SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, any applicable prospectus supplement, the documents that we incorporate by reference herein and therein, contain, and any free writing prospectus that we authorize for use may contain forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this prospectus supplement, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
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the timing, progress and results of our investigational programs for MM120, a proprietary, pharmaceutically optimized form of lysergide D-tartrate, and MM402, also referred to as R(-)-MDMA (together, our “lead product candidates”) and any other product candidates (together with our lead product candidates, our “product candidates”), including statements regarding the timing of initiation and completion of trials or studies and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
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our reliance on the success of our investigational MM120 product candidate;
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the timing, scope or likelihood of regulatory filings and approvals and our ability to obtain and maintain regulatory approvals for product candidates for any indication;
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our expectations regarding the size of the eligible patient populations for our lead product candidates;
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our ability to identify third-party treatment sites to conduct our trials and our ability to identify and train appropriate qualified healthcare practitioners to administer our treatments;
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our ability to implement our business model and our strategic plans for our product candidates;
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our ability to identify new indications for our lead product candidates beyond our current primary focuses;
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our ability to identify, develop or acquire digital technologies to enhance our administration of our product candidates, if they should become approved and commercialized;
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our ability to achieve profitability and then sustain such profitability;
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our commercialization, marketing and manufacturing capabilities and strategy;
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the pricing, coverage and reimbursement of our lead product candidates, if approved and commercialized;
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the rate and degree of market acceptance and clinical utility of our lead product candidates, in particular, and controlled substances, in general;
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future investments in our business, our anticipated capital expenditures and our estimates regarding our capital requirements;
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our ability to establish or maintain collaborations or strategic relationships or to obtain additional funding;
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our expectations regarding potential benefits of our lead product candidates;
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our ability to maintain effective patent rights and other intellectual property protection for our product candidates, and to prevent competitors from using technologies we consider important in our successful development and commercialization of our product candidates;
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infringement or alleged infringement on the intellectual property rights of third parties;