Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or
the “Company”), a clinical stage biotechnology company
discovering and developing novel antiviral therapeutics,
announced today its financial results for the year ended December
31, 2019, provided its business outlook for 2020 and outlined its
expected value-driving milestones.
Recent Highlights
- Entered into license agreement with KSURF to further develop
certain proprietary broad-spectrum antiviral compounds for the
treatment of norovirus and coronavirus infections;
- 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;
- Recognized revenue from Merck collaboration of $6,564,000
during 2019;
- Presented at American Association
for the Study of Liver Diseases (“AASLD”) 2019 Liver Meeting
positive data from U.S. Phase 2a study of CC-31244 demonstrating
ability to identify patients more likely to respond to ultrashort
treatment of hepatitis C (“HepC”).
- 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 currently witnessing a unique
opportunity to leverage our core competencies and decade of
experience in the antiviral therapeutics space with the global
health crisis of COVID-19. Our COVID-19 program consists of work
performed globally by CRO’s and in our own laboratory. Our team is
working to develop novel antiviral compounds to treat Coronavirus
infections by leveraging our proprietary drug discovery platform.
Given the growing global need for a treatment, our primary focus is
to advance this program further into preclinical development as
quickly and efficiently as possible,” stated Dr. Gary Wilcox,
Chairman and Chief Executive Officer of Cocrystal.
“Over the course of 2019, our exclusive
worldwide license and collaboration agreement with Merck to
discover and develop Cocrystal’s influenza A/B antiviral agents
provides additional validation of our platform technology and the
opportunity to develop novel broad spectrum antivirals.
Additionally, the advancements made across our pipeline throughout
2019 helped to establish the foundation from which we will leverage
to build momentum for our influenza, hepatitis C virus, norovirus
and coronavirus development programs,” added Dr. Wilcox. “Cocrystal
is fully committed to the successful execution of our strategy and
believes our achieving the corporate, clinical and regulatory
milestones we have outlined for 2020 has the potential to drive
significant shareholder value.”
Dr. Sam Lee, President of Cocrystal, commented,
“We are navigating our way through these unprecedented times. While
necessary mandates have been implemented by government officials,
we are still able to perform essential activities and keep our
development programs moving forward. Thankfully, our employees are
also able to continue working remotely and our team is functioning
well under these circumstances. We remain committed to meeting our
corporate and development milestones throughout the year.”
Upcoming Expected Value-Driving
Milestones in 2020
CC-42344: Influenza A Program
- Q4 2020: Complete preclinical
IND-enabling studies
- Q4 2020: File a regulatory
submission
- Q4 2020: Commence Phase 1a
study
Influenza A/B Inhibitors: Merck
Collaboration
- Q4 2020: Continue collaboration with Merck to discover and
develop certain proprietary influenza A/B antiviral agents
CC-31244: Hepatitis C Program
- Q1 2020: Complete final report of
Phase 2a U.S. study
- Q4 2020: Partnering effort underway
for Phase 2b study for fully owned ultrashort treatment of
HepC
COVID-19 Coronavirus Program
- Q2 2020: File patent application
- Q2/Q3 2020: Develop COVID-19 inhibitors using proprietary
platform technology
- H2 2020: Initiate preclinical studies of COVID-19
inhibitors
Norovirus Program
- Q2 2020: File patent application
- Q2 2020: Select lead preclinical molecule
Business Development
- Advance discussions with potential
strategic partners to secure development and commercialization
licensing agreement across pipeline
Summary of Financial Results for
2019
As of December 31, 2019, Cocrystal had
approximately $7,418,000 cash on hand. Based on the subsequent
capital raises discussed below and management’s current
projections, the Company believes it has sufficient capital to
continue operations for the next 24 months.
The Company recognized revenue from Merck of
$6,564,000 for the year ended December 31, 2019, compared with $0
for the year ended December 31, 2018. During the year ended
December 31, 2019 the revenue from Merck consisted of $4,368,000 as
consideration in exchange for conveyance of intellectual property
rights at the signing of the agreement, $1,838,000 for research and
development activities related to its influenza A/B program and
$358,000 for program expense reimbursements.
Research and development expenses were
$4,004,000 for the year ended December 31, 2019, compared with
$4,667,000 for the year ended December 31, 2018. This year over
year decrease in research and development expenditures was
primarily due to the completion of our HepC Phase 2 clinical trial
and continued expense reimbursements from Merck. We expect research
and development expenses to increase in 2020 due to advancing our
coronavirus and norovirus programs.
General and administrative expenses were
$4,863,000 for the year ended December 31, 2019, compared with
$4,352,000 for the year ended December 31, 2018. This increase of
$511,000 was primarily due to professional fees associated with
litigation matters and insurance increases.
We had a net loss of $48,169,000 for the year
ended December 31, 2019 primarily due to a $46,103,000 goodwill
impairment, compared to a net loss of $49,048,000 for the year
ended December 31, 2018 primarily due to a $53,905,000 IPR&D
impairment. These 2019 and 2018 impairments are non-cash
impairments of intangible assets.
Subsequent to December 31, 2019, 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 estimated 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 estimated 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 machinery of influenza
viruses, hepatitis C viruses, noroviruses and coronaviruses.
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 regarding our ability to
drive significant shareholder value, the achievement and the
expected timing of the corporate, clinical and regulatory
milestones, including the completion of IND-enabling studies,
filing of regulatory submissions and commencement of a Phase 1a
study in our Influenza A program, continued collaboration with
Merck in our Influenza A/B program, issuance of final report of the
Phase 2a study and expected progress of partnering effort in our
HepC program, filing of a patent application, development of
inhibitors and initiation of preclinical studies in our COVID-19
program, and filing of a patent application and selection of the
lead preclinical molecule in our Norovirus program, expected
advancement of discussions with potential strategic partners, our
expected research and development expenses, and our liquidity. 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, but are not
limited to, risks arising from the impact of the COVID-19 pandemic
on our Company, including our ability to proceed with our programs,
receive necessary regulatory approvals and continue to rely on
certain third parties, and on the national and global economy, our
reliance on continuing collaboration with Merck under the
collaboration agreement, the availability of products manufactured
by third parties, the results of preclinical and clinical studies,
general risks arising from clinical trials, receipt of regulatory
approvals, our ability to find and enter into agreements with
suitable collaboration partners, litigation expenses 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. 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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