Definium Therapeutics, Inc.

Definium Therapeutics, Inc. announced positive topline results from its Phase 3 Panorama study of DT120 ODT for the treatment of generalized anxiety disorder (GAD). The study met its primary endpoint, demonstrating a statistically significant reduction in the Hamilton Anxiety Rating Scale (HAM-A) score compared to placebo. DT120 ODT was found to be generally well-tolerated, with a safety profile consistent with previous trials. The company has scheduled a pre-NDA meeting with the FDA for Q4 2026 and anticipates filing the NDA in the first half of 2027.

Definium Therapeutics reported a net loss of $159.0 million for the second quarter of 2026, with a basic net loss per share of $1.44. For the six months ended June 30, 2026, the net loss was $236.1 million. The company significantly bolstered its financial position by raising approximately $805.0 million in gross proceeds from an equity offering in June 2026, increasing cash and cash equivalents to $655.3 million. Operating expenses rose, driven by increased research and development and general and administrative costs, reflecting the advancement of its four Phase 3 clinical studies.

Definium Therapeutics announced positive topline results from its Phase 3 Emerge study of DT120 ODT in major depressive disorder, demonstrating rapid and durable efficacy. The company reported a Q2 2026 net loss of $159.0 million, significantly impacted by a non-cash warrant liability adjustment. Definium also completed a public offering raising $805 million in gross proceeds, boosting its cash, cash equivalents, and investments to approximately $1.1 billion, sufficient to fund operations into 2030. Upcoming Phase 3 results for DT120 ODT in generalized anxiety disorder are anticipated in August and September 2026.

Definium Therapeutics, Inc. announced the pricing and full exercise of an upsized underwritten public offering, expecting to raise approximately $758 million in net proceeds. The company sold 20,588,236 common shares at $34.00 per share, with underwriters fully exercising their option for an additional 3,088,235 shares. Proceeds will fund research and development of product candidates, preparation for potential commercialization of DT120 ODT, and general corporate purposes. The offering is expected to close on June 25, 2026.

Definium Therapeutics announced positive topline results from its Phase 3 Emerge study of DT120 ODT for major depressive disorder (MDD). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in MADRS total score at Week 6, and all key secondary efficacy endpoints. DT120 ODT was generally well tolerated with no serious adverse events or suicidality signal, indicating a rapid, robust, and durable effect.

Definium Therapeutics, Inc. shareholders approved an amendment to the 2025 Equity Incentive Plan at its 2026 Annual General and Special Meeting, increasing the common shares available for issuance by 5,000,000. Additionally, seven director nominees were elected to the Board of Directors, and KPMG LLP was appointed as the independent registered public accounting firm until the 2027 Annual Meeting.

Definium Therapeutics, Inc. announced it posted an updated corporate presentation on its website, detailing its late-stage pipeline, financial position, and anticipated milestones. The presentation highlights the DT120 ODT program in five Phase 3 studies with three key readouts expected in 2026 for Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD). The company reported a strong financial position with $373.4 million in cash, cash equivalents, and investments as of March 31, 2026, projecting a cash runway into 2028.

Definium Therapeutics announced the dosing of the first patient in Ascend, its second Phase 3 pivotal study for DT120 ODT (lysergide tartrate) in Major Depressive Disorder (MDD). The study will evaluate the efficacy and safety of DT120 ODT against placebo, enrolling 175 participants in the U.S. This milestone follows positive Phase 2b results and positions the company for a pivotal period with anticipated topline data in 2027, aiming to address significant unmet needs in MDD treatment.

Definium Therapeutics reported a net loss of $(77.1) million for the first quarter of 2026, a significant increase from $(23.3) million in the same period last year, primarily driven by higher operating expenses, including a substantial increase in research and development costs and a negative change in the fair value of financing warrants. The company, which recently changed its name from Mind Medicine (MindMed) Inc., continues to advance its lead product candidates, DT120 and DT402, through clinical trials for brain health disorders. Despite the increased loss, Definium Therapeutics maintains a strong liquidity position with $262.5 million in cash and cash equivalents, which management believes is sufficient to fund operations for at least the next twelve months.

Definium Therapeutics reported its first quarter 2026 financial results, with a net loss of $77.1 million, significantly higher than the $23.3 million loss in the prior year. The company maintained a strong financial position with $373.4 million in cash, cash equivalents, and investments as of March 31, 2026, projected to fund operations into 2028. Operationally, Definium achieved significant progress, completing enrollment for its Phase 3 Emerge (MDD) and Voyage (GAD) studies, and expanding its DT120 ODT clinical development program into PTSD with the planned initiation of the Phase 3 Haven study in 2027. The company anticipates three pivotal data readouts for DT120 ODT within the next five months.