Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal”
or the “Company”), a clinical stage biotechnology company
discovering and developing novel antiviral therapeutics,
announced today its financial results for the quarter ended March
31, 2019 and provided a corporate update.
Recent Corporate Highlights
- Signed exclusive license and collaboration agreement with Merck
Sharp & Dohme Corp. (“Merck”) to discover and develop certain
proprietary influenza A/B antiviral agents and received a $4
million upfront license fee;
- Closed a common stock-only private placement to three
qualified, fundamental healthcare-focused institutional investors
for gross proceeds of approximately $4.2 million; and
- Reported encouraging safety and preliminary efficacy data for
its U.S. Phase 2a study evaluating CC-31244 for the ultra-short
treatment of hepatitis C virus (HCV) infected individuals. Eight of
12 subjects achieved the primary efficacy endpoint of sustained
virologic response at 12 weeks after completion of treatment
continue to lay the foundation to successfully achieve key
milestones over the course of 2019. Our recent collaboration with
Merck and additional progress advancing our pipeline has provided
the Company with continued confidence in the potential depth,
breadth and utility of our platform technology. Additionally, we
continue to be focused on advancing and expanding our hepatitis C
clinical development program as well as driving forward our
influenza program,” commented Dr. Gary Wilcox, Chairman and Chief
Executive Officer of Cocrystal.
Clinical Programs Overview
Pan-Genotypic Non-Nucleoside Inhibitor
for the Ultra-short Treatment of Hepatitis C
CC-31244 is an investigational, oral,
broad-spectrum replication inhibitor called a non-nucleoside
inhibitor (NNI). It has been designed and developed using the
Company's proprietary structure-based drug discovery technology to
have a high barrier to drug resistance and to be a highly potent,
selective NNI that is active against all HCV genotypes (1-6) with
low level cytotoxicity in multiple cell types.
U.S. Phase 2a Study - University of Maryland
The Company recently announced safety and
preliminary efficacy data from its triple regimen, U.S. Phase 2a
study evaluating CC-31244 and Epclusa (sofosbuvir/velpatasvir) for
the ultra-short treatment of HCV infected individuals.
The U.S. Phase 2a study is an open-label study
designed to evaluate the safety, tolerability, and preliminary
efficacy of CC-31244 and Epclusa, an approved 12-week
therapy for HCV developed by Gilead Sciences, Inc, in 12 subjects
with treatment-naïve HCV genotype 1. Subjects received
oral 400 mg of CC-31244 and Epclusa for 2 weeks.
Following this, the subjects continued Epclusa treatment
alone for another 4 weeks. All subjects completed the
6-week treatment regimen. The treatment was well tolerated with no
study discontinuations due to adverse events. Eight of 12 subjects
achieved the primary efficacy endpoint of sustained virologic
response at 12 weeks after completion of treatment (SVR12). SVR12
is defined as undetectable virus in blood 12 weeks after completion
of treatment and is considered a virologic cure.
For additional information about
the U.S. Phase 2a study of CC-31244 for the treatment of
viral hepatitis C, please visit ClinicalTrials.gov and
reference identifier NCT03501550.
Hong Kong Phase 2a Study
The Humanity & Health Research Centre has
received approval from the Hong Kong regulatory authorities to
commence a second study in the HCV clinical
development program, a Phase 2a investigator sponsored
study in Hong Kong evaluating the safety, tolerability
and preliminary efficacy of CC-31244 in combination with sofosbuvir
and daclatsavir with or without a protease inhibitor, for the
treatment of hepatitis C. The Humanity & Health
Research Centre expects to commence the study in Q2 2019. The
upcoming, Hong Kong Phase 2a open-label trial differs from the
current Phase 2a trial Cocrystal is conducting by
using a protease inhibitor as part of the combination regimen and
having a shorter treatment duration.
Expected Near-Term CC-31244 Clinical Program
- Present full data of U.S. Phase 2a
study at upcoming scientific conference.
- Commence Hong Kong Phase 2a
- Complete patient enrollment in Hong
Kong Phase 2a study.
- Complete Hong Kong Phase 2a study
and report top-line results.
Influenza A/B Inhibitors and Influenza
Influenza A/B Inhibitors
The Company recently announced it entered into
an exclusive license and collaboration agreement with Merck to
discover and develop certain proprietary influenza A/B antiviral
Under the terms of the agreement, Merck will
fund all research and development for the program, including
clinical development, and will be responsible for worldwide
commercialization of any products derived from the collaboration.
Cocrystal was paid a $4 million upfront license fee and is eligible
to receive payments related to designated development, regulatory
and sales milestones with the potential to earn up to $156 million,
plus undisclosed royalties on product sales.
Cocrystal is developing novel, broad spectrum
influenza antivirals that are specifically designed to be effective
against all significant A strains of the influenza virus and to
have a high barrier to resistance due to the way they target the
virus’s replication machinery. Cocrystal’s uniquely developed
molecules target the influenza polymerase, an essential replication
enzyme with several highly essential regions common to influenza
strains, including pandemic strains.
CC-42344, the Company’s lead molecule, binds to
a highly conserved PB2 site of influenza polymerase complex and
exhibits a novel mechanism of action which inhibits replication.
CC-42344 has shown excellent antiviral activity against influenza A
strains, including avian pandemic strains and Tamiflu® resistant
strains, and shows a favorable pharmacokinetic and safety profile.
CC-42344 is currently being evaluated in preclinical IND-enabling
studies for the treatment of influenza.
Further, the Company has identified molecules
which have activity against both Strain A and Strain B. Several of
these have potencies approaching single digit nanomolar. The
Company is considering oral, intravenous and inhaled routes of
Expected Near-Term CC-42344 Clinical Program
- Complete preclinical IND-enabling
- File a regulatory submission.
- Initiate Phase 1 study evaluating CC-42344 for the treatment of
Summary of Financial Results for Q1
As of March 31, 2019, Cocrystal had
approximately $8,571,000 cash on hand. Based on management’s
current projections, the Company expects to have sufficient cash to
fund operations into the first quarter of 2020. The Company has
approximately $8,500,000 cash on hand as of the date of this press
For the quarter ended March 31, 2019, the
Company had revenues of approximately $5,078,000 compared to no
revenue in the first quarter of 2018. Revenues all came from the
Merck Collaboration Agreement and consisted of the $4,000,000
license fee, and reimbursement of expenses for services provided by
For the quarter ended March 31, 2018, the
Company reported net income of approximately $2,971,000 compared to
a net loss of approximately $1,553,000 for the same period in 2018.
The overall income increase of $4,524,000 is primarily due to
revenue resulting from the Company’s recently executed
collaboration agreement with Merck.
Total research and development expenses were
approximately $878,000 for the three months ended March 31, 2019,
compared with $877,000 for the three months ended March 31, 2018.
General and administrative expenses were $1,323,000 for the three
months ended March 31, 2019, compared with $1,190,000 for the three
months ended March 31, 2018.
About Cocrystal Pharma,
Cocrystal Pharma, Inc. is a clinical stage
biotechnology company discovering and developing novel antiviral
therapeutics that target the replication machinery of influenza
viruses, hepatitis C viruses, and noroviruses. Cocrystal employs
unique structure-based technologies and Nobel Prize winning
expertise to create first- and best-in-class antiviral drugs. The
Company is developing CC-31244, an investigational, oral,
broad-spectrum replication inhibitor called a non-nucleoside
inhibitor (NNI). CC-31244 is currently being evaluated in Phase 2a
studies for the treatment of hepatitis C as part of a cocktail for
ultra-short therapy. Cocrystal recently entered into an exclusive
worldwide license and collaboration agreement with Merck Sharp
& Dohme Corp. to discover and develop certain proprietary
influenza A/B antiviral agents. CC-42344, the Company’s molecule
for the treatment of influenza A, is currently being evaluated in
preclinical IND-enabling studies. In addition, the Company has a
pipeline of promising early preclinical programs and continues to
identify and develop non-nucleoside polymerase inhibitors for
norovirus gastroenteritis using the Company’s proprietary
structure-based drug design technology platform. For further
information about Cocrystal, please visit
Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including anticipated advancements under our Merck collaboration
agreement, achievement of the expected near-term operational,
preclinical, clinical and research milestones, including the
expected progress and results of the University of Maryland and
Hong Kong Phase 2a studies, expected reductions in research and
development expenses in 2019 resulting from our collaborations and
our liquidity. The words "believe," "may," "estimate," "continue,"
"anticipate," "intend," "should," "plan," "could," "target,"
"potential," "is likely," "will," "expect" and similar expressions,
as they relate to us, are intended to identify forward-looking
statements. These forward-looking statements are based on
Cocrystal’s current expectations and actual results could differ
materially. There are a number of factors that could cause actual
events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, risks arising from our reliance on Merck’s continuing
the collaboration agreement, the results from preclinical and
clinical studies, the availability of products manufactured by
third parties, the research organizations’ ability to recruit
subjects, receipt of regulatory approvals, general risks arising
from clinical trials, unanticipated litigation and other expenses
and factors that affect the capital markets in general and early
stage biotechnology companies. See also the Risk Factors described
in the Company’s most recent Annual Report on Form 10-K for the
year ended December 31, 2018. The Company has based these
forward-looking statements on its current expectations and
assumptions about future events. While management considers these
expectations and assumptions to be reasonable, they are inherently
subject to significant business, economic, competitive, regulatory,
and other risks, contingencies, and uncertainties, most of which
are difficult to predict and many of which are beyond the Company’s
control. The Company does not assume any obligations to update any
of these forward-looking statements.
Investor and Media
Contact:Jenene Thomas Communications, LLC(833)
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