Definium Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
DFTX$35.39+6.4%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-338066
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001193125-26-453626
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 121 previous paragraphs and 118 current paragraphs.
75 unchanged; 28 reworded; 14 added; 18 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
DT120 ODT
Current report
Generalized Anxiety Disorder
Current report
On August 12, 2026, we announced that the Voyage study met its primary endpoint and all key secondary efficacy endpoints, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in HAM-A total score at Week 12. The Least Squares (“LS”) mean change from baseline in HAM-A total score at Week 12 in participants who received DT120 ODT 100 µg was -11.6 compared with -6.2 for participants who received placebo, an LS mean difference of -5.4 points (p<0.0001), corresponding to a standardized effect size of d=0.81. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A.
Current report
DT120 ODT 100 µg was generally well tolerated, with treatment-emergent adverse events (“TEAEs”) mild to moderate in severity, transient, and predominantly occurring on the day of dosing in Part A. No new safety signals were identified, including no suicidality signal or suicidal behavior. There were no drug-related serious adverse events in Part A. Overall discontinuation rates were similar between DT120 ODT 100 µg and placebo groups (10% and 12%). The overall TEAE rate for DT120 ODT 100 µg and placebo was 99% and 69%. The most common TEAEs (>10%) in the DT120 ODT 100 µg arm on dosing day were illusion (75%), nausea (38%), euphoric mood (26%) and headache (24%).
Current report
On September 14, 2026, we announced that the Panorama study met its primary endpoint and all key secondary efficacy endpoints, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in HAM-A total score at Week 12. The LS mean change from baseline in HAM-A total score at Week 12 in participants who received DT120 ODT 100 µg was -9.8 compared with -4.7 for participants who received placebo, an LS mean difference of -5.1 points (p<0.0001), corresponding to a standardized effect size of d=0.64. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A.
Current report
Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. Consistent with the dose-response profile demonstrated in our Phase 2b trial, for DT120 in GAD, DT120 ODT 50 µg demonstrated a placebo-adjusted change of -3.5 and -3.6 at weeks 4 and 12, approximately 50% and 29% lower than was observed for DT120 ODT 100 µg.
Current report
DT120 ODT 100 µg was generally well tolerated, with most TEAEs mild to moderate in severity, transient, and predominantly occurring on the day of dosing. No new safety signals were identified, including no suicidality signal or suicidal behavior. There were no drug-related serious adverse events in Part A. Overall discontinuation rates were similar between DT120 ODT 100 µg, DT120 50 µg, and placebo groups (10.4%, 11.5%, and 10.3%). The overall TEAE rate for DT120 ODT 100 µg, DT120 50 µg, and placebo was 94.8%, 96.1%, and 62.9%. The most common TEAEs (>10%) in the DT120 ODT 100 µg and 50 µg arms on dosing day were illusion (68%, 61%), nausea (37%, 26%), and headache (24%, 28%).
Current report
Major Depressive Disorder
Current report
In the Emerge study, DT120 ODT was generally well tolerated with 99% of TEAEs mild to moderate in severity, transient, and predominantly occurring on the day of dosing, and being consistent with expected acute effects of the study drug. No new safety signals were identified, including no suicidality signal or suicidal behavior. There were no drug-related serious adverse events in Part A. Overall discontinuation rates were similar between DT120 ODT 100 µg and placebo groups (15% and 18%). The overall TEAE rate for DT120 ODT 100 µg and placebo groups were 99% and 57%. The most common TEAEs (>10%) in the DT120 ODT 100 µg arm on dosing day were illusion (48%), euphoric mood (29%), and nausea (27%).
Current report
Posttraumatic Stress Disorder
Current report
DT402
Current report
In the fourth quarter of 2025, we initiated a Phase 2a trial of DT402 in adults with ASD. The 200 mg single-dose, single arm, open-label study enrolled five participants and 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 the initial findings observed in these participants, we ended enrollment in the Phase 2a study and now plan to further evaluate DT402 in a study that will investigate the safety and clinical activity of multiple dosing paradigms, which is expected to begin in 2027.
Current report
Pipeline
Current report
Our Product Pipeline
Removed paragraphs (18)
Previous report
We initiated a Phase 2a trial of DT402 in ASD in the fourth quarter of 2025. This study is a single-dose, open-label study to assess early signals of efficacy of DT402 in treating core socialization and communication symptoms in adults with ASD. This study is anticipated to enroll up to 20 participants. The objectives and endpoints of the study are designed to characterize the pharmacodynamics and clinical effects of DT402 in adults with ASD, including on multiple functional measures. We anticipate initial data from our Phase 2a study in 2026.
Previous report
As previously disclosed, in April 2020, we entered into a License and Collaboration Agreement (the “License Agreement”) with Dr. Matthias Liechti’s lab (the “Liechti Lab”) at the University Hospital Basel (“UHB”), a leading pharmacology and clinical research group studying psychedelic substances based in Basel, Switzerland. Pursuant to the License Agreement, we acquired exclusive worldwide rights to data, compounds, and patent rights associated with the Liechti Lab’s research with lysergide and other psychedelic compounds, including data from preclinical studies and completed or ongoing clinical trials of lysergide and MDMA. In exchange, UHB was entitled to receive milestone payments and royalties on commercially marketed products developed through the collaboration, subject to certain terms and conditions. In June 2026, we terminated the License Agreement. As part of the termination, we received a non-exclusive, worldwide, fully paid-up license to the applicable data, compounds, and patent rights. In addition, there are no future milestone or royalty payments owed to UHB.
Previous report
On January 9, 2026, we changed our corporate name from Mind Medicine (MindMed) Inc. to Definium Therapeutics, Inc. On January 12, 2026, we changed the name of our wholly-owned subsidiary from Mind Medicine, Inc. to Definium Therapeutics US, Inc. In connection with our rebrand, we changed our trading symbol on Nasdaq to “DFTX” on January 15, 2026.
Previous report
We were incorporated under the laws of the Province of British Columbia, Canada in 2010. Our wholly-owned subsidiary, Definium Therapeutics US, Inc. (“Definium US”), was incorporated in the State of Delaware, United States in 2019. Prior to February 27, 2020, our operations were conducted through Definium US.
Previous report
Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $236.1 million and $66.1 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $818.8 million and cash, cash equivalents and investments of approximately $1.1 billion.
Previous report
Our Product Candidate Pipeline
Previous report
1.Formerly known as MM120; USAN: lysergide tartrate.
Previous report
2.Formerly known as MM402.
Previous report
3.Full trial details and clinicaltrials.gov links available at definiumtx.com/clinical-digital-trials/
Previous report
4.Studies in exploration and/or planning stage.
Previous report
Recent Developments
Previous report
Phase 3 Emerge Data
Previous report
The mean baseline MADRS score at study entry was 35.0 in the DT120 ODT treatment group (n=75) and 34.0 in the placebo ODT group (n=74).
Previous report
Pre-specified primary endpoint
Previous report
** Pre-specified key secondary endpoint
Previous report
*** Pre-specified secondary endpoint
Previous report
CGI-S = Clinical Global Impressions — Severity Scale; LS = least squares; LS mean difference = difference in LS means of change from baseline between DT120 ODT and placebo groups
Previous report
In the Emerge study, DT120 ODT was generally well tolerated with 99% of treatment-emergent adverse events mild to moderate in severity, transient, and predominantly occurring on the day of dosing, and being consistent with expected acute effects of the study drug. The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, feeling of relaxation, abnormal thinking, headache, paresthesia, dizziness, nausea, crying, disorientation, emotional disorder, blood pressure increase, feeling of body temperature change and feeling abnormal.
Reworded paragraphs (28)
Previous wording
The following discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report. This Quarterly Report, including the following sections, contains forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see Item 1A “Risk Factors” in our 2025 Annual Report and this Quarterly Report. See also “Special Note Regarding Forward-Looking Statements.” We caution the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Quarterly Report. We undertake no obligation to update forward-looking statements, which reflect events or circumstances occurring after the date of this Quarterly Report, except as required by law.
Current wording
The following discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q (this "Quarterly Report"). This Quarterly Report, including the following sections, contains forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 (the "2025 Annual Report") and this Quarterly Report. See also “Special Note Regarding Forward-Looking Statements.” We caution the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Quarterly Report. We undertake no obligation to update forward-looking statements, which reflect events or circumstances occurring after the date of this Quarterly Report, except as required by law.
Previous wording
Our lead product candidate, DT120 (Lysergide) orally disintegrating tablet (“ODT”), is a proprietary, pharmaceutically optimized form of lysergide D-tartrate that we are developing for the treatment of adults with generalized anxiety disorder (“GAD”), major depressive disorder (“MDD”) and posttraumatic stress disorder (“PTSD”). In December 2023, we announced positive topline results from our Phase 2b clinical trial of DT120 for the treatment of GAD. The trial met its primary endpoint, with DT120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety Rating Scale (“HAM-A”) compared to placebo at Week 4. In March 2024, we announced that the U.S. Food and Drug Administration (“FDA”) granted breakthrough designation to our DT120 program for the treatment of GAD. We also announced in March 2024 that our Phase 2b clinical trial of DT120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12. In September 2025, we announced that the full results from our Phase 2b clinical trial of DT120 in GAD had been published in the Journal of the American Medical Association.
Current wording
Our lead product candidate, DT120 (Lysergide) orally disintegrating tablet (“ODT”), is a proprietary, pharmaceutically optimized form of lysergide D-tartrate that we are developing for the treatment of adults with generalized anxiety disorder (“GAD”), major depressive disorder (“MDD”) and posttraumatic stress disorder (“PTSD”).
Previous wording
In June 2024, we announced the completion of our End-of-Phase 2 meeting with the FDA, supporting the advancement of DT120 ODT into pivotal trials for the treatment of adults with GAD. Our Phase 3 clinical program for DT120 ODT consists of two clinical trials: the Voyage study (DT120-300) and the Panorama study (DT120-301). Both trials are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. Both trials use an adaptive trial design with a blinded interim sample size re-estimation (“SSRE”), allowing for an increase in sample size by up to 50% in each trial or, in the case of Panorama, a decrease in sample size, depending on the observed values for certain nuisance parameters. In February 2026, we announced that the SSRE for Voyage has been completed and it was determined that no increase in the sample size of the trial was required. In April 2026, we announced that Voyage was fully enrolled with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. In April 2026, we also announced that the SSRE for Panorama has been completed and it was determined that the sample size of the trial would be updated to a target of 200 participants. Panorama is fully enrolled with 245 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg or placebo. The primary endpoint for each trial is the change from baseline in HAM-A score at Week 12 between DT120 ODT 100 µg and placebo. We anticipate a topline readout (Part A results) for Voyage in mid-August 2026 and a topline readout (Part A results) for Panorama in September 2026.
Current wording
Our Phase 3 clinical program for DT120 ODT for GAD consists of two clinical trials: the Voyage study (DT120-300) and the Panorama study (DT120-301). Both trials are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. The primary endpoint for each trial is the change from baseline on the Hamilton Anxiety Rating Scale (“HAM-A”) at Week 12 between DT120 ODT 100 µg and placebo.
Previous wording
In addition to our Phase 3 clinical program for GAD, we are developing DT120 ODT for the treatment of adults with MDD. In the first quarter of 2024, we held a pre-IND meeting with FDA to discuss the initiation of our Phase 3 clinical program for DT120 ODT in MDD and the trial design for the Emerge study (DT120-310), which like our pivotal trials in GAD, will be comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. Emerge is fully enrolled with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. The primary endpoint is the change from baseline in Montgomery Åsberg Depression Rating Scale (“MADRS”) score at Week 6 between DT120 ODT 100 µg and placebo. In June 2026, we announced topline data (Part A results) for Emerge, which is described below under Recent Developments.
Current wording
In addition to our Phase 3 clinical program for GAD, we are developing DT120 ODT for the treatment of adults with MDD. Our Phase 3 clinical program for MDD consists of two clinical trials: the Emerge study (DT120-310) and the Ascend study (DT120-311). Both trials are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. The primary endpoint is the change from baseline in Montgomery Asberg Depression Rating Scale (“MADRS”) score at Week 6 between DT120 ODT 100 µg and placebo. In September 2026, we announced that the FDA granted breakthrough designation to our DT120 program for the treatment of MDD.
Previous wording
On June 22, 2026, we announced that the Emerge study of DT120 ODT for the treatment of MDD met its primary and all key secondary efficacy endpoints, demonstrating a statistically significant (p<0.0001) and clinically meaningful improvement from baseline compared with placebo, as measured by the change in MADRS total score at week 6. Least Squares (“LS”) mean change from baseline in MADRS total score at Week 6 in participants who received DT120 ODT 100 µg was -13.3 compared with -5.2 for patients who received placebo (LS mean difference -8.1 points; p<0.0001).
Current wording
On June 22, 2026, we announced that the Emerge study met its primary and all key secondary efficacy endpoints, demonstrating a statistically significant (p<0.0001) and clinically meaningful improvement from baseline compared with placebo, as measured by the change in MADRS total score at week 6. LS mean change from baseline in MADRS total score at Week 6 in participants who received DT120 ODT 100 µg was -13.3 compared with -5.2 for patients who received placebo (LS mean difference -8.1 points; p<0.0001).
Previous wording
We activated the initial sites in our second Phase 3 clinical trial of DT120 ODT in MDD, Ascend (DT120-311), in the first quarter of 2026 and announced that the first patient was dosed in May 2026. Ascend has a similar design to Emerge, with a 12-week, randomized, double-blind, placebo-controlled, parallel group design assessing the efficacy and safety of DT120 ODT versus placebo (Part A); and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT. Ascend is anticipated to enroll approximately 165 participants (randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg or placebo). The primary endpoint is the change from baseline in MADRS score at Week 6 between DT120 ODT 100 µg and placebo. We anticipate a topline readout (Part A results) for Ascend in 2027.
Current wording
We also activated sites in our Ascend study in the first quarter of 2026 and announced that the first patient was dosed in May 2026. Ascend is anticipated to enroll approximately 165 participants (randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg or placebo). The primary endpoint is the change from baseline in MADRS score at Week 6 between DT120 ODT 100 µg and placebo. We anticipate a topline readout (Part A results) for Ascend in 2027.
Previous wording
Our second lead product candidate, DT402, also referred to as R(-)-MDMA, is our proprietary form of the R-enantiomer of 3,4-methylenedioxymethamphetamine, which we are developing for the treatment of adults with 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 studies of R(-)-MDMA demonstrated its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggests that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. In October 2024, we completed our first clinical trial of DT402, a single-ascending dose trial in adult healthy volunteers. The data from this Phase 1 clinical trial helped to characterize the tolerability, pharmacokinetics and pharmacodynamics of DT402.
Current wording
Our second lead product candidate, DT402, also referred to as R(-)-MDMA, is our proprietary form of the R-enantiomer of 3,4-methylenedioxymethamphetamine, which we are developing for the treatment of adults with 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 studies of R(-)-MDMA demonstrated its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggests that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. In October 2024, we completed our first clinical trial of DT402, a single-ascending dose trial in adult healthy volunteers. The data from this Phase 1 clinical trial helped to characterize the tolerability, pharmacokinetics and pharmacodynamics of DT402.
Previous wording
Our business is premised on a growing body of research supporting the use of novel psychoactive compounds to treat a myriad of brain health disorders. For all product candidates, we intend to proceed through research and development, and with marketing of the product candidates that may ultimately be approved pursuant to the regulations of the FDA and the regulations in other jurisdictions. This entails, among other things, conducting clinical trials with research scientists, using internal and external clinical drug development teams, producing and supplying product candidates according to current Good Manufacturing Practices (“cGMP”), and conducting all trials and development in accordance with the regulations of the FDA, and other regulations in other jurisdictions.
Current wording
Our business is premised on a growing body of research supporting the use of novel psychoactive compounds to treat a myriad of brain health disorders. For all product candidates, we intend to proceed through research and development, and with marketing of the product candidates that may ultimately be approved pursuant to the regulations of the FDA and the regulations in other jurisdictions. This entails, among other things, conducting clinical trials with research scientists, using internal and external clinical drug development teams, producing and supplying product candidates according to current Good Manufacturing Practices, and conducting all trials and development in accordance with the regulations of the FDA, and other regulations in other jurisdictions.
Previous wording
The following table summarizes the status of our portfolio of product candidates:
Current wording
The following table summarizes the status of our lead product candidates:
Previous wording
We expect our research and development expenses to increase throughout 2026 as we continue the clinical development of our product candidates and other preclinical programs in GAD, MDD and PTSD and other potential or future indications, including initiating additional and larger clinical trials.
Current wording
We expect our research and development expenses to increase throughout 2026 as we continue the clinical development of our product candidates and other preclinical programs in GAD, MDD, PTSD and ASD and other potential or future indications, including initiating additional and larger clinical trials.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Current wording
Comparison of the Three and Nine Months Ended September 30, 2026 and 2025
Previous wording
Research and development expenses of $48.7 million for the three months ended June 30, 2026 increased by $18.9 million, or 63%, compared to $29.8 million for the three months ended June 30, 2025. 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.
Current wording
Research and development expenses of $46.1 million for the three months ended September 30, 2026 increased by $15.1 million, or 49%, compared to $31.0 million for the three months ended September 30, 2025. The increase was primarily due to an increase of $8.8 million in internal personnel costs associated with the expansion of our research and development organization, $5.9 million in expenses related to our DT120 development programs, and an increase of $0.6 million in preclinical and other program expenses, partially offset by a decrease of $0.2 million in DT402 program expenses.
Previous wording
Research and development expenses of $90.1 million for the six months ended June 30, 2026 increased by $36.9 million, or 70%, compared to $53.2 million for the six months ended June 30, 2025. The increase was primarily due to an increase of $28.2 million in expenses related to our DT120 programs, and an increase of $8.9 million in internal personnel costs as a result of increasing research and development capabilities, partially offset by a decrease of $0.1 million in DT402 program expenses and a $0.1 million in preclinical and other program expenses.
Current wording
Research and development expenses of $136.3 million for the nine months ended September 30, 2026 increased by $52.1 million, or 62%, compared to $84.2 million for the nine months ended September 30, 2025. The increase was primarily due to an increase of $34.1 million in expenses related to our DT120 development programs, an increase of $17.7 million in internal personnel costs associated with the expansion of our research and development organization, and an increase of $0.5 million in preclinical and other program expenses, partially offset by a decrease of $0.2 million in DT402 program expenses.
Previous wording
General and administrative expenses of $26.4 million for the three months ended June 30, 2026 increased by $15.3 million, or 138%, compared to $11.1 million for the three months ended June 30, 2025. 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.
Current wording
General and administrative expenses of $26.1 million for the three months ended September 30, 2026 increased by $11.4 million, or 78%, compared to $14.7 million for the three months ended September 30, 2025. The increase was primarily due to increases of $3.5 million in corporate and government affairs expenses, $3.4 million in commercial-preparedness related expenses, $3.3 million in personnel-related expenses as we expanded our organizational capabilities, $0.7 million in legal and patent expenses, $0.4 million in other miscellaneous administrative expenses, and $0.1 million in stock-based compensation expenses.
Previous wording
General and administrative expenses of $44.1 million for the six months ended June 30, 2026 increased by $24.2 million, or 122%, compared to $19.9 million for the six months ended June 30, 2025. The increase was primarily due to an increase of $11.5 million in stock-based compensation expenses, an increase of $4.0 million in corporate and government affairs expenses, an increase of $3.4 million in personnel-related expenses, an increase of $3.2 million in commercial-preparedness related expenses, an increase of $1.8 million in legal and patent expenses, and an increase of $0.3 million in other miscellaneous administrative expenses.
Current wording
General and administrative expenses of $70.3 million for the nine months ended September 30, 2026 increased by $35.7 million, or 103%, compared to $34.6 million for the nine months ended September 30, 2025. The increase was primarily due to increases of $11.6 million in stock-based compensation expenses, $7.4 million in corporate and government affairs expense, $6.8 million in personnel-related expenses as we expanded our organizational capabilities, $6.6 million in commercial-preparedness related expenses, $2.5 million in legal and patent expenses, and $0.8 million in other miscellaneous administrative expenses.
Previous wording
Other expense for the three months ended June 30, 2026 and 2025 was $83.9 million and $1.8 million, respectively. The variance was primarily attributable to an $84.0 million change in the fair value of the 2022 USD Financing Warrants, driven largely by the increase in our share price from $18.90 at March 31, 2026 to $47.04 at June 30, 2026.
Current wording
Other income for the three months ended September 30, 2026 was $21.3 million compared to other expense for the three months ended September 30, 2025 of $21.6 million. The variance was primarily attributable to an $34.9 million change in the fair value of the 2022 USD Financing Warrants, driven largely by the decrease in our share price from $47.04 at June 30, 2026 to $38.06 at September 30, 2026.
Previous wording
Other expense for the six months ended June 30, 2026 and June 30, 2025 was $101.8 million and $7.0 million, respectively. The variance was primarily attributable to an $111.1 million change in the fair value of the 2022 USD Financing Warrants, driven largely by the increase in our share price from $13.39 at December 31, 2025 to $47.04 at June 30, 2026.
Current wording
Other expense for the nine months ended September 30, 2026 and September 30, 2025 was $80.5 million and $14.6 million, respectively. The variance was primarily attributable to an $76.2 million change in the fair value of the 2022 USD Financing Warrants, driven largely by the increase in our share price from $13.39 at December 31, 2025 to $38.06 at September 30, 2026.
Previous wording
Our cash, cash equivalents and investments and our working capital at June 30, 2026, were approximately $1.1 billion and $934.9 million, respectively. Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of June 30, 2026 will be sufficient to fund our operations into 2030.
Current wording
Our cash, cash equivalents and investments and our working capital at September 30, 2026, were approximately $1.0 billion and $984.0 million, respectively. Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of September 30, 2026 will be sufficient to fund our operations into 2030.
Previous wording
On June 28, 2024, we entered into a sales agreement with Leerink Partners LLC (the “Sales Agreement”) to create an at-the-market equity program under which we from time to time may offer and sell the ATM Shares (as defined below), through or to the Agent. We also filed a prospectus supplement on June 28, 2024 allowing for up to $150.0 million of Common Shares (the “ATM Shares”) to be sold under the Sales Agreement.
Current wording
On June 28, 2024, we entered into a sales agreement (the "Sales Agreement") with Leerink Partners LLC (the “Agent”) to create an at-the-market equity program under which we from time to time may offer and sell the ATM Shares (as defined below), through or to the Agent. We also filed a prospectus supplement on June 28, 2024 allowing for up to $150.0 million of Common Shares (the “ATM Shares”) to be sold under the Sales Agreement.
Previous wording
On June 23, 2026, we entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC, Jefferies LLC, Leerink Partners LLC, and BofA Securities, Inc., as representatives of the several underwriters named therein (the “Underwriters”), in connection with an underwritten public offering (the “June 2026 Offering”) of 20,588,236 Common Shares. The public offering price was $34.00 per Common Share. In addition, under the terms of the Underwriting Agreement, we granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 3,088,235 Common Shares at the same price, which was exercised by the Underwriters in full on June 24, 2026.
Current wording
On June 23, 2026, we entered into an underwriting agreement with J.P. Morgan Securities LLC, Jefferies LLC, Leerink Partners LLC, and BofA Securities, Inc., as representatives of the several underwriters named therein, in connection with an underwritten public offering (the “June 2026 Offering”) of 20,588,236 Common Shares, at an offering price of $34.00 per Common Share. In addition, under the terms of the underwriting agreement, we granted the underwriters an option, exercisable for 30 days, to purchase up to an additional 3,088,235 Common Shares at the same price, which was exercised by the underwriters in full on June 24, 2026.
Previous wording
The gross proceeds to us from the June 2026 Offering, including the full exercise by the Underwriters of their option to purchase additional Common Shares, was approximately $805 million. Net proceeds were approximately $757.9 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
Current wording
The gross proceeds to us from the June 2026 Offering, including the full exercise by the underwriters of their option to purchase additional Common Shares, were approximately $805 million. Net proceeds were approximately $757.9 million, after deducting underwriting discounts and commissions and other offering expenses payable by us.
Previous wording
Cash used in operating activities for the six months ended June 30, 2025 was $59.0 million, which consisted of a net loss of $66.1 million, offset by a net change of $5.6 million in our net operating assets and liabilities, and $1.5 million in non-cash charges. The non-cash charges primarily consisted of share-based compensation of $8.7 million, offset by a change in fair value on the 2022 USD Financing Warrants liability of $4.8 million and accretion of discount on investments, net of $2.4 million.
Current wording
Cash used in operating activities for the nine months ended September 30, 2026 was $148.4 million, which consisted of a net loss of $287.0 million, offset by a net change of $14.6 million in our net operating assets and liabilities, and $124.0 million in non-cash charges. The non-cash charges primarily consisted of a change in fair value on the 2022 USD Financing Warrants liability of $93.9 million, stock-based compensation expense of $27.5 million, change in fair value of DDSU of $4.9 million, offset by accretion of discount on investments, net of $3.0 million.
Previous wording
Cash used in operating activities for the six months ended June 30, 2026 was $95.4 million, which consisted of a net loss of $236.1 million, offset by a net change of $11.7 million in our net operating assets and liabilities, and $128.9 million in non-cash charges. The non-cash charges primarily consisted of a change in fair value on the 2022 USD Financing Warrants liability of $106.3 million, share-based compensation expense of $16.8 million, change in fair value of DDSU of $6.2 million, and accretion of discount on investments, net of $0.8 million.
Current wording
Cash used in operating activities for the nine months ended September 30, 2025 was $88.6 million, which consisted of a net loss of $133.4 million, offset by a net change of $11.7 million in our net operating assets and liabilities, and $33.1 million in non-cash charges. The non-cash charges primarily consisted of a change in fair value on the 2022 USD Financing Warrants liability of $17.8 million, stock-based compensation expense of $14.5 million, change in fair value of DDSU of $1.0 million, offset by accretion of discount on investments, net of $0.3 million.
Previous wording
Cash used in investing activities for the six months ended June 30, 2026 consisted of purchases of investments of $355.7 million, offset by maturities of investments of $81.0 million.
Current wording
Cash used in investing activities for the nine months ended September 30, 2026 consisted of purchases of investments of $798.5 million, offset by maturities of investments of $151.0 million.
Previous wording
Cash used in investing activities for the six months ended June 30, 2025 consisted of purchases of investments of $235.7 million, offset by maturities of investments of $33.8 million.
Current wording
Cash used in investing activities for the nine months ended September 30, 2025 consisted of purchases of investments of $262.3 million, offset by maturities of investments of $75.8 million.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2026, was $767.6 million, which consisted of $758.6 million of net proceeds from the June 2026 Offering, $6.7 million of proceeds from the exercise of certain of the 2022 USD Financing Warrants, $2.1 million in proceeds from the exercise of stock options, and $0.3 million in proceeds from the issuance of Common Shares under the Employee Share Purchase Plan.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2026, was $779.2 million, which consisted of $758.7 million of net proceeds from the June 2026 Offering, $15.2 million of proceeds from the exercise of certain of the 2022 USD Financing Warrants, $4.6 million in proceeds from the exercise of stock options, and $0.7 million in proceeds from the issuance of Common Shares under the Employee Share Purchase Plan.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2025 was $20.7 million, which consisted of $20.0 million in net proceeds from the Amended Loan Agreement, $0.6 million of proceeds from the exercise of the 2022 USD Financing Warrants, $0.3 million in proceeds from the exercise of options, $0.2 million in proceeds from the issuance of Common Shares under the ESPP, partially offset by $0.4 million of Amended Loan Agreement issuance costs.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2025, was $21.4 million, which consisted of $20.0 million in net proceeds from the Amended Loan Agreement, $1.0 million of proceeds from the exercise of the 2022 USD Financing Warrants, $0.4 million in proceeds from the exercise of options, $0.4 million in proceeds from the issuance of Common Shares under the Employee Share Purchase Plan, partially offset by $0.4 million of Amended Loan Agreement issuance costs.
Previous wording
See Note 2 to our unaudited condensed consolidated financial statements located in “Part I – Financial Information, Item 1. Notes to Condensed Consolidated Financial Statements” in this Quarterly Report for a description of recent accounting pronouncements applicable to our financial statements.
Current wording
See Note 2 to our unaudited condensed consolidated financial statements located in “Part I – Financial Information, Item 1. Notes to Condensed Consolidated Financial Statements” in the Quarterly Report for a description of recent accounting pronouncements applicable to our financial statements.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
In March 2024, we announced that the U.S. Food and Drug Administration (“FDA”) granted breakthrough designation to our DT120 program for the treatment of GAD. In September 2025, we announced that the full results from our Phase 2b clinical trial of DT120 in GAD had been published in the Journal of the American Medical Association.