Veru(VERU) - 2025 Q2 - Quarterly Results

Q2 2025 Financial Results and Clinical Update Veru reported Q2 FY2025 financial results and clinical program updates, with key enobosarm data and FDA meeting expected in Q2/Q3 2025 Overview and Upcoming Catalysts Veru reported Q2 FY2025 results and clinical updates, with key enobosarm data and FDA meeting expected in Q2/Q3 2025 - Unblinded safety data from the Phase 2b QUALITY study is expected in Q2 2025[1] - Topline efficacy and safety data for the Phase 2b extension maintenance study, evaluating enobosarm's effect post-GLP-1 treatment, is also expected in Q2 2025[1][2] - Veru plans an End of Phase 2 meeting with the FDA in Q3 2025 to discuss the Phase 3 program for enobosarm[2] Clinical Program Progress Veru advanced its enobosarm program with positive Phase 2b results and initiated a Phase 3 path, while exploring sabizabulin for atherosclerosis with a planned H1 2026 IND submission Enobosarm Program (Cardiometabolic) The enobosarm Phase 2b QUALITY study met its primary endpoint, preserving lean muscle and augmenting fat loss, with a Phase 3 program and new formulation underway Phase 2b QUALITY Study Results The Phase 2b QUALITY study met its primary endpoint, showing enobosarm significantly reduced lean mass loss by 71% and improved fat-selective weight loss - The trial met its primary endpoint with a 71% relative reduction in lean mass loss for enobosarm + semaglutide versus placebo + semaglutide (p=0.002)[4] - The 3mg enobosarm dose achieved a >99% mean relative reduction in lean mass loss (p <0.001)[4] - Enobosarm shifted weight loss composition to be more fat-selective, with the 3mg group showing 99.1% fat and 0.9% lean mass loss versus 68% fat and 32% lean mass in placebo[5] - Enobosarm treatment led to a 54.4% relative reduction in patients experiencing a clinically significant decline in stair climb power (p=0.0049), preserving physical function[6] Safety, Extension Study, and Regulatory Path Unblinded safety data for the Phase 2b QUALITY study and extension study results are expected this quarter, with an FDA End of Phase 2 meeting planned - Unblinded safety data for the Phase 2b QUALITY study will be available in Q2 2025[8] - A Phase 2b extension study evaluating enobosarm's ability to maintain muscle and prevent fat regain post-semaglutide is expected to report topline results this quarter[9] - The company plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 program[10] Phase 3 Program and Formulation Development The proposed Phase 3 trial will assess physical function in GLP-1 RA patients, while a new enobosarm formulation with patent protection until 2045 is under development - The proposed Phase 3 trial's primary objective is assessing physical function via the Stair Climb Test at 24 weeks[11] - The Phase 3 study plans to include patients treated with WEGOVY (semaglutide) and/or Zepbound® (tirzepatide)[11] - A new modified-release oral formulation of enobosarm is under development, with an expected patent expiry of 2045, and is anticipated for Phase 3 studies[13] Atherosclerosis Inflammation Program (Sabizabulin) Veru is exploring sabizabulin for atherosclerotic cardiovascular disease, positioning it as a safer alternative to colchicine, with a Phase 2 IND submission planned by H1 2026 - Veru is exploring sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing residual inflammatory risk not managed by cholesterol-lowering therapies[15][16] - Sabizabulin has a similar mechanism to colchicine but may be safer due to lower potential for drug-drug interactions with cardiovascular drugs like statins[18] - The FDA agreed with the general design of a proposed small Phase 2 study using coronary CT angiography imaging as the primary endpoint during a pre-IND meeting[21] - Veru plans to submit a new IND for this indication by H1 2026, following completion of chronic nonclinical toxicology studies requested by the FDA[21] Financial Results Veru reported a Q2 FY2025 net loss of $7.9 million, an improvement year-over-year, with total assets at $32.7 million and cash at $20.0 million as of March 31, 2025 Financial Highlights Veru reported a Q2 FY2025 net loss of $7.9 million, an improvement from prior year, with cash and equivalents at $20.0 million as of March 31, 2025 - Cash, cash equivalents, and restricted cash totaled $20.0 million as of March 31, 2025, down from $24.9 million as of September 30, 2024[24] Q2 FY2025 vs Q2 FY2024 Financial Summary | Metric | Q2 FY2025 ($M) | Q2 FY2024 ($M) | | :--- | :--- | :--- | | R&D Expenses | $3.9 | $3.0 | | SG&A Expenses | $5.2 | $5.9 | | Operating Loss from Cont. Ops | $8.1 | $8.9 | | Net Loss from Cont. Ops | $7.9 | $8.7 | | Net Loss | $7.9 | $10.0 | YTD FY2025 vs YTD FY2024 Financial Summary | Metric | YTD FY2025 ($M) | YTD FY2024 ($M) | | :--- | :--- | :--- | | R&D Expenses | $9.6 | $4.6 | | SG&A Expenses | $10.4 | $12.6 | | Operating Loss from Cont. Ops | $18.4 | $16.3 | | Net Loss from Cont. Ops | $9.7 | $16.4 | | Net Loss | $16.8 | $18.3 | Condensed Consolidated Financial Statements The condensed financial statements show total assets of $32.7 million and stockholders' equity of $21.0 million as of March 31, 2025, with a $16.8 million net loss for the six months Condensed Balance Sheet | Balance Sheet (Condensed) | March 31, 2025 ($M) | September 30, 2024 ($M) | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $20.0 | $24.9 | | Total current assets | $21.4 | $35.2 | | Total assets | $32.7 | $60.4 | | Total current liabilities | $5.6 | $11.9 | | Total liabilities | $11.6 | $28.1 | | Total stockholders' equity | $21.0 | $32.3 | Condensed Statement of Operations | Statement of Operations (Condensed) | Six Months Ended Mar 31, 2025 ($M) | Six Months Ended Mar 31, 2024 ($M) | | :--- | :--- | :--- | | Total operating expenses | $20.0 | $17.2 | | Operating loss | $(18.4) | $(16.3) | | Net loss from continuing operations | $(9.7) | $(16.4) | | Net loss | $(16.8) | $(18.3) | | Net loss per share ($) | $(0.12) | $(0.15) | Condensed Statement of Cash Flows | Statement of Cash Flows (Condensed) | Six Months Ended Mar 31, 2025 ($M) | Six Months Ended Mar 31, 2024 ($M) | | :--- | :--- | :--- | | Net cash used in operating activities | $(19.1) | $(11.7) | | Net cash provided by (used in) investing activities | $18.4 | $(0.04) | | Net cash (used in) provided by financing activities | $(4.2) | $36.8 | | Net decrease in cash | $(4.9) | $25.1 | | Cash at end of period | $20.0 | $34.7 |