Veru(VERU) - 2025 Q2 - Quarterly Report

Forward Looking Statements This section outlines potential risks and uncertainties that could cause actual results to differ from forward-looking statements, including those related to product development, financial performance, and the company's ability to continue as a going concern - The company identifies its development and commercialization plans for enobosarm and sabizabulin as key areas subject to forward-looking risks[10] - Key risk factors that could cause actual results to differ from expectations include potential delays in clinical trials, failure to obtain FDA approval, and the ability to secure sufficient financing to continue as a going concern[11] - The company also highlights risks related to its history of losses, the fact it currently has no commercial revenue, and the potential for future material weaknesses in internal controls[14] PART I. FINANCIAL INFORMATION Financial Statements This section presents the unaudited condensed consolidated financial statements for the quarterly period ended March 31, 2025, including balance sheets, statements of operations, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining accounting policies and significant events Unaudited Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2025, shows a significant decrease in total assets to $32.7 million from $60.4 million at September 30, 2024, primarily due to the sale of the FC2 business, which also reduced liabilities Condensed Consolidated Balance Sheet Data | Metric | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $20,018,392 | $24,916,285 | | Total Assets | $32,671,943 | $60,418,772 | | Total Liabilities | $11,624,710 | $28,102,060 | | Total Stockholders' Equity | $21,047,233 | $32,316,712 | Unaudited Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, the company reported a net loss of $7.9 million, an improvement from $10.0 million in the prior-year period, with the six-month period showing a net loss of $16.8 million, improved by an $8.6 million gain on debt extinguishment Operating Results (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $3,932,102 | $2,985,118 | | Operating loss from continuing operations | $(8,122,232) | $(8,888,791) | | Net loss | $(7,901,619) | $(10,025,948) | | Net loss per share | $(0.05) | $(0.07) | Operating Results (Six Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $9,648,932 | $4,643,693 | | Gain on extinguishment of debt | $8,624,778 | $0 | | Net loss from discontinued operations | $(7,184,670) | $(1,931,448) | | Net loss | $(16,846,966) | $(18,301,929) | Unaudited Condensed Consolidated Statements of Cash Flows For the six months ended March 31, 2025, net cash used in operating activities was $19.1 million, offset by $18.4 million provided by investing activities, resulting in a net decrease in cash of $4.9 million Cash Flow Summary (Six Months Ended March 31, 2025) | Activity | Amount | | :--- | :--- | | Net cash used in operating activities | $(19,069,450) | | Net cash provided by investing activities | $18,393,168 | | Net cash used in financing activities | $(4,221,611) | | Net decrease in cash | $(4,897,893) | - The primary source of cash was $16.3 million from the sale of the FC2 business, while the main financing use was a $4.2 million payment to extinguish a residual royalty agreement[21] Notes to Unaudited Condensed Consolidated Financial Statements The notes detail accounting policies and significant events, including substantial doubt about going concern, the sale of the FC2 business, debt extinguishment, ongoing legal proceedings, and collection uncertainty from the ENTADFI asset sale - Going Concern: Management concluded there is substantial doubt about the company's ability to continue as a going concern for the next twelve months due to insufficient cash to fund operations (Note 2)[32][33] - Discontinued Operations: The company sold its FC2 business on December 30, 2024, for $18.0 million, resulting in a loss on sale of $4.2 million (Note 3)[34][35] - Debt Extinguishment: A $4.2 million payment was made to terminate the Residual Royalty Agreement, resulting in an $8.6 million gain on extinguishment of debt (Note 8)[57] - Legal Proceedings: The company faces several shareholder lawsuits related to statements about sabizabulin for COVID-19 and has resolved a commercial dispute with a supplier for $8.3 million (Note 12)[87][94] - ENTADFI Sale: The company continues to face collection uncertainty from the sale of ENTADFI assets to ONCO, which has defaulted on payments and is operating under a forbearance agreement (Note 15)[100][107] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's strategic shift to focus on developing enobosarm for obesity and sabizabulin for atherosclerosis following asset divestitures, reviewing operating results, liquidity, and capital resources, and disclosing substantial doubt about its going concern ability Overview and Drug Development Programs Veru has transitioned into a late-stage biopharmaceutical company focused on enobosarm for muscle loss in obesity and sabizabulin for atherosclerosis, reporting positive Phase 2b QUALITY study results for enobosarm and divesting commercial assets - The company's primary focus is now on two clinical-stage assets: enobosarm for preventing muscle loss in obese patients on GLP-1 RAs, and sabizabulin for treating inflammation in atherosclerotic cardiovascular disease[109][133] - The Phase 2b QUALITY trial for enobosarm met its primary endpoint, demonstrating a statistically significant preservation of lean body mass (71% relative reduction in lean mass loss), and the company plans to request an End of Phase 2 meeting with the FDA[116][123] - The FC2 business was sold on December 30, 2024, for $18.0 million in cash, resulting in a $4.2 million loss and the extinguishment of associated debt[139][140] Results of Operations For the three months ended March 31, 2025, R&D expenses increased by $0.9 million, while SG&A decreased by $0.7 million, with the six-month period significantly impacted by an $8.6 million gain on debt extinguishment and a $7.2 million net loss from discontinued operations Change in Operating Expenses (Six Months Ended March 31) | Expense | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $9.6M | $4.6M | +$5.0M | | Selling, general and administrative | $10.4M | $12.6M | -$2.2M | - The increase in R&D expenses is primarily attributed to costs associated with the ongoing Phase 2b QUALITY clinical study for enobosarm[147][152] - The six-month period includes a significant one-time gain of $8.6 million from the extinguishment of the Residual Royalty Agreement debt, related to the FC2 business sale[155] Liquidity and Sources of Capital As of March 31, 2025, the company held $20.0 million in cash, which management deems insufficient for the next 12 months, leading to substantial doubt about its going concern ability and a need for additional capital - The company had $20.0 million in cash, cash equivalents, and restricted cash at March 31, 2025[158] - Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as current cash is insufficient to fund operations for the next twelve months[159][160] - During the six months ended March 31, 2025, investing activities provided $18.4 million (primarily from the FC2 sale), while operating activities used $19.1 million and financing activities used $4.2 million[161][164][166] Quantitative and Qualitative Disclosures About Market Risk Following the sale of its FC2 business, the company is no longer subject to significant market risks related to raw material commodity prices or foreign currency exchange rates - After the FC2 Business Sale, the company is no longer exposed to significant market risk from raw material commodity prices or foreign currency exchange rate fluctuations[178] Controls and Procedures Management, including the CEO and CFO, deemed the company's disclosure controls and procedures effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[179] - No material changes were made to the company's internal control over financial reporting during the most recently completed fiscal quarter[180] PART II. OTHER INFORMATION Legal Proceedings This section directs readers to Note 12 of the unaudited condensed consolidated financial statements for a detailed description of the company's material pending legal proceedings - For a description of material pending legal proceedings, the report refers to Note 12, Contingent Liabilities, in the financial statements[181] Risk Factors This section provides a comprehensive overview of significant risks facing the company, including those related to regulation, commercialization, financial position, business operations, intellectual property, and common stock ownership Risks Related to Regulation and Commercialization The company faces substantial risks in regulation and commercialization, with no current commercial revenue and profitability dependent on obtaining regulatory approval for its drug candidates, alongside reliance on third-party CROs and manufacturers - The company currently has no commercial revenue and may never become profitable, as its future depends on the successful development and commercialization of its drug candidates[192] - The clinical development programs for enobosarm and sabizabulin are subject to significant risks, including trial delays, unfavorable results, and potential FDA disagreement with trial designs[205][206] - Reliance on third-party CROs and manufacturers creates risks related to performance, quality control, and compliance with cGCP and cGMP standards[210][213] Risks Related to Financial Position and Need for Capital The company's financial position is precarious, marked by a history of net losses and a 'going concern' warning, requiring significant additional capital for operations and clinical trials, with uncertainty regarding future payments from the ENTADFI asset sale - The company's independent registered public accounting firm has issued a 'going concern' opinion, highlighting substantial doubt about its ability to continue operations due to losses and the need for additional funding[234] - Veru needs to raise substantial additional capital to fund its operations, particularly for pivotal Phase 3 trials, and failure to do so could force the company to curtail programs or cease operations[235] - There is significant uncertainty regarding the collection of remaining payments from ONCO for the ENTADFI sale, as ONCO has previously defaulted and is operating under a forbearance agreement[242][243] Risks Related to Business and Operations The company faces significant business and operational risks, including intense competition in the obesity treatment market, ongoing shareholder lawsuits, and potential disputes arising from the recent sale of the FC2 business - The company faces intense competition for its lead candidate, enobosarm, from major pharmaceutical companies with substantially greater resources[245][246] - Veru is a defendant in several shareholder class action and derivative lawsuits, which could result in substantial legal fees and potential damages[257] - The sale of the FC2 business carries risks, including potential disputes over working capital adjustments and indemnification claims, with the purchaser already submitting an insurance claim alleging breaches of representations by Veru[270][272] Risks Relating to Intellectual Property The company's success depends on protecting its intellectual property, facing risks that patents may expire, be invalidated, or not be granted, particularly for enobosarm, and is reliant on third-party licenses which could be terminated - The company's commercial success depends on its ability to obtain, maintain, and defend intellectual property rights, which is an uncertain process[274] - Intellectual property protection for enobosarm in the obesity market is not secure, as it relies on a pending method of use patent application that may not be granted or may be too narrow[285] - The company is dependent on license relationships for its key drug candidates, sabizabulin and enobosarm, and could lose the rights to these assets if it fails to comply with license obligations[286] Risks Related to Ownership of Our Common Stock Stockholders face risks including high ownership concentration, a Nasdaq delisting notice for failing to maintain a minimum $1.00 bid price, and potential harm to investor confidence from past financial restatements and internal control weaknesses - As of May 5, 2025, executive officers and directors beneficially owned approximately 15.2% of the company's common stock, giving them significant influence over corporate matters[296] - The company received a delisting notice from Nasdaq due to its stock price falling below $1.00, and has until August 25, 2025, to regain compliance, which may necessitate a reverse stock split[297][298] - Previous financial restatements and identified material weaknesses in internal controls (though now remediated) pose risks to investor confidence and could lead to further legal or regulatory scrutiny[301][302] Unregistered Sales of Equity Securities and Use of Proceeds In March 2025, the company issued 200,000 shares of common stock to a third-party consultant, claiming exemption from registration under Section 4(a)(2) of the Securities Act of 1933 and/or Regulation D - The company issued 200,000 shares of common stock to a third-party consultant in March 2025, claiming the transaction was exempt from registration[316] Exhibits This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including the FC2 business sale agreement, ENTADFI asset purchase agreement amendments, corporate governance documents, and required certifications - Key filed exhibits include the purchase agreement for the FC2 Business Sale and limited waivers related to the Onconetix promissory notes[317][320]