Form 8-K

8-K — Cocrystal Pharma, Inc.

Accession: 0001493152-26-041877

Filed: 2026-09-09

Period: 2026-09-09

CIK: 0001412486

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

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): September 9, 2026

Cocrystal

Pharma, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-38418

35-2528215

(State

or other Jurisdiction

Incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

19805

N. Creek Parkway

Bothell,

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 ☐

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

7.01 Regulation FD Disclosure

September 9, 2026, Cocrystal Pharma, Inc. (the “Company”) issued a press release announcing the last subject has been dosed

in its Phase 1b norovirus challenge study (NCT07198139) evaluating CDI-988 as both a preventive and treatment for norovirus infections.

A copy of the press release is furnished as Exhibit 99.1.

The

information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities

Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities under such section, and shall not be deemed

to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

Description

99.1

Press Release dated September 9, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

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:

September 9, 2026

By:

/s/

James Martin

Name:

James

Martin

Title:

Chief

Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Cocrystal

Pharma Announces Last Subject Dosed in Phase 1b Human Challenge Study Evaluating CDI-988 for Norovirus Prevention and Treatment

serious adverse events reported to date

Preliminary

efficacy results expected in late 2026 or early 2027

MIAMI,

Fla. And BOTHELL, Wash., September 09, 2026 — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”),

a biotechnology company developing novel therapeutics to meet the growing global need for effective, safe antiviral treatments, today

announced that the last subject has been dosed in its Phase 1b norovirus challenge study (NCT07198139) evaluating CDI-988 as both a preventive

and treatment for norovirus infections.

CDI-988

is the first oral antiviral drug candidate developed for norovirus acute gastroenteritis and is designed to inhibit viral replication

in all known norovirus strains. CDI-988 completed a Phase 1 clinical trial in Australia, with data showing CDI-988 was safe and well

tolerated in humans, with no serious adverse events reported.

“Completion

of this critical milestone brings us closer to addressing one of the most pressing unmet needs in infectious disease,” said James

Sapirstein, Chief Executive Officer of Cocrystal Pharma. “Norovirus imposes an enormous burden on patients and health systems,

with particular risk in settings such as hospitals, nursing homes, cruise ships, schools and military facilities. We look forward to

reporting preliminary results near the end of 2026 or early 2027 and to advancing CDI-988 as a potential first-in-class oral antiviral

for norovirus.”

The

Phase 1b randomized, double-blind, placebo-controlled study was conducted at Emory University School of Medicine and enrolled healthy

subjects ages 18-49, who were infected with the norovirus GII.2 (Snow Mountain Virus) strain and orally administered CDI-988 or placebo.

The primary endpoint is efficacy versus placebo in reducing the incidence of clinical symptoms. Secondary endpoints include reduction

of viral shedding and disease severity, as well as safety and pharmacokinetic profiles.

“Reaching

last-subject-dosed in the first clinical trial of a direct-acting antiviral specifically targeting norovirus is a significant achievement

for our team,” said Sam Lee, Ph.D., President and Chief Scientific Officer of Cocrystal Pharma. “The efficacy and safety

data from this study are expected to provide a strong rationale for further clinical advancement of CDI-988.”

CDI-988

previously demonstrated favorable safety and tolerability in a Phase 1 study across all dose levels, including the highest dose of 1200

mg administered. The 1200 mg dose, established as safe in the earlier Phase 1 dose-escalation study in healthy volunteers conducted in

Australia, is the dose being administered to healthy volunteers who are then infected with norovirus in the ongoing Phase 1b challenge

study.

About

Norovirus

With

an estimated 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 109,000

hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is

estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children

in the developing world.

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 to create viable antiviral drugs. For more information, 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 advancing of CDI-988 as a potential first-in-class oral antiviral for norovirus. Words such as “believe,”

“may,” “estimate,” “continue,” “anticipate,” “intend,” “should,”

“plan,” “could,” “target,” “potential,” “is likely,” “will,”

and “expect,” as they relate to the Company, 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, the possibility of a 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 Ukraine and with Iran 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 our and our collaboration partners’ technology and

software performing as expected, financial difficulties experienced by certain partners, risks arising from the research into a related

virus was not done in animals and was necessarily early stage, the results of future preclinical and clinical trials, general risks arising

from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging 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, potential mutations in a virus we are targeting which may result in variants that are resistant to a product

candidate we develop, and our liquidity. 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:

Nicolas

Johnson

Russo

Partners

nic.johnson@russopartnersllc.com

(303)

482-6405

Media

Contact:

David

Schull

Russo

Partners

david.schull@russopartnersllc.com

(858)

717-2310

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