false
\n0000863894<\/p>\n
0000863894<\/p>\n
2026-06-02
\n2026-06-02<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
UNITED STATES<\/p>\n
SECURITIES AND EXCHANGE COMMISSION<\/p>\n
Washington, D.C. 20549<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
FORM 8-K<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
CURRENT REPORT<\/p>\n
Pursuant to Section\u00a013 or 15(d) of the Securities Exchange Act of 1934<\/p>\n
\u00a0<\/p>\n
Date of Report (Date of earliest event reported): June 2, 2026<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
VERU INC.<\/p>\n
(Exact name of registrant as specified in its charter)<\/p>\n
\u00a0<\/p>\n
Wisconsin<\/p>\n
\t\t\t\u00a0<\/p>\n
1-13602<\/p>\n
\t\t\t\u00a0<\/p>\n
39-1144397<\/p>\n
(State or other jurisdiction
of incorporation)<\/p>\n
\t\t\t\u00a0<\/p>\n
(Commission
File Number)<\/p>\n
\t\t\t\u00a0<\/p>\n
(IRS Employer
Identification No.)<\/p>\n
\u00a0<\/p>\n
2916 N. Miami Avenue, Suite 1000, Miami, Florida 33127<\/p>\n
Address of principal executive offices) (Zip Code)<\/p>\n
\u00a0<\/p>\n
Registrant\u2019s telephone number, including area code: (305) 509-6897<\/p>\n
\u00a0<\/p>\n
Not Applicable<\/p>\n
(Former name or former address, if changed since last report.)<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):<\/p>\n
\u00a0<\/p>\n
\u2610\u00a0<\/p>\n
Written communications pursuant to Rule\u00a0425 under the Securities Act (17 CFR 230.425)<\/p>\n
\t\t\t\u00a0<\/p>\n
\u00a0<\/p>\n
\u2610\u00a0<\/p>\n
Soliciting material pursuant to Rule\u00a014a-12 under the Exchange Act (17 CFR 240.14a-12)<\/p>\n
\t\t\t\u00a0<\/p>\n
\u00a0<\/p>\n
\u2610\u00a0<\/p>\n
Pre-commencement communications pursuant to Rule\u00a014d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<\/p>\n
\t\t\t\u00a0<\/p>\n
\u00a0<\/p>\n
\u2610\u00a0<\/p>\n
Pre-commencement communications pursuant to Rule\u00a013e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<\/p>\n
\u00a0<\/p>\n
Securities registered pursuant to Section 12(b) of the Act:<\/p>\n
\u00a0<\/p>\n
Title of each class<\/p>\n
Trading Symbol(s)<\/p>\n
Name of each exchange on which registered<\/p>\n
Common Stock, $0.01 par value per share<\/p>\n
VERU<\/p>\n
NASDAQ Capital Market<\/p>\n
\u00a0<\/p>\n
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (\u00a7230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (\u00a7240.12b-2 of this chapter).<\/p>\n
\u00a0<\/p>\n
Emerging growth company\u00a0\u2610<\/p>\n
\u00a0<\/p>\n
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.\u00a0\u2610<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
Item 8.01\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Other Events<\/p>\n
\u00a0<\/p>\n
On June 2, 2026, Veru Inc. (the \u201cCompany\u201d) entered into a clinical supply agreement (the \u201cSupply Agreement\u201d) with Novo Nordisk A\/S (\u201cNovo Nordisk\u201d) in conjunction with the Company\u2019s Phase 2b PLATEAU clinical study.* The objective of the Phase 2b PLATEAU clinical study is to evaluate the combination of enobosarm, the Company\u2019s oral, first-in-class, novel small molecule, selective androgen receptor modulator, with Novo Nordisk\u2019s Wegovy\u00ae** (semaglutide for injection), a GLP-1 RA, in older adults with obesity who are receiving Wegovy\u00ae therapy for weight reduction.<\/p>\n
\u00a0<\/p>\n
Under the terms of the Supply Agreement, the Company is solely responsible for conducting and sponsoring the Phase 2b\u00a0PLATEAU clinical study while Novo Nordisk will supply Wegovy\u00ae to the Company at no charge and as required for the conduct of the Phase 2b PLATEAU study. Novo\u00a0Nordisk provides Wegovy\u00ae solely for use within the study under a clinical supply agreement. In return, the Company will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates. While the Company maintains full global development and commercialization rights to enobosarm, the Company has granted Novo Nordisk a right of first negotiation in the Supply Agreement if the Company in the future intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy\u00ae, for any indication.<\/p>\n
\u00a0<\/p>\n
Forward-Looking Statements<\/p>\n
\u00a0<\/p>\n
This report contains \u201cforward-looking statements\u201d as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; and whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and\/or greater quantity weight loss in patients and whether this combination therapy will be the next generation drug that makes weight reduction more tissue selective for loss of fat, preservation of lean mass and physical function, improved body composition and maintaining or increasing bone mineral density. Forward-looking statements in this report can be identified by the use of forward-looking words or phrases such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201copportunity,\u201d \u201cplan,\u201d \u201cpredict,\u201d \u201cpotential,\u201d \u201cestimate,\u201d \u201cshould, \u201d \u201cwill,\u201d \u201cwould\u201d or the negative of these terms or other words of similar meaning. Any forward-looking statements in this report are based upon the Company\u2019s current plans and strategies and reflect the Company\u2019s current assessment of the risks and uncertainties related to its business and are made as of the date of this report. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, the Company\u2019s actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the development of the Company\u2019s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company\u2019s clinical trials support approval; the Company\u2019s ability to reach agreement with FDA on study design requirements for the Company\u2019s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government or any of its agencies; any products of the Company, if approved, not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company\u2019s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days\u2019 prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; and the effect of the SEC\u2019s \u201cbaby shelf\u201d rules on the Company\u2019s ability to raise sufficient capital when needed. This list is not exhaustive and other risks are detailed in the Company\u2019s periodic reports filed with the SEC, including the Company\u2019s Form\u00a010-K\u00a0for the year ended September\u00a030, 2026 and in the Company\u2019s subsequent Quarterly Reports on Form\u00a010-Q,\u00a0which are available at www.sec.gov.<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
*Novo Nordisk\u2019s participation in the PLATEAU study does not constitute endorsement of enobosarm or the combination approach tested in the study and Novo Nordisk\u2019s supply of Wegovy\u00ae (semaglutide) for the study does not constitute any representation regarding semaglutide\u2019s requirement for adjunctive therapy.<\/p>\n
\u00a0<\/p>\n
**Wegovy\u00ae is a registered trademark of Novo Nordisk A\/S.<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
SIGNATURES<\/p>\n
\u00a0<\/p>\n
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\t\t\t\u00a0
\n\t\t\t\u00a0
\n\t\t\t\u00a0<\/p>\n
Date: June 4, 2026<\/p>\n
VERU INC.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\n
\t\t\t\u00a0
\n\t\t\t\u00a0
\n\t\t\t\u00a0<\/p>\n
\t\t\t\u00a0<\/p>\n
By:\u00a0<\/p>\n
\/s\/\u00a0Michele Greco<\/p>\n
\t\t\t\u00a0
\n\t\t\t\u00a0<\/p>\n
Michele Greco<\/p>\n
\t\t\t\u00a0
\n\t\t\t\u00a0<\/p>\n
Chief Financial Officer and<\/p>\n
Chief Administrative Officer<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"false 0000863894 0000863894 2026-06-02 2026-06-02 \u00a0 \u00a0 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 \u00a0 \u00a0…\n","protected":false},"author":2,"featured_media":99879,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[51349,51346,51350,272,51348,51347,51351,51345,1910],"class_list":["post-99878","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-clinical-supply-agreement","tag-enobosarm","tag-glp-1-ra","tag-novo-nordisk","tag-obesity-trial","tag-phase-2b-plateau","tag-sec-8-k","tag-veru","tag-wegovy"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/116692176547917047","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/99878","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=99878"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/99878\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/99879"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=99878"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=99878"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=99878"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}