TARA-002 delivers high response rates in NMIBC, Protara (NASDAQ: TARA) advances to registrational trials
Rhea-AI Filing Summary
Protara Therapeutics filed an 8-K highlighting updated interim Phase 2 ADVANCED-2 data for its investigational cell-based therapy TARA-002 in high-risk non-muscle invasive bladder cancer. In the BCG-unresponsive cohort, TARA-002 achieved a high-grade complete response rate of 65.7% (23/35) at any time, 68.2% at six months and 33.3% at 12 months. In BCG-naïve patients, the high-grade complete response rate was 72.4% (21/29) at any time, 66.7% at six months and 57.9% at 12 months. Across 74 treated patients, most treatment-related adverse events were Grade 1 and transient, with no Grade 3 or higher treatment-related events, no related serious events and no discontinuations due to toxicity. Protara plans to complete enrollment of the registrational BCG-unresponsive cohort of ADVANCED-2 and to initiate the registrational ADVANCED-3 trial in BCG-naïve patients in the second half of 2026, while also advancing TARA-002 in pediatric lymphatic malformations and IV choline chloride for parenteral nutrition–dependent patients.
Positive
- TARA-002 shows strong efficacy: high-grade complete response rates of 65.7% in BCG-unresponsive and 72.4% in BCG-naïve non-muscle invasive bladder cancer, with meaningful six- and 12-month durability.
- Clean safety profile: among 74 treated patients there were no Grade 3 or higher treatment-related adverse events, no related serious adverse events and no discontinuations due to treatment-related toxicity.
- Clear registrational path: the company plans to complete enrollment of the BCG-unresponsive registrational ADVANCED-2 cohort and initiate the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of 2026.
Negative
- None.
Insights
Interim TARA-002 data show strong responses with clean safety, supporting registrational bladder cancer plans.
Protara Therapeutics reports encouraging Phase 2 ADVANCED-2 results for TARA-002 in high-risk non-muscle invasive bladder cancer. High-grade complete responses reached 65.7% in BCG-unresponsive and 72.4% in BCG-naïve patients, with substantial six- and 12-month durability in both cohorts.
Safety appears favorable: among 74 treated patients, most treatment-related adverse events were Grade 1, none were Grade 3 or higher, no related serious events occurred and no patients stopped therapy due to toxicity. This profile is important in a setting where bladder-sparing options can be limited by tolerability.
The company states it expects to complete enrollment of the registrational BCG-unresponsive ADVANCED-2 cohort and to start the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File No.) | (IRS Employer Identification No.) |
|
|
||
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including
area code: (
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 | ||
| The |
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 February 23, 2026, Protara Therapeutics, Inc. (the “Company” or “Protara”) posted a press release (the “Press Release”) to the “Investors—News—Press Releases” section of the Company’s website. On February 24, 2026, Protara posted an investor presentation (the “Investor Presentation”) and corporate deck (the “Corporate Deck”) to the “Investors—Events and Presentations” section of the Company’s website. The Press Release and the Investor Presentation are for use in connection with a conference call and webcast on February 24, 2026, at 8:00 a.m. ET, announcing updated interim data from the ongoing Phase 2 open-label ADVANCED-2 Trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (“NMIBC”).
Copies of the Press Release, Investor Presentation and Corporate Deck are attached as Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3, respectively. The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3, 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.
Updated Interim Results
On February 27, 2026, the Company will present updated interim data from its ongoing Phase 2 open-label ADVANCED-2 Trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) NMIBC at poster sessions at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancer Symposium in San Francisco, reporting positive results that continue to support TARA-002’s potential as a mainstay in the NMIBC treatment landscape and demonstrating meaningful and durable activity in Bacillus Calmette-Guérin (“BCG”)-Unresponsive or BCG-Naïve NMIBC patients. A copy of the posters, which have been published to the “Investors—Events and Presentations” section of the Company’s website, are filed as Exhibit 99.4 and Exhibit 99.5 to this Current Report on Form 8-K and are incorporated herein by reference.
The dataset includes 43 BCG-Unresponsive patients and 31 BCG-Naïve patients who received at least 1 dose of TARA-002; 35 BCG-Unresponsive patients and 29 BCG-Naïve patients completed at least one response assessment and were evaluable for efficacy as of a January 28, 2026 data cutoff. Patients received an induction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months. Re-induction was permitted for eligible patients with residual CIS and/or recurrent high-grade Ta disease. Complete response (“CR”) rates at the six months and 12 months landmark time points include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit.
For the BCG-Unresponsive cohort, the CR rate at any time was 65.7% (23/35). The CR rate was 68.2% (15/22) at six months and 33.3% (5/15) at 12 months. Among responders, the Kaplan-Meier (KM) estimated probability of maintaining a CR for six months was 71.1% (95% CI: 46.7, 95.5), and 100% (5/5) maintained their CR from nine to 12 months. Re-induction therapy successfully converted most initial non-responders to responders with durable responses: 61.5% (8/13) of re-induced patients converted to a CR at six months.
For the BCG-Naïve cohort, the CR rate at any time was 72.4% (21/29). The CR rate was 66.7% (18/27) at six months and 57.9% (11/19) at 12 months. Among responders, the KM estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4), and 100% (11/11) maintained their CR from nine to 12 months. Re-induction therapy successfully converted most initial non-responders to responders with durable responses: 66.7% (4/6) of re-induced patients converted to a CR at six months.
The majority of treatment-related adverse events (“TRAEs”) were Grade 1 and transient with no Grade 3 or greater TRAEs and no related serious adverse events as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly occurring TRAEs were dysuria (14%), bladder spasm (9%), fatigue (7%) and micturition urgency (5%).
1
Next Steps
The Company expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in the second half of 2026. Enrollment is complete in the BCG-Naïve cohort of the ADVANCED-2 trial with 31 patients, and the Company remains on track to initiate the ADVANCED-3 registrational trial in BCG- Naïve patients in the second half of 2026.
Forward-Looking Statements
Statements contained herein 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 Number |
Exhibit Description | |
| 99.1 | Press Release, dated February 23, 2026. | |
| 99.2 | Investor Presentation, dated February 24, 2026. | |
| 99.3 | Corporate Deck, dated February 24, 2026. | |
| 99.4 | Poster Presentation, dated February 27, 2026. | |
| 99.5 | Poster Presentation, dated February 27, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
2
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: February 24, 2026
| Protara Therapeutics, Inc. | ||
| By: | /s/ Patrick Fabbio | |
| Patrick Fabbio | ||
| Chief Financial Officer | ||
3
Exhibit 99.1
TARA-002 Demonstrates 68% Complete Response Rate at Six Months in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events
Company expects to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in 2H 2026
Company to host conference call and webcast tomorrow at 8:00 a.m. ET
NEW YORK, February 23, 2026 -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated interim results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve. These results will be featured on Friday, February 27, 2026 during poster sessions at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco.
“These interim data are highly encouraging with respect to TARA-002’s efficacy and safety,” said Raj Satkunasivam, MD, MS, FRCSC, Urologic Oncologist, Associate Professor at Houston Methodist Hospital and ADVANCED-2 study investigator. “The results in the BCG-Unresponsive cohort demonstrate compelling six-month response rates with maturing 12-month data showing promising signals of durability. These clinically meaningful response rates and favorable tolerability profile make TARA-002 a potentially promising treatment option.”
“TARA-002 continues to demonstrate impressive and durable response rates with excellent safety and tolerability,” said Neal Shore, MD, FACS, Medical Director of the START Carolinas/Carolina Urologic Research Center. “These results, coupled with a clean safety profile and a simple, streamlined administration for both physicians and patients, make TARA-002 a potentially innovative new therapy for urologists, particularly those in busy community practices.”
Updated Interim Results
BCG-Unresponsive Cohort
The interim analysis of the BCG-Unresponsive cohort includes 35 evaluable participants, of whom, 22 were evaluable at six months and 15 were evaluable at 12 months as of a January 28, 2026 data cutoff.
| · | The CR rate at any time was 65.7% (23 of 35) |
| · | The CR rate was 68.2% (15 of 22) at six months and 33.3% (5 of 15) at 12 months |
| · | Among responders: |
| o | The Kaplan-Meier (KM) estimated probability of maintaining a CR for six months was 71.1% (95% CI: 46.7, 95.5) |
| o | 100% (5 of 5) maintained their CR from nine to 12 months |
| · | 61.5% (8 of 13) of re-induced patients converted to a CR at six months |
BCG-Naïve Cohort
The interim analysis of the BCG-Naïve cohort includes 29 evaluable participants, 27 of whom, were evaluable at six months and 19 were evaluable at 12 months as of a January 28, 2026 data cutoff.
| · | The CR rate at any time was 72.4% (21 of 29) |
| · | The CR rate was 66.7% (18 of 27) at six months and 57.9% (11 of 19) at 12 months |
| · | Among responders: |
| o | The KM estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4) |
| o | 100% (11 of 11) maintained their CR from nine to 12 months |
| · | 66.7% (4 of 6) of re-induced patients converted to a CR at six months |
Safety and Tolerability
The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient with no Grade 3 or greater TRAEs and no related serious adverse events as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most common TRAEs were dysuria, bladder spasm, fatigue and micturition urgency. Most bladder irritations resolved shortly after administration or within a few hours to a few days.
“The data generated to date in these high-risk NMIBC patient populations highlight TARA-002’s potential as a meaningful addition to the treatment landscape,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “In addition to demonstrating impressive efficacy and safety, TARA-002 overcomes the limitations of existing NMIBC treatments that burden patients as well as urologists and their practices. We look forward to continuing to advance TARA-002’s clinical development as we work to bring this treatment to patients.”
Next Steps
Protara expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in the second half of 2026. Enrollment is complete in the BCG-Naïve cohort of the ADVANCED-2 trial with 31 patients, and the Company remains on track to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in the second half of 2026.
Conference Call and Webcast
Protara will host a conference call and webcast tomorrow at 8:00 a.m. ET to review the data reported this evening. Neal Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center will join management for the discussion. The live event and accompanying slides can be accessed by visiting https://protara-therapeutics-asco-gu-update-call.open-exchange.net/, 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.
2
About ADVANCED-2
ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). Trial subjects receive an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.
About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Breakthrough and Fast Track Designations by the U.S. Food and Drug Administration. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.
TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Bladder cancer is the sixth most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses, representing approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.
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 (CIS) 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.
3
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
4
Exhibit 99.2
Interim Data Presentation from the ADVANCED - 2 Trial of TARA - 002 in Patients with NMIBC American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium February 2026
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 (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 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. © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Forward Looking Statements
Jesse Shefferman Co - founder, Director, Chief Executive Officer Neal Shore, MD Medical Director, START Carolinas/Carolina Urologic Research Center Introduction Jesse Shefferman Review of Updated TARA - 002 Data Carla Beckham, MD, PhD KOL Discussion Neal Shore, MD Closing Remarks Jesse Shefferman ǪGA All 3 Carla Beckham, MD , PhD Lead Medical Director and Head of Clinical Development of TARA - 002 in NMIBC and Board - Certified Urologist Agenda © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. |
Key Clinical Updates TARA - 002 in NMIBC • No additional administration procedures or safety protocols required • Rapid administration typically performed by nurse 3. Next steps • Expect to complete enrollment in the BCG - Unresponsive registrational cohort of ADVANCED - 2 in 2H’26 • Expect to initiate enrollment in the BCG - Naive NMIBC ADVANCED - 3 registrational trial in 2H’26 TARA - 002 for Non - Muscle Invasive Bladder Cancer (NMIBC) 1. Interim data from the ADVANCED - 2 trial of TARA - 002 in patients with NMIBC • TARA - 002 demonstrated 66% CR rate at any time, 68% 6 - month landmark and 33% 12 - month landmark CR rate in patients with BCG - Unresponsive NMIBC 1 • TARA - 002 demonstrated 72% CR rate at any time, 67% 6 - month landmark and 58% 12 - month landmark CR rate in patients with BCG - Naïve NMIBC 1 • Favorable safety and tolerability profile observed with no Grade 3 or greater TRAEs 2. TARA - 002 has anticipated low burden on physicians G patients 1 Referencing data from poster presented at ASCO GU symposium with data cutoff of January 28, 2026 Abbreviation: CR = Complete Response © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | 4
*Currently in pre - clinical studies to define dosing and, once protocol is confirmed, expect to initiate P2 trial cohort. **IV Choline granted Orphan Drug Designations by the U.S. FDA for the prevention and/or treatment of choline deficiency in patients on long - term PN and Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. ***TARA - 002 granted Rare Pediatric Disease Designation as well as Breakthrough Therapy and Fast Track Designations by the U.S. FDA and Orphan Drug Designation by the European Commission for the treatment of LMs. † Trial also includes BCG - Exposed patients; 1 Subject to regulatory clearance 2 Potential expansion opportunity for NMIBC program © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Diversified Late - Stage Pipeline Expected Status Phase 3 Phase 2 Phase 1 Pre - Clinical Indication Indicates potential clinical programs yet to be initiated ONCOLOGY Fully enrolled ED - 2 (Cohort A) ADVANC CIS + Ta/T1 NMIBC BCG - Naïve † TARA - 002 ADV - 2 Full enrollment 2H’26 ED - 2 (Cohort B) ADVANC CIS + Ta/T1 NMIBC BCG - Unresponsive Trial initiation in 2H’26 - 3 (BCG - Naïve RCT) ADVANCED CIS + Ta/T1 NMIBC BCG - Naïve 1 TARA - 002 ADV - 3 HR NMIBC Ta / T1 PoC 2 TARA - 002 NMIBC Expansion HR NMIBC 2 TARA - 002 Systemic Administration * RARE DISEASES Interim data 2H’26 HRIVE - 3 T Choline for parenteral support (PS) patients** IV CHOLINE Regulatory feedback 1H’26 Full enrollment 2H’26 TARBORN - 1 S Lymphatic Malformations (LMs)*** TARA - 002 5
Safety G Tolerability Efficacy and Durability Ease - of - Use • Mild, self - limited local AEs • Predictable, well - characterized safety profile • Robust single agent activity • Competitive CR rates • Encouraging durability • Simple office - based intravesical instillation • No special handling requirements; Fits the high - volume, fast paced urology workflow TARA - 002 6 TARA - 002 Target Product Profile Sits at the Intersection that NMIBC Patients and Urologists Prioritize © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Abbreviations: CR = Complete Response; AEs = Adverse Events
ADVANCED - 2 RESULTS
TARA - 002 ignites both innate and adaptive immunity through dual TLR2/NOD2 activation, driving potent local anti - tumor / cystic responses via fully inactivated bacteria (1)(2)(3) 8 1 Fujimoto T., et al. J Immunol. 1997: 5619; 2 Ryoma Y, et al. Anticancer Res. 2004; 3295 - 3298; 3 Zhao H, et al. Microbiol. Immunol. 1994; 183 - 190 TARA - 002: A Unique TLR2/NOD2 Agonist Derived from Streptococcus Pyogenes that Brings a New Immunologic Mechanism to NMIBC Beyond BCG © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. |
Abbreviations: CR = complete response; CIS = carcinoma in situ *Aligned with the FDA’s 2024 BCG Unresponsive NMIBC: Developing Drugs and Biologics for Treatment Guidance for Industry. **Enrollment complete †Residual CIS and/or recurrence of HGTa; ^3 weekly instillations every 3 months through month 18 and then at month 24 Primary endpoint of high - grade complete response (CR) at any time up to 6 months; Key secondary endpoint of 12 - month DOR 9 DAY 1 MONTH 3 MONTH 6 MONTH 24 MONTH 60 REGISTRATIONAL DESIGN*: BCG - Unresponsive (CIS “ Ta/T1) BCG Naïve (CIS “ Ta/T1) Induction (N=100) 6 weekly instillations Induction (N=31**) 6 weekly instillations CR, Maintenance (months 3 - 24) 3 weekly instillations every 3 months through month 18 and then at month 24 Follow - up Follow - up CR, Maintenance (months 3 - 24) 3 weekly instillations every 3 months through month 18 and then at month 24 Maintenance (months 6 - 24) 3 weekly instillations every 3 months^ Maintenance (months 6 - 24) 3 weekly instillations every 3 months^ Re - Induction (if eligible † ) 6 weekly instillations Re - Induction (if eligible † ) 6 weekly instillations Follow - up Follow - up CT.gov identifier: NCT05951179 © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | TARA - 002 in NMIBC: ADVANCED - 2 Clinical Trial Design Mandatory biopsy at month 3
Abbreviations: CR = complete response High - grade CR is based on central pathology including a mandatory biopsy at Month 3 Notes: Evaluable participants include those who had at least one dose of study drug before the response assessment time point and completed at least one response assessment; CR rates at each landmark time point include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit. Two participants at Month 3 and 1 participant at Month 12 are pending central confirmation of response. High - grade CR rate at any time (%) 65.7% 100 23 of 35 80 60 40 20 0 N=35 High - grade CR rate (%) Landmark 68.2 (15 of 22) Month 6 33.3 (5 of 15) Month 12 61.5 (8 of 13) Reinduction Salvage TARA - 002 Monotherapy Demonstrates 68% CR at 6 Months with Durable Response Among BCG - Unresponsive Participants Data cutoff: January 28, 2026 © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. 10 100% Maintained CR from 9 Mo - 12 Mo (5 of 5) 71% * (95% CI, 46.7, 95.5) Maintained CR for > 6 Mo *Based on Kaplan - Meier (KM) probability of maintaining a CR
TARA - 002 Monotherapy Demonstrates 67% CR at 6 Months with Durable Response Among BCG - Naïve Participants High - grade CR rate at any time (%) 72.4% 100 21 of 29 80 60 40 20 0 N = 2G High - grade CR rate (%) Landmark 66.7 (18 of 27) Month 6 57.G (11 of 19) Month 12 66.6 (4 of 6) Reinduction Salvage Abbreviations: CR = complete response High - grade CR is based on central pathology. Notes: Evaluable participants include those who had at least one dose of study drug before the response assessment time point and completed at least one response assessment; CR rates at each landmark time point include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit ^ Participants enrolled under an earlier protocol version with 6 - month duration; therefore, they are not included in CR analyses from Month 9 onward. Data cutoff: January 28, 2026 11 100% Maintained CR from 9 Mo - 12 Mo (11 of 11) 73% * (95% CI, 52.9, 93.4) Maintained CR for > 6 Mo © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. *Based on Kaplan - Meier (KM) probability of maintaining a CR
Grade 4/5 Grade 3 Grade 2 Grade 1 Any Grade N = 74 0 0 4 (5) 19 (26) 19 (26) TRAEs, n (%) TRAEs ≥5%, n (%) 0 0 0 10 (14) 10 (14) Dysuria 0 0 3 (4) 4 (5) 7 (9) Bladder spasm 0 0 1 (1) 4 (5) 5 (7) Fatigue 0 0 0 4 (5) 4 (5) Micturition urgency 1 (1) 10 (14) 3 (4) 0 11 (15) SAEs, n (%) 0 0 0 0 0 Related SAEs, n (%) 0 0 0 0 0 TRAEs leading to Study Drug Withdrawal, n (%) Abbreviations: TRAE = treatment related adverse event; SAE = serious adverse event NOTE: A total of 74 participants were exposed to at least one dose of TARA - 002; 43 were BCG - unresponsive and 31 were BCG - naïve. Severity of adverse event is based on NCI - CTCAE Version 5.0 or later. TARA - 002 in NMIBC Demonstrated a Favorable Safety and Tolerability Profile with No Grade 3 or Greater TRAEs Across BCG Exposures © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | 12 Data cutoff: January 28, 2026
KOL DISCUSSION Neal Shore, MD Medical Director, START Carolinas/Carolina Urologic Research Center
CLOSING REMARKS
ǪCA Jesse Shefferman Co - founder, Director, Chief Executive Officer Jacqueline Zummo, PhD Co - founder, Senior Vice President, Chief RCD Officer © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | 15 Neal Shore, MD Medical Director, START Carolinas/ Carolina Urologic Research Center Carla Beckham, MD, PhD Lead Medical Director and Head of Clinical Development of TARA - 002 in NMIBC Bill Conkling Chief Commercial Officer Leonardo Viana Nicacio, MD Chief Medical Officer Pat Fabbio Chief Financial Officer
THANK YOU
APPENDIX
Cohort B N = 43 Baseline Demographics Age (years) 75 (47, 92) Median (Min, Max) Sex, n (%) 31 (72.1) Male 12 (27.9) Female Race, n (%) 5 (11.6) Asian 1 (2.3) Black or African American 35 (81.4) White 1 (2.3) Other 1 (2.3) Not Reported BCG - Unresponsive Cohort Demographics and Baseline Characteristics © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Data cutoff: January 28, 2026 ECOG PS = Eastern Cooperative Oncology Group Performance Status. Cohort B N = 43 Baseline Characteristics ECOG PS, n (%) 39 (90.7) 0 4 (9.3) 1 0 2 - 5 Diagnosis, n (%) 40 (93.0) CIS (only) 3 (7.0) CIS + Ta 0 CIS + T1 BCG Exposure, n (%) 43 (100.0) BCG - unresponsive
Cohort A N = 31 Baseline Demographics Age (years) 71 (45, 89) Median (Min, Max) Sex, n (%) 25 (80.6) Male 6 (19.4) Female Race, n (%) 1 (3.2) Black or African American 29 (93.5) White 1 (3.2) Not Reported BCG - Naïve Cohort Demographics and Baseline Characteristics © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Data cutoff: January 28, 2026 ECOG PS = Eastern Cooperative Oncology Group Performance Status. Cohort A N = 31 Baseline Characteristics ECOG PS, n (%) 26 (83.9) 0 4 (12.9) 1 1 (3.2) 2 0 3 - 5 Diagnosis, n (%) 18 (58.1) CIS (only) 9 (29.0) CIS + Ta 4 (12.9) CIS + T1 BCG Exposure, n (%) 24 (77.4) Never exposed 7 (22.6) BCG exposed >24 months
Exhibit 99.3
Corporate Presentation February 2026
Forward Looking Statements 1 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 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 (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 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.
Transformative Investigational Therapies in Oncology and Rare Disease TARA - 002 in Non - Muscle Invasive Bladder Cancer • Positive interim data in BCG - Unresponsive and BCG - Naïve patients from ADVANCED - 2 trial TARA - 002 in NMIBC • FDA supported Company’s BCG - Naïve registrational trial design • Unique product characteristics anticipated to drive significant adoption in large market with high unmet need IV Choline Chloride for Patients on Parenteral Support • 78% of patients dependent on PS are choline - deficient and the majority have resulting liver damage, yet no approved IV formulations exist • Granted FDA Orphan Drug and Fast Track designations ONCOLOGY RARE GI RARE PEDIATRIC TARA - 002 in Lymphatic Malformations • Pediatric program for indication with no currently approved therapies available in the US • Positive interim data update from the STARBORN - 1 trial assessing TARA - 002 in pediatric LMs • Granted FDA Rare Pediatric Disease, Breakthrough Therapy and Fast Track Designations 2 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
*Currently in pre - clinical studies to define dosing and, once protocol is confirmed, expect to initiate P2 trial cohort. **IV Choline granted Orphan Drug Designations by the U.S. FDA for the prevention and/or treatment of choline deficiency in patients on long - term PN and Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. ***TARA - 002 granted Rare Pediatric Disease Designation as well as Breakthrough Therapy and Fast Track Designations by the U.S. FDA and Orphan Drug Designation by the European Commission for the treatment of LMs. † Trial also includes BCG - Exposed patients; 1 Subject to regulatory clearance 2 Potential expansion opportunity for NMIBC program © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Diversified Late - Stage Pipeline Expected Status Phase 3 Phase 2 Phase 1 Pre - Clinical Indication Indicates potential clinical programs yet to be initiated ONCOLOGY Fully enrolled ED - 2 (Cohort A) ADVANC CIS + Ta/T1 NMIBC BCG - Naïve † TARA - 002 ADV - 2 Full enrollment 2H’26 ED - 2 (Cohort B) ADVANC CIS + Ta/T1 NMIBC BCG - Unresponsive Trial initiation in 2H’26 - 3 (BCG - Naïve RCT) ADVANCED CIS + Ta/T1 NMIBC BCG - Naïve 1 TARA - 002 ADV - 3 HR NMIBC Ta / T1 PoC 2 TARA - 002 NMIBC Expansion HR NMIBC 2 TARA - 002 Systemic Administration * RARE DISEASES Interim data 2H’26 HRIVE - 3 T Choline for parenteral support (PS) patients** IV CHOLINE Regulatory feedback 1H’26 Full enrollment 2H’26 TARBORN - 1 S Lymphatic Malformations (LMs)*** TARA - 002 3
Multiple Near - Term Milestones Anticipated 4 ADVANCED - 2 BCG - UN interim analysis (Ǫ1’26) NMIBC IV Choline LMs Ǫ1’2026 Ǫ2’2026 2H’2026 BALANCE SHEET: $134M of cash, cash equivalents and investments in marketable debt securities as of September 30, 2025. Cash runway into 2028 including $86M of gross proceeds from the December 2025 public offering COMMON SHARE EǪUIVALENTS (47.6M) * : 38.6M Common + 5.6M Preferred + 3.4M Pre - funded warrants on as converted basis as of September 30, 2025 not including 15M Common issued in the December 2025 public offering (62.6M common share equivalents) *Does not include 10.1M common warrants outstanding from the April 2024 private placement exercisable at $5.25 per share until the earlier of April 10, 2027 or 90 days after public announcement of a minimum 42% six - month CR rate from at least 25 BCG - Unresponsive patients in the ADVANCED - 2 clinical trial. ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute THRIVE - 3 dose confirmation lead - in interim analysis (2H’26) LMs Regulatory Feedback (1H’26) ADVANCED - 2 BCG - UN enrollment complete (2H’26) Initiate ADVANCED - 3 BCG - Naïve (2H’26) Systemic administration pre - clinical data (2H’26) STARBORN - 1 enrollment complete (2H’26)
TARA - 002 Non - Muscle Invasive Bladder Cancer (NMIBC)
Abbreviations: CR = complete response High - grade CR is based on central pathology including a mandatory biopsy at Month 3 Notes: Evaluable participants include those who had at least one dose of study drug before the response assessment time point and completed at least one response assessment; CR rates at each landmark time point include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit. Two participants at Month 3 and 1 participant at Month 12 are pending central confirmation of response. High - grade CR rate at any time (%) 65.7% 100 23 of 35 80 60 40 20 0 N=35 High - grade CR rate (%) Landmark 68.2 (15 of 22) Month 6 33.3 (5 of 15) Month 12 61.5 (8 of 13) Reinduction Salvage TARA - 002 Monotherapy Demonstrates 68% CR at 6 Months with Durable Response Among BCG - Unresponsive Participants Data cutoff: January 28, 2026 100% Maintained CR from 9 Mo - 12 Mo (5 of 5) 71% * (95% CI, 46.7, 95.5) Maintained CR for > 6 Mo 6 © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. *Based on Kaplan - Meier (KM) probability of maintaining a CR
TARA - 002 Monotherapy Demonstrates 67% CR at 6 Months with Durable Response Among BCG - Naïve Participants High - grade CR rate at any time (%) 72.4% 100 21 of 29 80 60 40 20 0 N = 2G High - grade CR rate (%) Landmark 66.7 (18 of 27) Month 6 57.G (11 of 19) Month 12 66.6 (4 of 6) Reinduction Salvage Abbreviations: CR = complete response High - grade CR is based on central pathology. Notes: Evaluable participants include those who had at least one dose of study drug before the response assessment time point and completed at least one response assessment; CR rates at each landmark time point include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit ^ Participants enrolled under an earlier protocol version with 6 - month duration; therefore, they are not included in CR analyses from Month 9 onward. Data cutoff: January 28, 2026 100% Maintained CR from 9 Mo - 12 Mo (11 of 11) 73% * (95% CI, 52.9, 93.4) Maintained CR for > 6 Mo 7 © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. *Based on Kaplan - Meier (KM) probability of maintaining a CR
Grade 4/5 Grade 3 Grade 2 Grade 1 Any Grade N = 74 0 0 4 (5) 19 (26) 19 (26) TRAEs, n (%) TRAEs ≥5%, n (%) 0 0 0 10 (14) 10 (14) Dysuria 0 0 3 (4) 4 (5) 7 (9) Bladder spasm 0 0 1 (1) 4 (5) 5 (7) Fatigue 0 0 0 4 (5) 4 (5) Micturition urgency 1 (1) 10 (14) 3 (4) 0 11 (15) SAEs, n (%) 0 0 0 0 0 Related SAEs, n (%) 0 0 0 0 0 TRAEs leading to Study Drug Withdrawal, n (%) Abbreviations: TRAE = treatment related adverse event; SAE = serious adverse event NOTE: A total of 74 participants were exposed to at least one dose of TARA - 002; 43 were BCG - unresponsive and 31 were BCG - naïve. Severity of adverse event is based on NCI - CTCAE Version 5.0 or later. TARA - 002 in NMIBC Demonstrated a Favorable Safety and Tolerability Profile with No Grade 3 or Greater TRAEs Across BCG Exposures © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | 8 Data cutoff: January 28, 2026
TARA - 002 ignites both innate and adaptive immunity through dual TLR2/NOD2 activation, driving potent local anti - tumor / cystic responses via fully inactivated bacteria 1, 2, 3 TARA - 002: A Unique TLR2/NOD2 Agonist Derived From Streptococcus pyogenes That Brings a New Immunologic Mechanism to NMIBC Beyond BCG 1 Fujimoto T., et al. J Immunol. 1997: 5619; 2 Ryoma Y, et al. Anticancer Res. 2004; 3295 - 3298; 3 Zhao H, et al. Microbiol. Immunol. 1994; 183 - 190 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 9
The Majority Of NMIBC Patients are Treated by Community Urologists Estimated NMIBC Patient Distribution by Site of Care (TDG Prior Research BCG Utilization Data Set, 2023 - 2024, Estimated % of NMIBC Patients) Community*, 68% Academic/Health System, 32% G5% 56% 31% 5% 44% 6G% NMIBC MIBC mUC Up to 35% of community urology practice treat their NMIBC patients internally Treat Internally Refer Out for Treatment Most NMIBC patients are treated in the community – Urologists prefer to retain their patients In community practice workflow is important. In addition to predictable safety and tolerability, key elements such as product handling, administration, preparation timing and reimbursement are critical when making treatment decisions *Includes Private/Community Urology practices, Community oncology practices and other VA etc. Source: Market research ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 10
23 16 11 11 9 2 1 5 12 6 Requirements to give BCG 11 Cost and financial burden Administration and logistics Risk and management of adverse events Lower efficacy than other options NMIBC: Safety C Ease Of Use Are Important to Adoption Bloomberg surveyed 51 urologists on their views of key adoption factors of approved and next - generation therapies 9 10 8 14 5 7 5 4 9 7 9 Patient comfort and tolerance of the device Logistical challenges for your clinic Risk and management of adverse events 3 Efficacy in patients with prior chemotherapy exposure 25 9 3 8 11 7 9 11 Cost and financial burden Administration and logistics Risk and management of adverse events Lower efficacy than other options 3 2 8 5 9 7 14 7 14 5 11 10 8 6 Logistical challenges for your clinic Length and frequency of patient visits Specific handling and safety protocols for the viral therapy Patient compliance with the wash and hold procedure NMIBC products launched in the last 2 years Products expected to launch in the next 2 years Admin G Logistics Safety G Tolerability Rank 1 – Most Primary Barrier Rank 2 Rank 3 1 4 2 3 1 Cytokine Superagonist. 2 AV Vectored Cytokine. 3 Enhanced Chemotherapy. 4 Oncolytic Virus Source: BI Survey of Urologists - August 2025 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 11
TARA - 002 No vial thaw, simple preparation; no pre/post treatment protocol Preparation: can be conducted on open table or benchtop; no special handling Detalimogene voraplasmid No vial thaw, simple preparation; no pre/post treatment protocol Anktiva + BCG - TICE Risk of infection for patient and caregivers; urine decontamination burden Adstiladrin Vial thaw introduces preparation bottleneck; elevated biosafety procedures required; additional pre/post burden for patients Cretostimogene Complex process with unclear vial thaw, biosafety, and urine decontamination requirements TARA - 002 has reduced burden for patients and physicians Preparation: can be conducted on open table or benchtop; no special handling Preparation: mask/gown required to avoid infection 6 - hour period of required urine bleaching Antichollinergic premedication 3 – 10 hour vial thaw Preparation : “universal biosafety precautions” required ; USPI contains infection risk warning 48 - hour period of required urine bleaching Thaw process not disclosed Preparation: BSL2/2+ handling likely required Saline wash DDM wash Saline wash DDM re - infusion and dwell (15 min) Urine bleaching requirements not disclosed Inlexzo Requires insertion every three weeks, potential for patients to feel device in bladder and removal requires cystoscopy Assembly of the device on open table or benchtop Cystoscopy is encouraged prior to instillation to check for bladder mucosal integrity Removal of the device requiring cystoscopy Repeat the same procedure every 3 weeks 12 TARA - 002 Is Designed For Best - in - Class Ease of Use in NMIBC Definitions: USPI – U.S. prescribing information; DDM - dodecyl maltoside Source: Derived from product SOPIs and clinical trial publications. Not based on head - to - head or comparator studies. ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
Safety G Tolerability Efficacy and Durability Ease - of - Use • Mild, self - limited local AEs • Predictable, well - characterized safety profile • Robust single agent activity • Competitive CR rates • Encouraging durability • Simple office - based intravesical instillation • No special handling requirements; Fits the high - volume, fast paced urology workflow TARA - 002 13 TARA - 002 Target Product Profile Sits at the Intersection that NMIBC Patients and Urologists Prioritize © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | Abbreviations: CR = Complete Response; AEs = Adverse Events
TARA - 002 Lymphatic Malformations (LMs)
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 to 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 TARA - 002 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 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 15 TARA - 002
Referral 1,400 - 1,800 Incident Patients are Typically Diagnosed in the Community Setting and Most are Referred to Vascular Anomaly Centers (VACs) VACs/Centers of Excellence (COE) Referral Complication, Treatment Failure, Recurrence Community prefers surgery or referral and COEs/VACs prefer sclerotherapy Community ENT, Dermatologist, Pediatrician, Surgeon Sclerotherapy Surgery 1,2 Market research sclerotherapy claims analysis 16 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
UNIVERSITY OF IOWA RESULTS: 84% * CLINICAL SUCCESS ǂ IN PATIENTS WITH MACROCYSTIC LESION TYPES 62% 28% 0% 22% 32% Macrocystic LMs (n=77) Mixed (n=47) Microcystic LMs (n=14) • Patients with radiographically confirmed macrocystic lesions had the greatest clinical success • In those patients with mixed lesions, clinical success was also achieved 1 Results based on retrospective analysis of source verified data that included the full dataset of subjects enrolled in randomized 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. Complete or Substantial Response by Radiographically Confirmed Lesion Type** 84% 60% Robust Clinical Results from OK - 432 1 , Predecessor to TARA - 002 University of Iowa study results potentially supportive of regulatory filing and are consistent with STARBORN - 1 Substantial Response Complete Response STARBORN - 1 INTERIM RESULTS: STRONG RESPONSE ACROSS CYST TYPES IN EVALUABLE POPULATION: MACROCYSTIC LMs, MIXED CYSTIC LMs 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 different from the Immediate Treatment Group. **Results were analyzed by lesion type across all treatment groups. • 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) Substantial Response Complete Response 83% 1 TARA - 002 is developed from the same master cell bank as OK - 432 Data cutoff: 12 - Nov - 2025 17 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 17% Macrocystic LMs (n = 6) Mixed - cystic LMs (n = 1) Ranula (n = 1) 100% 100% 100%
TARA - 002 in LMs Has a Favorable Safety Profile and is Well - Tolerated Data cutoff: November 12, 2025 18 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 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) Related 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
TARA - 002 Has Demonstrated Meaningful Results in LMs Patients Treated in the STARBORN - 1 Study BEFORE AFTER BEFORE AFTER Medical photography from 2 patients pre - and post - treatment with TARA - 002 in STARBORN - 1 trial ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 19
TARA - 002 in LMs is a Late - Stage Opportunity with Significant Unmet Need STARBORN - 1 DATA INDICATE TARA - 002 HAS COMPARABLE SAFETY G EFFICACY TO OK - 432 • 100% of evaluable patients who received TARA - 002 achieved clinical success • TARA - 002 demonstrated favorable safety and tolerability profile with no serious adverse events reported • Clinical Success was achieved with one or two doses in 88% of patients • OK - 432, predecessor therapy to TARA - 002, has shown strong safety and efficacy results in 500+ U.S. pediatric LMs patients in University of Iowa - led study • OK - 432 approved in Japan as standard of care for LMs for 30 years HIGH UNMET NEED WITH POTENTIAL TO TREAT OTHER MAXILLOFACIAL CYSTS AND TO ACHIEVE RARE DISEASE PRICING • FDA Rare Pediatric Disease, Breakthrough Therapy and Fast Track Designations • FDA has invited us to apply to the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program and we look forward to submitting a request to participate in this program • Historical literature and patient experience show TARA - 002 may also be effective in treating other maxillofacial cysts including ranula and thyroglossal duct cysts • LMs incidence/prevalence, unmet need and TARA - 002 product profile suggest rare disease pricing opportunity 20 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
IV Choline Chloride Phospholipid substrate replacement therapy for patients dependent on parenteral support (PS)
22 IV Choline Chloride is a Late - Stage Opportunity with High Unmet Medical Need HIGH UNMET NEED WITH LARGE MARKET OPPORTUNITY • ~30K patients on PS long term at home • 78% of PS - dependent patients are choline - deficient and 63% have some degree of liver damage 1 • Pricing analogues suggest significant market opportunity Has the potential to become the first approved IV choline formulation for PS patients POSITIVE CLINICAL DATA AND ALREADY INCLUDED IN MEDICAL GUIDELINES • Independently conducted Phase 2 data demonstrated significant improvement in serum choline concentrations and a pronounced impact on steatosis 2 • IV choline replacement for PS patients is included in US and EU medical guidelines, even though no therapy currently exists SINGLE PK STUDY REǪUIRED FOR REGULATORY APPROVAL • Single PK study demonstrating an increase in choline levels required for registration • FDA granted a targeted indication of source of choline when oral or enteral nutrition is not possible, insufficient or contra - indicated INTELLECTUAL PROPERTY PROTECTIONS • Both a compound patent and a method of treatment patent in U.S. to 2041 1 Micic D, Muhic E et al., JPEN J Parenter Enteral Nutr. 2025;49(6):e2733.; 2 Buchman A, et al. JPEN. 2001;5:260 - 268 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
Significant differences in the LS mean change from baseline in MRI - PDFF observed in Choline group vs. placebo at Weeks 4 - 24, demonstrating a clinically meaningful and statistically significant reduction in steatosis (range 31% - 54%) PLASMA FREE CHOLINE LEVELS: ALL PATIENTS 1 Choline supplementation was discontinued at week 24. Data are presented for all subjects up until time of withdrawal from the study. PLASMA FREE CHOLINE Nmol/ml 0 2 4 6 12 Assessment Week 16 20 34 P=0.225 P=0.043 P=0.034 P=0.025 P=0.011 P=0.021 P=0.074 45 40 35 30 25 20 15 10 5 0 Choline // // P=0.385 Placebo 24 Choline D/C’d Primary endpoint to replicate in registrational trial Secondary endpoint to replicate in registrational trial to support clinical benefit Independent Phase 2 Study Demonstrates that Treatment with IV Choline Rapidly Restores Choline Levels and Improves Steatosis CLINICALLY MEANINGFUL IMPROVEMENT IN STEATOSIS 1 sses s ek C d LS Means stderr) hange Baseli (+/ - of c from ne of MRI - PDFF p= 0.4770 p= 0.0197 p= 0.0312 p= 0.0180 p= 0.0014 p= 0.0091 p= 0.0021 p= 0.1823 // // - 15 - 12 - 9 - 6 - 3 0 3 2 4 6 12 A 16 ment We 20 24 holine D/C' 34 Placebo Choline Chloride * * * ** ** ** - 3 3 0 - 6 - 9 - 12 - 15 *p<0.02 **p<0.05 2 4 6 12 16 20 34 * CT converted to MRI - PDFF: *MRI - PDFF (%) = - 0.572*Liver CT(HU) + 37.264 LS Mean ( std err) of Change from Baseline in MRI - PDFF Assessment Week 24 Choline D/C’d 23 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 1 Buchman et al. JPEN, 2002 - Protara Therapeutics re - analysis of patient CRFs, data on file.
24 Large Market Opportunity for IV Choline to Address a Clear, Guideline Supported Unmet Medical Need in PS US Patients requiring PS >110,000 per year Patients on long term PS at home ~30,000 ASPEN (US) and ESPEN (EU) guidelines recommend choline for patients on PS, yet no product is available to meet this need. HCPs expect to prescribe IV Choline to the majority of their long - term PS patients, driven by IV Choline’s expected efficacy and ASPEN recommendation IV Choline Market Research – Intent to treat IV Choline Commercial Analogs Market Research and Claims Analysis ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
Appendix
TARA - 002 BCG Cytokines + -- - IFN - γ +++ + TNF - α + = IL - 12p70 - = IL - 8 + + IL - 6 +++ +++ IL - 1β + = IL - 10 + + IL - 4 = = IL - 13 - - - - IL - 2 26 TARA - 002 Demonstrates Differentiated Profile to BCG = : No change + : 2 - 5 fold upregulation +++ : ≥ 15 - fold upregulation - : 2 - 5 fold downregulation -- : 5 - 14 - fold downregulation --- : ≥ 15 - fold downregulation TARA - 002 treatment promotes differential pro - inflammatory TH1 - type cytokines than BCG in co - culture 1 TARA - 002 Potent Immune Activation with a Distinct Cytokine Signature • Distinct cytokine profile marked by strong TH1 activation (↑ IFN - γ, TNF - α, IL - 12p70), defining an immune signature different from BCG • Selectively downregulates IL - 8, a cytokine linked to tumor recurrence and progression in NMIBC ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 1 Internal pre - clinical data.
Abbreviations: CR = complete response; CIS = carcinoma in situ *Aligned with the FDA’s 2024 BCG Unresponsive NMIBC: Developing Drugs and Biologics for Treatment Guidance for Industry. **Enrollment complete †Residual CIS and/or recurrence of HGTa; ^3 weekly instillations every 3 months through month 18 and then at month 24 Primary endpoint of high - grade complete response (CR) at any time up to 6 months; Key secondary endpoint of 12 - month DOR 27 DAY 1 MONTH 3 MONTH 6 MONTH 24 MONTH 60 REGISTRATIONAL DESIGN*: BCG - Unresponsive (CIS “ Ta/T1) BCG Naïve (CIS “ Ta/T1) Induction (N=100) 6 weekly instillations Induction (N=31**) 6 weekly instillations CR, Maintenance (months 3 - 24) 3 weekly instillations every 3 months through month 18 and then at month 24 Follow - up Follow - up CR, Maintenance (months 3 - 24) 3 weekly instillations every 3 months through month 18 and then at month 24 Maintenance (months 6 - 24) 3 weekly instillations every 3 months^ Maintenance (months 6 - 24) 3 weekly instillations every 3 months^ Re - Induction (if eligible † ) 6 weekly instillations Re - Induction (if eligible † ) 6 weekly instillations Follow - up Follow - up CT.gov identifier: NCT05951179 © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | TARA - 002 in NMIBC: ADVANCED - 2 Clinical Trial Design Mandatory biopsy at month 3
Cohort B N = 43 Baseline Demographics Age (years) 75 (47, 92) Median (Min, Max) Sex, n (%) 31 (72.1) Male 12 (27.9) Female Race, n (%) 5 (11.6) Asian 1 (2.3) Black or African American 35 (81.4) White 1 (2.3) Other 1 (2.3) Not Reported © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | BCG - Unresponsive Cohort Demographics and Baseline Characteristics Data cutoff: January 28, 2026 ECOG PS = Eastern Cooperative Oncology Group Performance Status. Cohort B N = 43 Baseline Characteristics ECOG PS, n (%) 39 (90.7) 0 4 (9.3) 1 0 2 - 5 Diagnosis, n (%) 40 (93.0) CIS (only) 3 (7.0) CIS + Ta 0 CIS + T1 BCG Exposure, n (%) 43 (100.0) BCG - unresponsive
Cohort A N = 31 Baseline Demographics Age (years) 71 (45, 89) Median (Min, Max) Sex, n (%) 25 (80.6) Male 6 (19.4) Female Race, n (%) 1 (3.2) Black or African American 29 (93.5) White 1 (3.2) Not Reported © 2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute. | BCG - Naïve Cohort Demographics and Baseline Characteristics Data cutoff: January 28, 2026 ECOG PS = Eastern Cooperative Oncology Group Performance Status. Cohort A N = 31 Baseline Characteristics ECOG PS, n (%) 26 (83.9) 0 4 (12.9) 1 1 (3.2) 2 0 3 - 5 Diagnosis, n (%) 18 (58.1) CIS (only) 9 (29.0) CIS + Ta 4 (12.9) CIS + T1 BCG Exposure, n (%) 24 (77.4) Never exposed 7 (22.6) BCG exposed >24 months
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 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 C Mixed - cystic 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 (G0 - 100% reduction from baseline in total LM volume) or substantial response (60% - G0% reduction) 30 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute CT.gov identifier: NCT05871970
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) Response was assessed via central imaging (MRI or CT) or via Investigator assessment (physical exam, visual inspection and ultrasound). 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. Data cutoff: 12 - Nov - 2025 20% 70% 10% Withdrew n = 10 Complete Response Substantial Response 80% 80% CLINICAL SUCCESS RATE AT 8 - WEEKS POST - TREATMENT* STARBORN - 1 Interim Results: TARA - 002 Demonstrated Clinical Success in 80% of Patients who Completed Treatment and in 100% of Evaluable Patients 100% CLINICAL SUCCESS RATE AT 8 - WEEKS POST - TREATMENT IN EVALUABLE PATIENTS^ 88% 12% n = 8 Complete Response Substantial Response 31 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 100%
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 ultrasound). Clinical success is defined as complete (90 - 100% reduction) or substantial (60 - 90% reduction) response of the cyst from baseline in total LM volume. *Excludes 2 patients who are still in treatment; **Later diagnosed as a Ranula patient Data cut - off: 12 - Nov - 2025 32 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
THRIVE - 3 is a seamless Phase 2b/3 trial with dose confirmation followed by double - blinded, randomized, placebo - controlled trial to assess the safety and efficacy of IV Choline Chloride in adolescents and adults on long - term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated. Pivotal Trial with PK and Liver Function Endpoints • Primary endpoint: Change in plasma choline concentration from baseline to Week 8 • Secondary endpoints: Steatosis and liver function tests n ≥ 8 n ≥ 8 n ≥ 8 Open - Label Dose Selection 1:1:1 Randomization n ≥ 24 End of Open - Label PK Phase WEEK 8 1g/day Choline Chloride 2g/day Choline Chloride 4g/day Choline Chloride Enter OLE Phase Low Dose Choline Chloride High Dose Choline Chloride n = 42 n =42 n = 21 Double - Blind, Placebo Controlled Phase 2:2:1 Randomization n =105 End of Double - Blind Placebo Controlled Phase WEEK 24 Low Dose Choline Chloride High Dose Choline Chloride Placebo Enter OLE Phase Low Dose Choline Chloride High Dose Choline Chloride Dose Selection 33 ©2026 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute
Exhibit 99.4
ADVANCED - 2: Interim Efficacy and Safety Data in BCG - Unresponsive Participants with High - grade Non - muscle Invasive Bladder Cancer Raj Satkunasivam 1 , Timothy D. Lyon 2 , Mark Tyson 3 , Gautam Jayram 4 , Alexander Sankin 5 , Brian Mazzarella 6 , Timothy Clinton 7 , Eugene Kramolowsky 8 , Jacqueline Zummo 9 , Carla Beckham 9 , Khushboo Belani 9 , Andrea DiFiglia 9 , Claire Middleton 9 , Eppie Brown 9 , Brian Desch 9 , Chen Ǫuin Lam 10 , Neal Shore 11 1 Department of Urology, Houston Methodist Hospital, Houston, TX, USA; 2 Department of Urology, Mayo Clinic, Jacksonville, FL, USA; 3 Mayo Clinic, Phoenix, AZ, USA; 4 Urology Associates P.C., Nashville, TN, USA; 5 Montefiore Medical Center, Bronx, NY, USA; 6 Urology Austin, Austin, TX, USA; 7 Department of Urology, Brigham and Women’s Hospital, Boston, MA, USA; 8 Virginia Urology, Richmond, VA, USA; 9 Protara Therapeutics, Inc., New York, NY, USA, 10 Pharmapace Inc., San Diego, CA, USA, 11 START Carolinas/Carolina Urologic Research Center, Myrtle Beach, SC, USA BACKGROUND • Although patients with BCG - unresponsive NMIBC have several emerging therapeutic options, there remains a clinical unmet need to improve efficacy, durability of response, and tolerability while obviating the need for radical cystectomy. • TARA - 002 is a TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes Su strain with a mechanism of action that includes local activation of innate and adaptive immune pathways. • TARA - 002 requires no special handling or thawing and can be rapidly administered via catheter by a healthcare professional in a routine office - based setting. METHODS • ADVANCED - 2 (NCT05951179) Cohort B is a Phase 2, ongoing, open - label study to evaluate the safety and efficacy of intravesical TARA - 002 in BCG - unresponsive adults aged ≥ 18 years with high - grade NMIBC CIS “ Ta/T1. • Eligible patients included previously treated patients (BCG and non - BCG therapy), including those who received prior investigational therapies • Endpoints: — Primary: high grade complete response (CR) at any time according to central pathology — Key secondary: duration of response (12 months) • The data cutoff date is January 28, 2026 ADVANCED - 2 COHORT B (BCG - UNRESPONSIVE) STUDY SCHEMA Abbreviations: BCG = Bacillus Calmette - Guérin; CIS = carcinoma in situ; CR = complete response; HGTa = high grade Ta tumor; NMIBC = non - muscle invasive bladder cancer; T1 = carcinoma invading the lamina propria; Ta = non - invasive papillary carcinoma. *Aligned with FDA 2024 BCG Unresponsive NMIBC: Developing Drugs and Biologics for Treatment Guidance for Industry. † Eligible for re - induction: residual CIS and/or recurrence of HGTa. RESULTS TARA - 002 MONOTHERAPY DEMONSTRATES STRONG EFFICACY IN BCG - UNRESPONSIVE PARTICIPANTS Abbreviation: CR = complete response. High - grade CR is based on central pathology including a mandatory biopsy at Month 3. Notes: Evaluable participants include those who had at least one dose of study drug before the response assessment time point and completed at least one response assessment; CR rates at each landmark time point include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit. Two participants at Month 3 and 1 participant at Month 12 are pending central confirmation of response. • This dataset includes 43 BCG - unresponsive participants with a median age of 75.0 years (min: 47 years; max: 92 years), and the majority of participants are male (72.1%, 31/43) and White (81.4%, 35/43). • The rate of high - grade CR at any time was 65.7% (23 of 35). • The rate of high - grade CR was 68.2% (15 of 22) at Month 6 and 33.3% (5 of 15) at Month 12. • Among initial responders, 100% (7 of 7) maintained their response through Month 6, 80% (4 of 5) through Month 9 and 100% (2 of 2) through Month 12. • Among the initial non - responders who underwent re - induction, 61.5% (8 of 13) converted to a CR by Month 6, 71.4% (5 of 7) responders maintained the CR through Month 9 and 100% (3 of 3) through Month 12. • The majority of TRAES were Grade 1 and transient; commonly occurring TRAEs included dysuria, bladder spasm and micturition urgency. • No participants experienced Grade ≥ 3 TRAEs, related SAEs or TRAEs leading to withdrawal. FUTURE DIRECTIONS FOR RESEARCH • In participants w it h BCG - unresponsive high - grade NMIBC w it h CIS “ Ta/T 1 , TARA - 002 appears to be well tolerated and demonstrated encouraging efficacy, supporting ongoing accrual o f the ADVANCED - 2 study . • Re - induction therapy successfully salvaged a significant proportion o f initial non - responders, resulting in high conversion rates and durable responses TARA - 002 MONOTHERAPY DEMONSTRATES 68.2% HIGH - GRADE COMPLETE RESPONSE AT 6 MONTHS IN BCG - UNRESPONSIVE PARTICIPANTS TARA - 002 SHOWED A FAVORABLE SAFETY PROFILE Grade 4/5 Grade 3 Grade 2 Grade 1 Any Grade N = 43 0 0 3 (7) 11 (26) 11 (26) TRAEs, n (%) 1 (2) 6 (14) 2 (5) 0 7 (16) SAEs, n (%) 0 0 0 0 0 Related SAEs, n (%) 0 0 0 0 0 TRAEs leading to Study Drug Withdrawal, n (%) SAE = serious adverse event; TRAE = treatment related adverse event. Severity of adverse event is based on NCI - CTCAE Version 5.0 or later. Day 1 Month 3 Month 6 Month 24 Month 60 REGISTRATIONAL DESIGN*: BCG - unresponsive (CIS “ Ta/T1) Induction (N=100) 6 weekly instillations CR, Maintenance (months 3 - 24) 3 weekly instillations at M3, M6, M9, M12, M15, M18, M24 Follow - up Follow - up Re - induction (if eligible † ) 6 weekly instillations Maintenance (months 6 - 24) 3 weekly instillations at M3, M6, M9, M12, M15, M18, M24 Screenin g Mandatory biopsy at Month 3 0 3 6 Months 9 12 35 25 15 5 Complete Response Recurrence/Non - Response Eligible for Reinduction Treatment Ongoing Treatment/Study Discontinued Mandatory biopsy at Month 3 65.7% 23 of 35 Month 6 Month 12 68.2 (15 of 22) 33.3 (5 of 15) High - grade CR rate at any time (%) Landmark High - grade CR rate (%) 100 80 60 40 20 0 N = 35 Abstract Number: 743 Poster Board Number: F15 Contact: clinicaltrials@protaratx.com DISCLOSURES This study was funded by Protara Therapeutics, Inc. Presented at ASCO GU Annual Meeting. February 26 – 28, 2026, San Francisco, CA ACKNOWLEDGEMENTS Digital and print editorial services powered by Princeton Biomedical Comm., LLC.
Exhibit 99.5
Interim Safety and Tolerability of TARA - 002 in Patients with BCG - Naive and Unresponsive High - grade Non - muscle Invasive Bladder Cancer in ADVANCED - 2 Timothy Clinton 1 , Timothy D. Lyon 2 , Mark Tyson 3 , Raj Satkunasivam 4 , Gautam Jayram 5 , Alexander Sankin 6 , Brian Mazzarella 7 , Myroslava V Doronina 8,9 , Eugene Kramolowsky 10 , Jacqueline Zummo 11 , Carla Beckham 11 , Khushboo Belani 11 , Andrea DiFiglia 11 , Claire Middleton 11 , Eppie Brown 11 , Brian Desch 11 , Chen Ǫuin Lam 12 , Neal Shore 13 1 Department of Urology, Brigham and Women’s Hospital, Boston, MA, USA; 2 Department of Urology, Mayo Clinic, Jacksonville, FL, USA; 3 Mayo Clinic, Phoenix, AZ, USA; 4 Department of Urology, Houston Methodist Hospital, Houston, TX; 5 Urology Associates P.C., Nashville, TN, USA; 6 Montefiore Medical Center, Bronx, NY, USA; 7 Urology Austin, Austin, TX, USA; 8 Arensia Exploratory Medicine LLC, Kyiv, UKR; 9 Shupyk National Healthcare University of Ukraine, Kyiv, UKR; 10 Virginia Urology, Richmond, VA, USA; 11 Protara Therapeutics, Inc., New York, NY, USA; 12 Pharmapace Inc., San Diego, CA, USA; 13 START Carolinas/Carolina Urologic Research Center, Myrtle Beach, SC, USA BACKGROUND • There continues to be a significant unmet need for safe, effective, and bladder - sparing treatment options for patients with non - muscle invasive bladder cancer (NMIBC). • TARA - 002 is a TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes Su strain with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. • TARA - 002 requires no special handling or thawing and can be rapidly administered via catheter by a healthcare professional in a routine office - based setting. • TARA - 002 has shown evidence of safety and efficacy in patients with high - grade (HG) NMIBC who are BCG - naïve and BCG - unresponsive. METHODS • ADVANCED - 2 (NCT05951179) is an ongoing Phase 2, open - label study to evaluate the safety and efficacy of intravesical TARA - 002 in adults aged ≥ 18 years with HG NMIBC carcinoma in situ (CIS) “ Ta/T1. • The ADVANCED - 2 study includes 2 cohorts: — BCG - naïve (Cohort A) — BCG - unresponsive (Cohort B) • Endpoints: — Primary: high - grade complete response (CR) at any time according to central pathology — Key secondary: duration of response (12 months) • Safety is monitored throughout the study. • The data cutoff date was January 28, 2026. Abbreviations: BCG = Bacillus Calmette - Guérin; CIS = carcinoma in situ; CR = complete response; HGTa = high grade Ta tumor; T1 = carcinoma invading the lamina propria; Ta = non - invasive papillary carcinoma. *Aligned with FDA 2024 BCG Unresponsive NMIBC: Developing Drugs and Biologics for Treatment Guidance for Industry. † Eligible for re - induction: residual CIS and/or recurrence of HGTa. ADVANCED - 2 STUDY SCHEMA Day 1 Month 3 Month 6 Month 24 RESULTS TARA - 002 DEMONSTRATED A FAVORABLE SAFETY AND TOLERABILITY PROFILE WITH NO GRADE 3 OR GREATER TRAEs ACROSS BCG EXPOSURES N = 74 Any Grade Grade 1 Grade 2 Grade 3 Grade 4/5 TRAEs, n (%) 19 (26) 19 (26) 4 (5) 0 0 TRAEs ≥ 5%, n (%) Dysuria 10 (14) 10 (14) 0 0 0 Bladder spasm 7 (9) 4 (5) 3 (4) 0 0 Fatigue Micturition urgency 5 (7) 4 (5) 4 (5) 4 (5) 1 (1) 0 0 0 0 0 1 (1) 10 (14) 3 (4) 0 11 (15) SAEs, n (%) 0 0 0 0 0 Related SAEs, n (%) TRAEs leading to Study Drug Withdrawal, n (%) 0 0 0 0 0 SAE = serious adverse event; TRAE = treatment related adverse event. NOTE: A total of 74 participants were exposed to at least one dose of TARA - 002; 43 were BCG - unresponsive and 31 were BCG - naïve. Severity of adverse event is based on NCI - CTCAE Version 5.0 or later. Abbreviation : CR = complete response . High - grade CR is based on central pathology . Notes : Evaluable participants include those who had at least one dose of study drug before the response assessment time point and completed at least one response assessment ; CR rates at each landmark time point include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit . • In this analysis, 74 participants (median age: 74.0; range; min: 45 years; max: 92 years) were enrolled and exposed to TARA - 002 across two cohorts: — 31 BCG - naïve — 43 BCG - unresponsive • In both cohorts, 26% (19 of 74) participants reported treatment - related adverse events (TRAEs): 26% (19 of 74) were Grade 1, 5% (4 of 74) were Grade 2; no reported Grade 3 - 5. FUTURE DIRECTIONS FOR RESEARCH • TARA - 002 monotherapy was well tolerated, thus demonstrating a favorable tolerability profile to date for the treatment of BCG - naïve and BCG - unresponsive HG NMIBC with CIS “ Ta/T1. • In BCG - naïve and BCG - unresponsive HG NMIBC participants, TARA - 002 demonstrated a high rate of complete response, with a substantial proportion maintaining a durable response • TARA - 002 has a promising safety and efficacy profile as a bladder - sparing treatment in HG NMIBC across BCG exposure status. TARA - 002 MONOTHERAPY DEMONSTRATES DURABLE RESPONSE AT 12 MONTHS IN BCG - NAÏVE PARTICIPANTS ^ Participants enrolled under an earlier protocol version with 6 - month follow - up; therefore, they are not included in CR analyses from Month 9 onward. • Commonly reported TRAEs (≥ 5 %) across both cohorts included dysuria (14%, 10 of 74), bladder spasm (9%, 7 of 74), fatigue (7%, 5 of 74), and micturition urgency (5%, 4 of 74). — TRAEs were mild and transient. • In both cohorts, 15% (11 of 74) participants experienced serious adverse events (SAEs): 3 with Grade 2, 10 with Grade 3 and 1 with Grade 4/5. • No participants experienced Grade ≥ 3 TRAEs, related SAEs, or TRAEs leading to withdrawal or death. • Interim data showed promising CR rates and durable response in both BCG - naïve and BCG - unresponsive HG NMIBC patients treated with TARA - 002. — In the BCG - naïve cohort, the rate of high - grade CR was 72.4% (21 of 29) at any time, 66.7% (18 of 27) at Month 6, and 57.9% (11 of 19) at Month 12. — Response data from the BCG - unresponsive cohort is presented in Poster F15. Month 60 Induction 6 weekly instillations CR, Maintenance (months 3 - 24) 3 weekly instillations at M3, M6, M9, M12, M15, M18, M24 Follow - up Follow - up Re - induction (if eligible † ) 6 weekly instillations Maintenance (months 6 - 24) 3 weekly instillations at M3, M6, M9, M12, M15, M18, M24 Screening Cohort A = BCG - naive, N = 31 Cohort B = BCG - unresponsive, N = 100 (Registrational Design*) 0 3 6 Months 9 12 25 20 15 5 Complete Response Recurrence/Non - Response Eligible for Reinduction Treatment Ongoing Study Completed Treatment/Study Discontinued Earlier protocol version (6 - month follow up) ^ 10 ^ ^ ^ ^ 72.4% 21 of 29 Month 6 Month 12 TARA - 002 MONOTHERAPY DEMONSTRATES STRONG EFFICACY AND DURABILITY IN BCG - NAÏVE PARTICIPANTS High - grade CR rate at any time (%) Landmark High - grade CR rate (%) 66.7 (18 of 27) 57.9 (11 of 19) 100 80 60 40 20 0 N = 29 Abstract Number: 776 Poster Board Number: H8 Contact: clinicaltrials@protaratx.com DISCLOSURES This study was funded by Protara Therapeutics, Inc. ACKNOWLEDGEMENTS Digital and print editorial services powered by Princeton Biomedical Comm., LLC. Presented at ASCO GU Annual Meeting. February 26 – 28, 2026, San Francisco, CA
FAQ
What did Protara Therapeutics (TARA) report about TARA-002 in non-muscle invasive bladder cancer?
How durable are TARA-002 responses in BCG-unresponsive NMIBC patients according to Protara (TARA)?
What were the TARA-002 results in BCG-naïve NMIBC patients reported by Protara (TARA)?
What safety profile did Protara Therapeutics (TARA) observe for TARA-002 in ADVANCED-2?
What are the next clinical steps for TARA-002 in bladder cancer according to Protara (TARA)?
Which additional programs beyond TARA-002 in NMIBC is Protara Therapeutics (TARA) advancing?
Filing Exhibits & Attachments
64 documentsPress Releases
- EX-99.1 PRESS RELEASE, DATED FEBRUARY 23, 2026 28.0 KB
- EX-99.2 INVESTOR PRESENTATION, DATED FEBRUARY 24, 2026 25.4 KB
- EX-99.3 CORPORATE DECK, DATED FEBRUARY 24, 2026 53.2 KB
- EX-99.4 POSTER PRESENTATION, DATED FEBRUARY 27, 2026 7.0 KB
- EX-99.5 POSTER PRESENTATION, DATED FEBRUARY 27, 2026 8.2 KB
- EX-99 GRAPHIC 2.4 KB
- EX-99 GRAPHIC 316.2 KB
- EX-99 GRAPHIC 753.7 KB
- EX-99 GRAPHIC 252.6 KB
- EX-99 GRAPHIC 360.0 KB
- EX-99 GRAPHIC 354.9 KB
- EX-99 GRAPHIC 273.1 KB
- EX-99 GRAPHIC 266.5 KB
- EX-99 GRAPHIC 439.5 KB
- EX-99 GRAPHIC 361.4 KB
- EX-99 GRAPHIC 470.9 KB
- EX-99 GRAPHIC 458.0 KB
- EX-99 GRAPHIC 332.3 KB
- EX-99 GRAPHIC 150.4 KB
- EX-99 GRAPHIC 92.4 KB
- EX-99 GRAPHIC 248.4 KB
- EX-99 GRAPHIC 246.6 KB
- EX-99 GRAPHIC 154.9 KB
- EX-99 GRAPHIC 305.0 KB
- EX-99 GRAPHIC 312.4 KB
- EX-99 GRAPHIC 227.0 KB
- EX-99 GRAPHIC 753.5 KB
- EX-99 GRAPHIC 361.6 KB
- EX-99 GRAPHIC 355.0 KB
- EX-99 GRAPHIC 266.3 KB
- EX-99 GRAPHIC 286.6 KB
- EX-99 GRAPHIC 470.8 KB
- EX-99 GRAPHIC 457.9 KB
- EX-99 GRAPHIC 332.2 KB
- EX-99 GRAPHIC 448.3 KB
- EX-99 GRAPHIC 345.3 KB
- EX-99 GRAPHIC 400.5 KB
- EX-99 GRAPHIC 344.8 KB
- EX-99 GRAPHIC 273.2 KB
- EX-99 GRAPHIC 256.6 KB
- EX-99 GRAPHIC 341.4 KB
- EX-99 GRAPHIC 334.1 KB
- EX-99 GRAPHIC 435.8 KB
- EX-99 GRAPHIC 412.0 KB
- EX-99 GRAPHIC 301.7 KB
- EX-99 GRAPHIC 476.0 KB
- EX-99 GRAPHIC 303.4 KB
- EX-99 GRAPHIC 373.3 KB
- EX-99 GRAPHIC 360.7 KB
- EX-99 GRAPHIC 342.1 KB
- EX-99 GRAPHIC 250.7 KB
- EX-99 GRAPHIC 287.3 KB
- EX-99 GRAPHIC 362.0 KB
- EX-99 GRAPHIC 305.0 KB
- EX-99 GRAPHIC 312.4 KB
- EX-99 GRAPHIC 300.3 KB
- EX-99 GRAPHIC 349.0 KB
- EX-99 GRAPHIC 312.4 KB
- EX-99 GRAPHIC 323.2 KB
- EX-99 GRAPHIC 799.5 KB
- EX-99 GRAPHIC 1.5 MB
