Veru Inc. (VERU): Business Model Canvas [Dec-2025 Updated]

You're looking at a company that just made a massive strategic bet, shedding its legacy operations to become a pure-play biopharma focused entirely on two late-stage drug candidates: enobosarm and sabizabulin. Honestly, the runway is tight; they burned through $12.7 million in R&D and $15.4 million in SG&A in the first nine months of FY2025, leaving them with about $15 million in cash as of June 30, 2025, even after that $25 million public offering in October 2025. This pivot means their entire business model hinges on successful Phase 3 trials and landing a big pharma partner-so, let's break down exactly how Veru Inc. is structured for this high-stakes game below.

Veru Inc. (VERU) - Canvas Business Model: Key Partnerships

Veru Inc. is actively seeking a large pharmaceutical partner for enobosarm Phase 3 funding and commercialization. Management indicated the aim to secure nondilutive funding through partnerships, as discussions with multiple potential partners are ongoing. The company selected a novel modified-release oral enobosarm formulation with an Intellectual Property runway potentially extending to 2046, supporting Phase 3 and commercialization plans. The cash and equivalents balance declined to $15.01 million as of the third quarter of fiscal year 2025 reporting date. The company executed a 1-for-10 reverse stock split on August 8, 2025, to help maintain Nasdaq compliance. A public offering priced around October 31, 2025, aimed to raise approximately $25.2 million in gross proceeds, with net proceeds planned to fund enobosarm development, primarily the Phase 2b PLATEAU clinical study, and working capital.

Veru Inc. maintains collaborations with academic institutions and contract research organizations to execute multi-center trials. The company is advancing its late-stage program with expertise in pharmaceutical development, regulatory affairs, and oncology drug commercialization guiding advancement.

Engagement with the U.S. Food and Drug Administration (FDA) for regulatory clarity on Phase 3 design for enobosarm in obesity resulted in a successful meeting providing guidance. The FDA confirmed that enobosarm 3mg is an acceptable dosage for future clinical development. The FDA now guides that incremental weight loss with enobosarm added to GLP-1 RA treatment over the GLP-1 RA treatment alone is an acceptable primary endpoint to support approval. The proposed Phase 3 trial will focus on older adults (>60 years) with obesity, with stair climb performance as a clinically meaningful endpoint. The FDA has encouraged Veru to expand the enobosarm development program to include a younger population with obesity.

Scientific collaboration with Key Opinion Leaders (KOLs) on cardiometabolic disease is supported by the robust data from the Phase 2b QUALITY study. The data demonstrated clear differentiation based on physical function and body composition changes.

Regarding potential government grants for sabizabulin development, the latest available information shows that in April 2023, Veru Inc.'s research partner, The University of Tennessee Health Science Center (UTHSC), was awarded two new federal grants to support research. Sabizabulin is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.

• FDA confirmed enobosarm 3mg as acceptable dosage for future development.
• The Phase 2b QUALITY study involved patients >60 years of age.
• The company reported $5.7 million in Research and development expenses for fiscal Q1 2025.
• Cash, cash equivalents, and restricted cash totaled $26.6 million as of December 31, 2024.

Veru Inc. (VERU) - Canvas Business Model: Key Activities

You're looking at the core engine room of Veru Inc. (VERU) right now-the specific, high-stakes actions they must execute to move their pipeline forward as of late 2025. It's all about clinical milestones and securing the runway to hit them.

Executing the Phase 3 clinical program for enobosarm in high-quality weight loss

The immediate focus here is translating the success from the Phase 2b QUALITY study into a registrational Phase 3 trial. Regulatory clarity from the FDA following the end of Phase II meeting was anticipated in the third quarter of calendar 2025. The planned Phase 3 trial is designed to focus on older adults, specifically those over 60 years of age, who have obesity or are overweight and eligible for GLP-1 RA treatment. The 3 milligram dose of enobosarm is the one slated to move into this pivotal testing.

The Phase 2b data provided strong justification for this next step, showing significant body composition benefits when enobosarm was added to semaglutide:

• 100% average preservation of total lean mass at the 16-week mark for the 3mg dose.
• 42% greater relative loss of fat mass compared to placebo plus semaglutide at 16 weeks.
• In the Maintenance Extension study, the 3mg enobosarm group regained only 1.41% of body weight versus 43% for the placebo group after semaglutide discontinuation.

Developing a novel, patentable modified-release oral formulation for enobosarm

Developing a new formulation is a key activity because it helps secure the future market exclusivity for enobosarm. Veru Inc. selected a novel modified release oral formulation, which was planned for Phase 1 bioavailability clinical trials in the first half of calendar 2025. This new version is specifically intended to be available for the Phase 3 clinical study and for commercialization.

Here's a snapshot of the formulation and IP status:

Conducting R&D for sabizabulin in atherosclerotic cardiovascular disease inflammation

Veru Inc. is actively evolving the drug development strategy for sabizabulin, focusing its R&D on its potential as a novel oral broad anti-inflammatory agent for atherosclerotic cardiovascular disease (ASCVD) inflammation. The company has sufficient drug substance on hand to supply the proposed Phase 2 clinical study for this indication. This activity is separate from its prior focus on COVID-19.

Securing non-dilutive funding and strategic partnerships for late-stage assets

Given the need for capital to fund development, securing non-dilutive funding is a critical operational priority. Veru Inc. has been in discussions with potential partners, including big pharma and GLP-1 developers, to secure this type of financial support for future studies. The sale of the FC2 Female Condom business provided a one-time boost, generating $18 million in net proceeds.

Financially, as of June 30, 2025, the company's cash, cash equivalents, and restricted cash balance stood at $15.0 million. Net working capital was $9.5 million on that same date. The operating loss for the third quarter of fiscal 2025 narrowed to $7.5 million.

Managing intellectual property portfolio, including new patents expected to 2045

Managing and defending the intellectual property portfolio is key to protecting future revenue streams. The activity centers on filing and maintaining patents for the novel enobosarm formulation, which is expected to provide market exclusivity extending to 2045 as outlined, with specific data pointing to 2046 for the new formulation. This IP management is intertwined with the formulation development activity.

Key financial metrics related to R&D spending, which supports IP creation, for the nine months ended June 30, 2025, compared to the prior period:

• Research and development costs increased to $12.7 million year-to-date.
• Research and development expenses for the third quarter specifically decreased to $3.0 million from $4.8 million in the prior quarter, due to the wind down of the Phase 2b study.

Finance: draft 13-week cash view by Friday.

Veru Inc. (VERU) - Canvas Business Model: Key Resources

You're looking at the core assets Veru Inc. (VERU) is leaning on right now to push its late-stage pipeline forward. Honestly, for a biopharma company, the resources are almost entirely tied up in the science and the people who can execute the trials.

The most critical asset is the intellectual property surrounding enobosarm, a Selective Androgen Receptor Modulator (SARM). Veru Inc. is actively developing a novel, patentable, modified release formulation for enobosarm; the actual formulation, pharmacokinetic release profile(s), and method of manufacturing are expected to be the subjects of future patents. This focus on a modified release oral formulation is key, as it's the version intended for the upcoming Phase 3 clinical studies and eventual commercialization.

The clinical validation for enobosarm is a massive resource. The positive topline results from the Phase 2b QUALITY clinical study, announced on January 27, 2025, provided the proof of concept you need. The data showed that enobosarm treatment met the prespecified primary endpoint of preserving lean mass when combined with semaglutide (Wegovy®) in older patients with obesity. The data is concrete, showing that patients on enobosarm lost 71% less lean mass compared to the placebo group at 16 weeks. Furthermore, the Maintenance Extension portion of the study, reported June 24, 2025, showed that enobosarm monotherapy completely prevented fat regain and preserved lean mass compared to placebo after semaglutide discontinuation. The 3mg dose has been confirmed as the acceptable dosage for future clinical development.

Here's a quick look at the key data points underpinning this resource:

Financially, the company's liquidity position is a necessary resource for funding ongoing development. As of June 30, 2025, Veru Inc. reported cash, cash equivalents, and restricted cash of \$15 million.

The team driving this is a definite asset. You have an experienced executive team, led by Chairman, President, and Chief Executive Officer Mitchell Steiner, M.D., who are focused on navigating late-stage biopharmaceutical development, including securing regulatory clarity from the FDA for the enobosarm program.

Finally, the physical supply chain is in place for near-term needs. Veru Inc. confirmed as of February 2025 that it currently has sufficient clinical-grade drug substance to supply the proposed Phase 2 clinical study, with plans to utilize the modified release formulation for the planned Phase 3 studies. The next planned study, the Phase 2b PLATEAU trial, is expected to begin in calendar Q1 2026.

The current resource base is heavily weighted toward clinical progress, which is typical for a company at this stage.

Veru Inc. (VERU) - Canvas Business Model: Value Propositions

The core value proposition for Veru Inc. (VERU) centers on transforming body composition management in the context of weight loss and addressing critical inflammatory conditions, leveraging its late-stage clinical assets, Enobosarm and Sabizabulin.

Enobosarm: Preserving Lean Muscle Mass and Physical Function During GLP-1 RA-Induced Weight Loss

Enobosarm offers a tissue-selective approach to augment the efficacy of Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like semaglutide, specifically targeting fat loss while protecting muscle mass.

The Phase 2b QUALITY study provided clear data supporting this differentiation:

• Patients on Enobosarm 3mg + semaglutide achieved 99% fat loss relative to total weight lost, while preserving lean mass.
• On average, patients on Enobosarm lost 71% less lean mass compared to those on semaglutide alone.
• The 3mg dose demonstrated a greater than 99% relative reduction in lean mass loss.
• Enobosarm reduced the proportion of patients experiencing clinically significant physical function decline when compared to semaglutide monotherapy.

This value proposition is critical because, as seen in the study, the 3mg Enobosarm group showed 100% average lean mass preservation.

Enobosarm: Significantly Reducing Body Weight and Fat Regain After Stopping GLP-1 RA Treatment

A secondary, yet crucial, value proposition addresses the durability of weight loss, a known challenge when discontinuing GLP-1 RA therapy. The Phase 2b Maintenance Extension study provided data on this:

When semaglutide was discontinued, Enobosarm monotherapy prevented the regain of fat mass, which is a key differentiator:

The 3mg Enobosarm group showed a 46% reduction in body weight regain compared to placebo after stopping semaglutide. The novel modified-release oral formulation of Enobosarm is being developed with intellectual property runway potentially extending to 2046.

Sabizabulin: Novel Oral Treatment for Inflammation in Atherosclerotic Cardiovascular Disease

Sabizabulin is positioned to address inflammation within atherosclerotic cardiovascular disease, a major area of unmet need.

• Sabizabulin is a novel oral broad anti-inflammatory agent.
• Its mechanism of action is noted as being similar to colchicine.
• The existing safety database for Sabizabulin includes 266 dosed patients from prior clinical development programs.

Addressing a Significant Unmet Medical Need in Sarcopenic Obese Older Patients

The target population for Enobosarm-older patients receiving GLP-1 RAs-is highly relevant given the clinical risks associated with Sarcopenic Obesity (SO).

The prevalence and severity of SO highlight the market opportunity:

• In a study of hospitalized older adults (aged $\geq$ 65 years), the prevalence of SO was 24.5%.
• A global meta-analysis estimated the prevalence of SO in older adults to be 11%.
• In one cohort, 18% of obese older adults were classified as sarcopenic based on the European Working Group definition.
• SO is linked to worse outcomes; the SO group in one study had a mortality rate of 15.1% compared to 9.3% for non-SO patients.
• Sarcopenic obese older adults were 6.4 times more likely to have frailty compared to nonsarcopenic obese older adults.

The financial context shows Veru Inc. is focused on advancing this pipeline, reporting a net loss from continuing operations of $7.3 million for Q3 Fiscal 2025, with cash and equivalents at $15.01 million as of June 30, 2025. The sale of the FC2 Female Condom business previously added $18 million to cash reserves to support this focus.

Veru Inc. (VERU) - Canvas Business Model: Customer Relationships

High-touch engagement with the scientific and medical community via conferences and publications.

• Planned presentations at SCWD 18th International Conference, Rome, December 12 - December 13, 2025.
• Planned presentation of two abstracts at ObesityWeek 2025 on October 31, 2025.
• Announced positive results from Phase 2b QUALITY and Maintenance Extension clinical study on June 24, 2025.
• Full clinical efficacy and safety data for the Phase 2b extension study planned for future scientific conferences and publications after Q2 2025.

The enobosarm Phase 2b QUALITY study involved 168 older patients, greater than or equal to 60 years of age.

Direct communication with investors through earnings calls and virtual health forums.

• Hosted conference call for Fiscal Q2 2025 financial results on May 8, 2025.
• Reported Fiscal Q3 2025 financial results on August 12, 2025.
• Participated in the virtual BTIG Obesity Health Forum on June 18, 2025.
• Participated in the 2025 BTIG Virtual Biotech Conference on July 29-30, 2025.
• Samuel Fisch serves as Executive Director of Investor Relations & Corporate Communications.

As of the close on October 31, 2025, the stock price was $2.42.

Regulatory relationship management with the FDA for clinical trial progression.

• Successful meeting with FDA on September 23, 2025, providing regulatory clarity for enobosarm for obesity.
• FDA confirmed enobosarm 3mg is an acceptable dosage for future development.
• FDA guided that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint to support approval.
• Pre-IND meeting for sabizabulin for atherosclerotic disease occurred on December 26, 2024.

The planned Phase 2b PLATEAU clinical study will evaluate enobosarm 3mg in approximately 180 patients.

Seeking a strategic, long-term partnership with a large pharmaceutical company.

• Company is in active discussions for non-dilutive funding, preferably from a large pharmaceutical company.
• Discussions are based on the uniform positive Phase 2b data.

The company's cash balance as of March 31, 2025, was $20 million.

Veru Inc. (VERU) - Canvas Business Model: Channels

You're looking at how Veru Inc. gets its critical information and, eventually, its products to the right people. For a late clinical-stage biopharma company, the channels are heavily weighted toward scientific validation and investor communication right now, with commercial distribution being a future plan contingent on approval.

The primary channels for disseminating clinical data and engaging with the medical community as of late 2025 involve scientific forums and direct regulatory interaction.

• Scientific and medical journals for publishing Phase 2b and extension study data.
• Investor relations presentations and one-on-one meetings (e.g., BTIG conferences).
• Direct regulatory submissions to the FDA (e.g., End-of-Phase 2 meeting request).
• Future pharmaceutical distribution networks (post-approval) via a commercial partner.

Here's a look at the concrete activities and data points tied to these channels through the latter half of 2025.

For the enobosarm obesity program, the FDA meeting on September 23, 2025, established that incremental weight loss over GLP-1 RA alone is an acceptable primary endpoint to support approval. This clarity directly impacts the Phase 3 trial design, which is the next major regulatory channel milestone. The Phase 2b QUALITY Study completion was in 2025, with topline data for the extension study announced on June 24, 2025.

The existing commercial channel for the FC2 Female Condom® provides a baseline for distribution infrastructure, even as the company pivots focus. The net revenues from this segment were $16.9 million for the fiscal year ending September 30, 2024. This existing global footprint spans distribution in 149 other countries besides the U.S..

Investor engagement is a constant channel, evidenced by the recent financing activity and conference presence.

• The October 2025 public offering was for $25 Million.
• The stock price as of October 31, 2025, was $2.42.
• The company is actively presenting data, such as at ObesityWeek 2025 in October.

The company is developing a novel modified-release oral formulation of enobosarm, which was anticipated for Phase 1 trials in the first half of 2025, representing a future channel improvement for patient convenience.

Veru Inc. (VERU) - Canvas Business Model: Customer Segments

You're looking at the specific groups Veru Inc. targets with its late-stage assets, which is crucial for understanding near-term revenue potential and partnership strategy. The focus is clearly on patients where current GLP-1 RA therapy leaves a gap, specifically concerning body composition and inflammation.

Older patients (≥60 years) with obesity/overweight receiving GLP-1 RA therapy.

This segment is directly addressed by the enobosarm obesity program. The Phase 2b QUALITY clinical trial evaluated enobosarm in 168 obese or overweight older (>60 years of age) patients receiving semaglutide. The data showed that for patients on enobosarm + semaglutide, the median percentage of total body weight loss due to lean mass was 9.4%, while estimated fat loss was 90.6%. Furthermore, in the Maintenance Extension study, enobosarm monotherapy reduced body weight regain by 46% after semaglutide discontinuation. As of April/May 2025, 11.8 percent of U.S. adults reported ever taking a GLP-1 agonist. Among those 65 and older, GLP-1 agonist use is somewhat higher for men than for women.

Cardiologists and specialists treating inflammation in atherosclerotic coronary artery disease.

This group is the target for sabizabulin, which is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. The clinical context for this segment is significant: almost half of the US adult population has obesity, and obesity raises the chance of coronary artery disease (CAD) to 64% based on the Framingham Heart Study.

Future broader obesity and diabetic patient populations, if indications expand.

The potential market size here is massive, justifying the focus. As of September 2025, 2,454,615 patients were prescribed a GLP-1 RA between January 2018 and September 2025. GLP-1 prescriptions accounted for 6.5 out of every 100 prescriptions in the US in September 2025. Veru Inc. is planning the Phase 2b PLATEAU clinical study to evaluate enobosarm in approximately 200 patients who have obesity (BMI ≥ 35) and are initiating GLP-1 RA treatment. The company reported annual revenue of $16.89 million and a net loss of -$37.80 million for the fiscal year.

Large pharmaceutical companies seeking to license or acquire late-stage cardiometabolic assets.

This segment represents the potential exit or major partnership opportunity for Veru Inc. The market activity in late 2025 shows high valuation for such assets. For instance, in June 2025, Eli Lilly agreed to acquire Verve Therapeutics for up to USD 1.3 billion to advance cardiovascular gene editing therapies. Separately, Novartis completed the USD 3.1 billion acquisition of Anthos Therapeutics for a late-stage Factor XI inhibitor. Veru Inc. held $15.0 million in cash reserves as of June 30, 2025.

Here's a quick look at some of the relevant figures underpinning these segments:

The key takeaways for these segments involve the specific patient profile and the financial context of the company seeking to serve them:

• Older patients (≥60) on GLP-1 RA therapy are at risk for lean mass loss, with 32% of placebo + semaglutide weight loss being lean mass.
• The obesity market is large, with over 80% of obese or overweight patients not receiving GLP-1, surgery, or behavioral care in 2024.
• Cardiologists treat a population where obesity increases CAD risk to 64%.
• Veru Inc.'s operating loss from continuing operations decreased to $7.5 million for Q3 2025.
• Large pharma is actively acquiring late-stage cardiometabolic assets, evidenced by a $3.1 billion Novartis deal.

Finance: draft 13-week cash view by Friday.

Veru Inc. (VERU) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Veru Inc.'s operations as of late 2025, which are heavily weighted toward advancing its clinical pipeline, particularly enobosarm. Honestly, for a company at this stage, the cost structure is almost entirely operational expenditure (OpEx) tied to R&D and getting the necessary regulatory clarity.

The primary financial drivers for the cost structure in the first nine months of fiscal year 2025 are clearly laid out in their reporting. These figures reflect the ongoing investment required to move their drug candidates through late-stage development.

The R&D spend is directly linked to the clinical programs you mentioned. For instance, the year-to-date R&D increase was driven by approximately $4.5 million incurred related to the Phase 2b QUALITY study for enobosarm, which evaluated its effect on fat loss and muscle preservation when added to semaglutide.

The costs associated with clinical trials are significant and represent the largest variable component within R&D. You see this in the quarterly fluctuations; R&D dropped to $3.0 million in Q3 2025 from $5.72 million in Q1 2025, primarily because the Phase 2b QUALITY study was winding down that quarter. The focus is now clearly shifting toward funding the next steps, with recent capital raising efforts earmarked to fund enobosarm Phase 2b PLATEAU clinical activities.

Beyond the direct trial costs, the overall cost structure includes necessary expenditures to maintain the intellectual property foundation for their assets. This includes costs for:

• Drug formulation development, such as the novel modified-release oral enobosarm formulation.
• Manufacturing scale-up planning for future commercialization.
• Patent maintenance fees to secure the intellectual property runway, which for enobosarm is potentially through 2046.

General corporate overhead, which encompasses legal, compliance, and investor relations activities, is absorbed within the SG&A line item. For the three months ended June 30, 2025, SG&A was $5.0 million, a decrease from $5.8 million in the prior quarter, partly due to a reduction in share-based compensation. The company's cash position as of June 30, 2025, was $15 million, which management noted was not sufficient to fund operations for the next 12 months, highlighting the immediate need to manage this cost base against future financing.

Finance: draft 13-week cash view by Friday.

Veru Inc. (VERU) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Veru Inc. (VERU) as of late 2025, which is a company deep in its transition from a diversified entity to a pure-play biopharmaceutical developer. Honestly, the revenue picture is dominated by non-recurring events and capital raises right now, reflecting the pre-commercial status of its core assets.

The most significant recent cash infusion came from a financing event in the fourth quarter of fiscal 2025. Veru Inc. announced the pricing of an underwritten public offering in October 2025, which was expected to generate gross proceeds of approximately $25.2 million before deducting underwriting discounts and expenses. The combined unit price for the offering-consisting of common stock, Series A warrants, and Series B warrants-was set at $3.00. To be fair, this capital raise is critical for funding the development of enobosarm, specifically the Phase 2b PLATEAU clinical study activities.

This offering structure also includes a significant contingent revenue stream. If all the accompanying Series A and Series B warrants sold in the October 2025 offering were to be exercised for cash at their exercise price, Veru Inc. could receive an additional gross proceeds of approximately $50.4 million.

Revenue from continuing operations is minimal, as the company is focused on late-stage clinical development. For context, Veru Inc. reported revenues of $16.9M in the fourth quarter of calendar 2024. For the first three quarters of fiscal 2025, revenue from continuing operations was not explicitly detailed in the latest reports, supporting the view that it is not a primary, reliable income source.

The company realized a major one-time cash event from the divestiture of its former product line. Veru Inc. sold its FC2 Female Condom business in late 2024 for a gross amount of $18 million. After accounting for a change of control premium and other customary fees, the estimated net proceeds to the Company were approximately $12.5 million. This transaction also extinguished associated liabilities totaling $9.9 million as of September 30, 2024.

Regarding the ENTADFI assets sale to Onconetix, Inc. (formerly Blue Water Vaccines, Inc.), the initial upfront consideration totaled $20 million, paid via installments through fiscal year 2024. The potential future non-dilutive funding component is the sales milestones, which could total up to an additional $80 million, structured in tranches of $10.0 million, $20.0 million, and $50.0 million upon reaching net sales thresholds of $100.0 million, $200.0 million, and $500.0 million in a calendar year, respectively. However, as of late 2024 filings, Veru Inc. stated that the probability of receiving any of these Milestone Payments was considered remote.

Here is a summary of the key financial components contributing to the current cash position and potential future inflows:

• Gross proceeds from October 2025 Public Offering: $25.2 million
• Gross proceeds from FC2 Female Condom sale (late 2024): $18 million
• Potential future gross proceeds from warrant exercise (October 2025): $50.4 million
• Maximum potential future milestone payments from ENTADFI sale: $80 million
• Cash and cash equivalents as of June 30, 2025: $15 million

The structure of potential non-dilutive funding from licensing partnerships remains an opportunity, though specific amounts for upfront payments are not publicly detailed as of late 2025, aligning with the company's focus on advancing enobosarm through clinical milestones.

The company is definitely prioritizing the use of these capital proceeds for its drug pipeline, which means the revenue streams are currently weighted toward financing rather than product sales.