Veru Reports Fiscal 2025 First Quarter Financial Results and Clinical Program Progress
Veru Inc. (VERU) announced positive Phase 2b QUALITY study results for enobosarm combined with semaglutide (Wegovy). The study met its primary endpoint, showing a 71% reduction in lean mass loss, with enobosarm 3mg dose achieving >99% reduction. The treatment also demonstrated greater fat loss and improved physical function.
The company sold its FC2 Female Condom Business for $18 million, with estimated net proceeds of $12.3 million. Additionally, Veru announced a new cardiometabolic indication for sabizabulin to treat inflammation in atherosclerotic coronary artery disease.
Financial highlights include: R&D expenses increased to $5.7M from $1.7M, operating loss from continuing operations increased to $10.2M from $7.4M, and cash position stood at $26.6M as of December 31, 2024.
Veru Inc. (VERU) ha annunciato risultati positivi dello studio di fase 2b QUALITY per enobosarm combinato con semaglutide (Wegovy). Lo studio ha raggiunto il suo obiettivo primario, mostrando una riduzione del 71% nella perdita di massa magra, con la dose di enobosarm da 3 mg che ha ottenuto una riduzione superiore al 99%. Il trattamento ha inoltre dimostrato una maggiore perdita di grasso e un miglioramento della funzione fisica.
L'azienda ha venduto la sua attività di preservativi femminili FC2 per 18 milioni di dollari, con un ricavato netto stimato di 12,3 milioni di dollari. Inoltre, Veru ha annunciato una nuova indicazione cardiometabolica per sabizabulin per trattare l'infiammazione nella malattia coronarica aterosclerotica.
Tra i punti salienti finanziari: le spese per R&S sono aumentate a 5,7 milioni di dollari rispetto a 1,7 milioni, la perdita operativa delle operazioni continuative è aumentata a 10,2 milioni di dollari rispetto a 7,4 milioni, e la posizione di cassa si attestava a 26,6 milioni di dollari al 31 dicembre 2024.
Veru Inc. (VERU) anunció resultados positivos del estudio de fase 2b QUALITY para enobosarm combinado con semaglutida (Wegovy). El estudio cumplió con su objetivo principal, mostrando una reducción del 71% en la pérdida de masa magra, con la dosis de enobosarm de 3 mg logrando una reducción superior al 99%. El tratamiento también demostró una mayor pérdida de grasa y una mejora en la función física.
La empresa vendió su negocio de preservativos FC2 para 18 millones de dólares, con un ingreso neto estimado de 12,3 millones de dólares. Además, Veru anunció una nueva indicación cardiometabólica para sabizabulin para tratar la inflamación en la enfermedad arterial coronaria aterosclerótica.
Los aspectos financieros destacados incluyen: los gastos de I+D aumentaron a 5,7 millones de dólares desde 1,7 millones, la pérdida operativa de las operaciones continuas aumentó a 10,2 millones de dólares desde 7,4 millones, y la posición de efectivo se situó en 26,6 millones de dólares al 31 de diciembre de 2024.
Veru Inc. (VERU)는 enobosarm과 semaglutide (Wegovy) 조합에 대한 긍정적인 2b 단계 QUALITY 연구 결과를 발표했습니다. 이 연구는 주요 목표를 달성했으며, 근육량 손실이 71% 감소했음을 보여주었고, 3mg의 enobosarm 용량은 99% 이상의 감소를 기록했습니다. 이 치료법은 또한 더 큰 지방 손실과 신체 기능 개선을 나타냈습니다.
회사는 FC2 여성용 콘돔 사업을 1,800만 달러에 판매했으며, 예상 순수익은 1,230만 달러입니다. 또한 Veru는 죽상동맥경화증에서 염증을 치료하기 위한 sabizabulin의 새로운 심혈관 대사 적응증을 발표했습니다.
재무 하이라이트에는 다음이 포함됩니다: R&D 비용이 170만 달러에서 570만 달러로 증가했으며, 계속 운영에서의 운영 손실이 740만 달러에서 1,020만 달러로 증가했으며, 2024년 12월 31일 기준으로 현금 보유액은 2,660만 달러에 달했습니다.
Veru Inc. (VERU) a annoncé des résultats positifs de l'étude de phase 2b QUALITY pour enobosarm combiné avec semaglutide (Wegovy). L'étude a atteint son objectif principal, montrant une réduction de 71 % de la perte de masse maigre, avec une dose de 3 mg d'enobosarm atteignant une réduction de plus de 99 %. Le traitement a également démontré une plus grande perte de graisse et une amélioration de la fonction physique.
L'entreprise a vendu son activité de préservatifs féminins FC2 pour 18 millions de dollars, avec des produits nets estimés à 12,3 millions de dollars. De plus, Veru a annoncé une nouvelle indication cardiométabolique pour le sabizabulin afin de traiter l'inflammation dans la maladie coronarienne athéroscléreuse.
Les points forts financiers incluent : les dépenses de R&D ont augmenté à 5,7 millions de dollars contre 1,7 million, la perte d'exploitation des opérations continues a augmenté à 10,2 millions de dollars contre 7,4 millions, et la position de trésorerie était de 26,6 millions de dollars au 31 décembre 2024.
Veru Inc. (VERU) hat positive Ergebnisse der Phase 2b QUALITY-Studie für enobosarm in Kombination mit semaglutid (Wegovy) bekannt gegeben. Die Studie erreichte ihr primäres Ziel und zeigte eine Reduktion des Verlusts von fettfreier Masse um 71 %, wobei die Dosis von 3 mg enobosarm eine Reduktion von über 99 % erzielte. Die Behandlung zeigte auch einen größeren Fettverlust und eine verbesserte körperliche Funktion.
Das Unternehmen verkaufte sein Geschäft mit FC2-Frauenkondomen für 18 Millionen Dollar, mit geschätzten Nettoerlösen von 12,3 Millionen Dollar. Darüber hinaus kündigte Veru eine neue kardiometabolische Indikation für sabizabulin zur Behandlung von Entzündungen bei atherosklerotischer koronarer Herzkrankheit an.
Zu den finanziellen Highlights gehören: Die F&E-Ausgaben stiegen auf 5,7 Millionen Dollar von 1,7 Millionen Dollar, der operative Verlust aus fortgeführten Aktivitäten stieg auf 10,2 Millionen Dollar von 7,4 Millionen Dollar, und die Liquiditätsposition betrug zum 31. Dezember 2024 26,6 Millionen Dollar.
- Phase 2b QUALITY study met primary endpoint with 71% reduction in lean mass loss
- Sale of FC2 Female Condom Business for $18M, generating $12.3M in net proceeds
- Extinguishment of $9.9M in liabilities associated with Residual Royalty Agreement
- Cash position improved to $26.6M from $24.9M quarter-over-quarter
- Operating loss increased to $10.2M from $7.4M
- R&D expenses increased significantly to $5.7M from $1.7M
- Net loss increased to $8.9M from $8.3M year-over-year
Insights
The Phase 2b QUALITY study results represent a significant breakthrough in addressing a critical limitation of GLP-1 receptor agonists like Wegovy. The 71% reduction in lean mass loss and particularly the 99% preservation with the 3mg dose could position enobosarm as an essential companion therapy to GLP-1 drugs, especially for older adults where muscle preservation is crucial.
The body composition data is particularly compelling - while placebo + semaglutide patients lost 32% lean mass and 68% fat mass, the enobosarm 3mg combination achieved an optimal 0.9% lean mass loss versus 99.1% fat loss. This selective tissue targeting could be revolutionary in the obesity treatment landscape, especially given the 54.4% reduction in physical function decline measured by stair climb power.
The strategic pivot to explore sabizabulin for atherosclerotic cardiovascular disease is well-timed, targeting an established pathway validated by colchicine's recent FDA approval. Sabizabulin's potential advantages over colchicine, particularly regarding drug-drug interactions with statins, could provide a significant market opportunity in the cardiovascular space.
The
--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 disease--
--Company sold the FC2 Female Condom® (Internal Condom) Business for
--Company to host conference call and webcast today at 8:00 a.m. ET--
MIAMI, FL, Feb. 13, 2025 (GLOBE NEWSWIRE) -- 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 (
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
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 -
- A responders analysis was conducted using a greater than
10% decline in stair climb power as the cut off at 16 weeks which represents 8 to10 year loss of stair climb power function due to aging. In our study, the loss of lean mass mattered as42.6% of patients on placebo + semaglutide group had at least a10% decline in stair climb power physical function at 16 weeks. This is the first human study to demonstrate that older patients who are overweight or have obesity receiving semaglutide GLP-1 RA are at higher risk for accelerated loss of lean mass with physical function decline. - The all enobosarm + semaglutide group had a statistically significant and clinically meaningfully
54.4% mean relative reduction in the proportion of subjects that lost at least10% stair climb power compared to placebo + semaglutide group (p=0.0049). In enobosarm 3mg + semaglutide, there was a62.4% relative reduction in the proportion of patients with at least a10% decline in stair climb power from baseline vs. placebo + semaglutide group (p=0.0066). In enobosarm 6mg + semaglutide, there was a46.2% relative reduction in the proportion of patients with at least a10% decline in stair climb power from baseline vs. placebo + semaglutide group (p=0.0505) Therefore, enobosarm treatment preserved lean mass (muscle) which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline versus subjects receiving semaglutide alone.
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 as designed.
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 of calendar 2025.
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
Given the 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
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 β-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
First Quarter Financial Summary: Fiscal 2025 vs Fiscal 2024
- Research and development expenses increased to
$5.7 million from$1.7 million - Selling, general and administrative expenses decreased to
$5.2 million from$6.7 million - Operating loss from continuing operations increased to
$10.2 million from$7.4 million - Net loss from continuing operations decreased to
$1.8 million , or$0.01 per share, compared to$7.7 million , or$0.08 per share - Net loss increased to
$8.9 million , or$0.06 per share, compared to$8.3 million , or$0.08 per share
Balance Sheet Information
- Cash, cash equivalents, and restricted cash were
$26.6 million as of December 31, 2024 versus$24.9 million as of September 30, 2024 - Estimated net proceeds from the sale of the FC2 business are
$12.3 million , after the change of control payment to terminate the Residual Royalty Agreement of$4.2 million . - Due to the sale of the FC2 business, liabilities associated with the Residual Royalty Agreement, which totaled
$9.9 million as of September 30, 2024 were extinguished.
Event Details
The audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international), passcode 3764668, for one week.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory disease. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for fat loss thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.
About Sarcopenic Obesity
The clinical condition to improve body composition by preserving muscle and enhancing the loss of adiposity. We believe the market for this condition is quite large. Based on Medicare statistics,
Muscle weakness may lead to poor balance, decreased gait speed, mobility disability, functional limitations, loss of independence, and higher risk for falls and fractures. In fact, the safety section of the package insert for Wegovy has been updated based on the recently reported SELECT cardiovascular outcomes clinical trial which now highlights a
About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer causes the loss of appetite where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced appetite suppression provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.
Enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the full data set, including safety data, from the Phase 2b QUALITY study of enobosarm discussed above will be made available and whether that data will align with disclosed topline results or change any of the conclusions drawn from the topline data; whether and when the Company will present the full data from the Phase 2b QUALITY study and in what forum; whether and when patients will progress into the extension study; the planned design, number of sites, timing, endpoints, patient population and patient size of such extension study and whether such extension study will successfully meet any of its endpoints; whether and when the Company will have an end-of-Phase-2 meeting with FDA and the results of any such meeting; whether the results of the Phase 2b QUALITY study of enobosarm will be replicated to the same or any degree in any future Phase 3 studies; the expected costs, timing, patient population, design, endpoints and results of the planned Phase 3 studies of enobosarm as a body composition drug or any other Phase 3 studies; whether the Company and FDA will align on the Phase 3 program for enobosarm as a body composition drug and whether any such program will be able to be funded by the Company; whether the timed-released formation of enobosarm will be developed successfully and whether such formulation will have the same effectiveness as the current formulation, and whether and when such such timed-release formulation will be available for any planned or future clinical studies; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned Phase 3 study or other Phase 3 studies; whether FDA will require more than one Phase 3 study for enobosarm as a body composition drug; whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss in any planned or other Phase 3 studies or if approved, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will have a greater loss of adiposity or greater weight loss than with semaglutide alone; whether and when enobosarm will be approved by the FDA as a body composition drug; whether and when sabizabulin will be developed for an atherosclerotic coronary artery disease indication (“CAD”), and whether sabizabulin would provide a safer, effective alternative to colchicine; whether prior data regarding sabizabulin’s anti-inflammatory effects would be repeated in any such future CAD indication; the timing of the completion of tox studies and the submission of an IND for sabizabulin in a CAD indication; The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 3 program for enobosarm as a body composition drug and the number of Phase 3 studies to be required and the cost thereof; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; the Company’s failure to timely file certain reports in February 2024 may impair its ability to raise capital under the Company’s current effective shelf registration statement on Form S-3 or under a new registration statement; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.
*Wegovy® is a registered trademark of Novo Nordisk A/S
FINANCIAL SCHEDULES FOLLOW
| Veru Inc. Condensed Consolidated Balance Sheets (unaudited) | |||||
| December 31, | September 30, | ||||
| 2024 | 2024 | ||||
| Cash, cash equivalents, and restricted cash | $ | 26,607,002 | $ | 24,916,285 | |
| Prepaid expenses and other current assets | 1,773,134 | 1,547,928 | |||
| Current assets of discontinued operations | — | 8,759,011 | |||
| Total current assets | 28,380,136 | 35,223,224 | |||
| Property and equipment, net | 452,043 | 481,372 | |||
| Operating lease right-of-use assets | 3,127,887 | 3,250,623 | |||
| Goodwill | 6,878,932 | 6,878,932 | |||
| Other assets | 989,596 | 989,596 | |||
| Long-term assets of discontinued operations | — | 13,595,025 | |||
| Total assets | $ | 39,828,594 | $ | 60,418,772 | |
| Accounts payable | $ | 1,994,645 | $ | 2,259,668 | |
| Accrued research and development costs | 1,572,429 | 120,448 | |||
| Accrued compensation | 1,503,233 | 4,494,278 | |||
| Accrued expenses and other current liabilities | 1,277,921 | 1,286,207 | |||
| Residual royalty agreement liability, short-term portion | — | 1,025,837 | |||
| Current liabilities of discontinued operations | — | 2,681,530 | |||
| Total current liabilities | 6,348,228 | 11,867,968 | |||
| Residual royalty agreement liability, long-term portion | — | 8,850,792 | |||
| Operating lease liability, long-term portion | 2,775,190 | 2,905,309 | |||
| Other liabilities | 4,078,187 | 4,477,991 | |||
| Total liabilities | 13,201,605 | 28,102,060 | |||
| Total stockholders' equity | 26,626,989 | 32,316,712 | |||
| Total liabilities and stockholders' equity | $ | 39,828,594 | $ | 60,418,772 | |
| Veru Inc. Condensed Consolidated Statements of Operations (unaudited) | ||||||||
| Three Months Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 5,716,830 | $ | 1,658,574 | ||||
| Selling, general and administrative | 5,227,113 | 6,651,624 | ||||||
| Total operating expenses | 10,943,943 | 8,310,198 | ||||||
| Gain on sale of ENTADFI® assets | 695,216 | 918,372 | ||||||
| Operating loss from continuing operations | (10,248,727 | ) | (7,391,826 | ) | ||||
| Non-operating income (expenses): | ||||||||
| Gain on extinguishment of debt | 8,624,778 | — | ||||||
| Other non-operating expenses, net | (185,954 | ) | (275,557 | ) | ||||
| Total non-operating income (expenses) | 8,438,824 | (275,557 | ) | |||||
| Net loss from continuing operations | (1,809,903 | ) | (7,667,383 | ) | ||||
| Net loss from discontinued operations, net of taxes | (7,135,444 | ) | (608,598 | ) | ||||
| Net loss | $ | (8,945,347 | ) | $ | (8,275,981 | ) | ||
| Net loss from continuing operations per basic and diluted common shares outstanding | $ | (0.01 | ) | $ | (0.08 | ) | ||
| Net loss from discontinued operations per basic and diluted common shares outstanding | $ | (0.05 | ) | $ | (0.01 | ) | ||
| Net loss per basic and diluted common shares outstanding | $ | (0.06 | ) | $ | (0.08 | ) | ||
| Basic and diluted weighted average common shares outstanding | 146,383,920 | 100,601,946 | ||||||
| Veru Inc. Condensed Consolidated Statements of Cash Flows (unaudited) | ||||||||
| Three Months Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Net loss | $ | (8,945,347 | ) | $ | (8,275,981 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities | 1,067,088 | 3,044,876 | ||||||
| Changes in operating assets and liabilities | (3,454,728 | ) | (789,284 | ) | ||||
| Net cash used in operating activities | (11,332,987 | ) | (6,020,389 | ) | ||||
| Net cash provided by investing activities | 17,245,315 | — | ||||||
| Net cash (used in) provided by financing activities | (4,221,611 | ) | 36,973,954 | |||||
| Net increase in cash, cash equivalents, and restricted cash | 1,690,717 | 30,953,565 | ||||||
| Cash, cash equivalents, and restricted cash at beginning of period | 24,916,285 | 9,625,494 | ||||||
| Cash, cash equivalents, and restricted cash at end of period | $ | 26,607,002 | $ | 40,579,059 | ||||
Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
FAQ
What were the key results of VERU's Phase 2b QUALITY study in Q1 2025?
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When are the topline results expected for VERU's Phase 2b extension maintenance study?
