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SAN ANTONIO, Sept. 9, 2024 /PRNewswire/ -- Owl Therapeutics ("Owl"), a clinical-stage biopharmaceutical company specializing in artificial intelligence (AI) and diagnostic-powered neurotherapeutics for Traumatic Brain Injury (TBI) and related indications, will present its novel clinical development plan for OWL-1410 at the NY Venture Summit, LSX World Congress, LSN RESI, BIO-Europe and other conferences from September to December.

Treatment for TBI remains an urgent unmet medical need with no FDA-approved disease modifying therapies and more than 69,000 related deaths from 2.8 million cases reported annually in the US alone. Owl is pioneering a groundbreaking approach to address this critical gap with its leading treatment, OWL-1410, to protect and restore neurons following moderate and severe TBI. OWL-1410 holds the promise of providing transformative treatment for both civilian and military TBI patients.

• OWL-1410 is a small molecule therapeutic with an open US Investigational New Drug (IND) application and Fast Track designation from the FDA for moderate and severe TBI. It is considered by KOLs to be the most advanced best-in-class drug in development for TBI.
• Owl's Brain Health Pipeline is powered by novel diagnostic blood tests made possible through an exclusive partnership with Gryphon Bio. Gryphon's proprietary blood tests for brain biomarkers enable enrichment and tracking of responding patients to derisk and accelerate Owl's discovery and development workflows. This increases the likelihood of achieving successful outcomes in clinical trials and regulatory approvals.
• Owl's Brain Health Pipeline is also powered by novel AI and machine learning technologies to analyze vast public and private datasets, including three-dimensional chemical structures of small and large molecules as well as data from preclinical and clinical studies, to further improve product discovery and clinical trial efficiency.

Will Haskins, CEO of Owl Therapeutics, stated, "The early clinical data for OWL-1410, combined with our innovative delivery method and novel blood tests to confirm brain health restoration following treatment, are promising keys to unlocking the TBI market. Our clinical development plan closely aligns with the NIH call for Precision Medicine and the latest FDA guidance on clinical design, greatly enhancing the likelihood of clinical and regulatory success. Together with our partners, no other team has approached the TBI market with this level of sophistication."

Once approved, OWL-1410 has a peak annual revenue forecast of over $1B. Owl is now seeking funding to confirm early clinical data prior to pivotal clinical trials. CEO Will Haskins and company leadership will be meeting with investors at several scientific conferences from September to December. For more information or to inquire about investment reach out to ir@owltherapeutics.com.

Owl Therapeutics – Unlocking Wisdom for Brain Health
Owl is a clinical-stage biopharmaceutical company ready for investment in Phase 2 trials of derisked lead asset OWL-1410 to capture the $21B moderate and severe traumatic brain injury (TBI) market. The company has rapidly built a promising, diversified pipeline of small and large molecule neurotherapeutics poised to address the highly unmet medical needs of patients with TBI and related CNS indications (e.g., post-traumatic epilepsy, post-traumatic headache, Alzheimer's disease, etc.). Owl is led by a proven, cohesive, interdisciplinary, and internationally recognized team with deep scientific, clinical, and business experience in drug development and commercialization.

Media Inquiries:
ir@owltherapeutics.com

SOURCE Owl Therapeutics