DFTX

Our most advanced development candidate is DT120 ODT.
We initiated our Phase 3 clinical program in GAD in December 2024 and we initiated our Phase 3 clinical program in MDD in April 2025.
We have not yet demonstrated our ability to successfully 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.
We incurred net losses of $183.8 million and $108.7 million for the years ended December 31, 2025 and December 31, 2024, respectively, and as of December 31, 2025, we had an accumulated deficit of $582.7 million.
We anticipate that our expenses will increase substantially if and as we, among other things: • continue the clinical development of our product candidates and other preclinical programs in GAD, MDD, ASD and other potential or future indications, including initiating additional and larger clinical trials; • continue the training of healthcare practitioners who are qualified to deliver our product candidates in our clinical trials; • 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 DT120 and DT402; • seek additional indications for our product candidates and discover and develop any future product candidates; • seek regulatory approvals for any product candidates that successfully complete clinical trials; • experience heightened regulatory scrutiny; • 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 DT120 and DT402 product candidates; • experience animal toxicology issues significant enough for the FDA or other regulatory agencies to disallow investigation in humans; • explore external business development opportunities through acquisitions, partnerships, co-development deals and/or licensing deals to add future product candidates and technologies to our portfolio; • obtain, maintain, expand and protect our intellectual property portfolio, including litigation costs associated with defending against alleged patent or other intellectual property infringement claims; • add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts; • experience any delays or encounter any issues with respect to any of the above, including studies that impede further development with unfavorable results, ambiguous trial results, safety issues or other regulatory challenges; • expand our operations in the United States and potential other geographies in the future; and • incur additional legal, accounting and other expenses associated with operating as a public company listed in the U.S., including expenses that may result due to securities litigation or shareholder activism.
On April 18, 2025 (the “Effective Date”), we entered into the First Amendment to the Loan Agreement with K2HV (as amended, the “Amended Loan Agreement”).
On the Effective Date, we borrowed $42.0 million in the first tranche under the Amended Loan Agreement.
We may borrow an additional $28.0 million based upon the achievement of certain time-based, clinical and regulatory milestones, and an additional $50.0 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 Amended Loan Agreement are secured by a security interest in substantially all of our assets, other than certain intellectual property assets.
The Amended 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.
Additionally, if we borrow any additional amounts pursuant to the Amended Loan Agreement, we will be subject to 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.
The minimum liquidity covenant will be waived in any period where our market capitalization exceeds $500 million.
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.
Our ability to generate revenue and achieve profitability depends significantly on our ability, or any current or future collaborator’s ability, to achieve several objectives, including: • successful and timely completion of preclinical and clinical development of DT120, DT402 and our other product candidates; • establishing and maintaining relationships with CROs and clinical sites for the clinical development of DT120, DT402 and our other product candidates; • timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development; • developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale; • establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved; • achieving a successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more third parties; • demonstrating a continued acceptable safety profile following any marketing approval of our product candidates; • obtaining commercial acceptance of our product candidates by patients, the medical community and third-party payors; • satisfying any required post-marketing approval commitments to applicable regulatory authorities; • rescheduling of product candidates that are controlled substances by the DEA, individual states or other comparable foreign authorities; • identifying, assessing and developing new product candidates; • obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, in the United States and in other jurisdictions; • protecting our rights in our intellectual property portfolio; • defending against third-party interference or infringement claims, if any; • entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; • obtaining coverage and adequate reimbursement by third-party payors for our product candidates; • addressing any competing therapies and technological and market developments; and • attracting, hiring and retaining qualified personnel.
We are not permitted to market or promote DT120, DT402 or any other product candidate before we receive marketing approval from the FDA or other comparable foreign authorities.
As of December 31, 2025, we had $411.6 million in cash, cash equivalents and investments.
Based on our current operating plan and anticipated R&D milestones, we expect our cash runway to fund our operations into 2028.
Our future funding requirements, both short-term and long-term, will depend on many factors, including: • the progress, timing and completion of preclinical testing and clinical trials for our product candidates; • the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more preclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to, including any delays as a result of animal toxicology issues or the need to conduct bioequivalence studies; • the outcome and timing of any scheduling-related decisions by the DEA, individual states, and comparable foreign authorities; • the number of potential future product candidates we identify and decide to develop, either internally through our research and development efforts or externally through acquisitions, licensing or other collaboration agreements; • the costs involved in growing our organization to the size needed to allow for the research, development and potential commercialization of our product candidates; • the costs of developing sales and marketing capabilities to target public and private HCPs and clinic networks in major markets; • the costs of training and certifying healthcare practitioners who are supporting or will support our clinical trials; • generating and collecting data and obtaining intellectual property; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims of infringements raised by third parties; • 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 DT120 and DT402) or any other product candidates; • selling and marketing activities undertaken in connection with the potential commercialization of our product candidates, if approved, and costs involved in the creation of an effective sales and marketing organization; • the amount of revenue, if any, we may derive either directly or in the form of royalty payments from future sales of our product candidates, if approved; and • the costs of operating as a public company.
Subject to certain rules of the Nasdaq Stock Market (“Nasdaq”), our Board of Directors has the authority to authorize certain offers and sales of additional securities without the vote of, or prior notice to, shareholders.
We may plan to grow and develop our business through in-license agreements, acquisitions of or investment in new or complementary businesses, product candidates or technologies, and the failure to manage these license agreements, acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
We may consider opportunities to in-license, acquire or invest in other technologies, product candidates and businesses that might enhance our capabilities or complement our current product candidates.
Potential and completed acquisitions and strategic investments involve numerous risks, including potential problems or issues associated with the following: • assimilating the acquired or in-licensed technologies, product candidates, or business operations; • maintaining uniform standards, procedures, controls, and policies; • unanticipated costs associated with the license, acquisition or investment; • diversion of our management’s attention from our preexisting business; • maintaining or obtaining the necessary regulatory approvals or complying with regulatory standards; and • adverse effects on existing business operations We have no current commitments with respect to any in-license, acquisition or investment in other technologies or businesses.
We do not know if we will identify other suitable acquisitions, whether we will be able to successfully complete any acquisitions, or whether we will be able to successfully integrate any in-licensed or acquired product candidate, technology or business into our business operations or retain key personnel, suppliers, or collaborators.
Our ability to successfully develop our business through in-licenses or acquisitions will depend on our ability to identify, negotiate, complete, and integrate suitable target businesses, product candidates or technologies and obtain any necessary financing.
These efforts could be expensive and time-consuming and might disrupt our ongoing operations.
If we are unable to efficiently integrate any in-licensed product candidate, acquired business or technology, or product candidate into our business operations, our business and financial condition might be adversely affected.
We cannot be certain that DT120, 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 DT120 or DT402 does not receive regulatory approval or fail to achieve significant market acceptance, we would be delayed by many years in our ability to achieve profitability, if ever.
The success of our product candidates will depend on several factors, including the following: • successful completion of clinical trials and preclinical studies; • sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; • receiving regulatory approvals or clearance for conducting our clinical trials; • successful patient enrollment in and completion of clinical trials; • positive data from our clinical trials that support an acceptable risk-benefit profile of our product candidates in the intended populations; • receipt and maintenance of regulatory and marketing approvals from applicable regulatory authorities; • establishing and scaling up, either alone or with third-party manufacturers, manufacturing capabilities of clinical supply for our clinical trials and commercial manufacturing, if any product candidate is approved; • rescheduling of any Schedule I substance under the CSA and applicable state-controlled substance laws to Schedules II-V or equivalent categories at the state level, or out of the Schedules, and implementation of a REMS, if applicable; • entering into collaborations to further the development of our product candidates; • obtaining and maintaining patent and trade secret protection and/or regulatory exclusivity for our product candidates; • successfully launching commercial sales of our product candidates, if approved; • 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 Schedule I substances; • maintaining a continued acceptable safety profile of our product candidates following approval; • effectively competing with companies developing and commercializing other therapies in the indications which our product candidates targets; • obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; • enforcing and defending intellectual property rights and claims; and • complying with laws and regulations, including laws and regulations applicable to controlled 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.
If DT120 and DT402 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.
The annual quota allocated to us or our contract manufacturers for the active ingredient in DT120, DT402, or any other product candidate, may not be sufficient to complete clinical trials or meet potential future commercial demand.
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 uptake.
Opponents of these product candidates, which may include regulators, may seek to prevent approvals, restrict marketing or demand withdrawal of any regulatory approvals.
For example, Resilient (formerly Lykos Therapeutics), another company developing a drug product candidate containing MDMA, has faced significant public scrutiny and adverse publicity following negative public statements and allegations about clinical trial conduct made by clinical trial participants.
We may also experience numerous unforeseen events during preclinical and clinical development that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: • 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 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 or denial of a researcher registration to one or more research sites that will allow those sites to handle and dispense our product candidates and to obtain our product candidates from our importer; • delays in or failure to reach agreement on acceptable terms with prospective CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • delays in or inability to raise sufficient capital to fund research and development of our product candidates; • delays in or failure to obtain IRB, or ethics committee approval at each site; • delays in or failure to recruit a sufficient number of suitable patients to participate in a trial; • failure to have patients complete a trial or return for post-treatment follow-up; • clinical sites deviating from trial protocol or dropping out of a trial; • inability to identify or maintain a sufficient number of trial sites, many of which may be already engaged in other clinical trials, including some that may be for competing product candidates with the same indication; • challenges related to conducting adequate and well-controlled clinical trials, including designing an appropriate comparator arm in studies given the potential difficulties related to maintaining the blinding during the trial or placebo or nocebo effects; • delay or failure in adding new clinical trial sites; • ambiguous or negative interim results that are inconsistent with earlier results; • availability of adequately trained HCPs and appropriate third-party clinical trial sites for our product candidates; • sufficiency of any supporting digital services that may form part of the preparation, integration or long-term follow-up relating to any product candidate we develop; • failure to contract for the manufacture of sufficient quantities of our product candidates for use in clinical trials in a timely manner; • third-party actions claiming infringement by our investigational product candidates and other candidates or product candidates in clinical trials and obtaining injunctions interfering with our progress; • safety or tolerability concerns which could cause us or our collaborators, as applicable, to suspend or terminate a trial if we or our collaborators find that the participants are being exposed to unacceptable health risks; • unacceptable risk-benefit profile, unforeseen safety issues or adverse side effects or adverse events associated with a product candidate; • failure of a product candidate to demonstrate any or enough of a benefit; • methodological challenges associated with clinical research of psychotropic compounds that could hinder the interpretability or regulatory acceptability of clinical trial results, such as the effects of functional unblinding, expectation biases and protocols for patient support and monitoring during dosing sessions; • changes in regulatory requirements, policies and guidelines; • lower than anticipated retention rates of patients in clinical trials; • our third-party research contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • delays in establishing the appropriate dosage levels in clinical trials; • delays in our clinical trials related to public health 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; • the quality or stability of the underlying therapeutic substance falling below acceptable standards; • regulatory requirements to change the formulation of a product candidate, which can require expensive, risky and time-consuming bioequivalence studies; • business interruptions resulting from macroeconomic conditions, including inflation and rising interest rates, geo-political actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods and fires, pandemics, or failures or significant downtime of our information technology systems resulting from cyber-attacks on such systems or otherwise; and • changes in governmental regulations or administrative actions.
If we experience delays in the completion of, or termination of, any clinical trial of DT120, DT402 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 DT120, DT402 or any other product candidate development and approval process and jeopardize our ability to commence sales and generate revenue.
Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of DT120, 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.

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Gone since FY2024

Our most advanced development candidate is MM120 ODT.
We initiated our Phase 3 clinical program in GAD in December 2024 and we anticipate initiating our Phase 3 clinical program in MDD in the first half of 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.
We incurred net losses of $108.7 million and $95.7 million for the years ended December 31, 2024 and December 31, 2023, respectively, and as of December 31, 2024, we had an accumulated deficit of $398.9 million.
We anticipate that our expenses will increase substantially if and as we, among other things: • continue the clinical development of our product candidates and other preclinical programs in GAD, MDD, ASD and other potential or future indications, including initiating additional and larger clinical trials; • continue the training of healthcare practitioners who are qualified to deliver our product candidates in our clinical trials; • 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 MM120 and MM402; • seek additional indications for our product candidates and discover and develop any future product candidates, including product candidates in our digital medicine pipeline; • seek regulatory approvals for any product candidates that successfully complete clinical trials; • experience heightened regulatory scrutiny; • 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 MM120 and MM402 product candidates; • experience animal toxicology issues significant enough for the FDA or other regulatory agencies to disallow investigation in humans; • explore external business development opportunities through acquisitions, partnerships, co-development deals and/or licensing deals to add future product candidates and technologies to our portfolio; • obtain, maintain, expand and protect our intellectual property portfolio, including litigation costs associated with defending against alleged patent or other intellectual property infringement claims; • add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts; • experience any delays or encounter any issues with respect to any of the above, including studies that impede further development with unfavorable results, ambiguous trial results, safety issues or other regulatory challenges; • expand our operations in the United States and potential other geographies in the future; and • incur additional legal, accounting and other expenses associated with operating as a public company listed in the U.S., including expenses that may result due to securities litigation or shareholder activism.
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.
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 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 Loan Agreement.
Our ability to generate revenue and achieve profitability depends significantly on our ability, or any current or future collaborator’s ability, to achieve several objectives, including: • successful and timely completion of preclinical and clinical development of MM120, MM402 and our other product candidates; • establishing and maintaining relationships with CROs and clinical sites for the clinical development of MM120, MM402 and our other product candidates; • timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development; • developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale; • establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved; • achieving a successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more third parties; • demonstrating a continued acceptable safety profile following any marketing approval of our product candidates; • obtaining commercial acceptance of our product candidates by patients, the medical community and third-party payors; • satisfying any required post-marketing approval commitments to applicable regulatory authorities; • rescheduling of product candidates that are controlled substances by the DEA, individual states or other comparable foreign authorities; • identifying, assessing and developing new product candidates; • obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, in the United States and in other jurisdictions; • protecting our rights in our intellectual property portfolio; • defending against third-party interference or infringement claims, if any; • entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; • obtaining coverage and adequate reimbursement by third-party payors for our product candidates; • addressing any competing therapies and technological and market developments; and • attracting, hiring and retaining qualified personnel.
We are not permitted to market or promote MM120, MM402 or any other product candidate before we receive marketing approval from the FDA or other comparable foreign authorities.
As of December 31, 2024, we had $273.7 million in cash and cash equivalents.
Based on our current operating plan and anticipated R&D milestones, we expect our cash runway to extend at least 12 months beyond the first Phase 3 topline data readout for MM120 ODT in GAD.
Our future funding requirements, both short-term and long-term, will depend on many factors, including: • the progress, timing and completion of preclinical testing and clinical trials for our product candidates; • the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more preclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to, including any delays as a result of animal toxicology issues or the need to conduct bioequivalence studies; • the outcome and timing of any scheduling-related decisions by the DEA, individual states, and comparable foreign authorities; • the number of potential future product candidates we identify and decide to develop, either internally through our research and development efforts or externally through acquisitions, licensing or other collaboration agreements; • the costs involved in growing our organization to the size needed to allow for the research, development and potential commercialization of our product candidates; • the costs of developing sales and marketing capabilities to target public and private HCPs and clinic networks in major markets; • the costs of training and certifying healthcare practitioners who are supporting or will support our clinical trials; • generating and collecting data and obtaining intellectual property; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims of infringements raised by third parties; • 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 MM120 and MM402) or any other product candidates; • selling and marketing activities undertaken in connection with the potential commercialization of our product candidates, if approved, and costs involved in the creation of an effective sales and marketing organization; • the amount of revenue, if any, we may derive either directly or in the form of royalty payments from future sales of our product candidates, if approved; and • the costs of operating as a public company.
Subject to certain rules of the Nasdaq Stock Market (“Nasdaq”), the Board has the authority to authorize certain offers and sales of additional securities without the vote of, or prior notice to, shareholders.
We cannot be certain that MM120, MM402, 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 MM120 or MM402 does not receive regulatory approval or fails to achieve significant market acceptance, we would be delayed by many years in our ability to achieve profitability, if ever.
The success of our product candidates will depend on several factors, including the following: • successful completion of clinical trials and preclinical studies; • sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; • receiving regulatory approvals or clearance for conducting our clinical trials; • successful patient enrollment in and completion of clinical trials; • positive data from our clinical trials that support an acceptable risk-benefit profile of our product candidates in the intended populations; • receipt and maintenance of regulatory and marketing approvals from applicable regulatory authorities; • establishing and scaling up, either alone or with third-party manufacturers, manufacturing capabilities of clinical supply for our clinical trials and commercial manufacturing, if any product candidate is approved; • rescheduling of any Schedule I substance under the CSA and applicable state-controlled substance laws to Schedules II-V or equivalent categories at the state level, or out of the Schedules, and implementation of a REMS, if applicable; • entering into collaborations to further the development of our product candidates; • obtaining and maintaining patent and trade secret protection and/or regulatory exclusivity for our product candidates; • successfully launching commercial sales of our product candidates, if approved; • 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 Scheduled I substances; • maintaining a continued acceptable safety profile of our product candidates following approval; • effectively competing with companies developing and commercializing other therapies in the indications which our product candidates targets; • obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; • enforcing and defending intellectual property rights and claims; and • complying with laws and regulations, including laws and regulations applicable to controlled substances.
Even if approved by FDA, prescribing and dispensing of a controlled substance is subject to restrictions, with heightened restrictions for Schedule II controlled substances.
If MM120 and MM402 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.
The annual quota allocated to us or our contract manufacturers for the active ingredient in MM120, MM402, or any other product candidate, may not be sufficient to complete clinical trials or meet potential future commercial demand.
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.
Opponents of these product candidates may seek to prevent or restrict marketing or demand withdrawal of any regulatory approvals.
For example, Lykos Therapeutics, another company developing a drug product candidate containing MDMA, recently faced significant public scrutiny and adverse publicity following negative public statements and allegations about clinical trial conduct made by clinical trial participants.
We may also experience numerous unforeseen events during preclinical and clinical development that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: • 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”), 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 or denial of a researcher registration to one or more research sites that will allow those sites to handle and dispense our product candidates and to obtain our product candidates from our importer; • delays in or failure to reach agreement on acceptable terms with prospective CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • delays in or inability to raise sufficient capital to fund research and development of our product candidates; • delays in or failure to obtain IRB, or ethics committee approval at each site; • delays in or failure to recruit a sufficient number of suitable patients to participate in a trial; • failure to have patients complete a trial or return for post-treatment follow-up; • clinical sites deviating from trial protocol or dropping out of a trial; • inability to identify or maintain a sufficient number of trial sites, many of which may be already engaged in other clinical trials, including some that may be for competing product candidates with the same indication; • challenges related to conducting adequate and well-controlled clinical trials, including designing an appropriate comparator arm in studies given the potential difficulties related to maintaining the blinding during the trial or placebo or nocebo effects; • delay or failure in adding new clinical trial sites; • ambiguous or negative interim results that are inconsistent with earlier results; • availability of adequately trained HCPs and appropriate third-party clinical trial sites for our product candidates; • sufficiency of any supporting digital services that may form part of the preparation, integration or long-term follow-up relating to any product candidate we develop; • failure to contract for the manufacture of sufficient quantities of our product candidates for use in clinical trials in a timely manner; • third-party actions claiming infringement by our investigational product candidates and other candidates or product candidates in clinical trials and obtaining injunctions interfering with our progress; • safety or tolerability concerns which could cause us or our collaborators, as applicable, to suspend or terminate a trial if we or our collaborators find that the participants are being exposed to unacceptable health risks; • unacceptable risk-benefit profile, unforeseen safety issues or adverse side effects or adverse events associated with a product candidate; • failure of a product candidate to demonstrate any or enough of a benefit; • methodological challenges associated with clinical research of psychotropic compounds that could hinder the interpretability or regulatory acceptability of clinical trial results, such as the effects of functional unblinding, expectation biases and protocols for patient support and monitoring during dosing sessions; • changes in regulatory requirements, policies and guidelines; • lower than anticipated retention rates of patients in clinical trials; • our third-party research contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • delays in establishing the appropriate dosage levels in clinical trials; • delays in our clinical trials related to public health crises like the COVID-19 pandemic, 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; • the quality or stability of the underlying therapeutic substance falling below acceptable standards; • regulatory requirements to change the formulation of a product candidate, which can require expensive, risky and time-consuming bioequivalence studies; • business interruptions resulting from macroeconomic conditions, including inflation and rising interest rates, geo-political actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods and fires, pandemics, or failures or significant downtime of our information technology systems resulting from cyber-attacks on such systems or otherwise; and • changes in governmental regulations or administrative actions.
If we experience delays in the completion of, or termination of, any clinical trial of MM120, MM402 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, MM402 or any other product candidate development and approval process and jeopardize our ability to commence sales and generate revenue.
Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of MM120, MM402, or any other product candidates that we may identify and pursue, which would prevent, delay or limit the scope of regulatory approval and commercialization.
If the results of our clinical trials are inconclusive with respect to the efficacy of MM120, MM402 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, MM402 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, MM402 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.
Due to the inherent risk in the development of product substances, there is a significant likelihood that MM120, MM402 and any other product candidates will not successfully complete development and receive approval.
If we do not receive regulatory approvals for MM120, MM402 or any other product candidates, we may not be able to continue our operations.
Even if regulatory approval is secured for MM120, MM402 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 of MM120 could have a material adverse effect on our business, financial condition and results of operations.
In August 2023, we entered into an exclusive licensing agreement with Catalent for its patented Zydis® orally ODT technology.
Under the terms of the licensing agreement, Catalent granted us, among other things, access to its Zydis technology for the development of MM120.
In our Phase 2 clinical trials for MM120, we used a formulation of MM120 that did not include ODT technology.
In 2024, we completed a pharmacokinetics (“PK”) bridging study to support the advancement of the MM120 ODT formulation into pivotal clinical trials, and we are using the MM120 ODT formulation in our Phase 3 clinical trials for GAD and MDD.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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