Mitchell Steiner, MD, FACS, Chairman, CEO & President at Veru, A DotCom Magazine Exclusive Interview

    About Mitchell Steiner, MD, FACS, Chairman, CEO & President at Veru

    Mitchell S. Steiner, M.D., F.A.C.S. has served as President and Chief Executive Officer of the Company and as a director of the Company since October 2016. Dr. Steiner was the co-founder of Aspen Park and served as Aspen Park’s Chief Executive Officer, President and Vice Chairman of the Board from July 2014 to October 2016. From 2014 to 2016, Dr. Steiner was a consultant and then the President, Urology and member of senior management of OPKO Health, Inc. (NASDAQ:OPK) and had responsibilities for the launch, marketing, sales and reimbursement of 4Kscore prostate cancer test to urologists and primary care physicians. Dr. Steiner was also the co-founder of GTx, Inc., a men’s health and oncology public company, where he served as Chief Executive Officer and Vice Chairman of Board of Directors from 1997 to 2014. Dr. Steiner is a Board Certified Urologist and a Fellow of the American College of Surgeons and has held numerous academic appointments, including Assistant Professor of Urology, Cell Biology, and Pathology at Vanderbilt School of Medicine from 1993 to 1995 and Chairman and Professor of Urology, Director of Urologic Oncology and Research and the Chair of Excellence in Urologic Oncology at the University of Tennessee from 1995 to 2004. Dr. Steiner holds a B.A. in Molecular Biology and Chemistry from Vanderbilt University and an M.D. from the University of Tennessee. He performed his surgical and urologic training at The Johns Hopkins Hospital and postdoctoral research fellow in cell biology at Vanderbilt School of Medicine.

    Veru is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer.Veru is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancers. Our strategy is primarily to focus on the clinical development and commercialization of oncology drugs for the management of two of the most prevalent cancers globally – prostate cancer and breast cancer.

    Prostate cancer is the most commonly diagnosed cancer in men with estimated 191,930 new cases and 33,330 deaths expected for 2020 in the U.S. One in nine men will develop prostate cancer in their lifetime. Prostate cancer has new challenges as it develops resistance to current drugs and spreads throughout the body and as the patient suffers from the long-term side effects of prostate cancer treatments like hot flashes, bone loss and fractures, loss of libido, erectile dysfunction, and loss of muscle strength and frailty.

    Breast cancer is the most commonly diagnosed cancer in women with estimated 276,480 new cases and 42,170 deaths expected for 2020 in the U.S. One in eight women will develop invasive breast cancer in their lifetime. There are many different types of breast cancer with diverse clinical and molecular characteristics. The most common type is hormone receptor positive where estrogen is one of the main drivers of breast cancer proliferation, tumor progression, and metastasis. Consequently, treatments that target the ER are the mainstay of breast cancer therapy, but unfortunately almost all women will eventually develop resistance to endocrine therapies and alternative treatment approaches will be required including IV chemotherapy. Another form of breast cancer that occurs in 15% of all breast cancers is called triple negative breast cancer. Triple negative breast cancer does not have ER or PR and does not make HER2. As a consequence, it is an endocrine resistant, aggressive cancer that grows and spreads faster than ER+ and/or HER2+ breast cancers. Triple negative breast cancer also develops resistance to currently used chemotherapy drugs like taxanes, and as such, treatment options for TNBC are limited.

    Accordingly, we at Veru are dedicated to the development and commercialization of drug candidates to address unmet medical needs for prostate and breast cancer management while continuing to sell our commercial products in our sexual health business to help fund part of this development. The key elements of our strategy are as follows:

    Develop and launch high value, novel biopharmaceutical products for prostate cancer management.
    We are developing three drugs, VERU‑111, VERU‑100, and Zuclomiphene citrate, each of which addresses large potential markets relating to prostate cancer and prostate cancer supportive care.

    We initiated a Phase 1b/2 open label clinical trial of VERU‑111 in metastatic castration resistant and androgen receptor targeting agent resistant prostate cancer patients in January 2019. The Phase 1b study has yielded promising efficacy and safety clinical data. In September 2020, the Phase 2 clinical study completed enrollment of approximately 40 men with metastatic castration resistant prostate cancer who have also become resistant to at least one androgen receptor targeting agent, such as abiraterone, enzalutamide, or apalutamide, but prior to proceeding to IV chemotherapy. The Company anticipates starting the Phase 3 pivotal VERU‑111 VERACITY prostate cancer study in the first quarter of calendar year 2021. The potential U.S. market for oral cancer therapies in advanced prostate cancer is over $5 billion1.

    VERU‑100 is a long-acting GnRH antagonist formulation administered as a small volume, subcutaneous three-month depot injection without a loading dose with multiple beneficial clinical attributes addressing the shortfalls of current FDA-approved androgen deprivation therapy formulations for advanced prostate cancer. In animal models, VERU‑100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration, a problem which occurs with currently approved LHRH agonists used for ADT. There are no GnRH antagonist depot formulations commercially approved beyond a one-month duration injection. A Phase 2 study to evaluate VERU‑100 dosing is anticipated to begin in the first quarter of calendar year 2021 and the registration Phase 3 study will commence Q4 calendar year 2021. The global market for ADT was $2.6 billion in 20182.

    Zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist, is being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. The Company plans to have an End of Phase 2 meeting with the FDA. ADT-induced hot flashes affect approximately 600,000 men in the U.S., representing estimated annual sales of $600 million for Zuclomiphene citrate in the U.S. alone.

    Develop and launch high value, novel biopharmaceutical products for breast cancer.
    The Company’s breast cancer pipeline includes enobosarm and sabizabulin.

    Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets the androgen receptor (AR) in AR+/ER+/HER2- metastatic breast cancer without causing the unwanted virilizing adverse side effects. Enobosarm is the first new class of targeted endocrine therapy in advanced breast cancer in decades. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies in over 2,100 subjects, including five prior Phase 2 clinical studies in advanced breast cancer involving more than 250 patients. In the two Phase 2 clinical studies conducted in approximately 150 women with ER+/HER2- breast cancer, enobosarm demonstrated significant antitumor efficacy in heavily pretreated cohorts and was well tolerated with a favorable safety profile without virilizing (acne and facial hair), increase in hematocrit, or liver toxicity adverse side effects. In October 2020, the FDA agreed to a Phase 3 registration ARTEST clinical trial study to evaluate the efficacy and safety of enobosarm, selective androgen receptor targeting agonist, versus active control of either exemestane or tamoxifen (physician’s choice) for the treatment of ER+/HER2- metastatic breast cancer in approximately 240 patients who have failed a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor, but prior to IV chemotherapy. The primary endpoint is radiographic progression-free survival. The pivotal Phase 3, open label, randomized, active control ARTEST study is anticipated to commence in the second half of calendar year 2021. Global revenues for endocrine therapies for advanced breast cancer are over $6 billion.

    Sabizabulin is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta tubulin subunits of microtubules to disrupt the cytoskeleton for treatment of taxane resistant metastatic triple negative breast cancer. The first line of treatment usually includes IV taxane chemotherapy. Almost all women will eventually develop taxane resistance. Using the safety information from the Phase 1b and Phase 2 sabizabulin prostate cancer clinical studies, the Company plans to meet with the FDA in first half of calendar year 2021 and to commence a Phase 2b clinical study in the fourth quarter of calendar year 2021 to evaluate sabizabulin in women with metastatic triple negative breast cancer that has become resistant to taxane IV chemotherapy. Global revenues for oral therapies for advanced breast cancer are over $6 billion.

    Continue to grow our sexual health business to invest proceeds in the clinical development of our drug pipeline to access large premium oncology markets in prostate cancer and breast cancer.
    TADFIN™ for the administration of tadalafil 5mg and finasteride 5mg combination capsule to treat lower urinary tract symptoms caused from BPH- We plan to advance TADFIN™ toward commercialization in the U.S., Europe, and South America. The Company had a successful pre-NDA meeting with the FDA, stability testing of manufacturing batches is completed and the expected submission of the NDA for TADFIN™ will be in early calendar year 2021. We plan to initially launch TADFIN™ by telemedicine channels, if approved by the FDA, in late 2021 in the U.S. We also plan to secure partnership opportunities to commercialize TADFIN™ outside the U.S.

    FC2- We expect to continue the rapid growth of revenues in the U.S. market through prescription sales by leveraging our relationships with telemedicine and pharmacy internet providers and distributors, while continuing to pursue revenues in the public health sector in key markets both in the U.S. and globally.

    PREBOOST®– We recently completed the sale of PREBOOST®, our treatment for premature ejaculation, to Roman Health Ventures Inc. for $20 million in cash, consisting of $15 million paid at closing, $2.5 million payable 12 months after closing and $2.5 million payable 18 months after closing.

    Capitalize on expertise and reputation of our management team and board members.
    Our management team has significant expertise and experience in urology and oncology as well as drug development, regulatory, marketing and sales which will facilitate effective management of our preclinical studies and clinical trials of drug candidates and product commercialization. In addition, we intend to capitalize on the strong reputations of the members of our management and board of directors with academic institutions, hospitals, physicians, pharmacists and distributors to expand our customer base and to introduce new products.

    Be opportunistic.

    Sabizabulin, by targeting microtubules, may have broad antiviral and strong anti-inflammatory effects, including the potential to treat the cytokine release syndrome that is associated with the high COVID-19 mortality rates. As such, Sabizabulin has also been evaluated in a Phase 2 clinical trial to assess the efficacy of sabizabulin in combating COVID-19 to prevent ARDS. After favorable Phase 2 results, the Phase 3 trial is now underway and open for recruitment. The trial is being run in the US and select countries in Latin America. Enrollment is expected to conclude by end of calendar year 2021.