Form 8-K - Current report
December 06 2023 - 8:00AM
Edgar (US Regulatory)
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0001412486
0001412486
2023-12-06
2023-12-06
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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): December 6, 2023
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
December 6, 2023, Cocrystal Pharma, Inc. (the “Company”) issued a press release announcing its achievement of the first-patient-in
for its Phase 2a human challenge trial for its CC-42344 product candidate as a potential 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:
December 6, 2023
|
Cocrystal
Pharma, Inc. |
|
|
|
|
By: |
/s/James
Martin |
|
Name: |
James
Martin |
|
Title: |
Chief
Financial Officer and Co-Chief Executive Officer |
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/1412486/000149315223043786/ex99-1_001.jpg)
Cocrystal
Pharma Announces First-Patient-In for Phase 2a Human Challenge Study Evaluating Oral CC-42344 in Pandemic and Seasonal Influenza A
BOTHELL,
Wash. (December 6, 2023) – Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces
the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral
inhibitor for the treatment of pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study will evaluate
the safety, tolerability, viral and clinical measurements of influenza A infection in subjects
dosed with oral CC-42344 treatment.
“There
is an urgent need for new oral antivirals targeting pandemic and seasonal influenza that address drug resistance. CC-42344 was discovered
using our proprietary structure-based drug discovery platform technology to inhibit the viral replication process. The data from this
proof-of-concept clinical study will further validate CC-42344’s novel mechanism of action,” said Sam Lee, Ph.D., Cocrystal’s
President and co-CEO. “We expect to report topline data from this clinical trial in 2024.”
“We
are excited about the potential CC-42344 holds to create a paradigm shift in the treatment of one the world’s most common viral
infections,” added James Martin, Cocrystal’s CFO and co-CEO. “Currently approved
antiviral treatments for influenza are prone to viral resistance, increasing the need for improved influenza treatments for patients
that also provide significant cost savings to the global healthcare system.”
About
CC-42344
In
late 2022 Cocrystal reported favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions
of the healthy volunteer Phase 1 trial conducted in Australia. Preclinical data showed
that CC-42344 is highly active against seasonal and pandemic influenza A strains. In October 2023
Cocrystal received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency to initiate a Phase
2a human challenge trial with CC-42344 as a potential treatment for pandemic and seasonal influenza A.
About
Seasonal Influenza
Each
year there are approximately 1 billion cases of seasonal influenza worldwide, with 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.
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 initiation and characteristics of a Phase 2a study for CC-42344 as a product candidate for oral antiviral inhibitor
for the treatment of pandemic and seasonal influenza A, the potential efficacy and clinical benefits of, and market for, such product
candidate, and the expected results and topline data from this clinical trial in 2024. 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 proceed with the Phase 2a study including
recruiting volunteers and procuring materials for such study by our clinical research organizations and vendors, and the results of such
study. 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, 2022. 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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