Form 8-K

8-K — Forte Biosciences, Inc.

Accession: 0001193125-26-224214

Filed: 2026-05-14

Period: 2026-05-11

CIK: 0001419041

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

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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 11, 2026

FORTE BIOSCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-38052

26-1243872

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

3060 Pegasus Park Dr.

Building 6

Dallas, Texas

75247

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (310) 618-6994

Not Applicable

(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 (see General Instruction A.2. below):

☐

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, $0.001 par value

FBRX

The NASDAQ Stock Market LLC

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 11, 2026, Forte Biosciences, Inc. issued a press release reporting its financial results for the quarter ended March 31, 2026. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished in this Current Report under Item 2.02 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or 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 a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Description

99.1

Press Release dated May 11, 2026

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.

FORTE BIOSCIENCES, INC.

Date: May 14, 2026

By:

/s/ Antony Riley

Antony Riley

Chief Financial Officer

EX-99.1

Filename: d95486dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

FORTE BIOSCIENCES, INC. ANNOUNCES FIRST QUARTER 2026 RESULTS AND PROVIDES UPDATE

FB102 Received Fast Track Designation in Celiac Disease

DALLAS, TX – MAY 11, 2026 – Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company

focused on autoimmune and autoimmune-related diseases, today announced its first quarter 2026 financial results and provided a business update.

“FB102 received Fast Track Designation from the FDA in celiac disease, highlighting the unmet need and reinforcing FB102’s potential to address

the high unmet need in celiac disease. The clinical development for FB102 continues to progress well with important readouts coming shortly,” said Forte Biosciences CEO Paul Wagner, PhD. “The topline results from our phase 2 celiac

disease study are expected in 2026. Based on the strength of the positive results from the FB102 phase 1b CeD trial, which we reported in June 2025, we look forward to the phase 2 data further validating FB102 for the treatment of celiac disease.

The FB102 phase 1b vitiligo clinical study is expected to have topline results shortly and the alopecia areata phase 1b data readout is expected in 2026. We remain very optimistic about FB102’s potential to address the significant unmet

medical needs across multiple indications representing what we believe to be multi-billion-dollar potential market opportunities.”

Q1 2026 Operating Results

Research and

development expenses were $20.5 million for the three months ended March 31, 2026, compared to $12.7 million for the same period in 2025. The increase was primarily due to an increase of $6.7 million in clinical expenses related

to FB102 for our Phase 2 clinical trial for celiac disease and Phase 1b clinical trials for vitiligo and alopecia areata, an increase of $2.0 million in preclinical expenses, and an increase of $1.4 million in personnel-related expenses

due to an increase in headcount, partially offset by a decrease of $2.3 million in manufacturing expenses.

Our research and development expenses may

increase as we continue to advance FB102 through a celiac Phase 2 trial including a U.S. arm, multiple Phase 1b clinical trials and if we pursue additional autoimmune indications.

General and administrative expenses were $2.0 million for the three months ended March 31, 2026 compared to $3.4 million for the same period in

2025. The decrease was primarily due to the interim legal settlement payment, under a reservation of rights from an insurance carrier of $2.3 million, partially offset by an increase of $0.9 million in

non-cash stock-based compensation.

Our general and administrative expenses may fluctuate in the future due to

fluctuations in professional and advisory fees as we build out our infrastructure to advance FB102 through a Phase 2 trial, multiple Phase 1b clinical trials and if we pursue additional autoimmune indications.

Net losses per share were $(1.24) and $(1.37) for the quarters ended March 31, 2026 and 2025,

respectively.

Forte ended the first quarter of 2026 with $58.2 million in cash and cash equivalents. There are 13.9 million shares of common

stock and 4.0 million prefunded warrants outstanding as of March 31, 2026. In April 2026, Forte raised $172.5 million in gross proceeds through an offering and issued 6.6 million additional shares of common stock.

FORTE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value data)

March 31, 2026

December 31, 2025

(unaudited)

Assets

Current assets:

Cash and cash equivalents

58,223

76,957

Prepaid expenses and other current assets

6,887

3,632

Total current assets

65,110

80,589

Property and equipment, net

110

129

Other assets

2,003

2,061

Total assets

67,223

82,779

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

13,084

9,989

Accrued liabilities

10,563

10,762

Total current liabilities

23,647

20,751

Other liabilities

1,476

1,037

Total liabilities

25,123

21,788

Commitments and contingencies (Note 6)

Stockholders’ equity:

Common stock, $0.001 par value: 200,000,000 shares authorized as of March 31, 2026 (unaudited) and

December 31, 2025; 13,910,668 and 12,948,308 shares issued and outstanding as of March 31, 2026 (unaudited) and December 31, 2025, respectively

Additional paid-in capital

287,599

284,348

Accumulated other comprehensive (loss) income

)

Accumulated deficit

(245,509

)

(223,373

)

Total stockholders’ equity

42,100

60,991

Total liabilities and stockholders’ equity

67,223

82,779

FORTE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHE SIVE LOSS

(unaudited)

(in

thousands, except share and per share amounts)

For the Three Months Ended

March 31,

2026

2025

Operating expenses:

Research and development

20,320

12,542

Research and development - related party

150

General and administrative

1,969

3,432

Total operating expenses

22,439

16,124

Loss from operations

(22,439

)

(16,124

)

Other income, net

676

468

Net loss before taxes

(21,763

)

(15,656

)

Income tax expense

(373

)

—

Net loss

(22,136

)

(15,656

)

Per share information:

Net loss per share - basic and diluted

(1.24

)

(1.37

)

Weighted average shares and pre-funded warrants outstanding, basic and diluted

17,837,406

11,398,971

Comprehensive loss:

Net loss

(22,136

)

(15,656

)

Unrealized loss on available-for-sale securities, net

)

(11

)

Comprehensive loss

(22,143

)

(15,667

)

Additional details on Forte’s first quarter 2026 financial results can be found in Forte’s Form 10-Q as filed with the SEC on May 11, 2026. You can also find more information in the investor relations section of Forte’s website at www.fortebiorx.com.

About Forte

Forte Biosciences, Inc. is a clinical-stage

biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications.

Forward-Looking Statements

Forte cautions you that

statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,”

“should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,”

“estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations.

Forward-looking statements include statements regarding the Company’s beliefs, goals, intentions and expectations regarding its product candidate, FB102 and the therapeutic and commercial market potential of FB102, expectations for patient

enrollment and timing of clinical data readouts. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without

limitation: risks related to

Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidate, FB102; uncertainties associated with the clinical development and regulatory

approval of Forte’s product candidate, FB102, including potential delays in the commencement, enrollment and completion of clinical trials, including the timing of the completion of the Company’s patient-based trials; the risk that

results from preclinical and any interim result of our ongoing clinical trials may not be predictive of future results from clinical trials; risks associated with the failure to realize any value from FB102 in light of inherent risks, expense and

difficulties involved in successfully bringing product candidates to market; and additional risks, uncertainties, and other information affecting Forte’s business and operating results is contained in Forte’s Annual Report on Forms 10-K filed on March 31, 2026, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as

required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking

statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

LifeSci Advisors

Forte Biosciences, Inc.

Mike Moyer, Managing Director

Paul Wagner, CEO

mmoyer@lifesciadvisors.com

investors@fortebiorx.com

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