Full Press Release Details
Investor and Media Contact:
Executive Director, Investor Relations and
Corporate Communications
Email: veruinvestor@verupharma.com
Veru Reports Fiscal 2025 First Quarter Financial Results
and Clinical Program Progress
Company reported positive Phase 2b QUALITY study topline results for enobosarm + semaglutide (Wegovy ) with study meeting
prespecified primary endpoint of preservation of lean mass as well as greater fat loss and improvement of physical function
The Independent Data Monitoring Committee met this week on February 10, 2025 to evaluate the unblinded safety Phase 2b QUALITY
data and recommended to continue the QUALITY extension study as designed
Topline results of the Phase 2b extension
maintenance study to reduce fat regain following discontinuation of GLP-1 RA are expected in the second quarter of calendar 2025
Company announces new cardiometabolic indication for sabizabulin to treat inflammation in atherosclerotic coronary artery
Company sold the FC2 Female Condom (Internal Condom) Business for $18 million
Company to host conference call and webcast today at 8:00 a.m. ET--
MIAMI, FL February 13, 2025 Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on
developing innovative medicines for the treatment of cardiometabolic and inflammatory disease, today announced financial results for its fiscal 2025 first quarter and provided an update on progress of its clinical development programs.
Enobosarm is a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for fat
loss Phase 2b QUALITY clinical study update:
On January 27, 2025, the Company announced positive topline results from the Phase 2b QUALITY
clinical study which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding QUALITY clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and
to prevent muscle loss in sarcopenic obese or overweight older (>60 years of age) patients receiving semaglutide (Wegovy).
The Phase 2b QUALITY study
is the first human study to report the effects of a muscle preservation drug candidate on body composition in older patients who have obesity or are overweight and receiving a GLP-1 receptor agonist. In
the topline efficacy analysis, the trial met its prespecified primary endpoint
with a statistically significant and a clinically meaningful benefit in the preservation of total lean body mass in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at
16 weeks (71% relative reduction in lean mass loss, p=0.002). The enobosarm 3mg + semaglutide was the best dose with a >99% mean relative reduction in loss of lean mass (p <0.001). Enobosarm 6mg + semaglutide dose was not better than the
Enobosarm 3mg + semaglutide dose on lean mass.
As for secondary clinical endpoints, enobosarm + semaglutide treatment resulted in dose dependent greater
loss of fat mass compared to placebo + semaglutide with the enobosarm 6mg dose having a 46% greater relative loss of fat mass compared to placebo + semaglutide group at 16 weeks (p=0.014). Although enobosarm + semaglutide significantly
preserved lean mass, the additional loss of fat mass caused by enobosarm treatment was able to replace the lean mass preserved to allow a similar net mean weight loss with semaglutide at 16 weeks. Accordingly, the tissue composition of the total
weight loss shifted to greater and selective loss of fat with enobosarm treatment. The median percentage of total body weight loss in the placebo + semaglutide group that was due to lean mass was 32% and estimated fat loss was 68%. In contrast, in
the all enobosarm + semaglutide group, the total weight loss due to lean mass was 9.4% vs estimated fat loss of 90.6%, and for the enobosarm 3mg + semaglutide group, it was 0.9% lean mass vs 99.1% estimated fat loss. Therefore, enobosarm +
semaglutide improved changes in body composition resulting in more selective and greater loss of adiposity than in subjects receiving placebo + semaglutide.
Physical function was measured by the Stair Climb Test. Climbing stairs is an activity of daily living, and the Stair Climb Test measures functional muscle
strength, balance and agility. Declines in performance measured by Stair Climb Test predicts in older patients higher risk for mobility disabilities, gait difficulties, hospitalizations, falls, and bone fractures. As a point of reference, stair
climb power declines by -1.38% annually with aging according to Van Roie E. PLOS ONE 14:e0210653, 2019.
Enobosarm represents a next generation drug that improves GLP-1 RA therapy to result in tissue SELECTIVE quality weight reduction, that is, enobosarm + semaglutide improved changes in body composition which resulted in more selective and greater loss of adiposity (fat
mass) than in subjects receiving placebo + semaglutide alone.
Safety data for the Phase 2b QUALITY study remains blinded as the Phase 2b extension clinical study portion
is ongoing. The unblinded complete safety set will be available after the Phase 2b extension study is completed. However, the aggregate, blinded safety data have not shown any significant differences compared to previous studies of enobosarm and
what is expected with GLP-1 RAs. The Independent Data Monitoring Committee met this week on February 10, 2025 to evaluate the unblinded safety data, and they made the recommendation to continue the study
After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, the participants continued into a Phase 2b
extension trial where all patients have stopped treatment with semaglutide, but continue taking placebo, enobosarm 3mg, or enobosarm 6mg in a blinded fashion for 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can
maintain muscle and prevent the fat regain that generally occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in the second quarter
The Company plans to present the full clinical efficacy and safety data set for the Phase 2b QUALITY clinical study in future
scientific conferences and publications after the Phase 2b extension portion of the study is completed and unblinded.
As the Phase 2b QUALITY study has
positive topline clinical results, we plan to move forward to request an end of Phase 2 meeting with the FDA. We have previously met with the FDA to discuss our regulatory path forward as an improvement in body composition drug, and the FDA has
provided general advice on Phase 3 design. Based on the successful Phase 2b QUALITY clinical trial, we plan to run a similar study as a Phase 3 study. The duration of treatment is expected to be 52 weeks which will allow us to also capture the
longer-term benefits of enobosarm improvements on body composition for greater loss of adiposity and weight reduction.
Novel enobosarm modified
release oral formulation
Veru is currently developing a novel, patentable, modified release formulation for enobosarm. We anticipate the actual
formulation, pharmacokinetic release profile(s), and method of manufacturing will be the subjects of future patents. The drug product formulation is currently in animal trials and is anticipated to be available for a Phase 1 bioavailability
clinical trial during the first half of calendar 2025. The expectation is that the oral enobosarm modified release drug formulation will be utilized for the Phase 3 clinical studies and for commercialization.
Atherosclerosis Inflammation Program
recent positive topline results from the Phase 2b QUALITY study evaluating enobosarm as a cardiometabolic agent that has the potential to preserve muscle and augment fat loss in overweight and obese patients receiving
GLP-1 RA therapy for weight reduction, Veru has evolved its drug development strategy for sabizabulin and is exploring the possibility of the clinical development of sabizabulin, a novel oral broad
anti-inflammatory agent, for the treatment of inflammation in atherosclerotic cardiovascular disease. The Company believes there are compelling scientific evidence and rationale to evaluate sabizabulin as a treatment for the inflammation associated
with atherosclerotic cardiovascular disease.
Atherosclerotic coronary artery disease (CAD) remains the leading cause of mortality worldwide. Inflammation
and high cholesterol jointly contribute to atherosclerotic cardiovascular disease. It appears that the pathogenesis and progression of coronary artery disease, however, is largely driven by inflammation in response to atheromatous
plaques containing cholesterol in the arterial wall. Even with maximum cholesterol reduction therapies, there remains a major and largely untreated residual inflammatory risk. The realization that the combined use of aggressive lipid-lowering and
inflammation-inhibiting therapies might be needed to further reduce atherosclerotic risk has sparked the search for anti-inflammatory medications that could lower the risk of atherosclerotic events in patients with CAD.
An old drug, colchicine, inhibits tubulin polymerization to disrupt microtubules resulting in broad
anti-inflammatory activity. Recent randomized controlled trials assessing the role of low-dose colchicine to treat inflammation to reduce major adverse cardiovascular events had promising results demonstrating
significant cardiovascular risk reduction. Colchicine lowered major adverse cardiovascular events by 31% among those with stable CAD and by 23% in patients following a recent myocardial infarction. This magnitude of benefit is greater than what has
been observed in contemporary trials of lipid lowering medications including those with proprotein convertase subtilisin/kexin type 9 (PCSK-9) inhibitors. Data from these trials led the FDA in June
2023 to approve colchicine as the first anti-inflammatory drug for reducing cardiovascular events in adults with established atherosclerotic cardiovascular disease.
However, while colchicine may be the first FDA approved drug to treat atherosclerotic inflammation, unfortunately colchicine has significant safety concerns
that may limit its expected widespread use. Colchicine has high potential for drug-drug interactions with commonly used cardiovascular drugs including almost all statins (HMG-CoA reductase inhibitors). In
contrast, Veru s sabizabulin is a new molecular entity, small molecule that targets the colchicine binding site on -tubulin. Like colchicine, sabizabulin inhibits microtubule polymerization and has demonstrated the ability to reduce the
most important inflammatory mediators that play a role in the initiation and progression of atherosclerotic CAD. In contrast to colchicine, sabizabulin has stable pharmacokinetics and low potential for drug-drug interactions; thus, sabizabulin may
be administered potentially more safely as a secondary therapy in combination with statin therapy for the reduction of inflammation to slow the progression or promote regression of atherosclerotic cardiovascular disease. Overall preclinical data
from in vitro and in vivo inflammation studies show that sabizabulin treatment suppressed all cytokines and chemokines tested. In Phase 2 and 3 pulmonary inflammation COVID-19 clinical studies,
sabizabulin has demonstrated broad anti-inflammatory activity. The safety database consists of 266 dosed patients from the previous sabizabulin clinical development programs.
The Company s decision to explore this major cardiometabolic indication was based on the significant unmet medical need to treat inflammation in
atherosclerotic cardiovascular disease, the large global market opportunity, current clinical and safety sabizabulin database of 266 patients, high probability of success given that sabizabulin drug s mechanism of action is similar to
colchicine, strong intellectual property position, and is consistent with Company s focus on cardiometabolic diseases. Furthermore, the Company believes sabizabulin may be evaluated in a small Phase 2 dose finding proof of concept study to
assess the progression of coronary atherosclerosis in patients using as the primary endpoint coronary plaque volume and composition measured by coronary CT angiography imaging. If the Company decides to pursue the Phase 2 clinical study, the Company
plans to partner with the Colorado Prevention Center, Aurora, Colorado and Lundquist Institute, Torrence, California.
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 and concurred with the general design of the small Phase
2 study using coronary CT angiography imaging as primary endpoint. The FDA also requested that the Company conduct chronic nonclinical toxicology animal studies to support the chronic use of sabizabulin for this indication. The chronic nonclinical
toxicology studies are expected to be completed and a new IND for the proposed indication is planned to be submitted by the first half calendar 2026. Veru currently has sufficient drug substance to supply the proposed Phase 2 clinical study.
We are very excited with the Phase 2b QUALITY topline results. The efficacy data from the study provides the proof of concept that you can retain lean
mass and improve physical function and lose enough fat mass to make up for the lean mass retained to have the same weight loss as semaglutide alone at 16 weeks, said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of
Veru. The Phase 2b QUALITY study is the first human study to demonstrate that older patients who
are overweight or have obesity and receiving only a semaglutide GLP-1 RA are at higher risk for accelerated loss of lean mass and physical function
decline. The expectation is that all GLP-1 RA containing drugs could cause significant loss of lean mass in older patients raising concerns for potential declines in physical function, mobility disability,
functional limitations, and loss of balance with a higher risk for falls and fractures. Further, our expectation is that when patients are treated longer with enobosarm + semaglutide, this tissue SELECTIVE and greater loss of adiposity (fat) should
translate to a greater quality weight reduction than with semaglutide alone. Dr. Steiner added: Similarly, we are excited to explore advancing sabizabulin as a better option to colchicine to treat inflammation responsible for the
progression of atherosclerotic coronary artery disease, a major cardiometabolic indication.
FC2 Female Condom (Internal Condom) Sale
On December 30, 2024, The Female Health Company Limited entered into a Stock and Asset Purchase Agreement (the Purchase Agreement ) with Clear
Future, Inc. (the Purchaser ). Pursuant to, and subject to the terms and conditions of, the Purchase Agreement, the Purchaser purchased substantially all of the assets (the FC2 Business Sale ) related to the Company s FC2
female condom business (internal condom), including the stock of the Company s U.K. and Malaysian operating subsidiaries. The Purchaser assumed certain liabilities relating to the FC2 business that are specified in the Purchase Agreement.
The transaction closed on December 30, 2024. The purchase price for the FC2 Business Sale was $18.0 million in cash, subject to adjustment as set forth in the Purchase Agreement. The adjustments to the purchase price in the Purchase
Agreement include a customary working capital adjustment based on the amount by which certain working capital items at closing are greater or less than a target set forth in the Purchase Agreement. Estimated proceeds to the Company after deducting a