Athira Pharma Reports Third Quarter 2024 Financial Results and Pipeline and Business Updates
Athira Pharma reported Q3 2024 financial results and provided updates on its pipeline and business. The company is advancing ATH-1105, an oral drug candidate for ALS, with Phase 1 trials in healthy volunteers expected to complete by year-end and ALS patient dosing to begin in 2025. ATH-1105 has shown promising preclinical results in ALS models. However, the LIFT-AD Phase 2/3 trial for fosgonimeton in Alzheimer's did not meet primary or key secondary endpoints. Consequently, Athira is exploring strategic alternatives and has paused further fosgonimeton development. Financially, Athira's cash position was $68.9 million, with a net loss of $28.7 million for Q3 2024. R&D expenses decreased to $17.9 million, while G&A expenses remained stable at $7.6 million. Legal expenses were $4.1 million due to a DOJ investigative demand.
Athira Pharma ha riportato i risultati finanziari del terzo trimestre 2024 e fornito aggiornamenti sul suo pipeline e sulle attività commerciali. L'azienda sta avanzando con ATH-1105, un candidato farmaco orale per la SLA, con le sperimentazioni di Fase 1 su volontari sani previste per concludersi entro la fine dell'anno e la somministrazione ai pazienti affetti da SLA che inizierà nel 2025. ATH-1105 ha mostrato risultati preclinici promettenti nei modelli di SLA. Tuttavia, la sperimentazione LIFT-AD di Fase 2/3 per il fosgonimeton nell'Alzheimer non ha raggiunto i principali endpoint primari né quelli secondari chiave. Di conseguenza, Athira sta esaminando alternative strategiche e ha sospeso ulteriori sviluppi del fosgonimeton. Dal punto di vista finanziario, la posizione di cassa di Athira era di 68,9 milioni di dollari, con una perdita netta di 28,7 milioni di dollari per il terzo trimestre 2024. Le spese per ricerca e sviluppo sono diminuite a 17,9 milioni di dollari, mentre le spese generali e amministrative sono rimaste stabili a 7,6 milioni di dollari. Le spese legali ammontavano a 4,1 milioni di dollari a causa di una richiesta di indagine da parte del DOJ.
Athira Pharma informó los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre su pipeline y negocio. La compañía está avanzando con ATH-1105, un candidato a fármaco oral para la ELA, con ensayos de Fase 1 en voluntarios sanos que se espera que finalicen a finales de año y la dosificación a pacientes con ELA que comenzará en 2025. ATH-1105 ha mostrado resultados preclínicos prometedores en modelos de ELA. Sin embargo, el ensayo LIFT-AD de Fase 2/3 para fosgonimetón en Alzheimer no cumplió con los endpoints primarios ni secundarios clave. En consecuencia, Athira está explorando alternativas estratégicas y ha pausado el desarrollo adicional del fosgonimetón. Desde el punto de vista financiero, la posición de efectivo de Athira era de 68,9 millones de dólares, con una pérdida neta de 28,7 millones de dólares en el tercer trimestre de 2024. Los gastos de I+D disminuyeron a 17,9 millones de dólares, mientras que los gastos generales y administrativos se mantuvieron estables en 7,6 millones de dólares. Los gastos legales fueron de 4,1 millones de dólares debido a una demanda de investigación del DOJ.
Athira Pharma가 2024년 3분기 재무 결과를 보고하고 파이프라인 및 사업에 대한 업데이트를 제공하였습니다. 이 회사는 ALS를 위한 경구용 약물 후보인 ATH-1105를 발전시키고 있으며, 건강한 자원자를 대상으로 한 1상 시험이 연말까지 완료될 것으로 예상되며, ALS 환자에 대한 투약은 2025년에 시작될 예정입니다. ATH-1105는 ALS 모델에서 유망한 전임상 결과를 보였습니다. 그러나 알츠하이머를 위한 fosgonimeton의 LIFT-AD 2/3상 시험은 주요 및 주요 2차 endpoint를 충족하지 못했습니다. 결과적으로 Athira는 전략적 대안을 모색하고 fosgonimeton 개발을 중단했습니다. 재무적으로 Athira의 현금 보유액은 6,890만 달러였으며, 2024년 3분기에는 2,870만 달러의 순손실을 기록했습니다. 연구 개발 비용은 1,790만 달러로 줄어들었고, 일반 관리 비용은 760만 달러로 안정세를 유지했습니다. 법적 비용은 DOJ 조사 요구로 인해 410만 달러에 달했습니다.
Athira Pharma a rapporté les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur son pipeline et ses activités. L'entreprise avance avec ATH-1105, un candidat médicament oral pour la SLA, avec des essais de Phase 1 chez des volontaires sains devant se terminer d'ici la fin de l'année et une administration aux patients SLA qui débutera en 2025. ATH-1105 a montré des résultats précliniques prometteurs dans des modèles de SLA. Cependant, l'essai LIFT-AD de Phase 2/3 pour le fosgoniméton dans la maladie d'Alzheimer n'a pas atteint les résultats primaires ni les principaux secondaires. Par conséquent, Athira explore des alternatives stratégiques et a suspendu le développement ultérieur du fosgoniméton. Sur le plan financier, la position de liquidités d'Athira était de 68,9 millions de dollars, avec une perte nette de 28,7 millions de dollars pour le troisième trimestre 2024. Les dépenses de R&D ont diminué à 17,9 millions de dollars, tandis que les dépenses générales et administratives sont restées stables à 7,6 millions de dollars. Les frais juridiques ont atteint 4,1 millions de dollars en raison d'une demande d'enquête émanant du DOJ.
Athira Pharma hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und Updates zu seinem Pipeline und Geschäft bereitgestellt. Das Unternehmen entwickelt ATH-1105, einen oralen Medikamentenkandidaten für ALS, wobei die Phase-1-Studien mit gesunden Freiwilligen bis Ende des Jahres abgeschlossen sein sollen und die Dosierung bei ALS-Patienten 2025 beginnen wird. ATH-1105 hat vielversprechende präklinische Ergebnisse in ALS-Modellen gezeigt. Der LIFT-AD Phase 2/3-Test für Fosgonimeton bei Alzheimer erfüllte jedoch weder die primären noch die wichtigen sekundären Endpunkte. Infolgedessen untersucht Athira strategische Alternativen und hat die weitere Entwicklung von Fosgonimeton pausiert. Finanziell betrug die Bargeldposition von Athira 68,9 Millionen Dollar, mit einem Nettogewinnverlust von 28,7 Millionen Dollar für das dritte Quartal 2024. Die F&E-Ausgaben sank auf 17,9 Millionen Dollar, während die allgemeinen Verwaltungsaufwendungen stabil bei 7,6 Millionen Dollar blieben. Die Rechtskosten beliefen sich auf 4,1 Millionen Dollar aufgrund einer Anforderung zur Untersuchung durch das DOJ.
- ATH-1105 Phase 1 trials are progressing well, with completion expected by year-end 2024.
- ATH-1105 has shown promising preclinical results in ALS models.
- LIFT-AD Phase 2/3 trial for fosgonimeton did not meet primary or key secondary endpoints.
- Cash position decreased to $68.9 million from $147.4 million at the end of 2023.
- Net loss of $28.7 million for Q3 2024.
- Legal expenses of $4.1 million due to DOJ investigative demand.
Expects to complete healthy volunteer Phase 1 clinical study of ATH-1105 by year end and begin dosing ALS patients in 2025
BOTHELL, Wash., Nov. 07, 2024 (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 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 quarter ended September 30, 2024, in connection with the United States Department of Justice investigative demand. - Net Loss. Net loss was
$28.7 million , or$0.75 per share, for the quarter ended September 30, 2024, compared to a net loss of$33.0 million , or$0.87 per share, for the quarter ended September 30, 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 (formerly known as Twitter) 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, and other neurodegenerative diseases; future development plans; the anticipated reporting of data; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical 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. 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 expanded 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) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 68,856 | $ | 90,584 | ||||
| Short-term investments | — | 56,835 | ||||||
| Other short-term assets | 13,146 | 7,310 | ||||||
| Other long-term assets | 4,244 | 5,516 | ||||||
| Total assets | $ | 86,264 | $ | 160,245 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | $ | 27,751 | $ | 28,840 | ||||
| Long-term liabilities | 912 | 1,217 | ||||||
| Total liabilities | 28,663 | 30,057 | ||||||
| Stockholders' equity | 57,583 | 130,188 | ||||||
| Total liabilities and stockholders' equity | $ | 86,246 | $ | 160,245 | ||||
| Athira Pharma, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands, except share and per share amounts) (Unaudited) | ||||||||
| Three Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 17,922 | $ | 27,202 | ||||
| General and administrative | 7,572 | 7,840 | ||||||
| Legal expense | 4,127 | — | ||||||
| Total operating expenses | 29,621 | 35,042 | ||||||
| Loss from operations | (29,621 | ) | (35,042 | ) | ||||
| Other income, net | 880 | 2,072 | ||||||
| Net loss | $ | (28,741 | ) | $ | (32,970 | ) | ||
| Unrealized gain on available-for-sale securities | 41 | 261 | ||||||
| Comprehensive loss attributable to common stockholders | $ | (28,700 | ) | $ | (32,709 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.75 | ) | $ | (0.87 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 38,517,602 | 38,054,583 | ||||||
FAQ
What were Athira Pharma's financial results for Q3 2024?
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