{"success":true,"data":{"pressRelease":{"id":"5480","rtpr_id":"nBwbtXg2Va","ticker":"DFTX","exchange":"NASDAQ","all_tickers":["DFTX"],"title":"Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical Advancements and Commercial Strategy at Investor and Analyst Day","author":"Business Wire","published_at":"2026-04-22T20:15:00.339Z","article_body":"Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical\nAdvancements and Commercial Strategy at Investor and Analyst Day\n\nMDD: Emerge topline data readout on track for late 2Q 2026; Ascend sites\nactivated with first patient dosing anticipated in 2Q 2026\n\nGAD: Voyage enrollment complete with 214 patients with topline data readout on\ntrack for early 3Q 2026; Panorama sample size re-estimation complete and\ntarget sample size updated to 200; screening closed with topline readout now\nexpected in late 3Q 2026\n\nPTSD: DT120 ODT program expanded into PTSD with Phase 3 Haven study expected\nto initiate in 2027\n\nDefinium Therapeutics, Inc. (Nasdaq: DFTX) (“Definium” or the\n“Company”), a late-stage clinical biopharmaceutical company developing a\nnew generation of therapeutics intended to address the underlying causes of\npsychiatric and neurological disorders, today highlighted the advancement of\nits DT120 ODT (lysergide tartrate) clinical program and commercial strategy in\nmajor depressive disorder (MDD) and generalized anxiety disorder (GAD), with\nthree anticipated topline readouts in the next six months serving as important\nnear-term catalysts. The Company also announced an expansion of the DT120 ODT\nprogram with the planned initiation of the Phase 3 Haven study in\nposttraumatic stress disorder (PTSD).\n\n“We are building Definium to be a leader in psychiatry, focused on\ndelivering a differentiated, scalable franchise for patients with depression,\nanxiety, and trauma, anchored by DT120 ODT, which we believe could be a\nbest-in-class therapy,” said Rob Barrow, Chief Executive Officer of Definium\nTherapeutics. “With three pivotal readouts expected over the next six\nmonths, we are rapidly establishing comprehensive clinical evidence for DT120\nODT. Together, these trial outcomes will inform our regulatory approach,\nincluding an expeditious path to a potential NDA submission. We continue to\nexecute with focus and urgency to deliver transformative treatments for\npatients and sustained value for shareholders.”\n\nThe Company is preparing for its next phase of growth with the same rigor and\ndiscipline that have underpinned the clinical development of DT120 ODT, which\nrepresents a potential multi-billion-dollar commercial opportunity supported\nby a differentiated therapeutic profile and broad applicability across care\nsettings. Definium is advancing a focused, patient-centric commercial\nstrategy, including a scalable delivery model designed to support efficient\nadoption and long-term utilization. In parallel, the Company is proactively\npositioning for access and reimbursement with plans to leverage established\nand emerging practice patterns and existing administrative pathways to enable\ntimely market uptake.\n\nClinical Advancements\n\nDT120 ODT (lysergide tartrate) for MDD\n\n\n * Emerge: Fully enrolled with 149 participants randomized 1:1 to receive DT120\nODT 100 µg or placebo. Topline data on track for late 2Q 2026.\n\n * Ascend: Sites activated with first dosing anticipated in 2Q 2026. Study plans\nto enroll 175 participants randomized 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50\nµg control, or placebo.\n\nDT120 ODT (lysergide tartrate) for GAD\n\n\n * Voyage: Fully enrolled with 214 participants randomized 1:1 to receive DT120\nODT 100 µg or placebo. Topline data on track for early 3Q 2026.\n\n * Panorama: Blinded sample size re-estimation complete with total target\nenrollment updated to 200 participants. Current enrollment over 200\nparticipants and screening now closed. Participants randomized 2:1:2 to\nreceive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data\nnow anticipated in late 3Q 2026 (updated from 2H 2026).\n\nDT120 ODT (lysergide tartrate) for PTSD\n\n\n * Haven: Phase 3 study in PTSD expected to enroll approximately 200 participants\nrandomized 1:1 to receive DT120 ODT or placebo. Primary endpoint in the study\nis the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Study\ninitiation expected in 2027.\n\nToday’s Investor and Analyst Day featured Definium’s executive leadership\nteam alongside distinguished expert clinicians, who discussed the evolving\ntreatment landscape in psychiatry, persistent unmet need, and emerging\nopportunities to improve outcomes for patients, as well as the Company’s\nclinical progress and commercial strategy. Presentation materials from\ntoday’s event are available here\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fd1io3yog0oux5.cloudfront.net%2F_3e540a19247f64081674ca8aa824887c%2Fmindmed%2Fdb%2F2389%2F23524%2Fpresentation%2FDFTX%2BInvestor%2B%2526%2BAnalyst%2BDay%2BDeck_April%2B22%2B2026.pdf&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=here&index=1&md5=5d4deb367c0bc95d11d92ecfe0e7c15b)\n.\n\nAbout DT120 (lysergide tartrate) 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),\nposttraumatic stress disorder (PTSD), and is exploring its potential\napplications in other serious brain health disorders. 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.(1 )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.(1 )LSD, a definitional classic psychedelic,\ntemporarily alters perception, cognition, and emotion, is physiologically\nsafe, non-addictive, and isn’t associated with withdrawal.(1) 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.(2,3)\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 Company’s anticipated topline\nreadout for the Phase 3 Voyage study of DT120 ODT in GAD in early 3Q 2026; the\nCompany’s anticipated topline readout for the Phase 3 Panorama study for\nDT120 ODT in GAD in late 3Q 2026; the Company’s anticipated topline readout\nfor the Phase 3 Emerge study for DT120 ODT in MDD in late 2Q 2026; the\nCompany’s plans to dose the first patient in the Phase 3 Ascend study of\nDT120 ODT in MDD in 2Q 2026; the Company’s expectations regarding the\nenrollment for each of the Panorama and Ascend studies; the Company’s\nexpectation to initiate the Haven study of DT120 ODT in PTSD in 2027; the\nCompany’s expectations regarding enrollment and trial design for the Haven\nstudy; the Company’s beliefs regarding potential benefits of its product\ncandidates; the Company's belief that DT120 ODT could be a best-in-class\ntherapy; the Company's regulatory plans, including the timing of any potential\nNDA submissions; the Company's belief in DT120 ODT’s differentiated\ntherapeutic profile and broad applicability across care settings; the\npotential market opportunity for DT120 ODT; the Company’s commercial\nstrategy; and patient access to and reimbursement of DT120 ODT. There are\nnumerous risks and uncertainties that could cause actual results and the\nCompany's plans and objectives to differ materially from those expressed in\nthe forward-looking information, including history of negative cash flows;\nlimited operating history; incurrence of future losses; availability of\nadditional capital; compliance with laws and regulations; legislative and\nregulatory developments, including decisions by the Drug Enforcement\nAdministration and states to reschedule any of our product candidates, if\napproved, containing Schedule I controlled substances, before they may be\nlegally marketed in the U.S.; difficulty associated with research and\ndevelopment; risks associated with clinical studies or studies; heightened\nregulatory scrutiny; early stage product development; clinical study risks;\nregulatory approval processes; novelty of the psychedelic inspired medicines\nindustry; ability to maintain effective patent rights and other intellectual\nproperty protection; as well as those risk factors discussed or referred to\nherein and the risks, uncertainties and other factors described in the\nCompany's Annual Report on Form 10-K for the fiscal year ended December 31,\n2025 under headings such as \"Special Note Regarding Forward-Looking\nStatements,\" and \"Risk Factors\" and \"Management's Discussion and Analysis of\nFinancial Condition and Results of Operations\" and other filings and\nfurnishings made by the Company with the securities regulatory authorities in\nall provinces and territories of Canada, which are available under the\nCompany'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=54520616&newsitemid=20260422742468&lan=en-US&anchor=www.sedarplus.ca&index=2&md5=da83baf8f7dd36f774c54c7166ed7767)\n, and 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=54520616&newsitemid=20260422742468&lan=en-US&anchor=www.sec.gov&index=3&md5=9ef4dc26fc932f9601b81d00e9809531)\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\nFor more information, visit https://definiumtx.com/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdefiniumtx.com%2F&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdefiniumtx.com%2F&index=4&md5=041163f40a531b8ff253afae5dfc358b)\nand follow Definium Therapeutics on Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fdefiniumtherapeutics%2F&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=Instagram&index=5&md5=e04d2c0041dc0d2a3ab9058dd9b9b909)\n, LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fdefiniumtherapeutics%2F&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=LinkedIn&index=6&md5=d65a88bd4fc82489e88a52d1d946b28d)\n, and X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fx.com%2Fdefiniumtx&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=X&index=7&md5=9163fa8231f4b93c931aeb8e39f7c1c7)\n.\n\nReferences:\n\n\n 1. Nichols, D. E. (2016). Psychedelics. Pharmacological Reviews, 68(2),\n264–355. \nhttps://doi.org/10.1124/pr.115.011478\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1124%2Fpr.115.011478&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1124%2Fpr.115.011478&index=8&md5=ebfc983d477eb546430dd26b88d45008)\n\n 2. Passie, T., Halpern, J. H., Stichtenoth, D. O., Emrich, H. M., & Hintzen,\nA. (2008). The pharmacology of lysergic acid diethylamide: A review. CNS\nNeuroscience & Therapeutics, 14, 295–314. \nhttps://doi.org/10.1111/j.1755-5949.2008.00059.x\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1111%2Fj.1755-5949.2008.00059.x&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1111%2Fj.1755-5949.2008.00059.x&index=9&md5=c53ffa8cbaa3d4b668582380d144897e)\n\n 3. Liechti, M. E. (2017). Modern clinical research on LSD.\nNeuropsychopharmacology, 42, 2114–2127. \nhttps://doi.org/10.1038/npp.2017.86\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1038%2Fnpp.2017.86&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1038%2Fnpp.2017.86&index=10&md5=2aee25a5b03431fa0f2d890a7afd44ad)\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260422742468/en/\n(https://www.businesswire.com/news/home/20260422742468/en/)\n\nInvestors: \n\nGitanjali Jain\n\nVP, Head of Investor Relations ir@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":"nBwbtXg2Va","title":"Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical Advancements and Commercial Strategy at Investor and Analyst Day","author":"Business Wire","ticker":"DFTX","created":"2026-04-22T20:15:00.339Z","tickers":["DFTX"],"exchange":"NASDAQ","article_body":"Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical\nAdvancements and Commercial Strategy at Investor and Analyst Day\n\nMDD: Emerge topline data readout on track for late 2Q 2026; Ascend sites\nactivated with first patient dosing anticipated in 2Q 2026\n\nGAD: Voyage enrollment complete with 214 patients with topline data readout on\ntrack for early 3Q 2026; Panorama sample size re-estimation complete and\ntarget sample size updated to 200; screening closed with topline readout now\nexpected in late 3Q 2026\n\nPTSD: DT120 ODT program expanded into PTSD with Phase 3 Haven study expected\nto initiate in 2027\n\nDefinium Therapeutics, Inc. (Nasdaq: DFTX) (“Definium” or the\n“Company”), a late-stage clinical biopharmaceutical company developing a\nnew generation of therapeutics intended to address the underlying causes of\npsychiatric and neurological disorders, today highlighted the advancement of\nits DT120 ODT (lysergide tartrate) clinical program and commercial strategy in\nmajor depressive disorder (MDD) and generalized anxiety disorder (GAD), with\nthree anticipated topline readouts in the next six months serving as important\nnear-term catalysts. The Company also announced an expansion of the DT120 ODT\nprogram with the planned initiation of the Phase 3 Haven study in\nposttraumatic stress disorder (PTSD).\n\n“We are building Definium to be a leader in psychiatry, focused on\ndelivering a differentiated, scalable franchise for patients with depression,\nanxiety, and trauma, anchored by DT120 ODT, which we believe could be a\nbest-in-class therapy,” said Rob Barrow, Chief Executive Officer of Definium\nTherapeutics. “With three pivotal readouts expected over the next six\nmonths, we are rapidly establishing comprehensive clinical evidence for DT120\nODT. Together, these trial outcomes will inform our regulatory approach,\nincluding an expeditious path to a potential NDA submission. We continue to\nexecute with focus and urgency to deliver transformative treatments for\npatients and sustained value for shareholders.”\n\nThe Company is preparing for its next phase of growth with the same rigor and\ndiscipline that have underpinned the clinical development of DT120 ODT, which\nrepresents a potential multi-billion-dollar commercial opportunity supported\nby a differentiated therapeutic profile and broad applicability across care\nsettings. Definium is advancing a focused, patient-centric commercial\nstrategy, including a scalable delivery model designed to support efficient\nadoption and long-term utilization. In parallel, the Company is proactively\npositioning for access and reimbursement with plans to leverage established\nand emerging practice patterns and existing administrative pathways to enable\ntimely market uptake.\n\nClinical Advancements\n\nDT120 ODT (lysergide tartrate) for MDD\n\n\n * Emerge: Fully enrolled with 149 participants randomized 1:1 to receive DT120\nODT 100 µg or placebo. Topline data on track for late 2Q 2026.\n\n * Ascend: Sites activated with first dosing anticipated in 2Q 2026. Study plans\nto enroll 175 participants randomized 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50\nµg control, or placebo.\n\nDT120 ODT (lysergide tartrate) for GAD\n\n\n * Voyage: Fully enrolled with 214 participants randomized 1:1 to receive DT120\nODT 100 µg or placebo. Topline data on track for early 3Q 2026.\n\n * Panorama: Blinded sample size re-estimation complete with total target\nenrollment updated to 200 participants. Current enrollment over 200\nparticipants and screening now closed. Participants randomized 2:1:2 to\nreceive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data\nnow anticipated in late 3Q 2026 (updated from 2H 2026).\n\nDT120 ODT (lysergide tartrate) for PTSD\n\n\n * Haven: Phase 3 study in PTSD expected to enroll approximately 200 participants\nrandomized 1:1 to receive DT120 ODT or placebo. Primary endpoint in the study\nis the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Study\ninitiation expected in 2027.\n\nToday’s Investor and Analyst Day featured Definium’s executive leadership\nteam alongside distinguished expert clinicians, who discussed the evolving\ntreatment landscape in psychiatry, persistent unmet need, and emerging\nopportunities to improve outcomes for patients, as well as the Company’s\nclinical progress and commercial strategy. Presentation materials from\ntoday’s event are available here\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fd1io3yog0oux5.cloudfront.net%2F_3e540a19247f64081674ca8aa824887c%2Fmindmed%2Fdb%2F2389%2F23524%2Fpresentation%2FDFTX%2BInvestor%2B%2526%2BAnalyst%2BDay%2BDeck_April%2B22%2B2026.pdf&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=here&index=1&md5=5d4deb367c0bc95d11d92ecfe0e7c15b)\n.\n\nAbout DT120 (lysergide tartrate) 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),\nposttraumatic stress disorder (PTSD), and is exploring its potential\napplications in other serious brain health disorders. 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.(1 )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.(1 )LSD, a definitional classic psychedelic,\ntemporarily alters perception, cognition, and emotion, is physiologically\nsafe, non-addictive, and isn’t associated with withdrawal.(1) 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.(2,3)\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 Company’s anticipated topline\nreadout for the Phase 3 Voyage study of DT120 ODT in GAD in early 3Q 2026; the\nCompany’s anticipated topline readout for the Phase 3 Panorama study for\nDT120 ODT in GAD in late 3Q 2026; the Company’s anticipated topline readout\nfor the Phase 3 Emerge study for DT120 ODT in MDD in late 2Q 2026; the\nCompany’s plans to dose the first patient in the Phase 3 Ascend study of\nDT120 ODT in MDD in 2Q 2026; the Company’s expectations regarding the\nenrollment for each of the Panorama and Ascend studies; the Company’s\nexpectation to initiate the Haven study of DT120 ODT in PTSD in 2027; the\nCompany’s expectations regarding enrollment and trial design for the Haven\nstudy; the Company’s beliefs regarding potential benefits of its product\ncandidates; the Company's belief that DT120 ODT could be a best-in-class\ntherapy; the Company's regulatory plans, including the timing of any potential\nNDA submissions; the Company's belief in DT120 ODT’s differentiated\ntherapeutic profile and broad applicability across care settings; the\npotential market opportunity for DT120 ODT; the Company’s commercial\nstrategy; and patient access to and reimbursement of DT120 ODT. There are\nnumerous risks and uncertainties that could cause actual results and the\nCompany's plans and objectives to differ materially from those expressed in\nthe forward-looking information, including history of negative cash flows;\nlimited operating history; incurrence of future losses; availability of\nadditional capital; compliance with laws and regulations; legislative and\nregulatory developments, including decisions by the Drug Enforcement\nAdministration and states to reschedule any of our product candidates, if\napproved, containing Schedule I controlled substances, before they may be\nlegally marketed in the U.S.; difficulty associated with research and\ndevelopment; risks associated with clinical studies or studies; heightened\nregulatory scrutiny; early stage product development; clinical study risks;\nregulatory approval processes; novelty of the psychedelic inspired medicines\nindustry; ability to maintain effective patent rights and other intellectual\nproperty protection; as well as those risk factors discussed or referred to\nherein and the risks, uncertainties and other factors described in the\nCompany's Annual Report on Form 10-K for the fiscal year ended December 31,\n2025 under headings such as \"Special Note Regarding Forward-Looking\nStatements,\" and \"Risk Factors\" and \"Management's Discussion and Analysis of\nFinancial Condition and Results of Operations\" and other filings and\nfurnishings made by the Company with the securities regulatory authorities in\nall provinces and territories of Canada, which are available under the\nCompany'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=54520616&newsitemid=20260422742468&lan=en-US&anchor=www.sedarplus.ca&index=2&md5=da83baf8f7dd36f774c54c7166ed7767)\n, and 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=54520616&newsitemid=20260422742468&lan=en-US&anchor=www.sec.gov&index=3&md5=9ef4dc26fc932f9601b81d00e9809531)\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\nFor more information, visit https://definiumtx.com/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdefiniumtx.com%2F&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdefiniumtx.com%2F&index=4&md5=041163f40a531b8ff253afae5dfc358b)\nand follow Definium Therapeutics on Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fdefiniumtherapeutics%2F&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=Instagram&index=5&md5=e04d2c0041dc0d2a3ab9058dd9b9b909)\n, LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fdefiniumtherapeutics%2F&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=LinkedIn&index=6&md5=d65a88bd4fc82489e88a52d1d946b28d)\n, and X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fx.com%2Fdefiniumtx&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=X&index=7&md5=9163fa8231f4b93c931aeb8e39f7c1c7)\n.\n\nReferences:\n\n\n 1. Nichols, D. E. (2016). Psychedelics. Pharmacological Reviews, 68(2),\n264–355. \nhttps://doi.org/10.1124/pr.115.011478\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1124%2Fpr.115.011478&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1124%2Fpr.115.011478&index=8&md5=ebfc983d477eb546430dd26b88d45008)\n\n 2. Passie, T., Halpern, J. H., Stichtenoth, D. O., Emrich, H. M., & Hintzen,\nA. (2008). The pharmacology of lysergic acid diethylamide: A review. CNS\nNeuroscience & Therapeutics, 14, 295–314. \nhttps://doi.org/10.1111/j.1755-5949.2008.00059.x\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1111%2Fj.1755-5949.2008.00059.x&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1111%2Fj.1755-5949.2008.00059.x&index=9&md5=c53ffa8cbaa3d4b668582380d144897e)\n\n 3. Liechti, M. E. (2017). Modern clinical research on LSD.\nNeuropsychopharmacology, 42, 2114–2127. \nhttps://doi.org/10.1038/npp.2017.86\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1038%2Fnpp.2017.86&esheet=54520616&newsitemid=20260422742468&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1038%2Fnpp.2017.86&index=10&md5=2aee25a5b03431fa0f2d890a7afd44ad)\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260422742468/en/\n(https://www.businesswire.com/news/home/20260422742468/en/)\n\nInvestors: \n\nGitanjali Jain\n\nVP, Head of Investor Relations ir@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":"2026-04-22T20:15:00.551424377Z","server_sent_at_ms":1776888900551},"received_at":"2026-04-22T20:15:05.766Z","source_url":"https://www.businesswire.com/news/home/20260422742468/en/"},"analysis":null,"durationMs":null,"modelName":null}}