# EDGAR Filing Document

**Accession Number:** 0001359931
**File Stem:** 0001213900-25-112383
**Filing Date:** 2025-11
**Character Count:** 42280
**Document Hash:** b63cf8f2f7afb4aa96c66d5f2aa7b241
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-112383.hdr.sgml**: 20251119

**ACCESSION NUMBER**: 0001213900-25-112383

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 40

**CONFORMED PERIOD OF REPORT**: 20251119

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251119

**DATE AS OF CHANGE**: 20251119

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Protara Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001359931
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 204580525
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36694
- **FILM NUMBER:** 251496855

**BUSINESS ADDRESS:**
- **STREET 1:** 345 PARK AVENUE SOUTH
- **STREET 2:** 3RD FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10010
- **BUSINESS PHONE:** 646-844-0337

**MAIL ADDRESS:**
- **STREET 1:** 345 PARK AVENUE SOUTH
- **STREET 2:** 3RD FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10010

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ArTara Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20200110

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** PROTEON THERAPEUTICS INC
- **DATE OF NAME CHANGE:** 20060420

?xml version='1.0' encoding='ASCII'?

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 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):** November 19, 2025

**Protara Therapeutics, Inc.**

**(Exact name of registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-36694** | **20-4580525** |
| **(State or other jurisdiction<br> of incorporation)** | **(Commission File No.)** | **(IRS Employer<br> Identification No.)** |

---

---

| | |
|:---|:---|
| **345 Park Avenue South**<br> **Third Floor**<br> **New York, NY** | **10010** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

**Registrant's telephone number, including area code: (646) 844-0337** 

**N/A**

**(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:

☐ Written communications 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 communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications 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:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, par value $0.001 per share | TARA | The Nasdaq Global Market |

---

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

**Item 7.01 Regulation FD Disclosure.**

On November 19, 2025, Protara Therapeutics, Inc. (the "Company" or "Protara") posted an investor presentation (the "Investor Presentation") to the "Investors—Events and Presentations" section of the Company's website at http://www.protaratx.com and posted a press release (the " Press Release") to the "Investors—Press Releases" section of the Company's website at www.protaratx.com. The Investor Presentation and Press Release will be used in connection with a conference call and webcast today, November 19, 2025, at 8:30 am ET, to review the clinical data on the ongoing Phase 2 STARBORN-1 trial program. A copy of the Investor Presentation is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the Press Release is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

**Item 8.01 Other Events.**

On November 19, 2025, the Company announced interim results from its ongoing Phase 2 STARBORN-1 clinical trial of TARA-002 in pediatric patients with Lymphatic Malformations ("LMs") during a conference call. The Company also issued the Press Release in connection with the announcement of such results.

The Company reported data that highlights the potential of intracystic injection of TARA-002 in pediatric patients with LMs in its Phase 2 STARBORN-1 clinical trial, which is assessing TARA-002, the Company's investigational cell-based therapy, in patients with macrocystic and mixed-cystic LMs. The interim analysis includes a total of 12 patients who enrolled in the trial and received more than one dose of TARA-002 as of the November 12, 2025 data cutoff. The dataset includes eight patients who were evaluable at eight weeks, two patients who withdrew prior to the eight-week assessment, and two patients remaining in dosing as of the data cutoff on November 12, 2025. Assessment of efficacy is based on the proportion of participants with macrocystic and mixed-cystic LMs who demonstrate clinical success, defined as having either a complete response (90% to 100% reduction from baseline in total LM volume) or substantial response (60% to less than 90% reduction in total LM volume) as measured by axial imaging or via investigator assessment (physical exam, visual inspection and ultrasound). Of the eight patients who were evaluable, the majority (7/8) achieved clinical success with one or two doses. One patient, who presented with a 1,739 ml macrocystic LM, required all four doses, and achieved a complete response. 80% (8/10) of patients that completed treatment achieved clinical success. 100% (8/8) of patients who completed the eight-week response assessment achieved clinical success. 83% (5/6) of macrocystic patients achieved a complete response and the other patient achieved a substantial response. The only mixed-cystic patient achieved a complete response. Two LMs patients reached the 32-week post-treatment assessment and remain disease-free. One patient deemed a complete response was subsequently diagnosed with a ranula (a different type of maxillofacial cyst from LMs).

The majority of adverse events (AEs) were mild to moderate, with no serious AEs reported. The most common AEs were swelling and fatigue. One patient discontinued treatment due to a Grade 2 AE of fatigue.

**Forward-Looking Statements**

Statements contained in this press release regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara's business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials (including the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials or phases thereof); statements related to expectations regarding interactions with the U.S. Food and Drug Administration (FDA); Protara's financial position; statements regarding the anticipated safety or efficacy of Protara's product candidates; and Protara's outlook for the remainder of the year and future periods. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara's financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara's development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara's strategic and commercial plans; Protara's ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara's business and financial condition in general, including the risks and uncertainties described more fully under the caption "Risk Factors" and elsewhere in Protara's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law.

**Item 9.01 Financial Statements and Exhibits.** 

**(d) Exhibits** 

---

| | |
|:---|:---|
| **Exhibit<br> Number** | **Exhibit Description** |
| 99.1 | [Investor Presentation, dated November 19, 2025.](ea026638401ex99-1_protara.htm) |
| 99.2 | [Press Release, dated November 19, 2025.](ea026638401ex99-2_protara.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

**SIGNATURES**

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.

Date: November 19, 2025

---

| | |
|:---|:---|
| **Protara Therapeutics, Inc.** | **Protara Therapeutics, Inc.** |
| By: | /s/ Patrick Fabbio |
|  | Patrick Fabbio |
|  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

STARBORN - 1 Clinical Trial Interim Update November 19, 2025

![](ex99-1_002.jpg)

Forward Looking Statements 2 Statements contained in this presentation regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 . Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward - looking statements . Such forward - looking statements include but are not limited to, statements regarding Protara's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things : Protara's business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials ; statements related to expectations regarding interactions with the U . S . Food and Drug Administration (FDA) ; Protara's financial position ; statements regarding the anticipated safety or efficacy of Protara's product candidates ; and Protara's outlook for the remainder of the year and future periods . Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward - looking statements . Factors that contribute to the uncertain nature of the forward - looking statements include : risks that Protara's financial guidance may not be as expected, as well as risks and uncertainties associated with : Protara's development programs, including the initiation and completion of clinical trials and the timing of required filings with the FDA and other regulatory agencies ; general market conditions ; changes in the competitive landscape ; changes in Protara's strategic and commercial plans ; Protara's ability to obtain sufficient financing to fund its strategic plans and commercialization efforts ; having to use cash in ways or on timing other than expected ; the impact of market volatility on cash reserves ; failure to attract and retain management and key personnel ; the impact of general U . S . and foreign, economic, industry, market, regulatory, political or public health conditions ; and the risks and uncertainties associated with Protara's business and financial condition in general, including the risks and uncertainties described more fully under the caption "Risk Factors" and elsewhere in Protara's filings and reports with the United States Securities and Exchange Commission . All forward - looking statements contained in this presentation speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date . Protara undertakes no obligation to update any forward - looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law .© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \|

![](ex99-1_003.jpg)

Agenda Jesse Shefferman Co - founder, Director, Chief Executive Officer Jacqueline Zummo, PhD Co - founder, Senior Vice President, Chief Scientific Operations Officer Jesse G.A. Jones, MD University of Alabama – Department of Neurosurgery and Radiology, and STARBORN - 1 study investigator Introduction • LMs opportunity • Executive Summary Jesse Shefferman TARA - 002 in Lymphatic Malformations • TARA - 002 MOA • Interim STARBORN - 1 Data • OK - 432 Data Review Jacqueline Zummo, PhD KOL Discussion Jesse, G.A. Jones, MD Closing Remarks Jesse Shefferman Q&A All© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 3

![](ex99-1_004.jpg)

\*Currently in pre - clinical studies to define dosing and, once protocol is confirmed, expect to initiate P2 trial cohort. \*\*Granted Orphan Drug Designations by the U.S. FDA for the prevention and/or treatment of choline deficiency in patients on l on g - term PN and Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or co n traindicated. \*\*\*TARA - 002 granted Rare Pediatric Disease designation by the U.S. FDA and orphan drug designation by the European Commission f or the treatment of LMs. † Trial also includes BCG - Exposed patients. Robust De - Risked Pipeline with Multiple Upcoming Opportunities© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 4 Phase 3 Phase 2 Phase 1 Pre - Clinical Indication ONCOLOGY NMIBC BCG - Naïve † TARA - 002 NMIBC BCG - Unresponsive NMIBC BCG - Naïve TARA - 002 Systemic Priming NMIBC BCG - Naïve TARA - 002 Systemic Priming + maintenance NMIBC All - comers TARA - 002 Combination RARE DISEASES Choline for parenteral support (PS) patients\*\* IV CHOLINE Lymphatic Malformations (LMs)\*\*\* TARA - 002 ADVANCED - 2 (Cohort A) Fully enrolled ADVANCED - 2 (Cohort B) ADVANCED - 2 (Cohort C)\* STARBORN - 1 THRIVE - 3 ADVANCED - 2 (Cohort D)\*

![](ex99-1_005.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 5 LMs Represent a Significant Pediatric Rare Disease Opportunity with No Currently Approved Therapies Lymphatic Malformations (LMs) are rare, non - malignant, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system 1 LMs are diagnosed in early childhood and can cause significant morbidity affecting breathing, swallowing, feeding, and speaking 2 Macrocystic LMs Microcystic LMs Mixed Cystic Large cysts >1 - 2 cm diameter, well - defined fluid - filled spaces Small, infiltrative lesions with tiny cystic spaces Combination of both macro and microcystic components TARA - 002 has the potential to treat macrocystic and mixed cystic LMs, which most often are present in the head and neck region 1 Brouillard P, et al. J Clin Invest. 2014;124:898 - 904.; 2 Ha J, et al. Curr Ped Rev. 2014;10:238 - 248 TARA - 002 TARA - 002

![](ex99-1_006.jpg)

Lymphatic Malformations Incidence: 1,400 - 1,800 LM cases per year 1© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 6 Bringing the First FDA - approved Therapy to Market for Macrocystic and Mixed Cystic LMs Provides a Significant Rare Disease Opportunity Prevalence Seeking Treatment ~20,000 patients Macrocystic 2 ~ 47 % Microcystic 2 ~ 21 % Mixed 2 ~32% 1 Internal company estimates; 2 Hyvonen H, et al. Journal of Ped Surgery 2022 Unmet Medical Need Not a target for TARA - 002 No FDA approved therapies for macro - and mixed cystic LMs Current treatment options include: • Surgical excision with a high complication rate including infection, scarring or nerve injury, as well as a high recurrence rate • Unapproved, off - label use of sclerosants , which have various side effects and carry the risk of serious side effects for pediatric patients

![](ex99-1_007.jpg)

TARA - 002 HAS ROBUST SUPPORTING CLINICAL DATA IN LMS FROM PREDECESSOR COMPOUND, OK - 432 • OK - 432 has shown strong safety and efficacy results in 500+ U.S. pediatric LMs patients in University of Iowa - led study • Approved in Japan as standard of care for LMs for 30 years STARBORN - 1 DATA INDICATE TARA - 002 HAS COMPARABLE SAFETY & EFFICA CY TO OK - 432 • 100% of evaluable patients achieved clinical success • TARA - 002 demonstrated favorable safety and tolerability profile with no serious adverse events reported HIGH UNMET NEED WITH POTENTIAL TO TREAT OTHER MAXILLOFACIAL CYST S • Granted Rare Pediatric Disease Disorder (RPDD) in 2021 • Historical literature and patient experience show TARA - 002 may also be effective in treating other maxillofacial cysts© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 7 Executive Summary: TARA - 002 Provides a De - Risked Opportunity for a Significant Unmet Need

![](ex99-1_008.jpg)

LMs Overview & TARA - 002 MOA© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 8

![](ex99-1_009.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 9 TARA - 002 is an Investigational, Genetically Distinct Strain of Streptococcus Pyogenes that is Inactivated While Retaining its Immune - Stimulating Properties First Immune Response Further Recruitment of Immune Cells Breakdown of the Lymphatic Lining Lymphatic Fluid Aspiration TARA - 002 Injection

![](ex99-1_010.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 10 Following the Immune Cascade Triggering Vessel Collapse, the Formation of Mature Fibrous Tissue Prevents Cyst Recurrence Improved Fluid Drainage Fibrotic Adhesion Healing and Tissue Remodeling Vessel Collapse and Long - Term Stabilization Lymphatic Fluid Drainage

![](ex99-1_011.jpg)

TARA - 002 IN LMS Interim STARBORN - 1 Data Update and OK - 432 Data Review

![](ex99-1_012.jpg)

6 years to < 18 years 2 years to < 6 years 6 months to < 2 years Phase 2a: Safety Lead - In Phase 2b: Expansion Age De - escalation Age De - escalation DMC Review DMC Review DMC Review Phase 2 STARBORN - 1 Trial© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 12 Enroll N = 20 Expansion Expansion Expansion Enroll N = 3 Enroll N = 3 Enroll N = 3 STARBORN - 1 is a Single Arm, Open - Label Safety and Efficacy Study of TARA - 002 in Pediatric Patients with Macrocystic & Mixed - cyst ic LMs (N=29) • Patients receive up to four injections of TARA - 002 spaced approximately six weeks apart • DMC review with FDA for each safety lead - in cohort before expansion and age de - escalation • Clinical Success is defined as the proportion of patients who have either a complete response (90 - 100% reduction from baseline in total LM volume) or substantial response (60% - 90% reduction) CT.gov identifier: NCT05871970

![](ex99-1_013.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 13 Response was assessed via central imaging (MRI or CT) or via Investigator assessment (physical exam, visual inspection and ul tra sound). Clinical success is defined as complete (90 - 100% reduction) or substantial (60 - 90% reduction) response of the cyst from baseline in total LM volume. Note: Response assessment includes all patients who have completed treatment; Excludes 2 subjects who are still in treatment \*Patients who received at least one intracystic injection of the study intervention. ^ Patients who completed the 8 - week post - treatment assessment. 20% 70% 10% N = 10 Withdrew Complete Response Substantial Response 80% 80% CLINICAL SUCCESS RATE AT 8 - WEEKS POST - TREATMENT\* Data cut - off: 12 - Nov - 2025 88% 12% N = 8 Complete Response Substantial Response 10 0% 10 0% CLINICAL SUCCESS RATE AT 8 - WEEKS POST - TREATMENT IN EVALUABLE PATIENTS^ STARBORN - 1 Interim Results: TARA - 002 Demonstrated Clinical Success in 80% of Patients that Completed Treatment and 100% of Evaluable Patients 2 Patients withdrew before 8 - week post - treatment assessment • 1 participant was mis - diagnosed and had a rare form of cancer and did not respond to treatment • 1 participant dropped out after achieving a marked resolution of the LM: received 2 doses (160 ml aspiration at first dose reduced to 10 ml aspiration at second dose)

![](ex99-1_014.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 14 STARBORN - 1 Interim Results: Evaluable Patients Across Cyst Types • 2 patients have reached the 32 - weeks post - treatment assessment and remain disease free • One patient deemed a complete response was subsequently diagnosed with a ranula (a different type of maxillofacial cyst from LMs) 83% 17% Macrocystic LMs (N = 6) Mixed-cystic LMs (N = 1) Ranula (N = 1) Complete Response Substantial Response STRONG RESPONSE ACROSS CYST TYPES IN EVALUABLE POPULATION: MACROCYSTIC LMs, MIXED CYSTIC LMs, RANULAS 100% 100% 100%

![](ex99-1_015.jpg)

STARBORN - 1 Interim Results: Clinical Response Overview Assessment of Response 8 Weeks after Last Injection Number of Doses of TARA - 002 Age LM Type Cohort / Patients\* Ph2a: 6 - 18 years Complete Response 1 14 Ranula (Dx'd macro)\*\* 1 Complete Response 1 12 Mixed cystic 2 Withdrew 3 15 Mis - diagnosed cancer 3 Ph2a: 2 - 6 years Complete Response 1 4 Macrocystic 1 Complete Response 1 4 Macrocystic 2 Complete Response 2 3 Macrocystic 3 Complete Response 2 2 Macrocystic 4 Ph2b Expansion: 6 - 18 years Substantial Response 2 6 Macrocystic 1 Complete Response 4 8 Macrocystic 2 Withdrew – Demonstrated a Notable Resolution of the LM 2 15 Macrocystic 3 Response was assessed via central imaging (MRI or CT) or via Investigator assessment (physical exam, visual inspection and ul tra sound). Clinical success is defined as complete (90 - 100% reduction) or substantial (60 - 90% reduction) response of the cyst from baseline in total LM volu me. \*Excludes 2 patients who are still in treatment; \*\*Later diagnosed as a Ranula patient© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 15 Data cut - off: 12 - Nov - 2025

![](ex99-1_016.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 16 TARA - 002 Has a Favorable and Well - Tolerated Safety Profile Grade 4/5 Grade 3 Grade 2 Grade 1 Any Grade Number of Patients, N = 12 0 (0.0) 1 (8.3) 6 (50.0) 8 (66.7) 8 (66.7) TEAEs, n (%) 0 (0.0) 1 (8.3) 4 (33.3) 7 (58.3) 7 (58.3) Related TEAEs, n (%) Related TEAEs >10%, n (%) 0 (0.0) 1 (8.3) 2 (16.7) 0 (0.0) 3 (25.0) Swelling 0 (0.0) 0 (0.0) 1 (8.3) 2 (16.7) 3 (25.0) Fatigue 0 (0.0) 0 (0.0) 0 (0.0) 2 (16.7) 2 (16.7) Headache 0 (0.0) 0 (0.0) 0 (0.0) 2 (16.7) 2 (16.7) Injection site pain 0 (0.0) 0 (0.0) 0 (0.0) 2 (16.7) 2 (16.7) Injection site rash 0 (0.0) 0 (0.0) 0 (0.0) 2 (16.7) 2 (16.7) Pyrexia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) AESIs, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Serious TEAEs, n (%) 0 (0.0) 0 (0.0) 1 (8.3) 0 (0.0) 1 (8.3) R elated TEAEs leading to study drug withdrawal, n (%) • Most AEs were mild to moderate. • No SAEs or AESIs have occurred to date. • Related AEs and systemic reactions are in line with typical systemic responses to bacterial immunopotentiation and the established safety profile of OK - 432. AESI = adverse event of special interest; TEAE = treatment emergent adverse event Data cut - off: 12 - Nov - 2025

![](ex99-1_017.jpg)

TARA - 002 Demonstrated Meaningful Results in LMs Patients Treated in the STARBORN - 1 Study BEFORE AFTER BEFORE AFTER 17 Medical photography from 2 patients pre - and post - treatment with TARA - 002 in STARBORN - 1 trial

![](ex99-1_018.jpg)

69% CLINICAL SUCCESS ǂ IN IMMEDIATE TREATMENT GROUP 6 MONTHS AFTER ENROLLMENT 84% \* CLINICAL SUCCESS ǂ IN PATIENTS WITH MACROCYSTIC LESION TYPES 69% 7.5% Immediate Treatment Group (N=110) Delayed Treatment Group Pre-Treatment\*\* (N=40) ITT: Observations 6 Months After Enrollment 62% 28% 0% 22% 32% Macrocystic LMs (n=77) Mixed (n=47) Microcystic LMs (n=14) Complete or Substantial Response by Radiographically Confirmed Lesion Type\*\* • Patients with radiographically confirmed macrocystic lesions had the greatest chance for clinical success • In those patients with mixed lesions, clinical success was still achieved • During this same period, 7.5% of patients in the delayed treatment group experienced spontaneous regression of LM • Treatment: 1 - 4 injections at 8 - week intervals max of 0.2mg/session (2KE) P < 0.0001 84% 60% ǂ Clinical Success was defined as complete or substantial response. \*Reflects data prior to dosing with OK - 432. After dosing, the clinical success rate was 66%, which was not statistically differ ent from the Immediate Treatment Group. \*\*Results were analyzed by lesion type across all treatment groups. 1 Results based on retrospective analysis of source verified data that included the full dataset of subjects enrolled in random ize d study between January 1998 and August 2005, including data in the published study (Smith et al. 2009) which included subjects enrolled between January 1998 and November 2004. Robust Clinical Results from OK - 432 1 , Predecessor to TARA - 002© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. 18 Substantial Response Complete Response 1 TARA - 002 is developed from the same master cell bank as OK - 432 University of Iowa study results

![](ex99-1_019.jpg)

Robust Clinical Results from OK - 432 1 , Predecessor to TARA - 002© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 19 Completed clinical study of OK - 432 in U.S. suggests effectiveness with strong support for safety profile BEFORE AFTER BEFORE AFTER BEFORE AFTER BEFORE AFTER 1 TARA - 002 is developed from the same master cell bank as OK - 432 University of Iowa study results

![](ex99-1_020.jpg)

KOL Discussion Jesse G.A. Jones, M.D., University of Alabama – Department of Neurosurgery and Radiology, and STARBORN - 1 study investigator© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \|

![](ex99-1_021.jpg)

Closing Remarks

![](ex99-1_022.jpg)

Q&A 22 Jesse Shefferman Co - founder, Director, Chief Executive Officer Jacqueline Zummo, PhD Co - founder, Senior Vice President, Chief Scientific Operations Officer Jesse G.A. Jones, MD University of Alabama – Department of Neurosurgery and Radiology, and STARBORN - 1 study investigator

![](ex99-1_023.jpg)

Thank you!

![](ex99-1_024.jpg)

APPENDIX

![](ex99-1_025.jpg)© 2025 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. \| 25 STARBORN - 1 Interim Results: Demographics and Baseline Characteristics Two patients who were initially diagnosed with macrocystic LMs at baseline had a change in diagnosis of their target cyst (po st - treatment): One had a change in diagnosis to a ranula. Another had a change in diagnosis to low grade mucoepidermoid carcinoma. Data cut - off: 12 - Nov - 2025 N = 12 8.3 (4.77) Age, mean (years) 6 (50.0) Sex, female, n/N (%) 9 (75.0) Race, white, n/N (%) 8 (66.7) Ethnicity, not Hispanic, n/N (%) Lymphatic Malformation Type, n/N (%) 11 (91.7) Macrocystic 1 (8.3) Mixed cystic de Serres Stage, n/N (%) 3 (25.0) I 2 (16.7) II 6 (50.0) III 1 (8.3) M

## Exhibit 99.2

**Exhibit 99.2**

![](ex99-2_001.jpg)

**Protara Therapeutics Announces Positive Interim Results Demonstrating Robust Responses in the Ongoing Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations**

● *80% of patients that completed treatment and 100% of patients that completed the eight-week response assessment achieved clinical success* 

● *Clinical success achieved with one or two doses of TARA-002 in 88% of patients* 

 

● *TARA-002 demonstrated favorable safety and tolerability profile with no serious adverse events reported* 

 

● *Company to host conference call and webcast featuring Key Opinion Leader Dr. Jesse Jones at 8:30 a.m. ET* 

NEW YORK, November 19, 2025 -- Protara Therapeutics, Inc.(Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced positive interim results from its ongoing Phase 2 open-label STARBORN-1 trial assessing intracystic injection of TARA-002, the Company's investigational cell-based therapy, in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).

"We are pleased to report these robust results from the STARBORN-1 trial that demonstrate TARA-002's expected significant clinical benefit in treating patients with macrocystic and mixed cystic LMs," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "Treatment with TARA-002 resulted in clinically meaningful responses, with a favorable safety profile observed across all evaluable patients. The totality of available clinical data, including data from prior studies with TARA-002's predecessor compound OK-432, an established treatment for LMs in Japan, underscore our belief in the potential for TARA-002 to emerge as an important intervention for pediatric patients suffering from LMs."

"There are currently no approved therapies for LMs, with many patients turning to invasive surgical procedures that carry high rates of complication and recurrence, or off-label use of chemotherapies and chemicals, which can have challenging side effects, especially for pediatric patients," said Jesse G.A. Jones, M.D., Associate Professor, Department of Neurosurgery and Radiology, University of Alabama at Birmingham, and STARBORN-1 study investigator. "I am encouraged by the positive interim safety and efficacy data from TARA-002 and believe this promising candidate has the potential to help the many patients in need of FDA-approved therapeutic approaches for LMs."

**STARBORN-1 Interim Results**

The interim analysis includes a total of 12 patients who enrolled in the trial and received ≥ 1 dose of TARA-002 as of the November 12, 2025 data cutoff. Of those, eight patients were evaluable at an eight-week post-treatment assessment, two withdrew prior to the eight-week assessment and two remain in dosing. Patients receive up to four injections of TARA-002 spaced approximately six weeks apart. Of the eight patients who were evaluable, the majority (7/8) achieved clinical success with one or two doses. Only one patient, who presented with a 1,739 ml macrocystic LM, required all four doses, and achieved a complete response.

● 80% (8/10) of patients that completed treatment achieved clinical success

● 100% (8/8) of patients who completed the eight-week response assessment achieved clinical success

● 83% (5/6) of macrocystic patients achieved a complete response (90% to 100% reduction in total LM volume) and one patient achieved a substantial response (60% to less than 90% reduction in total LM volume)

![](ex99-2_001.jpg)

● The only mixed cystic patient treated achieved a complete response

● Two LMs patients reached the 32-week post-treatment assessment and remain disease-free

● One patient deemed a complete response was subsequently diagnosed with a ranula (a different type of maxillofacial cyst from LMs)

● Two patients withdrew before the eight-week post-treatment assessment:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o One patient was misdiagnosed and had a rare form of cancer and did not respond to treatment

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o One patient dropped out after achieving a notable resolution of the patient's macrocystic
LM. The patient received two doses of TARA-002 with 160 ml aspiration at the first dose, which was reduced to a 10 ml aspiration at second
dose.

 

*Safety*

The majority of adverse events (AEs) were mild to moderate, with no serious AEs reported. The most common AEs were swelling and fatigue. One patient discontinued treatment due to a Grade 2 AE of fatigue.

**About STARBORN-1**

STARBORN-1 is a Phase 2 single-arm, open-label, prospective clinical trial evaluating the safety and efficacy of intracystic injection of TARA-002 for the treatment of macrocystic and mixed cystic LMs (≥ 50% macrocystic disease) in 29 participants six months to less than 18 years of age. The trial includes age de-escalation safety lead-in cohorts of children ages six years to less than 18 years, two years to less than six years and six months to less than two years. Assessment of efficacy is based on the proportion of participants with macrocystic and mixed cystic LMs who demonstrate clinical success, defined as having either a complete response (90% to 100% reduction from baseline in total LM volume) or substantial response (60% to less than 90% reduction in total LM volume) as measured by axial imaging or via investigator assessment (physical exam, visual inspection and ultrasound). More information about the trial is available at clinicaltrials.gov (identifier: NCT05871970).

**Conference Call and Webcast**

Protara will host a conference call and webcast today at 8:30 am ET to review the data reported this morning, as well as provide an overview of LMs, the current treatment landscape and the TARA-002 program in LMs. Members of the management team will be joined by STARBORN-1 study investigator Jesse G.A. Jones, M.D., Associate Professor, Department of Neurosurgery and Radiology, University of Alabama at Birmingham. The live event and accompanying slides can be accessed by visiting https://protara-therapeutics-update-call.open-exchange.net/registration, or via the Events and Presentations section of the Company's website: https://ir.protaratx.com. A replay of the webcast will be archived for a limited time following the event.

**About TARA-002 in LMs**

TARA-002 is an investigational, genetically distinct strain of streptococcus pyogenes that is inactivated while retaining its immune-stimulating properties. It was developed from the same master cell bank as OK-432, which was originally granted marketing approval by the Japanese Ministry of Health for the treatment of LMs and has been the standard of care in Japan for 30 years. In addition, OK-432 was studied in a large Phase 2 trial in LMs in over 500 patients with significant clinical success. TARA-002 has been granted Rare Pediatric Disease designation by the U.S. Food and Drug Administration for the treatment of LMs.

**About Lymphatic Malformations**

Lymphatic malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels and lymphatics; recurrent infection; and cosmetic and other functional disabilities.

**About Protara Therapeutics, Inc.**

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.

**Forward-Looking Statements**

Statements contained in this press release regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara's business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials (including the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials or phases thereof); statements related to expectations regarding interactions with the U.S. Food and Drug Administration (FDA); Protara's financial position; statements regarding the anticipated safety or efficacy of Protara's product candidates; and Protara's outlook for the remainder of the year and future periods. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara's financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara's development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara's strategic and commercial plans; Protara's ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara's business and financial condition in general, including the risks and uncertainties described more fully under the caption "Risk Factors" and elsewhere in Protara's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law.

Company Contact:

Justine O'Malley

Protara Therapeutics

Justine.OMalley@protaratx.com

646-817-2836