DFTX 10-K & 10-Q changes, risk factors and insider trading

We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We commenced operations in 2019, have no products approved for commercial sale and have not generated any revenue. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. Our most advanced development candidate is MM120DT120 ODT. We initiated our Phase 3 clinical program in GAD in December 2024 and we anticipate initiatinginitiated our Phase 3 clinical program in MDD in the first half ofApril 2025.

We have not yet demonstrated our ability to successfully initiate and complete any pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer operating history.

establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates for which we may obtain regulatory approval, including MM120DT120 and MM402DT402;

seek additional indications for our product candidates and discover and develop any future product candidates, including product candidates in our digital medicine pipeline;

pursue necessary scheduling-related decisions to enable us to commercialize any future product candidates containing controlled substances for which we may obtain regulatory approval, including our MM120DT120 and MM402DT402 product candidates;

In August 2023, we entered into a Loan and Security Agreement (the “Loan Agreement”) with K2HV, as administrative agent and Canadian collateral agent for lenders thereunder (K2HV, and any other lender from time to time, the “Lenders”), and Ankura Trust Company, LLC, as collateral trustee for the Lenders. At closing, we borrowed $15.0 million in the first tranche under the Loan Agreement, and the second milestone-based tranche of $10.0 million was achieved and funded in the second quarter of 2024. We may borrow an additional $10.0 million based upon the achievement of certain time-based, clinical and regulatory milestones, and an additional $15.0 million upon our request, subject to review by the Lenders of certain information from us and discretionary approval by the Lenders. Our obligations under the Loan Agreement are secured by a security interest in substantially all of our assets, other than certain intellectual property assets. The Loan Agreement includes customary affirmative and negative covenants, as well as standard events of default, including an event of default based on the occurrence of a material adverse event. The negative covenants include, among others, restrictions on us transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying cash dividends or making other distributions, making investments, creating liens, selling assets and making any payment on subordinated debt, in each case subject to certain exceptions. These restrictive covenants could limit our flexibility in operating our business and our ability to pursue business opportunities that we or our shareholders may consider beneficial. In addition, the Lenders could declare a default upon the occurrence of any event that it interprets could have material adverse effect, subject to the limitations specified in the Amended Loan Agreement. Upon the occurrence and continuance of an event of default, the Lenders may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Amended Loan Agreement. Any declaration of an event of default could significantly harm our business and prospects and could cause the price of our common shares to decline. If we are liquidated, the rights of the Lenders to repayment would be senior to the rights of the holders of our common shares to receive any proceeds from the liquidation. We may not have enough available cash or be able to raise additional funds through equity or debt financings to repay these outstanding obligations at the time any event of default occurs. Further, if we raise any additional capital through debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.

successful and timely completion of preclinical and clinical development of MM120,DT120, MM402DT402 and our other product candidates;

establishing and maintaining relationships with CROs and clinical sites for the clinical development of MM120,DT120, MM402DT402 and our other product candidates;

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval for our product candidates and advance our other programs. Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations if we are required by the FDA or other comparable foreign authorities to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of any product candidate we develop. We are not permitted to market or promote MM120,DT120, MM402DT402 or any other product candidate before we receive marketing approval from the FDA or other comparable foreign authorities. Accordingly, we will need to obtain substantial additional funding in order to continue our operations.

As of December 31, 2024,2025, we had $273.7$411.6 million in cash, cash equivalents and cash equivalents.investments. Based on our current operating plan and anticipated R&D milestones, we expect our cash runway to extendfund atour leastoperations 12into months beyond the first Phase 3 topline data readout for MM120 ODT in GAD.2028. Our estimate as to how long we expect our existing cash to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

the time and costs involved in obtaining regulatory approval for our product candidates, and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to our product candidates (such as MM120DT120 and MM402DT402) or any other product candidates;

We expect our expenses to increase in connection with our planned operations. Unless and until we can generate a substantial amount of revenue from our product candidates, we expect to finance our future cash needs through a combination of public and private equity offerings, debt financings, strategic partnerships, sales of assets and licensing arrangements. We, and indirectly, our shareholders, will bear the cost of issuing and servicing any such securities and of entering into and maintaining any such strategic partnerships or other arrangements. Because any decision by us to issue debt or equity securities in the future will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future financing transactions. Subject to certain rules of the Nasdaq Stock Market (“Nasdaq”), theour Board of Directors has the authority to authorize certain offers and sales of additional securities without the vote of, or prior notice to, shareholders. Based on the need for additional capital to fund expected expenditures and growth, it is likely that we will issue additional securities to provide such capital. Such additional issuances may involve the issuance of a significant number of common shares at prices less than the current market price for the common shares. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve additional restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating and financing restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term, but may also limit our potential cash flow and revenue in the future. If we raise additional funds through strategic partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses or other rights on unfavorable terms.

We currently have no products that are approved for commercial sale, and we may never be able to develop marketable products. We expect that a substantial portion of our efforts and expenditures over the next several years will be devoted to the development of our product candidates. Accordingly, our business currently depends on the successful regulatory approval of our product candidates and the commercialization of our product candidates if they receive regulatory approval. We cannot be certain that MM120,DT120, MM402,DT402, or any of our other product candidates will receive regulatory approval or that our product candidates will be successfully commercialized even if they receive regulatory approval. If we are required to discontinue development of our product candidates, or if MM120DT120 or MM402DT402 does not receive regulatory approval or failsfail to achieve significant market acceptance, we would be delayed by many years in our ability to achieve profitability, if ever.

acceptance of our product candidates benefits and uses, if approved, by patients, the medical community and third-party payors, and overcoming potential public controversy regarding our product candidates containing ScheduledSchedule I substances;

Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and special requirements for distribution, importation, and exportation. Pharmaceutical products approved for medicinal use in the United States may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances. Even if approved by the FDA, prescribing and dispensing of a controlled substance is subject to restrictions, with heightened restrictions for Schedule II controlled substances. For example, prescriptions for a Schedule II drug may not be refilled without a new prescription. Further, most, if not all, state laws in the United States classify lysergide and MDMA as Schedule I controlled substances. Commercial marketing in the United States will also require state scheduling-related legislative or administrative action.

Scheduling determinations by the DEA are often dependent on FDA approval of a substance or a specific formulation of a substance. Therefore, while lysergide and MDMA are Schedule I controlled substances, products approved by the FDA for medical use in the United States that contain lysergide and/or MDMA must be descheduled or rescheduled to Schedules II-V, since approval by the FDA satisfies the “accepted medical use” requirement. If MM120DT120 and MM402DT402 receive FDA approval, HHS and the DEA must complete a scheduling analysis and make a scheduling determination to deschedule or place either the substance or the drug product in a schedule other than Schedule I in order for them to be able to be prescribed to patients in the United States. This scheduling determination will be dependent on FDA approval and the HHS’s recommendation as to the appropriate schedule under the CSA. The rescheduling process requires the DEA to conduct notice-and-comment rulemaking, including issuing an interim final rule 90 days after the later of notice of FDA approval or DEA receipt of the HHS scheduling analysis and recommendation. Such action will be subject to public comment and requests for hearing. Even assuming our product candidates are controlled in Schedule II or lower at the federal level, such substances or products may require separate rescheduling or descheduling determinations under state laws and regulations.

Manufacture in the United States. If, we were to conduct manufacturing or repackaging/relabeling in the United States, our contract manufacturers would be subject to the DEA’s annual manufacturing and procurement quota requirements. Additionally, regardless of the scheduling of our product candidates if approved, the active ingredient in the final dosage form is currently a Schedule I controlled substance and would be subject to such quotas as these substances could remain listed on Schedule I. The annual quota allocated to us or our contract manufacturers for the active ingredient in MM120,DT120, MM402,DT402, or any other product candidate, may not be sufficient to complete clinical trials or meet potential future commercial demand. Consequently, any delay or refusal by the DEA in establishing our, or our contract manufacturers’, procurement and/or production quota for controlled substances could delay or stop our clinical trials or product launches, which could have a material adverse effect on our business, financial position and results of operations.

Distribution in the United States. If our product candidates are scheduled as Schedule II, III or IV, we would also need to identify wholesale distributors with the appropriate DEA registrations and authority to distribute our product candidates. These distributors would need to obtain Schedule II, III or IV distribution registrations. This limitation in the ability to distribute our product candidates more broadly may limit commercial uptake and could negatively impact our prospects. The failure to obtain, or delay in obtaining, or the loss of any of those registrations could result in increased costs to us. If our product candidates are Schedule II drugs, participants in our supply chain may have to maintain enhanced security with alarms and monitoring systems and they may be required to adhere to recordkeeping and inventory requirements. This may discourage some pharmacies from carrying the product. In addition, our product candidates will likely be determined to have a high potential for abuse and therefore required to be administered at our trial sites, which could limit commercial update.uptake. Furthermore, state and federal enforcement actions, regulatory requirements, and legislation intended to reduce prescription drug abuse, such as the requirement that physicians consult a state prescription drug monitoring program, may make physicians less willing to prescribe, and pharmacies to dispense, Schedule II products.

Product candidates containing controlled substances have generated public controversy. Political and social pressures and adverse publicity could lead to delays in approval of, and increased expenses for, our product candidates. Anti-psychedelic protests have historically occurred and may occur in the future and generate media coverage.   Opponents of these product candidatescandidates, which may include regulators, may seek to prevent orapprovals, restrict marketing or demand withdrawal of any regulatory approvals. In addition, these opponents may generate negative publicity in an effort to persuade the medical community to reject these product candidates. For example, we may face media-communicated criticism directed at our clinical development program. In addition, adverse publicity related to lysergide or MDMA, or any other substance that underlies our product candidates or fall into the same drug or chemical class, which may be referred to as psychoactive or psychedelic drugs, may result from political or social opposition to controlled substances, misuse and abuse of controlled substances recreationally, or clinical trial conduct, including abuse by investigators. Adverse publicity of not only our product candidates, but also any similar controlled substances, may affect our clinical trials, potential regulatory approval, and the commercial success or market penetration achievable by our product candidates. For example, Resilient (formerly Lykos Therapeutics,Therapeutics), another company developing a drug product candidate containing MDMA, recentlyhas faced significant public scrutiny and adverse publicity following negative public statements and allegations about clinical trial conduct made by clinical trial participants. Public controversy over the misuse or abuse potential of our or our competitor’s product candidates may also harm our ability to recruit and retain clinical trial participants, negatively influence the recommendations of an FDA Advisory Committee, and/or result in the FDA requesting additional data related to the abuse potential of our product candidates, which could lead to delays in approval and increased research and development costs for our product candidates. Even if our product candidates are approved by the FDA, political pressures and adverse publicity could lead to delays in, and increased expenses for, and limit or restrict the introduction and marketing of, our product candidates.

delays in or failure to obtain regulatory approval to commence or modify a trial, including the imposition of a temporary or permanent clinical hold by regulatory authorities for a number of reasons, including after review of an Investigational New Drug Application (“IND”),IND, or amendment, clinical trial application (“CTA”), or amendment, or equivalent application or amendment, as a result of a finding that the trial presents unreasonable risk to clinical trial participants or a negative finding from an inspection of our clinical trial operations or study sites, or the occurrence of a suspected, unexpected serious adverse reaction (“SUSAR”), or serious adverse reaction (“SAE”), during our clinical trials or IITs, using our product candidates;

delays in our clinical trials related to public health crises like the COVID-19 pandemic,crises, due to factors such as a decrease in the willingness or availability of patients to enroll in our clinical trials and challenges in procuring sufficient supplies of the underlying therapeutic substance;

We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted or ethics committees, by the Data Review Committee (the “DRC”), or Data Safety Monitoring Board for such trial, as applicable, or by the FDA or other regulatory authorities or if the DEA registration of an investigator or site conducting the clinical trial is revoked. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, including any SUSARs or SAEs which have in the past or may in the future occur in our trials or any IITs or other studies using lysergide, MDMA and any other substance that underlies our product candidates and those relating to the class to which lysergide, MDMA and other Schedule I controlled substances or any other product candidates belong, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience delays in the completion of, or termination of, any clinical trial of MM120,DT120, MM402DT402 or any other product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate revenue from any such product candidates will be delayed. In addition, any delays in completing our clinical trials will likely increase our costs, slow down MM120,DT120, MM402DT402 or any other product candidate development and approval process and jeopardize our ability to commence sales and generate revenue. Moreover, if we make changes to our product candidates, we may need to conduct additional bioequivalence studies to bridge such modified product candidates to earlier versions, which could delay our clinical development plan or marketing approval for our product candidates. Significant preclinical and clinical trial delays could also allow our competitors to bring therapies to market before we do or shorten any periods during which we have the exclusive right to commercialize our product candidates and impair our ability to commercialize our product candidates and may harm our business and results of operations.

Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of MM120,DT120, MM402,DT402, or any other product candidates that we may identify and pursue, which would prevent, delay or limit the scope of regulatory approval and commercialization.

We cannot be certain that our clinical trials will be successful. Clinical trials that we conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market our product candidates. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. If the results of our clinical trials are inconclusive with respect to the efficacy of MM120,DT120, MM402DT402 and any other product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with MM120,DT120, MM402DT402 and any other product candidates, we may be delayed in obtaining marketing approval, or we may never obtain marketing approval. Any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of MM120,DT120, MM402DT402 and any other product candidates in those and other indications, which could have a material adverse effect on our business, financial condition and results of operations.

Even if our clinical trials are successfully completed, preclinical and clinical data are often susceptible to varying interpretations and analyses and we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do. Accordingly, more trials could be required before we submit any product candidates for approval. In addition, the FDA or other foreign regulatory authorities may change their recommendations for clinical trial conduct, such as for assessing abuse potential, like hallucinations, or the use of psychological support or psychotherapy in combination with a product candidate, for our product candidates or their drug class through regulation, guidance, or informal communications at any time, especially as drug development in this area increases. Because clinical trials take a significant period of time, we cannot assure that our trial design will comply with future FDA recommendations for clinical investigations involving psychedelic drugs. We may have already initiated or completed our clinical trials, and may need to amend our study protocol or conduct additional clinical trials as a result, which could be costly and time-consuming, and may significantly delay or limit our ability to commercialize our product candidates. For example, the FDA issued a draft guidance in June 2023 outlining clinical considerations for psychedelic drugs. There can be no assurances that the FDA will not change its recommendations in a revised guidance or final guidance, or issue a new draft guidance that could affect our development programs. To the extent that the results of the trials are not satisfactory to the FDA or comparable foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. Due to the inherent risk in the development of product substances, there is a significant likelihood that MM120,DT120, MM402DT402 and any other product candidates will not successfully complete development and receive approval. Many other companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval for the marketing of their product candidates. If we do not receive regulatory approvals for MM120,DT120, MM402DT402 or any other product candidates, we may not be able to continue our operations. Even if regulatory approval is secured for MM120,DT120, MM402DT402 or any other product candidate, the terms of such approval may limit the scope and use of a specific product candidate, which may also limit its commercial potential.

Changes in our formulation or components of MM120our formulation of DT120 or DT402 could have a material adverse effect on our business, financial condition and results of operations.

InChanges in our Phaseformulation 2or clinicalcomponents trialsof for MM120, we used aour formulation of MM120our thatproduct didcandidates, notincluding includeexcipients, ODTsalt technology.forms, Inpolymorphic 2024, we completed a pharmacokinetics (“PK”) bridging study to support the advancement of the MM120 ODT formulation into pivotal clinical trials,forms, and we are using the MM120 ODT formulation in our Phase 3 clinical trials for GAD and MDD. This change in formulationpackaging, could cause MM120our product candidates to perform differently, cause unforeseen side effects or affect the results of our Phase 3 clinical trials. This could delay completion of our Phase 3 clinical trials, require the conduct of additional bridging clinical trials or the repetition ofrepeat one or more clinical trials, increase clinical trial costs or delay or prevent the submission, or approval, of one or more NDAsproduct for MM120.candidates. Such delays and costs could jeopardize our ability to, if approved, commercialize MM120our forproduct GAD, MDD or other future indications,candidates, which could have a material adverse effect on our business, financial condition and results of operations.

Further, others, including regulatory agencies and independent organizations evaluating prescription drugs, such as the Institute for Clinical and Economic Review (“ICER”), may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate and our company in general, and regulatory agencies may request further data from us. In addition, you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize MM120,DT120, MM402DT402 or any other product candidate, our business, operating results, prospects or financial condition may be harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities to set approval policies and data requirements. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. Given the limited recent experience with clinical use of psychedelic drugs, it is likely the regulatory landscape will evolve, and could do so rapidly. We cannot guarantee that we will be able toto, or have the resources to adapt to changes in regulatory requirements. We have not obtained regulatory approval for any of our product candidates. It is possible that none of our product candidates will ever obtain regulatory approval.

the FDA or other comparable foreign regulatory authorities may determine that MM120,DT120, MM402DT402 or any other product candidates are not safe and effective, only moderately effective, or have undesirable or unintended side effects, toxicities, or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;

This lengthy approval process, the unpredictability of future clinical trial results, and the potential influence of public opinion may result in our failing to obtain regulatory approval to market any product candidates, which would significantly harm our business, results of operations and prospects. The FDA and other comparable foreign authorities have substantial discretion in the approval process, including the data required for regulatory approval, and determining when or whether regulatory approval will be obtained for any of our product candidates. Even if we believe the data collected from clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority. If MM120,DT120, MM402DT402 or any other product candidates fails to obtain approval on the basis of any applicable condensed regulatory approval process (such as priority review in the US), this will prevent such product candidate from obtaining approval on a shortened time frame, or at all, resulting in increased expenses which would materially harm our business.

Even if MM120,DT120, MM402DT402 or any other product candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, any such product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

If the FDA or a comparable foreign regulatory authority approves MM120,DT120, MM402DT402 or any other product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the product candidates and underlying product substance will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP, and with good clinical practices (“GCPs”),GCPs, for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such product candidates. Additionally, a company may not promote “off-label” uses for its drug products. An off-label use is the use of a product for an indication that is not described in the product’s FDA-approved label in the U.S. or for uses in other jurisdictions that differ from those approved by the applicable regulatory agencies. Physicians, on the other hand, may prescribe products for off-label uses. Although the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued. Later discovery of previously unknown problems with any approved product candidate, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

restrictions on the labeling, distribution, marketing or manufacturing of MM120,DT120, MM402DT402 or any other product candidates, withdrawal of such products from the market, or product recalls;

In addition, any regulatory approvals that we receive for MM120,DT120, MM402DT402 or any other product candidates may also be subject to limitations on the approved indicated uses for which the product candidates may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase IV clinical trials, and surveillance to monitor the safety and efficacy of such product candidates. For instance, we believe that MM120,DT120, if approved, would be subject to a Risk Evaluation and Mitigation Strategy (“REMS”) program, under the applicable FDA regulations and similar risk mitigation programs in other jurisdictions. REMS programs are costly and time-consuming for providers to comply with, involving high administrative burden, which could delay or limit our ability to commercialize our product candidates.

If there are changes in the application of legislation, regulations or regulatory policies, or if problems are discovered with our product candidates or our manufacture of an underlying product substance, or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulators could take various actions. These include imposing fines on us, imposing restrictions on the product or its manufacture and requiring us to recall or remove the product from the market. The regulators could also suspend or withdraw our marketing authorizations, require us to conduct additional clinical trials, change our product labeling or submit additional applications for marketing authorization. If any of these events occurs,occur, our ability to sell such product candidates may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could materially adversely affect our business, financial condition and results of operations.

Our product candidates may have serious adverse, undesirable or unacceptable side effects which may delay or prevent marketing approval. If such side effects are identified during the development of MM120,DT120, MM402DT402 or any other product candidates or following approval, if any, we may need to abandon our development or commercialization of such product candidates, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences.

Undesirable side effects that may be caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials or result in clinical holds and could result in a more restrictive label, a requirement that we implement a REMS plan to ensure that the benefits of the product candidates outweigh its risks, or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. We or regulatory authorities may also learn of and take similar actions based on side effects related to MM120,DT120, MM402,DT402, any other product candidates, or similar compounds in studies not conducted by us, including in IITs or studies conducted by other sponsors, from spontaneous reports of use of these compounds outside of the clinical trial setting or from safety reports in literature.

The results of future clinical trials may show that MM120,DT120, MM402DT402 or any other product candidates cause undesirable or unacceptable side effects or even death. There can be no assurance that deaths or serious side effects will not occur, even in a clinical setting. In the event serious side effects occur, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of MM120,DT120, MM402DT402 or any other product candidates for any or all targeted indications. Nonclinical toxicology studies may also delay or limit clinical development, for example, by limiting the dosing duration and dose interval in clinical trials. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Further, because of the high variability in how different individuals react to lysergide, certain patients may have negative experiences with the treatment that could subject us to liability or, if publicized, reputational harm. Any of these occurrences may harm our business, financial condition and prospects significantly.

Clinical trials are conducted in representative samples of the potential patient population which may have significant variability. Even if we receive regulatory approval for MM120,DT120, MM402DT402 or any other product candidates, we will have tested them in only a limited number of patients during our clinical trials. Clinical trials are by design based on a limited number of patients and of limited duration for exposure to the product candidates used to determine whether, on a potentially statistically significant basis, the planned safety and efficacy of any such product candidate can be achieved. As with the results of any statistical sampling, we cannot be sure that all side effects of MM120,DT120, MM402DT402 or any other product candidates may be uncovered, and it may be the case that only with a significantly larger number of patients exposed to such product candidate for a longer duration, may a more complete safety profile be identified. Further, even larger clinical trials may not identify rare serious adverse effects or the duration of such trials may not be sufficient to identify when those events may occur.

Even if we obtain FDA approval for MM120,DT120, MM402DT402 or any other product candidates, we may never obtain approval to commercialize any such product candidates outside of the United States, which would limit our ability to realize their full market potential.

Due to the complexity of the human brain and the central nervous system, it can be difficult to predict and understand why a drug, including MM120,DT120, MM402DT402 or any other product candidates, may have a positive effect on some patients but not others and why some individuals may react to the drug differently from others. Moreover, most of the patients we treat in clinical trials with MM120DT120 and MM110 (prior to when we paused development of MM110) have previously been treated with other drugs or therapies. All of these factors may make it difficult for us and any regulatory authority to assess the prior use or the overall efficacy of our product candidates, including MM120DT120 and MM402,DT402, and may result in the termination of a development program, or delay or limit our ability to obtain regulatory approval.

In addition, any negative results we may report in clinical trials of MM120,DT120, MM402DT402 or any other product candidates or results from companies investigating similar product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials of that same product candidate. Delays in the enrollment for any clinical trial of MM120,DT120, MM402DT402 or any other product candidates will likely increase our costs, slow down the approval process and delay or potentially jeopardize our ability to commence sales of our product candidates and generate revenue. In addition, some of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of MM120,DT120, MM402DT402 or any other product candidates.

our inability to train an adequate number of HCPs to meet the demand for psychedelic treatment sessions (including with MM120DT120 and any other product candidate within the therapeutic class);

the inability of commercial personnel to obtain access to or educate adequate numbers of physicians on the benefits of prescribing MM120,DT120, MM402DT402 or any other product candidates, if and when they are approved;

If we enter into arrangements with third parties to perform market access and commercial services for any approved product candidates, the revenue or the profitability of these revenues to us could be lower than if we were to commercialize any product candidates that we develop ourselves. Such collaborative arrangements may place the commercialization of any approved product candidates outside of our control and would make us subject to a number of risks including that we may not be able to control the amount or timing of resources that our collaborative partner devotes to our product candidates or that our collaborator’s willingness or ability to complete its obligations, and our obligations under our arrangements may be adversely affected by business combinations or significant changes in our collaborator’s business strategy. We may not be successful in entering into arrangements with third parties to commercialize our product candidates or may be unable to do so on terms that are favorable to us. Acceptable third parties may fail to devote the necessary resources and attention to commercialize our product candidates effectively, to set up sufficient number of treatment centers in third-party treatment sites, or to recruit, train and retain adequate number of HCPs to administer our product candidates. In addition, we are exploring ways in which we can use digital technology to improve the patient experience and product outcomes of our product candidates. Commercialization partners may lack incentives to promote our digital technology and we may face difficulties in implementing our digital technologies in third-party treatment sites through such third parties.

any restrictions on the use, sale or distribution of our product candidates, including through a REMS program; the extent to which product candidates are approved for inclusion and reimbursed on formularies of hospitals and managed care organizations; and whether our product candidates are designated under physician treatment guidelines or under reimbursement guidelines as a first-line, second-line, third-line or last-line product candidate.

We are a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to beforge a new era of psychiatry by applying scientific rigor to psychedelics, with the global leader in the development and deliverygoal of developing accessible treatments for brain health disorders that unlock newhealing opportunitiesat to improve patient outcomes. We are developing a pipeline of innovative product candidates targeting neurotransmitter pathways that play key roles in brain health disorders.scale. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes including MM120DT120 and MM402,DT402, our lead product candidates.

Our lead product candidate, MM120,DT120 ODT, is a proprietary, pharmaceutically optimized form of lysergide D-tartrate that we are developing for the treatment of adults with generalized anxiety disorder and major depressive disorder ("MDD").disorder. In December 2023, we announced positive topline results from our Phase 2b clinical trial of MM120DT120 for the treatment of GAD. The trial met its primary endpoint, with MM120DT120 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 MM120DT120 program for the treatment of GAD. We also announced in March 2024 that our Phase 2b clinical trial of MM120DT120 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.

On June 20, 2024, we announced the completion of our End-of-Phase 2 meeting with the FDA, supporting the advancement of MM120DT120 into pivotal trials for the treatment of adults with GAD. Our Phase 3 clinical program for MM120DT120 orally disintegrating tablet (“ODT”) is expected to consist of two clinical trials: the Voyage study (MM120-300DT120-300) and the Panorama study (MM120-301DT120-301). 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 MM120DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120DT120 ODT, subject to certain conditions for treatment eligibility. Voyage is anticipated to enroll approximately 200 participants (randomized 1:1 to receive MM120DT120 ODT 100 µg or placebo) and Panorama is anticipated to enroll approximately 250 participants (randomized 2:1:2 to receive MM120DT120 ODT 100 µg, MM120DT120 ODT 50 µg or placebo). We expect bothBoth trials will utilizeuse an adaptive trial design with a blinded interim sample size re-estimation,re-estimation (“SSRE”), allowing for an increase in sample size by up to 50% in each trial depending on the observed values for certain nuisance parameters. The SSRE for Voyage has been completed and it was determined that no increase in the casesample size of certainthe parameters.trial is required. The primary endpoint for each trial is the change from baseline in HAM-A score at Week 12 between MM120DT120 ODT 100 µg and placebo. OnIn December 16, 2024, we announced the initiation of Voyage, withand anwe anticipatedanticipate a topline readout (Part A results) in theearly firstthird half ofquarter 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.

In addition to our Phase 3 clinical program for GAD, we are developing MM120DT120 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 MM120DT120 ODT in MDD and the trial design for our plannedthe Emerge study (MM120-310DT120-310), 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 MM120DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120DT120 ODT, subject to certain conditions for treatment eligibility. Emerge is anticipatedfully toenrolled enrollwith at least 140149 participants (randomized 1:1 to receive MM120DT120 ODT 100 µg or placebo).placebo. The primary endpoint is the change from baseline in Montgomery Åsberg Depression Rating Scale ("MADRS") score at Week 6 between MM120DT120 ODT 100 µg and placebo. WeIn expectApril to2025, initiatewe Emerge inannounced the first halfinitiation of 2025Emerge, withand anwe anticipatedanticipate a topline readout (Part A results) in thelate second half ofquarter 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.

Our second lead product candidate, MM402,DT402, also referred to as R(-)-MDMA, is our proprietary form of the R-enantiomer of 3,4-methylenedioxymethamphetamine (“MDMA”),3,4-methylenedioxymethamphetamine, which we are developing for the treatment of autismadults spectrumwith disorder (“ASD”).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,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 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.DT402.

We were incorporated under the laws of the Province of British Columbia in 2010. Our wholly-owned subsidiary, MindDefinium Medicine,Therapeutics US, Inc. (“MindMedDefinium US”), was incorporated in Delaware in 2019. Prior to February 27, 2020, our operations were conducted through MindMedDefinium US.

Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $183.8 million for the year ended December 31, 2025, and $108.7 million for the year ended December 31, 2024, and $95.7 million for the year ended December 31, 2023.2024. As of December 31, 2024,2025, we had an accumulated deficit of $398.9$582.7 million and cash andcash, cash equivalents and investments of $273.7$411.6 million.

We expect our research and development expenses to increase forin the foreseeable future2026 as we continue the clinical development of our product candidates and other preclinical programs in GAD and MDD and other potential or future indications, including initiating additional and larger clinical trials.

Research and development expenses increased by $13.2$52.4 millionmillion, or 80%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The increase was primarily due to an increase of $11.4$44.7 million in expenses related to our MM120DT120 program supportingwhich thehas advancement intoongoing pivotal trials for the treatment of adults with GAD. The MM120 program completed a phase 2b trial in the first half of 2024,GAD and has incurred increased expenses in relation to the initiation of phase 3 trials.MDD. Additionally, there was an increase of $2.1 million in expenses related to our MM402 program driven by progress in phase 1 studies, and an increase of $2.7$9.3 million in internal personnel costs as a result of increasing research and development capacities,capacities and an increase of $0.4 million in preclinical and other program expenses. Such expenses were partially offset by a decrease of $3.0$2.0 million in expenses related to preclinicalour activities.DT402 program driven primarily by lower expenses while we worked on the commencement of our Phase 2a trial which initiated in the fourth quarter of 2025.

General and administrative expenses decreasedincreased by $3.1$10.0 millionmillion, or 26%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The decreaseincrease was primarily attributable to decreasedan increase of $6.0 million in professional services feesand pre-commercialization activities, an increase of $3.6 million in internal personnel costs to support expanded operational activities, an increase of $0.7 million in directors' deferred share unit ("DDSU") expenses due to an increase in the stock price year over year, and expenses$0.5 duringmillion thein yearmiscellaneous endedgeneral Decemberand 31,administrative 2024, partiallyexpenses, offset by increaseda stock-baseddecrease compensationof expense$0.8 million in legal and pre-commercializationpatent activitiesrelated during the year ended December 31, 2024.expenses.

Interest income increaseddecreased by $6.0$0.6 million for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. ThisThe decrease was primarily due to lower average interest earned on our cash and cash equivalents as a result of increased balances heldrates in cash2025 and cash equivalents during the year ended December 31,versus 2024.

Interest expense increased by $1.4$3.2 million for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. ThisInterest wasexpense is primarily due to interest expense related to our credit facility entered into onin August 11,2023 2023.and amended in April 2025. Interest expense in 2025 was higher than 2024 due to a larger outstanding balance on the credit facility and a $1.7 million final payment associated with the amendment.

Foreign Exchange (Loss)/Gain,Loss, Net

Foreign exchange loss increaseddecreased by $0.8$0.5 million for the year ended December 31, 20242025 compared to the year ended December 31, 2023,2024, the increasedecrease was primarily due to unfavorablefavorable changes in foreign exchange rates during the year ended December 31, 2024.2025.

Revaluation loss on the 2022 USD Financing Warrants liability was $15.9$22.8 million and $6.6$15.9 million for the years ended December 31, 20242025 and 2023,2024, respectively. Change in fair value of 2022 USD Financing Warrants consists of revaluation gains and losses attributed to the change in the fair value of our 2022 USD Financing Warrants that were issued as part of our public equity offering which closed on September 30, 2022. Losses primarily reflect higher share prices and accordingly, increased warrant liability values, at the applicable year ends.

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

Our cash andcash, cash equivalents and investments and our working capital at December 31, 20242025 was $273.7$411.6 million and $242.8$352.6 million, respectively. We believe that our cash and cash equivalents as of December 31, 2024 will be sufficient to fund our operations into 2027. Based on our current operating plan and anticipated R&D milestones, we expectbelieve that our cash, cash runwayequivalents and investments as of December 31, 2025 will be sufficient to extendfund atour leastoperations 12into months beyond the first Phase 3 topline data readout for MM120 ODT in GAD.2028.

On August 11, 2023 (the “Closing Date”),2023, we and certain of our subsidiaries party thereto, as co-borrowers (together with us, the “Borrowers”) entered into athe Loan and Security Agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”), as administrative agent and Canadian collateral agent for lenders thereunder (K2HV, and any other lender from time to time, the “Lenders”),thereunder, and Ankura Trust Company, LLC, as collateral trustee for the Lenders.Lenders, The Loan Agreement providesproviding for up to an aggregate principal amount of term loans of up to $50.0 millionmillion. inOn April 18, 2025, we entered into the First Amendment to the Loan Agreement with K2HV. The Amended Loan Agreement provides for, among other things, an aggregate principal amount of term loans (“Termof Loans”)up to $120.0 million, consisting of (A) a firstnew trancheRestatement termFirst loanTranche Term Loan (as defined in the Amended Loan Agreement) of $15.0$42.0 millionmillion, which was funded on the ClosingEffective 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 $20.0 millionup to be$28.0 fundedmillion, uponsubject to the achievementoccurrence of certain time-based,time-based clinical and regulatory milestones,milestones and (C) an additional tranche of term loanloans of up to $15.0$50.0 million upon our request, subject to review by the Lenders of certain information from us and discretionary approval by the Lenders. The second milestone-based tranche of $10.0 million was funded in the second quarter of 2024.

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 issuance and sale by us in an underwritten offering (the “March 2024 Offering”) of 16,666,667 of our common shares at an offering price of $6.00 per share, less underwriting discounts and commissions.

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.

Also onOn March 7, 2024, we also entered into a securities purchase agreement with certain investors, pursuant to which the Investors agreed to purchase, and we agreed to sell 12,500,000 of our common shares at a price of $6.00 per share, in a private placement transaction (the “Private Placement”).

The March 2024 Offering and the Private Placement both closed on March 11, 2024.

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 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.

We have not sold any Common Shares under the 2024 ATM as of December 31, 2025. 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.

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 the an offering of (i) our common shares, and (ii) to certain investors, pre-funded warrants to purchase our common shares. The offering price for the common shares was $7.00 per share, less underwriting discounts and commissions (the “August 2024 Offering”). 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.

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.

We believe that our cash and cash equivalents as of December 31, 2024 will be sufficient to fund our operations into 2027. Based on our current operating plan and anticipated R&D milestones, we expectbelieve that our cash, cash runwayequivalents and investments as of December 31, 2025 will be sufficient to extendfund atour leastoperations 12into months beyond the first Phase 3 topline data readout for MM120 ODT in GAD.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 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:

the costs, timing and outcome of regulatory review of our product candidatescandidates, and any delays we may encounter;

the costs of future activities, including building a commercial organization, product sales, medical affairs, marketing,sales and marketing capabilities, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

CashNet cash used in operating activities for the year ended December 31, 20232025 was $64.4$131.6 million, which consisted of a net loss of $95.7$183.8 million, partially offset by $25.1$42.8 million in non-cash charges and a net change of $6.2$9.4 million in our net operating assets and liabilities. The non-cash charges primarily consisted of share-based compensation of $20.1 million, a change in fair value on the 2022 USD Financing Warrants liability of $6.6$22.8 million, share-based compensationaccretion of $15.5 million,discounts and amortizationpremiums on investments, net of intangible$1.8 assetsmillion and DDSU expense of $3.2$1.5 million.

CashNet cash provided by financing activities for the year ended December 31, 20242025 was $253.2$267.3 million, which consisted of $175.0$258.9 million of gross proceeds from the MarchOctober Offering2025 andOffering, Private Placement, $75.0$20.0 million in proceeds from the August Offering, $10.0 millionnet proceeds from our amended credit facility, $8.3$3.7 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$0.6 million in proceeds from the exercise of options,options and $0.4 million in proceeds from the issuance of common shares in connection with our ESPP, partially offset by $11.1$15.9 million of issuance costs related to the MarchOctober 2025 Offering and Private Placement, $5.0$0.4 million ofin credit facility issuance costs related to the August Offering, $0.5 million payment of deferred financing fees related to the 2024 ATM, $0.1 millionamendment of our credit facility issuance costs and $0.1 million of withholding taxes paid on vested RSUs.facility.

Level 1 – QuotedUnadjusted quoted prices in active markets that are accessible at the measurement date for identicalidentical, unrestricted assets or liabilities.

Level 2 – Observable inputs (other than Level 1 quotedQuoted prices), such as quoted prices in active markets for similar assets orand liabilities,liabilities in active markets, quoted prices in markets that are not activeactive, or inputs which are observable, either directly or indirectly, for identicalsubstantially the full term of the asset or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.liability.

During the three months ended MarchJune 31,30, 2026, there were no material changes to the "Risk Factors" included in our Annual Report on Form 10-K for the year ended December 31, 2025. You should carefully consider the information described therein and in this Quarterly Report on Form 10-Q, which could materially affect our business condition, results of operations and cash flows.

We are a late-stage clinical biopharmaceutical company developing novela productnew candidatesgeneration of therapeutics intended to treataddress brainunderlying healthcauses 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 classesclasses, including DT120 and DT402, respectively, our lead product candidates.

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.

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 consistconsists 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 iswas 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. 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 quartermid-August 2026 and a topline readout (Part A results) for Panorama in late third quarterSeptember 2026.

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. WeIn anticipateJune a2026, we announced topline readoutdata (Part A results) infor lateEmerge, secondwhich quarteris 2026.described below under Recent Developments.

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 anticipateannounced dosingthat tothe beginfirst patient was dosed in the second quarter ofMay 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 includesis a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT. Ascend is anticipated to enroll approximately 175165 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.

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.

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,rebrand, we beganchanged our trading symbol on Nasdaq under the symbolto “DFTX” on January 15, 2026.

Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $77.1$236.1 million and $23.3$66.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $659.8$818.8 million and cash, cash equivalents and investments of $373.4approximately million.$1.1 billion.

Comparison of the Three and Six Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses of $41.5$48.7 million for the three months ended MarchJune 31,30, 2026 increased by $18.1$18.9 million, or 78%,63%, compared to $23.4$29.8 million for the three months ended MarchJune 31,30, 2025. The increase was primarily due to an increase of $15.2$12.9 million in expenses related to our DT120 program, an increase of $3.2$5.7 million in internal personnel costs as a result of increasing research and development capabilities, and an increase of $0.3$0.6 million in DT402preclinical and other program expenses, partially offset by a decrease of $0.6$0.3 million in preclinical and otherDT402 program expenses.

General and administrative expenses of $17.7$26.4 million for the three months ended MarchJune 31,30, 2026 increased by $8.9$15.3 million, or 101%,138%, compared to $8.8$11.1 million for the three months ended MarchJune 31,30, 2025. The increase was primarily due to an increase of $3.9$7.6 million in stock-based compensation expenses, an increase of $1.4$2.6 million in corporate and government affairs expenses, an increase of $2.0 million in personnel-related expenses, an increase of $1.4$1.8 million in commercial-preparedness related expenses, an increase of $1.4 million in corporate and government affairs expenses, and an increase of $1.2$0.6 million in legal and patent expenses, partiallyand offsetan by a decreaseincrease of $0.4$0.7 million in other miscellaneous administrative expenses.

Other expense for the three months ended MarchJune 31,30, 2026 was $17.9 million, and other income for the three months ended March 31, 2025 was $8.8$83.9 million.million and $1.8 million, respectively. The variance was primarily drivenattributable byto aan $84.0 million change in the 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")Warrants, duedriven primarilylargely toby anthe increase in the Company'sour share price from December$18.90 31, 2025 toat March 31, 2026 to $47.04 at June 30, 2026.

Our cash, cash equivalents and investments and our working capital at MarchJune 31,30, 2026, were $373.4approximately million$1.1 billion and $299.5$934.9 million, respectively. Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of MarchJune 31,30, 2026 will be sufficient to fund our operations into 2028.2030.

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 had not sold any Common Shares under the 2024 ATM as of MarchJune 31,30, 2026.

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"),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 Underwritingunderwriting Agreement,agreement, we granted the Underwritersunderwriters 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 Underwritersunderwriters in full on October 30, 2025.

The gross proceeds to us from the October 2025 Offering, including the full exercise by the Underwritersunderwriters 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.

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, 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:

Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of MarchJune 31,30, 2026 will be sufficient to fund our operations into 2028.2030. 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 willmay 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:

Cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $42.6$95.4 million, which consisted of a net loss of $77.1$236.1 million, offset by a net change of $5.4$11.7 million in our net operating assets and liabilities, and $29.0$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 $20.0$106.3 million, share-based compensation expense of $7.1$16.8 million, change in fair value of DDSU of $1.0$6.2 million, and amortizationaccretion of discounts and premiumsdiscount on investments, net of $0.6$0.8 million.

Cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 was $29.4$59.0 million, which consisted of a net loss of $23.3$66.1 millionmillion, andoffset by a net change of $2.5$5.6 million in our net operating assets and liabilities, and $3.6$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 $7.0$4.8 million,million and share-based compensationaccretion of $3.4discount on investments, net of $2.4 million.

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 threesix months ended MarchJune 31,30, 20252026 consisted of purchases of investments of $162.5$355.7 million, offset by maturities of investments of $81.0 million.

Cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026, was $5.3$767.6 million, which consisted of $3.8$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, $1.2$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.

Cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 was $1.0$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 certain of the 2022 USD Financing Warrants, $0.2$0.3 million in proceeds from the exercise of options, and $0.2 million in proceeds from the issuance of Common Shares under the EmployeeESPP, Sharepartially Purchaseoffset Plan.by $0.4 million of Amended Loan Agreement issuance costs.

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited interim condensed consolidated financial statements as of MarchJune 31,30, 2026, which have been prepared in accordance with U.S. GAAP, and on a basis consistent with those accounting principles followed by us and disclosed in Note 2 to our audited consolidated financial statements in the 2025 Annual Report. The preparation of these unaudited condensed consolidated financial statements requires our management to make judgments and estimates that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these judgments and estimates under different assumptions or conditions and any such differences may be material.