Definium Therapeutics, Inc. Common Shares 2026 Q2 Earnings Call

Good afternoon. I am Gita Jain, Head of Investor Relations, and I want to thank you for joining us today for Definium Therapeutics' second quarter 2026 financial results and recent highlights conference call. All participants are in listen-only mode. This webcast is live on the investor section of Definium's webcast at definiumtx.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 Karlin, our Chief Medical Officer, Brandi Roberts, 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 runway, 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 Form 10-Q filed today. Forward-looking statements are based on the 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 Definium's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, August 6th, 2026. Definium disclaims any obligation to update such statements, even if management's views change, except as required by law.

As announced in our earnings release, we anticipate presenting top-line results from VOYAGE, our first phase III study of DT120 ODT in generalized anxiety disorder or GAD during the week of August 10th, 2026. As such, we will not be holding a Q&A session at the conclusion of today's prepared remarks. With that, let me turn the call over to Rob.

Thank you, Gita, and thank you everyone for joining us today. Psychiatry has waited decades for therapies capable of fundamentally changing outcomes for patients. We believe that future is now coming into view. The unmet need has never been greater, and there is growing recognition that patients deserve treatments capable of delivering transformational outcomes. We are proud that Definium is leading the way in defining this next chapter, delivering pivotal evidence on DT120 ODT in pursuit of a best-in-class profile, targeting some of psychiatry's largest and most underserved indications. The first half of this year marked a key period of inflection and growth for our organization. In June, we reported positive top-line results from EMERGE, our first phase III study of DT120 ODT in major depressive disorder, or MDD.

These results establish a new benchmark in the field, having demonstrated what we believe to be the largest treatment effect ever reported in a phase III MDD study. Taken together, the rapid and durable efficacy and favorable tolerability that we have consistently observed throughout the DT120 development program strengthens our confidence that DT120 has the potential to meaningfully change the treatment paradigm for patients living with anxiety, depression, and PTSD. We've continued to make major progress across our pipeline, having completed enrollment in both VOYAGE and PANORAMA, our two phase III studies in GAD, initiated enrollment in ASCEND, our second phase III study in MDD from which we expect top-line data in 2027, and advanced preparations for HAVEN, our planned phase III study in PTSD, which we expect to initiate in 2027.

Looking ahead, we are in what we believe is one of the most important periods in our company's evolution. Next week, we plan to share top-line results from VOYAGE, and we expect to share top-line results from PANORAMA in September. Given that there has not been a new drug approved for this highly prevalent and burdensome disorder in almost 20 years, we believe there's an extraordinary opportunity to deliver a first and best-in-class treatment for GAD. In parallel to our clinical progress, we continue to efficiently advance toward a potential NDA submission for DT120 ODT. Throughout the development program, we have worked closely with FDA, maintaining a constructive dialogue that has shaped our program and aligned with expectations for the field. We believe the agency's recently finalized guidance closely reflects this alignment and the principles that have guided our regulatory strategy from the outset.

We've also continued growing and strengthening our organization to deliver on the clinical, regulatory, and commercial milestones ahead. Over the course of the year, we have significantly expanded our commercial capabilities in preparation for the potential launch of DT120 ODT if approved, and we have strengthened our balance sheet with an upsized public offering that generated approximately $805 million in gross proceeds. With our strong financial position and operational momentum, we are well-positioned to continue advancing our R&D programs while preparing for a launch of DT120 ODT that reflects both the scale of the commercial opportunity and, more importantly, the magnitude of patient need. Our progress is a result of disciplined execution of our team and our commitment to delivering meaningful value for patients and shareholders. With that, I'll turn the call over to Dan to review our clinical programs in more detail.

As Rob highlighted, our positive phase III EMERGE results represent an important milestone, not only for the DT120 program but for the field of psychiatry. As a psychiatrist, what is most exciting to me is the consistent profile of DT120 ODT we have seen across the development program: rapid onset of action, durable clinical benefit, and a favorable tolerability profile. We believe this combination has the potential to fundamentally change how anxiety, depression, and PTSD are treated EMERGE enrolled 149 participants with moderate to severe MDD.

The study population had a mean baseline Montgomery-Åsberg Depression Rating Scale, or MADRS, score of 34.5, and approximately half of participants in the study had previously been failed by two or more antidepressant therapies. Background antidepressant and anxiolytic medications were discontinued before randomization, and no psychotherapy was provided as a component of the study, allowing us to evaluate DT120 as a true monotherapy. The study met all of its primary and key secondary endpoints with highly statistically significant results across multiple clinically meaningful measures. DT120 demonstrated an 8.1 point placebo-adjusted improvement on the MADRS at week six, with a P value of less than 0.0001, corresponding to an effect size of approximately 0.83 for the primary endpoint. To our knowledge, this represents the largest treatment effect ever reported in a phase III trial in MDD.

Importantly, after a single dose of DT120 ODT, efficacy was evident as early as week one, remained statistically significant at every subsequent assessment, and persisted through week 12. Beyond the primary outcome measure, we observed statistically significant improvements across all key secondary endpoints and a favorable tolerability profile. We are extremely encouraged by the EMERGE results and look forward to delivering pivotal data in GAD. GAD affects millions of patients worldwide, yet treatment options have not changed over the past two decades. With the available approved medications, many patients continue to experience inadequate symptom control, delayed onset of benefit, poor tolerability, and the burden of taking chronic daily pharmacotherapy. Our objective with DT120 is fundamentally different. Rapid and durable clinical benefit from a single treatment session that can be reinforced with intermittent retreatment as needed based on patient presentation.

Our confidence in the DT120 program is grounded in the consistency of the evidence generated to date. In our phase II GAD study, DT120 demonstrated rapidly, clinically meaningful improvements that were sustained through 12 weeks following treatment. VOYAGE and PANORAMA are intended to rigorously confirm those findings in two independent, well-controlled pivotal studies. VOYAGE and PANORAMA were initially designed with approximately 90% power to detect a five-point placebo-adjusted treatment effect. Based on the protocol-specified blinded sample size re-estimation, which assessed variants of the primary outcome measure and dropout rates, both studies would be expected to have greater than 99% power to detect a five-point placebo-adjusted treatment effect. Notably, while the studies were powered to detect a five-point difference, we believe a placebo-adjusted improvement of four points or greater at week 12 would compare favorably with the currently available treatments and other investigational products in development.

Beyond DT120, we continue to advance DT402 in autism spectrum disorder, or ASD. We believe this program represents an important long-term opportunity given the significant unmet need and the absence of FDA-approved therapies that directly address the core social communication challenges associated with ASD. Across the development programs, we are incredibly excited by the results we've been able to produce to date and the ones we expect to share in the near term. I'll turn the call over to Matt to comment on our ongoing commercial preparations as we seek to translate clinical excellence into commercial success.

Thanks, Dan. I'm excited to spend a few minutes sharing more about our accelerating commercial momentum for DT120, which has been further strengthened by the positive phase III EMERGE results. These results have given us greater confidence in DT120's potential to deliver meaningful, rapid, and durable benefit for patients with MDD and GAD. In our market research, both patient populations have clearly expressed dissatisfaction with current treatment options and have responded positively to the DT120 product profile. On the heels of EMERGE, we are moving with urgency to further build a fully integrated commercial apparatus designed to deliver on the full potential of DT120 adoption if approved. A strong recent example of this execution is our Wired for Worry campaign launched in July.

This campaign is designed to raise awareness of the persistent burden and underlying neurobiology of GAD, highlight key unmet needs, and equip clinicians to better identify patients who may benefit from new treatment options. Early feedback has been highly positive, and the campaign is already driving meaningful engagement as we near the upcoming GAD data readouts. At the same time, we are rapidly expanding our commercial team and building our critical operational capabilities. We are hiring and onboarding key talent across marketing, market access, sales, and commercial operations while executing on essential launch activities, including promotional message development, payer value narratives and engagement, distribution model design, and detailed deployment planning. These efforts are advancing in parallel with the build-out of our centralized patient support services, reimbursement pathways, field operational readiness HCP engagement initiatives all align to ensure a strong, seamless launch.