Alto Neuroscience Reports First Quarter 2024 Financial Results and Recent Business Highlights
Alto Neuroscience (NYSE: ANRO) announced its Q1 2024 financial results and recent business updates. The company initiated a Phase 2 study of ALTO-203 for MDD and anhedonia, and reported positive Phase 1 data for the transdermal formulation of ALTO-101, showing improved drug exposure and tolerability. Patient enrollment for ALTO-100 and ALTO-300 Phase 2b MDD studies is progressing well. The company has a strong cash position of approximately $206 million, expected to support operations into 2027.
Alto's ongoing studies include ALTO-100 and ALTO-300, both targeting MDD, and ALTO-101 for CIAS. The company also announced the initiation of a Phase 2 proof-of-concept study for ALTO-203 in patients with MDD and high levels of anhedonia. Financial highlights include a net loss of $13.4 million, an increase in R&D expenses to $10 million, and higher G&A expenses reaching $4.4 million. Alto completed an upsized IPO in February 2024, netting $133 million in proceeds.
- Initiated Phase 2 study of ALTO-203 for MDD and anhedonia
- Reported positive Phase 1 data for transdermal ALTO-101, with improved drug exposure and tolerability
- Patient enrollment on track for ALTO-100 and ALTO-300 Phase 2b MDD studies
- Strong cash position of approximately $206 million, supporting operations into 2027
- Completed an upsized IPO in February 2024, netting $133 million
- ALTO-203 Phase 2 study for MDD and anhedonia initiated
- Increased R&D expenses to $10 million in Q1 2024, up from $5.6 million in Q1 2023
- Higher G&A expenses of $4.4 million in Q1 2024, up from $1.6 million in Q1 2023
- Net loss increased to $13.4 million in Q1 2024, compared to $7.3 million in Q1 2023
Insights
Alto Neuroscience's first-quarter financial report reveals several key points. The company has a strong cash position of $205.9 million, expected to fund operations through 2027. This significant cash reserve provides a solid financial buffer for ongoing and future clinical trials. Such liquidity is crucial, given the capital-intensive nature of pharmaceutical R&D.
However, the company also reported a net loss of $13.4 million, up from $7.3 million the previous year. This increase is attributed to higher R&D and administrative expenses. Investors should note that elevated expenses are typical during periods of aggressive clinical development and should be weighed against the potential long-term gains from successful trials.
R&D expenses rose to $10 million, reflecting the ramp-up in clinical trial activities, particularly for ALTO-100 and ALTO-300. General and administrative costs also increased significantly to $4.4 million due to growing operational needs and public company obligations. For retail investors, these figures suggest a robust commitment to advancing the pipeline, albeit with short-term financial strain.
Overall, the financial outlook appears cautiously optimistic, contingent on the successful outcome of their clinical trials.
Alto Neuroscience's clinical progress is promising, particularly the initiation of a Phase 2 study of ALTO-203 for MDD with anhedonia and the positive Phase 1 data for ALTO-101. These milestones highlight the company's strategic focus on personalized brain therapies.
The Phase 2b studies for ALTO-100 and ALTO-300 are essential to validate these treatments' efficacy and safety. For ALTO-100, the primary endpoint of the Montgomery-Åsberg Depression Rating Scale (MADRS) will provide critical data on its impact on MDD. The same scale will be used for ALTO-300, which is being tested in patients with an insufficient response to other antidepressants.
ALTO-101's transdermal formulation is particularly noteworthy. Historically, PDE4 inhibitors have faced development hurdles due to adverse effects, but the new formulation seems to mitigate these issues, suggesting a potential breakthrough for CNS disorders.
These developments underscore Alto’s strategic advancements in the CNS therapeutic area, with each trial phase marking a critical step towards potential market approval.
Alto Neuroscience's progress on multiple fronts is poised to generate investor interest. The company's engagement in Phase 2 studies for ALTO-203, ALTO-100 and ALTO-300, coupled with positive Phase 1 data for ALTO-101, positions them well within the competitive landscape of neuroscience and CNS therapies.
The unique formulation and improved tolerability of ALTO-101 could differentiate it from competitors, potentially capturing significant market share if clinical success is achieved. The focus on personalized medicine aligns with broader industry trends towards targeted therapies, which could appeal to healthcare providers and payers seeking effective, tailored treatments for CNS disorders.
Additionally, the company's ability to maintain a strong cash position while expanding clinical activities reflects sound financial management. This stability is important as Alto approaches key data readouts, which could serve as catalysts for stock performance. Investors should monitor upcoming milestones and data releases closely, as these will be pivotal in determining Alto's future market position.
– Initiated Phase 2 study of ALTO-203 in patients with MDD and anhedonia –
– Reported positive Phase 1 data with transdermal formulation of novel PDE4 inhibitor, ALTO-101; achieved significantly greater drug exposure with improved tolerability compared to oral administration –
– Patient enrollment on track across Phase 2b MDD studies for ALTO-100 and ALTO-300 –
– Strong cash position of approximately
“Our team’s commitment to developing personalized therapies for the brain is exemplified by our continued clinical execution and the recent progress across our pipeline,” said Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience. “We are proud to have initiated five Phase 2 clinical studies since Alto’s inception, and we look forward to reporting results from our depression studies for ALTO-100, ALTO-300, and ALTO-203, over the coming 12 months.”
Dr. Etkin added, “The Phase 1 data we recently reported for ALTO-101 showcase the depth and diversity of our clinical pipeline. We are excited to have a proprietary formulation that enables greater drug exposure while substantially reducing the typical PDE4-related adverse events. Our planned proof-of-concept study in schizophrenia with ALTO-101 will mark an important step forward for this program.”
First Quarter 2024 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).
Alto is currently evaluating ALTO-100 in a 266-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).
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 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 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: In Development for Cognitive Impairment Associated with Schizophrenia (CIAS)
ALTO-101 is a novel brain-penetrant PDE4 inhibitor currently in Phase 1 clinical development for the treatment of CIAS. In December 2023, the Company reported positive results from a Phase 1 study in healthy volunteers in which ALTO-101 was shown to positively impact key brain pharmacodynamic markers relevant to cognition that are indicative of potential clinical benefit.
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 (PK) profile and improve the overall tolerability profile relative to other PDE4 inhibitors.
In April 2024, the Company reported positive results from a Phase 1 study evaluating the pharmacokinetic and tolerability profile of transdermal administration of ALTO-101 compared to oral administration. Overall, ALTO-101 demonstrated a favorable pharmacokinetic and tolerability profile. The novel transdermal formulation delivered significantly greater drug exposure with substantially fewer adverse events typically associated with PDE4 inhibitors. The drug exposure demonstrated by the transdermal formulation is expected to be sufficient to achieve the desired 30
The Company expects to initiate a Phase 2 proof-of-concept study with ALTO-101 in CIAS in the first half of 2024.
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 dopamine release in the reward system and on positive subjective emotional measures in humans.
In April 2024, Alto announced the initiation of a Phase 2 proof-of-concept study to evaluate ALTO-203 in patients with MDD and higher levels of anhedonia. The study consists of two sequential double-blind, placebo-controlled treatment periods with two dose levels of ALTO-203 being studied as monotherapy. The first period uses a randomized single-dose treatment design to evaluate patient pharmacodynamic responses to ALTO-203 compared to placebo. The powered primary outcome is measured by an acute change in positive emotion assessed by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS), an established scale of subjective emotion also used in a prior Phase 1 study of ALTO-203. The second period uses a 28-day, multi-dose exposure design to assess the safety of ALTO-203 in patients with MDD. Exploratory, non-powered objectives for the multi-dose period will evaluate changes in measures of depression, anhedonia, and other clinical symptoms, along with cognition, EEG, and wearables.
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
-
The Company successfully completed its upsized initial public offering in February 2024, resulting in net proceeds of approximately
$133 million
Upcoming Milestones and Events
Near-Term Expected Milestones
- 1H 2024 — ALTO-101 Proof-of-Concept CIAS study initiation
- 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 Conference Presentation
- Members of the Alto Neuroscience team are expected to present data highlighting the breadth of the Company's pipeline and Precision Psychiatry Platform™ at the American Society of Clinical Psychopharmacology annual meeting.
First Quarter 2024 Financial Highlights
Cash Position: As of March 31, 2024, Alto had cash and cash equivalents of
The Company expects its cash balance to support planned operations into 2027.
R&D Expenses: Research and development expenses for the quarter ended March 31, 2024 were
G&A Expenses: General and administrative expenses for the quarter ended March 31, 2024 were
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 Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law.
ALTO NEUROSCIENCE, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) (unaudited) |
|||||||
|
|
||||||
|
Three months ended
|
||||||
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
||||
Research and development |
$ |
9,952 |
|
|
$ |
5,609 |
|
General and administrative |
|
4,434 |
|
|
|
1,592 |
|
Total operating expenses |
|
14,386 |
|
|
|
7,201 |
|
Loss from operations |
|
(14,386 |
) |
|
|
(7,201 |
) |
Other income (expense): |
|
|
|
||||
Interest income |
|
1,558 |
|
|
|
230 |
|
Interest expense |
|
(346 |
) |
|
|
(324 |
) |
Change in fair value of warrant liability |
|
(243 |
) |
|
|
11 |
|
Total other income (expense), net |
|
969 |
|
|
|
(83 |
) |
Net loss |
$ |
(13,417 |
) |
|
$ |
(7,284 |
) |
Other comprehensive loss |
|
|
|
||||
Foreign currency translation |
|
(5 |
) |
|
|
(19 |
) |
Total other comprehensive loss |
|
(5 |
) |
|
|
(19 |
) |
Comprehensive loss |
$ |
(13,422 |
) |
|
$ |
(7,303 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.76 |
) |
|
$ |
(1.97 |
) |
Weighted-average number of common shares outstanding, basic and diluted |
|
17,600 |
|
|
|
3,691 |
|
|
|
|
|
||||
ALTO NEUROSCIENCE, INC. Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) |
|||||||
|
|
|
|
||||
|
March 31, |
|
December 31, |
||||
|
|
2024 |
|
|
|
2023 |
|
Cash and cash equivalents |
$ |
205,895 |
|
|
$ |
82,548 |
|
Total assets |
|
209,922 |
|
|
|
86,628 |
|
Total liabilities |
|
16,818 |
|
|
|
16,823 |
|
Accumulated deficit |
|
(90,382 |
) |
|
|
(76,965 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240514832137/en/
Investor Contact:
Nick Smith
investors@altoneuroscience.com
Media Contact:
Jordann Merkert
media@altoneuroscience.com
Source: Alto Neuroscience, Inc.
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