Welcome to our dedicated page for Definium Therapeutics SEC filings (Ticker: DFTX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Our SEC filing database is enhanced with expert analysis from Rhea-AI, providing insights into the potential impact of each filing on Definium Therapeutics's stock performance. Each filing includes a concise AI-generated summary, sentiment and impact scores, and end-of-day stock performance data showing the actual market reaction. Navigate easily through different filing types including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, proxy statements (DEF 14A), and Form 4 insider trading disclosures.
Designed for fundamental investors and regulatory compliance professionals, our page simplifies access to critical SEC filings. By combining real-time EDGAR feed updates, Rhea-AI's analytical insights, and historical stock performance data, we provide comprehensive visibility into Definium Therapeutics's regulatory disclosures and financial reporting.
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, Inc. reported a larger net loss as it accelerated late-stage development of its psychedelic-derived therapies. For the three months ended March 31, 2026, net loss was $77.1 million compared with $23.3 million a year earlier, driven mainly by higher research and development and general and administrative expenses.
Research and development spending rose to $41.5 million, largely from its DT120 program in generalized anxiety disorder (GAD) and major depressive disorder (MDD), while general and administrative costs doubled to $17.7 million as the company built commercial and corporate infrastructure. A $20.0 million unfavorable change in the fair value of 2022 USD Financing Warrants also weighed on results.
Definium ended the quarter with $373.4 million in cash, cash equivalents and investments and an accumulated deficit of $659.8 million. Management believes this liquidity will fund operations into 2028 while it advances multiple Phase 3 trials for DT120 and a Phase 2a study for DT402 in autism spectrum disorder.
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 is asking shareholders to vote at its June 11, 2026 virtual annual and special meeting. Investors will elect seven directors, reappoint KPMG as auditor, and decide whether to amend the 2025 Equity Incentive Plan to add 5,000,000 common shares for future awards.
The proxy highlights strong governance practices, including an independent chair, fully independent board committees, no poison pill and high director attendance. It also outlines an advanced psychiatry-focused pipeline with multiple Phase 3 trials of DT120 ODT in major depressive disorder, generalized anxiety disorder and planned post‑traumatic stress disorder, plus a Phase 2a study of DT402 in autism spectrum disorder.
Definium reports enhancing its financial resources with $259 million in gross equity financing in the fourth quarter of 2025 and expanding its leadership team with a new chief financial officer, chief commercial officer and an additional independent director. As of the April 15, 2026 record date, 109,066,783 common shares are outstanding and entitled to vote.
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, Inc. Chief Medical Officer Daniel Karlin reported an open-market sale of 8,018 Common Shares on March 25, 2026 at a weighted average price of $18.47 per share. According to the footnotes, these shares were sold to satisfy withholding tax obligations tied to the settlement of vested restricted stock units under a Rule 10b5-1 sell-to-cover plan adopted on June 14, 2022.
After this transaction, Karlin directly owns 413,317 Common Shares, which includes 1,586 shares acquired through the Definium Therapeutics, Inc. 2024 Employee Share Purchase Plan. This filing reflects a tax-related, pre-planned disposition rather than a discretionary sale of a large ownership stake.
Definium Therapeutics, Inc. Chief Legal Officer Mark Sullivan sold 10,702 Common Shares on March 25, 2026 at a weighted average price of $18.47. According to the filing, the shares were sold to satisfy withholding tax obligations tied to vested restricted stock units under a Rule 10b5-1 sell-to-cover plan adopted on March 14, 2024. Following this tax-related sale, he directly holds 271,079 Common Shares, which includes 793 shares acquired under the company’s 2024 Employee Share Purchase Plan.
Definium Therapeutics, Inc. Chief Executive Officer Robert Barrow reported an open-market sale of 24,431 Common Shares at a weighted average price of $18.47 per share. The shares were sold to satisfy withholding tax obligations linked to vested restricted stock units under a Rule 10b5-1 sell-to-cover plan adopted on June 15, 2022.
Following this transaction, Barrow directly holds 752,454 Common Shares, and this amount includes 1,586 shares acquired under the Definium Therapeutics, Inc. 2024 Employee Share Purchase Plan. Because the sale was for tax withholding under a pre-planned trading arrangement, it reflects a routine administrative event rather than a discretionary change in ownership.
Robert Barrow filed a Form 144 reporting an intended sale of 24,431 shares of Common stock of DFTX on 03/25/2026, described as restricted stock vesting under a registered plan. The filing also shows a prior sale of 25,791 shares on 12/26/2025.
Daniel Karlin filed a Form 144 reporting 8,018 shares of Common Stock to be sold on 03/25/2026. The filing states the shares relate to restricted stock vesting under a registered plan and lists the disposition as Issuer with reason "Services Rendered". The form also shows 5,600 shares sold on 12/26/2025 with proceeds of $73,622.00.