Veru Inc. 2026年度季度报告

Veru Inc. Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file VERU INC.INDEX Item1. Financial Statements5 FORWARD LOOKING STATEMENTS Certain statements included in this quarterly report on Form 10-Q which are not statements of historical fact are intended to be, andare hereby identified as, “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.Such statements include, but are not limited to, statements about our financial condition or business, our development andcommercialization plans relating to our product candidates and products, including any potential development orcommercialization of enobosarm as a drug candidate that preserves muscle mass and augments fat loss in patients receiving aglucagon-like peptide-1 receptor agonist (“GLP-1 RA”) for greater amount and higher quality weight loss for the treatment ofobesity and sabizabulin to treat cardiovascular atherosclerotic disease to reduce major cardiovascular events, future financial andoperating results, plans, objectives, expectations and intentions, costs and expenses, royalty payments, outcome of litigation andother contingencies, financial condition, results of operations, liquidity, cost savings, our ability to continue as a going concern,objectives of management, business strategies, clinical trial timing, plans and results, the achievement of clinical and commercialmilestones, the advancement of our technologies and our products and drug candidates, our intellectual property strategy andwhether any products may be patented, and other statements that are not historical facts. Forward-looking statements can be ●potential delays in the timing of and results from clinical trials and studies, including potential delays in the recruitment ofpatients and their ability to effectively participate in such trials and studies, the potential suspension or termination of anysuch trials or studies, and the risk that such results will not support marketing approval or commercialization in the UnitedStates or in any foreign country;●potential delays in the timing of any submission to the U.S. Food and Drug Administration (the “FDA”) or any otherregulatory authority around the world and potential delays in, or failure to obtain, from any such regulatory authorityapproval of products under development, including the risk of a delay or failure in reaching agreement with the FDA onthe design of any clinical trial, including any post-approval or post-authorization study, or in obtaining authorization tocommence a clinical trial or commercialize a product candidate in the U.S. or elsewhere, and the risk that the terms of anyregulatory approval may limit the drug’s commercial potential;●although we have sought and received feedback from the FDA on the designs of our clinical trials and intend to continueto do so, the FDA may ultimately disagree that our trials support approval;●potential delays in the timing of approval by the FDA or any other regulatory authority of the release of manufactured lotsof approved products;●clinical trial results supporting any potential regulatory approval or authorization of any of our products, including Table of Contents ●risks related to our ability to obtain insurance reimbursement from private payors or government payors, includingMedicare and Medicaid, and similar risks relating to market or political acceptance of any potential or actual pricing forany of our product candidates that, if approved, we attempt to commercialize;●all of our products are in development and we may fail to obtain regulatory approval for or successfully commercializesuch products;●risks related to intellectual property, including the uncertainty of obtaining intellectual property protections and inenforcing them, the possibility of infringing a third party’s intellectual property, and licensing risks, and the Company’sability to fund any enforcement or defense of its intellectual property rights;●competition from existing and new competitors with respect to our products in development, if approved, including thepotential for reduced sales, pressure on pricing, and increased spending on marketing;●risks related to compliance and regulatory matters, including costs and delays resulting from extensive governmentregulation and reimbursement and coverage under healthcare insurance and regulation as well as potential healthcarereform measures;●the risk that we will be affected by regulatory and legal developments;●risks inherent in doing business on an international level, including currency risks, tariffs, regulatory requirements,political risks, export restrictions and other trade barriers, and including restrictions on the importation or sale o