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Veru Inc. (symbol: VERU) is a comprehensive biopharmaceutical company dedicated to advancing treatments in men’s and women’s health, as well as oncology. The company specializes in developing and commercializing innovative pharmaceuticals and medical devices.
Veru operates through three divisions:
- Pharmaceuticals and Devices: This division focuses on treatments for conditions such as benign prostatic hyperplasia, male infertility, prostate cancer, gout, sexual dysfunction, and side effects of hormonal therapies in men. For women's health, Veru is developing treatments targeting female sexual health and advanced breast and ovarian cancers.
- Consumer Health Products: This division includes the marketing and distribution of the FC2 Female Condom, the only FDA-approved female condom that offers dual protection against sexually transmitted infections, including HIV/AIDS and unintended pregnancies. Since its introduction, FC2 has been distributed to 144 countries.
- Public Sector: Veru collaborates with international health organizations, including ministries of health and the U.N., to improve global health outcomes. The company supplies large-scale tenders, such as a multi-year contract with the South African government for FC2.
Veru is currently in late-stage development for several pivotal pharmaceuticals:
- Enobosarm: A novel selective androgen receptor modulator (SARM) being developed to enhance fat loss while preserving muscle mass in overweight or obese patients receiving GLP-1 RA drugs. Enobosarm is also under investigation for treating metastatic breast cancer.
- Sabizabulin: A microtubule disruptor in Phase 3 clinical trials aimed at treating viral-induced acute respiratory distress syndrome (ARDS), particularly in hospitalized COVID-19 patients.
Recent achievements include the FDA's clearance for a Phase 2b clinical study of enobosarm, marking significant progress in its weight loss and muscle preservation programs. The company has also initiated the enrollment of patients for this study, with results expected by the end of 2024, and a follow-up study expected to complete by mid-2025.
Financially, Veru is committed to ensuring robust funding for its ongoing projects. Recent financial updates reveal successful financing rounds and strategic partnerships, positioning the company well for future growth and development. The company is also actively working to regain compliance with Nasdaq listing requirements following delays in its SEC filings.
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. (NASDAQ: VERU), a late clinical stage biopharmaceutical company, has announced it will host a conference call and audio webcast to discuss its fiscal 2025 first quarter financial results on Thursday, February 13, 2025, at 8:00 a.m. ET. The company focuses on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome.
The audio webcast will be available on the company's website at www.verupharma.com under the Home page and Investors section. Participants can join via telephone by dialing 1-800-341-1602 (domestic) or 1-412-902-6706 (international). A replay will be available on the website for approximately three months, and a telephonic replay will be accessible for one week by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) with passcode 3764668.
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company, which focuses on developing innovative medicines for muscle preservation in weight loss, oncology, and viral induced acute respiratory distress syndrome, will be represented by Mitchell Steiner, M.D., Chairman, President and CEO.
The presentation is scheduled for Tuesday, February 11, 2025, from 12:00 pm to 12:30 pm ET. The virtual event will be accessible through a live webcast on Veru's website (www.verupharma.com), with an archived version available for later viewing.
Veru (NASDAQ: VERU) announced positive topline results from its Phase 2b QUALITY clinical study evaluating enobosarm in combination with WEGOVY (semaglutide) for weight reduction. The study met its primary endpoint, demonstrating that enobosarm significantly preserved lean mass in patients receiving WEGOVY, with treated patients losing 71% less lean mass than those on WEGOVY alone.
Key findings include: patients on enobosarm lost 27% more fat mass than the control group, maintained similar total body weight loss, and showed reduced decline in physical function. The study involved 168 older patients (>60 years) over 16 weeks. In the placebo group, 32% of total weight loss was lean mass, while 42.6% experienced significant decline in stair climb power, compared to only 19.4% in the enobosarm group.
The company plans to proceed with Phase 3 trials following these positive results, with an anticipated sample size of 470 subjects over 52 weeks.
Veru Inc. (NASDAQ: VERU) has sold its FC2 Female Condom® business to clients managed by Riva Ridge Capital Management LP and co-investors for $18 million. The sale allows Veru to transform into a pure biopharmaceutical company, with estimated net proceeds of $12.5 million after deducting fees and premiums. The company will experience a significant workforce reduction of 90%, from 210 to 22 employees.
The company is currently focused on its Phase 2b QUALITY clinical trial evaluating enobosarm for muscle preservation and fat loss in patients using WEGOVY®, with topline results expected in January 2025. The transaction will also result in the termination of the Royalty Agreement with SWK Funding , eliminating $9.9 million in liabilities.
Veru Inc (NASDAQ: VERU) announced its upcoming presentation at the 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders in Washington, DC. The presentation, titled 'The use of muscle selective anabolics to make GLP-1 RA weight loss drugs more effective and precise,' is scheduled for December 6th, 2024, from 4:15 PM to 5:30 PM EST. The company, which focuses on developing medicines for muscle preservation, weight loss, oncology, and viral-induced acute respiratory distress syndrome, will showcase its research at this significant industry event.
Veru Inc. presented a meta-analysis of enobosarm's effects on body composition in older obese patients at ObesityWeek 2024. The analysis, based on four previous clinical trials, showed that enobosarm 3mg treatment led to better outcomes compared to placebo. By Day 147, enobosarm-treated subjects showed greater total weight loss (-2.93kg vs -2.11kg placebo), better lean mass preservation (-0.79kg vs -1.77kg placebo), and increased fat mass reduction (-2.05kg vs -0.05kg placebo). The drug was well-tolerated with no increase in gastrointestinal side effects.
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company, has announced its participation in ObesityWeek, scheduled for November 3-6, 2024, in San Antonio, Texas. The company will present a meta-analysis of subjects from four randomized clinical trials supporting the potential of enobosarm to optimize weight loss. This presentation, titled "Meta-analysis of subjects from 4 randomized clinical trials supports the potential of enobosarm to optimize weight loss," is set for November 5, 2024, from 2:30 PM to 3:30 PM CDT at the Henry B. González Convention Center.
Veru focuses on developing innovative medicines for preserving muscle for high-quality weight loss, oncology, and viral-induced acute respiratory distress syndrome. The presentation at ObesityWeek aligns with the company's research efforts in weight management and muscle preservation.
Veru Inc. (NASDAQ: VERU) announced its participation in the World Obesity and Weight Management Congress, scheduled for October 24-26, 2024, in Baltimore, Maryland. The company will deliver a keynote presentation on October 25, 2024, from 9:40 AM to 10:20 AM EDT at the Best Western Plus Hotel & Conference Center.
The presentation, titled 'Advancing enobosarm, an oral novel Selective Androgen Receptor Modulator (SARM), to avoid muscle loss and augment fat loss when combined with a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) drugs for potentially higher quality weight loss', will focus on the scientific support for combining enobosarm with GLP-1 receptor agonists to preserve muscle during weight loss.
Veru Inc. is a late clinical stage biopharmaceutical company developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome.
Veru Inc. (NASDAQ: VERU), a late-stage biopharmaceutical company, will present at the 2024 Cantor Global Healthcare Conference on September 18th at 1:55 PM Eastern Time. Dr. Mitchell Steiner, the company's Chairman, President, and CEO, will provide a corporate update focusing on Veru's Phase 2b clinical development program of enobosarm.
The presentation will highlight enobosarm's potential to enhance fat loss and prevent muscle loss when used in combination with GLP-1 drugs for weight loss. This aligns with Veru's mission to develop innovative medicines for preserving muscle in high-quality weight loss, oncology, and viral-induced acute respiratory distress syndrome.
Investors can access a live webcast of the presentation through Veru's website, with an archived version available afterward.