Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or
the “Company”), a clinical stage biotechnology company
discovering and developing novel antiviral therapeutics,
today announced its financial results for the quarter ended
September 30, 2020 and provided program updates.
Recent Highlights
- Announced promising in vitro and 7-day toxicity data
for its influenza A preclinical lead molecule, CC-42344.
- Announced new in vitro data demonstrating antiviral activity
with lead compound CC-42344 against major Xofluza
(baloxavir)-resistant H1N1 strain (I38T).
- Presented at the virtual World Antiviral Conference held on
November 12, 2020.
- Closed $17.2 million bought deal including partial exercise of
underwriter's overallotment option.
- Publication by collaborators of data demonstrating potent in
vitro inhibition against Coronavirus in Science Translational
Medicine Journal (August 3, 2020).
“We have made significant progress since
initiating our COVID-19 program this year by strengthening our
patent portfolio around these molecules, conducting a proof of
concept animal study, initiating preclinical studies and
identifying additional inhibitors using our proprietary platform.
Over the course of the last quarter we continued to make progress
on multiple fronts. We are pleased with the promising new data we
recently announced for our wholly owned influenza A development
program and continue to work towards finalizing the Phase 1 study
protocol in preparation to initiate the Phase 1 study in 2021,”
commented Dr. Gary Wilcox, Chairman and Chief Executive Officer of
Cocrystal. “In addition to advancing our development programs, we
closed the quarter with $31.8 million cash, which provides funding
for the expansion of our COVID-19 and influenza A programs. Our
team remains keenly focused on executing our milestones to drive
shareholder value.”
Development Programs
Overview
COVID-19 Coronavirus Programs:
We have two programs that are aggressively pursuing the development
of novel antiviral compounds for the treatment of coronavirus
infections.
Our first program is with compounds licensed
from Kansas State University Research Foundation (“KSURF”) that
have demonstrated in vitro anti-SARS-CoV-2 (responsible for the
COVID-19 pandemic) activity, and in vivo efficacy in
MERS-CoV-infected animal models. Cocrystal continued preclinical
studies of these COVID-19 inhibitors during the third quarter. We
anticipate the selection of a lead preclinical molecule by the end
of 2020.
Our second program in Covid-19 has identified
additional inhibitors using Cocrystal’s proprietary platform
technology.
We are evaluating multiple routes of
administration of COVID-19 antivirals.
Influenza A/B Inhibitors: Merck
CollaborationWe have an exclusive license and
collaboration agreement with Merck to discover and develop
proprietary influenza A/B antiviral agents.
Cocrystal’s exclusive license and collaboration
agreement with Merck Sharp & Dohme Corp. (“Merck”) to discover
and develop proprietary influenza A/B antiviral agents is ongoing.
Merck has funded the collaborative influenza A/B program and could
potentially provide up to $156 million in milestone payments
through clinical and commercial development, plus royalties
following commercialization.
The collaboration operates under a Research
Operating Plan which includes goals for both organizations. The
Company has achieved its anticipated goals through the third
quarter of 2020. CC-42344: Influenza A Program:
Novel, broad spectrum influenza antivirals that are specifically
designed to be effective against pandemic and seasonal influenza A
strains of the influenza virus and to have a high barrier to
resistance due to its novel mechanism of action.
The Company’s fully owned drug candidate
CC-42344 is a potent, broad spectrum inhibitor of the influenza
replication enzyme targeting the PB2 subunit, and has strong
synergistic effects when combined with approved influenza antiviral
drugs including Tamiflu (oseltamivir) and Xofluza (baloxavir).
Cocrystal has data showing that CC-42344 retained single digit
nanomolar potency (EC50 = 0.5 nM) against a Xofluza (baloxavir)
resistant influenza A strain (H1N1, I38T). This data can
potentially show CC-42344 drug superiority when seeking FDA
approval.
The Company plans to complete the ongoing
IND-enabling studies and enter into clinical trials in 2021.
CC-31244: Hepatitis C Program:
Potential best-in-class pan-genotypic inhibitor of NS5B polymerase
for the ultra-short combination treatment of hepatitis C
infection.
The Company is pursuing partnering opportunities
for CC-31244. The final study report of Cocrystal’s U.S. Phase 2a
clinical trial evaluating CC-31244 combination therapy for the
ultrashort treatment of hepatitis C virus (“HCV”) infected
individuals has been completed and filed with the FDA. The Company
has published with its collaborators from the University of
Maryland the results of the Phase 2a study (Journal of Medical
Virology, November 5, 2020).
Norovirus Program: Developing
inhibitors targeting Norovirus RNA-dependent RNA polymerase and
protease.
Cocrystal continues to identify and develop
non-nucleoside polymerase and protease inhibitors using its
proprietary structure-based drug design technology platform.
Cocrystal recently entered into license agreements with KSURF to
further develop proprietary broad-spectrum protease inhibitors to
treat Norovirus and Coronavirus infections.
Summary of Financial Results for Q3
2020
As of September 30, 2020, Cocrystal had
approximately $31,781,000 cash on hand.
Revenue recorded for the three and nine months
ended September 30, 2020 was $489,000 and $1,504,000, respectively,
compared with $492,000 and $6,162,000 for the three and nine months
ended September 30, 2019, respectively. The revenue difference for
the nine months ended September 30, 2019 is because that period
included $4,368,000 in initial revenue of intellectual property
rights conveyed at the signing of the Merck Collaboration Agreement
executed on January 2, 2019.
Research and development expenses for the three
and nine months ended September 30, 2020 were $2,077,000 and
$5,336,000, respectively, compared with $1,077,000 and $3,046,000
for the three and nine months ended September 30, 2019,
respectively. The increase for the three and nine months ended
September 30, 2020 compared to the three and nine months ended
September 30, 2019 was primarily due to initiating our COVID-19
program and advancing our Influenza A program in preparation for
clinical trials in 2021.
General and administrative expenses for the
three and nine months ended September 30, 2020 were $1,121,000 and
$4,288,000, respectively, compared with $1,223,000 and $3,597,000
for the three and nine months ended September 30, 2019,
respectively. The decrease for the three months ended September 30,
2020 compared to the three months ended September 30, 2019 was
primarily due to decreased litigation costs during the 2020
three-month period. The increase for the nine months ended
September 30, 2020 compared to the nine months ended September 30,
2019 was primarily due to higher litigation costs, insurance
increases and employee compensation in the first half of 2020.
Net loss for the three and nine months ended
September 30, 2020 was $2,670,000 and $8,155,000, respectively,
compared with a net loss of $1,780,000 and $324,000 for the three
and nine months ended September 30, 2019, respectively, as a result
of revenue and expenses described above.
About Cocrystal Pharma,
Inc.
Cocrystal Pharma, Inc. is a clinical stage
biotechnology company discovering and developing novel antiviral
therapeutics that target the replication process of influenza
viruses, SARS-CoV-2 virus, hepatitis C viruses, and norovirus.
Cocrystal employs unique, proprietary, structure-based technologies
and Nobel Prize winning expertise to create first- and
best-in-class antiviral drugs. For further information about
Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements related to the expected
progress of, and the anticipated timing of achieving the
value-driving milestones in, our coronavirus program, including the
selection of a preclinical lead molecule in Q4 2020; the expected
progress of, and the anticipated timing of achieving the
value-driving milestones in, our Influenza A program, including the
completion of the ongoing IND-enabling studies and commencement of
Phase 1 clinical study in 2021; our expectations with respect to
CC-42344 drug superiority; and the expected results of our
collaboration with Merck, including the potential future milestone
payments of up to $156,000,000 and royalties in connection with the
collaboration. The words "believe," "proceeds," "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, but are not limited to, the
risks arising from the impact of the COVID-19 pandemic on the
national and global economy and on our Company, including supply
chain disruptions, our continued ability to proceed with our
programs, our reliance on certain third parties, our reliance on
continuing with Merck under the license and collaboration
agreement, the future results of preclinical and clinical studies,
general risks arising from clinical trials, receipt of regulatory
approvals, and development of effective treatments and/or vaccines
by competitors, including as part of the programs financed by the
U.S. government. Further information on our risk factors is
contained in our filings with the SEC, including our Annual Report
on Form 10-K for the year ended December 31, 2019, as updated and
supplemented by the Quarterly Reports on Form 10-Q for the quarters
ended September 30, 2020 and June 30, 2020. Any forward-looking
statement made by us herein speaks only as of the date on which it
is made. Additional 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:
JTC Team, LLC(833) 475-8247COCP@jtcir.com
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