DFTX

Second FDA Breakthrough Therapy designation for DT120 reinforces its potential across MDD and generalized anxiety disorder (GAD), two disorders with significant unmet need NEW YORK, September 08, 2026--(BUSINESS WIRE)--Definium Therapeutics, Inc. ("Definium" or the "Company"), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for DT120 (lysergide) ODT. The designation was supported by the significant unmet medical need in MDD and results from the Company's Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT demonstrated a statistically significant 8.1-point placebo-adjusted improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (p<0.0001), with durable efficacy through Week 12. This milestone marks the second Breakthrough Therapy designation from the FDA for the DT120 development program, following its initial designation for the potential treatment of GAD. The FDA’s Breakthrough Therapy designation is a process designed to expedite the development and review of innovative medicines intended to treat serious conditions where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. "Securing our second Breakthrough Therapy designation, closely following the unprecedented results from our Phase 3 Emerge study, underscores the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders," said Rob Barrow, Chief Executive Officer of Definium Therapeutics. "This recognition of DT120’s promise, first in GAD and now in MDD, reinforces the urgency to advance and deliver rapid, durable benefit across multiple indications. Our focus remains on developing innovative therapies that have the potential to expand treatment options and improve outcomes for the millions of people who continue to seek meaningful relief." MDD is characterized by at least five depressive symptoms, lasting two weeks or longer, which may include feelings of worthlessness, fatigue, impaired social functioning, and recurrent thoughts of death.1 With more than 21 million U.S. adults experiencing a major depressive episode each year, MDD is the second-most common mental health disorder in the U.S. and a leading cause of disability worldwide.2,3,4 Despite the availability of first-line treatments, fewer than one-third of patients reach remission, underscoring the critical unmet need for more effective treatment options.5 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 serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of 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 Major Depressive Disorder (MDD)Major Depressive Disorder (MDD) is the second-most common mental health disorder in the U.S., with over 21 million adults experiencing a major depressive episode (MDE) each year.2,3 This disorder, a leading cause of disability worldwide,3 brings persistent feelings of worthlessness, fatigue, and recurrent thoughts of death1 while increasing long-term mortality risk by 40%.6 MDD also carries a $326 billion annual economic burden in the U.S., driven by healthcare costs and lost productivity.7 The MDD treatment paradigm is characterized by critical unmet needs, including fewer than one-third of patients reaching remission with first-line treatments,5 onset of clinical activity that takes weeks to months,8,9 poor tolerability,10,11 and frequent switching, augmentation, and discontinuation of pharmacotherapy.12 About Lysergide (LSD)Lysergide (LSD) is one of the most extensively studied psychopharmaceuticals in history, with over 1,000 published reports.13 First synthesized in 1938 by Swiss chemist Albert Hofmann in his search for active principles from ergot fungus, its profound psychological effects were discovered in 1943, which transformed psychiatric research.13 LSD, a definitional classic psychedelic, temporarily alters perception, cognition, and emotion, is physiologically safe, non-addictive, and is not associated with withdrawal.13 While its precise mechanism of action in the treatment of psychiatric illness is unknown, its acute perceptual, cognitive, and affective effects are mediated by agonism of the serotonin 5-hydroxytryptamine 2A (5-HT2A) receptor, and mechanistic hypotheses suggest that it causes sustained increases in neuroplasticity in a variety of brain regions.14,15 About Definium TherapeuticsThe 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. Forward-Looking StatementsCertain 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 potential of DT120 ODT across MDD and GAD; the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders; the potential of DT120 ODT to expand treatment options and improve outcomes; the Company's beliefs regarding potential benefits of its product candidates; and the potential to explore additional indications for DT120 ODT. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to 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 and June 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 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. References: American Psychiatric Association. "Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)." 2013. National Institute of Mental Health (NIMH). "Major Depression: Prevalence of Major Depressive Episode Among Adults." Updated 2024. Substance Abuse and Mental Health Services Administration (SAMHSA). "2023 National Survey on Drug Use and Health (NSDUH)." World Health Organization (WHO). "Depression Fact Sheet." Updated 2023. Rush, A. J., et al. "Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report." American Journal of Psychiatry, 2006. Cuijpers, P., et al. "Long-Term Mortality Risk in Depression: A 20-Year Follow-Up Study." JAMA Psychiatry, 2023. Greenberg, P. E., et al. "The Economic Burden of Adults with Major Depressive Disorder in the United States (2020)." Journal of Clinical Psychiatry, 2024. APA. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. Published 2010. Alemi F, Min H, et al. Effectiveness of common antidepressants: A post market release study. eClinicalMedicine. 2021;41. Cipriani A, et al. Comparative Efficacy and acceptability of 21 antidepressant drugs for the Acute Treatment of Adults with Major Depressive Disorder: A Systematic Review and Network Meta-analysis. Lancet. 2018;391(10128):1357-66. Braund TA, Tillman G, et al. Antidepressant Side Effects and Their Impact on Treatment Outcome in People with Major Depressive Disorder: An Ispot-D Report. Transl Psychiatry. 2021;11(1):417. Zhu L, Ferries E, et al. Economic Burden and Antidepressant Treatment Patterns Among Patients with Major Depressive Disorder in the United States. J Manag Care Spec Pharm. 2022 Nov;28(11-a Suppl): S2-S13. Nichols, DE. "Psychedelics." Pharmacological Reviews, 2016;68(2): 264–355. Passie, T, Halpern, JH, Stichtenoth, DO, et al. "The Pharmacology of Lysergic Acid Diethylamide: A Review." CNS Neuroscience & Therapeutics. 2008;14:295–314. Liechti, ME. "Modern clinical research on LSD." Neuropsychopharmacology. 2017;42: 2114–2127. View source version on businesswire.com: https://www.businesswire.com/news/home/20260827507027/en/ Contacts For Media: [email protected] For Investors: [email protected]

Patients who received a single 100 µg dose of DT120 showed a statistically significant and clinically meaningful drop in anxiety symptoms compared with placebo in the trial. CEO Rob Barrow said the results “should raise the bar for what patients and clinicians expect from GAD treatments.” A second late-stage GAD study, Panorama, is expected to report results in September. Shares of Definium Therapeutics (DFTX) rose about 9% on Wednesday after the company said that its psychedelic experimental drug DT120 reduced symptoms in adults with generalized anxiety disorder (GAD) in the late-stage Voyage trial. Voyage is the company’s second successful late-stage readout for DT120, following positive results in major depressive disorder in June. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox The study met its primary goal and all key secondary measures. Patients who received a single 100 µg dose of DT120 showed a statistically significant and clinically meaningful drop in anxiety symptoms compared with placebo after 12 weeks. The trial enrolled 214 adults with moderate-to-severe GAD across U.S. sites. On the Hamilton Anxiety Rating Scale (HAM-A), the treatment group improved by an average of 11.6 points from baseline versus 6.2 points for placebo—a 5.4-point difference. Benefits appeared as early as Day 2 and held through the 12-week period. Response rates or at least 50% symptom reduction reached 43% with DT120 versus 16% on placebo, the company said. Further, DT120 was generally well tolerated. Side effects were mostly mild to moderate, temporary, and occurred mainly on the day of dosing. No new safety concerns emerged, including no signs of increased suicidality. CEO Rob Barrow said the results “should raise the bar for what patients and clinicians expect from GAD treatments” and highlight DT120’s potential to redefine care. GAD affects roughly 26 million U.S. adults, and no new FDA-approved treatment has arrived in nearly two decades. A second late-stage GAD study, Panorama, is expected to report results in September. The company is positioning DT120 as a potential one-dose option delivering lasting relief through a different mechanism than existing therapies. On Stocktwits, retail sentiment around DFTX stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels. A Stocktwits user expressed optimism that DT120 ‘will likely disrupt the market.’ “With two successful Phase 3 readouts in hand (Emerge for MDD and Voyage for GAD)...Definium now holds the strongest multi-indication clinical foundation in the sector,” another user wrote. A third user predicts a buyout for the company. DFTX stock has gained over 200% year-to-date. Read More: WEN Stock Soars After Nelson Peltz Reportedly Prepares Take-Private Bid For The Burger Chain For updates and corrections, email newsroom[at]stocktwits[dot]com. Anan Ashraf has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: ASTS And RKLB Chase The SpaceX Playbook, But Analyst Flags ‘Very Inflated Valuations’ And Mounting Delays COHR Stock Dips Overnight Despite Strong Q4: Retail Bulls Keep The Faith ENVX Stock Falls Overnight Despite Q2 Beat: Retail Bulls Shrug It Off As CEO Backs Smartphone, Wearables And Defense Demand

Interested in Definium Therapeutics, Inc.? Here are five stocks we like better. Key clinical catalysts are imminent: Definium expects VOYAGE Phase III generalized anxiety disorder results during the week of Aug. 10 and PANORAMA results in September. Enrollment is complete in both studies, while ASCEND and a planned PTSD study are advancing. DT120 showed strong Phase III depression results: The EMERGE study delivered an 8.1-point placebo-adjusted MADRS improvement at week six, with benefits emerging by week one and remaining statistically significant through week 12. Definium strengthened its financial position: A June offering generated about $758 million in net proceeds, leaving roughly $1.1 billion in cash and investments expected to fund operations into 2030. Second-quarter net loss widened to $159 million, including an $86.2 million non-cash warrant valuation expense. Definium Therapeutics (NASDAQ:DFTX) said it expects to report top-line results from its Phase III VOYAGE study of DT120 ODT in generalized anxiety disorder during the week of Aug. 10, following positive Phase III results in major depressive disorder reported in June. Chief Executive Officer Rob Barrow said the company completed enrollment in both VOYAGE and PANORAMA, its two pivotal generalized anxiety disorder, or GAD, studies. Definium expects to release PANORAMA results in September. The company has also begun enrollment in ASCEND, its second Phase III study of DT120 ODT in major depressive disorder, with top-line data anticipated in 2027, and is preparing to start a Phase III post-traumatic stress disorder study, HAVEN, in 2027. → 3 Drone Stocks That Should Soar After the Summer Slump The company did not hold a question-and-answer session because of the planned VOYAGE data release. Chief Medical Officer Dr. Dan Karlin reviewed results from the Phase III EMERGE study in major depressive disorder, which enrolled 149 participants with moderate to severe disease. Participants had a mean baseline Montgomery-Åsberg Depression Rating Scale, or MADRS, score of 34.5, and about half had previously failed two or more antidepressant treatments, according to Karlin. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Background antidepressant and anxiolytic medications were discontinued before randomization, and psychotherapy was not part of the study, allowing the company to assess DT120 as monotherapy, Karlin said. EMERGE met its primary and key secondary endpoints, according to the company. DT120 ODT produced an 8.1-point placebo-adjusted improvement on the MADRS at week six, with a p-value of less than 0.0001 and an effect size of about 0.83. Karlin said the company believes this represents the largest treatment effect reported in a Phase III major depressive disorder trial. → Jersey Mike's Serves Fresh Gains After IPO Stumble He said efficacy was observed as early as week one after a single treatment and remained statistically significant at each subsequent assessment through week 12. The company also reported significant improvements across key secondary endpoints and what it characterized as a favorable tolerability profile. Karlin said Definium’s Phase II GAD study showed rapid, clinically meaningful improvements that persisted through 12 weeks after treatment. VOYAGE and PANORAMA were designed to confirm those findings in separate controlled pivotal studies. The studies were initially designed with roughly 90% power to detect a five-point placebo-adjusted treatment effect. Following a protocol-specified blinded sample-size re-estimation that considered variations in the primary measure and dropout rates, Definium said both studies would be expected to have more than 99% power to detect a five-point placebo-adjusted effect. While the company powered the trials to detect a five-point difference, Karlin said it believes a placebo-adjusted improvement of four points or more at week 12 would compare favorably with available treatments and other investigational products. He also cited the lack of a newly approved GAD drug in nearly 20 years. Beyond DT120, Definium said it continues to advance DT402 for autism spectrum disorder. Karlin said the program targets the core social-communication challenges associated with autism spectrum disorder, for which the company said no FDA-approved therapies directly address those symptoms. Chief Commercial Officer Matt Wiley said Definium is expanding its commercial organization and developing launch capabilities for DT120 if the product receives approval. The company is hiring across marketing, market access, sales and commercial operations, while working on promotional messaging, payer value narratives, distribution design and deployment planning. Wiley highlighted the July launch of Definium’s “Wired for Worry” campaign, which aims to raise awareness of the burden and underlying neurobiology of GAD and help clinicians identify patients who could benefit from new treatment options. He said early feedback has been positive and the campaign is generating engagement ahead of the GAD data readouts. Chief Financial Officer Brandi Roberts said Definium completed an upsized underwritten public offering in June that generated approximately $758 million in net proceeds. The company ended the second quarter with about $1.1 billion in cash equivalents and investments and said it expects that capital to fund planned operations into 2030. Research and development expense rose to $48.7 million from $29.8 million a year earlier, primarily due to DT120 program spending and added R&D personnel. General and administrative expense increased to $26.4 million from $11.1 million, reflecting stock-based compensation, corporate and government affairs activity, personnel costs and commercial-readiness investments. Net loss widened to $159 million from $42.7 million in the prior-year quarter. Roberts said the quarterly net loss included an $86.2 million non-cash expense from changes in the fair value of the company’s 2022 U.S. dollar financing warrants. The expense primarily reflected an increase in Definium’s share price to $47.04 on June 30 from $18.90 on March 31. Barrow said the company is continuing to prepare for a potential new drug application submission and potential launch of DT120 ODT while advancing its clinical programs and broader research pipeline. Definium Therapeutics, Inc, a clinical stage biopharmaceutical company, develops novel products to treat brain health disorders. The company's lead product candidates include MM120, which is in phase 3 for the treatment of generalized anxiety disorder and attention deficit hyperactivity disorder; and DT402, a R-enantiomer of 3,4-methylenedioxymethamphetamine, which is in phase 2a clinical trials for the treatment of core symptoms of autism spectrum disorder. The company was formerly known as Mind Medicine (MindMed) Inc and changed its name to Definium Therapeutics, Inc in January 2026. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Definium Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Definium Therapeutics Inc (NASDAQ:DFTX) reported positive top-line results from its first Phase III study of DT120 ODT in major depressive disorder (MDD), demonstrating the largest treatment effect ever reported in a Phase III MDD study. The company has completed enrollment in both Voyage and Panorama, its two Phase III studies in generalized anxiety disorder (GAD), with top-line results expected in August and September 2026, respectively. DT120 ODT showed rapid onset of action (efficacy as early as week one), durable clinical benefit through week 12, and a favorable tolerability profile in the eMERGE study. Definium Therapeutics Inc (NASDAQ:DFTX) strengthened its balance sheet with an upsized public offering generating approximately $758 million in net proceeds, ending Q2 2026 with about $1.1 billion in cash, sufficient to fund operations into 2030. The company is advancing commercial preparations, including the 'Wired for Worry' campaign and expansion of its commercial team, to support a potential launch of DT120 ODT if approved. The FDA's recently finalized guidance for psychiatric treatments aligns with Definium's regulatory strategy, reflecting constructive dialogue and potential for a smoother NDA submission path. Definium Therapeutics Inc (NASDAQ:DFTX) reported a net loss of $159 million for Q2 2026, a significant increase from $42.7 million in the prior year period, driven by higher operating expenses and a non-cash warrant fair value expense. The company's operating expenses are rising sharply, with R&D expenses up to $48.7 million (from $29.8 million) and G&A expenses up to $26.4 million (from $11.1 million) year-over-year, reflecting increased investment but also higher cash burn. The company is awaiting top-line results from its Voyage and Panorama GAD studies, and there is inherent uncertainty and risk that these trials may not meet their endpoints or achieve statistical significance. The net loss was significantly impacted by a non-cash expense of $86.2 million related to the change in fair value of USD financing warrants, which could lead to volatility in future financial results. The company is not holding a Q&A session on this call, which may limit transparency and leave investors with unanswered questions about the upcoming data readouts and financial outlook. Despite the positive eMERGE results, the company has not yet received regulatory approval for DT120 ODT, and there are risks associated with the NDA submission, potential delays, or additional data requirements from the FDA. Warning! GuruFocus has detected 5 Warning Signs with DFTX. Is DFTX fairly valued? Test your thesis with our free DCF calculator. Q: What were the key financial results for the second quarter of 2026, and what is the company's current cash position?A: Brandi Roberts, CFO, reported that R&D expenses increased to $48.7 million from $29.8 million in the prior year, and G&A expenses rose to $26.4 million from $11.1 million. The net loss for the quarter was $159 million, which included an $86.2 million non-cash expense from the change in fair value of warrants due to the share price increase. The company ended the quarter with approximately $1.1 billion in cash, sufficient to fund operations into 2030. Q: What were the top-line results from the eMERGE Phase III study of DT120 ODT in major depressive disorder (MDD)?A: Dr. Daniel Karlin, Chief Medical Officer, stated that eMERGE met all primary and key secondary endpoints with highly statistically significant results. DT120 demonstrated an 8.1-point placebo-adjusted improvement on the MADRS at week six (p<0.0001), corresponding to an effect size of approximately 0.83, which the company believes is the largest treatment effect ever reported in a Phase III MDD study. Efficacy was evident as early as week one and persisted through week 12. Q: What is the timeline for the upcoming GAD data readouts?A: CEO Robert Barrow confirmed that top-line results from Voyage, the first Phase III study in generalized anxiety disorder (GAD), are expected during the week of August 10, 2026, with results from Panorama expected in September 2026. The company did not hold a Q&A session on this call due to the proximity of the Voyage data release. Q: How is the company preparing for the potential commercial launch of DT120 ODT?A: Matt Wiley, Chief Commercial Officer, detailed that the company is rapidly expanding its commercial team across marketing, market access, sales, and operations. They launched the "Wired for Worry" campaign in July to raise awareness of GAD and are executing on launch activities including payer value narratives, distribution model design, and patient support services. Market research shows both MDD and GAD patients are dissatisfied with current treatments and respond positively to DT120's profile. Q: What is the status of the company's other pipeline programs?A: Dr. Karlin noted that enrollment has been completed in both Voyage and Panorama for GAD, enrollment has been initiated in Ascend (the second Phase III MDD study) with top-line data expected in 2027, and preparations are advancing for Haven, the planned Phase III study in PTSD, expected to initiate in 2027. Additionally, the company continues to advance DT-402 for autism spectrum disorder (ASD), which addresses core social communication challenges with no FDA-approved therapies currently available. Q: How does the company view the competitive landscape for GAD treatments?A: Management emphasized that there has not been a new drug approved for GAD in almost 20 years, creating an extraordinary opportunity for a first and best-in-class treatment. Dr. Karlin noted that while the studies were powered to detect a 5-point difference, a placebo-adjusted improvement of 4 points or greater at week 12 would compare favorably with currently available treatments and other investigational products in development. Q: What was the outcome of the company's recent financing activities?A: CFO Brandi Roberts reported that in June, the company completed an upsized underwritten public offering that generated approximately $758 million in net proceeds (approximately $805 million in gross proceeds). The financing saw strong participation from both existing and new investors, reflecting growing confidence in DT120 and the broader pipeline. Q: What is the company's regulatory strategy for DT120 ODT?A: CEO Robert Barrow stated that the company has worked closely with the FDA throughout the development program, maintaining a constructive dialogue that has shaped the program. He noted that the agency's recently finalized guidance closely reflects the principles that have guided Definium's regulatory strategy from the outset, positioning the company well for a potential NDA submission. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Announced positive topline results from Phase 3 Emerge study of DT120 ODT in major depressive disorder (MDD), demonstrating rapid, robust, and durable efficacy Topline results from Phase 3 GAD studies of DT120 ODT in generalized anxiety disorder (GAD) on track: Voyage results anticipated week of August 10; Panorama results anticipated September 2026 Approximately $1.1 billion in cash, cash equivalents, and investments as of June 30, 2026 Conference call scheduled today at 4:30 p.m. EDT NEW YORK, August 06, 2026--(BUSINESS WIRE)--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 June 30, 2026, and recent highlights. "The second quarter marked a meaningful inflection point for Definium as we further established our leadership position in psychedelic medicine," said Rob Barrow, Chief Executive Officer of Definium Therapeutics. "The unprecedented Phase 3 Emerge results validated the highly differentiated profile of DT120 ODT and reinforced its potential to become a best-in-class treatment across multiple psychiatric disorders. We also continued to execute across our pipeline, completing enrollment in Voyage and Panorama and initiating enrollment in Ascend. Our public offering generated approximately $805 million in gross proceeds and provides the capital to advance our clinical and commercial strategy from a position of strength. We believe Definium is uniquely positioned to advance a potential new treatment paradigm across some of the field’s largest and most underserved indications." Business Updates Completed an underwritten public offering of 23,676,471 common shares of the Company for gross proceeds of $805 million. Net proceeds from the offering were approximately $757.9 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Launched Wired for Worry, a new healthcare provider disease education platform designed to deepen understanding of GAD, reinforce the importance of ongoing assessment, and help healthcare professionals better understand the neurobiological mechanisms that may contribute to the disorder. Program Status and Anticipated Milestones Announced positive topline results from Phase 3 Emerge study (MDD) with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Key findings included: Completed enrollment of Phase 3 Voyage study (GAD) with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data anticipated the week of August 10, 2026. Completed enrollment of Phase 3 Panorama study (GAD) with 245 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data anticipated in September 2026. Initiated enrollment of Phase 3 Ascend study (MDD). The trial is expected to enroll approximately 165 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data expected in 2027. Phase 3 Haven study in posttraumatic stress disorder (PTSD) is expected to initiate in 2027 and enroll approximately 200 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. The primary endpoint in the study is expected to be the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Investments. As of June 30, 2026, Definium Therapeutics had cash, cash equivalents and investments of approximately $1.1 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 June 30, 2026 will be sufficient to fund the Company’s operations into 2030. Research and Development (R&D). R&D expenses were $48.7 million for the three months ended June 30, 2026 compared to $29.8 million for the three months ended June 30, 2025, an increase of $18.9 million. The increase was primarily due to an increase of $12.9 million in expenses related to our DT120 program, an increase of $5.7 million in internal personnel costs as a result of increasing research and development capabilities, and an increase of $0.6 million in preclinical and other program expenses, partially offset by a decrease of $0.3 million in DT402 program expenses. General and Administrative (G&A). G&A expenses were $26.4 million for the three months ended June 30, 2026, compared to $11.1 million for the three months ended June 30, 2025, an increase of $15.3 million. The increase was primarily due to an increase of $7.6 million in stock-based compensation expenses, an increase of $2.6 million in corporate and government affairs expenses, an increase of $2.0 million in personnel-related expenses, an increase of $1.8 million in commercial-preparedness related expenses, an increase of $0.6 million in legal and patent expenses, and an increase of $0.7 million in other miscellaneous administrative expenses. Net loss. Net loss for the three months ended June 30, 2026 was significantly impacted by an $86.2 million non-cash increase in the fair value of warrant liabilities associated with the appreciation in the Company's share price during the period. Net loss for the three months ended June 30, 2026 was $159.0 million, compared to $42.7 million for the three months ended June 30, 2025. Conference Call and Webcast ReminderDefinium Therapeutics management will host a webcast at 4:30 p.m. EDT today to provide a corporate update and review the Company’s second quarter 2026 financial results and business highlights. Listeners can register for the webcast via this link. 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. About DT120 Orally Disintegrating Tablet (ODT)DT120 ODT (lysergide tartrate) is an ergoline derivative belonging to the group of classic serotonergic psychedelics which acts as a partial agonist at serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of 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 faster onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and lower incidence of gastrointestinal side effects. Definium is developing DT120, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and is exploring its potential applications in other serious brain health disorders. 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 Definium TherapeuticsThe 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 www.definiumtx.com and follow Definium Therapeutics on Instagram, LinkedIn and X. Forward-Looking StatementsCertain 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 become a best-in-class treatment across multiple psychiatric disorders; the Company’s anticipated topline readout (Part A results) for the Phase 3 Voyage study of DT120 ODT in GAD the week of August 10, 2026; the Company’s anticipated topline readout (Part A results) for the Phase 3 Panorama study for DT120 ODT in GAD in September 2026; 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 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 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 our 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; 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 and June 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806201575/en/ Contacts For further information, please contact: Investors: Gitanjali JainVP, Head of Investor [email protected] Media: [email protected]

DT120 was generally well tolerated, with most side effects mild to moderate and occurring mainly on the day of dosing, Definium said. Canaccord raised its price target on the stock, citing higher conviction in the DT120 program and said the major depressive disorder data also bode well for upcoming late-stage results in generalized anxiety disorder. In a separate announcement, Definium said it plans to sell $500 million of common shares and pre-funded warrants in an underwritten public offering. Shares of Definium Therapeutics Inc (DFTX) clocked their best day in over two years on Monday after the company announced positive results from a trial of its psychiatric program DT120. DFTX shares closed up 50% in the regular trading session, marking the best day since March 2024. However, shares slipped 5% after hours after the company announced a public offering of shares, raising dilution concerns. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox Definium Therapeutics announced positive topline results from its late-stage EMERGE study of DT120, an orally disintegrating tablet containing lysergide, in adults with major depressive disorder. A single 100-microgram dose produced rapid and lasting antidepressant effects that were significantly better than placebo. The trial enrolled 149 patients with moderate to severe depression. Those who received DT120 improved by an average of 13.3 points on the MADRS depression scale after six weeks, compared with 5.2 points for the placebo group — a statistically significant 8.1-point advantage. The benefit appeared within the first week and remained strong through 12 weeks. Patients taking DT120 were also more likely to respond to treatment and reach remission. DT120 was generally well tolerated, with most side effects mild to moderate and occurring mainly on the day of dosing. There were no serious safety issues or increase in suicidal thoughts, and patients were typically able to leave the clinic about six hours after taking the dose, the company said. Analysts responded positively to the company update. Canaccord Genuity raised its price target to $60 from $38 while maintaining a ‘Buy’ rating. The firm cited higher conviction in the DT120 program and said the major depressive disorder data also bode well for upcoming late-stage results in generalized anxiety disorder, describing the drug as “a very solid contender” with further room to run. RBC Capital Markets called the results “best-case” efficacy. The firm, which raised its price target to $57 from $36 and kept an Outperform rating, said the data meaningfully exceeded expectations, showed rapid onset and sustained benefit, and carried no new safety signals. RBC said the results significantly de-risk the major depressive disorder indication. Jefferies analyst Andrew Tsai, meanwhile, said the “robust” data show that a single dose of DT120 safely delivers rapid, strong, and durable benefits that beat all currently approved therapies. He noted further improvement is expected with repeat dosing and believes the stock could rise another 50% to 100%. Jefferies has a Buy rating and $35 price target on Definium. In a separate announcement, Definium said it plans to sell $500 million of common shares and pre-funded warrants in an underwritten public offering, with underwriters having a 30-day option for up to an additional $75 million. Proceeds will support research and development, potential commercialization of DT120, and general corporate purposes, the company said. On Stocktwits, retail sentiment around DFTX stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels. A Stocktwits user expressed concerns about an upcoming massive dilution. Another user, however, opined that Compass Pathways is a better bet than Definium, citing first-mover advantage. Compass is developing COMP360 to treat severe and treatment-resistant depression. DFTX stock has risen 169% year-to-date. Read More: Tesla Under Fresh Federal Scrutiny After Model 3 Crashes Into Home, Killing Woman For updates and corrections, email newsroom[at]stocktwits[dot]com. Anan Ashraf has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Tesla Under Fresh Scrutiny After Model 3 Crashes Into Home, Killing Woman — EV Giant Shrugs Off FSD Involvement Tesla Under Fresh Scrutiny After Model 3 Crashes Into Home, Killing Woman — EV Giant Shrugs Off FSD Involvement PFE Stock Reacts To Mixed Topline Results For Seagen-Origin Cancer Drug