-FB-102 Has Demonstrated Potentially Best in Class Activity including Superiority to Standard of Care in GvHD

-Proof of Concept Pre-clinical Data in Additional Indications with Large Market Potential Underscores Meaningful Opportunity

-$25 Million Financing Highlights Significant Support from Top Tier Institutional Investors for FB-102 Potential

DALLAS, TX, USA I August 01, 2023 I Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases, today announced key R&D updates for FB-102 and the closing of financing to support the advancement of FB-102.

“FB-102 had demonstrated potentially best in class activity including in graft versus host disease (GvHD), an indication for which there is a very high unmet medical need and potentially abbreviated clinical development pathway. We plan to advance FB-102 into the clinic in 2024. Beyond GvHD, based on extensive proof of concept data, we believe FB-102 has considerable opportunity in a variety of indications with large markets.” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “Our financing by top-tier institutional investors highlights the meaningful potential for FB-102. We are deeply appreciative of the support from preeminent institutional biotechnology investors including Alger, BVF Partners, Farallon Capital Management, Perceptive Advisors and Tybourne Capital Management.”

FB-102 R&D Updates

Forte’s wholly owned antibody, FB-102, targets CD-122, a subunit of the IL-2 and IL-15 receptor and mediates NK and CD8+ T cells, which have been implicated in a variety of autoimmune and immune related diseases.

FB-102 has demonstrated potentially best in class activity including in validated models of GvHD with superiority to standard of care both as a single agent and in combination with standard of care.

In a validated preclinical model of aggressive acute GvHD using transplanted human donor PBMCs, FB-102 reported 90% survival versus 0% survival on vehicle control and compared to 60% survival on ruxolitinib. In combination with ruxolitinib, the only FDA-approved treatment for acute GvHD, FB-102 reported 90% survival compared to 0% survival on vehicle control and 30% survival for ruxolitinib alone with extended duration of dosing compared to the single agent study.

Additionally, in a mouse model of chronic GvHD conducted by Forte, anti-CD-122 treatment has shown superior activity compared to placebo or ruxolitinib.

Published preclinical PoC data also support the therapeutic potential of anti-CD122 in multiple autoimmune diseases anti-CD-122 including in vitiligo, celiac disease, alopecia areata, Type 1 diabetes and solid organ transplant.

About Forte

Forte Biosciences, Inc. is a biopharmaceutical company that is advancing its product candidate, FB-102, which is a proprietary molecule with potentially broad autoimmune applications including in such indications as graft versus host disease, vitiligo and alopecia areata.

SOURCE: Forte Biosciences