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

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

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

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

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

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

Protara Therapeutics to Present Interim Analysis from the Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC at the American Urological Association Annual Meeting (GlobeNewswire) - "Protara Therapeutics...announced that two presentations and a panel discussion highlighting the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured at the upcoming American Urological Association (AUA) 2025 Annual Meeting....Updated safety and efficacy data, including data from patients who have reached the 12-month evaluation timepoint, will be featured during an interactive poster session on Saturday, April 26, 2025....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 (n≈100) and BCG-Naïve (n=30)."

P2 data • Bladder Cancer

Protara Therapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "Reported positive six-month data from ADVANCED-2 trial of TARA-002 in patients with NMIBC; Announcement of initial data from 12-month evaluable patients expected by mid-2025; On track to provide an interim update from the Phase 2 STARBORN-1 trial of TARA-002 in pediatric LMs patients by the end of 1H 2025."

P2 data • Bladder Cancer • Oncology • Urothelial Cancer

ADVANCED-1: Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Protara Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Protara Highlights Recent Updates and Anticipated 2025 Milestones (GlobeNewswire) - "TARA-002 in NMIBC: The Company expects to report data on 12-month evaluable patients in the ADVANCED-2 trial in mid-2025 and results from a futility analysis of approximately 25 six-month evaluable BCG-Unresponsive patients are expected by the end of 2025....The Company expects to provide an update on the design of its planned BCG-Naïve registrational trial by the end of the first half of 2025 following regulatory alignment."

Clinical protocol • P2 data • Bladder Cancer • Genito-urinary Cancer • Urothelial Cancer

Protara Highlights Recent Updates and Anticipated 2025 Milestones (GlobeNewswire) - "TARA-002 in LMs: Protara remains on track to report initial results from additional cohorts in the Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic LMs by the end of the first half of 2025."

P2 data • Oncology

Protara Announces Closing of $100 Million Public Offering (GlobeNewswire) - "Protara Therapeutics, Inc...today announced the closing of its underwritten public offering of 13,690,000 shares of its common stock at a public offering price of $6.25 per share and pre-funded warrants to purchase 2,325,372 shares of common stock at a price of $6.249 per pre-funded warrant...In addition, Protara has granted the underwriters a 30-day option to purchase up to an additional 2,402,305 shares of common stock at the public offering price...The gross proceeds from the offering were approximately $100 million before deducting underwriting discounts and commissions and offering expenses payable by Protara and excluding any exercise of the underwriters’ option to purchase additional shares and the exercise of any pre-funded warrants. Protara intends to use the net proceeds received from the offering to fund the clinical development of TARA-002, as well as the development of other clinical programs."

Financing • Oncology

Protara Announces Positive Results from the Ongoing Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC (GlobeNewswire) - P2 | N=127 | ADVANCED-2 (NCT05951179) | Sponsor: Protara Therapeutics | "TARA-002 demonstrates 72% six-month landmark complete response rate and 70% complete response rate at any time across BCG exposures; 100% six-month landmark complete response rate and 80% complete response rate at any time observed in BCG-Unresponsive patients; 64% six-month landmark complete response rate and 67% complete response rate at any time observed in BCG-Naïve patients; 80% reinduction salvage rate and compelling durability observed with 100% of patients maintaining a complete response from three months to six months across BCG exposures; Favorable safety and tolerability profile with no Grade 2 or greater treatment-related adverse events."

P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC on Thursday, December 5, 2024 (GlobeNewswire) - "Protara Therapeutics...announced it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, December 5, 2024, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC). The data will be featured during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology on December 5, 2024, at 1:15 p.m. CT."

P2 data • Bladder Cancer

ADVANCED-2: PHASE 2 OPEN-LABEL STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF INTRAVESICAL INSTILLATION OF TARA-002 IN ADULTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2024) - P2 | "TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin and is being developed for the treatment of high-grade NMIBC. TARA-002 is manufactured using the same master cell bank as OK-432, which is approved in Japan and Taiwan for the treatment of several oncology indications... Preliminary data from the ADVANCED-2 study suggests that TARA-002 appears to be well tolerated, thus demonstrating a favorable tolerability profile for the treatment of BCG Naïve and BCG unresponsive subjects with CIS (±Ta/T1) NMIBC. Enrollment is ongoing and updated data will be shared at the time of the presentation."

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

Protara Therapeutics to Present New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC at the 25th Annual Meeting of the Society of Urologic Oncology (GlobeNewswire) - "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 (n≈100) and BCG-Naïve (n=27). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the FDA’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry. Trial subjects received an induction with or without a reinduction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly installations every three months in the BCG-Unresponsive cohort."

P2 data • Bladder Cancer

Protara Therapeutics Announces Third Quarter 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "On track to report interim data in six-month evaluable patients in ADVANCED-2 trial of TARA-002 in NMIBC in 4Q 2024; Expect to report interim 12-month data in ADVANCED-2 trial of TARA-002 in NMIBC in mid-2025; In pediatric LMs patients, TARA-002 demonstrated encouraging results and was generally well-tolerated in the first cohort of Phase 2 STARBORN-1 trial; initial results from next cohort expected in 1H 2025."

P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

ADVANCED-1: Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b) (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Protara Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Sep 2024

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

Protara Therapeutics Announces Completion of First Cohort in Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations (GlobeNewswire) - P2 | N=38 | STARBORN-1 (NCT05871970) | Sponsor: Protara Therapeutics | "Protara Therapeutics, Inc....today announced completion of the first cohort of the Phase 2 STARBORN-1 trial evaluating TARA-002...for the treatment of pediatric patients with lymphatic malformations (LMs). Enrollment is now underway in additional cohorts....Of three patients treated in the first cohort, which enrolled individuals six years to less than 18 years of age, two patients treated with TARA-002 achieved a complete response after receiving one dose of TARA-002; the responses were seen in a patient with a macrocystic lymphatic malformation and a patient with a ranula....We have received positive feedback from our investigators and already have a number of patients on waiting lists for our subsequent cohorts, and expect to share initial results from our next cohort in the first half of 2025."

P2 data • Trial status • Oncology

ADVANCED-1: Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (Phase 1a) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Protara Therapeutics | Recruiting ➔ Active, not recruiting | N=18 ➔ 12 | Trial completion date: Jul 2024 ➔ Jan 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor