5/7/2026

speaker
Geeta Jain
Head of Investor Relations

Good afternoon. I am Geeta Jain, Head of Investor Relations, and thank you for joining us today for DFINIUM Therapeutics' first quarter, 2026, financial results and recent highlights conference call. Currently, all participants are in listen-only mode. This webcast is live on the investor section of DFINIUM's website at DFINIUMTX.com, and a replay will be available after the webcast. Leading the call today will be Rob Barrow, our Chief Executive Officer, who is joined by Dr. Dan Carlin, our Chief Medical Officer, Brandy Roberts, our Chief Financial Officer, and Matt Wiley, our Chief Commercial Officer. During today's call, we will be making certain forward-looking statements, including without limitation statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runaway, and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC and the applicable Canadian securities regulators, including our annual report on Form 10-K and our Form 10-Q filed today. Forward-looking statements are based on assumptions, opinions, and estimates of management at the date the statements are made. including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of DFINIUM's normal course of business. Your caution not to place undue reliance on these forward-looking statements, which are made as of today, May 7th, 2026. DFINIUM disclaims any obligation to update such statements, even if management's views change, except as required by law. With that, let me turn the call over to Rob.

speaker
Rob Barrow
Chief Executive Officer

Thank you, Geeta, and thank you all for joining us today. The first quarter of 2026 marked a strong start to what we believe will be a pivotal year for Definium. We remain highly focused on disciplined execution as we have advanced our late-stage clinical programs, prepared for multiple near-term data readouts, and continue to build an incredible team to lead our potential commercialization efforts. As we discussed at our Investor and Analyst Day a few weeks ago, Definium is entering a period of meaningful clinical inflection Our lead program, DT120-ODT, is advancing with four ongoing Phase III studies across major depressive disorder, or MDD, and generalized anxiety disorder, or GAD, with top-line data from eMERGE expected later this quarter, followed by VOYAGE and PANORAMA in the third quarter. Our Phase III programs are designed to evaluate outcomes that we believe would represent a meaningful advance for patients, physicians, and the field of psychiatry. These include not only the magnitude of symptom improvement, but also safety, tolerability, and durability of response following a single administration, dimensions we believe will be critical in differentiating DT120-ODT in today's treatment landscape. We're also encouraged by the increasing recognition of the significant unmet need in these indications. With three phase three readouts anticipated across two of the largest indications in psychiatry, Decinium is approaching an important moment for the company and for the patients we aim to help. With Breakthrough Therapy designation for DT120 and GAD, we've established a constructive working relationship with FDA and will move as efficiently as possible towards an NDA submission subject to positive physical data. Beyond our ongoing phase three programs, we plan to expand development of DT120-ODT into additional indications, including post-traumatic stress disorder, or PTSD, with a planned initiation of our HAVEN study in 2027. We believe this represents an important opportunity to further leverage the potential of DT120 across areas of high unmet need. Overall, we continue to believe in DT120-ODT as a potential best-in-class product candidate, one that could help redefine what's possible for the millions of people living with depression, anxiety, and PTSD who remain underserved by existing treatments. And I'll turn it over to Dan to go into more detail on our clinical program.

speaker
Dr. Dan Carlin
Chief Medical Officer

Dan?

Disclaimer

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Investor presentation