– Exclusive worldwide license and collaboration
agreement with Merck further validates Company’s approach to
creating first- and best-in-class antiviral drugs and expected to
enable rapid advancement of important new treatments for influenza
–
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 year ended December
31, 2018 and provided a corporate overview and business outlook for
2019.
Key 2018 and Recent Corporate
Highlights
- Signed exclusive license and collaboration agreement with Merck
Sharp & Dohme Corp. to discover and develop certain proprietary
influenza A/B antiviral agents.
- Secured a total of $17 million over the past 12 months; $4
million from upfront payment from Merck and $13 million from
common-stock only financings led by fundamental healthcare focused
institutional investors.
- 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 showing
no drug-drug interactions and substantial efficacy. The data
obtained from this trial used 2 weeks of CC-31244 in combination
with Epclusa followed by 4 weeks of Epclusa alone.
- Signed Clinical Trial Agreement for investigator-initiated
Phase 2a study in Hong Kong of CC-31244 in a novel combination
therapy for ultra-short treatment of hepatitis C (HepC).
- Received U.S. Food and Drug (FDA) clearance to initiate Phase
2a clinical study evaluating CC-31244 for the treatment HepC
virus;
- Presented preclinical characterization data of CC-42344 at the
6th ISIRV-AVG Conference demonstrating excellent antiviral activity
against influenza A strains and favorable pharmacokinetic and
safety profile.
- Successfully completed up-listing on the Nasdaq Capital
Market.
“Over
the course of 2018, we accomplished a number of corporate and
clinical milestones including our up-listing on Nasdaq, the
advancement of our CC-31244 HepC Phase 2 program, our recent
collaboration with Merck and additional progress advancing our
proprietary platform technology. This notable progress has provided
the Company with a solid foundation which we believe will enable us
to continue driving value-creating momentum as we are well-funded
and positioned to achieve numerous operational, clinical and
regulatory milestones in 2019,” 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 for 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
Plans are underway 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
Milestones
- Present full data of U.S. Phase 2a
study at upcoming scientific conference.
- Commence Hong Kong Phase 2a
study.
- Complete patient enrollment in Hong
Kong Phase 2a study.
- Complete Hong Kong Phase 2a study
and report top-line results.
Influenza A and Influenza A/B
Inhibitors
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
agents.
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.
Influenza A
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
delivery.
Expected Near-Term CC-42344 Clinical Program
Milestones
- Complete preclinical IND-enabling
studies.
- File a regulatory submission.
- Initiate Phase 1 study evaluating CC-42344 for the treatment of
influenza.
Summary of Financial Results for
2018
Subsequent to the quarter end, on March 13,
2019, the Company closed a private placement of 1,602,283 shares of
its common stock and received gross proceeds of $4,181,958, before
deducting offering expenses and commissions.
As of March 26, 2019, Cocrystal had
approximately $8,700,000 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.
Research and development expenses were
$4,667,000, exclusive of a $53,905,000 IPR&D
impairment charge, for total R&D expenses of $58,572,000
for the year ended December 31, 2018, compared with
$5,822,000 for the year ended December 31, 2017. Excluding the
impact of the IPR&D impairment charge, research and development
expenses decreased $1,155,000, for the year ended December 31,
2018. This year over year decrease in research and development
expenditures was primarily due to decreased employee compensation
costs after closing the Tucker, Georgia lab facility in the fourth
quarter of 2017. Cocrystal expects research and development
expenses to decrease in 2019 with the completion of the Phase 2a
study in the U.S.
General and administrative expenses were
$4,352,000 for the year ended December 31, 2018, compared with
$2,440,000 for the year ended December 31, 2017. This increase of
$1,912,000 was primarily due to an $896,000 insurance reimbursement
received by the Company in 2017 for legal costs and a $132,000
non-cash reversal of stock compensation expense related to unvested
options for executives that are no longer with the Company which
decreased expenses during the year ended December 31, 2017. The
Company also had increases in expenses during the year ended
December 31, 2018 including approximately $141,000 in accounting
fees related to SEC filings and $556,000 in legal costs associated
with both litigation and collaboration matters, as well as listing
the Company on Nasdaq Capital Market.
About Cocrystal Pharma,
Inc.
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
www.cocrystalpharma.com.
Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including advancements under our Merck collaboration agreement and
completion of the preclinical and regulatory milestones, the
results of the 31244 trials, achievement of operational, clinical
and research milestones, reductions in research and development
expenses in 2019 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
Merck’s continuing the collaboration agreement, the results from
preclinical and clinical studies, the availability of products, the
CROs’ ability to recruit subjects, receipt of regulatory approvals,
general risks arising from all clinical trials, and unanticipated
litigation and other expenses. 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)
475-8247COCP@jtcir.com
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