Form 8-K - Current report

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): November 28, 2023

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: (786) 459-1831

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 November 28, 2023, Sam Lee, President and Co-Chief Executive Officer of Cocrystal Pharma, Inc. (the “Company”) is presenting at the World Vaccine Conference. A copy of the slide presentation is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Company will also make available a webcast recording of the presentation on its website at www.cocrystalpharma.com beginning on November 29, 2023. In addition, on November 29, 2023 the Company issued a press release regarding the presentation and the Company’s CC-42344 influenza A product candidate described therein, a copy of which is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

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.

Exhibit No.		Description

99.1		Cocrystal Pharma, Inc. Corporate Presentation, dated November 28, 2023
99.2		Press Release dated November 29, 2023
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.

Dated: November 29, 2023

	Cocrystal Pharma, Inc.

	By:	/s/ James Martin
	Name:	James Martin
	Title:	Chief Financial Officer and Co-Chief Executive Officer

Exhibit 99.1

Exhibit 99.2

Cocrystal Pharma Highlights its Novel Inhaled and Oral Influenza A Antiviral CC-42344 at the World Vaccine Congress West Coast

BOTHELL, Wash. (November 29, 2023) – Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces the presentation of favorable data demonstrating activity of its potent broad-spectrum PB2 inhibitor CC-42344 against pandemic and seasonal influenza A strains at the World Vaccine Congress West Coast. Cocrystal has initiated a Phase 2a human challenge trial with oral CC-42344 in the UK in subjects infected with influenza A, and plans to begin a Phase 1 trial with inhaled CC-42344 as a potential influenza A treatment and prophylaxis in Australia in the first half of 2024.

In his presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344,” Cocrystal President and co-CEO Sam Lee, PhD discussed the potential prevention and therapy of influenza infection using inhaled CC-42344. Dr. Lee commented that CC-42344 exhibits superior antiviral activity compared with oseltamivir (Tamiflu®) and demonstrates a novel mechanism of action with high barrier of resistance. He noted that Cocrystal discovered and developed CC-42344 utilizing the Company’s proprietary structure-based drug discovery platform technology, which is proving successful in delivering multiple broad-spectrum antiviral leads for influenza and other viral diseases.

“We are excited to accomplish another important milestone with the influenza antiviral CC-42344. Based on our recent preclinical data, CC-42344 exhibits superior lung exposure, a favorable safety profile, and efficacy in influenza-infected human lung epithelia. We also demonstrated highly efficient delivery of inhaled CC-42344 into the lung,” he said. “Inhaled CC-42344 could be developed for both therapeutic and prophylactic influenza treatment. We are encouraged by this potential breakthrough influenza treatment option.”

Slides from the presentation are available on the Company’s website.

About CC-42344

CC-42344 is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. 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 certain approved influenza antivirals, while also demonstrating favorable pharmacokinetic and safety profiles.

About Seasonal Influenza

Each year there are approximately 1 billion cases of seasonal influenza worldwide, 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. 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 Company’s ongoing Phase 2a human challenge trial for CC-42344 as a product candidate for oral treatment of influenza A, and the planned initiation of a Phase 1 clinical trial in the first half of 2024 for CC-42344 as a product candidate for inhaled treatment of influenza A, and the potential efficacy and clinical benefits of, and 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 proceed with the Phase 2a and Phase 1 studies referred to above including recruiting volunteers for and procuring or manufacturing materials for such studies by our clinical research organizations and vendors, and the results of such studies. 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

# # #

Cover	Nov. 28, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 28, 2023
Entity File Number	001-38418
Entity Registrant Name	Cocrystal Pharma, Inc.
Entity Central Index Key	0001412486
Entity Tax Identification Number	35-2528215
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	19805 N. Creek Parkway
Entity Address, City or Town	Bothell
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98011
City Area Code	(786)
Local Phone Number	459-1831
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	COCP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false