Definium Therapeutics(DFTX)
$34.47-0.17 (-0.49%)
DFTX
Definium Therapeutics earnings date
$34.47
At close:-0.17 (-0.49%)
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Definium Therapeutics (DFTX) Q3 2026 Earnings Report
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DFTX Q3 2026 EPS Results
- Actual EPS
- -$0.37
- Consensus EPS
- -$0.56
- Beat/Miss
- Beat by +$0.19
- One Year Ago EPS
- -$0.78
DFTX Q3 2026 Revenue Results
- Actual Revenue
- $0
- Expected Revenue
- $0
- Beat/Miss
- Met expectations
- YoY Revenue Growth
- ―
Earnings Announcement Details
- Quarter
- Q3 2026
- Date
- 11/09/2026
- Time
- After Close
- Conference Call
- Monday, November 9, 2026
DFTX Upcoming Earnings
Definium Therapeutics's next earnings date is estimated for March 11, 2027, based on past reporting schedules.
Q3 2026 Earnings Call Audio
DFTX Q3 2026 Earnings Call
0:00 / 0:00
Q3 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q3 2026 Earnings Call Summary
Earnings Call Sentiment|Positive
The call was strongly positive, driven by three positive Phase 3 studies, two FDA breakthrough therapy designations, constructive FDA engagement, a planned NDA filing in the first half of 2027, substantial cash resources expected to fund operations into 2030, and expanding commercial preparations. The main negative items were higher R&D and G&A expenses, the limited and early nature of the DT402 evidence, remaining uncertainty around filing details, and occasional extended monitoring cases. Management nevertheless characterized these issues as manageable and emphasized strong clinical validation, regulatory momentum, and launch readiness.
Company Guidance
Definium expects resources of approximately $1.05 billion as of 09/30/2026 to fund planned operations into 2030; it remains on track for NDA filing in the first half of 27, expects ASCEND top line data in 2027, plans to initiate HAVEN in 2027 with approximately 200 participants and change in the clinician administered PPSC scale for DSM 5 or CAPS-5 at week 8 as the primary endpoint, and plans a study in 2027 for DT402 investigating the safety and clinical activity of multiday dosing paradigms; the first commercial day is planned for the first half of 27, and payers have advised that the pricing corridor is somewhere between the $30 thousand to $75 thousand.
- Positive Phase 3 Results Across GAD and MDDDT120 ODT produced positive results across three Phase 3 studies—VOYAGE and PANORAMA in generalized anxiety disorder (GAD), and EMERGE in major depressive disorder (MDD). Management said the studies demonstrated rapid, clinically meaningful, and durable effects following a single 100 microgram dose, with efficacy evident as early as day 1 and sustained through week 12.
- VOYAGE GAD EfficacyVOYAGE enrolled 214 participants with moderate to severe GAD, met its primary endpoint and all key secondary efficacy endpoints, and showed a 5.4 placebo-adjusted improvement on HAM-A at week 12, with a p value of less than 0.0001 and a Cohen's d of 0.81.
- PANORAMA GAD EfficacyPANORAMA enrolled 245 participants and met its primary endpoint and all key secondary efficacy endpoints. The 100 microgram dose produced a 5.1 placebo-adjusted improvement on HAM-A at week 12, with a p value of less than 0.0001 and a Cohen's d of 0.64. The 50 microgram functional control supported interpretation of the efficacy results and selection of the 100 microgram dose.
- DT120 Safety and Treatment Session ProfileAcross the completed double-blind phases of all three studies, DT120 was generally well tolerated, with no drug-related serious adverse events and no suicidality signal. Most treatment-emergent adverse events occurred and resolved during the observed dosing session, and participants completed the standardized end-of-session checklist in an average of about 6 hours consistently across the studies.
- Breakthrough Therapy Designations and NDA TimelineDT120 ODT has received two FDA breakthrough therapy designations, one for MDD and one previously for GAD. Management said FDA engagement remains constructive and that the company remains on track for a planned NDA filing in the first half of 2027.
- ASCEND Enrollment and HAVEN PTSD PlansThe fourth Phase 3 study, ASCEND, continues to enroll well, with top-line data expected in 2027. Definium plans to initiate HAVEN, its Phase 3 PTSD study, in 2027, enrolling approximately 200 participants and using change in the clinician-administered CAPS-5 at week 8 as the primary endpoint, while maintaining a 12-week double-blind period.
- DT402 Autism Spectrum Disorder SignalsIn a Phase 2a single-dose, open-label study in adults with autism spectrum disorder, DT402 showed encouraging signals across socialization, communication, and functional outcomes. Reported improvements included reduced rigidity and fixation, increased engagement in social settings, increased empathy and closeness to others, and reduced anxiety and irritability.
- DT402 Tolerability and Continued DevelopmentDT402 was described as well tolerated, with the most common adverse events being euphoria, fatigue, and enhanced relaxation. Definium plans to initiate a 2027 study investigating the safety and clinical activity of multiday dosing paradigms.
- Commercial Infrastructure and Launch PreparationThe company has advanced its market access strategy, distribution planning, patient services, commercial operations, field deployment plans, and infrastructure for the supervised treatment model. Definium is engaging interventional psychiatry providers to assess capacity, workflow, and infrastructure needs ahead of a potential launch.
- Patient Advocacy and Provider ReadinessDefinium expanded its outreach efforts by hiring a head of patient advocacy. The company is working to understand the patient journey, identify barriers to care, and develop education and support resources, while also building referral networks and educating psychiatrists about DT21 and the potential GAD indication.
- Planned Commercial DayThe company plans to hold its first commercial day in the first half of 2027, when it expects to provide more detail on the market opportunity for DT120, its go-to-market approach, and launch preparations.
- Strong Cash and Investment PositionAs of September 30, 2026, cash, cash equivalents, and investments were approximately $1.05 billion, compared with $412 million as of December 31, 2025. Based on the current operating plan and anticipated milestones, management expects these resources to fund planned operations into 2030.
- Improved Quarterly Net LossThird-quarter 2026 net loss was $51 million, compared with a net loss of $67.3 million in the same period of 2025. The decrease was primarily attributable to a gain from the change in fair value of the 2022 financing warrant and higher interest income, partially offset by increased operating expenses.
- Commercial Opportunity and Pricing FeedbackManagement highlighted GAD and MDD as two large psychiatric indications and noted that no new treatment has been approved for GAD in 20 years. Payer feedback indicated a pricing corridor somewhere between $30,000 and $75,000, with management stating that DT120 has differentiated value and that the corridor could be narrowed through future payer discussions.
- Potential Access Through VA and Broader PTSD SitesDefinium is engaged with the VA and other stakeholders and expects to work with both VA and non-VA sites in the HAVEN PTSD study. Management said the goal is to represent a broad and generalizable PTSD population, while continuing to support access for veterans with anxiety and depression.
- Broad Patient Interest Based on Market ResearchPrevious market research indicated that among patients who had failed five or more medications, 55% said they would like to try DT21. Management said it did not see meaningful differentiation by indication and viewed patients with substantial treatment need as highly likely to try the therapy.
- Confidence in PTSD Development and Use ModelManagement said it does not fundamentally expect the PTSD program to be more difficult than the completed GAD and MDD programs. The PTSD studies are expected to use monotherapy for interpretability and clean data while continuing to demonstrate that DT21 can be used safely as part of a multidrug strategy.
- Ongoing Investment in Medical Affairs and InfrastructureDefinium is expanding its medical affairs organization, including field-based medical science liaisons, and continues to invest in the capabilities and infrastructure needed for potential commercialization. Management said these investments are intended to support regulatory submission, provider education, patient services, and launch execution.
DFTX Earnings History
| Report Date | Fiscal Quarter | Forecast / EPS | Last Year's EPS | EPS YoY Change | Press Release |
|---|---|---|---|---|---|
| Mar 11, 2027 | 2026 (Q4) | -0.50- | -0.51 | ― | ― |
| Nov 09, 2026 | 2026 (Q3) | -0.56-0.37 | -0.78 | 52.56% (+0.41) | |
| Aug 06, 2026 | 2026 (Q2) | -0.54-1.44 | -0.5 | -188.00% (-0.94) | |
| May 07, 2026 | 2026 (Q1) | -0.49-0.71 | -0.27 | -162.96% (-0.44) | |
| Feb 26, 2026 | 2025 (Q4) | -0.48-0.51 | -0.41 | -24.39% (-0.10) | |
| Nov 06, 2025 | 2025 (Q3) | -0.50-0.78 | -0.18 | -333.33% (-0.60) | |
| Aug 05, 2025 | 2025 (Q2) | -0.38-0.50 | -0.08 | -525.00% (-0.42) | |
| May 08, 2025 | 2025 (Q1) | -0.36-0.27 | -1.14 | 76.32% (+0.87) | |
| Mar 06, 2025 | 2024 (Q4) | -0.29-0.41 | -0.58 | 29.31% (+0.17) | |
| Nov 07, 2024 | 2024 (Q3) | -0.28-0.18 | -0.45 | 60.00% (+0.27) |
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat Missed
