Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for
the three and nine months ended September 30, 2022, and provides
updates on its antiviral pipeline, upcoming milestones and business
activities.
“We are reporting continued progress in
advancing our highly promising antiviral portfolio,” said Sam Lee,
Ph.D., President and co-interim CEO of Cocrystal. “With enrollment
completed in our CC-42344 Phase 1 study for the treatment of
pandemic and seasonal influenza A, we are on track to report
topline safety and pharmacokinetic (PK) results later this year.
The full trial results will be a key component of UK regulatory
agency submission for our influenza A Phase 2a human challenge
study. Subject to the agency’s review and clearance of our
submission, we expect Phase 2a study initiation in the second half
of 2023.
“We advanced our oral COVID-19 program with the
selected the novel, broad-spectrum protease inhibitor CDI-988 as
our lead development candidate,” he added. “We are conducting
IND-enabling toxicology studies with CDI-988 and plan to file for
regulatory clearance to begin a first-in-human trial in Australia
in the first quarter of 2023. Preclinical development activities
are ongoing in our norovirus program with plans to select a lead
candidate in the first half of 2023.”
“The recent increase in patients hospitalized
with viral disease particularly among the pediatric population
underscores the need for effective, broad-spectrum antivirals and
provides rationale for our approach in developing candidates with
barriers to drug resistance,” said James Martin, CFO and co-interim
CEO. “We continue to be well positioned to execute on our clinical
and regulatory goals given our clean capital structure,
cost-efficient business model and a cash balance we believe is
sufficient to fund planned operations for the next three years.
That said, we continue to pursue non-dilutive funding to further
support development of our promising antiviral programs.”
Antiviral
Product Pipeline
Overview
Many commercial antiviral drugs are only
effective against certain strains of a virus and are less effective
or not effective at all against other strains or variants.
Cocrystal is developing novel drug candidates that specifically
target proteins involved in viral replication. Despite the numerous
strains that may exist or emerge, these targeted enzymes are
required for viral replication and are essentially similar (highly
conserved) across all strains. By targeting these highly conserved
regions of the replication enzymes, our antiviral compounds are
designed to be effective against major virus strains.
COVID-19 and Other Coronavirus ProgramsBy
targeting viral replication enzymes and protease, we believe it is
possible to develop an effective treatment for all coronavirus
diseases including COVID-19, Severe Acute Respiratory Syndrome
(SARS) and Middle East Respiratory Syndrome (MERS). Our main
SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral
activity against common human coronaviruses, rhinoviruses and
respiratory enteroviruses that cause the common cold, as well as
against noroviruses that can cause symptoms of acute
gastroenteritis.
During 2022 Cocrystal entered into two
agreements with the National Institute of Allergy and Infectious
Diseases (NIAID) for exploratory preclinical studies to evaluate
our 3CL protease inhibitors for the treatment of COVID-19. The
NIAID collaboration announced in April 2022 for in vitro and in
vivo studies evaluating the antiviral activity of our compounds has
been successfully completed. In June 2022 we expanded our
collaboration with the NIAID with a second agreement in which we
provided our proprietary process chemistry information for oral 3CL
protease inhibitors to the NIAID to support scale-up synthesis of a
key intermediate of these compounds. This collaboration is
ongoing.
- Oral Protease Inhibitor CDI-988
- We selected CDI-988 as our lead
candidate for development as a potential oral treatment for
SARS-CoV-2. CDI-988, which was designed and developed using our
proprietary structure-based drug discovery platform technology,
targets a highly conserved region in the active site of SARS-CoV-2
3CL (main) protease required for viral RNA replication.
- CDI-988 exhibits superior in vitro
potency against SARS-CoV-2 with activity maintained against current
variants of concern, and demonstrated a safety profile and PK
properties that are supportive of daily dosing.
- We are currently conducting good
laboratory practice (GLP) toxicology studies in preparation for a
Phase 1 study.
- We plan to initiate a Phase 1 study
in the first quarter of 2023. We believe the FDA’s guidance for
further development of our antiviral candidate CDI-45205 (described
below) provides us with a clearer pathway for our planned Phase 1
study with CDI-988, as well as directives for designing a
subsequent Phase 2 study.
- Intranasal/Pulmonary Protease
Inhibitor CDI-45205
- An IND-enabling study is ongoing
with CDI-45205, our novel SARS-CoV-2 3CL (main) protease inhibitor
being developed as a potential treatment for COVID-19 and its
variants.
- We received guidance from the FDA
regarding further preclinical and clinical development of CDI-45205
that provides a clearer pathway for future clinical
development.
- CDI-45205 and several analogs
showed potent in vitro activity against the main SARS-CoV-2
variants to date including the Omicron variant, surpassing the
activity observed with the original Wuhan strain.
- CDI-45205 demonstrated good
bioavailability in mouse and rat PK studies via intraperitoneal
injection, and no cytotoxicity against a variety of human cell
lines. CDI-45205 also demonstrated a strong synergistic effect with
the FDA-approved COVID-19 medicine remdesivir.
- CDI-45205 was among the
broad-spectrum viral protease inhibitors we obtained from Kansas
State University Research Foundation (KSURF) under an exclusive
license agreement announced in April 2020. We believe the protease
inhibitors obtained from KSURF have the ability to inhibit the
inactive SARS-CoV-2 polymerase replication enzymes into an active
form.
- Replication Inhibitors
- We are using our proprietary
structure-based drug discovery platform technology to discover
replication inhibitors for orally administered therapeutic and
prophylactic treatments for SARS-CoV-2. Replication inhibitors hold
potential to work with protease inhibitors in a combination therapy
regimen.
Influenza ProgramsInfluenza is a severe
respiratory illness caused by either the influenza A or B virus
that results in outbreaks of disease mainly during the winter
months.
- Pandemic and Seasonal Influenza A
- A novel PB2 inhibitor, CC-42344 has
shown excellent antiviral activity against influenza A strains
including pandemic and seasonal strains, as well as strains
resistant to Tamiflu® and Xofluza®. CC-42344 also has favorable PK
and drug-resistance profiles.
- In March 2022 we initiated
enrollment in our randomized, double-controlled, dose-escalating
Phase 1 study to evaluate the safety, tolerability and
pharmacokinetics of orally administered CC-42344 in healthy
adults.
- In April 2022 we announced
preliminary Phase 1 study data, demonstrating a favorable safety
and PK profile in the first two cohorts administered single
ascending doses of CC-42344 at 100 mg and 200 mg.
- In July 2022 we reported PK results
from the single ascending dose of the study supporting once-daily
dosing.
- In November 2022 we announced the
Phase 1 study had reached full enrollment and reiterated our
expectation to report topline results in 2022.
- We entered into an agreement with a
UK-based clinical research organization to conduct a human
challenge Phase 2a study evaluating safety, viral and clinical
measures of orally administered CC-42344 in influenza A-infected
subjects. Under the human challenge model, healthy adults will be
infected with the influenza A virus under carefully controlled
conditions, which we believe will hasten trial enrollment and
ensure subjects are infected with influenza A.
- We expect to submit an application
with the United Kingdom Medicines and Healthcare Products
Regulatory Agency in early 2023 to conduct a human challenge Phase
2a study. Pending clearance by the agency, we expect to initiate
the study in the second half of 2023.
- Pandemic and Seasonal Influenza A/B
Program
- In January 2019 we entered into an
Exclusive License and Research Collaboration Agreement with Merck
Sharp & Dohme Corp. (Merck) to discover and develop certain
proprietary influenza antiviral agents that are effective against
both influenza A and B strains. This agreement includes milestone
payments of up to $156 million plus royalties on sales of products
discovered under the agreement.
- In January 2021 we announced
completion of all research obligations under the agreement. Merck
is now solely responsible for further preclinical and clinical
development of compounds discovered under this agreement, and
continues development activities with the compounds discovered
under this agreement.
- In April 2022 Merck indicated it
was continuing development of the compounds discovered under this
agreement.
Norovirus Program
- We are developing certain
proprietary broad-spectrum, non-nucleoside polymerases for the
treatment of human norovirus infections using our proprietary
structure-based drug design technology platform. We also hold
exclusive rights to norovirus protease inhibitors for use in humans
under the KSURF license.
- We are targeting the selection of a
preclinical lead in the first half of 2023.
- Norovirus is a global public health
problem responsible for nearly 90% of epidemic, non-bacterial
outbreaks of gastroenteritis around the world.
Hepatitis C Program
- We are seeking a partner to advance
the development of CC-31244 following the successful completion of
a Phase 2a study. This compound has shown favorable safety and
preliminary efficacy in a triple-regimen Phase 2a study in
combination with Epclusa (sofosbuvir/velpatasvir) for the
ultra-short duration treatment of individuals infected with the
hepatitis C virus (HCV).
- HCV is a viral infection of the
liver that causes both acute and chronic infection. In June 2022,
the World Health Organization estimates that 58 million people
worldwide have chronic HCV infections.
Third Quarter
Financial Results
Research and development (R&D) expenses for
the third quarter of 2022 were $3.9 million compared with $2.1
million for the third quarter of 2021, with the increase primarily
due to the ongoing influenza A Phase 1 trial and advancement of the
preclinical COVID-19 program. The Company anticipates higher
R&D spending during the remainder of 2022 in preparation for
additional clinical trials. General and administrative (G&A)
expenses were $1.8 million for the third quarters of both 2022 and
2021.
The net loss for the third quarter of 2022 was
$5.7 million, or $0.70 per share, compared with the net loss for
the third quarter of 2021 of $3.9 million, or $0.48 per share.
Nine Month
Financial Results
R&D expenses for the first nine months of
2022 were $9.1 million compared with $6.1 million for the first
nine months of 2021. G&A expenses were $4.5 million for the
first nine months of both 2022 and 2021.
The net loss for the first nine months of 2022
was $34.3 million, or $4.23 per share, and included the items
described above. The net loss for the first nine months of 2021 was
$10.5 million, or $1.44 per share.
Cocrystal reported unrestricted cash of $42.1
million as of September 30, 2022 compared with $58.7 million as of
December 31, 2021. Net cash used in operating activities for the
first nine months of 2022 was $16.5 million. The Company reported
working capital of $43.3 million with 8.1 million common shares
outstanding as of September 30, 2022.
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, coronaviruses (including SARS-CoV-2), hepatitis C viruses
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 regarding our goals of
initiating a Phase 1 study for our CDI-988 candidate in the first
quarter of 2023, our expectations of reporting data from the Phase
1 clinical study of our CC-42344 candidate later in 2022 and
timeline for filing with the UK regulatory agency and commencing a
Phase 2a study in 2023, our plans to select a lead candidate for
our norovirus program in the first half of 2023, the viability and
efficacy of potential treatments for coronavirus and other
diseases, expectations for the global market for therapeutics, our
attempts to discover replication inhibitors, our ability to execute
our clinical and regulatory goals, our expectations concerning
R&D expenses, the expected sufficiency of our cash balance to
fund our planned operations, our liquidity and our continued
pursuit of non-dilutive funding. 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, the
risks arising from the impact of COVID-19 (including long-term and
pervasive effects of the virus), inflation, interest rate increases
and the Ukraine war on our Company, our collaboration partners, and
on the national and global economy, including manufacturing and
research delays arising from raw materials and labor shortages,
supply chain disruptions and other business interruptions including
and adverse impacts on our ability to obtain raw materials and test
animals as well as similar problems with our vendors and our
current Contract Research Organization (CRO) and any future CROs
and Contract Manufacturing Organizations, the results of the
studies for CC-42344, the ability of our CROs to recruit volunteers
for, and to proceed with, clinical studies, our reliance on Merck
for further development in the influenza A/B program under the
license and collaboration agreement, our and our collaboration
partners’ technology and software performing as expected, financial
difficulties experienced by certain partners, the results of future
preclinical and clinical trials, general risks arising from
clinical trials, receipt of regulatory approvals, regulatory
changes, development of effective treatments and/or vaccines by
competitors, including as part of the programs financed by the U.S.
government, potential mutations in a virus we are targeting which
may result in variants that are resistant to a product candidate we
develop, and the outcome of our appeal of the summary judgment.
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, 2021. 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 Contact:LHA Investor
RelationsJody Cain310-691-7100jcain@lhai.com
Media Contact:JQA PartnersJules
Abraham917-885-7378Jabraham@jqapartners.com
COCRYSTAL PHARMA, INC.
CONSOLIDATED BALANCE
SHEETS(in
thousands)
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
42,056 |
|
|
$ |
58,705 |
|
Restricted cash |
|
|
75 |
|
|
|
50 |
|
Prepaid expenses and other current assets |
|
|
2,765 |
|
|
|
568 |
|
Total current assets |
|
|
44,896 |
|
|
|
59,323 |
|
Property and equipment,
net |
|
|
378 |
|
|
|
453 |
|
Deposits |
|
|
46 |
|
|
|
46 |
|
Operating lease right-of-use
assets, net (including $113 and 153 respectively, to related
party) |
|
|
327 |
|
|
|
478 |
|
Goodwill |
|
|
- |
|
|
|
19,092 |
|
Total assets |
|
$ |
45,647 |
|
|
$ |
79,392 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
1,378 |
|
|
$ |
1,297 |
|
Current maturities of finance lease liabilities |
|
|
14 |
|
|
|
27 |
|
Current maturities of operating lease liabilities (including $57
and 53 respectively, to related party) |
|
|
227 |
|
|
|
209 |
|
Derivative liabilities |
|
|
- |
|
|
|
12 |
|
Total current liabilities |
|
|
1,619 |
|
|
|
1,545 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Finance lease liabilities |
|
|
- |
|
|
|
7 |
|
Operating lease liabilities (including $57 and 101 respectively, to
related party) |
|
|
119 |
|
|
|
291 |
|
Total long-term
liabilities |
|
|
119 |
|
|
|
298 |
|
Total liabilities |
|
|
1,738 |
|
|
|
1,843 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par
value; 150,000 shares authorized as of September 30, 2022 and
December 31, 2021; 8,143 shares issued and outstanding as of
September 30, 2022 and December 31, 2021. |
|
|
8 |
|
|
|
8 |
|
Additional paid-in
capital |
|
|
337,330 |
|
|
|
336,634 |
|
Accumulated deficit |
|
|
(293,429 |
) |
|
|
(259,093 |
) |
Total stockholders’
equity |
|
|
43,909 |
|
|
|
77,549 |
|
Total liabilities and
stockholders’ equity |
|
$ |
45,647 |
|
|
$ |
79,392 |
|
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS(in
thousands, except per share data)
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,872 |
|
|
|
2,105 |
|
|
|
9,105 |
|
|
|
6,061 |
|
|
General and administrative |
|
|
1,822 |
|
|
|
1,848 |
|
|
|
4,530 |
|
|
|
4,458 |
|
|
Legal settlement |
|
|
- |
|
|
|
- |
|
|
|
1,600 |
|
|
|
- |
|
|
Impairments |
|
|
- |
|
|
|
- |
|
|
|
19,092 |
|
|
|
- |
|
|
Total operating
expenses |
|
|
5,694 |
|
|
|
3,953 |
|
|
|
34,327 |
|
|
|
10,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(5,694 |
) |
|
|
(3,953 |
) |
|
|
(34,327 |
) |
|
|
(10,519 |
) |
|
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
(2 |
) |
|
|
(4 |
) |
|
Foreign exchange loss |
|
|
(5 |
) |
|
|
(4 |
) |
|
|
(19 |
) |
|
|
(4 |
) |
|
Change in fair value of derivative liabilities |
|
|
- |
|
|
|
17 |
|
|
|
12 |
|
|
|
27 |
|
|
Total other (expense) income, net |
|
|
(6 |
) |
|
|
12 |
|
|
|
(9 |
) |
|
|
19 |
|
|
Net loss |
|
$ |
(5,700 |
) |
|
$ |
(3,941 |
) |
|
|
(34,336 |
) |
|
|
(10,500 |
) |
|
Net loss per
common share, basic and diluted |
|
$ |
(0.70 |
) |
|
$ |
(0.48 |
) |
|
|
(4.23 |
) |
|
|
(1.44 |
) |
|
Weighted average
number of common shares outstanding, basic and diluted |
|
|
8,143 |
|
|
|
8,143 |
|
|
|
8,143 |
|
|
|
7,108 |
|
|
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