BOTHELL, Wash., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the three and nine months ended September 30, 2022, and provides updates on its antiviral pipeline, upcoming milestones and business activities.
“We are reporting continued progress in advancing our highly promising antiviral portfolio,” said Sam Lee, Ph.D., President and co-interim CEO of Cocrystal. “With enrollment completed in our CC-42344 Phase 1 study for the treatment of pandemic and seasonal influenza A, we are on track to report topline safety and pharmacokinetic (PK) results later this year. The full trial results will be a key component of UK regulatory agency submission for our influenza A Phase 2a human challenge study. Subject to the agency’s review and clearance of our submission, we expect Phase 2a study initiation in the second half of 2023.
“We advanced our oral COVID-19 program with the selected the novel, broad-spectrum protease inhibitor CDI-988 as our lead development candidate,” he added. “We are conducting IND-enabling toxicology studies with CDI-988 and plan to file for regulatory clearance to begin a first-in-human trial in Australia in the first quarter of 2023. Preclinical development activities are ongoing in our norovirus program with plans to select a lead candidate in the first half of 2023.”
“The recent increase in patients hospitalized with viral disease particularly among the pediatric population underscores the need for effective, broad-spectrum antivirals and provides rationale for our approach in developing candidates with barriers to drug resistance,” said James Martin, CFO and co-interim CEO. “We continue to be well positioned to execute on our clinical and regulatory goals given our clean capital structure, cost-efficient business model and a cash balance we believe is sufficient to fund planned operations for the next three years. That said, we continue to pursue non-dilutive funding to further support development of our promising antiviral programs.”
Antiviral Product Pipeline Overview
Many commercial antiviral drugs are only effective against certain strains of a virus and are less effective or not effective at all against other strains or variants. Cocrystal is developing novel drug candidates that specifically target proteins involved in viral replication. Despite the numerous strains that may exist or emerge, these targeted enzymes are required for viral replication and are essentially similar (highly conserved) across all strains. By targeting these highly conserved regions of the replication enzymes, our antiviral compounds are designed to be effective against major virus strains.
COVID-19and Other CoronavirusPrograms
By targeting viral replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.
During 2022 Cocrystal entered into two agreements with the National Institute of Allergy and Infectious Diseases (NIAID) for exploratory preclinical studies to evaluate our 3CL protease inhibitors for the treatment of COVID-19. The NIAID collaboration announced in April 2022 for in vitro and in vivo studies evaluating the antiviral activity of our compounds has been successfully completed. In June 2022 we expanded our collaboration with the NIAID with a second agreement in which we provided our proprietary process chemistry information for oral 3CL protease inhibitors to the NIAID to support scale-up synthesis of a key intermediate of these compounds. This collaboration is ongoing.
InfluenzaPrograms
Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in outbreaks of disease mainly during the winter months.
Norovirus Program
Hepatitis C Program
Third Quarter Financial Results
Research and development (R&D) expenses for the third quarter of 2022 were $3.9 million compared with $2.1 million for the third quarter of 2021, with the increase primarily due to the ongoing influenza A Phase 1 trial and advancement of the preclinical COVID-19 program. The Company anticipates higher R&D spending during the remainder of 2022 in preparation for additional clinical trials. General and administrative (G&A) expenses were $1.8 million for the third quarters of both 2022 and 2021.
The net loss for the third quarter of 2022 was $5.7 million, or $0.70 per share, compared with the net loss for the third quarter of 2021 of $3.9 million, or $0.48 per share.
Nine Month Financial Results
R&D expenses for the first nine months of 2022 were $9.1 million compared with $6.1 million for the first nine months of 2021. G&A expenses were $4.5 million for the first nine months of both 2022 and 2021.
The net loss for the first nine months of 2022 was $34.3 million, or $4.23 per share, and included the items described above. The net loss for the first nine months of 2021 was $10.5 million, or $1.44 per share.
Cocrystal reported unrestricted cash of $42.1 million as of September 30, 2022 compared with $58.7 million as of December 31, 2021. Net cash used in operating activities for the first nine months of 2022 was $16.5 million. The Company reported working capital of $43.3 million with 8.1 million common shares outstanding as of September 30, 2022.
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), 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.
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 goals of initiating a Phase 1 study for our CDI-988 candidate in the first quarter of 2023, our expectations of reporting data from the Phase 1 clinical study of our CC-42344 candidate later in 2022 and timeline for filing with the UK regulatory agency and commencing a Phase 2a study in 2023, our plans to select a lead candidate for our norovirus program in the first half of 2023, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the global market for therapeutics, our attempts to discover replication inhibitors, our ability to execute our clinical and regulatory goals, our expectations concerning R&D expenses, the expected sufficiency of our cash balance to fund our planned operations, our liquidity and our continued pursuit of non-dilutive funding. 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 arising from the impact of COVID-19 (including long-term and pervasive effects of the virus), inflation, interest rate increases and the Ukraine war on our Company, our collaboration partners, and on the national and global economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including and adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Contract Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the results of the studies for CC-42344, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, 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 the outcome of our appeal of the summary judgment. 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.
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
COCRYSTAL PHARMA, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands) September 30,
2022 December 31,
2021 (unaudited) Assets Current assets: Cash $42,056 $58,705 Restricted cash 75 50 Prepaid expenses and other current assets 2,765 568 Total current assets 44,896 59,323 Property and equipment, net 378 453 Deposits 46 46 Operating lease right-of-use assets, net (including $113 and 153 respectively, to related party) 327 478 Goodwill - 19,092 Total assets $45,647 $79,392 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $1,378 $1,297 Current maturities of finance lease liabilities 14 27 Current maturities of operating lease liabilities (including $57 and 53 respectively, to related party) 227 209 Derivative liabilities - 12 Total current liabilities 1,619 1,545 Long-term liabilities: Finance lease liabilities - 7 Operating lease liabilities (including $57 and 101 respectively, to related party) 119 291 Total long-term liabilities 119 298 Total liabilities 1,738 1,843 Commitments and contingencies Stockholders’ equity: Common stock, $0.001 par value; 150,000 shares authorized as of September 30, 2022 and December 31, 2021; 8,143 shares issued and outstanding as of September 30, 2022 and December 31, 2021. 8 8 Additional paid-in capital 337,330 336,634 Accumulated deficit (293,429) (259,093)Total stockholders’ equity 43,909 77,549 Total liabilities and stockholders’ equity $45,647 $79,392
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data) Three months ended
September 30, Nine months ended
September 30, 2022 2021 2022 2021 Operating expenses: Research and development 3,872 2,105 9,105 6,061 General and administrative 1,822 1,848 4,530 4,458 Legal settlement - - 1,600 - Impairments - - 19,092 - Total operating expenses 5,694 3,953 34,327 10,519 Loss from operations (5,694) (3,953) (34,327) (10,519) Other (expense) income: Interest expense, net (1) (1) (2) (4) Foreign exchange loss (5) (4) (19) (4) Change in fair value of derivative liabilities - 17 12 27 Total other (expense) income, net (6) 12 (9) 19 Net loss $(5,700) $(3,941) (34,336) (10,500) Net loss per common share, basic and diluted $(0.70) $(0.48) (4.23) (1.44) Weighted average number of common shares outstanding, basic and diluted 8,143 8,143 8,143 7,108
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