Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company)
reports financial results for the 12 months ended December 31,
2023, and provides updates on its antiviral product pipeline,
upcoming milestones and business activities.
“We are highly encouraged by the FDA’s feedback
to our Pre-Investigational New Drug (Pre-IND) package, which
provides greater clarity on the regulatory requirements for a
planned Phase 2b clinical trial with our novel broad-spectrum oral
PB2 inhibitor CC-42344 for pandemic and seasonal influenza A,” said
Sam Lee, Ph.D., President and co-CEO of Cocrystal. “This is a major
step in the clinical and regulatory process for this program. We
plan to file an IND for late-stage clinical development of oral
CC-42344 that includes data from our ongoing Phase 2a human
challenge study, which are expected later this year.
“During 2024 we also expect to initiate a Phase
1 study in healthy volunteers with inhaled CC-42344 as a potential
prophylactic and therapeutic for influenza A. Our inhaled
formulation of CC-42344 has shown the ability to directly target
influenza-infected respiratory epithelial cells in lung, allowing
for higher accumulation of drug in the pulmonary system and
potentially producing a rapid clinical response while reducing
potential systemic side effects,” he added. “Also during the coming
year we expect topline data from the ongoing first-in-human study
with our pan-coronavirus and pan-norovirus oral protease inhibitor
CDI-988, which is expected to serve as a Phase 1 study for both
indications.”
“All our programs target high-value unmet
indications with novel, broad-spectrum, best-in-class antiviral
candidates whose design and development uses our proprietary
structure-based drug discovery platform technology,” said James
Martin, CFO and co-CEO. “I’m pleased to report that under our
cost-efficient business model, we believe our cash position is
sufficient to fund current operations including planned clinical
studies beyond the next 12 months.”
Antiviral Product Pipeline
Overview
We are developing therapeutics that inhibit the
viral replication function of RNA viruses that cause acute and
chronic diseases. Our drug-discovery process focuses on the highly
conserved regions of the viral enzymes and inhibitor-enzyme
interactions at the atomic level. By designing and selecting
antiviral drug candidates that interrupt the viral replication
process and have specific binding characteristics, we seek to
develop drugs that are effective against the virus and mutations of
the virus, and also have reduced 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 ProgramsInfluenza is a severe
respiratory illness that is caused by the influenza A or B virus
and results in disease outbreaks mainly during the winter months.
Influenza is a major global health threat that may become more
challenging to treat in the future 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, according to the World Health
Organization. On average, about 8% of the U.S. population contracts
influenza each season. In addition to the health risk, influenza is
responsible for approximately $10.4 billion in direct costs for
hospitalizations and outpatient visits for adults in the U.S.
annually.
- Pandemic and Seasonal Influenza A
- Our novel PB2 inhibitor CC-42344
has shown excellent in vitro antiviral activity against influenza A
strains including pandemic and seasonal strains, as well as strains
that are resistant to Tamiflu® and Xofluza®.
- In March 2022 we initiated
enrollment in a randomized, double-blind, dose-escalating Phase 1
study to evaluate the safety, tolerability and pharmacokinetics
(PK) of oral CC-42344 in healthy adults.
- In July 2022 we reported PK results
from the single-ascending dose portion of the study that support
once-daily dosing.
- In December 2022 we reported
favorable safety and tolerability results from the oral CC-42344
Phase 1 study.
- In October 2023 we announced
authorization from the United Kingdom Medicines and Healthcare
Products Regulatory Agency to conduct a Phase 2a human challenge
study.
- In December 2023 we began treating
influenza-infected subjects in the randomized, double-blind,
placebo-controlled Phase 2a human challenge study to evaluate the
safety, tolerability, viral and clinical measurements of influenza
A infection in subjects treated with oral CC-42344.
- In March 2024 we received feedback
from the FDA on a Pre-IND package improving clarity on clinical
trial design, drug manufacturing and nonclinical studies necessary
to file a Phase 2b trial design.
- Preclinical development is underway
with inhaled CC-42344 as a potential therapeutic and post-exposure
prophylaxis for influenza A. CC-42344 has exhibited superior
pulmonary exposure in preclinical testing. We expect to begin a
Phase 1 clinical study with inhaled CC-42344 in Australia in
2024.
- Influenza A/B Program
- Preclinical lead optimization of
replication inhibitor antiviral candidates is underway.
COVID-19 and Other Coronavirus ProgramsBy
targeting viral replication enzymes and protease, we believe it is
possible to develop effective treatments for all diseases caused by
coronaviruses 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. Driven by the anticipated emergence of new
COVID-19 variants, the global COVID-19 therapeutics market is
estimated to exceed $16 billion by the end of 2031.
- Oral Protease Inhibitor CDI-988
- In October 2022 we announced the
selection of CDI-988 as our lead candidate for development as a
potential oral treatment for SARS-CoV-2. CDI-988 exhibited superior
in vitro potency against SARS-CoV-2 with activity maintained
against variants of concern, and demonstrated a safety profile and
PK properties that support once-daily dosing.
- 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 PK of oral CDI-988 in healthy
volunteers.
- In August 2023 we announced the
selection of CDI-988 as our lead oral candidate for norovirus, in
addition to coronavirus.
- In September 2023 we dosed the
first subject in our dual norovirus-coronavirus oral CDI-988 study,
which is expected to serve as a Phase 1 study for both
indications.
- We expect topline data from the
Phase 1 study with CDI-988 in 2024.
Norovirus ProgramNorovirus is a highly
contagious infection and is the most common cause of acute
gastroenteritis, accounting for nearly one in five cases. According
to the Centers for Disease Control and Prevention (CDC), an
estimated 685 million cases and an estimated 200,000 deaths are
attributed to norovirus each year worldwide, with an estimated
societal cost of $60 billion.
3CL inhibitor CDI-988 has shown pan-viral
activity against multiple norovirus strains, including the
genogroup II, genotype 4 (GII.4) norovirus strain that is
responsible for major norovirus outbreaks. By targeting viral
replication, we believe it is possible to develop an effective
treatment or short-term prophylactic for closed environments for
all genogroups of norovirus.
- In August 2023 we announced our
selection of the novel broad-spectrum oral 3CL protease inhibitor
CDI-988 as our lead potential oral treatment for norovirus, in
addition to coronavirus.
- In September 2023 we began subject
dosing in a first-in-human study in healthy volunteers in
Australia. The randomized, double-blind, placebo-controlled study
to evaluate the safety, tolerability and PK of oral CDI-988 in
healthy volunteers is expected to serve as a Phase 1 study for both
indications.
- We expect topline data from the
Phase 1 study with CDI-988 in 2024.
2023 Financial Results
Research and development (R&D) expenses for
2023 were $15.2 million, compared with $12.4 million for 2022. The
increase was primarily due to advancing influenza candidate
CC-42344 into a Phase 2a study and advancing the dual
norovirus-coronavirus candidate CDI-988 into a Phase 1 study.
General and administrative (G&A) expenses for 2023 were $6.0
million, compared with $5.7 million for 2022.
During 2023 the Company received $2.6 million
related to litigation with an insurer, which included a $1.6
million refund from the registry of the United States Court of
Appeals for the Third Circuit, reflecting the recovery of funds
following a successful appeal, and $1.0 million in a settlement
agreement with the insurer.
Interest income for 2023 was $640,000, compared
with interest expense of $2,000 for 2022. The interest income in
2023 was related to interest earned from cash held in banks and
deposits with the court registry, and the interest expense in 2022
was related to finance lease agreements.
The net loss for 2023 was $18.0 million, or
$1.87 per share, compared with the net loss for 2022 of $38.8
million, or $4.77 per share, which included a $19.1 million
non-cash impairment-loss of goodwill.
Cocrystal reported unrestricted cash as of
December 31, 2023 of $26.4 million, compared with $37.1 million as
of December 31, 2022. Net cash used in operating activities for
2023 was $14.7 million, compared with $21.4 million for 2022. The
Company had working capital of $25.0 million and 10.2 million
common shares outstanding as of December 31, 2023.
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, 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, the expected sufficiency of our cash balance to advance
our programs and fund our planned operations, 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, the risks and uncertainties arising from the high
interest rates in response to inflation, uncertainty in the
financial markets, the possibility of a recession and geopolitical
conflict 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, and potential
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 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: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)
|
|
December 31, 2023 |
|
|
December 31, 2022 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
26,353 |
|
|
|
$ |
37,144 |
|
Restricted cash |
|
|
75 |
|
|
|
|
75 |
|
Tax credit receivable |
|
|
890 |
|
|
|
|
716 |
|
Prepaid expenses and other current assets |
|
|
1,773 |
|
|
|
|
2,243 |
|
Total current assets |
|
|
29,091 |
|
|
|
|
40,178 |
|
Property and equipment,
net |
|
|
271 |
|
|
|
|
342 |
|
Deposits |
|
|
46 |
|
|
|
|
46 |
|
Operating lease right-of-use
assets, net (including $42 and $99 to related party) |
|
|
1,851 |
|
|
|
|
274 |
|
Total assets |
|
$ |
31,259 |
|
|
|
$ |
40,840 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
3,022 |
|
|
|
$ |
976 |
|
Current maturities of finance lease liabilities |
|
|
- |
|
|
|
|
7 |
|
Current maturities of operating lease liabilities (including $42
and $59 to related party) |
|
|
240 |
|
|
|
|
233 |
|
Total current liabilities |
|
|
3,262 |
|
|
|
|
1,216 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Operating lease liabilities (including $0 and $42 to related
party) |
|
|
1,613 |
|
|
|
|
57 |
|
Total long-term
liabilities |
|
|
1,613 |
|
|
|
|
57 |
|
Total liabilities |
|
|
4,875 |
|
|
|
|
1,273 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock $0.001 par value;
150,000 shares authorized as of December 31, 2023 and December 31,
2022, respectively; 10,174 and 8,143 shares issued and outstanding
as of December 31, 2023 and December 31, 2022, respectively |
|
|
10 |
|
|
|
|
8 |
|
Additional paid-in
capital |
|
|
342,288 |
|
|
|
|
337,489 |
|
Accumulated deficit |
|
|
(315,914 |
) |
|
|
|
(297,930 |
) |
Total stockholders’
equity |
|
|
26,384 |
|
|
|
|
39,567 |
|
Total liabilities and
stockholders’ equity |
|
$ |
31,259 |
|
|
|
$ |
40,840 |
|
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited)(in thousands, except per
share data)
|
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
15,169 |
|
|
|
$ |
12,392 |
|
General and administrative |
|
|
5,990 |
|
|
|
|
5,745 |
|
Legal settlement |
|
|
(2,600 |
) |
|
|
|
1,600 |
|
Impairments |
|
|
- |
|
|
|
|
19,092 |
|
Total operating expenses |
|
|
18,559 |
|
|
|
|
38,829 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(18,559 |
) |
|
|
|
(38,829 |
) |
|
|
|
|
|
|
|
|
|
Other (expense) income: |
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
|
640 |
|
|
|
|
(2 |
) |
Change in fair value of derivative liabilities |
|
|
- |
|
|
|
|
12 |
|
Foreign exchange loss |
|
|
(65 |
) |
|
|
|
(18 |
) |
Total other income (expense), net |
|
|
575 |
|
|
|
|
(8 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(17,984 |
) |
|
|
$ |
(38,837 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
Loss per share, basic and
diluted |
|
$ |
(1.87 |
) |
|
|
$ |
(4.77 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
9,651 |
|
|
|
|
8,143 |
|
# # #
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