Protara Therapeutics, Inc. 8-K Filings

Protara Therapeutics, Inc. reported that its Chief Medical Officer, Leonardo Viana Nicacio, M.D., has resigned from the company to explore other opportunities, effective June 26, 2026. His responsibilities will transition to Carla Beckham, M.D., the company’s Lead Medical Director and Head of Clinical Development, under the continued oversight of Jacqueline Zummo, Ph.D., Chief Research & Development Officer. This represents a leadership change in the company’s medical and clinical development organization.

Protara Therapeutics, Inc. held its Annual Meeting of Stockholders, where all seven proposals received stockholder approval. Stockholders elected three Class III directors to serve until the 2029 annual meeting and ratified Ernst & Young LLP as independent auditor for the year ending December 31, 2026.

Stockholders approved, on an advisory basis, executive compensation and set the say‑on‑pay vote frequency at one year. They also approved an amendment to the 2024 Equity Incentive Plan and an amendment to increase authorized common shares from 100,000,000 to 200,000,000. An additional charter amendment allowing officer exculpation, as permitted by Delaware law, was also approved.

Protara Therapeutics reported a larger net loss as it advances its pipeline. For the quarter ended March 31, 2026, the company recorded a net loss of $17.8 million, compared with $11.9 million a year earlier, driven by higher research and development and general and administrative expenses.

Research and development spending rose to $13.6 million, while general and administrative costs were $6.1 million. Protara ended the quarter with cash, cash equivalents and investments of approximately $177 million, which it expects will fund operations into 2028.

Clinically, the company plans to submit a Biologics License Application for TARA‑002 in lymphatic malformations in the second half of 2027, and aims to complete enrollment of the BCG‑unresponsive registrational cohort of the ADVANCED‑2 bladder cancer trial and start the ADVANCED‑3 registrational trial in BCG‑naïve patients in the second half of 2026. It also expects multiple data readouts in 2026, including interim TARA‑002 data and interim THRIVE‑3 IV Choline Chloride results.

Protara Therapeutics, Inc. reported updated interim data from its ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ non-muscle invasive bladder cancer that is Bacillus Calmette-Guérin (BCG)-Unresponsive. The company confirmed the six-month complete response rate for the 25th BCG-Unresponsive patient, yielding an average six-month complete response rate of 68.0% in these 25 patients. This result is consistent with the previously announced six-month complete response rate of 68.2% and remains meaningfully above 41.9%. Based on this outcome, Protara determined that a condition in its April 2024 common stock purchase warrants has been satisfied, so those warrants are exercisable at $5.25 per share at any time on or prior to June 29, 2026.

Protara Therapeutics reported fourth quarter and full year 2025 results while highlighting progress across its late-stage pipeline. TARA-002 showed a 68% complete response rate at six months in BCG-unresponsive non-muscle invasive bladder cancer in the ADVANCED-2 trial. The company plans to complete enrollment of this registrational cohort and start the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of 2026.

For rare diseases, TARA-002 in lymphatic malformations received Breakthrough Therapy and Fast Track designations, with a regulatory update expected in the first half of 2026. Interim data from the THRIVE-3 registrational trial of IV Choline Chloride in patients on long-term parenteral support are expected in the second half of 2026. Protara completed an oversubscribed $86 million public offering and ended 2025 with about $198 million in cash, cash equivalents and investments, which it expects will fund operations into 2028. Full-year 2025 net loss was $57.4 million on operating expenses of $64.5 million, driven mainly by research and development spending.

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.

Protara Therapeutics, Inc. reports that underwriters have fully exercised their option to purchase an additional 1,956,521 shares of its common stock at the public offering price of $5.75 per share, following a previously completed sale of 13,043,479 shares. Including this option exercise, the public offering is expected to generate aggregate gross proceeds of approximately $86.3 million before underwriting fees and other expenses.

The company plans to use the net proceeds primarily to fund the clinical development of TARA-002 and other clinical programs, and may also allocate funds to working capital and general corporate purposes. The shares were issued under an effective shelf registration statement on Form S-3 and a related prospectus supplement.

Protara Therapeutics, Inc. entered into an underwriting agreement to sell 13,043,479 shares of its common stock at $5.75 per share, for expected gross proceeds of approximately $75 million. The offering, made under an effective shelf registration on Form S-3, closed on December 8, 2025.

The company granted the underwriters a 30-day option to purchase up to an additional 1,956,521 shares at the public offering price, less underwriting discounts and commissions. Protara plans to use the net proceeds primarily to fund clinical development of its lead candidate TARA-002 and other clinical programs, and may also apply funds to working capital and other general corporate purposes. The company and its officers and directors agreed to 60-day lock-up provisions that temporarily restrict additional share sales.

Protara Therapeutics reported updated interim Phase 2 data for TARA-002 in patients with carcinoma in situ non-muscle invasive bladder cancer who had not received BCG. Among 29 evaluable BCG-Naïve patients as of November 7, 2025, the complete response rate was 72% at any time, 69% at six months (18/26), and 50% at 12 months (7/14). Initial responders showed durable outcomes, with 88% maintaining response through six months and all three patients evaluated at 12 months remaining in response. Re-induction converted most initial non-responders, and all re-induced responders maintained responses at 12 months. Safety appeared manageable, with most treatment-related side effects mild and no Grade 3 or higher events or discontinuations. The FDA has provided written feedback supporting a registrational controlled trial design in BCG-Naïve patients using intravesical chemotherapy as the comparator and a six-month complete response rate as the primary endpoint.

Protara Therapeutics reported interim clinical results from its ongoing Phase 2 STARBORN-1 trial of TARA-002, an investigational cell-based therapy for pediatric patients with lymphatic malformations (LMs). The analysis covers 12 enrolled patients who received more than one dose as of the November 12, 2025 cutoff. Eight patients were evaluable at eight weeks and seven of these eight achieved clinical success, meaning at least a 60% reduction in LM volume by imaging or investigator assessment. Overall, 8 of 10 patients who completed treatment and all 8 patients who completed the eight-week response assessment achieved clinical success.

Among macrocystic patients, 5 of 6 achieved a complete response and the remaining patient had a substantial response; the only mixed-cystic patient achieved a complete response. Two patients reached a 32-week post-treatment assessment and remained disease-free, while one initial complete response was later reclassified as a ranula. Most adverse events were mild to moderate, with no serious events reported; the most common were swelling and fatigue, and one patient discontinued due to Grade 2 fatigue. Protara also posted an investor presentation and press release, and held a conference call and webcast to discuss the data.

Protara Therapeutics, Inc. furnished its financial results for the quarter ended September 30, 2025 via a press release attached as Exhibit 99.1.

The disclosure was provided under Item 2.02 and is designated as furnished, not filed, under the Exchange Act. The company’s common stock trades on The Nasdaq Global Market under the symbol TARA.

On August 11, 2025, Protara Therapeutics, Inc. announced that it released its financial results for the quarter ended June 30, 2025 via a press release attached as Exhibit 99.1 to this Form 8-K. The filing explicitly states the press release and related information are being furnished and shall not be deemed filed under the Exchange Act or incorporated by reference into other filings unless expressly stated. The 8-K lists Exhibits 99.1 and 104 and is signed by Chief Financial Officer Patrick Fabbio. No financial figures or operating metrics appear in the 8-K text; readers must consult Exhibit 99.1 for the detailed results.