Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the
“Company”) reports financial results for the three and nine months
ended September 30, 2024, and provides updates on its antiviral
product pipeline, upcoming milestones and business activities.
“The coming months are critically important to
Cocrystal as we expect to report topline results from two ongoing
clinical studies with our best-in-class antiviral candidates in
major medical indications,” said Sam Lee, Ph.D., President and
co-CEO of Cocrystal. “In the Phase 2a influenza A challenge study
with our oral PB2 inhibitor CC-42344, we expect to report topline
results before year end. Earlier this year, we received feedback
from the U.S. Food and Drug Administration (FDA) on a Pre-IND
package that improves our clarity on the regulatory path and
requirements for the late-stage influenza A clinical study we plan
to conduct in the U.S.
“The multiple-ascending dose portion in our
Phase 1 pan-norovirus/pan-coronavirus study with oral protease
inhibitor CDI-988 is underway and we are on track to report topline
results in late 2024 or early 2025,” he added. “We view the
development of an effective antiviral for norovirus as a
significant opportunity for Cocrystal. There is no approved vaccine
or antiviral for norovirus, which is highly contagious and the most
common cause of acute gastroenteritis. In in vitro studies, CDI-988
exhibited pan-viral activity against multiple norovirus strains,
including the strain that is responsible for major outbreaks.”
“Our significant clinical progress so far this
year puts us on track for an active 2025,” said James Martin, CFO
and co-CEO of Cocrystal. “I’m pleased to report that based on our
currently projected expenditures and our cost-efficient business
model, we expect our cash will be sufficient to fund the
advancement of our planned development programs through the coming
12 months.”
Antiviral Product Pipeline
Overview
We apply our proprietary structure-based drug
discovery platform technology for developing broad-spectrum
antivirals that inhibit viral replication. By designing and
selecting antiviral drug candidates that target the highly
conserved regions of the viral enzymes, we seek to develop drugs
that are effective against the virus and mutations of the virus,
and also reduce off-target interactions that may cause undesirable
side effects. Our drug discovery process differs from traditional,
empirical medicinal chemistry approaches that often require
iterative high-throughput compound screening and lengthy
hit-to-lead processes.
Influenza Programs
Influenza is a major global health threat that
may become more challenging to treat due to the emergence of highly
pathogenic avian influenza viruses and resistance to approved
influenza antivirals. Each year there are approximately 1 billion
cases of seasonal influenza worldwide, 3-5 million severe illnesses
and up to 650,000 deaths. On average, about 8% of the U.S.
population contracts influenza each season. In addition to the
health risk, influenza is responsible for an estimated $11.2
billion in direct and indirect costs in the U.S. annually.
- Oral CC-42344 for the treatment of
pandemic and seasonal Influenza A infections
- Our novel PB2 inhibitor CC-42344
showed excellent in vitro antiviral activity against pandemic and
seasonal influenza A strains, as well as strains that are resistant
to Tamiflu® and Xofluza®.
- In December 2022 we reported
favorable safety and tolerability results from the oral CC-42344
Phase 1 study.
- In December 2023 we began a
randomized, double-blind, placebo-controlled Phase 2a human
challenge study to evaluate the safety, tolerability, viral and
clinical measurements of CC-42344 in influenza A-infected subjects
in the United Kingdom, following authorization from the UK
Medicines and Healthcare Products Regulatory Agency (MHRA).
- In May 2024 we completed enrollment
in the Phase 2a human challenge study.
- In June 2024 we reported that in
vitro studies demonstrated CC-42344 inhibits the activity of the
new highly pathogenic avian influenza A (H5N1) PB2 protein recently
identified in humans exposed to infected dairy cows.
- We expect to report topline results
from the Phase 2a human challenge study by yearend and plan to file
an IND application in 2025 to conduct a late-stage study in the
U.S.
- Inhaled CC-42344 for the
therapeutic and prophylactic treatment of pandemic and seasonal
Influenza A infections
- Our preclinical testing showed
superior pulmonary pharmacology with CC-42344 including high
exposure to drug and a long half-life.
- We completed CC-42344 inhalation
formulation development.
- We initiated GLP toxicology
studies.
- Influenza A/B Program
- Our work to develop a preclinical
lead of novel influenza replication inhibitors is underway.
Norovirus Program
Norovirus is a highly contagious infection and
is the most common cause of acute gastroenteritis. Worldwide,
norovirus causes about one out of five cases of acute
gastroenteritis that leads to diarrhea and vomiting. An estimated
685 million cases and an estimated 50,000 child deaths are
attributed to norovirus each year worldwide, with an estimated
societal cost of $60 billion. By targeting viral replication, we
believe it is possible to develop an effective treatment and/or
short-term prophylactic for closed environments for all genogroups
of norovirus.
- Oral pan-viral protease inhibitor
CDI-988 for the treatment of norovirus and coronavirus infections
- Our novel broad-spectrum protease
inhibitor CDI-988 is being evaluated as a potential oral treatment
for noroviruses and coronaviruses.
- CDI-988 has shown in vitro
pan-viral activity against multiple norovirus strains, including
the genogroup II, genotype 4 (GII.4) norovirus strain that is
responsible for major norovirus outbreaks.
- In May 2023 we announced approval
of our application to the Australian regulatory agency for a
randomized, double-blind, placebo-controlled Phase 1 study to
evaluate the safety, tolerability and pharmacokinetics (PK) of oral
CDI-988 in healthy volunteers.
- In August 2023 we announced our
selection of CDI-988 as our lead for the oral treatment for
norovirus, in addition to coronavirus.
- In September 2023 we began dosing
subjects in a first-in-human study in healthy volunteers with oral
CDI-988.
- In July 2024 we reported favorable
safety and tolerability results from the single-ascending dose
cohort in the Phase 1 study.
- In September 2024 we advanced
CDI-988 into the multiple-ascending dose cohort of the Phase 1
study.
- We expect to report topline results
from the CDI-988 Phase 1 study in late 2024 or early 2025.
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and
proteases, we believe it is possible to develop effective
treatments for all diseases caused by coronaviruses including
COVID-19 and its variants, Severe Acute Respiratory Syndrome (SARS)
and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent
in vitro pan-viral activity against common human coronaviruses,
rhinoviruses and respiratory enteroviruses, as well as against
noroviruses. The global COVID-19 therapeutics market is estimated
to exceed $16 billion by the end of 2031.
- Oral pan-viral protease inhibitor
CDI-988 for the treatment of coronaviruses and noroviruses
- CDI-988 exhibited superior in vitro
potency against SARS-CoV-2 and demonstrated a favorable safety
profile and PK properties.
- In September 2023 we dosed the
first subject in our dual pan-norovirus/pan-coronavirus oral
CDI-988 study, which is expected to serve as a Phase 1 study for
both indications.
- In July 2024 we reported favorable
safety and tolerability results from the single-ascending dose
cohort in the Phase 1 study.
- In September 2024 we advanced
CDI-988 into the multiple-ascending dose cohort of the Phase 1
study.
- We expect to report topline results
from the CDI-988 Phase 1 study in late 2024 or early 2025.
Third Quarter Financial
Results
Research and development (R&D) expenses for
the third quarter of 2024 were $3.2 million, compared with $4.2
million for the third quarter of 2023, with the decrease primarily
due to lower clinical study expenses. General and administrative
(G&A) expenses for the third quarters of 2024 and 2023 remained
relatively stable at $1.8 million.
The net loss for the third quarter of 2024 was
$4.9 million, or $0.49 per share, compared with a net loss for the
third quarter of 2023 of $4.2 million, or $0.41 per share, that
included a $1.6 million payment to the Company in 2023 for a legal
settlement.
Nine Month Financial
Results
R&D expenses for the first nine months of
2024 were $10.5 million, compared with $10.9 million for the first
nine months of 2023. G&A expenses for the first nine months of
2024 were $4.1 million, compared with $4.6 million for the first
nine months of 2023.
The net loss for the first nine months of 2024
was $14.2 million, or $1.40 per share, compared with a net loss for
the first nine months of 2023 of $13.5 million, or $1.43 per
share.
Cocrystal reported unrestricted cash as of
September 30, 2024 of $13.0 million, compared with $26.4 million as
of December 31, 2023. Net cash used in operating activities for the
first nine months of 2024 was $13.3 million, compared with $11.3
million for the first nine months of 2023. The Company had working
capital of $12.3 million and 10.2 million common shares outstanding
as of September 30, 2024.
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), noroviruses and
hepatitis C viruses. 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 plans for
the future development of preclinical and clinical drug candidates,
our expectations regarding future characteristics of the product
candidates we develop, the expected time of achieving certain
value-driving milestones in our programs, including preparation,
commencement and advancement of clinical studies for certain
product candidates in 2024 and 2025, the viability and efficacy of
potential treatments for diseases our product candidates are
designed to treat, expectations for the markets for certain
therapeutics, our ability to execute our clinical and regulatory
goals and deploy regulatory guidance towards future studies, and
the expected sufficiency of our cash balance to advance our
programs and fund our planned operations. 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 and uncertainties arising from future
inflation, potential future increases in interest rates uncertainty
in the financial markets, the possibility of a recession, and
geopolitical conflict including in Ukraine and Israel on our
Company, our collaboration partners, and on the U.S., UK, Australia
and global economies, including manufacturing and research delays
arising from raw materials and labor shortages, supply chain
disruptions and other business interruptions on our ability to
proceed with studies as well as similar problems with our vendors
and our current and any future clinical research organization
(CROs) and contract manufacturing organizations (CMOs), the ability
of our CROs to recruit volunteers for, and to proceed with,
clinical studies, our and our collaboration partners’ technology
and software performing as expected, financial difficulties
experienced by certain partners, the results of any current and
future preclinical and clinical studies, general risks arising from
clinical studies, receipt of regulatory approvals, regulatory
changes including potential downward pressure on government
spending on healthcare in the wake of the recent presidential
election in the U.S., the impact of the recent U.S. presidential
election on regulation affecting the FDA and other healthcare
agencies and potential staffing issues, potential mutations in a
virus we are targeting that may result in variants that are
resistant to a product candidate we develop. 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, 2023. 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:Alliance
Advisors IRJody Cain310-691-7100jcain@allianceadvisors.com
Media Contact:JQA PartnersJules
Abraham917-885-7378Jabraham@jqapartners.com
Financial Tables to follow COCRYSTAL
PHARMA, INC.
CONSOLIDATED BALANCE
SHEETS(in thousands)
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
13,020 |
|
|
$ |
26,353 |
|
Restricted cash |
|
|
75 |
|
|
|
75 |
|
Tax credit receivable |
|
|
652 |
|
|
|
890 |
|
Prepaid expenses and other current assets |
|
|
509 |
|
|
|
1,773 |
|
Total current assets |
|
|
14,256 |
|
|
|
29,091 |
|
Property and equipment,
net |
|
|
181 |
|
|
|
271 |
|
Deposits |
|
|
29 |
|
|
|
46 |
|
Operating lease right-of-use
assets, net (including $163 and $42 respectively, to related
party) |
|
|
1,767 |
|
|
|
1,851 |
|
Total assets |
|
$ |
16,233 |
|
|
$ |
31,259 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
1,655 |
|
|
$ |
3,022 |
|
Current maturities of operating lease liabilities (including $55
and $42 respectively, to related party) |
|
|
293 |
|
|
|
240 |
|
Total current liabilities |
|
|
1,948 |
|
|
|
3,262 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities (including $163 and $0 respectively, to
related party) |
|
|
1,582 |
|
|
|
1,613 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,530 |
|
|
|
4,875 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value
100,000 and 150,000 shares authorized as of September 30, 2024, and
December 31, 2023; 10,174 shares issued and outstanding as of
September 30, 2024 and December 31, 2023 |
|
|
10 |
|
|
|
10 |
|
Additional paid-in
capital |
|
|
342,845 |
|
|
|
342,288 |
|
Accumulated deficit |
|
|
(330,152 |
) |
|
|
(315,914 |
) |
Total stockholders’
equity |
|
|
12,703 |
|
|
|
26,384 |
|
Total liabilities and
stockholders’ equity |
|
$ |
16,233 |
|
|
$ |
31,259 |
|
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited)(in thousands, except per
share data)
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,242 |
|
|
|
4,194 |
|
|
|
10,500 |
|
|
|
10,902 |
|
General and administrative |
|
|
1,800 |
|
|
|
1,849 |
|
|
|
4,148 |
|
|
|
4,591 |
|
Legal settlement |
|
|
- |
|
|
|
(1,600 |
) |
|
|
- |
|
|
|
(1,600 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
5,042 |
|
|
|
4,443 |
|
|
|
14,648 |
|
|
|
13,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,042 |
) |
|
|
(4,443 |
) |
|
|
(14,648 |
) |
|
|
(13,893 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
|
111 |
|
|
|
320 |
|
|
|
482 |
|
|
|
460 |
|
Foreign exchange loss |
|
|
(8 |
) |
|
|
(42 |
) |
|
|
(72 |
) |
|
|
(87 |
) |
Total other expense, net |
|
|
103 |
|
|
|
278 |
|
|
|
410 |
|
|
|
373 |
|
Net loss |
|
$ |
(4,939 |
) |
|
$ |
(4,165 |
) |
|
|
(14,238 |
) |
|
|
(13,520 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.41 |
) |
|
|
(1.40 |
) |
|
|
(1.43 |
) |
Weighted average number of
common shares, basic and diluted |
|
|
10,174 |
|
|
|
10,153 |
|
|
|
10,174 |
|
|
|
9,461 |
|
# # #
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