IND Filing for First-In-Class Clinical Candidate Targeted for 2023

Palo Alto, Calif. – October 4, 2022 – Endpoint Health, Inc., a Precision-First^TM therapeutics company, today unveiled its newest precision immunology program targeting inflammation mediated by tissue factor (TF)- dependent intracellular signaling. The company will leverage its precision AI platform to identify potential responders to the program’s lead asset, EP004, a first-in-class anti-TF monoclonal antibody (mAb), across multiple autoimmune indications. Developing this first-in-class therapy with an innovative precision AI platform across a wide range of indications could potentially transform the treatment paradigm for patients with immune-mediated inflammatory diseases (IMIDs). Rather than using traditional “one-size-fits-all” therapies, this novel precision medicine strategy could enable health care providers to design a treatment plan optimized for each patient’s unique biology.

Tissue factor has been a historically under-exploited central biological target and is a fundamental mediator of innate immune activity and coagulation. It is a driver of inflammation, chemotaxis, and hemostasis across a broad range of IMIDs, including ulcerative colitis, Crohn’s disease, lupus, and certain vasculitides. Tissue factor represents an attractive target for disease modifying therapies designed to decrease pro-inflammatory cytokines and chemokines. EP004 (formerly ICON-4) is a first-in-class anti-TF mAb that is uniquely designed to reduce inflammation by selectively inhibiting TF-dependent intracellular signaling, while avoiding interaction with hemostasis-related functions of the TF pathway. EP004 is currently completing IND-enabling studies, and the company expects an IND submission in 2023.

This newly unveiled precision immunology program was made possible by Endpoint Health’s recent acquisition of Iconic Therapeutics, a preclinical-stage biotech company developing selective therapies including ICON4 (now EP004) to address TF-mediated signaling.

“Using our precision AI platform, we could see the great potential for tissue factor, not only as a therapeutic target, but as an opportunity to develop a highly differentiated precision therapy across a wide range of indications where patients have significant unmet medical need. The opportunity to bring the incredible work of the Iconic Therapeutics team into the clinic for autoimmune diseases represents a key step towards our mission of getting the best therapy to each patient, based on their specific biological need,” said Jason Springs, CEO and Co-Founder of Endpoint Health.

“As an investor, drug developer and CEO, I’ve seen how precision approaches to drug development have transformed oncology and genetically defined diseases. We’re at the cusp of a similar revolution in immunology where there is a huge need for both new therapies and a better way to target them to the right patient. Combining our novel pipeline with Endpoint Health’s unique precision capability is a rare opportunity to solve for both needs,” said Bill Greene, CEO of Iconic Therapeutics.

This new program unveiling closely follows Endpoint Health’s appointment of Ransi Somaratne as Chief Medical Officer and a Series A financing round of $52 million, which closed earlier this year with commitments from major institutional investors, such as Mayfield, Humboldt Fund, AME Cloud Ventures, Global Health Investment Corporation (GHIC), and others.

About Endpoint Health

Endpoint Health is a Precision-First^TM therapeutics company dedicated to addressing unmet needs in immune-mediated chronic and acute diseases. We leverage our proprietary artificial intelligence (AI) platform and combine companion diagnostics with therapeutics to develop precision therapies. Our vision is a world in which all patients get the best treatment possible for their unique biology and disease. For more information, visit www.endpointhealth.com.

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About Iconic Therapeutics

Iconic Therapeutics, incorporated in 2002, a wholly owned subsidiary of Endpoint Health, developed a portfolio of proprietary molecules that bind to and antagonize TF-mediated signaling. Their unique approach to modulating TF-mediated regulation of multiple cytokines and chemokines without undue interference in coagulation (another cascade mediated by TF) creates the potential for a new class of biopharmaceuticals for improved treatment of serious diseases.

In 2020, Exelixis, Inc. exercised their rights under a May 2019 option & license agreement with Iconic for their ICON-2 asset, a TF-targeting antibody drug conjugate, with potential broad impact in oncology. Exelixis has since moved the molecule (now known as XB002) into a large, Phase I clinical trial enrolling patients with advanced solid tumors (ClinicalTrials.gov NCT04925284).