– First half of 2018 marked by management’s
successful execution of corporate, clinical and regulatory
strategies –
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 June 30, 2018 and provided a corporate update.
Recent Corporate Highlights:
- Commenced enrollment and initiated patient dosing in Phase 2a
study evaluating CC-31244 for the treatment of hepatitis C
(HepC);
- 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; 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 Chief
Executive Officer of Cocrystal, commented, “We are pleased with the
progress we have made over the course of the first half of the
year. Moving forward, our focus for the second half of this year is
delivering on the milestones we have set for our clinical programs.
We continue to make progress advancing our Phase 2a study of
CC-31244 for the ultra-short treatment of HepC and expect to
complete patient enrollment this quarter. Importantly, we look
forward to announcing topline results from the CC-31244 Phase 2a
study in the fourth quarter of this year and believe the safety,
tolerability and preliminary efficacy data will be integral in
guiding our next phase of development for our HepC program.”
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 technology. It is active against HepC 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
HepC-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 will
self-administer orally 400 mg of CC-31244 and a fixed dose of
Epclusa for 14 days. After 14 days the subjects will continue the
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.
Expected Near-Term CC-31244 Clinical Program
Milestones:
- Complete patient enrollment and dosing in CC-31244 Phase 2a
study in Q3 2018; and
- Announce topline results from CC-31244 HCV Phase 2a study in Q4
2018.
Influenza A and Influenza A/B
Inhibitors
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 important A strains of the influenza virus and to have a high
barrier to resistance due to the way they target the virus.
Cocrystal’s uniquely developed molecules target the influenza
polymerase, an essential replication enzyme with several highly
conserved regions common to all influenza strains, including
pandemic strains.
CC-42344, the Company’s lead molecule, binds to
a highly conserved PB2 site of influenza polymerase complex (PB1:
PB2: PA) and exhibits a novel mechanism of action. 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 based on data obtained
in Q3 and Q4 2018. The Company is considering both oral and inhaled
routes of delivery.
Expected Near-Term CC-42344 Clinical Program
Milestones:
- Complete preclinical IND-enabling studies near year end;
- File a regulatory submission in H1 2019; and
- Initiate Phase 1 study evaluating CC-42344 for the treatment of
influenza in H1 2019.
Summary of Financial Results for Q2
2018 For the three and six months ended June 30, 2018, the
Company reported a net loss of approximately $1,343,000 and
$2,897,000 compared to a net loss of approximately $1,002,000 and
$3,551,000 for the same periods in 2017. Total research and
development expenses were approximately $1,119,000 for the three
months ended June 30, 2018, compared with $1,255,000 for the three
months ended June 30, 2017. The decrease of $136,000, or 11%, was
due to the reduction in the timing of clinical trials costs. Total
research and development expenses for the six months ended June 30,
2018 were $1,997,000, compared with $3,325,000 for the six months
ended June 30, 2017. The decrease of $1,328,000 or 40%, was the
result of timing of clinical trials activity.
On May 3, 2018, Cocrystal announced the closing
of an underwritten public offering. The gross proceeds to Cocrystal
from this offering were approximately $8.0 million before deducting
underwriting discounts and commissions and other offering expenses.
On May 14, 2018, the underwriter exercised the option to purchase
additional shares of common stock to cover overallotments for
additional gross proceeds of $439,000.
For the six months ended June 30, 2018, cash
provided by financing activities totaled $8,869,000. Our 2018
financing activities included $7,684,000 net proceeds from the sale
of common stock, $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
six months ended June 30, 2017 amounted to approximately $3,000,000
in proceeds from our sale of common stock. 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 in a Phase 2a trial. It 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 clinical trials as part of a cocktail for
ultra-short therapy of 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 manner of conducting and
future progress of the Phase 2a study, the progress of preclinical
IND-enabling studies and regulatory submission and initiation of a
Phase 1 study for the influenza inhibitor. 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 clinical research
organizations conducting the Phase 2a study and the Phase 1
influenza study to recruit subjects. Further information on our
risk factors is contained in our filings with the SEC, including
our Quarterly Report on Form 10-Q for the quarter ended June 30,
2018, 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 and Media Contact:
Jenene Thomas Communications, LLC
(833) 475-8247
COCP@jtcir.com
Cocrystal Pharma (NASDAQ:COCP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cocrystal Pharma (NASDAQ:COCP)
Historical Stock Chart
From Sep 2023 to Sep 2024