Financial Position - As of December 31, 2024, the company reported cash and cash equivalents of approximately $168 million[9] - The company's financial closing procedures for the year ended December 31, 2024, are not yet complete, and final results may differ materially from preliminary estimates[10] - The preliminary financial data presented is subject to change and should not be relied upon without caution[10] - The independent registered public accounting firm has not audited or reviewed the preliminary financial data[10] Sales Agreement - The company has entered into a Sales Agreement with Leerink Partners LLC to offer and sell shares of its common stock, with an aggregate offering price of up to $75 million[5] - The agent will receive a commission of up to 3.0% on the aggregate gross sales price per share sold under the agreement[6] - The Sales Agreement is incorporated by reference in the company's Registration Statement on Form S-3 filed on February 3, 2025[13] - The ATM Shares will be sold through "at the market offerings" as defined in Rule 415(a)(4) under the Securities Act[7] - The company has no obligation to sell any of the ATM Shares and may suspend or terminate the agreement at any time[7] Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[4]

Core Viewpoint - Alto Neuroscience, Inc. is under investigation for potential violations of securities laws, prompting affected investors to reach out to the Schall Law Firm for assistance [1] Group 1 - The investigation into Alto Neuroscience, Inc. suggests possible misconduct related to securities regulations [1] - Investors who believe they have been impacted by the company's actions are encouraged to contact legal representation [1]

Core Viewpoint - The Schall Law Firm is inviting shareholders of Alto Neuroscience, Inc. who have experienced losses to participate in an inquiry regarding potential securities fraud [1] Group 1 - The inquiry is focused on allegations of securities fraud involving Alto Neuroscience, Inc. [1] - Shareholders who have incurred losses are encouraged to join the investigation [1] - The law firm aims to determine whether the company engaged in any fraudulent activities that may have affected shareholder value [1]

Core Viewpoint - Alto Neuroscience, Inc. (ANRO) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Alto Neuroscience for the fiscal year ending December 2024 is projected at -$2.54 per share, reflecting a 73.9% change from the previous year's reported figure [8]. - Over the past three months, analysts have raised their earnings estimates for Alto Neuroscience by 12.8% [8]. Impact of Institutional Investors - Changes in earnings estimates are strongly correlated with stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [4]. - An increase in earnings estimates typically leads to higher fair value calculations for stocks, prompting institutional buying or selling actions that affect stock prices [4]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Alto Neuroscience to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for near-term price appreciation [10].

Financial Performance - The company reported net losses of $16.8 million and $46.2 million for the three and nine months ended September 30, 2024, respectively, compared to $9.1 million and $25.1 million for the same periods in 2023[142]. - The company has not generated any revenue from product sales and expects to incur significant operating losses and negative cash flows for the foreseeable future[142][144]. - The company anticipates continued net losses and increased operating expenses as it expands its headcount and develops its product candidates[169]. - Net loss for the three months ended September 30, 2024, was $16.8 million, compared to a net loss of $9.1 million for the same period in 2023, indicating an increase of 84%[160]. - Net cash used in operating activities was $34.4 million for the nine months ended September 30, 2024, compared to $21.9 million for the same period in 2023, an increase of 57%[177]. - Net cash used in operating activities was $(34.4) million for the nine months ended September 30, 2024, compared to $(21.9) million for the same period in 2023[184]. Cash and Funding - As of September 30, 2024, the company had an accumulated deficit of $123.2 million and cash, cash equivalents, and restricted cash of $182.2 million[142][147]. - The company has raised approximately $275.6 million from equity financings since its inception in 2019, including $133.0 million from its IPO in February 2024[141][147]. - Cash, cash equivalents, and restricted cash amounted to $182.2 million as of September 30, 2024, compared to $82.5 million as of December 31, 2023[172]. - The company expects existing cash and cash equivalents of $181.7 million to fund operations into 2027, but actual results may vary[185]. - Net cash provided by financing activities was $135.6 million for the nine months ended September 30, 2024, primarily from the issuance of 9,246,000 shares at $16.00 per share[179]. - Material cash requirements as of September 30, 2024, include obligations under a Term Loan and lease commitments totaling $7.1 million over the next five years[188]. - The company entered into a Convertible Grant Agreement with Wellcome for up to approximately $11.7 million, with $1.3 million funded upon execution[192]. Research and Development - The company is currently evaluating ALTO-100 in a Phase 2b study for bipolar depression, with a target enrollment of approximately 200 patients and topline data expected in 2026[137]. - ALTO-300 is being evaluated in a 200-patient Phase 2b trial for major depressive disorder (MDD), with topline data expected in the first half of 2025[138]. - ALTO-203 is in a Phase 2 proof-of-concept trial for MDD, with topline data expected in the first half of 2025[139]. - ALTO-101 is being evaluated in a Phase 2 proof-of-concept trial for cognitive impairment associated with schizophrenia, with topline data expected in the second half of 2025[140]. - The company intends to develop ALTO-202, a novel NMDA receptor antagonist for the treatment of MDD[140]. - Research and development expenses increased to $13.1 million for the three months ended September 30, 2024, up from $8.0 million in the same period of 2023, representing a 64% increase[162]. - Research and development expenses for the nine months ended September 30, 2024, totaled $36.2 million, up from $20.6 million in the same period of 2023, a 75% increase[167]. Operating Expenses - General and administrative expenses rose to $5.8 million for the three months ended September 30, 2024, compared to $1.8 million in the same period of 2023, marking a 228% increase[163]. - General and administrative expenses for the nine months ended September 30, 2024, were $15.4 million, compared to $5.4 million in the same period of 2023, representing a 185% increase[167]. - Total operating expenses for the three months ended September 30, 2024, were $18.9 million, up from $9.7 million in the same period of 2023, reflecting a 95% increase[160]. - Stock-based compensation expenses increased by $3.8 million to $6.1 million for the nine months ended September 30, 2024, compared to $2.3 million for the same period in 2023[182]. Agreements and Milestones - The company achieved a clinical milestone under the Teva Agreement and paid $0.5 million in cash during the nine months ended September 30, 2024[197]. - A milestone under the MedRx Agreement was achieved in April 2024, resulting in a payment of $0.75 million in cash and the issuance of 46,875 shares, recognizing an expense of $1.5 million[199]. - The company has entered into multiple license agreements, including those with Stanford University, Sanofi, and Cerecor, to expand its product development capabilities[193][194][195]. Company Classification and Reporting - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to rely on certain exemptions from public company reporting requirements for up to five years post-IPO[202]. - The company has opted for an extended transition period for complying with new or revised accounting standards, delaying adoption until those standards apply to private companies[203]. - The company will cease to be an "emerging growth company" upon reaching $1.235 billion in annual revenue or other specified conditions[203]. - The company is also classified as a "smaller reporting company," which allows it to utilize scaled disclosures as long as certain revenue and stock valuation thresholds are met[204]. - The voting and non-voting common stock held by non-affiliates must be less than $250 million or annual revenue must be less than $100 million to maintain smaller reporting company status[204]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status[205].

Financial Performance - The company incurred a net loss of $16.8 million for Q3 2024, compared to a net loss of $9.1 million for the same period in 2023[13]. - The net loss for the three months ended September 30, 2024, was $16,783,000, compared to a net loss of $9,141,000 in the same period last year, reflecting an 83.5% increase in losses[18]. - The net loss per share attributable to common stockholders for the three months ended September 30, 2024, was $(0.62), compared to $(2.44) for the same period in 2023[18]. - Other income for the three months ended September 30, 2024, was $2,103,000, compared to $577,000 in the same period last year, showing a 264.5% increase[18]. Research and Development - Research and development expenses for Q3 2024 were $13.1 million, up from $8.0 million in Q3 2023, primarily due to costs associated with ongoing Phase 2b studies[11]. - Research and development expenses for the three months ended September 30, 2024, were $13,060,000, compared to $7,967,000 for the same period in 2023, representing a 64.5% increase[18]. - The company plans to incorporate learnings from the ALTO-100 study into its other ongoing clinical programs[2]. Clinical Trials - Topline data from two major depressive disorder (MDD) trials, ALTO-300 and ALTO-203, are expected in the first half of 2025[1]. - Enrollment for the Phase 2b trial of ALTO-300 is on track, with 200 patients expected to participate, and topline data anticipated in the first half of 2025[5]. - ALTO-203 is also on track for its Phase 2 proof-of-concept trial, with approximately 60 patients expected to be enrolled and topline data expected in the first half of 2025[6]. - ALTO-101's Phase 2 proof-of-concept trial is ongoing, with topline data expected by the end of 2025[7]. - ALTO-100 did not achieve the primary outcome in its Phase 2b study for MDD, but showed a clinically meaningful effect in a pre-specified analysis of biomarker-positive patients[3]. Financial Position - The company has a strong cash position of approximately $182 million, expected to fund operations into 2027[10]. - Cash, cash equivalents, and restricted cash as of September 30, 2024, totaled $182,201,000, significantly up from $82,548,000 at December 31, 2023, marking a 120.5% increase[19]. - Total assets increased to $191,608,000 as of September 30, 2024, compared to $86,628,000 at the end of 2023, representing a 120.5% growth[19]. - Total liabilities rose to $26,556,000 as of September 30, 2024, compared to $16,823,000 at December 31, 2023, indicating a 58.0% increase[19]. - The accumulated deficit increased to $(123,195,000) as of September 30, 2024, from $(76,965,000) at the end of 2023, reflecting a 60.0% increase[19]. Operating Expenses - General and administrative expenses for Q3 2024 were $5.8 million, compared to $1.8 million in Q3 2023, driven by increased headcount and operational requirements[12]. - Total operating expenses for the nine months ended September 30, 2024, were $51,613,000, up from $26,044,000 in 2023, indicating a 97.9% increase[18].

Core Viewpoint - Alto Neuroscience's Phase 2b study of ALTO-100 for major depressive disorder did not meet its primary endpoint, leading to a significant drop in share price [2]. Investigation Details - On October 22, 2024, Alto Neuroscience announced that the Phase 2b study did not achieve its primary endpoint as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo [2]. - Following this announcement, shares of Alto Neuroscience fell by nearly 60% during after-hours trading on the same day [2]. Next Steps - Investors who purchased Alto Neuroscience securities and have relevant information are encouraged to assist the investigation by visiting the firm's website [3]. - Contact information for the firm's representatives is provided for those who wish to contribute to the investigation [3]. Legal Representation - The firm represents investors in class actions on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorneys' fees if successful [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm specializing in securities fraud class actions and has recovered hundreds of millions of dollars for investors [5].

Core Insights - Alto Neuroscience, Inc. announced that the Phase 2b study of ALTO-100 for major depressive disorder (MDD) did not meet its primary endpoint compared to placebo, showing no statistically significant improvement in depressive symptoms [1] - The company plans to analyze the full data set to determine next steps for ALTO-100 in MDD and is also evaluating ALTO-100 as an adjunctive treatment for bipolar depression in a separate Phase 2b study [2] - Despite the setback with ALTO-100, analysts from William Blair maintain confidence in the biomarker enrichment strategy and are focused on upcoming results from ALTO-300 in MDD, expected in the first half of 2025 [2][3] Financial Position - Alto Neuroscience has a current cash position of $194 million, which is expected to fund operations into 2027 and support multiple upcoming clinical readouts, including two additional readouts in MDD [2] Market Reaction - Following the announcement, ANRO stock experienced a significant decline of 67.70%, trading at $4.70 [3]

Core Viewpoint - The Schall Law Firm is investigating Alto Neuroscience, Inc. for potential violations of securities laws following the announcement that its Phase 2b study of ALTO-100 for major depressive disorder did not meet its primary endpoint, leading to a significant drop in the company's stock price [1]. Group 1 - The investigation by the Schall Law Firm focuses on whether Alto Neuroscience made false or misleading statements or failed to disclose important information to investors [1]. - On October 22, 2024, Alto Neuroscience reported that the Phase 2b study of ALTO-100 did not meet its primary endpoint, as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo [1]. - Following this announcement, shares of Alto Neuroscience fell by nearly 60% in after-hours trading on the same day [1].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q _________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-41944 _________________________ | --- | --- | |---------- ...