Alto Neuroscience Reports Second Quarter 2024 Financial Results and Recent Business Highlights
– Completed enrollment of 301 patients in Phase 2b MDD study for ALTO-100; Investor Day focused on ALTO-100 planned for
– Initiated multiple Phase 2 studies: ALTO-101 in schizophrenia, ALTO-203 in MDD with anhedonia, and ALTO-100 in bipolar depression –
– Reported positive Phase 1 data on transdermal formulation of our novel PDE4 inhibitor, ALTO-101 –
– Strong cash position of approximately
“Over the recent months we achieved several important milestones for our company and for the field of precision psychiatry as a whole,” said
Second Quarter 2024 and Recent Business Highlights
ALTO-100: Completed Enrollment in Ongoing Phase 2b Study in MDD, Initiated Phase 2b Study in Bipolar Depression
ALTO-100, a first-in-class, oral small molecule believed to work through enhancing neural plasticity, is in development for the treatment of major depressive disorder (MDD) and bipolar depression (BPD).
Alto is currently evaluating ALTO-100 in a 301-patient Phase 2b study in MDD patients characterized by a memory-based 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).
In
The Company expects to report topline data from the Phase 2b MDD study in
In
The Company expects to report topline data from the Phase 2b BPD study in 2026.
ALTO-300: Enrollment on Track in 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 an antidepressant to which they had an insufficient response.
Alto is currently evaluating ALTO-300 in a 200-patient Phase 2b study in MDD patients characterized by an EEG biomarker signature. The study is evaluating ALTO-300 compared to placebo over a 6-week treatment period, and the primary outcome is 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: Initiated a Phase 2 Proof-of-Concept Study for Cognitive Impairment Associated with Schizophrenia (CIAS)
ALTO-101 is a novel brain-penetrant PDE4 inhibitor currently in Phase 2 clinical development for the treatment of CIAS.
PDE4 inhibitors have demonstrated, as a class, a propensity to induce significant dose-related 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 enhance the pharmacokinetic (PK) profile and improve the overall tolerability profile relative to other PDE4 inhibitors. Alto hypothesized that reducing the rate of drug absorption and delivering a stable blood target concentration could blunt typical PDE4-related adverse events such as nausea, vomiting, and diarrhea.
In
In
Enrollment is ongoing and the Company expects to report topline data in the second half of 2025.
ALTO-203: Initiated a Phase 2 Proof-of-Concept Study in 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 dopamine release in the reward system and on positive subjective emotional measures in humans.
In
Enrollment in this study is ongoing. Alto expects to enroll approximately 60 adult participants with MDD and evidence of anhedonia, and report topline data from this study in the first half of 2025.
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.
Corporate Updates
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The Company strengthened its management team with the addition of
Michael Hanley as Chief Operating Officer.Mr. Hanley brings over two decades of leadership experience in product development and commercialization across a wide range of neuropsychiatric indications, including MDD and schizophrenia. -
The Company plans to host an investor day on
September 9, 2024 focused on ALTO-100. The Company expects to provide information regarding the baseline characteristics of study participants, mechanistic and clinical rationale for ALTO-100, and the predictive cognitive test being used to select patients in the Phase 2b study. More details regarding the investor day are available on the Company’s investor relations website.
Upcoming Milestones and Events
Near-Term Expected Milestones
- 2H 2024 (October) — 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
- 2026 – ALTO-100 Phase 2b BPD study topline data
Upcoming Scientific Conferences
Members of the Company’s management team are expected to present at the following upcoming conferences;
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The International Society for CNS Clinical Trials and Methodology (ISCTM) -September 12-13 -
37th
European College of Neuropsychopharmacology (ECNP) Congress –September 21-24
Second Quarter 2024 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 quarter ended
G&A Expenses: General and administrative expenses for the quarter 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,” “look forward,” “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; Alto’s business strategy, financial position and the sufficiency of its financial resources to fund its operations through expected milestones; and other statements that are not historical fact. 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’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 Alto's Quarterly Report on Form 10-Q for the fiscal quarter ended
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Three months ended
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|
Six months ended
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|||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||||||
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
$ |
13,184 |
|
|
$ |
7,072 |
|
|
$ |
23,136 |
|
|
$ |
12,681 |
|
|
General and administrative |
|
5,157 |
|
|
|
2,053 |
|
|
|
9,591 |
|
|
|
3,645 |
|
|
Total operating expenses |
|
18,341 |
|
|
|
9,125 |
|
|
|
32,727 |
|
|
|
16,326 |
|
|
Loss from operations |
|
(18,341 |
) |
|
|
(9,125 |
) |
|
|
(32,727 |
) |
|
|
(16,326 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|||||||||
Interest income |
|
2,658 |
|
|
|
667 |
|
|
|
4,216 |
|
|
|
897 |
|
|
Interest expense |
|
(347 |
) |
|
|
(327 |
) |
|
|
(693 |
) |
|
|
(651 |
) |
|
Change in fair value of warrant liability |
|
— |
|
|
|
122 |
|
|
|
(243 |
) |
|
|
133 |
|
|
Total other income (expense), net |
|
2,311 |
|
|
|
462 |
|
|
|
3,280 |
|
|
|
379 |
|
|
Net loss |
$ |
(16,030 |
) |
|
$ |
(8,663 |
) |
|
$ |
(29,447 |
) |
|
$ |
(15,947 |
) |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|||||||||
Foreign currency translation |
|
(5 |
) |
|
|
(11 |
) |
|
|
(10 |
) |
|
|
(30 |
) |
|
Total other comprehensive loss |
|
(5 |
) |
|
|
(11 |
) |
|
|
(10 |
) |
|
|
(30 |
) |
|
Comprehensive loss |
$ |
(16,035 |
) |
|
$ |
(8,674 |
) |
|
$ |
(29,457 |
) |
|
$ |
(15,977 |
) |
|
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.60 |
) |
|
$ |
(2.33 |
) |
|
$ |
(1.32 |
) |
|
$ |
(4.31 |
) |
|
Weighted-average number of common shares outstanding, basic and diluted |
|
26,913 |
|
|
|
3,716 |
|
|
|
22,312 |
|
|
|
3,704 |
|
|
||||||||
|
|
|
|
|||||
|
2024 |
|
2023 |
|||||
Cash, cash equivalents, and restricted cash |
$ |
193,622 |
|
|
$ |
82,548 |
|
|
Total assets |
|
197,360 |
|
|
|
86,628 |
|
|
Total liabilities |
|
17,584 |
|
|
|
16,823 |
|
|
Accumulated deficit |
|
(106,412 |
) |
|
|
(76,965 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240813694757/en/
Investor Contact:
investors@altoneuroscience.com
Media Contact:
media@altoneuroscience.com
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