (PK) [Central lab only]
 
Rationale: To provide information on the central lab specimens. 
8.4.5 
Serum Tryptase Assessment 
Initial text: 
… The actual collection time must be recorded entered into the subject’s 
record/source documents and transcribed to the CRFaccordingly. 
Modified: 
… The actual collection time must be recordedentered into the subject’s 
record/source documents and transcribed to the CRFaccordingly.
Rationale: To provide clarity for appropriate documentation.
8.4.8      Pharmacokinetic Assessments 
Initial text:
 
Additional samples will be collected on the following day 24 hours (±1 hour) post 
prior injection of VP-315.  
 
Modified:
 
Additional samples will be collected on the following day 24 hours (±1 hour) post 
priorDay 1 first injection of VP-315 (prior to Day 2 injection).  
 
Rationale:  To provide clarification for timing of PK samples. 
8.5.1     Lesion Evaluation
Initial text:
…All specimens (including HISTORICAL samples) will be sent as slides to the central 
dermatopathologist for confirmation of eligibility. 
In accordance with the procedures noted in Table 8-1, all target and nontarget BCC 
lesions will be surgically excised with a 3 mm- margin 4 to 6 weeks (Part 1) and 12 to 
13 weeks (Part 2) after receipt of the W1D1 injection; slides will be sent to the central 
dermatopathologist for analysis/histology. If a lesion has clinically cleared, the area 
where the lesion was will be excised accordingly.
Modified:
…All specimens (including HISTORICAL samples) will be formalin-fixed and 
paraffin embedded (FFPE) and H&E stained slides of specimen slices will be 
prepared and reviewed locally to determine sent as slides to the central 
dermatopathologist for confirmation of eligibility. The H&E stained slides will be sent 
to the central lab for imaging and high quality images of the slides will be sent to 
the central dermatopathologist for confirmation of analysis/histology. 


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In accordance with the procedures noted in Table 8-1, all target and nontarget BCC 
lesions will be surgically excised with a 3 mm- margin 4 to 6 weeks (Part 1) and 12 to 
1314 weeks (Part 2) after receipt of the W1D1 injection and tissue specimens 
preserved by FFPE. If a lesion has clinically cleared, the area where the lesion was 
will be excised accordingly. Both the screening and post-excision tissue blocks will 
be sent to the central lab for analysis of immune activation biomarkers including 
TILs by multiplexed IF-IHC, as well as for sequencing of genomic DNA from the 
lesion specimens to assess changes in T-cell receptor clonality.; slides will be sent to 
the central dermatopathologist for analysis/histology. If a lesion has clinically cleared, 
the area where the lesion was will be excised accordingly. 
Rationale:  To provide updated central lab information on the process for BCC tissue samples and analysis. 
8.8
Assessment of the Immunological Response to VP-315 Treatment
Initial text: 
In a subset of subjects, the anti-tumor immunological response to VP-315 
treatment will be assessed in the excised tissue obtained from basal cell tumor 
biopsies performed at pre-screening (baseline) and at the approximate 12-week 
post-treatment visit, as well as in peripheral blood samples acquired at the same 
time points. 
Modified: 
In a subset of subjects, the anti-tumor immunological response to VP-315 
treatment will be assessed in the excised tissue obtained from basal cell tumor 
biopsies performed at pre-screening (baseline) and at the approximate 12 to 14-
week post-treatment visit, as well as in peripheral blood samples acquired at the 
same time points. 
Rationale: To include the window of the post-treatment visit.
10.2 
Dose-limiting Toxicity/Treatment-related Adverse Event of Special Interest 
Initial text:
In Part 1, any subject who experiences a DLT/TRAE SI will receive no further 
VP-315.  
If the DLT is caused by an unexpected drug-related event that is not listed in 
the consent form, Sponsor will revise the consent form appropriately and 
submit it to the IRB. 
Modified:
In Part 1, any Any subject who experiences a DLT/TRAE SI will receive no 
further VP-315. 
If the DLT/TRAE SI is caused by an unexpected drug-related event that is not 
listed in the consent form, Sponsor will revise the consent form appropriately 
and submit it to the IRB. 
Rationale:  To  provide clarification with TRAE SI.


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1.
PROTOCOL SYNOPSIS
Protocol Title: A Phase 2, Multicenter, Open-label, Proof-of-Concept Study with Safety 
Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects 
with Basal Cell Carcinoma
Phase: 2 
Indication: basal cell carcinoma (BCC)
Hypotheses, Objectives, and Endpoints:  
There is no formal hypothesis testing in this study. The following objectives and associated 
endpoints will be evaluated in this 2-part study: 
Part 1 
Primary Objectives
Endpoints
 
To assess the safety, tolerability, and 
maximum tolerated dose (MTD) of 
ascending dose strengths of VP-315  
Discontinuations due to adverse events 
(Aes); occurrence of dose-limiting toxicities 
(DLTs) 
 
Cutaneous Reaction Assessment (CRA) 
Exploratory Objectives 
Endpoints 
 
To evaluate the objective antitumor efficacy 
of VP-315 
Histological clearance of treated lesion(s) at 
excision 
Clinical clearance of treated lesion(s) as 
determined by visual assessment (no tumor 
seen upon visible inspection) at excision 
Estimate of remaining tumor volume 
(necrotic cells:tumor cells) at excision 
Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision 
Physician Global Assessment (PGA)
Part 2 (Cohorts 1 and 2) 
Primary Objectives 
Endpoints 
 
To determine the optimal regimen for 
dosing 8 mg of VP-315 based on safety and 
tolerability 
 
Treatment-related Aes; treatment-related 
serious adverse events (SAEs); 
discontinuations due to Aes; occurrence of 
TRAEs of special interest 
CRA 
 
 
 


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Secondary Objectives
Endpoints
To evaluate the antitumor efficacy of VP-
315 
Clinical clearance of treated lesion at 
excision as determined by visual assessment 
(no residual tumor seen on visual 
inspection) 
 
Histological clearance of treated lesion(s) at 
excision 
 
Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision if nontreated lesions exist 
 
Estimate of remaining tumor volume 
(necrotic cells:tumor cells) at excision 
 
PGA 
Exploratory Objectives 
Endpoints 
 
To assess the immune response to VP-315 
treatment in a subset of subjects by 
assessing the immune repertoire in blood 
and in tissue  
Multiplex immunohistochemical staining 
for T-cell subsets and immune activation 
markers in tumor tissue samples 
 
Analysis of T-cell clonality in blood and 
tumor tissue samples 
 
To assess subject satisfaction with the 
treatment 
SCAR-Q, FACE-Q
Part 2 (Cohorts 4 and 5) 
Primary Objectives 
Endpoints 
 
To gain additional information on the 
safety, tolerability, and dosing regimen of 
VP-315 to support a pivotal study protocol 
design 
Treatment-related Aes; treatment-related 
serious adverse events (SAEs); 
discontinuations due to Aes; occurrence of 
TRAEs of special interest 
 
CRA  
Secondary Objectives
Endpoints
 
To confirm the antitumor efficacy of VP-
315 using the optimal dosing regimen 
determined in Part 2 
Clinical clearance of treated lesion at 
excision as determined by visual assessment 
(no residual tumor seen on visual 
inspection) 
 
Histological clearance of treated lesion(s) at 
excision 
 
Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision if nontreated lesions exist 
 
Estimate of remaining tumor volume 
(necrotic cells:tumor cells) at excision 
 
PGA 


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To characterize the pharmacokinetics (PK) 
of an 8 mg dose of VP-315 administered 
with the optimal dosing regimen determined 
in Part 2.  
Plasma VP-315 concentrations
Exploratory Objectives 
Endpoints 
To assess subject and physician satisfaction 
with the treatment 
SCAR-Q, FACE-Q,
Scar Cosmesis Assessment and Rating 
(SCAR) Scale 
 
To assess the immune response to VP-315 
treatment in a subset of subjects by 
assessing the immune repertoire in blood 
and in tissue 
Multiplex immunohistochemical staining 
for T-cell subset and immune activation 
markers in tumor tissue samples 
 
Analysis of T-cell clonality in blood and 
tumor tissue samples  
Study Design: This is an open-label, multicenter, proof-of-concept study with a safety run-in 
designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of VP-315 
when administered intratumorally to adults with biopsy-proven BCC. 
This study is expected to enroll approximately 80 subjects with a histological diagnosis of 
BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy). 
This is a 2-part study with sequential enrollment. All enrolled subjects will receive VP-315 
intratumoral injection on an outpatient basis into up to 2 target lesions: 
Part 1 (N= 2 to 8): VP- 315 once-daily dosing; starting total daily dose of 2 mg for the first 
subject. Ascending once-daily 1-mg dosing increments (e.g., 2 mg on 
Day 1, 3 mg on Day 2). Subjects may be treated for a maximum of 
2 weeks and a maximum total daily dose of 8 mg in Part 1. The starting 
dose will be escalated between subject cohorts in 1-mg increments after 
the previous cohort has completed Week 1 dosing (the DLT observation 
period) (Figure 7-1 and Figure 7-2).
Part 2 (N= Approximately 66 to 72):VP-315 once-daily dosing; will be a total daily dose of 
8 mg in up to 5 cohorts (i.e. there were no DLTs that occurred during 
Part 1 and the maximum dose of 8 mg was achieved).
 Cohort 1 (N=3-6): VP-315 once-daily dosing of 8 mg with a loading 
dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all
remaining doses will be the full target dose without a loading dose.
Subjects will be treated until the lesion is necrosed, for a maximum of 
2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 – up to 
6 total doses). 
Cohort 2 (N=3-6): VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO 
LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is 
necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 – up 
to 6 total doses).  


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The study design and dosing strategy listed below for Cohorts 3, 4 and 5 are 
recommendations from the Safety Review Committee following an adhoc safety review 
meeting held on June 13-14, 2023 to discuss subjects reports of pain and burning at the 
injection site that were not observed in Part 1 of the study: 
 Recommendation: Remove/skip Cohort 3 in Part 2 of the protocol and advance from 
Cohort 2 to Cohorts 4 and 5.  Revert to Part 1 dosing strategy of a 30/70 split dose for 
all treatments with the injections 19dministered 15-minutes apart. 
 
Cohort 3 (N=0)This cohort has been removed at the recommendation 
of the SRC. : This cohort has been removed upon the completion of 
Cohort 2. 
For Part 2 (Cohorts 4 and 5) the highest total daily dose of VP-315 (8.0 mg) will be divided 
into a split dose; the first dose is not to exceed 2.4 mg (30% of 8-mg dose), and the 
remaining dose will not exceed 5.6 mg (70% of 8-mg dose) and administered 15 minutes 
apart (not to exceed 30 minutes).
 Cohort 4 (N=Approximately 30 [10 initial/up to 20 expansion]): 
(Two times weekly dosing) VP-315 once-daily dosing of 8 mg, 
administered on 2 consecutive days in one week (W1D1, W1D2). The 
planned dosing regimen will be a split dose of VP-315 for all 
treatments. The 500µL (8 mg) dose will be divided into 2 injections 
given at least 15 minutes and no more than 30 minutes apart, with 
30% (150 µL) administered in the first injection and the remaining 
70% (350 µL) with the second injection. Treatment for a second 
Target Lesion may begin on D1 of the next week (W2D1, W2D2). 
Each individual target lesion is treated for the assigned 2 days only 
(regardless of necrosis status). Up to 2 target lesions may be treated – 
up to 4 total doses.
Cohort 5 (N=Approximately 30 [10 initial/up to 20 expansion]): 
(Three times weekly dosing) VP-315 once-daily dosing of 8 mg, 
administered on 3 consecutive days in one week (W1D1, W1D2, 
W1D3). The planned dosing regimen will be a split dose of VP-315 
for all treatments. The 500µL (8 mg) dose will be divided into 
2 injections given at least 15 minutes and no more than 30 minutes 
apart, with 30% (150 µL) administered in the first injection and the 
remaining 70% (350 µL) with the second injection. Treatment for a 
second target lesion may begin on D1 of the next week (W2D1, 
W2D2, W2D3). Each individual target lesion is treated for the 
assigned 3 days only (regardless of necrosis status). Up to 2 target 
lesions may be treated – up to 6 total doses.
See (Table 7-1)
In Part 1 of the study, each 7-day treatment week comprises up to 3 consecutive treatment 
days followed by a no-treatment period of at least 4 days. In Part 2 of the study, each 7-day 


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treatment week comprises up to 2 or 3 consecutive treatment days followed by a no-treatment 
period of at least 4 days. Dosing will commence in a single target lesion. In Part 1 and Part 2 
Cohorts 1and 2, once a target lesion has necrosed, treatment of that lesion stops, and 
treatment of a subsequent target lesion (up to 2 total, including the original target lesion) may 
continue on Day 1 of the following week. In Part 2 Cohorts 4 and 5 , treatment of a second 
target lesion begins on W2D1 (not based on status of necrosis of target lesion 1). 
For the first 10 subjects enrolled into Cohorts 4 and 5: after each treatment, subjects will 
remain in the study center for up to 2-hours post second injection for safety monitoring 
(e.g., continuousblood pressure, electrocardiographic and AE monitoring).   
Following the final treatment of the 10th subject in Cohort 4, enrollment into Cohort 5 may be 
initiated for 10 subjects.   
Cohort 4 expansion group: 
An SRC meeting was convened after the 10 subjects in Cohort 4 completed the Safety 
Assessment and approved the following: 
Up to 20 additional subjects (for a total of approximately 30 subjects) will be 
enrolled into Cohort 4. 
 After each treatment, the additional subjects enrolled into Cohort 4 expansion: 
will remain in the study center for up to 1-hour (reduced from 2-hours) post 
second injection for safety monitoring (e.g., continuousblood pressure, 
electrocardiographic and AE monitoring), an additional hour may be continued at 
the discretion of the PI. 
 
Cohort 5 expansion group: 
An SRC meeting was convened after the 10 subjects in Cohort 5 completed the Safety 
Assessment and approved the following:
Up to 20 additional subjects (for a total of approximately 30 subjects) will be 
enrolled into Cohort 5.
After each treatment, the additional subjects enrolled into Cohort 5 expansion: 
will remain in the study center for up to 1-hour (reduced from 2-hours) post 
second injection for safety monitoring (e.g., continuous blood pressure, 
electrocardiographic and AE monitoring), an additional hour may be continued at 
the discretion of the PI. 
 
Plasma PK sampling will be collected in subjects in Cohorts 4 and 5 expansion groups as 
detailed in Table 8-1. 
Planned Sample Size: Approximately 80 subjects (Part 1: approximately 2 to 8 subjects; 
Part 2: approximately 66 to 72 subjects enrolled at up to 15 sites in the United States (US). 


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Duration of Treatment: The Sponsor estimates that the study will require approximately 
17 months from the time that the first subject provides signed informed consent through the 
last subject’s last study-related visit (up to 42 days Screening; treatment in 1-week intervals 
until visual confirmation of necrosis of target lesions; surgical excision of all target and 
nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up 
(F/U) visit at 1- or 2-weeks post excision).  
Duration of participation for an individual subject will depend on assessments of disease and 
tolerability of VP-315, as well as other factors. No subject will be treated for more than 
2 weeks. All lesions will be excised 4 to 6 weeks (Part 1) and 12 to 14 weeks (Part 2) after 
the W1D1 injection.  
Key Subject Eligibility Criteria: Screening: A
 years of age who have clinically 
suspected low-risk BCC with at least 1 eligible lesion suitable for biopsy and excision.
Additionally, to be eligible for participation in the study, subjects are required to have a 
histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or 
shave biopsy) that is suitable for biopsy and excision; all lesion(s) enrolled in the study 
(target and non-target) 
 cm, and 2.0 cm in the longest diameter, may not be 
recurrent or previously treated, and must not be within 1 cm of the eyelids or lips, or on the 
hands, ears, nose, or genitalia.  
Test Product, Dose, and Route of Administration: VP-315 comprises a de novo designed 
oncolytic peptide provided as LTX-315 Acetate 20 mg/vial lyophilized powder for injection 
that can be reconstituted in saline to a concentration ranging from 4 to 16 mg/mL. VP-315 
will be administered via intradermal injection into a single target lesion. In all parts of the 
study, the targeted total volume of delivery is 500 µL daily. In Part 1, the 500-uL dose will 
be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 
30% (150 µL) administered in the first injection and the remaining 70% (350 µL) with the 
second injection. Part 2 (Cohorts 1 and 2) will determine the optimal dosing regimen for an 
8mg dose based on safety, tolerability, and biological response to VP-315. This optimal 
dosing regimen will be used in Part 2 (Cohorts 4 and 5). 
Reference Product, Dose, and Route of Administration: None.
Statistical Considerations: No formal inferential statistical analyses will be performed. Data 
will be summarized using descriptive statistics (number of subjects, mean, median, standard 
deviation, minimum, and maximum) for continuous variables and using frequency and 
percentage for discrete variables. Results will be presented by study period. Data will be 
presented for all subjects in listings. 
An accounting of the study subjects by disposition will be tabulated. Demographic data 
(e.g., age, gender, and race), medical history, cancer history, and other baseline 
characteristics will be summarized. 
Safety Evaluation: The general safety and tolerability of VP-315 will be assessed using the 
following safety endpoints: AEs, DLTs (Part1), TRAE SIs (Part 2), CRAs, routine clinical 
laboratory evaluations (serum chemistry, hematology), serum tryptase levels, vital signs, 
electrocardiograms (ECGs) and physical examination. The incidence (%) of all treatment 
emergent adverse events (TEAEs) will be summarized by body system and preferred term. 


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Incidence rates of TEAEs will also be presented by severity and relatedness to study 
medication. Changes from baseline in vital signs, ECGs and laboratory values will be 
summarized.  
Efficacy Evaluation: Efficacy will be assessed using the following efficacy endpoints: 
clinical clearance, histological clearance, complete clearance, tumor volume estimate, 
abscopal effect, and Physician’s Global Assessment. The number and percentage of lesions 
in each category will be tabulated overall. The number and percent of lesions that achieve 
histological clearance will be displayed. The same analysis will be repeated for the number 
of lesions that achieve clinical clearance. Tumor volume estimates will be summarized using 
descriptive statistics.
Exploratory Evaluation: In Part 2 of the study, the immune response to VP-315 treatment
will be evaluated in a subset of subjects. Tumor tissue samples from the pre-treatment 
screening biopsies and from the post-treatment excised tumor tissue will undergo 
multiplexed IF-IHC and changes in the expression of a panel of 8 immune markers in 
response to the treatment will be analyzed. Additionally, genomic DNA will be isolated from 
the same tissue samples, as well as well as from peripheral blood samples collected at the 
same pre- and post-treatment time points and will undergo sequencing and analyzed for 
changes in T-cell receptor clonality. 
 
 


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TABLE OF CONTENTS
PROTOCOL SIGNATURE PAGE .................................................................................................. 2
SUMMARY OF CHANGES TO THE CLINICAL PROTOCOL...................................................4
1.
PROTOCOL SYNOPSIS .....................................................................................................16
TABLE OF CONTENTS ...............................................................................................................23
List of Tables .................................................................................................................................. 26
List of Figures ................................................................................................................................ 26
List of Appendices .......................................................................................................................... 26
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ...................................... 27
2. 
BACKGROUND AND RATIONALE ................................................................................ 29
2.1 
Disease ........................................................................................................................ 29
2.2 
LTX-315 ..................................................................................................................... 29
2.2.1
Nonclinical Pharmacology ............................................................................... 30
2.2.2
Nonclinical Toxicology and Safety ................................................................. 30
2.2.3
Preclinical Pharmacokinetic Drug Interactions ................................................ 30
2.2.4
Toxicology ....................................................................................................... 31
2.2.5
Summary of Clinical Experience ..................................................................... 31
2.3 
Rationale ..................................................................................................................... 32
2.3.1
Rationale for the Dose Selection ...................................................................... 32
2.3.2
Rationale for the Study Design ........................................................................ 33
3. 
OBJECTIVES ....................................................................................................................... 34
4.
EXPERIMENTAL PLAN....................................................................................................37
4.1
Study Design...............................................................................................................37
4.2
Number of Sites ..........................................................................................................40
4.3 
Estimated Study Duration ........................................................................................... 40
4.3.1
Study Duration for Subjects ............................................................................. 40
4.3.2
End of Study .................................................................................................... 41
5. 
STUDY POPULATION ....................................................................................................... 42
5.1 
Number of Subjects..................................................................................................... 42
5.2 
Subject Inclusion Criteria ........................................................................................... 42
5.3 
Subject Exclusion Criteria .......................................................................................... 43
5.4 
BCC Lesion Eligibility ............................................................................................... 44
5.4.1
BCC Lesion Inclusion Criterion ...................................................................... 44
5.4.2
BCC Lesion Exclusion Criteria ....................................................................... 45


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6. 
SUBJECT ENROLLMENT ................................................................................................. 46
7.
TREATMENT AND TREATMENT PROCEDURES ........................................................47
7.1 
Randomization and Blinding ...................................................................................... 47
7.2 
Description and Handling ........................................................................................... 47
7.2.1
Formulation......................................................................................................47
7.2.2
Storage and Handling ....................................................................................... 47
7.3
Dosage, Administration, and Schedule.......................................................................48
7.3.1
Management of Postinjection Reactions to VP-315 ........................................ 49
7.3.2
VP-315 Dosing Strategy ..................................................................................49
7.4 
Dose Escalation and Stopping Rules .......................................................................... 56
7.4.1
Safety Review Committee ............................................................................... 56
7.4.2
Dose Escalation ................................................................................................ 56
7.4.3
Stopping Rules.................................................................................................57
7.5 
Concomitant Therapy.................................................................................................. 57
7.6 
Treatment Restrictions ................................................................................................ 58
7.6.1
Prohibited Medications .................................................................................... 58
7.6.2
Other Restrictions ............................................................................................ 58
7.6.3
Dietary Restrictions ......................................................................................... 58
7.7 
For Women of Childbearing Potential ........................................................................ 58
8. 
STUDY PROCEDURES ...................................................................................................... 60
8.1 
Screening Assessments ............................................................................................... 60
8.2 
Treatment Period ......................................................................................................... 60
8.3 
End of Study and Follow-up ....................................................................................... 61
8.4 
Safety Assessments ..................................................................................................... 67
8.4.1
Physical Examination....................................................................................... 67
8.4.2
Vital Signs Data ............................................................................................... 67
8.4.3
Electrocardiograms .......................................................................................... 67
8.4.4
Clinical Laboratory Testing ............................................................................. 68
8.4.5
Serum Tryptase Assessment ............................................................................ 68
8.4.6
Cutaneous Reaction Assessment ...................................................................... 69
8.4.7
Pregnancy Testing ............................................................................................ 69
8.4.8
Pharmacokinetic Assessments ......................................................................... 69
8.5 
Pharmacodynamic Assessments and Endpoints ......................................................... 70
8.5.1
Lesion Evaluation ............................................................................................ 70
8.5.2
Lesion Photography ......................................................................................... 70
8.5.3
Subject-reported Outcomes .............................................................................. 71
8.6 
Observer-reported Outcomes ...................................................................................... 71
8.7 
Posttreatment Assessments ......................................................................................... 71
8.8 
Assessment of the Immunological Response to VP-315 Treatment ........................... 72


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8.8.1
Multiplexed Immunofluorescence Immunohistochemistry ............................. 72
8.8.2
Assessment of T-cell Clonality........................................................................72
9. 
REMOVAL AND REPLACEMENT OF SUBJECTS ......................................................... 73
9.1 
Removal of Subjects ................................................................................................... 73
9.2
Replacement of Subjects.............................................................................................73
10.
SAFETY DATA COLLECTION, RECORDING, AND REPORTING .............................. 74
10.1
Adverse Events ........................................................................................................... 74
10.1.1
Definition of Adverse Events...........................................................................74
10.1.2 
Reporting Procedures for Adverse Events ....................................................... 74
10.1.3
Serious Adverse Events ...................................................................................75
10.2
Dose-limiting Toxicity/Treatment-related Adverse Event of Special Interest ............ 77
11.
STATISTICAL CONSIDERATIONS .................................................................................78
11.1
General Considerations ............................................................................................... 78
11.2
Sample Size Considerations ........................................................................................ 78
11.3
Analysis Populations ................................................................................................... 78
11.4
Study Endpoints .......................................................................................................... 79
11.4.1 
Safety Endpoints .............................................................................................. 79
11.4.2 
Efficacy Endpoints ........................................................................................... 79
11.4.3 
Pharmacokinetic Endpoints ............................................................................. 79
11.4.4 
Exploratory Endpoints ..................................................................................... 80
11.5
Analysis Methods ....................................................................................................... 80
11.5.1 
Subject Characteristics and Disposition ........................................................... 80
11.5.2 
Safety Analyses ................................................................................................ 80
11.5.3 
Efficacy Analyses ............................................................................................ 81
11.5.4
Pharmacokinetic Analyses...............................................................................81
12.
ETHICAL, LEGAL AND ADMINISTRATIVE ASPECTS ............................................... 82
12.1
Ethical Conduct of the Study ......................................................................................82
12.2
Informed Consent ....................................................................................................... 82
12.3
Institutional Review Board ......................................................................................... 82
12.4
Subject Confidentiality ............................................................................................... 83
12.5
Investigator Signatory Obligations ............................................................................. 83
13.
ADMINISTRATIVE AND LEGAL OBLIGATIONS ........................................................ 84
13.1
Protocol Amendments and Study Termination ........................................................... 84
13.2
Study Documentation and Archive ............................................................................. 84
13.3
Study Monitoring and Data Collection ....................................................................... 85
13.4
Publication Policy ....................................................................................................... 85
14.
REFERENCES ..................................................................................................................... 86


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15.
APPENDICES ...................................................................................................................... 88
List of Tables 
Table 7-1 Dose Regimen (Part 2 Cohorts 1-5) ............................................................................... 54
Table 8-1 Schedule of Assessments ............................................................................................... 62
Table 8-2 Clinical Laboratory Tests ............................................................................................... 68
List of Figures 
Figure 7-1 Injection Pattern for VP-315 ......................................................................................... 48
Figure 7-2 Dosing Schema, Intra-subject Escalation (Part 1) ........................................................ 53
List of Appendices 
Appendix 1 Cutaneous Reaction Assessment* .............................................................................. 89
Appendix 2 Physician’s Global Assessment .................................................................................. 91
Appendix 3 SCAR-Q ...................................................................................................................... 92
Appendix 4 FACE-Q ...................................................................................................................... 93
Appendix 5 Scar Cosemesis and Rating Scale (SCAR) ................................................................. 94
 


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
Abbreviation or Term
Definition/Explanation 
AE 
adverse event 
BCC 
basal cell carcinoma 
BMI 
body mass index 
BP 
blood pressure
CFR
Code of Federal Regulations
CRA 
Cutaneous Reaction Assessment - also - clinical research associate 
CRF 
case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLT 
dose-limiting toxicity 
ECG 
Electrocardiogram 
eCRF 
electronic case report form 
EOS 
end of study (visit) 
EOT 
end of treatment (visit) 
ET 
early termination (visit) 
F/U 
follow-up (visit) 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
GCP 
gDNA 
Good Clinical Practice 
Genomic deoxyribonucleic acid 
hCG 
beta human chorionic gonadotropin 
HR 
heart rate 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IRB 
Institutional Review Board 
IV 
Intravenous 
MMS 
Mohs micrographic surgery 


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Abbreviation or Term
Definition/Explanation
MTD 
maximum tolerated dose 
NCI
National Cancer Institute
NMSC 
nonmelanoma skin cancer 
NOAEL
no observable adverse effect level(s)
Nontarget Lesion 
Nontreated Lesion 
PGA 
BCC lesion to be observed for abscopal effect 
Target lesion that was not treated with VP-315 
Physician’s Global Assessment 
PK 
pharmacokinetic(s)  
PPS
per-protocol analysis set
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SCAR 
SCAR-Q 
The Scar Cosmesis Assessment and Rating (SCAR) Scale 
Scar Cosmesis Assessment and Rating Questionnaire 
SRC 
Safety Review Committee 
Target Lesion 
Treated Lesion
TEAE 
BCC lesion identified for treatment 
Target lesion that was treated with VP-315 
treatment-emergent adverse event 
TRAE 
TRAE SI 
treatment-related adverse event 
treatment-related adverse event of special interest 
US 
United States 
W1D1 
Week 1/Day 1 
WFI 
water for injection 


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2. 
BACKGROUND AND RATIONALE
2.1 
Disease
Skin cancer is the most commonly diagnosed cancer in the United States (US), with 
nonmelanoma skin cancer (NMSC) being the most common malignancy in the US 
[Karimkhani, 2015] [Madan, 2010]. National incidence estimates based on the most recent 
year that new statistics were available (2012) estimated more than 5.4 million cases of 
NMSC were treated in more than 3.3 million people in the US, exceeding the number of all 
other cases of human malignancies combined [Rogers, 2015; AAD, 2020; Skin Cancer 
Foundation, 2021]. Data from the Medical Expenditure Panel Survey estimated an annual 
increase in treatment for NMSC (2002 to 2011) in US adults from 3.1 to 4.3 million 
[Guy, 2015].  
Current estimates show that the approximately 80% of NMSC cases occur in people 
 years of age, and that the number of cases in this population could increase by an 
estimated 50% by 2030, illustrating the significant worldwide healthcare burden of NMSC, 
particularly in light-skinned populations [Diffey, 2005] [Karimkhani, 2015]. Similar 
increases in basal cell carcinoma (BCC) incidence rates have been shown in other studies 
[Sveinbjørnsson, 2017] [Wu, 2013] [Goldenberg, 2016] [Adalsteinsson, 2020].
While skin cancers have a low mortality, the average annual total cost for skin cancer 
increased from 2006 to 2011 by 126.2%, from $3.6 billion to $8.1 billion [Guy, 2015].
Surgery is the most common treatment for BCC and includes procedures such as excision, 
curettage and electrodesiccation, and Mohs micrographic surgery (MMS). Both excision and 
curettage leave scarring of the treatment area; MMS aims to reduce scarring, particularly in 
treatment areas near the eye or other areas of the face, but is a complex, protracted surgery 
requiring specialized training.  
2.2 
LTX-315 
LTX-315 is a de novo designed oncolytic peptide being developed as a chemotherapeutic. 
LTX-315 is generated from the host-defense peptide lactoferricin. Host-defense peptides are 
present in almost every life form and are an integrated part of the eukaryotic immune system 
mounting a first-line defense against pathogens. These peptides can have both a direct killing 
activity and immunomodulatory properties [Hancock, 2001]. Several cationic host-defense 
peptides have shown anticancer activity due to their ability to bind to negatively charged 
membrane components on cells via electrostatic interactions [Zasloff, 2002] [Papo, 2005]. 
Extensive structure-activity relationship studies on peptides derived from the host-defense 
peptide lactoferricin has enabled the de novo design of LTX-315, in which the features 
important to oncolytic activity have been optimized.  
LTX-315 was designed to enhance the cytolytic activity of naturally occurring host-defense 
peptides, subsequently inducing lysis and cell death at high local concentration 
[Forveille, 2015]. LTX-315 induces immunogenic cell death, killing the cells in a manner 
that activates the adaptive immune system. A tumor-specific immune response is activated 
due to an effective release of potent immune stimulants (i.e, danger signals) and a broad 


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repertoire of tumor antigens [Sveinbjørnsson, 2017] [Jebsen, 2019] [Liao, 2019] 
[Nestvold, 2017] [Camilio, 2014] [Spicer, 2021].  
LTX-315 is in development by Lytix Biopharma AS as a potential anticancer agent for 
treatment of malignancies where at least 1 lesion is available for local injection; to date, 
3 clinical trials in subjects with end-stage cancer have been concluded. A trial that has 
recently completed enrollment (NCT03725605) is evaluating LTX-315 induction of T-cell 
infiltration in patients with advanced/metastatic soft tissue sarcoma, and a trial evaluating 
LTX-315 in combination with pembrolizumab in patients with percutaneously accessible 
advanced solid tumors (NCT04796194) is currently enrolling.  
Verrica is developing LTX-315 for dermatologic oncology indications with the first target 
indication being BCC under the name VP-315.
Additional information on preclinical studies may be found in the Investigator’s Brochure. 
2.2.1 
Nonclinical Pharmacology 
The nonclinical pharmacology data obtained for the oncolytic peptide LTX-315 supports its 
use as a locally injected agent for the treatment of solid tumors. LTX-315 has shown potent 
activity against multiple cancer cell lines, and pharmacodynamic studies of intratumoral 
injections have demonstrated prolonged local antitumor effects of complete response and 
transfer of protection from treated to untreated mice.  
2.2.2 
Nonclinical Toxicology and Safety 
LTX-315 was designed to be administered to tumors accessible for injection in the clinic. 
A cyclical regimen was used to cover repeat dosing. Although no observable adverse effect 
levels (NOAELs) could be determined due to the pharmacological action of the compound, 
these studies generated data that assisted in the selection of a tolerable clinical starting dose. 
Based on observations in rats and dogs, an acute reduction in mean arterial pressure was 
observed after intravenous (IV) administration and likely resulted from vasodilation in 
peripheral circulation with a decrease in total vascular resistance and was not considered to 
be a direct cardiac effect. In vitro studies evidenced that this transient hemodynamic effect 
may be caused by interaction between LTX-315 and the MRGX2 receptor on mast cells 
affecting peripheral blood pressure (BP) by histamine release.  
2.2.3 
Preclinical Pharmacokinetic Drug Interactions 
The inhibitory effect of LTX-315, at concentrations up to 100 µM, on the catalytic activity of 
the 9 major human CYP450 isozymes was investigated in vitro using pooled human liver 
microsomes and isozyme-specific probe substrates [R315-24]. The inhibition profile of 
LTX-315 was assessed using both a 5- and 30-minute preincubation period to ascertain 
whether any inhibition observed was reversible (direct competitive) or irreversible 
(mechanism-based or time-dependent). LTX-315 caused direct inhibition of all CYP450 
isozymes to some extent with IC50 values ranging from approximately 7 to 38 µM. The most 
marked inhibition was observed with CYPs 2A6, 2C8, 2C9, and 3A4 (testosterone) where 
IC50 values were all between 7 and 10 µM. There was little or no evidence for irreversible 


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CYP450 inhibition following a 30-minute preincubation. The greatest reduction in IC50 was 
observed with CYP2B6, where IC50 values of 28 and 19 µM, following a 5- or 30-minute 
preincubation respectively, indicating that some mild time-dependent inhibition was a 
possibility. In many cases, the IC50 increased following 30 minutes preincubation, suggesting 
either instability of LTX-315 in the incubation conditions, or metabolism to a less inhibitory 
metabolite. Based upon these results, it is considered unlikely that LTX-315 would 
participate in, or contribute to, inhibitory drug-drug interactions in vivo which are mediated 
by CYP450-dependent metabolism. 
2.2.4 
Toxicology 
The maximum tolerated IV dose was 2 mg/kg in the rat (equivalent to a human dose of 
0.324 mg/kg) and was limited by the local reaction at the injection site. In the dog, the 
maximum tolerated IV dose was considered to be 1.25 mg/kg based on vital clinical signs. 
The maximum tolerated concentration of LTX-315 in normal skin was determined to be 
5 mg/mL in the rat and 10 mg/mL in dog, with maximum dose volumes of approximately 
0.75 mL/injection site in rat (3 mL/kg) and approximately 2.5 mL/injection site in dog 
(0.25 mL/kg). 
2.2.5 
Summary of Clinical Experience 
LTX-315 has not previously been evaluated in BCC. Two Phase 1 studies have been 
concluded (C08-315-01, C09-315-02 as well as a Phase I/II (C12-315-03); these studies 
evaluated the efficacy, safety, and pharmacokinetics (PK) of LTX-315 injection at varying 
dose strengths in subjects with tumors accessible for percutaneous injection, including those 
located in cutaneous, subcutaneous, oral regions, and in lymph nodes. Overall, the antitumor 
activity (tumor necrosis) of LTX-315 was observed in a number of subjects, showing marked 
tumor regression in both the injected and noninjected lesions. The immune analysis of tissue 
samples (C12-315-03) clearly demonstrated that LTX-315 has the ability to invoke necrosis, 
stimulate clonal T-cell expansion, and increase the repertoire of activated and targeted 
T cells, both within the injected tumors and in the peripheral blood [Spicer, 2021]. 
The most frequently reported adverse events (AEs) in these initial clinical studies were 
hypersensitivity related reactions that included flushing, fatigue, hypersensitivity, and 
injection-site swelling, particularly when LTX-315 was administered at dosages above 8 mg 
as a single injection. In subjects with cutaneous, subcutaneous, oral, or lymph node lesions, 
including highly vascularized locally advanced or metastatic tumors, hypersensitivity-related 
AEs leading to discontinuation were noted. Discontinuations in response to hypersensitivity-
related AEs, however, were eliminated following amendment of the study protocols to reduce 
the maximum dose to 5 mg per injection and to limit the duration of treatment to 3 weeks. 
Additional information on clinical studies may be found in the Investigator’s Brochure. 


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2.3 
Rationale
2.3.1 
Rationale for the Dose Selection
The starting dose of VP-315 for this study was selected based on IND-directed toxicity 
studies and on experience gained from previous clinical studies of LTX-315 in adults with 
solid tumors. Although no NOAEL could be determined in toxicology studies due to the 
pharmacological action of the compound, these studies have generated data which assist in 
the selection of a tolerable clinical starting dose.
In the Phase 1 monotherapy dose-escalation study (C08-315-01), 14 subjects received 
injections of intratumoral LTX-315 at doses ranging from 1.4 mg to 9.0 mg on Day 1. Grade 
2 AEs were not noted at doses below 4.0 mg on Day 1, a determinative factor in the proposed 
LTX-315 starting total daily dose of 2.0 mg in the current study. Additionally, BCC lesions 
are expected to be less vascularized than the malignancies injected to date, which is also 
expected to further reduce systemic effects.  
In C08-315-01, at LTX-315 doses below 4.0 mg, the AEs occurring on Day 1 had a short 
duration (minutes), and at all doses became less severe and of shorter duration with 
additional LTX-315 exposure. Similarly, preclinical testing (IV administration in rats) 
indicates that LTX-315–related hypotension is a result of a direct effect on peripheral 
vasculature (without any central cardiac effect) and exhibits a tachyphylaxis effect (i.e., the 
largest reduction in BP occurs following the first LTX-315 dose; subsequent identical 
LTX-315 doses resulted in diminished BP reductions). For these reasons, the proposed total 
daily dose of VP-315 will be administered in 2 injections, with the initial 30% (150 µL) of 
the VP-315 dose being administered in the first injection, and the remaining 70% (350 µL) 
administered at least 15 minutes and no more than 30 minutes later. In all parts of the study, 
the targeted total volume of delivery is 500 µL daily. The Safety Review Committee (SRC; 
see Section 7.4.1) may determine in Part 2 to explore a lower volume of delivery at 250 µL 
daily at doses at or below 5.0 mg delivered as 75 µL in the first dose and 175 µL in the 
second dose.  
For Part 1 of this study, the highest proposed total daily dose of VP-315(8.0 mg), is broken 
into two administrations at least 15 minutes apart (not to exceed 30 minutes), with the first 
dose not to exceed 2.4 mg (30% of 8-mg dose), and the remaining dose will not exceed 
5.6 mg (70% of 8-mg dose); both doses are well below the historical 8 mg maximum 
tolerated dose (MTD). Therefore, the maximum dose of VP-315 in the proposed study 
(8.0 mg) and maximum concentration (16.0 mg/mL) should be well within the safety limits 
established in the previous Phase 1 monotherapy study. 
For Part 2 (Cohorts 4 and 5) the highest total daily dose of VP-315 (8.0 mg) will be divided 
into a split dose; the first dose is not to exceed 2.4 mg (30% of 8-mg dose), and the 
remaining dose will not exceed 5.6 mg (70% of 8-mg dose) and administered 15 minutes 
apart (not to exceed 30 minutes). This dosing strategy was selected as a recommendation 
from the Safety Review Committee following an adhoc safety review meeting held on June 
13-14, 2023 to discuss subjects reports of pain and burning at the injection site that were not 
observed in Part 1 of the study: 


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Remove/skip Cohort 3 in Part 2 of the protocol and advance from Cohort 2 to Cohorts 
4 and 5.  Revert to Part 1 dosing strategy of a 30/70 split dose with the injections 
adminstered 15-minutes apart. 
2.3.2 
Rationale for the Study Design 
LTX-315 has not previously been evaluated in BCC. While the dose has been established for 
malignant tumors, a safe and efficacious dose has not been established in otherwise healthy 
subjects, for whom the alternative treatment for BCC would be surgical excision. Therefore, 
a safety run-in to confirm the appropriate dose range will be conducted as part of the current 
study. 
The current study comprises 2 parts. Part 1 is designed to explore the initial VP-315 safety 
profile when administered in escalating doses to individual subjects with BCC, starting at 
2 mg and ending at a maximum of 8 mg total daily dose to a single lesion. This strategy is 
intended to quickly assess the MTD and gain preliminary assessment of VP-315 induction of 
clinical and histological necrosis of each treated lesion while seeking to establish an AE 
profile for BCC. Centralized photography and Cutaneous Reaction Assessment (CRA) by the 
investigator will be used to document BCC response to VP-315. 
During Part 1 of the study, no DLTs were reported, and escalation up to 8 mg total daily dose 
(the maximum dose for this study) was achieved. Therefore, Part 2 is designed to determine 
the optimal dosing regimen using 8 mg of VP-315 identified in Part 1 and confirm the 
optimal dosing regimen determined from Cohorts 4 and 5 to be used in the pivitol trial. 
Pharmacokinetic data will be collected to characterize the PK of an 8 mg dose of VP-315 
administered with the optimal dosing regimen in Part 2 (Cohorts 4 and 5 expansion group).


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3. 
OBJECTIVES
In this 2-part study, the following objectives and endpoints will be evaluated when 
-proven BCC:
Part 1
Primary Objectives
Endpoints
 
To assess the safety, tolerability, and MTD 
of ascending dose strengths of VP-315  
Discontinuations due to AEs; occurrence of 
DLTs
CRA 
Exploratory Objectives 
Endpoints 
 
To evaluate the objective antitumor efficacy 
of VP-315 
Histological clearance of treated lesion(s) at 
excision
Clinical clearance of treated lesion(s) at 
excision as determined by visual assessment 
(no tumor seen upon visible inspection) 
Estimate of remaining tumor volume 
(necrotic cells:tumor cells) at excision 
Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision 
PGA 
Part 2 (Cohorts 1 and 2) 
Primary Objectives 
Endpoints 
 
To determine the optimal regimen for 
dosing 8 mg of VP-315 based on safety and 
tolerability 
Treatment-related AEs; treatment-related 
serious adverse events (SAEs); 
discontinuations due to AEs; occurrence of  
TRAEs of special interest 
CRA
Secondary Objectives 
Endpoints 
 
To evaluate the antitumor efficacy of VP-
315 
Clinical clearance of treated lesion at 
excision as determined by visual assessment 
(no residual tumor seen on visual 
inspection) 
Histological clearance of target lesion(s) at 
excision
Abscopal effect as determined by clinical 
and histological clearance of non-target 
lesions at excision 
Estimate of remaining tumor volume 
(necrotic cells:tumor cells) at excision 
PGA 


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Exploratory Objectives
Endpoints
 
To assess the immune response to VP-315 
treatment in a subset of subjects by 
assessing the immune repertoire in blood 
and in tissue  
Multiplex immunohistochemical staining 
for T-cell subsets and immune activation 
markers in tumor tissue sample 
Analysis of T-cell clonality in blood and 
tumor tissue samples 
To assess subject  satisfaction with the 
treatment 
SCAR-Q, FACE-Q
Part 2 (Cohorts 4 and 5) 
Primary Objectives
Endpoints
 
To gain additional information on the 
safety, tolerability and dosing regimen of 
VP-315 to support a pivotal study protocol 
design  
Treatment-related AEs; treatment-related 
serious adverse events (SAEs); 
discontinuations due to AEs; occurrence of 
TRAEs of special interest 
CRA 
Secondary Objectives 
Endpoints 
 
To confirm the antitumor efficacy of VP-
315 using the optimal dosing regimen 
determined in Part 2 
Clinical clearance of treated lesion at 
excision as determined by visual assessment 
(no residual tumor seen on visual 
inspection) 
Histological clearance of treated lesion(s) at 
excision
Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision 
Estimate of remaining tumor volume 
(necrotic cells:tumor cells) 
PGA 
 
To characterize the pharmacokinetics (PK) 
of an 8 mg dose of VP-315 administered 
with the optimal dosing regimen  
Plasma VP-315 concentrations 


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Exploratory Objectives
Endpoints
 
To assess subject and physician satisfaction 
with the treatment 
SCAR-Q, FACE-Q 
Scar Cosmesis Assessment and Rating
(SCAR) Scale  
To assess the immune response to VP-315 
treatment in a subset of subjects by 
assessing the immune repertoire in blood 
and in tissue 
Multiplex immunohistochemical staining 
for T-cell subsets and immune activation 
markers in tumor tissue samples 
Analysis of T-cell clonality in blood and 
tumor tissue samples 


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4. 
EXPERIMENTAL PLAN 
4.1 
Study Design 
This is a 2-part, open-label, multicenter, proof-of-concept study with a safety run-in designed 
to assess the safety, tolerability, MTD, and objective antitumor efficacy of VP-315 when 
administered intratumorally to adults with biopsy-proven BCC.  
The study is expected to enroll approximately 80 subjects with a histological diagnosis of 
BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).  
All enrolled subjects will receive VP-315 intradermal injection on an outpatient basis into up 
to 2 target lesions. In all Parts of the study (1, or 2, as below), each 7-day treatment week 
comprises up to 3 consecutive treatment days followed by a no-treatment period of at least 
4 days. Dosing will commence in a single target lesion. In Study Part 1 and Study Part 2 
(Cohorts 1-2), once a target lesion has necrosed, treatment of that lesion stops, and treatment 
of subsequent target lesions (up to 2 total) may continue on Day 1 of the following week 
(week 2) (see Section 7.3.2). 
Part 1 (N= 2 to 8): VP-315 once-daily dosing; starting total daily dose of 2 mg for the first 
subject. Ascending once-daily 1-mg dosing increments (e.g., 2 mg on 
Day 1, 3 mg on Day 2). Subjects may be treated for a maximum of 
2 weeks and a maximum total daily dose of 8 mg in Part 1. The starting 
dose will be escalated between subject cohorts in 1-mg increments after 
the previous cohort has completed Week 1 dosing (the DLT observation 
period) (Table 7-1).  
Part 2 (N= Approximately 66 to 72): VP-315 once-daily dosing; will be a total daily dose of 
8 mg in up to 5 cohorts (i.e, there were no DLTs that occurred during 
Part 1 of the study and the maximum dose of 8 mg was achieved).  
Cohort 1 (N=3 to 6): VP-315 once-daily dosing of 8 mg with a 
loading dose of half the target dose of 8 mg (i.e., 4 mg) only on 
W1D1; the remaining 2 doses in the first treatment week (up to 
3 consecutive daily doses) will be the full target dose of 8 mg 
without a loading dose. Subjects will be treated until the lesion is 
necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and 
W2D1, W2D2, W2D3- up to 6 total doses). 
 Cohort 2 (N=3 to 6): VP-315 once-daily dosing of 8 mg on all 
treatment days (i.e., NO LOADING dose on W1D1) for up to 
3 consecutive daily doses/week until the lesion is necrosed, for a 
maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, 
W2D3- up to 6 total doses).  


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The study design and dosing strategy listed below for Cohorts 3, 4 and 5 are 
recommendations from the Safety Review Committee following an adhoc safety review 
meeting held on June 13-14, 2023 to discuss subjects reports of pain and burning at the 
injection site that were not observed in Part 1 of the study: 
 Recommendation: Remove/skip Cohort 3 in Part 2 of the protocol and advance 
from Cohort 2 to Cohorts 4 and 5.  Revert to Part 1 dosing strategy of a 30/70 
split dose for all treatments with the injections adminstered 15-minutes apart. 
Cohort 3: (N=0): This cohort has been removed at the recommendation of the SRC. 
For Part 2 (Cohorts 4 and 5) the highest total daily dose of VP-315 (8.0 mg) will be divided 
into a split dose; the first dose is not to exceed 2.4 mg (30% of 8-mg dose), and the 
remaining dose will not exceed 5.6 mg (70% of 8-mg dose) and administered 15 minutes 
apart (not to exceed 30 minutes). 
 Cohort 4 (N= Approximately 30 (10 initial/up to 20 expansion): 
(Two times weekly dosing) VP-315 once-daily dosing of 8 mg, 
administered 2 consecutive days in one week (W1D1, W1D2). The 
planned dosing regimen will be a split dose of VP-315 for all 
treatments. The 500µL (8 mg) dose will be divided into 2 injections 
given at least 15 minutes and no more than 30 minutes apart, with 
30% (150 µL) administered in the first injection and the remaining 
70% (350 µL) with the second injection. Treatment for a second 
target lesion may begin on D1 of the next week (W2D1, W2D2). 
Each individual target lesion is treated for the assigned 2 days only 
(regardless of necrosis status). Up to 2 target lesions may be treated 
– up to 4 total doses.
 Cohort 5 (N= Approximately 30 (10 initial/up to 20 expansion): 
(Three times weekly dosing) VP-315 once-daily dosing of 8 mg, 
administered 3 consecutive days in one week (W1D1, W1D2, 
W1D3). The planned dosing regimen will be a split dose of VP-315 
for all treatments. The 500µL (8 mg) dose will be divided into 
2 injections given at least 15 minutes and no more than 30 minutes 
apart, with 30% (150 µL) administered in the first injection and the 
remaining 70% (350 µL) with the second injection. Treatment for a 
second target lesion may begin on D1 of the next week (W2D1, 
W2D2, W2D3). Each individual target lesion is treated for the 
assigned 3 days only (regardless of necrosis status). Up to 2 target 
lesions may be treated – up to 6 total doses.
See (Table 7-1).  
The decision to initiate the next higher dose in Part 1 will be made by an SRC (described in 
Section 7.4) on the basis of a review of all safety data, and laboratory findings.


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Subjects will be screened within 42 days prior to receiving the first dose of VP-315 (biopsy 
may be collected within 90 days of W1D1); procedures are described in Table 8-1. On 
W1D1, after completion of all predose procedures, study subjects will receive the first dose 
of VP-315. Thereafter, each subject in Part 1 and Part 2 (Cohorts 1and 2) will be dosed every 
day until necrosis of the target lesion for up to 3 consecutive days before entering the no-
treatment period. Once a target lesion has necrosed, treatment of that lesion stops, and 
treatment of any subsequent target lesions (up to 2 total) may continue on Day 1 of the 
following week (see Section 7.3.2).  
In Part 1, DLT or visual confirmation of necrosis of all target lesions will result in 
termination of VP-315 dosing. 
In Part 2 (Cohorts 1and 2) will determine the optimal dosing regimen based on efficacy, 
safety and tolerability. In Cohorts 4 and 5, the optimal dosing regimen (as determined from 
Cohorts 1 and 2 or Part 1) will be administered in up to 2 target lesions on either 2 or 3 
consecutive days, respectively, regardless of whether necrosis occurs.  
Subjects in Part 2 (Cohorts 4 and 5) with only 1 target lesion, that complete week one of 
treatment and the W1 safety assessment visit without complete necrosis, should return for a 
Limited Safety Assessment Visit on W2D1 for further evaluation of the lesion for necrosis.  
No additional treatment will be provided. 
Subjects in Part 2 (all Cohorts) that complete week two of treatment and the W2 Safety 
Assessment Visit without complete necrosis, should return for a Limited Safety Assessment 
visit on W3D1 for further evaluation of the lesion for necrosis. No additional treatment will 
be provided. 
For the first 10 subjects enrolled into Part 2 (Cohorts 4 and 5): after each treatment, subjects 
will remain in the study center for up to 2 hours post second injection for safety monitoring 
(e.g., continuous blood pressure, electrocardiographic and AE monitoring).
Following the final treatment of the 10th subject in Cohort 4, enrollment into Cohort 5 may be 
initiated for 10 subjects.  
Cohort 4 expansion group:
An SRC meeting was convened after the 10 subjects in Cohort 4 completed the Safety 
Assessment and approved the following: 
Up to 20 additional subjects (for a total of approximately 30 subjects) will be 
enrolled into Cohort 4. 
After each treatment, the additional subjects enrolled into Cohort 4 expansion: 
will remain in the study center for up to 1-hour (reduced from 2-hours) post 
second injection for safety monitoring (e.g., continuous blood pressure, 
electrocardiographic and AE monitoring), an additional hour may be 
continued at the discretion of the PI. 
Cohort 5 expansion group: 
An SRC meeting was convened after the 10 subjects in Cohort 5 completed the Safety 
Assessment and approved the following: 


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Up to 20 additional subjects (for a total of approximately 30 subjects) will be 
enrolled into Cohort 5. 
After each treatment, the additional subjects enrolled into Cohort 5 expansion: 
will remain in the study center for up to 1-hour (reduced from 2-hours) post 
second injection for safety monitoring (e.g., continuous blood pressure, 
electrocardiographic and AE monitoring), an additional hour may be continued at 
the discretion of the PI. 
 
Plasma PK sampling will be collected in subjects in Part 2 (Cohorts 4 and 5 expansion group)
as detailed in Table 8-1.
Four to 6 weeks in Part 1, and 12 to 14 weeks (Part 2) after the first injection of VP-315, 
subjects will return for all target and nontarget BCC lesions (Section 5.4) to be excised for 
histological evaluation. If the lesion(s) has clinically cleared, the area where the lesion was 
will be excised, and tissue samples will be sent to the central dermatopathologist for 
analysis/histology. Suture removal and final photography should occur 7 (±1) or 14 (±2) days 
after excision (7 days on the face and 14 days on the body). Subjects with excised lesions on 
both the face and the body will be required to complete 2 end-of-study (EOS) visits 
accordingly. 
During the study period, subjects will be expected to visit the study facility and complete 
study procedures as outlined in the schedule of assessments (Table 8-1). 
If there is a clinically significant AE or abnormal laboratory result at the EOS visit, follow-up 
(F/U) visits may be required until resolution of the abnormality, or until the condition is 
considered clinically stable. 
4.2 
Number of Sites 
There will be up to 15 study sites in the US that will participate in this study.  
4.3 
Estimated Study Duration 
4.3.1 
Study Duration for Subjects 
The treatment duration for each subject is variable—each subject will receive VP-315 for up 
to a maximum of 2 weeks. In Part 1, in the event of DLT or necrosis of all target lesions, 
treatment will be stopped.  
All lesions will be excised 4 to 6 weeks (Part 1) and 12 to 14 weeks (Part 2) after the W1D1 
injection. The study duration for each subject is variable as a subject may require F/U visit at 
1- or 2- weeks post-excision. 
The study will require approximately 17 months from the time that the first subject provides 
signed informed consent through the last subject’s last study-related visit (up to 42 days 
Screening; treatment in 1-week intervals until visual confirmation of necrosis of target 
lesions; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 
14 weeks (Part 2) after W1D1 injection; F/U visit at 1 or 2 weeks post-excision). 


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4.3.2 
End of Study
Surgical excision of all target and nontarget BCC lesions will occur 4 to 6 weeks (Part 1) and 
12 to 14 weeks (Part 2) after the W1D1 injection, and a F/U visit will take place 1- or 
2- weeks post-excision (EOS visit). Suture removal and final photography should occur 
7 (±1) or 14 (±2) days after excision (7 days on the face and 14 days on the body). Subjects 
with excised lesions on both the face and the body will be required to complete 2 EOS visits 
accordingly. Scar Cosmesis Assessment and Rating (SCAR) Scale will be completed by the 
site investigator prior to excision at the EOS Visit (Part 2: Cohorts 4 and 5). 


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5. 
STUDY POPULATION 
Before any study-specific procedure may be performed, the appropriate written informed 
consent must be obtained (see Section 12.2).
Investigators will be expected to maintain a screening log in the electronic CRF of all 
potential study candidates who sign the informed consent form (ICF) that includes limited 
information about the potential candidate (age, gender, race), date, and outcome of the 
screening process (e.g., enrolled into study, reason for ineligibility, or refused to participate). 
5.1 
Number of Subjects
Safety Run-in (Part 1 of the Study) 
Approximately 2-8 subjects with a histological diagnosis of BCC will be enrolled for 
treatment with VP-315 in Part 1.
Dosing Regimen Optimization and Confirmation (Part 2 of the Study) 
Approximately 66-72 subjects with a histological diagnosis of BCC will be enrolled for 
treatment with VP-315 in Part 2.
5.2 
Subject Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in 
this study: 
7. A
8. Clinically suspected BCC with at least 1 (and up to 5) eligible lesion(s) suitable for 
biopsy and excision (see Section 5.4)
9. Willing to refrain from using nonapproved topical agents on, or within 2 cm of, the 
target BCC lesions and surrounding areas during the treatment period. Subjects 
should use topical agents that are gentle (e.g., Aquaphor®, CeraVe®) and will not 
irritate the skin in these areas 
10. Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the 
use of tanning parlors for the duration of the study 
11. Written informed consent obtained, including consent for tissue to be examined by 
the central dermatopathologist and stored by the Sponsor or designee 
12. Willing to undergo BCC surgical excision procedure of target and nontarget BCC 
lesions after study treatment
13. Willing to delay surgical excision of target and nontarget BCC lesions until the end of
treatment (EOT) visit 


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14. Provides written consent to allow photographs of the target and nontarget BCC lesion 
to be used as part of the study data 
15. Willing to practice a highly effective method of birth control while on study and until 
4 weeks after the last treatment. Highly effective birth control includes sexual 
abstinence, vasectomy, bilateral tubal ligation/occlusion, or a condom with 
spermicide (men) combined with hormonal birth control or intrauterine device in 
women. 
 
5.3 
Subject Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1. Presence of known or suspected systemic cancer 
2. Treatment with systemic chemotherapeutic agents within the 6 months prior to the 
screening visit
3. Treatment with systemic immunotherapy, immunomodulators or 
immunosuppressants within the 12 weeks prior to the screening period 
4. Genetic or nevoid conditions (e.g., Gorlin / basal cell nevus syndrome, xeroderma 
pigmentosum 
5. Clinically significant laboratory values, as assessed by the investigator, for the tests 
listed in the Schedule of Assessments, including: 
a. serum creatinine >1.5× the upper limits of normal and  
b. serum tryptase concentration >11.4 ng/mL  
6. Chronic medical condition such as, but not limited to:
a.
Uncontrolled infection or infection requiring antibiotics 
b. Uncontrolled cardiac failure: Classification III or IV New York Heart Association 
c.
Subjects presenting  with a systolic BP <110 mmHg and/or diastolic BP <70 mmHg at 
Screening or Week 1 Day 1 or a history of cerebrovascular or cardiac disorders, or 
subjects at particular risk of sequelae following a short hypotensive episode.  
d. Uncontrolled systemic or gastrointestinal inflammatory conditions 
e.
Known bone marrow dysplasia
f. History of positive tests for human immunodeficiency virus/acquired 
immunodeficiency syndrome or active hepatitis B or C
g. History of systemic autoimmune disease requiring anti-inflammatory or 
immunosuppressive therapy within 3 months prior to Day 1, with the following 
exceptions:  
i. Subjects with a history of autoimmune thyroiditis are eligible provided the 
subject requires only thyroid hormone replacement therapy and disease has 


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ii. Subjects with well-controlled type I diabetes (in the opinion of the 
investigator) are eligible 
h. Known mast cell activation syndrome, mastocytosis, or chronic idiopathic 
urticaria 
7. Known sensitivity to any of the ingredients in the study medication 
8. Elective surgery within 4 weeks prior to the screening visit, during the study, or 
4 weeks after the treatment period
9. Evidence of current chronic alcohol or drug abuse 
10. Current enrollment in an investigational drug or device study or participation in such 
a study within 4 weeks of the screening visit
11. In the investigator’s opinion, evidence of unwillingness, or inability to follow the 
restrictions of the protocol and complete the study 
12. Females who are pregnant or breastfeeding.
5.4 
BCC Lesion Eligibility
Eligible lesions are those that meet the BCC lesion eligibility specifications described herein, 
from samples that are either from: 
 HISTORICAL punch or shave biopsies (i.e., samples collected according to clinical 
standard of care collected within the 90 days prior to W1D1);  
 A 2-mm punch biopsy collected within 90 
 cm 
to 1.0 cm, and 3-mm punch biopsy for suspected BCC >1.0 cm to 2.0 cm; or  
 A shave biopsy performed according to standard of care to include superficial or 
middle papillary dermis collected within 90 days of W1D1. 
Lesions must meet the following criteria to be eligible for treatment with VP-315 as target 
lesions or for observation as nontarget lesions. Up to 2 target lesions may be treated, and any 
eligible lesions that do not receive treatment (up to 3) will be tracked as nontarget lesions for 
abscopal effect.  
Lesions that meet the inclusion criteria and are only excluded by Criteria 6 through 9 in 
Section 5.4.2 below (TARGET LESION EXCLUSION) may be tracked as nontarget lesions. 
Lesions that do not meet the inclusion criteria or are excluded by BCC Lesion Exclusion 
Criteria 1 through 5 below will not be treated or observed (i.e., ineligible) and should be 
excised after completion of the study unless otherwise clinically indicated.  
5.4.1 
BCC Lesion Inclusion Criterion 
1. For punch biopsies: the size of the lesion(s) must be 
 cm and 2 cm in the longest 
diameter prior to punch biopsy. 


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2. Histological diagnosis of nodular, micronodular, or superficial BCC, as confirmed by 
punch or shave biopsy performed within 90 days of W1D1. (NOTE: HISTORICAL 
punch or shave biopsies are acceptable, provided that the biopsy was performed 
according to clinical standard of care and was collected within the 90 days prior to 
Screening W1D1.) 
5.4.2 
BCC Lesion Exclusion Criteria 
1. Recurrent or previously treated lesions
2. Lesions within 1 cm of the eyelids or lips, or on the hands, feet, ears, nose, and 
genitalia 
3. Histological evidence of any other tumor in the biopsy specimen
4. Histological evidence of infiltrative, desmoplastic, sclerosing, or morpheaform BCC 
subtypes in the biopsy specimen  
5. Medium- and high-risk basal cell carcinomas as defined by the National 
Comprehensive Cancer Network (NCCN) or Mohs Appropriate Use Criteria 
(i.e., BCCs eligible for Mohs surgery).
TARGET LESION EXCLUSION ONLY:
6. For subjects with severe stasis dermatitis, target BCC lesions may not be on the lower 
extremities
7. Within 2 cm of the target BCC lesion(s):  
a. Treatment with the following topical agents within the 12 weeks prior to the 
screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids, diclofenac, 
imiquimod, ingenol mebutate 
b. Treatment with surgical excision, or curettage within the 2 weeks prior to the 
screening visit  
c. Evidence of dermatological disease or confounding skin condition that may 
interfere with clinical evaluation (i.e., psoriasis, atopic dermatitis, eczema, 
propensity to form keloids or hypertrophic scarring)  
d. Use of topical immunomodulators during study 
8. Within 5 cm of the target BCC lesion(s): history of any skin cancer, except for other 
currently identified target and nontarget BCC lesions  
9. Target BCC lesion is in the area of prior resurfacing procedure with CO2 laser or any 
photodynamic and phototherapy treatment within the 3 months prior to the screening 
visit.


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6. 
SUBJECT ENROLLMENT 
It is the responsibility of the investigator to ensure that subjects are eligible to participate in 
the study prior to enrollment and throughout the study.  
Approximately 80 adult subject
 years of age will be enrolled into the study. 
Before subjects begin participation in any study-specific activities/procedures, the Sponsor 
requires a copy of the site’s written Institutional Review Board (IRB) approval of the 
protocol, ICF, and all other subject information and/or recruitment material, if applicable. All 
subjects and/or legally acceptable representatives must personally sign and date the ICF 
before commencement of study-specific activities/procedures.  
When the investigator determines that the subject meets all of the inclusion criteria 
(Section 5.2) and none of the exclusion criteria (Section 5.3), confirmation of eligibility and 
the date of confirmation is recorded in the subject’s medical record and in/on the enrollment 
electronic case report form (eCRF). 
Each subject who enters into the screening period for the study (defined as the point at which 
the subject provides written informed consent) receives a unique identification number 
before any study procedures are performed. 
Subjects who meet the eligibility requirements for entry into this open-label study 
(Section 5.2 and Section 5.3) will be sequentially enrolled, with each subject receiving the 
next available subject number (beginning with 001). Enrolled subjects will receive study 
drug on Day 1 in accordance with the study treatments described in Section 4.1 (Figure 7-2). 
 


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7. 
TREATMENT AND TREATMENT PROCEDURES
7.1 
Randomization and Blinding
This is an open-label, multicenter, dose-escalating study. Eligible subjects will be enrolled 
sequentially.  
VP-315 will be dispensed by the study pharmacist, or designee, in an open-label fashion to 
the subjects. All Screening tests and procedures must be completed prior to the 
administration of the first dose of study drug on Day 1. Once a subject number has been 
assigned to a subject, it will not be reassigned to another subject. Replacement subjects may 
be enrolled if subjects do not complete all EOT lesion excisions. Replacement subjects will 
not be enrolled for subjects who discontinue the study due to treatment-related toxicity, 
including subjects who have not completed all lesion excisions. A new unique subject 
number will be assigned to the replacement subject. 
7.2 
Description and Handling
7.2.1 
Formulation 
LTX-315 is an oncolytic peptide provided as LTX-315 Acetate 20 mg/vial lyophilized 
powder for injection that will be reconstituted in saline to a concentration ranging from 4 to 
20 mg/mL based upon the target dose and volume for each subject. The single excipient, 
water for injection (WFI), is of pharmacopeial quality; the WFI is removed by lyophilization. 
LTX-315 is supplied in colorless glass vials (Ph. Eur. hydrolytic class I) fitted with a rubber 
stopper (Ph. Eur. type I). 
7.2.2 
Storage and Handling 
Unreconstituted LTX-315 vials (20 mg/vial) must be stored as follows: 
 refrigerated at 2-8°C (36- 46°F) or  
 frozen at -20 ± 5 °C (-13° to 5°F)  
protected from light at the study site, separated from other drugs. 
The reconstituted LTX-315 solution can be stored for up to 12 hours in a refrigerator at 
2-8°C (36–46°F). Syringes with LTX-315 drawn from the vial can be stored for up to 4 hours
at 20-25°C (68-77°F) protected from light. Any unused portion should be discarded. 
Storage conditions for LTX-315 are specified on the label. All vials of investigational 
product should be stored in a securely locked area, accessible only to authorized site 
personnel until reconstitution. To ensure the stability and proper identification, 
investigational product should not be stored in a container other than the containers in which 
they were supplied. 
Additional information regarding storage, handling and reconstitution is provided in the 
Pharmacy Manual.  


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7.3
Dosage, Administration, and Schedule
VP-315 will be administered via intradermal injection into a single target lesion (between 
cm in longest diameter) using the 1-mL syringe and 30-gauge ½-inch needle 
provided by Verrica. The subjects should be positioned in a way so that the target lesion lies 
flat, to avoid any dependent areas that may be susceptible to leakage of VP-315. Subsequent 
injections for the same lesion will be given in remaining nonnecrotic areas of the lesion, as 
assessed prior to treatment. In Parts 1 and Part 2 (Cohorts 4 and 5), each 500-µL dose will be 
divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 
30% (150 µL) administered in the first injection and the remaining 70% (350 µL) with the 
second injection. In all parts of the study, the targeted total volume of delivery is 500 µL 
daily.
In Part 2, refer to Table 7-1 for cohort dosing and regimen.
For all injections, VP-315 is injected intradermally. It is critical to assure adequate and even 
distribution of VP-315 across the entire base of the lesion. To accomplish this, the first 
150 µL is to be injected as centrally as possible such that the VP-315 can distribute radially 
outward. The second (350-µL) portion shall be injected in a clockface fashion (i.e., 12, 3, 6, 
9 o’clock [shown below in Figure 7-1]) as needed to ensure uniform distribution, into the 
edges of the lesion to infiltrate the entire tumor with VP-315. Insert the needle at a 10- to 
20-degree angle for a flat lesion, or at an increased angle for a raised lesion. Subcutaneous 
injection should be avoided.
Figure 7-1
Injection Pattern for VP-315
The maximum total daily dose of VP-315 in any treatment visit in any subject or cohort must not 
exceed 8 mg. 
12
9
6
3
C


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7.3.1 
Management of Postinjection Reactions to VP-315 
Should a subject experience a post-injection reaction to VP-315 administration, the 
investigator should treat the subject in accordance with institutional guidelines. 
In Part 1, for any Grade 1 (per CTCAE V5) postinjection reaction (with the exception of 
local reactogenicity) occurring during VP-315 injections, or within 1 hour after the last 
injection, injections should stop until resolution of the reaction. If the reaction occurs during 
the first injection of the dose and resolves within 1 hour, the second injection of the dose may 
continue.  
For Grade 2 and higher reactions, the investigator must stop further injections in accordance 
with TRAE SI/DLT descriptions (Section 10.2). 
In Part 2, subjects will continue to be closely monitored for any safety signaling. If a TRAE 
SI is identified (Section 10.2), the medical monitor will review and determine if treatment 
should be continued. 
7.3.2 
VP-315 Dosing Strategy 
7.3.2.1 
Study Part 1 
In Part 1 of the study, the starting total daily dose for the evaluation of VP-315 will be 2 mg 
for the first subject. Subjects will receive ascending once-daily doses (increasing in 1-mg 
increments for up to 3 days in a 7-
4 days off between treatment 
weeks]) until the first lesion is necrosed or until the subject experiences a DLT, whichever 
occurs first (Figure 7-2). Subjects will be observed for DLTs throughout the treatment period 
during Part 1. 
After receiving a dose, the subject will return to the clinic the following day for assessment 
by the investigator. If, in the opinion of the SRC (see Section 7.4), there has been no DLT 
and if the lesion is not necrotic, the dose will be escalated, and the same lesion will continue 
to be treated before any additional target BCC lesions may be treated.  
When a target lesion is deemed necrotic in the opinion of the SRC, the subject will not 
receive any additional treatment for that lesion, and a safety assessment visit will be 
performed instead. If the subject has additional lesions and no DLT has occurred, treatment 
of the next lesion may begin on day 1 (D1) of the next week. A maximum of 2 target BCC 
lesions may be treated, and only 1 lesion may be treated at a time. Subjects will be treated for 
a maximum of 2 weeks and a maximum total daily dose of 8 mg.  
The starting dose will be escalated between subject cohorts in 1-mg increments after the 
previous cohort has completed Week 1 dosing (the DLT observation period) (Table 7-1). 
Dose escalation in Part 1 will end when 2 subjects experience a DLT at the same nominal 
dose (indicating that the preliminary MTD has been exceeded, and the preliminary MTD is 
the dose immediately below where any DLT occurred) or until a maximum VP-315 total 
daily dose of 8 mg is reached in up to 6 subjects. 


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7.3.2.2
Study Part 2 
Part 2 will be initiated upon completion of Part 1 to determine the optimal dosing regimen of 
VP-315. There were no DLTs observed in Part 1 of the study and the maximum dose of 8 mg 
was achieved. Therefore, the dose to be evaluated in Part 2 will be a total daily dose of 8 mg 
in the following 5 Cohorts:  
 Cohort 1 (N=3-6): The planned dosing regimen in Week 1 of Part 2 will begin 
with a VP-315 loading dose on Week 1/Day 1 (W1D1) at half the target dose, 
followed by total daily doses at the full target dose for the remaining dosing days 
of the treatment week, until the lesion is necrosed. Additional weeks of treatment 
will not include a loading dose on W2D1. Subjects may be treated for a maximum 
of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 – up to 6 total 
doses).
 Cohort 2 (N=3-6): VP-315 once-daily dosing of 8 mg on all treatment days (i.e., no 
loading dose on W1D1) up to 3 consecutive daily doses/week for up to 2 weeks 
(W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 – up to 6 total doses).  
The study design and dosing strategy listed below for Cohorts 3, 4 and 5 are 
recommendations from the Safety Review Committee following an adhoc safety review 
meeting held on June 13-14, 2023 to discuss subjects reports of pain and burning at the 
injection site that were not observed in Part 1 of the study: 
 Recommendation: Remove/skip Cohort 3 in Part 2 of the protocol and advance 
from Cohort 2 to Cohorts 4 and 5. Revert to Part 1 dosing strategy of a 30/70 split 
dose for all treatments with the injections adminstered 15-minutes apart.
Cohort 3 (N=0): This cohort has been removed at the recommendation of the SRC.  
For Part 2 (Cohorts 4 and 5) the highest total daily dose of VP-315 (8.0 mg) will be divided 
into a split dose; the first dose is not to exceed 2.4 mg (30% of 8-mg dose), and the 
remaining dose will not exceed 5.6 mg (70% of 8-mg dose) and administered 15 minutes 
apart (not to exceed 30 minutes).
 Cohort 4 (N= Appproximately 30 (10 initial/up to 20 expansion): (Two times weekly 
dosing) VP-315 once-daily dosing of 8 mg, administered 2 consecutive days in one 
week (W1D1, W1D2).  The planned dosing regimen will be a split dose of VP-315 
for all treatments. The 500µL (8 mg) dose will be divided into 2 injections given at 
least 15 minutes and no more than 30 minutes apart, with 30% (150 µL) administered 
in the first injection and the remaining 70% (350 µL) with the second injection. 
Treatment for a second target lesion may begin on D1 of the next week (W2D1, 
W2D2). Each individual target lesion is treated for the assigned 2 days only 
(regardless of necrosis status). Up to 2 target lesions may be treated – up to 4 total 
doses. 
 Cohort 5 (N= Approximately 30 (10 initial/up to 20 expansion): (Three times weekly 
dosing) VP-315 once-daily dosing of 8 mg, administered 3 consecutive days in one 
week (W1D1, W1D2, W1D3. The planned dosing regimen will be a split dose of VP-


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315 for all treatments. The 500µL (8 mg) dose will be divided into 2 injections given 
at least 15 minutes and no more than 30 minutes apart, with 30% (150 µL) 
administered in the first injection and the remaining 70% (350 µL) with the second 
injection. Treatment for a second target lesion may begin on D1 of the next week 
(W2D1, W2D2). Each individual target lesion is treated for the assigned 3 days only 
(regardless of necrosis status). Up to 2 target lesions may be treated – up to 6 total 
doses. 
After receiving a dose, the subject will return to the clinic the following day for assessment 
by the investigator. If, in the opinion of the Medical Monitor, the lesion is not necrotic 
Cohorts 1 and 2 only, the same lesion will continue to be treated before any additional target 
BCC lesions are treated. When a lesion is deemed necrotic in the opinion of the Medical 
Monitor, the subject will not receive any additional treatment for that lesion.
 If the subject has additional lesions, treatment of the next lesion may begin on D1 
of the next week. A maximum of 2 target BCC lesions may be treated, and only 
1 lesion may be treated at a time.
 Subjects in Cohorts 4 and 5 with only 1 target lesion that complete week one of 
treatment and the W1 safety assessment visit without complete necrosis should 
return for a Limited Safety Assessment Visit on W2D1 for further evaluation of 
the lesion for necrosis.  No additional treatment will be provided. 
 Subjects in Part 2 (all Cohorts) that complete week two of treatment and the W2
Safety Assessment Visit without complete necrosis should return for a Limited 
Safety Assessment visit on W3D1 for further evaluation of the lesion for necrosis. 
No additional treatment will be provided. 
For the first 10 subjects enrolled into Cohorts 4 and 5: after each treatment, subjects will 
remain in the study center for up to 2 hours post second injection for safety monitoring 
(e.g., continuous blood pressure, electrocardiographic and AE monitoring).  
Following the final treatment of the 10th subject in Cohort 4, enrollment into Cohort 5 may be 
initiated for 10 subjects.   
SRC Meetings
Two separate SRC meetings were convened after 10 subjects in each initial cohort (4 and 5) 
completed the Safety Assessment Visit to review the following topics: 
o to review the safety signals that may have occurred that could impact further treatment 
o to determine if the 2-hours of safety monitoring could be reduced to 1-hour post 2nd
injection at treatment (an additional hour may be continued at the discretion of the PI).
o to dermine if enrollment could be expanded to include up to 20 additional subjects for a 
total of approximately 30 subjects in each cohort.   
The SRC approved the following for both Cohorts 4 and 5:
 Up to 20 additional subjects (for a total of approximately 30 subjects) will be 
enrolled into Cohorts 4 and 5 (expansion groups) respectively. 


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After each treatment, the additional subjects enrolled into Cohorts 4 and 5 
expansion groups: will remain in the study center for up to 1-hour (reduced from 
2-hours) post second injection for safety monitoring (e.g., continuous blood 
pressure, electrocardiographic and AE monitoring), an additional hour may be 
continued at the discretion of the PI. 
Plasma PK sampling will be collected in subjects in Cohorts 4 and 5 expansion group as 
detailed in Table 8-1. 
Twelve to 14 weeks after the first injection of VP-315, subjects will return for all target and 
nontarget BCC lesions (Section 5.4) to be excised for histological evaluation. If the lesion(s) 
has clinically cleared, the area where the lesion was will be excised, and tissue samples will 
be sent to the central dermatopathologist for analysis/histology. Suture removal and final 
photography should occur 7 (±1) or 14 (±2) days after excision (7 days on the face and 
14 days on the body). Subjects with excised lesions on both the face and the body will be 
required to complete 2 end-of-study (EOS) visits accordingly. 
During the study period, subjects will be expected to visit the study facility and complete 
study procedures as outlined in the schedule of assessments (Table 8-1). 
Management of TRAEs/TRAE SIs (see Sections 7.3.1and 10.2) 
Subject dosing will continue until any TRAE of any grade occurs, with the exception of 
Grade 1 TRAEs indicative of local reactogenicity (injection-site pain, erythema, induration). 
Systemic reactogenic AEs (fever, myalgia, headache) and Grade 2 local reactogenic AEs will 
be considered TRAEs of special interest (Section 10.2). 
If a TRAE SI is identified, the site will notify the medical monitor who will review and 
determine if treatment should be continued. 
For TRAE SIs occurring during VP-315 injections, or within 1-hour after the last injection, 
injections should stop until resolution of the reaction. If the reaction occurs during the first 
injection of the dose and resolves within 1-hour, the second injection of the dose may 
continue. 
For TRAE SIs Grade 2 (per CTCAE V5)  and higher reactions, the investigator must stop 
further injections in accordance with TRAE SI/DLT descriptions (Section 10.2) and Tryptase 
must be collected per protocol (Section 8.4.5). 
If there is a clinically significant AE or abnormal laboratory result at the EOS visit, follow-up 
(F/U) visits may be required until resolution of the abnormality, or until the condition is 
considered clinically stable. 
All AEs including TRAE SIs should be recorded on the subject’s AE Form. 
Subjects may be discontinued for AEs at any time per the discretion of the investigator.   




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Table 7-1 Dose Regimen (Part 2 Cohorts 1-5)  
 
CRO must be contacted for each subject before treatment to confirm Cohort assignment 
Cohorts 
W1D1 
W1D2 
W1D3 
W1D4 
W2D1 
W2D2 
W2D3 
W2D4* 
Cohort 1 – 
loading dose 
(N=3 to 6) 
4 mg 
loading 
8 mg 
8 mg 
Safety
8 mg
8 mg
8 mg
Safety
 
If no TRAE SI in the first 3 subjects, then begin enrollment into Cohort 2 
 
If 1 TRAE SI occurs in the first 3 subjects, enroll up to 6 subjects 
 If no further TRAEs SI occur, then begin enrollment into Cohort 2  
 If 2 TRAEs SI occur in 6 subjects, then begin enrollment into Cohort 3 
Cohort 2 – No 
loading dose 
(N=3 to 6)
W1D1 
W1D2 
W1D3 
W1D4 
W2D1 
W2D2 
W2D3 
W2D4 
8 mg 
8 mg 
8 mg 
Safety 
8 mg 
8 mg 
8 mg 
Safety 
 
If no TRAE SI in the first 3 subjects, then begin enrollment into Cohort 4  
 
If 1 TRAE SI occurs in the first 3 subjects, begin enrollment into Cohort 4 with 30/70 split dosing of 8mg for each treatment 
Cohort 3 – has 
been removed
 
NOTE: Cohorts 1-2: Treatment continues until TRAE (includes TRAE SI) or significant necrosis of Target Lesion #1 as determined by Sub-SRC. If significant 
necrosis is determined, the current assessment is changed to an assessment-only visit, and no VP-315 is administered for the remaining days of the current 
Treatment Interval/Week. If the subject has an additional target lesion and a TRAE has not occurred, treatment of Target Lesion #2 may begin at D1W2 of next 
Treatment Interval/Week. Up to 2 target lesions may be treated. Subjects that complete two weeks of treatment and the W2D4 Safety Assessment Visit without 
achieving complete necrosis, should return for a Limited Safety Assessment Visit on W3D1 for further evaluation of the lesion for necrosis. 


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Cohort 4
2-day dosing 
regimen  
N=30 
(10 initial/
20 expansion) 
Lesion #1 Treatment
Lesion #2 Treatment
W1D1
W1D2
W1D3
W2D1
W2D1
W2D2
W2D3
W3D1
30/70 8 mg
30/70 8 mg
Safety
Limited Safety
30/70 8 mg
30/70 8 mg
Safety
Limited 
Safety 
Cohort 5 
3-day dosing 
regimen
N=30 
(10 initial/ 
20 expansion)
Lesion #1 Treatment 
Lesion #2 Treatment 
W1D1 
W1D2 
W1D3 
W1D4 
W2D1 
W2D1 
W2D2 
W2D3 
W2D4 
W3D1 
30/70 8 mg 
30/70 8 mg 
30/70 8 mg 
Safety 
Limited 
Safety 
30/70 8 mg 
30/70 8 
mg 
30/70 8 mg 
Safety 
Limited 
Safety 
NOTE: Cohorts 4-5: The administration strategy will be based on the recommendation of the SRC, utilizing Part 1 dosing administration of 30/70 split for 2 or 
3 consecutive days. Target Lesion #2 may begin at D1 of next Treatment Interval/Week. Each individual target lesion is treated per cohort regimen of 2- or 3- 
days only (not based on necrosis). Up to 2 target lesions may be treated. Subjects with only 1 target lesion, that complete week one of treatment and the W1 
safety assessment visit without complete necrosis should return for a Limited Safety Assessment Visit on W2D1 for further evaluation of the lesion for necrosis. 
Subjects with 2 target lesions, that complete two weeks of treatment and the W2 Safety Assessment Visit without achieving complete necrosis, should return for 
a Limited Safety Assessment Visit on W3D1 for further evaluation of the lesion for necrosis. 
 
 
 
 
 
 
 


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7.4 
Dose Escalation and Stopping Rules
7.4.1 
Safety Review Committee
An SRC, comprising at least 2 Sponsor representatives (including the appointed Medical 
Monitor) and at least 1 investigator, will convene between study Parts to review data, 
monitor safety, and if warranted, suggest changes to the VP-315 dose. 
In addition, there will be a sub-SRC that is responsible for continued oversight and 
monitoring with a Sponsor-appointed Medical Monitor or designee and an Independent 
Reviewer to assist with real-time virtual review and assessment beginning on W1D2; this 
review will assist in determining the need for additional intra-subject treatments, necrosis, 
dosing instruction, AE reporting, and stopping rules.  
Safety data from the current subject or cohort and previous cohorts will be reviewed by the 
sub-SRC prior to the sub-SRC authorizing dose escalation (Part 1 only) for the next dose 
level. The decision to halt or proceed with the planned dose escalation schedule, or modify 
the schedule as appropriate, will be made by the sub-SRC after careful consideration of all 
available safety and central photography information. The SRC will recommend phase 
2 dose/regimen for the study.  
Any detected toxicity may require dose reductions, dose-schedule changes, or other action(s) 
as appropriate, including further refinement of the MTD. If a safety stopping rule criterion is 
observed (e.g., occurrence of a DLT), an ad hoc meeting of the SRC will convene to assess 
the AEs or findings. Safety findings will be reported to the investigators, the IRB, and any 
other appropriate regulatory authorities. 
After determination of the cause and significance of safety events, the SRC is empowered to 
recommend continuing enrollment of the current cohort, pausing of enrollment, ceasing dose 
escalation, changing the protocol and study assessments to enhance subject safety, or 
terminating the study, as appropriate. If the investigation indicates a high probability that the 
observed safety event was due to an identifiable cause other than the study drug, the SRC 
may recommend continuation of study enrollment. 
7.4.2 
Dose Escalation 
Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg 
in all parts of the study (1 and 2).  
Details of dose escalation are provided in Section 7.3.2. Determination of whether or not to 
advance VP-315 doses will be made following safety review by the SRC and 
Sponsor-appointed Medical Monitor (or designee). The National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade 
safety events. The safety review will include at a minimum: 
 
All AEs, including intensity and investigator assessment of drug causality 
 
Routine laboratory test results (chemistry, hematology) and available serum tryptase 
findings 


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Treatment-emergent changes on electrocardiogram (ECG) 
Treatment-emergent changes on vital signs
7.4.3
Stopping Rules
In Part 1, any detected toxicity may require dose reductions, dose-schedule changes, or other 
action(s) as appropriate, including further refinement of the MTD. If a safety stopping rule 
criterion is observed in Part 2 (e.g., occurrence of a TRAE SI), an ad hoc meeting of the SRC 
will convene to assess the AEs or findings.
All subjects will be monitored for evidence of DLTs (as defined in Section 10.2). The onset 
of DLTs will result in termination of dosing in that subject. Additionally, the following 
considerations will be made based on the occurrence of DLTs: 
Part 1 of the study: Dose escalation in Part 1 will end when 2 subjects experience a DLT at 
the same nominal dose (indicating that the preliminary MTD has been exceeded) 
Part 2 of the study: For Grade 2 TRAE SIs and higher (per CTCAE V5), the investigator 
should discontinue VP-315 treatment, collect Tryptase per protocol (Section 8.4.5) in that 
subject and the subject should return for all follow-up visits. 
 
In all cases, the SRC will have the authority to discontinue or modify VP-315 dosing if 
TRAEs, changes in vital signs, ECGs, or clinical laboratory results are observed and these 
changes are determined to pose a significant health risk to the subject.  
7.5 
Concomitant Therapy 
Throughout the study, investigators may prescribe any concomitant medications or 
treatments deemed necessary to provide adequate supportive care except for those listed in 
Section 7.6.1.  
All concomitant medications administered while the subject is enrolled in the study 
(including over-the-counter products) must be recorded on the eCRF, listing generic name or 
trade name, indication, quantity administered, and date(s) of administration. 
Hormonal birth control pills or hormonal replacements may be taken during the course of this 
study. If necessary, acetaminophen may be administered at the investigator’s discretion in 
single doses of up to 2 g/day. Prophylactic antibiotics may be prescribed and/or administered 
by the investigator in advance of excision of any target and nontarget lesions. 
For itching of the treated areas, subjects are permitted to use gentle topical agents 
(e.g., Aquaphor®, CeraVe®) that will not irritate the skin in these areas.


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7.6 
Treatment Restrictions  
7.6.1 
Prohibited Medications 
All prescription medications (other than those specifically excluded in Section 5.3 (Exclusion 
Criteria) that subjects have been prescribed will be continued during the subject’s 
participation in the study. 
Subjects should be advised to avoid the use of excluded medications and treatments. If, in the 
opinion of the investigator, a subject requires any of these medications, the Medical Monitor
should be consulted. 
Nonapproved topical agents should not be used on, or within 2 cm of, the target BCC lesions 
and surrounding areas during the treatment period and through the EOS visit.  
7.6.2 
Other Restrictions
Subjects should be advised to avoid exposure to direct sunlight or ultraviolet light and to 
avoid the use of tanning parlors for the duration of the study. 
During the study, from the time of screening through discharge from the study, subjects are 
restricted from the following: 
 Participating in another clinical trial 
 Use of illicit drugs 
In addition, subjects should avoid the following unless the investigator feels it is required for 
subject care or for the treatment of any AEs: 
 Receipt of any injections unless the subject has been maintained on the drug prior to 
being screened for this study
7.6.3 
Dietary Restrictions 
There will be no dietary restrictions during this study, except under the direction of the 
investigator. 
7.7 
For Women of Childbearing Potential
Female subjects of childbearing potential must agree to avoid all means of becoming 
pregnant for the duration of the study. Subjects may not take part in this study if they are 
pregnant or are planning to become pregnant during the time they are participating in the 
study.  
Female study subjects of childbearing potential must agree to use a method of birth control 
that is acceptable to them, their study doctor, and Sponsor for the duration of the study. 
Women who are postmenopausal for at least 2 years (by history and by confirmed follicle 
stimulating hormone testing [using local reference ranges]), women with documented total 
hysterectomy, documented bilateral oophorectomy, and women with documented bilateral 
tubal ligation are considered to be of nonchildbearing potential. 


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Pregnancy tests will be given at regular intervals throughout the study for female study 
subjects of childbearing potential (see Section 10.1.3.3 for additional information).  


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8. 
STUDY PROCEDURES 
8.1 
Screening Assessments 
Each subject must sign and date the ICF prior to their participation in any screening 
activities. Prospective subjects are expected to complete Screening evaluations (exclusive of 
biopsy) no more than 42 days prior to the planned date of the first study drug administration 
(Day 1). Note: Subjects with a systolic BP <110 mmHg and/or diastolic BP <70 mmHg at the
Screening visit do not meet inclusion criteria and should not be enrolled into the study. 
At Screening, subjects will either provide a HISTORICAL biopsy (punch or shave) collected 
according to clinical standard of care within 90 days of W1D1 or will undergo a punch or 
shave biopsy of the suspected BCC lesions within the 90 days prior to W1D1. All specimens 
will be sent as slides to the central dermatopathologist for confirmation of eligibility.
Shave biopsies for suspected BCCs will be performed according to standard of care and 
include superficial or middle papillary dermis; suspected BCC lesions must meet the criteria 
described in Section 5.4. 
Punch biopsies will be collected for suspected BCCs (a 2-mm punch biopsy for suspected 
 cm to 1.0 cm, and a 3-mm punch biopsy for suspected BCC >1.0 cm to 2.0 cm).
Biopsy sites should be closed with 1 to 2 non-absorbable sutures (sized 4-0 or 5-0) depending 
on investigator preference. Up to 5 suspected BCC lesions may be evaluated by punch biopsy 
during screening. The subject should return during the screening period to have sutures 
removed in accordance with standard of care.
All on-study treatment day visits and dosing should be scheduled from Day 1 (date of the 
first dose of study drug). 
During the study, every effort should be made to keep subjects on the timetable for 
procedures and assessments in accordance with the schedule of assessments (Table 8-1). 
8.2 
Treatment Period 
After completion of screening/baseline assessments (Table 8-1), subjects will be enrolled to 
receive intratumoral VP-315. In Part 1, each 7-day treatment week comprises up to 
3 consecutive treatment days followed by a no-treatment period of at least 4 days. Once a 
target lesion has necrosed, treatment of that lesion stops, and treatment of subsequent target 
lesions may continue on Day 1 of the following week. Subjects may be treated for a 
maximum of 2 treatment weeks. In Part 2 of the study, each 7-day treatment week comprises 
up to 2 or 3 consecutive treatment days followed by a no-treatment period of at least 4 days.
After each treatment, all subjects in Part 1, Part 2 – Cohort 1, Cohort 2 and Cohorts 4 and 5 
(first 10 subjects in each) will remain in the study center for up to 2 hours for safety 
monitoring (e.g., continuous blood pressure, electrocardiographic and AE monitoring) After 
each treatment, the additional 20 subjects enrolled into Cohort 4 and 5 expansion groups: will 
remain in the study center for up to 1-hour (reduced from 2-hours) post second injection for 
safety monitoring (e.g., continuous blood pressure, electrocardiographic and AE monitoring), 
an additional hour may be continued at the discretion of the PI. Plasma PK sampling will be 
collected (in Part 2, Cohorts 4 and 5 expansion groups) as detailed in Table 8-1. 


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The subject will return to the clinic the day after treatment for assessment by the investigator.
The treatment site will be photographed and assessed for CRA (Appendix 1) and PGA of 
response to treatment (Appendix 2), with images uploaded for real-time assessment by the 
SRC (Part 1) and/or Medical Monitor (Part 2). The CRA and PGA will be performed by the 
investigator or trained personnel at each treatment visit, at the EOT visit, and at the EOS 
visit.  
Subjects in Part 2 (Cohorts 4 and5) with only 1 target lesion, that complete week one of 
treatment and the W1 safety assessment visit without complete necrosis should return for a 
Limited Safety Assessment Visit on W2D1 for further evaluation of the lesion for necrosis.   
Subjects that complete two weeks of treatment and the W2 safety assessment visit without 
complete necrosis should return for a Limited Safety Assessment Visit on W3D1. 
Nontarget BCC lesions will be observed for abscopal effect. 
In Part 2 of the study, subject-reported outcomes will be collected with the SCAR-Q 
(Scar appearance, Scar symptoms, and Psychosocial impact scales) (Appendix 3) and 
relevant subscales of the FACE-Q (Satisfaction with outcome) completed at each Safety 
Assessment Visit, and EOT visit.  
8.3 
End of Study and Follow-up 
Subjects will be required to return for excision at the EOT visit and F/U visits regardless of 
clinical appearance of the lesions, including all subjects who prematurely discontinue 
administration of the study drug for any reason. 
Scar Cosmesis Assessment and Rating (SCAR) Scale will be completed by the PI at the EOT 
visit, prior to the excision. 
In accordance with the procedures noted in Table 8-1, all target and nontarget BCC lesions 
will be surgically excised with a 3 mm- margin  to 6 weeks (Part 1) and 12 to 14 weeks (Part 
2) after receipt of the W1D1 injection, and a tissue sample will be sent to the central 
dermatopathologist for analysis/histology. If a lesion has clinically cleared, the area where 
the lesion was will be excised accordingly. 
Suture removal and final photography should occur 7 (±1) or 14 (±2) days after excision 
(7 days on the face and 14 days on the body). Subjects with excised lesions on both the face 
and the body will be required to complete 2 EOS visits accordingly. 
Subjects will be contacted 30 (± 2) days after last injection with VP-315 to confirm any AEs 
that have occurred since the last study visit. Subjects attending EOS 30 days post last 
injection will not require a F/U phone call. 


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Table 8-1 
Schedule of Assessments 
Procedure
Screen a 
Treatment 
Treatment Assessment 
Follow-up 
(2 weeks 
max, each 
subject) 
Safety Assessment 
Visit
Limited 
Safety 
Assessment 
Visit 
EOT 
(excision)
Unsched. 
Visits
EOS q 
Follow-up call
Face
Body
Day -42 
to -1  
Day 1-3 of 
each Week 
(while lesion 
is not 
necrosed) 
Day 4 of each 
Week 
(or 1 day after last 
lesion injection 
upon necrosis) 
W2D1 or 
W3D1  
(Part 2) t
Day 84-98
(or 12-14 
wks from 
W1D1) 
 
 
1 
Week 
(7d±2) 
post 
excisio
n q
 
2 Weeks  
(14d ±2) 
post 
excision 
q 
30 Days 
post EOS 
with ongoing 
Aes s 
Written informed consent 
X 
 
 
 
 
 
 
 
 
Eligibility criteria b 
X 
 
 
 
 
 
 
 
 
Vital signs c
X 
X 
X 
X 
X 
X 
X 
X 
 
Fitzpatrick Skin Type and lesion 
count d
X 
 
 
 
 
 
 
 
 
Medical, surgical and cancer 
history 
X 
 
Limited physical examination 
(Dermatologic exam) e
X
X
X
X
X
X
Body weight, height, BMI
X
X
Electrocardiogram (12-lead) f
X
X
X
X
Cardiac Holter/telemetry (5-
lead) f
 
X 
 
 
Clinical laboratory assessments g
X
X
X
X
X
Serum tryptase assessment h
X
(X)


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Procedure
Screen a 
Treatment
Treatment Assessment
Follow-up
(2 weeks 
max, each 
subject) 
Safety Assessment 
Visit 
Limited 
Safety 
Assessment 
Visit
EOT 
(excision) 
Unsched.
Visits 
EOS q 
Follow-up call
Face 
Body 
Day -42 
to -1  
Day 1-3 of 
each Week 
(while lesion 
is not 
necrosed) 
Day 4 of each 
Week 
(or 1 day after last 
lesion injection 
upon necrosis) 
W2D1 or 
W3D1  
(Part 2) t 
Day 84-98
(or 12-14 
wks from 
W1D1) 
 
 
1 
Week 
(7d±2) 
post 
excisio
n q
 
2 Weeks  
(14d ±2) 
post 
excision 
q 
30 Days 
post EOS 
with ongoing 
Aes s
Serum pregnancy test i
X
X
X
X
Plasma immune response to 
VP-315 and T-cell clonality j
X 
 
 
 
X 
 
 
 
 
Urine pregnancy test k
X
Biopsy samples to 
dermatopathologist l 
X 
 
 
 
 
 
 
 
 
Biopsy suture removal 
X 
 
 
 
 
 
 
 
 
BCC Lesion 
count/location/measurement 
X 
 
 
 
 
 
 
 
 
Physician Global Assessment m
X
X
X
X
X
X
X
Cutaneous Reaction Assessment 
m
 
X 
X 
X 
X 
X 
X 
X 
 
Surgical excision tissue samples 
to dermatopathologist n
 
 
 
 
X 
 
 
 
 
PK sampling o
X
Adverse events
X
X
X
X
X
X
X
X
Prior/concomitant medications
X
X
X
X
X
X
X
X
X


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Procedure
Screen a 
Treatment
Treatment Assessment
Follow-up
(2 weeks 
max, each 
subject) 
Safety Assessment 
Visit 
Limited 
Safety 
Assessment 
Visit
EOT 
(excision) 
Unsched.
Visits 
EOS q 
Follow-up call
Face 
Body 
Day -42 
to -1  
Day 1-3 of 
each Week 
(while lesion 
is not 
necrosed) 
Day 4 of each 
Week 
(or 1 day after last 
lesion injection 
upon necrosis) 
W2D1 or 
W3D1  
(Part 2) t 
Day 84-98
(or 12-14 
wks from 
W1D1) 
 
 
1 
Week 
(7d±2) 
post 
excisio
n q
 
2 Weeks  
(14d ±2) 
post 
excision 
q 
30 Days 
post EOS 
with ongoing 
Aes s
Lesion photography p
X
X
X
X
X
X
X
Patient-Reported Outcomes q 
(SCAR-Q & FACE-Q)
 
 
X 
 
X 
 
 
 
 
Injection of VP-315
X
Suture Removal and Postsurgical 
Assessment r 
 
 
 
 
 
 
X 
X 
 
Observer-Related Outcomes u
(SCAR)
 
 
 
 
X 
 
 
 
 


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BMI=body mass index; BP=blood pressure; EOS=end of study; EOT=end of treatment; HR=heart rate; PK=pharmacokinetic 
a.
Screening can occur up to 42 days prior to Study drug injection on Day 1. An IRB-approved ICF must be signed before any study specific procedures are performed.
b. 
Confirmation of eligibility criteria. 
c.
Vital signs (e.g., temperature, HR, BP) will be obtained at screening and at each treatment prior to application of study drug. Height and weight will be collected at Screening and 
EOS. Subjects must be supine for at least 5 minutes before BP and pulse rate measurements. On VP-315 dosing days, BP will be monitored serially just prior to injection, at 1, 3, 
and 5 minutes after each injection, and then every 5 minutes until 2 hours post last injection of the day using a manual/automated cuff system. For subjects in Part 2 (Cohorts 4 and 
5 expansion groups), monitoring of BP has been decreased to 1-hour by the SRC following their safety meetings.  An additional hour may be continued at the discretion of the PI. 
d. 
Fitzpatrick Skin Type and lesion count. 
e. 
Limited physical examination (dermatological exam). Symptom- or AE-directed physical examination may be performed if warranted. (See Source/CRF for further outline of 
assessment.)
f. 
Resting 12-lead ECGs (equipment provided by ECG Core Lab) will be recorded after the subject has been supine and at rest for at least 5 minutes at all visits, and prior to dosing 
on VP-315 dosing days. On VP-315 dosing days, 5-electrode Holter/telemetry (equipment provided by ECG Core Lab) will also be monitored continuously starting 15 minutes 
prior to injection and continuing 2-hours post last injection of the day. For subjects in Part 2 (Cohorts 4 and 5 expansion groups), Holter/telemetry monitoring has been decreased 
to 1-hour by the SRC following their safety meetings. An additional hour may be continued at the discretion of the PI. Note, in the event of EGC Core Lab equipment failure for 
the 12-lead ECG, sites may use their own 12-lead ECG machine and contact the ECG Core Lab for directions regarding upload to the study portal. 
g. 
Clinical laboratory assessments to include a complete blood count and chemistry panel; samples will be collected at Screening, the Safety Assessment Visit, Unscheduled Visit and 
at the EOS (for subjects with excised lesions on both the face and the body, clinical laboratory samples will be collected only at the second EOS visit (i.e., at the EOS for Body; 
2 weeks after excision). Local laboratory procedures and analysis should be used for these tests. 
h. 
Blood samples for serum tryptase assessments will be collected at screening; additional samples will be collected as soon as possible following the occurrence of a hypersensitivity 
reaction, and again 60 to 120 minutes later. 
i. 
Serum pregnancy test will be performed only on subjects of childbearing potential at all visits where other clinical laboratory tests are collected and at the EOS visit, prior to the 
subject being discharged from the study (Note: for subjects with excised lesions on both the face and the body, clinical laboratory samples and the serum pregnancy testing will be 
collected only at the second EOS visit [i.e., at the EOS for Body; 2 weeks after excision]).
j.
Blood collected on a subset of subjects at screening and EOT visits. Approximately 3.0 mL will be collected in BD Vacutainer™tubes with K2EDTA.
k. 
Urine pregnancy test will be performed prior to injection on Day 1 of each week only on subjects of childbearing potential. 
l.
If an eligible, HISTORICAL biopsy (shave or punch biopsy sample taken within 90 days prior to the W1D1 visit) is available in advance of subject screening, slides are to be 
submitted to the central dermatopathologist in accordance with the laboratory manual. If the subject has no HISTORICAL biopsy, shave or punch biopsy of the suspected BCC 
must be performed within t 90 days of W1D1. Shave biopsies will be performed according to standard of care to include superficial or middle papillary dermis. For punch biopsies, 


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a 2-mm biopsy will be collected 
-mm punch biopsy for suspected BCC >1.0 cm to 2.0 cm. Up to 5 suspected lesions may be biopsied. 
Punch biopsy sites should be closed with 1 to 2 non-absorbable sutures (sized 40 or 50) depending on investigator preference.
m. Physician’s Global Assessment and Cutaneous Reaction Assessment will be performed prior to injection at all visits after Week 1 Day 1 for subjects in all parts of the study. The 
results of the Cutaneous Reaction Assessment are required in Parts 1 and 2 for evaluation of necrosis and DLTs. 
n. 
Subjects will return for Follow-up Visits approximately 28-42 days (4-6 weeks) for Part 1 and 84-91 days (12 to 14 weeks) for Part 2 after receipt of first dose of VP-315 for 
excision of all BCC lesions (EOT). 
o. 
Blood samples for PK assessments will be collected on the first day of full target dose administration immediately prior to the VP-315 dose and at 2- and 5-minutes post first 
injection and 2-, 5-, 10-, 20-, 30-, 60-, and 120-minutes post last injection; samples will also be collected on the following day 24 hours (±1 hour) post prior injection of VP-315. 
Blood samples for PK assessments will only be collected for subjects in Part 2 (Cohorts 4 and 5 expansion groups).
p. 
Photography of BCC lesion taken by a study team member prior to each treatment through EOS. Evaluation of lesion necrosis by the SRC (Part 1) or Medical Monitor (Part 2) is 
required for continued treatment. 
q. 
Subjects in Part 2, will complete SCAR-Q and FACE-Q if they feel they have scars related to study treatment (relevant subscales only) at Safety Assessment Visits, and EOT. 
r. 
Subjects will return approximately 7- or 14-days after excision (EOS) for a postsurgical assessment (7 days on the face and 14 days on the body). Subjects with excised lesions on 
both the face and the body will be required to complete 2 EOS visits accordingly. 
s. 
Subjects with AE(s) at the EOS visit will be contacted by phone at least 30 days after the EOS visit to confirm the status of any ongoing AE(s).  
t. 
Limited Safety Assessment Visit conducted only in Part 2 – 
a. 
Cohorts 1-2: If the treated lesion is not fully necrosed at the W2D4 Safety Assessment Visit, a Limited Safety Assessemnt Visit should occur on W3D1 for further 
evaluation of the lesion for necrosis. No additional treatment will be adminstered. 
b. 
Cohorts 4-5 (including expansion groups): If only 1 target lesion is treated and complete necrosis is not achieved at the W1 Safety Assessment Visit, subjects should 
return on W2D1 for further evaluation of the lesion for necrosis. No additional treatment will be administered. If a second target lesion was treated and complete necrosis 
is not achieved at the W2 Safety Assessment Visit, subjects should return on W3D1 for further evaluation of the lesion for necrosis. No additional treatment will be 
administered. 
u. 
Scar Cosmesis Assessment and Rating (SCAR) Scale will be completed by the site investigator prior to excision at the EOS Visit. 


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8.4
Safety Assessments
8.4.1 
Physical Examination
Limited physical examinations will include a dermatologic examination, including a 
Fitzpatrick Skin Type assessment (Screening only). Other systems will be examined as 
deemed necessary by the investigator depending on clinical signs and symptoms.  
Screening Physical examination findings should be recorded on the medical and surgical 
history eCRF. Post-Screening limited physical examinations will be performed predose at 
each study visit. Additional physical examinations (limited or complete) may be performed 
as medically necessary, in the opinion of the investigator, and new findings recorded on the 
AE eCRF as appropriate.
Physical examinations will be performed at the EOT (excision) visit, 4 – 6 week (Part 1) and 
12 to 14 weeks (Part 2) after the subject’s first VP-315 treatment.  
8.4.2 
Vital Signs Data 
Height and weight will be obtained at Screening and EOS.  
Vital signs (e.g., body temperature, BP, and heart rate [HR]) will be obtained at all visits 
after the subject has been in the supine position for at least 5-minutes. Vital signs will be 
measured at the final evaluation during the EOS visit before the subject is discharged from 
the study. 
On VP-315 dosing days, blood pressure will be monitored serially (observing for 
hypotension that meets the definitions as described in Section 10.1): just prior to injection, at 
1-, 3-, and 5-minutes after each injection, and then every 5-minutes until 2 hours after the last 
injection of the day using a manual or automated cuff system (Table 8-1). For subjects in Part 
2 – Cohorts 4 and 5 expansion groups, monitoring of BP has been decreased to 1-hour post 
treatment (an additional hour may be continued at the discretion of the PI).  
8.4.3 
Electrocardiograms
Subjects will be supine in a rested and calm state for at least 5 minutes before the ECG 
assessment is performed. ECG machines and Holter/telemetry will be provided by an ECG 
core lab, and these provided machines must be used for all study-related ECG requirements. 
Please note, in the event the provided 12-lead ECG machine (provided by the ECG core lab) 
is not functioning, the sites may utilize their own ECG machines and follow-up with the ECG 
core lab for uploading instructions. HR, QRS, QT, QTc, and PR intervals will be reported by 
the core lab. 
Resting 12-lead ECGs will be recorded at the timepoints outlined in Table 8-1. On VP-315 
dosing days, 5-electrode Holter/telemetry will also be monitored continuously starting 15 
minutes prior to injection and 2 hours after the last injection of the day. For subjects in Part 2 
Cohorts 4 and 5 expansion groups, Holter/telemetry has been decreased to 1-hour after the 
last injection of the day after receipt of the second daily dose of VP-315 (an additional hour 
may be continued at the discretion of the PI).  


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If a change in rhythm is detected during monitoring, the investigator will be notified by the 
central ECG core lab for evaluation of potential adverse events. 
8.4.4 
Clinical Laboratory Testing 
A Clinical Laboratory Improvement Amendments (CLIA) certified [either central or local] 
laboratory will perform the clinical laboratory tests for this study as scheduled in Table 8-1. 
Tests are listed in Table 8-2 and will be performed at Screening, at each Safety Assessment 
Visit, at Unscheduled Visits and at the EOS; for subjects with excised lesions on both the 
face and the body, clinical laboratory samples will be collected only at the second EOS visit 
(i.e, at the EOS for Body).
Table 8-1 
Clinical Laboratory Tests 
Clinical Laboratory Tests 
Hematology: 
Red Blood Cell Count (RBC)
White Blood Cell Count (WBC) w/ differential (absolute) 
Hematocrit 
Hemoglobin
Mean Corpuscular Volume (MCV)
Mean Corpuscular Hemoglobin Concentration (MCHC) 
Platelet Count 
Serum Chemistry: 
Blood Urea Nitrogen (BUN) 
Creatinine 
SGOT (AST) 
SGPT (ALT) 
Lactic Dehydrogenase (LDH) 
Alkaline Phosphatase (ALP) 
Total Bilirubin 
Total Protein 
Albumin
Glucose 
Calcium 
Sodium 
Chloride 
Potassium 
Bicarbonate 
Pregnancy Test: (Only on subjects of childbearing potential) 
-hCG (Screening, Safety Assessment Visits, and EOS)
Urine (prior to injection on Day 1 of each week) 
Serum tryptase  
T-Cell Clonality (Central lab only) 
Expansion Cohorts 4 and 5 
Serum Pharmacokinetics (PK) [Central lab 
only] 
EOS=end of study (visit); EOT=end of treatment (visit) 
8.4.5 
Serum Tryptase Assessment
Blood samples for serum tryptase assessments will be collected at screening; additional 
samples will be taken as necessary to monitor hypersensitivity reactions.
Blood samples will be collected in accordance with the National Institute for Health and Care 
Excellence clinical guideline 134 when any hypersensitivity reaction occurs (e.g., as soon as 
possible following the occurrence of a hypersensitivity reaction, and again 60 to 120 minutes 


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later). The actual collection time must be entered into the subject’s record/source and 
transcribed accordingly.  
8.4.6 
Cutaneous Reaction Assessment
A CRA will be performed prior to injection at all visits after W1D1 (Appendix 1); the 
evaluation results are required for the evaluation of necrosis and DLTs. These local skin 
reactions will be collected independently of the adverse reactions to provide information on 
the specific types of reactions that can be expected to occur. 
8.4.7 
Pregnancy Testing 
-human chorionic gonadotropin ( -hCG) pregnancy testing will be performed only 
on subjects of childbearing potential at all visits where clinical laboratory assessments are 
collected: Screening, Safety Assessment Visits, and at the EOS visit, prior to the subject 
being discharged from the study. For subjects with excised lesions on both the face and the 
body, serum pregnancy testing will be performed only at the second EOS visit (i.e., at the 
EOS for Body).
Urine pregnancy tests will be performed (only on subjects of childbearing potential) prior to 
injection on Day 1 of each week; urine pregnancy tests must be confirmed negative prior to 
administration of VP-315. The results of these tests will be retained in the source document. 
In the event of a pregnancy, a Pregnancy Reporting Form must be completed and forwarded 
to the Sponsor (see Section 10.1.3.3 for additional information).
8.4.8 
Pharmacokinetic Assessments 
There will be no PK samples collected in Part 1. 
In Part 2, a subset of up to 20 subjects in Cohorts 4 and 5 expansion group will have plasma 
PK samples obtained at the following timepoints on the first day of treatment with the full 
target dose: 
Predose, 
2- and 5- minutes post first injection, and 
2-, 5-, 10-, 20-, 30-, 60-, and 120-minutes post last injection.
Additional samples will be collected on the following day 24 hours (±1 hour) post 
Day 1 first injection of VP-315 (prior to Day 2 injection).
All efforts should be made to collect samples as close to the protocol specified time point as 
possible. The actual collection time must be recorded in the subject’s source documents and 
transcribed to the CRF.


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8.5
Pharmacodynamic Assessments and Endpoints
8.5.1 
Lesion Evaluation
At Screening, subjects will either provide a HISTORICAL biopsy (punch or shave) collected 
within the 90 days prior to the W1D1 visit or will undergo a punch or shave biopsy of the 
suspected BCC lesion within 90 days of W1D1. Shave biopsies will be performed according 
to standard of care and will include superficial or middle papillary dermis. For punch 
biopsies, a 2-mm punch biopsy will be collected 
 cm to 1.0 cm, and a 
3 -mm punch biopsy will be collected for suspected BCC >1.0 cm to 2.0 cm, up to 
5 suspected lesions may be biopsied. All specimens (including HISTORICAL samples) will 
be formalin-fixed and paraffin embedded (FFPE) and H&E stained slides of specimen slices 
will be prepared and reviewed locally to determine eligibility. The H&E stained slides will 
be sent to the central lab for imaging and high quality images of the slides will be sent to the 
central dermatopathologist for confirmation of analysis/histology. 
In accordance with the procedures noted in Table 8-1, all target and nontarget BCC lesions 
will be surgically excised with a 3 mm- margin 4 to 6 weeks (Part 1) and 12 to 14 weeks 
(Part 2) after receipt of the W1D1 injection and tissue specimens preserved by FFPE. If a 
lesion has clinically cleared, the area where the lesion was will be excised accordingly. Both 
the screening and post-excision tissue blocks will be sent to the central lab for analysis of 
immune activation biomarkers including TILs by multiplexed IF-IHC, as well as for 
sequencing of genomic DNA from the lesion specimens to assess changes in T-cell receptor 
clonality.
During the study, subjects will be monitored for signs of efficacy—specifically, evidence of 
necrosis in the treated lesion(s).  
8.5.2 
Lesion Photography 
Prior to each treatment, each safety visit, prior to excision and EOS, the treatment site, as 
well as any additional non-treated lesions that are to be followed, will be photographed, and 
assessed for the CRA. Site(s) will be provided with specialized equipment and training for 
consistent quality photographs. Photographs may be collected and stored on digital media.  
Custom photographic equipment will be manufactured by Canfield for use in this study. 
Canfield will provide each site with a laptop computer with Canfield’s proprietary Canfield 
Capture pre-installed on the equipment to guide site staff through all of steps of the image 
capture process required for this study. The software will be configured to include the 
specific visit schedule, image views and lighting modes to satisfy the needs of the study. In 
order to ensure consistent serial clinical photography is achieved during this study, all subject
photographs will be reviewed (monitored) on an ongoing basis. Digital images will be 
transferred to Canfield via the secure website. 
All images will be monitored for technical adherence to photographic protocol. Subject 
information, including site number, subject ID number, subject initials, and session date, will 
be entered into the database. The subject’s F/U images will be technically reviewed 
compared to the baseline images. Photographic documentation will be carefully monitored to 


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assure that consistent serial photography will be achieved. Any subject images received that 
show identifying features (as defined by the Sponsor) will be digitally modified in an effort 
to protect the subject’s identity. Image masking will occur where applicable during the 
monitoring process and a quality check will be completed before the images are available to 
view, download and print. 
8.5.3 
Subject-reported Outcomes
In Part 2 of the study, subject-reported outcomes will be collected with the SCAR-Q 
(Scar appearance, Scar symptoms, and Psychosocial impact scales) (Appendix 3) and 
relevant subscales of the FACE-Q (Appendix 4) (Satisfaction with outcome) completed at 
each Safety Assessment Visit, and EOT visit.
The FACE-Q will only be completed by subjects who have target or nontarget lesions on the 
face. 
Brief instructions are provided at the start of each scale, and questionnaires will be 
administered via electronic Patient Reported Outcomes tablets during the subject visit in 
accordance with Table 8-1.
Each SCAR-Q and FACE-Q scale provides 4 response options that measure frequency. All 
scales use a 4-point scale. There is no overall or total score, only scores for each independent 
scale. Each scale is transformed into scores that range from 0 to 100. The scores are 
computed from the responses to the items by adding them together and converting the raw 
score to a scale from 0 to 100. Higher scores reflect a better outcome. 
8.6 
Observer-reported Outcomes 
Scar Cosmesis Assessment and Rating (SCAR) Scale will be completed by the PI at the EOT 
visit, prior to the excision (Appendix 5).  The scale includes six questions with six 
parameters scored by a clinician (scar spread, erythema, dyspigmentation, suture marks, 
hypertrophy/atrophy, overall impression) and two simple questions regarding symptoms (itch 
and pain) with yes/no answer options that are answered by the patient [Kantor, 2016].  
8.7 
Posttreatment Assessments 
Approximately 4 to 6 weeks (Part 1) and 12 to 14 weeks (Part 2) after the first treatment with 
VP-315, subjects will return to the clinic for excision (3 mm margin) of all BCC lesions for 
histological evaluation.  
A F/U visit will take place 1- or 2-weeks post excision (EOS visit). Suture removal and final 
photography should occur 7 (±1) or 14 (±2) days after excision (7 days on the face and 
14 days on the body). Subjects with excised lesions on both the face and the body will be 
required to complete 2 EOS visits accordingly. 
Subjects with AE(s) at the EOS visit will be contacted at least 30 days after the EOS visit by 
phone to confirm the status of any ongoing AE(s). The evaluations and/or procedures to be 
completed during EOT and EOS Visit are outlined in Table 8-1. 


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8.8 
Assessment of the Immunological Response to VP-315 Treatment 
In a subset of subjects, the anti-tumor immunological response to VP-315 treatment will be 
assessed in the excised tissue obtained from basal cell tumor biopsies performed at pre-
screening (baseline) and at the approximate 12-24 -week post-treatment visit, as well as in 
peripheral blood samples acquired at the same time points. Analyses will include multiplexed 
immunofluorescence immunohistochemistry (IF-IHC) of slices from tumor tissue biopsies as 
well as assessment of T-cell clonality in both peripheral blood and in the same tissue 
obtained from the tumor biopsies. 
8.8.1 
Multiplexed Immunofluorescence Immunohistochemistry 
Tissue sections from the formalin-fixed, paraffin-embedded (FFPE) tissue from pre- and 
post-treatment biopsy samples will be analyzed by multiplexed IF-IHC using fluorescent 
staining using a panel of 8 markers to identify tumor infiltrating lymphocyte (TIL) T-cell 
subsets and changes in immune activation.  
8.8.2 
Assessment of T-cell Clonality 
The adaptive immune response to basal cell tumor antigens released following VP-315 
treatment will be assessed by measuring T-cell clonal expansion in peripheral blood and the 
repertoire of T-cell clones infiltrated into the tumor tissue microenvironment using a highly 
sensitive next-generation T-cell receptor sequencing assay. gDNA for the assay will be 
obtained from the same FFPE tissue blocks used for the multiplexed IF-IHC described in 
Section 8.7.1 and from peripheral blood samples (3.0 mL) collected in BD Vacutainer™ 
tubes with K2EDTA at the screening and approximate 12-week post-treatment visits. 


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9.
REMOVAL AND REPLACEMENT OF SUBJECTS
9.1 
Removal of Subjects 
Subjects have the right to withdraw from the study at any time and for any reason without 
prejudice to their future medical care by the investigator or at the institution. 
The investigator and/or sponsor can decide to withdraw a subject(s) from protocol required 
procedures or from the study as a whole at any time prior to study completion. 
Withdrawal of consent from the study means that the subject does not wish to undergo 
further protocol-required procedures, and the subject does not wish—or is unable—to 
continue further study participation. Subject data up to the withdrawal of consent will be 
included in the analysis of the study and, where permitted, publicly available data can be 
included after withdrawal of consent. The investigator is to discuss with the subject 
appropriate procedures for withdrawal from the study. 
Reasons for removal from the study include any of the following:  
 subject request (withdrawal of consent) 
 safety concern (e.g., due to an AE, ineligibility determined, protocol deviation, 
noncompliance, requirement for alternative therapy, protocol-specified criteria, 
pregnancy) 
 decision by sponsor (other than subject request or safety concern) 
 loss to F/U 
In the event of a premature withdrawal from the study, the subject should attend an EOS visit 
when possible, and the investigator is to discuss with the subject appropriate procedures for 
withdrawal from the study.  
9.2 
Replacement of Subjects 
Subjects who withdraw or are removed from the study for reasons other than DLT will be 
replaced to achieve the required number of evaluable subjects. Identifying subject numbers 
will not be reused; all newly enrolled subjects will have a unique subject identification 
number. 
 


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10.
SAFETY DATA COLLECTION, RECORDING, AND REPORTING
10.1 
Adverse Events 
10.1.1 
Definition of Adverse Events
Consistent with the US Code of Federal Regulations (CFR), Title 21 §312.32, an AE is 
defined as any untoward medical occurrence associated with the use of an investigational 
product, regardless of its causal relationship to the investigational product.  
The investigator is responsible for ensuring that any AEs observed by the investigator (or 
staff) or reported by the subject are recorded in the subject’s medical record.  
The definition of AEs includes worsening of a pre-existing medical condition. Worsening 
indicates the pre-existing medical condition (e.g., diabetes, migraine headaches, gout) has 
increased in severity, frequency, and/or duration, and/or has an association with a 
significantly worse outcome.  
Treatment-emergent adverse events (TEAE) include all AEs that occur during the treatment 
period (i.e., W1D1 through EOS).
Treatment-related adverse events (TRAE) include all AEs that occur during the treatment 
period (W1D1 through EOS) that the PI determines is related to the investigational 
agent/procedure. 
Treatment-related adverse events of special interest (TRAE SI) will be reported in Part 2 of 
the study. A treatment-related adverse event of special interest (TRAE SI) will be defined as 
any one of the VP-315 related adverse events (AE) that occurs during the treatment visit 
listed in Section 10.2. 
Interventions for pretreatment conditions (e.g., elective cosmetic surgery) or medical 
procedures that were planned before study enrollment are not considered to be AEs.
10.1.2 
Reporting Procedures for Adverse Events 
The investigator is responsible for ensuring that all AEs (i.e., those observed by the 
investigator [or staff] or reported by the subject) with an onset occurring any time between 
the subject providing the signed ICF through the completion of the F/U Visit are reported on 
the AE Summary eCRF.  
The investigator is required to assign the following AE attributes: 
 adverse event diagnosis or syndrome(s), if known (if not known, signs or symptoms)
 dates of onset and resolution 
 severity
 assessment of relatedness to study drug 
 action taken


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The investigator may be asked to provide F/U information, discharge summaries, and 
extracts from medical records or eCRFs. 
In Part 1 of the study, the AE grading scale used will be the CTCAE v5.0. The relationship of 
the AE to the investigational product will be assessed by means of the question: “Is there a 
reasonable possibility that the event may have been caused by the investigational product?”. 
The investigator should respond to this question with either Yes or No. 
If the AE occurred before VP-315 treatment, the relationship of the AE to study screening is 
to be assessed by means of a similar question: “Is there a reasonable possibility that the event 
may have occurred because of study screening?” The investigator should respond to this 
question with either Yes or No. If the answer is Yes, record what part of the study screening 
is suspected. 
Medically significant AEs considered by the investigator or Sponsor to be related to VP-315
will be followed until resolved or considered stable. The outcome of each AE must be 
recorded according to the following classification: unknown, completely resolved, resolved 
with sequelae, ongoing, death.  
The investigator is responsible for reviewing laboratory test results and determining whether 
an abnormal value in an individual study subject represents a change from values before the 
study. In general, abnormal laboratory findings without clinical significance (based on the 
investigator's judgment) should not be recorded as AEs; however, laboratory value changes 
requiring therapy or adjustment in prior therapy are considered AEs. 
The investigator's clinical judgment is used to determine whether a subject is to be removed 
from treatment due to an AE. A subject, or subject's legal guardian, can also voluntarily 
withdraw from treatment due to an AE. If the subject withdraws consent, the subject is 
encouraged to attend, at a minimum, the EOS visit (Table 8-1). 
10.1.3 
Serious Adverse Events 
10.1.3.1 
Definition of Serious Adverse Events 
An SAE is defined as an AE that meets at least 1 of the following serious criteria: 
 fatal 
 life threatening (places the subject at immediate risk of death) 
 requires in-patient hospitalization or prolongation of existing hospitalization 
 results in persistent or significant disability/incapacity 
 congenital anomaly/birth defect, and/or 
 other significant medical hazard 
An AE would meet the criterion of “requires hospitalization,” if the event necessitated an 
admission to a health care facility (e.g., overnight stay).  


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If an investigator considers an event to be clinically important, but it does not meet any of the 
serious criteria, the event could be classified as an SAE under the criterion of “other 
medically important serious event.” Examples of such events could include allergic 
bronchospasm, convulsions, and blood dyscrasias. 
10.1.3.2
Reporting Procedures for Serious Adverse Events 
Serious adverse events will be collected and recorded at least throughout the study period, 
beginning with the signing of the informed consent through 30 days after the last dose of 
investigational product or last subject visit, whichever is longer.
It is required that any SAE, regardless of its investigator-determined causal relationship to 
study drug, be reported to the Sponsor Medical Monitor within 1 working day of discovery or 
notification of the event. Each principal investigator will be provided with a Serious Adverse 
Event Report Form prefilled with the name, telephone number, and fax number of the local 
Sponsor Global Safety contact.  
Serious adverse events occurring after conclusion of the study AND thought to be possibly 
related to investigational product will be collected and reported within 1 working day of 
discovery or notification of the event. 
Follow-up SAE information should be provided by the investigator as appropriate until the 
SAE has resolved. The investigator is obligated to answer queries and to submit requested 
F/U information for any SAE until the case is considered closed by the Sponsor Medical 
Monitor or designee.  
The investigator should notify the appropriate IRB or ethics committee of SAEs occurring at 
the site and other AE reports received from Sponsor, in accordance with local procedures and 
statutes. 
10.1.3.3 
Pregnancy Reporting 
Pregnancies are not considered SAEs; however, any pregnancy complication or an induced 
therapeutic abortion to terminate any pregnancy due to complications or other medical 
reasons will be recorded as an SAE. The underlying medical reason for this procedure should 
be recorded as the AE term. Furthermore, any SAE occurring as an adverse pregnancy 
outcome post-study must be reported to the Sponsor.
The investigator must report any pregnancies to the Sponsor’s Medical Monitor (using the 
Pregnancy Reporting Form) within 24 hours of the initial report of a male subject’s female 
partner or female subject becoming pregnant during the course of the study. Any pregnancies 
that occur within the 30 days following the last investigational medicinal product dose should 
also be reported. 
Monitoring of the subject should continue until the conclusion of the pregnancy. Additional 
information regarding the pregnancy should be submitted to the Sponsor on the Pregnancy 
Form. The outcome should be reported to the Sponsor using the Pregnancy Outcome Form. If 
the end of the pregnancy occurs after the study has been completed, the outcome should be 
reported directly to the Sponsor. 


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10.2
Dose-limiting Toxicity/Treatment-related Adverse Event of Special 
Interest  
For Part 1 of the study, a dose limiting toxicity (DLT) is defined as any of the following 
VP-315 related adverse event (AE) that occurs during the DLT period: 
For Part 2 of the study, a treatment-related adverse event of special interest (TRAE SI) will 
be defined as any on the following VP-315 related adverse (AE) that occurs during the 
treatment visit: 
Hypotension meeting any of the following definitions: 
 
>20 mmHg decrease in systolic BP with absolute systolic BP <100 mmHg, or 
>20 mmHg decrease in systolic BP with clinical symptoms, or
 
absolute diastolic BP <60 mmHg 
 Significant elevation of serum tryptase concentration is defined as an increase of 
1.2× baseline plus 2 
 Any Grade 2 or higher AE occurring between start of dose administration and the end 
of the postdose observation period on any given treatment day 
 Any Grade 2 or higher AE considered by the investigator to be related to the 
investigational product 
 Any Grade 2 or higher local reactogenic AE (injection-site pain, erythema, 
induration) 
 Any Grade 2 or higher systemic reactogenic AEs (fever, myalgia, headache) 
 Any subject who experiences a DLT/TRAE SI will receive no further VP-315.  
If the DLT/TRAE SI is caused by an unexpected drug-related event that is not listed in the 
consent form, Sponsor will revise the consent form appropriately and submit it to the IRB. 
All subjects will be advised of the new toxicity and their willingness to continue on study 
will be confirmed. When the amended consent form is approved by the IRB, all subjects 
remaining on the study will be asked to sign the amended consent form.


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11.
STATISTICAL CONSIDERATIONS
11.1 
General Considerations 
A statistical analysis plan (SAP) will be provided that gives a complete description of the 
statistical methods to be used in this study. The SAP will describe the methods and data 
presentation to be used for the analysis of safety, efficacy, and PK outcome data. If analyses 
in the SAP do not align with the analyses described here, the SAP will identify where those 
methods differ. 
Analyses will be carried out by study part (Part 1 and Part 2). For Part 1 and Part 2, an 
overall summary will be provided. More detail will be provided in the SAP. 
Descriptive statistics for continuous variables will include number of subjects, mean, 
standard deviations, median, minimum, and maximum. Counts and percentages will be 
provided for categorical/ordinal variables. Unless specified otherwise, denominators for 
percentages will only consider non missing responses. For any summaries that involve 
change from baseline, baseline will be defined as the last measurement obtained prior to first 
injection of study drug. By-subject listings for all subjects will be provided for data collected.
11.2 
Sample Size Considerations 
The sample size determination is not based on statistical power considerations, as the primary 
objective of this study is the assessment of safety and tolerability. However, the number of 
subjects enrolled in each study part should be adequate to meet the safety objectives and to 
provide preliminary evidence of efficacy. 
11.3 
Analysis Populations 
The following populations will be used for the VP-315 study: 
 The Safety Population will include all subjects who take at least 1 dose of VP-315. 
Safety analyses will be conducted using the Safety Population.  
 Full Analysis Set (FAS): this set is a subset of all enrolled subjects, excluding 
subjects who do not receive at least 1 full dose of VP-315 and those with no 
assessment of histologic clearance. The FAS will serve as the primary population for 
the analysis of efficacy-related data.  
 Per-protocol Analysis Set (PPS): this set is a subset of the FAS, excluding subjects 
with important protocol deviations that may substantially affect the results of the 
primary efficacy analyses. The final determination on protocol violations, and thereby 
the composition of the PPS, will be made before clinical database lock. The PPS may 
be used for supportive analyses.  
 PK Analysis Set: this set consists of subjects in the Safety Population with at least 
1 plasma sample with quantifiable concentration of VP-315.


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11.4
Study Endpoints
11.4.1 
Safety Endpoints 
The safety endpoints associated with study objectives for the VP-315 study include the 
following:
 (Part 1, Part 2) Discontinuation due to AEs 
 (Part 1) Occurrence of DLTs 
 (Part 1, Part 2) CRAs 
 (Part 2) TRAEs 
(Part 2) TRAE SIs
(Part 2) Serious TRAEs
11.4.2 
Efficacy Endpoints 
Efficacy endpoints associated with study objectives for the VP-315 study include the 
following:
(Part 2 Cohorts 4 and 5) Complete clearance of treated lesions at excision
 (Part 1, Part 2) Histologic clearance of treated lesions at excision 
 (Part 1, Part 2) Clinical clearance of treated lesions at excision 
 (Part 1, Part 2) Estimate of remaining tumor volume at excision (necrotic cells:tumor 
cells)
 (Part 1, Part 2) Abscopal effect based on nontreated lesions at excision 
 (Part 1, Part 2) PGA
 (Part 2) SCAR-Q, FACE-Q
11.4.3 
Pharmacokinetic Endpoints
Blood samples for PK assessments will only be collected for subjects in Part 2 (Cohorts 4 
and 5 expansion groups) of the study. Pharmacokinetic endpoints of this study are to 
characterize the plasma PK parameters of VP-315 and its metabolites following multiple 
doses of VP-315; standard noncompartmental methods will be used. 


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11.4.4
Exploratory Endpoints
Tumor tissue samples from the pre-treatment screening biopsies and from the post-treatment 
excised tumor tissue will undergo multiplexed IF-IHC and changes in the expression of a 
panel of 8 immune markers in response to the treatment will be analyzed. Additionally,
genomic DNA will be isolated from the same tissue samples, as well as from peripheral 
blood samples collected at the same pre- and post-treatment time points and will undergo 
sequencing and analyzed for changes in T-cell receptor clonality. 
11.5 
Analysis Methods 
11.5.1 
Subject Characteristics and Disposition 
Descriptive summaries of demographic and baseline characteristics for all enrolled subjects 
will be tabulated by study part. The number of subjects included in each analysis population 
will be summarized, along with the reason for exclusion from any analysis populations.
Subjects discontinuing from study drug or withdrawing from the study and the primary 
reason for discontinuation/withdrawal will be summarized. 
11.5.2 
Safety Analyses 
All subjects who receive any amount of study drug will be included in the safety analysis. 
Safety will be evaluated by study part. 
All AEs will be coded using the MedDRA dictionary. Tabular summaries of AEs will only 
consider treatment-emergent adverse events (TEAEs), which are defined as those AEs with a 
start date on or after first dose of study drug. The incidence of TEAEs will be summarized by 
system organ class (SOC), preferred term (PT), relationship to study drug, and severity. 
Serious TEAEs will be summarized by SOC and PT. TEAEs leading to discontinuation as 
well as TEAEs identified as dose limiting toxicities will be listed and summarized if 
sufficient counts of either are reported. 
Hematology and serum chemistries will be summarized using conventional summary 
statistics (mean, standard deviation, median, and range). In addition, a change from baseline 
will be presented. Standard shift tables will also be prepared presenting toxicity grade vs 
baseline.  
Vital signs and ECG results will be summarized in a descriptive manner by calculating the 
mean, standard deviation, median, and range in the same manner described for laboratory 
values. Change from baseline for vital signs and ECG parameters will also be summarized.
For ECG parameters, both QTcB (Bazett’s correction) and QTcF (Fridericia’s correction) 
will be displayed.  
Cutaneous Reaction Assessments will be summarized using counts and percentages for each 
severity level (none, mild, moderate, severe). Separate summaries will be presented for each 
cutaneous reaction type and visit. 


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11.5.3
Efficacy Analyses
Efficacy analyses will be conducted for all lesions of all subjects enrolled in the study and 
carried out by study part.  
Complete clearance will be summarized using counts and percentages. Histological clearance 
and clinical clearance will be summarized using similar methods. Other efficacy endpoints to 
be summarized include estimates of tumor volume, abscopal effect on nontreated lesions, 
PGA, SCAR-Q (Part 2 and 3 only) and FACE-Q (Part 2 and 3 only). Each endpoint will be 
summarized as described in Section 11.1, based on the type of data collected. 
11.5.4 
Pharmacokinetic Analyses 
Blood samples will be collected on the first day of dose administration immediately prior to 
the VP-315 dose and at 2-and 5-minutes post first injection, and 2-, 5-, 10-, 20-, 30-, 60-, and 
120-minutes post last injection. Additional samples will we collected at 24 (±1) hours post-
dose prior to administration of the next VP-315 dose. Blood samples for PK will only be 
collected for subjects in Part2 (Cohorts 4 and 5 expansion groups) of the study.
Concentrations of VP-315 and metabolites will be determined in plasma using a validated 
bioanalytical assay(s). Individual subject VP-315 concentration-time data will be displayed 
using scheduled sampling times. Descriptive statistics (e.g., n, mean, SD, %CV, median and 
range) will be calculated for each sampling time. Plasma concentrations of the study drug 
over time will be plotted in semilogarithmic and linear formats as mean ± SD. Plasma 
concentration-time data for each subject will be analyzed using standard noncompartmental 
methods. Plasma PK parameters of VP-315 and metabolites will include Cmax, Tmax, AUC0-
last, and AUCinf. 
Dose proportionality information will be obtained by comparing plasma levels of VP-315 
across all dose levels. The primary method for evaluation of dose proportionality will be 
based on AUC0-last, AUCinf, AUCtau, and Cmax. The population mean slope will be estimated 
with a 90% CI. An alternate evaluation of dose proportionality will be conducted using 
ANOVA on dose-normalized AUC0-last, AUCinf, and Cmax. The analysis will be conducted on 
log-transformed data. The model will include dose as a fixed effect and subject as random 
effect. Calculations of the 90% CI for the ratio of dose comparisons will be constructed.
Descriptive statistics for VP-315 PK concentrations will be tabulated at each scheduled 
timepoint by cohort. Statistics for PK concentrations will include the number of subjects, 
mean, standard deviation, CV%, median, minimum, maximum, geometric mean, and 
geometric CV%.
Descriptive statistics for VP-315 PK parameters will be provided for Cohorts 4 and 5 
expansion subjects in Part 2. Summaries will include the number of subjects, mean, standard 
deviation, CV%, median, minimum, maximum, geometric mean, and geometric CV% (where 
applicable).


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12.
ETHICAL, LEGAL AND ADMINISTRATIVE ASPECTS
12.1 
Ethical Conduct of the Study  
The procedures set out in this protocol, pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that the Sponsor, its authorized 
representative, and investigators abide by Good Clinical Practice (GCP) as described in 
International Council for Harmonisation (ICH) guideline E6(R2), and in 21 CFR parts 11, 50, 
54, 56, and 312. Compliance with these regulations also constitutes compliance with the 
ethical principles described in the most recent revision of the Declaration of Helsinki 
(October 2013) that is recognized by the US Food and Drug Administration (FDA), the 
European Medicines Agency, and other regulatory agencies.  
12.2 
Informed Consent 
A template ICF will be provided by the Sponsor or designee. According to the Protection of 
Human Subjects regulations listing in 21 CFR Part 50, the ICF must be reviewed and 
approved by the IRB and must contain all elements required, as applicable, by national or 
local laws/regulations or requirements, US FDA regulations or regulations of the authority 
having jurisdiction over the location in which the study is being conducted, and institutional 
policies. If, during the approval process, the IRB makes any substantive changes to the ICF, 
then this altered ICF must be provided to the Sponsor or designee for review before it is 
implemented. 
All subjects will be provided with the approved written ICF for this study, which will provide 
sufficient information for the subject to make an informed decision about participation in this 
study and to facilitate comprehension of the information. Each subject will be provided 
adequate opportunity to ask questions and to consider whether to participate. The investigator 
is responsible for obtaining the potential subject’s voluntary agreement to participate, and to 
continue providing information as the clinical study progresses or as the subject or situation 
requires.  
Voluntary informed consent must be obtained from each eligible subject before any protocol-
defined procedures are performed. The subject’s signature on the ICF indicates his/her 
willingness to participate in this study. Other study personnel (e.g., Principal Investigator, 
Study Nurse) will sign the ICF in accordance with local procedures. 
12.3 
Institutional Review Board 
A copy of the protocol, proposed ICF, other written subject information, and any proposed 
advertising material must be submitted to the IRB for written approval. A copy of the written 
approval of the protocol and ICF must be received by Sponsor before recruitment of subjects 
into the study and shipment of VP-315. 
The investigator must submit and, where necessary, obtain approval from the IRB for all 
subsequent protocol amendments and changes to the ICF. The investigator is to notify the 
IRB of deviations from the protocol or SAEs occurring at the site and other AE reports 
received from Sponsor, in accordance with local procedures. 


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The investigator is responsible for obtaining annual IRB approval/renewal throughout the 
duration of the study. Copies of the investigator’s reports and the IRB continuance of 
approval must be sent to Sponsor.
12.4 
Subject Confidentiality 
All information generated in this study is considered highly confidential and must not be 
disclosed to any person or entity not directly involved with the study unless prior written 
consent is gained from the Sponsor. However, authorized regulatory officials, IRB personnel, 
the sponsor and its authorized representatives are allowed full access to the records. 
All study subjects must be informed that their personal study-related data will be used by the 
Sponsor in accordance with local data protection laws. The types of disclosure must also be 
explained to the subject, who will be required to be informed about how their data will be 
used as described in the ICF. The subjects must be informed that their medical records may 
be examined by auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB members, and by inspectors from regulatory authorities. 
Identification of subjects and eCRFs shall be by unique subject identification numbers (such 
as screening number) only. All personal identifiers according to applicable regulations (e.g., 
name, phone number) must be redacted permanently by the site personnel and replaced with 
the subject’s unique identification number in all records and data before transfer to the 
Sponsor (or designee). 
All personal details will be treated as confidential by the investigator and staff. 
12.5 
Investigator Signatory Obligations 
The investigator is to sign each clinical study report. 
 


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13.
ADMINISTRATIVE AND LEGAL OBLIGATIONS
13.1 
Protocol Amendments and Study Termination
Protocol amendments, except when necessary to eliminate an immediate hazard to subjects, 
must be made only with the prior approval of the Sponsor. Agreement from the investigator 
must be obtained for all protocol amendments and amendments to the ICF. The IRB must be 
informed of all amendments and give approval prior to their implementation. The Sponsor 
will submit any study protocol amendments to the concerned regulatory authorities for 
approval and keep the investigator updated as detailed in the ICH GCP guidelines. The 
amendment must be signed by the investigator and approved prior to implementation, except 
if amendments are issued to eliminate an immediate hazard(s); in such case the amendment 
may be retrospectively approved. The investigator should not implement a change to the 
protocol without prior review and documented approval/favorable opinion of the IRB of an 
amendment, except where to eliminate an immediate hazard(s) to the study subjects.
Where only administrative changes are required to the protocol, the IRB will be notified for 
informational purposes only. 
Sponsor reserves the right to terminate the study at any time. Both Sponsor and the 
investigator reserve the right to terminate the investigator’s participation in the study 
according to the study contract. The investigator is to notify the IRB in writing of the study’s 
completion or early termination (ET) and send a copy of the notification to Sponsor. 
13.2 
Study Documentation and Archive
The Principal Investigator shall retain all study-related documentation, including source data, 
source documents, eCRFs, laboratory and diagnostic results, protocol and amendments, study 
drug accountability records, regulatory documentation and correspondence, ICFs, patient 
identification lists, and correspondence. These records should be retained in the format they 
were originally obtained (e.g., electronic or paper) unless a quality controlled and authorized 
complete electronic version is created for long-term storage at the end of the study. The 
Sponsor will provide an electronic copy of the final eCRF for each study subject within 3
months of study closeout. 
The investigator must retain an organized file with all study-related documentation that is 
suitable for inspection by the Sponsor and representatives of Regulatory Authorities. 
The investigator shall retain all study records for the longer of 1) 2 years after the last 
marketing authorization for the investigational product has been approved or Sponsor has 
discontinued research on the investigational product, and 2) such longer period as required by 
regulatory requirements. 
Documents should be stored in such a way that they can be accessed, and data can be 
retrieved at a later date. Consideration should be given to security and environmental risks. 
Documentation retention will generally comply with Section 8 of the ICH consolidated 
guideline on GCP, Essential Documents for the Conduct of a Clinical Trial. 


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No study document will be destroyed without prior written agreement between the Sponsor 
and the investigator, or the Research Site should the investigator leave the institution. Should 
the investigator wish to assign the study records to another party or move them to another 
location, written agreement must be obtained from the Sponsor prior to any actions being 
taken.
13.3 
Study Monitoring and Data Collection 
Clinical research associates (CRAs) representing the Sponsor will routinely visit the study 
site or develop a remote monitoring strategy throughout the study. The investigator will 
ensure that the monitor, or other compliance or quality assurance reviewer, is given access to 
all study-related documents and study related facilities (e.g., pharmacy, diagnostic 
laboratory, medical records), and, if the visit occurs on site, has adequate space to conduct 
the monitoring visit. In addition to the monitoring visits, frequent communications (email, 
letter, telephone, and/or fax) by the CRA will ensure that the investigation is conducted 
according to protocol design and regulatory requirements. The investigator, or appropriate 
designee, will allocate adequate time for monitoring activities and F/U correspondences.  
The CRA will review ICFs, eCRFs, and laboratory and other diagnostic reports, comparing 
them with source documents to verify adherence to the protocol, and to ensure complete, 
accurate, consistent, and timely collection of data. The CRA will record and report any 
protocol deviations not previously sent to the Sponsor. The CRA will also confirm that AEs 
and SAEs have been properly documented on eCRFs and confirm that any SAEs have been 
forwarded to the Sponsor and those SAEs that met criteria for reporting have been forwarded 
to the IRB. The investigator will be asked to provide any missing information or to clarify 
any discrepancies found by the CRA. For on-site monitoring visits, it is expected that the 
investigator will be present for a concluding review at the end of each monitoring visit. 
Remote monitoring may be done if feasible, per the Monitoring Plan. 
13.4 
Publication Policy 
This study will be registered at ClinicalTrials.gov and after study completion, results 
information from this study will be posted to ClinicalTrials.gov. In addition, every attempt 
will be made to publish results in peer-reviewed journals. Publication of the results by the 
investigator will be subject to mutual written agreement between the investigator and the 
Sponsor or determined by the publication/steering committee prior to preparation of the 
publication. 
 


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14.
REFERENCES
Adalsteinsson JA, Ratner D, Olafsdóttir E, et al. Basal cell carcinoma: an emerging epidemic 
in women in Iceland. British Journal of Dermatology. 2020;183(5):847-856.  
American Academy of Dermatology Association (AAD). Skin Cancer; Incidence Rates. 
Accessed 01 February 2021. https://www.aad.org/media/stats-skin-cancer 
Camilio KA, Berge G, Ravuri CS, Rekdal O, Sveinbjørnsson B. Complete regression and 
systemic protective immune responses obtained in B16 melanomas after treatment with 
LTX-315. Cancer Immunol Immunother. 2014;63(6):601-613.  
Diffey B, Langtry J. Skin cancer incidence and the ageing population. British Journal Of 
Dermatology. 2005;153(3):679-680.  
Forveille S, Zhou H, Sauvat A, et al. The oncolytic peptide LTX-315 triggers necrotic cell 
death. Cell Cycle. 2015;14(21):3506-3512.  
Goldenberg G, Karagiannis T, Palmer JB, et al. Incidence and prevalence of basal cell 
carcinoma (BCC) and locally advanced BCC (LABCC) in a large commercially insured 
population in the United States: A retrospective cohort study. Journal of the American 
Academy of Dermatology. 2016;75(5):957-966.e2.  
Guy GP, Machlin SR, Ekwueme DU, Yabroff KR. Prevalence and Costs of Skin Cancer 
Medicine. 2015;48(2):183-187.  
Hancock RE. Cationic peptides: effectors in innate immunity and novel antimicrobials. 
Lancet Infect Dis. 2001;1(3):156-164. 
Jebsen NL, Apelseth TO, Haugland HK, et al. Enhanced T-lymphocyte infiltration in a 
desmoid tumor of the thoracic wall in a young woman treated with intratumoral injections of 
the oncolytic peptide LTX-315: a case report. J Med Case Rep. 2019;13(1):177.  
Kantor, J. The SCAR Scale (Scar Cosmesis Assessment and Rating Scale): Development and 
validation of a new outcome measure for postoperative scar assessment. British Journal of 
Dermatology. 2016;175(6), pp1394-1396. 
Karimkhani C, Boyers LN, Dellavalle RP, Weinstock MA. It’s time for “keratinocyte 
carcinoma” to replace the term “nonmelanoma skin cancer.” J Am Acad Dermatol. 
2015;72(1):186-187. 
Liao H-W, Garris C, Pfirschke C, et al. LTX-315 sequentially promotes lymphocyte-
independent and lymphocyte-dependent antitumor effects. Cell Stress. 2019;3(11):348-360.  
Madan V, Lear JT, Szeimies R-M. Non-melanoma skin cancer. The Lancet. 
2010;375(9715):673-685.  
Nestvold J, Wang M-Y, Camilio KA, et al. Oncolytic peptide LTX-315 induces an immune-
mediated abscopal effect in a rat sarcoma model. Oncoimmunology. 2017;6(8):e1338236.  


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Papo N, Shai Y. Host defense peptides as new weapons in cancer treatment. Cell Mol Life 
Sci. 2005;62(7-8):784-790.  
Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of 
Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the US Population, 2012. JAMA 
Dermatol. 2015;151(10):1081.  
Skin Cancer Foundation. Skin Cancer Facts and Statistics. Accessed 01 February 2021. 
https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/  
Spicer J, Marabelle A, Baurain J-F, et al. Safety, Antitumor Activity, and T-cell Responses in 
a Dose-Ranging Phase I Trial of the Oncolytic Peptide LTX-315 in Patients with Solid 
Tumors. Clin Cancer Res. 2021;27(10):2755-2763. 
Sveinbjørnsson B, Camilio KA, Haug BE, Rekdal Ø. LTX-315: a first-in-class oncolytic 
peptide that reprograms the tumor microenvironment. Future Med Chem. 2017;9(12):1339-
1344.  
Wu S, Han J, Li W-Q, Li T, Qureshi AA. Basal-cell carcinoma incidence and associated risk 
factors in U.S. women and men. Am J Epidemiol. 2013;178(6):890-897.  
Zasloff M. Antimicrobial Peptides in Health and Disease. New England Journal of Medicine. 
2002;347(15):1199-1200. 


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15.
APPENDICES
 


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Appendix 1
Cutaneous Reaction Assessment*
Evaluate the tissue condition at the treatment site for the presence and severity of each of the 
following cutaneous reactions. 
 
Reaction 
Target Lesions 
Nontarget Lesions 
Lesion 1 
Lesion 2 
Lesion 1 
Lesion 2 
Lesion 3 
Erythema 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
Induration 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
moderate
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
Swelling 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
moderate
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
Blister 
Formation 
 none 
 mild 
moderate
 severe 
 none 
 mild 
moderate
 severe 
 none 
 mild 
moderate
 severe 
 none 
 mild 
moderate
 severe 
 none 
 mild 
moderate
 severe 
Desquamation 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 


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Evaluate the tissue condition at the treatment site for the presence and severity of each of the 
following cutaneous reactions. 
 
Reaction 
Target Lesions 
Nontarget Lesions 
Lesion 1
Lesion 2
Lesion 1
Lesion 2
Lesion 3
Erosion 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
Ulceration 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
Necrosis 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
moderate
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
 none 
 mild 
 moderate 
 severe 
Orenberg EK, Miller BH, Greenway HT, et al. The effect of intralesional 5-fluorouracil therapeutic implant (MPI 5003) 
for treatment of basal cell carcinoma. J Am Acad Dermatol. 1992;27(5 Pt 1):723-728. 
*Complete the assessment for each reaction and for any reaction that is Mild, Moderate or Severe 
enter event on the Adverse Event Page
 


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Appendix 2
Physician’s Global Assessment
 
Global Assessment of Improvement
Nontarget Lesions 
Lesion 1 
Lesion 2 
Lesion 3 
 100% improvement, no 
visible tumor 
 75% to <100% improvement 
  50% to <75% improvement 
  25% to <50% improvement 
  up to 25% improvement 
  no change 
  worse 
 100% improvement, no visible 
tumor 
 75% to <100% improvement 
 50% to <75% improvement 
 25% to <50% improvement 
  up to 25% improvement 
 no change 
 worse 
 100% improvement, no visible 
 tumor 
 75% to <100% improvement 
 50% to <75% improvement 
 25% to <50% improvement 
 up to 25% improvement 
 no change 
 worse 
Target Lesions
Lesion 1
Lesion 2
 100% improvement, no visible tumor 
 75% to <100% improvement 
 50% to <75% improvement 
 25% to <50% improvement 
 up to 25% improvement 
 no change 
 worse 
 100% improvement, no visible tumor 
 75% to <100% improvement 
 50% to <75% improvement 
 25% to <50% improvement 
 up to 25% improvement 
 no change 
 worse 
 
Orenberg EK, Miller BH, Greenway HT, et al. The effect of intralesional 5-fluorouracil therapeutic implant (MPI 5003) 
for treatment of basal cell carcinoma. J Am Acad Dermatol. 1992;27(5 Pt 1):723-728. 


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Appendix 3
SCAR-Q
The SCAR-Q© is a rigorously developed patient-reported outcome (PRO) instrument that can 
be used to collect and compare evidence-based outcomes data from children and adults aged 
8 years and older with a surgical, traumatic, or burns scar. 
 
http://qportfolio.org/wp-content/uploads/2020/02/SCAR-Q-USERS-GUIDE-V1.pdf 


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Appendix 4
FACE-Q
The FACE-Q© is a PRO measure that can be used to measure outcomes of aesthetic facial 
procedures and products from the patient’s perspective. The FACE-Q© can be used to 
measure outcomes for any type of surgical or minimally invasive facial aesthetic treatment.
This PRO instrument has been used to evaluate the safety and effectiveness of facial aesthetic 
treatments in numerous clinical trial settings and to inform patient care in clinical practice.
The FACE-Q© is composed of a set of 39 independently functioning scales/checklists that 
measure 3 overarching domains: Facial Appearance, Health-Related Quality of Life, and 
Adverse Effects. These domains form the basis of the FACE-Q© conceptual framework (see 
link below). The FACE-Q© modular approach means that only the subset of scales most 
relevant to a specific research objective or clinical patient population need be administered. 
 
http://qportfolio.org/wp-content/uploads/2020/02/FACE-Q-AESTHETICS-USER-GUIDE-
V1.pdf


LTX-315 
Protocol VP-315-201 – Amendment 8 
Page 94 of 94 
Verrica Pharmaceuticals Inc.  
Confidential 
13 October 2023 
Appendix 5
Scar Cosemesis and Rating Scale (SCAR)
 

SAP_001.pdf: 
A Phase 2, Multicenter, Open-label, Proof of-Concept Study 
with Safety Run-in to Evaluate the Safety, Pharmacokinetics, 
and Efficacy of VP-315 in Adult Subjects with Basal Cell 
Carcinoma 
 
NCT05188729 
 
Statistical Analysis Plan Version/Date: 1.0: 6-Sep-2024 


 
1 
 
Statistical Analysis Plan 
 
 
 
 
This study will be conducted in compliance with the protocol, Good Clinical Practice, 
and all other applicable regulatory requirements, including the archiving of 
essential documents. 
Confidential Information 
No use or disclosure outside Verrica Pharmaceuticals Inc. is permitted without prior 
written authorization from Verrica Pharmaceuticals Inc.
Protocol Title 
A Phase 2, Multicenter, Open-label, Proof-of-concept 
Study with Safety Run-in to Evaluate the Safety, 
Pharmacokinetics, and Efficacy of VP-315 in Adult 
Subjects with Basal Cell Carcinoma 
Protocol Number 
VP-315-201 
Protocol Version 
Protocol Date 
9.0 (Amendment 8) 
13-Oct-2023 
Sponsor 
Verrica Pharmaceuticals Inc. 
44 West Gay Street, Suite 400 
West Chester, PA 19380 
SAP Version 
SAP Date 
1.0 
6-Sep-2024 
SAP Author 
Carrie Kaempfer 
Manager, Biostatistics 
Veristat LLC 


Verrica Pharmaceuticals Inc.
Statistical Analysis Plan
Protocol: VP-315-201
06-Sep-2024
2
SAP Document History
Version
Author
Date 
Change
V1.0
Carrie Kaempfer
6 September 
2024
Not Applicable
Signatures / Approvals
Verrica Pharmaceuticals Inc.
Date
Veristat LLC
Date


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
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Table of Contents 
List of Abbreviations .......................................................................................................... 5 
1. 
Introduction ................................................................................................................. 7 
2. 
Objectives and Endpoints ............................................................................................ 7 
3. 
Study Design.............................................................................................................. 10 
3.1. Part 1 (N = 10) .................................................................................................. 10 
3.2. Part 2 (N = 82) .................................................................................................. 10 
3.3. Cohort 1 (N = 6) ............................................................................................... 10 
3.4. Cohort 2 (N = 3) ............................................................................................... 11 
3.5. Cohort 3 (N = 0) ............................................................................................... 11 
3.6. Cohort 4 (N = 36 [10 initial / 26 expansion] at two times weekly dosing) ...... 11 
3.7. Cohort 5 (N = 37 [10 initial / 27 expansion] at three times weekly dosing) .... 11 
4. 
Dose-limiting Toxicity and Treatment-related Adverse Event of Special Interest ... 12 
4.1. Treatment-related Adverse Events ................................................................... 12 
5. 
Statistical Considerations .......................................................................................... 12 
5.1. Determination of Sample Size .......................................................................... 13 
5.2. Inferential and Descriptive Statistics ................................................................ 13 
5.3. Multiplicity/Multiple Comparisons .................................................................. 14 
5.4. Covariate Adjustments and Multicenter Analysis ............................................ 14 
5.5. Definition of Baseline and Treatment Groups ................................................. 14 
5.6. Handling Dropouts and Missing Data .............................................................. 14 
5.7. Statistical Programming ................................................................................... 14 
5.8. Coding Dictionaries .......................................................................................... 15 
5.9. Data Monitoring and Safety Review ................................................................ 15 
6. 
Analysis Populations ................................................................................................. 15 
7. 
Population Analysis ................................................................................................... 17 
7.1.1. 
Subject Disposition ................................................................................. 17 
7.1.2. 
Treatment Termination ........................................................................... 18 
7.2. Protocol Deviations .......................................................................................... 19 
7.3. Demographics and Baseline Characteristics .................................................... 20 


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Statistical Analysis Plan 
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7.4. Prior and Concomitant Medications ................................................................. 21 
7.5. Medical History ................................................................................................ 22 
7.6. Administration of Study Treatment .................................................................. 23 
8. 
Efficacy Analysis ....................................................................................................... 24 
8.1. Histologic Clearance of Treated Lesions at Excision ...................................... 24 
8.2. Clinical Clearance of Treated Lesions at Excision .......................................... 25 
8.3. Estimate of Remaining Tumor Volume and Reduction in Tumor Volume at 
Excision ..................................................................................................................... 26 
8.4. Abscopal Effect Based on Non-treated Lesions at Excision ............................ 26 
8.5. Physician Global Assessment ........................................................................... 27 
8.6. Complete Clearance of Treated Lesions at Excision ........................................ 27 
8.7. Sensitivity Analysis .......................................................................................... 28 
9. 
Safety Analysis .......................................................................................................... 28 
9.1. Adverse Events ................................................................................................. 28 
9.2. Clinical Laboratories ........................................................................................ 31 
9.3. Vital Signs Including Height and Weight ........................................................ 33 
9.4. Electrocardiogram ............................................................................................ 35 
9.5. Cutaneous Reaction Assessment ...................................................................... 38 
9.6. Dermatologic and Physical Examinations ........................................................ 38 
9.7. Pregnancy Tests and Partner Pregnancy .......................................................... 39 
10. Treatment Satisfaction Analysis ................................................................................ 40 
10.1. SCAR-Q  Appearance Scale ........................................................................... 40 
10.2. FACE-Q  Psychological Function .................................................................. 41 
10.3. Scar Assessment ............................................................................................... 42 
10.4. Scar Cosmesis Assessment and Rating Scale ................................................... 43 
11. Immune Response and Genomic Analyses ............................................................... 44 
12. Pharmacokinetic Analysis ......................................................................................... 44 
13. Differences Between Protocol and Statistical Analysis Plan .................................... 45 
14. Where Statistical Analysis Plan Differs from Protocol ............................................. 45 
15. Minor Changes in Displays ....................................................................................... 46 
16.  References ................................................................................................................. 46 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
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List of Abbreviations 
AE 
 
 
Adverse Event 
ALP 
 
 
Alkaline Phosphatase 
ALT 
 
 
Alanine Aminotransferase 
AST 
 
 
Aspartate Aminotransferase 
ATC  
 
Anatomical Therapeutic Chemical 
ATCC  
 
ATC Classification 
AUC  
 
Area under the plasma concentration-time curve 
BCC  
 
Basal Cell Carcinoma 
BMI 
 
 
Body Mass Index 
BP 
 
 
Blood Pressure 
BUN  
 
Blood Urea Nitrogen 
CRA  
 
Cutaneous Reaction Assessment 
CS 
 
 
Clinically Significant 
CSR 
 
 
Clinical Study Report 
CV 
 
 
Coefficient of Variation 
DLT 
 
 
Dose-limiting Toxicity 
DMP  
 
Data Management Plan 
Dy 
 
 
Day y, where y = 1, 2, 3 
ECG   
 
Electrocardiogram 
EDC  
 
Electronic Data Capture 
EOS 
 
 
End of Study 
EOT 
 
 
End of Treatment 
FACE-Q 
 
Patient-reported outcome measure for facial procedures 
FA 
 
 
Full Analysis 
ICH 
 
 
International Conference on Harmonization 
LDH  
 
Lactic Dehydrogenase 
LLQ 
 
 
Lower Limit of Quantitation 
MCHC 
 
Mean Corpuscular Hemoglobin Concentration 
MCV  
 
Mean Corpuscular Volume 
MedDRA 
 
Medical Dictionary for Regulatory Activities 
MTD  
 
Maximum Tolerated Dose 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
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NCS 
 
 
Not Clinically Significant 
NTL 
 
 
Non-target Lesion 
PGA  
 
Physician Global Assessment 
PK 
 
 
Pharmacokinetic 
PN 
 
 
Preferred Name 
PP 
 
 
Per-protocol 
PT 
 
 
Preferred Term 
RBC  
 
Red Blood Cell Count 
RT 
 
 
Reported Term 
SCAR  
 
Scar Cosmesis Assessment and Rating Questionnaire 
SCAR-Q 
 
Patient-reported outcome measure for scars (Note: not SCAR) 
SAE 
 
 
Serious Adverse Event 
SAF 
 
 
Safety 
SAP 
 
 
Statistical Analysis Plan 
SD 
 
 
Standard Deviation 
SGOT  
 
Serum Glutamic Oxaloacetic Transaminase 
SGPT  
 
Serum Glutamic Pyruvic Transaminase 
SOC 
 
 
System Organ Class 
SRC 
 
 
Safety Review Committee 
TEAE  
 
Treatment-emergent Adverse Event 
TL 
 
 
Target Lesion 
TRAE  
 
Treatment-related Adverse Event (same as related TEAE) 
TRAE SI 
 
TRAE of Special Interest 
ULQ  
 
Upper Limit of Quantitation 
WBC  
 
White Blood Cell Count 
WxDy  
 
Week x Day y, where x = 1, 2 and y = 1, 2, 3 
WHO  
 
World Health Organization 
Wx 
 
 
Week x, where x = 1, 2 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
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1. 
Introduction 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting for 
Verrica Pharmaceuticals Inc. protocol number VP-315-
Multicenter, Open-label, Proof-of-concept Study with Safety Run-in to Evaluate the 
Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects with Basal Cell 
 
This is an open-label, multicenter, proof-of-concept study with a safety run-in designed to 
assess the safety, tolerability, maximum tolerated dose (MTD), and objective antitumor 
efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal 
cell carcinoma (BCC). 
Conveyed in this SAP are the planned analyses of the primary, secondary, and 
exploratory endpoints.  This SAP and any modifications or changes must be finalized 
before the database is locked. 
2. 
Objectives and Endpoints 
The following objectives and endpoints will be considered. 
 
Part 1 
Primary Objectives 
Endpoints 
 To assess the safety, tolerability, 
and maximum tolerated dose 
(MTD) of ascending dose 
strengths of VP-315 
 Discontinuations due to adverse events 
(AEs); occurrence of dose-limiting 
toxicities (DLTs) 
 Cutaneous Reaction Assessment (CRA)
Exploratory Objectives 
Endpoints 
 To evaluate the objective antitumor 
efficacy of VP-315 
 Histological clearance of treated lesion(s) 
at excision 
 Clinical clearance of treated lesion(s) as 
determined by visual assessment (no 
tumor seen upon visible inspection) at 
excision 
 Estimate of remaining tumor 
volume (necrotic cells:tumor cells) 
at excision 
 Estimate of reduction in tumor 
volume (necrotic cells:tumor cells) 
at excision* 
 Abscopal effect as determined by 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
8 
 
clinical and histological clearance of 
nontreated lesions at excision 
 Physician Global Assessment (PGA) 
Part 2 (Cohorts 1 and 2) 
Primary Objectives 
Endpoints 
 To determine the optimal regimen for 
dosing 8 mg of VP-315 based on safety 
and tolerability 
 Treatment-related AEs; treatment-
related serious adverse events (SAEs); 
discontinuations due to AEs; occurrence 
of TRAEs of special interest 
 CRA 
Secondary Objectives 
Endpoints 
 To evaluate the antitumor efficacy of 
VP- 315 
 Clinical clearance of treated lesion at 
excision as determined by visual 
assessment (no residual tumor seen on 
visual inspection) 
 Histological clearance of treated lesion(s) 
at excision 
 Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision if nontreated lesions 
exist 
 Estimate of remaining tumor 
volume (necrotic cells:tumor cells) 
at excision 
 Estimate of reduction in tumor 
volume (necrotic cells:tumor cells) 
at excision* 
 PGA 
Exploratory Objectives 
Endpoints 
 To assess the immune response to VP-
315 treatment in a subset of subjects by 
assessing the immune repertoire in 
blood and in tissue 
 Multiplex immunohistochemical 
staining for T-cell subsets and immune 
activation markers in tumor tissue 
samples 
 Analysis of T-cell clonality in blood 
and tumor tissue samples 
 To assess subject satisfaction with 
the treatment
 
SCAR-Q, FACE-Q 
Part 2 (Cohorts 4 and 5) 
Primary Objectives 
Endpoints 
 To gain additional information on the 
 Treatment-related AEs; treatment-


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
9 
 
safety, tolerability, and dosing regimen 
of VP-315 to support a pivotal study 
protocol design 
related serious adverse events (SAEs); 
discontinuations due to AEs; occurrence 
of TRAEs of special interest 
 CRA 
Secondary Objectives 
Endpoints 
 To confirm the antitumor efficacy of 
VP- 315 using the optimal dosing 
regimen determined in Part 2 
 Clinical clearance of treated lesion at 
excision as determined by visual 
assessment (no residual tumor seen on 
visual inspection) 
 Histological clearance of treated lesion(s) 
at excision 
 Abscopal effect as determined by clinical 
and histological clearance of nontreated 
lesions at excision if nontreated lesions 
exist 
 Estimate of remaining tumor 
volume (necrotic cells:tumor cells) 
at excision 
 Estimate of reduction in tumor 
volume (necrotic cells:tumor cells) 
at excision* 
 PGA 
 To characterize the pharmacokinetics 
(PK) of an 8 mg dose of VP-315 
administered with the optimal dosing 
regimen determined in Part 2.
 Plasma VP-315 concentrations 
Exploratory Objectives 
Endpoints 
 To assess subject and physician 
satisfaction with the treatment 
 SCAR-Q, FACE-Q 
 Scar Cosmesis Assessment and 
Rating (SCAR) Scale
 To assess the immune response to VP-
315 treatment in a subset of subjects by 
assessing the immune repertoire in 
blood and in tissue 
 Multiplex immunohistochemical 
staining for T-cell subset and immune 
activation markers in tumor tissue 
samples 
 Analysis of T-cell clonality in blood 
and tumor tissue samples
*Additional endpoint not included in protocol. Further details are included in section 14.  
 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
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3. 
Study Design 
This is a two-part study with sequential enrollment.  All enrolled subjects will receive 
VP-315 intratumoral injections on an outpatient basis into up to two target lesions (TLs) 
and up to three non-target lesions (NTLs) will not be injected.  Dosing will commence in 
a single TL.  This study was expected to enroll approximately 80 subjects with a 
histologic diagnosis of BCC in at least one eligible TL (confirmed by punch or shave 
biopsy).  Up to 15 study sites in the US will participate.  The Schedule of Assessments 
can be found in Section 8.3 of the protocol. 
3.1. 
Part 1 (N = 10) 
Subjects are to receive VP- 315 via once-daily dosing, with a starting total daily dose of 2 
mg for the first cohort, escalating in 1 mg increments for subsequent cohorts after the 
current cohort has completed Week 1 dosing (the DLT observation period) and no DLT is 
observed.  The planned dosing regimen is a split dose of VP-315 for all treatments.  The 
irst injection and 
 
Subjects are to be treated until the lesion is necrosed or a DLT occurs, for a maximum of 
2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3  up to 6 total doses 
increasing from the starting dose in 1 mg increments) and a maximum total daily dose of 
8 mg.  If the treated lesion necrosed and the subject has additional lesions, treatment of 
the next lesion may begin on D1 of the next week.  A maximum of 2 TLs may be treated, 
and only 1 lesion may be treated at a time.  DLT or visual confirmation of necrosis of all 
TLs will result in termination of VP-315 dosing. 
3.2. 
Part 2 (N = 82) 
Subjects receive VP-315 via once-daily dosing, which is to be a total daily dose of 8 mg 
in up to 5 cohorts (i.e., there were no DLTs that occurred during Part 1, and the 
maximum dose of 8 mg was achieved). 
3.3. 
Cohort 1 (N = 6) 
Subjects receive VP-315 via once-daily dosing of 8 mg with a loading dose of half the 
target dose of 8 mg (i.e., 4 mg) only on W1D1; all remaining doses are to be the full 
target dose without a loading dose.  Subjects are to be treated until the lesion is necrosed, 
for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3  up to 6 
total doses).  If the treated lesion necrosed and the subject has additional lesions, 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
11 
 
treatment of the next lesion may begin on D1 of the next week.  A maximum of 2 TLs 
may be treated, and only 1 lesion may be treated at a time. 
3.4. 
Cohort 2 (N = 3) 
Subjects receive VP-315 via once-daily dosing of 8 mg on all treatment days (i.e., no 
loading dose on W1D1).  Subjects are to be treated until the lesion is necrosed, for a 
maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3  up to 6 total 
doses).  If the treated lesion necrosed and the subject has additional lesions, treatment of 
the next lesion may begin on D1 of the next week.  A maximum of 2 TLs may be treated, 
and only 1 lesion may be treated at a time. 
3.5. 
Cohort 3 (N = 0) 
This cohort has been removed at the recommendation of the Safety Review Committee 
(SRC). 
3.6. 
Cohort 4 (N = 36 [10 initial / 26 expansion] at two times weekly dosing) 
Subjects receive VP-315 via once-daily dosing of 8 mg, administered on 2 consecutive 
days in one week (W1D1, W1D2).  The planned dosing regimen is a split dose of VP-315 
for all treatments.  The 500µL (8 mg) dose is to be divided into 2 injections given at least 
15 minutes and no more than 30 minutes apart, with 30% (150 µL) administered in the 
first injection and the remaining 70% (350 µL) with the second injection.  Treatment for 
a second TL may begin on D1 of the next week (W2D1, W2D2).  Each individual TL is 
treated for the assigned 2 days only (regardless of necrosis status).  Up to 2 TLs may be 
treated  up to 4 total doses.  Subjects with only 1 TL who complete week one of 
treatment without complete necrosis receive no additional treatment. 
3.7. 
Cohort 5 (N = 37 [10 initial / 27 expansion] at three times weekly dosing) 
Subjects receive VP-315 via once-daily dosing of 8 mg, administered on 3 consecutive 
days in one week (W1D1, W1D2, W1D3).  The planned dosing regimen is a split dose of 
VP-315 for all treatments.  The 500µL (8 mg) dose is to be divided into 2 injections 
given at least 15 minutes and no more than 30 minutes apart, with 30% (150 µL) 
administered in the first injection and the remaining 70% (350 µL) with the second 
injection.  Treatment for a second TL may begin on D1 of the next week (W2D1, W2D2, 
W2D3).  Each individual TL is treated for the assigned 3 days only (regardless of 
necrosis status).  Up to 2 TLs may be treated  up to 6 total doses.  Subjects with only 1 
TL who complete week one of treatment without complete necrosis receive no additional 
treatment. 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
12 
 
4. 
Dose-limiting Toxicity and Treatment-related Adverse Event of 
Special Interest 
For Part 1 of the study, a dose-limiting toxicity (DLT) is defined as any of the following 
treatment-related adverse events (TRAEs) that occurs during the DLT period. 
 
For Part 2 of the study, a treatment-related adverse event of special interest (TRAE SI) is 
defined as any TRAE that occurs during the treatment visit and meets the criteria below. 
 
4.1. 
Treatment-related Adverse Events 
TRAEs are treatment-emergent adverse events that are related to study treatment.  
Adverse events (AEs) considered DLTs (Part 1) or TRAEs SI (Part 2) are defined as 
follows.  AEs considered DLTs or TRAEs SI are captured in EDC. 
 Hypotension meeting any of the following definitions: 
o > 20 mmHg decrease in systolic blood pressure (BP) with absolute 
systolic BP < 100 mmHg, or 
o > 20 mmHg decrease in systolic BP with clinical symptoms, or 
o absolute diastolic BP < 60 mmHg 
 Significant elevation of serum tryptase concentration is defined as an increase of 
(1.2 × baseline value) + 2 
 Any Grade 2 or higher AE occurring between start of dose administration and the 
end of the post-dose observation period on any given treatment day 
 Any Grade 2 or higher AE considered by the investigator to be related to the 
investigational product 
 Any Grade 2 or higher local reactogenic AE (injection site pain, erythema, 
induration) 
 Any Grade 2 or higher systemic reactogenic AEs (fever, myalgia, headache) 
5. 
Statistical Considerations 
The statistical analyses will be reported using summary tables and data listings.  
Numbering for the displays will be based on the recommended numbering convention 
provided by the International Conference on Harmonization (ICH). 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
13 
 
5.1. 
Determination of Sample Size 
No sample size calculations will be performed.  However, the number of subjects 
enrolled in each study part should be adequate to meet the safety objectives and to 
provide preliminary evidence of efficacy. 
5.2. 
Inferential and Descriptive Statistics 
No formal inferential statistical analyses will be performed.  Descriptive statistics for 
continuous variables will include number of subjects, mean, standard deviation, median, 
minimum, and maximum.  Counts and percentages will be provided for 
categorical/ordinal variables.  Unless specified in a display footnote, denominators for 
percentages will only consider the number of subjects being summarized or the number 
of non-missing responses being summarized, as appropriate.  Conversion factors that may 
be used are as follows: 1 C = 33.8 F; 1 in = 2.54 cm; 1 kg = 2.2 lb; 1 month = 30.4375 
days; 1 year = 365.25 days.  The number of decimal places shown in displays will follow 
as closely as possible the below convention: 
Statistic 
Decimal Places * 
n 
0 
Mean 
1 more than Min, Max 
Standard Deviation 
2 more than Min, Max 
Median 
1 more than Min, Max 
Min, Max 
Same as most common in data 
Percent 
1 
* May be limited to less than stated as space provides 
Tables will be summarized for scheduled visits unless stated otherwise in this SAP, and 
listings will be provided for data collected via the electronic data capture (EDC) system 
and from external vendor(s).  If date of assessment, collection, measurement, and the like 
is not available, then date of visit will be used if available, where applicable.  If there are 
multiple readings taken per visit, the most recent reading from that visit will be used in 
summaries, unless there are pre-dose and post-dose readings taken at the same visit, as 
mentioned elsewhere in this SAP. 
The analyses described in this plan are considered a priori, in that they have been defined 
prior to database lock.  Any analysis added after the database lock will be considered post 
hoc and exploratory.  Post hoc analyses will be labeled as such on the displays.  


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
14 
 
5.3. 
Multiplicity/Multiple Comparisons 
There are no inferential statistical analyses planned for this study, and therefore, there are 
no multiplicity concerns. 
5.4. 
Covariate Adjustments and Multicenter Analysis 
No covariate analyses will be performed.  No multicenter analyses will be performed. 
5.5. 
Definition of Baseline and Treatment Groups 
Baseline is defined as the most recent non-missing value obtained prior to first injection 
of study treatment.  Summaries will be provided for the following groups, unless limited 
to a subset of these groups elsewhere in this SAP: 
 Part 1 
 Part 2 
o Cohort 1 
o Cohort 2 
o Cohort 4 
o Cohort 4 Expansion 
o Cohort 5 
o Cohort 5 Expansion 
o Overall (i.e., Part 2 Total, Displayed Total, or Expansion Total) 
No other group or subgroup analyses will be performed. 
5.6. 
Handling Dropouts and Missing Data 
Unless described otherwise in other sections of this SAP, analyses will be carried out 
with the data available using no imputation for missing data. 
5.7. 
Statistical Programming 
All analyses, tabulations, and validation programming will be performed using SAS 
version 9.4 or higher.  Tables and listings will be presented in PDF format.  SDTM 
datasets will be produced using Version 3.3 of the SDTM Implementation Guide.  ADaM 
datasets will be produced using Version 1.1 of the ADaM Implementation Guide. 
SDTM, ADaM, and tables will be validated by an independent programmer.  The 
validation process will be used to confirm that statistically valid methods have been 
implemented and that all data manipulations and calculations are accurate.  Checks will 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
6-Sep-2024 
15 
 
be made to ensure accuracy, consistency with this SAP, consistency within tables, and 
consistency between tables and corresponding listings. 
5.8. 
Coding Dictionaries 
Medical Dictionary for Regulatory Activities (MedDRA) version 24.1 will be used for 
coding adverse events and medical history excluding prior BCC treatment, procedures, 
and surgeries.  World Health Organization (WHO) Drug Global B3 September 1, 2021 
will be used for coding prior BCC medications and prior and concomitant medications.  
Dictionary up-versioning, if any, will be based on the most recently signed Data 
Management Plan (DMP). 
5.9. 
Data Monitoring and Safety Review 
AEs, SAEs, DLTs, or TRAEs SI determined by the Investigator to be related to VP-315 
administration should be reviewed by the SRC for each cohort initiated.  The SRC should 
evaluate the adverse events for any safety implications of VP-315 and make 
recommendations regarding subsequent enrollment and dosing.  Subjects experiencing a 
DLT or TRAE SI are to be discontinued from treatment per Section 10.2 of the protocol. 
6. 
Analysis Populations 
Enrolled Subjects: Enrolled subjects are subjects who signed the informed consent form 
and were not screen failed.  Enrolled subjects will serve as the population for certain 
analyses as described in this SAP. 
 
Safety (SAF) Population: The Safety Population will include all subjects who received 
at least one injection of VP-315.  The SAF Population will serve as the primary 
population for the analysis of safety-related data. 
 
Full Analysis (FA) Population: The Full Analysis Population will include enrolled 
subjects who received one full dose (actual equals expected for at least one treated lesion) 
of VP-315 (for Part 1 and Part 2 Cohorts 4 and 5, a full dose consists of two injections) 
and have at least one non-missing post-baseline efficacy observation for histologic 
clearance of lesions at excision (see Section 8 of this SAP for details).  The FA 
Population will serve as the primary population for the analysis of efficacy-related data. 
 
Per-protocol (PP) Population: The Per-protocol Population will include FA subjects 
who have no major protocol deviations that may substantially affect the results of the 
efficacy analyses outlined in Section 8 of this SAP.  The final determination on protocol 
violations, and thereby the composition of the PP, will be made before database lock.  


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
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The PP Population will be used as the secondary population for the efficacy analyses 
outlined in Section 8 of this SAP. 
A non-exhaustive list of potential major protocol deviations is provided below: 
 Investigational Product Deviations 
o Subject received wrong treatment 
o Deviation in IP storage 
o Error in IP dosing 
 Enrollment Deviations 
o Subject is enrolled prior to determining whether eligible for study 
o Ineligible subject is enrolled 
o Enrollment occurs outside protocol window 
 Study Data and/or Forms Deviations 
o Forms or data not sent from clinical site to coordinating center 
o Missing data and/or form 
o Missing images and/or operative reports 
 Subject Deviations 
o Subject administration of a prohibited medication 
o Subject compliance with protocol 
o Subject met withdrawal criteria but was not withdrawn 
 Visit/Procedure Schedule Deviations 
o Visit/Procedure not completed 
o Visit/Procedure not completed in window 
Pharmacokinetic (PK) Population: The Pharmacokinetic Population will include SAF 
subjects who have at least one non-missing quantifiable observation (i.e., numeric) for 
LTX-315 (i.e., VP-315) concentration.  Blood samples for PK assessments will only be 
collected for a subset of subjects in Part 2 Expansion Cohorts 4 and 5.  The PK 
Population will be used for PK analyses. 
Non-missing observations outside the limits of quantitation for LTX-315 concentration 
will be handled as follows: 
 Observations < lower limit of quantitation (LLQ) will be assessed at 0.5 × LLQ 
 Observations > upper limit of quantitation (ULQ) will be assessed at ULQ 


Verrica Pharmaceuticals Inc. 
 
Statistical Analysis Plan 
Protocol: VP-315-201 
 
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17 
 
7. 
Population Analysis 
The conventions of Section 5 of this SAP will be applied.  Tables and figures will be 
prefixed with 14, and listings will be prefixed 16.  Tables will be provided for Part 1 and 
Part 2 unless noted otherwise. 
 
7.1.1. Subject Disposition 
A summary of subject disposition will be provided using enrolled subjects.  The number 
and percentage of subjects who were enrolled, completed the study, and are included in 
the Safety, Full Analysis, Per Protocol, and PK Populations will be summarized, along 
with the reason for exclusion from the Safety, Full Analysis, Per Protocol, and PK 
Populations.  The number and percentage of subjects discontinuing from study, and the 
primary reason for discontinuation from study, will also be included in the summary. 
Separate listings will be provided for the following using all subjects including screen 
failures: 
 Informed Consent (Was Subject Reconsented (Yes, No), Date of 
Consent/Reconsent, Date of Advarra ICF IRB Approved Version, Protocol 
Version Number, Version of Consent Signed (Part 1)), 
 Inclusion/Exclusion (Subject Enrolled in Study (Yes, No), Enrollment Date, Part 
(Part 1, Part 2), Cohort (Cohort 1, Cohort 2, Cohort 4, Cohort 4 Expansion, 
Cohort 5, Cohort 5 Expansion), Subject Current Screen Failure (Yes, No), Subject 
Previous Screen Failure (Yes, No), Previous Subject ID, category/label and text 
for each Inclusion Criterion Not Met and each Exclusion Criterion Met for current 
or previous screen failure, Screen Fail Reason for current or previous screen 
failure), and 
 Subject Visits (Visit, Date of Visit, whether Not Done, and Reason Not Done). 
Separate listings will be provided for the following using enrolled subjects: 
 Analysis Populations (Yes/No for Subject Inclusion in Each Population),  
 End of Treatment Surgical Excision (Date Assessment Performed, All Lesions 
Surgically Excised (Yes, No) with Specified Reason, if applicable, Other 
Assessments Performed (Yes, No) with Specified Assessments, if applicable), 
 End of Study Suture Removal and Post-surgical Assessment (Visit, Sutures 
Removed (Yes, No), Post-surgical Assessment Performed (Yes, No), Date 
Assessment Performed, Clinically Significant Findings (Yes, No)), 


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 Follow-up Call (Date of Visit, Ongoing Adverse Event Since End of Study (Yes, 
No), Subject Died Since Last Visit (Yes, No), Date of Death, Cause of Death 
(Adverse Event, Other)), and 
 Subject Disposition (Enrollment Date, Date of Last Dose of Study Treatment, 
Date of Discontinuation or Completion of Study, Study Treatment 
Discontinuation and Study Discontinuation Statuses and Reasons, Date of Last 
Contact, and Date and Cause of Death). 
 
7.1.2. Treatment Termination 
A summary of treatment termination will be provided for TL1 and TL2 using the safety 
population. 
Descriptive statistics will be provided for the following parameters: 
 Days to Necrosis where Days to Necrosis = Earliest Date of Necrosis of Lesion 
Specified  Treatment Start Date.   
 Total Dose to Necrosis (mg) where Total Dose to Necrosis = Sum of all Actual 
Injection Doses (mg) including Treatment Start Date up to but not including 
Earliest Date of Necrosis of Lesion Specified. 
Necrosed lesions are defined as treated lesions recorded in EDC as necrosed during 
scheduled and unscheduled Study Treatment Administration visits. 
The number and percentage of subjects will be provided for the following parameters: 
 Treatment Administered 
 Treatment Not Applicable (TL2 only) 
 Completed Treatment 
 Lesion Not Necrosed 
 Lesion Necrosed 
 Treatment Discontinued 
 Reason for Treatment Discontinuation (Adverse Event, Withdrawal of Consent, 
Lost to Follow-up, Death, Pregnancy, Subject Noncompliance, Sponsor 
Terminated Study, Investigator Decision, Other) 


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 Reason for Treatment Non-administration (Adverse Event, Withdrawal of 
Consent, Lost to Follow-up, Death, Pregnancy, Subject Noncompliance, Sponsor 
Terminated Study, Investigator Decision, Other) (TL2 only) 
A separate listing will be provided for Treatment Termination using the Safety 
Population, and the listing will include TL1 Treated (Yes, No), Date of Last TL1 
Treatment, Reason TL1 Treatment Not Done or Terminated (Adverse Event, Withdrawal 
of Consent, Lost to Follow-up, Death, Pregnancy, Subject Noncompliance, Completed 
Treatment, Sponsor Terminated Study, Investigator Decision, Other) with Specified 
Reason, TL2 Treated (Yes, No, Not Applicable), Date of Last TL2 Treatment, and 
Reason TL2 Treatment Not Done or Terminated (Adverse Event, Withdrawal of Consent, 
Lost to Follow-up, Death, Pregnancy, Subject Noncompliance, Completed Treatment, 
Sponsor Terminated Study, Investigator Decision, Other) with Specified Reason. 
7.2. 
Protocol Deviations 
Protocol deviations will be collected throughout the duration of the study.  Protocol 
deviations will be assigned a sponsor-defined category and subcategory, and each 
deviation will be classified by the sponsor as major or minor. 
A summary of Protocol Deviations will be provided using enrolled subjects.  The total 
number of subject-level deviations, major and minor, number and percentage of subjects 
with at least one deviation, major and minor, and the number and percentage of subjects 
with at least one deviation categorized by category and subcategory will be included in 
the summary.  Subjects having more than one deviation may appear in more than one 
category or subcategory but will be counted at most once per each category and 
subcategory.  Category and subcategory will be displayed in order of decreasing 
frequency of total category count, followed by decreasing frequency of total subcategory 
count, and then alphabetically if tied. 
A separate listing will be provided for Protocol Deviations using all subjects, and the 
listing will include Category (Eligibility Criteria, Informed Consent, Protocol 
Implementation, Safety, and possibly others), Subcategory (Laboratory Tests Not Done, 
Missed Assessment, Participant Does Not Meet Eligibility Criteria, Participant Received 
Wrong Treatment, Participant Seen Outside of Visit Window, and possibly others), 
Deviation Issue, Date of Issue, Date Issue Identified, and Classification (Major, Minor). 
Site-level deviations will not be summarized or listed.  Site-level deviations may be 
presented in the Clinical Study Report (CSR). 


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7.3. 
Demographics and Baseline Characteristics 
A summary of Demographics and Baseline Characteristics will be provided for enrolled 
subjects and for the analysis populations listed in Section 6 of this SAP.  Baseline values 
will be used in summaries of parameters collected at multiple visits. 
Descriptive statistics will be provided for the following parameters: 
 Age (years), 
 Height (cm), 
 Weight (kg), 
 Body Mass Index (BMI) (kg/m2), 
 Serum Tryptase (ug/L), 
 Total Number of Clinically Diagnosed BCC Lesions where a Clinically 
Diagnosed BCC Lesion means any reported lesion with a non-missing date of 
clinical diagnosis of BCC, 
 Total Number of Pathology Diagnosed BCC Lesions where a Pathology 
Diagnosed BCC Lesion means any reported lesion with a non-missing date of 
dermatopathology diagnosis of BCC, 
 Smallest Lesion Diameter Before Biopsy (cm), 
 Largest Lesion Diameter Before Biopsy (cm), and  
 Duration of Disease (months) where Duration of Disease = (Treatment Start Date 
 Earliest Date of Dermatopathology Diagnosis of BCC) / 30.4375. 
The number and percentage of subjects will be provided for the following parameters: 
 Sex (Male, Female), 
 Female Childbearing Potential (Yes, No), 
 Race (American Indian or Alaska Native, Asian, Black or African American, 
Native Hawaiian or Other Pacific Islander, White, Mixed Race, Unknown or Not 
Reported), 
 Ethnicity (Hispanic, Not Hispanic, Unknown or Not Reported), 
 Fitzpatrick Skin Type (I-VI), 
 Histologic Diagnosis at Screening (Micronodular, Nodular, Superficial) for TL1, 
TL2, NTL1, NTL2, NTL3, and 


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 BCC Location at Screening (Face or Neck, Clavicle or Shoulder, Arm, Chest or 
Abdomen, Back, Buttocks or Groin, Leg or Foot) for TL1, TL2, NTL1, NTL2, 
NTL3. 
Separate listings using enrolled subjects will be provided for the following: 
 Demographics and Baseline Characteristics (Age, Sex, Female Childbearing 
Potential, Race, Ethnicity, Height, Weight, BMI, Fitzpatrick Skin Type, Duration 
of Disease), 
 Screening Clinical Evaluation (Lesion Number, Lesion Diameter (cm), Location, 
Date of Clinical Diagnosis, Date of Dermatopathology Diagnosis, Histologic 
Diagnosis), 
 Screening Biopsy (Lesion Number, Biopsy Performed (Yes, No), Visit, Biopsy 
Date, Timing of Biopsy (Historical, At screening), Biopsy Type (Punch, Shave), 
Size of Punch Biopsy (2mm, 3mm, Other), Biopsy Sutures Removed (Yes, No), 
Date Biopsy Sutures Removed), and 
 Biopsy Results (Lesion Number, Visit, Biopsy Date, Biopsy Type (Punch, 
Shave), Location, Date of Review, Histologic Diagnosis, Specimen Gross 
Description). 
7.4. 
Prior and Concomitant Medications 
Summaries of (a) Prior Basal Cell Carcinoma Medications using the safety population, 
(b) Prior Medications Excluding Prior Basal Cell Carcinoma Medications using the safety 
population, and (c) Concomitant Medications using the full analysis population will be 
provided. 
For each summary, the total number of medications, the number and percentage of 
subjects with at least one medication, and the number and percentage of subjects with at 
least one medication categorized by Anatomical Therapeutic Chemical (ATC) 
Classification (ATCC) and Preferred Name (PN) will be provided.  ATC Level 4 will be 
displayed, but if not available, the nearest available parental ATC Level will be 
displayed.  Subjects having more than one medication may appear in more than one 
ATCC or PN but will be counted at most once per each ATCC and PN.  ATCC and PN 
will be displayed in order of decreasing frequency of total ATCC count, followed by 
decreasing frequency of total PN count, and then alphabetically if tied. 
Prior medications are defined as medications recorded in EDC as pre-study medications.  
Concomitant medications are defined as medications that are not recorded in EDC as pre-
study medications, as well as medications with unknown or undeterminable start dates. 


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Separate listings will be provided for the following using the safety analysis population: 
 Prior Basal Cell Carcinoma Medications (Medications to Report (Yes, No), Prior 
Therapy, Total Daily Dose, Dose Unit, Frequency, Route, Start Date, End Date), 
and  
 Prior and Concomitant Medications Excluding Prior Basal Cell Carcinoma 
Medications (Medications to Report (Yes, No), Medication/Therapy, Indication, 
Dose, Dose Unit, Frequency, Route, Prior or Concomitant, Start Date, End Date 
(or Ongoing at the End of Study), whether Medication Treated an Adverse Event 
(Yes, No)). 
7.5. 
Medical History 
Summaries of (a) Prior Basal Cell Carcinoma Treatment, Procedures, and Surgeries and 
(b) Medical History Excluding Prior Basal Cell Carcinoma Treatment, Procedures, and 
Surgeries will be provided using the safety population. 
For the Medical History Excluding Prior Basal Cell Carcinoma Treatment, Procedures, 
and Surgeries summary, the total number of events, the number and percentage of 
subjects with at least one event, and the number and percentage of subjects with at least 
one event categorized by system organ class (SOC) and preferred term (PT) will be 
provided.  Subjects having more than one event may appear in more than one SOC or PT 
but will be counted at most once per each SOC and PT.  SOC and PT will be displayed in 
order of decreasing frequency of total SOC count, followed by decreasing frequency of 
total PT count, and then alphabetically if tied. 
For the Prior Basal Cell Carcinoma Treatment, Procedures, and Surgeries summary, the 
total number of events, the number and percentage of subjects with at least one event, and 
the number and percentage of subjects with at least one event categorized by Reported 
Term (RT) (Curettage, Electrodessication, Excision, MOHS, Topical Treatment, Other), 
will be provided.  Subjects having more than one event may appear in more than one RT 
but will be counted at most once per each RT.  RT will be displayed in order of 
decreasing frequency of total RT count, and then alphabetically if tied. 
Separate listings using the safety population will be provided for the following: 
 Prior Basal Cell Carcinoma Treatment, Procedures, and Surgeries (Prior Events to 
Report (Yes, No), Previous Treatment Received (Curettage, Electrodessication, 
Excision, MOHS, Topical Treatment, Other), Most Recent Treatment Received, 
Date of Most Recent Treatment), and 


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 Medical History Excluding Prior Basal Cell Carcinoma Treatment, Procedures, 
and Surgeries (Any Relevant Medical or Surgical History (Yes, No), Diagnosis, 
Condition or Surgery, Onset Date, Resolution Date (or Ongoing)). 
7.6. 
Administration of Study Treatment 
A summary of Administration of Study Treatment will be provided using the safety 
population. 
Descriptive statistics will be provided for the following parameters: 
 Total Daily Target Volume (cc), 
 Total Daily Target Dose (mg), 
 
And for each injection (Injection 1, Injection 2) within each lesion (TL1, TL2): 
 Expected Injection Volume (cc), 
 Actual Injection Volume (cc), 
 Expected Injection Dose (mg), and 
 Actual Injection Dose (mg). 
The number and percentage of subjects will be provided for the following parameters: 
 Study Drug Reconstituted (Yes, No). 
The summary will present injection (Injection 1, Injection 2) within lesion (TL1, TL2) 
within scheduled visit (W1D1, W1D2, W1D3, W2D1, W2D2, W2D3). 
A separate listing will be provided using the safety population for the Administration of 
Study Treatment, and the listing will include the parameters described as above, as well 
as the following parameters (not all parameters were collected at all visits): 
 Lesion (to be) Injected, 
 Lesion Necrosed (Yes, No, Not Applicable), 
 Injection Number (1, 2), 
 Injection Administered (Yes, No), 
 Reason Injection Not Administered (Adverse Event, Drug Permanently 
Withdrawn, Investigator Decision, Subject Declined, Other), 


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 Received Full Dose (Yes, No), 
 Dose Received if Not Full Dose, 
 Reason Full Dose Not Received (Adverse Event, Drug Permanently Withdrawn, 
Investigator Decision, Subject Declined, Other), and 
 Visit, and Date and Time of Injection. 
8. 
Efficacy Analysis 
The conventions of Section 5 of this SAP will be applied.  Tables and figures will be 
prefixed with 14, and listings will be prefixed 16.  Tables will be provided for Part 1 and 
Part 2 unless noted otherwise. 
Each subject can have at most two distinct target lesions (TL1, TL2) and at most three 
distinct non-target lesions (NTL1, NTL2, NTL3).  All subjects are to have TL1, but not 
every subject will have additional lesions.  The efficacy table summaries will be provided 
by subject lesion. 
8.1. 
Histologic Clearance of Treated Lesions at Excision 
Histologic clearance means no residual tumor seen on dermatopathological inspection, 
i.e., the estimate of viable tumor within estimated volume of the entire tumor bed 
provided by the dermatopathologist and captured in EDC is zero.  When the estimated 
remaining tumor volume is zero, the histologic diagnosis should be scar. 
 
A summary of histologic clearance will be provided using the histologic diagnosis of 
excised treated lesions (TL1, TL2) from the end-of-treatment (EOT) visit.  The histologic 
diagnosis categories are as follows: 
 Micronodular 
 Nodular 
 Superficial 
 Superficial and Nodular 
 Scar 
The summary will use the full analysis population, and for each treated lesion, the 
number and percentage of subjects falling into each histologic diagnosis category will be 
provided in the summary.  The summary will also be run using the per-protocol 
population as outlined in Section 6 of this SAP. 


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A separate listing will also be provided for the Excision of all lesions (TL1, TL2, NTL1, 
NTL2, NTL3) using the enrolled subjects, and this listing will include Lesion Number, 
Visit, Excision Date, Location, Histologic Diagnosis, Date of Review, Estimate of 
Remaining Tumor Volume, and Specimen Gross Description. 
 
8.2. 
Clinical Clearance of Treated Lesions at Excision 
Clinical clearance means no residual tumor seen on clinical visual inspection. 
A summary of clinical clearance will be provided using the Physician Global Assessment 
(PGA) of treated lesions (TL1, TL2) at the EOT visit.  The PGA is an assessment of 
improvement that occurs post-baseline, where reported values were to be reported as 
change since pre-treatment.  Due to the nature of the EDC form, some reported values 
may be reported as change since previous visit.  As it is not possible to distinguish with 
100% accuracy whether the reported changes were from pre-treatment or previous visit, 
the PGA data will be summarized as reported.  The PGA categories are as follows: 
 100% Improvement, No Visible Tumor 
 75% to < 100% Improvement 
 50% to < 75% Improvement 
 25% to < 50% Improvement 
 Up to 25% Improvement 
 No Change 
 Worse 
 Not Applicable 
The summary will use the full analysis population, and for each treated lesion, the 
number and percentage of subjects falling into each PGA category will be provided in the 
summary.  The summary will also be run using the per-protocol population as outlined in 
Section 6 of this SAP. 
A separate listing will also be provided for the PGA of all lesions (TL1, TL2, NTL1, 
NTL2, NTL3) using the enrolled subjects, and this listing will include whether a PGA 
was Performed (Yes, No), Visit, Date Assessment Performed, and lesion assessments per 
the PGA categories as described above. 


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8.3. 
Estimate of Remaining Tumor Volume and Reduction in Tumor Volume at 
Excision 
Protocol endpoints reference that the estimated remaining tumor volume would be 
necrotic cells:tumor cells.  However, estimated remaining tumor volume is the estimated 
volume of residual viable tumor cells. The assessment in the EDC is expressed as a 
percentage of viable tumor cells within the tumor bed which is composed of tumor cells 
(viable and necrotic), fibrosis, and inflammation. 
A summary of the estimated remaining tumor volume (0 = None Remaining to 100 = All 
Remaining) will be provided using descriptive statistics for excised lesions (TL1, TL2, 
NTL1, NTL2, NTL3) from the end-of-treatment (EOT) visit.  A 95% confidence interval 
for the mean estimated remaining tumor volume will also be provided in the summary 
using a one sample, two-sided t-test. Summary measures will be repeated for reduction in 
tumor volume (0 = No reduction to 100 = None Remaining). 
The summaries will use the full analysis population, and for each lesion, descriptive 
statistics will be provided in the summary.  The summaries will also be run using the per-
protocol population as outlined in Section 6 of this SAP. 
A separate listing will be provided for the excision of all lesions as described in Section 
8.1 of this SAP. 
8.4. 
Abscopal Effect Based on Non-treated Lesions at Excision 
An abscopal effect is a phenomenon whereby the treatment of target lesions leads to 
improvement in both treated and non-treated lesions. 
A summary of (a) histologic clearance and (b) clinical clearance for non-treated lesions 
will be provided to investigate a possible abscopal effect using EOT data and the full 
analysis population. 
The histologic clearance will follow Section 8.1 of this SAP except for using the 
histologic diagnosis of excised non-treated lesions (NTL1, NTL2, NTL3), and the clinical 
clearance will follow Section 8.2 of this SAP except for using the PGA of non-treated 
lesions (NTL1, NTL2, NTL3).  The summary will be provided by clearance (Histologic, 
Clinical) within lesion (NTL1, NTL2, NTL3).  The summary will also be run using the 
per-protocol population as outlined in Section 6 of this SAP. 
A separate listing will be provided for the excision of all lesions as described in Section 
8.1 of this SAP, and a separate listing will be provided for the PGA of all lesions as 
described in Section 8.2 of this SAP. 


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8.5. 
Physician Global Assessment 
The PGA is an assessment of improvement as described in Section 8.2 of this SAP. 
A summary will be provided by scheduled visit (W1D2, W1D3, W1 Safety Assessment, 
W2D1, W2D2, W2D3, W2 Safety Assessment, EOT, EOS 1 Week Post-excision, EOS 2 
Weeks Post-excision) within lesion (TL1, TL2, NTL1, NTL2, NTL3). 
The summary will use the full analysis population, and for each lesion, the number and 
percentage of subjects falling into each PGA category will be provided in the summary.  
The summary will also be run using the per-protocol population as outlined in Section 6 
of this SAP. 
A separate listing will be provided for the PGA of all lesions as described in Section 8.2 
of this SAP. 
8.6. 
Complete Clearance of Treated Lesions at Excision 
Complete clearance occurs when histologic clearance, as defined in Section 8.1 of this 
SAP, and clinical clearance, as defined in Section 8.2 of this SAP, are both achieved. 
A summary of complete clearance will be provided using histologic clearance and 
clinical clearance of excised treated lesions (TL1, TL2) from the end-of-treatment (EOT) 
visit.  The clearance categories are as follows: 
 Histologic Clearance (i.e., Scar) and Clinical Clearance (i.e., 100% Improvement, 
No Visible Tumor) 
 Histologic Clearance and Not Clinical Clearance 
 Not Histologic Clearance and Clinical Clearance 
 Not Histologic Clearance and Not Clinical Clearance 
The summary will use the full analysis population, and for each treated lesion, the 
number and percentage of subjects falling into each clearance category will be provided 
in the summary.  The summary will also be run using the per-protocol population as 
outlined in Section 6 of this SAP. 
A separate listing will be provided for the excision of all lesions as described in Section 
8.1 of this SAP, and a separate listing will be provided for the PGA of all lesions as 
described in Section 8.2 of this SAP. 


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Part 2 Cohort 4, Cohort 4 Expansion, Cohort 5, Cohort 5 Expansion, and overall (Cohorts 
4 and 5 and Expansion Cohorts 4 and 5, i.e., Displayed Total) will be summarized in one 
display; Part 1, all Part 2 cohorts, and overall (Part 2 Total) will be summarized in 
another display. 
8.7. 
Sensitivity Analysis 
If the estimated remaining tumor volume or its related histologic diagnosis at EOT is 
missing for any subject lesion where a screening biopsy was performed, a sensitivity 
analysis will be provided using the full analysis population. 
The overall maximum non-missing estimated remaining tumor volume (worst case 
reported across all subjects and lesions) and its related histologic diagnosis at EOT will 
be determined.  All missing values for estimated remaining tumor volumes and histologic 
diagnoses at EOT will be set to the determined values mentioned previously in this 
section of the SAP, and two summaries with all parts/cohorts, one from Section 8.3 and 
one from Section 8.6 of this SAP, will then be rerun to explore sensitivity. 
9. 
Safety Analysis 
The conventions of Section 5 of this SAP will be applied.  Tables and figures will be 
prefixed with 14, and listings will be prefixed 16.  Tables will be provided for Part 1 and 
Part 2 unless noted otherwise. 
 
9.1. 
Adverse Events 
Adverse event (AE) summaries will be based on treatment-emergent adverse events 
(TEAEs).  TEAEs are defined as AEs that started or worsened upon or after study 
treatment initiation.  If it cannot be determined whether an AE is treatment emergent due 
to an incomplete or missing onset date and/or time, the AE will be considered treatment 
emergent.  All AEs will be summarized using the safety population. 
For AEs that are cutaneous injection site reactions (Erythema, Induration, Swelling, 
Blister Formation/Vesicles, Desquamation/Exfoliation, Erosion, Ulceration, Necrosis), 
severity was intended to be assessed on a cutaneous reaction assessment (CRA) grading 
scale (None (1), Mild (2), Moderate (3), Severe (4), Not Applicable (5)) and for all other 
AEs, severity was intended to be assessed according to the Common Terminology 
Criteria for Adverse Events (CTCAE) version 5.0 grading scale (Mild (1), Moderate (2), 
Severe (3), Life-threatening (4), Fatal (5)). 
As the actual AE grading scale used was not captured in EDC, and the meaning of the 
grades is different across scales, the Maximum Severity and Grade >= 2 summaries will 


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be split into two sets, one for AEs that are cutaneous injection site reactions and one for 
AEs that are not cutaneous injection site reactions.  For cutaneous injection site reactions, 
the preferred terms (PTs) that will be used are as follows: Injection site erythema, 
Injection site induration, Injection site swelling, Injection site vesicles, Injection site 
exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis. 
An overall summary of adverse events will be provided where the number of TEAEs and 
the number and percent of each of the following items will be displayed. 
 Subjects with at least one: 
o TEAE 
o TEAE by Strongest Relationship to Study Treatment (Not Related, 
Related) 
o TEAE Excluding Cutaneous Injection Site Reactions by Maximum 
Severity (Mild, Moderate, Severe, Life-threatening, Fatal) 
o TEAE of Only Cutaneous Injection Site Reactions by Maximum Severity 
(Mild, Moderate, Severe) 
 
o Grade >=2 Events Excluding Cutaneous Injection Site Reactions: 
 TEAE 
 TEAE by Strongest Relationship to Study Treatment 
 TEAE Occurring upon Study Treatment through Observation 
Period (explained in detail below) 
 TEAE with Local Reactogenicity (Injection site pain) 
 TEAE with Systemic Reactogenicity (Fever, Myalgia, Headache) 
o Severity >= Moderate Events of Only Cutaneous Injection Site Reactions 
(excluding Severity = Not Applicable): 
 TEAE 
 TEAE by Strongest Relationship to Study Treatment 
 TEAE Occurring upon Study Treatment through Observation 
Period 
 TEAE with Local Reactogenicity (Injection site erythema, 
Injection site induration) 
 
o Serious TEAE 
o DLT - Part 1 Only 
o TRAE SI - Part 2 Only 
o TEAE Leading to Study Treatment Discontinuation 


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o TEAE Leading to Study Discontinuation 
o TEAE Leading to Death 
Categories for Relationship to Study Treatment are Related and Not Related, and 
categories for Severity are Mild, Moderate, and Severe where the severe category will 
include severity levels of severe, life-threatening, and fatal as applicable. 
Summaries of DLT events, TRAE SI events, and TEAEs for a subject Occurring upon 
Study Treatment through its Observation Period (e.g. during the DLT observation period 
or TRAE SI observation period) are TEAEs that a subject experiences on any day on 
which treatment occurs. This definition of the DLT and TRAE SI observation periods 
deviates from the protocol as described in section 14. 
In addition, for each of the nineteen listed item mentioned previously in this section of 
the SAP, summaries for the total number of TEAEs, the number and percentage of 
subjects with at least one TEAE, and the number and percentage of subjects with at least 
one TEAE categorized by system organ class (SOC) and PT will be provided.  Subjects 
having more than one AE may appear in more than one SOC or PT but will be counted at 
most once per each SOC and PT.  For maximum severity, subjects will be counted at the 
most extreme category among the mild, moderate, and severe categories.  For 
relationship to study treatment, subjects will be counted at the most related category 
among the unrelated and related categories.  SOC and PT will be displayed in order of 
decreasing frequency of total SOC count, followed by decreasing frequency of total PT 
count, and then alphabetically if tied. 
Local reactogenicity is defined as the following events: Injection site pain, Erythema, 
Induration.  For local reactogenicity, the PTs that will be used are as follows: Injection 
Site Pain, Injection Site Erythema, Injection Site Induration.  Systemic reactogenicity is 
defined as the following events: Fever, Myalgia, Headache.  For systemic reactogenicity, 
the PTs that will be used are as follows: Fever, Myalgia, Headache. 
A separate listing will be provided for all AEs using the safety population, and the listing 
will include the following: 
 Subject Experience any Adverse Events (Yes, No), 
 Adverse Event, 
 TEAE (Yes, No), 
 DLT (Part 1) or TEAE SI (Part 2) (Yes, No), 
 Start Date and End Date (or Ongoing), 


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 Severity (Mild, Moderate, Severe, Life-threatening, Death), 
 Serious (Yes, No), 
 Relatedness (Related, Not Related), 
 Action Taken (No Action Taken, Dose Reduced, Dose Interrupted, Drug 
Withdrawn, Not Applicable), 
 Outcome (Resolved/Recovered, Resolved/Recovered with Sequelae, Not 
Resolved/Not Recovered, Resolving/Recovering, Fatal, Unknown), 
 Related to Screening (Yes, No), and 
 Screening Assessment if Related to Screening. 
Additionally, a separate listing will be provided for all SAEs using the safety population, 
and the listing will include the following: 
 Serious Adverse Event, 
 Start Date and End Date (or Ongoing) where End Date (or Ongoing) is taken from 
reported AEs, 
 Report Version (Initial, Follow-up, Final), 
 Reason for Reporting (Resulted in Death, Life-threatening, Required Prolonged 
Hospitalization, Persistent or Significant Disability, Congenital Anomaly/Birth 
Defect, Important Medical Event), 
 Death Date, 
 Hospitalization Date, 
 Autopsy (Yes, No), 
 Death Certificate (Yes, No), 
 Date Event Became Serious, and 
 Date Event Became Non-serious. 
9.2. 
Clinical Laboratories 
Summaries of (a) serum chemistry, (b) hematology, and (c) serum tryptase will be 
provided using descriptive statistics and the safety population.  Any clinically significant 
post-baseline laboratory result is to be collected as an adverse event and included in the 
summary of adverse events. 


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Results for serum tryptase and for the following laboratory parameters are expected to be 
available for summarization using the International System of Units (i.e., standard units). 
Serum Chemistry 
Hematology 
 Albumin 
 Alkaline Phosphatase (ALP) 
 Alanine Aminotransferase (ALT) (Serum 
Glutamic Pyruvic Transaminase (SGPT)) 
 Aspartate Aminotransferase (AST) 
(Serum Glutamic Oxaloacetic 
Transaminase (SGOT)) 
 Blood Urea Nitrogen (BUN) 
 Bicarbonate 
 Calcium 
 Chloride 
 Creatinine 
 Glucose 
 Lactic Dehydrogenase (LDH) 
 Potassium 
 Sodium 
 Total Bilirubin 
 Total Protein 
 Hematocrit 
 Hemoglobin 
 Mean Corpuscular Hemoglobin 
Concentration (MCHC) 
 Mean Corpuscular Volume (MCV) 
 Platelet Count 
 Red Blood Cell Count (RBC) 
 White Blood Cell Count (WBC) with 
Differential (Absolute) 
o Bands 
o Blasts 
o Basophils 
o Eosinophils 
o Lymphocytes 
o Monocytes 
o Neutrophils 
Serum chemistry and hematology summaries will present scheduled visit and include 
baseline (Screening, Baseline, W1 Safety Assessment, W2 Safety Assessment, EOS 1 
Week Post-excision, EOS 2 Weeks Post-excision) within alphabetically ordered 
laboratory parameters and, for continuous parameters, include descriptive statistics for 
baseline and change from baseline for post-baseline visits, if possible. 
The serum tryptase summary will present scheduled visit and include baseline 
(Screening, Baseline, W1D1, W1D2, W1D3, W2D1, W2D2, W2D3  not all labs are 
collected at all scheduled visits) and include descriptive statistics for baseline and change 
from baseline for post-baseline visits without timepoints, if possible.  If timepoint 
measurements occur, serum tryptase will be displayed by scheduled timepoint 
(Immediately after Hypersensitivity Reaction, 60-120 min after Hypersensitivity 
Reaction) within scheduled post-baseline visit and include (a) descriptive statistics for 


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baseline and change from baseline for post-baseline timepoints, if possible, and (b) the 
number and percent of subjects with at least one significant elevation, where significant 
elevation of serum tryptase is defined as a post-baseline value >= (1.2 × baseline value) + 
2. 
Shift tables for laboratory parameters previously listed in this section of the SAP for (a) 
serum chemistry and (b) hematology will be presented, if possible, at each scheduled 
post-baseline visit using the safety population.  Abnormal/out of range laboratory values 
are to be flagged as either Low or High.  As CTCAE grading is not provided for 
numerous laboratory data, shift tables to assess changes from baseline will be presented 
using Low, Normal, High, and Total as categories. 
Separate listing will be provided for serum chemistry, hematology, and serum tryptase 
using the safety population, and these lab listings will include whether Collection was 
Performed (Yes, No), Visit, Date and Time of Collection, Result and Units using the 
International System of Units (i.e., standard units), Lower and Upper Reference Range 
Limits using the International System of Units, Reference Range Indicator (Low, Normal, 
High), if available, CTCAE grade, if available, Clinical Significance (NCS, CS) for 
abnormal results, if available, and Change from Baseline using the International System 
of Units.  The serum tryptase listing will also include the following for post-baseline 
results: 
 Did the subject have a hypersensitivity reaction? 
 Was a blood sample collected immediately after the hypersensitivity reaction for 
the serum tryptase assessment collected? 
 Was the second blood sample collected between 60 - 120 minutes after the 
hypersensitivity reaction for the serum tryptase assessment collected? 
9.3. 
Vital Signs Including Height and Weight 
Summaries for vital signs will be provided using descriptive statistics and the safety 
population.  Vital signs include the following parameters: 
 Blood Pressure, Systolic (mmHg) 
 Blood Pressure, Diastolic (mmHg) 
 Height (cm) 
 Weight (kg) 
 BMI (kg/m2) 


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 Heart Rate (beats/min) 
 Respiratory Rate (breaths/min) 
 Temperature (C) 
Non-blood pressure vital signs (Height, Weight, BMI, Heart Rate, Respiratory Rate, 
Temperature) will be presented in one summary and blood pressure (Systolic, Diastolic) 
will be presented in other summaries (one each for systolic and diastolic). 
Summaries will present scheduled visit and include baseline (Screening, Baseline, 
W1D1, W1D2, W1D3, W1 Safety Assessment, W2D1, W2D2, W2D3, W2 Safety 
Assessment, Limited Safety Assessment, EOT, EOS 1 Week Post-excision, EOS 2 
Weeks Post-excision  not all vital signs are collected at all scheduled visits) within the 
parameters mentioned previously in this section of the SAP and include descriptive 
statistics for baseline and change from baseline for post-baseline visits, if possible. 
Blood pressure is also to be measured and will be displayed by scheduled timepoint (Pre-
injection, 1 Minute Post-injection, 3 Minutes Post-injection, and then 5 through 120 
Minutes Post-injection in increments of 5 minutes) within injection (Injection 1, Injection 
2  not all timepoints are collected for all injections) within scheduled visit and include 
descriptive statistics for change from pre-injection for post-injection readings on that 
same visit, if possible. 
A summary will also be provided for the number of events, and the number and 
percentage of subjects with at least one event, for each of the following parameters within 
injection visit (W1D1, W1D2, W1D3, W2D1, W2D2, W2D3): 
 20 mmHg decrease in systolic BP with absolute systolic BP < 100 mmHg 
 20 mmHg decrease in systolic BP with clinical symptoms 
 Absolute diastolic BP < 60 mmHg 
Decrease in systolic BP will be determined three ways: (a) change from baseline, (b) 
change from pre-injection for post-injection readings on that same visit, and (c) change 
from the previous most recent non-missing reading on the same visit.  The clinical 
symptoms tabulation related to a decrease in systolic BP will be determined by counting 
TEAEs with a start date matching the BP event date that are (a) recorded as DLTs (Part 
1) or TRAEs SI (Part 2), (b) related to study treatment, and (c) have the following 
symptomatic events: Dizziness, Shortness of breath, Fainting, Nausea, Diaphoresis, 
Blurry vision, Headache, Fatigue.  For symptomatic events, the PTs that will be used are 


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as follows: Dizziness, Dyspnoea, Syncope, Nausea, Hyperhidrosis, Vision blurred, 
Headache, Fatigue. 
A separate listing will be provided for Vital Signs using the safety population, and this 
listing will include Vital Signs Collected (Yes, No), Visit, Date of Reading, Reading 
Value and Unit, and Change from Baseline for all parameters. 
For BP collected on injection days, the listing will include BP Collected After Injection 
(Yes, No), Visit, Date and Time of Reading, Timepoint of Reading, Injection Number, 
Reading Value and Unit, Change from Baseline, Change from Pre-injection for post-
injection readings on that same visit, if possible, Change from the Previous Most Recent 
non-missing reading on the same visit, if possible, and Reason Timepoint Not Done. 
9.4. 
Electrocardiogram 
Summaries for electrocardiogram (ECG) readings from 12-lead and Holter/telemetry 5-
lead assessments will be provided using the safety population.  A continuous summary 
and a categorical summary will be presented for the 12-lead assessments, as well as for 
the Holter/telemetry 5-lead assessments. 
Descriptive statistics will be provided for the following parameters: 
 12-lead 
o Heart Rate (beats/min) 
o PR Interval (msec) 
o QRS Interval (msec) 
o QT Interval (msec) 
o QTc Interval (msec) (correction type not provided in data) 
o QTcB Interval (msec) 
o QTcF Interval (msec) 
o RR Interval (msec) 
o P-Axis (%) 
o R-Axis (%) 
o T-Axis (%) 
 Holter/telemetry 5-lead 
o Heart Rate (beats/min) 


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o PR Interval (msec) 
o QRS Interval (msec) 
o QT Interval (msec) 
The number and percentage of subjects will be provided for the following parameters: 
 12-lead 
o Modality (HeartCor, Locally) 
o Overall Assessment/Interpretation (Normal, Abnormal NCS, Abnormal 
CS) 
o Predominant Rhythm (Normal Sinus Rhythm, Sinus Tachycardia, Sinus 
Bradycardia, and possibly others) 
o Principal Investigator/Medical Doctor Notification (Yes, No) 
 Holter/telemetry 5-lead 
o Predominant Rhythm (Normal Sinus Rhythm, Sinus Tachycardia, Sinus 
Bradycardia, and possibly others) 
The Holter/telemetry 5-lead is to be monitored continuously on injection visits, with a 
planned start 15 minutes prior to injection and a planned continuance until after the last 
injection of the day.  As a continuous full-length reading, there are no 5-lead baseline or 
pre-injection values, but the 5-lead full-length reading is to be broken where possible into 
sub-readings/timepoints (Holter Start, Holter Pre-injection, Holter 5 Minute Post-
injection 1, Holter 15 Minute Post-injection 1, Holter 5 Minute Post-injection 2, Holter 
15 Minute Post-injection 2, Holter End, and any change in BP occurring during the full-
length Holter reading that would qualify as a DLT/TRAE SI (these specific changes in 
BP will be referred to as BP Dips below)). 
Due to different sources for recorded times related to the Holter/telemetry 5-lead data, the 
possibility of mis-ordering timepoints based on recorded times exists; therefore, the sub-
readings/timepoint labels of Holter Start and Pre-injection will be considered when 
determining the Baseline and Pre-injection values as follows. 
The 5-lead Baseline value for use in Change from Baseline calculations will be the most 
recent non-missing value from the following possibilities: 
 Holter Start Timepoint on Day of First Treatment Injection 


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 Holter Pre-injection Timepoint on Day of First Treatment Injection 
 BP Dip(s) on Day of First Treatment Injection where Time of Dip(s) < Time of 
First Treatment Injection, and there are Holter/telemetry 5-lead data associated 
with these BP Dip(s) 
Each subject has his or her own Baseline value per parameter, if determinable, to be used 
for calculating Change from Baseline. 
The 5-lead Pre-injection values for use in Change from Pre-injection for Post-injection 
Readings on that Same Visit calculations will be the most recent non-missing values, on 
the Same Visit, from the following possibilities: 
 Holter Start Timepoint on Day of Treatment Injection 
 Holter Pre-injection Timepoint on Day of Treatment Injection 
 BP Dip(s) on Day of Treatment Injection where Time of Dip(s) < Time of 
Treatment Injection, and there are Holter/telemetry 5-lead data associated with 
these BP Dip(s) 
Each subject has his or her own Pre-injection value per parameter per injection visit, if 
determinable, to be used for calculating Change from Pre-injection for Post-injection 
Readings on that Same Visit. 
Summaries will present scheduled visit and include baseline (Screening, W1D1, 
Baseline, W1D2, W1D3, W1 Safety Assessment, W2D1, W2D2, W2D3, W2 Safety 
Assessment, EOT  not all ECG parameters are collected at all scheduled visits) within 
the parameters mentioned previously in this section of the SAP and, for continuous 
parameters, include descriptive statistics for baseline and change from baseline for post-
baseline visits, if possible. 
Holter/telemetry 5-lead values will also be displayed by predetermined timepoint within 
scheduled visit and include descriptive statistics for change from pre-injection for post-
injection readings on that same visit, if possible.  Due to sparsity, the sub-
reading/timepoints for any change in BP that would qualify as a DLT/TRAE SI will not 
be included in the summary but will be displayed in the 5-lead listings. 
A separate listing will be provided for the continuous parameters from the 12-lead 
assessment using the safety population, and this listing will include Visit, Recording Date 
and Time, Heart Rate, Interval and Axis readings, and Change from Baseline. 


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A separate listing will also be provided for the categorical parameters from the 12-lead 
assessment using the safety population, and this listing will include whether the 
Assessment was Performed (Yes, No), Visit, Recording Date and Time, the categorical 
ECG parameters described above, and Abnormal Findings. 
Additionally, a separate listing will also be provided for the continuous parameters from 
the Holter/telemetry 5-lead assessment using the safety population, and this listing will 
include Visit, Date of Visit, Timepoint, Time of Timepoint, Heart Rate, Interval readings, 
Change from Baseline, and Change from Pre-injection. 
A separate listing will also be provided for the categorical parameter(s) from the 
Holter/telemetry 5-lead assessment using the safety population, and this listing will 
include Visit, Date of Visit, Timepoint, Time of Timepoint, and the categorical ECG 
parameter described above. 
9.5. 
Cutaneous Reaction Assessment 
A summary of the cutaneous reaction assessments (CRAs) will be provided using the 
safety population.  The number and percentage of subjects falling into each severity 
category (None (1), Mild (2), Moderate (3), Severe (4), Not Applicable (5)) for reactions 
of Erythema, Induration, Swelling, Blister Formation, Desquamation, Erosion, 
Ulceration, and Necrosis will be provided in the summary. 
The summary will present reaction within scheduled visit (W1D2, W1D3, W1 Safety 
Assessment, W2D1, W2D2, W2D3, W2 Safety Assessment, Limited Safety Assessment, 
EOT, EOS 1 Week Post-excision, EOS 2 Weeks Post-excision) within lesion (TL1, TL2, 
NTL1, NTL2, NTL3). 
A separate listing will be provided for CRAs using the safety population, and this listing 
will include whether a CRA was Performed (Yes, No), Visit, Date Assessment 
Performed, and reaction assessments as described above. 
A separate listing will also be provided for Photo Assessment using the safety population, 
and this listing will include Visit, Lesion Photos Taken (Yes, No), Date and Time of 
Photos, and Photos Uploaded (Yes, No). 
 
9.6. 
Dermatologic and Physical Examinations 
A dermatologic examination including Fitzpatrick Skin Type is to occur at screening, and 
a limited physical examination of the following body systems may occur at scheduled 
visits (Screening, W1D1, W1D2, W1D3, W1 Safety Assessment, W2D1, W2D2, W2D3, 


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W2 Safety Assessment, Limited Safety Assessment, EOT  not all body systems are 
examined at all scheduled visits) or for symptom or AE-directed reasons. 
 General Appearance 
 Head, Ears, Eyes, Nose, Oral, Throat 
 Respiratory 
 Cardiovascular 
 Gastrointestinal 
 Genitourinary 
 Musculoskeletal 
 Neurological 
 Lymphatic 
 Skin 
 Reproductive 
 Endocrine 
 Other 
Separate listings will be provided for Dermatologic and (Limited) Physical Examinations 
using the safety population.  The Dermatologic Examination listing will include Exam 
was Performed (Yes, No), Visit, Date Exam Performed, Clinically Significant (Yes, No), 
Description, and Fitzpatrick Skin Type (I-VI).  The (Limited) Physical Examination 
listing will include Exam was Performed (Yes, No), Visit, Date Exam Performed, Body 
System Examined, Result (Normal, Abnormal, Not Done), and Abnormal Findings. 
No summary tables will be provided.  Fitzpatrick Skin Type (I-VI) is summarized in the 
Demographics and Baseline Characteristics display described in Section 7.3 of this SAP. 
 
9.7. 
Pregnancy Tests and Partner Pregnancy 
Partner pregnancy is to be reported for all subjects at screening, and only females of 
childbearing potential are tested for pregnancy.  Urine pregnancy tests are to be 
performed prior to W1D1 and W2D1 injections.  Serum-based pregnancy tests are to be 
performed at other scheduled visits (Screening, W1 Safety Assessment, W2 Safety 
Assessment, EOS 1 Week Post-excision, EOS 2 Weeks Post-excision  not all laboratory 
parameters are collected at all scheduled visits). 


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Separate listings will be provided for Pregnancy Tests and Partner Pregnancies using the 
safety population.  The Pregnancy Tests listing will include Visit, Test Performed (Yes, 
No), Date of Test, Laboratory Test Name, Test Type (Serum, Urine), and Result 
(Positive, Negative).  The Partner Pregnancies listing will include Visit, Date of Visit, 
and whether Subject Shared Partner is Pregnant (Yes, No). 
No summary tables will be provided. 
10. 
Treatment Satisfaction Analysis 
The conventions of Section 5 of this SAP will be applied.  Tables and figures will be 
prefixed with 14, and listings will be prefixed 16.  Tables will be provided for Part 1 and 
Part 2 unless noted otherwise. 
10.1. SCAR-Q  Appearance Scale 
A summary of SCAR-Q  Appearance will be provided using the full analysis 
population.  Descriptive statistics will be provided for Raw Sum (12 = Best to 48 = 
Worst), Rescored Sum (12 = Worst to 48 = Best), and Score (0 = Worst to 100 = Best).  
The number and percentage of subjects falling into each scale level (1 = Not at all, 2 = A 
 
1. How your scar looks from far away 
2. How wide your scar looks 
3. How your scar looks from different angles 
4. How thick your scar looks (more raided than you would like) 
5. The length of your scar 
6. The surface of your scar (more bumpy than you would like) 
7. The color of your scar 
8. The difference between the color of your scar and your skin color 
9. The contour of your scar (not as flat as you would like) 
10. The overall size of your scar 
11. How your scar looks close up 
12. How noticeable your scar is 
Raw Sum is calculated as follows: 
 If the number of missing responses is 0, then Raw Sum is the total of the numeric 
response values. 


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 If the number of missing responses is >0 and <6, then Raw Sum is [(number of 
missing responses  mean of non-missing response) + total of non-missing 
numeric response values]. 
 If the number of missing responses is >=6, then Raw Sum is missing. 
Rescored Sum is calculated as follows: 
 Each non-missing numeric response value is transformed into 5  response value. 
 Then proceed the same as for Raw Sum, except use transformed response values. 
Score is calculated as follows: 
 If Rescored Sum is missing, then Score is missing. 
 Otherwise, Score is provided by the SCAR-Q Conversion Table. 
The summary will present Raw Sum, Rescored Sum, Score, and the above listed 
questions within scheduled visit (W1 Safety Assessment, W2 Safety Assessment, EOT). 
A separate listing will be provided for SCAR-Q  Appearance using the full analysis 
population, and this listing will include Visit, Date of Visit, and the parameters as 
described above. 
Only Part 2 will be summarized. 
 
10.2. FACE-Q  Psychological Function 
A summary of FACE-Q  Psychological Function will be provided using the full analysis 
population.  Descriptive statistics will be provided for Raw Sum (10 = Worst to 40 = 
Best) and Score (0 = Worst to 100 = Best).  The number and percentage of subjects 
falling into each scale level (1 = Definitely disagree, 2 = Somewhat disagree, 3 = 
Somewhat agree, 4 = Definitely agree) for responses to the following ten assessment 
statements will be provided in the summary: 
a. I like myself 
b. I feel positive about myself 
c. I feel okay about myself 
d. I feel happy 
e. I am comfortable with myself 
f. I am accepting of myself 


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g. I feel good about myself 
h. I feel confident 
i. I feel attractive 
j. I feel great about myself 
Raw Sum is calculated as follows: 
 If the number of missing responses is 0, then Raw Sum is the total of the numeric 
response values. 
 If the number of missing responses is >0 and <5, then Raw Sum is [(number of 
missing responses  mean of non-missing response) + total of non-missing 
numeric response values]. 
 If the number of missing responses is >=5, then Raw Sum is missing. 
Score is calculated as follows: 
 If Raw Sum is missing, then Score is missing. 
 Otherwise, Score is provided by the FACE-Q Conversion Table. 
The summary will present Raw Sum, Score, and the above listed statements within 
scheduled visit (W1 Safety Assessment, W2 Safety Assessment, EOT). 
A separate listing will be provided for FACE-Q  Psychological Function using the full 
analysis population, and this listing will include Visit, Date of Visit, and the parameters 
as described above. 
Only Part 2 will be summarized. 
 
10.3. Scar Assessment 
 
A summary of the Scar Assessment will be provided using the full analysis population.  
The number and percentage of subjects falling into each response category for the 
following items will be provided in the summary: 
 Subject Asked if Any Scars are Related to Study Treatment (Yes, No) 
 Subject Response to Scars Inquiry (Yes, I have scar(s), No, I don't have any 
scar(s)): 
And for each scared lesion (TL1, TL2, NTL1, NTL2, NTL3): 


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o Severity of Lesion Scar (Mild, Moderate, Severe) 
o Lesion is Most Bothersome to Subject (Yes, No) 
The summary will present the above listed parameters within scheduled visit (W1 Safety 
Assessment, W2 Safety Assessment, EOT). 
A separate listing will be provided for the Scar Assessment using the full analysis 
population, and this listing will include Visit, Date of Visit, and the parameters as 
described above. 
Only Part 2 will be summarized. 
 
10.4. Scar Cosmesis Assessment and Rating Scale 
A summary of the Scar Cosmesis Assessment and Rating (SCAR) Scale will be provided 
using the full analysis population.  Descriptive statistics will be provided for Sum (0 = 
Best to 15 = Worst) and Partial Sum (0 = Best to 13 = Worst). 
Sum is to be provided in EDC when all assessment items (i.e., clinical and patient items 
shown below) have non-missing responses.  Partial Sum is derived as the sum of non-
items); if any clinical item is missing a response, then Partial Sum is derived as missing. 
The number and percentage of subjects falling into each response category for the 
following clinical and patient items will be provided in the summary: 
Clinical Items 
o Scar Spread (0 = None to near-invisible; 1 = Pencil-thin line; 2 = Mild 
spread, noticeable on close inspection; 3 = Moderate spread, obvious 
scarring; 4 = Severe spread) 
o Erythema (0 = None; 1 = Light pink, some telangiectasias may be present; 
2 = Red, many telangiectasis may be present; 3 = Deep red or purple) 
o Dyspigmentation (0 = Absent; 1 = Present) 
o Track Marks or Suture Marks (0 = Absent; 1 = Present) 
o Hypertrophy/Atrophy (0 = None; 1 = Mild: Palpable, barely visible 
hypertrophy or atrophy; 2 = Moderate: Clearly visible hypertrophy or 
atrophy; 3 = Severe: Marked hypertrophy or atrophy or keloid formation) 
o Overall Impression (0 = Desirable scar; 1 = Undesirable scar) 
 
Patient Items 
o Subject Bothered by Any Itch from Scar (0 = No; 1 = Yes) 
o Subject Bothered by Any Pain from Scar (0 = No; 1 = Yes) 


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The SCAR Scale scheduled visit is EOT prior to excision. 
A separate listing will be provided for the SCAR Scale using the full analysis population, 
and this listing will include Visit, Date of Visit, and the parameters as described above. 
Only Part 2 Cohort 4, Cohort 4 Expansion, Cohort 5, Cohort 5 Expansion, and overall 
(Cohorts 4 and 5 and Expansion Cohorts 4 and 5, i.e., Displayed Total) will be 
summarized. 
11. 
Immune Response and Genomic Analyses 
Analysis of multiplex immunohistochemical staining for T-cell subsets and immune 
activation markers in tumor tissue samples, analysis of T-cell clonality in blood and 
tumor tissue samples, and other genomic or immune response summaries, modeling, 
analyses, and graphics will be addressed by an external vendor in a separate analysis 
plan. 
A separate listing will be provided for Plasma Immune Response Collections using 
enrolled subjects, and the listing will include Visit, whether the Subject Consented to 
Participate in the Plasma Immune Response Subgroup (Yes, No), whether the Related 
Sample Collected Prior to First Treatment (Yes, No), and Date and Time of Collection. 
No summary tables will be provided. 
12. 
Pharmacokinetic Analysis 
PK collections are to be performed on W1D1 and W1D2.  Per protocol, concentrations of 
LTX-315 and metabolites were to be provided, but the data will contain only LTX-315 
concentrations. 
Summaries of (a) PK concentrations by scheduled timepoint and (b) PK parameters will 
be provided using descriptive statistics and the PK population.  The PK parameters will 
be estimated by an external vendor, as specified in a separate specification document, and 
may include Cmax, Tmax, AUC0-last, AUCtau, and/or AUCinf among others.  Descriptive 
statistics as mentioned in Section 5.2 of this SAP, as well as the coefficient of variation 
(%), geometric mean, and geometric coefficient of variation (%) will be provided for 
both PK summaries. 
The scheduled timepoints are as follows: 
 Pre-first W1D1 Injection: Immediately Prior 
 Post-first W1D1 Injection: 2 and 5 Minutes 


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 Post-last W1D1 Injection: 2, 5, 10, 20, 30, 60, and 120 Minutes 
 Post-last W1D1 Injection: 24 Hours  Drawn on W1D2 Prior to Injection 
VP-315 metabolites, PK parameter estimates, dose proportionality, and other PK 
summaries, modeling, analyses, and graphics will be addressed by an external vendor in a 
separate analysis plan. 
A separate listing will be provided for PK collections using enrolled subjects, and the 
listing will include whether the Subject Consented to PK Collection (Yes, No), Visit, 
Timepoint, whether the PK Sample was Collected (Yes, No), and Date and Time of 
Collection. 
A separate listing will also be provided for PK concentrations of LXT-315 (i.e., VP-315) 
using the PK population, and this listing will include Visit, Timepoint, Analyte (LTX-
315), Concentration (ng/mL), Date and Time of Collection (from PK collections data), 
and Sample Comments. 
Additionally, a separate listing will be provided for PK parameters using the PK 
population, and this listing will include PK parameters provided by the external vendor. 
Only Part 2 Cohort 4 Expansion, Cohort 5 Expansion, and overall (Expansion Cohorts 4 
and 5, i.e., Expansion Total) will be summarized. 
13. 
Differences Between Protocol and Statistical Analysis Plan 
If there are differences between the protocol and this SAP, then this SAP takes 
precedence. 
14. 
Where Statistical Analysis Plan Differs from Protocol 
The following are changes in this SAP that differ from the protocol: 
 In Section 2 of this SAP, Objectives and Endpoints and Section 8.3, Estimate of 
Remaining Tumor Volume and Reduction in Tumor Volume at Excision: 
Estimate of reduction in tumor volume (necrotic cells:tumor cells) at 
excision is added as an additional endpoint not included in the protocol. 
 In Section 6 of this SAP, Analysis Populations: 
A definition of enrolled subjects is not included in the protocol but is 
included in this SAP. 
 In Section 8.3 of this SAP, Estimate of Remaining Tumor Volume at Excision: 


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The protocol mentions that the estimated remaining tumor volume would 
be necrotic cells:tumor cells.  However, the estimated remaining tumor 
volume will be provided by the dermatopathologist and captured in EDC 
as an estimate of viable tumor within estimated volume of the entire tumor 
bed expressed as a percentage. 
 In Section 9.1 of this SAP, Adverse Events: 
Per protocol, the DLT observation period for Part 1 subjects is given as 
completing Week 1 dosing.  In this SAP, to clarify that completing dosing 
is not necessary for observation, the DLT observation period for Part 1 
subjects any day on which treatment occurs Per protocol, the TRAE SI 
observation period for Part 2 subjects occurs during treatment visit.  In this 
SAP, the TRAE SI observation period for Part 2 subjects is defined as any 
day on which treatment occurs. 
 In Section 9.2 of this SAP, Clinical Laboratories: 
As CTCAE grading is not provided for numerous laboratory data, shift 
tables to assess changes from baseline will be presented using Low, 
Normal, High, and Total as categories. 
 In Section 12 of this SAP, Pharmacokinetic Analysis: 
Per protocol, concentrations of LTX-315 and metabolites were to be 
provided, but the data will contain only LTX-315 concentrations. 
15. 
Minor Changes in Displays 
Minor changes in display categories, minor rearrangement of display layouts, and 
changing single displays into multiple displays and vice versa due to spacing or 
presentation needs are permitted without sponsor approval. 
16.  
References 
Verrica Pharmaceuticals Inc.  VP-315-201: A Phase 2, Multicenter, Open-label, Proof-of-
Concept Study with Safety Run-in to Evaluate the Safety, Pharmacokinetics, and 
Efficacy of VP-315 in Adult Subjects with Basal Cell Carcinoma, Protocol Version 9.0 
(Amendment 8).  13-Oct-2023. 
 
 


Certificate Of Completion
Envelope Id: B073DB2ADEC74F0BA5FA7168C57AB071
Status: Completed
Subject: Complete with Docusign: Verrica_VP-315_DRAFT_SAP_2024-09-06.docx
Source Envelope: 
Document Pages: 46
Signatures: 2
Envelope Originator: 
Certificate Pages: 5
Initials: 0
Carolyn Kaempfer
AutoNav: Enabled
EnvelopeId Stamping: Enabled
Time Zone: (UTC-05:00) Eastern Time (US & Canada)
134 Turnpike Road
Southborough, MA  01772
Carolyn.Kaempfer@veristat.com
IP Address: 97.113.174.253 
Record Tracking
Status: Original
             9/6/2024 6:01:22 PM
Holder: Carolyn Kaempfer
             Carolyn.Kaempfer@veristat.com
Location: DocuSign
Signer Events
Signature
Timestamp
Carolyn Kaempfer
carolyn.kaempfer@veristat.com
Manager, Biostatistics
Security Level: Email, Account Authentication 
(Required)
Signature Adoption: Pre-selected Style
Signature ID: 
6C9CC10B-B834-4EA2-A9C1-69AA26C46E6E
Using IP Address: 97.113.174.253
With Signing Authentication via DocuSign password
With Signing Reasons (on each tab): 
   I am the author of this document
Sent: 9/6/2024 6:10:58 PM
Viewed: 9/6/2024 6:11:29 PM 
Signed: 9/6/2024 6:11:54 PM
Electronic Record and Signature Disclosure: 
      Accepted: 10/9/2023 5:32:40 PM
      ID: 7d9ed0b9-c12c-4283-905d-596b2ec8b35f
Tom Haws
thaws@verrica.com
Security Level: Email, Account Authentication 
(Required)
Signature Adoption: Pre-selected Style
Signature ID: 
A17BE5A0-0F41-4BE2-A667-17076D6F1532
Using IP Address: 100.14.119.244
With Signing Authentication via DocuSign password
With Signing Reasons (on each tab): 
   I approve this document
Sent: 9/6/2024 6:11:57 PM
Viewed: 9/6/2024 6:51:16 PM 
Signed: 9/6/2024 6:51:51 PM
Electronic Record and Signature Disclosure: 
      Accepted: 9/6/2024 6:51:16 PM
      ID: 451b356f-8ab9-41e5-84ec-51e1a81be45a
In Person Signer Events
Signature
Timestamp
Editor Delivery Events
Status
Timestamp
Agent Delivery Events
Status
Timestamp
Intermediary Delivery Events
Status
Timestamp
Certified Delivery Events
Status
Timestamp


Carbon Copy Events
Status
Timestamp
Witness Events
Signature
Timestamp
Notary Events
Signature
Timestamp
Envelope Summary Events
Status
Timestamps
Envelope Sent
Hashed/Encrypted
9/6/2024 6:10:58 PM
Certified Delivered
Security Checked
9/6/2024 6:51:16 PM
Signing Complete
Security Checked
9/6/2024 6:51:51 PM
Completed
Security Checked
9/6/2024 6:51:51 PM
Payment Events
Status
Timestamps
Electronic Record and Signature Disclosure


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