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Veru to Present at ObesityWeek: Meta-Analysis of 4 Previous Randomized Clinical Trials that Support the Potential of Enobosarm to Optimize Weight Loss

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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), un'azienda biofarmaceutica in fase clinica avanzata, ha annunciato la sua partecipazione a ObesityWeek, che si svolgerà dal 3 al 6 novembre 2024 a San Antonio, Texas. L'azienda presenterà una meta-analisi dei soggetti provenienti da quattro studi clinici randomizzati che supportano il potenziale dell'enobosarm nell'ottimizzazione della perdita di peso. Questa presentazione, intitolata "Meta-analisi dei soggetti di 4 studi clinici randomizzati a sostegno del potenziale dell'enobosarm nell'ottimizzazione della perdita di peso," è prevista per il 5 novembre 2024, dalle 14:30 alle 15:30 CDT presso il Centro Congressi Henry B. González.

Veru si concentra sullo sviluppo di farmaci innovativi per preservare la massa muscolare per una perdita di peso di alta qualità, oncologia e sindrome da distress respiratorio acuto indotto da virus. La presentazione a ObesityWeek è in linea con gli sforzi di ricerca dell'azienda nella gestione del peso e nella preservazione muscolare.

Veru Inc. (NASDAQ: VERU), una empresa biofarmacéutica en etapa clínica avanzada, ha anunciado su participación en ObesityWeek, programada del 3 al 6 de noviembre de 2024 en San Antonio, Texas. La empresa presentará un meta-análisis de sujetos de cuatro ensayos clínicos aleatorizados que respaldan el potencial del enobosarm para optimizar la pérdida de peso. Esta presentación, titulada "Meta-análisis de sujetos de 4 ensayos clínicos aleatorizados que apoyan el potencial del enobosarm para optimizar la pérdida de peso," está programada para el 5 de noviembre de 2024, de 2:30 PM a 3:30 PM CDT en el Centro de Convenciones Henry B. González.

Veru se enfoca en desarrollar medicamentos innovadores para preservar la masa muscular en la pérdida de peso de alta calidad, oncología y síndrome de dificultad respiratoria aguda inducida por virus. La presentación en ObesityWeek se alinea con los esfuerzos de investigación de la empresa en el manejo del peso y la preservación muscular.

Veru Inc. (NASDAQ: VERU), 후기 임상 단계의 생명공학 기업이 2024년 11월 3일부터 6일까지 텍사스주 샌안토니오에서 열리는 ObesityWeek에 참가한다고 발표했습니다. 이 회사는 enobosarm의 체중 감량 최적화 가능성을 뒷받침하는 네 개의 무작위 임상 시험 참여자에 대한 메타 분석을 발표할 예정입니다. 이 발표는 "네 개의 무작위 임상 시험에서의 참여자 메타 분석이 enobosarm의 체중 감량 최적화 가능성을 지지한다"는 제목으로 2024년 11월 5일 오후 2시 30분부터 3시 30분 CDT까지 헨리 B. 곤살레스 컨벤션 센터에서 진행됩니다.

Veru는 고품질 체중 감량, 종양학 및 바이러스 유발 급성 호흡 곤란 증후군을 위한 근육 보존 혁신 약물 개발에 집중하고 있습니다. ObesityWeek에서의 발표는 체중 관리 및 근육 보존에 대한 회사의 연구 노력과 일치합니다.

Veru Inc. (NASDAQ: VERU), une entreprise biopharmaceutique en phase clinique avancée, a annoncé sa participation à ObesityWeek, prévue du 3 au 6 novembre 2024 à San Antonio, Texas. L'entreprise présentera une méta-analyse de sujets issus de quatre essais cliniques randomisés soutenant le potentiel de enobosarm pour optimiser la perte de poids. Cette présentation, intitulée "Méta-analyse de sujets de 4 essais cliniques randomisés soutenant le potentiel d'enobosarm pour optimiser la perte de poids," est programmée pour le 5 novembre 2024, de 14h30 à 15h30 CDT au Henry B. González Convention Center.

Veru se concentre sur le développement de médicaments innovants pour préserver la masse musculaire lors d'une perte de poids de haute qualité, en oncologie et pour le syndrome de détresse respiratoire aigu induit par des virus. La présentation à ObesityWeek s'aligne avec les efforts de recherche de l'entreprise en matière de gestion du poids et de préservation musculaire.

Veru Inc. (NASDAQ: VERU), ein Unternehmen der biopharmazeutischen Industrie in der späten klinischen Phase, hat seine Teilnahme an der ObesityWeek angekündigt, die vom 3. bis 6. November 2024 in San Antonio, Texas, stattfinden wird. Das Unternehmen wird eine Meta-Analyse von Probanden aus vier randomisierten klinischen Studien präsentieren, die das Potenzial von enobosarm zur Optimierung des Gewichtsverlusts unterstützen. Diese Präsentation mit dem Titel "Meta-Analyse von Probanden aus 4 randomisierten klinischen Studien unterstützt das Potenzial von enobosarm zur Optimierung des Gewichtsverlusts" findet am 5. November 2024 von 14:30 bis 15:30 Uhr CDT im Henry B. González Convention Center statt.

Veru konzentriert sich auf die Entwicklung innovativer Medikamente zum Erhalt der Muskulatur für qualitativ hochwertigen Gewichtsverlust, Onkologie und durch Viren induziertes akutes Atemnotsyndrom. Die Präsentation bei der ObesityWeek steht im Einklang mit den Forschungsanstrengungen des Unternehmens im Bereich Gewichtsmanagement und Muskelerhalt.

Positive
  • Veru will present a meta-analysis of four clinical trials at ObesityWeek 2024
  • The meta-analysis supports enobosarm's potential for optimizing weight loss
  • Participation in ObesityWeek may increase visibility for Veru's research
Negative
  • None.

MIAMI, FL, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at ObesityWeek, taking place November 3-6, 2024, in San Antonio, Texas.

Presentation Name: Meta-analysis of subjects from 4 randomized clinical trials supports the potential of enobosarm to optimize weight loss
Date: November 5, 2024
Start and end time: 2:30 PM – 3:30 PM Central Daylight Time
Location: Henry B. González Convention Center, San Antonio, TX

Additional information on the meeting can be found on the following website: https://obesityweek.org

About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in 168 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected in January of 2025.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.

About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.

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 that were 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.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. 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 for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.
        
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 phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, 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 and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. 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 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; the Company’s existing product, FC2, and any future products, 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; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; 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, 2023, as amended by the Form 10-K/A, 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

Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com


FAQ

What is Veru Inc. presenting at ObesityWeek 2024?

Veru Inc. is presenting a meta-analysis of subjects from 4 randomized clinical trials supporting the potential of enobosarm to optimize weight loss at ObesityWeek 2024.

When and where is Veru's presentation at ObesityWeek 2024?

Veru's presentation is scheduled for November 5, 2024, from 2:30 PM to 3:30 PM CDT at the Henry B. González Convention Center in San Antonio, Texas.

What is the focus of Veru Inc.'s research presented at ObesityWeek 2024?

Veru Inc.'s research focuses on enobosarm's potential to optimize weight loss, as supported by a meta-analysis of four randomized clinical trials.

What are the main areas of focus for Veru Inc. (NASDAQ: VERU)?

Veru Inc. focuses on developing innovative medicines for preserving muscle for high-quality weight loss, oncology, and viral-induced acute respiratory distress syndrome.

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