VERU INC.
For the period ended Jun 30, 2026. Filed Aug 10, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 10, 2026
VERU$2.12+2.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001437749-26-016557
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001437749-26-026664
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 93 previous paragraphs and 105 current paragraphs.
60 unchanged; 31 reworded; 14 added; 1 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Phase 2b PLATEAU Clinical Study
Current report
On June 2, 2026, the Company entered into a clinical supply agreement (the “Supply Agreement”) with Novo Nordisk A/S (“Novo Nordisk”) in conjunction with the Company’s Phase 2b PLATEAU clinical study*. The objective of the Phase 2b PLATEAU clinical study is to evaluate the combination of enobosarm, the Company’s oral, first-in-class, novel small molecule, selective androgen receptor modulator, with Novo Nordisk’s Wegovy®** (semaglutide for injection), a GLP-1 RA, in older adults with obesity who are receiving Wegovy® therapy for weight reduction. Under the terms of the Supply Agreement, the Company is solely responsible for conducting and sponsoring the Phase 2b PLATEAU clinical study while Novo Nordisk will supply Wegovy® to the Company at no charge and as required for the conduct of the Phase 2b PLATEAU study. Novo Nordisk provides Wegovy® 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®, for any indication.
Current report
*Novo Nordisk’s participation in the PLATEAU study does not constitute endorsement of enobosarm or the combination approach tested in the study and Novo Nordisk’s supply of Wegovy® (semaglutide) for the study does not constitute any representation regarding semaglutide’s requirement for adjunctive therapy.
Current report
**Wegovy® is a registered trademark of Novo Nordisk A/S.
Current report
Recent Developments Regarding Enobosarm Intellectual Property
Current report
Recently the Company announced that it had received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent.
Current report
The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued.
Current report
The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide.
Current report
When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension.
Current report
These allowed claims add to the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications. In addition, the patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046.
Current report
The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide.
Current report
Sale Agreement with Oppenheimer & Co. Inc. and Canaccord Genuity LLC
Current report
On July 2, 2026, the Company entered into a Sales Agreement (the “Sales Agreement”), with Oppenheimer & Co. Inc. and Canaccord Genuity LLC (each, an “Sales Agent” and, collectively the “Sales Agents”), as sales agents, pursuant to which the Company may issue and sell, from time to time, to or through the applicable Sales Agent (the “Designated Sales Agent”), shares of the Company’s common stock. The offering and sale of up to $21.8 million of shares of the Company’s common stock pursuant to the Sales Agreement are registered pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-294911), which became effective on April 15, 2026, which includes a base prospectus and a related prospectus supplement that was filed with Securities and Exchange Commission on July 2, 2026.
Current report
The Company is not obligated to sell any shares of common stock under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, each Sales Agent will use commercially reasonable efforts consistent with its normal trading and sales practices, to sell shares of common stock from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Upon delivery of a placement notice, and subject to the Company’s instructions in that notice, and the terms and conditions of the Sales Agreement generally, the Designated Sales Agent may sell the common stock by any method permitted by law deemed to be an "at the market offering" as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The Sales Agents’ obligations to sell shares under the Sales Agreement are subject to satisfaction of certain conditions set forth in the Sales Agreement. The Company will pay the Designated Sales Agent a commission of 3.0% of the aggregate gross proceeds from each sale of the common stock and has agreed to provide the Sales Agents with customary indemnification and contribution rights, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. The Company has also agreed to reimburse the Sales Agents for certain specified expenses.
Removed paragraphs (1)
Previous report
Currently Enrolling Phase 2b PLATEAU Clinical Study
Reworded paragraphs (31)
Previous wording
Enobosarm is being developed for weight loss and as a treatment to preserve physical function as well as to augment fat loss resulting in incremental weight loss in patients with obesity receiving a GLP-1 RA for weight reduction. A Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding QUALITY clinical trial was conducted to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo in 168 patients with obesity (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. The primary endpoint for the QUALITY clinical trial was the percent change from baseline in total lean body mass, and the key secondary endpoints were the percent change from baseline in total body fat mass, total body weight, and physical function as measured by stair climb test at 16 weeks. After completing the efficacy dose-assessment portion of the Phase 2b QUALITY clinical trial, the participants continued into a Phase 2b maintenance extension trial where all patients stopped treatment with semaglutide, but continue taking placebo, enobosarm 3mg, or enobosarm 6mg monotherapy in a blinded fashion for 12 additional weeks. The Phase 2b extension clinical trial evaluated whether enobosarm can maintain muscle and prevent the fat and weight regain that generally occurs after discontinuing a GLP-1 RA.
Current wording
Enobosarm is being developed for weight loss and as a treatment to preserve physical function as well as to augment fat loss resulting in incremental weight loss in older patients with obesity receiving a GLP-1 RA for weight reduction. A Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding Phase 2b QUALITY clinical trial was conducted to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo in 168 older patients (≥60 years of age) with obesity receiving semaglutide (Wegovy®) for weight reduction. The primary endpoint for the Phase 2b QUALITY clinical trial was the percent change from baseline in total lean body mass, and the key secondary endpoints were the percent change from baseline in total body fat mass, total body weight, and physical function as measured by stair climb test at 16 weeks. After completing the efficacy dose-assessment portion of the Phase 2b QUALITY clinical trial, the participants continued into a Phase 2b maintenance extension trial where all patients stopped treatment with semaglutide, but continued taking placebo, enobosarm 3mg, or enobosarm 6mg monotherapy in a blinded fashion for 12 additional weeks. The Phase 2b extension clinical trial evaluated whether enobosarm can maintain muscle and prevent the fat and weight regain that generally occurs after discontinuing a GLP-1 RA.
Previous wording
On March 9, 2026, the Company announced it had enrolled its first patient in the Phase 2b PLATEAU clinical trial. Veru’s PLATEAU clinical trial design is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass and physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 yo) who have obesity (BMI ≥ 35) and are initiating semaglutide (Wegovy) GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass, total fat mass, percentage body fat mass, percentage body lean mass, and total body mass, as measured by DXA scan. The key secondary endpoints for the overall study are total fat mass, total lean mass, physical function (stair climb test), mobility-disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function), HbA1c, and insulin resistance.
Current wording
On July 27, 2026, the Company announced it had completed the enrollment of patients in the Phase 2b PLATEAU clinical trial. Veru’s PLATEAU clinical trial design is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass and physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 yo) who have obesity (BMI ≥ 35) and are initiating semaglutide (Wegovy) GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 32 weeks to assess the percent change from baseline in lean body mass, total fat mass, percentage body fat mass, percentage body lean mass, and total body mass, as measured by DXA scan. The key secondary endpoints for the overall study are total fat mass, total lean mass, physical function (stair climb test), mobility-disability assessment, bone mineral density (BMD), and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function), HbA1c, and insulin resistance.
Previous wording
The Phase 2b PLATEAU clinical study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 68 weeks. An interim analysis for the clinical study after all patients are treated for 36 weeks is planned for the first quarter of calendar 2027.
Current wording
The Phase 2b PLATEAU clinical study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 68 weeks. The interim analysis for the clinical study, to assess the percent change from baseline in lean body mass, total fat mass, percentage body fat mass, percentage body lean mass, and total body mass, as measured by DXA scan, will be conducted after all patients are treated for 32 weeks and is planned for the first quarter of calendar 2027.
Previous wording
Based on FDA regulatory feedback and qualification of BMD as an acceptable surrogate endpoint, results from the Phase 2b PLATEAU study may have three possible regulatory pathways to support efficacy for approval of enobosarm in combination with the GLP- 1 RA. If incremental weight loss is ≥ 5%, the Phase 3 study could be in patients with obesity with a primary endpoint of total body weight, and key secondary endpoints for prespecified subgroups of physical function in sarcopenic patients (age ≥ 65 yo) with mobility disability and another for BMD in postmenopausal women with osteoporosis. If the incremental weight loss is < 5%, the Phase 3 study could be in patients with obesity and mobility disability with a primary endpoint of physical function in sarcopenic obesity patients (age ≥ 65 yo) with mobility disability, and a key secondary endpoint could be BMD in a prespecified group of postmenopausal women with osteoporosis. Alternatively, the Phase 3 study could be in patients with obesity and osteoporosis with a primary endpoint of BMD in postmenopausal women with osteoporosis, and a key secondary endpoint of physical function in sarcopenic patients (age ≥ 65 yo) with mobility disability.
Current wording
Based on FDA regulatory feedback and qualification of BMD as an acceptable surrogate endpoint, results from the Phase 2b PLATEAU study may have three possible regulatory pathways to support efficacy for approval of enobosarm in combination with the GLP- 1 RA. If incremental weight loss is ≥ 5%, the Phase 3 study could be a study in patients with obesity with a primary endpoint of total body weight, and key secondary endpoints for prespecified subgroups of physical function in sarcopenic patients (age ≥ 65 yo) with mobility disability and another for BMD in postmenopausal women with osteoporosis. If the incremental weight loss is < 5%, the Phase 3 study could be a study in patients with obesity and mobility disability with a primary endpoint of physical function in sarcopenic obesity patients (age ≥ 65 yo) with mobility disability, and a key secondary endpoint of BMD in a prespecified group of postmenopausal women with osteoporosis. Alternatively, the Phase 3 study could be a study in patients with obesity and osteoporosis with a primary endpoint of BMD in postmenopausal women with osteoporosis, and a key secondary endpoint of physical function in sarcopenic patients (age ≥ 65 yo) with mobility disability.
Previous wording
Veru had a pre-IND meeting with the FDA Division of Cardiology and Nephrology Center for Drug Evaluation and Research on December 26, 2024. The indication for discussion was the use of sabizabulin to slow progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease. The FDA agreed that there remains an unmet medical need based on disease pathophysiology. Initially, we plan to evaluate sabizabulin in a small Phase 2 dose finding proof of concept study to assess whether sabizabulin reduces blood levels of high sensitivity C-reactive protein, a important measurement of inflammation, in 45 patients with stable CAD following 3 months of treatment. Veru currently has sufficient drug substance to supply the proposed Phase 2 clinical study in patients with stable CAD to measure levels of high sensitivity C-reactive protein.
Current wording
Veru had a pre-IND meeting with the FDA Division of Cardiology and Nephrology Center for Drug Evaluation and Research on December 26, 2024. The indication for discussion was the use of sabizabulin to slow progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease. The FDA agreed that there remains an unmet medical need based on disease pathophysiology. Initially, we plan to evaluate sabizabulin in a small Phase 2 dose finding proof of concept study to assess whether sabizabulin reduces blood levels of high sensitivity C-reactive protein, an important measurement of inflammation, in 45 patients with stable CAD following 3 months of treatment. Veru currently has sufficient drug substance to supply the proposed Phase 2 clinical study in patients with stable CAD to measure levels of high sensitivity C-reactive protein.
Previous wording
During the three months ended March 31, 2026, the Company recognized an additional gain on sale of the FC2 business of $351,000, which is for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability.
Current wording
During the nine months ended June 30, 2026, the Company recognized an additional gain on sale of the FC2 business of $351,000, which is for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability.
Previous wording
The FC2 Business Sale represented a strategic shift, which had a major effect on our operations and financial results. We have classified all direct revenues, costs and expenses related to the FC2 business within loss from discontinued operations, net of tax, in the condensed consolidated statements of operations for the three and six months ended March 31, 2025. We did not allocate any amounts for shared general and administrative operating support expense to discontinued operations. The assets and liabilities sold as part of the FC2 Business Sale were written off upon the closing of the FC2 Business Sale, and therefore there are no assets and liabilities of discontinued operations in our condensed consolidated balance sheet as of March 31, 2026 or September 30, 2025.
Current wording
The FC2 Business Sale represented a strategic shift, which had a major effect on our operations and financial results. We have classified all direct revenues, costs and expenses related to the FC2 business within loss from discontinued operations, net of tax, in the condensed consolidated statements of operations for the three and nine months ended June 30, 2025. We did not allocate any amounts for shared general and administrative operating support expense to discontinued operations. The assets and liabilities sold as part of the FC2 Business Sale were written off upon the closing of the FC2 Business Sale, and therefore there are no assets and liabilities of discontinued operations in our condensed consolidated balance sheet as of June 30, 2026 or September 30, 2025.
Previous wording
As of September 22, 2025, an aggregate of $8.8 million was payable to the Company under the ONCO Promissory Notes and related amendments. On September 22, 2025, the Company and ONCO entered into a Settlement Agreement and Release (the “Settlement Agreement”), whereby the Company agreed to accept a cash payment of $6.3 million, 3,125 shares of ONCO’s Series D Convertible Preferred Stock (the “ONCO Series D Preferred Stock”) and a warrant to purchase 169,395 shares of ONCO’s common stock (the “ONCO Warrant”) (such cash payment, shares of ONCO Series D Preferred Stock, and the ONCO Warrant, collectively, the “Settlement Amount”) in full satisfaction of all amounts due under the ONCO Promissory Notes, as amended by all preceding amendments, forbearance agreements, and waivers, in complete discharge of all obligations thereunder. The ONCO Promissory Notes and the Forbearance Agreement terminated upon payment of the Settlement Amounts. The Company received proceeds of $3.2 million from the sale of shares of ONCO’s common stock acquired from the conversion of ONCO Series D Preferred Stock during the three months ended March 31, 2026 and $1.8 million from the sale of shares of ONCO’s common stock acquired from the conversion of ONCO Series D Preferred Stock subsequent to March 31, 2026, and after such sales the Company no longer holds any shares of ONCO Series D Preferred Stock. There can be no assurances as to whether and when the Company will be able to receive any cash proceeds from the shares of ONCO Warrant or any shares of ONCO’s common stock that the Company might acquire upon exercise of the ONCO Warrant.
Current wording
As of September 22, 2025, an aggregate of $8.8 million was payable to the Company under the ONCO Promissory Notes and related amendments. On September 22, 2025, the Company and ONCO entered into a Settlement Agreement and Release (the “Settlement Agreement”), whereby the Company agreed to accept a cash payment of $6.3 million, 3,125 shares of ONCO’s Series D Convertible Preferred Stock (the “ONCO Series D Preferred Stock”) and a warrant (the “ONCO Warrant”) to purchase 3,216,344 shares of ONCO’s common stock (the “ONCO Common Stock”) (such cash payment, shares of ONCO Series D Preferred Stock, and the ONCO Warrant, collectively, the “Settlement Amount”) in full satisfaction of all amounts due under the ONCO Promissory Notes, as amended by all preceding amendments, forbearance agreements, and waivers, in complete discharge of all obligations thereunder. The ONCO Promissory Notes and the Forbearance Agreement terminated upon payment of the Settlement Amount. The Company received proceeds of $5.0 million from the sale of shares of ONCO Common Stock acquired from the conversion of ONCO Series D Preferred Stock during the nine months ended June 30, 2026, and after such sales the Company no longer holds any shares of ONCO Series D Preferred Stock. There can be no assurances as to whether and when the Company will be able to receive any cash proceeds from the shares of ONCO Warrant or any shares of ONCO Common Stock that the Company might acquire upon exercise of the ONCO Warrant.
Previous wording
Operating Expenses. Conducting research and development is central to our drug development programs. The Company has several products under development and management routinely evaluates each product in its portfolio of products. Advancement is limited to available working capital and management’s understanding of the prospects for each product. If future prospects do not meet management’s strategic goals, advancement may be discontinued. We have invested and expect to continue to invest significant time and capital in our research and development operations. Our research and development expenses were $3.1 million and $3.9 million for the three months ended March 31, 2026 and 2025, respectively, and $4.5 million and $9.6 million for the six months ended March 31, 2026 and 2025, respectively. We expect to continue investing significant resources in research and development in the future due to advancement of our drug candidates.
Current wording
Operating Expenses. Conducting research and development is central to our drug development programs. The Company has several products under development and management routinely evaluates each product in its portfolio of products. Advancement is limited to available working capital and management’s understanding of the prospects for each product. If future prospects do not meet management’s strategic goals, advancement may be discontinued. We have invested and expect to continue to invest significant time and capital in our research and development operations. Our research and development expenses were $4.4 million and $3.0 million for the three months ended June 30, 2026 and 2025, respectively, and $8.8 million and $12.7 million for the six months ended June 30, 2026 and 2025, respectively. We expect to continue investing significant resources in research and development in the future due to advancement of our drug candidates.
Previous wording
Research and development expenses decreased to $3.1 million in the three months ended March 31, 2026 from $3.9 million in the same period in fiscal 2025. The decrease in research and development expenses is primarily due to reduced personnel costs, driven by lower share-based compensation expense.
Current wording
Research and development expenses increased to $4.4 million in the three months ended June 30, 2026 from $3.0 million in the same period in fiscal 2025. The increase in research and development expenses is primarily due to increased expenses related to the ongoing Phase 2b PLATEAU clinical study.
Previous wording
General and administrative expenses were $4.1 million in the three months ended March 31, 2026, which is a decrease from $5.2 million in the three months ended March 31, 2025. The decrease is due primarily to a reduction in corporate personnel costs, due to reduced share-based compensation expense.
Current wording
General and administrative expenses were $3.4 million in the three months ended June 30, 2026, which is a decrease from $5.0 million in the three months ended June 30, 2025. The decrease is due primarily to a reduction in corporate personnel costs, primarily due to reduced share-based compensation expense, and a decrease in third-party consulting expenses.
Previous wording
The Company recorded a gain on sale of ENTADFI assets of $1.0 million in the three months ended March 31, 2025. The Company recognized a gain on sale of ENTADFI assets as nonrefundable consideration was received from the ONCO Promissory Notes. The ONCO Promissory Notes were settled in fiscal 2025 so no additional gain from additional consideration is expected in future periods. Refer to Note 15 to the financial statements included in this report for additional information.
Current wording
The Company recorded a gain on sale of ENTADFI assets of $0.5 million in the three months ended June 30, 2025. The Company recognized a gain on sale of ENTADFI assets as nonrefundable consideration was received from the ONCO Promissory Notes. The ONCO Promissory Notes were settled in fiscal 2025 so no additional gain from additional consideration is expected in future periods. Refer to Note 15 to the financial statements included in this report for additional information.
Previous wording
The Company also recorded a gain from the increase in fair value of equity securities of $3.9 million in the three months ended March 31, 2026. The increase in fair value was driven by realized gain from the conversion of the ONCO Series D Preferred Stock and sale of the underlying ONCO common stock and a change in the fair value of the remaining outstanding ONCO Series D Preferred Stock and the ONCO Warrants, driven by favorable provisions triggered by ONCO’s reverse stock split on March 25, 2026.
Current wording
The Company also recorded a gain from the increase in fair value of equity securities of $0.5 million in the three months ended June 30, 2026. The increase in fair value was driven by realized gain from the conversion of the ONCO Series D Preferred Stock and sale of the underlying ONCO Common Stock and a change in the fair value of the remaining outstanding ONCO Warrants, driven by favorable provisions triggered by ONCO’s reverse stock split in May 2026.
Previous wording
Six MONTHS ENDED March 31, 2026 COMPARED TO Six MONTHS ENDED March 31, 2025
Current wording
Nine MONTHS ENDED June 30, 2026 COMPARED TO Nine MONTHS ENDED June 30, 2025
Previous wording
Research and development expenses decreased to $4.5 million in the six months ended March 31, 2026 from $9.6 million in the same period in fiscal 2025. The decrease in research and development expenses is due primarily to the wind down of the Company’s Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and to prevent muscle loss, which was completed during fiscal 2025. The Company initiated the Phase 2b PLATEAU clinical study during the three months ended March 31, 2026. Personnel costs also decreased due primarily to reduced share-based compensation expense.
Current wording
Research and development expenses decreased to $8.8 million in the nine months ended June 30, 2026 from $12.7 million in the same period in fiscal 2025. The decrease in research and development expenses is due primarily to the wind down of the Company’s Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and to prevent muscle loss, which was completed during fiscal 2025. The Company initiated the Phase 2b PLATEAU clinical study in March 2026. Personnel costs also decreased due primarily to reduced share-based compensation expense.
Previous wording
General and administrative expenses were $8.2 million in the six months ended March 31, 2026, which is a decrease from $10.4 million in the six months ended March 31, 2025. The decrease is due primarily to a reduction in corporate personnel costs, due to reduced share-based compensation expense.
Current wording
General and administrative expenses were $11.5 million in the nine months ended June 30, 2026, which is a decrease from $15.4 million in the nine months ended June 30, 2025. The decrease is due primarily to a reduction in corporate personnel costs, due to reduced share-based compensation expense, and a decrease in third-party consulting expenses.
Previous wording
The Company recorded a gain on sale of ENTADFI assets of $1.7 million in the six months ended March 31, 2025. The Company recognized a gain on sale of ENTADFI assets as nonrefundable consideration was received from the ONCO Promissory Notes. The ONCO Promissory Notes were settled in fiscal 2025 so no additional gain from additional consideration is expected in future periods. Refer to Note 15 to the financial statements included in this report for additional information.
Current wording
The Company recorded a gain on sale of ENTADFI assets of $2.2 million in the nine months ended June 30, 2025. The Company recognized a gain on sale of ENTADFI assets as nonrefundable consideration was received from the ONCO Promissory Notes. The ONCO Promissory Notes were settled in fiscal 2025 so no additional gain from additional consideration is expected in future periods. Refer to Note 15 to the financial statements included in this report for additional information.
Previous wording
Gain on extinguishment of debt of $8.6 million was recognized during the six months ended March 31, 2025, related to the termination of the Residual Royalty Agreement, in connection with the FC2 Business Sale. The gain was the difference between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt of $12.8 million, which included an embedded derivative for the change of control provision at fair value of $4.7 million.
Current wording
Gain on extinguishment of debt of $8.6 million was recognized during the nine months ended June 30, 2025, related to the termination of the Residual Royalty Agreement, in connection with the FC2 Business Sale. The gain was the difference between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt of $12.8 million, which included an embedded derivative for the change of control provision at fair value of $4.7 million.
Previous wording
During the six months ended March 31, 2026, the Company also recorded a gain from the increase in fair value of equity securities of $3.8 million compared to a loss from a decrease in fair value of equity securities of $0.3 million during the six months ended March 31, 2025. The increase in fair value in the fiscal 2026 period was driven by realized gain from the conversion of the ONCO Series D Preferred Stock and sale of the underlying ONCO common stock and a change in the fair value of the remaining outstanding ONCO Series D Preferred Stock and the ONCO Warrants, driven by favorable provisions triggered by ONCO’s reverse stock split on March 25, 2026.
Current wording
During the nine months ended June 30, 2026, the Company also recorded a gain from the increase in fair value of equity securities of $4.4 million compared to a loss from a decrease in fair value of equity securities of $0.3 million during the nine months ended June 30, 2025. The increase in fair value in the fiscal 2026 period was driven by realized gain from the conversion of the ONCO Series D Preferred Stock and sale of the underlying ONCO Common Stock and a change in the fair value of the remaining outstanding ONCO Warrants, driven by favorable provisions triggered by ONCO’s reverse stock splits in March 2026 and May 2026.
Previous wording
Net income from discontinued operations, net of taxes, related to the FC2 business of $351,000 for the six months ended March 31, 2026, which is an additional gain on the sale of the FC2 business for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability. The Company recorded a net loss from discontinued operations, net of taxes, related to the FC2 business of $7.2 million for the six months ended March 31, 2025. The net loss from discontinued operations during the six months ended March 31, 2025 is attributable to the operations of the FC2 business during that period and the recognition of the loss on sale of FC2, initially estimated as $4.2 million for the six months ended March 31, 2025 and adjusted to $4.1 million in a subsequent quarter during fiscal 2025.
Current wording
Net income from discontinued operations, net of taxes, related to the FC2 business of $0.4 million for the nine months ended June 30, 2026, which is an additional gain on the sale of the FC2 business for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability. The Company recorded a net loss from discontinued operations, net of taxes, related to the FC2 business of $7.2 million for the nine months ended June 30, 2025. The net loss from discontinued operations during the nine months ended June 30, 2025 is attributable to the operations of the FC2 business during that period and the recognition of the loss on sale of FC2, initially estimated as $4.3 million for the nine months ended June 30, 2025 and adjusted to $4.1 million in a subsequent quarter during fiscal 2025.
Previous wording
Our cash, cash equivalents, and restricted cash on hand at March 31, 2026 was $27.6 million, compared to $15.8 million at September 30, 2025. Restricted cash included in this balance is $0.1 million at each of March 31, 2026 and September 30, 2025. At March 31, 2026, the Company had working capital of $28.0 million and stockholders’ equity of $34.8 million compared to working capital of $11.1 million and stockholders’ equity of $18.3 million as of September 30, 2025. The increase in working capital is primarily due to an increase in cash, cash equivalents, and restricted cash of $11.8 million, an increase in prepaid expenses of $2.0 million, a decrease in accrued compensation of $1.3 million, and a decrease in accounts payable of $1.0 million.
Current wording
Our cash, cash equivalents, and restricted cash on hand at June 30, 2026 was $23.9 million, compared to $15.8 million at September 30, 2025. Restricted cash included in this balance is $54,000 at each of June 30, 2026 and September 30, 2025. At June 30, 2026, the Company had working capital of $21.1 million and stockholders’ equity of $28.4 million compared to working capital of $11.1 million and stockholders’ equity of $18.3 million as of September 30, 2025. The increase in working capital is primarily due to an increase in cash, cash equivalents, and restricted cash of $8.1 million and a decrease in accounts payable of $1.4 million.
Previous wording
Operating activities used cash of $15.1 million in the six months ended March 31, 2026. Cash used in operating activities included net loss of $8.1 million, adjustments to reconcile net loss to net cash used in operating activities totaling a decrease of $2.7 million and changes in operating assets and liabilities resulting in a decrease of $4.3 million. Adjustments to net loss primarily consisted of $3.8 million for the gain from the change in fair value of equity securities and $1.2 million for share-based compensation. The decrease in cash from changes in operating assets and liabilities primarily included a decrease in accounts payable of $1.6 million, a decrease in accrued expenses and other liabilities of $1.4 million, and an increase in prepaid expenses and other assets of $1.1 million.
Current wording
Operating activities used cash of $20.6 million in the nine months ended June 30, 2026. Cash used in operating activities included net loss of $15.1 million, adjustments to reconcile net loss to net cash used in operating activities totaling a decrease of $2.5 million and changes in operating assets and liabilities resulting in a decrease of $3.0 million. Adjustments to net loss primarily consisted of $4.4 million for the gain from the change in fair value of equity securities, partially offset by $1.7 million for share-based compensation. The decrease in cash from changes in operating assets and liabilities primarily included a decrease in accounts payable of $2.3 million, a decrease in accrued expenses and other liabilities of $0.3 million, and a decrease in operating lease liabilities of $0.4 million.
Previous wording
Operating activities used cash of $19.1 million in the six months ended March 31, 2025. Cash used in operating activities included net loss of $16.8 million, adjustments to reconcile net loss to net cash used in operating activities totaling an increase of $2.5 million and changes in operating assets and liabilities resulting in a decrease of $4.7 million. Adjustments to net loss primarily consisted of $4.9 million for share-based compensation, $4.2 million for the loss on sale of the FC2 business, $3.1 million for the change in fair value of derivative liabilities, partially offset by the gain on extinguishment of debt of $8.6 million and the gain on sale of ENTADFI assets of $1.7 million. The decrease in cash from changes in operating assets and liabilities included a decrease in accrued expenses and other current liabilities of $2.6 million and a decrease in accounts payable of $1.7 million. The cash flows related to discontinued operations have not been segregated and are included in the consolidated statements of cash flows. Total operating cash flows of discontinued operations for the six months ended March 31, 2025 are outflows of $0.3 million.
Current wording
Operating activities used cash of $24.6 million in the nine months ended June 30, 2025. Cash used in operating activities included net loss of $24.2 million, adjustments to reconcile net loss to net cash used in operating activities totaling an increase of $3.9 million and changes in operating assets and liabilities resulting in a decrease of $4.3 million. Adjustments to net loss primarily consisted of $6.6 million for share-based compensation, $4.3 million for the loss on sale of the FC2 business, $3.1 million for the change in fair value of derivative liabilities, partially offset by the gain on extinguishment of debt of $8.6 million and the gain on sale of ENTADFI assets of $2.2 million. The decrease in cash from changes in operating assets and liabilities primarily included a decrease in accrued expenses and other current liabilities of $1.9 million and a decrease in accounts payable of $1.9 million. Total operating cash flows of discontinued operations for the nine months ended June 30, 2025 are outflows of $0.3 million.
Previous wording
Net cash provided by investing activities was $3.5 million during the six months ended March 31, 2026, and consisted of net proceeds from the sale of equity securities of $3.2 million and net proceeds of $0.4 million from the sale of the FC2 business for the settlement of a dispute related to a pre-closing tax receivable and liability.
Current wording
Net cash provided by investing activities was $5.3 million during the nine months ended June 30, 2026, and consisted of net proceeds from the sale of equity securities of $5.0 million and net proceeds of $0.4 million from the sale of the FC2 business for the settlement of a dispute related to a pre-closing tax receivable and liability.
Previous wording
Net cash provided by investing activities was $18.4 million during the six months ended March 31, 2025, and consisted of net proceeds of $16.3 million from the sale of the FC2 business, proceeds of $1.7 million from the sale of ENTADFI assets, and proceeds of $0.4 million from the sale of equity securities.
Current wording
Net cash provided by investing activities was $18.9 million during the nine months ended June 30, 2025, and consisted of net proceeds of $16.3 million from the sale of the FC2 business, proceeds of $2.2 million from the sale of ENTADFI assets, and proceeds of $0.4 million from the sale of equity securities.
Previous wording
The cash flows related to discontinued operations have not been segregated and are included in the consolidated statements of cash flows. Total investing cash flows of discontinued operations for the six months ended March 31, 2026 and 2025 are inflows of $0.3 million and $16.2 million, respectively, which consist of net proceeds from the sale of the FC2 business.
Current wording
The cash flows related to discontinued operations have not been segregated and are included in the consolidated statements of cash flows. Total investing cash flows of discontinued operations for the nine months ended June 30, 2026 and 2025 are inflows of $0.4 million and $16.3 million, respectively, which consist of net proceeds from the sale of the FC2 business.
Previous wording
Net cash provided by financing activities in the six months ended March 31, 2026 was $23.4 million, which consisted of proceeds from the sale of common stock and warrants in an underwritten public offering, net of commissions and costs, of $23.4 million.
Current wording
Net cash provided by financing activities in the nine months ended June 30, 2026 was $23.3 million, which consisted primarily of proceeds from the sale of common stock and warrants in an underwritten public offering, net of commissions and costs, of $23.4 million.
Previous wording
Net cash used in financing activities in the six months ended March 31, 2025 was $4.2 million, which represented a change of control payment of $4.2 million to SWK pursuant to the Residual Royalty Agreement, which terminated the Residual Royalty Agreement and extinguished the related debt.
Current wording
Net cash used in financing activities in the nine months ended June 30, 2025 was $4.2 million, which represented a change of control payment of $4.2 million to SWK pursuant to the Residual Royalty Agreement, which terminated the Residual Royalty Agreement and extinguished the related debt.
Previous wording
Excluding the change of control payment, the Company made total payments under the Residual Royalty Agreement of $0.3 million during the three and six months ended March 31, 2025. The Company is not required to make any additional payments under the Residual Royalty Agreement.
Current wording
Excluding the change of control payment, the Company made total payments under the Residual Royalty Agreement of $0.3 million during the three and nine months ended June 30, 2025. The Company is not required to make any additional payments under the Residual Royalty Agreement.
Previous wording
During the six months ended March 31, 2026 and 2025, we did not sell any shares under the Lincoln Park Purchase Agreement. Since inception of the Lincoln Park Purchase Agreement through March 31, 2026, we sold 302,500 shares of common stock to Lincoln Park resulting in proceeds to the Company of $3.1 million.
Current wording
During the nine months ended June 30, 2026 and 2025, we did not sell any shares under the Lincoln Park Purchase Agreement. Since inception of the Lincoln Park Purchase Agreement through June 30, 2026, we sold 302,500 shares of common stock to Lincoln Park resulting in proceeds to the Company of $3.1 million.
Previous wording
The Company has investments in equity securities consisting of the ONCO Series D Preferred Stock and the ONCO Warrant as of March 31, 2026 and September 30, 2025. The ONCO Series D Preferred Stock and the ONCO Warrant were received on September 22, 2025 as a settlement of the ONCO Promissory Notes. See Note 15 to the financial statements included in this report for additional information. The Company has elected to measure the ONCO Series D Preferred Stock and the ONCO Warrant at fair value in accordance with ASC 825. The investments in the ONCO Series D Preferred Stock and the ONCO Warrant are classified within Level 3 of the fair value hierarchy because there is no market for these types of securities and the fair value is determined using significant unobservable inputs. The fair value of the ONCO Series D Preferred Stock and the ONCO Warrant have been determined using a Monte Carlo simulation model. This valuation model incorporates the contractual terms of the instruments and assumptions including the stock price of ONCO Common Stock, expected volatility, and a selected discount rate. Additionally, the ONCO Series D Preferred Stock and the ONCO Warrant were issued by ONCO as part of a Securities Purchase Agreement, which included the sale of 16,099 shares of Series D convertible preferred stock and warrants to purchase 4,362,827 shares of ONCO Common Stock to eleven institutional investors, for an aggregate purchase price of $12.9 million. The valuation of the ONCO Series D Preferred Stock and ONCO Warrant at issuance included a calibration discount to the proceeds of the original transaction, which was done at arms’ length. The calibration discount was reduced to zero as of March 31, 2026 as the Company began to convert the ONCO Series D Preferred Stock during the three months ended March 31, 2026, which had the effect of increasing the fair value of the ONCO Series D Preferred Stock and the ONCO Warrant. The assumptions used in calculating the fair value of the financial instruments represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, the use of different estimates or assumptions would result in a higher or lower fair value and different amounts being recorded in the Company’s financial statements. Material changes in any of these inputs could result in a significantly higher or lower fair value measurement at future reporting dates, which could have a material effect on our results of operations. See Note 4 to the financial statements included in this report for additional information.
Current wording
The Company has investments in equity securities consisting of the ONCO Warrant as of June 30, 2026 and the ONCO Series D Preferred Stock and the ONCO Warrant as of September 30, 2025. The ONCO Series D Preferred Stock and the ONCO Warrant were received on September 22, 2025 as a settlement of the ONCO Promissory Notes. See Note 15 to the financial statements included in this report for additional information. The Company elected to measure the ONCO Series D Preferred Stock and the ONCO Warrant at fair value in accordance with ASC 825. The investments in the ONCO Series D Preferred Stock and the ONCO Warrant are classified within Level 3 of the fair value hierarchy because there is no market for these types of securities and the fair value is determined using significant unobservable inputs. The fair value of the ONCO Series D Preferred Stock and the ONCO Warrant were determined using a Monte Carlo simulation model. This valuation model incorporates the contractual terms of the instruments and assumptions including the stock price of ONCO Common Stock, expected volatility, and a selected discount rate. Additionally, the ONCO Series D Preferred Stock and the ONCO Warrant were issued by ONCO as part of a Securities Purchase Agreement, which included the sale of 16,099 shares of Series D convertible preferred stock and warrants to purchase 87,256 shares of ONCO Common Stock to eleven institutional investors, for an aggregate purchase price of $12.9 million. The valuation of the ONCO Series D Preferred Stock and ONCO Warrant at issuance included a calibration discount to the proceeds of the original transaction, which was done at arms’ length. The calibration discount was reduced to zero when the Company began to convert the ONCO Series D Preferred Stock during the nine months ended June 30, 2026, which had the effect of increasing the fair value of the ONCO Series D Preferred Stock and the ONCO Warrant. The assumptions used in calculating the fair value of the financial instruments represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, the use of different estimates or assumptions would result in a higher or lower fair value and different amounts being recorded in the Company’s financial statements. Material changes in any of these inputs could result in a significantly higher or lower fair value measurement at future reporting dates, which could have a material effect on our results of operations. See Note 4 to the financial statements included in this report for additional information.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Net income from discontinued operations, net of taxes, related to the FC2 business of $351,000 for the three months ended March 31, 2026, which is an additional gain on the sale of the FC2 business for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability. The net loss from discontinued operations of $49,000 during the three months ended March 31, 2025 is due to changes in estimates made at the time the FC2 business was sold.