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Definium Therapeutics (DFTX)
NASDAQ:DFTX
Earnings Data
Report Date
May 07, 2026Before Open (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.48Last Year’s EPS
-0.27Same Quarter Last Year
Strong Buy
Based on 11 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call emphasized clear operational and clinical progress: multiple pivotal trials on track with strong enrollment, a favorable blinded SSRE in Voyage that suggests high statistical power, supportive Phase II efficacy data (published in JAMA), an expanded commercial and leadership team, and a strengthened balance sheet with cash runway into 2028. These positives are tempered by substantial y/y expense increases and a larger net loss, dependence on upcoming pivotal results and regulatory interactions, and the absence of disclosed long-term open-label durability data to date. Overall, the company appears well-capitalized and operationally prepared entering a data-rich 2026, but material clinical and regulatory outcomes remain pending.Company Guidance
Late-Stage Pipeline Momentum and Upcoming Catalysts
Three Phase III readouts expected in 2026. Emerge (first pivotal MDD) is fully enrolled with top-line data expected in late Q2 2026. Voyage (GAD) is ~80% enrolled with top-line expected in early Q3 2026. Panorama (second GAD) is rapidly progressing with top-line expected in H2 2026. Ascend (second MDD) has site activation completed and first dosing anticipated by early Q2 2026.
Statistical Confidence from Voyage Blinded SSRE
Voyage blinded sample size re-estimation required no increase in enrollment. Observed model-based standard deviation on HAM-A was 6.7 vs the planned 10, and non-evaluable rate was 10% vs the assumed 15%, implying >99% power to detect a 5-point HAM-A difference and a minimum detectable difference <2 points if parameters hold.
Strong Phase II Clinical Efficacy Evidence
Phase IIb (published in JAMA) showed placebo-adjusted improvements of 7.7 points (HAM-A) and 6.4 points (MADRS) at week 12. Absolute reductions included a 21.9-point HAM-A decrease (48% remission, 65% response) and an 18.7-point MADRS decrease — metrics management cites as potentially best-in-class versus existing anxiolytics/antidepressants.
Financial Position and Runway
Cash, cash equivalents and investments were $411.6M at December 31, 2025 vs $273.7M at year-end 2024, an increase of $137.9M (+50.4%). Management believes this cash runway is sufficient to fund operations into 2028.
Balance Sheet Strength and Share Price Appreciation
Management noted a change in fair value of financing warrants of $22.8M driven by stock price appreciation from $6.96 to $13.39 (≈+92.5% year-over-year), reflecting investor interest as the company advances toward pivotal readouts.
Commercial Readiness and Organizational Build
Commercial infrastructure expanded: new Chief Commercial Officer (joined March 2025), assembled commercial leadership in marketing, market access and operations, REMS/scheduled-drug experience, and a hub/"white-glove" launch strategy planned. Analyst Day scheduled April 22 for further commercial detail.
Pipeline Expansion: DT402 for Autism Spectrum Disorder
DT402 (R-enantiomer of MDMA) Phase IIa study initiated (single-dose open-label) after completion of Phase I single-ascending dose study; first participant dosed and initial data expected later in 2026. Program targets core social communication deficits in ASD.
Operational Efficiencies and Enrollment Execution
Faster-than-expected site activations and DEA approvals reported (weeks), ability to fast-track sites that participated in Emerge, and improved non-evaluable/dropout metrics (Voyage interim non-evaluable rate 10% vs ~25% in Phase II), supporting rapid enrollment and retention.
DFTX Earnings History
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
DFTX Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
Feb 26, 2026 | $17.29 | $17.45 | +0.93% |
Nov 06, 2025 | $11.34 | $11.70 | +3.17% |
Aug 05, 2025 | $9.64 | $9.89 | +2.59% |
May 08, 2025 | $6.59 | $6.46 | -1.97% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Definium Therapeutics (DFTX) report earnings?
Definium Therapeutics (DFTX) is schdueled to report earning on May 07, 2026, Before Open (Confirmed).
What is Definium Therapeutics (DFTX) earnings time?
Definium Therapeutics (DFTX) earnings time is at May 07, 2026, Before Open (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is DFTX EPS forecast?
DFTX EPS forecast for the fiscal quarter 2026 (Q1) is -0.48.