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NEW YORK — 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 announced six poster presentations at the Psych Congress taking place September 15 through 19 in New Orleans, LA.

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“This year at Psych Congress, we will share clinical findings from our DT120 Orally Disintegrating Tablet Phase 3 clinical development program in GAD and MDD, reflecting the broad potential of DT120 in the two largest psychiatric disorders,” said Dan Karlin, Chief Medical Officer, Definium Therapeutics. “We also will present new epidemiological research examining suicidal ideation in anxiety, depression, and comorbid populations, adding to the growing body of research needed to better understand suicide risk. We are proud to contribute to this important conversation during National Suicide Prevention Awareness Month.”

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All poster presentations will take place on Thursday, September 17, from 1:15 PM – 3:30 PM CDT and Friday, September 18, from 1:15 PM – 3:30 PM CDT.

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Additional Congress activities include Definium’s medical affairs booth located at #912, and details of the poster presentations are as follows:

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Title

Session/Location

Invited Oral Presentation

Latest Discoveries & Emerging Trends in MDD

Thursday, September 17th

9:00 AM – 10:00 AM CDT

Great Hall A

Posters

Poster #

Phase 3 Topline Results of DT120 (lysergide) in Generalized Anxiety Disorder

195

Poster Hall

Phase 3 Topline Results of DT120 (lysergide) in Major Depressive Disorder

115

Poster Hall

DT120 (lysergide) Safety Profile from Phase 1 and Phase 2 Clinical Studies

198

Poster Hall

Phase 3 trial design and methodology: treatment with DT120 (lysergide) in Generalized Anxiety Disorder (GAD) & Major Depressive Disorder (MDD)

196

Poster Hall

Suicidal Ideation Frequency Across Generalized Anxiety Disorder, Major Depressive Disorder, and Comorbid Cohorts: The Roles of Symptom Severity, Diagnosis, and Undetected Disorder Burden

192

Poster Hall

DT120 for Major Depressive Disorder: Number Needed to Treat (NNT) and Number Needed to Harm (NNH)

125

Poster Hall

Article contentAbout Definium TherapeuticsArticle content

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’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

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Article contentForward-Looking StatementsArticle content

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 broad potential of DT120 in the two largest psychiatric disorders. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of the Company’s product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection for the Company’s product candidates, the Company’s expectations regarding the size of the eligible patient populations for its lead product candidates, if approved and commercialized; the Company’s ability to identify third-party treatment sites to conduct its trials and its ability to identify and train appropriate qualified healthcare practitioners to administer its treatments; the pricing, coverage and reimbursement of the Company’s lead product candidates, if approved and commercialized; the rate and degree of market acceptance and clinical utility of the Company’s lead product candidates, in particular, and controlled substances, in general as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2026 and June 30, 2026, under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. 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.

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Gitanjali Jain

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VP, Head of Investor Relations

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