MapLight Therapeutics (MPLT) secures $150M PIPE to fund Phase 3 CNS trials
Rhea-AI Filing Summary
MapLight Therapeutics, Inc. entered into a private placement with institutional investors to sell 9,197,887 shares of common stock and pre-funded warrants to purchase 3,983,168 shares at $11.38 per share (and $11.3799 per pre-funded warrant), for anticipated gross proceeds of approximately $150.0 million before fees. Each pre-funded warrant is exercisable at $0.0001 per share and does not expire, subject to beneficial ownership limits.
A Registration Rights Agreement requires MapLight to file resale registration statements within 30 days of closing and achieve effectiveness by specified deadlines, with liquidated damages of 1.0% per 30 days on invested amounts if it fails to meet those timelines, subject to caps. Cash, cash equivalents and investments were $351.3 million as of June 30, 2026, and together with the private placement are expected to extend the cash runway through 2028, including projected readouts for the VISTA and ZEPHYR-2 trials.
MapLight reported positive Phase 2 ZEPHYR results for ML-007C-MA in schizophrenia, including meeting the primary PANSS endpoint, a potentially differentiating cognitive signal, and a favorable tolerability profile, supporting advancement into registrational Phase 3 ZEPHYR-2. For the quarter ended June 30, 2026, the company recorded a net loss of $60.2 million, driven by research and development expenses of $53.4 million as it advances its CNS pipeline.
Positive
- $150.0 million private placement financing significantly strengthens liquidity and supports key clinical programs, including ZEPHYR-2 in schizophrenia and VISTA in Alzheimer’s disease psychosis.
- Cash, cash equivalents and investments of $351.3 million as of June 30, 2026, plus the private placement, are expected to provide runway through 2028, covering projected pivotal trial readouts.
- Phase 2 ZEPHYR trial of ML-007C-MA in schizophrenia met its primary PANSS endpoint with a potentially differentiating cognitive signal and favorable tolerability, supporting advancement to a registrational Phase 3 study.
- Phase 2 IRIS data for ML-004 in autism spectrum disorder showed clinically meaningful improvements in irritability in a prespecified adolescent subgroup, supporting further regulatory engagement.
Negative
- Net loss increased to $60.2 million for Q2 2026 and $120.9 million for the first half of 2026, reflecting substantial growth in research and development and operating expenses.
- Cash, cash equivalents and investments declined from $453.1 million at December 31, 2025 to $351.3 million at June 30, 2026, indicating a high cash burn ahead of the new financing.
Filing Explained
MapLight had agreed to a potentially dilutive financing expected to close August 14; proceeds were not yet reported as received.
This Form 8-K reports that on
If completed and exercised as applicable, the disclosed issuance would increase the share count and reduce existing holders’ percentage ownership absent offsetting changes.
The financing was not yet complete at filing: the accompanying release said closing was expected on
The securities had not been registered and could be offered or sold in the United States only under an effective registration statement or an applicable exemption. After closing, the company agreed to file resale registration statements within 30 days; effectiveness has a separate contractual deadline.
8-K Event Classification
Key Figures
Key Terms
Pre-Funded Warrants financial
Registration Rights Agreement regulatory
beneficial ownership limitation financial
End-of-Phase 2 meeting regulatory
PANSS Total Score medical
circuit-based discovery platform technical
FAQ
What is MapLight Therapeutics (MPLT) raising in its August 2026 private placement?
How will MapLight Therapeutics (MPLT) use the proceeds from the PIPE financing?
What is MapLight Therapeutics’ (MPLT) cash runway after the private placement?
What key clinical results did MapLight Therapeutics (MPLT) report for ML-007C-MA?
How did MapLight Therapeutics (MPLT) perform financially in Q2 2026?
What are the key terms of the pre-funded warrants issued by MapLight Therapeutics (MPLT)?
What registration rights do investors in MapLight Therapeutics’ (MPLT) PIPE receive?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 1.01 | Entry Into A Material Definitive Agreement. |
On August 13, 2026, MapLight Therapeutics, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors (the “Purchasers”), pursuant to which the Company agreed to sell and issue to the Purchasers in a private placement transaction (the “Private Placement”) (i) 9,197,887 shares (the “Shares”) of the Company’s voting common stock, par value $0.0001 (“Common Stock”) per share, and (ii) with respect to certain Purchasers, pre-funded warrants to purchase 3,983,168 shares of Common Stock (the “Pre-Funded Warrants”) in lieu of Shares. The purchase price per share of Common Stock is $11.38 per share (the “Purchase Price”) and the purchase price for the Pre-Funded Warrants is the Purchase Price minus $0.0001 per share underlying the Pre-Funded Warrants. The Company anticipates receiving gross proceeds of approximately $150.0 million from the Private Placement, before deducting placement agent fees and estimated offering expenses payable by the Company.
The Pre-Funded Warrants have a per share exercise price of $0.0001, subject to proportional adjustments in the event of stock splits or combinations or similar events. The Pre-Funded Warrants will not expire until exercised in full. The Pre-Funded Warrants may not be exercised if the aggregate number of shares of Common Stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation; provided, however, that a holder that holds less than 20% of the Common Stock prior to such exercise may increase or decrease the beneficial ownership limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 19.99%.
Also on August 13, 2026, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Purchasers. Under the terms of the Registration Rights Agreement, the Company has agreed to prepare and file, within 30 days after the Closing (the “Filing Deadline”), one or more registration statements with the Securities and Exchange Commission (the “SEC”) to register for resale the Common Stock issued under the Purchase Agreement and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants (the “Warrant Shares”) issued pursuant to the Purchase Agreement (together, the “Registrable Securities”), and to cause the applicable registration statements to become effective within a specified period set forth in the Registration Rights Agreement (the “Effectiveness Deadline”).
In the event the registration statement has not been filed by the Filing Deadline or has not been declared effective by the SEC by the Effectiveness Deadline, subject to certain limited exceptions, the Company has agreed to make pro rata payments to each Purchaser as liquidated damages in an amount equal to 1.0% of the aggregate amount paid pursuant to the Purchase Agreement by such Purchaser for the Purchaser’s Registrable Securities then held, per 30-day period or pro rata for any portion thereof for each such 30-day period during which such event continues, subject to certain caps set forth in the Registration Rights Agreement.
The Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Purchase Agreement is included with this filing only to provide investors with information regarding the terms of transaction and not to provide investors with any other factual information regarding the Company.
The Company has engaged Morgan Stanley & Co. LLC, Jefferies LLC, Leerink Partners LLC and Stifel, Nicolaus & Company, Incorporated as placement agents for the Private Placement. The Company has agreed to pay customary placement fees and reimburse certain expenses of the placement agents.
The Company has granted the Purchasers customary indemnification rights in connection with the registration statement. The Purchasers have also granted the Company customary indemnification rights in connection with the registration statement.
The foregoing is only a summary of the terms of the Purchase Agreement, the Registration Rights Agreement and the Pre-Funded Warrants issued under the Purchase Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of (i) the form of the Purchase Agreement, a copy of which is attached to this
Current Report on Form 8-K as Exhibit 10.1, (ii) the form of the Registration Rights Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.2, and (iii) the form of Pre-Funded Warrant issued under the Purchase Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 4.1.
| Item 2.02 | Results of Operations and Financial Condition. |
On August 13, 2026, the Company issued a press release announcing its financial results for the second quarter ended June 30, 2026. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On August 13, 2026, the Company issued a press release entitled “MapLight Therapeutics Announces $150 Million Private Placement Financing” which includes the following selected preliminary financial information: MapLight’s cash, cash equivalents and investments were $351.3 million as of June 30, 2026. A copy of this press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, including Exhibits 99.1 and 99.2 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
| Item 3.02 | Unregistered Sales of Equity Securities. |
The disclosure regarding the securities to be sold and issued under the Purchase Agreement as set forth under Item 1.01 of this report is incorporated by reference under this Item 3.02.
The securities described above under Item 1.01 have not been registered under the Securities Act. Based in part upon the representations of the Purchasers in the Purchase Agreement, the offering and sale of the securities described above are being offered and sold in a private placement under section 4(a)(2) of the Securities Act, and corresponding provisions of state securities or “blue sky” laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The sale of the securities did not involve a public offering and was made without general solicitation or general advertising.
Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy any securities of the Company.
| Item 7.01 | Regulation FD Disclosure. |
On August 13, 2026, the Company updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is available on the Company’s website and a copy is furnished as Exhibit 99.3 to this Current Report on Form 8-K.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01, and Exhibit 99.3 hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statement and Exhibits. |
(d) Exhibits
| Exhibit Number |
Exhibit Description | |
| 4.1 | Form of Pre-Funded Warrant. | |
| 10.1 | Form of Securities Purchase Agreement, dated August 13, 2026, by and among MapLight Therapeutics, Inc. and the Purchasers. | |
| 10.2 | Form of Registration Rights Agreement, dated August 13, 2026, by and among MapLight Therapeutics, Inc. and the Purchasers. | |
| 99.1 | Press Release, dated August 13, 2026. | |
| 99.2 | Press Release, dated August 13, 2026. | |
| 99.3 | Corporate Presentation, dated August 13, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MapLight Therapeutics, Inc. | ||||||
| Dated: August 13, 2026 | By: | /s/ Christopher A. Kroeger | ||||
| Christopher A. Kroeger, M.D. | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
Reported positive results from the potentially registrational Phase 2 ZEPHYR trial of ML-007C-MA in schizophrenia, supporting advancement into a Phase 3 ZEPHYR-2 trial
Continued advancement of ML-007C-MA in ADP, with enrollment ongoing in the Phase 2 VISTA trial and topline results expected in the second half of 2027
Reported Phase 2 IRIS results for ML-004 in autism spectrum disorder, with clinically meaningful improvements in irritability observed in a prespecified adolescent subgroup
Primarily focusing resources on the advancement of ML-007C-MA
Ended the quarter with $351.3 million in cash, cash equivalents and investments, which, together with the Company’s recent $150 million private placement, is expected to extend cash runway through 2028, including through the projected readouts for both VISTA and ZEPHYR-2
SAN FRANCISCO and BOSTON, August 13, 2026 (GLOBE NEWSWIRE) — MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today reported financial results for the second quarter ended June 30, 2026, and provided a business update.
“With positive Phase 2 data from ZEPHYR and continued progress in VISTA, we are focusing our efforts on advancing ML-007C-MA in both schizophrenia and ADP,” said Chris Kroeger, Co-Founder and Chief Executive Officer of MapLight. “In schizophrenia, ZEPHYR met its primary endpoint and achieved meaningful efficacy results, an encouraging cognitive signal and a tolerability profile designed to translate into real-world use, supporting our planned registrational Phase 3 ZEPHYR-2 trial. In ADP, enrollment in VISTA remains ongoing, with topline results expected in the second half of 2027. Together with our recent private placement and continued focus on capital discipline, we believe we are well positioned to execute on both programs through these key milestones.”
Business Update and Upcoming Milestones
ML-007C-MA (M1/M4 Muscarinic Agonist) for the Treatment of Schizophrenia
| • | Reported positive topline results in July 2026 from the Phase 2 ZEPHYR trial of ML-007C-MA in adults with schizophrenia experiencing an acute exacerbation of psychosis. The trial met its primary endpoint, with the 210/3 mg twice-daily dose demonstrating a statistically significant and clinically meaningful reduction in PANSS total score compared with placebo at Week 5. |
| • | ML-007C-MA also demonstrated improvement on a prespecified cognitive-function endpoint in participants with baseline cognitive impairment and significant separation on key secondary endpoints, including CGI-S and the PANSS Marder positive factor. |
| • | ML-007C-MA was generally well tolerated, with no serious or drug-related severe adverse events and low rates of GI-related discontinuations. Its clinical profile, including simple initiation, 99% of patients reaching the target dose and no fasting requirement, is designed to translate into real-world use. |
| • | The Company plans to engage with the FDA at an End-of-Phase 2 meeting to discuss the registrational path forward, including the planned Phase 3 ZEPHYR-2 trial, with topline results expected in 2028. |
ML-007C-MA for the Treatment of Alzheimer’s Disease Psychosis (ADP)
| • | Continued enrollment in the Phase 2 VISTA trial, a randomized, double-blind, placebo-controlled study evaluating ML-007C-MA in approximately 300 participants with ADP. |
| • | ML-007C-MA received Fast Track designation from the FDA in December 2025 for the treatment of hallucinations and delusions associated with ADP. |
| • | Topline results from VISTA are expected in the second half of 2027. |
ML-004 (5-HT1B/1D Agonist) for the Treatment of Autism Spectrum Disorder (ASD)
| • | Reported topline results in June 2026 from the Phase 2 IRIS trial of ML-004 in autism spectrum disorder. While the study did not meet its primary endpoint in social communication, a prespecified analysis demonstrated clinically meaningful improvements in irritability among adolescents with moderate or greater baseline irritability. |
| • | ML-004 was generally well tolerated in the IRIS trial, with no severe or serious adverse events in the active treatment arm. This profile is relevant in a treatment setting with limited approved options, where antipsychotic-associated tolerability concerns can present challenges for long-term use, particularly in younger patients. |
| • | Following its planned End-of-Phase 2 discussion with the FDA, the Company intends to evaluate the path forward for ML-004, including potential strategic collaborations and/or funding alternatives. |
Corporate Updates
| • | In August 2026, the Company announced a $150 million private placement, with participation from new and existing institutional investors. Proceeds from the financing are expected to primarily support the continued advancement of ML-007C-MA, including funding the planned Phase 3 ZEPHYR-2 trial and ongoing Phase 2 VISTA trial, and for working capital and other general corporate purposes. Based on its current operational plans and assumptions, MapLight expects that its existing cash, cash equivalents and investments, together with the net proceeds from the PIPE, will be sufficient to fund the continued advancement of ML-007C-MA through 2028. |
| • | The Company is focusing resources on the advancement of ML-007C-MA, including pausing further investment in preclinical and discovery-stage programs and foregoing advancement of those programs into clinical development under the current operating plan. |
Second Quarter 2026 Financial Results
| • | Cash Position: Cash, cash equivalents and investments were $351.3 million as of June 30, 2026. Based on current operational plans and assumptions, the Company expects that its existing cash, cash equivalents and investments, together with the net proceeds from the recent private placement, will be sufficient to fund the continued advancement of ML-007C-MA through the end of 2028. |
| • | R&D Expenses: Research and development (R&D) expenses were $53.4 million for the second quarter of 2026, as compared to $26.8 million for the second quarter of 2025. R&D expenses increased primarily due to increases in clinical trial expenses and employee-related expenses, including an increase in stock-based compensation expense of $5.6 million. |
| • | G&A Expenses: General and administrative (G&A) expenses were $10.1 million for the second quarter of 2026, as compared to $3.8 million for the second quarter of 2025. G&A expenses increased primarily due to increases in employee-related expenses, including an increase in stock-based compensation expense of $2.9 million, and increases in professional fees and other expenses. |
| • | Net Loss: Net loss was $60.2 million for the second quarter of 2026, as compared to $29.8 million for the second quarter of 2025. |
About MapLight Therapeutics
MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The Company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. The Company’s discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation.
For more information, please visit www.maplightrx.com.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the clinical development and potential benefits of ML-007C-MA and ML-004, the design, timing and conducting of future clinical trials, the registrational pathway for the Company’s product candidates, including holding EOP2 meetings with the FDA for ML-007C-MA and ML-004 and planned regulatory submissions, the availability and timing of results from the Company’s Phase 2 VISTA trial and the Company’s Phase 3 ZEPHYR-2 trial, and the potential benefits of the Company’s discovery platform. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in the Company’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: the unpredictable relationship between preclinical study results and clinical study results; the risk that results obtained in any clinical trials to date may not be indicative of results obtained in ongoing or future trials; the timing or likelihood of regulatory filings and approvals; expectations regarding the Company’s ability to fund its current operations; and other risks and uncertainties identified in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and subsequent disclosure documents the Company may file with the SEC. The Company claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
MapLight Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: |
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| Research and development |
$ | 53,435 | $ | 26,846 | $ | 107,119 | $ | 46,633 | ||||||||
| General and administrative |
10,113 | 3,817 | 20,932 | 7,573 | ||||||||||||
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| Total operating expenses |
63,548 | 30,663 | 128,051 | 54,206 | ||||||||||||
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| Loss from operations |
(63,548 | ) | (30,663 | ) | (128,051 | ) | (54,206 | ) | ||||||||
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| Other income, net: |
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| Interest income |
2,349 | 688 | 4,821 | 1,499 | ||||||||||||
| Other income, net |
1,007 | 130 | 2,370 | 522 | ||||||||||||
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| Net loss |
$ | (60,192 | ) | $ | (29,845 | ) | $ | (120,860 | ) | $ | (52,185 | ) | ||||
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| Net loss per share - basic and diluted |
$ | (1.32 | ) | $ | (39.11 | ) | $ | (2.66 | ) | $ | (68.46 | ) | ||||
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| Weighted-average number of common shares outstanding - basic and diluted |
45,431,359 | 763,044 | 45,354,488 | 762,325 | ||||||||||||
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Select Condensed Consolidated Balance Sheet Data
(Unaudited)
(in thousands)
| June 30, 2026 |
December 31, 2025 |
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| Cash, cash equivalents and investments |
$ | 351,341 | $ | 453,096 | ||||
| Total assets |
368,348 | 479,512 | ||||||
| Total current liabilities |
19,294 | 16,229 | ||||||
| Total liabilities |
20,049 | 21,140 | ||||||
| Total stockholders’ equity |
348,299 | 458,372 | ||||||
For investor inquiries: investors@maplightrx.com
For media inquiries: media@maplightrx.com
Exhibit 99.2
MapLight Therapeutics Announces $150 Million Private Placement Financing
SAN FRANCISCO and BOSTON, August 13, 2026 (GLOBE NEWSWIRE) — MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, announced today that it has entered into a securities purchase agreement with institutional and accredited investors to sell securities in a private placement financing (the “PIPE”) for gross proceeds of approximately $150 million, before deducting placement agent fees and estimated offering expenses. The financing is being led by new and existing institutional investors.
In the PIPE, MapLight is selling an aggregate of 9,197,887 shares of its common stock at a price of $11.38 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 3,983,168 shares of common stock at a purchase price of $11.3799 per pre-funded warrant. Each pre-funded warrant has an exercise price of $0.0001 per share of common stock, will be immediately exercisable, subject to certain conditions set forth in each pre-funded warrant, and will not expire. The PIPE is expected to close on August 14, 2026, subject to customary closing conditions.
MapLight intends to use the proceeds from the PIPE primarily to support the continued advancement of ML-007C-MA, including funding the ongoing VISTA Phase 2 study in Alzheimer’s disease psychosis as well as the ZEPHYR-2 registrational Phase 3 study in schizophrenia and its associated open-label safety study, and for working capital and other general corporate purposes. The Company plans to engage with the U.S. Food and Drug Administration at an End-of-Phase 2 meeting to discuss the path forward for ML-007C-MA in schizophrenia, including the design of a Phase 3 trial, which, together with ZEPHYR, would be designed to support a New Drug Application submission. MapLight’s cash, cash equivalents and investments were $351.3 million as of June 30, 2026. Based on its current operational plans and assumptions, MapLight expects that its existing cash, cash equivalents and investments, together with the net proceeds from the PIPE, will be sufficient to fund the continued advancement of ML-007C-MA through 2028.
Morgan Stanley, Jefferies, Leerink Partners and Stifel are acting as placement agents for the PIPE.
Cooley LLP served as counsel to MapLight for the PIPE. Latham & Watkins LLP served as counsel to the placement agents for the PIPE.
The securities to be sold in the PIPE, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, these securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. MapLight has agreed to file a registration statement with the Securities and Exchange Commission (“SEC”) registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the pre-funded warrants issued in the PIPE.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About MapLight Therapeutics
MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The Company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. The Company’s discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including statements regarding the closing of the proposed PIPE; the anticipated use of proceeds of the PIPE; the clinical development and potential benefits of ML-007C-MA and ML-004, including the design, timing and conducting of future clinical trials; and the registrational pathway for the Company’s product candidates, including holding End-of-Phase 2 meetings with the FDA for ML-007C-MA and planned regulatory submissions. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in the Company’s filings with the SEC, many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties regarding MapLight’s business are identified in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and subsequent disclosure documents the Company may file with the SEC, which are available on the SEC’s website at www.sec.gov. The Company claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
For investor inquiries: investors@maplightrx.com
For media inquiries: media@maplightrx.com
Corporate Presentation August 13, 2026 Exhibit 99.3
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MapLight Therapeutics Working to Improve the Lives of Patients Suffering From Debilitating CNS Disorders Novel M1/M4 muscarinic agonist in combination with a peripheral antagonist with a lead indication in schizophrenia, a disease affecting >20 million people globally ~20-35%+ of patients with ASD experience clinically significant irritability or aggression, while available therapies have substantial safety and tolerability challenges Targeting Areas of High Unmet Need Founded by globally recognized leaders in neuropsychiatry to address lack of circuit-specific therapies Discovery platform to identify and validate novel drug targets causally linked to disease symptoms Diversified product pipeline with potential across several CNS disorders Circuit-Driven Discovery Engine Plan to initiate ZEPHYR-2, a registrational study of ML-007C-MA in schizophrenia Plan to engage with the FDA at an End-of-Phase 2 meeting following the ASD irritability signal Strong financial position with ~$501M in cash and runway through 2028 (1) Led by a team with CNS drug discovery and development expertise Advancing Key Near-Term Milestones ADP = Alzheimer’s disease psychosis; ASD = autism spectrum disorder; CNS = central nervous system. Unaudited cash, cash equivalents, and investments of $351 million as of June 30, 2026; pro forma for $150M in gross proceeds from private placement announced in August 2026.
Program Circuit Indications Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones ML-007C-MA M1/M4 agonist co-formulated with PAC Direct and Indirect Pathways Schizophrenia Engage with FDA at EOP2 meeting Alzheimer’s Disease Psychosis Topline results in 2H 2027 ML-004 5-HT1B/1D agonist Dorsal Raphe to Nucleus Accumbens Autism Spectrum Disorder Sociability/Irritability Engage with FDA at EOP2 meeting ML-009 GPR52 PAM Indirect Pathway Hyperactivity/Impulsivity Complete IND-enabling studies in 2027 ML-055 Next-Gen M1/M4 agonist Direct and Indirect Pathways Neuropsychiatric Disorders Nominate preclinical candidate in 2026 ML-021 M4 antagonist Direct Pathway Parkinson’s Disease Finalize preclinical candidate in 2027 Potential in other indications being explored ZEPHYR VISTA IRIS Fast Track Leveraging our versatile circuit-based discovery platform for ongoing pipeline expansion Broad and Diversified Pipeline GPR = G-protein-coupled receptor. PAC = peripherally acting anti-cholinergic. PAM = positive allosteric modulator.
ML-007C-MA Lead Asset in Development for Schizophrenia and ADP
Existing evidence is derived from post hoc or exploratory pooled analyses across two studies Cognitive benefit remains unproven ~30% show no meaningful response to treatment (1) ~40-50% experience an inadequate response to standard of care (1) ~70% discontinue oral therapies within 18 months, often due to burdensome side effects (e.g., EPS, weight gain) (2) Patients Remain Underserved by Current SOC Antipsychotics… 2024: First New Mechanism Approved in Decades (Cobenfy) …Yet Significant Treatment Gaps Still Remain After First Muscarinic Approval Failure to achieve adequate therapeutic exposure may leave symptoms insufficiently controlled (3) Many patients cannot reach or remain at target dose Tolerability challenges observed in controlled trials amplified in practice, given dosing / fasting complexity (3) Tolerability burden is exacerbated in real world Unmet Need in Schizophrenia Remains High Affects Over 20 Million People Globally, Including More Than 3 Million in the U.S. SOC = standard of care; EPS = extrapyramidal symptoms. Siskind et al., Br J Psychiatry (2022); treatment-resistant≥2 treatments. Samara et al., Schizophrenia Bulletin (2019); response as measured within 4-6 weeks. Lieberman et al., NEJM (2005). CATIE trial; all-cause discontinuation. BMS. Real-world transition strategies with xanomeline/trospium. Poster, Psych Congress 2025.
Met the primary endpoint on PANSS Total Score (ES=0.37), with a stronger effect in completers in which there are no modelled assumptions of missing data (ES=0.50) Achieved significance on CGI-S and PANSS Positive Marder Factor Statistically Significant Across Complementary Measures Prespecified Cognitive Composite Score improved significantly (ES=0.51) Change in the cognitive composite score was independent of changes in PANSS, suggesting it was not simply driven by better control of psychotic symptoms Potentially Differentiating Cognitive Signal No serious or drug-related severe adverse events; 99% of patients reached the target dose; low rates of moderate GI side-effects No fasting requirement or complex titration, unlike other agents in the class, potentially increasing adherence and persistence Tolerability Built for Real-World Use Data support advancement of 210/3 mg BID into a confirmatory pivotal trial and continued investment in indication expansion, leveraging the observed cognitive signal; next steps will be guided by the planned EOP2 meeting Developing a Differentiated Treatment, Designed to Translate into Real-World Use
LS Mean CFB (SE) in PANSS Total Score Primary Endpoint: PANSS Total Score 210/3 mg BID Met Primary Endpoint Change From Baseline in PANSS Total Score (LS Mean Difference) *p<0.05 LS = least squares; SE = standard error. Note: Negative treatment deltas favor active treatment; effect size presented as an absolute value. Analysis based on the mITT population. NCT06887192: Evaluating ML-007C-MA for the treatment of hallucinations and delusions associated with Alzheimer’s Disease Psychosis (ADP) ML-007C-MA 210/3 mg BID Placebo ML-007C-MA 330/6 mg QD Placebo 210/3 mg BID 330/6 mg QD N N=103 N=93 N=98 LS Mean CFB -7.2 -11.7 -10.0 LS Mean Diff vs. Placebo -4.5 -2.8 P-value p=0.015 p=0.110 Effect Size 0.37 0.23 * * * Week 1 Week 2 Week 3 Week 4 Week 5 ZEPHYR met its primary endpoint: Demonstrated a statistically significant, clinically meaningful reduction in PANSS total score vs. placebo at Week 5 210/3 mg dose is also being evaluated for the treatment of ADP (VISTA(1) study ongoing)
Week 1 Week 2 Week 3 Week 4 Week 5 Primary Endpoint: PANSS Total Score Robust Effect Demonstrated in Prespecified Completer Analysis Change From Baseline in PANSS Total Score (LS Mean Difference) LS Mean CFB (SE) in PANSS Total Score *p<0.05, **p<0.01 MMRM= Mixed model for repeated measures. Note: Negative treatment deltas favor active treatment; effect size presented as an absolute value. Analysis based on the mITT population. ML-007C-MA 210/3 mg BID (mITT) Placebo (Completer) ML-007C-MA 210/3 mg BID (Completer) Placebo (mITT) z ** ** ** * * * Placebo (Completers) 210/3 mg BID (Completers) N N=88 N=73 LS Mean CFB -7.5 -13.4 LS Mean Diff vs. Placebo -6.0 P-value p=0.002 Effect Size 0.50 The completer analysis excludes modelled assumptions about missing data, relying solely on observed data from the full assessment period Bigger difference in completer analysis driven mostly by improvement in BID arm, not placebo
Key Secondary Endpoint: CGI-S Significant Improvement Corroborates PANSS Improvement Change From Baseline in CGI-S (LS Mean Difference) LS Mean CFB (SE) in CGI-S Clinically meaningful and statistically significant improvement in CGI-S vs. placebo at Week 5 0.38-point improvement -0.75 active vs. -0.36 placebo p=0.002(1) ES = 0.48 Numerical separation starting at Week 1, with statistical significance emerging by Week 3 and continuing over time **p<0.01 Note: Negative treatment deltas favor active treatment; effect size presented as an absolute value. Analysis based on the mITT population. (1) Multiplicity-adjusted one-sided P value= 0.017 ML-007C-MA 210/3 mg BID Placebo ** ** ** Week 1 Week 2 Week 3 Week 4 Week 5
Change From Baseline in PANSS Positive Symptoms (LS Mean Difference) *p<0.05 , **p<0.01 Note: Negative treatment deltas favor active treatment; effect size presented as an absolute value. Analysis based on the mITT population. PANSS Positive Symptoms Significant Improvement in PANSS Positive Marder Factor and Positive Subscale Placebo PANSS + Marder PANSS + Subscale N 103 93 93 LS Mean CFB -1.9/-1.9 (Marder/ Subscale) -3.4 -4.2 LS Mean Diff vs. Placebo -1.6 -2.3 P-value p=0.012 p=0.0003 Effect Size 0.39 0.56 Week 1 Week 2 Week 3 Week 4 Week 5 ML-007C-MA 210/3 mg BID (Marder Factor) Placebo (Subscale) ML-007C-MA 210/3 mg BID (Subscale) Placebo (Marder Factor) LS Mean CFB (SE) in PANSS Positive Symptoms ** ** ** * * * ** Clinically meaningful and statistically significant improvement in PANSS positive symptoms vs. placebo at Week 5 PANSS Positive Marder Factor was a key secondary- PANSS positive Subscale was prespecified
Pre-specified Cognitive Composite Score Results Cognitive Composite Score CFB to Week 5 PANSS Total Score CFB to Week 5 Cognitive Composite Score Placebo 210/3 mg BID N with baseline impairment N=37 N=31 LS Mean Change from Baseline 0.11 0.55 LS Mean Difference vs. Placebo 0.44 P-value p=0.041 Effect Size 0.51 Dose used in VISTA ML-007C-MA 210/3 mg BID Placebo Note: Prespecified Cognitive Composite score derived from Cogstate Battery consisting of 6 individual tests Secondary Endpoint: Cognitive Composite Robust and Clinically Meaningful Improvement on Cognitive Performance No observed significant relationship between cognitive improvement and PANSS change Placebo: r=-0.071, p=0.678; BID: r=-0.187, p=0.314
Implications of Cognitive Signal Beyond ZEPHYR Supports Rationale for VISTA and Broader Development Cognitive impairment is estimated to affect >80% of patients with schizophrenia (1) Cognitive impairment is a major determinant of long-term functional outcomes, including employment, independent living and quality of life Despite decades of research, no therapies have been approved to treat cognitive impairment in schizophrenia Highlights both the unmet need and the difficulty of demonstrating meaningful cognitive benefit Sedation and dopamine blockade from many SOC antipsychotics may worsen cognition Cognitive Impairment Remains an Unmet Need The Signal Supports the Underlying Biology The cognitive benefit was observed on a prespecified secondary endpoint Change in the cognitive composite score was independent of changes in PANSS, suggesting it was not simply driven by better control of psychotic symptoms The finding is consistent with the established role of M1 receptor activation in learning and memory, strengthening confidence in the underlying mechanism Why This Matters for VISTA (3) and Future Development A positive cognitive signal observed outside AD increases confidence that the biology translates across neuropsychiatric populations Off-label use of antipsychotics in ADP has been associated with accelerated cognitive decline (CATIE-AD), highlighting the need for new therapies (2) The 210/3 mg BID dose currently being evaluated in VISTA is the same dose that demonstrated cognitive benefit in ZEPHYR Maroney, Ment Health Clin. 2022. Vigen et al., Am J Psychiatry. 2011. NCT06887192: Evaluating ML-007C-MA for the treatment of hallucinations and delusions associated with Alzheimer’s Disease Psychosis (ADP).
210/3 mg BID Demonstrated Effect Across Multiple Endpoints and Symptom Domains N Active / PBO LS Mean Difference [95% CI] Effect Size P-value PANSS Total Score – mITT 93 / 103 0.37 0.015 PANSS Total Score - Completers 73 / 88 0.50 0.002 CGI-S 93 / 103 0.48 0.002 Cognitive Composite 31 / 37 0.51 0.041 PANSS Marder Positive Factor 93 / 103 0.39 0.012 PANSS Marder Negative Factor 93 / 103 0.18 0.244 CGI-C 93 / 103 0.47 0.002 PGI-C 93 / 103 0.38 0.015 -0.6 -0.4 -0.2 0 1.0 0.8 0.6 0.4 0.2 0 -3 -2 -1 0 -3 -2 -1 0 ← ML-007C-MA favored PBO favored → -10 -8 -6 -4 -2 0 -10 -8 -6 -4 -2 0 CGI-C = Clinical Global Impression of Change; PGI-C = Patient Global Impression of Change. Note: Graphed data represent the LS mean difference (ML-007C-MA 210/3 mg BID − placebo) and 95% confidence intervals -0.8 -0.6 -0.4 -0.2 0 -0.8 -0.6 -0.4 -0.2 0 Participants on active treatment were, compared to placebo: 2.4x more likely to achieve ≥30% response on the PANSS total score by Week 5 (p=0.021) 2.8x more likely to be ready for discharge out of the inpatient hospital setting by Week 5 (p=0.002)
ML-007C-MA Was Generally Well Tolerated Single serious adverse event occurred in placebo arm was worsening schizophrenia. Adverse events, primarily cholinergic in nature, were mostly mild No serious or drug-related severe TEAEs occurred with either dose (1) The only severe TEAE (pneumonia) was assessed as unrelated to study drug There were no instances of failure to reach target dose due to tolerability Dose reduction due to TEAE was infrequent (4 participants); TEAEs leading to dose reduction started in the first week, and most (75%) completed treatment following dose reduction Low rates of moderate GI side-effects Low rates of discontinuation (2 participants) due to gastrointestinal adverse events No urinary retention signal observed: The active and placebo arms each had a single moderate urinary event (UTI) No metabolic, hepatic, or EPS signals observed: mean weight, glucose, lipid, liver enzyme, and movement-related parameters remained comparable to placebo Heart rate increases were mild and consistent with the fesoterodine label, with no evidence of significant blood pressure elevation Adverse Events Mostly Mild GI Events Rarely Led to Discontinuation with BID Dosing No Signal Across Key Safety Domains
Placebo N=104 210/3 mg BID N = 99 Mild Moderate Mild Moderate Nausea 6% 0 20% 9% Vomiting 1% 2% 9% 4% Dyspepsia (3) 0 1% 8% 1% Constipation 3% 0 8% 1% Abdominal pain (3) 3% 0 6% 3% Diarrhea 1% 0 5% 0 GERD 2% 0 2% 0 Rates of TEAEs With BID Dosing GI TEAEs ≥2% in Active Arm and > Placebo Most Adverse Events Were Mild All Cause Discontinuation Was Low at 19.9% Across Active Treatment Arms All GI TEAEs were mild to moderate in severity AE = adverse event. One participant was withdrawn due to baseline (pre-dose) lab findings following titration dose but prior to first target dose. Assessed as unrelated to study drug (pneumonia). Dyspepsia includes dyspepsia and esophageal discomfort; abdominal pain includes abdominal discomfort, abdominal pain upper, abdominal pain, abdominal pain lower, abdominal distension, and abdominal tenderness Other TEAEs ≥5% include: headache, salivary hypersecretion, dizziness, hyperhidrosis, hot flushes, somnolence, chills, decreased appetite, tremor, and insomnia Single episode of unrelated hypertension; one episode of orthostatic hypotension observed in each of the placebo and BID dosing arms Placebo N=104 210/3 mg BID N = 99 Discontinuations Due to TEAE 1.0% 7.1% Due to GI TEAE 0 2.0% Utilization of Lower Dose Dose Reduction Due to TEAE 1.9% 4.0% Inability to Reach Target Dose 0 1% (1) Any TEAE 48.1% 74.7% Mild 36.5% 48.5% Moderate 11.5% 25.3% Severe TEAE 0 1.0% (2) Serious TEAE 1.0% 0
EMERGENT-2 EMERGENT-3 Placebo Active Placebo Active Discontinuations Due to TEAE 5.6% (2) 7.1% (2) 5.5% (3) 6.4% (3) Due to GI TEAE Not reported 3.2% (4) Not reported 3.2% (4) Utilization of Lower Dose Dose Reduction Due to TEAE(1) 0 5.6% 0.8% 0.8% Inability to Reach Target Dose 1.6% (2) 17.5% (2) 9% (5) 21% (5) Any TEAE 58.4% 75.4% 50.0% 70.4% Mild (1) 27.2% 38.1% 25.8% 36.0% Moderate (1) 24.8% 28.6% 20.3% 26.4% Severe TEAE (1) 4.0% 7.1% 2.3% 8.0% Serious TEAE 1.6% (2) 1.6% (2) 0 0.8% (6) Rates of TEAEs for Cobenfy in Pivotal Studies All Cause Discontinuation Ranged From 25.4%-36.8% at 5 weeks (1) Moderate-or-worse TEAE burden was meaningfully lower for ML-007C-MA (26%) than reported in Cobenfy's pivotal trials (34-36%) Cobenfy FDA Label EMERGENT-2/3 Pooled Placebo (N=253) Active (N=251) Nausea 4% 19% Dyspepsia (7) 5% 18% Constipation 7% 17% Vomiting 1% 15% Abdominal Pain (7) 4% 8% Diarrhea 2% 6% GERD <1% 5% GI TEAEs >2% in Active Arm and > Placebo 51%-78% did not complete 1 year of treatment in the open-label studies (8) Real-world non-persistence is ~80% by Month 13 (9) Real-world Patient Experience (N=90) (10) >2-3x >80% 55% the rates of nausea and vomiting did not reach the highest dose (125/30 mg) received medication for GI events >50% had no or only partial response to intervention Cobenfy FDA Summary Basis of Approval (SBA). EMERGENT-2 primary manuscript: Kaul et al., 2024. Pbo: appendicitis(n=1), schizophrenia (n=1). Active: suicidal ideation (n=2). EMERGENT-3 primary manuscript: Kaul et al., 2024. Pooled EMERGENT-2 and -3 rate. 8 participants discontinued in the Cobenfy arm per the SBA (Table 35) in the pooled EMERGENT-1,2,3 studies. Per Karuna 2023 10-K filing, only N=2 participants discontinued from the active arm of EMERGENT-1 (N=89), neither from the GI system organ class. Karuna 2023 10-K filing. EMERGENT-3 topline results, per Karuna Therapeutics press release (March 2023). Active: GERD (n=1). Dyspepsia includes dyspepsia and esophageal discomfort; abdominal pain includes abdominal discomfort, abdominal pain upper, abdominal pain, abdominal pain lower, and abdominal tenderness. EMERGENT-4 and EMERGENT-5 results, Kaul et al., 2026. Non-persistence: MapLight estimate, third-party Rx data. Retrospective analysis of real-world transition strategies for xanomeline and trospium chloride in adult patients with schizophrenia. Poster, Psych Congress 2025.
PANSS Total Score: Standardized Effect Sizes (Cohen’s d) Peak Sales (Year) (1) $5.0B $3.2B $3.4B $5.8B $6.2B $2.0B $4.3B $6.0B $2.6B (2010) (2036E) (2007) (2011) (2013) (2020) (2028E) (2039E) (2027E) Significant Opportunity for New Therapies 210/3 mg BID Effect Size Falls Within the Range of Approved Antipsychotics Approved Therapies (mITT ES) Completers ES (Range Shown, if Available) ML-007C-MA (mITT ES) Active arm favored → ← PBO favored Note: Assessments reflect management’s current views based on publicly available information and internal analyses; comparisons are subject to uncertainty around interpretation. Differences exist among study designs, and caution should be exercised when comparing data across trials. Sources: Approved antipsychotic effect sizes per Huhn et al., Lancet 2019; Correll et al., JAMA Psychiatry 2020; Cobenfy per Fabiano et al., 2025 meta-analysis. Completer analysis effect size for Cobenfy estimated based on data from Kaul et al., 2023 and Kaul et al., 2024; Zyprexa and Latuda based on data from Latuda’s FDA Summary Basis of Approval Tables 37 and 52. Completer/observed-case values reflect trial-completer populations only, not intent-to-treat; ranges reflect variation across available analyses. ML-007C-MA completer analysis: N=73 (p=0.002). WW consensus peak sales (oral) as per Evaluate Pharma and Visible Alpha as of July 2026; Caplyta projections only available through 2030 (LOE 2039); all indications.
Program Mechanism of Action Efficacy in RCTs 210/3 mg BID hit primary endpoint Cognitive Improvement Prespecified secondary endpoint Tolerability/Safety Meaningfully lower rates of significant side effects No Fasting Requirement Taken with food Simple Titration One-dose titration Dosing Frequency QD dose to be further explored ML-007C-MA Target Product Profile has Potential to be Differentiated Across Multiple Dimensions RCT = randomized controlled trials; PAM = positive allosteric modulator. Note: Assessments reflect management’s current views based on publicly available information and internal analyses; comparisons are qualitative and subject to uncertainty around interpretation. Differences exist among study designs, and caution should be exercised when comparing data across trials. Based on results from ZEPHYR-1 Phase 2 study, and product profile is subject to the completion of additional studies and review by the FDA Based on FDA prescribing information. Based on results from the Phase 2 EMPOWER-1 and EMPOWER-2 clinical trials, which failed to demonstrate a statistically significant improvement in PANSS total score. Based on results from the Phase 2 clinical trial, which showed statistically significant improvement only at the lowest dose of the four active drug arms evaluated. No activity at M1 No activity at M1 Some may cause impairment Factors expected to impact real world translation SOC Antipsychotics Primarily D2-blockade Direclidine (4) M4 Agonist Emraclidine (3) M4 PAM Cobenfy (2) M1/M4 Agonist + Peripheral Antagonist ML-007C-MA (1) M1/M4 Agonist + Peripheral Antagonist In development U-shaped dose response Post-hoc/pooled analyses Moderate to severe TEAEs Must be taken fasted 3-8 day, 2-step titration BID Not stat. sig. in Ph 2 Metabolic, movement, sedation Varies across APs Varies across APs
Phase 3 Program and Path to NDA Submission Confirmatory Pivotal Trial Expected to Support Initial Approval Trial in ADP patients evaluating 210/3 mg BID (potentially registrational) On track, supported by ZEPHYR's prespecified cognitive signal Ongoing VISTA (Study 221) Topline results expected in 2H 2027 Evaluating potential in additional indications, including for the treatment of mild-moderate Alzheimer’s disease Engage with the FDA at EOP2 Meeting Established primary efficacy signal and safety for 210/3 mg BID Result supports pivotal status, pending confirmation with the FDA Complete ZEPHYR-1 (Study 211) Similar design to Phase 2, evaluating 210/3 mg BID vs. placebo in U.S. sites Together with Study 211, intended to support initial NDA submission Planned ZEPHYR-2 (Study 311)(1) Additional pivotal trial evaluating 210/3 mg BID Potential to evaluate an alternate QD regimen (would pursue as sNDA) For Future Consideration ZEPHYR-3 (Study 312) Subject to FDA feedback at EOP2 Meeting.
ML-007 Positioning: Clinically Meaningful Symptom Improvement, Well Tolerated, Built for Simple, Real-World Dosing Consistent, clinically meaningful benefit across PANSS, global measures, and responder analyses Effect size of 0.37 in mITT and 0.50 among study completers Prespecified cognitive benefit observed in patients with baseline impairment Cognitive improvement was independent of improvements in PANSS 99% of adverse events were mild or moderate; 80% completed treatment Low anticholinergic burden, no urinary-retention signal, and placebo-like cardiometabolic profile 99% reached the target dose following a simple, one-step initiation No fasting requirement, supporting straightforward and practical real-world use EFFICACY Meaningful, Concordant Efficacy Across Core Measures COGNITION Prespecified Cognitive Signal, Independent of Symptom Change SAFETY & TOLERABILITY Well Tolerated, With Low Anticholinergic Burden and Discontinuation Rates DOSING & ADMINISTRATION Simple Initiation and Administration Translating to Better Real-World Use
ML-004 5-HT1B/1D Agonist in Development for Autism Spectrum Disorder (ASD)
Unmet Need in ASD Irritability Remains High ~830K adolescents diagnosed with ASD (U.S., 2039E) (1) ~20-35%+ experience clinically significant irritability or aggression (2) 1 in 6 young people with ASD receive antipsychotics (3) Only 2 approved therapies both with warnings and precautions relevant to adolescents Additional options are needed to improve responses across a heterogeneous population Incomplete Treatment Response Weight gain, sedation and movement-related effects may impair daily functioning Meaningful Side-Effect Burden Tolerability concerns may limit chronic treatment, particularly in younger populations Challenges with Long-Term Use Safety concerns may discourage treatment, particularly in younger patients without psychosis Caregiver Hesitancy 2039 projection of U.S. adolescents; 2022 NSCH and Grosvenor et al., 2023 claims data. Alatrash et al., 2024; Manter et al., BMC Medicine 2025. Park et al., JAACAP 2016 meta-analysis.
Irritability Outcomes Includes Subjects with ABC-I >16 at Baseline ABC-I Subscale (1) Care partner-reported CGI-I Irritability Domain (2) Clinican-reported Two measures of irritability assessed by different raters LS Mean Difference vs. Placebo (95% CI), by Scale and Age Group Total N = 26 Adolescent N = 20 Total N = 26 Adolescent N = 20 LS Mean Diff. [95% CI] Effect Size P-value (* p < 0.05) -5.5 [-12.8, 1.8] 0.64 0.131 -9.6 [-16.8, -2.3] 1.33 0.013 * -0.4 [-1.0, 0.2] 0.61 0.153 -0.6 [-1.2, -0.0] 1.08 0.036 * ß ML-004 favored PBO favored à Note: Negative treatment deltas favor active treatment; effect size presented as an absolute value. Full Analysis set (FAS): The FAS includes all randomized subjects who received at least 1 dose of study drug after randomization and have DB Baseline and at least 1 post-DB Baseline assessment. ABC-I in the whole population was a key secondary endpoint evaluated in IRIS study; evaluation of change in the adolescent population was a prespecified endpoint CGI-I Global is included in labels for approved therapies.
ML-004 Has the Potential to Address Unmet Needs Through Established Development Path ML-004 demonstrated clinically meaningful improvements in irritability in adolescents with moderate or greater baseline irritability across both caregiver- and clinician-rated scales ABC-I (effect size of 1.33, nominal p-value of 0.013) CGI-I irritability (effect size of 1.08, nominal p-value of 0.036) 01 ML-004 was generally well tolerated across all doses and age groups No drug-related severe or serious AEs Meaningful differentiation from standard of care atypical antipsychotics No weight gain relative to placebo No evidence of extrapyramidal symptoms Low rates of fatigue / somnolence 02 Data support potential development of ML-004 for irritability associated with ASD, an indication with high unmet need and an established regulatory path; next steps will be guided by upcoming regulatory interactions
Appendix
Screening Period (Day -7 to -1) Blinded Treatment Period (Day 1 to 35) Follow-up Period (Day 36 to 42) Week 1 Week 2 Week 3 Week 4 Week 5 N = 307 Randomized 1:1:1 Sites: 25 (US only) Placebo Ÿ (N=104) ML-007C-MA Ÿ 330/6 mg QD (1) Ÿ (N=102) ML-007C-MA Ÿ 210/3 mg BID (1) Ÿ (N=101) Primary Endpoint Study Population 18 to 64 years of age with diagnosis of schizophrenia with MINI PANSS 80-120 at screening and baseline Score ≥4 for two or more positive symptom items CGI-S score ≥4 Untreated or recent wash-out of antipsychotics Primary Endpoint CFB PANSS Total Score at Week 5 Key Secondary Endpoints CFB CGI-S at Week 5 CFB PANSS positive Marder factor at Week 5 CFB PANSS negative Marder factor at Week 5 Other Secondary (Prespecified) CFB Cognitive Composite Score at Week 5 in the cognitively impaired at baseline subgroup ZEPHYR Study Outline Designed and Sized to Serve as a Registrational Study CFB = Change from baseline; MINI = Mini-International Neuropsychiatric Interview; QD = once-daily. Single-dose titration; reduction of dose permitted once between Week 1 to 3 to 165/3 mg BID or 270/6 mg QD
Screening Period (Day -35 to -1) Blinded Treatment Period (Day 1 to 49) Follow-up Period (7 + 2 days after last dose) Week 1 Week 2 Week 3 Week 5 Week 7 ML-007C-MA 210/3mg BID (n=150) Primary Endpoint Week 1 105/1.5mg BID Weeks 2-7 210/3mg BID (1) Placebo BID (n=150) N = 300 Randomized 1:1 Sites: 100 (global) Topline results expected in 2H 2027 VISTA Study Outline Designed and Sized to Serve as a Registrational Study NPI-C A+A = Neuropsychiatric Inventory Clinician, Agitation and Aggression; NPI-C H+D = Neuropsychiatric Inventory Clinician, Hallucinations and Delusions. Increase to the target dose of 210/3 mg BID at Week 1, unless the participant is experiencing tolerability issues that, in the investigator’s opinion, would preclude a higher dose. Every effort should be made to increase to the target dose as soon as possible up until Week 3. One-time dose reduction to 105/1.5 mg allowed for tolerability. Study Population 55 to 90 years of age Possible or probable Alzheimer’s disease Psychotic symptoms for >2 months NPI-C H+D score of ≥6; and ≥2 on at least two items of either the H or D domain scores CGI-S score ≥4 Primary Endpoint CFB to Week 7 on the NPI-C H+D domain scores Key Secondary Endpoints CFB to Week 7 on CGI-S score CFB to Week 7 on NPI-C A+A domain score in participants with moderate agitation at Baseline