Athira Pharma Reports Second Quarter 2024 Financial Results and Pipeline and Business Updates
2024年8月2日 - 5:05AM
Athira Pharma, Inc. (NASDAQ: ATHA), a late
clinical-stage biopharmaceutical company focused on developing
small molecules to restore neuronal health and slow
neurodegeneration, today reported financial results for the quarter
ended June 30, 2024, and provided recent pipeline and business
updates.
“We are excited to be fast approaching the topline data readout
from our Phase 2/3 LIFT-AD clinical trial by the end of the third
quarter, as we believe it will further support fosgonimeton's
potential as a first-in-class therapy for mild-to-moderate
Alzheimer’s disease patients,” said Mark Litton, Ph.D., President
and Chief Executive Officer of Athira. “We were delighted to
present preclinical data at the recent Alzheimer’s Association
International Conference that showed fosgonimeton attenuated
amyloid-β-induced autophagic impairments in primary cortical
neurons, which may have important implications regarding the
mitigation of pTau pathology and neurodegeneration observed in our
preclinical models. These results suggest that fosgonimeton may
have beneficial impacts on key indicators of protein pathology
(pTau) and the associated neurodegeneration in Alzheimer’s disease.
Plasma biomarkers of Alzheimer’s disease pathology, including
Amyloid-β and pTau, will be evaluated in our LIFT-AD trial in
addition to our primary endpoint combining measures of cognition
and function.”
Clinical Development & Pipeline
Programs
Athira’s drug development pipeline includes potential
first-in-class (fosgonimeton) and next-generation (ATH-1105 and
ATH-1020) small molecule drug candidates designed to promote the
neurotrophic hepatocyte growth factor (HGF) system, which activates
neuroprotective, neurotrophic and anti-inflammatory pathways in the
central nervous system. Athira’s drug candidates have distinct
properties, which the Company believes may be applicable to a broad
range of neurodegenerative diseases.
Fosgonimeton (ATH-1017) – A
potentially first-in-class, once daily, subcutaneously administered
drug candidate initially targeted for the potential treatment of
Alzheimer’s disease.
LIFT-AD Phase 2/3 clinical trial of fosgonimeton in
mild-to-moderate Alzheimer’s disease (NCT04488419)
- Athira is targeting to release topline data from LIFT-AD in the
third quarter of 2024 and plans to present the fuller dataset in an
oral presentation at the 17th Annual Clinical Trials on Alzheimer’s
Disease (CTAD) taking place October 29-November 1, 2024, in Madrid,
Spain.
- In July 2024, Athira announced the
completion of dosing for the last patient enrolled in the LIFT-AD
study.
- The LIFT-AD study is investigating
the effects of fosgonimeton 40 mg compared with placebo in a
primary analysis population of approximately 315 mild-to-moderate
AD patients who are not receiving background therapy. The
primary endpoint is the Global Statistical Test (GST), a
combination of results of measures of cognition (ADAS-Cog11) and
function (ADCS-ADL23), which Athira believes is a comprehensive
measure of overall disease burden. Other secondary and exploratory
endpoints include changes in plasma biomarkers of
neurodegeneration, protein pathology, and neuroinflammation.
Open Label Extension (OLEX) fosgonimeton trial
(NCT04886063)
- Eligible participants who complete the Company’s LIFT-AD or
ACT-AD clinical trials and elect to participate in the ongoing OLEX
are able to receive up to 48 months of open-label treatment.
- Notably, 85% of eligible participants who completed either
study elected to enroll in OLEX.
- Currently, more than 70 patients are continuing fosgonimeton
treatment beyond 18 months, with nearly 50 patients continuing
fosgonimeton treatment beyond 24 months, reflecting an unexpected
long-term participation rate in a progressive mild-to-moderate
Alzheimer’s disease population.
- Athira believes the OLEX will provide insights into
fosgonimeton’s long-term effects for potentially over four years of
investigational treatment.
ATH-1105 – A next-generation, orally
administered, small molecule drug candidate in development for the
potential treatment of ALS.
- Athira is currently conducting a first-in-human, dose
escalation Phase 1 clinical trial evaluating safety, tolerability
and pharmacokinetics of ATH-1105 in up to 80 healthy
volunteers.
- Athira announced the completion of the first cohort of healthy
volunteers in June 2024, and the Company expects trial completion
by year-end 2024.
- ATH-1105’s potential is supported by a growing body of
preclinical evidence demonstrating statistically significant
improvements on nerve and motor function, biomarkers of
inflammation and neurodegeneration, and survival in various models
of ALS.
- These data have been presented at a variety of key scientific
and medical meetings including the American Association of
Neurology (AAN), the Alzheimer’s Association International Congress
(AAIC), the Northeast Amyotrophic Lateral Sclerosis Consortium®
(NEALS), and the Motor Neurone Disease Association (MNDA).
Recent Presentations and Publications
- In July 2024, Athira presented
preclinical data in poster presentations at the Alzheimer’s
Association International Conference (AAIC) 2024. One highlighted
fosgonimeton’s ability to potentially address autophagic impairment
in AD, which may have important implications regarding the
attenuation of pTau pathology. In the presentation titled,
“Fosgonimeton attenuates amyloid-β-induced autophagic impairments
in primary cortical neurons,” study authors concluded that the data
“demonstrate the ability of fosgonimeton to potentially address
autophagic impairment in Alzheimer’s disease, which may lead to the
reduction of pTau pathology with treatment.” The other presentation
titled “Neuroprotective effects of fosgonimeton and
amyloid-β-targeting monoclonal antibodies against amyloid-β
toxicity in primary neuron culture” highlighted research that
demonstrated the neuroprotective ability of fosgonimeton, alone or
in combination with lecanemab, against amyloid-β-mediated toxicity
in primary neurons. Athira’s scientific presentations can be
accessed on the Athira website here: Medical Affairs – Athira
Pharma.
- In June 2024, Athira hosted a Key
Opinion Leader webinar event focused on the LIFT-AD trial endpoint
of GST. The event featured presentations from Suzanne Hendrix,
Ph.D., Founder and CEO of Pentara Corporation, and Anton P.
Porsteinsson, M.D., Director of the University of Rochester
Alzheimer’s Disease Care, Research, and Education Program
(AD-CARE). A replay of the event can be accessed
here.
Financial Results
- Cash Position. Cash, cash equivalents and
investments were $91.8 million as of June 30, 2024, compared to
$147.4 million as of December 31, 2023. Net cash used in operations
was $48.1 million for the six months ended June 30, 2024, compared
to $50.5 million for the six months ended June 30, 2023.
- Research and Development (R&D) Expenses.
R&D expenses were $22.2 million for the quarter ended June 30,
2024, compared to $21.6 million for the quarter ended June 30,
2023. The increase was driven primarily by an increase in ATH-1105
program costs associated with the Phase 1 clinical trial, which
commenced in the second quarter of 2024. This increase was
partially offset by decreases in fosgonimeton program costs,
preclinical programs and other direct costs, and personnel-related
expenses.
- General and Administrative (G&A)
Expenses. G&A expenses were $5.9
million for the quarter ended June 30, 2024, compared to $10.0
million for the quarter ended June 30, 2023. The decrease was
driven by decreases in legal costs, business development expenses,
professional services expenses, and other general corporate
expenses.
- Net Loss. Net loss was $26.9 million, or
$0.70 per share, for the quarter ended June 30, 2024, compared to a
net loss of $29.6 million, or $0.78 per share, for the quarter
ended June 30, 2023.
About Athira Pharma, Inc.Athira Pharma, Inc.,
headquartered in the Seattle, Washington area, is a late
clinical-stage biopharmaceutical company focused on developing
small molecules to restore neuronal health and slow
neurodegeneration. Athira aims to alter the course of neurological
diseases by advancing its pipeline of drug candidates that modulate
the neurotrophic HGF system. For more information,
visit www.athira.com. You can also follow Athira
on Facebook, LinkedIn, X (formerly known as
Twitter) and Instagram.
Forward-Looking Statements This communication
contains “forward-looking statements” within the meaning of Section
27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are not based on
historical fact and include statements regarding: Athira’s drug
candidates as potential treatments for Alzheimer’s disease,
Parkinson’s disease, dementia with Lewy bodies, amyotrophic lateral
sclerosis and other neurodegenerative diseases; future development
plans; the anticipated reporting of data; the potential learnings
from preclinical studies and other nonclinical data and their
ability to inform and improve future clinical development plans;
expectations regarding the potential efficacy and commercial
potential of Athira’s drug candidates; and Athira’s ability to
advance its drug candidates into later stages of development.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as “may,” “will,” “should,” “on
track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,”
“continue,” “suggest,” “potential,” “target,” and similar
expressions. Any forward-looking statements are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the data from
preclinical and clinical trials may not support the safety,
efficacy and tolerability of Athira’s drug candidates; development
of drug candidates may cease or be delayed; regulatory authorities
could object to protocols, amendments and other submissions; future
potential regulatory milestones for drug candidates, including
those related to current and planned clinical studies, may be
insufficient to support regulatory submissions or approval; the
anticipated timing of the topline data from the LIFT-AD trial may
be delayed; whether Athira’s trials are sufficiently powered to
meet the planned endpoints; Athira may not be able to recruit
sufficient patients for its clinical trials; the outcome of legal
proceedings that have been or may in the future be instituted
against Athira, its directors and officers; possible negative
interactions of Athira's drug candidates with other treatments;
Athira’s assumptions regarding its financial condition and the
sufficiency of its cash, cash equivalents and investments to fund
its planned operations may be incorrect; adverse conditions in the
general domestic and global economic markets; the impact of
competition; the impact of expanded drug candidate development and
clinical activities on operating expenses; the impact of new or
changing laws and regulations; as well as the other risks detailed
in Athira’s filings with the Securities and Exchange Commission
from time to time. These forward-looking statements speak only as
of the date hereof and Athira undertakes no obligation to update
forward-looking statements. Athira may not actually achieve the
plans, intentions, or expectations disclosed in its forward-looking
statements, and you should not place undue reliance on the
forward-looking statements.
Investor & Media Contact:
Julie RathbunAthira
PharmaJulie.rathbun@athira.com206-769-9219
Athira Pharma, Inc. |
|
Condensed Consolidated Balance Sheets |
|
(Amounts in thousands) |
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
73,828 |
|
|
$ |
90,584 |
|
Short-term investments |
|
|
17,941 |
|
|
|
56,835 |
|
Other short-term assets |
|
|
6,562 |
|
|
|
7,310 |
|
Other long-term assets |
|
|
12,922 |
|
|
|
5,516 |
|
Total assets |
|
$ |
111,253 |
|
|
$ |
160,245 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
26,902 |
|
|
$ |
28,840 |
|
Long-term liabilities |
|
|
1,016 |
|
|
|
1,217 |
|
Total liabilities |
|
|
27,918 |
|
|
|
30,057 |
|
Stockholders' equity |
|
|
83,335 |
|
|
|
130,188 |
|
Total liabilities and
stockholders' equity |
|
$ |
111,253 |
|
|
$ |
160,245 |
|
|
Athira Pharma, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Amounts in thousands, except share and per share amounts) |
(Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
22,154 |
|
|
$ |
21,615 |
|
General and administrative |
|
|
5,874 |
|
|
|
10,025 |
|
Total operating expenses |
|
|
28,028 |
|
|
|
31,640 |
|
Loss from operations |
|
|
(28,028 |
) |
|
|
(31,640 |
) |
Other income, net |
|
|
1,169 |
|
|
|
2,043 |
|
Net loss |
|
$ |
(26,859 |
) |
|
$ |
(29,597 |
) |
Unrealized gain on
available-for-sale securities |
|
|
99 |
|
|
|
90 |
|
Comprehensive loss
attributable to common stockholders |
|
$ |
(26,760 |
) |
|
$ |
(29,507 |
) |
Net loss per share attributable
to common stockholders, |
|
|
|
|
|
|
|
|
basic and diluted |
|
$ |
(0.70 |
) |
|
$ |
(0.78 |
) |
Weighted-average shares used in
computing net loss per |
|
|
|
|
|
|
|
|
share attributable to common stockholders, basic and diluted |
|
|
38,379,733 |
|
|
|
37,999,578 |
|
Athira Pharma (NASDAQ:ATHA)
過去 株価チャート
から 8 2024 まで 9 2024
Athira Pharma (NASDAQ:ATHA)
過去 株価チャート
から 9 2023 まで 9 2024