Athira Pharma Reports Full Year 2024 Financial Results and Pipeline and Business Updates
Athira Pharma (NASDAQ: ATHA) has completed its Phase 1 clinical study of ATH-1105 for amyotrophic lateral sclerosis (ALS) treatment. The study, involving 80 healthy volunteers, demonstrated favorable safety profiles and good tolerability, positioning the company to begin dosing ALS patients in 2025.
The company reported significant financial changes, with cash positions decreasing to $51.3 million as of December 31, 2024, compared to $147.4 million in 2023. Net loss improved to $96.9 million ($2.52 per share) from $117.7 million ($3.09 per share) in 2023. R&D expenses decreased to $70.7 million from $93.8 million, while G&A expenses reduced to $26.1 million from $33.3 million.
Following unsuccessful LIFT-AD Phase 2/3 trial results for fosgonimeton in Alzheimer's disease, Athira has paused its development and engaged Cantor Fitzgerald & Co. to explore strategic alternatives for maximizing stockholder value.
Athira Pharma (NASDAQ: ATHA) ha completato il suo studio clinico di Fase 1 per ATH-1105 nel trattamento della sclerosi laterale amiotrofica (SLA). Lo studio, che ha coinvolto 80 volontari sani, ha dimostrato profili di sicurezza favorevoli e una buona tollerabilità, posizionando l'azienda per iniziare a somministrare il trattamento ai pazienti affetti da SLA nel 2025.
L'azienda ha riportato significativi cambiamenti finanziari, con le disponibilità liquide che sono scese a $51.3 milioni al 31 dicembre 2024, rispetto ai $147.4 milioni del 2023. La perdita netta è migliorata a $96.9 milioni ($2.52 per azione) rispetto ai $117.7 milioni ($3.09 per azione) nel 2023. Le spese per R&S sono diminuite a $70.7 milioni da $93.8 milioni, mentre le spese generali e amministrative si sono ridotte a $26.1 milioni da $33.3 milioni.
Dopo i risultati insoddisfacenti della sperimentazione LIFT-AD di Fase 2/3 per il fosgonimeton nella malattia di Alzheimer, Athira ha sospeso il suo sviluppo e ha coinvolto Cantor Fitzgerald & Co. per esplorare alternative strategiche per massimizzare il valore per gli azionisti.
Athira Pharma (NASDAQ: ATHA) ha completado su estudio clínico de Fase 1 de ATH-1105 para el tratamiento de la esclerosis lateral amiotrófica (ELA). El estudio, que involucró a 80 voluntarios sanos, demostró perfiles de seguridad favorables y buena tolerancia, posicionando a la compañía para comenzar a tratar a pacientes con ELA en 2025.
La compañía reportó cambios financieros significativos, con posiciones de efectivo disminuyendo a $51.3 millones al 31 de diciembre de 2024, en comparación con $147.4 millones en 2023. La pérdida neta mejoró a $96.9 millones ($2.52 por acción) desde $117.7 millones ($3.09 por acción) en 2023. Los gastos de I+D disminuyeron a $70.7 millones desde $93.8 millones, mientras que los gastos generales y administrativos se redujeron a $26.1 millones desde $33.3 millones.
Tras los resultados no satisfactorios del ensayo LIFT-AD de Fase 2/3 para el fosgonimeton en la enfermedad de Alzheimer, Athira ha pausado su desarrollo y ha contratado a Cantor Fitzgerald & Co. para explorar alternativas estratégicas para maximizar el valor para los accionistas.
아티라 파마 (NASDAQ: ATHA)는 근위축성 측삭 경화증 (ALS) 치료를 위한 ATH-1105의 1상 임상 연구를 완료했습니다. 80명의 건강한 자원자를 포함한 이 연구는 유리한 안전성 프로파일과 좋은 내약성을 입증하여, 회사가 2025년에 ALS 환자에게 투여를 시작할 수 있는 위치를 마련했습니다.
회사는 2024년 12월 31일 기준으로 현금 보유액이 $51.3 백만으로 감소했으며, 이는 2023년의 $147.4 백만과 비교됩니다. 순손실은 2023년의 $117.7 백만 ($3.09 per share)에서 $96.9 백만 ($2.52 per share)으로 개선되었습니다. 연구개발 비용은 $93.8 백만에서 $70.7 백만으로 감소했으며, 일반 및 관리 비용은 $33.3 백만에서 $26.1 백만으로 줄어들었습니다.
알츠하이머병에 대한 포스고니메톤의 LIFT-AD 2/3상 시험 결과가 불만족스러웠던 후, 아티라는 개발을 중단하고 Cantor Fitzgerald & Co.를 고용하여 주주 가치를 극대화할 전략적 대안을 모색하고 있습니다.
Athira Pharma (NASDAQ: ATHA) a terminé son étude clinique de Phase 1 sur ATH-1105 pour le traitement de la sclérose latérale amyotrophique (SLA). L'étude, impliquant 80 volontaires en bonne santé, a démontré des profils de sécurité favorables et une bonne tolérance, positionnant l'entreprise pour commencer à traiter les patients atteints de SLA en 2025.
L'entreprise a signalé des changements financiers significatifs, avec des liquidités passant à $51.3 millions au 31 décembre 2024, contre $147.4 millions en 2023. La perte nette s'est améliorée à $96.9 millions ($2.52 par action) contre $117.7 millions ($3.09 par action) en 2023. Les dépenses de R&D ont diminué à $70.7 millions contre $93.8 millions, tandis que les dépenses générales et administratives ont été réduites à $26.1 millions contre $33.3 millions.
Suite aux résultats insatisfaisants de l'essai LIFT-AD de Phase 2/3 pour le fosgonimeton dans la maladie d'Alzheimer, Athira a suspendu son développement et a engagé Cantor Fitzgerald & Co. pour explorer des alternatives stratégiques afin de maximiser la valeur pour les actionnaires.
Athira Pharma (NASDAQ: ATHA) hat seine Phase-1-Studie zu ATH-1105 zur Behandlung von amyotropher Lateralsklerose (ALS) abgeschlossen. Die Studie, an der 80 gesunde Freiwillige teilnahmen, zeigte günstige Sicherheitsprofile und gute Verträglichkeit, was das Unternehmen in die Lage versetzt, 2025 mit der Behandlung von ALS-Patienten zu beginnen.
Das Unternehmen berichtete von erheblichen finanziellen Veränderungen, wobei die liquiden Mittel zum 31. Dezember 2024 auf $51.3 Millionen gesunken sind, verglichen mit $147.4 Millionen im Jahr 2023. Der Nettoverlust verbesserte sich auf $96.9 Millionen ($2.52 pro Aktie) von $117.7 Millionen ($3.09 pro Aktie) im Jahr 2023. Die F&E-Ausgaben sanken auf $70.7 Millionen von $93.8 Millionen, während die allgemeinen und Verwaltungskosten auf $26.1 Millionen von $33.3 Millionen reduziert wurden.
Nach den unbefriedigenden Ergebnissen der LIFT-AD-Phase-2/3-Studie zu Fosgonimeton bei Alzheimer hat Athira die Entwicklung pausiert und Cantor Fitzgerald & Co. beauftragt, strategische Alternativen zur Maximierung des Aktionärswertes zu prüfen.
- ATH-1105 Phase 1 trial showed favorable safety profile
- Net loss improved by $20.8M year-over-year
- R&D expenses reduced by $23.1M
- G&A expenses decreased by $7.2M
- Cash position declined by $96.1M year-over-year
- LIFT-AD Phase 2/3 trial failed to meet endpoints
- Fosgonimeton development program paused
- $4.1M legal expense accrued for DOJ settlement
- $97.2M net cash burned in operations
Insights
Athira Pharma's 2024 financial results reveal a company at a critical juncture following the failure of its lead candidate. The $96.9 million annual net loss ($2.52 per share) represents a concerning cash burn rate that has depleted reserves from $147.4 million to $51.3 million in just one year. With $97.2 million used in operations during 2024, the company's current runway appears to approximately 6 months at existing spending levels, creating urgent financing pressure.
The company's strategic pivot follows the September 2024 failure of fosgonimeton in the LIFT-AD Phase 2/3 trial, which represented Athira's most advanced asset. This setback forced management to pause the program's development and engage Cantor Fitzgerald to explore strategic alternatives – typically code for seeking acquisition, merger, or significant partnership opportunities.
Athira's future now depends heavily on ATH-1105, its preclinical-stage ALS candidate. While the completed Phase 1 study demonstrated favorable safety and tolerability in healthy volunteers, this represents just the first step in a lengthy clinical development process. The planned progression to ALS patient dosing in 2025 is promising, but investors should recognize that even with perfect execution, ATH-1105 remains years away from potential commercialization and faces significant development risks.
The $4.1 million DOJ settlement related to an NIH grant adds another layer of concern, potentially indicating compliance issues that could impact future grant funding opportunities. The 26% reduction in R&D expenses to $70.7 million primarily reflects scaled-back investment in the now-paused fosgonimeton program rather than operational efficiency.
With a market cap of approximately $15 million, investors appear to have already priced in substantial challenges. The strategic alternatives exploration may provide an exit opportunity, but such processes often result in acquisitions at modest premiums, especially for companies with runway and early-stage assets.
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., Feb. 27, 2025 (GLOBE NEWSWIRE) -- 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 development, and other general corporate expenses. - Legal Expense. Legal expense of
$4.1 million was accrued during the year ended December 31, 2024, in connection with a settlement agreement reached with the United States Department of Justice related to Athira’s NIH grant. - Net Loss. Net loss was
$96.9 million , or$2.52 per share, for the year ended December 31, 2024, compared to a net loss of$117.7 million , or$3.09 per share, for the year ended December 31, 2023.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological diseases by advancing its pipeline of drug candidates that modulate the neurotrophic HGF system. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn, X and Instagram.
Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: Athira’s drug candidates as potential treatments for amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative diseases; future development plans; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical development plans; the potential learnings from our Phase 1 ATH-1105 clinical trial and its implications for future development plans; expectations regarding the potential efficacy and commercial potential of Athira’s drug candidates; Athira’s ability to advance its drug candidates into later stages of development; and Athira’s plans and expectations regarding Athira’s exploration of strategic alternatives and partnering options. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” “suggest,” “potential,” “target,” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of Athira’s drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; whether Athira’s trials are sufficiently powered to meet the planned endpoints; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that have been or may in the future be instituted against Athira, its directors and officers; possible negative interactions of Athira's drug candidates with other treatments; Athira’s assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets; the impact of competition; the impact of drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; risks related to Athira’s exploration of strategic alternatives; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission from time to time. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
| Athira Pharma, Inc. Condensed Consolidated Balance Sheets (Amounts in thousands) | |||||||
| December 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 48,438 | $ | 90,584 | |||
| Short-term investments | 2,837 | 56,835 | |||||
| Other short-term assets | 3,566 | 7,310 | |||||
| Other long-term assets | 3,938 | 5,516 | |||||
| Total assets | $ | 58,779 | $ | 160,245 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities | $ | 13,135 | $ | 28,840 | |||
| Long-term liabilities | 803 | 1,217 | |||||
| Total liabilities | 13,938 | 30,057 | |||||
| Stockholders' equity | 44,841 | 130,188 | |||||
| Total liabilities and stockholders' equity | $ | 58,779 | $ | 160,245 | |||
| Athira Pharma, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands, except share and per share amounts) | |||||||
| Year Ended December 31, | |||||||
| 2024 | 2023 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 70,682 | $ | 93,790 | |||
| General and administrative | 26,093 | 33,304 | |||||
| Legal expense | 4,127 | — | |||||
| Insurance recovery related to legal settlement | — | (1,628 | ) | ||||
| Total operating expenses | 100,902 | 125,466 | |||||
| Loss from operations | (100,902 | ) | (125,466 | ) | |||
| Grant income | — | 157 | |||||
| Other income, net | 3,962 | 7,637 | |||||
| Net loss | $ | (96,940 | ) | $ | (117,672 | ) | |
| Unrealized gain on available-for-sale securities | 350 | 1,607 | |||||
| Comprehensive loss attributable to common stockholders | $ | (96,590 | ) | $ | (116,065 | ) | |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.52 | ) | $ | (3.09 | ) | |
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 38,480,875 | 38,020,182 | |||||
FAQ
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