\nDefinium Therapeutics, Inc. (\u201cDefinium\u201d or the \u201cCompany\u201d) (NASDAQ: DFTX), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today reported financial results for the quarter ended June 30, 2026, and recent highlights.<\/p>\n
\n\u201cThe second quarter marked a meaningful inflection point for Definium as we further established our leadership position in psychedelic medicine,\u201d said Rob Barrow, Chief Executive Officer of Definium Therapeutics. \u201cThe unprecedented Phase 3 Emerge results validated the highly differentiated profile of DT120 ODT and reinforced its potential to become a best-in-class treatment across multiple psychiatric disorders. We also continued to execute across our pipeline, completing enrollment in Voyage and Panorama and initiating enrollment in Ascend. Our public offering generated approximately $805 million in gross proceeds and provides the capital to advance our clinical and commercial strategy from a position of strength. We believe Definiumis uniquely positioned toadvance a potential new treatment paradigm across some of the field\u2019s largest and most underserved indications.\u201d<\/p>\n
Business Updates<\/span><\/b><\/p>\n Program Status and Anticipated Milestones<\/span><\/b><\/p>\n Second Quarter 2026 Financial Results<\/span><\/b><\/p>\n Cash, Cash Equivalents and Investments.<\/i> As of June 30, 2026, Definium Therapeutics had cash, cash equivalents and investments of approximately $1.1 billion compared to $411.6 million as of December 31, 2025. Based on the Company\u2019s current operating plan and anticipated milestones, the Company believes that its cash, cash equivalents and investments as of June 30, 2026 will be sufficient to fund the Company\u2019s operations into 2030.<\/p>\n Research and Development (R&D). <\/i>R&D expenses were $48.7 million for the three months ended June 30, 2026 compared to $29.8 million for the three months ended June 30, 2025, an increase of $18.9 million. The increase was primarily due to an increase of $12.9 million in expenses related to our DT120 program, an increase of $5.7 million in internal personnel costs as a result of increasing research and development capabilities, and an increase of $0.6 million in preclinical and other program expenses, partially offset by a decrease of $0.3 million in DT402 program expenses.<\/p>\n General and Administrative (G&A).<\/i> G&A expenses were $26.4 million for the three months ended June 30, 2026, compared to $11.1 million for the three months ended June 30, 2025, an increase of $15.3 million. The increase was primarily due to an increase of $7.6 million in stock-based compensation expenses, an increase of $2.6 million in corporate and government affairs expenses, an increase of $2.0 million in personnel-related expenses, an increase of $1.8 million in commercial-preparedness related expenses, an increase of $0.6 million in legal and patent expenses, and an increase of $0.7 million in other miscellaneous administrative expenses.<\/p>\n Net loss.<\/i> Net loss for the three months ended June 30, 2026 was significantly impacted by an $86.2 million non-cash increase in the fair value of warrant liabilities associated with the appreciation in the Company’s share price during the period. Net loss for the three months ended June 30, 2026 was $159.0 million, compared to $42.7 million for the three months ended June 30, 2025.<\/p>\n Conference Call and Webcast Reminder About DT120 Orally Disintegrating Tablet (ODT) About Definium Therapeutics \nFor more information, visit www.definiumtx.com<\/a> and follow Definium Therapeutics on Instagram<\/a>, LinkedIn<\/a> and X<\/a>.<\/p>\n Forward-Looking Statements Definium Therapeutics, Inc.<\/b><\/p>\n Consolidated Balance Sheets<\/b><\/p>\n<\/td>\n<\/tr>\n (in thousands, except share amounts)<\/b><\/p>\n<\/td>\n June 30, December 31, Assets<\/b><\/p>\n<\/td>\n \nCurrent assets:<\/p>\n<\/td>\n \nCash and cash equivalents<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n655,267<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n257,837<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nShort-term investments<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n428,612<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n153,756<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nPrepaid and other current assets<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n8,222<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n7,727<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal current assets<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,092,101<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n419,320<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nGoodwill<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n19,918<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n19,918<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nOther non-current assets<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n880<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n862<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal assets<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n1,112,899<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n440,100<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Liabilities and Shareholders\u2019 Equity<\/b><\/p>\n<\/td>\n \nCurrent liabilities:<\/p>\n<\/td>\n \nAccounts payable<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n6,965<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n5,347<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nAccrued expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n37,222<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n20,446<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n2022 USD Financing Warrants<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n113,017<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n40,905<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal current liabilities<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n157,204<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n66,698<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nCredit facility, long-term<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n36,467<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n40,579<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nOther non-current liabilities<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n549<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n496<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal liabilities<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n194,220<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n107,773<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nCommitments and contingencies<\/p>\n<\/td>\n \nShareholders’ equity:<\/p>\n<\/td>\n \nCommon shares, no par value, unlimited authorized as of June 30, 2026 and December 31, 2025; 134,365,950 and 98,776,265 issued and outstanding as of June 30, 2026 and December 31, 2025, respectively<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u2014<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u2014<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nAdditional paid-in capital<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,737,018<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n913,914<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nAccumulated other comprehensive income<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n417<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,085<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nAccumulated deficit<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(818,756<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(582,672<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nTotal shareholders’ equity<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n918,679<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n332,327<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal liabilities and shareholders’ equity<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n1,112,899<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n440,100<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Definium Therapeutics, Inc.<\/b><\/p>\n Consolidated Statements of Operations and Comprehensive Loss<\/b><\/p>\n (unaudited)<\/b><\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n Three Months Ended June 30,<\/b><\/p>\n<\/td>\n Six Months Ended June 30,<\/b><\/p>\n<\/td>\n<\/tr>\n (in thousands, except share and per share amounts)<\/b><\/p>\n<\/td>\n 2026<\/b><\/p>\n<\/td>\n 2025<\/b><\/p>\n<\/td>\n 2026<\/b><\/p>\n<\/td>\n 2025<\/b><\/p>\n<\/td>\n<\/tr>\n \nOperating expenses:<\/p>\n<\/td>\n \nResearch and development<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n48,665<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n29,809<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n90,149<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n53,166<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nGeneral and administrative<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n26,412<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n11,094<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n44,148<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n19,896<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal operating expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n75,077<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n40,903<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n134,297<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n73,062<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nLoss from operations<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(75,077<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(40,903<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(134,297<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(73,062<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nOther income\/(expense):<\/p>\n<\/td>\n \nInterest income<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n3,587<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n2,774<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n7,044<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n5,207<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nInterest expense<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(1,233<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2,338<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2,478<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2,940<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nForeign exchange loss, net<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(32<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(49<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(76<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(68<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nChange in fair value of 2022 USD Financing Warrants<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(86,231<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2,228<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(106,277<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n4,771<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal other income\/(expense)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(83,909<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(1,841<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(101,787<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n6,970<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nNet loss<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(158,986<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(42,744<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(236,084<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(66,092<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nOther comprehensive loss<\/p>\n<\/td>\n \nUnrealized gain\/(loss) on investments<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(406<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n36<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(668<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n46<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nLoss on foreign currency translation<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(1<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(31<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u2014<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(58<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nComprehensive loss<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(159,393<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(42,739<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(236,752<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(66,104<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nNet loss per common share, basic<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(1.44<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(0.50<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(2.15<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(0.78<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nNet loss per common share, diluted<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(1.44<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(0.50<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(2.15<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(0.81<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nWeighted-average common shares, basic<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n110,684,720<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n85,347,677<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n109,743,062<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n85,208,539<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nWeighted-average common shares, diluted<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n110,684,720<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n85,347,677<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n109,743,062<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n87,099,006<\/p>\n<\/td>\n \n\u00a0<\/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\/20260806201575\/en\/<\/a><\/span><\/p>\n For further information, please contact:<\/b><\/p>\n Investors:\n
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<\/span><\/b>Definium Therapeutics management will host a webcast at 4:30 p.m. EDT today to provide a corporate update and review the Company\u2019s second quarter 2026 financial results and business highlights. Listeners can register for the webcast via this link<\/a>. 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
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<\/b>DT120 ODT (lysergide tartrate) 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 faster onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and lower incidence of gastrointestinal side effects. Definium is developing DT120, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and is exploring its potential applications in other serious brain health disorders. 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
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<\/b>The 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
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<\/b>Certain 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 Company\u2019s belief in DT120 ODT\u2019s potential to become a best-in-class treatment across multiple psychiatric disorders; the Company\u2019s anticipated topline readout (Part A results) for the Phase 3 Voyage study of DT120 ODT in GAD the week of August 10, 2026; the Company\u2019s anticipated topline readout (Part A results) for the Phase 3 Panorama study for DT120 ODT in GAD in September 2026; the Company\u2019s anticipated topline readout (Part A results) for the Phase 3 Ascend study for DT120 ODT in MDD in 2027; the Company\u2019s expectations regarding enrollment for each of the Haven and Ascend studies; the Company\u2019s expectations to initiate the Haven study in 2027; the Company\u2019s planned trial design for Ascend and Haven; the Company\u2019s beliefs regarding potential benefits of its product candidates; the Company\u2019s expectation that its cash, cash equivalents and investments will fund operations into 2030; and potential additional indications for DT120 ODT. 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 our 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; 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 or to be 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\n
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2026
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(unaudited)<\/b><\/p>\n<\/td>\n\n \n
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2025<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n <\/tr>\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 \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 \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n <\/tr>\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 \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 \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n <\/tr>\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 \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 \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
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Gitanjali Jain
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VP, Head of Investor Relations
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ir@definiumtx.com<\/a><\/p>\n
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