Announcement • Sep 04

Athira Pharma, Inc. Announces Topline Results from Phase 2/3 Lift-AD Clinical Trial of Fosgonimeton for Mild-to-Moderate Alzheimer's Disease

Athira Pharma, Inc. announced topline results from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton, a hepatocyte growth factor (HGF) positive modulator, in patients with mild-to-moderate Alzheimer's disease (AD). The topline results showed that neither the trial's primary endpoint (the Global Statistical Test (GST), a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23)) nor its key secondary endpoints of ADAS-Cog11 and ADCS-ADL23 reached statistical significance compared with placebo at 26 weeks. However, both components of GST, cognition (ADAS-Cog11) and function (ADCS-ADL23), directionally favored fosgonimeton treatment, and in pre-specified subgroups characterized by more rapid disease progression (moderate AD and APOE4 carriers), cognition and function improved or stabilized in the fosgonimeton treated group. In addition, data across biomarkers of protein pathology (Aß42/40, p-Tau181, and p-Tau217), inflammation (GFAP) and neurodegeneration (NfL) showed directional improvements with fosgonimeton treatment that are consistent with the broad neuroprotective mechanism of HGF modulation. LIFT-AD (NCT04488419) was a randomized, placebo-controlled, double-blind study that evaluated the efficacy and safety of once-daily subcutaneous injections of fosgonimeton (40 mg) in 312 mild-to-moderate AD patients not on acetylcholinesterase inhibitors (AChEIs) compared to placebo over a 26-week treatment period.?The primary endpoint of LIFT-AD was the change from baseline after 26 weeks of treatment using the Global Statistical Test (GST), a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23). Secondary endpoints included cognition (ADAS-Cog11), function (ADCS-ADL23), and a plasma biomarker of neurodegeneration, neurofilament light chain (NfL). The trial explored additional plasma biomarkers including glial fibrillary acidic protein (GFAP), a marker of neuroinflammation, and both amyloid beta and phosphorylated tau (pTau), hallmark measures of AD pathology. Primary Analysis Population Topline results from the LIFT-AD study of fosgonimeton in mild-to-moderate AD patients after 26 weeks showed: A -0.08 change in GST favoring fosgonimeton that did not reach statistical significance (p=0.70) The change in cognition from baseline as assessed by ADAS-Cog11, for which a decrease from baseline represents improvement, was -0.39 for the placebo group and -1.09 for the fosgonimeton treated group, a difference of -0.70 (p=0.35) favoring fosgonimeton; In the fosgonimeton treated group, there was an increase (improvement) of 0.65 in function as measured by ADCS-ADL23 versus a decline of -0.02 in placebo, although this difference did not meet statistical significance (p=0.61). Prespecified Biomarker Analyses: Data from the plasma biomarkers of neurodegeneration (NfL), inflammation (GFAP), and protein pathology (p-Tau181, p-Tau217, and amyloid beta 42/40 ratio) showed consistent directional improvements favoring fosgonimeton versus placebo after 26 weeks. Notably, fosgonimeton treatment reduced plasma levels of pTau217, a hallmark of AD, by -0.12 pg/mL compared to placebo (p<0.01). Prespecified Subgroup Analyses: In a prespecified subgroup analyses of more advanced AD patients, a greater numerical treatment effect in clinical outcomes was observed in the fosgonimeton treatment group compared to placebo after 26 weeks: The change in cognition from baseline as assessed by ADAS-Cog11 in moderate AD patients, for which a decrease from baseline represents improvement, showed the fosgonimeton treatment group (n=61) improved compared to placebo (n=70), with a delta of -1.16 (p=0.39); For AD patients who are carriers of the APOE4 gene, the placebo group (n=74) declined in cognition as assessed by ADAS-Cog11 over the 26-week period as expected, whereas the fosgonimeton treatment group (n=74) remained stable, with a delta of -1.07 (p=0.33). Post Hoc Subgroup Analyses: In a post hoc analyses by disease severity as defined by baseline ADAS-Cog11 (>30) and Clinical Dementia Rating (CDR) 2, fosgonimeton showed a larger effect size mainly driven by an improvement in cognition at week 26. Patients with the highest baseline ADAS-Cog11 (>30) who were treated with fosgonimeton (n=42) compared to placebo (n=52) showed a -2.51 improvement in cognition as assessed by ADAS-Cog11 (p=0.16), for which a lower number represents improvement; A small subset of patients with a CDR 2 (moderate dementia) who were treated with fosgonimeton (n=20) compared to placebo (n=19) showed a -3.74 improvement in cognition as assessed by ADAS-Cog11 (p=0.21). Full analysis of these results is scheduled to be reviewed at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) taking place October 29 - November 1, 2024, in Madrid, Spain. Athira continues to evaluate ATH-1105, a next-generation, orally administered, small molecule drug candidate in development for the potential treatment of amyotrophic lateral sclerosis (ALS), AD, and other neurodegenerative diseases. 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 completed the first cohort of healthy volunteers in June 2024 and expects trial completion by year-end 2024, with a goal to be in 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.

Announcement • Aug 04

Athira Pharma Presents Data from ACT-AD Phase 2 Proof-of-Concept Clinical Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Patients at the Alzheimer's Association International Conference 2022

Athira Pharma, Inc. announced that Hans Moebius, M.D., Ph.D., Athira’s Chief Medical Officer, is leading an oral presentation titled, “ACT-AD: Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease – First Results of a Randomized, Placebo-Controlled, 26-Week Phase 2 Proof-of-Concept Trial” on August 3, 2022 at the Alzheimer’s Association International Conference (AAIC) 2022. Athira’s lead candidate, fosgonimeton (ATH-1017), is a small-molecule positive modulator of the HGF/MET neurotrophic factor system. ACT-AD was an exploratory, randomized, double-blind, placebo-controlled, parallel-group 26-week trial evaluating fosgonimeton compared to placebo in patients with mild-to-moderate Alzheimer’s disease. The study enrolled 77 patients in the United States and Australia (age 55 to 85 years, Mini-Mental State Exam (MMSE) score of 14-24 and Clinical Dementia Rating (CDR) scale global score of 1 or 2). Patients were allowed to continue standard-of-care therapy (AChEIs), with 60 percent remaining on stable doses of AChEIs and 40 percent not receiving AChEIs during the study. Patients were randomized 1:1:1 to receive placebo or fosgonimeton at either 40 mg/d or 70 mg/d. The primary endpoint for ACT-AD was Event-Related-Potential (ERP) P300 Latency, a functional measure of working memory processing speed. Secondary endpoints included ADAS-Cog11, a measure of cognition; ADCS-CGIC, a measure of global clinical change; and ADCS-ADL23, a measure of functional change. Safety data were evaluated throughout. As previously reported, the ACT-AD study did not meet the primary endpoint of a statistically significant change in ERP P300 Latency for the modified intent to treat (mITT) population by a mixed model repeated measures (MMRM) analysis when compared with placebo at 26 weeks in a pooled analysis of the 40 mg and 70 mg dose groups. Secondary endpoints, including ADAS-Cog11, ADCS-CGIC, and ADCS-ADL23, were not statistically significant in treated subjects compared with placebo at 26 weeks as the study was only powered to show statistical significance for change in ERP P300 latency. While not statistically significant, the data showed a numerical improvement in the functional measure of ADCS-ADL23, which evaluates improvements in patients’ activities of daily living as assessed by their caregivers compared to placebo at 26 weeks (+2.12 points). A post hoc analysis, based on the mITT population on fosgonimeton monotherapy, showed a potentially beneficial change 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. In addition, among subjects treated with fosgonimeton monotherapy, a prespecified subgroup analysis of the plasma levels of NfL, a validated fluid biomarker of neurodegeneration, demonstrated a statistically significant improvement compared with placebo, Least Squared (LS) means difference of 6.89 pg/ml (p=0.018), and showed a numerical improvement in all fosgonimeton treated patients compared with placebo, LS means difference 1.67 pg/ml (n.s.), regardless of background therapy. Athira reports that more than 90 percent of patients completing the ACT-AD and LIFT-AD studies have elected to participate in the ongoing open label extension study. 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 and at AAIC is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health. LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group study of fosgonimeton for patients with mild-to-moderate Alzheimer’s disease. The study has enrolled more than 300 patients in the United States, with enrollment ongoing. Patients are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily over a treatment course of 26 weeks. The primary endpoint for LIFT-AD will be measured by the Global Statistical Test, which is a mathematical algorithm that combines the scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]), and either global impression of change (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change [ADCS-CGIC]), or function (Alzheimer’s Disease Cooperative Study-Activities of Daily Living [ADCS-ADL23]). Fosgonimeton (ATH-1017) is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. In addition to Alzheimer’s disease, fosgonimeton has the potential to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain.

Total Shareholder Yield	-95.0%
Future Dividend Yield	n/a
Dividend Growth	n/a
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	n/a

Segment	Dividend Yield
Company (LONA)	n/a
Market Bottom 25% (US)	1.4%
Market Top 25% (US)	4.3%
Industry Average (Pharmaceuticals)	2.1%
Analyst forecast (LONA) (up to 3 years)	n/a

Data	Last Updated (UTC time)
Company Analysis	2026/05/21 07:09
End of Day Share Price	2026/05/20 00:00
Earnings	2026/03/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Esther Lannie Hong	Berenberg
Eric Schmidt	Cantor Fitzgerald & Co.
Jason Butler	Citizens JMP Securities, LLC

LeonaBio Dividends and Buybacks

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