Athira Pharma Reports Second Quarter 2023 Financial Results and Pipeline and Business Updates
2023年8月11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, 2023, and provided
pipeline and business updates.
“During the second quarter, we advanced and strengthened our
pipeline of small molecule therapeutic candidates, with particular
focus on continued enrollment of the Phase 2/3 LIFT-AD trial of
investigational fosgonimeton for the treatment of mild-to-moderate
Alzheimer’s disease and advancement of our preclinical ATH-1105
program toward clinical testing, initially targeting amyotrophic
lateral sclerosis,” said Mark Litton, Ph.D., President and Chief
Executive Officer of Athira. “At the July Alzheimer’s Association
International Conference, we presented new findings regarding both
our fosgonimeton and ATH-1105 programs. These data, along with the
totality of evidence generated to date, strengthen our view that
our pipeline of drug candidates, which are designed to positively
modulate the HGF/MET neurotrophic system, have the potential to
deliver novel treatments for neurodegenerative diseases.”
“Our end of Phase 2 meeting with the U.S. Food and Drug
Administration was very productive and enabled alignment with
senior leadership from the Office of Neuroscience and Division of
Neurology 1 on important aspects of the fosgonimeton
program. We look forward to continued communication
with the FDA including discussions regarding our biomarker strategy
and the LIFT-AD results, now expected in the second half of 2024,”
concluded Dr. Litton.
Clinical Development & Pipeline
Programs
Fosgonimeton (ATH-1017) –
Small molecule designed to enhance the HGF/MET system with the
potential to protect and repair neuronal networks.
End of Phase 2 Meeting (EOP2) with the U.S. Food and Drug
Administration (FDA)
- In July, the Company completed an EOP2 meeting with the FDA to
gain alignment on its plans for the continued clinical development
of fosgonimeton as a potential treatment for mild-to-moderate
Alzheimer’s disease (AD).
- The Company provided an update and discussed with FDA the
ongoing LIFT-AD trial including use of the 40 mg dose, concomitant
acetylcholinesterase inhibitor (AChEIs) use, biomarker analyses
including neurofilament light (NfL), and the statistical analysis
plan.
- The FDA noted the importance of showing effects on both
cognition (ADAS-Cog11) and function (ADCS-ADL23) in this
population.
- Based on FDA interactions, the Company believes that all
registrational pathways remain viable and contingent on LIFT-AD
results. The FDA is open to ongoing dialogue with the
Company regarding the LIFT-AD trial once completed as well as other
aspects of our program to develop fosgonimeton as a potential
treatment for mild-to-moderate AD.
LIFT-AD Phase 2/3 trial in mild-to-moderate Alzheimer’s disease
(NCT04488419)
- In September 2022, an independent, unblinded interim efficacy
and futility analysis was performed on 100 patients without
concomitant AChEIs who completed the LIFT-AD Phase 2/3 trial.
The positive outcome from the independent data monitoring committee
supports the potential clinically meaningful activity of
fosgonimeton and its potential to achieve the primary endpoint of
the trial.
- LIFT-AD’s primary endpoint is the Global Statistical Test
(GST), a composite of the co-key secondary endpoints ADAS-Cog11 and
ADCS-ADL23. The Company expects the GST endpoint to increase the
understanding of the clinical impact of fosgonimeton despite the
limited trial size, while elucidating the key drivers of potential
treatment effect.
- Key secondary and exploratory endpoints include changes in
plasma biomarkers of neurodegeneration, protein pathology, and
inflammation.
- In a protocol amendment submitted to FDA in May 2023, the
LIFT-AD trial was modified to focus prospectively only on 40 mg
dosing and to use this dosing group compared to placebo for the
primary analysis of results.
- The Company now expects to report topline LIFT-AD results in
the second half of 2024.
Open Label Extension (OLEX) trial (NCT04886063)
- In May, the Company extended the OLEX study for the Phase 2/3
LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton for the treatment
of mild-to-moderate AD by an additional 12 months. Eligible
participants who have completed the LIFT-AD or ACT-AD trials and
elect to participate in the ongoing OLEX are now able to receive up
to 30 months of open-label treatment. The extension addressed
investigator and patient interest in continuing treatment with
fosgonimeton beyond 18 months.
- The Company believes the extension will also further enhance
its long-term safety database and provide insights into
fosgonimeton’s long-term effects for up to 3 years.
- The OLEX continues to enroll with greater than 85% of
participants who completed either study having elected to enroll in
the OLEX study.
ATH-1105 – A novel, orally available, small
molecule designed to be a positive modulator of the HGF/MET system
as a potential treatment candidate initially for amyotrophic
lateral sclerosis (ALS).
- ATH-1105 is supported by preclinical findings that demonstrated
statistically significant improvements on nerve and motor function,
biomarkers of inflammation and neurodegeneration, and survival in
an ALS animal model.
- IND-enabling studies will continue through the remainder of
2023 in order to support the potential initiation of first-in-human
studies in the first half of 2024 to evaluate this promising drug
candidate as a treatment for ALS.
Presentations and Publications
In July, the Company presented three posters at the Alzheimer’s
Association International Conference 2023 (AAIC) that highlighted
its pipeline of small molecule therapeutic candidates targeting
HGF/MET. Data presented included:
- A post-hoc analysis of the Phase 2 ACT-AD study and data from
the OLEX study in patients with mild-to-moderate AD. The data
suggested that improvements in plasma biomarkers of
neurodegeneration (NfL) and neuroinflammation (glial fibrillary
acidic protein, or GFAP) significantly correlate with GST, a
composite score of cognition and function, further supporting the
potential clinical utility of these biomarkers.
- Preclinical data demonstrating that fosgonimeton attenuates
amyloid-β-mediated toxicity in vitro and highlighting its potential
as a therapeutic candidate to slow disease progression and restore
neuronal health.
- Preclinical data demonstrating that ATH-1105 offers protection
against several pathologies common to ALS and frontotemporal
dementia and supporting its therapeutic potential for the treatment
of these indications.
Corporate Updates
The Company appointed seasoned finance and corporate strategy
executive Andrew Gengos as Chief Financial Officer and Chief
Business Officer.
- Most recently, Mr. Gengos served as the Chief Business Officer
at Cyteir Therapeutics and has held executive roles at
ImmunoCellular Therapeutics, Neuraltus Pharmaceuticals, AOBiome
Therapeutics, and Synlogic. Previously, Mr. Gengos was Vice
President of Strategy and Corporate Development at Amgen for eight
years.
- Mr. Gengos holds a Master of Business Administration from the
UCLA Anderson School of Management and a Bachelor of Science in
Chemical Engineering from the Massachusetts Institute of
Technology.
Financial Results
- Cash Position. Cash, cash
equivalents and investments were $196.3 million as of June 30,
2023, compared with $245.2 million as of December 31, 2022. Net
cash used in operations was $50.5 million for the six months ended
June 30, 2023, compared with $35.2 million for the six months ended
June 30, 2022.
- Research and Development (R&D) Expenses.
R&D expenses were $21.6 million for the quarter ended June 30,
2023, compared with $14.8 million for the quarter ended June 30,
2022. The increase was driven primarily by costs related to
increased clinical trial activities, manufacturing activities,
headcount and increased preclinical R&D.
- General and Administrative (G&A) Expenses.
G&A expenses were $10.0 million for the quarter ended June 30,
2023, compared with $8.8 million for the quarter ended June 30,
2022. The increase was primarily due to increases in consulting,
professional services, and business development expenses, and an
increase in personnel expenses as the Company’s headcount expanded
to support its growth, partially offset by a decrease in legal
expenses.
- Net Loss. Net loss was $29.6 million, or $0.78
per share, for the quarter ended June 30, 2023, compared with a net
loss of $24.3 million, or $0.65 per share, for the quarter ended
June 30, 2022.
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
disease by advancing its pipeline of therapeutic candidates
targeting the HGF/MET neurotrophic system for Alzheimer’s and
Parkinson’s disease, Dementia with Lewy bodies, and amyotrophic
lateral sclerosis. For more information, visit www.athira.com.
You can also follow Athira on Facebook, LinkedIn and
@athirapharma on X, formerly known as Twitter,
and Instagram.
Forward-Looking StatementsThis 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: product
candidates as a potential treatment for Alzheimer’s disease and
other neurodegenerative diseases, such as amyotrophic lateral
sclerosis and frontotemporal dementia; Athira’s platform technology
and potential therapies; future development plans; expectations
regarding the potential efficacy and commercial potential of
Athira’s product candidates; the anticipated reporting of
data; the impact of Athira’s July 2023 End of Phase 2 Meeting with
the U.S. Food and Drug Administration on its future development
plans and pipeline candidates; and Athira’s ability to advance its
product 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,” and other similar expressions,
among others. 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 for our
product candidates from our preclinical and clinical trials not
supporting the safety, efficacy and tolerability of our product
candidates; cessation or delay of Athira’s development of product
candidates may occur; regulatory authorities could object to
protocols, amendments and other submissions; future potential
regulatory milestones for product candidates, including those
related to current and planned clinical studies, may be
insufficient to support regulatory submissions or approval; the
impact of the COVID-19 pandemic on Athira’s business, research and
clinical development plans and timelines, and the regulatory
process for Athira product candidates; 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 us and certain of our directors and officers; clinical
trials may not demonstrate safety and efficacy of any of Athira’s
product candidates; possible negative interactions of Athira's
product candidates with other treatments; Athira’s assumptions
regarding 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; regulatory agencies may be
delayed in reviewing, commenting on or approving any of Athira’s
clinical development plans as a result of the COVID-19 pandemic,
which could further delay development timelines; the impact of
expanded product 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. 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 ContactJulie RathbunAthira
PharmaJulie.rathbun@athira.com 206-769-9219
|
|
Athira Pharma, Inc.Condensed Consolidated
Balance Sheets(Amounts in thousands) |
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
113,628 |
|
|
$ |
95,966 |
|
Short-term investments |
|
|
72,462 |
|
|
|
104,378 |
|
Other short-term assets |
|
|
6,043 |
|
|
|
7,189 |
|
Long-term investments |
|
|
10,217 |
|
|
|
44,829 |
|
Other long-term assets |
|
|
5,698 |
|
|
|
5,791 |
|
Total
assets |
|
$ |
208,048 |
|
|
$ |
258,153 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
21,662 |
|
|
$ |
21,431 |
|
Long-term liabilities |
|
|
1,407 |
|
|
|
1,585 |
|
Total
liabilities |
|
|
23,069 |
|
|
|
23,016 |
|
Stockholders' equity |
|
|
184,979 |
|
|
|
235,137 |
|
Total
liabilities and stockholders' equity |
|
$ |
208,048 |
|
|
$ |
258,153 |
|
|
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, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
21,615 |
|
|
$ |
14,803 |
|
General and administrative |
|
|
10,025 |
|
|
|
8,766 |
|
Total operating expenses |
|
|
31,640 |
|
|
|
23,569 |
|
Loss
from operations |
|
|
(31,640 |
) |
|
|
(23,569 |
) |
Grant
income |
|
|
— |
|
|
|
(1,259 |
) |
Other
income, net |
|
|
2,043 |
|
|
|
493 |
|
Net
loss |
|
$ |
(29,597 |
) |
|
$ |
(24,335 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
|
90 |
|
|
|
(469 |
) |
Comprehensive loss attributable to common stockholders |
|
$ |
(29,507 |
) |
|
$ |
(24,804 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.65 |
) |
Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted |
|
|
37,999,578 |
|
|
|
37,667,971 |
|
Athira Pharma (NASDAQ:ATHA)
過去 株価チャート
から 5 2024 まで 6 2024
Athira Pharma (NASDAQ:ATHA)
過去 株価チャート
から 6 2023 まで 6 2024