Form 8-K

8-K — Cocrystal Pharma, Inc.

Accession: 0001493152-26-014819

Filed: 2026-04-02

Period: 2026-04-02

CIK: 0001412486

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

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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): April 2, 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.

April 2, 2026, Cocrystal Pharma, Inc. (the “Company”) issued a press release, announcing that the U.S. Food and Drug Administration

(FDA) has granted Fast Track designation to the Company’s oral, direct acting protease inhibitor, CDI-988, the first oral antiviral

candidate being developed for treatment and prophylaxis of norovirus infection. 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 April 2, 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:

April 2, 2026

By:

/s/

James Martin

Name:

James

Martin

Title:

Co-Chief

Executive Officer and Chief Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Cocrystal

Pharma Receives FDA Fast Track Designation for CDI-988 for Norovirus Infection Treatment and Preventive

● FDA

Fast Track designation supports accelerated development and expedites regulatory review

● Norovirus

is responsible for an estimated 685 million global cases each year and approximately $60

billion in worldwide economic impact

BOTHELL,

Wash. (April 2, 2026) – Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces

that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its oral, direct-acting protease inhibitor, CDI-988,

the first oral antiviral candidate being developed for treatment and prophylaxis of norovirus infection.

FDA

Fast Track designation aims to facilitate the development and accelerate the review process for drugs that treat serious conditions and

address unmet medical needs. The designation enables early and frequent communication with the FDA throughout the development process,

allows for rolling review of a New Drug Application (NDA), and may qualify a product for Priority Review at the time of NDA submission.

CDI-988

was designed and developed as an inhibitor of a highly conserved region of noroviruses, coronaviruses, and other 3CL viral proteases.

A Phase 1b norovirus challenge study is underway at Emory University School of Medicine to evaluate CDI-988 to both prevent and treat

norovirus infection.

“We

are pleased that the FDA has granted Fast Track designation for CDI-988, marking a significant milestone for Cocrystal and a critical

step toward helping patients with norovirus,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal Pharma. “Norovirus infections

are highly contagious and can cause acute gastroenteritis, resulting in nausea, vomiting, stomach pain, diarrhea, fatigue, fever and

dehydration. While most people recover within a few days, immunocompromised individuals can experience chronic, long-term norovirus infections

that can persist for weeks to years. Based on compelling data generated to date, we believe that CDI-988 has the potential to both prevent

and treat norovirus infection.

“This

designation further validates using our unique structure-based drug discovery technology to design pan-viral antivirals that are effective

new treatment options,” added Dr. Lee. “We look forward to more frequent interactions with the FDA with the goal of delivering

the first therapeutic and preventive medicine to treat norovirus infections.”

About

Norovirus

is a leading cause of acute gastroenteritis, responsible for an estimated 685 million global cases each year and approximately $60

billion in worldwide economic impact. In the United States alone, the virus is associated with 21 million infections annually,

resulting in around 109,000 hospitalizations, 465,000 emergency department visits, and 900 deaths. The estimated annual economic

burden in the U.S. exceeds $10.6 billion. In developing nations, norovirus contributes to up to 1.1 million hospitalizations

and 218,000 pediatric deaths each year.

Cocrystal’s

ongoing Phase 1b randomized, double-blind, placebo-controlled challenge study (NCT07198139) at Emory University School of Medicine

will evaluate CDI-988 in up to 40 healthy adults. The primary endpoint is a reduction in the incidence of clinical symptoms, with secondary

endpoints assessing viral shedding, disease severity, safety, and pharmacokinetics.

About

Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal

is leveraging its structure-based drug discovery platform technology to design next-generation antiviral candidates that precisely target

viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain

potency against mutating strains while minimizing off-target effects, offering potentially safer, broad-spectrum antiviral solutions.

This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust

resistance 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 noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and rhinoviruses. 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 more frequent interactions with the FDA and our goals with respect to our norovirus 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, the risks and uncertainties

arising from 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 for and otherwise 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, the progress and

results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise

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 any adverse developments which may arise therefrom, and general economic

adverse effects from the ongoing conflict with Iran. 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

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