Pan-coronavirus inhibitor(Orthogon Therapeutics)

Topline single ascending dose (SAD) Phase 1 results of oral CDI-988, the first potential pan-coronavirus-pan-norovirus oral antiviral, expected in the second quarter of 2024 Enrollment completed in Phase 2a influenza A human challenge study of oral CC-42344, with topline results expected in the second half of 2024FDA pre-IND feedback for oral CC-42344 received in first quarter of 2024 provides better clarity on late-stage trial designInitiation of Phase 1 study of inhaled CC-42344, a potential influenza treatment and post-exposure prophylactic, planned for the second half of 2024 BOTHELL, Wash., May 13, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “The coming months promise to be exceptionally eventful with major inflection points in our dual norovirus-coronavirus and influenza programs expected this year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “Among these, we expect topline results from the SAD portion of a first-in-human study with our pan-coronavirus and pan-norovirus oral protease inhibitor CDI-988, with the multiple ascending dose (MAD) portion of this study expected to begin in the second half of 2024. “In our Phase 2a human challenge study with our novel broad-spectrum oral PB2 inhibitor CC-42344 for pandemic and seasonal influenza A, we expect to report topline results and to prepare an IND application to conduct a late-stage clinical study in the U.S. in the second half of 2024,” Dr Lee added. “Also in our influenza program, preparations are underway to initiate a Phase 1 study in healthy volunteers with inhaled CC-42344 as a potential prophylactic and therapeutic for influenza A in the second half of this year.” “We continue advancing our development programs in high-value indications through a cost-efficient business model,” said James Martin, CFO and co-CEO of Cocrystal. “We anticipate significant milestones this year and expect our cash will be sufficient to fund operating activities beyond the next twelve months as we tightly manage our financial resources.” Antiviral Product Pipeline Overview We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit the viral replication. By designing and selecting antiviral drug candidates that target the highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations 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 ProgramsInfluenza 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 World Health Organization. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually. Oral CC-42344 for the treatment of pandemic and seasonal Influenza A infections Our novel PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.In March 2022 we initiated enrollment in a randomized, double-blind, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CC-42344 in healthy adults.In July 2022 we reported PK results from the SAD portion of the study that support once-daily dosing.In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.In April 2023 we received approval from UK MHRA for oral CC-42344 Phase 2a study.In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A infected subjects.In March 2024 we received feedback from the FDA on a Pre-IND package improving clarity on clinical trial design, drug manufacturing and nonclinical studies necessary to file a Phase 2b trial design.In May 2024 we completed enrollment in the Phase 2a human challenge study.In the second half of 2024 we expect to report topline results from the Phase 2a human challenge study and to prepare an IND application to conduct a late-stage study in the U.S. Inhaled CC-42344 for the treatment of pandemic and seasonal Influenza A infections GLP toxicology study is underway with inhaled CC-42344 as a potential therapeutic and post-exposure prophylaxis for influenza A. CC-42344 has exhibited superior pulmonary exposure in preclinical studies.We expect to begin a Phase 1 study with inhaled CC-42344 in Australia in the second half of 2024. Influenza A/B Program Preclinical lead development of novel influenza replication inhibitors is underway. COVID-19 and Other Coronavirus ProgramsBy 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 SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses, and respiratory enteroviruses, 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 $16 billion by the end of 2031. Oral Pan-viral Protease Inhibitor CDI-988 for the treatment of coronaviruses and noroviruses Our novel broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for coronaviruses and noroviruses. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and noroviruses, and demonstrated a favorable safety profile and PK properties.In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers.In August 2023 we announced the selection of CDI-988 as our lead oral candidate for norovirus, in addition to coronavirus.In September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.We expect to report SAD cohort topline results from the Phase 1 study with CDI-988 in the second quarter of 2024. Norovirus ProgramNorovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion. By targeting viral replication, we believe it is possible to develop an effective treatment or short-term prophylactic for closed environments for all genogroups of norovirus. Oral Pan-viral Protease Inhibitor CDI-988 for the treatment of norovirus infection CDI-988 has shown pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain that is responsible for major norovirus outbreaks.In August 2023 we announced our selection of the novel broad-spectrum oral 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus, in addition to coronavirus.In September 2023 we began dosing subjects in a first-in-human study in healthy volunteers in Australia with oral CDI-988 that is expected to serve as a Phase 1 study for both indications.We expect to report SAD cohort topline results from the Phase 1 study with CDI-988 in the second quarter of 2024. First Quarter Financial Results Research and development (R&D) expenses for the first quarter of 2024 were $3.0 million, compared with $3.9 million for the first quarter of 2023. The decrease was primarily due to a reduction of clinical preparation expenses as the CC-42344 influenza product candidate moved into a Phase 2a clinical study and the CDI-988 dual norovirus-coronavirus product candidate moved into a Phase 1 clinical study. General and administrative (G&A) expenses for the first quarters of 2024 and 2023 remained consistent at $1.2 million. Interest income for the first quarter of 2024 was $220,000 and was primarily related to interest earned on cash held in interest bearing bank accounts, with no comparable item for the first quarter of 2023. Foreign exchange loss for the first quarter of 2024 were $18,000, compared with $78,000 in the prior-year quarter, with such expenses for both quarters related to foreign currency exchange rate fluctuations. The net loss for the first quarter of 2024 was $4.0 million, or $0.39 per share, compared with the net loss for the first quarter of 2023 of $5.2 million, or $0.64 per share. Cocrystal reported unrestricted cash as of March 31, 2024 of $21.8 million, compared with $26.4 million as of December 31, 2023. Net cash used in operating activities for the first quarter of 2024 was $4.5 million, compared with $3.1 million for the first quarter of 2023. The Company had working capital of $22.1 million and 10.2 million common shares outstanding as of March 31, 2024. 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 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 2024, 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, and the expected sufficiency of our cash balance to advance our programs and fund our planned operations. 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 the high interest rates in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, 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 RelationsJody Cain310-691-7100jcain@lhai.com Media Contact:JQA PartnersJules Abraham917-885-7378Jabraham@jqapartners.com Financial Tables to follow COCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS(in thousands) March 31, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash $21,842 $26,353 Restricted cash 75 75 Tax credit receivable 1,003 890 Prepaid expenses and other current assets 1,572 1,773 Total current assets 24,492 29,091 Property and equipment, net 244 271 Deposits 46 46 Operating lease right-of-use assets, net (including $26 and $42 to related party) 1,764 1,851 Total assets $26,546 $31,259 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $2,139 $3,022 Current maturities of operating lease liabilities (including $26 and $42 to related party) 240 240 Total current liabilities 2,379 3,262 Long-term liabilities: Operating lease liabilities (including $0 and $0 to related party) 1,582 1,613 Total long-term liabilities 1,582 1,613 Total liabilities 3,961 4,875 Commitments and contingencies Stockholders’ equity: Common stock, $0.001 a par value: 150,000 shares authorized as of March 31, 2024, and December 31, 2023; 10,174 shares issued and outstanding as of March 31, 2024 and December 31, 2023 10 10 Additional paid-in capital 342,445 342,288 Accumulated deficit (319,870) (315,914)Total stockholders’ equity 22,585 26,384 Total liabilities and stockholders’ equity $26,546 $31,259 COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)(in thousands, except per share data) Three months ended March 31, 2024 2023 Operating expenses: Research and development 2,950 3,907 General and administrative 1,208 1,204 Total operating expenses 4,158 5,111 Loss from operations (4,158) (5,111)Other income (expense): Interest income (expense), net 220 - Foreign exchange loss (18) (78)Total other income (expense), net 202 (78)Net loss $(3,956) $(5,189)Net loss per common share, basic and diluted $(0.39) $(0.64) Weighted average number of common shares, basic and diluted 10,174 8,143 # # #

SOUTH SAN FRANCISCO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the first quarter 2024. “We have executed on a number of key deliverables to position Aligos for success,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President & CEO of Aligos Therapeutics. “Importantly, we began dosing in the Phase 2a HERALD study of our THR- drug candidate, ALG-055009, and we expect topline data in Q4 2024. In addition, we recently presented data from our three clinical programs at scientific conferences, showcasing our robust pipeline of potentially best-in-class small molecule drug candidates. In particular, we demonstrated positive safety, tolerability, and antiviral activity data after dosing for up to 64 weeks with our hepatitis B virus capsid assembly modulator, ALG-000184, and positive safety and PK data for our ritonavir-free, pan-coronavirus protease inhibitor, ALG-097558. We remain excited by the potential of these programs and look forward to continuing to deliver for our shareholders.” Recent Business Progress Aligos Portfolio of Drug Candidates ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH Data presented at the Asian Pacific Association for the Study of the Liver (APASL) conference highlighted ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liverThe Phase 2a HERALD study was initiated in Q1 2024 with the first subject dosed in April 2024Topline HERALD data are anticipated in Q4 2024 ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB Interim data from Parts 3 and 4 of Study ALG-000184-201 were presented at the APASL conference and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV) x ≤ 64 weeksDosing continues in this ongoing Phase 1a/1b study, with subjects planning to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the following conferences: European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD)Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor Topline data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Annual Meeting demonstrated single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of ALG-097558 were well tolerated in healthy volunteers with a pharmacokinetic (PK) profile supporting twice daily, ritonavir-free dosing without a food effectReceived an additional $1.3M grant from the National Institutes of Health (NIH)Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH Financial Results for the First Quarter 2024 Cash, cash equivalents and investments totaled $112.7 million as of March 31, 2024, compared with $135.7 million as of December 31, 2023. Additionally, in October 2023, we raised $92.1 million in gross proceeds in private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025. Net losses for the three months ended March 31, 2024 were $34.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $23.0 million or basic and diluted net loss per common share of $(0.53) for the three months ended March 31, 2023. Research and development (R&D) expenses for the three months ended March 31, 2024 were $16.4 million, compared with $18.1 million for the same period of 2023. The decrease was primarily due to a decrease in employee related costs, partially offset by an increase in third party expenses. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.4 million, compared with $2.2 million for the same period of 2023. General and administrative (G&A) expenses for the three months ended March 31, 2024 were $6.7 million, compared with $8.5 million for the same period of 2023. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.2 million, compared with $1.5 million for the same period of 2023. Interest and other income (expense), net, for the three months ended March 31, 2024 was an expense of $12.8 million compared with income of $1.0 million for the same period of 2023. The change in interest and other income (expense), net, is primarily due to an increase in the fair value of the Common Warrants liability, which resulted in a non-cash charge, associated with the Securities Purchase Agreement entered into in October 2023 following the private investment in public equity (PIPE) offering. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the potential of the company’s three clinical programs and the company looking forward to continuing to deliver for its shareholders; the expectation of topline Phase 2a HERALD data for ALG-055009 in Q4 2024; the continuation of dosing in the ongoing Phase 1a/1b study for ALG-000184 with subjects planning to dose for up to 96 weeks and the planned presentation of additional interim data readouts at this year’s EASL and AASLD; and the company’s continued belief its cash balance provides sufficient cash to fund planned operations through the end of 2025. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on the Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Aligos Therapeutics, Inc Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 (Unaudited) (Unaudited) Revenue from Collaborations$292 $2,583 Revenue from Customers 694 140 Operating Expenses: Research and development 16,366 18,135 General and administrative 6,666 8,506 Total operating expenses 23,032 26,641 Loss from operations (22,046) (23,918) Interest and other income (expense), net (12,793) 1,002 Loss before income tax expense (34,839) (22,916) Income tax expense (24) (39)Net loss (34,863) (22,955)Basic and diluted net loss per common share$(0.22)$(0.53)Weighted-average number of shares used in computing basic and diluted net loss per common share 156,154,156 42,910,065 Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets(In thousands) March 31, 2024 December 31, 2023 (Unaudited) (audited) (1)Assets Current assets: Cash and cash equivalents$24,151 $135,704Short-term investments 88,588 -Prepaid expenses and other current assets 5,325 5,380Total current assets 118,064 141,084Other assets 9,838 10,443Total assets$127,902 $151,527 Liabilities and Stockholders’ Equity Current liabilities$18,880 $23,906Other liabilities, noncurrent 49,226 35,541Total liabilities 68,106 59,447Total stockholders’ equity 59,796 92,080Total liabilities and stockholders’ equity$127,902 $151,527 _____________________________________________ (1) The balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Investor ContactJordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactMichael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com