EX-99.2
Exhibit 99.2 MM-120 for Generalized Anxiety Disorder (GAD) Phase 2b
Topline Data December 2023
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to time, whether as a result of new information, future developments or otherwise. Cautionary Note Regarding Regulatory Matters The United States federal government regulates drugs through the Controlled Substances Act. MM-120 is a proprietary,
pharmaceutically optimized form of lysergide D-tartrate. Lysergide is a Schedule I substance under the Controlled Substances Act. While the Company is focused on programs using psychedelic or hallucinogenic compounds and non-hallucinogenic
derivatives of these compounds, including in its MM-120 and MM-402 product candidates, the Company does not have any direct or indirect involvement with the illegal selling, production or distribution of any substances in the jurisdictions in which
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relied upon by such sources. References in this Presentation to research reports or to articles and publications should be not construed as depicting the complete findings of the entire referenced report or article. MindMed does not make any
representation as to the accuracy of such information. December 2023 2 Topline Data from Study MMED008
Today’s Agenda Speaker Topic Introduction Schond Greenway - Chief
Financial Officer Summary of Phase 2b GAD Trial Results Rob Barrow - Chief Executive Officer Phase 2b GAD Trial Results Analysis Dan Karlin, MD - Chief Medical Officer MM-120 Development Plan Rob Barrow - Chief Executive Officer Summary and Closing
Remarks Questions & Answers Rob Barrow - Chief Executive Officer Dan Karlin, MD - Chief Medical Officer Miri Halperin Wernli, PhD - Executive President Francois Lilienthal, MD - Chief Commercial Officer Schond Greenway - Chief Financial Officer
December 2023 3 Topline Data from Study MMED008
MM-120 Summary of Phase 2b LSD D-tartrate GAD Trial Results for
Generalized Anxiety Disorder (GAD) December 2023 4 Topline Data from Study MMED008
MM-120 | Potential to Address a Large Unmet Need in GAD Opportunity in
Generalized Anxiety Disorder (GAD) 1 • GAD is the 2nd most common mental disorder among adults , yet Potential Best-in-Class there are limited treatment options Therapy with Novel MOA • Symptoms may be debilitating and treatment
inefficacy leads to incomplete remission and intolerable side effects. 1 Large Market 6.5 million do not respond to ~20 million US adults with GAD 13 million 3 2 1 first-line treatment 77% moderate to severe Opportunity receive treatment 3
SSRI/SNRIs : 50% failure rate with often undesirable side effects Benzodiazepines: addiction, tolerance risk; generally used in short-term Significant Need 4 for New Treatments Buspirone : poor efficacy Antipsychotics: short- and long-term risks;
poorly tolerated 1. Mental and Substance Use Disorders Prevalence Study: Findings Report 2023. 2. Kessler RC, Chiu WT, Demler O et al. Prevalence, Severity, and Comorbidity of 12-month DSM-IV Disorders in the National Comorbidity Survey-Replication.
2005 Arch Gen Psychiatry; 62(6): 617-627. December 2023 5 3. Ansara, Management of Treatment-Resistant Generalized Anxiety Disorder, Ment Health Clin 2020 Nov; 10(6) 326-334) United States Census Bureau, company calculations. Topline Data from Study
MMED008 4. Garakani A, et al., (2020) Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. Front. Psychiatry 11:595584. doi: 10.3389/fpsyt.2020.595584 MOA - Mechanism of Action; SSRI - Selective serotonin reuptake inhibitor;
SNRI - Serotonin and norepinephrine reuptake inhibitor
1 Summary of Topline Phase 2b Results • Met the primary endpoint
with statistical significance; MCP-Mod analysis results support dose-response relationship for MM-120 in GAD 2,3 • Large observed effect size of d=0.88 at 100 µg dose level is more than double the standard of care • Statistically
and clinically significant 21.3-point improvement in HAM-A score through week 4 with 2 maximum observed activity at 100 µg dose level (p=0.001) o Rapid and durable clinical activity with no loss of effect through the observation period 4 o 78%
clinical response rate through the observation period 5 o Clinically and statistically significant improvements on all analyzed secondary endpoints through the observation period • MM-120 was well-tolerated with no related serious adverse
events o Mostly transient, mild-to-moderate adverse events (occurring on dosing day) consistent with drug class and prior studies 6 o No drug-related serious adverse event (SAE) or suicide-related safety signal • Data supports advancement into
Phase 3 development for GAD 1. Source: Study MMED008 internal study documents and calculations. 2. Based on 100 µg dose group; HAM-A scores based on ANCOVA LS Mean. Effect size based on post hoc calculation by study statistician using LS Mean
change between group and pooled standard deviation of ending HAM-A scores across groups. 3. Examination of baseline group assignment for all of the studies (20 studies utilizing the HAM-A (Hamilton Anxiety Scale) and 1 study using the PARS
(Pediatric Anxiety Scale) for the primary outcome measurement. Source: RB Hidalgo, J Psychopharmacol. 2007 Nov;21(8):864-72. December 2023 6 4. Response defined as >50% improvement from baseline in HAM-A score 5. Represents all analyzed secondary
endpoints at all timepoints through the week 4 topline analysis, including HAM-A, CGI-S and MADRS. Topline Data from Study MMED008 6. Suicidality assessment based on reported adverse events. MCP-Mod – Multiple Comparisons Procedure –
Modelling, μg - microgram; HAM-A - Hamilton Anxiety scale
1 Large Observed Effect Size is Over Double the Standard of Care 1
Reported Effect Size in Generalized Anxiety Disorder Key Highlights of Phase 2b Results 2 ▶ Maximum observed effect size of MM-120 100 µg 0.88 0.88 is more than double the 2,3 2 standard of care MM-120 200 µg 0.64 ▶ Rapid and
durable clinical response 4 3 Benzodiazapines 0.38 after single administration 4 SSRIs 0.36 ▶ Clinical activity demonstrated with no psychotherapeutic intervention 4 Buspirone 0.17 0 0.2 0.4 0.6 0.8 p-values not displayed 1. Source: Study
MMED008 internal study documents and calculations. 2. HAM-A scores based on ANCOVA LS Mean. in Study MMED008. Effect size based on post hoc calculation using LS Mean change between group and pooled standard deviation of week 4 HAM-A scores between
groups. December 2023 7 3. Based on 100 µg dose group. Topline Data from Study MMED008 4. Source: RB Hidalgo, J Psychopharmacol. 2007 Nov;21(8):864-72. μg - microgram; HAM-A - Hamilton Anxiety scale; SSRI - Selective serotonin reuptake
inhibitor;
MM-120 Phase 2b GAD Trial LSD D-tartrate Key Design Elements for
Generalized Anxiety Disorder (GAD) December 2023 8 Topline Data from Study MMED008
1 Phase 2b Trial Design Overview • Standard GAD study design with
endpoints that have supported registration for approved drugs • Randomized, double-blind, placebo-controlled, 12-week trial o Single administration of MM-120 or placebo o No psychotherapeutic intervention o Trial design closely aligned with
subsequently issued FDA 2023 Draft Guidance o Patients washed out of anxiety pharmacotherapy prior to randomization • Enrolled 198 patients with GAD • Five-arm dose optimization design with 1:1:1:1:1 randomization • Primary
endpoint: change in Hamilton Anxiety Scale (HAM-A) at week 4 o Assessed by central rater blinded to treatment assignment and visit number 1. Source: Study MMED008 internal study documents and calculations. December 2023 2. FDA 2023 Draft Guidance:
Psychedelic Drugs: Considerations for Clinical Investigations. 9 Topline Data from Study MMED008 FDA - U.S. Food and Drug Administration
1 Phase 2b Trial Design Overview PSYCHIATRY | MM-120 (LSD D-tartrate) |
Indication: GAD | PHASE 2b Study MMED008 | MM-120 for GAD 198 participants total (actual) A Phase 2b Dose Optimization Study of a -5 to -1 1 2 4 8 12 Week Single Dose of MM-120 in Generalized Anxiety Disorder Screening Dose Follow-Up KEY ENTRY
CRITERIA MM-120 200 µg • Men and Women MM-120 100 µg • Ages 18-74 • Diagnosis of GAD MM-120 50 µg • HAM-A ≥ 20 MM-120 25 µg Placebo ADDITIONAL ENDPOINTS • MADRS• EQ-5D-5L • CGI-S /
I• PSQI • PGI-S / C• ASEX Randomize Primary Endpoint Secondary Endpoints • SDS (HAM-A) (HAM-A) 1. Source: Study MMED008 internal study documents. December 2023 μg: microgram; HAM-A: Hamilton Anxiety Rating Scale; MADRS:
Montgomery-Asberg Depression Rating Scale; CGI-S: Clinical Global Impressions - Severity; PGI-S: Patient Global Impression - 10 Topline Data from Study MMED008 Severity; SDS: Sheehan Disability Scale; EQ-5D-5L: EuroQol-5 Dimension; PSQI: Pittsburgh
Sleep Quality Index; ASEX: Arizona Sexual Experiences Scale
1 Details of Phase 2b Treatment Delivery Protocol • Designed to
demonstrate drug-only effect with no psychotherapeutic intervention 2 • Delivery protocol consistent with 2023 FDA Draft Guidance • No planned changes to delivery protocol from Phase 2 to Phase 3 Pre-treatment During treatment
Post-treatment ✓ Comprehensive informed consent process✓ Continuous participant monitoring by ✓ Follow-up visits for safety and efficacy dosing session monitors assessments Patient ✓ Eligibility evaluation✓
Participants provided with music, eye Journey in shades, reading and writing materials MMED008 ✓ Participants released from observation when discharge criteria met Not Part of x No “preparation” – pre-treatment x No
“assisted therapy” x No “integration” Patient activities consisted of only standard x No psychotherapy and no therapeutic x No ongoing therapeutic engagement as Journey in MMED008 informed consent process intervention beyond
study drug part of clinical trial activities 1. Source: Study MMED008 internal study documents. December 2023 2. FDA 2023 Draft Guidance: Psychedelic Drugs: Considerations for Clinical Investigations. 11 Topline Data from Study MMED008 FDA - U.S.
Food and Drug Administration
MM-120 Phase 2b GAD Trial LSD D-tartrate Results Analysis for
Generalized Anxiety Disorder (GAD) December 2023 12 Topline Data from Study MMED008
1 Phase 2b GAD Participant Disposition - Included in FAS population:
100% 200 µg - Completed 4 weeks (n=39) (n=40) - Discontinued at any time (n=8) 97.5% 4-week completion rate - Included in FAS population: 100% 2 100 µg in high dose groups despite need for follow- - Completed 4 weeks (n=39) (n=40) up
visits with no additional treatment - Discontinued at any time (n=6) Randomized - Included in FAS population: 90% 50 µg - Completed 4 weeks (n=35) (n=198) (n=40) - Discontinued at any time (n=11) • Safety Set (n=198) • Full Analysis
Set (FAS) 89.4% 4-week completion rate (n=194) - Included in FAS population: 100% of all randomized participants despite need for 25 µg - Completed 4 weeks (n=34) follow-up visits with no additional treatment (n=39) - Discontinued at any time
(n=10) - Included in FAS population: 100% Placebo - Completed 4 weeks (n=30) (n=39) - Discontinued at any time (n=13) 1. Source: Study MMED008 internal study documents and calculations. Safety population. December 2023 2. High dose groups include
100 and 200 µg dose groups. 13 Topline Data from Study MMED008 μg - microgram; HAM-A - Hamilton Anxiety scale
1 Demographics and Baseline Characteristics Participant demographics
and baseline characteristics generally balanced across groups MM-120 Placebo Demographic (n=194) 25 µg 50 µg 100 µg 200 µg (n=39) (n=36) (n=40) (n=40) (n=39) Mean age (years) 38.0 45.3 42.7 42.1 38.7 Sex, female (%) 51.3% 55.6%
40.0% 70.0% 66.7% Race (% white) 84.6% 80.6% 90.0% 82.5% 76.9% Baseline HAM-A score 30.2 30.3 29.3 31.0 30.3 Baseline CGI-S score 4.9 4.9 4.8 5.1 4.9 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population.
December 2023 14 μg - microgram; HAM-A - Hamilton Anxiety scale; CGI-S - Clinical Global Impressions of Severity Topline Data from Study MMED008
1 Primary Endpoint | Change in HAM-A Score through Week 4 Statistically
and clinically significant reductions in HAM-A score at all timepoints through week 4 in 100 and 200 µg dose groups HAM-A Change from Baseline 0 Change to Week 4 ▶ 100 µg: -21.3 points ▶ 200 µg: -19.3 points -5 Improvement
over Placebo -10 ▶ 100 µg: -7.6 pts, p=0.0004 ▶ 200 µg: -5.5 pts, p=0.01 -15 ** -20 *** -25 0 1 2 3 4 Baseline Week 1 Week 2 Week 4 Placebo 25 μg 50 μg 100 μg 200 μg **p≤0.01 ***p≤0.001 1.
Source: Study MMED008 internal study documents and calculations. Full analysis set population. December 2023 µg - microgram; HAM-A - Hamilton Anxiety Rating Scale 15 Topline Data from Study MMED008 NOTE: Significance achieved despite study not
being powered for these pairwise comparisons. LS Mean Change (SEM) in HAM-A score
1 Exploratory Endpoint | HAM-A Response and Remission at Week 4
Dose-dependent increases in response with 78% responders in 100 and 200 µg dose groups; 50% of participants achieved remission in 100 µg dose group 2 2 HAM-A Response Rate at Week 4 HAM-A Remission Rate at Week 4 60 90 50 78 78 80 50 70 40
58 60 35 51 50 28 30 25 40 31 18 20 30 20 10 10 0 0 Placebo 25 µg 50 µg 100 µg 200 µg Placebo 25 µg 50 µg 100 µg 200 µg p-values not displayed p-values not displayed 1. Source: Study MMED008 internal study
documents and calculations. Full analysis set population. December 2023 2. Response is defined as a 50% or greater improvement on HAM-A score; Remission is defined as a HAM-A score of ≤ 7. 16 Topline Data from Study MMED008 µg -
microgram; HAM-A - Hamilton Anxiety Rating Scale % Responders % Remitters
1 Primary Analysis | Multiple Comparison Procedure – Modeling
(MCP-Mod) of HAM-A Statistically significant dose-response relationship with identification of target therapeutic range 2 Key Takeaways from MCP-Mod Analysis ▶ Statistically significant dose response relationship with multiple model fits
▶ Supports dose selection above 50 µg for subsequent clinical studies in GAD ▶ Pre-specified model estimates and observed responses drive dose selection for Phase 3 studies Dose 1. Source: Study MMED008 internal study documents and
calculations. Full analysis set population. December 2023 2. Source: Novartis. “The MCP-Mod methodology – A statistical methodology for dose-response. 17 Topline Data from Study MMED008 µg - microgram; HAM-A - Hamilton Anxiety
Rating Scale Model Means
1 Secondary Endpoint | Clinical Global Impressions – Severity
(CGI-S) Statistically significant reductions in Clinical Global Impressions of Severity (CGI-S) scale through Week 4 in 100 and 200 µg dose groups 2 CGI-S Improvement in 100 and 200 µg Groups CGI-S Scores 6 – Severely Ill ▶
Statistically and clinically significant improvement by Day 2 5 – Markedly Ill and maintained through Week 4 4 – Moderately Ill ▶ Greater than 2-unit improvement in CGI-S score through Week 4 3 – Mildly Ill ** *** ▶
Participants on average only 2 – Borderline Ill borderline-to-mildly ill at Week 4 1 – Normal, not ill at all Baseline Week 4 Placebo 25 μg 50 μg 100 μg 200 μg **p≤0.01 ***p≤0.001 1. Source: Study MMED008
internal study documents and calculations. Full analysis set population. December 2023 2. Significance achieved despite study not being powered for these pairwise comparisons. 18 Topline Data from Study MMED008 µg - microgram; CGI-S - Clinical
Global Impressions - Severity
1 Secondary Endpoint | Change from Baseline in Comorbid Depression
Scores (MADRS) 2 Statistically and clinically significant reductions in MADRS score at all timepoints through week 4 in 100 and 200 µg dose groups 2 MADRS Change from Baseline 0 Change to Week 4 -2 ▶ 100 µg: -18.1 points -4 ▶
200 µg: -18.3 points -6 Improvement over Placebo -8 ▶ 100 µg: -5.7 points, p<0.05 -10 ▶ 200 µg: -5.9 points, p<0.05 -12 -14 -16 * -18 ** -20 Base 0 line Wee 1k 1 Wee 2k 2 3 Wee 4 k 4 *p<0.05 Placebo 25 μg 50
μg 100 μg 200 μg **p≤0.01 1. Source: MindMed internal study documents and calculations. Full analysis set population. December 2023 2. Significance achieved despite study not being powered for these pairwise comparisons. Based
on observed MADRS score at each timepoint. 19 Topline Data from Study MMED008 µg - microgram; MADRS - Montgomery-Åsberg Depression Rating Scale Observed Change (SEM) in MADRS score
1 Safety Overview MM-120 was well-tolerated with mostly transient,
mild-to-moderate adverse events consistent with drug class expectations • Virtually all AEs (>98%) were mild-to-moderate in severity Favorable tolerability 2 • Minimal (2.5%) TEAEs led to study withdrawal (none in high dose groups )
profile • No drug-related serious adverse events No SAEs related to • Only serious adverse event was in 50 µg dose group and deemed unrelated study drug • AE profile consistent with historical studies and drug class • No
suicidal or self-injurious behavior No suicidal behavior • ≤ 1 participant per arm reported suicidal ideation during the study 3 or suicidality signal • No indication of increased suicidality or suicide-related risk 1. Source:
Study MMED008 internal study documents and calculations. Safety population. 2. High dose groups include 100 and 200 µg dose groups. December 2023 20 3. Suicidality assessment based on reported adverse events. Topline Data from Study MMED008 AE
- Adverse Event; TEAE - Treatment Emergent Adverse Event;
1,2 Most Common TEAEs On Dosing Day (>10% in High Dose Groups)
MM-120 was well-tolerated across all dose groups with mostly transient, mild-to-moderate adverse events MM-120 Placebo Preferred Term 25 µg 50 µg 100 µg 200 µg Subjects (%) with AE (n=39) (n=40) (n=40) (n=40) (n=39) Illusion 12
(30.8) 18 (45.0) 23 (57.5) 30 (75.0) 3 (7.7) Hallucination, visual 6 (15.4) 9 (22.5) 9 (22.5) 6 (15.0) 1 (2.6) Euphoric mood 2 (5.1) 5 (12.5) 11 (27.5) 6 (15.0) 1 (2.6) Anxiety 1 (2.6) 3 (7.5) 4 (10.0) 5 (12.5) 0 (0) Thinking abnormal 0 (0) 2 (5.0)
4 (10.0) 5 (12.5) 0 (0) Headache 4 (10.3) 9 (22.5) 10 (25.0) 10 (25.0) 8 (20.5) Paraesthesia 2 (5.1) 2 (5.0) 3 (7.5) 9 (22.5) 2 (5.1) Dizziness 3 (7.7) 2 (5.0) 3 (7.5) 5 (12.5) 1 (2.6) Tremor 0 (0) 3 (7.5) 2 (5.0) 8 (20.0) 0 (0) Nausea 3 (7.7) 11
(27.5) 16 (40.0) 24 (60.0) 1 (2.6) Vomiting 0 (0) 2 (5.0) 2 (5.0) 5 (12.5) 0 (0) 3 Feeling abnormal 1 (2.6) 2 (5.0) 1 (2.5) 1 (2.5) 1 (2.6) Mydriasis 1 (2.6) 7 (17.5) 8 (20.0) 4 (10.0) 1 (2.6) Hyperhidrosis 1 (2.6) 4 (10.0) 9 (22.5) 5 (12.5) 0 (0)
1. Source: Study MMED008 internal study documents and calculations. Safety population. 2. High dose groups include 100 and 200 µg dose groups. December 2023 21 3. Incidence during study greater than 10% for 200 µg dose group, but less than
10% for all dose groups on dosing day. Topline Data from Study MMED008 µg - microgram; AE - Adverse Event; TEAE – Treatment Emergent Adverse Event
1,2 Most Common TEAEs (>10% in High Dose Groups) MM-120 was
well-tolerated across all dose groups with mostly transient, mild-to-moderate adverse events MM-120 Placebo Preferred Term 25 µg 50 µg 100 µg 200 µg Subjects (%) with AE (n=39) (n=40) (n=40) (n=40) (n=39) Illusion 12 (30.8) 18
(45.0) 24 (60.0) 30 (75.0) 3 (7.7) Hallucination, visual 6 (15.4) 9 (22.5) 9 (22.5) 6 (15.0) 1 (2.6) Euphoric mood 2 (5.1) 5 (12.5) 11 (27.5) 6 (15.0) 1 (2.6) Anxiety 4 (10.3) 5 (12.5) 4 (10.0) 6 (15.0) 2 (5.1) Thinking abnormal 0 (0) 2 (5.0) 4
(10.0) 5 (12.5) 0 (0) Headache 5 (12.8) 9 (22.5) 14 (35.0) 11 (27.5) 8 (20.5) Paraesthesia 2 (5.1) 2 (5.0) 3 (7.5) 9 (22.5) 3 (7.7) Dizziness 3 (7.7) 2 (5.0) 3 (7.5) 5 (12.5) 1 (2.6) Tremor 0 (0) 3 (7.5) 3 (7.5) 8 (20.0) 0 (0) Nausea 3 (7.7) 11
(27.5) 16 (40.0) 24 (60.0) 3 (7.7) Vomiting 0 (0) 2 (5.0) 2 (5.0) 5 (12.5) 0 (0) Feeling abnormal 1 (2.6) 2 (5.0) 1 (2.5) 5 (12.5) 2 (5.1) Mydriasis 1 (2.6) 7 (17.5) 8 (20.0) 4 (10.0) 1 (2.6) Hyperhidrosis 1 (2.6) 4 (10.0) 9 (22.5) 5 (12.5) 0 (0) 1.
Source: Study MMED008 internal study documents and calculations. Safety population. December 2023 2. High dose groups include 100 and 200 µg dose groups. 22 Topline Data from Study MMED008 µg - microgram; AE - Adverse Event; TEAE –
Treatment Emergent Adverse Event
MM-120 MM-120 Development Plan LSD D-tartrate for Generalized Anxiety
Disorder (GAD) December 2023 23 Topline Data from Study MMED008
Multiple Studies Support Phase 3 Development of MM-120 1 •
Achieved goals of Phase 2 development o Characterized dose-response to inform dose selection in GAD o Achieved large, statistically significant and clinically meaningful effect in GAD o Showed rapid and durable therapeutic benefits on validated
endpoint o Demonstrated standalone drug effect in absence of psychotherapeutic intervention • Multiple studies support activity of MM-120 o Phase 2b randomized, placebo-controlled dose optimization trial in GAD (Study MMED008) o One prior
modern, randomized, placebo-controlled IIT of lysergide in anxiety disorders o Over twenty legacy studies of lysergide in anxiety and other neurotic disorders • Company believes Phase 2b data supports dose selection and advancement into Phase
3 development 1. Source: Study MMED008 internal study documents and calculations. December 2023 24 GAD - Generalized Anxiety Disorder; IIT - Investigator Initiated Trial Topline Data from Study MMED008
MM-120 Development Pathway • Key design elements expected to be
consistent between Phase 2b and Phase 3 studies o Hamilton Anxiety Scale (HAM-A) at week 4 expected primary endpoint o Limited changes to key inclusion/exclusion criteria o No planned change in dosing session monitoring protocol • Two Phase 3
pivotal clinical trials in planning o 12-week randomized, placebo-controlled primary efficacy study design o Open-label extension to establish retreatment parameters o Expect to initiate Phase 3 development in the second half of 2024 December 2023
1. Phase 3 and subsequent clinical study design subject to regulatory discussion and review, including at potential End of Phase 2 meeting. 25 Topline Data from Study MMED008
Next Steps and Anticipated Milestones for MM-120 Program Q4 2023 Q1
2024 Q3 2024 Q4 2024 Q2 2024 MM-120 GAD MM-120 GAD MM-120 GAD Phase 2b Phase 2b Full data presentation at scientific meeting 4-wk Topline 12-wk Topline MM-120 GAD Zydis ODT PK Bridging Data MM-120 GAD EOP2 meeting MM-120 GAD Phase 3 initiation
MM-120 Evaluate additional clinical indication(s) for MM-120 December 2023 26 Topline Data from Study MMED008
Q&A December 2023 27 Topline Data from Study MMED008
Appendix – Phase 2b GAD Study December 2023 28 Topline Data from
Study MMED008
1 Phase 2b Trial Design Aligns with Subsequent FDA Draft Guidance FDA
issued 2023 draft guidance on clinical trials with psychedelic drugs • Provides clarity on regulatory expectations and R&D considerations • Guidance will “help researchers design studies that will yield interpretable results 1
that will be capable of supporting future drug applications” Phase 2b design is aligned with FDA guidance • No concurrent psychotherapy – “Psychotherapeutic interventions have the 1 potential to increase expectancy and
performance biases” 1 • Placebo-controlled – “allows for better contextualization of safety findings” • Dose-ranging – “The dose-response relationship for most psychedelic drugs is poorly understood.
Sponsors should take appropriate steps to characterize the 1 dose-response relationship.” December 2023 1. FDA 2023 Draft Guidance: Psychedelic Drugs: Considerations for Clinical Investigations. 29 Topline Data from Study MMED008
1 Primary Endpoint | HAM-A Score over Time Statistically and clinically
significant reductions in HAM-A score at all timepoints through week 4 in 100 and 200 µg dose groups MM-120 Placebo Timepoint 25 µg 50 µg 100 µg 200 µg 2 Mean (SD) HAM-A score (n=39) (n=36) (n=40) (n=40) (n=39) Baseline 30.2
(6.05) 30.3 (5.71) 29.3 (6.42) 31.0 (6.98) 30.3 (6.56) Week 1 14.2 (7.54) 16.1 (11.20) 10.2 (5.42) 12.6 (8.71) 18.5 (11.21) Week 2 14.0 (8.13) 15.9 (11.76) 9.9 (7.26) 10.0 (7.49) 17.4 (10.54) Week 4 13.0 (8.31) 15.5 (11.04) 8.6 (7.44) 11.1 (7.24)
16.3 (9.82) p<0.05p≤0.01p≤0.001 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. December 2023 2. Actual values [mean (SD)] reported for each group and timepoint. p-value based on LS
Mean change from baseline versus placebo. 30 Topline Data from Study MMED008 µg - microgram; HAM-A - Hamilton Anxiety scale
Exploratory Endpoint | HAM-A Response Rates over Time 75% or greater
HAM-A Response Rate achieved in 100 µg dose group from Weeks 1-4 2 HAM-A Response Rate over Time 90 78 78 78 78 80 75 70 58 60 54 53 51 51 50 47 50 38 40 33 31 30 20 10 0 Week 1 Week 2 Week 4 Placebo 25 μg 50 μg 100 μg 200
μg p-values not displayed 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. December 2023 2. Response is defined as a 50% or greater improvement on HAM-A score. 31 Topline Data from Study MMED008
µg - microgram; HAM-A - Hamilton Anxiety scale % RESPONDERS
1 Secondary Endpoint | Clinical Global Impressions – Severity
through Week 4 Statistically significant reductions in Clinical Global Impressions of Severity (CGI-S) scale at all timepoints through Week 4 in 100 and 200 µg dose groups 2 CGI-S Scores Over Time 6 – Severely Ill 5 – Markedly Ill 4
– Moderately Ill * * * **** 3 – Mildly Ill **** ** **** **** **** *** 2 – Borderline Ill 1 – Normal, not ill at all Baseline Day 2 Week 1 Week 2 Week 4 *p<0.05 Placebo 25 μg 50 μg 100 μg 200 μg
**p≤0.01 ***p≤0.001 ****p≤0.0001 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. December 2023 2. p-value based on change from baseline in CGI-S score versus placebo. 32 Topline
Data from Study MMED008 μg - microgram
1 Primary Endpoint | Change in HAM-A Score through Week 4 Statistically
and clinically significant reductions in HAM-A score at all timepoints through week 4 in 100 µg dose group 2 HAM-A Scores Over Time 50 45 40 35 30 25 20 15 10 5 0 Baseline Week 1 Week 2 Week 4 p-values not displayed 1. Source: Study MMED008
internal study documents and calculations. Full analysis set population. December 2023 2. Actual values [mean (SD)] reported for each timepoint. 33 Topline Data from Study MMED008 µg - microgram; HAM-A - Hamilton Anxiety Rating Scale HAM-A
Scores
1 Secondary Endpoint| Comorbid Depression Scores (MADRS) over Time 2,3
Statistically and clinically significant reductions in MADRS score at all timepoints through week 4 in 100 and 200 µg dose groups MM-120 Placebo Timepoint 25 µg 50 µg 100 µg 200 µg 2 Mean (SD) MADRS score (n=39) (n=36)
(n=40) (n=40) (n=39) Baseline 25.4 (7.58) 27.7 (8.30) 26.5 (7.99) 28.9 (8.31) 27.6 (9.69) Week 1 13.2 (9.62) 16.5 (13.50) 8.6 (6.74) 10.6 (8.96) 16.5 (11.96) Week 2 12.7 (10.37) 15.4 (13.44) 8.6 (8.30) 9.3 (8.35) 16.6 (12.00) Week 4 13.4 (11.37)
15.4 (13.60) 8.4 (9.52) 10.4 (8.23) 14.8 (10.74) p<0.05p≤0.01p≤0.001 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. December 2023 2. Actual values [mean (SD)] reported for each group
and timepoint. p-value based on change from baseline versus placebo. 34 Topline Data from Study MMED008 µg - microgram; MADRS - Montgomery-Åsberg Depression Rating Scale
1 Secondary Endpoint | Comorbid Depression Scores (MADRS) over Time in
100 µg Dose Group 2,3 Comorbid depressive symptoms in GAD improved through week 4 with 75% meeting remission and >75% responders 2 MADRS Scores Over Time 50 45 40 35 30 25 20 15 10 5 0 Baseline Week 1 Week 2 Week 4 p-values not displayed 1.
Source: Study MMED008 internal study documents and calculations. Full analysis set population. 2. 100 µg dose group. December 2023 35 3. Response is defined as a 50% or greater improvement on MADRS score; Remission is defined as a MADRS score
of ≤ 10. Topline Data from Study MMED008 µg - microgram; MADRS - Montgomery-Åsberg Depression Rating Scale MADRS Score
1 Most Common TEAEs with ≥10% Incidence in Any Dose Group MM-120
Placebo Preferred Term Subjects (%) with AE 25 µg (n=39) 50 µg (n=40) 100 µg (n=40) 200 µg (n=40) (n=39) Illusion 12 (30.8) 18 (45.0) 24 (60.0) 30 (75.0) 3 (7.7) Hallucination, visual 6 (15.4) 9 (22.5) 9 (22.5) 6 (15.0) 1 (2.6)
Euphoric mood 2 (5.1) 5 (12.5) 11 (27.5) 6 (15.0) 1 (2.6) Anxiety 4 (10.3) 5 (12.5) 4 (10.0) 6 (15.0) 2 (5.1) Depressed mood 0 (0) 3 (7.5) 3 (7.5) 4 (10.0) 0 (0) Thinking abnormal 0 (0) 2 (5.0) 4 (10.0) 5 (12.5) 0 (0) Emotional Distress 2 (5.1) 0
(0) 1 (2.5) 4 (10.0) 1 (2.6) Headache 5 (12.8) 9 (22.5) 14 (35.0) 11 (27.5) 8 (20.5) Paraesthesia 2 (5.1) 2 (5.0) 3 (7.5) 9 (22.5) 3 (7.7) Dizziness 3 (7.7) 2 (5.0) 3 (7.5) 5 (12.5) 1 (2.6) Tremor 0 (0) 3 (7.5) 3 (7.5) 8 (20.0) 0 (0) Balance
disorder 0 (0) 4 (10.0) 2 (5.0) 2 (5.0) 1 (2.6) Disturbance in attention 1 (2.6) 7 (17.5) 1 (2.5) 0 (0) 0 (0) Nausea 3 (7.7) 11 (27.5) 16 (40.0) 24 (60.0) 3 (7.7) Vomiting 0 (0) 2 (5.0) 2 (5.0) 5 (12.5) 0 (0) Fatigue 2 (5.1) 6 (15.0) 4 (10.0) 4
(10.0) 1 (2.6) Feeling abnormal 1 (2.6) 2 (5.0) 1 (2.5) 5 (12.5) 2 (5.1) Feeling hot 0 (0) 4 (10.0) 0 (0) 1 (2.5) 1 (2.6) Mydriasis 1 (2.6) 7 (17.5) 8 (20.0) 4 (10.0) 1 (2.6) Blood pressure increased 3 (7.7) 5 (12.5) 4 (10.0) 3 (7.5) 0 (0)
Hyperhidrosis 1 (2.6) 4 (10.0) 9 (22.5) 5 (12.5) 0 (0) Decreased appetite 1 (2.6) 1 (2.5) 1 (2.5) 4 (10.0) 0 (0) 1. Source: MindMed internal study documents and calculations. Safety population. December 2023 36 TEAE - Treatment Emergent Adverse
Event Topline Data from Study MMED008
Appendix – Intellectual Property December 2023 37 Topline Data
from Study MMED008
1 MM-120 | Multiple Layers of Intellectual Property and Barriers to
Entry 2 Regulatory Barriers New Chemical Entity Exclusivity 30-Month Stay +1y +2y +3y +4y +5y +7y +9y … 2043+ MM-120 Launch Patent Protection API: Polymorph, Salt Form Method of Use / Method of Treatment: Treatment of a Disorder Drug Product:
Method of Manufacture/Process Delivery: Delivery Method, PK / PD • Supply chain availability• Trade secrets & know-how Additional • Exclusive rights to key technology• Differentiated product performance Barriers to Entry
• Life cycle management with improved • Differentiated combination performance (drug and/or device products) 1. Contingent upon FDA approval and grant of claims by USPTO. 2. Section 505 of the Federal Food, Drug and Cosmetic Act, 21
U.S.C. § 355. December 2023 38 PK - pharmacokinetic; PD - pharmacodynamic Topline Data from Study MMED008
MM-120 | Multipronged Market Protection Strategies 1 • Highlights
of Patent Protection Strategy o Methods of treating GAD o Stability and methods of manufacturing for API (salt form and polymorphs) o Improved product performance with faster absorption, less variability and potential shorter duration o Methods of
use related to ODT formulation, treatment of GAD and other patient outcomes o Additional claims related to dose identification, patient monitoring, digital technology and others • Highlights of Non-Patent Protection Strategy o FDA-granted NCE
exclusivity o 30-month stay against generic applicants (with Paragraph IV claims) o Limited supply chain availability 2 o Exclusive rights to key technology (e.g. Catalent Zydis® ODT) o Trade secrets and know-how 1. Source: US Patent and Trade
Office (https://ppubs.uspto.gov/). 2. Catalent has granted exclusive rights to intellectual property for Zydis® for lysergide (LSD). December 2023 39 FDA - U.S. Food and Drug Administration; API – active pharmaceutical ingredient; ODT
– orally disintegrating tablet; NCE – new chemical entity Topline Data from Study MMED008
MM-120 | Intellectual Property Portfolio Highlights 1 1 1 2 Patent /
Application Title / Overview Status Estimated Expiration Provisional TBD [Claims based on pharmacokinetic findings from ODT bridging study] 2043 Application Provisional TBD [Claims based on pharmacodynamic findings from ODT bridging study] 2043
Application Provisional TBD [Claims based on clinical findings from Phase 2b GAD study] 2043 Application US & PCT 20230285384 USING GENO- OR PHENOTYPING TO ADJUST LSD DOSING 2043 Publications US & PCT 20230330085 LSD DOSE IDENTIFICATION 2043
Publications US & PCT 20220348575 LSD SALT CRYSTAL FORMS 2042 Publications US & PCT 20230064429 IMMEDIATE RELEASE FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR THERAPEUTIC APPLICATIONS 2042 Publications US & PCT 20230107398 IMMEDIATE
RELEASE FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR THERAPEUTIC APPLICATIONS 2042 Publications LYOPHILIZED ORALLY DISINTEGRATING TABLET FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR US & PCT 20230122949 2042 3 THERAPEUTIC APPLICATIONS
Publications US & PCT 20230000431 SYSTEM AND METHOD FOR MONITORING A CONSCIOUSNESS-ALTERING THERAPEUTIC SESSION 2042 Publications EFFECTS OF LYSERGIC ACID DIETHYLAMIDE (LSD) AND OF LSD ANALOGS TO ASSIST PSYCHOTHERAPY FOR US & PCT 20220273628
2042 GENERALIZED ANXIETY DISORDER OR OTHER ANXIETY NOT RELATED TO LIFE-THREATENING ILLNESS Publications 1. Source: US Patent and Trade Office (https://ppubs.uspto.gov/). 2. Based on 20 years after non-provisional filing date. For provisional
applications based on MindMed management’s estimated filing date. December 2023 3. Catalent has granted exclusive rights to intellectual property for Zydis® for lysergide (LSD). 40 Topline Data from Study MMED008 PCT – Patent
Cooperation Treaty
MM-120 | Recent Addition to Intellectual Property Portfolio •
Exclusive license agreement with Catalent for its patented Zydis® 1 fast-dissolve technology for use with MM-120 o Exclusive rights for the use of the Zydis® technology to develop all salt and polymorphic forms of lysergide in the U.S.,
UK, and EU among other key territories o ODT formulation dissolves almost instantly in the mouth, potentially bypassing first pass metabolism o Zydis technology platform has exhibited superiority over other ODTs as illustrated by its use in the
launch of more than 36 products in over 60 countries 2,3 • Potential patent protection until at least 2042 1. Catalent has granted exclusive rights to intellectual property for Zydis® for lysergide (LSD). 2. Source: US Patent and Trade
Office (https://ppubs.uspto.gov/). December 2023 41 3. Based on 20 years after non-provisional filing date. For provisional applications based on MindMed management’s estimated filing date. Topline Data from Study MMED008 ODT - Orally
Disintegrating Tablet.
MM-120 | Strong Innovative Intellectual Property Moat for Incumbency
Position 505(b)(1) 505(b)(2) 505(j) ANDA / Generic Original “Standalone” NDA “Follow-on” NDA 1 Description• Contains full reports of investigations of safety • Contains full reports of investigations of safety and
• Generally duplicates previously approved and effectiveness that were conducted by or effectiveness, where at least some of the drug and relies on the findings of safety for the applicant or for which the applicant information required for
approval comes from and effectiveness of a reference listed drug has a right of reference or use studies not conducted by or for the applicant and (RLD) for which the applicant has not obtained a right of reference or use 1 Trials Required Full
clinical program from start to finish, • Depends on similarity to reference drug• Product equivalence including:• Possible to bypass preclinical and Phase 1 studies• Bioequivalence • Two adequate well-controlled
studies• Trial requirements subject to FDA discretion • Full clinical pharmacology reports • Full toxicology reports • Full safety pharmacology reports • Full nonclinical pharmacology reports • Full chemistry,
manufacturing & controls reports 2 3 3 Development Time ~10+ years 6-8 years 1-2 years 3 Development Cost $300M-$1.5B+ $10-$100M $1-$5M nd 3 Litigation Cost/Risk for 2 Applicant $10-20M + Jury Trial + Treble Damages $10-20M + Jury Trial + Treble
Damages $10-20M + Bench Trial + Damages if Launch at Risk Barriers to Market Entry IP, CD/DE, SP/L, EDC, MFG, LCM OB, IP, RME, CD/DE, SP/L, EDC, MFG, LCM, RLD OB, IP, RME, CD/DE, SP/L, EDC, MFG, LCM, RLD 1. Source: FDA Center for Drug Evaluation and
Research (https://www.fda.gov/regulatory-information). 2. “Clinical Development Success Rates and Contributing Factors 2011–2020” by BIO, PharmaIntelligence and QLS Advisors. Estimate for psychiatric indications. nd 3.
Company’s estimate of development costs, litigation costs and time for a 2 entrant based on past precedents. Estimated Research and Development Investment Needed to Bring a New December 2023 42 Medicine to Market, 2009-201 JAMA.
2020;323(9):844-853. doi:10.1001/jama.2020.1166 Topline Data from Study MMED008 OB = Orange Book, IP = Intellectual Property, RME = Regulatory market exclusivity, CD/DE = Clinical Development and Data Exclusivity, SP/L = Strategic Partnerships and
Licensing, EDC = Extensive Development Costs (505(b)(1)), MFG = Supply Chain and Manufacturing Excellence, LCM = Life Cycle Management, RLD = Requires demonstrated equivalence to Reference Listed Drug.
MM-120 | Benefits of A New Chemical Entity (NCE) First Filer 1 Expected
Protection for MM-120 with NCE Filing Status Submission Package for NCE Initial Filer Legal/Regulatory Exclusivity • Lysergide has not been previously approved, enabling NCE status; key differentiator versus Full NDA package. All clinical
studies conducted by or on behalf of applicant, applications that rely on a previously approved Reference Listed Drug including: • 5-year marketing exclusivity per Hatch Waxman Act • Two adequate well-controlled studies • 30-month
stay on subsequent 505(b)(2) or 505(j) filers • Full clinical pharmacology reports • Possibility of treble damages if there is an at-risk launch by subsequent filer, regardless of pathway • Full toxicology reports • Full
safety pharmacology reports Intellectual Property • Full nonclinical pharmacology reports 4 • Over 10 US & PCT patent applications covering claims key to approval/labeling • Full chemistry, manufacturing & controls reports
• All intellectual property claims (including both those listed and not listed in OB) • Methods of treating generalized anxiety disorder 2 Typical development package can range from $300 million to $1.5 billion+ • Method of
manufacturing and product claims for API (salt form and polymorphs) 3 and takes 10+ years from inception on average for psychiatric indications • Method of manufacturing and product claims for DP (MM-120 ODTs) • Claims covering key
aspects of product performance (e.g. faster absorption, less variability and potential shorter duration) • Methods of use related to ODT formulation, treatment of GAD and other patient outcomes • Additional claims related to dose
identification, patient monitoring, digital technology and others Additional Structural Protections and Benefits • Limited supply chain availability 5 • Exclusive rights to key technology (e.g. Catalent Zydis® ODT) •
Differentiated delivery, documentation and reimbursement support • Sensitivities and specific requirements due to controlled substance classification • Trade secrets and know-how 1. Contingent upon FDA approval and grant of claims by
USPTO. 2. Management’s estimate of development costs based on past precedents. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-201 JAMA. 2020;323(9):844-853. doi:10.1001/jama.2020.1166. December
2023 3. Clinical Development Success Rates and Contributing Factors 2011–2020” by BIO, PharmaIntelligence and QLS Advisors. 43 4. Includes three provisional applications Topline Data from Study MMED008 5. Catalent has granted exclusive
rights to intellectual property for Zydis® for lysergide (LSD). NCE: New Chemical Entity; OB: Orange Book; ODT: Orally Disintegrating Tablet
