FBRX

EX-99.1

2 d95486dex991.htm

EX-99.1

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

14

13

Additional paid-in capital

287,599

284,348

Accumulated other comprehensive (loss) income

(4 )

3

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

150

Ge

EX-99.1

2 d63145dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

FORTE BIOSCIENCES, INC. ANNOUNCES 2025 RESULTS AND PROVIDES UPDATE

DALLAS, TX – MARCH 31, 2026 – Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its full year 2025 financial results and provided a business update.

“The clinical development for FB102 continues to progress well with important readouts in 2026.” said Forte Biosciences CEO Paul Wagner, PhD. “The topline results from our phase 2 celiac disease study is 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 in 1H 2026 and the alopecia areata phase 1b data readout is expected in 2026. This will be a very eventful year and further highlight FB102’s potential to address the significant unmet medical needs across multiple indications representing multi-billion dollar potential market opportunities.”

2025 Operating Results

Research and development expenses were $58.2 million for the year ended December 31, 2025, compared to $21.2 million during the same period in 2024. The increase was primarily due to an increase of $36 million in manufacturing and 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 $0.4 million in discovery work, and an increase of $1.9 million in personnel-related expenses due to an increase in headcount, partially offset by a decrease of $1.5 million in preclinical expenses as a result of toxicology work performed in 2024.

Our research and development expenses may increase as we continue to advance FB102 through a celiac Phase 2 trial including a U.S. arm as a result of the FDA approving our IND, multiple Phase 1b clinical trials and if we pursue additional autoimmune indications.

General and administrative expenses were $12.4 million for the year ended December 31, 2025 compared to $15.4 million for the same period in 2024. The decrease was primarily due to decreases in professional and legal advisory fees, including litigation and settlement expenses, of $6.1 million, partially offset by an increase of $3.0 million in personnel-related expenses, including additional non-cash stock-based compensation of $2.5 million.

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 $(4.71) and $(12.17) for the year ended December 31, 2025 and 2024, respectively.

Forte ended the fourth quarter of 2025 with $77.0 million in cash and cash equivalents. There are 12.9 million shares of common stock and 4.9 million prefunded warrants outstanding as of December 31, 2025.

Forte Biosciences, Inc.

Consolidated Balance Sheets

(in thousands, except share and par value data)

December 31, 2025

December 31, 2024

Assets

Current assets:

Cash and cash equivalents

$ 76,957

$ 22,244

Short-term investment

—

36,121

Prepaid expenses and other current assets

3,632

2,981

Total current assets

80,589

61,346

Property and equipment, net

129

77

Other assets

2,061

138

Total assets

$ 82,779

$ 61,561

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 9,989

$ 4,879

Accrued liabilities

10,762

4,202

Total current liabilities

20,751

9,081

Income tax payable

1,037

—

Total liabilities

21,788

9,081

Commitments and contingencies (Note 6)

Stockholders’ equity:

Common stock, $0.001 par value: 200,000,000 share, authorized as of December 31, 2025 and December 31, 2024; 12,948,308 and 6,393 ,323 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively

13

6

Additional paid-in capital

284,348

206,461

Accumulated other comprehensive income

3

11

Accumulated deficit

(223,373 )

(153,998 )

Total stockholders’ equity

60,991

52,480

Total liabilities and stockholders’ equity

$ 82,779

$ 61,561

Forte Biosciences, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

Year Ended December 31,

2025

2024

Operating expenses:

Research and development

$ 57,647

$ 20,714

Research and development - related party

600

479

General and administrative

12,410

15,409

Total operating expenses

70,657

36,602

Loss from operations

(70,657 )

(36,602 )

Interest income

2,715

1,314

Other expense, net

(396 )

(190 )

Total other income, net

2,319

1,124

Net loss before taxes

(68,338 )

(35,478 )

Income tax expense

1

8-K

false 0001419041 0001419041 2025-11-14 2025-11-14

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): November 14, 2025

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 November 14, 2025, Forte Biosciences, Inc. issued a press release reporting its financial results for the quarter ended September 30, 2025. 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 November 14, 2025.

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: November 14, 2025

By:

/s/ Antony Riley

Antony Riley Chief Financial Officer