LONA

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Exhibit 99.1

LeonaBio Reports Second Quarter 2026 Financial Results and Provides Business Update

On Track to Complete Enrollment of Phase 3 ELAINE-3 Clinical Trial of Lasofoxifene in ER-positive (ER+), HER2-negative, ESR1-mutated Metastatic Breast Cancer in 4Q 2026 with Topline Data Expected in 2H 2027

BOTHELL, Wash., August 14, 2026 – LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today reported financial results for the quarter ended June 30, 2026, and provided recent pipeline and business updates.

“We enter the second half of 2026 with a clear focus on executing our Phase 3 ELAINE-3 trial and advancing lasofoxifene toward what we believe could be a transformative treatment option for patients with ESR1-mutated metastatic breast cancer,” said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. “We have enrolled 495 patients and remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027. As the treatment landscape for metastatic breast cancer continues to evolve, we believe the differentiated profile of lasofoxifene positions it to address a significant unmet need as a potential endocrine therapy partner and create opportunities beyond ELAINE-3, including additional combination strategies and future label expansions. The body of clinical and scientific evidence behind lasofoxifene supports our confidence in its potential to greatly benefit patients battling this difficult-to-treat form of breast cancer.”

“As we approach the completion of enrollment in this Phase 3 registrational trial, we are investing today in critical CMC, regulatory, and commercial readiness activities to ensure we are well-positioned to bring this therapy to patients as quickly as possible, if approved. With our talented team and the potential to add up to an additional $146 million upon exercise of cash-exercisable warrants issued in our December 2025 financing, we believe LeonaBio is well-positioned to deliver on multiple value-creating milestones in the years ahead,” added Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A third generation novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

• Lasofoxifene is being advanced in ELAINE-3, a Phase 3 clinical trial (NCT05696626), in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, following progression on

aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is a statistically significant improvement in progression free survival (PFS), as determined by blinded, independent central review (BICR). ELAINE-3 aims to establish a new standard of care for this genetically defined patient group with limited treatment options.

• The Company expects to complete enrollment of ~600 participants in the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.

• Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2.

o ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.

o ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade.

• In April 2026, LeonaBio hosted a virtual Key Opinion Leader event with two leading physicians in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of car

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Exhibit 99.1

LeonaBio Reports First Quarter 2026 Financial Results and Provides Business Update

Advancing Phase 3 Lasofoxifene Development Program of Novel Selective Estrogen Receptor Modulator, a Potential Multi-Billion Dollar Opportunity as Treatment Option for Patients with ESR1-Mutations

Expects to Complete Enrollment of Phase 3 Clinical Trial of Lasofoxifene in treatment-resistant ER-positive, HER2-negative, ESR1-mutated Metastatic Breast Cancer in 4Q 2026 with Topline Data Anticipated in 2H 2027

On-track to Initiate Phase 2 Proof-of-Concept Study of ATH-1105 in ALS patients in 2H 2026

Recent Events Include Three Appointments to Board of Directors and Virtual Key Opinion Leader Event Highlighting Potential of Lasofoxifene

BOTHELL, Wash., May 7, 2025 – LeonaBio, Inc.(NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today reported financial results for the quarter ended March 31, 2026, and provided recent pipeline and business updates.

“We entered 2026 with a clear focus on disciplined execution across our portfolio, led by the continued advancement of lasofoxifene in the Phase 3 ELAINE‑3 clinical trial for patients with ESR1‑mutated metastatic breast cancer, a population with significant unmet need,” said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. “As the treatment landscape continues to evolve, we remain confident in the ELAINE‑3 program, supported by a body of nonclinical and clinical evidence that we believe reinforces lasofoxifene’s differentiated profile and its potential to meaningfully address endocrine resistance, including independent mechanistic data from animal models on its bone protective potential, which further strengthens our conviction in the scientific and clinical rationale underlying this pivotal study.”

“In parallel, we are continuing to advance ATH‑1105 toward a Phase 2 proof‑of‑concept trial in amyotrophic lateral sclerosis (ALS), building on encouraging Phase 1 data demonstrating a favorable safety profile, pharmacokinetics, and central nervous system (CNS) penetration,” continued Dr. Litton. “With a strengthened balance sheet following our December 2025 $90 million common stock and warrant financing together with the potential additional $146 million upon exercise of the cash-exercisable warrants, we believe we are well positioned to execute on multiple value‑creating milestones in 2026 and beyond as we work to bring transformative therapies to patients in urgent need of new medicines.”

Clinical Development & Pipeline Programs

Lasofoxifene – A novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to act as a potent antagonist against breast wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer, while preserving estrogen signaling in nontarget tissues such as bone.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. (Sermonix) for rights to develop and commercialize lasofoxifene.

• Lasofoxifene is being advanced in a Phase 3 clinical trial (NCT05696626) in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is a statistically significant improvement in progression free survival (PFS) as determined by blinded, independent central review (BICR). The ongoing Phase 3 trial aims to establish a new standard of care for this genetically defined patient group.

• LeonaBio is amending the ELAINE-3 trial protocol to increase the sample size from 500 participants to up to 600 participants. The primary goal of the amendment is to help ensure that the trial will have the appropriate number of disease progression events.

• The Company expects to complete enrollment of the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.

• Independent researchers at Virginia Commonwealth University’s Massey Comprehensive Cancer Center presented nonclinical data on lasofoxifene and its potential bone protective role in metastatic breast cancer at the American Association for Cancer Research Annual Meeting 2026 (AACR26), which was consistent with LeonaBio’s data.

• The results showed lasofoxifene protected against hormone withdrawal-induced bone loss and maintained a robust anti-tumor response in primary and metastatic animal models of ER+ breast cancer. The lasofoxifene studied by the researchers was obtained from an independent s

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LeonaBio Reports Full Year 2025 Financial Results and Provides Business Update

Acquired License to Phase 3 Lasofoxifene Development Program of Novel Selective Estrogen Receptor Modulator (SERM), a Potential Multi-Billion Dollar Opportunity as Treatment Option for Breast Cancer Patients with ESR1-Mutations

Received Gross Proceeds of $90 Million in Private Placement Financing of Common Stock and Warrants with Cash-Exercisable Warrants Potentially Providing up to an Additional $146 Million to Support Development of Lasofoxifene Through Key Clinical and Regulatory Milestones

Expect to Complete Enrollment of Phase 3 Clinical Trial of Lasofoxifene in ER-positive (ER+), HER2-negative, ESR1-mutated Metastatic Breast Cancer in 4Q 2026 with Topline Data Anticipated in 2H 2027

On-track to Initiate Phase 2 Proof-of-Concept Study of ATH-1105 in ALS patients in 2H 2026

BOTHELL, Wash., March 26, 2025 – LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today reported financial results for the year ended December 31, 2025, and provided recent pipeline and business updates.

“2025 was a truly transformational year for LeonaBio. With our license for lasofoxifene, we added a late-stage drug candidate that has the potential to become the endocrine therapy of choice in the multi-billion-dollar second line metastatic breast cancer setting” stated Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. “Coupled with our successful $90 million fundraise with the potential for $146 million in additional capital available through warrant exercises, we enter 2026 with the financial resources needed to advance both our oncology and neurodegeneration programs with confidence.”

“Our transition from Athira Pharma to LeonaBio reflects far more than a name change; it represents our evolution into a more focused, diversified, and opportunity-driven biopharmaceutical company. We now have two clinical-stage programs and an experienced team aligned around focused execution. As we look ahead to meaningful clinical milestones in 2026 — including the anticipated completion of enrollment of the Phase 3 ELAINE-3 clinical trial and initiation of patient dosing in our ATH-1105 ALS program — we are energized by what lies ahead. We are building a company that we believe has the potential to change the treatment landscape for patients who urgently need better options, and I couldn’t be more optimistic about the momentum we carry into 2026 and beyond,” concluded Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

• Lasofoxifene is being advanced in a Phase 3 clinical trial (NCT05696626) in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is statistically significant improvement in progression free survival (PFS) as determined by blinded, independent central review (BICR). The ongoing Phase 3 trial aims to establish a new standard of care for this genetically defined patient group.

• LeonaBio is amending the ELAINE-3 trial protocol to increase the sample size from 500 participants to up to 600 participants. The primary goal of the amendment is to help ensure that the trial will have the appropriate number of disease progression events. The Company expects to complete enrollment of the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.

• Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2

• ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.

• ELAINE-2, an open-label st

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Exhibit 99.1

Athira Pharma Reports Third Quarter 2025 Financial Results and Provides Business Update

Continuing to explore strategic alternatives focusing on maximizing stockholder value

Presented results from Phase 1 clinical trial of ATH-1105 in healthy volunteers demonstrating a favorable safety and tolerability profile as well as dose proportional pharmacokinetics and CNS penetration, supporting continued clinical development

BOTHELL, Wash., November 6, 2025 – Athira Pharma, Inc. (NASDAQ: ATHA), a 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, 2025, and provided recent business updates.

“We continue to explore strategic alternatives focusing on maximizing stockholder value and remain encouraged by the promising data to-date supporting the continued development of ATH-1105 as a potential therapy for ALS,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We were especially pleased to present results from the Phase 1 study of ATH-1105 that continue to demonstrate favorable safety and tolerability in healthy volunteers and dose proportional pharmacokinetics and CNS penetration. We look forward to an opportunity to advance this program into ALS patients, in order to move us one step closer to bringing a potential novel therapy to patients desperately in need of an effective treatment option.”

Clinical Development & Pipeline Programs

Athira’s drug development pipeline includes next-generation 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.

ATH-1105 – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently in clinical development for the potential treatment of ALS.

• Athira conducted the first-in-human Phase 1 (NCT 06432647) double-blind, placebo-controlled clinical trial that enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study was completed in November

2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes.

• Previously this year, the Company presented data from the Phase 1 clinical trial of ATH-1105 at the 4thAnnual ALS Drug Development Summit. Key highlights from the presentation include:

• ATH-1105 showed a favorable safety profile and was well tolerated in both single and multiple ascending dose studies in healthy volunteers

• ATH-1105 showed dose proportional pharmacokinetics and central nervous system (CNS) penetration

• ATH-1105 has demonstrated consistent and robust beneficial effects in preclinical models of ALS

• In August 2025, Athira presented results from the Phase 1 clinical trial of ATH-1105 in healthy volunteers at the ALS Nexus 2025 conference.

• ATH-1105’s potential is supported by a growing body of preclinical evidence demonstrating statistically significant improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, and survival in various models of ALS.

Corporate Updates

• In September 2025, Athira implemented a 10-for-1 reverse stock split of Athira’s issued and authorized common stock. The reverse stock split became effective on September 17, 2025 at 5:00 p.m., Eastern Time.

• Athira continues to explore strategic alternatives focused on maximizing stockholder value. Athira engaged Cantor Fitzgerald & Co. to act as an advisor in this process, following Athira’s receipt of the topline results of the Company’s Phase 2/3 LIFT-AD clinical trial in September 2024.

Financial Results

• Cash Position. Cash, cash equivalents and investments were $25.2 million as of September 30, 2025, compared to $51.3 million as of December 31, 2024. Net cash used in operations was $26.3 million for the nine months ended September 30, 2025, compared to $71.2 million for the nine months ended September 30, 2024.

• Research and Development (R&D) Expenses. R&D expenses were $2.8 million for the quarter ended September 30, 2025, compared to $17.9 million for the quarter ended September 30, 2024.

• General and Administrative (G&A) Expenses. G&A expenses were $4.1 million for the quarter ended September 30, 2025, compared to $7.6 million for the quarter ended September 30, 2024.

• Net Loss.Net loss was $6.6 million, or $1.68 per share, for the quarter ended

September 30, 2025, compared to a net loss of $28.7 million, or $7.46 per share (on a split-adjusted basis), for the quarter ended September 30, 2024.

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Exhibit 99.1

Athira Pharma Reports Second Quarter 2025 Financial Results and Provides Business Update

Data from Phase 1 clinical trial of ATH-1105 in healthy volunteers showed a favorable safety and tolerability profile; dose proportional pharmacokinetics and CNS penetration support continued clinical development

BOTHELL, Wash., August 7, 2025 – Athira Pharma, Inc. (NASDAQ: ATHA), a 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, 2025, and provided recent pipeline and business updates.

“We are pleased with the progress we made in the first half of 2025 advancing ATH-1105 as a potential therapy for ALS,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “In May, we announced encouraging first-in-human safety and pharmacokinetic data from our Phase 1 clinical trial of ATH-1105 at the Annual ALS Drug Development Summit. The data presented showed favorable safety and tolerability in healthy volunteers and dose proportional pharmacokinetics and CNS penetration, which support ATH-1105’s continued development. We have substantially completed preparation activities to enable initiation of a future clinical trial in people living with ALS by us or in conjunction with a partner subject to our continued exploration of strategic alternatives focused on maximizing stockholder value. We look forward to providing an update regarding our plans in the near future.”

Clinical Development & Pipeline Programs

Athira’s drug development pipeline includes next-generation 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.

ATH-1105 – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently in clinical development for the potential treatment of ALS.

• In May 2025, Athira presented data from the first-in-human Phase 1 clinical trial (NCT 06432647) of ATH-1105 at the 4th Annual ALS Drug Development Summit. Key highlights from the presentation include:

o ATH-1105 has demonstrated consistent and robust beneficial effects in preclinical models of ALS

o ATH-1105 showed a favorable safety profile and was well tolerated in both single and multiple ascending dose studies in healthy volunteers

o ATH-1105 showed dose proportional pharmacokinetics and central nervous system (CNS) penetration

• Athira conducted the first-in-human Phase 1 (NCT 06432647) double-blind, placebo-controlled clinical trial that enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study was completed in November 2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes. The results of the Phase 1 trial showed that ATH-1105 demonstrated a favorable safety profile and was well-tolerated in healthy volunteers, supporting continued clinical development.

• ATH-1105’s potential is supported by a growing body of preclinical evidence demonstrating statistically significant improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, and survival in various models of ALS.

Fosgonimeton (ATH-1017) – A once daily, subcutaneously administered drug candidate initially targeted for the potential treatment of Alzheimer’s disease.

• In September 2024, Athira announced topline results from the LIFT-AD Phase 2/3 clinical trial of fosgonimeton in mild-to-moderate Alzheimer’s disease. The study did not meet its primary or key secondary endpoints, but biomarker and subgroup data were directionally consistent with the broad neuroprotective mechanism of action.

Exploration of Strategic Alternatives

• Following Athira’s receipt of the topline results of LIFT-AD, the company made the determination to explore strategic alternatives focused on maximizing stockholder value. Athira engaged Cantor Fitzgerald & Co. to act as an advisor in this process.

• Additionally, Athira paused further development of fosgonimeton, including the related open label extension clinical trial, while continuing the development of ATH-1105 and exploring partnering options.

Financial Results

• Cash Position. Cash, cash equivalents and investments were $29.8 million as of June 30, 2025, compared to $51.3 million as of December 31, 2024. Net cash used in operations was $21.7 million for the six months ended June 30, 2025, compared to $48.1 million for the six months ended June 30, 2024.

• Research and Development (R&D) Expenses. R&D expens

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Exhibit 99.1

Athira Pharma Reports First Quarter 2025 Financial Results and Pipeline and Business Updates

Completed healthy volunteer Phase 1 clinical study of ATH-1105 as a potential treatment for amyotrophic lateral sclerosis (ALS); full healthy volunteer data expected in 2H25

On-track to enable dosing ALS patients in late 2025

BOTHELL, Wash., May 9, 2025 – Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the quarter ended March 31, 2025, and provided recent pipeline and business updates.

“We continue to focus our efforts on advancing ATH-1105 as a potential therapy for ALS. ATH-1105 has shown encouraging evidence of statistically significant improvements in nerve and motor function and biomarkers of inflammation and neurodegeneration in various preclinical models, along with a favorable safety profile and tolerability in healthy volunteers,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We look forward to sharing the full results from the first-in-human Phase 1 trial of ATH-1105 in healthy volunteers in the second half of this year, keeping us on-track to enable dosing ALS patients in late 2025.”

Clinical Development & Pipeline Programs

Athira’s drug development pipeline includes next-generation 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 and peripheral nervous systems.

ATH-1105 – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently in clinical development for the potential treatment of ALS.

• Athira conducted the first-in-human Phase 1 (NCT 06432647) double-blind, placebo-controlled clinical trial that enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study was completed in November 2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes. The results of the Phase 1 trial showed that ATH-1105 demonstrated a favorable safety profile and was well-tolerated in healthy volunteers, supporting continued clinical development.

• Athira is on track to enable dosing ALS patients in late 2025.

• ATH-1105’s potential is supported by a growing body of preclinical evidence demonstrating statistically significant improvements in 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), and published in Frontiers in Neuroscience, 2024.

Upcoming Presentation

Athira will be presenting Phase 1 and nonclinical efficacy data for ATH-1105 for the potential treatment of ALS at the 4th Annual ALS Drug Development Summit taking place May 12-14, 2025, in Boston, Massachusetts.

Presentation details:

Title: Advancing ATH-1105 for ALS Through Early Clinical and PK Data

Scope: Nonclinical efficacy and Ph1 data supporting clinical translation of ATH-1105 in ALS

Format: Oral

Date/time: Tuesday May 13th at 11:00 AM EST

Presenters: Sherif Reda, Ph.D., Director, Drug Discovery Research, Athira Pharma; and Kai-Bin Ooi, Director, Drug Development Operations, Athira Pharma

Exploration of Strategic Alternatives

• Following Athira’s receipt of the topline results of LIFT-AD in September 2024, the company's Phase 2/3 clinical trial of its then-lead drug candidate fosgonimeton in mild-to-moderate Alzheimer’s disease which did not meet its primary or key secondary endpoints, the company made the determination to explore strategic alternatives focused on maximizing stockholder value. Athira engaged Cantor Fitzgerald & Co. to act as an advisor in this process.

• Additionally, Athira paused further development of fosgonimeton, including the related open label extension clinical trial, while continuing the development of ATH-1105 and exploring partnering options.

Financial Results

• Cash Position. Cash, cash equivalents and investments were $36.7 million as of March 31, 2025, compared to $51.3 million as of December 31, 2024. Net cash used in operations was $14.7 million for the quarter ended March 31, 2025, compared to $25.8 million for the quarter ended March 31, 2024.

• Research and Development (R&D) Expenses.

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Exhibit 99.1

Athira Pharma Reports Full Year 2024 Financial Results and Pipeline and Business Updates

Completed healthy volunteer Phase 1 clinical study of ATH-1105 as a potential treatment for amyotrophic lateral sclerosis (ALS)

On-track to enable dosing ALS patients in 2025

BOTHELL, Wash., February 27, 2025 – Athira Pharma, Inc. (NASDAQ: ATHA), a 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, 2024, and provided recent pipeline and business updates.

“We look forward to the opportunity to continue to advance ATH-1105 as a potential therapy for ALS, which in various preclinical models has demonstrated a consistent ability to improve motor and nerve function, enhance neuronal survival, and improve biomarkers of inflammation and neurodegeneration, including neurofilament light chain (NfL), a key marker of ALS disease progression,” said Mark Litton, Ph.D, President and Chief Executive Officer of Athira. “With the healthy volunteer Phase 1 clinical study of ATH-1105 complete, we are pleased to remain on track to enable dosing ALS patients in 2025.”

Clinical Development & Pipeline Programs

Athira’s drug development pipeline includes novel next-generation 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 and peripheral nervous system.

ATH-1105 – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently in development for the potential treatment of ALS.

• Athira conducted the first-in-human Phase 1 (NCT 06432647) double-blind, placebo-controlled clinical trial that enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study was completed in November 2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes. The results of the Phase 1 trial showed that ATH-1105 demonstrated a favorable safety profile and was well-tolerated in healthy volunteers, supporting continued clinical development.

• Athira is on track to enable dosing ALS patients in 2025.

• ATH-1105’s potential is supported by a growing body of preclinical evidence demonstrating statistically significant improvements in 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), and published in Frontiers in Neuroscience, 2024.

Fosgonimeton (ATH-1017) – A once daily, subcutaneously administered drug candidate initially targeted for the potential treatment of Alzheimer’s disease.

• In September 2024, Athira announced topline results from the LIFT-AD Phase 2/3 clinical trial of fosgonimeton in mild-to-moderate Alzheimer’s disease. The study did not meet its primary or key secondary endpoints, but biomarker and subgroup data were directionally consistent with the broad neuroprotective mechanism of action.

Exploration of Strategic Alternatives

• Following Athira’s receipt of the topline results of LIFT-AD, the company made the determination to explore strategic alternatives focused on maximizing stockholder value. Athira engaged Cantor Fitzgerald & Co. to act as an advisor in this process.

• Additionally, Athira paused further development of fosgonimeton, including the related open label extension clinical trial, while continuing the development of ATH-1105 and exploring partnering options.

Financial Results

• Cash Position. Cash, cash equivalents and investments were $51.3 million as of December 31, 2024, compared to $147.4 million as of December 31, 2023. Net cash used in operations was $97.2 million for the year ended December 31, 2024, compared to $100.8 million for the year ended December 31, 2023.

• Research and Development (R&D) Expenses. R&D expenses were $70.7 million for the year ended December 31, 2024, compared to $93.8 million for the year ended December 31, 2023. The decrease was driven primarily by decreases in fosgonimeton program costs.

• General and Administrative (G&A) Expenses. G&A expenses were $26.1 million for the year ended December 31, 2024, compared to $33.3 million for the year ended December 31, 2023. The decrease was driven by decreases in legal, business

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Exhibit 99.1

Athira Pharma Reports Third Quarter 2024 Financial Results and Pipeline and Business Updates

Expects to complete healthy volunteer Phase 1 clinical study of ATH-1105 by year end and begin dosing ALS patients in 2025

BOTHELL, Wash., November 7, 2024 – Athira Pharma, Inc. (NASDAQ: ATHA), a 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, 2024, and provided recent pipeline and business updates.

“We are pleased to be continuing the advancement of ATH-1105 as a potential treatment for ALS. This novel, oral, next-generation HGF-modulating drug candidate has improved blood-brain-barrier penetration and pharmacokinetic properties. Specifically, preclinically ATH-1105 has shown a consistent ability in various ALS models to reduce plasma neurofilament light chain (NfL) levels, a key marker of ALS disease progression, and to improve motor and nerve function, enhance neuronal survival, and improve biomarkers of inflammation and neurodegeneration,“ said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We continue to progress ATH-1105 in the ongoing Phase 1 study in healthy volunteers, which is targeted to complete by year end, and look forward to dosing ALS patients in 2025.”

Clinical Development & Pipeline Programs

Athira’s drug development pipeline includes potential first-in-class and next-generation novel 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.

ATH-1105 – A next-generation, novel, orally administered, small molecule drug candidate in development for the potential treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.

• Athira is conducting a first-in-human Phase 1 (NCT 06432647) double-blind, placebo-controlled trial that is enrolling up to 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study is evaluating the safety and tolerability of ATH-1105 and includes measurements of pharmacokinetic outcomes.

• In June 2024, Athira completed the first cohort of healthy volunteers in its ongoing, dose escalation Phase 1 trial.

• Athira expects to complete the Phase 1 study by year-end 2024 and plans to begin dosing ALS patients in 2025.

• ATH-1105’s potential is supported by a growing body of preclinical evidence demonstrating improvements in 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).

Fosgonimeton (ATH-1017) – A once daily, subcutaneously administered drug candidate initially targeted for the potential treatment of Alzheimer’s disease.

• In September 2024, Athira announced topline results from the LIFT-AD Phase 2/3 clinical trial of fosgonimeton in mild-to-moderate Alzheimer’s disease. The study did not meet its primary or key secondary endpoints, but biomarker and subgroup data were directionally consistent with the broad neuroprotective mechanism of action.

Plans to Explore Strategic Alternatives

• Following Athira’s receipt of the topline results of LIFT-AD, the company made the determination to explore strategic alternatives focused on maximizing stockholder value. As part of that effort, Athira has paused further development of fosgonimeton while continuing our ongoing development of ATH-1105 and are exploring partnering options. Athira has engaged Cantor Fitzgerald & Co. to act as an advisor in the process to explore strategic alternatives.

Financial Results

• Cash Position. Cash, cash equivalents and investments were $68.9 million as of September 30, 2024, compared to $147.4 million as of December 31, 2023. Net cash used in operations was $71.2 million for the nine months ended September 30, 2024, compared to $74.5 million for the nine months ended September 30, 2023.

• Research and Development (R&D) Expenses. R&D expenses were $17.9 million for the quarter ended September 30, 2024, compared to $27.2 million for the quarter ended September 30, 2023.

• General and Administrative (G&A) Expenses. G&A expenses were $7.6 million for the quarter ended September 30, 2024, compared to $7.8 million for the quarter ended September 30, 2023.

• Legal Expense. Legal expense of $4.1 million was accrued during the quarte

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EX-99.1

Exhibit 99.1

Athira Pharma Reports Second Quarter 2024 Financial Results and Pipeline and Business Updates

Topline data from completed Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease targeted for September 2024

Phase 2/3 LIFT-AD data to be presented in an oral presentation at CTAD in October 2024

Phase 1 clinical trial of ATH-1105 underway for the potential treatment of amyotrophic lateral sclerosis (ALS)

BOTHELL, Wash., August 1, 2024 – 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.

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Exhibit 99.1

Athira Pharma Reports First Quarter 2024 Financial Results and Pipeline and Business Updates

Topline data from Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease expected in second half of 2024

Submitted Investigational New Drug application to U.S. Food and Drug Administration for ATH-1105 for the treatment of amyotrophic lateral sclerosis; On track to dose subjects in a first-in-human study in second quarter of 2024

Strong balance sheet to support innovative pipeline through key clinical inflection points

BOTHELL, Wash., May 15, 2024 – 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 March 31, 2024, and provided recent pipeline and business updates.

“We are on the cusp of a potentially transformative milestone as we are fast approaching the expected topline data readout from our Phase 2/3 LIFT-AD clinical trial of fosgonimeton in Alzheimer’s disease (AD) in the second half of this year,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “The totality of clinical and nonclinical data to date support our confidence in the LIFT-AD trial and underscore the potential of our differentiated approach in targeting the neurotrophic HGF system to induce neuroprotective effects across a number of neurodegenerative diseases.”

“We were delighted to welcome Javier San Martin, M.D. as our new Chief Medical Officer. His insight and expertise will be invaluable as we move toward the LIFT-AD data readout and the potential opportunity to deliver fosgonimeton as a new treatment option for AD patients in need of better therapies. In parallel, we continue to progress ATH-1105 in amyotrophic lateral sclerosis (ALS) and expect to initiate a first-in-human study of this oral small molecule drug candidate in the coming months,” added Dr. Litton.

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 expects to report topline data from LIFT-AD in the second half of 2024.

• In January 2024, Athira announced the completion of enrollment of the LIFT-AD study.

• 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. The primary endpoint is the Global Statistical Test (GST), combining the results from the co-key secondary endpoints 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.

• Greater than 85% of participants who completed either study have elected to enroll in OLEX to date.

• Currently, more than 65 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 potentially over four years of investigational treatment.

SHAPE Phase 2 clinical trial of fosgonimeton in Parkinson’s disease dementia and dementia with Lewy bodies (NCT04831281)

• In December 2023, Athira announced encouraging findings 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 directional improvements in certain cognitive, functional and biomarker measurements, including ADAS-Cog13, MMSE, and COWAT over the 6-month double-blind treatment period.

• The primary endpoint of the trial, a composite scor

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Exhibit 99.1

Athira Pharma Reports Full Year 2023 Financial Results and Pipeline and Business Updates

Enrollment completed in Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease; topline data expected in second half of 2024

On track to initiate first-in-human studies of ATH-1105 for the treatment of amyotrophic lateral sclerosis in first half of 2024

Strong balance sheet to support innovative pipeline through key inflection points

BOTHELL, Wash., February 22, 2024 – 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:

o 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

o Abstract Title: Neuroprotective mechanisms of Fosgonimeton Against Excitotoxicity in Primary Neuron Culture – Poster #: P0256/#1757; Presenter: Sherif Reda, Ph.D., Associate Director, Discovery Biology

o 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

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Exhibit 99.1

Athira Pharma Provides 2024 Clinical Pipeline Outlook and Business Update

Completed enrollment in Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease and expects topline data in second half of 2024

Plans to initiate first-in-human studies of ATH-1105 to treat amyotrophic lateral sclerosis in first half of 2024

BOTHELL, WA, Jan. 8, 2024 — Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today provided a clinical pipeline outlook and business update for 2024.

“The new year is off to a strong start with the completion of enrollment in our Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease (AD), which we expect will enable topline data readout from the study in the second half of 2024,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “The potential of fosgonimeton as a treatment for AD is supported by the independent, unblinded interim efficacy and futility analysis of the first 100 subjects in the Phase 2/3 LIFT-AD study and the results from the exploratory Phase 2 ACT-AD clinical trial, which showed potential congruent improvements in biomarkers of neurodegeneration, inflammation and Alzheimer’s disease protein pathologies as well as measures of cognition and function.”

“The totality of data shared to date strengthens our confidence in and supports the potential of our small molecule approach to targeting the neurotrophic hepatocyte growth factor (HGF) system for diseases including Alzheimer’s, Parkinson’s, and amyotrophic lateral sclerosis (ALS). The consistency of data from preclinical models across various neurodegenerative diseases and in Alzheimer’s patients suggests that our small molecule drug candidates may be neuroprotective, neurotrophic, procognitive and potentially disease-modifying. This includes our recently reported findings from the exploratory SHAPE Phase 2 clinical trial, the results of which showed positive effects on several cognitive measures in the fosgonimeton 40 mg dose group, which is the same dose being investigated in the LIFT-AD trial.”

“We look forward to an exciting year ahead with key preclinical and clinical milestones on the horizon. Importantly, we continue to advance and expand our understanding of the potential for modulating the neurotrophic HGF system and have a strong balance sheet to support these initiatives through key inflection points.

“Finally, I want to thank Dr. Hans Moebius for his considerable contributions as Athira’s Chief Medical Officer and congratulate him on his retirement. In addition to his five years with Athira, Hans has more than 30 years of industry experience and is an internationally recognized expert in neuropsychiatry, drug research and development, and regulatory strategy. We look forward to a continued relationship with Hans in his new role as Senior Scientific Advisor to Athira,” added Dr. Litton.

Athira’s 2024 Clinical Pipeline Outlook: Status and Upcoming Milestones

Athira’s drug development pipeline consists of potential first-in-class (fosgonimeton) and next-generation small molecule therapeutic candidates (ATH-1105 and ATH-1020) 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 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 size 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 announced completion of enrollment in the LIFT-AD study, ultimately randomizing approximately 315 patients in the primary analysis population.

• The Company expects to report topline data in the second

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Exhibit 99.1

Athira Pharma Reports Third Quarter 2023 Financial Results and Pipeline and Business Updates

Continues to report clinical and preclinical findings supporting the potential benefits of its small molecule therapeutic candidates targeting the neurotrophic HGF system as potential novel treatments for neurodegenerative diseases

Expects to complete enrollment of Phase 2/3 LIFT-AD clinical trial of fosgonimeton in mild-to-moderate Alzheimer’s disease patients by the first quarter of 2024 with topline data expected in second half 2024

Maintains strong balance sheet to support innovative clinical development pipeline through key inflection points

BOTHELL, Wash., November 9, 2023 -- 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

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Exhibit 99.1

Athira Pharma Reports Second Quarter 2023 Financial Results and Pipeline and Business Updates

Completed end of Phase 2 meeting and continued engagement with U.S. Food and Drug Administration

Appointed Andrew Gengos as Chief Financial Officer and Chief Business Officer

Maintains strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points

BOTHELL, Wash., August 10, 2023 — 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 re

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Exhibit 99.1

Athira Pharma Reports First Quarter 2023 Financial Results

and Recent Pipeline and Business Updates

Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease to focus on 40 mg dose

Open label extension trial to be extended, providing up to 36 months of long-term exposure data

ATH-1105 significantly prolongs survival and improves motor function in a mouse model of ALS; Strongly supports development as a treatment for ALS

Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points

BOTHELL, Wash., May 11, 2023 – 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):

o Phase 1b trial results showed 73 milliseconds improvement in P300 latency from baseline compared with placebo at eight days (p=0.027);

o 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 AC

EX-99

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EX-99.1

EX-99

Exhibit 99.1

Athira Pharma Reports Full Year 2022 Financial Results and Recent Pipeline and Business Updates

On track to complete enrollment in Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease in mid-2023 with topline data in early 2024

Continuing to advance development of ATH-1105 as a potential clinical candidate for amyotrophic lateral sclerosis

Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points

BOTHELL, Wash., March 23, 2023 – 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 year ended December 31, 2022, and reviewed recent pipeline and business updates.

“The progress we made throughout 2022 and in recent months continues to support our strategy to advance our small molecule therapeutic candidates, such as fosgonimeton, to impact neurodegenerative diseases, as both clinical and preclinical data suggest potential neuroprotective, neurotrophic, anti-inflammatory, procognitive and disease-modifying effects,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “Furthermore, recent and upcoming presentations at medical and scientific meetings provide the opportunity to highlight our diverse and robust clinical and preclinical data supporting the therapeutic potential of enhancing the HGF/MET system in a variety of neurodegenerative diseases including Alzheimer’s disease, Parkinson’s disease and ALS.

“We believe the independent, unblinded interim efficacy and futility analysis of the Phase 2/3 LIFT-AD trial reported in October 2022 mitigates fosgonimeton program risk, supports the potential clinical benefits of fosgonimeton treatment, and underscores the rationale for continued development of this promising potential new therapy for mild-to-moderate Alzheimer’s disease. We are targeting to complete enrollment of the LIFT-AD trial in mid-2023 and to have topline data in early 2024. Additionally, we continue to advance IND-enabling studies with ATH-1105 and expect to initiate a Phase 1 study in 2024 to evaluate its potential as a treatment for ALS.

“We ended 2022 with a strong balance sheet that enables us to continue to explore the potential of fosgonimeton in Alzheimer’s and to advance our other pipeline candidates in neurodegenerative diseases, such as ATH-1105 in ALS, through key inflection points,” concluded Dr. Litton.

Recent Highlights

• Presented multiple preclinical datasets that continue to support the therapeutic potential of enhancing the hepatocyte growth factor (HGF) and its receptor, MET, or the HGF/MET system,

in a variety of neurodegenerative disease models at the American Society for Experimental Neurotherapeutics (ASENT) 2023 Annual Meeting;

• Promoted Kevin Church, Ph.D. to Chief Scientific Officer in recognition of his leadership directing the Company’s efforts to elucidate and evaluate the promise of enhancing the HGF/MET system and its potential applications for the treatment of neurodegenerative diseases;

• Published a review paper highlighting the need for novel treatment approaches to address Alzheimer’s disease and the therapeutic potential of fosgonimeton, one of the Company’s novel small molecule positive modulators of the HGF/MET system in the Journal of Alzheimer’s Disease; and

• Published preclinical data demonstrating the neuroprotective, neurotrophic and procognitive effects of fosgonimeton in models of dementia in the peer-reviewed journal Neurotherapeutics.

Clinical Development & Pipeline Programs

Fosgonimeton (ATH-1017) - Small molecule designed to enhance the activity of the HGF/MET system with the potential to protect and repair neuronal networks.

LIFT-AD phase 2/3 trial in mild-to-moderate Alzheimer’s disease (NCT04488419)

• Following results from the exploratory Phase 2 ACT-AD trial, Athira proactively amended the entry criteria for the LIFT-AD trial in September 2022 to investigate the effects of fosgonimeton compared with placebo, without background acetylcholinesterase inhibitors (AChEIs).

• In October 2022, following an unblinded interim efficacy and futility analysis, an independent data monitoring committee recommended continuation of the LIFT-AD trial in participants with mild-to-moderate AD.

• The committee also determined that, with the additional enrollment of fewer than 150 participants for a total enrollment of less than 300 participants without background AChEIs, the trial would be well powered for the primary endpoint given the preliminary effect size observed.

• The Company is targeting to complete enrollment of the LIFT-AD trial in mid-2023 and to report topline data in early 2024.

Open Label Extension (OLEX) trial (NCT04886063)

• The Open Label Extension (OLEX) for the ACT-AD

8-K

0001620463false00016204632023-01-062023-01-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 6, 2023

Athira Pharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-39503

45-3368487

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

18706 North Creek Parkway, Suite 104 Bothell, WA 98011

(Address of principal executive offices, including zip code)

(425) 620-8501

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

ATHA

The Nasdaq Stock Market LLC (The Nasdaq Global Select Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company

☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act). ☐

Item 1.01. Entry into a Material Definitive Agreement

On January 6, 2023, Athira Pharma, Inc, a Delaware corporation (the “Company”), entered into a Controlled Equity Offering Sales AgreementSM (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) and BTIG, LLC (“BTIG” and together with Cantor, the “Agents” and each, an “Agent”). The Sales Agreement provides for the offer and sale of the Company’s common stock, par value $0.0001 per share, from time to time through an “at the market offering” program under which the Agents will each act as sales agent, subject to certain limitations, including the maximum aggregate dollar amount registered pursuant to the applicable prospectus supplement.

Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any

one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, the Agents may sell the shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Stock Market LLC or on any other existing trading market for the common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices and/or any other method permitted by law. The Agents will use commercially reasonable efforts consistent with their normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC. The Sales Agreement may be terminated by the Company upon written notice to the Agents for any reason or by an Agent, with respect to itself only, upon written notice to the Company for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company. Under the terms of the Sales Agreement, the Company may also sell shares to each Agent acting as principal for such Agent’s own account at prices agreed upon at the time of sale.

The Sales Agreement provides that each Agent will be entitled to compensation for its services equal to 3.0% of the aggregate gross proceeds from each sale made by such Agent under the Sales Agreement. The Company has no obligation to sell any shares under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement. The Sales Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Agents, other obligations of the parties

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Athira Pharma Reports Third Quarter 2022 Financial Results and Recent Clinical and Corporate Updates

Independent, unblinded, interim efficacy and futility analysis of Phase 2/3 LIFT-AD study in mild-to-moderate Alzheimer’s disease patients supports potential clinically meaningful activity of fosgonimeton without background acetylcholinesterase therapy and mitigates program risk

Strong balance sheet to support clinical development pipeline through key data inflection points

BOTHELL, Wash., Nov. 10, 2022 — 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 third quarter ended September 30, 2022 and reviewed recent clinical and corporate updates.

“During the third quarter, we undertook a systematic and data-driven process to determine the next steps for our Phase 2/3 LIFT-AD study of fosgonimeton in mild-to-moderate Alzheimer’s disease (AD) patients. Most recently, we were encouraged to report that an independent, unblinded, interim efficacy and futility analysis supported the potential clinically meaningful activity of fosgonimeton without background therapy (acetylcholinesterase inhibitors) and determined that, with the additional enrollment of fewer than 150 patients, the study will be well powered for the primary endpoint given the preliminary effect size observed,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira.

“The exploratory Phase 2 ACT-AD study in the same patient population suggested benefits in measurements of cognition, function and neuroprotection, and the results of the LIFT-AD interim analysis corroborate those findings in approximately 100 patients not on background therapy. We now look forward to completing enrollment of the Phase 2/3 LIFT-AD study in mid-2023 and to reporting topline data in early 2024. Importantly, we are pleased to have a strong balance sheet that can support our programs through a number of key data inflection points and beyond,” concluded Dr. Litton.

Clinical Update:

Fosgonimeton (ATH-1017) is a small molecule specifically designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET.

LIFT-AD Phase 2/3 study in mild-to-moderate Alzheimer’s disease (NCT04488419)

• Following results from the exploratory ACT-AD trial, Athira proactively amended the entry criteria for the LIFT-AD trial in September 2022 to investigate the effects of fosgonimeton compared with placebo, without 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 of fosgonimeton in patients with mild-to-moderate AD. The committee also determined that, with the additional enrollment of fewer than 150 patients for a

total enrollment of less than 300 patients without background therapy, the study will be well powered for the primary endpoint given the preliminary effect size observed.

ACT-AD Phase 2 study in mild-to-moderate Alzheimer’s disease (NCT04491006)*

• Additional data from the ACT-AD Phase 2 study were presented in August 2022 at the Alzheimer's Association International Conference 2022 (AAIC). This included a numerical, but not statistically significant, improvement in the secondary endpoint ADCS-ADL23, a functional measure of independence, and a statistically significant improvement in plasma levels of neurofilament light chain (NfL), a validated fluid biomarker of neurodegeneration, in a prespecified subgroup of subjects treated with fosgonimeton without background therapy compared with placebo at 26 weeks.

Open Label Extension (OLEX) study (NCT04886063)

• The Open Label Extension (OLEX) study for the ACT-AD and LIFT-AD studies continues, with over 200 patients currently enrolled. As of October 2022, more than 90 percent of patients who have completed either study have elected to participate in the OLEX study.

SHAPE Phase 2 study in Parkinson’s disease dementia or Dementia with Lewy bodies (NCT04831281)

• The SHAPE Phase 2 proof-of-concept study of fosgonimeton in participants with Parkinson’s disease dementia or Dementia with Lewy bodies is approximately 40% enrolled.

• The company is evaluating next steps for this program in light of the ACT-AD results and the interim LIFT-AD analysis.

ATH-1020 is an orally available, brain-penetrant small molecule designed to enhance the HGF/MET system that is being advanced as a potential treatment candidate for neuropsychiatric indications.

Phase 1 study of ATH-1020 in healthy volunteers (NCT05169671)

• Athira is conducting a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of ATH-1020 in approximately 68 healthy young and elderly volunteers. The single ascending dose escalation portion of the tria

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Athira Pharma Reports Second Quarter 2022 Financial Results and Recent Clinical and Corporate Updates

Presented clinical and preclinical data at Alzheimer’s Association International Conference 2022

Strong balance sheet to support clinical development pipeline

BOTHELL, WA, August 15, 2022 — 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 second quarter ended June 30, 2022 and reviewed recent clinical and corporate updates.

“We are encouraged by the biologic activity and safety topline results from the ACT-AD trial in Alzheimer’s disease. While the primary endpoint did not reach statistical significance, the trial results are the first ever to show potential cognitive improvement through positive modulation of the HGF/MET receptor by fosgonimeton. This is an important achievement supporting our conviction that we have a unique opportunity to reshape the course of neurodegenerative diseases,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira.

“The growing body of clinical and preclinical data with fosgonimeton and our other novel HGF/MET positive modulators support the potential for this pathway to improve neuronal health in a number of neurodegenerative diseases. Importantly, we are pleased to have a strong balance sheet that can support our programs through a number of key inflection points,” concluded Dr. Litton.

Clinical Update:

Fosgonimeton (ATH-1017) is a small molecule specifically designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET.

ACT-AD Phase 2 Study in mild-to-moderate Alzheimer’s disease (NCT04491006)

• Announced topline results in June 2022 from the proof-of-concept ACT-AD Phase 2 study of fosgonimeton (ATH-1017) in patients with mild-to-moderate Alzheimer’s disease (AD).

• The study did not meet the primary endpoint of a statistically significant change in event related potential (ERP) P300 latency for the protocoled modified intent to treat (mITT) population by a mixed model repeated measures (MMRM) analysis (-6.02 milliseconds) when compared with placebo at 26 weeks in a pooled analysis of the 40 mg and 70 mg dose groups.

• A post hoc analysis, based on the mITT population on fosgonimeton monotherapy, showed potentially beneficial, but not statistically significant, changes in ERP P300 latency compared to placebo at 26 weeks (-28 milliseconds) as well as cognitive

improvement as measured by ADAS-Cog11 (-3.3 points) compared with placebo at 26 weeks.

• Additional data from the ACT-AD Phase 2 study were presented in August 2022 at the Alzheimer's Association International Conference 2022 (AAIC 2022) by Hans Moebius, M.D., Ph.D., Athira’s Chief Medical Officer. Highlights of the additional data showed:

• A numerical, but not statistically significant, improvement in the functional measure of ADCS-ADL23, a secondary endpoint which evaluates improvements in patients’ activities of daily living as assessed by their caregivers, compared to placebo at 26 weeks in the protocoled mITT population by MMRM analysis (+2.12 points, n.s.).

• A statistically significant improvement in plasma levels of neurofilament light chain (NfL), a validated fluid biomarker of neurodegeneration, in a prespecified subgroup of subjects treated with fosgonimeton monotherapy compared with placebo at 26 weeks (difference of 6.89 pg/ml (p=0.018)), and showed a numerical, but not statistically significant, improvement in all fosgonimeton treated patients compared with placebo at 26 weeks (difference of 1.67 pg/ml), regardless of background therapy.

• The ACT-AD trial 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.

LIFT-AD Phase 3 Study in mild-to-moderate Alzheimer’s Disease (NCT04488419)

• Recruitment in the LIFT-AD trial is ongoing, with over 300 patients enrolled to-date.

• With feedback from its Scientific Advisory Board and the Data Safety Monitoring Board, Athira continues to evaluate the best next steps for the LIFT-AD trial.

Open Label Extension Study (NCT04886063)

• In May 2022, Athira extended its Open Label Extension (OLEX) study for the ACT-AD and LIFT-AD studies to up to 18 months following the completion of the 26-week treatment period in the ACT-AD or LIFT-AD study.

• As of August 2022, more than 90 percent of patients who have completed the LIFT-AD and ACT-AD studies have elected to participate in the OLEX study.

SHAPE Phase 2 Study in Parkinson’s disease dementia and Dementia with Lewy bodies (NCT04831281)

• Athira dosed the first

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EX-99.1

EX-99.1

Exhibit 99.1

Athira Pharma Reports First Quarter 2022 Financial Results

and Provides Pipeline and Business Updates

On track to report topline data from ACT-AD Phase 2 Alzheimer’s disease study by end of 2Q22

BOTHELL, WA, May 12, 2022 — 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 resumlts for the quarter ended March 31, 2022 and provided pipeline and business updates.

“Throughout the first quarter of 2022 we made significant progress advancing our strategy across Athira’s clinical development programs, with a focus on bringing our lead drug candidate, fosgonimeton, and the other molecules in our pipeline to patients while continuing to create lasting shareholder value,” stated Mark Litton, Ph.D., MBA, President and Chief Executive Officer of Athira. “During the first quarter, we published and presented a growing body of clinical and preclinical evidence in support of targeting the HGF/MET neurotrophic system. We were pleased to initiate two new studies in the first quarter: the Phase 2 SHAPE study of fosgonimeton in Parkinson’s disease dementia and Dementia with Lewy Bodies and a Phase 1 study of ATH-1020 to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers.”

“In addition to our considerable clinical progress, we advanced our corporate strategy through the expansion of our senior management team, as well as the expansion of our Board of Directors with two talented industry leaders – Grant Pickering, a proven life sciences leader with over 30 years of experience across all stages of corporate and clinical development, and Dr. Michael Panzara, an industry veteran with more than 20 years of CNS drug development and commercialization experience.

“We are looking forward to reporting topline data from our Phase 2 ACT-AD study in Alzheimer’s disease by the end of 2Q22 as we expect to gain insights into the safety and efficacy of our novel intervention as well as optimize the analysis plan for our potentially pivotal LIFT-AD study. We continue to advance these important studies in order to bring this potentially transformative medicine to the millions of patients impacted by Alzheimer’s disease,” concluded Dr. Litton.

First Quarter and Recent Highlights:

• Announced it is extending the ongoing Open Label Extension study for the LIFT-AD and ACT-AD clinical trials of fosgonimeton for mild-to-moderate Alzheimer’s disease, enabling eligible patients who have completed either trial, and elect to participate in the ongoing open label extension, to now receive up to 18 months of open-label treatment with fosgonimeton;

• Presented baseline Event Related Potential (ERP) P300 latency and patient demographic data from the ACT-AD study at the AD/PD™ conference that showed the study patient population enrolled in the Phase 2 trial is representative of the mild-to-moderate Alzheimer’s population

and is appropriate to evaluate the effect of fosgonimeton on ERP P300 latency, a functional, objective measure of working memory processing speed and executive function that highly correlates with cognition;

• Highlighted preclinical data that demonstrate the mechanism of action of the active metabolite of fosgonimeton is through positive modulation of HGF/MET and results in neurotrophic and procognitive effects in an oral presentation at the American Society for Experimental Neurotherapeutics (ASENT) annual meeting;

• Presented preclinical data at ASENT showing that ATH-1020, a novel, orally available, brain-penetrant small molecule, demonstrated neuroprotective effects, mitigated depression-like behaviors and normalized an electroencephalography (EEG) hallmark of schizophrenia in animal models;

• Published results from Phase 1 clinical trial of fosgonimeton in healthy volunteers and patients with Alzheimer’s disease in the peer-reviewed Journal of Alzheimer's Disease showing that fosgonimeton demonstrated a statistically significant improvement of ERP P300 latency as compared with placebo in Alzheimer’s disease patients;

• Announced fosgonimeton as the World Health Organization’s recommended international nonproprietary name for lead product candidate ATH-1017, and the United States Adopted Names (USAN) Council has adopted fosgonimeton as a USAN;

• Dosed the first patient in the SHAPE Phase 2 clinical trial of fosgonimeton in Parkinson’s disease dementia and Dementia with Lewy bodies;

• Dosed the first subject in a Phase 1 study of ATH-1020, designed to target neuropsychiatric conditions;

• Appointed life science industry leaders Grant Pickering and Michael Panzara, M.D. to the Board of Directors; and

• Expanded the senior management team with new hires, including the addition of:

o Donald Mackenzie, Ph.D., Senior Vice President CMC and Technical Operations. Dr. Mackenzie br