Form 8-K
8-K — Cocrystal Pharma, Inc.
Accession: 0001493152-26-013837
Filed: 2026-03-31
Period: 2026-03-31
CIK: 0001412486
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
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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): March 31, 2026
Cocrystal
Pharma, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
001-38418
35-2528215
(State
or other Jurisdiction
of
Incorporation)
(Commission
File
Number)
(IRS
Employer
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
(Former
name or former address, if changed since last report.): n/a
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:
☐
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))
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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. ☐
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)
Item
2.02 Results of Operations and Financial Condition.
On
November 14, 2025, Cocrystal Pharma, Inc. (the “Company”) issued a press release announcing its results of operations for
the fiscal year ended December 31, 2025 and providing certain business updates. A copy of the press release is furnished as Exhibit 99.1
to this Current Report on Form 8-K.
The
information in this Item 2.02, and Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of or otherwise
subject to the liabilities under Section 18 of the Securities Exchange Act of 1934, as amended. Unless expressly incorporated into a
filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, the information contained in this Item 2.02
and Exhibit 99.1 hereto shall not be incorporated by reference into any Company filing, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
Description
99.1
Press Release dated March 31, 2026
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.
Cocrystal Pharma, Inc.
Date: March 31, 2026
By:
/s/ James
Martin
Name:
James Martin
Title:
Co-Chief Executive Officer and Chief Financial
Officer
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit
99.1
Cocrystal
Pharma Reports 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
● Phase
1b norovirus challenge study is underway at Emory University School of Medicine
● CDI-988
is the first oral antiviral candidate being developed for norovirus treatment and prevention
● No
approved treatments or vaccines are available for norovirus infection, posing a significant
unmet need and contributing to a global economic burden of $60 billion annually
BOTHELL,
Wash. (March 31, 2026) – Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports
financial results for the year ended December 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and
business activities.
“We
are delighted to report that our norovirus human challenge study evaluating efficacy and safety of CDI-988 is underway at Emory
University School of Medicine. In our first cohort, healthy subjects are being inoculated with the GII.2 (Snow Mountain Virus) strain
under highly controlled conditions,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal.
“Norovirus
remains a significant and underserved market. Developing an effective norovirus antiviral or vaccine has been challenging due to the
high genetic and antigenic diversity of norovirus and lack of simple in vitro cell-based assays and animal model system,”
Dr. Lee continued. “Using our proprietary structure-based drug discovery platform technology, we developed CDI-988 as a
direct-acting, oral antiviral that targets a highly conserved region of the viral 3CL protease found in all known norovirus strains.
As a pan-viral 3CL protease inhibitor, CDI-988 also holds potential as a broad-spectrum antiviral effective against coronaviruses.”
“Norovirus
outbreaks can strike at any time of year in semi-closed environments such as cruise ships, military settings, and healthcare and assisted-living
facilities,” said James Martin, Cocrystal’s CFO and co-CEO. “This constant threat underscores the need for an effective
oral treatment and preventive that can be deployed whenever and wherever norovirus infections emerge. With CDI-988, our goal is
to provide an easy-to-administer, safe and effective drug to combat these unpredictable outbreaks. We believe CDI-988 represents
a key value-creating opportunity for our Company and our investors.”
The
Phase 1b randomized, double-blind, placebo-controlled study will enroll up to 40 subjects. The study’s primary endpoint is efficacy
in reducing the incidence of clinical symptoms; secondary endpoints include reduction of viral shedding and disease severity, and safety
and pharmacokinetic profiles.
1
Antiviral
Product Pipeline Overview
We
leverage our innovative structure-based drug discovery platform technology to develop next-generation, broad-spectrum antivirals that
effectively block viral replication. Unlike other drug discovery approaches, our technology identifies compounds that bind to highly
conserved regions of viral drug targets, including proteases and replication enzymes. By specifically targeting these essential viral
functions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that
typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition,
our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive
cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising
candidates with superior resistance profiles and safety characteristics.
Norovirus
Program
Norovirus
is a common, highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea,
vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There are currently no effective treatments or vaccines
for norovirus, and the ability to curtail outbreaks is inadequate.
With
685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare’s most
pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including an estimated
109,000 hospitalizations, 465,000 emergency department visits and 900 deaths. The annual burden of norovirus to the U.S. is estimated
at $10.6 billion. In the developing world, each year noroviruses are responsible for up to 1.1 million hospitalizations and
218,000 pediatric deaths.
Oral
protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses: Our novel, broad-spectrum 3CL protease inhibitor
CDI-988 is designed as a potential treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro activity
against multiple norovirus strains.
○ In
April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity
against the norovirus GII.17 strain, the most prevalent strain in the U.S. and Europe in
2024-2025.
○ In
August 2025 we presented favorable Phase 1 safety and tolerability data from all CDI-988
doses, including a high-dose 1200 mg cohort, at the 2025 Military Health System Research
Symposium (MHSRS).
○ In
September 2025 we discussed CDI-988’s scientific foundation and clinical progress
in an oral presentation at the 9th International Calicivirus Conference, the leading
calicivirus scientific meeting.
○ In
September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b
challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment.
○ In
March 2026 we enrolled the first subjects in our Phase 1b challenge study with the initial
cohort evaluating the infectivity rate of the GII.2 challenge inoculum, and subsequent cohorts
to be orally administered CDI-988 or placebo.
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. Currently approved antiviral treatments for influenza are effective but are burdened
with significant viral resistance.
Each
year approximately 1 billion cases of seasonal influenza, 3-5 million severe illnesses and up to 650,000 deaths are reported worldwide.
About 8% of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for
an estimated $10.4 billion in direct medical costs in the U.S. each year.
2
CC-42344
is our novel PB2 inhibitor that showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well
as against strains that are resistant to Tamiflu® and Xofluza®.
● Oral
CC-42344 as a treatment for pandemic and seasonal influenza A
○ In
December 2022 we reported favorable Phase 1 safety and tolerability results.
○ In
December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge
study to evaluate the safety, tolerability, and 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.
○ In
May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic
2024 Texas H5N1 avian influenza strain.
○ In
November 2025 an initial Phase 2a study was completed, with CC-42344 showing a favorable
safety and tolerability profile with no serious adverse events and no drug-related discontinuations
by study participants. Efficacy analyses were not reported due to issues with trial conduct.
○ We
plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal
influenza A with an additional Phase 2a study.
● Inhaled
CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
○ Our
preclinical testing showed superior pulmonary pharmacology with CC-42344, including
high exposure to drug and a long half-life.
○ We
have developed a dry powder inhalation formulation and have completed toxicology studies.
● Influenza
A/B program
○ In
October 2025 we received a $500,000 Small Business Innovation Research Phase I award from
the NIH’s National Institute of Allergy and Infectious Diseases to support the development
of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex.
SARS-CoV-2
and Other Coronavirus Program
By
targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused
by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome.
CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses,
as well as against noroviruses. By the end of 2031, the global COVID-19 therapeutics market is estimated to exceed $16 billion annually.
Oral
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 pharmacokinetic properties.
○ In
August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988
doses, including a high-dose 1200 mg cohort, at the MHSRS.
○ We
are currently pursuing further development of CDI-988 as a prophylaxis and treatment
for norovirus and remain optimistic about its viability as a treatment for coronaviruses.
3
2025
Financial Results
Research
and development expenses for 2025 were $5.1 million compared with $12.5 million for 2024, with the decrease primarily due to lower costs
with the winddown of the Phase 2a influenza study and reduction in employee-related expenses. General and administrative expenses for
2025 were $4.0 million compared with $5.3 million for 2024, with the decrease primarily due to a reduction in compensation, insurance
and corporate expenses.
Net
loss for 2025 was $8.8 million, or $0.78 per share, compared with a net loss for 2024 of $17.5 million, or $1.72 per share.
Cocrystal
reported unrestricted cash as of December 31, 2025, of $7.7 million compared with $9.9 million as of December 31, 2024. Net cash used
in operating activities for 2025 was $8.2 million compared with $16.5 million for 2024. The Company had working capital of $5.9 million
and 11.3 million common shares outstanding as of December 31, 2025.
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 noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based
technologies and Nobel Prize-winning expertise to create viable 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 product candidates, the and the potential characteristics
and benefits of and market for our product candidates. 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 inflation, affordability, a deteriorating labor market, the possibility of recession, increases or other
developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments
with respect thereto, and wars and geopolitical conflicts including those in the Middle East and Ukraine on our Company, our collaboration
partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages,
supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test
animals as well as similar problems with our vendors and our current and any future CROs and CMOs, the progress and results of the studies
for CC-42344 and CDI-988 including issues with the initial Phase 2a study for CC-42344 which will prolong the development timeline of
such product candidate, 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
future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes
including based on initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory
approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including
as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting which 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 the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. 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 IR
Jody
Cain
310-691-7100
jcain@allianceadvisors.com
Financial
Tables to follow
4
COCRYSTAL
PHARMA, INC.
CONSOLIDATED
BALANCE SHEETS
(Dollars
and shares in thousands, except per share data)
December 31, 2025
December 31, 2024
Assets
Current assets:
Cash
$ 7,025
$ 9,860
Restricted cash
75
75
Tax credit receivable
662
1,215
Prepaid expenses and other current assets
372
430
Total current assets
8,134
11,580
Property and equipment, net
93
153
Deposits
95
29
Operating lease right-of-use assets, net (including $152 and $42 to related party)
1,390
1,694
Total assets
$ 9,712
$ 13,456
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 1,876
$ 2,127
Current maturities of operating lease liabilities (including $49 and $42 to related party)
334
301
Total current liabilities
2,210
2,428
Long-term liabilities:
Operating lease liabilities (including $104 and $0 to related party)
1,171
1,505
Total long-term liabilities
1,171
1,505
Total liabilities
3,381
3,933
Commitments and contingencies
Stockholders’ equity:
Common stock $0.001 par value; 100,000 and 150,000 shares authorized as of December 31, 2025 and 2024, respectively; 13,784 and 10,174 shares issued and outstanding as of December 31, 2025 and 2024, respectively
13
10
Additional paid-in capital
348,567
342,931
Accumulated deficit
(342,249 )
(333,418 )
Total stockholders’ equity
6,331
9,523
Total liabilities and stockholders’ equity
$ 9,712
$ 13,456
5
COCRYSTAL
PHARMA, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Dollars
and shares in thousands, except per share data)
December
31,
2025
2024
Operating
expenses:
Research
and development
$
5,055
$
12,537
General
and administrative
3,964
5,341
Total
operating expenses
9,019
17,878
Loss
from operations
(9,019
)
(17,878
)
Other
income (expense):
Interest
income, net
134
537
Foreign
exchange gain (loss)
54
(163
)
Total
other income, net
188
374
Net
loss
$
(8,831
)
$
(17,504
)
Net
loss per common share, basic and diluted
$
(0.78
)
$
(1.72
)
Weighted
average number of common shares outstanding, basic and diluted
11,290
10,174
#
# #
6
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
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-Section 12
-Subsection d1-1
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
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- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
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-Section 425
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