Athira Pharma Reports First Quarter 2023 Financial Results and Recent Pipeline and Business Updates
12 5월 2023 - 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 announced the company’s financial results
for the first quarter ended March 31, 2023, and reviewed recent
pipeline and business updates.
“We continue to advance the Phase 2/3 LIFT-AD trial of
fosgonimeton as a treatment for mild-to-moderate Alzheimer’s
disease and will focus on the 40 mg dose, as the totality of the
data supports the selection of this dose to enhance both our
chances for success and the trial’s potential to be a
registrational study,” said Mark Litton, Ph.D., President and Chief
Executive Officer of Athira.
“Throughout the first quarter and in the recent months, we
presented supportive preclinical and clinical data describing the
therapeutic potential of enhancing the HGF/MET system to protect
and repair neuronal networks in neurodegenerative diseases such as
Alzheimer’s (AD), Parkinson’s and amyotrophic lateral sclerosis
(ALS). Clinical data recently presented at AAN showed a
statistically significant improvement in Mini-Mental State Exam
(MMSE) scores in the participants treated with fosgonimeton without
concomitant acetylcholinesterase inhibitors (AChEIs) in a post-hoc
analysis of the exploratory six-month Phase 2 ACT-AD trial. These
data, along with a statistically significant improvement in a
plasma biomarker of neurodegeneration (neurofilament light chain,
NfL), and directional improvements in biomarkers of
neuroinflammation and AD protein pathology continue to give us
confidence in the potential for fosgonimeton to become a meaningful
therapy for people living with Alzheimer’s.
“We have a strong balance sheet that enables us
to continue to advance fosgonimeton in Alzheimer’s and ATH-1105 in
ALS, through key inflection points,” 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.
- The Company has selected the 40 mg dose for further development
and potential regulatory approval for mild to moderate AD.
- Fosgonimeton continues to demonstrate a favorable safety
profile in patients on both the 40 mg and 70 mg doses in all
completed and ongoing clinical studies.
- The dose selection was based on a review of the totality of the
data across preclinical and clinical studies and in consultation
with independent regulatory and biostatistical experts.
- This decision was based on supportive data from participants
treated with 40 mg fosgonimeton without concomitant
acetylcholinesterase inhibitors (AChEIs):
- Phase 1b trial results showed 73 milliseconds improvement in
P300 latency from baseline compared with placebo at eight days
(p=0.027);
- Post-hoc analyses of the Phase 2 ACT-AD trial of the 40 mg arm
at 6 months showed:
- P300 latency
improvement of 37 milliseconds (p=0.050) compared to placebo;
- ADAS-Cog11
improvement of - 2.6 points (n.s.) compared to placebo; and
- NfL, improvement of
8.15 pg/mL (p=0.019) compared to placebo.
- A higher number of participants from the ACT-AD trial receiving
the 40 mg dose transitioned into the OLEX trial compared to those
receiving the 70 mg dose.
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 trial. The positive outcome
from the independent data monitoring committee supports the
potential clinically meaningful activity of fosgo and its potential
to achieve the primary endpoint, which is a composite score of
cognition and function.
- The Phase 2/3 LIFT-AD trial of fosgonimeton for
mild-to-moderate Alzheimer’s disease will now focus enrollment and
the primary analysis on 40 mg dosing and will discontinue
enrollment of the 70 mg arm going forward.
- The Company was granted an end of Phase 2 meeting with the U.S.
Food and Drug Administration this summer. The timeline for LIFT-AD
will be updated following this meeting.
Open Label Extension (OLEX) trial (NCT04886063)
- The Company plans to further extend the current OLEX 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.
Following this extension, eligible participants who have completed
the LIFT-AD or ACT-AD trials and elect to participate in the
ongoing OLEX will be able to receive up to 30 months of open-label
treatment. This extension is intended to address
investigator and patient interest in continuing treatment with
fosgonimeton beyond 18 months. We believe it will also further
enhance our 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 have completed either study having elected to
enroll in the OLEX trial.
The ACT-AD trial and the related open-label
extension for ACT-AD participants was supported by a grant from the
National Institute on Aging of the National Institutes of Health
under Award Number R01AG06268. The information presented in this
press release is solely the responsibility of Athira and does not
necessarily represent the official views of the National Institutes
of Health.
Presentations and Publications
- The Company presented preclinical and clinical data in support
of its small molecule pipeline of therapeutic candidates targeting
the HGF/MET neurotrophic system:
- Delivered an oral presentation at the American Association of
Neurology (AAN) 2023 Annual Meeting that highlighted data from
additional post hoc analyses from the completed, exploratory Phase
2 ACT-AD trial of fosgonimeton in mild-to-moderate AD, which
included statistically significant improvements in MMSE scores
following fosgonimeton treatment without concomitant AChEIs. This
is in line with previously reported findings showing directional
changes in improvements in measures of cognition and plasma
biomarkers of neuroinflammation and protein pathology, as well as a
statistically significant improvement in Nfl, an established
biomarker of neurodegeneration, following fosgonimeton treatment
without concomitant AChEIs.
- Presented an oral presentation at AAN 2023 that reviewed
compelling preclinical data that continue to elucidate
fosgonimeton’s multimodal mechanism of action and therapeutic
potential in neurodegenerative diseases.
- Reported new data at AAN 2023 that provided further insights
into the interaction of fosgonimeton with donepezil. Preclinical
data presented suggested that the neuroprotective effects of
fosgonimeton are muted in combination with donepezil, which we
believe to be due, in part, to an interference on neuroprotective
AKT signaling, one of the multimodal mechanisms enhanced by
targeting the HGF/MET system.
- Presented three posters at the AD/PD™ 2023 International
Conference on Alzheimer's and Parkinson's Diseases and Related
Neurological Disorders (AD/PD) that highlighted the potential
neuroprotective, neurotrophic and anti-inflammatory effects of
enhancing the HGF/MET system.
ATH-1105 – A novel, orally available, small
molecule designed to be a positive modulator of the HGF/MET system
as a potential treatment candidate for amyotrophic lateral
sclerosis (ALS).
- Presented preclinical findings for ATH-1105 at AAN that
demonstrated statistically significant improvements on multiple
measures of nerve and motor function, biomarkers of inflammation
and neurodegeneration, and survival in an animal model of
amyotrophic lateral sclerosis (ALS), including prolonged survival
and delayed time to first mortality (p=0.0035); improvement in
balance, coordination, and muscle strength in motor function tests
(p<0.0001); protection against body weight reduction
(p<0.01); preservation of nerve function and structure
(p<0.001); and reduction of plasma biomarkers of systemic
inflammation and neurodegeneration (p<0.0001).
- Completing IND-enabling work throughout 2023 in order to
initiate first-in-human studies in 2024 to evaluate this promising
product candidate as a treatment for ALS.
Financial Results
- Cash Position. Cash, cash equivalents and
investments were $219.9 million as of March 31, 2023, compared with
$245.2 million as of December 31, 2022. Net cash used in operations
was $26.2 million for the quarter ended March 31, 2023, compared
with $16.6 million for the quarter ended March 31, 2022.
- Research and Development (R&D) Expenses.
R&D expenses were $21.3 million for the quarter ended March 31,
2023, compared with $14.5 million for the quarter ended March 31,
2022. The increase was driven primarily by costs related to
increased clinical trial activities, headcount and increased
preclinical research and development expenses.
- General and Administrative (G&A)
Expenses. G&A expenses were $8.5
million for the quarter ended March 31, 2023, compared with $8.9
million for the quarter ended March 31, 2022. The decrease was
primarily due to a decrease in legal and other general corporate
expenses, partially offset by increases in personnel expenses as
the Company’s headcount expanded to support its continued
growth.
- Net Loss. Net loss was $27.8 million, or
$0.73 per share, for the quarter ended March 31, 2023, compared
with a net loss of $21.0 million, or $0.56 per share, for the
quarter ended March 31, 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 provide rapid cognitive
improvement and alter the course of neurological diseases with its
novel mechanism of action. Athira is currently advancing its
pipeline therapeutic candidates targeting the HGF/MET neurotrophic
system for Alzheimer’s and Parkinson’s disease, Dementia with Lewy
bodies and ALS. For more information, visit www.athira.com.
You can also follow Athira on Facebook, LinkedIn,
Twitter and @athirapharma on 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,
Parkinson’s disease dementia, Dementia with Lewy bodies,
neuropsychiatric diseases, and other neurodegenerative diseases,
such as amyotrophic lateral sclerosis; Athira’s platform technology
and potential therapies; future development plans; clinical and
regulatory objectives and the timing thereof; expectations
regarding the safety, potential efficacy and commercial potential
of Athira’s product candidates; the anticipated reporting of data;
the potential learnings from the LIFT-AD unblinded interim efficacy
and futility analysis and their ability to inform and improve
future clinical development plans; Athira’s plans to further
extend the open label extension trial for its LIFT-AD and ACT-AD
clinical trials; 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.com206-769-9219
Athira Pharma, Inc. |
Condensed Consolidated Balance Sheets |
(Amounts in thousands) |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
105,182 |
|
|
$ |
95,966 |
|
Short-term investments |
|
|
80,799 |
|
|
|
104,378 |
|
Other short-term assets |
|
|
6,915 |
|
|
|
7,189 |
|
Long-term investments |
|
|
33,903 |
|
|
|
44,829 |
|
Other long-term assets |
|
|
5,973 |
|
|
|
5,791 |
|
Total assets |
|
$ |
232,772 |
|
|
$ |
258,153 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
20,150 |
|
|
$ |
21,431 |
|
Long-term liabilities |
|
|
1,497 |
|
|
|
1,585 |
|
Total liabilities |
|
|
21,647 |
|
|
|
23,016 |
|
Stockholders' equity |
|
|
211,125 |
|
|
|
235,137 |
|
Total liabilities and
stockholders' equity |
|
$ |
232,772 |
|
|
$ |
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
March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
21,293 |
|
|
$ |
14,460 |
|
General and administrative |
|
|
8,477 |
|
|
|
8,927 |
|
Total operating expenses |
|
|
29,770 |
|
|
|
23,387 |
|
Loss from operations |
|
|
(29,770) |
|
|
|
(23,387) |
|
Grant income |
|
|
157 |
|
|
|
2,234 |
|
Other income, net |
|
|
1,793 |
|
|
|
173 |
|
Net loss |
|
$ |
(27,820) |
|
|
$ |
(20,980) |
|
Unrealized gain (loss) on
available-for-sale securities |
|
|
927 |
|
|
|
(1,068) |
|
Comprehensive loss
attributable to common stockholders |
|
$ |
(26,893) |
|
|
$ |
(22,048) |
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.73) |
|
|
$ |
(0.56) |
|
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
37,923,402 |
|
|
|
37,593,328 |
|
Athira Pharma (NASDAQ:ATHA)
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