- Enrollment underway in Phase 1 trial with novel protease inhibitor CDI-988, the first potential dual coronavirus-norovirus oral antiviral
- Dosing expected to begin later this year in Phase 2a human challenge trial with oral CC-42344 for the treatment of pandemic and seasonal influenza A
- Phase 1 trial with inhaled CC-42344 expected to begin in the first half of 2024
“We are making excellent progress in the clinical development of potent antivirals that address some of the world’s leading viral diseases,” said
“Enrollment is underway in a Phase 1 trial with our first-in-class pan-coronavirus and pan-norovirus protease inhibitor CDI-988,” added
“With three clinical-stage antiviral programs in high-value unmet medical indications, the coming year promises to be active and potentially transformational for Cocrystal,” said
Antiviral Product Pipeline Overview
We are developing therapeutics that inhibit the viral replication function of RNA viruses that cause acute and chronic diseases. Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. By designing and selecting antiviral drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that are effective against the virus and mutants of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.
Influenza Programs
Influenza is a severe respiratory illness caused by the influenza A or B virus that results in disease outbreaks mainly during the winter months. Influenza is a major global health threat that may become more challenging to treat in the future due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals.
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
- Pandemic and Seasonal Influenza A
- Our novel oral PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
- In
March 2022 we initiated enrollment in a randomized, double-controlled, dose-escalating Phase 1 trial to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered CC-42344 in healthy adults. - In
July 2022 we reported PK results from the single-ascending dose portion of the trial that support once-daily dosing. - In
December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 trial. - In
October 2023 we announced authorization from theUnited Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge trial and we expect to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023. - Preclinical development is underway with inhaled CC-42344 as a potential therapeutic treatment and prophylaxis for influenza A. We expect to begin a Phase 1 clinical trial with inhaled CC-42344 in
Australia in the first half of 2024.
- Pandemic and Seasonal Influenza A/B Program
- In
January 2019 we entered into an Exclusive License and Research Collaboration Agreement withMerck Sharp & Dohme Corp. (Merck) to discover and develop certain proprietary influenza antiviral agents that are effective against influenza A and B strains. This agreement includes milestone payments of up to$156 million plus royalties on sales of products discovered under the agreement. - In
January 2021 we announced completion of all research obligations under the agreement, making Merck solely responsible for further preclinical and clinical development of these compounds. - In early 2023 Merck notified us of its intent to continue development of the compounds discovered under this agreement and of their filing on behalf of both companies of multiple
U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.
- In
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses 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. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed
- Oral Protease Inhibitor CDI-988
- In
October 2022 we announced the selection of CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. Designed and developed using our proprietary structure-based drug discovery platform technology, CDI-988 targets a highly conserved region in the active site of SARS-CoV-2 3CL (main) protease required for viral RNA replication. - CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and PK properties that support once-daily dosing.
- In
May 2023 we announced approval of our application to the Australian regulatory agency for a planned randomized, double-blind, placebo-controlled Phase 1 trial to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers. - In
September 2023 we dosed the first subject in the CDI-988 Phase 1 trial.
- In
- Intranasal/Pulmonary Protease Inhibitor CDI-45205
- CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor and was among the broad-spectrum viral protease inhibitors we obtained from
Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced inApril 2020 . We believe the protease inhibitors obtained from KSURF have the ability to convert the inactive SARS-CoV-2 polymerase replication enzymes into an active form. - CDI-45205 and several analogs showed potent in vitro activity against the main SARS-CoV-2 variants, surpassing the activity observed with the original
Wuhan strain of the virus. - CDI-45205 delivered via intraperitoneal injection demonstrated good bioavailability in mouse and rat PK studies, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
- In
January 2022 we received guidance from the FDA regarding further preclinical and clinical development of CDI-45205.
- CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor and was among the broad-spectrum viral protease inhibitors we obtained from
Norovirus Program
Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the
- In
August 2023 we announced our selection of the novel broad-spectrum 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus. CDI-988 is being evaluated in a first-in-human trial in healthy volunteers inAustralia . The CDI-988 trial is expected to serve as a Phase 1 trial for both our norovirus and our coronavirus programs. - In
September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 Phase 1 trial.
Third Quarter Financial Results
Research and development (R&D) expenses for the third quarter of 2023 were
During the third quarter of 2023, the Company received a
Total other income, net for the third quarter of 2023 was
The net loss for the third quarter of 2023 was
Nine Month Financial Results
R&D expenses for the nine months ended
During the first nine months of 2023, the Company received a
During the first nine months of 2022, the Company recorded a
Total other income, net for the first nine months of 2023 was
The net loss for the nine months ended
Cocrystal reported unrestricted cash as of
About
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 the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including, preparation, commencement and advancement of clinical studies for certain product candidates in 2023 and beyond, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to advance our programs and fund our planned operations, and our liquidity. 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 interest rate increases in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in
Investor Contact:
LHA Investor Relations
310-691-7100
jcain@lhai.com
Media Contact:
917-885-7378
Jabraham@jqapartners.com
Financial Tables to follow
CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 29,738 | $ | 37,144 | ||||
Restricted cash | 75 | 75 | ||||||
Tax credit receivable | 550 | 716 | ||||||
Prepaid expenses and other current assets | 1,842 | 2,243 | ||||||
Total current assets | 32,205 | 40,178 | ||||||
Property and equipment, net | 252 | 342 | ||||||
Deposits | 46 | 46 | ||||||
Operating lease right-of-use assets, net (including | 111 | 274 | ||||||
Total assets | $ | 32,614 | $ | 40,840 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 1,806 | $ | 976 | ||||
Current maturities of finance lease liabilities | - | 7 | ||||||
Current maturities of operating lease liabilities (including | 118 | 233 | ||||||
Total current liabilities | 1,924 | 1,216 | ||||||
Long-term liabilities: | ||||||||
Operating lease liabilities (including | - | 57 | ||||||
Total liabilities | 1,924 | 1,273 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock, | 10 | 8 | ||||||
Additional paid-in capital | 342,130 | 337,489 | ||||||
Accumulated deficit | (311,450 | ) | (297,930 | ) | ||||
Total stockholders’ equity | 30,690 | 39,567 | ||||||
Total liabilities and stockholders’ equity | $ | 32,614 | $ | 40,840 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
Three months ended | Nine months ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 4,194 | 3,872 | 10,902 | 9,105 | ||||||||||||
General and administrative | 1,849 | 1,822 | 4,591 | 4,530 | ||||||||||||
Legal settlement | (1,600 | ) | - | (1,600 | ) | 1,600 | ||||||||||
Impairments | - | - | - | 19,092 | ||||||||||||
Total operating expenses | 4,443 | 5,694 | 13,893 | 34,327 | ||||||||||||
Loss from operations | (4,443 | ) | (5,694 | ) | (13,893 | ) | (34,327 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income (expense), net | 320 | (1 | ) | 460 | (2 | ) | ||||||||||
Foreign exchange loss | (42 | ) | (5 | ) | (87 | ) | (19 | ) | ||||||||
Change in fair value of derivative liabilities | - | - | - | 12 | ||||||||||||
Total other income (expense), net | 278 | (6 | ) | 373 | (9 | ) | ||||||||||
Net loss | $ | (4,165 | ) | $ | (5,700 | ) | (13,520 | ) | (34,336 | ) | ||||||
Net loss per common share, basic and diluted | $ | (0.41 | ) | $ | (0.70 | ) | (1.43 | ) | (4.23 | ) | ||||||
Weighted average number of common shares, | 10,153 | 8,143 | 9,461 | 8,143 | ||||||||||||
basic and diluted |
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Source:
2023 GlobeNewswire, Inc., source