Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company, has announced its participation in the BTIG Virtual Biotechnology Conference on August 5th, 2024. The company will engage in one-on-one meetings with investors during the event.
Veru specializes in developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome. This conference participation provides an opportunity for Veru to connect with potential investors and showcase its latest developments in these critical areas of medical research.
The virtual format of the conference aligns with the ongoing trend of digital interactions in the biotechnology sector, allowing for efficient and widespread engagement with the investment community.
Veru Inc. (NASDAQ: VERU), un’azienda biofarmaceutica in fase clinica avanzata, ha annunciato la sua partecipazione al BTIG Virtual Biotechnology Conference che si terrà il 5 agosto 2024. L’azienda si impegnerà in incontri individuali con gli investitori durante l’evento.
Veru si specializza nello sviluppo di farmaci innovativi per preservare la massa muscolare per una perdita di peso di alta qualità, oncologia e sindrome da distress respiratorio acuto indotta da virus. La partecipazione a questa conferenza offre a Veru l’opportunità di connettersi con potenziali investitori e mostrare i suoi ultimi sviluppi in queste aree critiche della ricerca medica.
Il formato virtuale della conferenza si allinea con la tendenza attuale delle interazioni digitali nel settore biotecnologico, consentendo un coinvolgimento efficiente e diffuso con la comunità degli investimenti.
Veru Inc. (NASDAQ: VERU), una compañía biofarmacéutica en etapa clínica avanzada, ha anunciado su participación en la BTIG Virtual Biotechnology Conference el 5 de agosto de 2024. La empresa participará en reuniones uno a uno con inversores durante el evento.
Veru se especializa en el desarrollo de medicamentos innovadores para preservar la masa muscular para una pérdida de peso de alta calidad, oncología y síndrome de dificultad respiratoria aguda inducida por virus. La participación en esta conferencia brinda a Veru la oportunidad de conectar con inversores potenciales y mostrar sus últimos avances en estas áreas críticas de la investigación médica.
El formato virtual de la conferencia se alinea con la tendencia actual de interacciones digitales en el sector biotecnológico, lo que permite un compromiso eficiente y amplio con la comunidad de inversiones.
Veru Inc. (NASDAQ: VERU)는 후기 임상 단계의 바이오 제약 회사로, 2024년 8월 5일에 열리는 BTIG 가상 생명공학 회의에 참여한다고 발표했습니다. 이 회사는 행사 기간 동안 투자자와의 일대일 미팅을 진행할 예정입니다.
Veru는 고품질 체중 감량을 위한 근육 보존, 종양학 및 바이러스 유도 급성 호흡 곤란 증후군을 위한 혁신적인 약물을 개발하는 데 특화되어 있습니다. 이번 회의 참여는 Veru에게 잠재 투자자와 연결하고 이러한 중요한 의학 연구 분야에서 최신 개발 사항을 선보일 수 있는 기회를 제공합니다.
회의의 가상 형식은 생명공학 분야의 디지털 상호 작용의 지속적인 추세와 일치하며, 투자 커뮤니티와의 효율적이고 광범위한 참여를 가능하게 합니다.
Veru Inc. (NASDAQ: VERU), une entreprise biopharmaceutique en phase clinique avancée, a annoncé sa participation à la BTIG Virtual Biotechnology Conference le 5 août 2024. L’entreprise participera à des réunions individuelles avec des investisseurs pendant l’événement.
Veru se spécialise dans le développement de médicaments innovants pour préserver la masse musculaire dans le cadre d’une perte de poids de haute qualité, l’oncologie et le syndrome de détresse respiratoire aigu induit par des virus. Cette participation à la conférence offre à Veru l’opportunité de se connecter avec des investisseurs potentiels et de présenter ses derniers développements dans ces domaines critiques de la recherche médicale.
Le format virtuel de la conférence correspond à la tendance actuelle des interactions numériques dans le secteur biotechnologique, permettant un engagement efficace et largement diffusé avec la communauté des investisseurs.
Veru Inc. (NASDAQ: VERU), ein biopharmazeutisches Unternehmen in der späten klinischen Phase, hat seine Teilnahme an der BTIG Virtual Biotechnology Conference am 5. August 2024 bekannt gegeben. Das Unternehmen wird während der Veranstaltung Einzelgespräche mit Investoren führen.
Veru ist auf die Entwicklung innovativer Arzneimittel zur Erhaltung von Muskelmasse für hochwertigen Gewichtsverlust, Onkologie und virale induzierte akute Atemnotsyndrome spezialisiert. Die Teilnahme an dieser Konferenz bietet Veru die Möglichkeit, mit potenziellen Investoren in Kontakt zu treten und die neuesten Entwicklungen in diesen kritischen Bereichen der medizinischen Forschung vorzustellen.
Das virtuelle Format der Konferenz entspricht dem anhaltenden Trend zu digitalen Interaktionen im Biotechnologiesektor und ermöglicht eine effiziente und umfassende Einbindung der Investitionsgemeinschaft.
07/29/2024 – 08:30 AM
MIAMI, FL, July 29, 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 the company will be participating in one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference on August 5th, 2024.
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 approximately 150 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 by the end of calendar year 2024.
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 simulates a “starvation state” 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.
Importantly, 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, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program 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; 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
When is Veru (VERU) participating in the BTIG Virtual Biotechnology Conference?
Veru (VERU) is participating in the BTIG Virtual Biotechnology Conference on August 5th, 2024.
What type of meetings will Veru (VERU) be conducting at the BTIG Virtual Biotechnology Conference?
Veru (VERU) will be conducting one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference.
What are the main areas of focus for Veru’s (VERU) drug development?
Veru (VERU) focuses on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome.
What is the current stage of Veru (VERU) in terms of drug development?
Veru (VERU) is described as a late clinical stage biopharmaceutical company, indicating that it has drugs in advanced stages of clinical trials.
