Every 8-K that Veru Inc. (VERU) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow VERU and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full VERU filings page.
Veru Inc. (VERU) reported new preclinical data showing that its oral microtubule-targeting agent sabizabulin maintains potent anticancer activity in KRAS-driven pancreatic and colon cancer cell lines that have become resistant to Revolution Medicines’ daraxonrasib (RASONQUE™), including an IC50 of 18.2 nM in a daraxonrasib‑resistant pancreatic cancer cell line. Based on these and prior data, Veru plans to advance sabizabulin into a planned Phase 2b clinical trial for metastatic KRAS-driven pancreatic cancer after daraxonrasib failure and has decided not to continue exploring sabizabulin for chronic inflammation related to atherosclerotic cardiovascular disease. Sabizabulin is protected by issued patents until 2043, with Veru retaining global development and commercialization rights.
The company also highlighted its obesity program: the Phase 2b PLATEAU trial of enobosarm plus semaglutide in older patients with obesity is fully enrolled with 239 patients, with an interim DXA-based analysis expected in Q1 2027 and topline data in Q4 2027. Veru has a clinical supply agreement with Novo Nordisk and a newly issued U.S. patent for enobosarm with GLP‑1 receptor agonists extending to late 2044. Veru plans a preIND meeting with the FDA in Q4 2026 to refine the sabizabulin pancreatic cancer development plan.
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. 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 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. reported results from its March 12, 2026 annual shareholder meeting. Shareholders approved an amendment to the 2018 Equity Incentive Plan, increasing common shares authorized for issuance from 2,600,000 to 5,850,000 and raising annual award limits for both executives and non-employee directors.
All nominated directors were re-elected, with votes for individual nominees ranging from 5,331,961 to 5,498,489, out of 16,050,320 shares eligible to vote. Shareholders ratified Cherry Bekaert LLP as auditor for the fiscal year ending September 30, 2026 and approved the advisory vote on executive compensation and the proposal allowing adjournment of the meeting if needed to solicit additional proxies.
Veru Inc. reported a narrower net loss for fiscal 2026 first quarter while advancing its obesity drug pipeline. Net loss from continuing operations was $5.33 million versus $1.81 million a year ago, but total net loss improved to $5.33 million from $8.95 million, which previously included discontinued operations. Operating expenses fell sharply to $5.42 million from $10.94 million, reflecting lower research and development and general and administrative spending. Cash, cash equivalents and restricted cash increased to $33.0 million from $15.8 million at September 30, 2025, helped by $23.37 million of net cash provided by financing activities.
Veru highlighted positive Phase 2b QUALITY data for obesity drug enobosarm in combination with semaglutide, showing greater fat loss and preservation of lean mass in older patients with obesity. The company received FDA feedback outlining regulatory pathways based on incremental weight loss and physical function or bone mineral density benefits. Veru plans a Phase 2b PLATEAU trial in about 200 older patients with obesity initiating semaglutide, with a 68‑week primary endpoint and an interim analysis at 34 weeks, expected to start in the first quarter of calendar 2026 and yield interim results in the first quarter of calendar 2027.
Veru Inc. released a press release announcing its financial results for the year ended September 30, 2025, and made that release available to investors as an exhibit to a current report. The press release is included as Exhibit 99.1.
The company furnished this information rather than formally filing it, so it is not treated as filed under certain securities law provisions or automatically included in other reports unless it is specifically referenced there.
Veru Inc. announced an underwritten public offering of 8,400,000 shares of common stock (or pre-funded warrants in lieu of shares), each sold together with Series A and Series B warrants to purchase up to 8,400,000 shares each, at a combined public offering price of $3.00 per share and accompanying warrants.
The company expects net proceeds of approximately $23.4 million, with closing anticipated on or about October 31, 2025, subject to customary conditions. The offering is made off Veru’s effective Form S-3 shelf. Pre-funded warrants are immediately exercisable at $0.001 per share, with holder ownership limits of 4.99% (or 9.99% upon election). Series A warrants are immediately exercisable at $3.00 and expire five years from issuance. Series B warrants are immediately exercisable at $3.00 and expire on the earlier of three years from issuance or achievement of specified clinical and stock price thresholds. Veru and its directors and officers agreed to a 90‑day lock-up, subject to exceptions.
Veru Inc. reported that amounts owed under two promissory notes issued by Onconetix, Inc. (formerly Blue Water Vaccines) totaling $8,826,155.41 as of September 22, 2025 were settled under a Settlement Agreement and Release. Under the settlement the company received $6,326,155.41 in cash, 3,125 shares of Onconetix Series D Convertible Preferred Stock (stated value $1,000 per share) and 846,975 warrants to purchase Onconetix common stock, and the promissory notes and the amended forbearance agreement terminated on payment.
The Series D Preferred is convertible (including at Veru's option) into Onconetix common stock, carries certain registration rights and may be redeemable by the borrower in specified circumstances. Veru states there is no assurance it will realize cash proceeds from the preferred shares, warrants, or any common stock acquired on exercise of the warrants. The full Settlement Agreement is filed as Exhibit 10.1.
Veru Inc. notified Nasdaq on August 26, 2025 that it has regained compliance with Nasdaq's minimum $1.00 bid price requirement for continued listing, and Nasdaq has closed the related matter. The earlier notice of noncompliance was issued August 29, 2024 because Veru's common stock had not maintained a minimum bid of $1.00 for 30 consecutive business days. Nasdaq originally gave Veru 180 calendar days to regain compliance, which was later extended to August 25, 2025. This 8-K confirms the company met the minimum bid price threshold by the extended deadline and the listing deficiency is resolved.
Veru Inc. effected a 1-for-10 reverse stock split of its common stock, effective 11:59 pm CT on August 8, 2025, converting every ten pre-split shares into one post-split share. The Nasdaq listing will trade on a split-adjusted basis beginning with the opening of trading on or about August 11, 2025, under the same ticker VERU and new CUSIP 92536C202. Fractional shares will not be issued; shareholders will receive cash in lieu of any fractional interest.
The split does not change the number of authorized shares or par value. The Board approved the 1-for-10 ratio after shareholders authorized a 1-for-2 to 1-for-20 range at a July 25, 2025 special meeting. Outstanding equity awards and reserved shares under the Company’s Schedules of equity plans were proportionately adjusted and the Company’s Form S-8 registration statements were amended by operation of Rule 416(b).
Veru Inc. filed a current report stating that it issued a press release announcing its financial results for the quarter and nine months ended June 30, 2025. The press release is included as Exhibit 99.1 and provides the detailed figures and commentary on the company’s performance for this period. The report clarifies that this information is being furnished rather than filed under securities law, which affects how it may be used in future legal and regulatory contexts.