COCP Cocrystal Pharma Inc

 

 

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): July 18, 2024

 

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 July 18, 2024, Cocrystal Pharma, Inc. (the “Company”) issued a press release providing updates on the clinical development and results from the single-ascending dose cohorts of the Phase 1 study for its CDI-988 candidate as a potential antiviral treatment for coronaviruses and noroviruses. A copy of the press release is being furnished as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit No.		Description
99.1		Press Release issued by Cocrystal Pharma, Inc. on July 18, 2024
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: July 18, 2024

 

	Cocrystal Pharma, Inc.
	By:	/s/ James Martin
	Name:	James Martin
	Title:	Chief Financial Officer and Co-Chief Executive Officer

 

 

Exhibit 99.1

 

 

Cocrystal Pharma Reports Favorable Results from Single-Ascending Dose Cohorts of Phase 1 Study with CDI-988, its Oral Pan-Viral Norovirus/Coronavirus Protease Inhibitor

 

BOTHELL, Wash. (July 18, 2024) – Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) today reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. It is being developed as the first dual, broad-spectrum antiviral for the treatment of norovirus and coronaviruses.

 

“Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a strong candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. We are pleased with the encouraging safety and tolerability data from the CDI-988 Phase 1 study SAD cohorts,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are currently manufacturing drug product for the multiple-ascending dose (MAD) cohorts of this study, with subject enrollment planned to begin in the fourth quarter of this year.”

 

The single-center, randomized, double-blind Phase 1 study is evaluating the safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo in healthy adults and is being conducted in Australia. Study participants in the SAD cohorts received CDI-988 in doses ranging from 100 mg to 600 mg. All participants completed the study with no discontinuations. There were no serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms.

 

About Norovirus

 

Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The NIH estimates the annual burden of noroviruses to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.

 

Coronaviruses Including COVID-19 and Variants

 

Coronaviruses (CoV) are a family of viruses that historically have been associated with a wide range of symptoms, ranging from no symptoms at all to more severe disease that includes pneumonia, acute respiratory distress syndrome (ARDS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including SARS-CoV-2 and its variants, ARDS and Middle East Respiratory Syndrome (MERS). The ability of an asymptomatic individual to transmit infection heightened the public health challenge of COVID-19.

 

 

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 potential efficacy of CDI-988 against coronaviruses and noroviruses, the results of the CDI-988 Phase 1 trial for the antiviral treatment of coronaviruses and noroviruses, the expected timing of the CDI-988 MAD cohorts of the study, including estimated subject enrollment in the fourth quarter of fiscal year 2024, and the potential 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 obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers and procuring materials for the MAD cohorts CDI-988 Phase 1 study by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential 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 that 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 our Annual Report on Form 10-K for the year ended December 31, 2023. 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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v3.24.2

Cover	Jul. 18, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 18, 2024
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	(877)
Local Phone Number	262-7123
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

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