– 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 $206
million expected to support planned operations into 2027 –
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported
financial results for the first quarter ended March 31, 2024, and
highlighted recent corporate progress.
“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
30-40% target occupancy, which has been shown through positron
emission tomography (PET) to be the relevant occupancy to induce
the brain effects observed with oral administration of
ALTO-101.
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 $205.9 million.
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 $10.0 million, as compared to
$5.6 million for the same period in 2023. The increase was
primarily attributable to costs associated with the ALTO-100 and
ALTO-300 Phase 2b clinical studies, which were initiated in January
2023 and June 2023, respectively.
G&A Expenses: General and administrative expenses for
the quarter ended March 31, 2024 were $4.4 million, as compared to
$1.6 million for the same period in 2023. The increase was
primarily attributable to costs associated with higher headcount to
support expanded clinical development efforts, growing operational
requirements, and costs associated with operating as a public
company.
Net Loss: The Company incurred a net loss of $13.4
million for the quarter ended March 31, 2024, as compared to $7.3
million for the quarter ended March 31, 2023.
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
March 31,
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
Alto Neuroscience (NYSE:ANRO)
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