FBRX

FB102 Received Fast Track Designation in Celiac Disease DALLAS, May 11, 2026--(BUSINESS WIRE)--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 re...

DALLAS, March 31, 2026--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its full year 2025 financial results and provided a business update. "The clinical development for FB102 continues to progress well with important readouts in 2026," said Forte Biosciences CEO Paul Wagner, PhD. "The topline results from our phase 2 celiac disease study is 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 in 1H 2026 and the alopecia areata phase 1b data readout is expected in 2026. This will be a very eventful year and further highlight FB102’s potential to address the significant unmet medical needs across multiple indications representing multi-billion dollar potential market opportunities." 2025 Operating Results Research and development expenses were $58.2 million for the year ended December 31, 2025, compared to $21.2 million during the same period in 2024. The increase was primarily due to an increase of $36 million in manufacturing and 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 $0.4 million in discovery work, and an increase of $1.9 million in personnel-related expenses due to an increase in headcount, partially offset by a decrease of $1.5 million in preclinical expenses as a result of toxicology work performed in 2024. Our research and development expenses may increase as we continue to advance FB102 through a celiac Phase 2 trial including a U.S. arm as a result of the FDA approving our IND, multiple Phase 1b clinical trials and if we pursue additional autoimmune indications. General and administrative expenses were $12.4 million for the year ended December 31, 2025 compared to $15.4 million for the same period in 2024. The decrease was primarily due to decreases in professional and legal advisory fees, including litigation and settlement expenses, of $6.1 million, partially offset by an increase of $3.0 million in personnel-related expenses, includi...

Three clinical trial readouts for FB102 expected in 2026, including phase 2 in celiac disease and phase 1b in both vitiligo and alopecia areata DALLAS, November 14, 2025--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its third quarter 2025 financial results and provided a business update. "We continue to make excellent progress with FB102," said Forte Biosciences CEO Paul Wagner, PhD. "The US IND is now open and enrolment in the FB102 phase 2 celiac disease (CeD) clinical trial has expanded to US sites with topline results expected in 2026. Based on the strength of the positive results from the FB102 phase 1b CeD trial, which we reported in June, 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 ongoing and we continue to expect topline data in 1H26. We have also begun enrolling patients in the phase 1b trial in alopecia areata and expect data from that study in 2026. With 3 key clinical trial readouts for FB102, 2026 will be a very eventful year and further highlight FB102’s potential to address the significant unmet medical needs across multiple indications including celiac disease, vitiligo and alopecia areata, which represent multi-billion dollar potential market opportunities." Q3 2025 Operating Results Research and development expenses were $15.2 million for the three months ended September 30, 2025, compared to $5.9 million for the same period in 2024. The increase was primarily due to increases of $9.7 million in clinical and manufacturing expenses related to our Phase 2 clinical trial for celiac disease and Phase 1b clinical trials for vitiligo and alopecia areata, and $0.8 million in personnel-related expenses due to an increase in headcount, partially offset by a decrease of $1.2 million in preclinical expenses as a result of toxicology work performed in 2024. Research and development expenses were $36.5 million for the nine months ended September 30, 2025, compared to $16.0 million for the same period in 2024. The increase was primarily due to an increase of $21.6 million in manufacturing and clinical expenses of our Phase 2 clinical trial for celiac disease and Phase 1b clinical trials for vitiligo and alopeci...

Three clinical trial readouts for FB102 expected in 2026, including phase 2 in celiac disease and phase 1b in both vitiligo and alopecia areata DALLAS, August 14, 2025--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its second quarter 2025 financial results and provided a business update. "I am deeply appreciative of the Forte team’s incredible accomplishments in initiating 3 clinical trials for FB102 with data readouts shortly." said Forte Biosciences CEO Paul Wagner, PhD. "We have begun dosing subjects in the FB102 phase 2 celiac disease clinical trial and look forward to reporting topline results from that study in 2026. Based on the strength of the positive results from the FB102 phase 1b CeD trial, which we reported in June, we look forward to the phase 2 data further validating FB102 for the treatment of celiac disease. Enrolment in the FB102 phase 1b vitiligo clinical study is ongoing and topline data are expected in 1H26. Additionally, we are initiating a phase 1b trial in alopecia areata and expect data from that study in 2026. With 3 key clinical trial readouts for FB102, 2026 will be a very eventful year and further highlight FB102’s potential to address the significant unmet medical needs across multiple indications including celiac disease, vitiligo and alopecia areata, which represent multi-billion dollar potential market opportunities." Prof. Jason Tye-Din, Head of Celiac Research at the Walter and Eliza Hall Institute at the Royal Melbourne Hospital and principal investigator in the FB102 phase 1b trial, will give an oral presentation of the phase 1b data at the Tampere Celiac Disease Symposium, Tampere Finland (September 10-12, 2025). Financing Update On June 25, 2025, the Company closed a public offering in which it sold 5,630,450 shares of common stock at a price of $12.00 per share and pre-funded warrants to purchase 619,606 shares of common stock at a price of $11.999 per pre-funded warrant. The net proceeds from the June offering were $69.9 million after underwriting discounts, commissions and offering expenses. In July 2025 the underwriters of the offering exercised the over-allotment option and purchased an additional 148,258 shares of common stock for net proceeds to the Company of $1.7 mill...

DALLAS, May 15, 2025--(BUSINESS WIRE)--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 2025 financial results and provided a clinical update. "We are looking forward to reading out the topline data from the FB102 celiac disease trial this quarter. FB102 continues to be well-tolerated and there have been no dropouts to date. Additionally, we have now dosed the first patient in the FB102 vitiligo trial. 2025 is shaping up to be a very eventful year which we believe will further validate the potential for FB102," said Forte Biosciences CEO Paul Wagner, Ph.D. Q1 2025 Operating Results Research and development expenses were $12.7 million for the three months ended March 31, 2025, compared to $4.4 million for the same period in 2024. The increase was primarily due to an increase of $8.9 million in manufacturing expenses to support our two clinical trials and clinical expenses for celiac disease and vitiligo indications, partially offset by a decrease of $0.5 million in personnel-related expenses. General and administrative expenses were $3.4 million for the three months ended March 31, 2025 compared to $3.5 million for the same period in 2024. The decrease was primarily due to decreases in legal and professional expenses of $1.0 million offset by an increase of $0.9 million in personnel related expenses including additional non-cash stock-based compensation of $0.7 million. Net losses per share were $(1.37) and $(4.03) for the quarters ended March 31, 2025 and 2024, respectively. Forte ended the first quarter of 2025 with $45.9 million in cash and cash equivalents. There are 6.6 million shares of common stock and 4.8 million prefunded warrants outstanding as of March 31, 2025. Additional details on Forte’s first quarter 2025 financial results can be found in Forte’s Form 10-Q as filed with the SEC on May 15, 2025. 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...

DALLAS, March 31, 2025--(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. 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, 20...