Lexeo Therapeutics Reports Second Quarter 2024 Financial Results and Operational Highlights
Lexeo Therapeutics (Nasdaq: LXEO) reported Q2 2024 financial results and operational highlights. Key points include:
1. Positive interim data from Phase 1/2 studies of LX2006 for Friedreich ataxia (FA) cardiomyopathy, showing good tolerability and sustained treatment effect.
2. Initiated FDA engagements on surrogate endpoints for LX2006 registrational study.
3. Phase 1/2 trial of LX2020 (HEROIC-PKP2) recruiting patients; data update expected in 2H 2024.
4. Cash position of $175.0 million, expected to fund operations into 2027.
5. Q2 2024 financial results: R&D expenses $16.6M, G&A expenses $7.0M, net loss $21.2M ($0.64 per share).
6. Upcoming milestones for LX2006, LX2020, LX1001, and LX2021 programs.
Lexeo Therapeutics (Nasdaq: LXEO) ha riportato risultati finanziari del secondo trimestre 2024 e punti salienti operativi. I punti chiave includono:
1. Dati intermedi positivi dagli studi di fase 1/2 di LX2006 per l'atassia di Friedreich (FA) cardiomiopatia, che mostrano una buona tollerabilità e un effetto terapeutico sostenuto.
2. Avviati colloqui con la FDA riguardo ai parametri surrogate per lo studio registrativo di LX2006.
3. Studio di fase 1/2 di LX2020 (HEROIC-PKP2) in corso di reclutamento; aggiornamenti sui dati previsti nella seconda metà del 2024.
4. Posizione di cassa di 175,0 milioni di dollari, prevista per finanziare le operazioni fino al 2027.
5. Risultati finanziari del Q2 2024: spese R&D 16,6 milioni di dollari, spese generali e amministrative 7,0 milioni di dollari, perdita netta di 21,2 milioni di dollari (0,64 dollari per azione).
6. Prossimi traguardi per i programmi LX2006, LX2020, LX1001 e LX2021.
Lexeo Therapeutics (Nasdaq: LXEO) informó sobre los resultados financieros del segundo trimestre de 2024 y aspectos operativos destacados. Los puntos clave incluyen:
1. Datos interinos positivos de los estudios de fase 1/2 de LX2006 para la cardiomiopatía por ataxia de Friedreich (FA), mostrando buena tolerancia y efecto terapéutico sostenido.
2. Se iniciaron compromisos con la FDA sobre los endpoints sustitutos para el estudio de registro de LX2006.
3. El ensayo de fase 1/2 de LX2020 (HEROIC-PKP2) está reclutando pacientes; se espera una actualización de datos en la segunda mitad de 2024.
4. Posición de efectivo de 175,0 millones de dólares, que se espera financiará las operaciones hasta 2027.
5. Resultados financieros del Q2 2024: gastos en I+D de 16,6 millones de dólares, gastos administrativos de 7,0 millones de dólares, pérdida neta de 21,2 millones de dólares (0,64 dólares por acción).
6. Próximos hitos para los programas LX2006, LX2020, LX1001 y LX2021.
Lexeo Therapeutics (Nasdaq: LXEO)는 2024년 2분기 재무 결과 및 운영 하이라이트를 보고했습니다. 주요 사항은 다음과 같습니다:
1. 프리드리히 운동실조증(FA) 심근병증에 대한 LX2006의 1/2상 연구에서 긍정적인 중간 데이터가 나오며, 좋은 내약성과 지속적인 치료 효과를 보여줍니다.
2. LX2006 등록 연구를 위한 대체 기준점에 대해 FDA와의 접촉을 시작했습니다.
3. LX2020 (HEROIC-PKP2)의 1/2상 시험이 환자를 모집 중이며, 2024년 하반기에 데이터 업데이트가 예상됩니다.
4. 1억7500만 달러의 현금 보유, 2027년까지 운영 자금으로 예정되어 있습니다.
5. 2024년 2분기 재무 결과: 연구개발(R&D) 비용 1660만 달러, 일반관리(G&A) 비용 700만 달러, 순손실 2120만 달러(주당 0.64 달러).
6. LX2006, LX2020, LX1001 및 LX2021 프로그램의 향후 이정표.
Lexeo Therapeutics (Nasdaq: LXEO) a annoncé les résultats financiers du deuxième trimestre 2024 et les points saillants opérationnels. Les points clés incluent :
1. Des données intermédiaires positives des études de phase 1/2 sur le LX2006 pour la cardiomyopathie liée à l'ataxie de Friedreich (FA), montrant une bonne tolérance et un effet thérapeutique durable.
2. Engagements avec la FDA concernant les critères de substitution pour l'étude d'enregistrement du LX2006.
3. Essai de phase 1/2 du LX2020 (HEROIC-PKP2) recrutant des patients ; mise à jour des données attendue au second semestre 2024.
4. Position de liquidités de 175 millions de dollars, prévue pour financer les opérations jusqu'en 2027.
5. Résultats financiers du T2 2024 : dépenses R&D de 16,6 millions de dollars, dépenses G&A de 7,0 millions de dollars, perte nette de 21,2 millions de dollars (0,64 dollars par action).
6. Prochaines étapes pour les programmes LX2006, LX2020, LX1001 et LX2021.
Lexeo Therapeutics (Nasdaq: LXEO) hat die Finanzergebnisse des zweiten Quartals 2024 und betriebliche Höhepunkte bekannt gegeben. Die wichtigsten Punkte sind:
1. Positive Zwischenresultate aus den Phase 1/2-Studien zu LX2006 für Herzmuskelkrankheit bei Friedreich-Ataxie (FA), die eine gute Verträglichkeit und anhaltende Behandlungseffekte zeigen.
2. Gespräche mit der FDA zu Surrogat-Endpunkten für die Zuludungsstudie zu LX2006 aufgenommen.
3. Phase 1/2-Studie zu LX2020 (HEROIC-PKP2) rekrutiert Patienten; Datenupdates werden für das zweite Halbjahr 2024 erwartet.
4. Liquiditätsposition von 175,0 Millionen Dollar, die voraussichtlich die Operationen bis 2027 finanzieren wird.
5. Finanzergebnisse für Q2 2024: F&E-Ausgaben 16,6 Millionen Dollar, allgemeine Verwaltungskosten 7,0 Millionen Dollar, Nettoverlust 21,2 Millionen Dollar (0,64 Dollar pro Aktie).
6. Kommende Meilensteine für die Programme LX2006, LX2020, LX1001 und LX2021.
- Positive interim data from LX2006 Phase 1/2 studies showing good tolerability and sustained treatment effect
- Initiated FDA engagements for LX2006 registrational study surrogate endpoints
- Strong cash position of $175.0 million, providing runway into 2027
- LX2006 granted Orphan Medicinal Product designation by European Commission
- Appointment of Tim Van Hauwermeiren to Board of Directors, bringing valuable industry experience
- Increased net loss to $21.2 million in Q2 2024 compared to $13.4 million in Q2 2023
- R&D expenses increased to $16.6 million in Q2 2024 from $11.2 million in Q2 2023
- G&A expenses rose to $7.0 million in Q2 2024 from $2.7 million in Q2 2023
Insights
Lexeo's Q2 2024 results reveal a mixed financial picture. While the company's
The net loss per share improved from
The interim data for LX2006 in Friedreich ataxia (FA) cardiomyopathy is promising. The absence of treatment-related serious adverse events and evidence of sustained improvements across multiple cardiac biomarkers are encouraging signs. The increased frataxin protein levels in all SUNRISE-FA participants post-treatment is particularly noteworthy, as frataxin deficiency is the root cause of FA.
The initiation of FDA engagements for surrogate endpoints in a registrational study signals confidence in the data and could potentially accelerate the path to market. However, investors should remain cautious as early-stage data can be misleading. The upcoming data presentation in Fall 2024 and regulatory update by year-end will be important in assessing LX2006's potential. The diverse pipeline, including programs for PKP2-ACM and APOE4-associated Alzheimer's disease, provides multiple shots on goal but also increases development risks.
Announced positive interim data from Phase 1/2 studies in Friedreich ataxia (FA) cardiomyopathy, which showed LX2006 was well tolerated with no treatment-related serious adverse events and demonstrated evidence of sustained and consistent treatment effect across multiple cardiac measures
Recently initiated formal engagements with FDA on surrogate endpoints for LX2006 registrational study; expects to provide update by end of year
Phase 1/2 clinical trial of LX2020 (HEROIC-PKP2) currently recruiting patients; data update from Cohort 1 on track for 2H 2024
Cash and cash equivalents of
NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today reported second quarter 2024 financial results and provided operational highlights.
“We were proud to present the recent interim data of LX2006 for the treatment of FA cardiomyopathy, the first ever to show promise of treating this rare and fatal condition,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. “Based on the favorable evidence to date, we have initiated engagements with FDA on surrogate endpoints for a registrational study so we can work to bring this potentially transformative gene therapy to patients as quickly as possible.”
Business and Program Updates
- LX2006 for the Treatment of FA Cardiomyopathy: In July 2024, Lexeo announced positive interim data of LX2006 across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the Weill Cornell Medicine investigator-initiated Phase 1A trial (NCT05302271).
- Safety and Tolerability: Interim safety results showed LX2006 was well tolerated with no treatment-related serious adverse events in either study.
- Efficacy and Protein Expression: Sustained and consistent improvements were observed across multiple cardiac biomarkers associated with outcomes in FA cardiomyopathy, and increased frataxin protein levels were observed in all SUNRISE-FA participants post-treatment.
- Regulatory Plans: In light of the evidence of treatment effect with improvements across multiple cardiac measures, Lexeo recently initiated formal engagements with FDA to discuss surrogate endpoints for a future registrational study and expects to provide an update on ongoing regulatory engagements by end of 2024. LX2006 was also granted Orphan Medicinal Product designation for the treatment of Friedreich ataxia by the European Commission in July 2024.
- Appointment of Tim Van Hauwermeiren to Board of Directors: In July 2024, Lexeo announced the appointment of Tim Van Hauwermeiren to its Board of Directors. Mr. Van Hauwermeiren currently serves as the co-founder and CEO of argenx SE, a global immunology company focused on severe autoimmune diseases, and he brings over 20 years of life sciences business development and general management experience to Lexeo.
Expected Upcoming Milestones
- LX2006 for the treatment of Friedreich ataxia cardiomyopathy
- Previously disclosed data, and one additional cardiac biopsy from Cohort 2, will be shared at a scientific conference in Fall 2024
- Update on ongoing regulatory engagements expected by end of 2024
- LX2020 for the treatment of PKP2-ACM
- Interim data readout (Cohort 1) in 2H 2024
- LX1001 for the treatment of APOE4-associated Alzheimer’s disease
- Interim Phase 1/2 data readout (all cohorts) in 2H 2024
- LX2021 for the treatment of DSP cardiomyopathy
- Initiate IND-enabling studies in 2024
- Initiate IND-enabling studies in 2024
Second Quarter Financial Results
- Cash Position: As of June 30, 2024, cash and cash equivalents were
$175.0 million , which Lexeo believes will be sufficient to fund operations into 2027. - R&D Expenses: R&D expenses were
$16.6 million for the three months ended June 30, 2024, compared to$11.2 million for the three months ended June 30, 2023. - G&A Expenses: G&A expenses were
$7.0 million for the three months ended June 30, 2024, compared to$2.7 million for the three months ended June 30, 2023. - Net Loss: Net loss was
$21.2 million or$0.64 per share (basic and diluted) for the three months ended June 30, 2024, compared to$13.4 million or$8.30 per share (basic and diluted) for the three months ended June 30, 2023.
About Lexeo Therapeutics
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Lexeo’s expectations and plans regarding its current product candidates and programs, including statements regarding the potential benefits of LX2006 for the treatment of Friedreich ataxia cardiomyopathy and the timing for receipt and announcement of data from its clinical trials, the timing and likelihood of potential regulatory approval, expectations regarding the time period over which Lexeo’s capital resources will be sufficient to fund its anticipated operations and estimates regarding Lexeo’s financial condition. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward-looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Annual Report on Form 10-K for the annual period ended December 31, 2023, filed with the SEC on March 11, 2024, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, filed with the SEC on May 9, 2024, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Media Response:
Janine Bogris
(201) 245-6838
janine.bogris@inizioevoke.com
Investor Response:
Stephen Jasper
(858) 525-2047
stephen@gilmartinir.com
| Lexeo Therapeutics, Inc. Selected Condensed Financial Information (unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
| Condensed Statements of Operations | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 16,560 | $ | 11,236 | $ | 32,302 | $ | 27,674 | ||||||||
| General and administrative | 6,990 | 2,739 | 14,539 | 5,592 | ||||||||||||
| Total operating expenses | 23,550 | 13,975 | 46,841 | 33,266 | ||||||||||||
| Operating loss | (23,550 | ) | (13,975 | ) | (46,841 | ) | (33,266 | ) | ||||||||
| Other income and expense | ||||||||||||||||
| Other income (expense), net | (1 | ) | (3 | ) | (6 | ) | (7 | ) | ||||||||
| Interest expense | (35 | ) | (53 | ) | (72 | ) | (103 | ) | ||||||||
| Interest income | 2,348 | 590 | 3,999 | 1,277 | ||||||||||||
| Total other income and expense | 2,312 | 534 | 3,921 | 1,167 | ||||||||||||
| Loss from operations before income taxes | (21,238 | ) | (13,441 | ) | (42,920 | ) | (32,099 | ) | ||||||||
| Income taxes | - | - | - | - | ||||||||||||
| Net loss and comprehensive loss | $ | (21,238 | ) | $ | (13,441 | ) | $ | (42,920 | ) | $ | (32,099 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.64 | ) | $ | (8.30 | ) | $ | (1.41 | ) | $ | (19.87 | ) | ||||
| Weighted average number of shares outstanding used in computation of net loss per common share, basic and diluted | 33,001,946 | 1,619,547 | 30,490,892 | 1,615,194 | ||||||||||||
| Condensed Balance Sheet Data | ||||||||
| June 30 | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash and cash equivalents | $ | 174,981 | $ | 121,466 | ||||
| Total assets | 192,007 | 139,807 | ||||||
| Total liabilities | 27,059 | 26,272 | ||||||
| Total stockholders' equity | 164,948 | 113,535 | ||||||
FAQ
What were Lexeo Therapeutics' (LXEO) Q2 2024 financial results?
What progress has Lexeo Therapeutics (LXEO) made with its LX2006 program for Friedreich ataxia cardiomyopathy?
What are the upcoming milestones for Lexeo Therapeutics (LXEO) in 2024?
How long is Lexeo Therapeutics' (LXEO) current cash expected to fund operations?
