Alto Neuroscience Reports Full Year 2023 Financial Results and Recent Business Highlights
– Reported positive results from ALTO-100 and ALTO-300 Phase 2a studies demonstrating prospective replication of response prediction using Alto’s Precision Psychiatry Platform™ –
– Patient enrollment on track across Phase 2b MDD studies for two lead product candidates –
– Successful completion of oversubscribed initial public offering; cash position of approximately
“2024 is shaping up to be a transformational year for Alto as we advance our mission of redefining the treatment paradigm for patients with neuropsychiatric disorders,” said
Full Year 2023 and Recent Business Highlights
ALTO-100: Ongoing Phase 2b Study in MDD
ALTO-100, a first-in-class, oral small molecule believed to work through enhancing neural plasticity, is in development in Phase 2b for the treatment of major depressive disorder (MDD). In
Alto is currently evaluating ALTO-100 in a 266-patient Phase 2b study in MDD patients characterized by the cognitive biomarker. The study is evaluating ALTO-100 compared to placebo over a 6-week double blind treatment period. The primary endpoint is the change from baseline on the standard regulatory clinical endpoint in depression, the Montgomery-Åsberg Depression Rating Scale (MADRS).
Enrollment is ongoing and the Company expects to report topline data in the second half of 2024.
ALTO-300: Ongoing Phase 2b Study in MDD
ALTO-300 (agomelatine), an oral small molecule that is believed to act as a melatonin agonist and 5HT2C antagonist, is being developed as a new treatment for patients with MDD as an adjunctive treatment to a standard antidepressant.
ALTO-300 has demonstrated positive results in Phase 2a in patients with MDD in which patients with an EEG biomarker signature were discovered to have more robust response to ALTO-300 compared to those without the biomarker signature. The biomarker signature was prospectively replicated to predict clinical response in an independent, locked, and blinded data set. The Company initiated a Phase 2b study in 200 patients with MDD. In the Phase 2b study ALTO-300 will be evaluated compared to placebo over a 6-week treatment period, and the primary outcome will be the change from baseline in MADRS score.
Enrollment is ongoing and the Company expects to report topline data in the first half of 2025.
ALTO-101: PDE4 Inhibitor in Development for Cognitive Impairment in Schizophrenia (CIAS)
ALTO-101 is a novel PDE4 inhibitor currently in Phase 1 clinical development for the treatment of CIAS. In
PDE4 inhibitors have demonstrated, as a class, a propensity to induce significant adverse events, historically limiting their development in CNS disorders. Alto is developing ALTO-101 as a novel transdermal formulation in partnership with MedRx Co., Ltd. to potentially enhance the pharmacokinetic profile and improve the overall tolerability profile relative to other PDE4 inhibitors. The Company expects to report data from a Phase 1 study evaluating the PK properties of the transdermal formulation in the first half of 2024, and subsequently initiate a proof-of-concept study in patients with CIAS.
ALTO-203: Histamine H3 Inverse Agonist in Development for MDD with Anhedonia
ALTO-203 is a novel, oral small molecule that uniquely acts as a histamine H3 inverse agonist, a histamine receptor primarily expressed in the brain. The Company is developing ALTO-203 as a novel treatment for patients with MDD and increased levels of anhedonia given the demonstrated effects of ALTO-203 on subjective affective clinical measures.
ALTO-203 was previously studied in a Phase 1 study and demonstrated significant acute benefits on a scale of subjective positive emotion, compared to placebo. The magnitude of this effect was shown to be equivalent to, or better than modafinil, an active comparator with demonstrated antidepressant activity in clinical trials.
In
ALTO-202: NMDAr Antagonist in Development for Depression
ALTO-202 is a novel, oral small molecule believed to specifically target the GluN2b subunit of NMDA receptors, acting as a selective NMDA receptor antagonist. Alto plans to develop ALTO-202 for patients with depression.
Recent Business Highlights
-
Maha Radhakrishnan , M.D., former Group SVP and Chief Medical Officer at Biogen, was appointed to the Company's board of directors inMarch 2024 . -
Husseini Manji , M.D., Ph.D., former Global Therapeutic Head for Neuroscience at Johnson & Johnson, was appointed to the Company’s board of directors inFebruary 2024 . -
The Company successfully completed its upsized initial public offering in
February 2024 , resulting in net proceeds of approximately$133 million . -
In
January 2024 theCalifornia Institute for Regenerative Medicine (CIRM) voted to approve a$15 million grant to Alto in support of a proposed Phase 2b study of ALTO-100 in patients with bipolar depression. The Company is evaluating the terms and conditions of the grant and, if accepted, the Company plans to initiate the Phase 2b study in 2024.
Upcoming Milestones and Events
Near-Term Expected Milestones
- 1H 2024 — ALTO-101 transdermal formulation pharmacokinetic and safety Phase 1 results
- 2H 2024 — ALTO-100 Phase 2b MDD study topline data
- 1H 2025 — ALTO-300 Phase 2b MDD study topline data
- 1H 2025 — ALTO-203 Proof-of-Concept MDD study topline data
- 2025 — ALTO-101 Proof-of-Concept CIAS study topline data
Upcoming Scientific Conferences
Members of Alto’s scientific team are expected to present data at the following upcoming conferences:
-
Society of Biological Psychiatry -
American Society of Clinical Psychopharmacology
Full Year 2023 Financial Highlights
Cash Position: As of
The Company expects its cash balance to support planned operations into 2027.
R&D Expenses: Research and development expenses for the full year ended
G&A Expenses: General and administrative expenses for the full year ended
Net Loss: The Company incurred a net loss of
About Alto Neuroscience
Alto Neuroscience is a clinical-stage biopharmaceutical Company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X (Twitter).
Forward-Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations with regard to the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); Alto’s expectations with regard to the design and results of its research and development programs and clinical trials, including the timing of enrollment and the timing and availability of data from such trials; Alto’s clinical and regulatory development plans for its product candidates, including the timing or likelihood of regulatory filings and approvals for its product candidates; and Alto’s business strategy, financial position and the sufficiency of its financial resources to fund its operations through expected milestones. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of Alto’s product candidates; the risk that Alto may not realize the intended benefits of its Platform; availability and timing of results from clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; the risk that Alto does not accept the CIRM grant; the risk that Alto’s projections regarding its financial position and expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in Alto’s Final Prospectus filed with the
Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
|||||||
|
Year Ended |
||||||
|
2023 |
|
2022 |
||||
Operating expenses: |
|
|
|
||||
Research and development |
$ |
30,291 |
|
|
$ |
23,688 |
|
General and administrative |
|
7,518 |
|
|
|
5,504 |
|
Total operating expenses |
|
37,809 |
|
|
|
29,192 |
|
Loss from operations |
|
(37,809 |
) |
|
|
(29,192 |
) |
Other income (expense): |
|
|
|
||||
Interest income |
|
2,349 |
|
|
|
114 |
|
Interest expense |
|
(1,370 |
) |
|
|
— |
|
Change in fair value of warrant liability |
|
525 |
|
|
|
(369 |
) |
Grant income |
|
— |
|
|
|
1,737 |
|
Total other income, net |
|
1,504 |
|
|
|
1,482 |
|
Net loss |
$ |
(36,305 |
) |
|
$ |
(27,710 |
) |
Other comprehensive loss: |
|
|
|
||||
Foreign currency translation |
|
(33 |
) |
|
|
(24 |
) |
Total other comprehensive loss |
|
(33 |
) |
|
|
(24 |
) |
Comprehensive loss |
$ |
(36,338 |
) |
|
$ |
(27,734 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(9.73 |
) |
|
$ |
(8.04 |
) |
Weighted-average number of common shares outstanding, basic and diluted |
|
3,731 |
|
|
|
3,446 |
|
Selected Consolidated Balance Sheet Data (in thousands) (unaudited) |
|||||||
|
|
||||||
|
2023 |
|
2022 |
||||
Cash and cash equivalents |
$ |
82,548 |
|
|
$ |
48,344 |
|
Total assets |
|
86,628 |
|
|
|
50,854 |
|
Total liabilities |
|
16,823 |
|
|
|
17,025 |
|
Accumulated deficit |
|
(76,965 |
) |
|
|
(40,660 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240321066221/en/
Investor Contact:
investors@altoneuroscience.com
Media Contact:
media@altoneuroscience.com
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