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 September 30, 2018 and provided a corporate update.
Recent Corporate Highlights
- Announced 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).
- Completed patient enrollment in Phase 2a study evaluating
CC-31244 for ultra-short treatment of HepC.
“Over the course of the quarter, we continued to
advance our U.S. Phase 2a study of CC-31244 for the ultra-short
treatment of HepC. We are very pleased to be moving forward with
our Hong Kong investigator-initiated Phase 2a study for the
ultra-short treatment of HepC, which will include for the first
time a protease inhibitor with CC-31244,” commented Dr. Gary
Wilcox, Vice Chairman and Chief Executive Officer of Cocrystal. “In
addition, our R&D team has been focused on advancing our
preclinical IND-enabling studies for our influenza program with the
goal of starting our human clinical program next year. We are
setting the stage for numerous operational, clinical and regulatory
milestones in 2019.”
Clinical Programs Overview
Pan-Genotypic Non-Nucleoside Inhibitor
for the Ultra-short 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 a non-nucleoside
inhibitor (NNI). It has a high barrier to drug resistance designed
and developed using the Company's proprietary structure-based drug
discovery platform. It is active against HCV genotypes 1-6 with low
level cytotoxicity in multiple cell types.
CC-31244 is currently being evaluated in an
ongoing Phase 2a clinical study for the ultra-short treatment of
HCV-infected individuals. The Phase 2a open-label study is designed
to evaluate the safety, tolerability and preliminary efficacy of
CC-31244 with Epclusa®. Enrolled subjects self-administered orally
400 mg of CC-31244 daily and a fixed dose of Epclusa daily for 14
days. After 14 days the subjects continued daily treatment for
another 4 weeks on Epclusa alone. Subjects will be followed up
until 24 weeks after the last dose of Epclusa to determine if they
have achieved a sustained virologic response (SVR). Primary and
secondary efficacy endpoints are SVR at 12 weeks post-treatment
(SVR12) and at 24 weeks post-treatment (SVR24), respectively.
Additionally, the Company recently announced the
signing of a Clinical Trial Agreement for an investigator-initiated
study with the Humanity & Health Research Centre, Hong Kong, PR
China. Under the Clinical Trial Agreement, the Phase 2a study of
CC-31244 for the treatment of HepC will be sponsored and conducted
by the Humanity & Health Research Centre, Hong Kong under the
guidance of Dr. George Lau, MBBS (HKU), M.D. (HKU), FRCP (Edin,
Lond), FHKAM (Med), FHKCP, FAASLD, Chairman of Humanity and Health
Medical Centre, Hong Kong. As part of the agreement, Cocrystal will
provide CC-31244.
The Hong Kong Phase 2a open-label study for the
treatment of HepC will evaluate the safety, tolerability and
preliminary efficacy of CC-31244 in combination with Sofosbuvir and
Daclatasvir with or without a protease inhibitor. Sixteen patients
will be enrolled in the Phase 2a study. This trial differs from the
current Phase 2a trial Cocrystal is conducting in that testing will
include for the first time a protease inhibitor.
Expected Near-Term CC-31244 Clinical Program
Milestones
- Announce interim topline results from CC-31244 U.S. Phase 2a
study in December 2018.
- Commence Hong Kong Phase 2a open-label study of CC-31244.
Influenza A and Influenza A/B
Inhibitors
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. Cocrystal
is comparing them with its influenza A inhibitor, CC-42344 and will
determine which program(s) to take forward. 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 in 2019.
Summary of Financial Results
For the three and nine months ended September 30, 2018, the Company
reported a net loss of approximately $1,868,000 and $4,762,000
compared to a net loss of approximately $2,260,000 and $5,810,000
for the same periods in 2017. Total research and development
expenses were approximately $1,467,000 for the three months ended
September 30, 2018, compared with $1,393,000 for the three months
ended September 30, 2017. The increase of $74,000, or 5.3%, was due
to the timing of Phase 2a clinical trials costs in 2018. Total
research and development expenses for the nine months ended
September 30, 2018 were $3,464,000, compared with $4,718,000 for
the nine months ended September 30, 2017. The decrease of
$1,254,000 or 26.6%, was the result of reduced cost and timing of
clinical trials activity.
For the nine months ended September 30, 2018,
cash provided by financing activities totaled $8,869,000. Our 2018
financing activities included $7,684,000 net proceeds from the
issuance of common stock and warrants, $1,000,000 in proceeds from
the issuance of convertible notes and $185,000 in proceeds from the
exercise of stock options. Net cash provided by financing
activities for the nine months ended September 30, 2017 amounted to
approximately $3,000,000 in proceeds from issuance of common stock
and $80,000 in proceeds from the exercise of stock options.
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 C 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 broad-spectrum novel
non-nucleoside replication inhibitor of the hepatitis C virus.
Phase 1b studies in HCV-infected patients showed the largest
reduction in viral load of any non-nucleoside inhibitor tested to
date. CC-31244 is now in a Phase 2a clinical trial as part of a
cocktail for the ultra-short therapy of 6 weeks. The Company’s lead
candidate CC-42344 for influenza is effective in animal models
against both the pandemic and seasonal strains of influenza A. In
addition, novel inhibitors effective against both influenza strains
A and B have been identified and are in the preclinical stage.
Several of these have potencies approaching single digit nanomolar.
We continue to identify and develop non-nucleoside polymerase
inhibitors for Norovirus infections 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 our expectations regarding the timing
for the initiation and future progress of the Hong Kong Phase 2a
study and influenza A study. 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, receipt of regulatory approvals and
the ability of the Hong Kong clinical research organization and the
clinical research organization we contract with for the influenza A
study to recruit subjects. Further information on our risk factors
is contained in our filings with the SEC, including our 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 and Media
Contact:Jenene Thomas Communications, LLC(833)
475-8247COCP@jtcir.com
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