Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the
“Company”), a clinical stage biotechnology company discovering and
developing novel antiviral therapeutics that target the
replication machinery of hepatitis viruses, influenza viruses
and noroviruses, announced today its financial results for the
quarter ended March 31, 2018 and provided a corporate update.
Recent Corporate Highlights
- Completed an $8.0 million underwritten public offering,
including participation from Cocrystal Board Members, Dr. Raymond
Schinazi and Dr. Phillip Frost, as well as healthcare-focused
institutional investors;
- Received U.S. Food and Drug (“FDA”) clearance to initiate Phase
2a clinical study evaluating CC-31244 for the treatment of
hepatitis C (“HepC”) virus;
- Successfully completed up-listing on the Nasdaq Capital Market;
and
- Presented an overview of the Company’s unique structure-based
drug discovery technology and Nobel Prize winning expertise to
create what the Company believes to be first- and best-in-class
antiviral drugs at the Fred Hutch and Merck Infectious Disease
Summit.
Dr.
Gary Wilcox, Vice Chairman and Interim Chief Executive Officer of
Cocrystal, commented, “The first quarter was marked by the
successful up-listing on the Nasdaq Capital Market and raising
capital to complete our Phase 2a clinical study of CC-31244 for the
treatment of hepatitis C. We believe this study is pivotal in
supporting an ultra-short therapy cocktail regimen that we see as
the future of hepatitis C treatment. Moving forward, we believe
Cocrystal is well positioned to achieve a number of value-driving
milestones in the near term.”
Clinical Programs Overview
CC-31244: Pan-Genotypic Non-Nucleoside
Inhibitor for the Treatment of Hepatitis C
CC-31244, the Company’s lead product in
development for HepC, is an investigational, oral, potent,
broad-spectrum replication inhibitor called an NNI. It has a high
barrier to drug resistance designed and developed using the
Company's proprietary structure-based drug discovery technology. It
is a highly potent, selective pan-genotypic non-nucleoside
inhibitor that is active against all genotypes (1-6) with low level
cytotoxicity in multiple cell types. The Company recently announced
that its Investigational New Drug (IND) application submitted to
the FDA is now open and the Company is cleared to initiate its
Phase 2a clinical study evaluating CC-31244 for the treatment of
HepC-infected individuals.
The Company previously announced positive data
from the Phase 1a/1b trial of CC-31244 for the treatment of chronic
HepC infection. This randomized, placebo-controlled, double-blind
Phase 1a/1b study evaluated single and multiple ascending doses of
CC-31244 for safety/tolerability, pharmacokinetics, and antiviral
activity in HepC-infected patients. In Phase 1a, 30 healthy
volunteers received single doses (20-400 mg) of CC-31244, and 12
healthy volunteers received repeated doses of CC-31244 (either 200
or 400 mg) for 7 days. In Phase 1b, 15 patients with HepC
genotype-1 infection received CC-31244 for 7 days (6, 400 mg daily;
6, 600 mg daily; 3, 200 mg twice daily).
As reported, there were no dose-limiting adverse
events, study discontinuations due to adverse events, or serious
adverse events. Viral load data showed that CC-31244 administered
once daily (400 mg or 600 mg) or twice daily (200 mg) for 7 days
had a substantial and durable antiviral effect, with an average
HepC RNA viral load decline from baseline of 1000-fold by Day 4.
Interestingly, the mean viral load at 6 days after the last dose
persisted in the range of 100-fold below baseline. HepC genotype 1b
cell-based replicon assays using combinations of CC-31244 with
other classes of HepC drugs showed additive and synergistic effects
of CC-31244, providing important information for ultra-short
therapy cocktail regimens.
Expected Near-Term CC-31244 Clinical Program
Milestones:
- Commence patient enrollment in Phase 2a study evaluating
CC-31244 for the treatment of HepC this quarter;
- Commence patient dosing in CC-31244 Phase 2a study this
quarter;
- Complete patient dosing in CC-31244 Phase 2a study in Q3 2018;
and
- Announce topline results from CC-31244 HCV Phase 2a study in Q4
2018.
CC-42344: Influenza A PB2
Inhibitor
In addition to the Company’s HepC clinical
program, Cocrystal is developing novel, broad spectrum influenza
antivirals that are specifically designed to be effective against
all strains of the influenza virus and to have a high barrier to
resistance due to the way it targets the virus. Cocrystal’s
uniquely developed lead molecules target the influenza polymerase,
an essential replication enzyme with several highly conserved
regions common to all influenza strains, enabling the inhibitors to
be active against all strains of the influenza virus, including
pandemic strains.
CC-42344 is a highly potent PB2 inhibitor and
shows a favorable pharmacokinetic and safety profile. This lead
molecule is currently being evaluated in preclinical IND-enabling
studies for the treatment of influenza and the Company expects to
initiate a Phase 1 study in Q4 2018.
Expected Near-Term CC-42344 Clinical Program
Milestones:
- Complete preclinical IND-enabling studies; and
- Initiate Phase 1 study evaluating CC-42344 for the treatment of
influenza in Q4 2018.
Summary of Financial Results for Q1
2018 For the quarter ended March 31, 2018, the Company
reported a net loss of approximately $1,553,000 compared to a net
loss of approximately $2,548,000 for the same period in 2017. The
overall decrease of $995,000 is primarily due to staff changes that
led to a $373,000 reduction in personnel expenses, settlement of
outstanding legal matters resulting in a $139,000 reduction in
legal expenses, and a $579,000 reduction in R&D program spend
as Phase 1 testing concluded during 2017. Total research and
development expenses were approximately $877,000 for the three
months ended March 31, 2018, compared with $2,071,000 for the three
months ended March 31, 2017. This decrease of $1,194,000, or 58%,
was due to the conclusion of Phase 1 clinical trial during the 1st
quarter of 2017 and lower pre-clinical testing. Pre-clinical work
previously performed in house is now being outsourced. General and
administrative expenses were $1,190,000 for the three months ended
March 31, 2018, compared with $1,050,000 for the three months ended
March 31, 2017.
As of March 31, 2018, the Company had $1.2
million in cash and cash equivalents. Subsequent to the quarter
end, on May 3, 2018, Cocrystal announced the closing of an
underwritten public offering. The gross proceeds to Cocrystal from
this offering were approximately $8 million before deducting
underwriting discounts and commissions and other offering expenses.
Cocrystal has granted the underwriter a 45-day option to purchase
up to an additional 631,578 shares of common stock to cover
over-allotments, if any. 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 hepatitis
viruses, influenza viruses, and noroviruses. Cocrystal employs
unique structure-based technologies and Nobel Prize winning
expertise to create first- and best-in-class antiviral drugs.
CC-31244 is a Phase 2a ready broad-spectrum novel non-nucleoside
replication inhibitor of HepC. Phase 1b studies in HepC infected
patients showed the largest reduction in viral load of any
non-nucleoside inhibitor tested to date. The next step for CC-31244
is clinical trials as part of a cocktail for ultra-short therapy of
2 to 6 weeks. The lead candidate for influenza has advanced to
IND-enabling studies. It is effective in animal models against both
the pandemic and seasonal strains of influenza. In addition, the
Company has a pipeline of promising early preclinical programs. Two
private investors own approximately 48% of the Company. Corporate
investors include OPKO Health, Inc., Brace Pharma Capital, LLC and
Teva Pharmaceuticals Industries, Ltd. 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 our expectations regarding the commencement and future
progress of the Phase 2a study, our achievement of the clinical
program milestones in 2018, the effect of such achievement, and our
future success. 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. We have based these forward-looking statements largely
on our current expectations and projections about future events.
Some or all of the events anticipated by these forward-looking
statements may not occur. Important factors that could cause actual
results to differ from those in the forward-looking statements
include the availability of products manufactured by third parties,
the ability of the clinical research organization conducting the
Phase 2a study to recruit subjects and obtaining regulatory
clearance for our planned Phase 1 study. Further information on our
risk factors is contained in our filings with the SEC, including
the Prospectus Supplement dated April 30, 2018, and our Annual
Report on Form 10-K for the year ended December 31, 2017. Any
forward-looking statement made by us herein speaks only as of the
date on which it is made. Factors or events that could cause our
actual results to differ may emerge from time to time, and it is
not possible for us to predict all of them. We undertake no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future developments or
otherwise, except as may be required by law.
Investor Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
(833) 475-8247
COCP@jtcir.com
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