{"success":true,"data":{"pressRelease":{"id":"116481","rtpr_id":"nBw7FkqfXa","ticker":"DFTX","exchange":"NASDAQ","all_tickers":["DFTX"],"title":"Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage Study of DT120 ODT in Generalized Anxiety Disorder","author":"Business Wire","published_at":"2026-08-12T11:00:00.470Z","article_body":"Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage\nStudy of DT120 ODT in Generalized Anxiety Disorder\n\nStudy met primary and all key secondary efficacy endpoints\n\nParticipants receiving DT120 ODT achieved a statistically significant\nreduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a\nplacebo-adjusted change of 5.4 points from baseline at Week 12 (p<0.0001,\nCohen’s d=0.81)\n\nDT120 ODT was generally well tolerated, with a safety profile consistent with\nprior clinical experience\n\nCompany to host webcast today at 8:00 am EDT\n\nDefinium Therapeutics, Inc. (Nasdaq: DFTX) (\"Definium\" or the \"Company\"), a\nlate-stage clinical biopharmaceutical company developing a new generation of\ntherapeutics intended to address underlying causes of psychiatric and\nneurological disorders, today announced positive topline results from Voyage,\nits first Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet\n(ODT) 100 µg in adults with generalized anxiety disorder (GAD). The results\nmark the Company’s second positive DT120 ODT Phase 3 readout, following the\npositive Emerge results in major depressive disorder (MDD) announced in June.\n\nVoyage met its primary endpoint, demonstrating a statistically significant and\nclinically meaningful improvement from baseline compared with placebo, as\nmeasured by the change in HAM-A total score at Week 12. The Least Squares (LS)\nmean change from baseline in HAM-A total score at Week 12 in participants who\nreceived DT120 ODT 100 µg was -11.6 compared with -6.2 for participants who\nreceived placebo, an LS mean difference of -5.4 points (p<0.0001),\ncorresponding to a standardized effect size of d=0.81. Efficacy was rapid,\nwith changes seen as early as Day 2 and sustained at all post-baseline\ntimepoints in Part A.\n\n“The unprecedented efficacy demonstrated in Voyage should raise the bar for\nwhat patients and clinicians expect from GAD treatments and reinforces our\nbelief that DT120 has the potential to redefine care for the millions of\npatients in need,” said Rob Barrow, Chief Executive Officer of Definium\nTherapeutics. “Importantly, the consistent, large effect size we’ve now\nobserved across three studies underscores the potential of DT120 to transform\npsychiatry and usher in a new era of mental health care. With our Panorama\ntopline results in GAD expected in September, we remain focused on bringing\nthis potential new treatment to patients as quickly as possible. We are deeply\ngrateful to the patients, investigators, site personnel, and our team whose\ncommitment made this milestone possible.”\n\nDT120 ODT was generally well tolerated, with treatment-emergent adverse events\nmild to moderate in severity, transient, and predominantly occurring on the\nday of dosing in Part A. No new safety signals were identified, including no\nsuicidality signal or suicidal behavior.\n\nOn the day of dosing, participants were assessed hourly beginning at hour 5\npost-dose on a structured end-of-session checklist (EoSC). The average time to\nmeeting EoSC criteria was 6.4 hours for participants receiving DT120 ODT in\nPart A, with a median of 6.1 hours and 92% of participants meeting the EoSC\ncriteria by hour 8.\n\n“GAD affects approximately 26 million adults in the United States, and when\nleft untreated, can cause chronic, pervasive, and debilitating symptoms that\ncan seriously impact a person’s daily life. It is one of the most\nundertreated conditions in psychiatry,” said Brian Barnett, MD, Vice Chair\nof Psychiatry at Cleveland Clinic, and a Voyage principal investigator.\n“Despite the burden of the disorder, the last new FDA-approved treatment for\nthis condition was nearly two decades ago, and many of the patients I see have\nnot found relief despite trying multiple therapies. A single-dose treatment\noption delivering meaningful benefits for 12 weeks is a promising step forward\nnot found in today’s therapies. If approved, it could give patients and\ntheir physicians a treatment option that works through an entirely different\nmechanism than anything currently used in clinical practice.”\n\nHighlights from Voyage Topline Results\n\nThe mean baseline HAM-A score at study entry was 28.4 in the DT120 ODT\ntreatment group (n=107) and 27.4 in the placebo group (n=107).\n Primary Endpoint DT120 ODT 100 µg Placebo ODT Placebo-Adjusted Difference \n HAM-A: LS mean change at Week 12 -11.6 -6.2 -5.4 (p<.0001) \n Key Secondary Endpoints       \n CGI-S: LS mean change at Week 12 -1.0 -0.4 -0.6 (p<.0001) \n HAM-A: LS mean change at Week 1 -11.9 -4.2 -7.7 (p<.0001) \n CGI-S: LS mean change at Day 2 -1.0 -0.2 -0.8 (p<.0001) \n Other Secondary Endpoints       \n HAM-A: response rate (≥50%) at Week 12 43% 16% 27% (p<0.0001) \n HAM-A: remission rate (≤7) at Week 12 14% 4% 10% (p=0.0222) \n HAM-A: mild or better (<16) at Week 12 51% 23% 28% (p<0.0001) \n HAM-A = Hamilton Anxiety Rating Scale; CGI-S = Clinical Global \n Impression-Severity Scale; LS = least squares; LS mean difference = difference \n in LS means of change from baseline between DT120 and placebo groups \n\n\nWebcast Details\n\nDefinium Therapeutics management will host a webcast at 8:00 a.m. EDT today to\nreview the Phase 3 Voyage study topline results. Listeners can register for\nthe webcast via this link\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fphase3-voyage-topline-results-webcast-aug2026.open-exchange.net%2F&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=link&index=1&md5=326fa7a4cfe8be607e9f34a406deef71)\n. Analysts wishing to participate in the question-and-answer session should\nuse this link\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdefinium-phase3-voyage-topline-results-analyst-qa.open-exchange.net%2F&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=link&index=2&md5=ce049682a4d19d7ea591954df2e56143)\n. A replay of the webcast will be available via the Investor Relations section\nof the Definium Therapeutics website, ir.definiumtx.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fir.definiumtx.com%2F&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=ir.definiumtx.com&index=3&md5=df5413dd0f37d93ab27306d54dd32478)\n, and archived for at least 30 days after the webcast. Those who plan on\nparticipating are advised to join 15 minutes prior to the start time.\n\nAbout Voyage\n\nVoyage is a Phase 3, multicenter, randomized, double-blind, placebo-controlled\nstudy evaluating the efficacy and safety of a single 100 µg dose of DT120 ODT\nversus placebo in adults with generalized anxiety disorder (GAD). The study\nconsists of a 12-week double-blind period (Part A) followed by a 40-week\nopen-label extension (Part B), during which participants may be eligible to\nreceive up to four additional doses of DT120 ODT based on symptom severity.\n\nThe study enrolled 214 participants aged 18 to 74 years across approximately\n35 sites in the United States with a DSM-5-confirmed diagnosis of GAD, based\non clinical assessment and the Mini-International Neuropsychiatric Interview\n(MINI), and a Hamilton Anxiety Rating Scale (HAM-A) total score of at least 20\nat screening and baseline.\n\nThe primary endpoint is change from baseline in HAM-A total score at Week 12.\nKey secondary multiplicity-controlled endpoints are change from baseline in\nClinical Global Impression-Severity (CGI-S) scale score at Week 12, change\nfrom baseline in HAM-A total score at Week 1, and change from baseline in\nCGI-S score at Day 2.\n\nVoyage is one of two pivotal Phase 3 studies in GAD. Panorama, the second\nPhase 3 study in GAD, is aligned with Voyage, but includes a low-dose 50 µg\ndose arm. Participants will be randomized 2:1:2 to receive DT120 ODT 100 µg,\nDT120 ODT 50 µg, or placebo. The 50 µg arm is intended to confound\nparticipants’ ability to accurately assess the dose condition to which they\nhave been randomized. This approach continues to build on the Company’s\nPhase 2b study of DT120 in GAD, which the Company believes demonstrated that\nDT120's clinical activity is not attributable to functional unblinding and\naligns with FDA guidance on the use of complementary designs across the\nCompany’s DT120 clinical development program. The primary endpoint of\nPanorama is change from baseline in HAM-A total score at Week 12 between DT120\nODT 100 µg and placebo.\n\nAbout Generalized Anxiety Disorder (GAD)\n\nGAD is one of the most common psychiatric disorders, affecting approximately\n26 million U.S. adults.(1,2 )People with GAD experience constant, overwhelming\nworry that is hard to control. Common symptoms include fatigue, muscle\ntension, trouble concentrating, and difficulty sleeping.(3) GAD is associated\nwith the development of other chronic physical illnesses, as well as\ndepression, other anxiety disorders, and trauma-related conditions. Together,\nthese issues can seriously impact a person’s daily life, including\nsubstantial functional, economic, and quality-of-life burdens, and are\nassociated with increased healthcare utilization and costs.(4,5,6) Despite the\nsignificant personal and societal burden of GAD, there has been little\ninnovation in the treatment of GAD in the past several decades, with the last\nnew drug approval occurring in 2007.(7)\n\nAbout DT120 (lysergide) Orally Disintegrating Tablet (ODT)\n\nDT120 ODT is an ergoline derivative belonging to the group of classic\nserotonergic psychedelics, which acts as a partial agonist at serotonin-2A\n(5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically\noptimized formulation of LSD. DT120 ODT is an advanced formulation\nincorporating Catalent’s Zydis® ODT fast-dissolve technology, designed to\ndeliver several unique advantages, including faster absorption and onset of\ntransient cognitive, perceptual, and affective changes, improved\nbioavailability, and a lower incidence of gastrointestinal side effects.\nDefinium is developing DT120 ODT, the tartrate salt form of lysergide, for\ngeneralized anxiety disorder (GAD), major depressive disorder (MDD), and\nposttraumatic stress disorder (PTSD), and is exploring its potential\napplications in other serious brain health disorders. DT120 has received\nBreakthrough Therapy designation from the FDA for GAD. Definium maintains a\nstrong foundation to protect and extend the long-term value of the DT120 ODT\nfranchise through a multi-layered intellectual property strategy spanning\ncomposition, formulation, and methods-of-use patents.\n\nAbout Lysergide (LSD)\n\nLysergide (LSD) is one of the most extensively studied psychopharmaceuticals\nin history, with over 1,000 published reports.(8) First synthesized in 1938 by\nSwiss chemist Albert Hofmann in his search for active principles from ergot\nfungus, its profound psychological effects were discovered in 1943, which\ntransformed psychiatric research.(8) LSD, a definitional classic psychedelic,\ntemporarily alters perception, cognition, and emotion, is physiologically\nsafe, non-addictive, and is not associated with withdrawal.(8 )While its\nprecise mechanism of action in the treatment of psychiatric illness is\nunknown, its acute perceptual, cognitive, and affective effects are mediated\nby agonism of the serotonin 5-hydroxytryptamine 2A (5-HT2A) receptor, and\nmechanistic hypotheses suggest that it causes sustained increases in\nneuroplasticity in a variety of brain regions.(9,10)\n\nAbout Definium Therapeutics\n\nThe mission of Definium Therapeutics is to forge a new era of psychiatry by\napplying scientific rigor to psychedelics, with the goal of developing\naccessible treatments that unlock healing at scale. Guided by a recognition\nthat patients deserve more than better, Definium is relentlessly advancing a\nnew generation of therapeutics intended to address underlying causes of\npsychiatric and neurological disorders. By turning evidence into impact,\nDefinium aims to change the trajectory of today’s mental health care crisis\nand enable a healthier future. Headquartered in New York, Definium\nTherapeutics trades on Nasdaq under the symbol DFTX.\n\nForward-Looking Statements\n\nCertain statements in this news release related to the Company constitute\n\"forward-looking information\" within the meaning of applicable securities laws\nand are prospective in nature. Forward-looking information is not based on\nhistorical facts, but rather on current expectations and projections about\nfuture events and are therefore subject to risks and uncertainties which could\ncause actual results to differ materially from the future results expressed or\nimplied by the forward-looking statements. These statements generally can be\nidentified by the use of forward-looking words such as \"will\", \"may\",\n\"should\", \"could\", \"intend\", \"estimate\", \"plan\", \"anticipate\", \"expect\",\n\"believe\", \"potential\" or \"continue\", or the negative thereof or similar\nvariations. Forward-looking information in this news release includes, but is\nnot limited to, statements regarding the anticipated design, timing, progress\nand results of the Company's investigational programs for DT120 ODT for the\ntreatment of generalized anxiety disorder, major depressive disorder and\nposttraumatic stress disorder; the success and timing of the Company's\ndevelopment activities; the likelihood of success of any clinical trials or of\nobtaining U.S. Food and Drug Administration or other regulatory approvals; the\nCompany's beliefs regarding potential benefits of its product candidates; the\nCompany's belief that DT120 ODT has the potential to transform psychiatry and\nusher in a new era of mental health care; and the ability of DT120 ODT to\nredefine care for the millions of patients in need. There are numerous risks\nand uncertainties that could cause actual results and the Company's plans and\nobjectives to differ materially from those expressed in the forward-looking\ninformation, including history of negative cash flows; limited operating\nhistory; incurrence of future losses; availability of additional capital;\ncompliance with laws and regulations; legislative and regulatory developments,\nincluding decisions by the Drug Enforcement Administration and states to\nreschedule any of the Company's product candidates, if approved, containing\nSchedule I controlled substances, before they may be legally marketed in the\nU.S.; difficulty associated with research and development; risks associated\nwith clinical studies or studies; heightened regulatory scrutiny; early stage\nproduct development; clinical study risks; regulatory approval processes;\nnovelty of the psychedelic inspired medicines industry; ability to maintain\neffective patent rights and other intellectual property protection for the\nCompany's product candidates, the Company's expectations regarding the size of\nthe eligible patient populations for its lead product candidates, if approved\nand commercialized; the Company's ability to identify third-party treatment\nsites to conduct its trials and its ability to identify and train appropriate\nqualified healthcare practitioners to administer its treatments; the pricing,\ncoverage and reimbursement of the Company's lead product candidates, if\napproved and commercialized; the rate and degree of market acceptance and\nclinical utility of the Company's lead product candidates, in particular, and\ncontrolled substances, in general as well as those risk factors discussed or\nreferred to herein and the risks, uncertainties and other factors described in\nthe Company's Annual Report on Form 10-K for the fiscal year ended December\n31, 2025 and its Quarterly Reports on Form 10-Q for the fiscal quarters ended\nMarch 31, 2026 and June 30, 2026, under headings such as \"Special Note\nRegarding Forward-Looking Statements,\" and \"Risk Factors\" and \"Management's\nDiscussion and Analysis of Financial Condition and Results of Operations\" and\nother filings and furnishings made by the Company with the securities\nregulatory authorities in all provinces and territories of Canada which are\navailable under the Company's profile on SEDAR+ at www.sedarplus.ca\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sedarplus.ca&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=www.sedarplus.ca&index=4&md5=31b1f786aa7f65b23bb1d540bed4910a)\nand with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=www.sec.gov&index=5&md5=f908535998019ff2bdb95c8174dd2249)\n. Except as required by law, the Company undertakes no duty or obligation to\nupdate any forward-looking statements contained in this release as a result of\nnew information, future events, changes in expectations or otherwise.\n References \n \n 1. Ringeisen, H., et al. (2023). Mental and substance use disorders prevalence \n study (MDPS): Findings report. RTI International and current U.S. Census data \n and internal company estimates. \n 2. Ferries, E., et al. The Prevalence and Burden of Generalized Anxiety \n Disorder in the United States Healthcare System: Real-World Prevalence and \n Incidence from 2020-2023. Journal of Mood and Anxiety Disorders. 2026;13. \n 3. Patriquin, M. A., & Mathew, S. J. (2017). The neurobiological \n mechanisms of generalized anxiety disorder and chronic stress. Chronic Stress. \n Mar 2017;1:1-10. \n 4. Barrera, T. L., & Norton, P. J. (2009). Quality of life impairment in \n generalized anxiety disorder, social phobia, and panic disorder. Journal of \n Anxiety Disorders. 2009;23(8):1086–1090. \n 5. Armbrecht, E., Shah, R., Poorman, G. W., et al. (2021). Economic and \n humanistic burden associated with depression and anxiety among adults with \n non-communicable chronic diseases (NCCDs) in the United States. Journal of \n Multidisciplinary Healthcare. 2021;14;887–896. \n 6. Newman, M. G., Llera, S. J., Erickson, T. M., Przeworski, A., & \n Castonguay, L. G. (2013). Worry and generalized anxiety disorder: A review and \n theoretical synthesis of evidence on nature, etiology, mechanisms, and \n treatment. Annual Review of Clinical Psychology, 2013;9:275–297. \n 7. U.S. Food and Drug Administration. (2007, August 9). FDA approves Cymbalta \n for treatment of generalized anxiety disorder [Press release]. \n https://investor.lilly.com/static-files/499f0aa3-281f-49f4-9655-049aae179593 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.lilly.com%2Fstatic-files%2F499f0aa3-281f-49f4-9655-049aae179593&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=https%3A%2F%2Finvestor.lilly.com%2Fstatic-files%2F499f0aa3-281f-49f4-9655-049aae179593&index=6&md5=b7b19f11b0f896b41553e71e005f4079) \n . \n 8. Nichols, DE. “Psychedelics.” Pharmacological Reviews. \n 2016;68(2):264-355. \n 9. Passie, T, Halpern, JH, Stichtenoth, DO, et al. “The Pharmacology of \n Lysergic Acid Diethylamide: A Review.” CNS Neuroscience & Therapeutics. \n 2008;14:295-314. \n 10. Liechti, ME. “Modern clinical research on LSD.” \n Neuropsychopharmacology. 2017;42:2114-2127. \n\n\n \n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260812579720/en/\n(https://www.businesswire.com/news/home/20260812579720/en/)\n\nInvestors: \n\nGitanjali Jain\n\nVP, Head of Investor Relations\n\nir@definiumtx.com (mailto:ir@definiumtx.com)\n\nMedia: \n\nmedia@definiumtx.com (mailto:media@definiumtx.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw7FkqfXa","title":"Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage Study of DT120 ODT in Generalized Anxiety Disorder","author":"Business Wire","ticker":"DFTX","created":"2026-08-12T11:00:00.470Z","tickers":["DFTX"],"exchange":"NASDAQ","article_body":"Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage\nStudy of DT120 ODT in Generalized Anxiety Disorder\n\nStudy met primary and all key secondary efficacy endpoints\n\nParticipants receiving DT120 ODT achieved a statistically significant\nreduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a\nplacebo-adjusted change of 5.4 points from baseline at Week 12 (p<0.0001,\nCohen’s d=0.81)\n\nDT120 ODT was generally well tolerated, with a safety profile consistent with\nprior clinical experience\n\nCompany to host webcast today at 8:00 am EDT\n\nDefinium Therapeutics, Inc. (Nasdaq: DFTX) (\"Definium\" or the \"Company\"), a\nlate-stage clinical biopharmaceutical company developing a new generation of\ntherapeutics intended to address underlying causes of psychiatric and\nneurological disorders, today announced positive topline results from Voyage,\nits first Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet\n(ODT) 100 µg in adults with generalized anxiety disorder (GAD). The results\nmark the Company’s second positive DT120 ODT Phase 3 readout, following the\npositive Emerge results in major depressive disorder (MDD) announced in June.\n\nVoyage met its primary endpoint, demonstrating a statistically significant and\nclinically meaningful improvement from baseline compared with placebo, as\nmeasured by the change in HAM-A total score at Week 12. The Least Squares (LS)\nmean change from baseline in HAM-A total score at Week 12 in participants who\nreceived DT120 ODT 100 µg was -11.6 compared with -6.2 for participants who\nreceived placebo, an LS mean difference of -5.4 points (p<0.0001),\ncorresponding to a standardized effect size of d=0.81. Efficacy was rapid,\nwith changes seen as early as Day 2 and sustained at all post-baseline\ntimepoints in Part A.\n\n“The unprecedented efficacy demonstrated in Voyage should raise the bar for\nwhat patients and clinicians expect from GAD treatments and reinforces our\nbelief that DT120 has the potential to redefine care for the millions of\npatients in need,” said Rob Barrow, Chief Executive Officer of Definium\nTherapeutics. “Importantly, the consistent, large effect size we’ve now\nobserved across three studies underscores the potential of DT120 to transform\npsychiatry and usher in a new era of mental health care. With our Panorama\ntopline results in GAD expected in September, we remain focused on bringing\nthis potential new treatment to patients as quickly as possible. We are deeply\ngrateful to the patients, investigators, site personnel, and our team whose\ncommitment made this milestone possible.”\n\nDT120 ODT was generally well tolerated, with treatment-emergent adverse events\nmild to moderate in severity, transient, and predominantly occurring on the\nday of dosing in Part A. No new safety signals were identified, including no\nsuicidality signal or suicidal behavior.\n\nOn the day of dosing, participants were assessed hourly beginning at hour 5\npost-dose on a structured end-of-session checklist (EoSC). The average time to\nmeeting EoSC criteria was 6.4 hours for participants receiving DT120 ODT in\nPart A, with a median of 6.1 hours and 92% of participants meeting the EoSC\ncriteria by hour 8.\n\n“GAD affects approximately 26 million adults in the United States, and when\nleft untreated, can cause chronic, pervasive, and debilitating symptoms that\ncan seriously impact a person’s daily life. It is one of the most\nundertreated conditions in psychiatry,” said Brian Barnett, MD, Vice Chair\nof Psychiatry at Cleveland Clinic, and a Voyage principal investigator.\n“Despite the burden of the disorder, the last new FDA-approved treatment for\nthis condition was nearly two decades ago, and many of the patients I see have\nnot found relief despite trying multiple therapies. A single-dose treatment\noption delivering meaningful benefits for 12 weeks is a promising step forward\nnot found in today’s therapies. If approved, it could give patients and\ntheir physicians a treatment option that works through an entirely different\nmechanism than anything currently used in clinical practice.”\n\nHighlights from Voyage Topline Results\n\nThe mean baseline HAM-A score at study entry was 28.4 in the DT120 ODT\ntreatment group (n=107) and 27.4 in the placebo group (n=107).\n Primary Endpoint DT120 ODT 100 µg Placebo ODT Placebo-Adjusted Difference \n HAM-A: LS mean change at Week 12 -11.6 -6.2 -5.4 (p<.0001) \n Key Secondary Endpoints       \n CGI-S: LS mean change at Week 12 -1.0 -0.4 -0.6 (p<.0001) \n HAM-A: LS mean change at Week 1 -11.9 -4.2 -7.7 (p<.0001) \n CGI-S: LS mean change at Day 2 -1.0 -0.2 -0.8 (p<.0001) \n Other Secondary Endpoints       \n HAM-A: response rate (≥50%) at Week 12 43% 16% 27% (p<0.0001) \n HAM-A: remission rate (≤7) at Week 12 14% 4% 10% (p=0.0222) \n HAM-A: mild or better (<16) at Week 12 51% 23% 28% (p<0.0001) \n HAM-A = Hamilton Anxiety Rating Scale; CGI-S = Clinical Global \n Impression-Severity Scale; LS = least squares; LS mean difference = difference \n in LS means of change from baseline between DT120 and placebo groups \n\n\nWebcast Details\n\nDefinium Therapeutics management will host a webcast at 8:00 a.m. EDT today to\nreview the Phase 3 Voyage study topline results. Listeners can register for\nthe webcast via this link\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fphase3-voyage-topline-results-webcast-aug2026.open-exchange.net%2F&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=link&index=1&md5=326fa7a4cfe8be607e9f34a406deef71)\n. Analysts wishing to participate in the question-and-answer session should\nuse this link\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdefinium-phase3-voyage-topline-results-analyst-qa.open-exchange.net%2F&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=link&index=2&md5=ce049682a4d19d7ea591954df2e56143)\n. A replay of the webcast will be available via the Investor Relations section\nof the Definium Therapeutics website, ir.definiumtx.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fir.definiumtx.com%2F&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=ir.definiumtx.com&index=3&md5=df5413dd0f37d93ab27306d54dd32478)\n, and archived for at least 30 days after the webcast. Those who plan on\nparticipating are advised to join 15 minutes prior to the start time.\n\nAbout Voyage\n\nVoyage is a Phase 3, multicenter, randomized, double-blind, placebo-controlled\nstudy evaluating the efficacy and safety of a single 100 µg dose of DT120 ODT\nversus placebo in adults with generalized anxiety disorder (GAD). The study\nconsists of a 12-week double-blind period (Part A) followed by a 40-week\nopen-label extension (Part B), during which participants may be eligible to\nreceive up to four additional doses of DT120 ODT based on symptom severity.\n\nThe study enrolled 214 participants aged 18 to 74 years across approximately\n35 sites in the United States with a DSM-5-confirmed diagnosis of GAD, based\non clinical assessment and the Mini-International Neuropsychiatric Interview\n(MINI), and a Hamilton Anxiety Rating Scale (HAM-A) total score of at least 20\nat screening and baseline.\n\nThe primary endpoint is change from baseline in HAM-A total score at Week 12.\nKey secondary multiplicity-controlled endpoints are change from baseline in\nClinical Global Impression-Severity (CGI-S) scale score at Week 12, change\nfrom baseline in HAM-A total score at Week 1, and change from baseline in\nCGI-S score at Day 2.\n\nVoyage is one of two pivotal Phase 3 studies in GAD. Panorama, the second\nPhase 3 study in GAD, is aligned with Voyage, but includes a low-dose 50 µg\ndose arm. Participants will be randomized 2:1:2 to receive DT120 ODT 100 µg,\nDT120 ODT 50 µg, or placebo. The 50 µg arm is intended to confound\nparticipants’ ability to accurately assess the dose condition to which they\nhave been randomized. This approach continues to build on the Company’s\nPhase 2b study of DT120 in GAD, which the Company believes demonstrated that\nDT120's clinical activity is not attributable to functional unblinding and\naligns with FDA guidance on the use of complementary designs across the\nCompany’s DT120 clinical development program. The primary endpoint of\nPanorama is change from baseline in HAM-A total score at Week 12 between DT120\nODT 100 µg and placebo.\n\nAbout Generalized Anxiety Disorder (GAD)\n\nGAD is one of the most common psychiatric disorders, affecting approximately\n26 million U.S. adults.(1,2 )People with GAD experience constant, overwhelming\nworry that is hard to control. Common symptoms include fatigue, muscle\ntension, trouble concentrating, and difficulty sleeping.(3) GAD is associated\nwith the development of other chronic physical illnesses, as well as\ndepression, other anxiety disorders, and trauma-related conditions. Together,\nthese issues can seriously impact a person’s daily life, including\nsubstantial functional, economic, and quality-of-life burdens, and are\nassociated with increased healthcare utilization and costs.(4,5,6) Despite the\nsignificant personal and societal burden of GAD, there has been little\ninnovation in the treatment of GAD in the past several decades, with the last\nnew drug approval occurring in 2007.(7)\n\nAbout DT120 (lysergide) Orally Disintegrating Tablet (ODT)\n\nDT120 ODT is an ergoline derivative belonging to the group of classic\nserotonergic psychedelics, which acts as a partial agonist at serotonin-2A\n(5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically\noptimized formulation of LSD. DT120 ODT is an advanced formulation\nincorporating Catalent’s Zydis® ODT fast-dissolve technology, designed to\ndeliver several unique advantages, including faster absorption and onset of\ntransient cognitive, perceptual, and affective changes, improved\nbioavailability, and a lower incidence of gastrointestinal side effects.\nDefinium is developing DT120 ODT, the tartrate salt form of lysergide, for\ngeneralized anxiety disorder (GAD), major depressive disorder (MDD), and\nposttraumatic stress disorder (PTSD), and is exploring its potential\napplications in other serious brain health disorders. DT120 has received\nBreakthrough Therapy designation from the FDA for GAD. Definium maintains a\nstrong foundation to protect and extend the long-term value of the DT120 ODT\nfranchise through a multi-layered intellectual property strategy spanning\ncomposition, formulation, and methods-of-use patents.\n\nAbout Lysergide (LSD)\n\nLysergide (LSD) is one of the most extensively studied psychopharmaceuticals\nin history, with over 1,000 published reports.(8) First synthesized in 1938 by\nSwiss chemist Albert Hofmann in his search for active principles from ergot\nfungus, its profound psychological effects were discovered in 1943, which\ntransformed psychiatric research.(8) LSD, a definitional classic psychedelic,\ntemporarily alters perception, cognition, and emotion, is physiologically\nsafe, non-addictive, and is not associated with withdrawal.(8 )While its\nprecise mechanism of action in the treatment of psychiatric illness is\nunknown, its acute perceptual, cognitive, and affective effects are mediated\nby agonism of the serotonin 5-hydroxytryptamine 2A (5-HT2A) receptor, and\nmechanistic hypotheses suggest that it causes sustained increases in\nneuroplasticity in a variety of brain regions.(9,10)\n\nAbout Definium Therapeutics\n\nThe mission of Definium Therapeutics is to forge a new era of psychiatry by\napplying scientific rigor to psychedelics, with the goal of developing\naccessible treatments that unlock healing at scale. Guided by a recognition\nthat patients deserve more than better, Definium is relentlessly advancing a\nnew generation of therapeutics intended to address underlying causes of\npsychiatric and neurological disorders. By turning evidence into impact,\nDefinium aims to change the trajectory of today’s mental health care crisis\nand enable a healthier future. Headquartered in New York, Definium\nTherapeutics trades on Nasdaq under the symbol DFTX.\n\nForward-Looking Statements\n\nCertain statements in this news release related to the Company constitute\n\"forward-looking information\" within the meaning of applicable securities laws\nand are prospective in nature. Forward-looking information is not based on\nhistorical facts, but rather on current expectations and projections about\nfuture events and are therefore subject to risks and uncertainties which could\ncause actual results to differ materially from the future results expressed or\nimplied by the forward-looking statements. These statements generally can be\nidentified by the use of forward-looking words such as \"will\", \"may\",\n\"should\", \"could\", \"intend\", \"estimate\", \"plan\", \"anticipate\", \"expect\",\n\"believe\", \"potential\" or \"continue\", or the negative thereof or similar\nvariations. Forward-looking information in this news release includes, but is\nnot limited to, statements regarding the anticipated design, timing, progress\nand results of the Company's investigational programs for DT120 ODT for the\ntreatment of generalized anxiety disorder, major depressive disorder and\nposttraumatic stress disorder; the success and timing of the Company's\ndevelopment activities; the likelihood of success of any clinical trials or of\nobtaining U.S. Food and Drug Administration or other regulatory approvals; the\nCompany's beliefs regarding potential benefits of its product candidates; the\nCompany's belief that DT120 ODT has the potential to transform psychiatry and\nusher in a new era of mental health care; and the ability of DT120 ODT to\nredefine care for the millions of patients in need. There are numerous risks\nand uncertainties that could cause actual results and the Company's plans and\nobjectives to differ materially from those expressed in the forward-looking\ninformation, including history of negative cash flows; limited operating\nhistory; incurrence of future losses; availability of additional capital;\ncompliance with laws and regulations; legislative and regulatory developments,\nincluding decisions by the Drug Enforcement Administration and states to\nreschedule any of the Company's product candidates, if approved, containing\nSchedule I controlled substances, before they may be legally marketed in the\nU.S.; difficulty associated with research and development; risks associated\nwith clinical studies or studies; heightened regulatory scrutiny; early stage\nproduct development; clinical study risks; regulatory approval processes;\nnovelty of the psychedelic inspired medicines industry; ability to maintain\neffective patent rights and other intellectual property protection for the\nCompany's product candidates, the Company's expectations regarding the size of\nthe eligible patient populations for its lead product candidates, if approved\nand commercialized; the Company's ability to identify third-party treatment\nsites to conduct its trials and its ability to identify and train appropriate\nqualified healthcare practitioners to administer its treatments; the pricing,\ncoverage and reimbursement of the Company's lead product candidates, if\napproved and commercialized; the rate and degree of market acceptance and\nclinical utility of the Company's lead product candidates, in particular, and\ncontrolled substances, in general as well as those risk factors discussed or\nreferred to herein and the risks, uncertainties and other factors described in\nthe Company's Annual Report on Form 10-K for the fiscal year ended December\n31, 2025 and its Quarterly Reports on Form 10-Q for the fiscal quarters ended\nMarch 31, 2026 and June 30, 2026, under headings such as \"Special Note\nRegarding Forward-Looking Statements,\" and \"Risk Factors\" and \"Management's\nDiscussion and Analysis of Financial Condition and Results of Operations\" and\nother filings and furnishings made by the Company with the securities\nregulatory authorities in all provinces and territories of Canada which are\navailable under the Company's profile on SEDAR+ at www.sedarplus.ca\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sedarplus.ca&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=www.sedarplus.ca&index=4&md5=31b1f786aa7f65b23bb1d540bed4910a)\nand with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=www.sec.gov&index=5&md5=f908535998019ff2bdb95c8174dd2249)\n. Except as required by law, the Company undertakes no duty or obligation to\nupdate any forward-looking statements contained in this release as a result of\nnew information, future events, changes in expectations or otherwise.\n References \n \n 1. Ringeisen, H., et al. (2023). Mental and substance use disorders prevalence \n study (MDPS): Findings report. RTI International and current U.S. Census data \n and internal company estimates. \n 2. Ferries, E., et al. The Prevalence and Burden of Generalized Anxiety \n Disorder in the United States Healthcare System: Real-World Prevalence and \n Incidence from 2020-2023. Journal of Mood and Anxiety Disorders. 2026;13. \n 3. Patriquin, M. A., & Mathew, S. J. (2017). The neurobiological \n mechanisms of generalized anxiety disorder and chronic stress. Chronic Stress. \n Mar 2017;1:1-10. \n 4. Barrera, T. L., & Norton, P. J. (2009). Quality of life impairment in \n generalized anxiety disorder, social phobia, and panic disorder. Journal of \n Anxiety Disorders. 2009;23(8):1086–1090. \n 5. Armbrecht, E., Shah, R., Poorman, G. W., et al. (2021). Economic and \n humanistic burden associated with depression and anxiety among adults with \n non-communicable chronic diseases (NCCDs) in the United States. Journal of \n Multidisciplinary Healthcare. 2021;14;887–896. \n 6. Newman, M. G., Llera, S. J., Erickson, T. M., Przeworski, A., & \n Castonguay, L. G. (2013). Worry and generalized anxiety disorder: A review and \n theoretical synthesis of evidence on nature, etiology, mechanisms, and \n treatment. Annual Review of Clinical Psychology, 2013;9:275–297. \n 7. U.S. Food and Drug Administration. (2007, August 9). FDA approves Cymbalta \n for treatment of generalized anxiety disorder [Press release]. \n https://investor.lilly.com/static-files/499f0aa3-281f-49f4-9655-049aae179593 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.lilly.com%2Fstatic-files%2F499f0aa3-281f-49f4-9655-049aae179593&esheet=54588041&newsitemid=20260812579720&lan=en-US&anchor=https%3A%2F%2Finvestor.lilly.com%2Fstatic-files%2F499f0aa3-281f-49f4-9655-049aae179593&index=6&md5=b7b19f11b0f896b41553e71e005f4079) \n . \n 8. Nichols, DE. “Psychedelics.” Pharmacological Reviews. \n 2016;68(2):264-355. \n 9. Passie, T, Halpern, JH, Stichtenoth, DO, et al. “The Pharmacology of \n Lysergic Acid Diethylamide: A Review.” CNS Neuroscience & Therapeutics. \n 2008;14:295-314. \n 10. Liechti, ME. “Modern clinical research on LSD.” \n Neuropsychopharmacology. 2017;42:2114-2127. \n\n\n \n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260812579720/en/\n(https://www.businesswire.com/news/home/20260812579720/en/)\n\nInvestors: \n\nGitanjali Jain\n\nVP, Head of Investor Relations\n\nir@definiumtx.com (mailto:ir@definiumtx.com)\n\nMedia: \n\nmedia@definiumtx.com (mailto:media@definiumtx.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-08-12T11:00:00.927365436Z","server_sent_at_ms":1786532400927},"received_at":"2026-08-12T11:00:01.051Z","source_url":"https://www.businesswire.com/news/home/20260812579720/en/"},"analysis":{"id":"105479","press_release_id":"116481","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Definium Therapeutics reported positive topline results from the Phase 3 Voyage study of DT120 ODT in generalized anxiety disorder, meeting the primary endpoint of change in HAM-A score at Week 12.\n\nParticipants receiving DT120 ODT achieved a placebo-adjusted reduction of 5.4 points compared to placebo (p<0.0001), with a Cohen's d effect size of 0.81, and the drug was generally well tolerated with no new safety signals.\n\nThis marks the company's second positive Phase 3 readout for DT120, following the Emerge study in MDD, with topline results from a second pivotal GAD study (Panorama) expected in September.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Phase 3 GAD study hits primary endpoint with strong effect size, validating the psychedelic-based platform."},"keyFigures":{"drugName":"DT120 (lysergide)","phaseOfTrial":"Phase 3","customDimensions":{"p_value":"<0.0001","cohens_d":0.81,"ham_a_change_dt120":-11.6,"response_rate_dt120":"43%","ham_a_change_placebo":-6.2,"remission_rate_dt120":"14%","response_rate_placebo":"16%","remission_rate_placebo":"4%","ham_a_placebo_adjusted_difference":-5.4}},"quotedText":"The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments and reinforces our belief that DT120 has the potential to redefine care for the millions of patients in need","namedEntities":{"people":[{"name":"Rob Barrow","role":"Chief Executive Officer"},{"name":"Brian Barnett","role":"Vice Chair of Psychiatry at Cleveland Clinic"}],"products":["DT120 ODT","DT120","lysergide","Zydis ODT"],"companies":[{"name":"Definium Therapeutics, Inc.","ticker":"DFTX"},{"name":"Cleveland Clinic","relationship":"clinical trial site"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Positive topline results from the first pivotal Phase 3 study (Voyage) of lead asset DT120 ODT in GAD, meeting primary and key secondary endpoints with high statistical significance and large effect size (Cohen's d=0.81). This de-risks the pipeline significantly following prior positive MDD data, though FDA approval remains the final binary step."},"tickerRelevance":{"others":[],"primary":"DFTX"},"globalImportance":35,"audienceRelevance":35,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"clinical-stage-biotech","eventGravity":"positive-pivotal-phase-3-data","sectorWeight":"biotech-mental-health"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Definium Therapeutics reported positive topline results from the Phase 3 Voyage study of DT120 ODT in generalized anxiety disorder, meeting the primary endpoint of change in HAM-A score at Week 12.\n\nParticipants receiving DT120 ODT achieved a placebo-adjusted reduction of 5.4 points compared to placebo (p<0.0001), with a Cohen's d effect size of 0.81, and the drug was generally well tolerated with no new safety signals.\n\nThis marks the company's second positive Phase 3 readout for DT120, following the Emerge study in MDD, with topline results from a second pivotal GAD study (Panorama) expected in September.","key_figures":{"drugName":"DT120 (lysergide)","phaseOfTrial":"Phase 3","customDimensions":{"p_value":"<0.0001","cohens_d":0.81,"ham_a_change_dt120":-11.6,"response_rate_dt120":"43%","ham_a_change_placebo":-6.2,"remission_rate_dt120":"14%","response_rate_placebo":"16%","remission_rate_placebo":"4%","ham_a_placebo_adjusted_difference":-5.4}},"named_entities":{"people":[{"name":"Rob Barrow","role":"Chief Executive Officer"},{"name":"Brian Barnett","role":"Vice Chair of Psychiatry at Cleveland Clinic"}],"products":["DT120 ODT","DT120","lysergide","Zydis ODT"],"companies":[{"name":"Definium Therapeutics, Inc.","ticker":"DFTX"},{"name":"Cleveland Clinic","relationship":"clinical trial site"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-12T12:07:28.970Z","global_importance":35,"audience_relevance":35,"importance_components":{"tickerTier":"clinical-stage-biotech","eventGravity":"positive-pivotal-phase-3-data","sectorWeight":"biotech-mental-health"}},"durationMs":505154,"modelName":"glm-4.7"}}