picibanil biosimilar (TARA-002) / Protara Therap - LARVOL DELTA

ADVANCED-2: A PHASE 2 OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVESICAL INSTILLATION OF TARA-002 IN ADULTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - P2 | "Subjects are followed for safety throughout the study. This Phase 2 study is currently open for enrollment."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • Urinary Incontinence • Urology

ADVANCED-2: PRELIMINARY EFFICACY AND SAFETY DATA IN BCG-NAÏVE PARTICIPANTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "Preliminary data suggest that TARA-002 monotherapy is well-tolerated and produces clinically meaningful rates of initial and complete response coupled with durability of response in BCG-naïve HG NMIBC with CIS (± Ta/T1) through twelve months of treatment. Updated efficacy and safety data will be provided based on evaluable time points at the time of the presentation."

Clinical • Metastases • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • TLR2

ADVANCED-2 (Cohort B): Interim Efficacy and Safety Data in BCG-Unresponsive Participants With High-Grade Non-Muscle Invasive Bladder Cancer (AUA 2026) - "In participants with BCG-unresponsive high-risk NMIBC with CIS ± Ta/T1, TARA-002 appears to be well tolerated and demonstrated encouraging efficacy, supporting ongoing accrual of the ADVANCED-2 study. Further follow up will inform durability of response, and data will be updated based on evaluable time points at the time of the presentation."

Clinical • Metastases • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • TLR2

ADVANCED-2 (Cohort A): Preliminary Efficacy and Safety Data in BCG-Naïve Participants With High-Grade Non-Muscle Invasive Bladder Cancer (AUA 2026) - "Preliminary data suggest that TARA-002 monotherapy is well-tolerated and produces clinically meaningful rates of initial CR coupled with durability of response in BCG-naïve HG NMIBC with CIS (±Ta/T1) through twelve months of treatment. Updated efficacy and safety data will be provided based on evaluable time points at the time of the presentation."

Clinical • Metastases • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • TLR2

Recent Progress and Highlights: TARA-002 in NMIBC (GlobeNewswire) - "The Company expects to complete enrollment of the BCG-Unresponsive cohort in the fourth quarter of 2026. The Company is redesigning the recently initiated ADVANCED-3 trial to be a multi-cohort, open-label, exploratory trial to evaluate the efficacy and safety of intravesical TARA-002 in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary (Ta/T1) patients across BCG exposures. Importantly, this new design allows Protara to accelerate and expand the breadth of TARA-002 data in a broader high-grade, high-risk NMIBC patient population."

Clinical protocol • Enrollment status • Bladder Cancer

ADVANCED-3: Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-nave High-grade Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=284 | Recruiting | Sponsor: Protara Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

STARBORN-1: Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Protara Therapeutics | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date

ADVANCED-2: Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=131 | Recruiting | Sponsor: Protara Therapeutics | Trial completion date: Aug 2030 ➔ Mar 2032 | Trial primary completion date: May 2030 ➔ Oct 2031

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CXCL8

Protara’s TARA-002 Shows Durable Bladder Cancer Response at 12 Months (BriefGlance) - “Protara Therapeutics…updated 12-month results from the ongoing Phase 2 ADVANCED-2 trial…at AUA 2026 Annual Meeting, demonstrate both durable efficacy and a strong safety profile in patients…According to the announcement, TARA-002 achieved a 55% complete response (CR) rate at the 12-month mark in this BCG-naïve patient group. The therapy showed even higher response rates at earlier time points, with a 66.7% CR rate at six months and an impressive 72.4% CR rate at any time during the evaluation.”

P2 data • Bladder Cancer

ADVANCED-3: Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=284 | Not yet recruiting | Sponsor: Protara Therapeutics

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Interim safety and tolerability of TARA-002 in patients with BCG-naïve and unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2. (ASCO-GU 2026) - P2 | "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). TARA-002 has a promising safety profile as a bladder-sparing treatment in HG NMIBC across BCG exposure status. Updated safety data will be provided based on evaluable time points at the time of the presentation."

Clinical • Metastases • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • TLR2

ADVANCED-2: Interim efficacy and safety data in BCG-unresponsive participants with high-grade non-muscle invasive bladder cancer. (ASCO-GU 2026) - P2 | "In participants with BCG-unresponsive high-risk NMIBC with CIS ± Ta/T1, TARA-002 appears to be well tolerated and demonstrated encouraging efficacy, supporting ongoing accrual of the ADVANCED-2 study. Further follow-up will inform durability of response, and data will be updated based on evaluable time points at the time of the presentation."

Clinical • Metastases • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • TLR2

Next Steps (GlobeNewswire) - "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."

Enrollment status • New trial • Bladder Cancer

Protara Therapeutics…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… (PRNewswire) - "These results will be featured on Friday, February 27, 2026 during poster sessions at the American Society of Clinical Oncology Genitourinary Cancers Symposium....BCG-Unresponsive Cohort:...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: The Kaplan-Meier (KM) estimated probability of maintaining a CR for six months was 71.1% (95% CI: 46.7, 95.5); 100% (5 of 5) maintained their CR from nine to 12 months....BCG-Naïve Cohort:...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."

P2 data • Bladder Cancer

Protara Therapeutics to Present Updated Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Unresponsive NMIBC Patients at the ASCO Genitourinary Cancers Symposium (GlobeNewswire) - "The poster presentation will include updated safety and efficacy data from approximately 25 six-month evaluable BCG-Unresponsive NMIBC patients in the ongoing Phase 2 ADVANCED-2 trial. 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)."

P2 data • Bladder Cancer

Protara Therapeutics Receives Both FDA Breakthrough Therapy and Fast Track Designations for TARA-002 in Pediatric Patients with Lymphatic Malformations (The Manila Times) - "In addition, the FDA has selected TARA-002 to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program, which aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access...'expect to meet with the FDA to define the path to registration for TARA-002 in LMs in the first half of this year.'"

Breakthrough therapy • Commercial • Fast track • FDA event • Rare Diseases

Regulatory Update (GlobeNewswire) - "The FDA has provided written feedback supporting a registrational design for a controlled trial in BCG-Naïve patients (who have never been exposed and those who have not received BCG within the last 24 months and are ineligible to receive BCG or contraindicated, cannot tolerate BCG, do not have access to BCG, or refuse BCG). The FDA has agreed that BCG is not required as a comparator and that intravesical chemotherapy is an acceptable comparator to TARA-002 in BCG-Naïve patients. The FDA also is aligned with the primary endpoint of the trial as the CR rate at month 6 with duration of response as a key secondary endpoint."

FDA event • Bladder Cancer

Protara Therapeutics Announces Updated Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients (GlobeNewswire) - "The CR rate at any time was 72% (21/29). The CR rate was 69% (18/26) at six months and 50% (7/14) at 12 months. Among initial responders, 88% (14/16) maintained their response through six months and 100% (3/3) through 12 months. Re-induction therapy successfully salvaged most initial non-responders, resulting in high conversion rates and durable responses....Company remains on track to report interim results from approximately 25 six-month evaluable BCG-Unresponsive patients in the registrational cohort of the ADVANCED-2 trial in Q1 2026. Company expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in 2H 2026."

Enrollment status • P2 data • Bladder Cancer

Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients on Wednesday, December 3, 2025 (GlobeNewswire) - "The data will be featured during a poster session at the 26th Annual Meeting of the Society of Urologic Oncology (SUO). The Company will also provide an update on feedback from the U.S. Food and Drug Administration on a registrational path forward for TARA-002 in BCG-Naïve patients."

FDA event • P2 data • Bladder Cancer

Protara Therapeutics…announced that interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming 26th Annual Meeting of the Society of Urologic Oncology (SUO)… (GlobeNewswire) - "The presentation will include data featured in the abstract published on the SUO website, as well as updated safety and efficacy data from 31 enrolled BCG-Naïve patients, the majority of whom have reached the six-month evaluation time point."

P2 data • Bladder Cancer

Comparative analysis of the anti-tumor activity and mechanism of action of TARA-002 and BCG in bladder cancer models. (ASCO 2025) - "Our results suggest that the mechanism of action of TARA-002 differs from that of BCG, leading to variations in their biological activity. This leads to more potent anti-tumor activity of TARA-002 in both in vitro and in vivo models compared to BCG, accompanied by an enhanced immune-mediated pro-inflammatory response."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • ANXA5 • CXCL8 • IFNG • TLR2 • TNFA

Protara Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Interim results from approximately 25 six-month evaluable BCG-Unresponsive patients are expected to be announced by the end of 2025; Following regulatory alignment with the FDA, the Company expects to provide an update on the design of its planned BCG-Naïve registrational trial in the second half of 2025....Dosing continues to progress in the Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic LMs and the Company intends to provide an interim update from the trial in the second half of 2025."

New trial • P2 data • Bladder Cancer • Oncology • Rare Diseases

Protara Therapeutics Announces Positive Interim Results Demonstrating Durable Responses in the Ongoing Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC (GlobeNewswire) - P2 | N=127 | ADVANCED-2 (NCT05951179) | Sponsor: Protara Therapeutics | "The BCG-Unresponsive dataset includes a total of five patients, all of whom were six- and nine-month evaluable...as of an April 16, 2025 data cutoff: The complete response (CR) rate at any time in BCG-Unresponsive patients was 100% (5/5); The CR rate in BCG-Unresponsive patients was 100% (5/5) at six months, 80% (4/5) at nine months, and 67% (2/3) at 12 months...The BCG-Naïve dataset includes a total of 21 patients, including 16 evaluable at six months, eight at nine months, and seven at 12 months as of an April 16, 2025 data cutoff: The CR rate at any time in BCG-Naïve patients was 76% (16/21); The CR rate in BCG-Naïve patients was 63% (10/16) at six months, 63% (5/8) at nine months, and 43% (3/7) at 12 months....The Company continues to expect to present an interim update with results from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025."

P2 data • Bladder Cancer

Protara Therapeutics to Host Conference Call and Webcast to Review Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC on Monday, April 28, 2025 (GlobeNewswire) - "Protara Therapeutics, Inc...announced it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025, to review updated safety and efficacy data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), including data from patients who have reached the 12-month evaluation timepoint. The data will be featured during an interactive poster session at the American Urological Association 2025 Annual Meeting on Saturday, April 26, 2025, at 7:00 a.m. PT."

P2 data • Bladder Cancer

PRELIMINARY ANTI-TUMOR ACTIVITY AND SAFETY RESULTS FROM ADVANCED-2: A PHASE 2 OPEN-LABEL STUDY OF INTRAVESICAL TARA-002 IN ADULTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - "Preliminary data from the ADVANCED-2 study suggests that TARA-002 monotherapy is well-tolerated with encouraging anti-tumor activity for the treatment of BCG naïve, BCG exposed and BCG unresponsive subjects with CIS (±Ta/T1) NMIBC. Updated efficacy and safety data will be provided based on enrollment and evaluable time points at the time of presentation."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • Urinary Incontinence • Urology