FBRX

• Forte is developing FB-401, a live biotherapeutic for atopic dermatitis. FDA granted Fast Track designation to FB-401. • Phase 2 trial enrolled 154 subjects (majority under 18, moderate severity) and results expected in the third quarter. • Cash position at quarter end was $54.8 million, sufficient to fund operations for at least the next 12 months. • Two new patents issued, bringing total US patents to 11 with >15 ex-US filings. • Research and development expenses expected to increase in the next 12 months for FB-401 clinical development. • General and administrative expenses increased due to professional fees, headcount, and stock-based compensation.

• Cash on hand is sufficient to fund operations for at least the next 12 months. • Expect research and development expenses to increase during the next 12 months as clinical development of FB-401 continues. • Results of the phase 2 trial are expected to be announced in the third quarter.

At the end of the first quarter of 2021, Forte Biosciences had approximately $54.8 million in cash and cash equivalents. Cash utilization for the first quarter of 2021 was $4.0 million. Research and development expense was $3.3 million in 2021 compared to $1.4 million in 2020, primarily due to manufacturing and clinical development costs and non-cash stock based compensation. General and administrative expenses were $1.4 million in 2021 versus $0.7 million in 2020, driven by professional fees and headcount expenses. Losses per share were $0.36 for the quarter ended March 31, 2021, compared to $0.97 in 2020.

• Forward-looking statements made during the call are subject to risks that actual results could differ materially from those contemplated. • No specific operational failures discussed, but forward-looking statements are based on information available at the time and may not be updated unless required by law.

Q: Regarding the use of EASI-50 as an endpoint in the phase two trial versus IGA, any thoughts on which endpoint is better for the patient population?

A: Dan Birch stated IGA is used in phase three studies, but EASI-50 is a common alternative endpoint for phase two trials. Paul Wagner added there are secondary endpoints including IGA and various EASI measures.

Q: Vision of the FDA overseeing FB-401, is it immune permission division or given it's live bacteria?

A: Paul Wagner said it's overseen by the division of vaccines and related products, with close collaboration with the Derm division.

Q: Plans for open label extension in the ongoing phase 2 trial and thoughts on rolling over placebo patients to treatment?

A: Dan Birch said an open label extension has been initiated for phase two subjects, allowing placebo patients to enroll, focusing on safety over a year.

Q: Thoughts on European and ex-U.S. development plans?

A: Paul Wagner mentioned an integrated global development plan including Europe and Asia, with discussions on scientific advice in Europe.

Q: Specific delta looking for in the ongoing trial beyond hitting certain endpoints?

A: Paul Wagner said a clinically meaningful delta could be a 10 to 15 point difference in EASI-based endpoints with a clean safety profile.

Q: IP surrounding FB-401, is it related to formulation or bacterial species?

A: Paul Wagner said IP is broad, covering culturing Gram negative bacteria, composition, formulation, use for diseases like atopic dermatitis, and kit formulation.