Forte Biosciences (NASDAQ: FBRX) Reports 2025 Financial Results and Clinical Progress: Key Readouts Expected in 2026

DALLAS, TX – March 31, 2026 – Forte Biosciences, Inc., a clinical-stage biopharmaceutical company specializing in treatments for autoimmune and autoimmune-related diseases, has released its full-year 2025 financial results and provided an update on its pipeline, with significant clinical catalysts expected in 2026.

Key Highlights and Potential Price-Sensitive Developments

• FB102 Pipeline Progress:
  • Celiac Disease: Topline results from the Phase 2 clinical trial of FB102 for celiac disease are expected in 2026. This follows positive results from the Phase 1b trial reported in June 2025, raising anticipation for further validation of the drug’s efficacy in this large market indication.
  • Vitiligo: Topline results from the Phase 1b vitiligo clinical study are expected in the first half of 2026.
  • Alopecia Areata: Phase 1b data readout for alopecia areata is also expected in 2026.
  • These readouts are considered significant catalysts that could affect the company’s valuation as they address large, unmet medical needs with multi-billion dollar market potential.
• Financial Overview:
  • Forte ended 2025 with \$77.0 million in cash and cash equivalents, providing a solid financial runway to support ongoing and future clinical development.
  • Research and development expenses rose to \$58.2 million in 2025, up from \$20.7 million in 2024, primarily driven by increased manufacturing and clinical expenses for FB102, as well as higher personnel costs due to expanded headcount.
  • General and administrative expenses decreased to \$12.4 million in 2025 from \$15.4 million in 2024, mainly due to reduced professional and legal fees, offset by higher personnel-related expenses and non-cash stock-based compensation.
  • Net loss per share improved to \$(4.71) in 2025 from \$(12.17) in 2024, with the net loss for 2025 reported at \$(69.4) million.
  • Weighted average shares and pre-funded warrants outstanding increased significantly to 14.7 million in 2025 versus 2.9 million in 2024, reflecting capital raises or warrant conversions.
• Balance Sheet Strength:
  • Total assets grew to \$82.8 million at year-end 2025, up from \$61.6 million in 2024.
  • Stockholders’ equity increased to \$61.0 million from \$52.5 million.
  • The company has 12.9 million shares of common stock and 4.9 million pre-funded warrants outstanding as of December 31, 2025.
  • Total liabilities saw an uptick to \$21.8 million, driven by higher accounts payable and accrued liabilities due to increased R&D activities.

Implications for Shareholders and Potential Share Price Drivers

• Multiple Major Clinical Readouts in 2026: The company anticipates pivotal data releases for FB102 in celiac disease, vitiligo, and alopecia areata throughout 2026. Positive results could significantly de-risk the lead program and unlock substantial value, given the large addressable markets.
• Regulatory Progress: The FDA’s approval of Forte’s IND for the celiac disease Phase 2 trial, including a U.S. arm, represents a meaningful milestone that supports the company’s clinical strategy and potential for future regulatory submissions.
• Financial Position: The cash position and recent equity raises provide operational runway, but continued advancement toward late-stage trials may necessitate further capital, which could result in future dilution.
• Risks and Forward-Looking Considerations: As with all clinical-stage biotech companies, risks include the possibility of negative or inconclusive clinical data, regulatory delays, and the need for additional capital to fund ongoing operations and trials.

Additional Details

• R&D expenses increased primarily due to \$36 million in manufacturing and clinical expenses for FB102 trials, \$0.4 million more in discovery work, and \$1.9 million in personnel costs. This was partially offset by a \$1.5 million reduction in preclinical costs as some toxicology work concluded in 2024.
• G&A expenses dropped mainly due to a \$6.1 million reduction in litigation and settlement expenses, even as personnel and stock-based compensation increased by \$3.0 million (including \$2.5 million in non-cash compensation).
• Interest income grew to \$2.7 million in 2025, compared to \$1.3 million in 2024, reflecting higher cash balances or improved yields on investments.
• The company’s accumulated deficit widened to \$223.4 million at the end of 2025, reflective of its ongoing investment in pipeline development.

Forte Biosciences is advancing FB102, a proprietary anti-CD122 monoclonal antibody therapeutic candidate, which is being studied across several high-value autoimmune indications. The company’s progress and upcoming clinical data readouts will be critical to its valuation trajectory in 2026.

Forward-Looking Statements and Risks

Management cautions that forward-looking statements, including expectations for clinical readouts and regulatory progress, are subject to various risks and uncertainties. These include the potential for negative clinical outcomes, regulatory delays, and the possibility that interim or preclinical results may not be predictive of future data. There is also risk associated with the company’s ability to secure sufficient capital as needed for further development and commercialization.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should review Forte Biosciences’ filings with the SEC and consult their financial advisors before making investment decisions. The company’s future performance is subject to numerous risks, including clinical, regulatory, and financial uncertainties. Past performance is not indicative of future results.

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