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Protara Therapeutics, Inc. filings document a Nasdaq-listed, Delaware clinical-stage biotechnology company developing TARA-002 for non-muscle invasive bladder cancer and lymphatic malformations, and IV Choline Chloride for patients receiving parenteral support. Form 8-K disclosures include clinical-data updates, Regulation FD materials, financial results, investor presentations, and business updates related to the company's investigational programs.
The filing record also covers Protara's capital structure and governance, including common stock registered on The Nasdaq Global Market, public offering and underwriting agreements, warrant-related disclosures, and proxy materials for annual stockholder voting. Proxy filings describe board elections, executive compensation matters, equity plans, audit oversight, and other corporate-governance proposals.
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 filed its quarterly report, showing a net loss of $13.3 million for the three months ended September 30, 2025 and $40.1 million for the nine-month period. Operating expenses rose to $14.8 million in the quarter, driven by research and development of $9.6 million and general and administrative of $5.2 million. Interest and investment income was $1.5 million in the quarter.
Liquidity remained solid with unrestricted cash, cash equivalents and marketable debt securities of $133.6 million as of September 30, 2025; management believes resources are sufficient for at least twelve months. Working capital was $125.7 million. Shares outstanding were 38,587,260 as of November 6, 2025.
Program updates: In NMIBC, interim ADVANCED-2 data (April 2025 cutoff) showed complete response rates in BCG‑Unresponsive patients of 100% at six months (5/5) and 67% at 12 months (2/3). An interim read from Cohort B (~25 six‑month evaluable patients) is planned for Q1 2026. IV Choline Chloride advanced toward THRIVE‑3 with EU‑CTR approval in July 2025 and first dosing targeted by year‑end 2025. In LMs, STARBORN‑1 early data included two complete responses; an interim update is expected in Q4 2025.
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.
RA Capital and affiliated individuals report shared beneficial ownership of 1,971,765 shares of Protara Therapeutics common stock, representing a 4.99% stake. The position reflects 1,039,295 directly held shares plus pre-funded warrants exercisable for up to 1,400,144 additional shares, but exercise is restricted by 9.99% and 4.99% beneficial ownership blockers. The 4.99% blocker currently limits exercise so reported beneficial ownership is capped at 1,971,765 shares. RA Capital serves as investment adviser and holds sole voting and dispositive power over the Fund's holdings; the filers disclaim group status and broader beneficial ownership except as required by Section 13(d).
Protara Therapeutics, Inc. is the subject of a Schedule 13G/A disclosing institutional holdings in its common stock. Janus Henderson Group plc reports beneficial ownership of 4,102,620 shares, representing 10.6% of the class, with shared voting and dispositive power over those shares. A related vehicle, Janus Henderson Biotech Innovation Master Fund Ltd, reports beneficial ownership of 3,512,932 shares, or 9.1%. The filing states these securities are held in the ordinary course of business and were not acquired to change or influence control of the issuer. The disclosure includes a power of attorney authorizing certain compliance officers to file required reports.
Protara Therapeutics, Inc. filed a Form S-8 to register an additional 2,800,000 shares of common stock for issuance under its 2024 Equity Incentive Plan, following a board amendment adopted on April 17, 2025 and stockholder approval at the annual meeting on June 11, 2025. The filing incorporates by reference the company’s prior Form S-8 (filed August 6, 2024) and specified SEC reports, including the Annual Report filed March 5, 2025 and Quarterly Reports filed May 8, 2025 and August 11, 2025.
The registration statement discloses corporate governance items such as indemnification provisions and the inclusion of a DGCL 102(b)(7) limitation on director liability in the certificate of incorporation, and indicates the company is a non-accelerated filer and a smaller reporting company.
Protara Therapeutics is a clinical-stage biopharmaceutical company advancing TARA-002 (cell therapy) and IV Choline Chloride (intravenous choline) and has no product revenues. For the six months ended June 30, 2025 the company reported a net loss of $26.9 million versus $20.6 million in the prior year period, driven by higher research and development and general and administrative expenses. Cash and cash equivalents declined to $31.5 million while marketable debt securities increased after purchases, leaving $145.6 million in unrestricted cash and marketable securities and $115.3 million in working capital, which management states is sufficient for at least twelve months.
The company highlighted clinical progress: interim ADVANCED-2 data showed high complete response rates in small cohorts (BCG-Unresponsive 100% any-time CR 5/5; BCG-Naive 76% any-time CR 16/21) with mostly Grade 1 adverse events and no Grade 3+ treatment-related events. IV Choline Chloride received FDA Fast Track and orphan considerations and patents through 2041; Protara plans to initiate the THRIVE-3 registrational trial in Q3 2025 and obtained EU-CTR approval in July 2025. Recent financings include a December 2024 public offering (gross ~$100.1M, net ~$93.4M) and an April 2024 private placement (net ~$41.96M). The company notes it will need additional capital to fully execute its clinical plans.
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.