Veru Announces Appointment of Dr. David D. Ho as Chairman of its Infectious Disease Scientific Advisory Board

MIAMI. FL, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced the appointment of David D. Ho, M.D., a trailblazer of infectious disease viral research and therapeutic development, as Chairman of its Scientific Advisory Board (SAB).

"Today's appointment of Dr. Ho as Chairman of Veru's SAB illustrates our commitment to building a team of scientific experts to support our goal of developing and delivering life-saving therapies to patients with COVID-19 and other viral ARDS-related diseases," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "Dr. Ho's exemplary scientific contributions to the field, historically in HIV/AIDS and more recently in COVID-19, ideally position him to help shape the clinical development strategies of our expanding infectious disease program."

David D. Ho, M.D., is the Founding Scientific Director of the Aaron Diamond AIDS Research Center and the Clyde and Helen Wu Professor of Medicine at Columbia University Irving Medical Center, a Member of The National Academy of Medicine, as well as a Member of The American Academy of Arts & Sciences, and a Fellow of The American Association for the Advancement of Science. He received his M.D. from Harvard Medical School and has received fourteen honorary doctorates over the course of his career.

In his noteworthy research, Dr. Ho discovered the nature of HIV replication, and the resulting innovative combination therapy remarkably enabled patients to manage this disease. In 1996, Dr. Ho was named TIME magazine's Man of the Year based on his groundbreaking research and treatments, which provide hope to millions of patients in the daunting fight against HIV. In addition, Dr. Ho is leading a multi-disciplinary team of physicians, scientists, and engineers to advance the development of new drugs that target SARS-CoV-2 mutants. To date, his team at Columbia University has identified one of the broadest and most potent panels of antibodies against SARS-CoV-2.

"I am thrilled to join Veru's SAB as Chairman while their team works diligently to prepare for the potential commercialization of sabizabulin, a novel microtubular disruptor, for the treatment of hospitalized adult COVID-19 patients," said David D. Ho, M.D. "The Company has generated compelling data on sabizabulin in COVID-19, and I am eager to collaborate with and help guide the management team regarding future development plans for sabizabulin treatment and its potential to work against additional viral ARDS-related diseases."

About Veru Inc.

Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology.

Infectious disease program:

The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo.

Oncology program:

The Company's late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.

Current studies on the two drugs include:

• Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with sufficient AR expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA.
  
  
  
  
• Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with sufficient AR expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly is supplying Verzenio^® (abemaciclib).
  
  
  
  
• Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with sufficient AR expression (third-line metastatic setting).
  
  

Veru's late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.

Current studies on these drugs include:

• Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy.
  
  
  
  
• Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer.
  
  
  
  
• Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.
  
  

Commercial sexual health program, Urev, has 2 FDA approved products:

• ENTADFI™ (tadalafil and finasteride) capsules for oral use, a new treatment for benign prostatic hyperplasia.
  
  
  
  
• FC2 Female Condom^® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
  
  

Forward-Looking Statements

The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether the Company will successfully develop or commercialize any drug in the infectious disease area and whether any such drug will serve a potentially life-saving unmet need; whether the Company's infections disease franchise will generate any commercially available product and whether it will expand sabizabulin or any other compound beyond the potential treatment of certain COVID-19 patients; whether the Scientific Advisory Board will successfully make a meaningful contribution to sabizabulin's prospects or Veru's prospects or plans generally; whether any other leading physicians or scientists will join Veru's Scientific Advisory Board; whether and when the Company will receive an emergency use authorization or any approval from FDA or from any regulatory authority outside the U.S. for sabizabulin for certain COVID-19 patients; whether and when sabizabulin will become an available treatment option for certain COVID-19 patients in the U.S. or anywhere outside the U.S.; whether any additional efficacy or safety clinical studies of sabizabulin for certain COVID-19 patients will be required by the FDA or any other regulatory authority as a condition to any authorization or as a post-authorization requirement; whether the Company will have sufficient supply of sabizabulin to meet demand, if an emergency use authorization or other approval is granted in the U.S. or in any other country; whether the Company will secure any advance purchase agreement with the U.S. government or any foreign government; whether the current and future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company's drug candidates and companion diagnostic; whether the drug candidates will be approved for the targeted line of therapy; the anticipated design and scope of clinical studies and FDA acceptance of such design and scope; whether any regulatory pathways, including the accelerated Fast Track designations, to seek FDA approval for sabizabulin, enobosarm or any of the Company's drug candidates are or continue to be available; whether the expected commencement and timing of the Company's clinical studies, including the Phase 3 ENABLAR-2 study, the sabizabulin monotherapy Phase 2b clinical study for 3^rd line treatment of metastatic breast cancer, the Phase 2 registration clinical study for VERU-100, and the development of the companion diagnostic will be met; when clinical results from the ongoing clinical studies will be available, whether sabizabulin, enobosarm, VERU-100, or zuclomiphene will serve any unmet need or, what dosage, if any, might be approved for use in the U.S. or elsewhere, and also statements about the potential, timing and efficacy of the rest of the Company's development pipeline, and the timing of the Company's submissions to FDA and FDA's review of all such submissions; whether any of the selective clinical properties previously observed in clinical studies of sabizabulin, enobosarm, VERU-100 or other drug candidates will be replicated in the current and planned clinical development program for such drug candidates and whether any such properties will be recognized by the FDA in any potential approvals and labeling; whether the companion diagnostic for enobosarm will be developed successfully or be approved by the FDA for use; whether ENTADFI will be commercialized successfully, the Company will grow sales of ENTADFI or the Company will be able to successful partner with any other entity to grow sales of ENTADFI; whether the telemedicine customers for FC2 will return to historical ordering patterns or increase their purchases of FC2 at all; and whether the Company's current cash will be sufficient to fund its planned or expected operations, especially if any authorizations for sabizabulin for certain COVID-19 patients are not obtained. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related 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; 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 possibility that as vaccines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company's existing products, including FC2 and ENTADFI and, if authorized, sabizabulin, and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical studies, supply chain and other third-party providers, commercial efforts, and business development operations; 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; the Company's ability to successfully commercialize any of its products, if approved; risks relating to the Company's development of its own dedicated direct to patient telemedicine and telepharmacy services platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, and development costs; 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, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims; 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 fiscal year ended September 30, 2022 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. The Company disclaims any intent or obligation to update these forward-looking statements.

Verzenio^® is a registered trademark of Eli Lilly and Company

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