Forte Biosciences (FBRX -1.18%), a clinical-stage biotech developing treatments for autoimmune diseases, released its results for Q2 2025 on August 14, 2025. The company reported a GAAP net loss per share of $(0.96) for Q2 2025, which was better than the analyst estimate of $(1.11) (GAAP) for Q2 2025 and a significant improvement from the prior-year’s GAAP net loss of $(6.78) per share in Q2 2024. There was no revenue, in line with expectations for an early-stage biotech. Operating losses moderated year over year on a GAAP basis in Q2 2025, with notable reductions in administrative spending despite higher research and development costs as the company advanced its main pipeline asset. The quarter reflected a solid infusion of new capital and progress across Forte’s clinical programs.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.96) | $(1.11) | $(6.78) | 85.8 % |
| Revenue (GAAP) | $0 | $0 | $0 | n/a |
| Research & Development Expenses | $8.6 million | $5.7 million | 49.3 % | |
| General & Administrative Expenses | $3.0 million | $7.1 million | (58.0 %) | |
| Net Loss | $11.2 million | $12.5 million | -10.4 % |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Strategic Focus
Forte Biosciences specializes in developing immunology medicines, focusing on FB102, a biologic therapy targeting autoimmune conditions. Its central research area includes diseases such as celiac disease, vitiligo (a skin disorder causing loss of skin color), and alopecia areata (an autoimmune-related hair loss condition). The company’s business model revolves around pushing its lead drug candidate through clinical trials to unlock value, aiming for regulatory approval and future commercial use.
Recent priorities for Forte revolve around clinical progress, cost control, and financial stability. Success in clinical trials—demonstrating both a strong safety profile and initial efficacy—is critical to future prospects. With no products on the market yet, the company’s prospects depend on advancing FB102 efficiently, protecting its patents, and maintaining financial flexibility.
Quarterly Developments: Financials, Pipeline, and Operations
Forte's loss per share improved to $(0.96) (GAAP) for Q2 2025, a significant positive swing from the GAAP net loss per share of $(6.78) recorded in Q2 2024. This was notably better than the GAAP consensus estimate of $(1.11) for Q2 2025. Administrative costs fell sharply year-over-year in Q2 2025, General and administrative expenses dropped to $3.0 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024, following the resolution of legal matters from the previous year. This helped offset a substantial rise in research and development spending.
Research and development expenses (GAAP) rose 50.9% to $8.6 million for the three months ended June 30, 2025, compared to $5.7 million in the same period of 2024. The increase was primarily due to clinical expenses related to phase 1b trials of FB102 for celiac disease and vitiligo, as well as personnel-related expenses. Net loss (GAAP) for Q2 2025 improved to $11.2 million, a 10.1% reduction compared to Q2 2024. These financial trends indicate Forte is deploying capital into pipeline development while carefully managing overall losses.
On the pipeline front, FB102 made meaningful progress in three parallel programs. The company began dosing participants in its Phase 2 clinical trial for celiac disease, an autoimmune condition triggered by gluten intolerance. Forte also has a Phase 1b trial enrolling for vitiligo—a condition where skin loses pigment—and has launched a new Phase 1b study for alopecia areata, with both indications targeting top-line results in 2026. These programs place Forte in position for multiple high-value clinical milestones over the next year and a half.
Financing was another key theme. The company completed a public offering in June 2025, raising $69.9 million in net proceeds, followed by an additional $1.7 million in July 2025 through an overallotment. This lifted cash and cash equivalents to $106.1 million as of June 30, 2025, from $22.2 million in cash and cash equivalents (GAAP) as of December 31, 2024. The share count rose in tandem with these capital raises. These initiatives provide the means for Forte to fund its clinical and administrative operations through the near term, aligning its financial resources with the cadence of upcoming clinical trial data readouts. There was no product revenue, which is standard for a company at this stage. There were no dividends declared or paid.
Looking Forward: Guidance and Investor Watchpoints
Management did not issue quantitative revenue or earnings targets for the coming quarters or fiscal 2025. Instead, it emphasized that the next year will center on clinical trial execution and reporting results for three programs: celiac disease, vitiligo, and alopecia areata. The company expects 2026 to bring major inflection points as it discloses key safety and preliminary efficacy data for FB102 across these conditions.
Forte Biosciences does not currently pay a dividend. Investors tracking Forte may want to watch for the pace of clinical trial enrollment, data releases in 2026, and the sustainability of its cash resources as research costs continue to build. Risks include potential setbacks in clinical development, no current product revenue, and competitive dynamics with peers in the autoimmune disease therapy segment. No additional guidance was offered by management this quarter.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
