COMPASS-Pathways-investor-presentation_Jan-25_JPM_updated-FLS.pdf

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1、Transforming Mental Health CareInvestor PresentationJanuary 20252|Compass PathwaysDisclaimerCautionary Note Regarding ForwardCautionary Note Regarding Forward-Looking Statements Looking Statements This presentation includes“forward-looking statements”within the meaning of the Private Securities Liti

2、gation Reform Act of 1995,as amended.In some cases,you can identify forward-looking statements by terms such as“believe,”“continue,”“could,”“estimate,”“expect,”“may,”“might,”“plan,”“potential,”“project,”“should,”“target,”“will,”“would,”or the negative of these terms,and similar expressions intended

3、to identify forward-looking statements.However,not all forward-looking statements contain these identifying words.These forward-looking statements include express or implied statements relating to our financial guidance;our strategic plans or objectives;our expectations and projections about our fut

4、ure cash needs and financial results;the anticipated proceeds,if any,to be received from the exercise for cash of the warrants sold in the January 2025;our plans for a strategic reorganization,including a reduction in workforce,and our expectations regarding impact of and cost savings from our plann

5、ed reduction in workforce;our plans and expectations regarding our phase 3 trials in treatment-resistant depression(TRD),including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available;the potential for the pivotal phase 3 program in TRD

6、,any future trials in PTSD,or other trials to support regulatory filings and approvals;our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment,including as a treatment for TRD,PTSD,and anorexia nervosa;our expectations regarding the benefits of our inves

7、tigational COMP360 psilocybin treatment;and our plans,expectations and ability to achieve our goals related to our research collaboration agreements.By their nature,these statements are subject to numerous risk and uncertainties,including the our need for substantial additional funding to achieve ou

8、r business goals,including to repay the term loan facility,and if we are unable to obtain this funding when needed and on acceptable terms,we could be forced to delay,limit or terminate our clinical development efforts;the risk that holders of the warrants sold in the January 2025 financing may neve

9、r exercise the warrants and we may not receive any additional proceeds from the exercise of the warrants sold in the January 2025 offering;negative general economic and market conditions;the availability of future tranches under the term loan facility is dependent,in part,on the approval of the lend

10、er,achievement of certain milestones and other factors;clinical development is lengthy and outcomes are uncertain,and therefore our phase 3 clinical trials in TRD and our other clinical trials may be delayed or terminated;impact of global macroeconomic trends on our business,our expectations about t

11、he outcomes of our clinical programs and actions of regulatory agencies;the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials;our efforts to obtain marketing approval from the applicable regu

12、latory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful;the risk that our research collaborations will not continue or will not be successful;and our efforts to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment,i

13、f approved,may be unsuccessful;our dependence on third parties in connection with our clinical trials and other factors beyond our control,that could cause our actual results,performance or achievements to differ materially and adversely from those anticipated or implied in our statements.For additi

14、onal disclosure regarding these and other risks we may face,see the disclosure contained under the heading Risk Factors and elsewhere in the Companys most recent Annual Report on Form 10-K,Quarterly Reports on Form 10-Q and subsequent public filings with the US Securities and Exchange Commission(the

15、“SEC”).You should not rely upon forward-looking statements as predictions of future events.Although our management believes that the expectations reflected in our statements are reasonable,we cannot guarantee that the future results,levels of activity,performance or events and circumstances describe

16、d in the forward-looking statements will be achieved or occur.Moreover,neither we,nor any other person,assumes responsibility for the accuracy and completeness of these statements.Accordingly,you are cautioned not to place undue reliance on these forward-looking statements,which speak only as of the

17、 date such statements are made and should not be construed as statements of fact.Except as required by applicable law,we undertake no obligation to update these forward-looking statements to reflect any new information,events or circumstances after the date hereof,or to reflect the occurrence of una

18、nticipated events.No representations or warranties(expressed or implied)are made about the accuracy of any such forward-looking statements.Market&Industry Data Market&Industry Data Market&industry data projections,estimates,industry data and information contained in this presentation,including our g

19、eneral expectations about our market position and market opportunity,are based on information from third-party sources,publicly available information,our knowledge of our industry and assumptions based on such information and knowledge.Although we believe that our third party-sources are reliable,we

20、 cannot guarantee the accuracy or completeness of our sources.All of the projections,estimates,market data and industry information used in this presentation involve a number of assumptions and limitations,and you are cautioned not to give undue weight to such information.In addition,projections,est

21、imates and assumptions relating to our and our industrys future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors,including,but not limited to,those described above,that could cause future performance to differ materially from our expressed proj

22、ections,estimates and assumptions or those provided by third parties.3|Compass PathwaysCompass Pathways Dedicated to accelerating patient access to evidence-based innovation in mental health.Lead product candidate:COMP360 psilocybin treatment in treatment resistant depression(TRD)Phase 2 TRD program

23、 published in The New England Journal of Medicine Phase 3 TRD program recruitingPivotal trial 1(COMP005):top-line 6-week data expected Q2 2025Pivotal trial 2(COMP006):top-line 26-week data expected H2 2026Phase 2 PTSD positive top-line data reported in Q2 2024$207 million cash and cash equivalents a

24、t September 30,2024$150 million of gross proceeds from January 2025 financing and up to approx.$353 million if the ADS Warrants are fully exercised for cash4|Compass PathwaysTRD treatment pathway:significant unmet need for millions of patientsTreatment pathway stageNew onset depressionNew onset depr

25、essionMajor depressive disorder Major depressive disorder(MDD)(MDD)Persistent depressionPersistent depressionMajor depressive disorder Major depressive disorder(MDD)(MDD)TreatmentTreatment-resistant resistant depression(TRD)depression(TRD)Line of therapyEstimated number of patients(WW)300300 million

26、million200 million200 million100 million(1 in 3 of total)Available treatments Antidepressants Psychological interventions,e.g.,CBT*Antidepressants Antidepressant combinations Psychological interventions Antidepressants Augmentation therapy(antidepressants,mood stabilizers,anticonvulsants,atypical an

27、tipsychotics,esketamine)Ketamine Somatic therapy(rTMS,tDCS,ECT,DBS)*High-intensity psychological interventions%relapse6060-70%70%5050-75%75%80-90%*NOTE:CBT=cognitive behavioural therapy;rTMS=repetitive transcranial magnetic stimulation;tDCS=transcranial direct current stimulation;ECT=electroconvulsi

28、ve therapy;DBS=deep brain stimulationSOURCE Table adapted from Rush,A.J.,Trivedi,M.H.,Wisniewski,S.R.,Nierenberg,A.A.,Stewart,J.W.,Warden,D.,.&Fava,M.(2006).Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps:a STAR*D report.American Journal of Psychiatry

29、,163(11),1905-1917;Zhdanava M,Pilon D,Ghelerter I,et al.The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States.J Clin Psychiatry.2021;82(2):20m13699.First lineSecond lineThird line+6|Compass PathwaysPhase 3 program:Overview of ongoing

30、pivotal trial designsPivotal trial 1 Single dose monotherapy(COMP 005)COMP360 25 mgPlaceboPivotal trial 2 Fixed repeat dose monotherapy(COMP 006)COMP360 25 mgCOMP 360 1 mgCOMP360 25 mgCOMP360 1 mgCOMP360 10 mgCOMP360 10 mgRandomisation=2:1:1 n=568(284:142:142)Week 6(Part A)Primary endpoint*Randomisa

31、tion=2:1 n=255(170:85)Week 3Week 6(Part A)Primary endpoint*Long-term follow-upLong-term follow-upThe phase 3 program will be conducted across approx.150 sites in 12 countries.The participant population(TRD definition and core inclusion/exclusion criteria)remains unchanged compared to Phase 2b*Primar

32、y endpoint-change from baseline in MADRS total score at Week 6Top line 6-week data expected Q2 202526-week data expected H2 20267|Compass PathwaysPhase 3 program long-term follow up componentpivotal trial 1(005)n=255Part A(blinded):Part A(blinded):Week 6primary endpoint*Part B(blinded):Part B(blinde

33、d):to week 26Part C(open label):Part C(open label):week 26 to week 52*Primary endpoint-change from baseline in MADRS total score at Week 6COMP360 25 mgCOMP360 25 mg x2COMP360 1 mg x2COMP360 10 mg x2option for retreatment(same dose as Part A)COMP360 25mg treatment(after relapse)Placebooption for retr

34、eatment(same dose as Part A)COMP360 25mg treatment(after relapse)pivotal trial 2(006)N=5688|Compass PathwaysPhase 2b trial:Results demonstrate the potential for a rapid,sustained response in TRDPublished in The NEW ENGLAND JOURNAL of MEDICINE*Randomized,controlled,double-blind trial,3 arms,single do

35、se(either 1mg,10mg or 25 mg)of COMP360 psilocybin alongside psychological support.Results were measured as a change on the MADRS*depression scale from baseline(a day prior to administration)over a 12-week period.The primary endpoint of this study was the change from baseline in MADRS total score at

36、week 3.Rapid onset of action:Rapid onset of action:The effect occurred the day after the administration.Clinical EffClinical Effectect:We saw a statistically significant and clinically meaningful reduction in depression symptoms.Durability:Durability:We saw a sustained response at week 12 a positive

37、 indication for high potential as a monotherapy.NOTE:*Least square mean change from baseline in MADRS total score;MADRS=Montgomery-sberg Depression Rating ScaleWithout imputation for use of anti-depressants during trial period(consistent with phase 3 design)With imputation for use of anti-depressant

38、s during trial period(applied in phase 2b)*N Engl J Med 2022;387:1637-48.DOI:10.1056/NEJMoa2206443 9|Compass PathwaysPhase 2b most frequent TEAEs ordered by the 25mg arm(at least 5%in any treatment group)TEAE incidence is higher in the 25mg group overallKey mood-related TEAEs(euphoric mood,depressio

39、n,depressed mood,suicidal ideation)do not have a higher incidence in the 25mg armNote:MedDRA=Medical Dictionary for Regulatory Activities;TEAE=treatment emergent adverse event;N=number of participants in the population;n=number observedMedDRA TEAE preferred term COMP36025mgCOMP36010mgCOMP3601mgOvera

40、llN=79N=75N=79N=233n(%)Headache27(34.2)16(21.3)20(25.3)63(27.0)Nausea18(22.8)7(9.3)4(5.1)29(12.4)Fatigue12(15.2)5(6.7)7(8.9)24(10.3)Insomnia8(10.1)11(14.7)14(17.7)33(14.2)Anxiety7(8.9)13(17.3)3(3.8)23(9.9)Mood altered 7(8.9)3(4.0)1(1.3)11(4.7)Back pain6(7.6)03(3.8)9(3.9)Dizziness6(7.6)1(1.3)1(1.3)8(

41、3.4)Suicidal ideation5(6.3)5(6.7)4(5.1)14(6.0)Myalgia5(6.3)2(2.7)1(1.3)8(3.4)Euphoric mood4(5.1)5(6.7)4(5.1)13(5.6)Depression4(5.1)6(8.0)5(6.3)15(6.4)Abdominal pain upper4(5.1)2(2.7)1(1.3)7(3.0)Irritability4(5.1)2(2.7)1(1.3)7(3.0)Panic reaction4(5.1)1(1.3)1(1.3)6(2.6)Depressed mood3(3.8)5(6.7)4(5.1)

42、12(5.2)Paraesthesia3(3.8)4(5.3)1(1.3)8(3.4)Thinking abnormal04(5.3)04(1.7)10|Compass PathwaysPhase 2b trial:COMP360 psilocybin treatment was generally well-toleratedThere were no concerns with vital signs,ECG or clinical laboratory data in any of the treatment groupsTEAEs involving hallucinations(wh

43、ich only occurred in the 25mg and 10mg groups)and illusions(all groups)started and resolved on the day of administration.TESAEs of suicidal ideation,suicidal behaviour and intentional self-injury were uncommon but occurred unevenly across groups in non-responders All patients who experienced these e

44、vents during the trial had said during screening that they had had suicidal thoughts prior to the trial.3 TESAEs of suicidal behavior in non-responders,30 days post administration in the 25 mg arm emphasizing the need for a vigilant approach to the TRD condition.90%of TEAEs were of mild or moderate

45、severity.5most frequent TEAEs across the 10mg and 25mg doses were headaches,nausea,fatigue,insomnia and anxiety.Treatment-emergent adverse events(TEAEs)77%of TEAEs occurring on the day of administration resolved on the same or next day;most were mild or moderate.11|Compass PathwaysPlanning for comme

46、rcial execution through an existing and well-established infrastructure of interventional psychiatry treatment centersIf approved,COMP360 is expected to be delivered to patients through an established infrastructure of interventional psychiatry treatment centers4,000 sites currently set up to delive

47、r available interventional psychiatry treatments#1.4 million prescriptions/procedureswere administered at established treatment centers in 2023Strategic collaborations have been established between Compass and select treatment centers across the US to help inform preparation for a scalable delivery

48、model for COMP360,if approved#Compass estimate.Interventional psychiatry treatments:Spravato(esketamine),ketamine,transcranial magnetic stimulation(TMS)and electroconvulsive therapy(ECT);treatment#s represent a typical course over 6 months Esketamine:IQVIA Longitudinal Access and Adjudication Data(L

49、AAD),2023;rTMS&ECT:Definitive ATLAS All-payer claims database,7/27/2024 updateReferences:1 ICER,2019;2 Ross,2018;3 Petrides,2011;4 Thirthalli,2020;5 Voigt,2017;6 Wilkinson,2018*New CPT III codes accepted,and language released by AMA for Psychedelic Drug Monitoring Services;published in the CPT Manua

50、l and effective on January 1,2024ketamine:12-15 treatments(6)ECT:6-12+treatments(3)(4)Spravato(esketamine):20-28 treatments(1)TMS:30-36 treatments(2)(5)Current interventional psychiatry treatments are delivered frequently#,allowing for operational experience at the treatment centers,but requiring a

51、cumulatively high number of hours of patient and provider timeIf approved,COMP360 and the services/time*provided at treatment centers are expected to be reimbursed by Payers 12|Compass PathwaysWe are developing a balanced and differentiated pipelineDiscoveryPreclinicalPhase 1Phase 2Phase 3ApprovedCO

52、MP360 for TRDCOMP360 for PTSDCOMP360 for anorexia nervosaBeyond TRD:Were assessing the safety and efficacy of COMP360 psilocybin therapy for PTSD and anorexia nervosa.NOTE:NCE=new chemical entity;PTSD=post-traumatic stress disorder;TRD=treatment-resistant depressionLead COMP360 program in TRDPTSD is

53、 a key target for COMP360 given encouraging phase 2 data and similarities in PTSD and TRD patient co-morbidities.We have a range of options for a clinical development program and we are now exploring those options.13|Compass PathwaysPhase 2 PTSD study safety profile(primary endpoint)NOTE:E=events,Me

54、dDRA=Medical Dictionary of Regulatory Authorities,n=number of participants with TEAE,PT=preferred term,TEAE=treatment emergent adverse eventCOMP360 was well tolerated with no treatment emergent serious adverse events reported No participants re-started SSRIs or antidepressants after COMP360 administ

55、ration in studySummary of most frequent TEAES(10%prevalence)There were 2 events of suicidal ideation,the first event was a moderate and transient event on administration day who went on to be a responder.The second event was mild and occurred at Week 7 by a non-responder.Both events resolved during

56、the study.14|Compass PathwaysPost-traumatic stress disorder(PTSD)positive phase 2 studyN=22,multi-center open-label,single administration of 25mg COMP360 with psychological supportEarly onset and sustained change from baseline in CAPS-5 observed at week 4 and week 12 Durability in CAPS-5 reductions

57、from baseline seen at week 4(29.5 points)and week 12(29.9)Response in CAPS-5:81.8%at week 4,77.3%at week 12Remission in CAPS-5:63.6%at week 4,54.5%at week 12COMP360 was generally well tolerated with no treatment emergent serious adverse events reported No participants re-started SSRIs or antidepress

58、ants after COMP360 administration in studyMean baseline of 47.5 CAPS-5 total score,which is considered severeNOTE:CAPS-5=clinician administered PTSD scaleSummary of change from baseline in CAPS-5 scoreSummary of change from baseline in SDS score15|Compass PathwaysWere a biotechnology companydedicated to accelerating patient access to evidence-based innovation in mental health.Stephen SchultzSVP,Investor R+1 401-290-7324