Biotech Co.'s Q3/25 Progress on Lead Programs Steady
Research Report

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Disclosures for H.C. Wainwright & Co., Alto Neuroscience Inc., November 14, 2025

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Alto Neuroscience Inc. (ANRO:NYSE) provided a Q3/25 financial and operational update, reported H.C. Wainwright & Co. (HCW) Analyst Patrick Trucchio in a November 14 earnings update.

"Alto continues to translate its precision psychiatry platform into tangible regulatory, clinical, and financial momentum heading into 2026," Trucchio wrote.

340% Uplift Suggested

HCW maintained its US$50 per share (US$50/share) target price on the biotechnology firm, trading at the time of Trucchio's report at about US$11.35/share, the analyst noted. The difference between these two prices implies a potential return of 340%.

Alto remains a Buy.

The company has 27.1 million shares outstanding. Its market cap is US$353 million (US$353M). Its 52-week range is US$1.60–15.18/share.

Cash Runway Into 2028

Alto has US$138.3M in cash, cash equivalents, and restricted cash, following and including the US$50M of net proceeds from its private placement that closed Oct. 21. The company expects its cash runway to extend into 2028, getting it through four significant clinical trial data readouts and planned operations.

In Q3/25, Alto's research and development expense was US$10.5M, lower than HCW's US$13.7M estimate. General and administrative expense was US$4.4M, also below HCW's US$7.6M forecast.

Alto posted a net loss of US$14.2M in Q3/25, reflecting better performance than HCW's projection of a US$19.7M net loss.

Precision Psychiatry Foundation

Alto's precision psychiatry approach to drug development "continued to demonstrate reproducibility and scalability across its lead programs during Q3/25," wrote Trucchio. It involves using biomarkers, like electroencephalogram (EEG) results, cognitive testing data, and digital behavioral measures, to identify, in advance of clinical trials, patients who will respond the best to the new drug being evaluated. Two examples of specific EEG biomarkers Alto uses are theta intertrial coherence (theta-ITC) in schizophrenia and the neural noise signal in major depressive disorder (MDD).

The intent behind Alto's biomarkers is not to tighten trial enrollment criteria but rather, serve as "prospective measures to stratify response, reduce placebo variability and improve statistical power," the analyst explained.

"Collectively, we believe that the growing body of replicated biomarker data underscores Alto's leadership in advancing a scalable, data-driven framework that can systematically derisk psychiatric drug development and improve the probability of clinical and regulatory success," Trucchio wrote.

Q3/25 Operational Highlights

Trucchio presented the highlights of Alto's numerous operational accomplishments involving its lead programs during Q3/25, noting that "these developments underscore operational rigor and clinical consistency across Alto's biomarker-guided portfolio."

The analyst also provided HCW's view and potential valuation of each drug.

ALTO-207: Being Accelerated

Alto and the U.S. Food and Drug Administration (FDA) agreed on accelerating the advancement of ALTO-207 for patients with treatment-resistant depression (TRD), a large and underserved population. ALTO-207 is a fixed-dose combination of Pramipexole, a dopamine D3-preferring D3/D2 agonist, and Ondansetron, a 5-HT3 antagonist.

As planned before the meeting with the FDA, Alto is moving forward with its possibly pivotal Phase 2b trial in TRD, expected to commence in H1/26. Now, post-meeting, Alto will also launch a Phase 3 in early 2027 and run it concurrently with the Phase 2b. Alto expects to use dopamine-related EEG and behavioral assessments as prespecified secondary endpoints "to support its precision-psychiatry labeling strategy," noted Trucchio.

Given the FDA's blessing and Alto's secured funding, the firm is well-positioned to accelerate development of ALTO-207.

"Overall, we view ALTO-207 as a potential first-in-class oral TRD therapy with blockbuster potential if pivotal data replicate the Phase 2a signal," Trucchio wrote. "Risk adjusted, we estimate ALTO-207 is worth US$25/share."

ALTO-101: Now On Fast Track

During Q3/25, the FDA granted Alto's ALTO-101 fast track designation in cognitive impairment associated with schizophrenia (CIAS), a significant unmet need. ALTO-101 is a novel transdermal phosphodiesterase-4 (PDE4) inhibitor.

Earlier in the quarter, Alto announced that the most robust EEG biomarker distinguishing schizophrenia from healthy controls is prospective replication and validation of theta-ITC. This finding directly supports the program's Phase 2 proof-of-concept design.

Further, a blinded pharmacokinetic (PK) analysis in Q3/25 confirmed 100% PK-positive samples, reflecting strong compliance and improved operational execution.

Enrollment of about 70 patients with schizophrenia for the ongoing Phase 2 trial continues and is on track for a topline data readout in Q1/26.

"Taken together, we believe the regulatory recognition, biomarker validation, and clean execution signal growing momentum for ALTO-101 as a potentially first-in-class, biomarker-guided treatment in CIAS," Trucchio wrote.

ALTO-300: Enrollment Ongoing

During Q3/25, Alto continued enrollment for its ongoing, randomized, double-blind, placebo-controlled Phase 2b clinical trial of ALTO-300 as an adjunctive treatment for MDD. ALTO-300, an oral melatonergic agonist and 5-HT2C antagonist, is approved in the European Union as agomelatine (25 milligrams).

The Phase 2b trial is to encompass about 200 patients with an EEG signal indicating increased neural noise and reduced dopaminergic activity. Alto is expected to announce topline Phase 2b results in mid-2026.

"Overall, we continue to view ALTO-300 as a well-differentiated, biomarker-guided adjunctive therapy with a clear safety advantage over existing atypical antipsychotic adjuncts," Trucchio wrote. "Not risk adjusted, we estimate ALTO-300 may generate peak annual revenues of US$2.5 billion-plus (US$2.5B-plus) in MDD. Risk adjusted, we estimate ALTO-300 is worth US$20/share."

ALTO-100: Positive PK Results

Currently, Alto is advancing ALTO-100 in a randomized, double-blind, placebo-controlled Phase 2b clinical trial in bipolar depression (BPD), specifically in patients having a cognitive biomarker associated with chronicity and treatment resistance.

"This first-in-class small molecule is designed to enhance neuroplasticity through brain-derived neurotrophic factor pathway modulation," wrote Trucchio.

During Q3/25, a blinded PK analysis of the Phase 2b's first cohort showed that 96% of patient samples achieved PK positivity, reported Trucchio. This is well above industry norms for central nervous system trials and consistent with ALTO-101's 100% PK-positive result. Both ALTO-100 and ALTO-101's PK results show that Alto's efforts to lower noncompliance risk, through better site monitoring and stricter protocol compliance procedures, are effective.

Enrollment for the Phase 2b is ongoing. A topline data readout is expected in H2/26.

"Overall, we continue to see ALTO-100 as a differentiated proplasticity mechanism with potential applicability across mood disorders where impaired neuroplasticity underlies treatment resistance," Trucchio wrote. "Not risk adjusted, we estimate ALTO-100 may generate peak annual revenues of US$1B-plus in BPD. Risk adjusted, we estimate ALTO-100 is worth US$3/share."

What to Watch For

Investors have a slew of Alto catalysts ahead, noted Trucchio, including:

• Q1/26:               Data readout of Phase 2 trial of ALTO-101 in CIAS
• H1/26:               Start of Phase 2b trial of ALTO-207 in TRD
• Mid-2026:         Data readout of Phase 2b trial of ALTO-300 in MDD
• H2/26:               Data readout of Phase 2b trial of ALTO-100 in BPD
• Early 2027:       Start of Phase 3 trial of ALTO-207 in TRD

"Capital strength, regulatory momentum, and multiple upcoming catalysts position Alto Neurosciences for an inflection point in 2026," the analyst wrote.