Day: March 27, 2025

Preclinical Work Advancing with Plans to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later This Year Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, Expected to Initiate in 2025 Well-Capitalized with $420.8M Balance Sheet as of YE 2024 to Support Operating Runway into Early 2028 SOUTH SAN FRANCISCO, Calif., March 27, 2025 (GLOBE NEWSWIRE) — Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today provided a corporate overview complete with upcoming milestones and reported fourth quarter and full year 2024 financial results. “Our Native Complex Platform™ continues to produce a deep pipeline of oral small molecule programs,” said Jeffrey Finer, M.D., Ph.D., chief executive officer...

HOLMDEL, N.J., March 27, 2025 (GLOBE NEWSWIRE) — BIO-key® International, Inc. (Nasdaq: BKYI), an innovative provider of workforce and customer Identity and Access Management (IAM) solutions featuring passwordless, phoneless and token-less Identity-Bound Biometric (IBB) authentication, announced results for its fourth quarter (Q4’24) and year ended December 31, 2024 (2024). BIO-key’s 2023 results, which were restated and filed with the Company’s 2023 Form 10-K, are reflected in this release for comparison purposes. BIO-key will host an investor call today, Thursday, March 27th at 10:00am ET (details below). BIO-key CEO, Mike DePasquale commented, “From a strategic standpoint, we substantially strengthened our business in 2024, growing our high-margin software license fee revenue by 20% while exiting our low margin services relationship...

Randomized-controlled Phase 3 trial, SUPRAME, to evaluate ACTengine® IMA203 TCR-T (PRAME) in advanced melanoma patients; first patient randomized and enrollment continues as plannedACTengine® IMA203 TCR-T (PRAME): Phase 1b IMA203 data published in October 2024 demonstrated a confirmed ORR of 54%, 12.1 months mDOR, 6 months mPFS and OS not reached at a mFU time of 8.6 months in advanced melanoma patients; next data update on Phase 1b trial with extended follow-up planned in 2025Second-generation ACTengine® IMA203CD8 TCR-T (PRAME): Phase 1a data published in November 2024 showed enhanced pharmacology and potency, demonstrating potential to address solid tumor indications with both high- and medium-level PRAME copy numbers; dose escalation advancing as planned; next data update including ovarian cancer data planned in 2025TCER® IMA402...

– Presented preclinical non-human primate (NHP) data at the 20th Congress of European Crohn’s and Colitis Organization in Inflammatory Bowel Diseases 2025 (ECCO) for SL-325, a potentially first-in-class blocking antibody to DR3, the receptor for TL1A; data demonstrated favorable safety profile, full receptor occupancy, lack of DR3 agonism – – SL-325 advances toward Phase 1; on track for IND filing in the third quarter of 2025 – – Cash balance of approximately $73.0 million as of December 31, 2024, expected to fund operations into 2027 – AUSTIN, TX and DURHAM, NC, March 27, 2025 (GLOBE NEWSWIRE) — Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated...

First Analysis from Phase 1b Study of GT-02287 in Parkinson’s Disease Expected in Q2 2025 BETHESDA, Md., March 27, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today reported financial results for the fourth quarter and year ended December 31, 2024, and provided a corporate update. “2024 was a year of significant progress for Gain, as we made important advancements related to both the scientific understanding and clinical development of our lead candidate GT-02287, in development for the treatment of Parkinson’s disease with or without GBA1 mutation,” said Gene Mack, President and CEO of Gain. “Building upon this momentum in 2025, we have recently...