Athira Pharma Reports Full Year 2023 Financial Results and Pipeline and Business Updates
22 Février 2024 - 10:05PM
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 year
ended December 31, 2023, and reviewed recent pipeline and business
updates.
“We’ve made important progress in our pursuit to advance
potential new treatment options for neurodegenerative diseases.
Importantly, in January, we announced completing enrollment in our
Phase 2/3 LIFT-AD clinical trial, which is evaluating fosgonimeton
in approximately 315 patients with mild-to-moderate Alzheimer’s
disease,” stated Mark Litton, Ph.D., President and Chief Executive
Officer of Athira. “We are encouraged by results shown to date,
which we believe support fosgonimeton’s potential to deliver a
first-in-class therapy to Alzheimer’s disease patients and expect
to report topline data from LIFT-AD in the second half of 2024.
Additionally, we are excited to advance ATH-1105 for the potential
treatment of ALS and remain on-track to initiate the first-in-human
study in the first half of 2024. We ended 2023 with a strong
balance sheet that we believe will support the ongoing advancement
of our pipeline, including fosgonimeton and ATH-1105, through key
inflection points.”
Recent Highlights
Pipeline
- In February 2024, the Company announced publication of research
highlighting the neuroprotective and anti-inflammatory effects of
ATH-1105 in preclinical models of amyotrophic lateral sclerosis
(ALS) in the peer-reviewed journal, Frontiers in Neuroscience. The
original research article is titled: “ATH-1105, a small-molecule
positive modulator of the neurotrophic HGF system, is
neuroprotective, preserves neuromotor function, and extends
survival in preclinical models of ALS.”
- In January 2024, the Company completed enrollment in the Phase
2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment
for mild-to-moderate Alzheimer’s disease (AD). The Phase 2/3
LIFT-AD clinical trial enrolled approximately 315 patients.
- In December 2023, the Company announced encouraging results
from the exploratory Phase 2 SHAPE clinical trial to evaluate
fosgonimeton in patients with Parkinson's disease dementia and
dementia with Lewy bodies.
- In December 2023, the Company presented preclinical data at
the Motor Neurone Disease Association (MNDA)
34th International Symposium on ALS/MND demonstrating ATH-1105
is neuroprotective, extends survival, reduces motor and nerve
function decline when administered early or late in disease
progression and is effective in combination with riluzole in a
transgenic mouse model of ALS.
- In November 2023, the Company presented new preclinical data at
the Society for Neuroscience (SfN) Annual Meeting 2023 highlighting
the anti-inflammatory activity of fosgonimeton in microglial
models, as well as the neuroprotective and procognitive effects of
fosgonimeton in amyloid-β models of Alzheimer’s disease.
Corporate
- In February 2024, Rachel Lenington, the Company’s Chief
Operating Officer, was appointed as Chief Operating Officer and
Chief Development Officer, and Samantha Willing was appointed as
Chief People Officer.
Upcoming Presentations
- Athira will present clinical and preclinical data at the 18th
International Conference on Alzheimer’s and Parkinson’s Diseases
(AD/PD 2024) taking place March 5-9, 2024, in Lisbon, Portugal.
Presentation details include:
- Abstract Title: Results from SHAPE: A Phase 2 Study of
Fosgonimeton in Patients with Parkinson’s Disease Dementia and
Dementia with Lewy Bodies – Poster #: P1050/#1857: Presenter: Hans
Moebius, M.D., Ph.D., Senior Scientific Advisor
- Abstract Title: Neuroprotective mechanisms of Fosgonimeton
Against Excitotoxicity in Primary Neuron Culture – Poster #:
P0256/#1757; Presenter: Sherif Reda, Ph.D., Associate Director,
Discovery Biology
- Abstract Title: Fosgonimeton protects against
α-synuclein-mediated pathology in preclinical models of Parkinson’s
disease – Poster #: P1046/#1243; Presenter: Sharay Setti, Ph.D.,
Senior Scientist II
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)
- The LIFT-AD study is investigating the effects of fosgonimeton
40 mg compared with placebo in mild-to-moderate AD patients who are
not receiving background therapy.
- In October 2022, following an unblinded interim efficacy and
futility analysis, an independent data monitoring committee
recommended continuation of the LIFT-AD study in patients with
mild-to-moderate AD who are not receiving background
therapy. The committee also determined that the study
would be well powered to achieve the primary endpoint with
approximately 300 patients given the preliminary effect observed in
the unblinded interim analysis of approximately 100 patients
treated.
- In May 2023, Athira selected the 40 mg dose for further
development and potential regulatory approval.
- In January 2024, Athira completed enrollment of the LIFT-AD
study, randomizing approximately 315 patients in the primary
analysis population.
- The Company expects to report topline data in the second half
of 2024.
Open Label Extension (OLEX) fosgonimeton trial
(NCT04886063)
- Eligible participants who complete 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.
- Greater than 85% of participants who completed either study
have elected to enroll in OLEX to date.
- Currently, more than 60 patients are continuing fosgonimeton
treatment beyond 18 months, which is unexpected in a progressive
mild-to-moderate Alzheimer’s disease population.
- Athira believes the OLEX will complement its long-term safety
database and provide insights into fosgonimeton’s long-term effects
for up to three years of investigational treatment.
SHAPE Phase 2 clinical trial of fosgonimeton in
mild-to-moderate Parkinson’s disease dementia and Dementia with
Lewy bodies (NCT04831281)
- In December 2023, Athira announced encouraging results from the
exploratory SHAPE Phase 2 clinical trial of fosgonimeton for the
potential treatment of Parkinson's disease dementia and dementia
with Lewy bodies.
- Treatment with fosgonimeton 40 mg (n=5) compared to placebo
(n=7) showed positive effects in cognitive measures including
ADAS-Cog13, MMSE, and COWAT over the 6-month double-blind treatment
period.
- The primary endpoint of the trial, a composite score of the
change in Event-Related-Potential (ERP) P300 latency and cognitive
assessment (ADAS-Cog13), was not met by protocoled analysis
compared with placebo.
- Fosgonimeton was generally well tolerated, with a favorable
safety profile. There were no treatment-related serious adverse
events observed in the study. The most common adverse event
in the treatment groups was injection site
reactions.
ATH-1105 – A next-generation, orally
administered, small molecule drug candidate in development for the
potential treatment of ALS as the Company’s initial indication.
- 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 animal
models of ALS.
- These data were presented throughout 2023 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).
- The Company expects to initiate the first-in-human studies of
ATH-1105 in the first half of 2024.
Financial Results
- Cash Position. Cash, cash equivalents and
investments were $147.4 million as of December 31, 2023, compared
to $245.2 million as of December 31, 2022. Cash used in operations
was $100.8 million for the year ended December 31, 2023, compared
to $72.5 million for the year ended December 31, 2022.
- Research and Development (R&D) Expenses.
R&D expenses were $93.8 million for the year ended December 31,
2023, compared to $61.5 million for the year ended December 31,
2022. The increase was driven primarily by costs related to
increased clinical trial and manufacturing activities, personnel
costs, and preclinical research and development
expenses.
- General and Administrative (G&A)
Expenses. G&A expenses were
$33.3 million for the year ended December 31, 2023, compared to
$32.6 million for the year ended December 31, 2022.
- Legal Settlement Expense and Insurance
Recovery. In February 2023, the Company reached an
agreement in principle to resolve all claims in the Company’s
securities class action lawsuit. Under the proposed settlement, the
Company agreed to make a one-time payment of $10.0 million and
recorded a legal settlement expense of $10.0 million for the year
ended December 31, 2022. Additionally, the Company recorded an
insurance recovery of $1.6 million for the year ended December 31,
2023, representing the amount to be covered by the Company’s
insurers.
- Net Loss. Net loss was $117.7 million, or
$3.09 per share, for the year ended December 31, 2023, compared to
a net loss of $95.6 million, or $2.53 per share, for the year ended
December 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 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 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: drug
candidates as a potential treatment for Alzheimer’s disease,
Parkinson’s disease, Parkinson’s disease dementia, 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, the ACT-AD and SHAPE trials, and LIFT-AD
unblinded interim efficacy and futility analysis 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,” 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; 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; 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 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) |
|
|
|
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
90,584 |
|
|
$ |
95,966 |
|
Short-term investments |
|
|
56,835 |
|
|
|
104,378 |
|
Other short-term assets |
|
|
7,310 |
|
|
|
7,189 |
|
Long-term investments |
|
|
— |
|
|
|
44,829 |
|
Other long-term assets |
|
|
5,516 |
|
|
|
5,791 |
|
Total
assets |
|
$ |
160,245 |
|
|
$ |
258,153 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
28,840 |
|
|
$ |
21,431 |
|
Long-term liabilities |
|
|
1,217 |
|
|
|
1,585 |
|
Total
liabilities |
|
|
30,057 |
|
|
|
23,016 |
|
Stockholders' equity |
|
|
130,188 |
|
|
|
235,137 |
|
Total
liabilities and stockholders' equity |
|
$ |
160,245 |
|
|
$ |
258,153 |
|
|
|
Athira Pharma, Inc.Condensed Consolidated
Statements of Operations and Comprehensive Loss(Amounts in
thousands, except share and per share amounts) |
|
|
|
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
93,790 |
|
|
|
$ |
61,464 |
|
General and administrative |
|
|
33,304 |
|
|
|
|
32,552 |
|
Legal settlement |
|
|
— |
|
|
|
|
10,000 |
|
Insurance recovery related to legal settlement |
|
|
(1,628 |
) |
|
|
|
— |
|
Total operating expenses |
|
|
125,466 |
|
|
|
|
104,016 |
|
Loss
from operations |
|
|
(125,466 |
) |
|
|
|
(104,016 |
) |
Grant
income |
|
|
157 |
|
|
|
|
5,161 |
|
Other
income, net |
|
|
7,637 |
|
|
|
|
3,216 |
|
Net
loss |
|
$ |
(117,672 |
) |
|
|
$ |
(95,639 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
|
1,607 |
|
|
|
|
(1,568 |
) |
Comprehensive loss attributable to common stockholders |
|
$ |
(116,065 |
) |
|
|
$ |
(97,207 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(3.09 |
) |
|
|
$ |
(2.53 |
) |
Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted |
|
|
38,020,182 |
|
|
|
|
37,733,240 |
|
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