Definium Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 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.
Jun 30, 2026 · Filed Aug 6, 2026
DFTX$33.27+9.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-211989
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 107 previous paragraphs and 121 current paragraphs.
78 unchanged; 22 reworded; 17 added; 7 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 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 (17)
Current 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.
Current report
Recent Developments
Current report
Phase 3 Emerge Data
Current report
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 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).
Current report
Pre-specified primary endpoint
Current report
** Pre-specified key secondary endpoint
Current report
*** Pre-specified secondary endpoint
Current 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
Current 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.
Current report
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 report
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 report
ATM Program
Current report
October 2025 Offering
Current report
June 2026 Offering
Current report
K2 Credit Facility
Current report
On July 22, 2025, May 27, 2026 and June 25, 2026, under the terms of the Amended Loan Agreement, K2HV converted a total of $5.5 million of the outstanding term loans into 843,393 Common Shares. As of June 30, 2026, K2HV may convert up to an additional $1.5 million of the outstanding term loans into Common Shares at a conversion price of $9.00 per share.
Removed paragraphs (7)
Previous report
Other expense for the three months ended March 31, 2026 was $17.9 million, and other income for the three months ended March 31, 2025 was $8.8 million. The variance was primarily driven by a change in fair value of $20.0 million on the warrants to purchase Common Shares issued in our underwritten public offering that closed on September 30, 2022 (the “2022 USD Financing Warrants") due primarily to an increase in the Company's share price from December 31, 2025 to March 31, 2026.
Previous report
On March 7, 2024, we entered into an underwriting agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., as representatives of the underwriters named therein, in connection with the offering of 16,666,667 of our Common Shares, at an offering price of $6.00 per share, less underwriting discounts and commissions (the "March 2024 Offering").
Previous report
The net proceeds from the March 2024 Offering were approximately $93.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us.
Previous report
On March 7, 2024, we also entered into a securities purchase agreement with certain investors, pursuant to which such investors agreed to purchase, and we agreed to sell 12,500,000 Common Shares at a price of $6.00 per share, in a private placement (the "March 2024 Private Placement").
Previous report
The net proceeds from the March 2024 Private Placement were approximately $70.1 million, after deducting fees and expenses payable. The March 2024 Offering and the Private Placement both closed on March 11, 2024.
Previous report
On August 9, 2024, we entered into an underwriting agreement with Leerink Partners LLC and Evercore Group L.L.C., as representatives of the several underwriters named therein, in connection with an offering of (i) Common Shares, and (ii) to certain investors, pre-funded warrants to purchase Common Shares (the "August 2024 Offering"). The offering price for the common shares was $7.00 per share, less underwriting discounts and commissions. The offering price for the pre-funded warrants was $6.999 per pre-funded warrant, which represents the per share public offering price for the Common Shares less a $0.001 per share exercise price for each such pre-funded warrant.
Previous report
On July 4, 2025, the One Big Beautiful Bill Act was signed into law, which enacts significant changes to U.S. tax and related laws. Some of the provisions of the new tax law affecting corporations include but are not limited to current deduction of domestic research expenses, increasing the limit of the deduction of interest expense deduction to thirty percent of EBITDA, and one hundred percent bonus depreciation on eligible property acquired after January 19, 2025. There were no changes to our tax expense or effective income tax rate given our valuation allowance position.
Reworded paragraphs (22)
Previous wording
We are a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission 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. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes including DT120 and DT402, our lead product candidates.
Current wording
We are a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. Our mission 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. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes, including DT120 and DT402, respectively, our lead product candidates.
Previous wording
Our lead product candidate, DT120 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”). 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.
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 is expected to consist 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 is 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 randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg or placebo. We also announced that enrollment in Panorama exceeded the 200 participant target and that screening for Panorama has closed. 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 early third quarter 2026 and a topline readout (Part A results) for Panorama in late third quarter 2026.
Current 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.
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, we anticipate 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. We anticipate a topline readout (Part A results) in late second quarter 2026.
Current 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.
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 anticipate dosing to begin in the second quarter of 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 includes a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT. Ascend is anticipated to enroll approximately 175 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.
Current 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.
Previous wording
Beyond our clinical stage product candidates, we are exploring additional programs, including through external collaborations, which we seek to expand our drug development pipeline and broaden the potential applications of our lead product candidates. These research and development programs include nonclinical, preclinical and human clinical trials of current and new product candidates and research compounds with our collaborators.
Current wording
Beyond our clinical stage product candidates, we are exploring additional programs, including through external collaborations, which we seek to expand our drug development pipeline and broaden the potential applications of our lead product candidates. These research and development programs may include nonclinical, preclinical and human clinical trials of current and new product candidates and research compounds with our collaborators.
Previous wording
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 name change, we began trading on Nasdaq under the symbol “DFTX” on January 15, 2026.
Current wording
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 wording
Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $77.1 million and $23.3 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $659.8 million and cash, cash equivalents and investments of $373.4 million.
Current wording
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 wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Current wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Previous wording
Research and development expenses of $41.5 million for the three months ended March 31, 2026 increased by $18.1 million, or 78%, compared to $23.4 million for the three months ended March 31, 2025. The increase was primarily due to an increase of $15.2 million in expenses related to our DT120 program, an increase of $3.2 million in internal personnel costs as a result of increasing research and development capabilities, and an increase of $0.3 million in DT402 program expenses, partially offset by a decrease of $0.6 million in preclinical and other program expenses.
Current 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.
Previous wording
General and administrative expenses of $17.7 million for the three months ended March 31, 2026 increased by $8.9 million, or 101%, compared to $8.8 million for the three months ended March 31, 2025. The increase was primarily due to an increase of $3.9 million in stock-based compensation expenses, an increase of $1.4 million in personnel-related expenses, an increase of $1.4 million in commercial-preparedness related expenses, an increase of $1.4 million in corporate and government affairs expenses, and an increase of $1.2 million in legal and patent expenses, partially offset by a decrease of $0.4 million in other miscellaneous administrative expenses.
Current 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.
Previous wording
Our cash, cash equivalents and investments and our working capital at March 31, 2026, were $373.4 million and $299.5 million, respectively. Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of March 31, 2026 will be sufficient to fund our operations into 2028.
Current 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.
Previous wording
On October 29, 2025, we entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, Leerink Partners LLC and Evercore Group L.L.C. (the "Underwriters"), as representatives of the several underwriters named therein, in connection with an underwritten public offering (the "October 2025 Offering") of 18,375,000 Common Shares, at an offering price of $12.25 per Common Share, less underwriting discounts and commissions. 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 2,756,250 Common Shares at the same price, which was exercised by the Underwriters in full on October 30, 2025.
Current wording
On October 29, 2025, we entered into an underwriting agreement with Jefferies LLC, Leerink Partners LLC and Evercore Group L.L.C., as representatives of the several underwriters named therein, in connection with an underwritten public offering (the “October 2025 Offering”) of 18,375,000 Common Shares, at an offering price of $12.25 per Common Share, less underwriting discounts and commissions. 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 2,756,250 Common Shares at the same price, which was exercised by the underwriters in full on October 30, 2025.
Previous wording
The gross proceeds to us from the October 2025 Offering, including the full exercise by the Underwriters of their option to purchase additional Common Shares, were approximately $258.9 million. Net proceeds were approximately $242.8 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The October 2025 Offering closed on October 31, 2025.
Current wording
The gross proceeds to us from the October 2025 Offering, including the full exercise by the underwriters of their option to purchase additional Common Shares, were approximately $258.9 million. Net proceeds were approximately $242.8 million, after deducting underwriting discounts and commissions and other offering expenses payable by us.
Previous wording
The net proceeds from the August 2024 Offering were approximately $70.0 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. The August 2024 Offering closed on August 12, 2024.
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, 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.
Previous wording
To date, we have not generated any revenue. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if it will occur at all. We will continue to require substantial additional capital to develop our product candidates and to fund operations for the foreseeable future. Moreover, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the development of and seek regulatory approvals for our product candidates. Further, we are subject to all the risks incidental to the development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. Our expenses will increase if, and as, we:
Current wording
To date, we have not generated any revenue. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if it will occur at all. We will continue to require additional capital to develop our product candidates and to fund operations for the foreseeable future. Moreover, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the development of and seek regulatory approvals for our product candidates, as well as prepare for the potential commercialization of our product candidates. Further, we are subject to all the risks incidental to the development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. Our expenses will increase if, and as, we:
Previous wording
Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of March 31, 2026 will be sufficient to fund our operations into 2028. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties or from grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our Common Shares, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise funds through collaborations, strategic partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional funds or enter into such agreements or arrangements on favorable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts. We have based our projections of operating capital requirements on our current operating plan, which is based on several assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our working capital requirements. Our future funding requirements will depend on many factors, including:
Current wording
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. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we may require additional funding. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties or from grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our Common Shares, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise funds through collaborations, strategic partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional funds or enter into such agreements or arrangements on favorable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts. We have based our projections of operating capital requirements on our current operating plan, which is based on several assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our working capital requirements. Our future funding requirements will depend on many factors, including:
Previous wording
Cash used in operating activities for the three months ended March 31, 2026 was $42.6 million, which consisted of a net loss of $77.1 million, offset by a net change of $5.4 million in our net operating assets and liabilities, and $29.0 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 $20.0 million, share-based compensation expense of $7.1 million, change in fair value of DDSU of $1.0 million, and amortization of discounts and premiums on investments, net of $0.6 million.
Current 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.
Previous wording
Cash used in operating activities for the three months ended March 31, 2025 was $29.4 million, which consisted of a net loss of $23.3 million and a net change of $2.5 million in our net operating assets and liabilities, and $3.6 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 $7.0 million, and share-based compensation of $3.4 million.
Current 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.
Previous wording
Cash provided by investing activities for the three months ended March 31, 2026 consisted of maturities of investments of $42.0 million. Cash used in investing activities for the three months ended March 31, 2025 consisted of purchases of investments of $162.5 million.
Current 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.
Previous wording
Cash provided by financing activities for the three months ended March 31, 2026, was $5.3 million, which consisted of $3.8 million of proceeds from the exercise of certain of the 2022 USD Financing Warrants, $1.2 million in proceeds from the exercise of 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 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.
Previous wording
Cash provided by financing activities for the three months ended March 31, 2025 was $1.0 million, which consisted of $0.6 million of proceeds from the exercise of certain of the 2022 USD Financing Warrants, $0.2 million in proceeds from the exercise of options, and $0.2 million in proceeds from the issuance of Common Shares under the Employee Share Purchase Plan.
Current 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.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.