Novel medicines for prostate cancer treatment and supportive care as well as near term specialty pharmaceuticals to address significant unmet needs in urology.

Our strategy is to be known as “the prostate cancer company”. We aspire to be disease focused by providing a “continuum of care” for prostate cancer patients. Prostate cancer is becoming a chronic disease with new challenges as prostate cancer develops resistance to current drugs and progresses and as the patient suffers from the long-term side effects of these treatments like bone loss and fractures, hot flashes, loss of libido and erectile dysfunction, loss of muscle strength and frailty. Accordingly, we are dedicated to the development and commercialization of products to address unmet medical needs for prostate cancer treatment and supportive care. Given our core expertise and the number and type of drugs in our pipeline, we are uniquely positioned to understand, develop, and commercialize medicines for these unmet medical needs of prostate cancer patients.

The Veru prostate cancer pipeline includes zuclomiphene citrate (also known as VERU-944, cis-clomiphene) and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen receptor agonist being evaluated in a Phase 2 trial to treat hot flashes, a common side effect caused by hormone treatment for men with advanced prostate cancer. VERU-111 is an oral, next-generation, first-in-class selective small molecule that targets and disrupts alpha and beta subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agent (abiraterone or enzalutamide) therapies. VERU-111 is being evaluated in men with metastatic refractory prostate cancer in an open label phase 1b/2 clinical trial.

We’re also advancing new drug formulations in our specialty pharmaceutical pipeline addressing unmet medical needs in urology.  The clinical trial of the Company’s proprietary Tadalafil and Finasteride Combination tablet (TADFIN™ tablet) met FDA requirements for bioavailability and bioequivalence for the co-administration of tadalafil 5mg and finasteride 5mg dosed daily for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS®) is currently approved for treatment of BPH and erectile dysfunction and finasteride (PROSCAR® and PROPECIA®) is currently approved for treatment BPH and male pattern hair loss. The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than either drug alone. The Company anticipates submitting an NDA for its TADFIN™ tablet under the 505(b)(2) regulatory pathway in the second half of calendar year 2019. Veru is also developing Tamsulosin DRS granules and Tamsulosin XR capsules which are formulations of tamsulosin, the active ingredient in FLOMAX®, which Veru has designed to avoid the “food effect” inherent in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance.

Veru’s commercial products include the FC2 Female Condom / FC2 Internal Condom® (FC2), an FDA-approved product for the dual prevention of unwanted pregnancy and sexually transmitted infections, and the PREBOOST® medicated individual wipe for the prevention of premature ejaculation. Veru’s Female Health Company Division markets FC2 commercially and in the public health sector both in the U.S. and globally. FC2 is available by prescription in the U.S. including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com. For PREBOOST® Veru has a co-promotion and distribution agreement with Timm Medical Technologies, Inc., a specialty urology sales organization, and the Company has also entered into a multi-year exclusive supply and distribution agreement with Roman Health Ventures Inc., a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet.

Management Team

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. (NYSE: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.

Ms. Greco has served as Chief Financial Officer since March 2018 and as Chief Administrative Officer of the Company since December 2017. Ms. Greco served as Executive Vice President of Finance from October 2016 to March 2018 and Executive Vice President and Chief Financial Officer of The Female Health Company from December 2014 to October 2016 and served as Vice President and Chief Financial Officer of the Company from January 2013 to December 2014. Ms. Greco is a CPA with nearly 30 years of experience in public accounting with Ernst & Young LLP. From January 2011 to February 2012, Ms. Greco provided consulting services to Systems Research Incorporated as a recruiter of finance professionals. From March 2009 to January 2011, Ms. Greco was involved in a series of personal business ventures. From 1994 to March 2009, Ms. Greco served as an audit partner with Ernst & Young LLP. Ms. Greco joined Ernst & Young LLP in 1981.

Gary Barnette, Ph.D. is the Chief Scientific Officer of the Company. Prior to joining Veru, Dr. Barnette was Sr. Vice President of Scientific and Regulatory Affairs at Camargo Pharmaceutical Services, LLC from 2012 to August 2018 and had responsibility of the oversight and development of scientific and regulatory drug development strategies across virtually all therapeutic areas, including urology, reproductive, oncology, cardiovascular, and analgesics/anesthetics. From 2000 to 2012, Dr. Barnette served in various positions at GTx, Inc. including Vice President, Clinical Development Strategy with responsibilities in regulatory, clinical, and clinical pharmacology in the development of drug products in urology (men’s health) and cancer supportive care. Prior to that, Dr. Barnette was a Clinical Pharmacology and Biopharmaceutics Reviewer at the US FDA, receiving numerous awards for review, mentoring, and serving on various FDA guidance development groups and FDA initiative task forces. Dr. Barnette holds a Ph.D. in Basic Pharmaceutical Sciences (Clinical Pharmacology and Pharmacokinetics) from West Virginia University, School of Pharmacy.

Dr. Harry FischHarry Fisch, M.D., F.A.C.S. has served as a director of the Company since October 2016. Dr. Fisch was the co-founder of Aspen Park and served as the Chairman of the Board and Chief Scientific Officer of Aspen Park from July 2014 to October 2016. From 1994 to 2016, Dr. Fisch served as the Chief Executive Officer and President of Millennium Sciences, Inc. Dr. Fisch has also had numerous academic and clinical appointments including Clinical Professor of Urology and Reproductive Medicine at Weill College of Medicine, Cornell University from 2009 to 2016, Director of the Male Reproductive Center at Albert Einstein College of Medicine/Montefiore Medical Center from 1998 to 1999 and Professor of Clinical Urology at Columbia University, College of Physicians and Surgeons from 1999 to 2009. From 2014 to 2015, Dr. Fisch hosted The Dr. Harry Fisch Show on Men’s Health on Howard Stern’s SiriusXM radio channel 101. Dr. Fisch is a Board Certified Urologist and a Fellow of the American College of Surgeons. Dr. Fisch holds a B.A. in Chemistry from the State University of New York at Binghamton, an M.D. from Mount Sinai School of Medicine, New York, and performed his surgical and urologic training at Albert Einstein College of Medicine/Montefiore Medical Center.

Mr. Gilbert has served as Executive Vice President Corporate Development since May 2018. Previously Mr. Gilbert served as Senior Vice President Corporate Development and Legal from January 2017 to April 2018. From 2015 to 2016, Mr. Gilbert was a consultant to the Company’s Board and CEO and charged with assisting with the diversification strategy. From 2012 to 2015 Mr. Gilbert was Vice President Corporate Development and General Counsel of Third Stream Bioscience Inc., a developer of a novel, topical antimicrobial technology. From 2008 to 2012, Mr. Gilbert was Executive Vice President Development and General Counsel of NanoCarbons LLC, a developer of nanomaterials for the energy storage industry. Prior to 2008, Mr. Gilbert worked nearly 20 years in a variety of officer roles in development and legal at Motorola Inc. and prior to that, Mr. Gilbert was a transactional and securities attorney at the large, multinational law firm, McDermott, Will & Emery. Mr. Gilbert has successfully completed more than 100 different transactions in more than 25 different countries around the world, including a number of complex, cross-border transactions. Mr. Gilbert holds a Bachelor of Science in Accountancy from the University of Illinois at Urbana-Champaign and a Juris Doctor from the University of California at Berkeley and has been a Guest Lecturer on Mergers & Acquisitions at the UCLA Anderson Graduate Business School as well as the Purdue University Krannert Graduate Business School.

Phil Kuhn

Mr. Kuhn joined Veru in January 2018. He is responsible for leading the company’s licensing and strategy execution. Mr. Kuhn’s thirty years of experience in commercial and strategy work for leading biologics, diagnostics, and device manufacturers have prepared him well for leading Veru’s strategy efforts.

During Mr. Kuhn’s career he has had the opportunity to lead sales, marketing, and strategy activities on a global basis for a number firms including Abbott, Johnson & Johnson, Boston Scientific, Smith & Nephew, Orthofix, and most recently ISTO Biologics. Prior to joining the Company, Mr. Kuhn served as the Chief Commercial Officer for Isto Biologics where he engineered the successful turnaround and sale of the commercial business to private equity. Earlier in is his career Mr. Kuhn held senior roles as Global Vice President Marketing at Orthofix and Smith & Nephew. In addition, Mr. Kuhn held roles as Director Marketing Peripheral Vascular Stents, and Director Marketing Indigo Medical (a JNJ Urology focused division).

Mr. Kuhn has a BA degree from Duke University and an MBA from Emory University.

Domingo Rodriguez M.D. has served as Executive Vice President of Clinical Operations since April 2018.

Prior to joining Veru, Dr. Rodriguez was the Vice President of Global Development Operations at Mallinckrodt Pharmaceuticals from 2013 to April 2018 where he was a member of the Science and Technology Senior Management Team with his main responsibility being the clinical trial execution of all clinical-stage programs and indications both in the U.S. and abroad.

From 2004 to 2013, Dr. Rodriguez served in various positions at GTx, Inc., including Vice President of Clinical Operations.

Dr. Rodriguez brings more than 30 years of biotechnology, pharmaceutical and device experience to Veru Inc. in small, mid-size and large companies with expertise in Clinical Development, Medical Affairs, Due Diligence, Acquisitions, Integrations, FDA Inspections and Sales and Marketing.

Dr. Rodriguez has conducted global clinical development that includes oncology, male health and autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology, regenerative medicine, immunotherapy and neonatal respiratory critical care therapies, transplants, analgesics, pediatrics, orphan/rare diseases and devices.

Dr. Rodriguez completed medical school at CETEC University in the Dominican Republic.

The Female Health Company Division

Mr. Tayler has served as Executive Vice President of Global Operations of the Company since October 2016. Mr. Tayler served as Executive Vice President of Global Operations of The Female Health Company from December 2014 to October 2016 and served as Executive Vice President of Operations of the Company from September 2014 to December 2014. From July 2013 to September 2014, Mr. Tayler provided manufacturing and quality management consulting services in Asia as the owner of Lean Manufacturing Limited. From April 2009 to April 2012, Mr. Tayler served as Operations Director of Qingdao London Durex Company, a subsidiary of Reckitt Benckiser Group plc, a consumer health and hygiene company. Prior to its acquisition by Reckitt Benckiser Group, Mr. Tayler served in a variety of operations leadership positions with SSL International PLC, a manufacturer of healthcare products, for approximately eight years, most recently as Project Director of Qingdao London Durex Company from August 2007 to March 2009.

Denise van DijkAs President of the Female Health Company, the global public sector division of Veru, Denise acts as the main liaison for ministries of health all over the world, large multilateral donors such as UNFPA and USAID and CBOs, NGOs and INGOs globally. Denise leads a team of business development managers, master trainers, project- and communication managers to install sustainable and context specific FC2 female condom education and distribution programs worldwide.  Half Dutch, half American: Denise is an accomplished professional with over 10 years of experience in market development and the designing, implementing, and monitoring / evaluation of global and community development programs focusing in particular on SRHR. Denise has extensive international experience in Africa, Latin America, North America and Asia cultivating an exceptional ability to create partnerships with corporate/private partners, local NGOs, civil society groups and all levels of government. Denise specializes in public private partnerships and sustainable PPP programming. She has worked with a diverse network of partners, including USAID, UNFPA, UNHCR, Dutch Ministry of Foreign Affairs, Ministries of Health and Education and other multilateral agencies in Africa, Latin America and Asia. She has worked in 38 countries worldwide and speaks 5 languages. Denise Holds a BA in Social Sciences and an MPhil in Development Studies from the University of Cambridge.