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Biotech / Medical : Female Health FHCO
VERU 2.965-1.5%Oct 31 9:30 AM EST

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From: Savant11/19/2021 12:36:24 PM
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Veru Ranked as one of the Fastest-Growing Companies in North America on the 2021 Deloitte Technology Fast 500

-- Veru is a Late-Stage Clinical Development Biopharmaceutical Company Developing Drugs for the Treatment of Breast Cancer, Prostate Cancer, and COVID-19, Large Premium Global Markets--

-- 212% Revenue Growth Over Last Three Fiscal Years from Sexual Health Division--

--Sexual Health Division Based on Three Quarters Year to Date Financial Performance Has Already Produced Another Revenue Record Breaking Year for FY 2021--

MIAMI, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, today announced the Company's inclusion in Deloitte's Technology Fast 500(TM), a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 27(th) year. Veru's revenue grew 212% during the 2017 to 2020 fiscal year period from sales generated by the Sexual Health Division which includes sales of FC2 Female Condom(R) , an FDA-approved product for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections, and PREBOOST(R) (4% benzocaine wipes), for the treatment of premature ejaculation.

Veru is an oncology biopharmaceutical company with a principal focus on developing novel medicines for the management of breast and prostate cancers:

-- The Company's late-stage breast cancer development portfolio is comprised of enobosarm, a selective androgen receptor targeting agonist, and sabizabulin, a cytoskeleton disruptor, which are being evaluated for the treatment of hormone receptor positive and triple negative metastatic breast cancers. -- The Company's late-stage prostate cancer development portfolio is comprised of sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist, which are being evaluated in metastatic prostate cancer. -- One of the Company's anticancer drugs, sabizabulin, also has dual antiviral and anti-inflammatory effects and is currently in a Phase 3 study for the potential treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). -- Veru also has in its Sexual Health Division another drug candidate, ENTADFI(TM) (tadalafil 5mg and finasteride 5mg capsule), for the treatment of benign prostatic hyperplasia with a December 2021 PDUFA date.

Veru's Chairman, President and Chief Executive Officer, Mitchell Steiner, M.D., credits the increased awareness and sales of the FC2 Female Condom(R) and PREBOOST(R) through telemedicine services platform sales channels for the Company's 212% revenue growth. Dr. Steiner said, "We are honored to be recognized as one of the fastest growing companies in North America. Our continued growth enables us to significantly invest in our robust oncology pipeline focused on breast cancer and prostate cancer."

"Each year the Technology Fast 500 shines a light on leading innovators in technology and this year is no exception," said Paul Silverglate, vice chair, Deloitte LLP and U.S. technology sector leader. "In the face of innumerable challenges resulting from the pandemic, the best and brightest were able to pivot, reinvent and transform and grow. We celebrate the winning organizations and especially the talented employees driving their success."

"The pandemic has underscored the urgent need for tech solutions in a variety of areas across health care, fintech, energy tech, entertainment, to name a few, so reliance on innovators like the winners of the Technology Fast 500 is more important than ever," said Christie Simons, partner, Deloitte & Touche LLP and industry leader for technology, media and telecommunications within Deloitte's audit & assurance practice. "These companies are not only at the cutting edge, transforming the way we do business, but most importantly, recognize the strategic importance of ongoing innovation, especially in the ever-changing world of technology."

About the 2021 Deloitte Technology Fast 500(TM)

Now in its 27th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies -- both public and private -- in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2017 to 2020.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company's operating revenues. Companies must have base-year operating revenues of at least US $50,000, and current-year operating revenues of at least US $5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.

About Veru Inc.

Veru is an oncology biopharmaceutical company with a principal focus on developing novel medicines for the management of breast and prostate cancers.

The Company's late-stage breast cancer development portfolio is comprised of enobosarm, a selective androgen receptor targeting agonist, and sabizabulin, a cytoskeleton disruptor, and includes: the ongoing Phase 3 ARTEST study of enobosarm in AR+ ER+ HER2- metastatic breast cancer with AR >= 40% (3rd line metastatic setting); the planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR 40% (3rd line metastatic setting); the planned Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) in AR+ ER+ HER2- metastatic breast cancer with AR >= 40% (2nd line metastatic setting); and the planned Phase 2 study of sabizabulin + enobosarm combination therapy in metastatic triple negative breast cancer after two systemic chemotherapies.

The Company's late-stage prostate cancer development portfolio is comprised of sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist and includes: the ongoing Phase 3 VERACITY and Phase 2 studies of sabizabulin in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy; the ongoing Phase 2 dose finding study of VERU-100 in advanced hormone sensitive prostate cancer; and the planned Phase 2b study of zuclomiphene citrate in men with advanced prostate cancer on androgen deprivation therapy who suffer from hot flashes.

One of the Company's anticancer drugs, sabizabulin, also has dual antiviral and anti-inflammatory effects and is currently enrolling in a Phase 3 study for the potential treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS).

Veru also has a commercial Sexual Health Division which includes a drug candidate, ENTADFI(TM) (tadalafil 5mg and finasteride 5mg capsule), for the treatment of benign prostatic hyperplasia with a December 2021 PDUFA date, and a commercial product, the FC2 Female Condom(R) (Internal Condom), an FDA-approved product for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
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