AI Earnings Predictions for Protara Therapeutics Inc. (TARA)

EX-99.1

2 ea029923601ex99-1.htm

PRESS RELEASE DATED AUGUST 11, 2026, ISSUED BY THE REGISTRANT

Exhibit 99.1

Protara Therapeutics Announces Second Quarter 2026 Financial Results and Provides a Business Update

Expect to complete enrollment of the BCG-Unresponsive

registrational cohort of the ADVANCED-2 trial in 4Q 2026

The ADVANCED-3 trial is being redesigned as

an exploratory trial to expand into and accelerate data in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary (Ta/T1) patients across BCG exposures

Expect to provide an update and complete enrollment of the STARBORN-1 trial in LMs in 4Q 2026; expect to submit a Biologics License Application for TARA-002 in LMs in 2H 2027

On track to report interim results from THRIVE-3

registrational trial of IV Choline Chloride in patients dependent on long-term parenteral support in 4Q 2026

Cash, cash equivalents and investments of approximately $162 million as of June 30, 2026, expected to support planned operations into 2028

NEW YORK,

August 11, 2026 -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the second quarter ended June 30, 2026 and provided a business update.

“In the second quarter, we strengthened our late-stage pipeline through continued clinical and operational execution, positioning us for multiple important clinical and regulatory milestones over the coming quarters,” said Jesse Shefferman, Chief Executive Officer at Protara Therapeutics. “We continue to make progress in the ADVANCED-2 trial and expect to complete enrollment in the fourth quarter of 2026. We remain confident that TARA-002 will be a preferred treatment option in the non-muscle invasive bladder cancer (NMIBC) BCG-Unresponsive setting and we are redesigning ADVANCED-3 to be a multi-cohort, open-label, exploratory trial, which will allow us to study TARA-002 in a broader high-grade, high-risk NMIBC patient population. The redesigned ADVANCED-3 protocol is expected to accelerate and expand the breadth of data available at or around the time of the potential launch of TARA-002 in BCG-Unresponsive carcinoma in situ (CIS) patients.”

Mr. Shefferman added, “We also advanced our rare disease programs during the quarter. We recently presented encouraging interim durability and safety data from the STARBORN-1 pivotal trial of TARA-002 in Lymphatic Malformations (LMs) and, following discussions with the FDA, expect to submit our Biologics License Application (BLA) in the second half of 2027. At the same time, enrollment in the THRIVE-3 registrational trial evaluating IV Choline Chloride continues as planned, with interim results expected in the fourth quarter of this year. As we continue to execute across our portfolio, we believe we are well positioned to deliver a series of important clinical, regulatory and operational catalysts that have the potential to create meaningful value for patients and shareholders.”

Recent Progress and Highlights

TARA-002

in NMIBC

●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.

TARA-002

in LMs

●Protara presented updated interim safety and durability data from the ongoing Phase 2 STARBORN-1 trial evaluating TARA-002 in pediatric patients with macrocystic and mixed cystic LMs in a poster session at the International Society for the Study of Vascular Anomalies World Congress in Philadelphia, Pennsylvania. As of an April 10, 2026 data cutoff:

○TARA-002 demonstrated clinical success in 83% (10/12) of participants that completed treatment and in 100% (10/10) of evaluable patients. All seven participants that reached the 32-week post-treatment assessment remained disease free as of the data cutoff.

○The majority of AEs were mild to moderate, with no serious AEs reported. The most common AEs were swelling and fatigue, and most were transient and resolved within a few days.

●Based on engagement with the FDA under Breakthrough Therapy designation, the Company intends to submit a BLA for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027 and will continue to submit safety and efficacy data from the trial on an ongoing basis to support the FDA’s evaluation of the risks and benefits of TARA-002 in LMs.

IV Choline Chloride for Patients on Parenteral Support (PS)

●THRIVE-3,

the Company’s registrational Phase 3 clini

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 10, 2026

Protara Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-36694

20-4580525

(State or other jurisdiction

of incorporation)

(Commission File No.)

(IRS Employer

Identification No.)

345 Park Avenue South

Third Floor

New York, NY

10010

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (646) 844-0337

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

TARA

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On March 10, 2026, Protara Therapeutics, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2025 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing regardless of any general incorporation language.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release dated March 10, 2026, issued by the Registrant.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

1

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.

PROTARA THERAPEUTICS, INC.

Date: March 10, 2026 By: /s/ Patrick Fabbio

Patrick Fabbio

Chief Financial Officer

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