Definium Therapeutics Inc (DFTX) investor relations material

Executive summary

• Positive Phase III EMERGE results for DT120 ODT in MDD demonstrated rapid, robust, and durable efficacy, meeting all primary and key secondary endpoints with favorable tolerability and no serious adverse events or suicidality signals.

• Enrollment completed for Phase III VOYAGE and PANORAMA studies in GAD, with topline results expected in August and September 2026.

• Initiated Phase III ASCEND study in MDD and advanced preparations for HAVEN study in PTSD, with pivotal data expected in 2027.

• Expanded commercial capabilities and launched the Wired for Worry campaign to raise GAD awareness and prepare for DT120 ODT's potential launch.

• Terminated UHB license agreement, securing a non-exclusive, fully paid-up license and eliminating future milestone or royalty obligations.

Financial highlights

• Completed a public offering in June 2026, raising $805 million gross ($757.9 million net), ending the quarter with $1.1 billion in cash equivalents and investments.

• R&D expenses were $48.7 million for Q2 2026, up from $29.8 million year-over-year, mainly due to DT120 program advancement and personnel expansion.

• G&A expenses rose to $26.4 million from $11.1 million in Q2 2025, reflecting increased stock-based compensation, corporate activities, and commercial readiness investments.

• Net loss for Q2 2026 was $159 million, compared to $42.7 million in Q2 2025, significantly impacted by an $86.2 million non-cash expense from warrant revaluation due to share price increase.

• Net loss per share for Q2 2026 was $1.44 (basic and diluted), with weighted-average shares outstanding at 110.7 million.

Outlook and guidance

• Cash position is expected to fund planned operations into 2030, supporting ongoing R&D and commercial launch activities.

• Topline results for Phase III GAD trials (VOYAGE and PANORAMA) expected in August and September 2026; ASCEND (MDD) and HAVEN (PTSD) trials progressing with pivotal data in 2027.

• NDA submission for DT120 ODT is being prepared, with ongoing alignment with FDA guidance.