Definium Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and investments totaled approximately $1.05 billion as of September 30, 2026, compared to $411.6 million as of December 31, 2025.
• Research and development expenses were $46.1 million for the three months ended September 30, 2026, an increase from $31.0 million in the same period in 2025.
• General and administrative expenses were $26.1 million for the three months ended September 30, 2026, an increase from $14.7 million in the same period in 2025.
• Net loss for the three months ended September 30, 2026, was $51.0 million, a decrease from $67.3 million in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $287.0 million, compared to $133.4 million in the same period in 2025.
• Total operating expenses for the three months ended September 30, 2026, were $72.3 million, compared to $45.7 million in the same period in 2025.
• Interest income for the three months ended September 30, 2026, was $10.1 million, compared to $2.3 million in the same period in 2025.
• Change in fair value of 2022 USD Financing Warrants resulted in a gain of $12.4 million for the three months ended September 30, 2026, compared to a loss of $22.5 million in the same period in 2025.
• Total liabilities were $106.2 million as of September 30, 2026, compared to $107.8 million as of December 31, 2025.
• Total shareholders' equity was $968.0 million as of September 30, 2026, compared to $332.3 million as of December 31, 2025.
• The Company believes its cash position as of September 30, 2026, will be sufficient to fund operations into 2030.

Guidance and Future Outlook:

• The Company is on track for an NDA filing for DT120 ODT in the first half of 2027.
• Topline data for the Phase 3 Ascend study in MDD is expected in 2027.
• The Phase 3 Haven study in PTSD is planned to initiate in 2027.
• A study evaluating multiple dosing paradigms for DT402 is expected to begin in 2027.
• The Company plans to hold its first Commercial Day in the first half of 2027.

Business Segments and Product Lines:

• DT120 ODT in GAD: Reported positive topline results from the Phase 3 Voyage study (214 participants), meeting primary and key secondary endpoints with a 5.4-point placebo-adjusted improvement in HAM-A total score at Week 12 (p<0.0001).
• DT120 ODT in GAD: Reported positive topline results from the Phase 3 Panorama study (245 participants), meeting primary and key secondary endpoints with a 5.1-point placebo-adjusted improvement in HAM-A total score at Week 12 (p<0.0001).
• DT120 ODT in MDD: Received FDA Breakthrough Therapy designation following positive topline results from the Phase 3 Emerge study, which met primary and key secondary endpoints.
• DT120 ODT in MDD: The Phase 3 Ascend study is continuing enrollment with approximately 165 participants.
• DT120 ODT in PTSD: The Phase 3 Haven study is planned to enroll approximately 200 participants with a primary endpoint of CAPS-5 at Week 8.
• DT402 in ASD: Phase 2a trial in five adults showed positive initial results with improvements in socialization, communication, rigidity, and anxiety; a study investigating multiple dosing paradigms is planned for 2027.
• Commercial Readiness: The Company is advancing commercial readiness activities and expanding organizational capabilities in preparation for potential approval and commercialization.

Market and Competitive Landscape:

• DT120 ODT has received Breakthrough Therapy designation from the FDA for both GAD and MDD.
• The Company presented clinical and scientific data at Psych Congress 2026, the 39th ECNP Congress, and the 2026 NEI Fall Congress.
• At Psych Congress 2026, the Emerge and Voyage posters were named finalists, with Voyage receiving the Top Poster award.

Risks and Challenges:

• Risks include history of negative cash flows, limited operating history, and incurrence of future losses.
• Regulatory risks involve compliance with laws, legislative developments, and potential rescheduling of controlled substances by the Drug Enforcement Administration.
• Clinical development risks include difficulty associated with research, clinical study risks, and the novelty of the psychedelic-inspired medicines industry.
• Commercialization risks include the ability to identify treatment sites, train healthcare practitioners, and achieve market acceptance, pricing, and reimbursement.
• Intellectual property risks involve maintaining effective patent rights and other protections.

Management Commentary and Tone:

• CEO Rob Barrow stated that positive Phase 3 topline results from Voyage and Panorama strengthened evidence supporting DT120 ODT.
• Management expressed confidence in DT120 ODT's potential to address significant unmet needs across GAD and MDD.
• Management noted that DT402 represents an exciting opportunity with initial results supporting continued development.
• The tone reflects confidence in advancing late-stage programs while building capabilities for commercialization.

Other Key Points:

• The Company's outstanding common shares increased to 136,887,557 as of September 30, 2026, from 98,776,265 as of December 31, 2025.
• Additional paid-in capital increased to $1.84 billion as of September 30, 2026, from $913.9 million as of December 31, 2025.
• Accumulated deficit increased to $(869.7) million as of September 30, 2026, from $(582.7) million as of December 31, 2025.
• The 2022 USD Financing Warrants liability decreased to $21.3 million as of September 30, 2026, from $40.9 million as of December 31, 2025.
• A conference call and webcast were scheduled for November 9, 2026, at 4:30 p.m. EST to review results and highlights.