Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the
“Company”) reports financial results for the three and six months
ended June 30, 2024, and provides updates on its antiviral product
pipeline, upcoming milestones and business activities.
“We are rapidly approaching major inflection
points in our clinical programs,” said Sam Lee, Ph.D., President
and co-CEO of Cocrystal. “In the coming months we expect to report
topline results from our Phase 2a study with PB2 inhibitor CC-42344
including an initial indication of virology in humans infected with
the influenza A virus. Our plan is to file an Investigational New
Drug (IND) application in 2025 to conduct our next study in the
U.S. We further validated CC-42344’s broad-spectrum activity
through in vitro testing demonstrating it inhibits the new, highly
pathogenic avian flu PB2 protein identified as infecting U.S. dairy
cows. We also are preparing to initiate a Phase 1 study in healthy
volunteers as the first clinical step in evaluating inhaled
CC-42344 as a potential prophylactic and therapeutic for influenza
A.
“Preparations are underway to begin the
multiple-ascending dose portion of the first-in-human study with
our pan-norovirus/pan-coronavirus oral protease inhibitor CDI-988,
following favorable safety and tolerability data from the
single-ascending dose (SAD) portion of this study,” said Dr. Lee.
“We expect to report topline results from the full study in late
2024 or early 2025.”
“I’m pleased to report that through our
cost-efficient business model, we expect our cash to be sufficient
to advance our planned development programs through the coming 12
months,” said James Martin, CFO and co-CEO of Cocrystal.
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 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 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, 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.
- 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 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 SAD 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 April 2023 we received
authorization from United Kingdom Medicines and Healthcare Products
Regulatory Agency (MHRA) for an oral CC-42344 Phase 2a human
challenge study.
- In December 2023 we began a
randomized, double-blind, placebo-controlled Phase 2a study to
evaluate the safety, tolerability, viral and clinical measurements
of CC-42344 in influenza A-infected subjects.
- In March 2024 we received feedback
from the FDA on a Pre-IND package improving clarity on clinical
study design, drug manufacturing and nonclinical studies necessary
to file a Phase 2b study design.
- In May 2024 we completed enrollment
in the Phase 2a human challenge study.
- In June 2024 we reported that in
vitro testing showed CC-42344 inhibited the activity of the highly
pathogenic avian influenza A (H5N1) PB2 protein that was identified
as infecting U.S. dairy cows.
- We expect to report topline results
from the Phase 2a human challenge study in 2024 and to plan to file
an IND application in 2025 to conduct a late-stage study in the
U.S.
- Inhaled CC-42344 for the treatment
of pandemic and seasonal Influenza A infections
- GLP toxicology study 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 studies.
- We expect to begin a Phase 1 study
with inhaled CC-42344 in Australia in 2025.
- Influenza A/B Program
- Preclinical lead development of
novel influenza replication inhibitors is underway.
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 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 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 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 in
Australia with oral CDI-988.
- In July 2024 we reported favorable
safety and tolerability results from the SAD cohorts in 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 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). 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 norovirus/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 SAD cohorts in the Phase 1
study.
- We expect to report topline results
from the CDI-988 Phase 1 study in late 2024 or early 2025.
Second Quarter Financial
Results
Research and development (R&D) expenses for
the second quarter of 2024 were $4.3 million, compared with $2.8
million for the second quarter of 2023. The increase was primarily
due to CC-42344 entering into a Phase 2a clinical study and
norovirus and coronavirus candidate CDI-988 entering into a Phase 1
clinical study. General and administrative (G&A) expenses for
the second quarter of 2024 were $1.1 million, compared with $1.5
million for the second quarter of 2023, with the decrease mainly
due to lower legal expenses.
The net loss for the second quarter of 2024 was
$5.3 million, or $0.54 per share, compared with a net loss for the
second quarter of 2023 of $4.2 million, or $0.41 per share.
Six Month Financial Results
R&D expenses for the first six months of
2024 were $7.3 million, compared with $6.7 million for the first
six months of 2023. G&A expenses for the first six months of
2024 were $2.3 million, compared with $2.7 million for the first
six months of 2023.
The net loss for the first six months of 2024
was $9.3 million, or $0.91, per share, compared with a net loss for
the first six months of 2023 of $9.4 million, or $1.03 per
share.
Cocrystal reported unrestricted cash as of June
30, 2024 of $18.1 million, compared with $26.4 million as of
December 31, 2023. Net cash used in operating activities for the
first six months of 2024 was $8.2 million, compared with $8.7
million for the first six months of 2023. The Company had working
capital of $17.0 million and 10.2 million common shares outstanding
as of June 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 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
Financial Tables to follow COCRYSTAL
PHARMA, INC.
CONSOLIDATED BALANCE
SHEETS(in thousands)
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
18,143 |
|
|
|
$ |
26,353 |
|
Restricted cash |
|
|
75 |
|
|
|
|
75 |
|
Tax credit receivable |
|
|
1,077 |
|
|
|
|
890 |
|
Prepaid expenses and other current assets |
|
|
365 |
|
|
|
|
1,773 |
|
Total current assets |
|
|
19,660 |
|
|
|
|
29,091 |
|
Property and equipment,
net |
|
|
211 |
|
|
|
|
271 |
|
Deposits |
|
|
29 |
|
|
|
|
46 |
|
Operating lease right-of-use
assets, net (including $11 and $42 to related party) |
|
|
1,673 |
|
|
|
|
1,851 |
|
Total assets |
|
$ |
21,573 |
|
|
|
$ |
31,259 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
2,403 |
|
|
|
$ |
3,022 |
|
Current maturities of operating lease liabilities (including $10
and $42 to related party) |
|
|
251 |
|
|
|
|
240 |
|
Total current liabilities |
|
|
2,654 |
|
|
|
|
3,262 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities (including $0 and $0 to related
party) |
|
|
1,529 |
|
|
|
|
1,613 |
|
Total long-term
liabilities |
|
|
1,529 |
|
|
|
|
1,613 |
|
Total liabilities |
|
|
4,183 |
|
|
|
|
4,875 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 a par
value: 100,000 and 150,000 shares authorized as of June 30, 2024,
and December 31, 2023; 10,174 shares issued and outstanding as of
June 30, 2024 and December 31, 2023 |
|
|
10 |
|
|
|
|
10 |
|
Additional paid-in
capital |
|
|
342,593 |
|
|
|
|
342,288 |
|
Accumulated deficit |
|
|
(325,213 |
) |
|
|
|
(315,914 |
) |
Total stockholders’
equity |
|
|
17,390 |
|
|
|
|
26,384 |
|
Total liabilities and
stockholders’ equity |
|
$ |
21,573 |
|
|
|
$ |
31,259 |
|
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited)(in thousands, except per
share data)
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,308 |
|
|
|
|
2,801 |
|
|
|
7,258 |
|
|
|
|
6,708 |
|
General and administrative |
|
|
1,140 |
|
|
|
|
1,538 |
|
|
|
2,348 |
|
|
|
|
2,742 |
|
Total operating expenses |
|
|
5,448 |
|
|
|
|
4,339 |
|
|
|
9,606 |
|
|
|
|
9,450 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,448 |
) |
|
|
|
(4,339 |
) |
|
|
(9,606 |
) |
|
|
|
(9,450 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
|
151 |
|
|
|
|
140 |
|
|
|
371 |
|
|
|
|
140 |
) |
Foreign exchange loss |
|
|
(46 |
) |
|
|
|
33 |
|
|
|
(64 |
) |
|
|
|
(45 |
) |
Total other expense, net |
|
|
105 |
|
|
|
|
173 |
|
|
|
307 |
|
|
|
|
95 |
|
Net loss |
|
$ |
(5,343 |
) |
|
|
$ |
(4,166 |
) |
|
|
(9,299 |
) |
|
|
|
(9,355 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.53 |
) |
|
|
$ |
(0.41 |
) |
|
|
(0.91 |
) |
|
|
|
(1.03 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
10,174 |
|
|
|
|
10,065 |
|
|
|
10,174 |
|
|
|
|
9,109 |
|
# # #
Cocrystal Pharma (NASDAQ:COCP)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024
Cocrystal Pharma (NASDAQ:COCP)
Gráfica de Acción Histórica
De Ago 2023 a Ago 2024