Forte Biosciences Q1 loss widens as FB102 advances

Forte Biosciences reported a larger first quarter 2026 net loss while advancing its lead drug candidate FB102.

Rhea-AI Filing Summary

Forte Biosciences reported a larger first quarter 2026 net loss while advancing its lead drug candidate FB102. The company posted a net loss of $22.1 million, or $(1.24) per share, compared with a $15.7 million loss a year earlier, driven mainly by higher research and development spending.

Research and development expenses rose to $20.5 million, largely from FB102 Phase 2 celiac disease and Phase 1b vitiligo and alopecia areata trials, while general and administrative costs declined to $2.0 million helped by a $2.3 million interim legal settlement payment from an insurance carrier.

The FDA granted FB102 Fast Track Designation in celiac disease, and Forte highlighted upcoming topline data for Phase 1b vitiligo and Phase 2 celiac disease studies. The company held $58.2 million in cash and cash equivalents at March 31, 2026 and subsequently raised $172.5 million in gross proceeds in an April equity offering, issuing 6.6 million additional common shares.

Insights

Biotech equity analyst

FB102 advances with Fast Track status, but losses deepen on higher R&D.

Forte Biosciences is clearly prioritizing FB102, with Fast Track Designation in celiac disease and multiple active trials. R&D reached $20.5 million in Q1 2026, reflecting Phase 2 celiac and Phase 1b dermatology programs running in parallel.

The net loss widened to $22.1 million, yet general and administrative expense declined to $2.0 million, helped by a $2.3 million interim legal settlement payment from an insurance carrier. Cash fell to $58.2 million at March 31, 2026, but an April equity offering brought in $172.5 million in gross proceeds.

Future results will hinge on topline Phase 1b vitiligo data expected shortly and Phase 2 celiac disease readout in 2026, alongside how the expanded cash balance supports continued FB102 development and operating losses.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Net loss: $22.1M Net loss per share: $(1.24) R&D expenses: $20.5M +5 more

8 metrics

Net loss $22.1M Net loss for three months ended March 31, 2026

Net loss per share $(1.24) Basic and diluted, quarter ended March 31, 2026

R&D expenses $20.5M Research and development, Q1 2026

G&A expenses $2.0M General and administrative, Q1 2026

Cash and cash equivalents $58.2M Cash position as of March 31, 2026

Equity offering proceeds $172.5M Gross proceeds raised in April 2026 offering

Shares outstanding 13.9M shares Common stock outstanding as of March 31, 2026

Prefunded warrants 4.0M warrants Prefunded warrants outstanding as of March 31, 2026

Key Terms

Fast Track Designation, Phase 2 clinical trial, Phase 1b clinical trials, pre-funded warrants, +2 more

6 terms

Fast Track Designation regulatory

"FB102 received Fast Track Designation in celiac disease"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

Phase 2 clinical trial medical

"Phase 2 clinical trial for celiac disease"

A phase 2 clinical trial is a research study that tests a new medical treatment or drug to see if it is effective and safe for a specific condition. It involves a larger group of people than earlier trials and helps determine whether the treatment should move forward to more extensive testing. For investors, successful phase 2 results can signal potential for future approval and commercial success, while setbacks may indicate challenges ahead.

Phase 1b clinical trials medical

"Phase 1b clinical trials for vitiligo and alopecia areata"

Phase 1b clinical trials are early-stage human studies that test a new drug or therapy in a small group of patients with the target condition to refine safe dosing and look for initial signs it might work. Think of it as a short, careful test-drive of a prototype on real roads: successful results reduce technical and regulatory risk, increase the chance of larger trials, and can materially affect investor valuations and timelines.

pre-funded warrants financial

"4.0 million prefunded warrants outstanding as of March 31, 2026"

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

forward-looking statements regulatory

"statements included in this press release that are not a description of historical facts are forward-looking statements"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Private Securities Litigation Reform Act of 1995 regulatory

"This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995"

Earnings Snapshot

Net loss: $22.1M

Q1 2026

Net loss $22.1M

Net loss per share (basic and diluted) $(1.24)

Research and development expenses $20.5M

General and administrative expenses $2.0M

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Forte Biosciences (FBRX) Q1 2026 financial results?

Forte Biosciences reported a Q1 2026 net loss of $22.1 million, or $(1.24) per share. Operating expenses totaled $22.4 million, mainly from $20.5 million in research and development as FB102 clinical programs expanded.

How did Forte Biosciences (FBRX) research and development spending change in Q1 2026?

Research and development expenses rose to $20.5 million in Q1 2026 from $12.7 million a year earlier. The increase was driven by higher clinical costs for FB102 Phase 2 celiac disease and Phase 1b vitiligo and alopecia areata trials, plus higher preclinical and personnel expenses.

What cash position did Forte Biosciences (FBRX) report at March 31, 2026?

Forte Biosciences ended Q1 2026 with $58.2 million in cash and cash equivalents. The company later strengthened its balance sheet further by raising $172.5 million in gross proceeds through an equity offering in April 2026.

Did FB102 receive any new regulatory designations mentioned in the Q1 2026 update?

Yes. FB102 received Fast Track Designation from the FDA for celiac disease. This designation is intended to facilitate development of drugs that address serious conditions and unmet medical needs, and it was highlighted as an important milestone for the FB102 program.

What upcoming clinical milestones for FB102 did Forte Biosciences highlight?

Forte Biosciences expects topline results from the Phase 2 celiac disease study in 2026 and noted Phase 1b vitiligo topline data is expected shortly. A Phase 1b alopecia areata data readout is also anticipated in 2026, supporting broader FB102 development.

How did general and administrative expenses change for Forte Biosciences in Q1 2026?

General and administrative expenses decreased to $2.0 million in Q1 2026 from $3.4 million in Q1 2025. The decline mainly reflected a $2.3 million interim legal settlement payment from an insurance carrier, partly offset by higher non-cash stock-based compensation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 05/14/2026 - 04:42 PM EDT Learn about SEC filing dates

false 0001419041 0001419041 2026-05-11 2026-05-11

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

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
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			(7	)			(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

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 47.1 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB