Protara Therapeutics Files 8-K with Financials

TL;DR

Protara Therapeutics dropped an 8-K with financials and other events on Dec 5th.

AI Summary

On December 5, 2024, Protara Therapeutics, Inc. filed an 8-K report detailing a Regulation FD Disclosure and Other Events. The filing also includes financial statements and exhibits. The company, formerly known as ArTara Therapeutics, Inc. and PROTEON THERAPEUTICS INC, is based in New York, NY.

Why It Matters

This 8-K filing provides crucial updates and financial information for Protara Therapeutics, Inc., which is important for investors and stakeholders to assess the company's current status and future prospects.

Risk Assessment

Risk Level: low — This filing is a routine 8-K report and does not appear to contain any significant negative news or events.

Key Players & Entities

• Protara Therapeutics, Inc. (company) — Registrant
• ArTara Therapeutics, Inc. (company) — Former company name
• PROTEON THERAPEUTICS INC (company) — Former company name
• December 5, 2024 (date) — Date of earliest event reported

FAQ

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share TARA The Nasdaq Capital M

Filing Documents

• ea0223706-8k_protara.htm (8-K) — 35KB
• ea022370601ex99-1_protara.htm (EX-99.1) — 21KB
• ea022370601ex99-2_protara.htm (EX-99.2) — 21KB
• ea022370601ex99-3_protara.htm (EX-99.3) — 8KB
• ex99-1_001.jpg (GRAPHIC) — 362KB
• ex99-1_002.jpg (GRAPHIC) — 842KB
• ex99-1_003.jpg (GRAPHIC) — 440KB
• ex99-1_004.jpg (GRAPHIC) — 424KB
• ex99-1_005.jpg (GRAPHIC) — 535KB
• ex99-1_006.jpg (GRAPHIC) — 529KB
• ex99-1_007.jpg (GRAPHIC) — 552KB
• ex99-1_008.jpg (GRAPHIC) — 653KB
• ex99-1_009.jpg (GRAPHIC) — 508KB
• ex99-1_010.jpg (GRAPHIC) — 325KB
• ex99-1_011.jpg (GRAPHIC) — 251KB
• ex99-1_012.jpg (GRAPHIC) — 525KB
• ex99-1_013.jpg (GRAPHIC) — 520KB
• ex99-2_001.jpg (GRAPHIC) — 2KB
• ex99-3_001.jpg (GRAPHIC) — 851KB
• 0001213900-24-105782.txt ( ) — 10355KB
• tara-20241205.xsd (EX-101.SCH) — 3KB
• tara-20241205_lab.xml (EX-101.LAB) — 33KB
• tara-20241205_pre.xml (EX-101.PRE) — 22KB
• ea0223706-8k_protara_htm.xml (XML) — 4KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 5, 2024, Protara Therapeutics, Inc. (the "Company" or "Protara") posted an investor presentation (the "Investor Presentation") to the "Investors—Events and Presentations" section of the Company's website at www.protaratx.com. The Investor Presentation will be used in connection with a conference call and webcast today, December 5, 2024, at 8:30 am ET, to review the clinical data to be presented during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology in Dallas, Texas (the "2024 SUO Conference") and provides an update on the ongoing Phase 2 ADVANCED-2 trial program. A copy of the Investor Presentation is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. On December 5, 2024, the Company also issued a press release reporting new interim clinical data on the ongoing Phase 2 ADVANCED-2 trial program (the "Press Release"). A copy of the Press Release is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K. The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, 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.

01 Other Events

Item 8.01 Other Events. On December 5, 2024, the Company presented interim results from its ongoing Phase 2 ADVANCED-2 clinical trial of TARA-002 in patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") at a poster session at the 2024 SUO Conference. A copy of the poster, which has been published to the "Investors—Events and Presentations" section of the Company's website, is filed as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated herein by reference. The Company reported data that highlights the potential of TARA-002 in patients with NMIBC in its Phase 2 ADVANCED-2 clinical trial, which is assessing the safety and anti-tumor activity of intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk NMIBC patients with carcinoma in situ ("CIS") ( Ta/T1) who are Bacillus Calmette-Gurin ("BCG")-Unresponsive or BCG-Nave. The dataset includes 20 patients who were evaluable at three months, 18 patients who were evaluable at six months and three patients who were evaluable at nine months with a data cutoff of November 19, 2024. The complete response ("CR") rate across BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time, with 100% (9/9) of patients maintaining a CR from three months to six months. In addition, two of three patients maintained a CR at nine months. In the pivotal cohort of the ADVANCED-2 trial in BCG-Unresponsive patients, the CR rate was 100% (4/4) at six-months and 80% (4/5) at any time. In the proof-of-concept cohort of BCG-Nave patients, the CR rate was 64% (9/14) at six months and 67% (10/15) at any time. To date, TARA-002 has demonstrated a favorable safety and tolerability profile with no Grade 2 or greater treatment-related adverse events, and no patients discontinued treatment due to adverse events. The majority of adverse events were Grade 1 and transient, and the most common adverse events were in line with typical responses to bacterial immunopotentiation, such as flu-like s

Forward-Looking Statements

Forward-Looking Statements 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 reporting initial data from 12-month evaluable patients in mid-2025); statements related to expectations regarding interactions with the 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 Prota

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Exhibit Description 99.1 Investor Presentation, dated December 5, 2024. 99.2 Press Release, dated December 5, 2024. 99.3 Poster Presentation, dated December 5, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). 2

SIGNATURES

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: December 5, 2024 Protara Therapeutics, Inc. By: /s/ Patrick Fabbio Patrick Fabbio Chief Financial Officer 3

View Full Filing

View this 8-K filing on SEC EDGAR