Alto Neuroscience Inc. (ANRO:NYSE) provided an update on some of its clinical programs and its recent private placement, reported Dr. Myles Minter, analyst at William Blair, in an October 20 research note.
About the biotech's prospects, the analyst wrote, "Ultimately, we see a diversified asset pipeline, mixed with a strong cash position through at least four clinical readouts, as increasing the likelihood of eventual clinical win(s) and the room for a several-fold price appreciation from current levels."
Stock Rated Outperform
William Blair reiterated its Outperform rating on the California-based firm, trading at the time of Minter's report at about US$11.03 per share, the analyst noted. The financial services firm does not have a price target on Alto.
"Alto is early stage but uniquely positioned in the neuropsychiatry drug development landscape, and we see an attractive risk/reward profile," added Minter.
The life sciences company has 27.1 million shares outstanding, a market cap of US$301 million (US$301M) and a 52-week range of US$2–15 per share.
Two Concurrent Studies
Following a recent U.S. Food and Drug Administration (FDA) meeting, Alto decided to fast track development of ALTO-207 in treatment-resistant depression (TRD) by starting a Phase 3 trial while the Phase 2b study is in progress versus carrying out the two consecutively, Minter reported.
The Phase 2b, already planned before the FDA meeting, is scheduled to start by mid-2026. Alto intends to commence the Phase 3 by early 2027, once it completes preparation work and finalizes the trial protocol with the FDA.
As such, Alto will have two pivotal studies happening at the same time and intends to keep the size and geography of both similar, management told Minter. This concurrent approach will move up filing of a new drug application by more than a year.
Minter pointed out that TRD is "a major market with significant unmet need." To put its size in context, he noted that in this indication, Johnson & Johnson's (JNJ:NYSE) Spravato recently annualized US$1.84 billion, and this represented 62% year-over-year growth.
About the Asset
Earlier this year, in June, Alto acquired a portfolio of dopamine agonist combination candidates from private firm Chase Therapeutics, and ALTO-207, a combination of Pramiprexole and Ondansetron, was one of them. Pramipexole was shown in the PAX-D study to be efficacious in TRD, and data Chase generated suggested that combining it with the antiemetic Ondansetron could improve tolerability of the Pramipexole.
"We viewed the ALTO-207 acquisition as intriguing given promising PAX-D clinical trial data, and view the acceleration of the program to Phase 3 as a positive with the asset now in Alto's hands," Minter wrote.
Cashed Up for Program
Minter reported that Alto has runway into 2028, including the additional development activities for ALTO-207, according to management. The company just completed a US$50M private placement at about US$5.91 per share and as of June 30, 2025, had US$148.1M in cash.
"We have updated our model to include the financing, and further updates are pending to include value for ALTO-207," noted Minter.
Positive Compliance Rates
Alto's recently completed blinded pharmacokinetic (PK) analysis of the ongoing Phase 2b study of ALTO-100 in bipolar depression (BPD) showed a 96% compliance rate. This rate is much higher than those generally seen in central nervous system studies. According to management, this is due to optimized trial design and execution and implies strong patient tolerability and treatment engagement. Topline data from this trial are expected in H2/26.
Alto's recent blinded PK analysis of the ongoing proof-of-concept Phase 2 study of ALTO-101 in cognitive impairment associated with schizophrenia (CIAS) showed a 100% compliance rate.
"PK updates from the ALTO-100 and ALTO-101 programs ensuring compliance comes from prior clinical trial learnings and is an incremental positive to management execution here," Minter wrote.
Topline data from ALTO-101 in CIAS now is expected in Q1/26 versus H2/25 previously, reported the analyst. This is because management chose to complete the study in the new year to avoid possible disruptions to in-clinic patch replacements during the holidays.
Precision Psychiatry Approach
In its method of developing psychiatric drugs, Alto employs a biomarker enrichment strategy. Yes, the Phase 2b trial of ALTO-100 in major depressive disorder (MDD) failed to show a statistically significant benefit over placebo as measured with the Montgomery-Asberg Depression Rating Scale, Minter acknowledged but added that one failure does not invalidate the entire approach. Also, he pointed out, compliance was a problem in that trial with a cognitive biomarker.
"We look to the next readout of ALTO-300 in MDD, which leverages electroencephalogram-based biomarkers identified by Alto Scope, combined with an already internationally approved commercial antidepressant (agomelatine)," the analyst wrote.
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Important Disclosures:
- As of the date of this article, officers, contractors, shareholders, and/or employees of Streetwise Reports LLC (including members of their household) own securities of Alto Neuroscience Inc.
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- This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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Disclosures for William Blair, Alto Neuroscience Inc., October 20, 2025
William Blair or an affiliate was a manager or co-manager of a public offering of equity securities for Alto Neuroscience, Inc. within the prior 12 months. William Blair or an affiliate is a market maker in the security of Alto Neuroscience, Inc. William Blair or an affiliate expects to receive or intends to seek compensation for investment banking services from Alto Neuroscience, Inc. or an affiliate within the next three months. William Blair or an affiliate received compensation for investment banking services or non-investment-banking services from Alto Neuroscience, Inc. within the last 12 months. Alto Neuroscience, Inc. is or was, within the last 12 months, an investment banking client of William Blair & Company and/or one or more of its affiliates. Officers and employees of William Blair or its affiliates (other than research analysts) may have a financial interest in the securities of Alto Neuroscience, Inc. This report is available in electronic form to registered users via R*Docs™ at https://williamblairlibrary.bluematrix.com or www.williamblair.com. Please contact us at +1 800 621 0687 or consult https://www.williamblair.com/equity-research/coverage for all disclosures. Myles R. Minter attests that 1) all of the views expressed in this research report accurately reflect his/her personal views about any and all of the securities and companies covered by this report, and 2) no part of his/her compensation was, is, or will be related, directly or indirectly, to the specific recommendations or views expressed by him/her in this report. We seek to update our research as appropriate. Other than certain periodical industry reports, the majority of reports are published at irregular intervals as deemed appropriate by the research analyst. DOW JONES: 46190.60 S&P 500: 6664.01 NASDAQ: 22680.00 Alto Neuroscience, Inc. Rating History as of 10/17/2025 powered by: BlueMatrix 25 20 15 10 5 0 Jan 23 Apr 23 Jul 23 Oct 23 Jan 24 Apr 24 Jul 24 Oct 24 Jan 25 Apr 25 Jul 25 Oct 25 I:OP 02/27/24 Closing Price OP:Outperform Mkt:Market Perform UP:Under Perform NR:Not Rated I:Initiation of Coverage D:Dropped Coverage Source: FactSet & William Blair Additional information is available upon request. Current Rating Distribution (as of October 20, 2025): Coverage Universe Percent Inv. Banking Relationships * Percent Outperform (Buy) 73 Outperform (Buy) 10 Market Perform (Hold) 27 Market Perform (Hold) 3 Underperform (Sell) 1 Underperform (Sell) 0
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