# EDGAR Filing Document

**Accession Number:** 0001472091
**File Stem:** 0001140361-23-002136
**Filing Date:** 2023-1
**Character Count:** 21902
**Document Hash:** ffac50e01c32276d62790085c6741f8b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001140361-23-002136.hdr.sgml**: 20230119

**ACCESSION NUMBER**: 0001140361-23-002136

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 28

**CONFORMED PERIOD OF REPORT**: 20230119

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230119

**DATE AS OF CHANGE**: 20230119

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** PDS Biotechnology Corp
- **CENTRAL INDEX KEY:** 0001472091
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 264231384
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37568
- **FILM NUMBER:** 23537612

**BUSINESS ADDRESS:**
- **STREET 1:** 25B VREELAND ROAD
- **STREET 2:** SUITE 300
- **CITY:** FLORHAM PARK
- **STATE:** NJ
- **ZIP:** 07932
- **BUSINESS PHONE:** 800-208-3343

**MAIL ADDRESS:**
- **STREET 1:** 25B VREELAND ROAD
- **STREET 2:** SUITE 300
- **CITY:** FLORHAM PARK
- **STATE:** NJ
- **ZIP:** 07932

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Edge Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20090911

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, DC 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d) of the

#### Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): January 19, 2023

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**PDS BIOTECHNOLOGY CORPORATION**

#### (Exact Name of Registrant as Specified in Charter)

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| | | |
|:---|:---|:---|
| <u>Delaware</u><br>| <u>001-37568</u><br>| <u>26-4231384</u><br>|
| **(State or Other Jurisdiction of Incorporation)** | **(Commission File Number)** | **(I.R.S. Employer Identification No.)** |

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#### 25B Vreeland Road, Suite 300, Florham Park, NJ 07932

#### (Address of Principal Executive Offices, and Zip Code)
<u>(800) 208-3343</u>

#### Registrant's Telephone Number, Including Area Code

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#### (Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (*see* General Instruction A.2. below):

☐ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which<br> registered |
| Common Stock, par value $0.00033 per share<br>| PDSB<br>| The Nasdaq Capital Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

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On January 20, 2023, PDS Biotechnology Corporation will attend a meeting and present a deck. A copy of the slide deck is filed as Exhibit 99.1 hereto and incorporated herein by reference.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit**<br> **Number** | **Description** |
| [99.1](brhc10046805_ex99-1.htm) | Slide deck presentation |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL Document) |

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#### Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **PDS BIOTECHNOLOGY CORPORATION** | **PDS BIOTECHNOLOGY CORPORATION** |
| Date: January 19, 2023 | By: | <u>/s/ Frank Bedu-Addo, Ph.D.</u> |
|  | Name: Frank Bedu-Addo, Ph.D. | Name: Frank Bedu-Addo, Ph.D. |
|  | Title:President and Chief Executive Officer | Title:President and Chief Executive Officer |

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## Exhibit 99.1

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**Exhibit 99.1**<br>

![](brhc10046805_ex99-1slide1.jpg)

Precision Designed Science For Immunotherapy Oncology Platforms and Clinical Data Summary NASDAQ: PDSB \| January 2023

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![](brhc10046805_ex99-1slide2.jpg)

2 Certain information in this presentation may include forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the "Company") and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company's management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," "forecast," "guidance", "outlook" and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company's ability to protect its intellectual property rights; the Company's anticipated capital requirements, including the Company's anticipated cash runway and the Company's current expectations regarding its plans for future equity financings; the Company's dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company's operations or require the Company to relinquish rights to the Company's technologies or product candidates; the Company's limited operating history in the Company's current line of business, which makes it difficult to evaluate the Company's prospects, the Company's business plan or the likelihood of the Company's successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company's interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company's product candidates; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company's ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the success of the Company's license agreements, including the potential for the clinical and nonclinical data available under the Company's exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® is a registered trademark, and Infectimune™ is a trademark of PDS Biotechnology Corporation KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Forward-Looking Statements 2

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![](brhc10046805_ex99-1slide3.jpg)

1 2 4 5 6 Company Overview Clinical-stage Company developing proprietary targeted immunotherapies to treat cancer and infectious disease Versamune® based platforms leverage the body's own defense systems to induce tumor-specific killer T cells to overcome immune suppression and attack cancer Exclusive global license with Merck KGaA, Darmstadt, Germany for tumor targeting IL-12 fusion protein (PDS0301) Clinical partnerships with Merck, MD Anderson Cancer Center, National Cancer Institute and Mayo Clinic Cash as of September 30, 2022 - $71.6M cash runway to Q2 2024 with a potential registrational trial in 2023 3 Infectimune™ activates the immune system to induce pathogen-specific T cells and antibodies to protect against infectious disease 3 PDS0101 granted FDA Fast Track designation. Four Phase 2 clinical trials addressing multiple HPV-positive cancers. Safety and efficacy data have been reported in over 100 and 60 patients, respectively 7

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![](brhc10046805_ex99-1slide4.jpg)

Oncology Platforms based on Independently Validated\* Science with Translation to Humans 4 Proprietary Versamune® T cell activating platform Pure biologically active R-enantiomer of positively charged lipid that specifically activates the Type I Interferon signaling pathway known to be essential for effective T cell activation Promotes antigen uptake by dendritic cells, promotes antigen processing, and presentation into MHC Class I (CD8+ T cells) and MHC Class II pathways (CD4+ T cells) Tumor targeting cytokine (PDS0301) PDS0301 is a tumor-targeting fusion protein of IL-12 (IgG1 antibody-IL12) that can promote inflammation in tumors The proprietary platform combination of Versamune® + cytokines down-regulates immune suppressive factors such as myeloid derived suppressor cells (MDSC) In advanced refractory cancers the Versamune® -PDS0301 combination promotes tumor infiltration and proliferation of the Versamune® induced T cells in the tumors \*National Cancer Institute, University of Texas MD Anderson Cancer Center

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![](brhc10046805_ex99-1slide5.jpg)

Phase 2 Clinical Data To Date 5 Versamune® Technology Platform: In-vivo tumor-specific killer (CD8+) T cell induction HPV-positive head and neck cancer: PDS0101 + KEYTRUDA® (standard of care) in patients whose cancer has returned or spread after treatment 41% (7/17) Objective response rate (ORR)1 89% survival at 9 months Cervical cancer: PDS0101 + Chemoradiotherapy (standard of care) in patients with large localized tumors >5cm in the cervix and lymph nodes 100% (9/9) >60% shrinkage at midpoint 89% (8/9) complete response (CR) 0% deaths from cancer or treatment at 1 year Versamune® IL-12 Technology Platform: Overcomes cancer-induced immune suppression HPV-Associated cancers: PDS0101 + PDS0301 + Checkpoint inhibitor in patients who have failed all treatment options including checkpoint inhibitors (median survival reported 3-4 months) 63% (5/8) ORR in optimal dose group2 21-month OS (all dose groups)2 HPV-Associated cancers: PDS0101 + PDS0301 + Checkpoint inhibitor in patients whose cancer has returned or spread after treatment 88% (7/8) ORR3 38% (3/8) CR 75% (6/8) survival at 27 months 119% response rate with Keytruda monotherapy reported in KEYNOTE-048 study (CPS >1) 2 Objective response rates in CPI refractory cancer reported to be <10%, and historical median survival is 3-4 months 3Obective response rates in HPV-positive cancer with pembrolizumab and nivolumab is <25% and overall survival of <12 months

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![](brhc10046805_ex99-1slide6.jpg)

Promotes clinically effective antigen-specific killer (CD8+) T cell induction Versamune® Based T Cell Immunotherapies 6 PDS Biotech's Versamune® technology platform has shown the ability to overcome a critical limitation of current immuno-oncology to induce active CD8+ T cells in vivo In oncology clinical studies, the Versamune® based immunotherapies promote the in vivo induction of high quality and quantity of multi-functional, antigen-specific killer T-cells (CD8+) that specifically target and infiltrate the tumors In Phase 2 clinical studies, the tumor infiltrating killer T cells have demonstrated the ability to target and kill the cancer cells leading to tumor shrinkage, delay in disease progression, and prolonged survival in patients with advanced cancer

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![](brhc10046805_ex99-1slide7.jpg)

PDS0101 + CRT Induce Clinical Efficacy with 100% (9/9) Response Rate in Cervical Cancer Patients Having Tumors Over 5cm 1Residual traces of the cancer were detected in one patient who only received 3 of the schedule 5 doses of PDS0101 2In agreement with published preclinical findings that Versamune® promotes in vivo induction of the more potent, polyfunctional (multi-cytokine inducing) and tumor infiltrating killer T cells – J. Immunology 2019; 202 (12): 3524-3536 7 Partner: FDA approved standard of care: Chemo-radiotherapy (CRT) Preliminary Results (Phase 2 Clinical Trial) Preliminary efficacy data (Society for Immunotherapy of Cancer (SITC) Conference, November 2022): Clinical response with tumor shrinkage of over 60% at 1 month - 100% (9/9) Complete response (No evidence of cancer) by day 170 - 89% (8/9)1 Majority of patients have Stage III and Stage IV cancer 1-year overall survival – No patients have died from the cancer or treatment. One patient has died from an unrelated cause/event

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![](brhc10046805_ex99-1slide8.jpg)

PDS0101 Induces Tumor-Infiltrating CD8+ T cells & Elimination of Circulating Tumor DNA in High-Risk Cervical Cancer 1Yoshida-Court et al,, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771); SITC 2022 8 PDS0101 induces multi-functional killer T cells (CD8+ T cells that induce granzyme-B) The killer T cells target, infiltrate and eliminate the cervical cancer tumors HPV16 tumor DNA in the blood circulation declines by day 170 (T5) Quantity of tumor cells circulating in the blood at start of treatment Killer T cells that infiltrated the tumors Representative Data Shown for Patient PDS05

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![](brhc10046805_ex99-1slide9.jpg)

PDS0101 + KEYTRUDA® Preliminary Phase 2 Data Shows 41% Response Rate vs. 19% in Published Results for CPI Monotherapy 9 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data Best Overall Response and % Change from Baseline by Investigator Assessment per RECIST 1.1 119% objective response rate with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 212-month overall survival of 49% with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 317% of patients had treatment related grade 3 and higher adverse events with KEYTRUDA® monotherapy reported in KEYNOTE-048 study Objective response (% of patients with ≥ 30% tumor shrinkage) - 7/17 (41.1%)1 Clinical benefit (stable disease + objective response) – 13/17 (76.5%) 9-month overall survival rate – 87.2%2 No treatment related grade 3 and higher (serious) adverse events - 0/43 (0%)3 Fast Track Designation – June 2022

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![](brhc10046805_ex99-1slide10.jpg)

Versamune® IL-12 (PDS0301) Platform Addresses Advanced, Refractory Cancers 10 In Phase 2 clinical trials PDS Biotech's Versamune® IL-12 combination platform has shown the ability to overcome the I-O limitation of more broadly overcoming immune suppression in advanced cancer Overcomes immune suppression in pre-treated cancer patients (100% failed chemo, 90% failed radiation treatments) including checkpoint inhibitor refractory patients leading to favorable tumor shrinkage and prolonged overall survival compared to published results with current therapies In checkpoint inhibitor refractory patients with HPV-associated cancers, induction of multi-functional, HPV-specific CD8+ T cells was demonstrated in 79% (11/14) of patients Increases in granzyme B (associated with active CD8+ T cells), IFN-γ, TNF-α, etc., signal a pro-inflammatory response and role in overcoming tumor immune suppression

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![](brhc10046805_ex99-1slide11.jpg)

Best Overall Response Active Against Diverse HPV16 Cancers PDS0101 + Higher PDS0301 dose + CPI Induces Tumor Shrinkage in Advanced CPI Refractory HPV16-Cancers 11 \*HNSCC – head and neck squamous cell carcinomas Higher PDS0301 Dose Cervical Vaginal/Vulvar Anal HNSCC\* Percentage Change Weeks Baseline Responses Occurred Irrespective of Tumor Type Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 2518. Best Overall Response is defined by RECIST 1.1

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![](brhc10046805_ex99-1slide12.jpg)

1Objective response rates with standard of care < 10% 2No tumor shrinkage in HPV16-negative subjects (ASCO 2021) – Suggests critical role of PDS0101-induced HPV16-specific CD8+ T cells 3Historical median overall survival in the population is 3-4 months 12 Checkpoint inhibitor refractory patients Efficacy data in HPV16-positive patients: Objective response in optimal dose group (high dose PDS0301) - 5/8 (62.5%)1,2 Median overall survival (OS) is 21 months (all dose groups n=29)3 Checkpoint inhibitor naive patients Interim data: Objective response - 7/8 (87.5%)4 Percent of patients alive at median follow-up of 27 months – 6/8 (75.0%)5 PDS0101 HPV16-Targeted Immunotherapy Partner: Types of cancer included in the trial: Anal, cervical, head and neck, penile, vaginal, vulvar Standard of care: Checkpoint inhibitor (CPI) refractory - None Recurrent, metastatic cancer (CPI naive) – Checkpoint inhibitors PDS0101 + PDS0301 + CPI Showed Survival Benefit in Advanced HPV16-Cancers (Phase 2 Interim Data) 436% objective response with Keytruda + chemotherapy reported in KEYNOTE-048 study 512-month overall survival of 51% with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study

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![](brhc10046805_ex99-1slide13.jpg)

136% objective response with Keytruda + chemotherapy reported in KEYNOTE-048 study 212-month overall survival of 51% with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study 373% treatment related grade 3 and higher adverse events with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study 13 Partner: Types of cancer included in the trial: Anal, cervical, head and neck, penile, vaginal, vulvar FDA approved standard of care for checkpoint inhibitor naïve patients: Checkpoint inhibitors e.g. OPDIVO® (nivolumab), KEYTRUDA® (Pembrolizumab)1 and Checkpoint inhibitors plus chemotherapy1,2 Phase 2 Trial Interim Results Safety results (Arms 1 & 2)3 24/50 (48%) of patients experienced grade 3 and higher adverse events 2/50 (4%) experienced grade 4 adverse events PDS0101 + PDS0301 + Checkpoint Inhibitor Shows Encouraging Safety Profile

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![](brhc10046805_ex99-1slide14.jpg)

Next Steps Towards Registrational Trials and New Oncology Indications 14 VERSATILE-002 (PDS0101 + KEYTRUDA): FDA Fast Track; FDA alignment on key elements of a registrational trial; Protocol development in progress; Initiation anticipated 2023and/or Triple Combination (PDS0101 + PDS0301 + CPI): Meeting with FDA in Q1 2023 to discuss registrational pathway and selection of preferred checkpoint inhibitor (CPI). Initiation anticipated late 2023 pending FDA feedback PDS0103 + CPI +/- PDS0301: CPI naïve and refractory MUC1 associated cancers e.g. colon, breast, NSCLC, CRC, gall bladder, bladder, nasopharyngeal etc.; IND for Phase 1/2 anticipated 2023

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![](brhc10046805_ex99-1slide15.jpg)

Precision Designed Science For Immunotherapy Oncology Platforms and Clinical Data Summary NASDAQ: PDSB \| January 2023

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