NEW YORK, July 22, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Alto Neuroscience, Inc. (“Alto” or “the Company”) (NYSE: ANRO) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired (1) Alto ...

Core Viewpoint - A class action lawsuit has been filed against Alto Neuroscience, Inc. for allegedly misleading investors regarding the effectiveness of its product ALTO-100 and its business prospects [1][5]. Group 1: Lawsuit Details - The lawsuit is on behalf of purchasers of Alto common stock during the IPO on February 2, 2024, and securities purchased between February 2, 2024, and October 22, 2024 [1]. - Investors may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A lead plaintiff must move the Court by September 19, 2025, to represent other class members [3]. Group 2: Allegations Against Alto Neuroscience - Defendants allegedly made materially false and misleading statements about Alto's business and operations [5]. - Specific claims include that ALTO-100 was less effective in treating major depressive disorder than represented, leading to overstated clinical and commercial prospects [5]. - The lawsuit asserts that when the true information became public, investors suffered damages [5]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest against a Chinese company at the time [4]. - The firm has been consistently ranked among the top for securities class action settlements and has recovered hundreds of millions for investors [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in handling such cases [4].

Group 1 - A shareholder class action lawsuit has been filed against Alto Neuroscience, Inc. alleging that the company made materially false and/or misleading statements regarding its business and operations [1] - The lawsuit claims that ALTO-100 was less effective in treating Major Depressive Disorder (MDD) than previously communicated to investors, leading to overstated clinical, regulatory, and commercial prospects [1] - As a result of these allegations, the lawsuit asserts that Alto's overall business and financial prospects were also overstated [1] Group 2 - Investors who purchased shares of Alto between February 2, 2024, and October 22, 2024, and suffered significant losses are encouraged to discuss their legal rights [2] - The deadline for investors to request to be appointed as lead plaintiff in the case is September 19, 2025 [3] - Holzer & Holzer, LLC is a law firm specializing in representing shareholders and has a history of recovering significant amounts for investors affected by corporate misconduct [3]

NEW YORK, July 22, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all persons or entities who purchased or otherwise acquired Alto Neuroscience, Inc. (“Alto Neuroscience” or the “Company”) (NYSE: ANRO) (i) between February 2, 2024 and October 22, 2024, inclusive (the “Class Period”); and/or (ii) pursuant and/or traceable to Alto Neuroscience’s registrat ...

NEW YORK, July 22, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Alto Neuroscience, Inc. ("Alto" or the "Company") (NYSE: ANRO) and certain officers. The class action, filed in the United States District Court for the Northern District of California, and docketed under 25-cv-06105, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired: (a) Alto common stock pursuant and/or traceable to the O ...

Core Viewpoint - A class action lawsuit has been filed against Alto Neuroscience, Inc. for allegedly misleading investors regarding the effectiveness of its drug candidate ALTO-100 during its IPO and subsequent period [1][2]. Group 1: Company Overview - Alto Neuroscience, Inc. is a clinical-stage biopharmaceutical company based in the U.S. with a product pipeline that includes ALTO-100, which was in a Phase 2b clinical trial for treating major depressive disorder (MDD) at the time of its IPO [1]. - The IPO occurred on or about February 2, 2024, and the class period for the lawsuit extends from this date to October 22, 2024 [1]. Group 2: Allegations and Misleading Information - The lawsuit alleges that the Offering Documents related to the IPO were negligently prepared and that the company failed to disclose critical information about ALTO-100's effectiveness [2]. - Specifically, it is claimed that ALTO-100 was less effective in treating MDD than represented, leading to overstated clinical, regulatory, and commercial prospects, which in turn inflated Alto's business and financial outlook [2]. Group 3: Impact of Clinical Trial Results - On October 22, 2024, Alto announced that ALTO-100 did not meet its primary endpoint in the Phase 2b trial, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo [3]. - Following this announcement, Alto's stock price plummeted by $10.17 per share, a decrease of 69.99%, closing at $4.36 per share on October 23, 2024 [3]. Group 4: Legal Proceedings - Shareholders interested in participating in the class action have until September 19, 2025, to seek lead plaintiff status, which allows them to represent other class members in the litigation [4]. - Participation in the case is not required to be eligible for recovery, and shareholders can choose to remain absent class members [4].

Summary of Alto Neuroscience (ANRO) FY Conference - June 17, 2025 Company Overview - **Company**: Alto Neuroscience - **Industry**: Clinical stage biopharmaceutical company focused on precision psychiatry through biomarker-guided drug development - **Pipeline**: Five phase two programs targeting depression, bipolar disorder, and schizophrenia using a proprietary platform that integrates EEG, cognitive assessments, and wearable data to optimize patient treatment matching [2][8] Core Points and Arguments Challenges in Psychiatry - Traditional psychiatric treatments often lack data-driven selection, relying on historical responses from patients or family members [3][9] - There is a significant gap in understanding which treatments work for specific patients and the underlying reasons [3][9] Precision Psychiatry Approach - Alto Neuroscience aims to address these challenges by utilizing biomarkers to understand drug effects on brain functions related to psychiatric disorders [4][10] - The company employs biomarkers to determine drug efficacy and predict patient responses, thereby reducing risks in drug development [5][12] Clinical Programs and Prioritization - Alto has five clinical stage programs, with a focus on late-stage trials that leverage existing data to inform patient selection and drug efficacy [13][14] - The company is broadening its representation of psychopathology, including various forms of depression and cognitive impairment in schizophrenia [14][15] FDA Guidance and Digital Biomarkers - Alto aligns its strategies with evolving FDA guidance on enrichment strategies in psychiatry trials, particularly regarding digital biomarkers [17][19] - The company has engaged with the FDA to ensure its biomarker strategies are scientifically sound and regulatory compliant [19] Alto 207 - Dopamine Agonist for Treatment-Resistant Depression (TRD) - Alto 207 is positioned as a next-generation dopamine agonist, differentiating itself from existing treatments by directly stimulating the dopamine system [20][21] - The combination of pramipexole (a D3-preferring dopamine agonist) with ondansetron (an antiemetic) aims to mitigate side effects like nausea and vomiting, allowing for faster and higher dosing [22][23] - The program is set to enter a late-stage phase 2b trial, with promising preliminary data indicating significant antidepressant efficacy [23][26] Upcoming Trials and Expectations - The phase 2b trial for Alto 207 is designed to support registration, with expectations for interactions with the FDA to clarify pivotal design [30][31] - The company anticipates a broad TRD label, with biomarkers serving as adjuncts to enhance clinical decision-making [27][28] Other Pipeline Developments - **Alto 203**: An early-stage program using an H3 inverse agonist strategy, focusing on subjective response and cognition [36][37] - **Alto 101**: Targets cognitive impairment associated with schizophrenia, utilizing a transdermal formulation to improve tolerability [41][43] - **Alto 300**: An approved antidepressant in Europe, being developed in the US with a focus on biomarker-defined patient populations [46][48] Market Positioning - Alto 207 is expected to compete favorably against existing treatments like SPRAVATO, with advantages in efficacy, safety profile, and ease of use [34][35] - The company aims to address a significant unmet need in the TRD population, estimated at three million patients in the US annually [32][33] Important but Overlooked Content - The company emphasizes the importance of rigorous patient selection and compliance monitoring to ensure trial integrity and data quality [56][58] - Alto is implementing advanced AI tools to enhance patient profiling and trial execution, aiming to mitigate risks associated with noncompliance and professional patients [58] This summary encapsulates the key insights from the conference, highlighting Alto Neuroscience's innovative approach to psychiatric treatment and its strategic positioning within the biopharmaceutical industry.

Summary of Alto Neuroscience (ANRO) Conference Call Company Overview - **Company**: Alto Neuroscience - **Focus**: Precision psychiatry, aiming to understand individual brain biology to guide treatment development and patient selection [4][5] Key Points and Arguments Precision Psychiatry Approach - Alto Neuroscience employs a precision psychiatry approach, focusing on understanding the biology of individual patients to improve treatment outcomes [4] - The company identifies a significant need for innovation in psychiatry, given the high prevalence of mental health issues and limited advancements [4] Biomarkers and Drug Development - All programs incorporate biomarkers to enhance patient selection and treatment efficacy [5] - The company is developing multiple phase 2B studies, utilizing biomarkers to define patient populations that will benefit from treatments [6] FDA Interaction and Regulatory Strategy - The FDA is primarily concerned with clear patient definitions and inclusion/exclusion criteria, which Alto believes can be effectively addressed through their biomarker approach [12][14] - The company has engaged with the FDA regarding their programs, indicating a supportive stance if the biomarker rationale is clear [14] Recent Acquisition - Alto recently acquired a new asset, Alto 207, a fixed-dose combination of pramipexole and ondansetron, aimed at treating treatment-resistant depression (TRD) [15][16] - The combination is designed to enhance antidepressant efficacy while minimizing side effects, allowing for faster titration [16][19] Clinical Data and Efficacy - Initial studies show promising results for the combination, with a significant effect size on MADRS scores, indicating potential for rapid effects in TRD patients [22][23] - The study demonstrated a Cohen's D of 1.1, with an eight-point difference in MADRS scores between drug and placebo at eight weeks [23] Future Plans and Trials - Phase 2B trials for Alto 207 are set to begin in the first half of next year, with results expected in 2027 [26] - The company has sufficient cash runway into 2028, allowing for multiple upcoming catalysts, including three phase 2B trials [55] Other Programs - Alto is also developing an H3 inverse agonist compound, with a focus on pharmacodynamics and cognitive benefits [34][35] - The company is exploring biomarkers for cognitive impairment in schizophrenia, specifically using EEG to measure treatment effects [47][49] Additional Important Insights - The company emphasizes the importance of selecting the right patient populations based on cognitive impairment metrics, which could enhance the efficacy of treatments [50] - Alto's strategy includes leveraging existing safety data to streamline the regulatory pathway for new drug combinations [31][32] - The potential for complementary biomarkers to improve treatment outcomes and payer acceptance is a key aspect of Alto's strategy [30] This summary encapsulates the critical insights from the conference call, highlighting Alto Neuroscience's innovative approach to psychiatric treatment and its strategic plans for future development.

Alto Neuroscience (ANRO) Update / Briefing June 03, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Alto Neuroscience Investor Conference Call to discuss the company's acquisition of a novel dopamine agonist combination product candidate. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Amit Edkin, Founder ...

Part I - Financial Information [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Q1 2025 reflect a net loss of $15.2 million, a decrease in total assets, and an increase in total liabilities, with $160.8 million in cash Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $160,754 | $168,229 | | Total assets | $171,915 | $177,542 | | Total liabilities | $32,819 | $26,082 | | Total stockholders' equity | $139,096 | $151,460 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $9,974 | $9,952 | | General and administrative | $5,702 | $4,434 | | Loss from operations | $(15,676) | $(14,386) | | Net loss | $(15,169) | $(13,417) | | Net loss per share, basic and diluted | $(0.56) | $(0.76) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,556) | $(10,983) | | Net cash used in investing activities | $(24) | $(224) | | Net cash provided by financing activities | $9,127 | $134,559 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage biopharmaceutical business, its accumulated deficit of $153.6 million, and key financing activities including an amended $75.0 million loan and an $11.7 million convertible grant - The company is a clinical-stage biopharmaceutical firm developing personalized psychiatry treatments with **five clinical-stage assets** in its pipeline[28](index=28&type=chunk) - As of March 31, 2025, the company reported an **accumulated deficit of approximately $153.6 million**, primarily funded through equity financings including **$133.0 million net proceeds from its February 2024 IPO**[29](index=29&type=chunk)[30](index=30&type=chunk) - In January 2025, the company amended its loan agreement with K2 HealthVentures, increasing the total term loan facility to **$75.0 million** and drawing **$20.0 million**[46](index=46&type=chunk)[48](index=48&type=chunk) - A convertible grant agreement with The Wellcome Trust Limited, signed in July 2024, provides up to **$11.7 million** for ALTO-100 development, with **$1.3 million drawn** as of March 31, 2025[64](index=64&type=chunk) - The company holds multiple license and asset purchase agreements requiring potential future milestone and royalty payments upon achieving development, regulatory, and commercial targets[73](index=73&type=chunk)[77](index=77&type=chunk)[83](index=83&type=chunk)[89](index=89&type=chunk)[92](index=92&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage biopharmaceutical operations, reporting a net loss of $15.2 million for Q1 2025, and projects sufficient cash resources of $161.3 million to fund operations into 2028 - The company's pipeline includes **five clinical-stage assets**: ALTO-100 (BPD), ALTO-300 (MDD), ALTO-203 (MDD with anhedonia), ALTO-101 (CIAS), and ALTO-202 (MDD)[140](index=140&type=chunk) Key Clinical Trial Updates and Expected Data Readouts | Product Candidate | Indication | Status | Expected Topline Data | | :--- | :--- | :--- | :--- | | ALTO-100 | BPD | Phase 2b Enrollment Ongoing | H2 2026 | | ALTO-300 | MDD | Phase 2b Enrollment Ongoing | Mid-2026 | | ALTO-203 | MDD | Phase 2 POC Enrollment Complete | Q2 2025 | | ALTO-101 | CIAS | Phase 2 POC | H2 2025 | - The company held **$161.3 million in cash, cash equivalents, and restricted cash** as of March 31, 2025, projected to fund operations into **2028**[160](index=160&type=chunk)[199](index=199&type=chunk) - Net loss for Q1 2025 was **$15.2 million**, an increase from **$13.4 million** in Q1 2024, primarily due to higher G&A costs and a **$0.7 million loss on debt extinguishment**[155](index=155&type=chunk)[173](index=173&type=chunk)[176](index=176&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Total operating expenses increased to $15.7 million in Q1 2025, driven by a $1.3 million rise in general and administrative expenses and a $0.7 million loss on debt extinguishment, while research and development costs remained stable Research and Development Expenses by Program (in thousands) | Program | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | ALTO-100 | $1,124 | $2,207 | $(1,083) | | ALTO-300 | $922 | $1,116 | $(194) | | ALTO-101 | $969 | $406 | $563 | | ALTO-203 | $737 | $620 | $117 | | Personnel-related costs | $5,093 | $4,353 | $740 | | **Total R&D** | **$9,974** | **$9,952** | **$22** | - General and administrative expenses increased by **$1.3 million**, from $4.4 million in Q1 2024 to **$5.7 million** in Q1 2025, primarily due to higher personnel costs and professional fees associated with public company operations[175](index=175&type=chunk) - Other income, net, decreased by **$0.5 million**, mainly due to a **$0.7 million loss on debt extinguishment** in Q1 2025[176](index=176&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $161.3 million in cash, cash equivalents, and restricted cash, with operations funded by IPO proceeds and debt facilities, projected to be sufficient into 2028 - The company held **$161.3 million in cash, cash equivalents, and restricted cash** as of March 31, 2025[178](index=178&type=chunk) - In January 2025, the company amended its loan agreement, increasing the total facility to **$75.0 million** and drawing **$20.0 million**, with approximately **$10.0 million** used for refinancing[179](index=179&type=chunk)[182](index=182&type=chunk) - In July 2024, the company secured a convertible grant agreement with Wellcome for up to approximately **$11.7 million** to fund ALTO-100 development[190](index=190&type=chunk) - Net cash used in operating activities increased to **$16.6 million** in Q1 2025 from **$11.0 million** in Q1 2024, mainly due to timing of bonus payments and higher operational spending[195](index=195&type=chunk) - Net cash from financing activities was **$9.1 million** in Q1 2025 from new loan proceeds, compared to **$134.6 million** in Q1 2024 from the IPO[197](index=197&type=chunk)[198](index=198&type=chunk) - Management projects current cash and equivalents will sufficiently fund operating expenses and capital requirements into **2028**[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Alto Neuroscience, Inc. is not required to provide quantitative and qualitative disclosures about market risk[220](index=220&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025[221](index=221&type=chunk)[222](index=222&type=chunk) - No material changes occurred in internal control over financial reporting during Q1 2025[223](index=223&type=chunk) Part II - Other Information [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business - As of the report date, the company is not involved in any legal proceedings expected to have a material adverse effect on the business[227](index=227&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have occurred to the risk factors previously disclosed in the company's Annual Report[228](index=228&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities and no material change in the planned use of **$133.0 million** net proceeds from its February 2024 IPO - The company's IPO closed on February 6, 2024, generating **$133.0 million in net proceeds** from the sale of **9,246,000 shares** at **$16.00 per share**[230](index=230&type=chunk)[231](index=231&type=chunk) - No material change has occurred in the planned use of IPO proceeds[231](index=231&type=chunk) [Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable [Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable [Other Information](index=45&type=section&id=Item%205.%20Other%20Information) Not applicable [Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, financial agreements, and officer certifications