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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): June 20, 2024
Cocrystal
Pharma, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-38418 |
|
35-2528215 |
| (State
or other jurisdiction |
|
(Commission |
|
(IRS
Employer |
| of
incorporation) |
|
File
Number) |
|
Identification
No.) |
| 19805
N. Creek Parkway |
|
|
| Bothell,
WA |
|
98011 |
| (Address
of principal executive offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code: (877) 262-7123
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
Stock |
|
COCP |
|
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
June 20, 2024, Cocrystal Pharma, Inc. (the “Company”) issued a press release providing an update regarding its CC-42344 product
candidate as a potential antiviral treatment for pandemic and seasonal influenza A. A copy of the press release is being furnished as
Exhibit 99.1.
Item
9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| Dated:
June 20, 2024 |
|
|
| |
|
|
| |
Cocrystal
Pharma, Inc. |
| |
|
|
| |
By: |
/s/James Martin |
| |
Name: |
James
Martin |
| |
Title: |
Chief Financial Officer and Co-Chief Executive Officer |
Exhibit
99.1
New
Broad-Spectrum Antiviral Currently in a Phase 2a Clinical Trial in Influenza A may be Effective Against the H5N1 Avian Influenza Strain
Identified in Humans Exposed to Infected Dairy Cows
BOTHELL,
Wash. (June 20, 2024) – Cocrystal Pharma, Inc.’s (Nasdaq: COCP) novel, broad-spectrum antiviral CC-42344 inhibits activity
in the highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in infected dairy cattle, according to recently completed
in vitro studies. CC-42344 is a new class of antiviral drugs designed to block essential steps in the replication and transcription
of the influenza A virus.
Cocrystal
is conducting an influenza A Phase 2a clinical study with orally administered CC-42344 and expects to report topline results in the second
half of 2024. This study is evaluating the safety, tolerability, antiviral and clinical benefits in influenza A infected subjects. In
late 2022 Cocrystal reported favorable safety and tolerability results from a Phase 1 study in healthy volunteers.
Cocrystal
demonstrated the potential efficacy of CC-42344 against the new avian flu strain with the recently published genome sequence for H5N1.
Using its proprietary structure-based platform, Cocrystal created a high-resolution crystal structure of this avian PB2 protein and confirmed
that CC-42344 binds to its highly conserved PB2 region. The in vitro data were generated testing CC-42344 against the avian H5N1
PB2 protein and further support CC-42344’s activity similar to that of Cocrystal’s data with pandemic and seasonal influenza
A.
CC-42344
binds to the highly conserved region of
the
avian influenza A H5N1 PB2 protein
“The
findings validate our broad-spectrum approach to the treatment and prevention of pandemic flu. This is important as there are no specific
FDA-approved vaccines to prevent infections by this virus in humans,” said Sam Lee, PhD, President and co-CEO of Cocrystal. “These
findings support our previously reported preclinical data showing that CC-42344 is highly active
against seasonal and pandemic influenza A strains, including emerging mutations. CC-42344 is an inhibitor compound providing a
unique mechanism of action with a high barrier to resistance.”
“Recent
CDC reported avian flu outbreaks in the U.S., which include the first cases of humans exposed to infected dairy cows, are concerning,”
said James Martin, CFO and co-CEO of Cocrystal. “The CDC reported three additional cases of avian influenza infection from
exposure to dairy cows in early June and avian flu is now confirmed in more than 100 dairy herds in 12 U.S. states.”
About
Avian Influenza A H5N1
Avian
influenza A H5N1 was reported in 889 cases and caused 463 deaths in 23 countries between 2003 and April 2024, according to the World
Health Organization (WHO). On April 1, 2024, the CDC reported a case of highly pathogenic avian influenza A H5N1 in a farmworker
in Texas during a multistate outbreak of avian influenza in dairy cows. Two more cases were subsequently reported in farmworkers in Michigan.
The
CDC analyzed sera (blood) collected from people of all ages in all 10 Health & Human Services regions during the 2022-2023 and 2021-2022
flu seasons. These samples were challenged with H5N1 virus to see whether there was an antibody reaction. Data from this study suggest
that there is extremely low to no population immunity to clade 2.3.4.4b A (H5N1) viruses in the U.S. Antibody levels remained
low regardless of whether or not the participants received a seasonal flu vaccination, meaning that seasonal flu vaccination did not
produce antibodies to H5N1 viruses.
Cocrystal
Pharma determined the high resolution X-ray crystal structure of the recent avian influenza A (H5N1) PB2 protein and confirmed activity
of CC-42344 in vitro (NIH GeneBank ID:influenza A/Texas/37/2024(H5N1). The crystal structure of the avian influenza A (H5N1) PB2
protein showed new mutations located outside the PB2 active site. Subsequent studies showed that CC-42344 binds to the active site of
the avian influenza A (H5N1) PB2 protein as previously demonstrated with the pandemic and seasonal influenza A PB2. Preliminary in
vitro assays confirmed that CC-42344 exhibits high potency against the avian influenza A (H5N1) PB2 protein.
About
CC-42344
CC-42344
is Cocrystal’s novel, broad-spectrum, antiviral investigational candidate for the treatment of pandemic and seasonal influenza
A. CC-42344 inhibits the first step in influenza A’s viral replication by binding to a highly conserved PB2 site of the influenza
polymerase complex that is essential to replication and was discovered using Cocrystal’s proprietary structure-based drug discovery
platform technology.
Cocrystal
is conducting a Phase 2a human challenge study in the United Kingdom to evaluate safety, viral and clinical measures of oral CC-42344
in healthy volunteers who are challenged with influenza A. CC-42344 was advanced into Phase 2a testing following favorable safety and
tolerability results reported in a Phase 1 study in healthy volunteers conducted in Australia. In vitro testing showed CC-42344’s
excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant
to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles.
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 the potential efficacy of CC-42344 against the avian influenza A H5N1 virus, the expected timing and results of
the Phase 2a trial for CC-42344 for the oral treatment of influenza A in 2024, and the potential market for such product candidate. 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 relating to our
ability to obtain regulatory authority for and proceed with clinical trials including recruiting volunteers and procuring materials for
such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’
technology and software performing as expected, 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 Relations
Jody
Cain
310-691-7100
jcain@lhai.com
Media
Contact:
JQA
Partners
Jules
Abraham
917-885-7378
Jabraham@jqapartners.com
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