Slides
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Phase 3 Panorama Study Topline Data Readout
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This presentation (the “Presentation”) has been prepared by Definium Therapeutics, Inc. (“ Definium ”, the “Company”, “we”, “our” or “us") solely for informational purposes. This Presentation does not constitute an offering o f, or a solicitation of an offer to purchase, securities of Definium and under no circumstances is it to be construed as a prospectus or advertisement or public offering of securities. Any trade ma rks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of Definium . Any amounts are in USD unless otherwise noted. Definium’s securities have not been approved or disapproved by the U.S. Securities and Exchange Commission (the "SEC") or by any state, provincial or other securities regulatory authority, nor has the SEC or any state, pr ovi ncial or other securities regulatory authority passed on the accuracy or adequacy of this Presentation. Any representation to th e contrary is a criminal offense. Cautionary Note Regarding Forward - Looking Statements This Presentation contains, and our officers and representatives may from time to time make, “forward - looking statements” within the meaning of applicable securities laws and are prospective in nature. Forward - looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks a nd uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forwa rd - looking statements. These statements generally can be identified by the use of forward - looking words such as “will”, “may", “sho uld”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential”, “continue”, “budget”, “scheduled ”, “forecasts”, “intends”, “anticipates”, “projects” or the negative thereof or similar variations. Forward - looking statements in t his Presentation include, but are not limited to, statements regarding the anticipated design, timing, progress and results o f o ur investigational programs for DT120 oral disintegrating tablet (“ODT”), a proprietary, pharmaceutically optimized form of lysergide tartrate for the treatment of generalized anxiety disorder, major depressive disorder and posttraumatic stress disorder (including the anticipated topline readout for the Ascend study); the timing of our pre - NDA meeting scheduled for the fourth qua rter of 2026; our anticipated NDA filing in the first half of 2027; the success and timing of our development activities; our ab ility to meet the milestones set forth herein; the likelihood of success of any clinical trials or of obtaining U.S. Food and Drug Adm inistration (“FDA”) or other regulatory approvals; our beliefs regarding potential benefits and side effects (or lack thereof ) o f DT120 ODT; our belief that DT120 ODT represents a best - in - class profile; the potential commercial opportunity for DT120 ODT, if approv ed, including total addressable market and revenue opportunity; our plans to continue to advance commercial readiness activities, including patient education, access and support, and site of care readiness; our cash runway; our ability to succ ess fully execute on our planned clinical, regulatory and commercial preparation activities; and the potential for psychedelics a s a class of treatment options in psychiatry. There are numerous risks and uncertainties that could cause actual results, plans and objectives to differ materially from th ose expressed in forward - looking statements, including history of negative cash flows, limited operating history, incurrence of fut ure losses, availability of additional capital, compliance with laws and regulations, difficulty associated with research and dev elo pment, risks associated with clinical trials or studies, heightened regulatory scrutiny, early stage product development, cli nic al trial risks, regulatory approval processes, novelty of the psychedelic inspired medicines industry, our ability to maintain effecti ve patent rights and other intellectual property protection for our product candidates, our expectations regarding the size of t he eligible patient populations for our lead product candidates, if approved and commercialized; our ability to identify third - part y treatment sites to conduct our trials and our ability to identify and train appropriate qualified healthcare practitioners to administer our treatments; the pricing, coverage and reimbursement of our lead product candidates, if approved and commercial ize d; the rate and degree of market acceptance and clinical utility of our lead product candidates, in particular, and controlle d substances, in general; as well as those risk factors described in the Company's Annual Report on Form 10 - K for the fiscal year ended December 31, 2025, the Company’s Quarterly Report on Form 10 - Q for the quarterly period ended March 31, 2026, and the Company’s Quarterly Report on Form 10 - Q for the quarterly period ended June 30, 2026, under headings such as “Special Note R egarding Forward - Looking Statements,” and “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory aut hor ities in all provinces and territories of Canada which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the SEC on EDGAR at www.sec.gov . Any forward - looking statement made by Definium in this Presentation is based only on information currently available to the Company and speaks only as of the date on which it is made. Except as required by law, the Company undertakes no duty or obligation to update any forward - looking statements contained in this Presentation as a result of new information, future events , changes in expectations or otherwise. Cautionary Note Regarding Regulatory Matters The United States federal government regulates drugs through the Controlled Substances Act. DT120 ODT is a proprietary, pharm ace utically optimized form of lysergide D - tartrate and DT402, or R( - ) - MDMA, is our proprietary form of the R - enantiomer of MDMA (3,4 - methylenedioxymethamphetamine). Lysergide and MDMA are Schedule I substances under the Controlled Substances Act. While the Company is focused on programs using psyche de lic or hallucinogenic compounds and non - hallucinogenic derivatives of these compounds, including in DT120 ODT, DT402 and its other product candidates, the Company does not have any di rect or indirect involvement with the illegal selling, production or distribution of any substances in the jurisdictions in which it operates. The Company is a neuro - pharmaceutical drug development company and does not deal with psychedelic or hallucin ogenic substances except within laboratory and clinical trial settings conducted within approved regulatory frameworks. The Company's products will not be commercialized prior to applicable regulatory approval, which will only be granted if clin ica l evidence of safety and efficacy for the intended uses is successfully developed. Market and Industry Data This Presentation includes market and industry data that has been obtained from third party sources, including industry publi cat ions. Definium believes that the industry data is accurate and that the estimates and assumptions are reasonable, but there is no assurance as to the accuracy or completeness of this data. Third party sources generally state that the information contai ned therein has been obtained from sources believed to be reliable, but there is no assurance as to the accuracy or completeness of included information. Although the data is believed to be reliable, Definium has not independently verified any of the data from third party sources referred to in this Presentation or ascertained the u nd erlying economic assumptions relied upon by such sources. References in this Presentation to research reports or to articles and publications should not be construed as depic tin g the complete findings of the entire referenced report or article. Definium does not make any representation as to the accuracy of such information. Panorama Topline Results | September 2026 2 Disclaimer
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Opening Remarks Rob Barrow Chief Executive Officer
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Thank you to our study participants, investigators and partners who made Panorama possible
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Significant need for innovation in the treatment of GAD 5 Population prevalence increased from 3% to 10% over last 20 years 1 No new drugs approved for GAD since 2007 Significant disease burden , with impairment in daily functioning, work productivity and quality of life Panorama Topline Results | September 2026 1. Generalized Anxiety Disorder, https:// www.nimh.nih.gov /health/statistics/generalized - anxiety - disorder; Mental and Substance Use Disorders Prevalence Study, https:// www.rti.org /publication/mental - substance - use - disorders - prevalence - study - findings - report GAD: generalized anxiety disorder
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Panorama Topline Results | September 2026 6 Third Positive Pivotal Readout for DT120 ODT 100 µg 1. Clinical study designs subject to change based on ongoing regulatory discussion and review, including of Phase 3 clinical tri al protocols 2. Includes the primary endpoint and all hierarchically controlled key secondary endpoints. DB: double blind; ODT: orally disintegrating tablet; OL: open - label; RCT: randomized controlled trial Generalized Anxiety Disorder (GAD) Major Depressive Disorder (MDD) n=214 1 :1 randomization DT120 ODT vs. Placebo ▪ Part A: 12 - week DB, RCT ▪ Part B: 40 - week Extension with OL Treatment n=245 2:1:2 randomization DT120 ODT vs. Placebo including 50 µg control ▪ Part A: 12 - week DB, RCT ▪ Part B: 40 - week Extension with OL Treatment n=149 1:1 randomization DT120 ODT vs. Placebo ▪ Part A: 12 - week DB, RCT ▪ Part B: 40 - week Extension with OL Treatment Target n=165 1 2:1:2 randomization DT120 ODT vs. Placebo including 50 µg control ▪ Part A: 12 - week DB, RCT ▪ Part B: 40 - week Extension with OL Treatment Target n=200 1 1:1 randomization DT120 ODT vs. Placebo ▪ Part A: 12 - week DB, RCT ▪ Part B: 40 - week Extension with OL Treatment Posttraumatic Stress Disorder (PTSD) Met All Primary & Key Secondaries2 Met All Primary & Key Secondaries2 Enrolling PlanningMet All Primary & Key Secondaries2 Study met all primary and key secondary endpoints & consistent with dose response demonstrated in Phase 2b
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Panorama Topline Results | September 2026 7 Panorama Results Demonstrate Potential Best - in - Class Efficacy in Generalized Anxiety Disorder 1 Limited side effect burden Efficient session dynamics Rapid, robust and durable efficacy after single dose ▪ All primary and key secondary endpoints highly statistically significant ▪ 5.1 point HAM - A improvement over placebo at week 12 primary endpoint (p<0.0001) ▪ 5.3 point HAM - A improvement over placebo at week 1 (p<0.0001) ▪ 0.8 point CGI - S improvement over placebo at day 2 (p<0.0001) ▪ Results consistent with Phase 2 dose - response data ▪ DT120 ODT 100 µg was generally well tolerated with no new safety signals identified ▪ No suicidality signal or suicidal behavior ▪ 6.2 hour average time to clear End of Session Checklist ( EoSC ) ▪ 94% participants cleared EoSC by 8 hours 1. Source: Panorama study documents. Safety population in study part A (through week 12) CGI - S: Clinical Global Impression - Severity Scale; HAM - A: Hamilton Anxiety Scale; ODT: orally disintegrating tablet
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8 Panorama Topline Results | September 2026 DT120 Dose Response Relationship Highlights 1. Based on Phase 2b best - fit prespecified dose response model (Emax) at week 4; per protocol population. 2. ITT population. Placebo - adjusted HAM - A at week 12 using a Mixed - Effects Model Repeated Measures (MMRM) statistical analysis with reference - based imputation. 3. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. GAD: generalized anxiety disorder Phase 3 Results Align with DT120 Dose - Response Model Largest separation from placebo observed at 100 µg ▪ Week 4: 50% less separation at 50 µg 3 ▪ Week 12: 29% less separation at 50 µg Dose response observed despite ‘functional unblinding’ at all doses ▪ 91% and 95% of participants at 50 and 100 µg correctly guessed assignment to drug Phase 3 results align with dose-response model established in Phase 2b Results support the conclusion that DT120 dose response is not attributable to functional unblinding -8.0 -7.0 -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 25 50 75 100 125 Placebo - adjusted HAM - A Change DT120 Dose (µg) Phase 2b Dose Response Model (mean +/ - SD) 1 2 2 Phase 2b results
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Panorama Topline Results | September 2026 9 Benefit - Risk Highlights Differentiation of DT120 ODT 100 µg 1. Mechanism - based adverse event rates based on number of participants experiencing in Part A; safety population. Adverse event cat egories are a summary of MedDRA preferred terms that represent distinct domains of anticipated lysergide effects. 2. Dashed line represents target product profile: durable efficacy of 4 points or greater which represents a potential best - in - clas s profile. EoSC : end of session checklist; HAM - A: Hamilton Anxiety Rating Scale; MedDRA: Medical Dictionary for Regulatory Activities xxx Efficacy target only achieved at 100 µg with similar adverse event profile across doses Placebo-Adjusted Change in HAM-A Mechanism-based Adverse Event Rates1 DT120 ODT 100 µg DT120 ODT 50 µg Median time to EoSC clearance: 6 hours Week 1 Week 2 Week 4 Week 8 Week 12 -8-7-6-5-4-3-2-10 Week 1 Week 2 Week 4 Week 8 Week 12 Efficacy Target 2 Perceptual changes 87% Affective changes 66% Behavioral changes 18% Changes in thinking 27% Perceptual changes 78% Affective changes 65% Behavioral changes 4% Changes in thinking 35% - 4 Median time to EoSC clearance: 6 hours
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Panorama Topline Results | September 2026 10 DT120 100 µg Efficacy Stands Out Against Approved GAD Treatments 1 DT120 observed effect size consistently larger than GAD standard of care 1) The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and settings. As such, these data may not be directly comparable due to the lack of a head - to - head comparison. Differences in trial design, patient demographics, and other variables may account for variations in the observed outcomes. Study results fo r e ach drug are intended to be representative, however, multiple trials of the approved treatments have been conducted with varying results, including results that may have demonstrated a larger or smaller treatment effect than those presented. Bu spirone and benzodiazepines are approved for anxiety disorders which include GAD; 2) R Robison, JAMA. 2025 Sep 4; e2513481. doi:10.1001/jama.2025.13481 ; 3) Source: Voyage study documents; 4) Source: Panorama study documents ; 5) RB Hidalgo, J Psychopharmacol. 2007 Nov;21(8):864 - 72 GAD: generalized anxiety disorder, SRI: serotonin reuptake inhibitors 5 Benzodiazepines SRIs Buspirone 5 5 3 4 Phase 2b 2 UPDATE CHART IN EXCEL DOCUMENT 3 4 Phase 2b 2 0.81 0.81 0.64 0.88 0.99 0.96 0.38 0.36 0.17 0.0 0.2 0.4 0.6 0.8 1.0 Effect Size Week 4 Week 12
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Phase 3 Panorama Study Results Part A – Topline Results Dan Karlin, MD Chief Medical Officer
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Panorama Trial Design 1. Source: Definium internal study documents. 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. ePRO: electronic Patient - Reported Outcome; GAD: generalized anxiety disorder; GAD - 7: a multipurpose instrument for screening, di agnosing, monitoring and measuring the severity of anxiety; HAM - A: Hamilton Anxiety Rating Scale; ODT: orally disintegrating tablet; µg: microgram DT120 ODT 1 00 µg n=96 DT120 ODT 5 0 µg control 2 n=52 Part A 12 Week Randomized, Double - Blind Part B 40 Week Extension with Opportunity for Open - Label Treatment PHASE 3 STUDY1 Single Dose Primary Endpoint: HAM-A at Week 12 Statistical analyses & endpoints only compare 100 µg vs placebo Up to four open - label doses of DT120 ODT 1 00 µg Follow-up Observation GAD - 7 (ePRO): biweekly HAM - A (central rater): monthly or when GAD - 7 ≥ 10 Potential Treatment Eligible for open - label treatment if HAM - A ≥ 16 12 Panorama Topline Results | September 2026 Placebo n=97 Primary and Key Secondary Endpoints: ▪ HAM - A: LS mean change at Week 12 100 µ g vs. placebo ▪ CGI - S: LS mean change at Week 12 100 µ g vs. placebo ▪ HAM - A: LS mean change at Week 1 100 µ g vs. placebo ▪ CGI - S: LS mean change at Day 2 100 µ g vs. placebo
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13 1. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. ITT: intent to treat; ODT: orally disintegrating tablet Participant Disposition Panorama Topline Results | September 2026 Randomized n=245 DT120 ODT 100 µg n=96 DT120 ODT 50 µg control 1 n=52 Placebo ODT n=97 ▪ 100% included in ITT population ▪ 90% completed Part A ▪ 100% included in ITT population ▪ 90% completed Part A Table 14.1.1 – Participant Disposition, All Participants Screened ▪ 100% included in ITT population ▪ 87% completed Part A
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14 1. Based on ITT population. 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. 3. Mean (SD). 4. The HAM - A is a 14 - item clinician - rated outcome measure assessing various domains of anxiety with a range of 0 - 56. In Panorama, H AM - A ratings were assessed by central raters blinded to both treatment assignment and visit number. 5. The CGI - S is a clinician - rated outcome measure assessing overall severity of illness with a range of 1 to 7. 6. Psychedelics include LSD, psilocybin, dimethyltryptamine and other classic serotonergic psychedelics. CGI - S: Clinical Global Impressions – Severity Scale; HAM - A: Hamilton Anxiety Rating Scale; ITT: intent to treat; LSD: lysergic a cid diethylamide; ODT: orally disintegrating tablet Demographics & Baseline Characteristics 1 Demographic DT120 ODT 100 µg n=96 DT120 ODT 50 µg control2 n=52 Placebo ODT n=97 Overall n=245 Mean age (years) 39.8 40.4 42.3 40.9 Sex (% female) 62% 56% 62% 60% Race (% white) 82% 85% 84% 83% Baseline HAM - A score 3,4 28.3 (5.5) 27.7 (4.8) 28.0 (5.6) 28.0 (5.4) Baseline CGI - S score 3.5 4.7 (0.5) 4.7 (0.6) 4.7 (0.6) 4.7 (0.6) Past Psychedelic Use, n (%) Any psychedelic 6 11 (12%) 8 (15%) 16 (17%) 35 (14%) LSD 4 (4%) 4 (8%) 8 (8%) 16 (7%) Panorama Topline Results | September 2026 Table 14.1.2 – Summary of Demographics & Baseline Disease Characteristics, ITT Population Table 14.1.4.3 - Summary of Past Mind - Altering Drug Use, ITT Population
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15 1. Based on ITT population 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. 3. Mean (SD) 4. Eligibility criteria required a baseline HAM - A score of 20 or greater; Moderate symptoms are defined as a HAM - A score of 16 – 23 . 5. Eligibility criteria excluded participants currently in a major depressive episode. GAD: generalized anxiety disorder; HAM - A: Hamilton Anxiety Rating Scale; ITT: intent to treat; MADRS: Montgomery - Åsberg Depression Rating Scale; MDD: major depressive disorder; ODT: orally disintegrating tablet; SD: standard deviation Baseline Characteristics | Representative of GAD Patients with High Burden of Disease 1 Panorama Topline Results | September 2026 Diagnostic Trait DT120 ODT 100 µg n=96 DT120 ODT 50 ug control2 n=52 Placebo ODT n=97 Overall n=245 HAM - A score 2 28.3 (5.5) 27.7 (4.8) 28.0 (5.6) 28.0 (5.4) HAM - A severity, n (%) Moderate (<24) 4 20 (21%) 9 (17%) 27 (28%) 56 (23%) Severe ( ≥24) 76 (79%) 43 (83%) 70 (72%) 189 (77%) Number of past GAD treatments, n (%) 0 29 (30%) 14 (27%) 17 (18%) 60 (25%) 1 20 (21%) 15 (29%) 22 (23%) 57 (23%) 2+ 47 (49%) 23 (44%) 58 (60%) 128 (52%) Comorbid MDD 5 , n (%) 28 (29%) 17 (33%) 25 (26%) 70 (29%) MADRS score 3 13.3 (4.4) 13.4 (4.5) 13.5 (3.9) 13.4 (4.2) Years since Diagnosis of GAD 3 6.9 (7.6) 9.4 (11.4) 9.9 (8.8) 8.6 (9.0) Years since Onset of GAD Symptoms 3 16.4 (12.6) 18.2 (15.5) 19.1 (13.4) 17.8 (13.6) Table 14.1.2 Summary of Demographics and Baseline Disease Characteristics , ITT Population Table 14.1.3.1 Summary of GAD and Other Psychiatric History, ITT Population
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Primary Endpoint: HAM-A Change from Baseline to Week 12 16 1. Source: Panorama study documents. ITT population. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designe d o r powered for statistical comparisons. 2. Primary endpoint of the study was change in HAM - A at week 12 between 100 µg and placebo using a Mixed - Effects Model Repeated Mea sures (MMRM) statistical analysis with reference - based imputation. HAM - A: Hamilton Anxiety Rating Scale; LS Mean: least squares mean; ODT: orally disintegrating tablet; SEM: standard error of the mean DT120 ODT 100 µg Showed Statistically & Clinically Significant HAM - A Improvements at All Timepoints 1,2 Panorama Topline Results | September 2026 **** **** **** **** **** Week 1 Week 2 Week 4 Week 8 Week 12 Change from Baseline2 Improvement over Placebo2 ****p<0.0001 (DT120 100 µg vs placebo) Highlights UPDATE CHART IN EXCEL DOCUMENT – HIGHLIGHTS TO BE UPDATED ON SLIDE Table 14.2.1.1 – Primary Analysis of Change from Baseline in HAM - A Total Score by MMRM, ITT Population -15 -10 -5 0 LS Mean Change (SEM) in HAM - A score DT120 ODT 100 µg DT120 ODT 50 µg control Placebo ODT 100 µg 50 µg ▪ Week 1: - 9.8 - 10.3 ▪ Week 4: - 12.3 - 8.8 ▪ Week 8: - 10.4 - 8.1 ▪ Week 12: - 9.8 - 8.3 100 µg 50 µg ▪ Week 1: - 5.3 - 5.8 ▪ Week 4: - 7.0 - 3.5 ▪ Week 8: - 5.3 - 3.0 ▪ Week 12: - 5.1 - 3.6
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Change from Baseline2 Improvement over Placebo2 17 1. Source: Panorama study documents. ITT population. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designe d o r powered for statistical comparisons. 2. Key secondary endpoints of the study was change in CGI - S at day 2 and week 12 between 100 µg and placebo using a Mixed - Effects M odel Repeated Measures (MMRM) statistical analysis with reference - based imputation. CGI - S: Clinical Global Impressions – Severity scale; LS Mean: least squares mean; ODT: orally disintegrating tablet; SEM: standa rd error of the mean DT120 ODT 100 µg Showed Statistically & Clinically Significant CGI - S Improvements at All Timepoints 1,2 Panorama Topline Results | September 2026 Change from Baseline (100 µg)2 ▪ Day 2: - 1.1 points ▪ Week 1: - 1.2 points ▪ Week 4: - 1.4 points ▪ Week 8: - 1.2 points ▪ Week 12: - 1.0 points Improvement over Placebo (100 µg)2 ▪ Day 2: - 0.8 points ▪ Week 1: - 0.7 points ▪ Week 4: - 1.0 points ▪ Week 8: - 0.7 points ▪ Week 12: - 0.6 points **** **** **** **** **** Week 1 Week 2 Week 4 Week 8 Week 12 **** Day 2 Key Secondary Endpoint: CGI-S Change from Baseline to Week 12 Highlights ****p<0.0001 (DT120 100 µg vs placebo) UPDATE CHART IN EXCEL DOCUMENT – HIGHLIGHTS TO BE UPDATED ON SLIDE Table 14.2.2.1 – Main Analysis of Change from Baseline in CGI - S Score by MMRM, ITT Population -1.5 -1.0 -0.5 0.0 LS Mean Change (SEM) in CGI - S score DT120 ODT 100 µg DT120 ODT 50 µg control Placebo ODT 100 µg 50 µg ▪ Day 2: - 1.1 - 1.1 ▪ Week 1: - 1.2 - 1.3 ▪ Week 4: - 1.4 - 1.2 ▪ Week 12: - 1.1 - 0.9 100 µg 50 µg ▪ Day 2: - 0.8 - 0.8 ▪ Week 1: - 0.7 - 0.8 ▪ Week 4: - 1.0 - 0.7 ▪ Week 12: - 0.6 - 0.4
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18 DT120 ODT 100 µg Effects Supported by Robust, Clinically Significant Response and Remission Rates 1 Panorama Topline Results | September 2026 Remission Rate at Week 12 Response Rate at Week 12 1. Source: Panorama study documents. ITT population. Pre - planned secondary endpoints. HAM - A: Hamilton Anxiety Rating Scale; ODT: orally disintegrating tablet ** p<0.01; *p<0.05 * * Placebo ODT DT120 ODT 100 µg UPDATE CHARTS IN EXCEL DOCUMENT – ODDS RATIOS & P-Value ** TO BE UPDATED ON SLIDE Part A – Table 14.2.1.8 – Analysis of HAM - A Response (HAM - A Total Score Reduction from Baseline ≥ 50%) by Visit, ITT Population Part A – Table 14.2.1.9 – Analysis of HAM - A Remission (HAM - A Total Score ≤ 7) by Visit, ITT Population Part A – Table 14.2.1.10 – Analysis of HAM - A Mild Remission (HAM - A Total Score < 16) by Visit, ITT Population ** Mild or Better at Week 12 15% 4%0% 10% 20% 30% 40% 50% 60% Remission HAM - A ≤ 7 Odds ratio: 4.2 35% 17% 0% 10% 20% 30% 40% 50% 60% Mild or better HAM-A < 16 Odds ratio: 2.6 32% 14% 0% 10% 20% 30% 40% 50% 60% Response HAM - A ≥ 50% Improvement Odds ratio: 2.9
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19 1. Source: Panorama study documents. Subgroup analysis of ITT population; 100 µg and placebo groups only. 2. Data presented as Least Squares mean ± standard error. 3. For each subgroup, the change from baseline in HAM - A total score is analyzed using the same MMRM model as the primary efficacy a nalysis. If the number of patients is small for a subgroup, the treatment difference will not be stable as it would be highly sensitive to outliers. Δ : change; GAD: generalized anxiety disorder; HAM - A: Hamilton Anxiety Rating Scale; MMRM: Mixed - Effects Model Repeated Measures Treatment Effect Maintained Across Key Subgroups – Including Those Failed by 2+ Prior Treatments 1 Panorama Topline Results | September 2026 Placebo Adjusted Δ Subgroup Analysis of HAM-A Change at Week 122, 3 - 7 - 6 - 5 - 4 - 3 - 2 - 1 0 1 2 3 4 5 6 7 All participants Time since onset <22 yrs (n=135) > 22 yrs (n=58) Previous GAD Medications Less than two (n=88) Two or more (n=105) Sex Male (n=74) Female (n=119) Favors DT120 Table 14.2.1.1 – Primary Analysis of Change from Baseline in HAM - A Total Score by MMRM, ITT Population Table 14.2.1.7 – Subgroup Analysis for HAM - A Total Score Change from Baseline to Week 12, ITT Population Favors Placebo
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DT120 ODT 100 µg was Generally Well - Tolerated and Consistent with Prior Clinical Experience 1 1. Source: Panorama study documents. Safety population in study part A (through week 12). 2. Participant suicidality assessment based on changes in C - SSRS. C - SSRS: Columbia - Suicide Severity Rating Scale; ODT: orally disintegrating tablet ▪ AE profile consistent with prior studies of DT120 ▪ Most adverse events (AEs) were mild - to - moderate in severity ▪ Most treatment emergent AEs (TEAEs) occurred and resolved on dosing day ▪ No drug related serious adverse events (SAEs) Favorable tolerability profile No suicidal behavior or suicidality signal2 ▪ No suicidal or self - injurious behavior ▪ No indication of increased suicide - related risk 20 Panorama Topline Results | September 2026 Table 14.3.1.1 – Overall Summary of Treatment - Emergent Adverse Events, Safety Population Table 14.3.1.10 – Summary of Treatment - Emergent Adverse Events by Preferred Term and Occurrence at Dosing Day and Post - Dosing Days, Safety Population Table 14.3.5.2 – Summary of Shifts from Baseline in Columbia - Suicide Severity Rating Scale (C - SSRS) to Anytime Post - baseline, Safety Population
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Panorama Topline Results | September 2026 21 Adverse Events Were Generally Mild - to - Moderate in Severity 1,2 Adverse Event DT120 ODT 100 µg n=96 DT120 ODT 50 µg control3 n=51 Placebo ODT n=97 Any TEAE 91 (95%) 49 (96%) 61 (63%) Mild 51 (53%) 29 (57%) 30 (31%) Moderate 39 (41%) 19 (37%) 29 (30%) Severe 1 (1%) 1 (2%) 2 (2%) Any Study Drug - Related TEAE 90 (94%) 47 (92%) 34 (35%) Any Adverse Event of Special Interest (AESI) 84 (88%) 43 (84%) 31 (32%) Any SAE 4 2 (2%) 1 (2%) 1 (1%) Any Treatment Related SAE 0 0 0 Any TEAE Leading to Discontinuation 0 0 0 Any TEAE Leading to Death 0 0 0 1. Source: Panorama study documents. Safety population in study part A. 2. Adverse events were collected in accordance with FDA Final Guidance for Psychedelic Drug Development, which includes expected ef fects characterized as positive, favorable, or neutral. 3. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. 4. All SAEs were deemed unrelated to the study drug. AESI: adverse event of special interest; ODT: orally disintegrating tablet; SAE: serious adverse event; TEAE: treatment - emergent adverse event Table 14.3.1.1 – Overall Summary of Treatment - Emergent Adverse Events, Safety Population Source: https://psychedelicalpha.com/wp - content/uploads/2026/07/59936051fnl_Psychedelic - Drugs_Considerations - for - Clinical - Invest igations.pdf
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22 Most Common TEAEs Demonstrated Favorable Tolerability Profile of DT120 ODT 100 µg 1,2,3 Panorama Topline Results | September 2026 TEAEs with Incidence ≥10% Dosing Day After Dosing Day DT120 ODT 100 µg (n=96) DT120 ODT 50 µg control4 (n=51) Placebo ODT (n=97) DT120 ODT 100 µg (n=96) DT120 ODT 50 µg control4 (n=51) Placebo ODT (n=97) Illusion 65 (68%) 31 (61%) 12 (12%) 3 (3%) 0 0 Nausea 35 (37%) 13 (26%) 4 (4%) 2 (2%) 4 (8%) 1 (1%) Headache 23 (24%) 14 (28%) 13 (13%) 13 (14%) 6 (12%) 10 (10%) Euphoric Mood 30 (31%) 16 (31%) 5 (5%) 1 (1%) 0 0 Fatigue 22 (23%) 5 (10%) 6 (6%) 7 (7%) 1 (2%) 4 (4%) Dizziness 22 (23%) 10 (20%) 3 (3%) 1 ( 1%) 1 (2%) 0 Anxiety 16 (17%) 7 (14%) 7 (7%) 6 (6%) 3 (6%) 5 (5%) Crying 20 (21%) 6 (12%) 0 0 1 (2%) 0 Feeling cold 14 (15%) 2 (4%) 6 (6%) 0 0 1 (1%) Paraesthesia 13 (14%) 4 (8%) 3 (3%) 0 1 (2%) 1 (1%) Time Perception Altered 13 (14%) 4 (8%) 1 (1%) 0 0 0 Feeling of Relaxation 12 (13%) 8 (16%) 11 (11%) 1 (1%) 0 0 Inappropriate Affect 12 (13%) 4 (8%) 0 0 0 0 Feeling Hot 11 (12%) 4 (8%) 4 (4%) 0 0 0 Emotional Disorder 8 (8%) 3 (6%) 3 (3%) 3 (3%) 0 0 Feeling Abnormal 10 (10%) 7 (14%) 4 (4%) 0 0 1 (1%) Restlessness 10 (10%) 1 (2%) 3 (3%) 1 (1%) 0 1 (1%) Tremor 10 (10%) 4 (8%) 1 (1%) 1 (1%) 0 0 1. Source: Voyage study documents. Safety population in study part A (through week 12). 2. Adverse events were collected in accordance with FDA Guidance for Psychedelic Drug Development, which includes expected effec ts characterized as positive, favorable, or neutral. ODT: orally disintegrating tablet; TEAE: treatment - emergent adverse event Table 14.3.1.10 – Summary of Treatment - Emergent Adverse Events by Preferred Term and Occurrence at Dosing Day and Post - Dosing Days, Safety Population 1. Source: Panorama study documents. Safety population in study part A (through week 12). 2. Adverse events were collected in accordance with FDA Guidance for Psychedelic Drug Development, which includes expected effec ts characterized as positive, favorable, or neutral. 3. AEs over 10% in the 100 µg arm are shown above 4. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. AE: adverse event; ODT: orally disintegrating tablet; TEAE: treatment - emergent adverse event
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23 1. Source: Panorama study documents. Safety population in study part A (100 µ g). Time at which participant first meets End of Session Checklist criteria. 2. Based on Interim analysis of EoSC as of September 10, 2026 from all dosing sessions in Emerge, Voyage and Panorama. ODT: orally disintegrating tablet; EoSC : End of Session Checklist 1,000+ DT120 ODT 100 µg Dosing Sessions Demonstrated a Scalable Path to Clinical Practice 1 Panorama Topline Results | September 2026 Time to End of Session Checklist (EoSC) Clearance Highlights ▪ Average time to clearance of EoSC is 6.2 hours in Panorama 1 ▪ Two thirds of participants clear EoSC at hour 6 1 ▪ 95+% of participants clear EoSC by hour 8 2 ▪ Emerging evidence of predictable 5 to 8 hour sessions UPDATE CHART IN EXCEL DOCUMENT – KEY HIGHLIGHTS TO BE UPDATED ON SLIDE Table 14.3.6.1.1 – Number and Percentage of Participants Who Answered Yes to All Items in End of Session Checklist (EOSC), Safet y Population Table 14.3.6.1.2 - Summary of Time to First Hour of All Yes Responses to End of Session Checklist (EOSC), Safety Population All Phase 3 Studies (n=1,061 sessions) 2 Panorama (Part A; n=96) Note for legal review: we had to derive these values from a listing of EoSC not the table as there were duplicate counts in the table that did not represent ‘first time clearing EoSC ’ 45% 66% 88% 94% 48% 66% 87% 97% 0% 20% 40% 60% 80% 100% Hour 5 Hour 6 Hour 7 Hour 8
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Phase 3 Panorama Topline Results Part B – Interim Analysis Dan Karlin, MD Chief Medical Officer
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25 1. Based on interim analysis as of August 11, 2026. Interim analysis based on partial data and subject to change. 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. ITT: intent - to - treat; ODT: orally disintegrating tablet Part B Disposition 1 Panorama Topline Results | September 2026 ▪ Safety population (n=244) ▪ ITT population (n=245) Part A Progress at Time of Interim AnalysisPart B Randomized N=245 DT120 ODT 100 µg n=96 Placebo ODT n=97 DT120 ODT 100 µg up to 4 times n= 86 e ntered Part B ▪ Through Week 28 (n=35) ▪ Through Week 36 (n=24) ▪ Through Week 52 (n=8) ▪ Through Week 28 (n=43) ▪ Through Week 36 (n=35) ▪ Through Week 52 (n=14) DT120 ODT 100 µg up to 4 times n=76 e ntered Part B Table 14.1.1 – Participant Disposition, All Participants Screened Part B Table 14.1.2 – Summary of Demographics and Baseline Disease Characteristics - Part B, Extension Population DT120 ODT 50 µg control 2 n=52 DT120 ODT 100 µg up to 4 times n=42 e ntered Part B ▪ Through Week 28 (n=19) ▪ Through Week 36 (n=10) ▪ Through Week 52 (n=3)
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26 1. Based on interim analysis as of August 11, 2026. Extension population. Interim analysis based on partial data and subject t o c hange. 2. ITT population who entered Part B. Data based on Week 12 in Part A. 3. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. CGI - S: Clinical Global Impressions – Severity Scale; HAM - A: Hamilton Anxiety Rating Scale; ITT: intent - to - treat; ODT: orally dis integrating tablet Part B Enrollment & Baseline Characteristics 1 Panorama Topline Results | September 2026 Demographic (Part B)2 DT120 ODT 100 µg n=62 DT120 ODT 50 µg control3 n=33 Placebo ODT n=68 Total n=163 Mean age (years) 39.5 42.3 42.8 41.4 Sex, female (%) 62.9% 51.5% 58.8% 58.9% Race (% white) 82.3% 87.9% 83.8% 84.0% HAM - A score at Part B Entry 18.3 21.6 23.3 21.1 CGI - S score at Part B Entry 3.7 4.0 4.2 4.0 Part A Table 14.2.1.1 and 14.2.2.1 Part B Table 14.1.2 – Summary of Demographics and Baseline Disease Characteristics - Part B, Extension Population
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27 1. Based on interim analysis as of August 11, 2026. Extension population. Interim analysis based on partial data and subject t o c hange. 50 µ g cohort not included due to small n. 2. n is the number of participants in the Extension population who had the specified number of doses up to the corresponding vis it. ITT: intent - to - treat; ODT: orally disintegrating tablet; OLTx : open - label treatment Treatment Patterns in Part B Provide Early Insights into Paradigm beyond 12 Weeks 1 Panorama Topline Results | September 2026 Summary of Cumulative DT120 ODT Doses through Week 28 Week 16 Week 20 Week 24 Week 28 DT120 ODT 100 µg in Part A 2 Placebo ODT in Part A 2 Part A Dose only One OLTx Two OLTx Three OLTx UPDATE CHARTS IN EXCEL DOCUMENT – N’s TO BE UPDATED ON SLIDE Part B Table 14.2.1.3 – Summary of Retreatment Status in Part B and Cumulative MM120 Exposure in Part A + B by Visit, Extension Population n=62 n=54 n=43 n=35 n=68 n=55 n=44 n=43
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28 1. Based on interim analysis as of August 11, 2026. ITT Part A+B population with treatment policy strategy. Interim analysis b ase d on partial data and subject to change. 50 µ g cohort not included due to small n. 2. n is the number of participants in the ITT Part A+B population with non - missing HAM - A score at Baseline and the respective visit . HAM - A: Hamilton Anxiety Rating Scale; LS Mean: least squares mean; ODT: orally disintegrating tablet HAM - A Scores Improved Further with Additional Treatments in Part B Panorama Topline Results | September 2026 HAM-A Scores through Week 281,2 Placebo ODT in Part A Part A Part B Part B Table 14.2.2.3 – Summary of HAM - A Total Score Observed Values and Change from Baseline by Visit, ITT Part A+B Population Baseline -16 -14 -12 -10 -8 -6 -4 -2 0 Mean Change in HAM - A Score Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 Week 28 First Open - Label Dosing 96 92 89 87 66 49 35 27 97 91 85 86 70 47 36 32 DT120 ODT, n= Placebo ODT, n= DT120 ODT 100 µ g in Part A
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29 Subsequent Treatments Further Improved Response and Remission Rates through Week 28 1,2 Panorama Topline Results | September 2026 Mild and Remission Rates in Part B Response Rates in Part B 1. Source: Panorama study documents. Based on interim analysis as of August 11, 2026. ITT Part A+B population. Interim analysi s b ased on partial data and subject to change. 2. Only includes participants who received DT120 ODT in Part A. HAM - A: Hamilton Anxiety Rating Scale, ITT: intent - to - treat HAM - A Improvement ≥ 50% HAM - A ≤ 7 HAM - A < 16 87 66 49 35 27 n= 87 66 49 35 27 n= UPDATE CHARTS IN EXCEL DOCUMENT – N’s TO BE UPDATED ON SLIDE Part B Table 14.2.2.1 – Summary of HAM - A Response by Visit, ITT Part A+B Population Part B Table 14.2.2.2 – Summary of HAM - A Remission by Visit, ITT Part A+B Population 15% 12% 18% 34% 19% 36% 32% 53% 66% 59% 0% 10% 20% 30% 40% 50% 60% 70% Week 12 Week 16 Week 20 Week 24 Week 28 32% 23% 51% 60% 48% 0% 10% 20% 30% 40% 50% 60% 70% Week 12 Week 16 Week 20 Week 24 Week 28
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Next Steps Rob Barrow Chief Executive Officer
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Panorama Topline Results | September 2026 31 Compelling Evidence Across Four Late - Stage Trials with Complementary Designs 1 1. The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and se ttings. As such, these data may not be directly comparable due to the lack of a head - to - head comparison. 2. Primary endpoint in Voyage and Panorama is the change from baseline in HAM - A total score at Week 12; in Study MMED008 the primar y endpoint was change from baseline in HAM - A total score at week 4. Primary endpoint in Emerge was the change from baseline in MADRS score at Week 6. 3. Regulatory strategy for GAD & MDD to be discussed at pre - NDA meeting in 4Q 2026. HAM - A: Hamilton Anxiety Rating Scale; MADRS: Montgomery - Åsberg Depression Rating Scale, SD: standard deviation Generalized Anxiety Disorder (GAD) Primary endpoint2 DT120 vs. placebo Design Baseline HAM-A Baseline MADRS -5.4 p<0.0001 2 arms 27.9 13.5 7.2Pooled endpoint SD -5.1 p<0.0001 3 arms 28.0 13.4 8.4 Major Depressive Disorder (MDD) -8.1 p<0.0001 2 arms 17.1 34.5 10.4 -7.7 p<0.01 5 arms 30.2 27.2 11.1 Phase 2b Study MMED008 Robust data package aligned with FDA g uidance supports advancement of NDA submission for DT120 ODT 3
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Panorama Topline Results | September 2026 32 Compelling Development Program Supporting Plans for DT120 ODT New Drug Application 1. Registrational program represents studies anticipated to be required at the time of NDA submission; additional studies, inclu din g Part B of Phase 3 studies, are ongoing. 2. Regulatory filing strategy for GAD & MDD to be discussed at pre - NDA meeting. CMC: chemistry, manufacturing and controls; GAD: generalized anxiety disorder; MDD: major depressive disorder; NDA: new drug app lication; ODT: oral dissolving tablet Registrational Program Completion Anticipated by YE 20261 Key Psychedelics Considerations ✓ No psychotherapeutic intervention beyond study drug ✓ Statistically significant dose - response demonstrated ✓ Blinded central raters with assessment of blind integrity ✓ Thorough evaluation of blinding & expectancy ✓ Structured real world - ready assessment to determine session monitoring duration ✓ Robust and consistent adverse event capture supports a well - characterized safety profile Four positive Phase 2 & 3 studies with complementary designs across multiple indications and control conditions Comprehensive clinical pharmacology, nonclinical and CMC programs NDA - enabling manufacturing at established commercial sites Breakthrough therapy designations in GAD & MDD with enhanced regulatory engagement Pre - NDA meeting scheduled for 4Q 2026 2 ; NDA filing anticipated in 1H 2027 4
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Panorama Topline Results | September 2026 33 Opportunity to Deliver Significant Impact and Value Creation 1 1. Ringeisen, H., et al. (2023). Mental and Substance Use Disorders Prevalence Study (MDPS): Findings Report, Zhou, Y,. Et al. (20 17). Nature. Comorbid generalized anxiety disorder and its association with quality of life in patients with major depressive disorder. RTI International and current U.S. Census data and internal company estimates. Veeva COMPASS Open Claims An alysis Data on File, 2017 – 2025. 2. Assuming median Spravato ® surrogate pricing range; the price of DT120 ODT has not been established. GAD: generalized anxiety disorder; MDD: major depressive disorder; Rx: prescription Addressable market means potential 100,000 patient impact & $5 billion revenue opportunity per 2.5% penetration 2 50 million US Adults with GAD / MDD 26 million Diagnosed with GAD / MDD 13 million Rx Treated 4.2 million Failed by 2+ Rx Strong Patient Desire & Willingness Large & Expanding Treatment Network Payer Understanding & Intent Large & Growing Unmet Need
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34 Modest Adoption Yields Significant Opportunity Given Large and Growing Delivery Ecosystem Panorama Topline Results | September 2026 Significant revenue potential requires only modest uptake across an established treatment network patients per month patients per year interventional psychiatry clinics 1 patients treated Potential Gross Revenue Opportunity 2 2 24 ~4,000 100K $5B 1. Represents approximately half of estimated number of sites in the Spravato ® REMS program. https:// www.spravatohcp.com /find/treatment - center / 2. Assumes midpoint of surrogate pricing range for Spravato ®. The price of DT120 ODT has not been established.
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35 Core Focus to Enable Commercial Impact & Success Panorama Topline Results | September 2026 Patient Treatment Education Access & Navigation Logistical Barrier Support Provider Access Support Reimbursement Support Referral & Treatment Coordination Site of Care Site Readiness Operational Enablement Treatment - Day Logistics We are committed to delivering the best patient and provider experience to maximize impact INTEGRATED COMMERCIAL SUPPORT MODEL Connecting patients, providers and sites of care
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36 Building a Psychiatry Powerhouse with Two Distinct Drivers 1 1. Timing estimates subject to clinical progress and regulatory interactions. ASD: autism spectrum disorder; ODT: orally disintegrating tablet; NDA: new drug application; TLR: topline data readout Clinical & Regulatory Execution 2026 2027 2028 Commercial Execution Value Creation Expanding Site of Care Engagement & Commercial Footprint Accelerating Scheduling & Reimbursement Optimizing Patient Care Model Positive Voyage Topline Data Initial DT402 Data in ASD 2026 Positive Panorama Topline Data NDA for DT120 ODT Ascend TLR Commercial Launch DT120 ODT Panorama Topline Results | September 2026 Positive Emerge Topline Data
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2026 – Recent Completed Milestones Emerge (MDD) Positive Topline Data | June 2026 Voyage (GAD) Topline Readout | August 2026 Panorama (GAD) Topline Readout | September 2026 MDD BTD | September 2026 2026 – Anticipated Milestones DT120 NDA Pre - NDA Meeting | 4Q 2026 DT402 Initial Data in ASD | 4Q 2026 2027 – Anticipated Milestones DT120 NDA Filing | 1H 2027 DT120 Commercial Day Event | 1H 2027 DT120 Ascend (MDD) Topline Readout | 2027 DT120 Haven (PTSD) Study Initiation | 2027 Panorama Topline Results | September 2026 37 Maintaining Momentum with Multiple Milestones Ahead 1. Based on the Company’s current operating plan and anticipated milestones. ASD: autism spectrum disorder; BTD: breakthrough therapy designation; GAD: generalized anxiety disorder; G&A: general & admin ist rative; MDD: major depressive disorder; NDA: new drug application; PTSD: posttraumatic stress disorder Cash, Cash Equivalents & Investments ~$1.1 billion a s of June 30, 2026 Cash runway expected to extend into 2030 1
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Q&A Session
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Appendix
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41 1. Bar chart shows the percentage change between the high dose and lowest dose of drug studied in each clinical trial. 2. Phase 2b study: 100 µ g vs. 25 µ g; 3. Panorama: 100 µ g vs. 50 µ g; 4. Study 3: 84 mg vs 56 mg; 5. Study 2: 3 mg vs 1 mg; 6. Study 3+4: 4 mg vs 2 mg; 7. Study 5: 20 mg vs 10 mg; 8. Study 3+4: 20 mg vs 15 mg; 9. Study 1+2: 10 mg vs 5 mg; 10. Study COMP006: 25 mg vs 10 mg; 11. Study 11: 2 - 4.5 mg vs 1 - 2 mg 12. Study 10: 3 mg vs 1.5 mg; 13. Study 302: 42 mg vs 14 mg; 14.. Study 301: 42 mg vs 28 mg; 15. Study 005: 84 mg vs 42 mg; 16 . Study 1: 90 µ g vs 60 µ g 2. The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and se ttings. As such, these data may not be directly comparable due to the lack of a head - to - head comparison. DT120 Program is a Rare Example of Consistent Dose - Dependent Efficacy in Psychiatry 1 Panorama Topline Results | September 2026 19% 18% 14% 9% 8% 11% 9% 2% 6% 9% - 7% - 3% 12% - 9% Higher Dose Outperforms 2 3 5 4 8 6 7 9 10 11 12 13 14 15 16 - 37% Lower Dose Outperforms % Improvement of High Dose over Low Dose in Late-Stage Studies2 COMP360