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Mind Medicine (MindMed) Inc.

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

View on SEC.gov

About 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, 2025 · Filed Nov 6, 2025

DFTX$33.27+9.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-07-31.

0000950170-25-100925

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001193125-25-269596

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 113 current paragraphs.

75 unchanged; 25 reworded; 13 added; 5 removed; 2 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 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 (13)

Current report

We anticipate initiating a second Phase 3 clinical trial of MM120 ODT in MDD, Ascend (MM120-311), in mid-2026. Ascend is expected to have a similar design to Emerge, with a 12-week, randomized, double-blind, placebo-controlled, parallel group design assessing the efficacy and safety of MM120 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 MM120 ODT. Ascend is anticipated to enroll at least 175 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo). The primary endpoint is expected to remain the change from baseline in MADRS score at Week 6 between MM120 ODT 100 µg and placebo.

Current report

We anticipate initiating a Phase 2a trial of MM402 in ASD in the fourth quarter of 2025. This study is expected to be a single-dose, open-label study to assess early signals of efficacy of MM402 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 MM402 in adults with ASD, including on multiple functional biomarkers.

Current report

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., as representatives of the several underwriters named therein (the “Underwriters”), in connection with an underwritten public offering (the “October 2025 Offering”) of 18,375,000 of our common shares, without par value (“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 report

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, was 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 report

We intend to use the net proceeds from the October 2025 Offering to fund the research and development of our product candidates and working capital and general corporate purposes. We may also use a portion of the net proceeds to invest in or acquire additional businesses or compounds that we believe are complementary to our own, although we have no current plans, commitments or agreements with respect to any future acquisitions.

Current report

General and administrative expenses of $14.7 million for the three months ended September 30, 2025 increased by $7.1 million, or 93%, compared to $7.6 million for the three months ended September 30, 2024. The increase was primarily due to an increase of $3.0 million in personnel-related expenses, an increase of $2.0 million in commercial-preparedness related expenses, an increase of $1.6 million in corporate and government affairs expenses and an increase of $0.5 million in other miscellaneous administrative expenses.

Current report

General and administrative expenses of $34.6 million for the nine months ended September 30, 2025 increased by $6.7 million, or 24%, compared to $27.9 million for the nine months ended September 30, 2024. The increase was primarily due to an increase of $2.8 million in corporate affairs expenses, an increase of $2.1 million in commercial-preparedness related expenses, an increase of $1.7 million in personnel-related expenses and an increase of $0.7 million in other miscellaneous administrative expenses, offset by a decrease of $0.6 million in legal related expenses.

Current report

Other expense for the three months ended September 30, 2025 was $21.6 million, and other income for the three months ended September 30, 2024 was $11.1 million. The variance was primarily driven by a change in fair value of $30.9 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 June 30, 2025 to September 30, 2025.

Current report

On October 29, 2025, we entered into the Underwriting Agreement with the Underwriters, in connection with 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 report

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 report

We intend to use the net proceeds from the October 2025 Offering to fund the research and development of our product candidates and working capital and general corporate purposes. We may also use a portion of the net proceeds to invest in or acquire additional businesses or compounds that we believe are complementary to our own, although we have no current plans, commitments or agreements with respect to any future acquisitions.

Current 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.
Removed paragraphs (5)

Previous report

The Term Loans mature on April 1, 2029, provided that upon the occurrence of certain events the maturity date may be extended to October 1, 2029. The obligations of the Borrowers under the Amended Loan Agreement are secured by substantially all of the assets of the Borrowers, excluding intellectual property.

Previous report

Other than as described above, the proceeds of borrowings under the Amended Loan Agreement are expected to be used for working capital and other general corporate purposes and/or to further support commercial activities and/or business development opportunities. Once repaid, the Term Loans may not be reborrowed. For additional information, please refer to our Current Report on Form 8-K filed with the SEC on April 21, 2025.

Previous report

General and administrative expenses of $11.1 million for the three months ended June 30, 2025 increased by $1.3 million, or 13%, compared to $9.8 million for the three months ended June 30, 2024. The increase was primarily attributable to an increase in personnel-related expenses related to additional headcount.

Previous report

General and administrative expenses of $19.9 million for the six months ended June 30, 2025 decreased by $0.4 million, or 2%, compared to $20.3 million for the six months ended June 30, 2024. The decrease was primarily attributable to additional allocations of general and administrative expenses to research and development.

Previous report

Other expense of $1.8 million for the three months ended June 30, 2025 decreased by $20.4 million compared to other income of $18.6 million for the three months ended June 30, 2024. The decrease was primarily driven by a change in fair value on the 2022 USD Financing Warrants and increased interest expense which included the final payment of $1.7 million in connection with the Amended Loan Agreement and the refinancing of the existing Term Loans.
Reworded paragraphs (25)

Previous wording

Our first lead product candidate, MM120, is a proprietary, pharmaceutically optimized form of lysergide D-tartrate that we are developing for the treatment of generalized anxiety disorder ("GAD") and major depressive disorder (“MDD”). In December 2023, we announced positive topline results from our Phase 2b clinical trial of MM120 for the treatment of GAD. The trial met its primary endpoint, with MM120 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 MM120 program for the treatment of GAD. We also announced in March 2024 that our Phase 2b clinical trial of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12.

Current wording

Our first lead product candidate, MM120, is a proprietary, pharmaceutically optimized form of lysergide D-tartrate that we are developing for the treatment of generalized anxiety disorder ("GAD") and major depressive disorder (“MDD”). In December 2023, we announced positive topline results from our Phase 2b clinical trial of MM120 for the treatment of GAD. The trial met its primary endpoint, with MM120 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 MM120 program for the treatment of GAD. We also announced in March 2024 that our Phase 2b clinical trial of MM120 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 MM120 in GAD had been published in the Journal of the American Medical Association.

Previous wording

On June 20, 2024, we announced the completion of our End-of-Phase 2 meeting with the FDA, supporting the advancement of MM120 into pivotal trials for the treatment of adults with GAD. Our Phase 3 clinical program for MM120 orally disintegrating tablet (“ODT”) is expected to consist of two clinical trials: the Voyage study (MM120-300) and the Panorama study (MM120-301). 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 MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility. Voyage is anticipated to enroll approximately 200 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo) and Panorama is anticipated to enroll approximately 250 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo). We expect both trials will utilize an adaptive trial design with a blinded interim sample size re-estimation, allowing for an increase in sample size by up to 50% in each trial in the case of certain parameters. The primary endpoint for each trial is the change from baseline in HAM-A score at Week 12 between MM120 ODT 100 µg and placebo. On December 16, 2024, we announced the initiation of Voyage, with an anticipated topline readout (Part A results) in the first half of 2026. On January 30, 2025, we announced the initiation of Panorama, with an anticipated topline readout (Part A results) in the second half of 2026. Both trials are subject to ongoing regulatory review and discussions, which could result in changes to trial design, including of the Phase 3 clinical trials.

Current wording

On June 20, 2024, we announced the completion of our End-of-Phase 2 meeting with the FDA, supporting the advancement of MM120 into pivotal trials for the treatment of adults with GAD. Our Phase 3 clinical program for MM120 orally disintegrating tablet (“ODT”) is expected to consist of two clinical trials: the Voyage study (MM120-300) and the Panorama study (MM120-301). 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 MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility. Voyage is anticipated to enroll approximately 200 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo) and Panorama is anticipated to enroll approximately 250 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo). We expect both trials will utilize an adaptive trial design with a blinded interim sample size re-estimation, allowing for an increase in sample size by up to 50% in each trial in the case of certain parameters. The primary endpoint for each trial is the change from baseline in HAM-A score at Week 12 between MM120 ODT 100 µg and placebo. On December 16, 2024, we announced the initiation of Voyage, with an anticipated topline readout (Part A results) in the first half of 2026. On January 30, 2025, we announced the initiation of Panorama, with an anticipated topline readout (Part A results) in the second half of 2026. Both trials are subject to ongoing regulatory review and discussions, which could result in changes to trial design.

Previous wording

In addition to our Phase 3 clinical program for GAD, we are developing MM120 ODT for the treatment of 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 MM120 ODT in MDD and the trial design for our planned Emerge study (MM120-310), 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 MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility. Emerge is anticipated to enroll at least 140 participants (randomized 1:1 to receive MM120 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 MM120 ODT 100 µg and placebo. On April 15, 2025, we announced the initiation of Emerge, with an anticipated topline readout (Part A results) in the second half of 2026. We expect to conduct a second Phase 3 pivotal trial in MDD, with the trial design and timing to be informed by the progress from Emerge and additional regulatory discussions.

Current wording

In addition to our Phase 3 clinical program for GAD, we are developing MM120 ODT for the treatment of 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 MM120 ODT in MDD and the trial design for our planned Emerge study (MM120-310), 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 MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility. Emerge is anticipated to enroll at least 140 participants (randomized 1:1 to receive MM120 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 MM120 ODT 100 µg and placebo. On April 15, 2025, we announced the initiation of Emerge, with an anticipated topline readout (Part A results) in mid-2026.

Previous wording

Our second lead product candidate, MM402, also referred to as R(-)-MDMA, is our proprietary form of the R-enantiomer of 3,4-methylenedioxymethamphetamine (“MDMA”), which we are developing for the treatment of autism spectrum disorder (“ASD”). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical 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 MM402, 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 MM402. We expect to initiate further trials of MM402 for the treatment of ASD, with the exact timing and scope of such trials to be determined.

Current wording

Our second lead product candidate, MM402, also referred to as R(-)-MDMA, is our proprietary form of the R-enantiomer of 3,4-methylenedioxymethamphetamine (“MDMA”), which we are developing for the treatment of autism spectrum disorder (“ASD”). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical 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 MM402, 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 MM402.

Previous wording

Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $42.7 million and $66.1 million for the three and six months ended June 30, 2025, and $5.9 million and $60.3 million for the three and six months ended June 30, 2024. As of June 30, 2025, we had an accumulated deficit of $465.0 million and an aggregate of $237.9 million of cash, cash equivalents and investments.

Current wording

Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $67.3 million and $133.4 million for the three and nine months ended September 30, 2025, and $13.7 million and $73.9 million for the three and nine months ended September 30, 2024. As of September 30, 2025, we had an accumulated deficit of $532.2 million and an aggregate of $209.1 million of cash, cash equivalents and investments.

Previous wording

We may also incur in-process research and development expenses as we acquire or in-license assets from other parties. Technology acquisitions are expensed or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. Acquired in-process research and development costs that have no alternative future use are immediately expensed.

Current wording

We may also incur in-process research and development expenses when we acquire or in-license assets from other parties. Technology acquisitions are expensed or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. Acquired in-process research and development costs that have no alternative future use are immediately expensed.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Comparison of the Three and Nine months Ended September 30, 2025 and 2024

Previous wording

Research and development expenses of $29.8 million for the three months ended June 30, 2025 increased by $15.2 million, or 104%, compared to $14.6 million for the three months ended June 30, 2024. The increase was primarily due to increases of $14.5 million in expenses related to our MM120 program, an increase of $1.5 million in internal personnel costs as a result of increasing research and development capacities, an increase of $0.2 million in preclinical and other program expenses, partially offset by a decrease of $1.0 million in MM402 program expenses.

Current wording

Research and development expenses of $31.0 million for the three months ended September 30, 2025 increased by $13.8 million, or 80%, compared to $17.2 million for the three months ended September 30, 2024. The increase was primarily due to an increase of $11.7 million in expenses related to our MM120 program, an increase of $2.5 million in internal personnel costs as a result of increasing research and development capabilities, an increase of $0.2 million in preclinical and other program expenses, partially offset by a decrease of $0.6 million in MM402 program expenses.

Previous wording

Research and development expenses of $53.2 million for the six months ended June 30, 2025 increased by $26.8 million, or 102%, compared to $26.4 million for the six months ended June 30, 2024. The increase was primarily due to increases of $23.9 million in expenses related to our MM120 program, an increase of $3.9 million in internal personnel costs as a result of increasing research and development capacities, an increase of $0.3 million in expenses related to preclinical activities, partially offset by a decrease of $1.3 million in expenses related to our MM402 program.

Current wording

Research and development expenses of $84.1 million for the nine months ended September 30, 2025 increased by $40.6 million, or 93%, compared to $43.5 million for the nine months ended September 30, 2024. The increase was primarily due to an increase of $35.6 million in expenses related to our MM120 program, an increase of $6.4 million in internal personnel costs as a result of increasing research and development capabilities, an increase of $0.5 million in expenses related to preclinical activities, partially offset by a decrease of $1.9 million in expenses related to our MM402 program.

Previous wording

Other income of $7.0 million for the six months ended June 30, 2025, increased by $20.6 million compared to other expense of $13.6 million for the six months ended June 30, 2024. The increase was primarily driven by a change in fair value on the 2022 USD

Current wording

Other expense for the nine months ended September 30, 2025 was $14.6 million, and other expense for the nine months ended September 30, 2024 was $2.5 million. The variance was primarily driven by a change in fair value of $6.7 million on the 2022 USD

Previous wording

Financing Warrants, which was partially offset by the gain on extinguishment of contribution payable in 2024 and increased interest expense in 2025.

Current wording

Financing Warrants, increased interest expense of $2.6 million, and the impact from the $2.5 million gain on extinguishment of contribution payable in 2024.

Previous wording

Since inception, we have financed our operations primarily from the issuance of equity and debt under our Amended Loan Agreement. Our primary capital needs are for funds to support our scientific research and development activities including staffing, manufacturing, preclinical studies, clinical trials, administrative costs and for working capital.

Current wording

Since inception, we have financed our operations primarily from the issuance of equity and debt under our Amended Loan Agreement (as defined below). Our primary capital needs are for funds to support our scientific research and development activities including staffing, manufacturing, preclinical studies, clinical trials, administrative costs and for working capital.

Previous wording

Our cash, cash equivalents, and investments and our working capital at June 30, 2025, were $237.9 million and $151.2 million, respectively. Based on our current operating plan and anticipated R&D milestones, we believe that our cash, cash equivalents and investments as of June 30, 2025 will be sufficient to fund our operations into 2027 and at least 12 months beyond the first Phase 3 topline data readout for MM120 in GAD.

Current wording

Our cash, cash equivalents and investments and our working capital at September 30, 2025, were $209.1 million and $150.4 million, respectively. Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of September 30, 2025, along with the net proceeds of $242.8 million raised in the October 2025 Offering, will be sufficient to fund our operations into 2028.

Previous wording

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, no par value per share ("Common Shares), at an offering price of $6.00 per share, less underwriting discounts and commissions (the "March 2024 Offering").

Current wording

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 wording

We intend to use the net proceeds from the March 2024 Offering and the March 2024 Private Placement for (i) the research and development of our product candidates and (ii) working capital and general corporate purposes.

Current wording

We are using the net proceeds from the March 2024 Offering and the March 2024 Private Placement for the research and development of our product candidates and working capital and general corporate purposes.

Previous wording

We have no obligation to sell any of the ATM Shares and may, at any time suspend offers under the Sales Agreement or terminate the Sales Agreement.

Current wording

We have no obligation to sell any of the ATM Shares and may, at any time suspend offers under the Sales Agreement or terminate the Sales Agreement. We have not sold any Common Shares under the 2024 ATM as of September 30, 2025.

Previous wording

We intend to use the net proceeds from the August 2024 Offering to fund the research and development of our product candidates and for working capital and general corporate purposes.

Current wording

We are using the net proceeds from the August 2024 Offering to fund the research and development of our product candidates and for working capital and general corporate purposes.

Previous wording

On August 11, 2023, we entered into the Loan Agreement. On April 18, 2025, we entered into the Amended Loan Agreement. The Amended Loan Agreement provides for, among other things, an aggregate principal amount of Term Loans of up to $120.0 million, consisting of (A) a new Restatement First Tranche Term Loan (as defined in the Amended Loan Agreement) of $42.0 million, which was funded on the Effective Date, a portion of the proceeds of which was used on the Effective Date to refinance in full all term loans outstanding under the original Loan Agreement, and to pay fees and expenses in connection with the Amended Loan Agreement and the refinancing of the existing Term Loans, (B) subsequent tranches of Term Loans totaling up to $28.0 million, subject to the occurrence of certain time-based clinical and regulatory milestones and (C) an additional tranche of Term Loans of up to $50.0 million upon our request, subject to review by the Lenders of certain information from us and discretionary approval by the Lenders.

Current wording

On August 11, 2023, we entered into a Loan and Security Agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”) as administrative agent and Canadian collateral agent for lenders thereunder (K2HV, together with any other lender from time to time, the “Lenders”), and Ankura Trust Company, LLC, as collateral trustee for the Lenders, providing for an aggregate principal amount of term loans of up to $50.0 million (the “Term Loans”).. On April 18, 2025 (the “Effective Date”), we entered into the First Amendment to the Loan Agreement with K2HV (as amended by the First Amendment, the “Amended Loan Agreement”). The Amended Loan Agreement provides for, among other things, an aggregate principal amount of term loans of up to $120.0 million, consisting of (A) a new Restatement First Tranche Term Loan (as defined in the Amended Loan Agreement) of $42.0 million, which was funded on the Effective Date, a portion of the proceeds of which was used on the Effective Date to refinance in full all term loans outstanding under the original Loan Agreement, and to pay fees and expenses in connection with the Amended Loan Agreement and the refinancing of the existing term loans, (B) subsequent tranches of term loans totaling up to $28.0 million, subject to the occurrence of certain time-based clinical and regulatory milestones and (C) an additional tranche of term loans of up to $50.0 million upon our request, subject to review by the Lenders of certain information from us and discretionary approval by the Lenders.

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 at all, that will occur. 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 incident in 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 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:

Previous wording

Based on our current operating plan and anticipated R&D milestones, we believe that our cash, cash equivalents and investments as of June 30, 2025 will be sufficient to fund our operations into 2027 and at least 12 months beyond the first Phase 3 topline data readout for MM120 in GAD. 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 will be or 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 September 30, 2025, along with the net proceeds of $242.8 million raised in our October 2025 Offering, 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:

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 a change in fair value on the 2022 USD Financing Warrants liability of $4.8 million, accretion of discounts and premiums on investments, net of $2.4 million, offset by share-based compensation expense of $8.7 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 $13.7 million in our net operating assets and liabilities, and $31.1 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, share-based compensation expense of $14.5 million, change in fair value of DDSU of $1.0 million, offset by accretion of discounts and premiums on investments, net of $2.3 million.

Previous wording

Cash used in operating activities for the six months ended June 30, 2024 was $36.6 million, which consisted of a net loss of $60.3 million and a net change of $4.1 million in our net operating assets and liabilities, partially offset by $27.8 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 $19.4 million, share-based compensation of $9.7 million, unrealized foreign exchange of $0.5 million, and amortization of intangible assets of $0.5 million, partially offset by a gain on extinguishment of the contribution payable of $2.5 million.

Current wording

Cash used in operating activities for the nine months ended September 30, 2024 was $53.8 million, which consisted of a net loss of $73.9 million and a net change of $3.1 million in our net operating assets and liabilities, partially offset by $23.3 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 $11.1 million, share-based compensation of $13.0 million, unrealized foreign exchange of $0.5 million, and amortization of intangible assets of $0.5 million, change in fair value of DDSU of $0.5 million, partially offset by a gain on extinguishment of the contribution payable of $2.5 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 $75.7 million.

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

Cash provided by financing activities for the six months ended June 30, 2024 was $180.0 million, which consisted of $175.0 million of gross proceeds from the March Offering and Private Placement, $10.0 million proceeds from the Amended Loan Agreement, $4.4 million of proceeds from the exercise of the 2022 USD Financing Warrants, $1.0 million net proceeds from the Prior ATM, net of issuance costs, $0.6 million in proceeds from the exercise of options, partially offset by $10.8 million of issuance costs related to the March Offering and Private Placement, $0.1 million of our credit facility issuance costs and $0.1 million of withholding taxes paid on vested RSUs.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2024 was $249.4 million, which consisted of $175.0 million of gross proceeds from the March 2024 Offering and March 2024 Private Placement, $75.0 million in proceeds from the August 2024 Offering, $10.0 million proceeds from our credit facility, $4.4 million of proceeds from the exercise of the 2022 USD Financing Warrants, $1.0 million net proceeds from the 2022 ATM, net of issuance costs, and $0.7 million in proceeds from the exercise of options, partially offset by $11.1 million of issuance costs related to the March 2024 Offering and March 2024 Private Placement, $5.0 million of issuance costs related to the August 2024 Offering, $0.4 million payment of deferred financing fees related to the 2024 ATM, $0.1 million of our credit facility issuance costs and $0.1 million of withholding taxes paid on vested RSUs.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

On April 18, 2025 (the “Effective Date”), we and certain of our subsidiaries party thereto, as co-borrowers (together with us, the “Borrowers”), entered into the First Amendment to that certain Loan and Security Agreement, dated as of August 11, 2023, by and among the Borrowers, the lenders referred to therein (the “Lenders”), K2 HealthVentures LLC, as administrative agent and Canadian collateral agent for the Lenders, and Ankura Trust Company, LLC, as collateral trustee for the Lenders (as amended by the First Amendment, the “Amended Loan Agreement”).

Previous report — wording carried elsewhere

The Amended Loan Agreement provides for, among other things: (i) an aggregate principal amount of term loans (the “Term Loans”) of up to $120.0 million, consisting of (A) a new Restatement First Tranche Term Loan (as defined in the Amended Loan Agreement) of $42.0 million, which was funded on the Effective Date, a portion of the proceeds of which was used on the Effective Date to refinance in full all term loans outstanding under the original Loan Agreement, and to pay fees and expenses in connection with the Amended Loan Agreement and the refinancing of the existing term loans, (B) subsequent tranches of Term Loans totaling up to $28.0 million, subject to the occurrence of certain time-based clinical and regulatory milestones and (C) an additional tranche of Term Loans of up to $50.0 million upon our request, subject to review by the Lenders of certain information from us and discretionary approval by the Lenders, (ii) to the extent any Term Loans other than the Restatement First Tranche Term Loans are made during the term of the Amended Loan Agreement, a minimum liquidity covenant, beginning on the earlier to occur of (x) July 1, 2026 (which may be extended to July 1, 2027 to the extent we have achieved certain fundraising milestones) and (y) the date on which certain clinical and regulatory milestones are not achieved, which covenant shall be waived in any period where our market capitalization exceeds $500.0 million, (iii) a decrease in the interest rate applicable to all Term Loans under the Amended Loan Agreement to the greater of (x) 10.25% and (y) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) 2.75% per annum, and (iv) a conversion right at the election of the Lenders at any time following the Effective Date and prior to the full repayment of the Term Loans to convert up to $7.0 million of the outstanding Term Loans into our common shares (the “Conversion Shares”), at conversion prices ranging from $4.01 per Conversion Share to $9.00 per Conversion Share.