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Analogy 1

Think of Forte Biosciences as an early-stage Biogen, but hyper-focused on developing a single drug for autoimmune diseases like vitiligo and alopecia areata.

Analogy 2

It's like a startup Moderna, but developing treatments for specific autoimmune conditions rather than vaccines.

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• FB-102 program: This is a clinical-stage developmental program focused on addressing various autoimmune diseases, including vitiligo and alopecia areata.

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As a clinical-stage biopharmaceutical company, Forte Biosciences (FBRX) is currently focused on the research and development of its FB-102 program for autoimmune diseases. At this stage, the company does not have commercialized products and, therefore, does not have major customers in the traditional sense of selling goods or services to other companies or individuals.

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Paul A. Wagner, Ph.D. Chief Executive Officer and Chairperson of the Board

Dr. Wagner founded Forte Biosciences and has served as its Chief Executive Officer since 2018 and a member of its board of directors since 2017. In 2017, he was the Head of Corporate Strategy and Development at CANBridge Life Sciences. From 2014 to 2017, Dr. Wagner served as the Chief Financial Officer of Pfenex Inc., a biotechnology company. Earlier in his career, he was a Director and Portfolio Manager/Sr. Equity Analyst with Allianz Global Investors, focusing on biotechnology and pharmaceutical investments, and held roles at PDL BioPharma and Lehman Brothers.

Antony A. Riley Chief Financial Officer

Mr. Riley has served as Forte's Chief Financial Officer since March 2020. Prior to joining Forte, he was the Chief Financial Officer at Krystal Biotech, Inc., a biotechnology company, from September 2017 to February 2020. Mr. Riley was also a founding partner of CFO Network LLC, a consulting firm, since 2002 and held positions as Acting Chief Financial Officer at Avanex Corporation and Corporate Controller at Kosan Biosciences.

Christopher Roenfeldt Chief Operating Officer

Mr. Roenfeldt joined Forte Biosciences in October 2020 as Chief Operating Officer, bringing over 20 years of experience in clinical drug development. Before Forte, he was an Alliance and Program Manager at Halozyme, and previously held leadership positions at various biopharmaceutical companies, including Pfenex, Genentech, and Amgen.

Dr. Barbara K. Finck, M.D. Senior Medical Clinician

Dr. Finck currently serves as Forte's Senior Medical Clinician. She previously held the role of acting Chief Medical Officer, Chief Clinical Advisor, and Chief Medical Officer at Coherus BioSciences from 2012 to 2019. Dr. Finck also served as Senior Vice President and Chief Medical Officer of NKT Therapeutics Inc. and Senior Vice President of Research and Development and Chief Medical Officer at Osprey Pharmaceuticals U.S.A., Inc.

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Key Risks to Forte Biosciences (FBRX)

1. Clinical Development and Regulatory Approval Risks: Forte Biosciences, as a clinical-stage biopharmaceutical company, faces substantial risks associated with the development and regulatory approval of its lead product candidate, FB-102. These risks include potential unforeseen adverse reactions during clinical trials, variability in clinical outcomes as more patient data is collected, and the inherent difficulties and potential delays in navigating complex regulatory pathways to gain approval for its therapeutic candidates. The company's future success is entirely dependent on the successful completion of these trials and subsequent regulatory clearances.
2. Financial Risks and Ability to Obtain Additional Capital: Forte Biosciences has a history of incurring losses and negative cash flows from operations since its inception. The company's ongoing research and development activities, particularly advancing FB-102 through clinical trials, require significant capital, and there is a continuous risk regarding its ability to obtain sufficient additional funding. While the company has secured funding through public offerings, its cash burn rate and the need for future capital to sustain operations until it potentially reaches profitability remain a key concern.
3. Market Competition and Product Efficacy Concerns: Forte Biosciences operates in a highly competitive biopharmaceutical market, where existing and emerging therapies for autoimmune diseases could impact the market penetration and pricing power of FB-102 if approved. Additionally, concerns have been raised about the efficacy of FB-102 compared to competitive offerings, particularly highlighted by a low placebo change from baseline in an earlier Phase 1b study for celiac disease, which could affect its commercial viability.

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The addressable markets for Forte Biosciences' main products or services, specifically for its FB-102 program targeting vitiligo and alopecia areata, are estimated to be multi-billion dollar opportunities.

Vitiligo

The global vitiligo treatment market was estimated at approximately USD 1.6-1.8 billion in 2024-2025. This market is projected to reach between USD 2.3 billion and USD 2.7 billion by 2032-2034.

In 2025, the global vitiligo treatment market size was valued at USD 1.84 billion, with some estimations placing it at USD 1.69 billion. By 2034, the market is projected to grow to USD 2.54 billion, demonstrating a Compound Annual Growth Rate (CAGR) of 3.8% from 2026 to 2034. North America held a significant share of the global market, accounting for 24.87% in 2025. The U.S. market alone is projected to reach USD 0.43 billion by 2026.

Alopecia Areata

The global alopecia treatment market, which includes alopecia areata, was valued at around USD 3-3.5 billion in 2024, with some forecasts indicating a potential rise to USD 6 billion by 2032-2034.

More specifically for alopecia areata, the global market size was estimated at USD 3.32 billion in 2024 and is expected to grow to USD 6.92 billion by 2034, with an anticipated CAGR of 7.6% from 2024 to 2034. North America held the largest revenue share in the broader alopecia treatment market in 2024. It is estimated that alopecia areata affects 700,000 people in the U.S., with 300,000 experiencing moderate to severe forms of the condition. In 2023, the diagnosed prevalent cases of alopecia areata in the 7MM (United States, EU4, UK, and Japan) were approximately 1.7 million, with the United States accounting for 35% of these cases.

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Forte Biosciences, Inc. (FBRX), a clinical-stage biopharmaceutical company focused on autoimmune diseases, is projected by analysts to begin generating revenue in 2028. Consequently, the key drivers of future revenue growth over the next two to three years will be primarily centered on the advancement and potential commercialization of its lead product candidate, FB-102.

The expected drivers of future revenue growth for Forte Biosciences are:

1. Successful Clinical Trial Readouts for FB-102: Forte Biosciences anticipates three critical clinical trial readouts for FB-102 in 2026. These include topline results from a Phase 2 clinical trial for celiac disease, and data from Phase 1b clinical studies in both vitiligo and alopecia areata. Positive outcomes from these trials are fundamental for advancing FB-102 through the development pipeline toward regulatory approval and eventual commercialization.
2. Expansion into Multiple Autoimmune Indications: FB-102 is being developed for a range of autoimmune and autoimmune-related conditions, specifically targeting celiac disease, vitiligo, and alopecia areata. These indications collectively represent multi-billion dollar market opportunities. Successfully demonstrating efficacy and safety across these areas would significantly broaden the potential market and revenue base for Forte Biosciences.
3. Regulatory Approvals and Commercialization of FB-102: While analyst forecasts suggest initial revenue generation in 2028, progress toward obtaining regulatory approvals for FB-102 within the next 2-3 years is a crucial driver. Securing regulatory clearances would enable the company to launch the product, which is essential for generating product sales revenue.
4. Strategic Partnerships and Collaborations: As a clinical-stage biotechnology company, Forte Biosciences may pursue strategic collaborations. Such partnerships could provide non-dilutive funding through upfront payments and milestone payments, or facilitate shared commercialization efforts. The company's ability to successfully enter into and fulfill obligations under collaboration agreements is a forward-looking consideration for its financial trajectory.

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Share Issuance

• In June 2025, Forte Biosciences completed a public offering of 5,630,450 shares of common stock at $12.00 per share and 619,606 pre-funded warrants at $11.999 per warrant, generating approximately $75.0 million in gross proceeds.
• The 2021 Equity Incentive Plan was amended and restated in September 2023 to increase the number of shares reserved for issuance by 2,500,000 shares.
• The number of outstanding shares increased by 538.39% in the year prior to March 2026.

Inbound Investments

• A public offering in June 2025 resulted in gross proceeds of approximately $75.0 million for Forte Biosciences.

Capital Expenditures

• Capital expenditures for the 12 months prior to March 2026 were approximately -$147,000.
• In Q3 2025, Forte Biosciences invested $55,000 in capital expenditures, which was primarily focused on funding long-term assets and infrastructure.