Definium Therapeutics, Inc. 8-K Filings

Definium Therapeutics reported positive topline Phase 3 results from Voyage, a pivotal study of DT120 ODT 100 µg in adults with generalized anxiety disorder. The trial enrolled 214 participants randomized 1:1 to DT120 or placebo over a 12‑week double‑blind period.

Voyage met its primary endpoint, with a least‑squares mean change in Hamilton Anxiety Rating Scale (HAM‑A) score at Week 12 of -11.6 for DT120 vs -6.2 for placebo, a placebo‑adjusted difference of -5.4 points (p<0.0001, Cohen’s d=0.81). Efficacy appeared rapidly, with improvements seen as early as Day 2 and sustained through all post‑baseline timepoints. Key secondary endpoints, including change in Clinical Global Impression‑Severity (CGI‑S), were also highly statistically significant at multiple visits.

DT120 ODT was generally well tolerated. In Part A, adverse events were mostly mild to moderate, transient, and concentrated on the dosing day, with no serious adverse events reported in the DT120 arm and no suicidality signal or suicidal behavior identified. About 43% of DT120‑treated patients achieved ≥50% HAM‑A improvement at Week 12 versus 16% on placebo, and 14% vs 4% reached remission (HAM‑A ≤7. The company highlighted consistent large effect sizes across three late‑stage studies of DT120 and noted that a second GAD Phase 3 trial, Panorama, is expected to deliver topline results in September 2026.

Definium Therapeutics, Inc. reported second-quarter 2026 results alongside major clinical milestones. The Phase 3 Emerge trial in major depressive disorder randomized 149 participants 1:1 to DT120 ODT 100 µg or placebo and met its primary and all key secondary endpoints, showing an 8.1-point placebo-adjusted improvement in MADRS total score at Week 6 (Cohen’s d = 0.83; p<0.0001) and a 7.3-point improvement at Week 12. DT120 ODT was generally well tolerated, with no serious adverse events or suicidality signal observed.

The company completed enrollment in the Phase 3 Voyage and Panorama GAD studies, with topline data expected in August and September 2026, initiated the Phase 3 Ascend MDD study, and plans to start the Haven PTSD study in 2027. Definium completed an underwritten public offering of 23,676,471 common shares for gross proceeds of $805 million and net proceeds of approximately $757.9 million, ending June 30, 2026 with about $1.1 billion in cash, cash equivalents and investments versus $411.6 million at December 31, 2025. R&D expenses rose to $48.7 million and G&A to $26.4 million for the quarter. Net loss was $159.0 million, compared with $42.7 million a year earlier, largely reflecting an $86.2 million non-cash increase in the fair value of warrant liabilities; the company states its cash resources are expected to fund operations into 2030.

Definium Therapeutics, Inc. entered into an underwriting agreement for an underwritten public offering of 20,588,236 common shares at $34.00 per share, plus an additional 3,088,235 shares under a 30‑day option that was exercised in full. Including this option, gross proceeds are expected to be about $805 million, with net proceeds of approximately $758 million after underwriting discounts, commissions, and estimated expenses. The company plans to use the cash to fund research and development, prepare for potential commercialization of DT120 ODT if approved, and for working capital and general corporate purposes. Directors and executives agreed to a 60‑day lock‑up restricting share sales without underwriter consent.

Definium Therapeutics reported positive topline Phase 3 results from its Emerge study of DT120 ODT 100 µg in adults with major depressive disorder. The trial met its primary endpoint, showing an 8.1-point placebo-adjusted improvement in MADRS depression scores at Week 6 (p<0.0001), and maintained a 7.3-point advantage at Week 12 (p<0.0001). A key secondary endpoint, the CGI-S severity scale, also improved rapidly, with a 0.9-point placebo-adjusted benefit by Day 2 (p<0.0001). DT120 ODT was generally well tolerated, with 99% of treatment-emergent adverse events mild to moderate, no serious adverse events, and no suicidality signal, and all participants cleared the monitored dosing session by 8 hours. Response and remission rates at Week 6 favored DT120 ODT, and interim extension data suggest additional open-label doses can deepen and sustain benefit through Week 28.

Definium Therapeutics, Inc. reported results of its 2026 Annual General and Special Meeting of Shareholders. Investors approved an amendment to the 2025 Equity Incentive Plan, adding 5,000,000 common shares available for future equity awards to employees and other eligible participants.

Shareholders also elected seven directors to serve until the 2027 annual meeting and approved the appointment of KPMG LLP as the company’s independent registered public accounting firm. A quorum was achieved, with 78,673,592 common shares present or represented, about 72% of the 109,066,783 shares entitled to vote as of April 15, 2026.

Definium Therapeutics, Inc. filed an 8‑K to share an updated May 2026 corporate presentation detailing its late‑stage psychedelic‑derived CNS pipeline and financial position. Lead candidate DT120 ODT (lysergide tartrate) is in five Phase 3 studies across generalized anxiety disorder (GAD), major depressive disorder (MDD) and post‑traumatic stress disorder.

The company highlights Phase 2b data in GAD showing a 21.9‑point improvement on the HAM‑A at week 12 for the 100 µg dose, with a 7.7‑point advantage over placebo and 48% remission at week 12, alongside a generally favorable tolerability profile. Three Phase 3 readouts for DT120 are anticipated in 2026, and the FDA has granted Breakthrough Therapy Designation.

Second program DT402 (R(‑)‑MDMA) is in a Phase 2a autism spectrum disorder study after a well‑tolerated Phase 1 trial. Definium reports cash, cash equivalents and investments of $373.4 million and access to a credit facility up to $120 million as of March 31, 2026, supporting a cash runway into 2028, with 109.1 million shares outstanding as of April 30, 2026 and first‑quarter 2026 operating expenses of $59.2 million.

Definium Therapeutics reported that the first patient has been dosed in Ascend, its second Phase 3 pivotal study of DT120 Orally Disintegrating Tablet (DT120 ODT) for major depressive disorder (MDD). The trial will enroll about 175 participants in the U.S. and compare DT120 ODT with placebo.

The primary goal is to measure the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between the 100 µg dose and placebo. Ascend uses a two-part design with a 12-week double-blind period followed by a 40-week open-label extension and includes 100 µg, 50 µg, and placebo arms randomized 2:1:2.

The company anticipates topline data from Ascend’s 12-week double-blind period in 2027 and expects a topline readout from its first Phase 3 MDD trial, Emerge, in late Q2 2026. DT120 ODT is Definium’s proprietary LSD-based fast-dissolve formulation being developed for MDD, generalized anxiety disorder, PTSD, and other serious brain health disorders.

Definium Therapeutics reported a larger net loss as it advances multiple late-stage trials for DT120 ODT in mood and anxiety disorders. Net loss for the quarter ended March 31, 2026 was $77.1 million, compared with $23.3 million a year earlier, driven mainly by higher R&D and G&A spending and a non‑cash warrant fair value loss.

R&D expenses rose to $41.5 million from $23.4 million, reflecting expanded DT120 ODT development and internal research capacity, while G&A increased to $17.7 million from $8.8 million on higher compensation, commercial-preparedness, and legal costs. Cash, cash equivalents and investments totaled $373.4 million as of March 31, 2026, and the company believes this will fund operations into 2028.

Clinically, Definium has completed enrollment in its Phase 3 Emerge (MDD) and Voyage (GAD) studies, with topline data expected in late 2Q and early 3Q 2026, respectively, and updated late 3Q 2026 timing for Panorama (GAD). The DT120 ODT program is being expanded into PTSD with the Phase 3 Haven study expected to initiate in 2027.

Definium Therapeutics provided a detailed update on its lead candidate DT120 ODT (lysergide tartrate), an orally disintegrating psychedelic formulation being developed for generalized anxiety disorder (GAD), major depressive disorder (MDD) and posttraumatic stress disorder (PTSD). The company highlighted that three pivotal Phase 3 topline readouts are expected within roughly six months: the Emerge study in MDD in late 2Q 2026, the Voyage study in GAD in early 3Q 2026, and the Panorama study in GAD in late 3Q 2026. Emerge is fully enrolled with 149 participants, Voyage with 214 participants, and Panorama’s target enrollment has been updated to 200 after a blinded sample size re‑estimation that preserved high statistical power. A Phase 3 Ascend study in MDD plans to enroll 175 participants, while the Haven Phase 3 PTSD trial is expected to start in 2027 with about 200 participants.

Phase 2b data in GAD showed rapid and durable symptom improvement after a single 100 µg dose of DT120 ODT, with a 21.9‑point reduction on the HAM‑A anxiety scale at Week 12 and 48% of participants in remission, and a favorable tolerability profile dominated by mild, dosing‑day adverse events. Phase 3 designs use single‑dose, double‑blind cores with 40‑week extension phases to characterize durability and retreatment patterns, and employ adaptive sample size re‑estimation to maintain power. Management positions DT120 ODT as a potential best‑in‑class, multi‑billion‑dollar commercial opportunity supported by a scalable, single‑visit dosing model, existing psychiatric delivery infrastructure, and payer feedback referencing Spravato as a pricing and access analog. The company reports $411 in cash, cash equivalents and investments as of December 31, 2025 and expects its cash runway to extend into 2028 based on its current operating plan and anticipated milestones.

Definium Therapeutics reported a larger full-year 2025 net loss of $183.8 million, compared with $108.7 million in 2024, as it ramped late-stage development for its psychedelic-based therapies.

Cash, cash equivalents and investments rose to $411.6 million as of December 31, 2025, up from $273.7 million a year earlier, helped by a $259 million equity financing completed in the fourth quarter. The company expects this cash to fund operations into 2028.

Research and development expenses increased to $117.7 million from $65.3 million, driven mainly by higher DT120 program spending and expanded R&D staffing. General and administrative costs rose to $48.6 million from $38.6 million, reflecting greater professional services, pre-commercial efforts, and personnel expenses.

Definium highlighted progress across four Phase 3 trials of DT120 ODT in major depressive disorder and generalized anxiety disorder, with its Emerge MDD study fully enrolled and multiple topline readouts anticipated in 2026. It also advanced DT402 into a Phase 2a study for autism spectrum disorder.

Definium Therapeutics, Inc. reported a change to its board of directors. On January 28, 2026, the board expanded from six to seven members and appointed Roger Adsett as a director effective January 29, 2026, with a term running until the 2026 annual general meeting, or until a successor is chosen or he departs earlier.

Adsett was not assigned to any board committees at this time. Under the company’s non-employee director compensation policy, he will receive an annual cash retainer of $40,000, paid quarterly on a pro-rata basis. He also received an option to purchase 50,000 common shares, vesting one-third on the first anniversary of the grant date and the remainder in equal monthly installments thereafter, subject to continued board service.

The option grant was issued under the company’s 2025 Equity Incentive Plan. The filing notes there are no special arrangements leading to his appointment and no related-party transactions requiring disclosure under Item 404(a) of Regulation S-K.