Form 8-K

8-K — Protara Therapeutics, Inc.

Accession: 0001213900-26-055462

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001359931

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0288581-8k_protara.htm (Primary)

EX-99.1 — PRESS RELEASE DATED MAY 13, 2026, ISSUED BY THE REGISTRANT (ea028858101ex99-1.htm)

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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):

May 13, 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 May 13, 2026, Protara Therapeutics,

Inc. (the “Company”) announced its financial results for the quarter ended March 31, 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 May 13, 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: May 13, 2026

By:

/s/ Patrick Fabbio

Patrick Fabbio

Chief Financial Officer

EX-99.1 — PRESS RELEASE DATED MAY 13, 2026, ISSUED BY THE REGISTRANT

EX-99.1

Filename: ea028858101ex99-1.htm · Sequence: 2

Exhibit 99.1

Protara

Therapeutics Announces First Quarter 2026 Financial Results and Provides a Business Update

The Company intends to submit a Biologics License

Application (BLA) for TARA-002 in Lymphatic Malformations (LMs) in 2H 2027

Hosting virtual investor webinar discussing

LMs program with key opinion leader (KOL) perspectives on May 19, 2026 at 4:30 pm ET

Interim safety and durability data from STARBORN-1

trial of TARA-002 in LMs to be presented at the

International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026

in May

Company expects to complete enrollment of the

BCG-Unresponsive registrational cohort of the ADVANCED-2 trial

and initiate the ADVANCED-3 registrational trial in BCG-Naïve patients

in 2H 2026

Presenting updated 12-month data from Phase

2 ADVANCED-2 trial of TARA-002 in patients with high-grade,

BCG-Naïve non-muscle invasive bladder cancer (NMIBC) at the American

Urological Association (AUA) Annual Meeting 2026 in May

Cash,

cash equivalents and investments of approximately $177 million as of March 31, 2026, expected to support planned operations into 2028

NEW YORK,

May 13, 2026 -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology

company developing transformative therapies for the treatment of cancer and rare diseases, today provided a business update and announced

financial results for the first quarter ended March 31, 2026.

“We’re

pleased with the productive discussions we’ve had with the FDA around TARA-002 in LMs,” said Jesse Shefferman, Chief Executive

Officer of Protara Therapeutics. “We intend 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. Later this month, we look forward to presenting updated safety and durability data from the STARBORN-1 trial

at the ISSVA World Congress and hosting an investor webinar with KOL perspectives.”

Mr. Shefferman

added, “In non-muscle invasive bladder cancer (NMIBC), we continue to establish TARA-002’s potential as a differentiated treatment

through a robust clinical data set demonstrating excellent safety, promising efficacy and encouraging durability, as well as a convenient

and tolerable method of administration, in both Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naive patients. Looking ahead,

we remain focused on completing enrollment in the BCG-Unresponsive registrational cohort in the ADVANCED-2 trial and initiating the ADVANCED-3

registrational trial in BCG-Naïve patients, both in the second half of the year. Additionally, our THRIVE-3 program for IV Choline

Chloride remains on track, and we expect to announce interim results in the second half of 2026.”

Recent

Progress and Highlights

TARA-002

in LMs

● Under Breakthrough Therapy designation, Protara

is engaged in an ongoing dialogue with the FDA and has received confirmation that the review of TARA-002 has been moved from the Office

of Vaccines Research and Review to the Office of Therapeutic Products, which has significant experience in pediatric rare disease and

is the review division for TARA-002 in NMIBC.

● Based on engagement with the FDA, 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.

● Protara plans to host a virtual investor webinar

discussing TARA-002 in LMs at 4:30 pm ET on May 19, 2026. The event will provide an overview of TARA-002 in LMs, KOL perspectives on the

unmet need and TARA-002’s potential role in the treatment paradigm. The live event and accompanying slides can be accessed visiting

the Events and Presentations section of the Company’s website https://ir.protaratx.com. A replay of the webcast will be archived

for a limited time following the event.

● The Company will present updated interim safety

and durability data from the ongoing Phase 2 STARBORN-1 trial evaluating TARA-002 in macrocystic and mixed cystic LMs in a poster session

at the ISSVA World Congress on May 20, 2026 in Philadelphia, Pennsylvania.

TARA-002

in NMIBC

● The Company expects

to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in the second half of 2026.

● The Company will present updated 12-month landmark

results for TARA-002 in BCG-Naïve NMIBC patients in Cohort A of the ADVANCED-2 trial during a poster presentation at the American

Urological Association (AUA) Annual Meeting on May 15, 2026 in Washington, D.C.

● The Company is planning

a proposed registrational trial in BCG-Naïve and potentially BCG-Exposed patients. Protara continues to engage with the FDA on aspects

of the analysis plan and intends to initiate the ADVANCED-3 trial in the second half of 2026.

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 second half of 2026.

First Quarter 2026 Financial Results

● As of March 31, 2026,

unrestricted cash and cash equivalents and marketable debt securities totaled $177.4 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 first quarter of 2026 increased to $13.6 million from $9.1 million for the prior year period. This increase was primarily

due to a $2.2 million increase in direct expenses for our product candidates and a $2.2 million increase in indirect expenses not directly

attributable to one specific product candidate. The increase in direct expenses was primarily due to higher ongoing costs associated with

the ADVANCED-2 trial for NMIBC as well as start-up costs related to the ADVANCED-3 trial for NMIBC.

● General and administrative

expenses for the first quarter of 2026 increased to $6.1 million from $5.0 million for the prior year period. The increase was primarily

due to personnel-related expenses, including stock-based compensation.

● For the first quarter

of 2026, Protara incurred a net loss of $17.8 million, or $0.31 per share, compared with a net loss of $11.9 million, or $0.29 per share,

for the same period in 2025. Net loss for the first quarter of 2026 included approximately $1.4 million in stock-based compensation expenses.

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. 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.

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. They are most frequently present in the

head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% 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 a known 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.

PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing

choline. Approximately 78% of patients dependent on PS are choline-deficient and of those approximately 63% have some degree of liver

dysfunction, which can lead to hepatic failure. Every year in the U.S. there are approximately 90,000 people who require PS

at home and of those approximately 30,000 are on long-term PS. 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 an ongoing Phase 2 trial 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

March 31,

2026

December 31,

2025

Assets

Current assets:

Cash and cash equivalents

$ 14,737

$ 49,657

Marketable debt securities

121,049

105,897

Prepaid expenses and other current assets

4,211

3,950

Total current assets

139,997

159,504

Restricted cash, non-current

745

Marketable debt securities, non-current

41,641

42,336

Property and equipment, net

669

759

Operating lease right-of-use asset

2,891

3,174

Other assets

5,980

2,950

Total assets

$ 191,923

$ 209,468

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 4,031

$ 3,468

Accrued expenses and other current liabilities

3,627

6,229

Operating lease liability

1,264

1,242

Total current liabilities

8,922

10,939

Operating lease liability, non-current

1,793

2,117

Total liabilities

10,715

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 March 31, 2026 and December 31, 2025, 4,644 and 5,615 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

Common stock, $0.001 par value, authorized 100,000,000 shares:

Common stock, 55,055,582 and 53,587,260 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital

501,718

498,687

Accumulated deficit

(320,201 )

(302,419 )

Accumulated other comprehensive income (loss)

(364 )

Total stockholders’ equity

181,208

196,412

Total liabilities and stockholders’ equity

$ 191,923

$ 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 March 31,

2026

2025

Operating expenses:

Research and development

$ 13,562

$ 9,148

General and administrative

6,067

4,976

Total operating expenses

19,629

14,124

Income (Loss) from operations

(19,629 )

(14,124 )

Other income (expense), net:

Interest and investment income (expense)

1,847

1,729

Other income (expense)

481

Other income (expense), net

1,847

2,210

Net income (loss)

$ (17,782 )

$ (11,914 )

Other comprehensive income (loss):

Net unrealized gain (loss) on marketable debt securities

(454 )

Other comprehensive income (loss)

(454 )

Comprehensive income (loss)

$ (18,236 )

$ (11,827 )

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

$ (0.31 )

$ (0.29 )

Weighted-average shares outstanding, basic and diluted

57,538,833

40,707,937

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

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- 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

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- 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

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

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

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- 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

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

duration