– 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 $210
million as of February 29, 2024 –
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported
financial results for the full year ended December 31, 2023, and
highlighted recent corporate progress.
“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 Amit Etkin, M.D.,
Ph.D., founder and CEO of Alto Neuroscience. “Our lead product
candidates, ALTO-100 and ALTO-300, have demonstrated positive Phase
2a results and we remain focused on clinical execution to deliver
value to patients and our shareholders. Looking ahead, we are on
track to report data from the Phase 2b depression studies of
ALTO-100 and ALTO-300 in the second half of 2024 and the first half
of 2025, respectively, in biomarker characterized patients.”
Nick Smith, CFO of Alto Neuroscience, added, “As we begin 2024,
Alto is in its strongest financial position to date. With the
proceeds from our IPO, combined with our existing cash balance, we
are well-positioned to read out data from at least four important
studies across our clinical-stage pipeline over the next two
years.”
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 January
2023, Alto reported positive results from a Phase 2a study in which
patients with MDD and a cognitive biomarker signature were
identified as more responsive to ALTO-100. This signal was
prospectively replicated to predict clinical response in an
independent, locked, and blinded data set of patients from the same
study.
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 December 2023, the
Company reported positive results from a Phase 1 study 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 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 January 2024, Alto received IND clearance for ALTO-203 and
expects to initiate a proof-of-concept study in the first half of
2024 in patients with MDD and increased levels of anhedonia.
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 in March 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 in February 2024.
- The Company successfully completed its upsized initial public
offering in February 2024, resulting in net proceeds of
approximately $133 million.
- In January 2024 the California 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 December 31, 2023, Alto had cash and
cash equivalents of $82.5 million. Following the closing of the
Company’s initial public offering, the Company had approximately
$210 million of cash and cash equivalents as of February 29,
2024.
The Company expects its cash balance to support planned
operations into 2027.
R&D Expenses: Research and development expenses for
the full year ended December 31, 2023 were $30.3 million, as
compared to $23.7 million for the same period in 2022. The increase
was primarily attributable to costs associated with the Phase 2a
clinical studies for ALTO-100 and ALTO-300, which were completed in
2023.
G&A Expenses: General and administrative expenses for
the full year ended December 31, 2023 were $7.5 million, as
compared to $5.5 million for the same period in 2022. The increase
was primarily attributable to costs associated with higher
headcount to support expanded clinical development efforts and
growing operational requirements.
Net Loss: The Company incurred a net loss of $36.3
million for the full year ended December 31, 2023, as compared to
$27.7 million for the year ended December 31, 2022.
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
Securities and Exchange Commission (“SEC”) on February 5, 2024,
pursuant to Rule 424(b)(4) under the Securities Act of 1933, as
amended, as well as in other filings Alto may make with the SEC in
the future, including its Annual Report on Form 10-K for the year
ended December 31, 2023. 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.
Consolidated Statements of
Operations and Comprehensive Loss
(in thousands, except share
and per share data)
(unaudited)
Year Ended December
31,
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
ALTO NEUROSCIENCE,
INC.
Selected Consolidated Balance
Sheet Data
(in thousands)
(unaudited)
December 31,
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: Nick Smith
investors@altoneuroscience.com
Media Contact: Jordann Merkert
media@altoneuroscience.com
Alto Neuroscience (NYSE:ANRO)
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Alto Neuroscience (NYSE:ANRO)
過去 株価チャート
から 5 2023 まで 5 2024