MPLT — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-14

• Our second clinical stage product candidate, ML-004, is a 5-HT1B/1D agonist that we are developing for the treatment of social communication deficit and/or irritability in autism spectrum disorder, or ASD. We are conducting IRIS, a Phase 2 trial evaluating the efficacy, safety and tolerability of ML…

• Since our inception in 2018, we have devoted substantially all of our time and efforts to performing research and development activities, raising capital and recruiting management and technical staff to support our operations. To date, we have financed our operations primarily with proceeds from the…

• We have incurred significant net losses since inception. Our net losses for the three months ended March 31, 2026 and 2025 were $60.7 million and $22.3 million, respectively. As of March 31, 2026, we had an accumulated deficit of $421.2 million. We expect to continue to incur significant and increas…

• We expect to incur additional costs associated with operating as a public company, including significant legal, accounting, insurance, investor relations and other expenses that we did not incur as a private company. We will not generate revenue from product sales unless and until we successfully co…

• the costs associated with clinical trials and preclinical studies; and

Text removed vs the prior filing · source: 10-Q · 2025-12-04

• Since our inception in 2018, we have devoted substantially all of our time and efforts to performing research and development activities, raising capital and recruiting management and technical staff to support our operations. To date, we have financed our operations primarily with proceeds from the…

• We have incurred significant net losses since inception. Our net losses for the nine months ended September 30, 2025 and 2024 were $81.6 million and $56.4 million, respectively. As of September 30, 2025, we had an accumulated deficit of $281.0 million. We expect to continue to incur significant and …

• Following the closing of our IPO, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, insurance, investor relations and other expenses that we did not incur as a private company. We will not generate revenue from product sales u…

• In June 2020, we entered into an Asset Purchase Agreement, or the NeuroSolis Agreement, with NeuroSolis Inc., or NeuroSolis, to acquire NeuroSolis's proprietary M1/M4 agonist molecules and associated intellectual property.

• Pursuant to the NeuroSolis Agreement, NeuroSolis sold us its assets related to both its proprietary M1/M4 agonist molecules, and its program for the identification of molecules that modulate the activity of the muscarinic M1 receptor or the muscarinic M4 receptor. We did not assume any liabilities o…

Text added vs the prior filing · source: 10-Q · 2026-05-14

• As a "smaller reporting company" as defined by Item 10 of Regulation S-K, we are not required to provide quantitative and qualitative disclosures about market risk.

Text removed vs the prior filing · source: 10-Q · 2025-12-04

• Our primary exposure to market risk is interest rate sensitivity, which is impacted by changes to the general level of U.S. interest rates, particularly because of our investments in U.S. government-backed securities, corporate debt securities and commercial paper and because our cash equivalents ar…

• As of September 30, 2025 and December 31, 2024, we had no debt outstanding, and therefore we are not subject to interest rate risk related to debt.

• Our reporting currency is the U.S. dollar. The functional currency for MapLight Australia Pty. Ltd., our wholly-owned subsidiary in Australia, is also the U.S. dollar. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the functional currency are i…

• We do not currently engage in currency hedging activities in order to reduce our currency exposure, but we may begin to do so in the future. Instruments that may be used to hedge future risks may include foreign currency forward and swap contracts. These instruments may be used to selectively manage…

• Inflation generally affects us by increasing our cost of labor and clinical trial costs. We believe that inflation has not had a material effect on our consolidated financial statements included elsewhere in this Quarterly Report.

Text added vs the prior filing · source: 10-Q · 2026-05-14

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial report…

Text removed vs the prior filing · source: 10-Q · 2025-12-04

• Due to a transition period established by SEC rules applicable to newly public companies, our management is not required to evaluate the effectiveness of our internal control over financial reporting until after the filing of our Annual Report on Form 10-K for the year ending December 31, 2025. As a…

Text added vs the prior filing · source: 10-Q · 2026-05-14

• Our operations have consumed substantial amounts of cash since our inception. We expect to continue to spend substantial amounts of cash to conduct further research and development, preclinical studies and clinical trials of our current and future product candidates, to seek regulatory approvals for…

• the scope, timing, progress, costs and results of discovery efforts, preclinical development and clinical trials for our current or future product candidates;

• our ability to address any potential supply chain interruptions or delays;

• We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining regulatory approval from the FDA. Foreign regulatory authorities, such as the European Medicines Agency, impose similar requirements. The time required to obtain approval by th…

• Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. Clinical development is susceptible to the risk …

Text removed vs the prior filing · source: 10-Q · 2025-12-04

• Our business is subject to a number of risks of which you should be aware before making a decision to invest in our common stock. These risks are more fully described in this "Risk Factors" section, including the following:

• We are a clinical-stage biopharmaceutical company with a limited operating history and no history of commercializing products, which may make it difficult to evaluate our approach to the discovery and development of product candidates and the prospects for our future viability.

• We have incurred substantial losses since our inception. We anticipate incurring substantial and increasing losses for the foreseeable future and may never achieve or maintain profitability.

• We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed or on acceptable terms, could cause us to delay, limit, reduce or terminate our product development or future commercialization efforts.

• If we are unable to successfully identify, develop and commercialize any product candidates or experience significant delays in doing so, our business, financial condition, results of operations and prospects will be materially and adversely affected.