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 March
31, 2020 and provided program updates.
Recent Highlights
- Entered into license agreement with
Kansas State University Research Foundation (“KSURF”) to further
develop certain proprietary broad-spectrum antiviral compounds for
the treatment of norovirus and coronavirus infections
(“COVID-19”).
- Entered into additional license
agreement with KSURF to include rights to additional preclinical
leads and further develop certain proprietary broad-spectrum
antiviral compounds for the treatment of coronavirus
infections.
- Appointed Nobel Laureate and
Scientific Advisor, Roger D. Kornberg, Ph.D., to its Board of
Directors.
- Completed the final report of U.S.
Phase 2a clinical trial evaluating CC-31244 combination therapy for
the ultrashort combination treatment of individuals infected with
hepatitis C virus (“HCV”), confirming the previously released data
that it is effective and well tolerated.
- Completed three registered direct
offerings since January 31, 2020 for combined total gross proceeds
of $20 million, before deducting placement agent fees and offering
expenses.
- The Company’s Bothell, WA research
lab remains open for essential operations as it continues to work
while meeting COVID-19 quarantine challenges.
“We are pleased with the progress we have made
over the course of the first quarter, despite the challenges due to
the COVID-19 pandemic. The fundamentals of Cocrystal have never
been stronger. Importantly, the Company has a strong cash position,
with capital that we expect will be sufficient to fund our
operations through 2021. Our pipeline of novel antivirals in
development includes treatments for two of the most prevalent
viruses affecting the globe: COVID-19 and influenza. By leveraging
our novel platform technology, we believe Cocrystal is well
positioned to continue addressing the shortcomings in the treatment
of viruses with significant unmet needs, as well as develop safe
and effective antiviral therapies for new or resistant viruses as
they arise,” commented Dr. Gary Wilcox, Chairman and Chief
Executive Officer of Cocrystal.
Development Programs
Overview
Influenza A/B Inhibitors: Merck
CollaborationExclusive license and collaboration agreement
with Merck to discover and develop certain proprietary influenza
A/B antiviral agents.
Cocrystal’s exclusive license and collaboration
agreement with Merck Sharp & Dohme Corp. (“Merck”) to discover
and develop certain proprietary influenza A/B antiviral agents
remains ongoing. Cocrystal has been working with the scientific
leadership at Merck over the past year in advancing the joint
influenza A/B program. Merck, a global healthcare company with a
history of over 125-years of drug discovery and innovation, has
funded the collaborative influenza A/B program and could
potentially provide up to $156 million in milestone payments as the
collaboration proceeds through clinical and commercial development.
The research and collaboration agreement with Merck also provides
for royalties following commercialization. CC-42344:
Influenza A Program: 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’
replication machinery.
The Company’s lead molecule in development,
CC-42344, is currently being evaluated in preclinical IND-enabling
studies for the treatment of influenza. 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.
Cocrystal is currently working to secure its
supply chain and initiate its second lot of API synthesis for its
influenza A program in Q3 2020. Subject to any additional delays
due to the evolving COVID-19 pandemic, Cocrystal expects to file
its regulatory submission and commence its Phase 1a study in
2021.
COVID-19 Coronavirus Program:
Aggressively pursuing the development of novel antiviral compounds
for the treatment of coronavirus infections using our established
proprietary drug discovery platform.
The Company is currently advancing its
Coronavirus program by leveraging the rights to preclinical leads
from its license agreements with KSURF to further develop certain
proprietary broad-spectrum antiviral compounds for the treatment of
coronavirus (COVID-19) infections. The additional compounds
licensed from KSURF have demonstrated both in vitro and in vivo
activity in animal models against the viral pathogens causing MERS
and SARS, coronaviruses that are structurally similar to
SARS-CoV-2, which is responsible for the COVID-19 pandemic.
Cocrystal initiated its preclinical studies of
COVID-19 inhibitors received from KSURF during Q2 2020, and further
intends to identify additional COVID-19 inhibitors from KSURF
utilizing its proprietary platform technology over the course of
the second and third quarter of this year. The Company also plans
to identify additional inhibitors from internal sources using its
proprietary platform technology in Q3 2020 and anticipates the
selection of its lead preclinical molecule in Q4 2020.
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 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 confirms the previously released
data that it is effective and well tolerated. Partnering efforts
are currently underway for the Company’s fully owned ultrashort
treatment of HCV.
Norovirus Program: Developing
inhibitors of the RNA-dependent RNA polymerase of norovirus.
Cocrystal continues to identify and develop
non-nucleoside polymerase inhibitors using its proprietary
structure-based drug design technology platform. Cocrystal recently
entered into license agreements with KSURF to further develop
certain proprietary broad-spectrum antiviral compounds for humans
to treat Norovirus and Coronavirus infections. Preclinical
activities for Cocrystal’s Norovirus program are currently
underway. The Company expects to complete its proof-of-concept
animal model study in Q4 2020.
Summary of Financial Results for Q1
2020
As of March 31, 2020, Cocrystal had
approximately $21,686,000 cash on hand. Based on management’s
current projections, the Company believes it has sufficient capital
to continue operations through 2021.
For the quarter ended March 31, 2020, the
Company had revenues of approximately $461,000 compared to
$5,078,000 in revenue in the first quarter of 2019. The revenue for
the three months ended March 31, 2019 included $4,368,000 as
consideration in exchange for conveyance of intellectual property
rights at the signing of the Merck Collaboration Agreement executed
on January 2, 2019.
For the quarter ended March 31, 2020, the
Company reported net loss of approximately $1,990,000 compared to a
net income of approximately $2,971,000 for the same period in 2019,
primarily due to Merck revenue as explained above.
Total research and development expenses were
approximately $1,283,000 for the three months ended March 31, 2020,
compared with $878,000 for the three months ended March 31, 2019.
The increase was primarily due to increases in COVID-19 and
Influenza programs. General and administrative expenses were
$1,139,000 for the three months ended March 31, 2020, compared with
$1,323,000 for the three months ended March 31, 2019.
During the first quarter 2020, the Company
closed the following offerings of its common stock to certain
institutional investors:
- January 29, 2020: Registered direct
offering of 3,492,063 shares of common stock at a purchase price
per share of $0.63 for aggregate gross proceeds to the Company of
approximately $2.2 million, before deducting fees payable to the
placement agent and other estimated offering expenses payable by
the Company. The Company closed the offering on January 31, 2020.
- February 27, 2020: Registered
direct offering of 8,461,540 shares of common stock at a purchase
price per share of $1.30 for aggregate gross proceeds to the
Company of approximately $11.0 million, before deducting fees
payable to the placement agent and other offering expenses payable
by the Company. The Company closed the offering on February 28,
2020.
- March 9, 2020: Registered direct
offering of 5,037,038 shares of common stock at a purchase price
per share of $1.35 for aggregate gross proceeds to the Company of
approximately $6.8 million, before deducting fees payable to the
placement agent and other offering expenses payable by the Company.
The Company closed the offering on March 10, 2020.
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, hepatitis C viruses, coronaviruses and noroviruses.
Cocrystal employs unique 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 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 anticipated timing of
achieving the value-driving milestones in our influenza A program,
including securing a supply chain and initiating the 2nd lot API
synthesis in Q3 2020, filing the regulatory submission and
commencing the Phase 1a study in 2021; the anticipated timing of
achieving the value-driving milestones in our COVID-19 program,
including identifying additional COVID-19 inhibitors using the
Company’s proprietary platform technology in Q2 and Q3 2020, and
the selection of a preclinical lead molecule in Q4 2020; the
anticipated timing of achieving the value-driving milestones in our
norovirus program, including completion of a proof-of-concept
animal study in Q4 2020; and our expectations regarding future
liquidity. 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 our
Company, including (i) supply chain disruptions, (ii) our continued
ability to proceed with our programs, and (iii) on the national and
global economy, our reliance on certain third parties, our reliance
on continuing collaboration with Merck under the collaboration
agreement, the future results of preclinical and clinical studies,
general risks arising from clinical trials, receipt of regulatory
approvals, development of effective treatments and/or vaccines by
competitors, any unanticipated litigation and other expenses and
factors that affect the capital markets in general and early stage
biotechnology companies specifically. 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. 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
###
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