Alector Reports Third Quarter 2024 Financial Results and Provides Business Update
Alector reported Q3 2024 financial results with collaboration revenue of $15.3 million and a net loss of $42.2 million. The company maintains a strong cash position of $457.2 million, providing runway through 2026. Key clinical updates include: the INVOKE-2 Phase 2 trial data for AL002 in early Alzheimer's disease expected in 2024, with 98% participant retention in long-term extension; INFRONT-3 Phase 3 trial for latozinemab in FTD-GRN progressing with enrollment completed; and PROGRESS-AD Phase 2 trial for AL101 reaching over one-third of target enrollment. The company reaffirmed 2024 guidance with expected collaboration revenue of $60-70 million.
Alector ha riportato i risultati finanziari del Q3 2024, con ricavi da collaborazioni pari a 15,3 milioni di dollari e una perdita netta di 42,2 milioni di dollari. L'azienda mantiene una solida posizione di cassa di 457,2 milioni di dollari, garantendo fondi sufficienti fino al 2026. Tra gli aggiornamenti clinici chiave ci sono: i dati del trial di Fase 2 INVOKE-2 per AL002 nella fase precoce della malattia di Alzheimer, attesi per il 2024, con una retention dei partecipanti del 98% nell'estensione a lungo termine; il trial di Fase 3 INFRONT-3 per latozinemab nella FTD-GRN che sta procedendo con l'arruolamento completato; e il trial di Fase 2 PROGRESS-AD per AL101 che ha superato un terzo dell'arruolamento target. L'azienda ha confermato le previsioni per il 2024, con ricavi da collaborazioni attesi tra 60 e 70 milioni di dollari.
Alector informó los resultados financieros del tercer trimestre de 2024, con ingresos por colaboraciones de 15,3 millones de dólares y una pérdida neta de 42,2 millones de dólares. La compañía mantiene una sólida posición de efectivo de 457,2 millones de dólares, lo que proporciona recursos hasta 2026. Las actualizaciones clínicas clave incluyen: los datos del ensayo de Fase 2 INVOKE-2 para AL002 en la enfermedad de Alzheimer temprana, que se esperan en 2024, con una retención del 98% de los participantes en la extensión a largo plazo; el ensayo de Fase 3 INFRONT-3 para latozinemab en FTD-GRN que avanza con el reclutamiento completado; y el ensayo de Fase 2 PROGRESS-AD para AL101 que ha alcanzado más de un tercio del reclutamiento objetivo. La compañía reafirmó su guía para 2024, con ingresos de colaboración esperados entre 60 y 70 millones de dólares.
Alector는 2024년 3분기 재무 결과를 보고했으며, 협력 수익은 1,530만 달러, 순손실은 4,220만 달러로 나타났습니다. 이 회사는 4억 5,720만 달러의 강력한 현금 보유를 유지하고 있으며, 이는 2026년까지 자금을 지원합니다. 주요 임상 업데이트로는: AL002에 대한 초기 알츠하이머병의 INVOKE-2 2상 시험 데이터가 2024년에 예상되며, 장기 연장에 참가한 참가자의 유지율은 98%에 이릅니다; FTD-GRN에서 latozinemab에 대한 INFRONT-3 3상 시험이 진행 중이며, 모집이 완료되었습니다; AL101에 대한 PROGRESS-AD 2상 시험이 목표 모집의 3분의 1 이상에 도달했습니다. 이 회사는 2024년의 지침을 재확인하였으며, 예상되는 협력 수익은 6,000만에서 7,000만 달러입니다.
Alector a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus de collaboration de 15,3 millions de dollars et une perte nette de 42,2 millions de dollars. La société maintient une solide position de trésorerie de 457,2 millions de dollars, offrant des ressources jusqu'en 2026. Les mises à jour cliniques clés incluent : les données de l'essai de Phase 2 INVOKE-2 pour AL002 dans la maladie d'Alzheimer précoce attendues en 2024, avec un taux de rétention des participants de 98% lors de l'extension à long terme ; l'essai de Phase 3 INFRONT-3 pour latozinemab dans la FTD-GRN qui progresse avec un recrutement terminé ; et l'essai de Phase 2 PROGRESS-AD pour AL101 atteignant plus d'un tiers de l'objectif de recrutement. La société a réaffirmé ses prévisions pour 2024, avec des revenus de collaboration attendus entre 60 et 70 millions de dollars.
Alector berichtete über die Finanzergebnisse für das 3. Quartal 2024, mit Einnahmen aus Kooperationen von 15,3 Millionen Dollar und einem Nettoverlust von 42,2 Millionen Dollar. Das Unternehmen hält eine starke Liquiditätsposition von 457,2 Millionen Dollar, die bis 2026 ausreicht. Wichtige klinische Aktualisierungen umfassen: die Daten der INVOKE-2 Phase-2-Studie für AL002 bei früher Alzheimer-Krankheit, die für 2024 erwartet werden, mit einer Teilnehmerbindung von 98% in der Langzeitverlängerung; die INFRONT-3 Phase-3-Studie für latozinemab in FTD-GRN, die mit abgeschlossenem Rekrutierungsprozess voranschreitet; und die PROGRESS-AD Phase-2-Studie für AL101, die mehr als ein Drittel der angestrebten Rekrutierung erreicht hat. Das Unternehmen bestätigte die Prognose für 2024 mit erwarteten Kooperationsumsätzen von 60 bis 70 Millionen Dollar.
- Strong cash position of $457.2 million providing runway through 2026
- 98% retention rate in INVOKE-2 trial long-term extension
- Potential $250 million payment from AbbVie upon option exercise for AL002
- Collaboration revenue increased to $15.3 million from $9.1 million YoY
- Net loss per share improved to $0.43 from $0.53 YoY
- Net loss of $42.2 million in Q3 2024
- Increased R&D expenses to $48.0 million from $46.3 million YoY
- G&A expenses increased to $15.8 million from $13.4 million YoY
Insights
Alector's Q3 results show a strengthening financial position with
The clinical pipeline shows robust progress with three key programs: AL002 for Alzheimer's with data expected in 2024, latozinemab for FTD-GRN with Phase 3 results due late 2025/early 2026 and AL101 in Phase 2 for early Alzheimer's. The 98% retention rate in AL002's extension study suggests strong participant engagement and potentially promising tolerability. The INFRONT-3 trial's baseline characteristics indicate a well-designed study population, increasing confidence in the eventual results' applicability. The proprietary ABC platform technology development adds strategic value for future drug delivery optimization.
Data from INVOKE-2, evaluating TREM2 agonist candidate AL002 in patients with early Alzheimer’s disease (AD), on track for 2024
Participant baseline characteristics in pivotal INFRONT-3 Phase 3 trial suggest a representative study population for testing the effects of latozinemab in frontotemporal dementia with a progranulin gene mutation (FTD-GRN)
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported third quarter 2024 financial results and recent portfolio and business updates. As of September 30, 2024, Alector’s cash, cash equivalents, and investments totaled
“We continue to make meaningful progress advancing our innovative pipeline of product candidates and remain on track to report data in 2024 from the INVOKE-2 Phase 2 trial of AL002, the most advanced TREM2 candidate in clinical development for early Alzheimer’s disease,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We believe that increased TREM2 signaling via AL002 may recruit disease-fighting microglia to broadly counteract the progression of Alzheimer’s disease. INVOKE-2 is designed to provide meaningful insights into AL002’s potential benefits across a combination of clinical and functional endpoints, as well as imaging and fluid biomarkers. We also believe that the broad mechanism of AL002 may have the potential to deliver potent and durable therapeutic benefits, both as a standalone therapy and in combination with anti-amyloid beta antibodies.”
Dr. Rosenthal continued, “For our progranulin franchise, we recently reported the patient baseline characteristics for our INFRONT-3 Phase 3 clinical trial of latozinemab in frontotemporal dementia with a progranulin gene mutation, suggesting a representative study population in this indication. We are approaching a top-line data readout for INFRONT-3 in late 2025/early 2026. Additionally, PROGRESS-AD, the Phase 2 trial of AL101/GSK4527226 in early Alzheimer’s disease, has reached more than one-third of its target enrollment. It is an exciting time at Alector, and we are well positioned to advance our proprietary pipeline of novel immuno-neurology drugs.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, “We are actively advancing our Alector Brain Carrier, ABC, a proprietary versatile blood-brain barrier technology, and we are strategically leveraging this platform across our portfolio. We believe our ABC technology may advance treatment of neurodegenerative diseases by potentially enabling improved delivery of our therapeutics to the brain.”
Recent Clinical Updates
Immuno-Neurology Portfolio
TREM2 Program (AL002) Being Developed in Collaboration with AbbVie
- The results of the INVOKE-2 Phase 2 clinical trial of AL002 are expected in 2024. INVOKE-2, a randomized, double-blind, placebo-controlled, dose-ranging study, is designed to assess the efficacy and safety of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). AL002 is a novel investigational humanized monoclonal antibody (mAb) that is designed to bind to TREM2 to increase TREM2 signaling and, thereby, is hypothesized to improve the functionality of microglia. It is the most advanced TREM2 agonist product candidate in clinical development worldwide.
98% of eligible participants who completed the planned treatment period of INVOKE-2 have elected to participate in the long-term extension (LTE) study.
- In October 2024, Alector published a manuscript titled “Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease” in Alzheimer’s Research & Therapy. The publication outlines preclinical and INVOKE-1 Phase 1 study results, demonstrating that AL002 engaged TREM2, and induced pharmacodynamic biomarker changes associated with microglial proliferation, survival, and phagocytic activity in a dose-dependent manner.
- AbbVie has an exclusive option to globally develop and commercialize AL002. Alector will deliver a data package resulting from the INVOKE-2 study to AbbVie for their evaluation. AbbVie’s exercise of its option would prompt a
$250 million payment to Alector.
Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK
- The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab targeting frontotemporal dementia with a progranulin gene mutation (FTD-GRN) is ongoing and on track, with enrollment completed in October 2023 and a treatment duration of 96 weeks. Latozinemab is a novel investigational human mAb that aims to increase progranulin (PGRN) levels by inhibiting sortilin and is the most advanced PGRN-elevating candidate in development for the treatment of FTD-GRN.
- In September 2024, Alector presented a poster highlighting the patient baseline characteristics for INFRONT-3 at the 14th International Conference on Frontotemporal Dementias (ISFTD 2024). Notably, the baseline characteristics of symptomatic INFRONT-3 participants, including age, Clinical Dementia Rating scale plus National Alzheimer’s Disease Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB) score and neurofilament light chain (NfL) levels, were representative of the broader FTD-GRN registry population, based on available registry data. Additionally, Alector shared findings from the FTD Caregiver Survey and FTD Insights Survey, highlighting the challenges faced by caregivers of individuals living with FTD.
- PROGRESS-AD, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating AL101/GSK4527226 in early AD has reached more than one-third of its target enrollment of 282 participants, with dosing initiated in February 2024. AL101 is an investigational human mAb designed to block and downregulate the sortilin receptor to elevate the level of PGRN in the brain in a manner that is similar to investigational latozinemab but with different pharmacokinetic and pharmacodynamic properties.
Early Research Pipeline
- Alector continues to advance its Alector Brain Carrier (ABC), a proprietary, versatile blood-brain barrier technology platform, which is being applied selectively to the company’s next-generation product candidates and research pipeline. The technology platform enables customization of affinity, valency, and format to optimize effector function and half-life in preclinical models. Alector is applying its ABC technology, combined with its expertise in immuno-neurology, to work on novel targets and develop first or best-in-class therapeutics.
Third Quarter 2024 Financial Results
Revenue. Collaboration revenue for the quarter ended September 30, 2024, was
R&D Expenses. Total research and development expenses for the quarter ended September 30, 2024, were
G&A Expenses. Total general and administrative expenses for the quarter ended September 30, 2024, were
Net Loss. For the quarter ended September 30, 2024, Alector reported a net loss of
Cash Position. Cash, cash equivalents, and investments were
2024 Guidance. The Company continues to anticipate collaboration revenue to be between
About Alector
Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector has discovered and is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable rejuvenated immune cells to counteract emerging brain pathologies. Alector’s immuno-neurology product candidates are supported by biomarkers and seek to treat indications, including Alzheimer’s disease and genetically defined frontotemporal dementia patient populations. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, product candidates, blood-brain barrier technology platform, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding release of data for INVOKE-2 and INFRONT-3, expected milestones, expectations of our collaborations, expectations of our interactions with regulatory authorities, and financial and cash guidance. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Quarterly Report on Form 10-Q filed on November 6, 2024, with the Securities and Exchange Commission (“SEC”), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.
| Selected Consolidated Balance Sheet Data (in thousands) | ||||||
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash, cash equivalents, and marketable securities | $ | 457,202 | $ | 548,861 | ||
| Total assets | 516,023 | 621,827 | ||||
| Total current liabilities (excluding deferred revenue) | 87,098 | 94,973 | ||||
| Deferred revenue (including current portion) | 248,202 | 293,820 | ||||
| Total liabilities | 397,090 | 487,669 | ||||
| Total stockholders’ equity | 118,933 | 134,158 | ||||
| Consolidated Statement of Operations Data (in thousands, except share and per share data) | ||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| Collaboration revenue | $ | 15,342 | $ | 9,109 | $ | 46,318 | $ | 81,872 | ||||||||||
| Operating expense: | ||||||||||||||||||
| Research and development | 47,998 | 46,328 | 139,479 | 144,392 | ||||||||||||||
| General and administrative | 15,778 | 13,364 | 44,587 | 41,767 | ||||||||||||||
| Total operating expenses | 63,776 | 59,692 | 184,066 | 186,159 | ||||||||||||||
| Loss from operations | (48,434 | ) | (50,583 | ) | (137,748 | ) | (104,287 | ) | ||||||||||
| Other income, net | 6,214 | 7,360 | 20,853 | 18,876 | ||||||||||||||
| Net loss before income tax | (42,220 | ) | (43,223 | ) | (116,895 | ) | (85,411 | ) | ||||||||||
| Income tax expense | — | 1,252 | 80 | 3,546 | ||||||||||||||
| Net loss | $ | (42,220 | ) | $ | (44,475 | ) | $ | (116,975 | ) | $ | (88,957 | ) | ||||||
| Net loss per share: | ||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.43 | ) | $ | (0.53 | ) | $ | (1.22 | ) | $ | (1.07 | ) | ||||||
| Shares used in computing net loss per share basic and diluted | 97,519,595 | 83,927,961 | 96,007,105 | 83,513,954 | ||||||||||||||
Alector Contacts:
Alector
Katie Hogan
202-549-0557
katie.hogan@alector.com
1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com
Argot Partners (investors)
Laura Perry
212-600-1902
alector@argotpartners.com
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