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Exhibit 99.1

Definium Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights

Announced positive topline results from Phase 3 Emerge study of DT120 ODT in major depressive disorder (MDD), demonstrating rapid, robust, and durable efficacy

Topline results from Phase 3 GAD studies of DT120 ODT in generalized anxiety disorder (GAD) on track: Voyage results anticipated week of August 10; Panorama results anticipated September 2026

Approximately $1.1 billion in cash, cash equivalents, and investments as of June 30, 2026

Conference call scheduled today at 4:30 p.m. EDT

NEW YORK, August 6, 2026 -- Definium Therapeutics, Inc. (“Definium” or the “Company”) (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.

“The second quarter marked a meaningful inflection point for Definium as we further established our leadership position in psychedelic medicine,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “The 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 Definium is uniquely positioned to advance a potential new treatment paradigm across some of the field’s largest and most underserved indications.”

Business Updates

▪ Completed an underwritten public offering of 23,676,471 common shares of the Company for gross proceeds of $805 million. Net proceeds from the offering were approximately $757.9 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

▪ Launched Wired for Worry, a new healthcare provider disease education platform designed to deepen understanding of GAD, reinforce the importance of ongoing assessment, and help healthcare professionals better understand the neurobiological mechanisms that may contribute to the disorder.

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Program Status and Anticipated Milestones

▪ Announced positive topline results from Phase 3 Emerge study (MDD) with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Key findings included:

o Met the primary endpoint and all key secondary efficacy endpoints with a high degree of statistical significance.

o Demonstrated a statistically significant and clinically meaningful placebo-adjusted improvement of 8.1 points in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline at Week 6 (Cohen’s d = 0.83; p<0.0001), the study's primary endpoint.

o Demonstrated a statistically significant placebo-adjusted improvement of 7.3 points in MADRS total score from baseline at Week 12 (p<0.0001), the study’s key secondary endpoint.

o DT120 ODT was generally well tolerated, with no serious adverse events and no suicidality signal observed.

▪ Completed enrollment of Phase 3 Voyage study (GAD) with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data anticipated the week of August 10, 2026.

▪ Completed enrollment of Phase 3 Panorama study (GAD) with 245 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data anticipated in September 2026.

▪ Initiated enrollment of Phase 3 Ascend study (MDD). The trial is expected to enroll approximately 165 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data expected in 2027.

▪ Phase 3 Haven study in posttraumatic stress disorder (PTSD) is expected to initiate in 2027 and enroll approximately 200 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. The primary endpoint in the study is expected to be the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8.

Second Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments. 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’s 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’s operations into 2030.

Research and Development (R&D). 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 milli

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Exhibit 99.1

Definium Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights

Three Phase 3 topline data readouts for DT120 ODT expected in the coming months

DT120 ODT program expanded into PTSD with Phase 3 Haven study expected to initiate in 2027

$373.4 million in cash, cash equivalents, and investments as of March 31, 2026, expected to fund operations into 2028

Conference call scheduled today at 4:30 p.m. EDT

NEW YORK, May 7, 2026 -- Definium Therapeutics, Inc. (“Definium” or the “Company”) (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 March 31, 2026, and recent highlights.

“After an exceptionally productive start to 2026, we are thrilled to enter an exciting and transformative period for Definium, marked by three pivotal data readouts for DT120 ODT anticipated within the next five months and an expanded development program in PTSD,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “With enrollment complete in our Emerge and Voyage studies, Panorama enrolling its final participants, and Ascend now underway, our momentum has never been stronger. We are energized by the prospect of reaching multiple critical milestones that will shape our path forward and propel our regulatory strategy for DT120 ODT. Our team remains laser-focused on executing with discipline and scientific rigor to deliver robust, high-quality studies across our pivotal pipeline. We are driven by the urgent need to bring new hope and effective solutions to the millions of individuals battling depression, anxiety, and PTSD.”

First Quarter 2026 and Other Recent Highlights

▪ Completed enrollment in Emerge (MDD) with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data expected in late 2Q 2026.

▪ Completed enrollment in Voyage (GAD) with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data expected in early 3Q 2026.

▪ Completed the blinded sample size re-estimation for Panorama (GAD) with total target enrollment updated to 200 participants. Current enrollment is over 200 participants, and screening has been closed. Participants are randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data expected in late 3Q 2026 (updated from 2H 2026).

▪ Continued to activate sites for Ascend, with first patient dosing anticipated in 2Q 2026. The trial is expected to enroll approximately 175 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.

▪ Expanded DT120 ODT clinical development program into PTSD with plans to initiate Haven, a Phase 3 study in PTSD. Haven is expected to enroll approximately 200 participants randomized 1:1 to receive DT120 ODT or placebo. The primary endpoint in the study is the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Study initiation expected in 2027.

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▪ Hosted an Investor and Analyst Day in New York on April 22, 2026. The event featured Definium’s executive leadership team alongside distinguished expert clinicians, who discussed the evolving treatment landscape in psychiatry, significant unmet need, emerging opportunities to improve outcomes for patients, and the Company’s clinical and commercial progress for DT120 ODT.

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments. As of March 31, 2026, Definium Therapeutics had cash, cash equivalents and investments of $373.4 million compared to $411.6 million as of December 31, 2025. Based on the Company’s current operating plan and anticipated milestones, the Company believes that its cash, cash equivalents and investments as of March 31, 2026 will be sufficient to fund the Company’s operations into 2028.

Research and Development (R&D). R&D expenses were $41.5 million for the three months ended March 31, 2026 compared to $23.4 million for the three months ended March 31, 2025, an increase of $18.1 million. The increase was primarily due to increases of $15.2 million in DT120 ODT program expenses, $3.2 million in internal personnel costs reflecting expanded research and development capabilities, and $0.3 million in DT402 program expenses, partially offset by a decrease of $0.6 million in preclinical and other program expenses.

General and Administrative (G&A). G&A expenses were $17.7 million for the three months ended March 31, 2026, compared to $8.8 million for the three months ended March 31, 2025, an increase of $8.9 million. The increase was primarily due to increases of $3.9 million in stock-based compensation expense, $1.4 million in personnel-related expenses, $1.4 million in commercial-preparedness related expenses, $1.4 million in corporate and government affairs expenses, and $1.2 million in l

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Definium Therapeutics Reports Full-Year 2025 Financial Results and Business Updates

Emerge (Phase 3 MDD) enrollment complete; topline data anticipated in late 2Q 2026

Voyage (Phase 3 GAD) approximately 80% enrolled; no change in sample size required; topline readout anticipated in early 3Q 2026

Panorama (Phase 3 GAD) enrollment on track; topline readout expected in 2H 2026

$411.6 million in cash, cash equivalents and investments as of December 31, 2025 expected to fund operations into 2028

Conference call scheduled today at 4:30 p.m. EST

NEW YORK, February 26, 2026 -- Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today reported its full-year 2025 financial results and provided business updates.

“We are proud of the strong execution and momentum across our organization, following a year of significant progress in our comprehensive development programs for DT120 ODT,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “With our first Phase 3 MDD trial, Emerge, now fully enrolled and advancing toward topline data sooner than anticipated, and our Phase 3 GAD studies, Voyage and Panorama, rapidly progressing toward enrollment completion, 2026 represents a monumental year for Definium. Each of these pivotal readouts represents an important catalyst opportunity to move DT120 ODT one step closer to delivering on its best-in-class potential in both MDD and GAD. We remain committed to precise science and our ambitious view of the potential to deliver meaningful improvements for patients, reinforce our leadership in mental health innovation, and drive long-term shareholder value.”

Business Updates

▪ Completed equity financing in 4Q 2025 totaling approximately $259 million in gross proceeds, before deducting underwriting discounts and commissions and offering expenses payable by the Company, bringing in multiple new institutional investors, and extending the Company’s cash runway into 2028.

▪ Published full study results in the Journal of the American Medical Association from the Company’s randomized, placebo-controlled Phase 2b trial evaluating a single dose of DT120 across four dose levels in patients with moderate to severe generalized anxiety disorder (GAD). DT120 has received FDA Breakthrough Designation for GAD.

▪ Further strengthened the leadership team with the appointments of Brandi L. Roberts as Chief Financial Officer and Matt Wiley as Chief Commercial Officer.

▪ Expanded Board of Directors with appointment of Roger Adsett in January 2026. Mr. Adsett is a highly accomplished biopharmaceutical executive with more than two decades of experience leading landmark drug launches, scaling global commercial organizations, and helping companies establish leadership positions within their therapeutic areas, including specialty, rare disease, and primary care markets. He currently serves as Chief Operating Officer of Insmed.

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▪ Company to host Investor and Analyst Day on April 22, 2026, to discuss program updates and the commercial opportunity for DT120 orally disintegrating tablet (ODT) (lysergide tartrate).

Program Updates and Anticipated Milestones

The program for DT120 ODT (lysergide tartrate) consists of four pivotal Phase 3 studies, two in GAD and two in major depressive disorder (MDD). Each study is comprised of two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel group assessing the efficacy and safety of DT120 ODT versus placebo, and Part B, a 40-week open-label extension period. The primary endpoint in the GAD studies is the change from baseline in Hamilton Anxiety Scale (HAM-A) score at Week 12 between DT120 ODT 100 µg and placebo; and in the MDD studies the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between DT120 ODT 100 µg and placebo.

DT120 ODT (lysergide tartrate) for MDD

▪ Emerge: study is fully enrolled with 149 patients randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data are anticipated in late 2Q 2026.

▪ Ascend: initial sites have been activated, and study initiation has been accelerated with first patient dosing anticipated by early 2Q 2026. The trial is expected to enroll approximately 175 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.

DT120 ODT (lysergide tartrate) for GAD

▪ Voyage: study enrollment is approximately 80% complete and is expected to conclude in the coming weeks. Topline data are anticipated in early 3Q 2026. The protocol-specified blinded sample size re-estimation is complete, requiring no increase in enrollment. Voyage is expected to enroll approximately 200 participants in the U.S. randomized 1:1 to receive DT120 ODT 100 µg or placebo.

▪ Panorama: study enrollment on track