Veru Inc.

Company Overview

Business Model: Veru Inc. is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. Its drug development program consists of two late-stage new chemical entities: enobosarm, an oral selective androgen receptor modulator (SARM) for obesity, and sabizabulin, a microtubule disruptor for atherosclerotic cardiovascular disease. Veru Inc. completed the sale of its FDA-approved commercial product, the FC2 Female Condom (Internal Condom) business, on December 30, 2024, and its ENTADFI assets on April 19, 2023, thereby transitioning its focus entirely to biopharmaceutical product development.

Market Position: Veru Inc. is developing drug candidates for significant unmet medical needs.

• Enobosarm: Positioned as a first-in-class oral SARM, no drugs are currently approved by the FDA for chronic weight management with preservation of lean mass (muscle) and bone, either alone or in combination with GLP-1 receptor agonists. The annual revenues for muscle preservation drugs for obesity treatment are expected to reach $30 billion.
• Sabizabulin: Positioned as a novel oral broad anti-inflammatory agent for atherosclerotic cardiovascular disease, aiming to offer a potentially better efficacy and safety profile than colchicine, the first FDA-approved anti-inflammatory drug for this indication, which has known serious safety concerns and drug-drug interactions.

Recent Strategic Developments:

• FC2 Business Sale: On December 30, 2024, Veru Inc. sold its FC2 Female Condom (Internal Condom) business for $18.0 million in cash, with net proceeds of $16.5 million, marking a strategic shift to focus on biopharmaceutical development.
• ENTADFI Asset Sale Settlement: On September 22, 2025, Veru Inc. entered into a Settlement Agreement with Onconetix, Inc. for the sale of ENTADFI assets, accepting a cash payment of $6.3 million, 3,125 shares of Onconetix, Inc.'s Series D Convertible Preferred Stock, and a warrant to purchase 846,975 shares of Onconetix, Inc.'s common stock in full satisfaction of amounts due.
• Enobosarm Clinical Development:
  • Announced positive topline results for the Phase 2b QUALITY clinical trial in January 2025, meeting the primary endpoint with a statistically significant and clinically meaningful benefit in the preservation of total lean body mass (100% relative reduction in lean mass loss, p<0.001) with enobosarm 3mg + semaglutide versus placebo + semaglutide at 16 weeks.
  • Announced positive topline safety results for the Phase 2b QUALITY clinical study in May 2025, showing a positive safety profile for the enobosarm + semaglutide combination compared to semaglutide alone, with no increases in gastrointestinal side effects, drug-induced liver injury, obstructive sleep apnea, prostate specific antigen in men, or masculinization in women.
  • Announced positive results from the Maintenance Extension portion of the Phase 2b QUALITY clinical study in June 2025, demonstrating that enobosarm monotherapy significantly prevented the regain of both weight and fat mass after semaglutide discontinuation.
  • Received FDA guidance that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint for approval, and enobosarm 3mg is an acceptable dosage. The FDA also encouraged expansion to a younger population.
  • A planned Phase 2b PLATEAU clinical study for enobosarm 3mg in approximately 200 patients with obesity (BMI ≥ 35) and age ≥ 65, initiating GLP-1 RA treatment, is expected to begin in Q1 calendar 2026. The primary endpoint is the percent change from baseline in total body weight at 72 weeks.
  • Veru Inc. is developing a novel, patentable, modified release oral formulation for enobosarm, with expected patent expiry in 2046 if issued. A pilot pharmacokinetic study showed a 25-33% reduction in maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak, and similar extent of absorption (AUC) compared to historical values for enobosarm immediate release capsules.
• Sabizabulin Clinical Development:
  • Veru Inc. evolved its drug development strategy to explore clinical development for inflammation in atherosclerotic cardiovascular disease, based on unmet medical need, large market opportunity, existing safety database (266 patients), mechanism of action similar to colchicine, and strong intellectual property.
  • A pre-IND meeting with the FDA Division of Cardiology and Nephrology Center for Drug Evaluation and Research on December 26, 2024, confirmed the unmet medical need.
  • Veru Inc. plans a small Phase 2 dose-finding proof of concept study to assess the reduction in blood levels of high sensitivity C-reactive protein in patients with stable coronary artery disease.
• Reverse Stock Split: Veru Inc. effected a 1-for-10 reverse stock split on August 8, 2025, to regain compliance with Nasdaq listing rules.
• Equity Offering (Subsequent Event): On October 31, 2025, Veru Inc. completed an underwritten public offering, raising approximately $23.4 million in net proceeds.

Geographic Footprint: Veru Inc.'s headquarters are located in Miami, Florida. The company had U.K. and Malaysian operating subsidiaries related to the FC2 business, which were sold on December 30, 2024. Other foreign subsidiaries (Veru Biopharma Netherlands B.V., Veru Biopharma UK Limited, and Veru Biopharma Europe Limited) were dissolved in November 2024, July 2025, and September 2025, respectively. All 20 full-time employees are located in the U.S.

Financial Performance

Revenue Analysis

Note: Veru Inc. currently has no commercial revenue from continuing operations after the sale of the FC2 Business and ENTADFI assets. The reported Net Income reflects the total net loss, including discontinued operations. The net loss from continuing operations was $(15.7) million in FY2025 compared to $(35.3) million in FY2024.

Profitability Metrics:

• Gross Margin: Not applicable (no revenue from continuing operations).
• Operating Margin: Not applicable (no revenue from continuing operations).
• Net Margin: Not applicable (no revenue from continuing operations).

Investment in Growth:

• R&D Expenditure: $15.6 million (FY2025) vs. $12.8 million (FY2024), an increase of 21.9%.
• Capital Expenditures: $1,083 (FY2025) vs. $158,322 (FY2024).
• Strategic Investments: Investment in equity securities (Onconetix, Inc. Series D Preferred Stock and Warrant) valued at $2.5 million as of September 30, 2025, received as part of the ENTADFI asset sale settlement.

Business Segment Analysis

Veru Inc. operates as a single operating segment focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. The company does not have revenue from continuing operations and manages business activities on a consolidated basis.

Obesity Program (Enobosarm)

Financial Performance:

• Revenue: Not applicable (in clinical development).
• Operating Margin: Not applicable.
• Key Growth Drivers:
  • Positive Phase 2b QUALITY clinical trial results demonstrated 100% relative reduction in lean mass loss (p<0.001) and dose-dependent greater fat mass loss (42% greater with 6mg, 12% greater with 3mg) when enobosarm was combined with semaglutide.
  • Positive safety profile in Phase 2b QUALITY study, with no increases in gastrointestinal side effects, drug-induced liver injury, obstructive sleep apnea, prostate specific antigen in men, or masculinization in women.
  • Maintenance Extension study showed enobosarm monotherapy significantly prevented weight and fat mass regain after semaglutide discontinuation.
  • FDA guidance accepting incremental weight loss as a primary endpoint and 3mg dosage for future development, and encouragement to expand to a younger population.
  • Planned Phase 2b PLATEAU clinical study to evaluate enobosarm 3mg on total body weight, physical function, and safety in approximately 200 obese patients (BMI ≥ 35, age ≥ 65) initiating GLP-1 RA treatment, starting Q1 calendar 2026.

Product Portfolio:

• Enobosarm: An oral selective androgen receptor modulator (SARM) being developed to preserve muscle/physical function and augment fat loss in patients with obesity receiving GLP-1 RA for weight reduction.
• Novel Modified Release Oral Enobosarm Formulation: Currently developing a patentable formulation with reduced Cmax, delayed Tmax, and similar AUC, expected to be available for Phase 3 clinical studies and commercialization. Patent expiry expected in 2046 if issued.

Market Dynamics:

• Addresses an urgent unmet medical need for a drug that can augment fat loss and preserve muscle and physical function in obese patients receiving GLP-1 RAs, especially those with sarcopenic obesity (up to 34.4% of obese patients over 60 in the U.S.).
• Aims to optimize weight loss by shifting tissue composition to greater selective fat loss, potentially resetting the weight loss plateau observed with GLP-1 RAs alone.
• The market for muscle preservation drugs for obesity treatment is expected to reach $30 billion annually.

Atherosclerosis Inflammation Program (Sabizabulin)

Financial Performance:

• Revenue: Not applicable (in clinical development).
• Operating Margin: Not applicable.
• Key Growth Drivers:
  • Significant unmet medical need to treat inflammation in atherosclerotic cardiovascular disease, which is a leading cause of mortality worldwide.
  • Large global market opportunity.
  • Mechanism of action similar to colchicine, which has shown significant cardiovascular risk reduction (31% in stable CAD, 23% post-myocardial infarction) and is FDA-approved for reducing cardiovascular events.
  • Sabizabulin has a different chemical structure than colchicine, is not a substrate for CYP3A4 and P-glycoprotein, potentially eliminating drug-drug interactions and offering a safer profile for combination with statin therapy.
  • Existing clinical and safety database of 266 dosed patients from prior COVID-19 and prostate cancer studies.
  • Strong intellectual property position with method of use patent applications pending with expected expiry of 2046.

Product Portfolio:

• Sabizabulin: A novel oral broad anti-inflammatory agent (microtubule disruptor) being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.

Market Dynamics:

• Aims to address the residual inflammatory risk in atherosclerotic cardiovascular disease, which remains largely untreated even with cholesterol reduction therapies.
• Leverages the clinical pathway opened by FDA approval of colchicine for reducing cardiovascular events in ASCVD, but seeks to overcome colchicine's serious safety concerns (drug-drug interactions, narrow therapeutic index, gastrointestinal side effects, rare but fatal blood dyscrasias, neurotoxicity, rhabdomyolysis).
• Planned Phase 2 dose-finding proof of concept study to assess reduction in high sensitivity C-reactive protein in patients with stable coronary artery disease.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: Not mentioned.
• Dividend Payments: Veru Inc. has not declared or paid cash dividends on its common stock since May 2014 and currently intends to retain all future earnings, if any, to finance the growth and development of its business.
• Dividend Yield: Not applicable.
• Future Capital Return Commitments: Not mentioned.

Balance Sheet Position:

• Cash and Equivalents: $15.8 million (as of September 30, 2025) vs. $24.9 million (as of September 30, 2024).
• Total Debt: $3.1 million (as of September 30, 2025), primarily operating lease liabilities. The Residual Royalty Agreement liability of $9.9 million (including $1.0 million short-term) as of September 30, 2024, was extinguished in FY2025.
• Net Cash Position: $12.7 million (as of September 30, 2025) vs. $11.4 million (as of September 30, 2024).
• Credit Rating: Not disclosed.
• Debt Maturity Profile:
  • Operating Lease Liabilities: $788,467 (FY2026), $810,055 (FY2027), $831,579 (FY2028), $856,526 (FY2029), $361,270 (FY2030). Total $3,647,897.
  • Settlement Liabilities (supplier dispute): $2,572,961 (FY2026), $1,029,397 (FY2027), $330,474 (FY2028). Total $3,932,832 (subsequent to September 30, 2025 payment).

Cash Flow Generation:

• Operating Cash Flow: $(30.0) million (FY2025) vs. $(21.7) million (FY2024).
• Free Cash Flow: $(30.0) million (FY2025) vs. $(21.9) million (FY2024) (Operating Cash Flow less Capital Expenditures).
• Cash Conversion Metrics: Not disclosed.

Operational Excellence

Production & Service Model: Veru Inc. relies on third-party manufacturers and other third parties to produce, package, and store drug candidates for use in its clinical trials. These drug candidates are complicated and expensive to manufacture. The company does not have internal manufacturing capabilities for its drug candidates.

Supply Chain Architecture: Key Suppliers & Partners:

• Contract Research Organizations (CROs): Veru Inc. relies on CROs to conduct research and development activities and clinical studies for its drug candidates.
• Third-Party Manufacturers: Veru Inc. relies on third-party manufacturers to produce, package, and store drug candidates for clinical trials. These manufacturers are required to comply with the FDA’s current Good Manufacturing Practices (cGMPs).
• Technology Partners: Veru Inc. is developing a novel modified release oral enobosarm formulation that utilizes proprietary third-party patented technology.

Facility Network:

• Manufacturing: Not disclosed as internal facilities. Relies on third-party manufacturers.
• Research & Development: Not disclosed as internal facilities. Relies on CROs.
• Distribution: Not disclosed.
• Headquarters: Miami, Florida, in approximately 12,000 square feet of office space under a lease term from March 1, 2022, to February 28, 2030.

Operational Metrics:

• Capacity utilization, efficiency measures, quality indicators: Not explicitly disclosed in the filing.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Not applicable for current drug candidates in development.
• Channel Partners: Not applicable for current drug candidates in development.
• Digital Platforms: Not applicable for current drug candidates in development.

Customer Portfolio: Enterprise Customers:

• Tier 1 Clients: Not applicable for current drug candidates in development.
• Strategic Partnerships: Veru Inc. may enter into collaboration arrangements with strategic partners to develop and commercialize drug candidates or companion diagnostics. A past collaboration with Eli Lilly and Company for the ENABLAR-2 clinical trial was terminated on August 22, 2024.
• Customer Concentration: Not applicable for current drug candidates in development.

Geographic Revenue Distribution:

• Not applicable as Veru Inc. currently has no commercial revenue from continuing operations.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The pharmaceutical industry is highly competitive and characterized by extensive research efforts and rapid technological progress.

• Obesity Market: The market for treatments relating to obesity, including treatments for muscle atrophy and muscle weakness in patients receiving GLP-1 RA, is highly competitive and includes major pharmaceutical companies. The annual revenues for muscle preservation drugs for obesity treatment are expected to reach $30 billion.
• Atherosclerotic Cardiovascular Disease Market: Atherosclerotic coronary artery disease (CAD) is the leading cause of mortality worldwide. Inflammation and high cholesterol jointly contribute to the disease, with inflammation largely driving pathogenesis and progression. There remains a major and largely untreated residual inflammatory risk even with cholesterol reduction therapies. Colchicine was FDA-approved in June 2023 for reducing cardiovascular events in adults with established ASCVD, making it the first anti-inflammatory drug with such an indication, but it has known serious safety concerns and drug-drug interactions.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• Major Pharmaceutical Companies: Many competitors have substantially greater research and development, regulatory capabilities, and financial resources.
• Specialty Pharmaceutical Companies and Biotechnology Firms: Also active in the competitive landscape.
• Universities and Other Research Institutions and Government Agencies: Contribute to research and development.
• For Enobosarm: Other companies developing treatments for obesity, particularly those addressing muscle atrophy and weakness in GLP-1 RA patients. No drugs are currently approved for this specific indication.
• For Sabizabulin: Colchicine (FDA-approved for reducing cardiovascular events in ASCVD) is a direct mechanistic comparator, but sabizabulin aims to differentiate on safety profile.

Emerging Competitive Threats:

• New products or technologies that are more effective, safer, or less costly.
• Unforeseen complications arising with respect to Veru Inc.'s products.
• Insufficient third-party insurance coverage or reimbursement for Veru Inc.'s products.

Competitive Response Strategy:

• Focus on clinical development and commercialization of novel medicines for unmet medical needs.
• Leverage management team's expertise in drug development and regulatory matters.
• Protect intellectual property through patents and trade secrets.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics:

• No Commercial Revenue: Veru Inc. currently has no commercial revenue and may never generate revenue or become profitable.
• Technology Disruption: New products or technologies introduced by competitors could be more effective, safer, or less costly.
• Market Acceptance: Physicians, patients, and payors may not accept Veru Inc.'s drug candidates if approved, or market acceptance may not be maintained over time.
• Governmental Pricing Controls: Potential for governmental pricing controls in foreign markets and the U.S. could negatively impact profitability.
• FDA Regulatory Exclusivity: Competing products may obtain FDA approval with marketing exclusivity before Veru Inc., delaying or preventing market entry.
• Economic Sensitivity: Potential products may be affected by general economic conditions, including inflation, recessionary pressures, rising interest rates, labor shortages, and rising unemployment, which could reduce expenditures for products.

Operational & Execution Risks

Supply Chain Vulnerabilities:

• Third-Party Manufacturing Reliance: Reliance on third-party manufacturers for drug candidates for clinical trials. Failure to deliver timely, with sufficient quality, or at reasonable prices could delay or suspend clinical trials.
• CRO Reliance: Reliance on CROs for research and development activities and clinical studies. Failure to conduct research properly, timely, or cost-effectively, or non-compliance with cGCPs, could delay or terminate clinical trials.
• Capacity Constraints: Potential for manufacturing delays if CMOs give greater priority to the supply of other products over Veru Inc.'s products.

Financial & Regulatory Risks

Market & Financial Risks:

• Net Losses & Going Concern: Veru Inc. has incurred net losses in recent fiscal years and expects to continue incurring losses. Its independent registered public accounting firm has included an explanatory paragraph relating to Veru Inc.'s ability to continue as a going concern.
• Need for Additional Capital: Veru Inc. will need to raise substantial additional capital to fund operations and development programs. Financing may not be available on favorable terms, or at all, and could be dilutive to existing stockholders.
• Unstable Market & Economic Conditions: Global and domestic credit and financial markets disruptions (e.g., severely diminished liquidity, declines in consumer confidence, inflation, recessionary pressures, rising interest rates, geopolitical conflicts) may adversely affect Veru Inc.'s ability to raise funds.
• Supplier Dispute Payment Obligations: Veru Inc. is subject to aggregate liabilities of $3.9 million (as of September 30, 2025, after a $1.6 million payment subsequent to year-end) from a resolved dispute with a sabizabulin supplier.
• Credit & Liquidity: Veru Inc.'s cash, cash equivalents, and restricted cash are estimated to be insufficient to fund operating, investing, and financing cash flow needs for the twelve months subsequent to the financial statements' issuance date.

Regulatory & Compliance Risks:

• Limited Regulatory Approval Experience: Veru Inc. has limited experience in obtaining regulatory approval for a drug (only ENTADFI, which was sold).
• Clinical Trial Delays/Failures: Clinical trials are lengthy, expensive, and have uncertain outcomes. Delays or unfavorable results could prevent regulatory approval.
• FDA/Government Agency Disruptions: The ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by government budget, policy changes, and shutdowns.
• Employee Misconduct: Exposure to risk of employee fraud or other misconduct, including failures to comply with FDA regulations, marketing laws, healthcare fraud laws, and anti-corruption laws.
• Extensive Governmental Regulation: Subject to extensive and costly domestic and foreign government regulation (FDA, Federal Trade Commission, Centers for Medicare & Medicaid Services, U.S. Department of Justice, state/local governments).
• Changes in Law: Changes in regulatory requirements (e.g., new legislation, regulations, or policies) may require amendments to clinical trial protocols or new clinical trials, significantly affecting cost, timing, and completion.
• Data Privacy & Security: Subject to data privacy and security regulations (HIPAA, HITECH, GDPR, California Consumer Privacy Act) and risks from cyber-attacks or security breaches.
• Anti-Corruption Laws: Subject to the Foreign Corrupt Practices Act (FCPA) and similar anti-corruption laws in other countries (e.g., the United Kingdom’s Bribery Act).
• Legal Proceedings:
  • Shareholder Litigation: Veru Inc. and certain officers/directors are defendants in six shareholder lawsuits alleging violations of securities laws and state law claims primarily related to public statements about sabizabulin as a treatment for COVID-19. Veru Inc. has a $5 million retention amount for insurance coverage.
  • Clear Future Lawsuit: Clear Future, Inc. (purchaser of FC2 Business) filed a complaint on August 5, 2025 (amended October 2, 2025) alleging breach of representations and warranties and fraud related to the FC2 Business Sale, and seeking indemnification for a pre-closing tax liability of approximately $137,000. Potential exposure for breach of representations and warranties is limited to $54,000 except in case of fraud.

Geopolitical & External Risks

Geopolitical Exposure:

• Trade Relations: Tensions in trading relations between the U.S. and other countries could reduce trade volume, investment, technological exchange, and other economic activities, resulting in disruptions in global economic conditions and financial markets.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• Enobosarm (SARM): Investment in developing as a next-generation drug to make GLP-1 RA weight reduction more tissue-selective for fat loss and lean mass preservation, improving body composition and physical function.
• Sabizabulin (Microtubule Disruptor): Investment in developing for the treatment of inflammation in atherosclerotic cardiovascular disease, aiming to reduce major cardiovascular events.
• Innovation Pipeline:
  • Enobosarm: Planned Phase 2b PLATEAU clinical study for obesity (Q1 calendar 2026 start). Development of a novel, patentable, modified release oral formulation.
  • Sabizabulin: Planned small Phase 2 dose-finding proof of concept study for atherosclerotic cardiovascular disease.

Intellectual Property Portfolio:

• Patent Strategy:
  • Enobosarm: Veru Inc. holds an exclusive worldwide license to 16 issued U.S. patents, 2 pending U.S. patent applications, and 60 patents and patent applications in countries outside the U.S. The latest composition of matter patent expiration is 2029 (extended to 2034 if Patent Term Extension (PTE) applies). Veru Inc. owns 6 pending method of use patent applications (5 U.S., 1 PCT) related to the use of enobosarm in chronic weight management, with the longest patent term, if issued, expected to expire in 2044. Veru Inc. also owns 2 pending formulation composition of matter patent applications for the novel modified release formulation, with expected patent term to 2046 if issued.
  • Sabizabulin: Veru Inc. holds an exclusive worldwide license to 13 issued U.S. patents, 1 pending U.S. patent application, and 14 patents and patent applications in countries outside the United States. The latest molecule composition of matter patent expiration is 2031 (extended to 2036 if PTE applies). Veru Inc. owns 2 U.S. patents (a polymorph composition of matter patent expiring in 2043, extended to 2048 if PTE applies; and methods of treating coronavirus expiring in 2041), 6 U.S. applications, and 69 patents and patent applications in countries outside of the U.S. (including pending polymorph composition of matter patents with an expected term to 2043, and methods of use of sabizabulin in cardiometabolic diseases with expected expiry of 2046).
• Licensing Programs: Veru Inc. has license agreements requiring milestone and royalty payments to licensors (University of Tennessee Research Foundation for enobosarm, Ohio State Innovation Foundation for sabizabulin).
• IP Litigation: Not explicitly mentioned as current material litigation, but a general risk factor is facing claims that intellectual property infringes on third-party rights.

Technology Partnerships:

• Strategic Alliances: Veru Inc. may enter into collaboration arrangements with strategic partners for development and commercialization. A past collaboration with Eli Lilly and Company for the ENABLAR-2 clinical trial was terminated on August 22, 2024.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: Veru Inc.'s key human capital management objectives include identifying, recruiting, integrating, retaining, and motivating new and existing employees.

Board Composition:

• Audit Committee: Lucy Lu, M.D. (Chairperson), Michael L. Rankowitz, and Loren Katzovitz.
• Independence: Information regarding director independence is incorporated by reference to the Proxy Statement for the 2026 Annual Meeting of Shareholders.
• Expertise Areas: Not explicitly detailed in the filing.

Human Capital Strategy

Workforce Composition:

• Total Employees: 20 full-time employees (as of December 1, 2025).
• Geographic Distribution: All employees are located in the U.S.
• Skill Mix: Not explicitly detailed, but the company plans to expand its scientific, sales and marketing, managerial, operational, financial, and other resources to support planned research, development, and commercialization activities.

Talent Management: Acquisition & Retention:

• Hiring Strategy: Objectives include identifying, recruiting, integrating, retaining, and motivating new and existing employees.
• Retention Metrics: Not disclosed.
• Employee Value Proposition: Offers an annual base salary and a comprehensive package of additional benefits that support the physical and mental health and wellness of all employees and their families. May grant equity awards, presently vesting over a three-year period, to attract and promote employee retention.

Diversity & Development:

• Diversity Metrics: Not disclosed.
• Development Programs: Committed to fostering an environment where all employees can grow and thrive.
• Culture & Engagement: Not explicitly detailed beyond fostering an environment for growth and thriving.

Environmental & Social Impact

Environmental Commitments: Climate Strategy:

• Emissions Targets: Not disclosed.
• Carbon Neutrality: Not disclosed.
• Renewable Energy: Not disclosed.

Supply Chain Sustainability:

• Supplier Engagement: Not disclosed.
• Responsible Sourcing: Not disclosed.

Social Impact Initiatives:

• Community Investment: Not disclosed.
• Product Impact: Not disclosed.

Note: Veru Inc. believes there are no material issues or material costs associated with its compliance with environmental laws and did not incur environmental expenses in fiscal 2025 or 2024, nor does it anticipate environmental expenses in the foreseeable future.

Business Cyclicality & Seasonality

Demand Patterns:

• Seasonal Trends: Not applicable for drug candidates in development.
• Economic Sensitivity: Veru Inc.'s financing strategy and potential future product sales may be adversely affected by an economic downturn, volatile business environment, and unpredictable market conditions, including inflation, recessionary pressures, rising interest rates, and unemployment.
• Industry Cycles: Not explicitly detailed for its specific drug development focus.

Planning & Forecasting:

• Veru Inc. uses cash forecast models to assess entity-wide operating results and performance, and to decide how to invest in the drug development segment. Net loss, net cash used in operating activities, and cash on hand are monitored for segment performance.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations:

• FDA Regulation of Prescription Pharmaceutical Products: Veru Inc. is subject to extensive and rigorous requirements for clinical development, manufacture, and marketing, including nonclinical tests, Investigational New Drug (IND) submission, human clinical trials (Phase 1, 2, 3), pre-approval manufacturing inspections, and New Drug Application (NDA) approval.
• 505(b)(1) Approval Process: Enobosarm and sabizabulin are expected to follow this regulatory pathway, requiring all studies for approval to be conducted by or for Veru Inc.
• Post-Approval Requirements: Any approved pharmaceutical products will be subject to continuing FDA regulation, including recordkeeping requirements, reporting of adverse experiences, and compliance with current Good Manufacturing Practices (cGMPs).
• Federal Trade Commission (FTC) Regulation of Advertising: The FTC regulates OTC drug and non-restricted medical device advertising and promotional materials, requiring substantiation of claims.
• Other Healthcare Regulations: Veru Inc. is subject to federal and state laws including the federal health care program anti-kickback statute (AKS), the Federal False Claims Act, the Medicare/Medicaid civil monetary penalties statute, federal and state health care practitioner payment sunshine laws, state price increase transparency laws, and various federal laws requiring price reporting or discounted pricing to the government.
• Data Privacy and Security: Veru Inc. is subject to data privacy and security regulations by both the federal government (e.g., Health Insurance Portability and Accountability Act of 1996 (HIPAA), Health Information Technology for Economic and Clinical Health Act (HITECH)) and states, as well as international regulations like the General Data Protection Regulation (GDPR).
• Anti-Corruption Laws: Veru Inc. is subject to the Foreign Corrupt Practices Act (FCPA) and similar anti-corruption laws in other countries, such as the United Kingdom’s Bribery Act.
• International Compliance: To the extent Veru Inc. chooses to develop or sell any products outside of the U.S., it will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution, which may be equally or more demanding than U.S. regulation.

Trade & Export Controls:

• Export Restrictions: Not explicitly detailed for current drug candidates.
• Sanctions Compliance: Not explicitly detailed for current drug candidates.

Legal Proceedings:

• Shareholder Litigation: Veru Inc. and certain officers/directors are defendants in six shareholder lawsuits (Ewing Lawsuit, Maglia Lawsuit, Franchi Lawsuit, Renbarger Lawsuit, Alshourbagy Lawsuit, Ovadias Lawsuit) alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, and state law claims (breach of fiduciary duty, waste of corporate assets, unjust enrichment, abuse of control, gross mismanagement, contribution) primarily related to public statements about sabizabulin as a treatment for COVID-19. Veru Inc. has a $5 million retention amount for insurance coverage.
• Clear Future Lawsuit: Clear Future, Inc. (purchaser of the FC2 Business) filed a complaint on August 5, 2025 (amended October 2, 2025) alleging breach of representations and warranties and fraud related to the FC2 Business Sale, and seeking indemnification for a pre-closing tax liability of approximately $137,000. Veru Inc.'s potential exposure for breach of representations and warranties is limited to $54,000 except in the case of fraud.
• License and Purchase Agreements: Veru Inc. licenses or purchases rights to technology or intellectual property from third parties, requiring upfront payments, development or other payments upon successful completion of preclinical, clinical, regulatory, or revenue milestones, and potentially royalties on sales.
• Collaborative Arrangements: The Clinical Trial Collaboration and Supply Agreement with Eli Lilly and Company for the ENABLAR-2 clinical trial was terminated on August 22, 2024.
• Resolution of Commercial Dispute: Veru Inc. agreed to pay a supplier $8.3 million to resolve a dispute related to sabizabulin commercialization efforts. $2.3 million was paid in February 2024, $3.5 million is payable in equal monthly installments through January 31, 2028, and $2.5 million is payable from proceeds of certain payments from the ONCO Promissory Notes (if not paid in full by December 31, 2025, the balance will be paid in 24 equal monthly installments commencing in January 2026). Aggregate liabilities related to this agreement are $3.9 million as of September 30, 2025 (after a $1.6 million payment subsequent to year-end).

Tax Strategy & Considerations

Tax Profile:

• Effective Tax Rate: Not explicitly stated as a single rate due to net losses and valuation allowances.
• Geographic Tax Planning: Veru Inc. is subject to income taxes in the U.S., the U.K., and other global jurisdictions. Foreign subsidiaries (Veru Biopharma Netherlands B.V., Veru Biopharma UK Limited, and Veru Biopharma Europe Limited) were dissolved in fiscal 2025.
• Tax Reform Impact: The One Big Beautiful Bill Act (OBBBA) was enacted in the U.S. on July 4, 2025, with significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act of 2017 (TCJA), allowing for accelerated tax deductions for qualified property and research expenditures, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in fiscal year 2026 and others implemented through fiscal year 2028.
• Net Operating Loss (NOL) Carryforwards: As of September 30, 2025, Veru Inc. had U.S. federal NOL carryforwards of approximately $161.8 million and state NOL carryforwards of $92.8 million. Federal research and development tax credit carryforwards totaled $8.2 million.
• Valuation Allowance: A full valuation allowance of $75.5 million was recorded against U.S. deferred tax assets as of September 30, 2025, due to projected future pretax losses. A full valuation allowance of $3.2 million was also recorded against the U.K. holding company.

Insurance & Risk Transfer

Risk Management Framework:

• Insurance Coverage: Veru Inc. maintains limited general commercial liability insurance coverage. It has tail product liability insurance coverage of $10.0 million for claims arising from previously sold products. Veru Inc. also has director and officer liability insurance coverage, subject to a $5 million retention amount, for shareholder litigation.
• Risk Transfer Mechanisms: Not explicitly detailed beyond insurance coverage.