Reported positive topline Phase 3 results from two Phase 3 studies of DT120 ODT in generalized anxiety disorder (GAD)
Received FDA Breakthrough Therapy Designation for DT120 ODT in major depressive disorder (MDD)
On track for DT120 ODT NDA filing in first half of 2027
DT402 demonstrated positive initial results in a Phase 2a trial in adults with autism spectrum disorder (ASD); clinical study evaluating multiple dosing paradigms planned for 2027
Approximately $1.05 billion in cash, cash equivalents, and investments as of September 30, 2026
Conference call scheduled today at 4:30 p.m. EST
NEW YORK--(BUSINESS WIRE)--November 09, 2026--
Definium Therapeutics, Inc. ("Definium" or the "Company") (NASDAQ: DFTX), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today reported financial results for the quarter ended September 30, 2026, and recent highlights. The Company also reported positive initial results from its Phase 2a trial of DT402 in adults with ASD, with improvements observed across several measures of socialization, communication and other functional outcomes.
"Our positive Phase 3 topline results from Voyage and Panorama this quarter further strengthened the evidence supporting DT120 ODT. Together with our previously reported results, these findings demonstrate consistent, clinically meaningful results across three Phase 3 studies in GAD and MDD, reinforcing our confidence in DT120 ODT's potential to address significant unmet needs across both conditions," said Rob Barrow, Chief Executive Officer. "With Breakthrough Therapy designation in MDD and Ascend progressing, we continue to advance our late-stage program while building the capabilities needed to prepare for potential approval and commercialization. Beyond DT120, we believe DT402 represents an exciting opportunity and its initial results support continued development as we work to deliver differentiated therapies for patients with significant unmet needs."
Third Quarter and Recent Highlights
-- DT120 ODT in GAD: Reported positive topline results from Phase 3 Voyage
study in GAD with 214 participants randomized 1:1 to receive DT120 ODT
100 ug or placebo. Key findings included:
-- Met the primary endpoint and all key secondary efficacy
endpoints with a high degree of statistical significance.
-- Demonstrated a statistically significant and clinically
meaningful placebo-adjusted improvement of 5.4 points in Hamilton
Anxiety Rating Scale (HAM-A) total score from baseline at Week 12
(p<0.0001, Cohen's d=0.81), the study's primary endpoint.
-- DT120 ODT was generally well tolerated, with no drug-related
serious adverse events and no suicidality signal observed in Part
A.
-- DT120 ODT in GAD: Reported positive topline results from Phase 3
Panorama study in GAD with 245 participants randomized 2:1:2 to receive
DT120 ODT 100 ug, DT120 ODT 50 ug control, or placebo. Key findings
included:
-- Met the primary endpoint and all key secondary efficacy
endpoints with a high degree of statistical significance.
-- Demonstrated a statistically significant and clinically
meaningful placebo-adjusted improvement of 5.1 points in HAM-A
total score from baseline at Week 12 (p<0.0001, Cohen's d=0.64),
the study's primary endpoint.
-- DT120 ODT was generally well tolerated, with no drug-related
serious adverse events and no suicidality signal observed in Part
A.
-- DT120 ODT in MDD:
-- Received Breakthrough Therapy designation for DT120 ODT in MDD
following positive topline results from Phase 3 Emerge study,
which met the primary endpoint and all key secondary efficacy
endpoints with a high degree of statistical significance.
-- Continuing enrollment for the Phase 3 Ascend study in MDD. The
trial is expected to enroll approximately 165 participants
randomized 2:1:2 to receive DT120 ODT 100 ug, DT120 ODT 50 ug
control, or placebo. Topline data is expected in 2027.
-- DT120 ODT in PTSD: Planning to initiate the Phase 3 Haven study in PTSD
in 2027 with approximately 200 participants randomized 1:1 to receive
DT120 ODT 100 ug or placebo. The planned primary endpoint in the study is
the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8.
-- DT402 in ASD: The Company's Phase 2a trial of DT402 in five adults with
ASD demonstrated positive initial results. The 200 mg single-dose, single
arm, open-label study was designed to characterize the pharmacodynamic
and clinical effects of DT402 and explore changes across measures of
socialization, communication and other functional outcomes. The study
endpoints were considered exploratory and were not powered to draw
statistical conclusions. Following treatment, improvements were observed
across several measures, including reduced rigidity and fixation and
increased engagement in social settings, as well as increases in empathy
and closeness to others and reductions in anxiety and irritability. DT402
was well tolerated, with the most common adverse events being euphoria,
fatigue and enhanced relaxation. Based on these initial findings, the
Company plans to further evaluate DT402 in a study that will investigate
the safety and clinical activity of multiple dosing paradigms expected to
begin in 2027.
-- Scientific engagement: Presented clinical and scientific data at
several major medical meetings, including Psych Congress 2026, the 39th
ECNP Congress and the 2026 NEI Fall Congress. Presentations included
topline results from the Phase 3 Emerge, Voyage and Panorama studies of
DT120 ODT, an overview of the DT120 ODT Phase 3 safety data, and the
DT120 ODT Phase 3 development program. At Psych Congress, the Emerge and
Voyage posters were named finalists, with Voyage receiving the Top Poster
award and Emerge selected for a podium presentation during the Latest
Discoveries & Emerging Trends in MDD session.
-- Commercial readiness and organizational growth: Advancing commercial
readiness activities and expanding organizational capabilities to support
the Company's transition toward commercialization. The Company is also
planning its first Commercial Day in the first half of 2027 to highlight
the market opportunity for DT120 ODT and provide greater detail on its
commercialization strategy and launch preparations.
Third Quarter 2026 Financial Results
Cash, Cash Equivalents and Investments. As of September 30, 2026, the Company had cash, cash equivalents and investments of approximately $1.05 billion compared to $411.6 million as of December 31, 2025. Based on the Company's current operating plan and anticipated milestones, the Company believes that its cash, cash equivalents and investments as of September 30, 2026 will be sufficient to fund the Company's operations into 2030.
Research and Development (R&D). R&D expenses were $46.1 million for the three months ended September 30, 2026 compared to $31.0 million for the three months ended September 30, 2025, an increase of $15.1 million. The increase was primarily attributable to an $8.8 million increase in personnel-related costs associated with the expansion of the Company's research and development organization, a $5.9 million increase in expenses related to the DT120 development program, and a $0.6 million increase in preclinical and other program expenses, partially offset by a $0.2 million decrease in DT402 program expenses.
General and Administrative (G&A). G&A expenses were $26.1 million for the three months ended September 30, 2026, compared to $14.7 million for the three months ended September 30, 2025, an increase of $11.4 million. The increase was primarily due to a $3.5 million increase in corporate and government affairs expenses, a $3.4 million increase in commercial-preparedness related expenses, a $3.3 million increase in personnel-related expenses as the Company expanded its organizational capabilities, a $0.7 million increase in legal and patent expenses, a $0.4 million increase in other miscellaneous administrative expenses, and a $0.1 million increase in stock-based compensation expenses.
Net loss. Net loss for the three months ended September 30, 2026 was $51.0 million, compared to $67.3 million for the three months ended September 30, 2025. The decrease in net loss was primarily attributable to a gain from the change in fair value of the Company's 2022 USD financing warrants and higher interest income, partially offset by increased operating expenses.
Conference Call and Webcast Reminder
Definium Therapeutics management will host a webcast at 4:30 p.m. EST today to provide a corporate update and review the Company's third quarter 2026 financial results and business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the Definium Therapeutics website, ir.definiumtx.com, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.
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