MindMed management will host a conference call at 4:30 PM EDT today to provide a corporate update and review the Company's first quarter 2024 financial results. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, https://ir.mindmed.co/, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.
About MM120
Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and other psychiatric indications.
About MM402
MM402 is our proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), which we are developing for the treatment of core symptoms of 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 demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.
Forward-Looking Statements
Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company's belief that results from its Phase 1 pharmacokinetics bridging trial will support the advancement of its MM120 ODT formulation into pivotal clinical trials; the Company's belief that it is on track to initiate a Phase 3 clinical program for MM120 Zydis$(R)$ ODTs in the second half of 2024; the Company's plans to provide additional updates on its GAD program and other product candidates in its pipeline; the Company's beliefs regarding potential benefits of its product candidates; the Company's plans to hold an End-of-Phase 2 meeting with the FDA in the second quarter of 2024; the Company's belief that its Phase 1 trial for MM402 (R(-)-MDMA) should enable further clinical trials to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population; the Company's expectation that topline results from UHB's Phase 1 investigator-initiated clinical trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA will be presented in the second quarter of 2024; the Company's expectation that its cash and cash equivalents are expected to fund operations into 2026; anticipated upcoming milestones, trials and studies; results and timing of and reporting of data from clinical trials; and potential additional indications for MM120 and MM402. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 under headings such as "Special Note Regarding Forward-Looking Statements," and "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.
Mind Medicine (MindMed) Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except share and per share amounts) Three Months Ended March 31, ------------------------- 2024 2023 ----------- ----------- Operating expenses: Research and development $ 11,705 $ 12,599 General and administrative 10,499 8,263 ---------- ---------- Total operating expenses 22,204 20,862 ---------- ---------- Loss from operations (22,204) (20,862) Other income/(expense): Interest income 1,656 1,360 Interest expense (434) (76) Foreign exchange loss, net (525) (52) Change in fair value of 2022 USD Financing Warrants (32,893) (5,185) ---------- ---------- Total other expense, net (32,196) (3,953) ---------- ---------- Net loss (54,400) (24,815) ---------- ---------- Other comprehensive loss Gain on foreign currency translation 493 14 ---------- ---------- Comprehensive loss $ (53,907) $ (24,801) ========== ========== Net loss per common share, basic and diluted $ (1.14) $ (0.65) ========== ========== Weighted-average common shares, basic and diluted 47,860,757 38,077,251 ========== ========== Mind Medicine (MindMed) Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands, except share amounts) March 31, 2024 December 31, (unaudited) 2023 ---------------- -------------- Assets Current assets: Cash and cash equivalents $ 252,332 $ 99,704 Prepaid and other current assets 3,139 4,168 ------------ ---------- Total current assets 255,471 103,872 ------------ ---------- Goodwill 19,918 19,918 Intangible assets, net -- 527 Other non-current assets 144 224 ------------ ---------- Total assets $ 275,533 $ 124,541 ============ ========== Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 7,595 $ 4,136 Accrued expenses 9,974 11,634 2022 USD Financing Warrants 47,700 16,476 ------------ ---------- Total current liabilities 65,269 32,246 Credit facility, long-term 14,190 14,129 Other liabilities, long-term 15 32 ------------ ---------- Total liabilities 79,474 46,407 ------------ ---------- Shareholders' Equity: Common shares, no par value, unlimited authorized as of March 31, 2024 and December 31, 2023; 71,163,720 and
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