8-K
Cocrystal Pharma, Inc. (COCP)
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
Dateof Report (Date of earliest event reported): October 25, 2022
CocrystalPharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38418 | 35-2528215 |
|---|---|---|
| (State<br> or other Jurisdiction<br><br> <br>of<br> Incorporation) | (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
| 19805<br> N. Creek Parkway<br><br> <br>Bothell,<br> WA | 98011 | |
| --- | --- | |
| (Address<br> of principal executive offices) | (Zip<br> Code) |
Registrant’s telephone number, including area code: (305) 425-1780
(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:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> Stock | COCP | The<br> Nasdaq Stock Market LLC <br><br> (The Nasdaq Capital Market) |
Item3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On October 25, 2022, Cocrystal Pharma, Inc. (the “Company”) received a letter from Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company of its compliance with Nasdaq Listing Rule 5550(a)(2) (the “Rule”) by maintaining a minimum bid price for its common stock of at least $1.00 for the last 10 consecutive business days, from October 11, 2022 to October 24, 2022. Accordingly, the Company has regained compliance with the Rule and the matter is now closed.
Item7.01 Regulation FD Disclosure
On October 26, 2022, the Company issued a press release announcing developments with respect to its orally administered, novel, broad-spectrum antiviral candidate CC-42344 for the treatment of pandemic and seasonal influenza A. A copy of the press release is being furnished as Exhibit 99.1.
On October 26, 2022, Dr. Sam Lee, President and Co-Interim Chief Executive Officer of the Company, will be making a presentation at the LD Micro Main Event XV Conference. A copy of the presentation is being furnished as Exhibit 99.2.
The information in this Item 7.01 (including Exhibits 99.1 and 99.2) 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.
Item9.01 Financial Statements and Exhibits
(d)Exhibits
| Exhibit | Description |
|---|---|
| 99.1 | Cocrystal Pharma, Inc. Press Release, dated October 26, 2022 |
| 99.2 | Cocrystal Pharma, Inc. Corporate Presentation, dated October 26, 2022 |
| 104 | Cover Page Interactive<br> 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: October 26, 2022 | By: | /s/ James Martin |
| Name: | James<br>Martin | |
| Title: | Chief<br>Financial Officer and Co-Interim Chief Executive Officer |
Exhibit 99.1
EnrollmentCompleted in Phase 1 Influenza A Study with Cocrystal Pharma’s Oral Antiviral Candidate CC-42344
BOTHELL,Wash. (October 26, 2022) – Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the completion of enrollment in a Phase 1 healthy volunteer study to assess the safety, tolerability and pharmacokinetics (PK) of its orally administered, novel, broad-spectrum antiviral candidate CC-42344 for the treatment of pandemic and seasonal influenza A. CC-42344 represents a new class of antiviral treatment designed to block an essential step in the viral replication and transcription of pandemic and seasonal influenza A.
In March 2022 enrollment was initiated in the randomized, double-blind, placebo-controlled Phase 1 study, which is being conducted in Australia. In July 2022 the company announced PK results from the single-ascending-dose portion of the study, which support once-daily dosing. Enrollment is now complete with the highest dose of the multiple-ascending-dose portion of the study.
To continue advancing the development of CC-42344, Cocrystal engaged a U.K.-based clinical research organization in August 2022 to conduct a human challenge Phase 2a study evaluating the antiviral activity safety and PK of CC-42344 in subjects infected with influenza A. This study will expose healthy volunteers to the virus in a controlled setting, which will significantly shorten the timeline for generating results.
“Completing enrollment in our Phase 1 study keeps us on track to announce topline results this year,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Results from this study will be incorporated into a regulatory submission to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct the human challenge Phase 2a study. Pending approval by the Agency, we expect initiation of the Phase 2a study in the second half of 2023.”
AboutCC-42344 and Influenza
CC-42344is an oral PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It 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 Tamiflu® and Xofluza®, while also demonstrating favorable PK and safety profiles.
According to a June 2022 report by Precision Reports, the global influenza therapeutics market is projected to reach $9.5 billion by 2027, up from $6.6 billion in 2020 and growing at a 4.8% CAGR between 2021 and 2027.
AboutCocrystal 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), hepatitis C viruses and noroviruses. 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.
CocrystalPharma 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 expected completion and submission of our Phase 1 results to the United Kingdom Medicines and Healthcare Products Regulatory Agency, our collaboration with a U.K.-based clinical research organization to conduct a Phase 2a clinical trial and the characteristics and anticipated resulting shortened timeline for the study including the anticipated initiation of the study in the second half of 2023, the potential design and efficacy of CC-42344, and the demand for products designed to treat influenza and opportunities presented thereby. 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 availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the Russian invasion of Ukraine, and/or inflation and interest rate increases on the global economy, the U.K. and on our Company and collaboration partners, including supply chain disruptions and our continued ability to proceed with our programs such as obtaining the requisite regulatory approvals including from the United Kingdom Medicines and Healthcare Products Regulatory Agency, the ability of the CRO to recruit patients into clinical trials, and the results of the studies for CC-42344. 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, 2021. 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.
InvestorContact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com
MediaContact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com
Exhibit 99.2
