Veru Sells ENTADFI® Business for $20 Million Plus up to an Additional $80 Million from Sales Milestones
20 April 2023 - 8:45PM
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on
developing novel medicines for oncology and SARS-CoV-2 and other
viral ARDS-related diseases, today announced the sale of its
ENTADFI® (finasteride and tadalafil) capsules business for benign
prostatic hyperplasia (BPH) to Blue Water Vaccines, Inc. (NASDAQ:
BWV) for $20 million and up to an additional $80 million from sales
milestones. Under the terms of the agreement, Veru received $6
million at closing and Blue Water is obligated to pay the Company
an additional $4 million in the Company’s fiscal year 2023, and an
additional $10 million in installments in the Company’s fiscal year
2024. In addition, Veru could receive up to an additional $80
million if certain ENTADFI sales milestones are achieved.
“The sale of ENTADFI and revenues from our FC2
business provide Veru with financial flexibility and resources to
advance our important drug candidates, enobosarm for 2nd line AR+
ER+ HER2- metastatic breast cancer and sabizabulin for SARS-CoV-2
viral ARDS, that could yield Phase 3 clinical trial data in 2024,”
said Mitchell Steiner, M.D., Chairman, President and Chief
Executive Officer of Veru Inc.
About Veru Inc.Veru is a
biopharmaceutical company focused on developing novel medicines for
the treatment of breast cancer and for SARS-Cov-2 and other viral
ARDS-related diseases.
Oncology program focuses on breast
cancer
The Company’s late-stage breast cancer development
portfolio comprises enobosarm, a selective androgen receptor
targeting agonist.
- Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a
CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast
cancer (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 will supply
Verzenio® (abemaciclib).
- Planned Phase 3 study of enobosarm in nonmeasurable bone only
metastatic breast cancer.
Infectious disease program
focuses on viruses that pose serious worldwide global
threat
- COVID-19: Sabizabulin is an
oral, first-in-class, new chemical entity, microtubule disruptor
that has dual anti-inflammatory and host mediated antiviral
properties. Veru has conducted a positive double-blind, randomized,
placebo-controlled Phase 3 COVID-19 clinical trial 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. Treatment with sabizabulin resulted in a clinically
meaningful and statistically significant 51.6% relative reduction
in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track
designation to the Company’s COVID-19 program in January
2022. The Company is planning to conduct a Phase 3
confirmatory clinical trial to evaluate sabizabulin in hospitalized
moderate to severe COVID-19 patients at high risk for ARDS. Veru
has been granted a meeting with U.S. FDA in April 2023 to finalize
clinical trial design and requirements for an EUA submission and
new drug application.
- Smallpox, Ebola, and Marburg viruses: The
Company is planning a pre-IND meeting with FDA to discuss the
development of sabizabulin for smallpox virus, Ebola, and Marburg
virus under the Animal Rules FDA regulatory approval pathway.
- Influenza: The Company is planning a Phase 3
clinical trial to evaluate sabizabulin in hospitalized influenza
patients at high risk for ARDS.
Sexual health program – Urev
Veru has a commercial sexual health division called
Urev that is comprised of:
- 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 StatementsThe
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
and when the Company will receive the future installment payments
of the ENTADFI purchase price or sales milestone payments; whether
the Company’s clinical programs for enobosarm or sabizabulin will
yield Phase 3 clinical trial data in 2024; whether and when the
Company will commence the Phase 3 influenza study, any poxvirus
study and the confirmatory COVID-19 study for sabizabulin; whether
and when the planned Type C meeting with the FDA regarding the
confirmatory Phase 3 sabizabulin study will happen as planned, what
the resulting protocol for such study might be and when the Company
will disclose any such protocol publicly; whether and when the
Company will meet with BARDA regarding any potential partnering
opportunities and whether those efforts will be successful; whether
and how the Company will fund the planned Phase 3 studies of
sabizabulin in influenza pox virus and COVID-19; whether and when
the Company will expand the study of sabizabulin into other ARDS
indications; whether the current and future clinical development
efforts of the Company, including all studies of sabizabulin in
infectious disease indications and enobosarm in oncology
indications, and any of their results will demonstrate sufficient
efficacy and safety and potential benefits to secure FDA approval
of any of the Company’s drug candidates; whether the drug
candidates will be approved for the targeted line of therapy;
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. 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 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 possibility that as
vaccines, anti-virals and other treatments 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 FC2 product 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; 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 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 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.
Investor Contact:
Samuel FischExecutive Director, Investor Relations
and Corporate CommunicationsEmail: veruinvestor@verupharma.com
Media Contact:Hannah GendelManager, Corporate
CommunicationsEmail: media@verupharma.com
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