Definium Therapeutics: DT120 ODT Phase 3 trials meet goals
Two Phase 3 studies in generalized anxiety disorder met their primary and key secondary endpoints, with placebo-adjusted symptom improvements.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Definium Therapeutics, Inc. reported third-quarter 2026 results and clinical updates for DT120 ODT and DT402. Its Phase 3 Voyage and Panorama studies in GAD met primary and all key secondary endpoints; placebo-adjusted HAM-A improvements at Week 12 were 5.4 points among 214 participants and 5.1 points among 245 participants, respectively (both p<0.0001). DT120 ODT received FDA Breakthrough Therapy designation for MDD, and the company said an NDA filing remains on track for the first half of 2027.
Cash, cash equivalents and investments totaled approximately $1.05 billion at September 30, 2026, versus $411.6 million at December 31, 2025; Definium believes these resources will fund operations into 2030 based on its current operating plan and anticipated milestones. Quarterly R&D and G&A expenses were $46.1 million and $26.1 million, versus $31.0 million and $14.7 million a year earlier. Quarterly net loss was $51.0 million versus $67.3 million; nine-month net loss was $287.0 million versus $133.4 million. DT402’s Phase 2a study included five adults; its endpoints were exploratory and not powered for statistical conclusions. Definium plans a multiple-dosing study expected to begin in 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointGAD trials met endpoints; placebo-adjusted HAM-A improved 5.4 and 5.1 points.
- Minor pointQuarterly net loss fell to $51.0 million from $67.3 million.
Negative
- Moderate pointNine-month net loss increased to $287.0 million from $133.4 million.
Filing Explained
The balance sheet reports 136,887,557 common shares issued and outstanding at
8-K Event Classification
Key Figures
Key Terms
Breakthrough Therapy designation regulatory
Hamilton Anxiety Rating Scale (HAM-A) medical
Cohen’s d technical
open-label medical
NDA regulatory
Earnings Snapshot
The company believes cash, cash equivalents and investments as of September 30, 2026 will fund operations into 2030 based on its current operating plan and anticipated milestones.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2026, Definium Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its fiscal quarter ended September 30, 2026, as well as information regarding a conference call to discuss these financial results and the Company’s recent corporate highlights. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02.
The information contained in this Item 2.02 of this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. |
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Description |
99.1 |
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Press Release, dated November 9, 2026 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DEFINIUM THERAPEUTICS, INC. |
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Date: |
November 9, 2026 |
By: |
/s/ Robert Barrow |
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Name: Robert Barrow |
Exhibit 99.1 |
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Definium Therapeutics Reports Third Quarter 2026 Financial Results and Recent Highlights
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, November 9, 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
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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.
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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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About DT120 Orally Disintegrating Tablet (ODT)
DT120 ODT is an ergoline derivative belonging to the group of classic serotonergic psychedelics, which acts as a partial agonist at 5-hydroxytryptamine serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium's proprietary and pharmaceutically optimized formulation of Lysergide (LSD). DT120 ODT is an advanced formulation incorporating Catalent's Zydis® ODT fast-dissolve technology, designed to deliver several unique advantages, including faster absorption and onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and a lower incidence of gastrointestinal side effects. Definium is developing DT120 ODT, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and posttraumatic stress disorder (PTSD), and is exploring its potential applications in other serious brain health disorders. DT120 has received Breakthrough Therapy designation from the FDA for GAD and MDD. Definium maintains a strong foundation to protect and extend the long-term value of the DT120 ODT franchise through a multi-layered intellectual property strategy spanning composition, formulation, and methods-of-use patents.
About DT402
DT402 is the Company’s proprietary form of R(-)-MDMA (rectus-3,4 methylenedioxymethamphetamine), being developed for the treatment of core symptoms of autism spectrum disorder (ASD). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical and early-stage clinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer.
About Definium Therapeutics
The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
For more information, visit https://definiumtx.com/ and follow Definium Therapeutics on Instagram, LinkedIn and X.
Forward-Looking Statements
Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company’s belief in DT120 ODT’s potential to address significant unmet needs across GAD and MDD; the Company’s anticipated NDA filing in the first half of 2027; the Company’s anticipated topline readout (Part A results) for the Phase 3 Ascend study for DT120 ODT in MDD in 2027; the Company’s expectations regarding enrollment for each of the Haven and Ascend studies; the Company’s expectations to initiate the Haven study in 2027; the Company’s planned trial design for Ascend and Haven; the Company’s expectations to further evaluate DT402 in a study that will investigate the safety and clinical activity of multiple dosing paradigms beginning in 2027; the Company’s expectation to hold a Commercial Day in the first half of 2027; the Company’s beliefs regarding potential benefits of its product candidates; the Company’s expectation that its cash, cash equivalents and investments will fund operations into 2030; and potential additional indications for DT120 ODT. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to
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differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of the Company's product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection for the Company's product candidates; the Company's expectations regarding the size of the eligible patient populations for its lead product candidates, if approved and commercialized; the Company's ability to identify third-party treatment sites to conduct its trials and its ability to identify and train appropriate qualified healthcare practitioners to administer its treatments; the pricing, coverage and reimbursement of the Company's lead product candidates, if approved and commercialized; the rate and degree of market acceptance and clinical utility of the Company's lead product candidates, in particular, and controlled substances, in general; as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2026, June 30, 2026 and September 30, 2026 under headings such as "Special Note Regarding Forward-Looking Statements," and "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other filings and furnishings made or to be made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.
For further information, please contact:
Investors:
ir@definiumtx.com
Media:
media@definiumtx.com
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Definium Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts) |
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September 30, 2026 |
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December 31, 2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 241,150 |
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$ 257,837 |
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Short-term investments |
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805,698 |
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153,756 |
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Prepaid and other current assets |
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4,911 |
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7,727 |
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Total current assets |
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1,051,759 |
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419,320 |
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Goodwill |
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19,918 |
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19,918 |
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Other non-current assets |
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2,606 |
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862 |
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Total assets |
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$ 1,074,283 |
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$ 440,100 |
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Liabilities and Shareholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ 9,277 |
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$ 5,347 |
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Accrued expenses |
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37,125 |
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20,446 |
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2022 USD Financing Warrants |
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21,328 |
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40,905 |
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Total current liabilities |
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67,730 |
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66,698 |
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Credit facility, long-term |
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36,661 |
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40,579 |
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Other non-current liabilities |
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1,858 |
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496 |
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Total liabilities |
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106,249 |
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107,773 |
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Commitments and contingencies |
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Shareholders' equity: |
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Common shares, no par value, unlimited authorized as of September 30, 2026 and December 31, 2025; 136,887,557 and 98,776,265 issued and outstanding as of September 30, 2026 and December 31, 2025, respectively |
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Additional paid-in capital |
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1,838,580 |
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913,914 |
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Accumulated other comprehensive (loss) income |
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(829) |
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1,085 |
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Accumulated deficit |
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(869,717) |
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(582,672) |
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Total shareholders' equity |
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968,034 |
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332,327 |
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Total liabilities and shareholders' equity |
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$ 1,074,283 |
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$ 440,100 |
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Definium Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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(in thousands, except share and per share amounts) |
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2026 |
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2025 |
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2026 |
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2025 |
Operating expenses: |
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Research and development |
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$ 46,141 |
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$ 30,978 |
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$ 136,290 |
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$ 84,144 |
General and administrative |
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26,138 |
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14,691 |
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70,286 |
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34,587 |
Total operating expenses |
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72,279 |
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45,669 |
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206,576 |
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118,731 |
Loss from operations |
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(72,279) |
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(45,669) |
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(206,576) |
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(118,731) |
Other income/(expense): |
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Interest income |
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10,139 |
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2,262 |
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17,183 |
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7,469 |
Interest expense |
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(1,150) |
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(1,274) |
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(3,628) |
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(4,214) |
Foreign exchange loss, net |
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(21) |
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(39) |
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(97) |
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(107) |
Change in fair value of 2022 USD Financing Warrants |
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12,350 |
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(22,545) |
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(93,927) |
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(17,774) |
Total other income/(expense) |
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21,318 |
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(21,596) |
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(80,469) |
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(14,626) |
Net loss |
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(50,961) |
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(67,265) |
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(287,045) |
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(133,357) |
Other comprehensive loss |
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Unrealized gain/(loss) on investments |
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(1,245) |
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196 |
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(1,913) |
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242 |
Loss on foreign currency translation |
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(1) |
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(2) |
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(1) |
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(60) |
Comprehensive loss |
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$ (52,207) |
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$ (67,071) |
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$ (288,959) |
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$ (133,175) |
Net loss per common share, basic |
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$ (0.37) |
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$ (0.78) |
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$ (2.42) |
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$ (1.56) |
Net loss per common share, diluted |
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$ (0.46) |
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$ (0.78) |
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$ (2.42) |
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$ (1.56) |
Weighted-average common shares, basic |
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135,941,973 |
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85,885,516 |
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118,571,999 |
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85,436,678 |
Weighted-average common shares, diluted |
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137,346,685 |
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85,885,516 |
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118,571,999 |
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85,436,678 |
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