Filed by Eleusis Inc.
Pursuant to Rule 425 under the Securities Act of 1933, and
deemed filed pursuant to Rule 14a-12 under the
Securities Exchange Act of 1934
Subject Company: Silver Spike Acquisition Corp II
Commission File No.: 001-40182
Disclaimer Forward-Looking StatementsThis document contains certain “forward-looking statements” within the meaning of the federal securities laws, with respect to the proposed transaction between Eleusis Holdings Limited and Eleusis Inc. (collectively, “Eleusis”) and Silver Spike Acquisition Corp II (“Silver Spike”). These forward-looking statements are generally identified by words such as “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” or the negatives of these words or words of similar meaning. These forward looking statements include, but are not limited to, statements regarding the benefits of the transaction, the anticipated timing of the transaction, Eleusis’s product candidates and expected markets, and Eleusis's projected future results. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Such forward-looking statements are based upon the current beliefs and expectations of the management of each of Silver Spike and Eleusis and are inherently subject to significant business, economic and competitive risks, uncertainties and contingencies. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of Silver Spike’s securities, (ii) the failure to satisfy the conditions to the consummation of the transaction, including the adoption of the agreement and plan of merger by the shareholders of Silver Spike, the satisfaction of the minimum trust account amount following redemptions by Silver Spike’s public shareholders and the receipt of certain governmental and regulatory approvals, (iii) the lack of a third party valuation in determining whether or not to pursue the proposed transaction, (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement and plan of merger, (v) the effect of the announcement or pendency of the transaction on Eleusis’s business relationships, performance, and business generally, (vi) risks that the proposed transaction disrupts current plans of Eleusis and potential difficulties in Eleusis employee retention as a result of the proposed transaction, (vii) the outcome of any legal proceedings that may be instituted against Eleusis or against Silver Spike or Eleusis related to the agreement and plan of merger or the proposed transaction, (viii) the ability of Eleusis’ securities to qualify to list on The Nasdaq Capital Market, (ix) volatility in the price of Silver Spike’s securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Eleusis plans to operate, variations in performance across competitors, changes in laws and regulations affecting Eleusis’s business and changes in the combined capital structure, (x) the impact of the global COVID-19 pandemic, (xi) the enforceability of Eleusis's intellectual property, including its trademarks, and the potential infringement on the intellectual property rights of others, cyber security risks or potential breaches of data security, (xii) the ability of Eleusis to protect the intellectual property and confidential information of its customers, (xiii) unexpected costs, charges, or expenses resulting from the proposed business combination, (xiv) evolving legal, regulatory and tax regimes, (xv) the possibility that Eleusis may be adversely affected by other economic, business and/or competitive factors, (xvi) actions by third parties, including government agencies, and (xvii) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Silver Spike’s Quarterly Reports on Form 10-Q, the registration statement on Form S-4 and proxy statement/prospectus included therein discussed below and other documents filed by Silver Spike and Eleusis from time to time with the U.S. Securities and Exchange Commission (the “SEC”). You are cautioned not to place undue reliance on these forward-looking statements as a predictor of future results, performance and/or achievements as projected financial information and other information are based on estimates and assumptions, whether or not identified in this document, that are inherently subject to various significant risks, uncertainties, contingencies and other factors, many of which are difficult to predict and generally beyond the control of the parties. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Eleusis and Silver Spike assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Neither Eleusis nor Silver Spike gives any assurance that either Eleusis or Silver Spike will achieve its expectations.Additional Information and Where To Find ItThis document relates to a proposed transaction between Eleusis and Silver Spike. This document does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Silver Spike and Eleusis intend to file a registration statement on Form S-4 that will include a preliminary proxy statement for the solicitation of Silver Spike shareholder approval and prospectuses of Silver Spike and Eleusis Inc. The proxy statement/prospectus will be sent to all Silver Spike stockholders. Silver Spike and Eleusis Inc. also will file other documents regarding the proposed transaction with the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF SILVER SPIKE ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/ PROSPECTUS AND ALL OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.Investors and security holders will be able to obtain free copies of the proxy statement/prospectus and all other relevant documents filed or that are or will be filed with the SEC by Silver Spike and Eleusis through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by Silver Spike and Eleusis Inc. may be obtained free of charge from their respective websites at silverspikecap.com or by written request to Silver Spike at 660 Madison Ave, Suite 1600, New York, New York 10065.Participants in SolicitationSilver Spike and Eleusis and their respective directors and officers may be deemed to be participants in the solicitation of proxies from Silver Spike’s stockholders in connection with the proposed transaction. Information about Silver Spike’s directors and executive officers and their ownership of Silver Spike’s securities is set forth in Silver Spike’s filings with the SEC. To the extent that holdings of Silver Spike’s securities have changed since the amounts printed in Silver Spike’s proxy statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the proxy statement/ prospectus regarding the proposed transaction when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph. 2
CHALLENGE: Unlock the Therapeutic Potential of Psychedelics 3 Promising Efficacy Data in Depression Major Depressive Disorder (MDD) is the leading cause of disability worldwide and a major contributor to global disease burden1 Psilocybin, an investigational psychedelic drug, observed to have rapid, robust, and durable antidepressant effect in third party clinical studies2 Concerns About Practicality Encapsulated psilocybin may only be “half-way” to a medicine due to the limitations of oral formulation The “Last Mile”of Care Delivery Psilocybin and other psychedelic drug therapies in development may not be compatible with conventional psychiatric practice or existing frameworks for “in-network” insurance coverage and reimbursement 1 2 3 Source: 1) WHO Fact Sheet, 9/13/21 https://www.who.int/news-room/fact-sheets/detail/depression 2) Carhart-Harris, R.L ,et al. (2021). Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine, 384(15), 1402–1411; Compass Pathways Press Release, 11/9/2021 ; https://compasspathways.com/positive-topline-results/); Davis, A. K., et al. (2020). Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. JAMA Psychiatry.
4 Eleusis at-a-glanceDedicated to transforming psychedelics into medicines for livingWE ARE DEVELOPINGA 2nd generation investigational psilocybin-based drug candidate for Major Depressive Disorder (MDD) and a discovery platform for exploration beyond psychiatryA care delivery management company to help facilitate seamless “in-network” integration with existing US healthcare infrastructure
Key Investment Highlights 5 Significant Market Opportunity Source: 1) Global Antidepressants Market Report 2021: COVID-19 Causes a Surge in Demand for Antidepressant Drugs as Mental Health Problems Rise - ResearchAndMarkets.com, Business Wire, April 26, 2021; 2) Partheniou, A. (2021) Psychedelics – A possible disrupter to legacy treatments, Stifel Nicholaus Canada Inc., January 14, 2021 (estimate based in part on data from existing ketamine clinics). Antidepressant total addressable market (TAM) expected to reach $21bn by 20251US psychedelic care delivery TAM estimated to be ~$7bn2 2nd Generation Psilocybin Drug Candidate for MDD ELE-Psilo is our lead product candidate, comprised of the active ingredient in psilocybin formulated for IV deliveryTargeting a consistent, controllable, and practical psilocybin-based therapy for the treatment of MDD A First-in-Class Care Delivery Management Company Andala is an operationally integrated platform of “in-network” clinics targeting the “last mile” challenge of psychedelic drug therapy 1 Anticipated initiation of Phase Ia study in 1H 2022Anticipated Phase Ia / IIa results in 2H 2022 Anticipated Cash Flow Positive Clinic Operations in 1H 2023 2 3
Potential to Achieve Full Proof of Concept: ELE-Psilo Phase I Data by 2H 2022, Care Delivery by 1H 2023 Note: MDD = Major depressive disorder, IND = investigational new drug application. 6 Clinical Development Program IND enabling Phase Ia Phase IIa ELE-Psilo (ELE-101; IV formulation) Plan to Initiate Ph Ia in 1H 2022 Plan to Initiate Ph IIa in MDD patients in 2H 2022 SelectAnticipated Milestones 2H 2022 2023 Phase Ia Safety, Tolerability and PK/PD Results Phase IIa MDD Patient Results Initiation of Phase IIb in MDDCash Flow Positive Andala Operations 2021 2022 Innovation Passport Designation granted as a part of MHRA’s Innovative Licensing and Access Pathway for adult patients with treatment resistant depression (10/21)FDA Pre-IND Written Responses expected in 3/22
DAVID WEINER, MD VP, Drug Discovery Discovery and Preclinical Clinical Commercial David Nichols, PhDDirector, Molecular Pharmacology Allan Shepard, PhDDirectorTranslational Research Yoni Weiss, MDVP,Clinical Development Neiloufar Family, PhDVP, Health Solutions Berrak Kocaoglu, MScVP,Commercial Strategy Charles Nichols, PhDScientific Founder &Sponsored Researcher Tim Foster, PhDSponsored Researcher Sarah Blondell, MScVP,Clinical Operations Rachel Handy, PhDVP,Quality Assurance Alex SpeiserDirector,Corporate Development Graham Johnson, PhDDirector,Medicinal Chemistry Tim Williams, MDDirector, Clinical Development Joanna Sambor VP,Regulatory Affairs Leadership Team 7 GENE RAMIREZ Chief Financial Officer SHLOMI RAZ Chief Executive Officer KATHY KALUHIOKALANI President, Andala ROB CONLEY SVP, Clinical Development Deep Expertise Spanning Discovery, Development, and Delivery; 972 Peer-Reviewed Publications1 1) Statistics are cumulative across all six professionals listed herein.
Psychedelics May Transform the Treatment of Depression We aim to mainstream the transformation ELE-Psilo and Drug DiscoveryCare DeliveryTransaction Summary
Major Depressive Disorder (MDD) is the Silent Epidemic of the 21st Century 50M+ Adults in the US with depression symptoms prior to the pandemic1 $113B Driving massive direct health care expenditures2 $21B+ Antidepressant total addressable market expected by 20253 Source: 1) Millions to gain access to Psychedelic Psychotherapy in bid to fight pandemic induced depression and anxiety. Yahoo Finance (June 17, 2021) (citing Anxiety and Depression Household Pulse Survey. CDC National Center for Health Statistics (accessed July 3, 2021); 2) Greenberg, P.E., et al. (2021) The Economic Burden of Adults With Major Depressive Disorder in the United States (2010 and 2018) PharmacoEconomics 39, 653-665 (number from 2018 and represents the aggregate of pharmaceutical and medical services); 3) Global Antidepressants Market Report 2021: COVID-19 Causes a Surge in Demand for Antidepressant Drugs as Mental Health Problems Rise - ResearchAndMarkets.com, Business Wire, April 26, 2021; 4) Partheniou, A. (2021) Psychedelics – A possible disrupter to legacy treatments, Stifel Nicholaus Canada Inc, 01/14/2021 (estimate based in part on data from existing ketamine clinics). $7B Estimated psychedelic care delivery total addressable US market4 9
Source: 1) Kadriu et al., Ketamine and Serotonergic Psychedelics: Common Mechanisms Underlying the Effects of Rapid-Acting Antidepressants, Int J Neurops, 1(24), 2020 2) Carhart-Harris, R.L ,et al. (2021). Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine, 384(15), 1402–1411; Compass Pathways Press Release, 11/9/2021 ; https://compasspathways.com/positive-topline-results/); Davis, A. K., et al. (2020). Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. JAMA Psychiatry. 3) Publication in draft; partial results published in Nardou R et al (2019) Oxytocin-dependent reopening of a social reward learning critical period with MDMA. Nature. 2019 May;569(7754):116-120. 10 Rapid, Robust, and Durable Antidepressant Effects of PsychedelicsAcademic Preclinical and Clinical Study Observations Modulated pathways associated with synaptic growth in preclinical studies1 Rapid, robust, and durable antidepressant effects observed in third party clinical trials2 Potential to open a “critical window” for adaptation and behavior change3
Third Party Oral Psilocybin Proof of Concept Studies in MDD and Treatment Resistant Depression (TRD) TRD Phase IIb Study: Psilocybin (25mg, 10mg, 1mg)4 Significant Effect from Day 2 to Week 6 Reported in Third Party Topline Data Release 11 MADRS: -6.6 (p<.001; 25mg vs 1mg) “We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder” 5 Prof David Hellerstein, Principal Investigator, Columbia University Met Primary Endpoint MADRS:-14.4 vs -7.2 “A series of studies by Carhart-Harris and colleagues…provide tantalizing evidence for the efficacy of psilocybin in the treatment of major depressive disorder” 3 Prof Jeffery Lieberman, Columbia University MDD Clinical Study: Psilocybin (25mg) vs. Escitalopram1 Mean Change (QIDS-SR-16 Score) Day Rapid, robust, and durable efficacy observed – but significant room for improvement No statistically significant difference in QIDS-SR-16 depression score at 6 weeks, but assessments favored psilocybin2 Secondary outcomes2 include: HAM-D-17: -10.5 vs -5.1 Source: 1) Carhart-Harris et al.(2021). Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine, 384(15), 1402–1411; psilocybin dosing at day 0, 21; escitalopram group received 2 separate doses of 1 mg of psilocybin plus daily escitalopram 2) As per Carhart-Harris et al. (2021), statistical significance assessments not conducted other than for primary endpoint at 6-week timepoint, and no correction for multiple comparisons of the outcomes was conducted at any intermediate time points, so no clinical conclusions can be drawn. 3) Lieberman, J. (2021) Back to the Future - The Therapeutic Potential of Psychedelic Drugs, NEJM 384,15. 4_15_2021; 4) COMPASS Pathways Press Release, 11/9/2021; and COMPASS Pathways Phase IIb Trial Presentation 11/9/2021 5) https://www.columbiapsychiatry.org/news/psilocybin-found-rapidly-improve-depressive-symptoms-clinical-trial
Practical Limitations of Oral Psilocybin 12 Source: 1) Madsen, M. K. et al. (2019). Psychedelic effects of psilocybin correlate with serotonin 2A receptor occupancy and plasma psilocin levels. Neuropsychopharmacology, 44(7), 1328–1334; Brown, R. T. et al. (2017). Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clinical Pharmacokinetics, 56(12), 1543–1554. 2) Johnson M.. et al. (2008); Human hallucinogen research: guidelines for safety. Journal of Psychopharmacology (Oxford, England), 22(6), 603–620; Rucker, J. et. al (2019) Psilocybin administration to healthy participants: safety and feasibility in a placebo-controlled study. Poster presented at the 58th Annual Meeting of The American College of Neuropsychopharmacology, Orlando, FL, USA, 8–11 December 2019. Passie, T.(2002). The pharmacology of psilocybin. Addiction Biology, 7(4), 357–364., 2) Single and Escalating Dose PK1 Single dose Cmax for Subject 3 (12 mg) higher than Cmax values for Subjects 4, 5, and 6 (15, 18, and 24 mg) Study of escalating oral psilocybin doses revealed considerable inter and intra-individual variability Encapsulating psilocybin is only “half-way” to developing a useful drug therapy Absorption rates varied between 40% to 70% in these academic studies Oral Psilocybin LimitationsVariabilityConsiderable variations in absorption and metabolism necessitated high doses and gave rise to unpredictable PK/PD1Prolonged Administration and Observation6-hour sessions used for administration and observation in these studies, and required monitoring by multiple clinicians2Difficult to Optimize or HaltOral dosing is not amenable to personalization or rapid termination2
13 CONSISTENTFormulated to reduce variability in drug exposureCONTROLLABLEDesigned to be personalized and enable control over duration and intensityPRACTICALDeveloped to be convenient for patients and cost-effective for payors Active moiety of psilocybin ELE-Psilo (Psilocin) ELE-Psilo: A Potential Advance in Formulation Source: Madsen, M. K. et al. (2019). Psychedelic effects of psilocybin correlate with serotonin 2A receptor occupancy and plasma psilocin levels. Neuropsychopharmacology, 44(7), 1328–1334 Hasler, F. et al. (1997). Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharmaceutica Acta Helvetiae, 72(3), 175–184. Carhart-Harris et al. (2011). The administration of psilocybin to healthy, hallucinogen-experienced volunteers in a mock-functional magnetic resonance imaging environment: a preliminary investigation of tolerability. Journal of Psychopharmacology, 25(11), 1562–1567. Designed for delivery via proprietary salt formulated for IV/infusion
14 ELE-Psilo Target Profile Source: 1) Johnson, M. W. et al. (2018). The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act. Neuropharmacology. 142, 143–166. Proposed Indication Rapid Acting Treatment of MDD Proposed Formulation Proprietary Psilocin Salt Form in Ready-to-Use Vial Proposed Administration IV Infusion Potential Duration of Administration 10-to-30 min infusion≤ 2 hours in-clinic Investigational Dose Range 1 - 5mg Abuse Potential Potential reclassification if FDA Approved1
IV Psilocybin Pharmacokinetics and Pharmacodynamics (PK/PD): Academic Studies Source: 1) Hasler, F. et al. (1997). Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharmaceutica Acta Helvetiae, 72(3), 175–184. 2) Carhart-Harris et al. (2011). The administration of psilocybin to healthy, hallucinogen-experienced volunteers in a mock-functional magnetic resonance imaging environment: a preliminary investigation of tolerability. Journal of Psychopharmacology, 25(11), 1562–1567. Psilocin PK following IV and Oral Psilocybin IV Psilocybin PD 15 IV administration enabled (1) immediate target drug intensity, and (2) greatly reduced treatment time and variability compared to oral administration
Psilocin Receptor Occupancy, Drug Intensity, and Treatment Effect: Academic Studies 16 Source: 1) Madsen, M. K. et al. (2019). Psychedelic effects of psilocybin correlate with serotonin 2A receptor occupancy and plasma psilocin levels. Neuropsychopharmacology, 44(7), 1328–1334; 2) Brown, R. T. et al. (2017). Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clinical Pharmacokinetics, 56(12), 1543–1554 3) Yaden, D. B., & Griffiths, R. R. (2021). The Subjective Effects of Psychedelics Are Necessary for Their Enduring Therapeutic Effects. ACS Pharmacology and Translational Science; 4) Davis, A. K., et al. (2020). Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. JAMA Psychiatry. 5) GH Research Ltd. Press Release “GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression”, 12/6/2021 5-HT2A receptor occupancywas correlated withvolunteer-reported drug intensity1 Psilocin concentration was correlated with serotonin 5-HT2A receptor occupancy1 ELE-Psilo Target Range Patient-reported psychedelic drug intensity was correlated with the antidepressant effects of psilocybin3,4 and 5-MeO-DMT5
ELE-Psilo PK/PD Simulations IV administration could rapidly reach target intensity and rapidly return below perceptual threshold 17 Psilocin Concentration-Time Profile (Simulated)(10 and 20-minute IV Psilocin vs Oral 25 mg of Psilocybin) Source: 1) Hasler, F. et al. (1997). Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharmaceutica Acta Helvetiae, 72(3), 175–184; Eleusis simulations based on primary data from Brown et al. 2017, Madsen et al . 2019, Hasler et al. 1997, and Carhart-Harris et al. 2011. Plasma psilocin concentration (μg/L) (Predicted) Time (min) Estimated PD Threshold 5-HT2A Receptor Occupancy Target Range 25 mg PO; Psilocybin 4 mg IV Psilocin; 20 min infusion 2 mg IV Psilocin; 10 min infusion Eleusis simulations suggest target concentrations of psilocin reachable in ~2 minSimulations also support potential personalization of intensity via alteration of infusion rate
Study Population Healthy Volunteers (40 maximum) Moderate-to-Severe MDD Patients (Monotherapy Only) Treatment Groups 6:2 volunteer ratio per cohort(Anticipated 3-to-4, 5 maximum) 6 patients(single cohort, open label) Infusion Duration and Dose 10 minutes; 0.5, 1.5, 2.5 mg (plus, optional 2 additional cohorts) Selected after 3rd or 4th Phase Ia cohort Clinical Assessments PK (including metabolites), 5 questionnaires includingSubjective Drug Intensity MADRS1 (Day 2, 4, 8, 15, 29)5 questionnaires includingSubjective Drug Intensity Safety Assessments Vitals, Labs, ECG, AEs, C-SSRS2 Vitals, Labs, ECG, AEs, C-SSRS2 Attendant Non-directive support from clinician;no manualized psychotherapy3 Non-directive support from clinician;no manualized psychotherapy3 Time to Completion 3-4 months 4 months from dose selection and initiation of patient recruitment Source: Eleusis estimates and current proposed clinical trial design, subject to modification, regulatory review and approval, and further amendment (as of 2/07/2022); 1) Montgomery–Åsberg Depression Rating Scale 2) Columbia Suicide Severity Rating Scale 3) In-session support during treatment will be provided by an 'Attendant', as per the ELE-101 Attendant Manual. An Attendant will be always present with each participant and their sole role will be the participant's psychological safety; Attendants will not be involved in any medical, nursing or other research activities. The Attendant will be a clinical trials assistant (CTA) (or equivalent level of training and experience). Each Attendant will receive training to enable them to competently use and follow the ELE-101 Attendant Manual. An Attendant may at any time ask for extra support from the study nurse, doctor or on-call medical/psychiatric help if needed. A psychiatrist will be on-call during the ELE-101 dosing of each participant. ELE-Psilo – Clinical Trial Design Phase Ia Phase IIa 18
Formulation IV Oral Intranasal Onset / PK Design Attribute Designed to be Immediate with Low Variability Observed to be Delayed and Highly Variable in Clinical Studies Observed to be Immediate and Highly Variable3 Potential Duration of Treatment Administration Simulated ≤ 2 hours ~6 hours Unknown; duration affected by individualized dosing regimen3 Potential Monitoring Cost $3501 $3,1502 Unknown Compatibility with Existing (US) Reimbursement Targeting Compatibility with Existing Reimbursement Frameworks May Require New Reimbursement Framework Unknown Anticipated Infrastructure Requirements Designed for Existing Clinical Infrastructure New Infrastructure Potentially Required for Prolonged Safety Monitoring2 Unknown Safety Considerations Phase Ia and IIa results anticipated in 2022 Variable onset/duration of drug effect, inability to terminate drug effect Multiple administrations per treatment3; incidence of reactivations/flashbacks5 1) Eleusis simulations based on primary data from Brown et al. 2017, Madsen et al . 2019, Hasler et al. 1997, and Carhart-Harris et al. 2011; 2) ELE-Psilo care delivery estimates based on 3 hours of psychiatric-mental health nurse involvement ($50 per hour) and 2 hours of psychiatric oversight ($100 per hour); Oral psilocybin based on estimated hourly cost of a certified therapist ($150) and assumes 2 therapists and 1 supervising psychiatrist, and the current clinical trial paradigm (1 hour preparation session, one 6-hour dosing session, and 1 hour integration session). Rucker, J. et. al (2019) Psilocybin administration to healthy participants: safety and feasibility in a placebo-controlled study. Poster presented at the 58th Annual Meeting of The American College of Neuropsychopharmacology, Orlando, FL, USA, 8–11 December 2019 (treatment program); Carhart-Harris et al. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med. 2021 Apr 15;384(15):1402-1411. doi: 10.1056/NEJMoa2032994 (Supplement) (assumptions about therapist treatment); Occupational Employment and Wages, May 2018, 29-1171 Nurse Practitioners. US Bureau of Labor Statistics (Nurse Practitioner rates); How Much Does Therapy Cost? (And Why Is It So Expensive?), The Talkspace Voice (October 29, 2015); Occupational Employment and Wages, May 2018, 29-1066 Psychiatrists. US Bureau of Labor Statistics (Psychiatrist rates) 3) GH Research Corporate Presentation, June 2021; 4) Weil, A. T., & Davis,W. (1994). Bufo alvarius: A potent hallucinogen, of animal origin. Journal of Ethnopharmacology, 41(1–2), 1–8. 5) Uthaug, M.V., Lancelotta, R., Ortiz Bernal, A.M., Davis, A.K., & Ramaekers, J.G. (2020). A comparison of reactivation experiences following vaporization and intramuscular injection (IM) of synthetic 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting. Journal of Psychedelic Studies. ELE-Psilo - Potentially Favorable Differentiation Psilocin Psilocybin 19 5-MeO-DMT
ELE-Psilo IP Portfolio 20 Claimed Subject Matter Estimated Expiration1 Pharmaceutically Acceptable Salts of Psilocin and Uses Thereof Composition of pharmaceutically acceptable salts of psilocin with improved stability, physical properties, and handling characteristics 2041 Method Of Treatment For Psilocybin or Psilocin Infusion Methods for treating patients by administering intravenous psilocybin or psilocin 2040 Psilocin Salt Forms and Methods of Treatment 1 Note: 1) Assumes expiration is 20 years from the associated patent filing date in the United States.
Exploring Psychedelics Beyond Psychiatry - Eleusis Drug Discovery Platform 21 Clarifying MoA to Guide Discovery Validated Target in Multiple Therapeutic Areas Ubiquitous Expression and Key Modulatory Role Source: 1) Flanagan, T. W., et al. (2018). Psychedelics as anti-inflammatory agents. International Review of Psychiatry, 1–13; 2) Nichols, D. E et al. (2016). Psychedelics as Medicines: An Emerging New Paradigm. Clinical Pharmacology and Therapeutics 3) Eleusis sponsored studies and sponsored university research program Receptor target (5-HT2A) is highly expressed throughout the periphery and CNS on key cell types that modulate immune, metabolic, and synaptic function1,2 Psychedelics have been validated in multiple translational models and across a broad range of therapeutic areas beyond psychiatry1,3 Studying effects on innate and adaptive immune function, cell viability, and metabolic functionMedicinal chemistry effort focused harnessing these effects and identifying new drug candidates Identify new indications beyond psychiatry and expand new chemistry library Advance a topically delivered therapyfor ocular disease Discovery Mission Translation Mission
Exploring Psychedelics Beyond Psychiatry - Eleusis Drug Discovery Platform 22 Translation inOphthalmology Source: 1) NZW rabbits administered topical ELE-01 6x the day prior, and once 1hr prior the challenge with compound 48/80, which induces histamine release and mast cell degranulation; 4 animals per group, 8 eyes per group 2) Eleusis sponsored study of topical ELE-01 (0.01%, TID) in TB-induced Uveitis in NZW rabbits 3) Eleusis sponsored university research program Efficacy observed in translational models of allergic conjunctivitis1, uveitis2, glaucoma and tear production3 ELE-102 is a topically delivered drug candidate currently in IND-enabling preclinical studies Identify new indications beyond psychiatry and expand new chemistry library Advance a topically delivered therapyfor ocular disease Discovery Mission Translation Mission
Psychedelic Drug Therapy Will Require Care Delivery Innovation Enabling Access to Insurance Covered Psychedelic Drug Treatment ELE-Psilo and Drug DiscoveryCare DeliveryTransaction Summary
24 Source: 1) Wilkinson ST, Howard DH, Busch SH. Psychiatric Practice Patterns and Barriers to the Adoption of Esketamine. JAMA. 2019;322(11):1039–1040. Addressing the “Last Mile” Challenge for Psychedelic Drug Therapy OPPORTUNITY Conventional psychiatric practice appears incompatible with psychedelic drug therapy1SPRAVATO roll-out highlights “last mile” challenge of specialty pharma in psychiatryRequirement for supervised care delivery in a specialized facility on a periodic basis
25 Establish Best-in-Class Platformfor In-Network Care Delivery MISSION Provide patients seamless access to careSecure in-network preferred provider status nationwide for Andala-managed clinicsDevelop diversified referral pathways to increase access to care
Introducing Andala-Managed Clinics1 1st Anticipated Milestone Prototype Launch1H 2022In-network Payor ModelTargeting 3 Prototype Managed Clinics 26 Commercial Proof-of-Concept2H 2022 - 2023Prototype Managed Clinics Achieve Cash Flow Positive OperationsNational Expansion 2nd Anticipated Milestone Opportunity Address the “last mile” challenge of psychedelic drug therapy TAM (US) $7bn1(estimate assumes FDA approved psychedelic drug therapy for MDD, PTSD, and substance abuse) Business Model In-network high-throughput specialty psychiatric drug therapy Core Competency Operational integration with existing healthcare infrastructure Launch Therapy SPRAVATO (esketamine)(Indications: TRD, MDD w/Acute Suicidality) Notes and Sources: 1) Eleusis expects to divest Andala in advance of FDA approval of ELE-Psilo or any other drug candidate and may elect to divest in whole or in part in advance of FDA approval. 2) Partheniou, A. (2021) Psychedelics – A possible disrupter to legacy treatments, Stifel Nicholaus Canada Inc, 01/14/2021 (estimate based in part on data from existing ketamine clinics).
Andala-Managed Clinic Prototype - Estimated Unit Level Economics 27 1) Estimated covered lives (adults) in anticipated prototype region (Texas) based on BCBS/Anthem (https://www.bcbs.com/news/state-by-state) data and US census data on US adult population relative to total population (https://www.census.gov/quickfacts/fact/table/US/PST045219) 2) Estimate of TRD patient population in prototype regions covered by BCBS/Anthem adjusted for MDD/TRD prevalence in US adults; prevalence data from 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.depression) 3) Estimate assumes 3 clinics and full capacity is assumed to be at 375 patients treated 24 times per year per clinic based on capacity for 9,000 treatment per year per clinic; 4) Assumes 6 rooms per facility, 6 treatments per room per day, 250 operating days per year; 5) Eleusis estimates based on capital budget and financial projections as of 12/1/2021 ; 6) Eleusis estimates; per patient net revenues assume SPRAVATO treatment under a 1yr authorization from a large group insurance payor. Clinic Capacitation Capacity for 9,000 treatments per year per clinic4Clinics aim to:Treat 30 new patients per month within 4 months5Reach 85% capacitation within 9 months5 Patient Acquisition &Reimbursement $1,267 per patient acquisition cost assumed5 $6,356 per patient net revenues6Average net reimbursement $265 per visit5 Estimated Run-rate and Return 85% capacitated run-rate revenue of ~$2.4m; EBITDA of ~$800k5Cash flow positive at ~50% capacity5~220% annual return on invested capital per clinic5 Patient Population ~5.7m large group covered lives in prototype region1~60k TRD patients covered2~1% TRD patient acquisition required for full capacitation3
Care Delivery Model Comparison 28 Source: 1) Partheniou, A. (2021) Psychedelics – A possible disrupter to legacy treatments, Stifel Nicholaus Canada Inc, 01/14/2021 (estimate based in part on data from existing ketamine clinics). ReimbursementModel Expected coverage and reimbursement by large insurance providers “Out-of-pocket” patient payment AvailableTherapies SPRAVATO (generally covered) IV/IM Ketamine if ineligible for SPRAVATO (partial or no coverage) IV/IM/Oral Ketamine Patient Acquisition (Referral Sources) Direct, PCP, Psychiatrist, Psychotherapist, Telehealth Platforms Direct Oversight and Safety Monitoring Psychiatric Consultation and Oversight; FDA REMS Compliance Unknown Andala-Managed Clinics Ketamine Clinics (Cash-Pay)
Transaction Summary ELE-Psilo and Drug DiscoveryCare DeliveryTransaction Summary
Transaction Summary Transaction Structure Silver Spike Acquisition Corp II (NASDAQ: SPKB) is a publicly listed special purpose acquisition company with $287.5million in cash in trustUpon completion of the transaction, former shareholders of Silver Spike and former shareholders of Eleusis will holdshares of a new holding company named Eleusis Inc., which is expected to be listed on Nasdaq under the symbol ELEU 30 Valuation Pro forma enterprise value of approximately $446 million with 100% rollover by existing Eleusis equityholdersExisting Eleusis equityholders to receive additional earnout shares at closing equal to approximately 14% of an adjusted measure of pro forma enterprise value, vesting as follows: 20% at $12.50, 30% at $15.00 and 50% at $17.50 within three years after closing Use of Proceeds Clinical development of ELE-Psilo, preclinical development, and care delivery platform development by Andala Ownership Eleusis existing shareholders are rolling over 100% of their equity(1)Pro Forma ownership49% existing Eleusis equityholders51% SPAC shareholders and SPAC sponsor Note: Assumes no redemptions by SPKB shareholders and cash on Eleusis’s balance sheet of $5.5 million, as of 12/31/2021. Excludes the impact of any incremental financing between announcement and close. Assumes35.0 million shares to existing Eleusis equityholders, 28.8 million shares to existing SPKB shareholders, and 7.2 million shares to SPKB’s sponsor. Excludes earnout consideration to existing Eleusis equityholders andimpact of equity incentive plan, employee stock purchase plan and management LTIP (up to 3% of fully diluted shares outstanding, with 25% vesting at $15.00, 25% vesting at $20.00 and 50% vesting at $30.00). Alsoexcludes impact of unvested rollover options representing approximately 10% of Eleusis’s fully diluted shares outstanding as of January 2022. Excludes impact of 7.2 million public warrants and 5.2 million privateplacement warrants struck at $11.50. 1) If additional financing raised by Eleusis via equity or equity-linked securities, such investors will also roll 100% of the financing into the pro forma company.
Lead Candidate ELE-Psilo (Psilocin) COMP360 (Psilocybin) GH001 (5-MeO-DMT) Formulation IV Oral Intranasal Indication Major Depressive Disorder Treatment-Resistant Depression Treatment-Resistant Depression Clinical Stage Anticipated Ph Ia and IIa Results in 2H 2022 Phase II Completed Phase I/II Completed Drug Discovery Platform - Care Delivery Services - - Enterprise Value(USD) $446M (Pro Forma Valuation) $479M $719M Attractive Valuation Relative to Peers – Phase I Results May Drive Convergence 31 Enterprise value (USD) of Compass Pathways PLC (CMPS) and GH Research PLC (GHRS) as of January 14, 2022
Eleusis is Ready to Transform Psychedelics into Medicines for Living 32 Source: 1) Global Antidepressants Market Report 2021: COVID-19 Causes a Surge in Demand for Antidepressant Drugs as Mental Health Problems Rise - ResearchAndMarkets.com, Business Wire, April 26, 2021; 2) Partheniou, A. (2021) Psychedelics – A possible disrupter to legacy treatments, Stifel Nicholaus Canada Inc., January 14, 2021 (estimate based in part on data from existing ketamine clinics). ELE-Psilo – Transforming psilocybin into modern drug therapy for MDD Andala-Managed Clinics – Bridging “the last mile” of care delivery 1 Anticipated initiation of Phase Ia study in 1H 2022Anticipated Phase Ia/IIa results in 2H 2022 Anticipated Cash Flow Positive Clinic Operations in 1H 2023 2 3 Significant Market Opportunity Antidepressant TAM ~$21bn1 + Psychedelic Care Delivery TAM ~$7bn2
Appendix
Transaction Details Transaction summary Sources Cash in trust $288 Total uses $288 Uses Cash to balance sheet $258 Estimated transaction fees and expenses $30 Total uses $288 a Pro forma valuation Illustrative share price $10.00 Pro forma shares outstanding (M) 70.9 Total equity value $709 Net cash on balance sheet ($263) Total enterprise value $446 ($M except per share values) Pro forma ownership Pro forma enterprise value of $446 million with 100% rollover by existing Eleusis equityholders(1) Up to 3.5 million founder shares subject to forfeiture based on total cash delivered 35 Eleusis equityholders to receive additional earnout shares at closing equal to approximately 14% of an adjusted measure of pro forma enterprise value, vesting:20% at $12.50, 30% at $15.00 and 50% at $17.50 within three years after closing ($ in millions) Note: Assumes no redemptions by SPKB shareholders and cash on Eleusis’s balance sheet of $5.5 million, as of 12/31/2021. Excludes the impact of any incremental financing between announcement and close. Assumes 35.0 million shares to existing Eleusis equityholders, 28.8 million shares to existing SPKB shareholders, and 7.2 million shares to SPKB’s sponsor. Excludes earnout consideration to existing Eleusis equityholders and impact of equity incentive plan, employee stock purchase plan and management LTIP (up to 3% of fully diluted shares outstanding, with 25% vesting at $15.00, 25% vesting at $20.00 and 50% vesting at $30.00). Also excludes impact of unvested rollover options representing approximately 10% of Eleusis’s fully diluted shares outstanding as of January 2022. Excludes impact of 7.2 million public warrants and 5.2 million private placement warrants struck at $11.50.1) If additional financing raised by Eleusis via equity or equity-linked securities, such investors will also roll 100% of the financing into the pro forma company.
Use of Proceeds 36 Clinical development of ELE-Psilo in MDD into Ph2b / Ph3 trialsLaunch and expansion of Andala-managed clinicsDrug discovery platform expansionClinical development of ELE-Psilo in additional areas of high unmet need with proof-of-concept dataWorking capital and other general corporate purposes SPKB trust account together with existing cash and cash equivalents will be used to support the following:
Board of Directors and Psychiatric Advisory Board 37 PETER HENDRICKS GEORGE PAPAKOSTAS TOM LAUGHREN MANISH JHA MICHAEL THASE SANJAY MATHEW DAN IOSIFESCU EXPECTED POST-MERGER INDEPENDENT DIRECTORS SAMUEL WILKINSON PSYCHIATRIC ADVISORY BOARD DAVID EDDIE DAVID SOCKSChairman ROBERT HERSHBERG SCOTT GORDON ESTHER VAN DEN BOOM JOHN TUCKER Former Director of FDA Division of Psychiatry Products
Mechanism of Action Discovery Development & Translational Research Focus: MoA, SAR, translational disease models Focus: Drug discovery and optimization Focus: MoA, SAR, translational disease models Focus: Drug discovery and optimization Graham Johnson, PhD35+ years of development experience Medicinal Chemistry Director Significant 5-HT2A Focused Expertise Drives Drug Discovery Platform 38 606 Publications and 180 Years of Experience1 Charles Nichols, PhDProfessor of PharmacologyScientific Founder & Sponsored Researcher David Nichols, PhDDistinguished Professor of PharmacologyMolecular Pharmacology Director Timothy Foster, PhDAssociate Professor of VirologySponsored Researcher Source: 1) Statistics are cumulative across all six professionals listed herein.
Highly Experienced Silver Spike Capital Team Greg Gentile, CFOGreg was CEO of GMG Investment Advisors, an emerging market direct lending asset management firmPrior to GMG, he was a Managing Director at both Barclays Capital and Lehman Brothers Scott Gordon, Founder, CEO and ChairmanScott was co-Founder & Chairman of Egg Rock Holdings, the parent company of Papa & Barkley — a leading California based cannabis companyScott has over 30 years of emerging markets and distressed investment experience with roles at JP Morgan, ING Barings and Bank of America Senior Management Directors Ken Landis, DirectorKen has over 30 years experience as an entrepreneur, investor and executive in the cosmetics, accessory and fashion spacesHe co-founded Bobbi Brown cosmetics, later acquired by Estee Lauder, and was the CEO of Benetton Cosmetics Rich Goldman, DirectorRich is a Managing Member of Becket Capital, an advisory services firm for investment management companiesHe has served in a variety of executive leadership positions, including at Guggenheim Investments and Rydex Investments Bill Healy, PartnerBill has over 30 years of corporate, investment banking and fundraising experience. He was President of Pantera Capital, a leading blockchain venture capital managerBill spent 18 years at Deutsche Bank in various Senior Client Sales functions, and was head of EM sales at ING Barings Robert Josephson, Partner, Toronto OfficeRob was responsible for the initial funding of Cronos in 2013 and has consulted and raised funds for multiple cannabis-focused organizationsHe founded Seed Capital, which was later sold to DNA Genetics. Rob was also the co-founder of WeedMD, now a Canadian public company 39 Note: Logos refer to previous experience. Dr. Orrin Devinsky, DirectorDr. Devinsky is the Director of the Comprehensive Epilepsy Center at NYU Langone, where his research includes the use of cannabinoids to treat epilepsyHe is the Chairman of the Medical Advisory Board at Tilray and led the clinical trials for the FDA approval of Epidiolex, a cannabis-based epilepsy treatment Dino Colonna, PartnerDino has 18 years of investing and capital markets experience in the US and EuropePrior to Silver Spike, Dino had roles advising emerging growth companies in the cannabis, life sciences, and tech sectors, as an ECM investment banker for Barclays, and managing investments at a multi-strategy hedge fund
Applicable Recent deSPAC Experience – SSPK merger with WM Holdings WM Holding (“WMH”) operates Weedmaps, the leading online listings marketplace for cannabis consumers, and WM Business, a comprehensive software-as-a-service (“SaaS”) subscription offering for cannabis retailers and brandsWMH provides consumers with information regarding cannabis retailers and brands, as well as the availability of cannabis products, facilitating product discovery and online order-ahead for pickup or delivery by participating retailerSolely provides software and other technology solutions and is non-plant touchingMillions of monthly active users and over 18,000 business listings across every U.S. state, the District of Columbia and Puerto Rico with a legal cannabis market WHO IS WM HOLDINGS? Silver Spike successfully listed a $250M Special Purpose Acquisition Company (SPAC) on the Nasdaq (ticker: SSPK) in August 2019, representing the first Cannabis SPAC underwritten by a global investment bank in the US, Credit Suisse Silver Spike announced its merger agreement with WM Holdings, the leading technology platform to the cannabis industry in December 2020 WM Holding operated Weedmaps, the leading online listings marketplace for cannabis consumers, and WM Business, a comprehensive software-as-a-service (“SaaS”) subscription offering for cannabis retailers and brands The estimated post transaction equity value of the combined company is ~$1.5 billion and provided $579 million of gross proceeds and a PIPE of $325 million (including $35mm contribution from Silver Spike)(1) Source: 1) https://www.sec.gov/Archives/edgar/data/1779474/000114036121020601/brhc10025706_8k.htm. SSPK merged with WMHPro forma Enterprise Value of ~$1.5B$325M PIPE raised at $10.00 per share:100% rollover by WMH management TRANSACTION SUMMARY(1) 40