Form 8-K

8-K — Protara Therapeutics, Inc.

Accession: 0001213900-26-087506

Filed: 2026-08-11

Period: 2026-08-11

CIK: 0001359931

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0299236-8k_protara.htm (Primary)

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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):

August 11, 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 August 11, 2026, Protara

Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2026 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 August 11, 2026, issued by the Registrant.

104

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

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: August 11, 2026

By:

/s/ Patrick Fabbio

Patrick Fabbio

Chief Financial Officer

EX-99.1 — PRESS RELEASE DATED AUGUST 11, 2026, ISSUED BY THE REGISTRANT

EX-99.1

Filename: ea029923601ex99-1.htm · Sequence: 2

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 clinical trial, is ongoing, and the Company expects to report interim results in the fourth

quarter of 2026.

Second Quarter 2026 Financial Results

● As

of June 30, 2026, unrestricted cash and cash equivalents and marketable debt securities totaled $161.9 million.

The Company expects its cash and cash equivalents and marketable debt securities will be sufficient to fund its planned operations and

milestones into 2028.

● Research and development

expenses for the second quarter of 2026 increased to $17.0 million from $10.8 million for the prior year period. This increase was primarily

due to higher direct costs associated with ongoing clinical trials of $3.2 million, increased personnel-related expenses of $1.8 million

and increased non-program specific research and development expenses, primarily attributable to chemistry, manufacturing and controls

of $1.2 million.

● General and administrative

expenses for the second quarter of 2026 increased to $6.4 million from $5.8 million for the prior-year period. The increase was primarily

due to an increase in personnel-related expenses of $0.7 million, offset by a decrease in other general and administrative expenses of

$0.1 million.

● For the second quarter

of 2026, Protara incurred a net loss of $21.7 million, or $0.36 per share, compared with a net loss of $15.0 million, or $0.35 per share,

for the prior-year period.

About

TARA-002

TARA-002 is an investigational

cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Orphan Drug,

Breakthrough Therapy and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator

derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune

pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst

or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha,

interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing

immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed

from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as

Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd.

About

Non-Muscle Invasive Bladder Cancer

Bladder

cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately

80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines

the inner surface of the bladder that has not spread into the bladder muscle. Patients suffering from high-grade, high-risk NMIBC face

high rates of disease recurrence and are potentially subject to full removal of the bladder (cystectomy).

About

Lymphatic Malformations

Lymphatic

Malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or

drain into the venous system. Protara’s focus is on macrocystic and mixed cystic LMs, for which there are no currently approved

therapies. More than 50% of LMs are detected at birth and 90% diagnosed before the age of three years. The most common morbidities and

serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation

and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels and lymphatics;

recurrent infection; and cosmetic and other functional disabilities. TARA-002 has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough

Therapy and Fast Track designations by the FDA for the treatment of LMs.

About

IV Choline Chloride for Patients on Parenteral Support

IV Choline

Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral

support (PS). Choline is an important substrate for phospholipids that are critical for healthy liver function and play an important role

in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function and bone health. There

are currently no available PS formulations containing choline. IV Choline Chloride has the potential to become the first FDA approved

IV choline formulation for PS patients. It has been granted Orphan Drug designation by the

FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition and has been

granted Fast Track designation as a source of choline when oral or enteral nutrition is not

possible, insufficient or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline

composition and a U.S. patent claiming a method of treating choline deficiency with a choline composition, each with a term expiring in

2041.

About Protara Therapeutics, Inc.

Protara is a clinical-stage biotechnology company

committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead

candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC)

and lymphatic malformations (LMs). The Company is evaluating TARA-002 in ongoing clinical trials in NMIBC patients with carcinoma in situ

(CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a pivotal Phase 2 trial in pediatric

patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for

patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. For more information,

visit www.protaratx.com.

Forward-Looking Statements

Statements contained in this press release regarding

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 the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials

or phases thereof); statements related to expectations regarding interactions with the U.S. Food and Drug Administration (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 Protara’s strategic and commercial plans; Protara’s ability to obtain sufficient financing

to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of

market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign,

economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara’s

business and financial condition in general, including the risks and uncertainties described more fully under the caption “Risk

Factors” and elsewhere in Protara’s filings and reports with the United States Securities and Exchange Commission. All forward-looking

statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions

and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt

of new information, the occurrence of future events or otherwise, except as required by law.

PROTARA THERAPEUTICS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share data)

As of

June 30,

2026

December 31,

2025

Assets

Current assets:

Cash and cash equivalents

$ 17,076

$ 49,657

Marketable debt securities

125,418

105,897

Prepaid expenses and other current assets

3,658

3,950

Total current assets

146,152

159,504

Restricted cash, non-current

745

Marketable debt securities, non-current

19,356

42,336

Property and equipment, net

1,318

759

Operating lease right-of-use asset

2,602

3,174

Other assets

5,920

2,950

Total assets

$ 176,093

$ 209,468

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 4,663

$ 3,468

Accrued expenses and other current liabilities

7,370

6,229

Operating lease liability

1,286

1,242

Total current liabilities

13,319

10,939

Operating lease liability, non-current

1,463

2,117

Total liabilities

14,782

13,056

Commitments and contingencies

Stockholders’ Equity:

Preferred stock, $0.001 par value, authorized 10,000,000 shares:

Series 1 Convertible Preferred Stock, 8,028 shares authorized at June 30, 2026 and December 31, 2025, 872 and 5,615 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Common stock, $0.001 par value, 200,000,000 and 100,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively:

Common stock, 59,083,935 and 53,587,260 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

503,484

498,687

Accumulated deficit

(341,869 )

(302,419 )

Accumulated other comprehensive income (loss)

(363 )

Total stockholders’ equity

161,311

196,412

Total liabilities and stockholders’ equity

$ 176,093

$ 209,468

PROTARA THERAPEUTICS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

and Comprehensive Loss (Unaudited)

(in thousands, except share and per share data)

For the Three Months Ended

June 30,

For the Six Months Ended

June 30,

2026

2025

2026

2025

Operating expenses:

Research and development

$ 16,955

$ 10,770

$ 30,517

$ 19,918

General and administrative

6,369

5,816

12,436

10,792

Total operating expenses

23,324

16,586

42,953

30,710

Income (Loss) from operations

(23,324 )

(16,586 )

(42,953 )

(30,710 )

Other income (expense), net:

Interest and investment income (expense)

1,656

1,626

3,503

3,355

Other income (expense)

481

Other income (expense), net

1,656

1,626

3,503

3,836

Net income (loss)

$ (21,668 )

$ (14,960 )

$ (39,450 )

$ (26,874 )

Other comprehensive income (loss):

Net unrealized gain (loss) on marketable debt securities

(12 )

(453 )

Other comprehensive income (loss)

(12 )

(453 )

Comprehensive income (loss)

$ (21,667 )

$ (14,972 )

$ (39,903 )

$ (26,799 )

Net income (loss) per share attributable to common stockholders, basic and diluted

$ (0.36 )

$ (0.35 )

$ (0.67 )

$ (0.65 )

Weighted-average shares outstanding, basic and diluted

61,006,766

42,270,855

59,282,380

41,493,714

Company Contact:

Justine O’Malley

Protara Therapeutics

Justine.OMalley@protaratx.com

646-817-2836

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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