Primary Endpoint<\/b><\/p>\n<\/td>\n
DT120 ODT 100 \u00b5g<\/b><\/p>\n<\/td>\n
Placebo ODT<\/b><\/p>\n<\/td>\n
Placebo-Adjusted Difference<\/b><\/p>\n<\/td>\n<\/tr>\n \nHAM-A: LS mean change at Week 12<\/p>\n<\/td>\n \n-11.6<\/p>\n<\/td>\n \n-6.2<\/p>\n<\/td>\n \n-5.4 (p<.0001)<\/p>\n<\/td>\n<\/tr>\n Key Secondary Endpoints<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nCGI-S: LS mean change at Week 12<\/p>\n<\/td>\n \n-1.0<\/p>\n<\/td>\n \n-0.4<\/p>\n<\/td>\n \n-0.6 (p<.0001)<\/p>\n<\/td>\n<\/tr>\n \nHAM-A: LS mean change at Week 1<\/p>\n<\/td>\n \n-11.9<\/p>\n<\/td>\n \n-4.2<\/p>\n<\/td>\n \n-7.7 (p<.0001)<\/p>\n<\/td>\n<\/tr>\n \nCGI-S: LS mean change at Day 2<\/p>\n<\/td>\n \n-1.0<\/p>\n<\/td>\n \n-0.2<\/p>\n<\/td>\n \n-0.8 (p<.0001)<\/p>\n<\/td>\n<\/tr>\n Other Secondary Endpoints<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nHAM-A: response rate (\u226550%) at Week 12<\/p>\n<\/td>\n \n43%<\/p>\n<\/td>\n \n16%<\/p>\n<\/td>\n \n27% (p<0.0001)<\/p>\n<\/td>\n<\/tr>\n \nHAM-A: remission rate (\u22647) at Week 12<\/p>\n<\/td>\n \n14%<\/p>\n<\/td>\n \n4%<\/p>\n<\/td>\n \n10% (p=0.0222)<\/p>\n<\/td>\n<\/tr>\n \nHAM-A: mild or better (<16) at Week 12<\/p>\n<\/td>\n \n51%<\/p>\n<\/td>\n \n23%<\/p>\n<\/td>\n \n28% (p<0.0001)<\/p>\n<\/td>\n<\/tr>\n HAM-A = Hamilton Anxiety Rating Scale; CGI-S = Clinical Global Impression-Severity Scale; LS = least squares; LS mean difference = difference in LS means of change from baseline between DT120 and placebo groups<\/i><\/p>\n<\/td>\n<\/tr>\n<\/table>\n Webcast Details<\/b><\/p>\n \nDefinium Therapeutics management will host a webcast at 8:00 a.m. EDT today to review the Phase 3 Voyage study topline results. Listeners can register for the webcast via this link<\/a>. Analysts wishing to participate in the question-and-answer session should use this link<\/a>. A replay of the webcast will be available via the Investor Relations section of the Definium Therapeutics website, ir.definiumtx.com<\/a>, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.<\/p>\n About Voyage<\/b><\/p>\n \nVoyage is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a single 100 \u00b5g dose of DT120 ODT versus placebo in adults with generalized anxiety disorder (GAD). The study consists of a 12-week double-blind period (Part A) followed by a 40-week open-label extension (Part B), during which participants may be eligible to receive up to four additional doses of DT120 ODT based on symptom severity.<\/p>\n \nThe study enrolled 214 participants aged 18 to 74 years across approximately 35 sites in the United States with a DSM-5-confirmed diagnosis of GAD, based on clinical assessment and the Mini-International Neuropsychiatric Interview (MINI), and a Hamilton Anxiety Rating Scale (HAM-A) total score of at least 20 at screening and baseline.<\/p>\n \nThe primary endpoint is change from baseline in HAM-A total score at Week 12. Key secondary multiplicity-controlled endpoints are change from baseline in Clinical Global Impression-Severity (CGI-S) scale score at Week 12, change from baseline in HAM-A total score at Week 1, and change from baseline in CGI-S score at Day 2.<\/p>\n \nVoyage is one of two pivotal Phase 3 studies in GAD. Panorama, the second Phase 3 study in GAD, is aligned with Voyage, but includes a low-dose 50 \u00b5g dose arm. Participants will be randomized 2:1:2 to receive DT120 ODT 100 \u00b5g, DT120 ODT 50 \u00b5g, or placebo. The 50 \u00b5g arm is intended to confound participants\u2019 ability to accurately assess the dose condition to which they have been randomized. This approach continues to build on the Company\u2019s Phase 2b study of DT120 in GAD, which the Company believes demonstrated that DT120’s clinical activity is not attributable to functional unblinding and aligns with FDA guidance on the use of complementary designs across the Company\u2019s DT120 clinical development program. The primary endpoint of Panorama is change from baseline in HAM-A total score at Week 12 between DT120 ODT 100 \u00b5g and placebo.<\/p>\n About Generalized Anxiety Disorder (GAD)<\/b><\/p>\n \nGAD is one of the most common psychiatric disorders, affecting approximately 26 million U.S. adults.1,2 <\/sup>People with GAD experience constant, overwhelming worry that is hard to control. Common symptoms include fatigue, muscle tension, trouble concentrating, and difficulty sleeping.3<\/sup> GAD is associated with the development of other chronic physical illnesses, as well as depression, other anxiety disorders, and trauma-related conditions. Together, these issues can seriously impact a person\u2019s daily life, including substantial functional, economic, and quality-of-life burdens, and are associated with increased healthcare utilization and costs.4,5,6<\/sup> Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.7<\/sup><\/p>\n About DT120 (lysergide) Orally Disintegrating Tablet (ODT)<\/b><\/p>\n \nDT120 ODT is an ergoline derivative belonging to the group of classic serotonergic psychedelics, which acts as a partial agonist at serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium\u2019s proprietary and pharmaceutically optimized formulation of LSD. DT120 ODT is an advanced formulation incorporating Catalent\u2019s Zydis\u00ae ODT fast-dissolve technology, designed to deliver several unique advantages, including faster absorption and onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and a lower incidence of gastrointestinal side effects. Definium is developing DT120 ODT, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and posttraumatic stress disorder (PTSD), and is exploring its potential applications in other serious brain health disorders. DT120 has received Breakthrough Therapy designation from the FDA for GAD. Definium maintains a strong foundation to protect and extend the long-term value of the DT120 ODT franchise through a multi-layered intellectual property strategy spanning composition, formulation, and methods-of-use patents.<\/p>\n About Lysergide (LSD)<\/b><\/p>\n \nLysergide (LSD) is one of the most extensively studied psychopharmaceuticals in history, with over 1,000 published reports.8<\/sup> First synthesized in 1938 by Swiss chemist Albert Hofmann in his search for active principles from ergot fungus, its profound psychological effects were discovered in 1943, which transformed psychiatric research.8<\/sup> LSD, a definitional classic psychedelic, temporarily alters perception, cognition, and emotion, is physiologically safe, non-addictive, and is not associated with withdrawal.8 <\/sup>While its precise mechanism of action in the treatment of psychiatric illness is unknown, its acute perceptual, cognitive, and affective effects are mediated by agonism of the serotonin 5-hydroxytryptamine 2A (5-HT2A) receptor, and mechanistic hypotheses suggest that it causes sustained increases in neuroplasticity in a variety of brain regions.9,10<\/sup><\/p>\n About Definium Therapeutics<\/b><\/p>\n \nThe mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today\u2019s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nCertain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the anticipated design, timing, progress and results of the Company’s investigational programs for DT120 ODT for the treatment of generalized anxiety disorder, major depressive disorder and posttraumatic stress disorder; the success and timing of the Company’s development activities; the likelihood of success of any clinical trials or of obtaining U.S. Food and Drug Administration or other regulatory approvals; the Company’s beliefs regarding potential benefits of its product candidates; the Company’s belief that DT120 ODT has the potential to transform psychiatry and usher in a new era of mental health care; and the ability of DT120 ODT to redefine care for the millions of patients in need. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of the Company’s product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection for the Company’s product candidates, the Company’s expectations regarding the size of the eligible patient populations for its lead product candidates, if approved and commercialized; the Company’s ability to identify third-party treatment sites to conduct its trials and its ability to identify and train appropriate qualified healthcare practitioners to administer its treatments; the pricing, coverage and reimbursement of the Company’s lead product candidates, if approved and commercialized; the rate and degree of market acceptance and clinical utility of the Company’s lead product candidates, in particular, and controlled substances, in general as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2026 and June 30, 2026, under headings such as “Special Note Regarding 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 authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca<\/a> and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov<\/a>. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.<\/p>\n References<\/b><\/p>\n<\/td>\n<\/tr>\n \n1. Ringeisen, H., et al. (2023). Mental and substance use disorders prevalence study (MDPS): Findings report. RTI International and current U.S. Census data and internal company estimates.<\/p>\n<\/td>\n<\/tr>\n \n2. Ferries, E., et al. The Prevalence and Burden of Generalized Anxiety Disorder in the United States Healthcare System: Real-World Prevalence and Incidence from 2020-2023. Journal of Mood and Anxiety Disorders<\/i>. 2026;13.<\/p>\n<\/td>\n<\/tr>\n \n3. Patriquin, M. A., & Mathew, S. J. (2017). The neurobiological mechanisms of generalized anxiety disorder and chronic stress. Chronic Stress<\/i>. Mar 2017;1:1-10.<\/p>\n<\/td>\n<\/tr>\n \n4. Barrera, T. L., & Norton, P. J. (2009). Quality of life impairment in generalized anxiety disorder, social phobia, and panic disorder. Journal of Anxiety Disorders<\/i>. 2009;23(8):1086\u20131090.<\/p>\n<\/td>\n<\/tr>\n \n5. Armbrecht, E., Shah, R., Poorman, G. W., et al. (2021). Economic and humanistic burden associated with depression and anxiety among adults with non-communicable chronic diseases (NCCDs) in the United States. Journal of Multidisciplinary Healthcare.<\/i> 2021;14;887\u2013896.<\/p>\n<\/td>\n<\/tr>\n \n6. Newman, M. G., Llera, S. J., Erickson, T. M., Przeworski, A., & Castonguay, L. G. (2013). Worry and generalized anxiety disorder: A review and theoretical synthesis of evidence on nature, etiology, mechanisms, and treatment. Annual Review of Clinical Psychology<\/i>, 2013;9:275\u2013297.<\/p>\n<\/td>\n<\/tr>\n \n7. U.S. Food and Drug Administration. (2007, August 9). FDA approves Cymbalta for treatment of generalized anxiety disorder [Press release]. https:\/\/investor.lilly.com\/static-files\/499f0aa3-281f-49f4-9655-049aae179593<\/a>.<\/p>\n<\/td>\n<\/tr>\n \n8. Nichols, DE. \u201cPsychedelics.\u201d Pharmacological Reviews. 2016;68(2):264-355.<\/p>\n<\/td>\n<\/tr>\n \n9. Passie, T, Halpern, JH, Stichtenoth, DO, et al. \u201cThe Pharmacology of Lysergic Acid Diethylamide: A Review.\u201d CNS Neuroscience & Therapeutics. 2008;14:295-314.<\/p>\n<\/td>\n<\/tr>\n \n10. Liechti, ME. \u201cModern clinical research on LSD.\u201d Neuropsychopharmacology. 2017;42:2114-2127.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260812579720\/en\/<\/a><\/span><\/p>\n Investors:\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
\n \n \n <\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n <\/p>\n
\n<\/b>
Gitanjali Jain
\n
VP, Head of Investor Relations
\n
ir@definiumtx.com<\/a><\/p>\n
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