EX-99.1 2 d55858dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Veru Reports Fiscal Year 2025 Financial Results and Clinical Program Progress - Following positive efficacy and safety results from Phase 2b QUALITY study, company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA - - Incremental weight loss is an acceptable approvable primary endpoint with key secondary endpoints on physical function and body composition improvements - - Company plans to initiate Phase 2 PLATEAU clinical study in calendar Q1 2026 - - Post fiscal year end, company completed public offering for net proceeds of approximately $23.4 million - - Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL - December 17, 2025 - Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal year 2025 ended September 30, 2025 and provided an update on the…
Open exhibit ↗Current Report · Items 2.02, 9.01 · 8-K
Veru Inc.
VERUNASDAQEQUITYCurrent
Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition On December 17, 2025, Veru Inc. issued a press release (the “Press Release”) announcing results for the year ended September 30, 2025. A copy of the Press Release is attached as Exhibit 99.1 to this report. The attached Exhibit 99.1 is furnished pursuant to Item 2.02 of Form 8-K.…
Company context
Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and oncology. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Based on previous and new preclinical and clinical studies, sabizabulin, an oral novel microtubule targeting agent that targets downstream components of the KRAS signaling pathway, has demonstrated the potential to become the next treatment for KRAS-driven metastatic pancreatic cancer resistant to the recent FDA approved daraxonrasib multi-selective KRAS inhibitor therapy. Accordingly, the Company plans to pursue a Phase 2b clinical study to evaluate the efficacy and safety of sabizabulin in patients for the treatment of metastatic pancreatic cancer after daraxonrasib failure. We will first seek regulatory clarity from the FDA through a preIND meeting in calendar Q4 2026.