Veru(VERU) - 2025 Q3 - Quarterly Results

Overview and Key Announcements Veru Inc. reported Q3 FY2025 financial results and clinical program advancements, including a new enobosarm formulation and anticipated FDA feedback Report Highlights Key updates include a new enobosarm formulation, awaited FDA guidance, and positive Phase 2b QUALITY study results for lean mass preservation - A novel modified-release oral formulation of enobosarm has been selected after a successful pharmacokinetic clinical study[1] - The company is awaiting FDA feedback to clarify the regulatory pathway for enobosarm for preserving lean mass in conjunction with chronic weight loss treatments[1][3] - Positive efficacy and safety data were reported from the Phase 2b QUALITY study, showing enobosarm with semaglutide preserved muscle, increased fat loss, and reduced GI side effects compared to semaglutide alone[4] - The Phase 2b QUALITY Maintenance Extension study demonstrated that enobosarm significantly reduced body weight regain and preserved lean mass after discontinuing semaglutide[4] Enobosarm Clinical Program Update This section details the latest clinical trial results and formulation advancements for enobosarm in chronic weight loss management Phase 2b QUALITY Study Results The Phase 2b QUALITY study demonstrated enobosarm's efficacy in preserving lean mass and enhancing fat loss when combined with semaglutide - The primary endpoint was met, with the enobosarm 3mg + semaglutide group showing a statistically significant 100% average preservation of total lean mass compared to the placebo + semaglutide group at 16 weeks (p<0.001)[7] - The tissue composition of weight lost was 100% fat for the enobosarm 3mg group, compared to 66% fat and 34% lean mass for the placebo group[7] - Enobosarm treatment provided a 59.8% relative reduction in the proportion of subjects who experienced a clinically significant decline (>10%) in stair climb power compared to the placebo group (p=0.006)[7] - The combination of enobosarm and semaglutide demonstrated a positive safety profile in the Phase 2b trial[7] Phase 2b Maintenance Extension Study Results The Maintenance Extension study showed enobosarm monotherapy significantly reduced weight regain and preserved lean mass after semaglutide discontinuation - Enobosarm 3mg monotherapy significantly reduced body weight regain by 46% after semaglutide was discontinued (p=0.038)[9] - The tissue composition of regained weight was 100% lean mass in the enobosarm groups, versus 28% fat and 72% lean mass in the placebo group[9] - By the end of the full study, the enobosarm 6mg group showed a 93% greater loss of fat compared to the placebo group (p=0.008)[9] - Enobosarm monotherapy had a positive safety profile with virtually no gastrointestinal side effects and no other significant adverse events of special interest after semaglutide discontinuation[9] Novel Modified Release Oral Enobosarm Formulation A new modified-release enobosarm formulation with a distinct pharmacokinetic profile has been selected, enhancing intellectual property protection - The new formulation demonstrated a distinct release profile with reduced Cmax, delayed Tmax, and a secondary peak concentration, while maintaining similar overall absorption (AUC)[10] - The novel formulation is planned for future clinical studies and commercialization[10] - Intellectual property has been strengthened, with new patent filings on the modified-release formulation potentially extending expiry to 2046[10] Financial Performance This section provides an overview of Veru's financial results for Q3 and year-to-date fiscal 2025, including key statements Financial Summary Veru reported reduced Q3 FY2025 operating and net losses, with year-to-date net loss also decreasing, and a cash position of $15.0 million Q3 Fiscal 2025 vs Q3 Fiscal 2024 | Metric | Q3 2025 | Q3 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $3.0M | $4.8M | -37.5% | | SG&A Expenses | $5.0M | $5.8M | -13.8% | | Operating Loss (Continuing Ops) | $7.5M | $10.5M | -28.6% | | Net Loss (Continuing Ops) | $7.3M | $10.3M | -29.1% | | Net Loss per Share (Continuing Ops) | $0.50 | $0.71 | -29.6% | YTD Fiscal 2025 vs YTD Fiscal 2024 | Metric | YTD 2025 | YTD 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $12.7M | $9.5M | +33.7% | | SG&A Expenses | $15.4M | $18.4M | -16.3% | | Operating Loss (Continuing Ops) | $25.9M | $26.8M | -3.4% | | Net Loss (Continuing Ops) | $17.0M | $26.7M | -36.3% | | Net Loss per Share (Continuing Ops) | $1.16 | $2.04 | -43.1% | - Cash, cash equivalents, and restricted cash stood at $15.0 million as of June 30, 2025, down from $24.9 million as of September 30, 2024[13] Financial Statements Condensed consolidated financial statements detail the company's financial position, operational performance, and cash flows for Q3 and YTD FY2025 Condensed Consolidated Balance Sheets The balance sheet shows a decrease in total assets, liabilities, and stockholders' equity as of June 30, 2025, primarily due to discontinued operations Key Balance Sheet Items (unaudited) | Metric | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $15,010,154 | $24,916,285 | | Total current assets | $16,193,177 | $35,223,224 | | Total assets | $27,330,758 | $60,418,772 | | Total current liabilities | $6,682,015 | $11,867,968 | | Total liabilities | $11,986,125 | $28,102,060 | | Total stockholders' equity | $15,344,633 | $32,316,712 | Condensed Consolidated Statements of Operations The statement of operations shows a reduced net loss for both the three and nine months ended June 30, 2025, with a significant debt extinguishment gain Key Statement of Operations Items (unaudited) | Metric | Three Months Ended June 30, 2025 | Nine Months Ended June 30, 2025 | | :--- | :--- | :--- | | Research and development | $3,020,563 | $12,669,495 | | Selling, general and administrative | $5,010,528 | $15,402,074 | | Operating loss | $(7,546,476) | $(25,917,435) | | Net loss from continuing operations | $(7,323,101) | $(16,985,397) | | Net loss | $(7,332,820) | $(24,179,786) | | Net loss per share | $(0.50) | $(1.65) | Condensed Consolidated Statements of Cash Flows Cash flow statement indicates net cash used in operating activities, offset by investing activities, resulting in a net cash decrease for the nine months Key Cash Flow Items (Nine Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(24,551,752) | $(17,316,239) | | Net cash provided by investing activities | $18,867,232 | $14,714 | | Net cash (used in) provided by financing activities | $(4,221,611) | $36,826,910 | | Net (decrease) increase in cash | $(9,906,131) | $19,525,385 | | Cash at end of period | $15,010,154 | $29,150,879 | Corporate Information and Forward-Looking Statements This section provides an overview of Veru Inc. and includes standard forward-looking statements with associated risk disclosures Company Overview Veru Inc. is a late clinical-stage biopharmaceutical company focused on cardiometabolic and inflammatory diseases with key pipeline assets enobosarm and sabizabulin - Veru is a late clinical stage biopharmaceutical company[14] - The company's focus is on cardiometabolic and inflammatory diseases[14] - Key pipeline assets are enobosarm for body composition and sabizabulin for cardiovascular inflammation[14] Forward-Looking Statements This section contains standard forward-looking statements, outlining risks related to clinical trials, regulatory approvals, funding, competition, and intellectual property - The press release includes forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995[16] - Key risks include potential for unsuccessful clinical trials, uncertainty of FDA approval, ability to fund operations, and competition[16][17]