VERU INC. SEC Filings

Veru Inc. reported continued losses for the quarter and nine months ended June 30, 2026 as it transitions to a pure drug development business focused on enobosarm for obesity in older adults on GLP‑1 therapies and sabizabulin for atherosclerotic cardiovascular disease. The company had $23.9 million in cash, cash equivalents and restricted cash and $37.0 million in total assets, with $8.7 million in total liabilities and $28.4 million of stockholders’ equity.

For the nine months, Veru generated no revenue from continuing operations, recorded an operating loss of $20.4 million and a net loss of $15.1 million, improved from a $24.2 million loss a year earlier, aided by a $4.4 million gain from equity securities. Net cash used in operating activities was $20.6 million. Management states that existing cash is insufficient to fund the next 12 months under its current plan and concludes there is substantial doubt about the company’s ability to continue as a going concern absent additional financing.

Liquidity was bolstered by $23.4 million of net proceeds from an October 2025 underwritten offering and $5.3 million of net cash from investing activities, including monetization of its ENTADFI-related ONCO stake. Veru previously sold its FC2 business, which is now fully in discontinued operations, and in July 2026 put a $21.8 million at‑the‑market equity program in place.

Veru Inc. reported fiscal 2026 third quarter results and updates on its obesity and cardiometabolic pipeline. The company is a late clinical stage biopharmaceutical developer of enobosarm for high-quality weight loss in combination with GLP-1 receptor agonists and sabizabulin for inflammatory cardiovascular disease.

The Phase 2b PLATEAU trial of enobosarm plus semaglutide in older obese patients is fully enrolled with 239 patients, above the 200-patient target. An interim analysis based on 32 weeks of treatment is expected in calendar Q1 2027, with final topline data planned for Q4 2027. Veru highlighted prior positive results from the Phase 2b QUALITY study, which showed enobosarm plus semaglutide preserved lean mass and physical function, increased fat loss over 16 weeks, and that enobosarm monotherapy helped prevent weight regain after GLP-1 discontinuation.

The company recently received a USPTO Notice of Allowance for a U.S. patent covering enobosarm combined with weight-loss drugs, including semaglutide, with expected U.S. patent protection until at least October 2044, and is prosecuting additional method-of-use and formulation patents. Financially, Veru reported a Q3 2026 net loss of $6.99 million and a nine-month net loss of $15.06 million, narrower than the prior-year period. Cash, cash equivalents and restricted cash were $23.88 million as of June 30, 2026, versus $15.79 million at September 30, 2025, with total stockholders’ equity of $28.38 million.

Veru Inc. entered into a Sales Agreement with Oppenheimer & Co. Inc. and Canaccord Genuity LLC that allows it to issue and sell, from time to time, up to $21,800,000 of its common stock through an at-the-market offering program.

Sales will be made under Veru’s effective Form S-3 shelf registration, using a base prospectus and a prospectus supplement filed on July 2, 2026. Each sales agent will use commercially reasonable efforts to execute trades based on Veru’s instructions, and Veru will pay a 3.0% commission on aggregate gross proceeds, plus certain expenses, and provide customary indemnification.

Veru Inc. registered an at-the-market offering to sell up to $21,800,000 of its common stock pursuant to a Sales Agreement dated July 2, 2026 with Oppenheimer & Co. Inc. and Canaccord Genuity LLC.

The offering is being made under the company’s Form S-3 shelf (total capacity $200,000,000) and shares may be sold from time to time at market prices. The prospectus supplement states the shares may be sold through the designated Sales Agent as agent or principal and that the Sales Agents’ commission is 3.0% of gross proceeds. The company intends to use net proceeds for general corporate purposes. The offering size is subject to the Form S-3 instruction limiting sales to one-third of public float while public float remains below $75.0 million.

Veru Inc. entered a clinical supply agreement with Novo Nordisk A/S to support Veru’s Phase 2b PLATEAU obesity study. The trial will test Veru’s oral selective androgen receptor modulator enobosarm in combination with Novo Nordisk’s Wegovy (semaglutide) in older adults with obesity already receiving Wegovy for weight reduction.

Veru will sponsor and run the Phase 2b study, while Novo Nordisk will supply Wegovy at no charge for use solely within the trial. Veru will share trial design insights, methodology, and ongoing safety and protocol updates with Novo Nordisk. Veru keeps full global development and commercialization rights to enobosarm but grants Novo Nordisk a right of first negotiation if Veru later pursues development, commercialization, or licensing of enobosarm in combination with any Novo Nordisk GLP‑1 product.

The disclosure highlights typical clinical and regulatory risks, including whether PLATEAU will meet endpoints, FDA feedback and approvals, potential delays in enrollment, and the possibility that the Novo Nordisk supply arrangement can be terminated for convenience on 60 days’ notice. Veru also cites financing needs and the effect of SEC “baby shelf” rules as additional risk factors.

Veru Inc. reported a smaller net loss while remaining a pre‑revenue, late‑stage biotech focused on enobosarm and sabizabulin. For the six months ended March 31, 2026, net loss was $8.1 million versus $16.8 million a year earlier, helped by a $3.8 million gain on equity securities and lower operating expenses.

The company had $27.6 million in cash, cash equivalents, and restricted cash and used $15.1 million in operating cash over six months. Management states there is substantial doubt about Veru’s ability to continue as a going concern over the next 12 months without additional capital.

Veru sold its FC2 condom business and ENTADFI rights, reshaping itself around obesity and cardiovascular drug candidates. It raised about $23.4 million in an October 2025 equity offering that included common stock, pre‑funded warrants, and 16.8 million tradable warrants, but now depends on future financings to fund development.

Veru Inc. reported fiscal 2026 second quarter results and highlighted progress in its Phase 2b PLATEAU obesity trial of enobosarm plus semaglutide, which is actively enrolling and targeting an interim analysis in the first quarter of calendar 2027.

For the quarter ended March 31, 2026, Veru reduced its net loss to $2.7 million from $7.9 million a year earlier, helped by higher non-operating income of $4.1 million. Operating expenses fell to $7.2 million from $9.1 million as both research and development and general and administrative costs declined.

For the first six months of fiscal 2026, net loss narrowed to $8.1 million from $16.8 million. Cash, cash equivalents and restricted cash increased to $27.6 million as of March 31, 2026, supported by $23.4 million of net cash provided by financing activities during the period.

VERU INC. President and CEO Mitchell Steiner received a grant of options on 604,000 shares of common stock. The options have an exercise price of $2.25 per share and expire on May 4, 2036. One-third of the options vest on each of May 4, 2027, May 4, 2028, and May 4, 2029, reflecting a multi‑year compensation award tied to continued service.

VERU INC. Chief Admin Officer and CFO Michele Greco received a grant of options to purchase 164,000 shares of common stock at an exercise price of $2.25 per share. These are compensation-related awards, not open-market share purchases or sales.

According to the vesting schedule, options for one-third of the shares vest on each of May 4, 2027, May 4, 2028, and May 4, 2029, and the options expire on May 4, 2036. After this grant, Greco holds 164,000 options directly.