COCP Investor Presentation - 011025 final.pdf

《COCP Investor Presentation - 011025 final.pdf》由會員分享，可在線閱讀，更多相關《COCP Investor Presentation - 011025 final.pdf（27頁珍藏版）》請在三個皮匠報告上搜索。

1、Investor PresentationJanuary 2025Nasdaq:COCPPotent antivirals to combat some of the most serious diseases facing humanity2Forward-Looking StatementsThis presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,including our developme

2、nt pipeline;our technology platforms ability to produce viable drug candidates at reduced development timelines and costs;development efforts in our clinical programs,including our ongoing Phase 2a study for oral influenza PB2 inhibitor;our ongoing Phase 1 study with 3CL protease inhibitor for coron

3、avirus and norovirus;and the expected sufficiency of our cash balance to fund our planned operations.Forward-looking statements are prefaced by words such as“anticipate,”“expect,”“plan,”“could,”“may,”“will,”“should,”“would,”“intend,”“seem,”“potential,”“appear,”“continue,”“future,”believe,”“estimate,

4、”“forecast,”“project,”and similar words.Forward-looking statements are based on our current expectations and assumptions regarding our business,the economy and other future conditions.Because forward-looking statements relate to the future,they are subject to inherent uncertainties,risks and changes

5、 in circumstances that are difficult to predict.We caution you,therefore,against relying on any of these forward-looking statements.Our actual results may differ materially from those contemplated by the forward-looking statements for a variety of reasons,including,without limitation,the risks arisi

6、ng from any future interest rate increases in response to inflation,uncertainty in the financial markets,the possibility of a recession and the geopolitical conflicts in Israel and Ukraine on our Company,our collaboration partners,and on the U.S.,UK,Australia and global economies,our ability to proc

7、eed with studies including recruiting volunteers for and procuring or manufacturing materials for such studies by our clinical research organizations and vendors,the results of our CROs studies referred to above,our and our collaboration partners technology and software performing as expected and ma

8、intenance and protection of related intellectual property rights,financial difficulties experienced by certain partners and our ability to secure and maintain new collaboration partners,general risks arising from clinical trials,receipt of regulatory approvals,regulatory changes,development of effec

9、tive treatments and/or vaccines by competitors,including as part of the programs financed by the U.S.government,and potential mutations in the viruses we are targeting which may result in variants that are resistant to a product candidate we develop.Further information on our risk factors is contain

10、ed in our filings with the Securities and Exchange Commission,including our Annual Report on Form 10-K for the year ended December 31,2023.Any forward-looking statement made by us in this presentation speaks only as of the date on which it is made.Factors or events that could cause our actual result

11、s 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.233About Cocrystal Pharma

12、Advancing programs in high-value antiviral drug targets Influenza Norovirus Coronavirus and respiratory viruses Drug candidates with clinically validated mechanisms of action Effectively cure viral diseases Broad-spectrum and potent antiviral activity Designed to be effective for emerging variants a

13、nd existing drug-resistant viruses Multiple routes of administration(oral,inhalation,and injectable)Proprietary drug discovery platform technology Unique drug discovery platform technology developed with Nobel Prize-winning technology Applying powerful,proprietary drug discovery platform technology

14、to develop first-and best-in-class broad-spectrum antiviral drugs44Investment Highlights Targeting multibillion-dollar,global markets for the treatment of acute and pandemic viral diseases Proprietary structure-based drug discovery platform technology provides opportunity for discovery and developme

15、nt of novel,broad-spectrum drug candidates Advancing multiple clinical programs Oral influenza PB2 inhibitor CC-42344 Phase 2a study continues in 2025 First-in-class dual oral norovirus and coronavirus protease inhibitor CDI-988 Phase 1 study interim data available Developing multiple discovery prog

16、rams for respiratory viral diseases Pan-viral protease inhibitors and influenza replication inhibitors Exploring pandemic preparedness collaboration opportunities Seasoned leadership includes experienced management,senior scientists and two Nobel laureates Cost-efficient operations and clean capital

17、 structure;cash sufficient to fund planned operations55Influenza A Influenza A/BProgram Candidate Discovery Preclinical Phase 1 Phase 2 Phase 3Robust Pipeline Addressing Unmet Medical NeedsNorovirusRespiratory virusesPan-viral inhibitorsMultiple clinical assets poised to deliver significant growthRe

18、plication inhibitorsOral Pan-viral protease inhibitor CDI-988Oral PB2 inhibitor CC-42344Norovirus&Coronavirus Replication inhibitorsInhaled PB2 inhibitor CC-4234466Proprietary Drug Discovery Platform Technology for Direct-Acting Antivirals Select drug binding pocketGrow drug target X-ray crystalsHit

19、-to-lead processDrugCandidateLead optimizationCocrystals technology platform provides potential for novel drug candidates at reduced development timelines and costsDirect-Acting AntiviralProvide high-resolution 3D structures of drug target77Urgent Unmet Need for Safe,Effective,Broad-Spectrum,Pan-Vir

20、al TherapiesUrgent health risks with newly emerging pandemic viral outbreaks1,2Significant delay of effective new antiviral therapeutics and vaccine developmentChallenging issues with current drug discovery approach one-target/one-drug paradigmSignificant advantages of Cocrystals pan-viral drug disc

21、overy approachCocrystals proprietary structure-based drug design platform technology enables simultaneous drug design on the highly conserved regions of multiple viral drug targetsFirst pan-viral clinical drug candidate CDI-988 developed for the treatment of both norovirus and coronavirus infections

22、Facilitates the rapid development and may allow expedited regulatory pathways(fast track and/or breakthrough designation,and emergency use authorization)1 Accelerating antiviral drug discovery:lessons from COVID-19 https:/ urgent need for pan-antiviral agents:from multitarget discovery to multiscale

23、 design https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC7682558/8Pandemic and Seasonal Influenza Program99Pandemic and Seasonal Influenza:A Major Global Health Concern1 billion cases,3-5 million severe illnesses and up to 650,000 deaths worldwide annually1Not well managed with currently approved vaccine

24、s having only 40-60%effectiveness2On average 8%of the U.S.population contracts influenza each season3Influenza is responsible for$10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S.annuallyOnly influenza A causes pandemic flu and is responsible for majority

25、 of seasonal influenza infections1Potential emerging pandemic influenza A strains and drug-resistant strains against approved influenza antivirals,Tamiflu and Xofluza Tamiflu has long history of drug resistance5 Xofluza has shown emergence of drug resistant mutations61 World Health Organization(WHO)

26、(March 2019):https:/www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)2 Center for Disease Control and Prevention(CDC):Vaccine Effectiveness:How Well Do Flu Vaccines Work?:https:/www.cdc.gov/flu/vaccines-work/vaccineeffect.htm3 CDC Seasonal Flu Microsite4 CDC:Make It Your Business to Figh

27、t the Flu5 ScienceDaily(March 2014)Tamiflu-resistant influenza related to mutations in genome:https:/ NEJM Journal Watch(September 2018)A Promising Drug for Influenza?:https:/www.jwatch.org/na47413/2018/09/12/promising-drug-influenza 1010Influenza Development Programs Focused on Therapeutic Inhibito

28、rsClinical assets for pandemic and seasonal influenzaPromising Early-Stage ProgramsOral PB2 inhibitorCC-42344Ongoing Phase 2a studyPotent broad-spectrum activityInhibits activity in the avian influenza A(H5N1)PB2 proteinFavorable safety profile and tolerabilityPotential for best-in-classReplication

29、inhibitorsDiscovery ongoingPotent broad-spectrum activity against influenza A and B strainsNovel mechanisms of action11CC-42344 Shows Broad-Spectrum Antiviral Activity Against Pandemic and Seasonal Influenza A StrainsInfluenza serotypeStrainCC-42344,EC50 nMH1N1A/PR/8/341Pandemic H1N1California/04/20

30、090.5H1N1A1/Denver/1/573H1N1A/Fort Monmouth/1/472H1N1A/NY/18/095H3N2A/AICHI/2/680.2Highly pathogenic Avian H5N1Duck/MN/1524/813.2Highly pathogenic Avian H5N1Hong Kong/213/20034.5Highly pathogenic Avian H5N1Thailand/16/20043.2Highly pathogenic Avian H7N7Netherlands/219/20135.6Highly pathogenic Avian

31、H7N9Anhui/1/20133.2H1N1-Oseltamivir resistantA/HK/2369/09 H274Y9H3N2-Oseltamivir resistantA/Wuhan/395/950.5H1N1-Baloxavir resistant(I38T)A/PR/8/34 I38T0.51112CC-42344 Binds to Highly Conserved Active Site of Influenza A PB2 ProteinCocrystal proprietary drug discovery platform technologyHighly pathog

32、enic influenza A strainsH7N9M431H432S337F363E361H357R355F323F325N429CC-42344H1N1M431H432S337F363E361H357R355F323F325CC-42344H5N1M431H432S337F363E361H357R355F323F325N429CC-42344Confidential1313CC-42344 Binds to 2024 Texas Avian Influenza H5N1 PB2 Active SiteMutationsCocrystal influenza antiviralCC-42

33、344https:/www.cdc.gov/bird-flu/situation-summary/mammals.htmlAvian influenza A(H5N1)infection in dairy cows and human casesFirst cocrystal structure of 2024 H5N1:CC-423442024 HPAI:CC-42344 crystals14CC-42344 Shows Potent Antiviral Activity in Influenza-Infected Human Lung Epithilium14Uninfected huma

34、n bronchialairway epitheliaInfluenza AH1N1 infectionNo CC-42344CC-42344 treatmentCells are killed by H1N1 virus,and most cilia are destroyedFavorable safety profile:No toxicity in CC-42344-treated human lung epitheliumShowed potent antiviral activity in influenza A(H1N1)-infected human lung epitheli

35、um15CC-42344:Potential Influenza Therapeutic Treatment 15Favorable safety profile and tolerabilityPotent,broad-spectrum activity against pandemic and seasonal strainsHigh barrier to resistanceOral CC-42344:Human challenge Phase 2a study ongoing in UK Oral CC-42344:FDA feedback provides improved clar

36、ity on regulatory path and requirements for oral CC-42344 Phase 2b trial 16Norovirus and Coronavirus Program Overview1717Norovirus Infection:No Approved Treatments or Vaccines Available CDC:Norovirus Disease in the United States https:/www.cdc.gov/norovirus/burden.html 1818Significant Unmet Need for

37、 New Antivirals to Combat Norovirus Infections Highly contagious virus that causes symptoms of acute gastroenteritis including nausea,vomiting,stomach pain and diarrheaTransmissible by infected person,contaminated food or water,or touching contaminated surfacesMajor cause of gastrointestinal illness

38、 in closed and crowded environments including hospitals,nursing homes,childcare facilities,military facilities and cruise shipsWorldwide norovirus-related healthcare and lost productivity costs of$60 billion dollarsGII.4 noroviruses have caused the majority of recent norovirus outbreaks worldwideNo

39、approved antivirals or vaccines for norovirusCDC:Norovirus Disease in the United States https:/www.cdc.gov/norovirus/burden.htmlNational Foundation for Infections Diseases https:/www.nfid.org/infectious-disease/norovirus/1919Cocrystal Viral Protease Inhibitors Block the Essential Replication Process

40、Main(3CL)protease inhibitorNorovirus or SARS-CoV-220First-in-Class Pan-Viral Protease Inhibitor CDI-988 for Treatment of Norovirus and COVID infections2020Cocrystal structures of Pandemic Norovirusand SARS-CoV-2 with CDI-988CDI-988,pan-viral protease inhibitorCDI-988,pan-viral protease inhibitorDeve

41、loped using Cocrystals proprietary drug discovery platform technologyBinds to a highly conserved region required for viral proteases Exhibits pan-viral antiviral activity against pandemic norovirus and coronavirus strainsDemonstrated a favorable safety profileSidney(2015)MD145(1987)Far.Hills(2002)SA

42、RS-CoV-221Accelerating Progress with First-in-Class Oral Pan-Viral Protease Inhibitor CDI-988:Phase 1 Near CompletionPhase 1 study in healthy participants to evaluate the safety,tolerability and PK of CDI-988Single-center,randomized,double-blind,placebo-controlledSingle-ascending dose and multiple-a

43、scending dose cohorts;7-day nontreatment follow-up periodHealthy adult volunteersEach cohort comprised 8 participants(6 on CDI-988;2 on placebo)100 mg200 mg400mg600 mg1200 mg5 cohorts of 8 participants each21Multiple-ascending dose(MAD)200 mg400 mg800mg1200 mg4 cohorts of 8 participants each21Single

44、-ascending dose(SAD)All dose cohorts well tolerated;No treatment-related study discontinuationsNo serious adverse effects(SAEs)Few overall AEs:Most commonly occurring treatment-related AE was headacheNext step in clinical development:human challenge study in norovirus-infected subjectsCOMPLETECOMPLE

45、TE2222Experienced Board of Directors Roger Kornberg,Ph.D.Co-founder,Chairman of the Board&Chairman of the Scientific Advisory Board Nobel Laureate in Chemistry-the process by which genetic information from DNA is copied to RNA Welch Prize highest award granted in the field of chemistry in the U.S.Le

46、opald Mayer Prize highest award granted in the field of biomedical sciences from the French Academy of SciencesSteve Rubin Vice Chairman EVP-Administration&Director of OPKO Health,Inc.Former SVP&General Counsel of IVAX Corporation;SVP&General Counsel of Telergy Inc.Phillip Frost,M.D.Director Chairma

47、n&CEO of OPKO Health,Inc.Former Chairman of Teva Pharmaceuticals;Chairman and CEO of IVAX Corporation sold for$7.4 billion Board of Regents of Smithsonian Institution;Board of Trustees of University of Miami;Trustee of Scripps Research InstitutesFred HassanDirector Chairman of the investment firm Ca

48、ret Group;Director of global private equity firm Warburg Pincus LLC Former Chairman&CEO of Schering-Plough acquired by Merck Former Chairman&CEO of Pharmacia Corporation;senior positions at Wyeth&Sandoz Pharmaceuticals Anthony Japour,M.D.Director President,CEO&Director of iTolerance Former CEO of Ad

49、vancedDx Biological Laboratories-USA;Medical Director of ICON plc Former with Elite Health Medical Group specializing in infectious diseasesRichard C.Pfenniger,Jr.Director Director of OPKO Health,GP Strategies Corporation&Asensus Surgical,Inc.Former Chairman,CEO&President of Continucare Corporation;

50、CEO&Vice Chairman of Whitman Education Group.Former COO,SVP-Legal Affairs&General Counsel of IVAX Corporation2323Seasoned LeadershipSam Lee,Ph.D.Co-Chief Executive Officer&President25+years of anti-infective drug discovery research experience,including HCV and influenza antivirals;played key role in

51、 early development of phosphoinositide 3-kinase(PI3K)delta inhibitor,Zydelig James J.Martin,MBA,CPACo-Chief Executive Officer&Chief Financial Officer25+years of finance and management experience including providing financial leadership to commercial-stage,publicly traded health science companies Rog

52、er Kornberg,Ph.D.Chairman of the Board,Chairman of the Scientific Advisory Board Professor Stanford University School of Medicine Nobel LaureateMichael Levitt,Ph.D.Member Professor Stanford University School of Medicine Nobel LaureateBaek Kim,Ph.D.Member Director of Center for Drug Discovery Emory U

53、niversityBob Lehman,Ph.D.Member Professor(Emeritus)Stanford University School of MedicineGary Schoolnik,M.D.Member Professor(Emeritus)Stanford University School of MedicineRoland Strong,Ph.D.Member Professor Fred Hutchinson Cancer Research CenterChristophe Verlinde,Ph.D.Member Professor(Emeritus)Uni

54、versity of WashingtonManagementScientific Advisory Board2424Expanding Intellectual Property Portfolio Coronavirus Issued patents in U.S.and major countriesPending U.S.provisional applicationsPandemic Influenza APB2(influenza A inhibitor)Pending applications in PCT and TaiwanPending U.S.provisional a

55、pplicationsInfluenza A/B Influenza A/B inhibitorPending applications in U.S.and worldwideNorovirusIssued patents in U.S.and major countriesPending U.S.provisional applicationsHCVNS5B(NNI)Issued patents in U.S.Pending applications in U.S.and worldwidePending U.S.provisional application25252025 Clinic

56、al MilestonesCDI-988 as oral treatment and prophylaxis for noroviruses,coronaviruses and other viral infectionsInterim topline Phase 1 study resultsPhase 1 results including higher-dose cohortFDA pre-IND meetingFDA IND submissionEnrollment initiation in norovirus challenge study CC-42344 as an oral

57、treatment of pandemic and seasonal influenza A Continuation of Phase 2a influenza challenge study2626Financial Snapshot1 Yahoo Finance(January 6,2025)Clean balance sheetNo preferred sharesNo debtCash sufficient to fund planned operations$25 MillionMarket cap110.2 MillionCommon shares outstanding42,0

58、00Average 3 monthdaily share volume1$13.0 MillionCash/equivalents as of September 30,202410.3 Million Fully diluted shares2727Investment Highlights Targeting multibillion-dollar,global markets for the treatment of acute and pandemic viral diseases Proprietary structure-based drug discovery platform

59、technology provides opportunity for discovery and development of novel,broad-spectrum drug candidates Advancing multiple clinical programs Developing multiple discovery programs for respiratory viral diseases Exploring pandemic preparedness collaboration opportunities Seasoned leadership includes experienced management,senior scientists and two Nobel laureates Cost-efficient operations and clean capital structure;cash sufficient to fund planned operations