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 September 30, 2023, and
provided pipeline and business updates.
“We enter the balance of the year more encouraged than ever by
our increasing understanding of the power of modulating the
neurotrophic HGF system as a potential strategy for treating a wide
range of neurodegenerative diseases. Our pipeline of small molecule
HGF system modulators has the potential to become the basis of a
future product line of neurodegenerative disease treatments,” said
Mark Litton, Ph.D., President and Chief Executive Officer of
Athira. “During the third quarter and recent weeks, we continued to
present new data at key medical meetings that provide further
evidence supporting the promise of both our fosgonimeton and
ATH-1105 programs, and neurotrophic HGF system modulation in
general, to modify the disease course for patients across a broad
range of neurodegenerative diseases, including Alzheimer's disease
(AD) and amyotrophic lateral sclerosis (ALS). We believe we have a
leading position in understanding the neurotrophic HGF system
biology.”
“We remain keenly focused on advancing the ongoing Phase 2/3
LIFT-AD study, where we have added clinical sites and continued to
engage with investigators to ensure completion of enrollment of
this important study by the first quarter of 2024. This summer, we
had a productive end-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) which enabled alignment with the FDA 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 topline results,
which are expected in the second half of 2024,” concluded Dr.
Litton.
Clinical Development & Pipeline
Programs
Athira’s drug development pipeline consists of potential
first-in-class (fosgonimeton) and next-generation (ATH-1105 and
ATH-1020) small molecule therapeutic candidates designed to promote
the neurotrophic HGF system, which activates neuroprotective,
neurotrophic and anti-inflammatory pathways in the central nervous
system. Athira’s therapeutic candidates have distinct properties
which the Company believes may be applicable to a range of
neurodegenerative diseases.
Fosgonimeton (ATH-1017) – A
potentially first-in-class, once daily, subcutaneously administered
drug candidate initially targeted to the potential treatment of
Alzheimer’s.
LIFT-AD Phase 2/3 trial of fosgonimeton 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 acetylcholinesterase inhibitors (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, while
elucidating the key drivers of potential treatment effect.
- Key secondary and exploratory endpoints include changes in
plasma biomarkers of neurodegeneration, protein pathology, and
neuroinflammation.
- 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 dose group compared to placebo for the
primary analysis of results.
- The Company expects to complete patient enrollment by the first
quarter of 2024 and to report topline LIFT-AD results in the second
half of 2024.
- Based on interactions with the FDA, 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.
Open Label Extension (OLEX) fosgonimeton trial (NCT04886063)
- Eligible participants who completed the LIFT-AD or ACT-AD
trials and elect to participate in the ongoing OLEX are able to
receive up to 30 months of open-label treatment.
- The Company believes OLEX will complement the Company’s
long-term safety database and provide insights into fosgonimeton’s
long-term effects for up to three years.
- 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 next-generation, orally
administered drug candidate developed for the potential treatment
of amyotrophic lateral sclerosis (ALS) as the Company’s initial
indication.
- 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
various ALS animal models.
- 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.
Recent and Upcoming Presentations Athira
continues to expand the body of clinical and preclinical findings
supporting the potential benefits of its pipeline of small molecule
therapeutic candidates targeting the neurotrophic HGF system to
deliver novel treatments for neurodegenerative diseases.
The Company presented new data at the Alzheimer’s Association
International Conference 2023 (AAIC) that included:
- A post-hoc analysis of the Phase 2 ACT-AD study and data from
the OLEX study in subjects 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.
The Company presented preclinical data that further supports the
potential of fosgonimeton to treat neurodegenerative diseases such
as AD at the 16th Annual Clinical Trials on Alzheimer’s Disease
conference (CTAD). The data presented:
- Demonstrated the ability of fosgonimeton to counteract
mechanisms of amyloid-β (Aβ)-induced toxicity, reduce tau
pathology, and promote neuronal survival in vitro.
- Showed treatment with fosgonimeton leads to improved cognitive
performance in an Aβ-driven rat model of AD, suggesting that the in
vitro activity of fosgonimeton Aβ-toxicity translates to functional
benefits in vivo.
The Company presented preclinical data demonstrating the
neuroprotective properties of ATH-1105 in several preclinical
models of ALS at the 22nd Annual Northeast ALS Consortium (NEALS)
Meeting that demonstrated:
- In vitro, ATH-1105 protected motor neurons from excitotoxicity,
reduced TDP-43 mis-localization, preserved metabolic stability, and
maintained neuromuscular junction integrity.
- In vivo, treatment with ATH-1105 improved motor and nerve
function, mitigated inflammation and neurodegeneration, and reduced
plasma NfL and pTDP-43 accumulation in ALS mice when administered
alone or in combination with riluzole.
Athira will be presenting new preclinical data supporting the
potential therapeutic benefit of fosgonimeton for the treatment of
Alzheimer’s disease at Neuroscience 2023. The event is hosted by
the Society for Neuroscience and will take place at the Walter E.
Washington Convention Center in Washington, D.C., November 11-15,
2023.
Presentation Details:
Title: Fosgonimeton, a small-molecule positive
modulator of the neurotrophic HGF system, protects against amyloid
beta-induced pathological alterations in Alzheimer's disease models
in vitro and in vivoFormat: Oral
NanosymposiumSession: NAN076Development of Novel
Therapies for Neurodegenerative and Neuromuscular
DiseasesPresenter: Sharay Setti, PhD, Senior
Scientist, Athira PharmaTime/Date: Wednesday,
November 15, Session time: 8:00 a.m. – 12:00 p.m. Eastern Time,
Presentation time: 8:15 a.m. – 8:30 am. Eastern Time
Title: Fosgonimeton, a small-molecule positive
modulator of the neurotrophic hepatocyte growth factor system,
inhibits LPS-mediated neuroinflammation in BV2
microgliaFormat: PosterSession:
PSTR 203.06. Neuroinflammation:
MicrogliaPresenter: Wei Wu, PhD, Senior Scientist
II, Athira PharmaTime/Date: Monday, November 13,
Session time: 8:00 a.m. – 12:00 p.m. Eastern Time, Presentation
time: 9:00 a.m. – 10:00 a.m. Eastern Time
Financial Results
- Cash Position. Cash, cash equivalents and
investments were $172.9 million as of September 30, 2023, compared
with $245.2 million as of December 31, 2022. Net cash used in
operations was $74.5 million for the nine months ended September
30, 2023, compared with $56.8 million for the nine months ended
September 30, 2022.
- Research and Development (R&D)
Expenses. R&D expenses were $27.2 million for the
quarter ended September 30, 2023, compared with $17.0 million for
the quarter ended September 30, 2022. The increase was driven
primarily by costs related to increased clinical trial activities,
manufacturing activities and personnel expense.
- General and Administrative (G&A)
Expenses. G&A expenses were $7.8 million for the
quarter ended September 30, 2023, compared with $7.2 million for
the quarter ended September 30, 2022. The increase was primarily
due to increases in personnel expenses, partially offset by a
decrease in business development expenses.
- Net Loss. Net loss was $32.7 million, or
$0.87 per share, for the quarter ended September 30, 2023, compared
with a net loss of $20.2 million, or $0.53 per share, for the
quarter ended September 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
diseases by advancing its pipeline of therapeutic 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 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 neurodegenerative diseases
such as Alzheimer’s disease and amyotrophic lateral sclerosis;
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 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 product candidates;
development of product candidates may cease or be delayed;
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; 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 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
pandemics or health epidemics, 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
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 ContactJulie RathbunAthira
PharmaJulie.rathbun@athira.com 206-769-9219
Athira Pharma,
Inc.Condensed Consolidated Balance
Sheets(Amounts in thousands)
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
110,334 |
|
|
$ |
95,966 |
|
Short-term investments |
|
|
62,614 |
|
|
|
104,378 |
|
Other short-term assets |
|
|
5,556 |
|
|
|
7,189 |
|
Long-term investments |
|
|
— |
|
|
|
44,829 |
|
Other long-term assets |
|
|
6,196 |
|
|
|
5,791 |
|
Total assets |
|
$ |
184,700 |
|
|
$ |
258,153 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
28,622 |
|
|
$ |
21,431 |
|
Long-term liabilities |
|
|
1,314 |
|
|
|
1,585 |
|
Total liabilities |
|
|
29,936 |
|
|
|
23,016 |
|
Stockholders' equity |
|
|
154,764 |
|
|
|
235,137 |
|
Total liabilities and
stockholders' equity |
|
$ |
184,700 |
|
|
$ |
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 September
30, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
27,202 |
|
|
$ |
16,965 |
|
General and administrative |
|
|
7,840 |
|
|
|
7,168 |
|
Total operating expenses |
|
|
35,042 |
|
|
|
24,133 |
|
Loss from operations |
|
|
(35,042 |
) |
|
|
(24,133 |
) |
Grant income |
|
|
— |
|
|
|
2,959 |
|
Other income, net |
|
|
2,072 |
|
|
|
985 |
|
Net loss |
|
$ |
(32,970 |
) |
|
$ |
(20,189 |
) |
Unrealized gain (loss) on
available-for-sale securities |
|
|
261 |
|
|
|
(547 |
) |
Comprehensive loss
attributable to common stockholders |
|
$ |
(32,709 |
) |
|
$ |
(20,736 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.87 |
) |
|
$ |
(0.53 |
) |
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
38,054,583 |
|
|
|
37,817,724 |
|
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