Forte Biosciences, Inc. Announces Results and Provides Clinical Update

Rhea-AI Summary

Forte Biosciences (NASDAQ: FBRX) reported its full year 2024 results and provided a clinical update. The company highlighted significant progress in developing FB102, with the completion of a healthy volunteer study and ongoing celiac patient trial, which is progressing well with no dropouts. Topline results are expected in Q2 2025.

Financial highlights include:

• R&D expenses decreased to $21.2M from $21.9M in 2023
• G&A expenses increased to $15.4M from $10.6M in 2023
• Net loss per share improved to $(12.17) from $(24.92)
• Year-end cash position of $58.4M

The company completed a 1:25 reverse stock split in August 2024 and raised $53.0M through an over-subscribed private placement in November 2024. As of December 31, 2024, there were 6.4M shares of common stock and 5.0M prefunded warrants outstanding.

Positive

• Net loss per share improved significantly from $(24.92) to $(12.17)
• Successfully raised $53M in over-subscribed private placement
• Strong cash position of $58.4M at year-end
• R&D expenses decreased by $0.7M year-over-year
• FB102 celiac trial progressing well with no dropouts

Negative

• G&A expenses increased by $4.8M (45.3%) year-over-year
• Implemented 1:25 reverse stock split, indicating previous share price weakness
• Still operating at a significant net loss

Insights

Biopharmaceutical Analyst

Forte Biosciences has released its 2024 annual results showing a stable financial position alongside important clinical progress. The company ended 2024 with $58.4 million in cash and successfully raised $53 million in an oversubscribed private placement last November, significantly strengthening their runway.

The clinical updates provide cautiously encouraging signals about FB102's development. Their celiac disease trial has reached an important milestone with nearly half of patients completing both dosing and gluten challenge phases, with no dropouts reported and good tolerability profiles so far. However, it's critical to note that efficacy data remains pending until Q2 2025.

Financially, R&D expenses decreased slightly by $0.7 million to $21.2 million, while G&A expenses increased by $4.8 million to $15.4 million. The reduction in manufacturing costs ($7.0 million) was largely offset by increased clinical expenses ($5.5 million) as programs advanced. The company's net loss per share improved to $12.17 from $24.92 in 2023, though this calculation is affected by the 1:25 reverse stock split executed in August 2024.

The company's immediate value will be determined by the upcoming clinical readouts rather than current financials, particularly the celiac disease data expected next quarter and the initiation of the vitiligo program.

Biotech Investment Strategist

Forte's annual results and pipeline update present a balanced picture for a clinical-stage biotech. While their cash position of $58.4 million appears robust following their November fundraising, their annual burn rate remains substantial at approximately $36.6 million (combining R&D and G&A expenses).

The company's focus on two autoimmune indications (celiac disease and vitiligo) with FB102 represents a pragmatic approach to maximizing their lead asset's potential. The interim safety update from the celiac trial is modestly encouraging, with good tolerability and no patient dropouts reported, though these are very preliminary signals.

What's notable in their financial structure is the 46% increase in G&A expenses against a slight R&D reduction. This administrative cost growth warrants monitoring as clinical-stage companies typically prioritize R&D efficiency. The 1:25 reverse split executed in 2024 should also be viewed in context – while often perceived negatively, it has successfully restructured their capital base with 6.4 million shares now outstanding.

For investors, Forte represents a binary bet on the FB102 readout expected in Q2 2025. Without efficacy data, the current tolerability information provides only de-risking. The company's ability to simultaneously advance their vitiligo program while completing the celiac study will be an important operational test in the coming months.

DALLAS--(BUSINESS WIRE)-- Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced full year 2024 results and provides a clinical update.

“2024 was a very productive year with significant progress on the development of FB102, including the completion of the healthy volunteer study and the initiation of celiac patient trial,” said Forte Biosciences CEO Paul Wagner, Ph.D.

“The celiac patient trial is progressing very well. Nearly half of the patients have completed both FB102 dosing and the gluten challenge. FB102 continues to be well-tolerated and there have been no dropouts to date. We are looking forward to reading out the topline results of the trial in the second quarter of 2025. Additionally, we are expecting to dose the first patient in the FB102 vitiligo trial shortly. 2025 is shaping up to be a very eventful year which we believe will further validate the potential for FB102.”

2024 Operating Results

Research and development expenses were $21.2 million for the year ended December 31, 2024, compared to $21.9 million during the same period in 2023. The decrease of $0.7 million was primarily due to a decrease of $7.0 million in manufacturing expenses primarily offset by increases of $5.5 million in preclinical and clinical expenses as our FB102 program entered the clinic, and a net increase in payroll and related expenses of $1.3 million primarily due to an increase in headcount.

General and administrative expenses were $15.4 million for the year ended December 31, 2024 compared to $10.6 million for the same period in 2023. The increase of $4.8 million was primarily due to an increase in professional and legal expenses.

Net losses per share were $(12.17) and $(24.92) for the years ended December 31, 2024 and 2023, respectively.

Forte ended 2024 with $58.4 million in cash, cash equivalents and short-term investments. In August 2024, Forte effected a 1:25 reverse stock split. In November 2024, Forte raised $53.0 million in gross proceeds from an over-subscribed private placement. There are 6.4 million shares of common stock and 5.0 million prefunded warrants outstanding as of December 31, 2024.

Forte Biosciences, Inc. Consolidated Balance Sheets (in thousands, except share and par value data)
		December 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	22,244			$	37,125
Short-term investments			36,121				-
Prepaid expenses and other current assets			2,981				1,202
Total current assets			61,346				38,327
Property and equipment, net			77				109
Other assets			138				544
Total assets		$	61,561			$	38,980
Liabilities and stockholders' equity
Current liabilities:
Accounts payable		$	4,879			$	1,424
Accrued liabilities			4,202				2,242
Total current liabilities			9,081				3,666
Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, $0.001 par value: 200,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 6,393,323 and 1,453,402 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively			6				1
Additional paid-in capital			206,461				153,829
Accumulated other comprehensive income			11				4
Accumulated deficit			(153,998	)			(118,520	)
Total stockholders’ equity			52,480				35,314
Total liabilities and stockholders’ equity		$	61,561			$	38,980

Forte Biosciences, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data)
		Year Ended December 31,
		2024				2023
Operating expenses:
Research and development		$	20,714			$	21,862
Research and development - related party			479				-
General and administrative			15,409				10,624
Total operating expenses			36,602				32,486
Loss from operations			(36,602	)			(32,486	)
Interest income			1,314				1,124
Other expense, net			(190	)			(114	)
Net loss		$	(35,478	)		$	(31,476	)
Per share information:
Net loss per share - basic and diluted		$	(12.17	)		$	(24.92	)
Weighted average shares and pre-funded warrants outstanding, basic and diluted			2,915,894				1,262,840
Comprehensive Loss:
Net loss		$	(35,478	)		$	(31,476	)
Unrealized gain on available-for-sale securities			7				4
Comprehensive loss		$	(35,471	)		$	(31,472	)

Additional details on Forte’s full year 2024 financial results can be found in Forte’s Form 10-K as filed with the SEC on March 28, 2025. You can also find more information in the investor relations section of Forte’s website at www.fortebiorx.com.

Inducement Awards

In accordance with NASDAQ Listing Rule 5635(c)(4), the Compensation Committee of Forte’s Board of Directors approved the grant of equity awards in the form of restricted stock units totaling 5,000 shares of common stock, and options to purchase a total of 50,000 shares of common stock to new non-executive employees as a material inducement to such individuals accepting employment with the Company. The restricted stock unit award shall vest over four years, with twenty-five percent vesting yearly on the anniversary of the grantee’s employment commencement date such that all shares shall be fully vested on the four year anniversary of the vesting commencement date, subject to the individual’s continuous employment through each vesting date. The option award shall vest over four years, with twenty-five percent vesting on the one-year anniversary of the applicable optionee’s employment commencement date and the remaining seventy-five percent vesting in approximately equal monthly increments over the succeeding thirty-six months, subject to the individual’s continuous employment through each vesting date.

The Inducement Awards were made under Forte’s 2020 Inducement Equity Incentive Plan and related award agreements and will have terms and conditions generally consistent with those of Forte’s 2021 Equity Incentive Plan.

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, Forte’s plans to continue a patient trial in celiac disease with data expected in the second quarter of 2025, and Forte’s expectation to dose the first patient in the FB102 vitiligo trial in the immediate future. 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 28, 2025, 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.

Source: Forte Biosciences, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250331162226/en/

LifeSci Advisors

Mike Moyer, Managing Director

mmoyer@lifesciadvisors.com

Forte Biosciences, Inc.

Paul Wagner, CEO

investors@fortebiorx.com

Source: Forte Biosciences, Inc.

FAQ

What were Forte Biosciences (FBRX) financial results for 2024?

FBRX reported R&D expenses of $21.2M, G&A expenses of $15.4M, and a net loss per share of $(12.17) for 2024, with $58.4M in cash and equivalents at year-end.

When will Forte Biosciences (FBRX) release FB102 celiac trial results?

FBRX expects to release topline results from the FB102 celiac patient trial in the second quarter of 2025.

How much capital did FBRX raise in their November 2024 private placement?

Forte Biosciences raised $53.0M in gross proceeds through an over-subscribed private placement in November 2024.

What was the ratio of Forte Biosciences' reverse stock split in 2024?

FBRX implemented a 1:25 reverse stock split in August 2024.

How many shares does Forte Biosciences (FBRX) have outstanding?

As of December 31, 2024, FBRX had 6.4 million shares of common stock and 5.0 million prefunded warrants outstanding.