Definium Therapeutics Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 6, 2026

Key Takeaways

  • Positive Sentiment: EMERGE phase III results were highly positive, with DT120 ODT producing an 8.1-point placebo-adjusted MADRS improvement in major depressive disorder at week six, statistically significant benefits from week one through week 12, and what management described as a favorable tolerability profile.
  • Neutral Sentiment: Definium expects to report topline results from its VOYAGE phase III generalized anxiety disorder study during the week of August 10, 2026, followed by PANORAMA results in September; both trials completed enrollment and were estimated to have more than 99% power to detect the targeted treatment effect.
  • Positive Sentiment: The company raised approximately $758 million in net proceeds from an upsized public offering and ended the quarter with about $1.1 billion in cash, cash equivalents, and investments, which management believes can fund operations into 2030.
  • Positive Sentiment: Definium is expanding its commercial infrastructure ahead of a potential DT120 launch, including market access, sales, patient support, payer engagement, and clinician-awareness initiatives for GAD and MDD.
  • Negative Sentiment: Quarterly net loss increased to $159 million from $42.7 million a year earlier, while R&D and G&A expenses rose substantially as the company invested in clinical programs, personnel, and commercialization; an $86.2 million non-cash warrant valuation expense was a major contributor to the loss.
AI Generated. May Contain Errors.
Earnings Conference Call
Definium Therapeutics Q2 2026
00:00 / 00:00

There are 5 speakers on the call.

Operator

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.

Operator

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.

Operator

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.

Speaker 1

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.

Speaker 1

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.

Speaker 1

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.

Speaker 1

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.

Speaker 2

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

Speaker 2

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.

Speaker 2

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.

Speaker 2

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.

Speaker 2

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.

Speaker 3

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.

Speaker 3

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

Speaker 3

HCP engagement initiatives all align to ensure a strong, seamless launch. Throughout this process, we are focused on making the patient and provider experience exceptional, leveraging the same unique insights and disciplined execution that have defined our R&D approach. We are highly confident in the clinical profile of DT120, our go-to-market strategy, and our commercial readiness. We believe our recent MDD and upcoming GAD pivotal data, combined with the momentum from market conditioning efforts and our accelerated infrastructure build, position Definium exceptionally well for a successful launch and to set the standard for this new and exciting treatment modality. With that, I'll turn it over to Brandi for our financial results.

Speaker 4

Thank you, Matt. Before reviewing our financial results, I'd like to briefly discuss the financing we completed during the quarter and how it positions Definium for the years ahead. In June, we completed an upsized, underwritten public offering that generated approximately $758 million in net proceeds. We were pleased by the strong participation from both existing and new investors, and we believe the successful financing reflects growing confidence in DT120, our broader pipeline, and our long-term vision for the company. Importantly, this financing significantly strengthened our balance sheet, and we ended the quarter with approximately $1.1 billion in cash equivalents, and investments. Based on our current operating plans, we believe this capital is sufficient to fund planned operations into 2030. This strong financial position provides the resources to execute our strategy while maintaining financial flexibility.

Speaker 4

If DT120 is approved, our goal is to ensure it reaches the patients who need it and the providers who have long been seeking better treatment options. We continue to make significant investments in market access, medical affairs, provider education, patient support programs, and other critical launch activities while simultaneously advancing our pivotal DT120 programs, DT402 program, and broader R&D pipeline. We believe this positions us to maximize the opportunity for DT120 and continue building long-term value across the organization. I'll now turn to our financial results for the second quarter of 2026, which are detailed in the earnings press release we issued this afternoon. Research and development expenses were $48.7 million for the second quarter of 2026, compared to $29.8 million in the prior year period. The increase was primarily driven by higher DT120 program expenses and additional personnel costs as we expanded our R&D capabilities.

Speaker 4

General and administrative expenses were $26.4 million, compared to $11.1 million in the second quarter of 2025. The increase was primarily due to higher stock-based compensation, corporate and government affairs activities, personnel-related costs, and commercial readiness investments. The year-over-year increase in both R&D and G&A expenses reflects continued investment across our clinical development programs, commercial readiness activities, and broader organizational capabilities as we prepare for potential commercialization. Overall, our operating expenses for the quarter were in line with our internal expectations. Net loss for the second quarter of 2026 was $159 million, compared to $42.7 million for the second quarter of 2025. As a reminder, net loss can be significantly impacted by changes in the fair value of our 2022 USD financing warrants, which are marked to market each quarter.

Speaker 4

During the second quarter, the change in fair value of these warrants resulted in an $86.2 million non-cash expense, primarily reflecting the increase in our share price from $18.90 at March 31st, 2026, to $47.04 at June 30th, 2026. As we look ahead, our focus remains on disciplined execution and thoughtful capital allocation. We have an important period ahead of us, and we believe our strong financial position gives us the flexibility to invest in our key priorities while continuing to create long-term value for both patients and shareholders. With that, I'll turn the call back to Rob.

Speaker 1

Thanks, Brandi. I want to extend my sincere thanks to the entire Definium team for your tireless work to make our successes possible. The progress we have made reflects years of scientific rigor, disciplined execution, and an unwavering commitment to developing therapies that have the potential to meaningfully improve the lives of patients living with anxiety, depression, PTSD, and other serious psychiatric disorders. As I said at the outset of today's call, we believe a new chapter for psychiatric care is on the horizon, and we could not be more energized or excited to play a leading role in seeking to make that promise a reality. In pursuit of that mission, we remain highly focused on executing against the clinical, regulatory, and commercial objectives ahead of us.

Speaker 1

As we expect to share top-line results from Voyage next week, we will not be holding a question and answer session following today's call. We look forward to discussing the results in greater detail after the data release, and thank you all for your continued support of Definium.

Operator

That concludes today's session. You may now disconnect.

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