Akero Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Akero Therapeutics (AKRO) reports Q3 2024 financial results and progress in its Phase 3 SYNCHRONY program for efruxifermin (EFX) in MASH treatment. The company reached a milestone with first patient dosing in SYNCHRONY Outcomes study for compensated cirrhosis. Cash position stands at $787.1 million, expected to fund operations into H2 2027. Q3 operating expenses increased to $81.7 million from $46.6 million year-over-year, mainly due to expanded clinical trials. Phase 3 SYNCHRONY Real-World and Histology studies are progressing, with results expected in 2026 and H1 2027, respectively. Phase 2b SYMMETRY study week 96 results anticipated in February 2025.
Akero Therapeutics (AKRO) riporta i risultati finanziari del terzo trimestre del 2024 e i progressi nel programma di Fase 3 SYNCHRONY per l'efruxifermin (EFX) nel trattamento della MASH. L'azienda ha raggiunto un traguardo con la somministrazione della prima dose nel studio SYNCHRONY Outcomes per la cirrosi compensata. La posizione di cassa si attesta a 787,1 milioni di dollari, attesa a finanziare le operazioni fino al secondo semestre del 2027. Le spese operative nel terzo trimestre sono aumentate a 81,7 milioni di dollari rispetto ai 46,6 milioni di dollari dell'anno precedente, principalmente a causa dell'espansione delle sperimentazioni cliniche. Gli studi di Fase 3 SYNCHRONY Real-World e Histology stanno proseguendo, con risultati attesi nel 2026 e nel primo semestre del 2027, rispettivamente. I risultati della settimana 96 dello studio di Fase 2b SYMMETRY sono previsti per febbraio 2025.
Akero Therapeutics (AKRO) informa sobre los resultados financieros del tercer trimestre de 2024 y los avances en su programa de Fase 3 SYNCHRONY para el efruxifermin (EFX) en el tratamiento de la MASH. La compañía ha alcanzado un hito con la dosis del primer paciente en el estudio SYNCHRONY Outcomes para la cirrosis compensada. La posición de efectivo se sitúa en 787.1 millones de dólares, que se espera que financie operaciones hasta el segundo semestre de 2027. Los gastos operativos del tercer trimestre aumentaron a 81.7 millones de dólares desde 46.6 millones de dólares en el año anterior, principalmente debido a la expansión de los ensayos clínicos. Los estudios de Fase 3 SYNCHRONY Real-World y Histology están avanzando, con resultados esperados para 2026 y la primera mitad de 2027, respectivamente. Se anticipan los resultados de la semana 96 del estudio de Fase 2b SYMMETRY para febrero de 2025.
Akero Therapeutics (AKRO)는 2024년 3분기 재무 실적과 MASH 치료를 위한 efruxifermin (EFX)의 3상 SYNCHRONY 프로그램의 진행 상황을 보고합니다. 이 회사는 보상성 간경변에 대한 SYNCHRONY Outcomes 연구에서 첫 환자 용량을 투여함으로써 이정표를 달성했습니다. 현금 보유액은 7억 8,710만 달러로, 2027년 하반기까지 운영 자금을 지원할 것으로 예상됩니다. 3분기 운영 비용은 지난해 4,660만 달러에서 8,170만 달러로 증가했으며, 이는 주로 임상 시험 확장으로 인한 것입니다. 3상 SYNCHRONY Real-World 및 Histology 연구는 진행 중이며, 각각 2026년과 2027년 상반기에 결과가 예상됩니다. 2b상 SYMMETRY 연구의 96주차 결과는 2025년 2월에 예상됩니다.
Akero Therapeutics (AKRO) annonce les résultats financiers du troisième trimestre 2024 et les avancées de son programme de Phase 3 SYNCHRONY pour l'efruxifermin (EFX) dans le traitement de la MASH. L'entreprise a franchi une étape importante avec l'administration de la première dose au premier patient dans l'étude SYNCHRONY Outcomes pour la cirrhose compensée. La position de liquidité s'élève à 787,1 millions de dollars, prévue pour financer les opérations jusqu'au deuxième semestre 2027. Les dépenses d'exploitation du troisième trimestre ont augmenté à 81,7 millions de dollars contre 46,6 millions de dollars l'année précédente, principalement en raison de l'expansion des essais cliniques. Les études de Phase 3 SYNCHRONY Real-World et Histologie progressent, avec des résultats attendus en 2026 et au premier semestre 2027, respectivement. Les résultats de la semaine 96 de l'étude SYMMETRY de Phase 2b sont prévus pour février 2025.
Akero Therapeutics (AKRO) berichtet über die Finanzergebnisse des dritten Quartals 2024 und den Fortschritt im Phase-3-Programm SYNCHRONY für Efruxifermin (EFX) zur Behandlung von MASH. Das Unternehmen hat einen Meilenstein mit der ersten Patienten-Dosierung in der SYNCHRONY Outcomes-Studie für kompensierte Leberzirrhose erreicht. Die Liquiditätsposition beläuft sich auf 787,1 Millionen US-Dollar, die voraussichtlich die Geschäftstätigkeit bis ins zweite Halbjahr 2027 finanzieren werden. Die Betriebskosten im dritten Quartal stiegen von 46,6 Millionen US-Dollar im Vorjahr auf 81,7 Millionen US-Dollar, hauptsächlich aufgrund erweiterter klinischer Studien. Die Phase-3-Studien SYNCHRONY Real-World und Histologie sind im Gange, mit Ergebnissen, die für 2026 bzw. die erste Hälfte von 2027 erwartet werden. Die Ergebnisse der 96. Woche der Phase-2b-Studie SYMMETRY werden für Februar 2025 erwartet.
- Strong cash position of $787.1 million sufficient to fund operations into H2 2027
- All three Phase 3 studies actively enrolling patients
- Phase 3 SYNCHRONY program advancing with first patient dosed in Outcomes study
- Operating expenses increased 75% YoY to $81.7 million in Q3 2024
- R&D expenses nearly doubled to $72.2 million from $38.6 million YoY
- G&A expenses increased to $9.5 million from $8.0 million YoY
Insights
Akero's Q3 2024 financials reveal a strong cash position of
The company's Phase 3 SYNCHRONY program progression, with all three trials now actively enrolling, represents significant development momentum. Key catalysts include SYMMETRY study results in February 2025, SYNCHRONY Real-World results in 2026 and SYNCHRONY Histology primary endpoint data in H1 2027. The robust cash position adequately supports these extensive clinical programs through major milestones.
The comprehensive Phase 3 SYNCHRONY program demonstrates strategic depth in targeting both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) populations. The program's design, building on Phase 2b data from 300 patients, shows methodical development progression. The dual-cohort approach in SYNCHRONY Outcomes and Histology trials, with both histological and clinical endpoints, strengthens the potential regulatory pathway.
The Real-World study's inclusion of both MASH and MASLD patients broadens the potential therapeutic application. The structured timeline for multiple data readouts over 2025-2027 provides multiple opportunities to validate efruxifermin's efficacy across different patient populations and endpoints.
— First patients dosed in Phase 3 SYNCHRONY Outcomes study of lead candidate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to MASH —
— Phase 3 SYNCHRONY Real-World and Histology studies on track to report results for their respective primary endpoints in 2026 and the first half of 2027 —
— Phase 2b SYMMETRY study week 96 results expected to readout in February 2025 —
SOUTH SAN FRANCISCO, Calif., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH), today reported third quarter financial results for the period ending September 30, 2024 and provided business updates.
"The third quarter of 2024 marked an important milestone for EFX with the first patient dosed in the Phase 3 SYNCHRONY Outcomes study," said Andrew Cheng, president and CEO. "With this advancement, all three of our Phase 3 studies are actively enrolling — furthering our assessment of the safety and efficacy of EFX and moving us closer to delivering a differentiated treatment option, if approved, to patients living with MASH."
Phase 3 SYNCHRONY Program
- Akero's Phase 3 SYNCHRONY program is comprised of three ongoing, randomized, placebo-controlled trials evaluating the safety and tolerability of EFX to support marketing applications for both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH. The SYNCHRONY program builds on two biopsy-based Phase 2b studies in corresponding patient populations, with a combined total of 300 patients treated for up to 96 weeks.
- SYNCHRONY Outcomes (F4, compensated)
- SYNCHRONY Outcomes is a two-cohort study evaluating EFX in the treatment of patients with compensated cirrhosis (F4) due to MASH. Patients were first dosed in the study in the third quarter of 2024 and are receiving weekly injections of either EFX 50mg or placebo.
- The primary histology endpoint, for Cohort 1 only, is the proportion of patients experiencing ≥ 1-stage improvement in fibrosis and no worsening of steatohepatitis after 96 weeks of treatment.
- The primary outcomes endpoint is measured as the time from randomization to first occurrence of any of the protocol-specified clinical events across all patients enrolled in Cohort 1 and Cohort 2.
- SYNCHRONY Histology (F2-F3)
- SYNCHRONY Histology is a two-cohort study evaluating EFX in the treatment of patients with pre-cirrhotic MASH, fibrosis stage 2 or 3 (F2-F3). Patients are receiving weekly injections of EFX 28mg, EFX 50mg, or placebo.
- The primary histology endpoint (Cohort 1 only), to support an application for accelerated approval, is the proportion of patients experiencing ≥ 1-stage fibrosis improvement AND resolution of MASH after 52 weeks of treatment.
- All patients in Cohort 1 and Cohort 2 will be evaluated for long-term clinical outcomes for up to 240 weeks of treatment.
- Results for the 52-week primary histology endpoint are expected in the first half of 2027.
- SYNCHRONY Real-World (F1-F4)
- SYNCHRONY Real-World is enrolling patients with MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) to receive weekly injections of EFX 50mg or placebo. The primary endpoint of safety and tolerability will be assessed after 52 weeks of treatment.
- Results from the SYNCHRONY Real-World study are expected in 2026.
Phase 2b SYMMETRY Study
- The ongoing Phase 2b SYMMETRY study is evaluating the efficacy and safety of EFX in patients with compensated cirrhosis (F4) due to MASH, who were treated with EFX 28mg, EFX 50mg or placebo for up to 96 weeks.
- All planned end-of-treatment biopsies have been collected. Consistent with the protocol, enrolled patients continue in the study through follow-up assessments 30 days after completion of treatment with EFX or placebo.
- Week 96 results are on track to be reported in February 2025.
Third Quarter 2024 Financial Results
- Akero's cash, cash equivalents and short and long-term marketable securities as of September 30, 2024, were
$787.1 million . - Akero believes that its current cash, cash equivalents, and short- and long-term marketable securities will be sufficient to fund its Phase 3 SYNCHRONY Histology and Real-World studies through readout of their respective primary endpoints and Akero's current operating plan into the second half of 2027.
- Research and development expenses for the three-month period ended September 30, 2024 were
$72.2 million , compared to$38.6 million for the comparable period in 2023. These increases were attributable to higher expenses associated with the ongoing SYMMETRY study, the ongoing Phase 3 SYNCHRONY Histology and Real-World studies, initiation of the Phase 3 SYNCHRONY Outcomes study, and manufacture of clinical supplies for Phase 3 and potential marketing applications, as well as higher expenses for personnel. - General and administrative expenses for the three-month period ended September 30, 2024 were
$9.5 million , compared to$8.0 million for the comparable period in 2023. These increases are attributable to higher expenses for personnel, professional services and other costs associated with operating as a public company. - Total operating expenses were
$81.7 million for the three-month period ended September 30, 2024, compared to$46.6 million for the comparable period in 2023.
About Efruxifermin
Efruxifermin (EFX), Akero's lead product candidate for MASH, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipid metabolism. This holistic approach offers the potential to address the complex, multi-system disease state of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease — the leading cause of death in MASH patients. EFX is designed to offer convenient once-weekly dosing and has been generally well tolerated in clinical trials to date.
About MASH
MASH is a serious form of MASLD that is estimated to affect more than 17 million Americans. MASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero's lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH (F2-F3) or compensated cirrhosis (F4) due to MASH: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. The SYNCHRONY program builds on the results of two Phase 2b clinical trials, the completed HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the ongoing SYMMETRY study in patients with compensated cirrhosis (F4) due to MASH, in which more than 300 patients have been treated for up to 96 weeks. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero's business plans and objectives, including future plans or expectations for EFX; expectations regarding the SYNCHRONY Phase 3 program, including the anticipated timing to report Phase 3 study results and the program's clinical trial design; the timing to report results of the ongoing Phase 2b SYMMETRY Study; the therapeutic effects of EFX as well as the dosing, safety and tolerability of EFX; and Akero's growth as a company and expectations regarding its uses of capital, expenses, and financial results, including the expected cash runway. Any forward-looking statements in this press release 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. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Christina Tartaglia
212.362.1200
IR@akerotx.com
Media Contact:
Peg Rusconi
617.910.6217
peg.rusconi@deerfieldgroup.com
| Akero Therapeutics, Inc. | ||||||||||||||||
| Condensed Consolidated Balance Sheets | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (In thousands) | ||||||||||||||||
| September 30, 2024 | December 31, 2023 | |||||||||||||||
| Assets | ||||||||||||||||
| Cash, cash equivalents and short-term marketable securities | $ | 717,247 | $ | 550,010 | ||||||||||||
| Other current assets | 29,641 | 9,952 | ||||||||||||||
| Non-current assets | 70,659 | 20,309 | ||||||||||||||
| Total assets | $ | 817,547 | $ | 580,271 | ||||||||||||
| Liabilities and Stockholders' Equity | ||||||||||||||||
| Current liabilities | $ | 43,291 | $ | 19,128 | ||||||||||||
| Non-current liabilities | 35,931 | 25,837 | ||||||||||||||
| Stockholders' equity | 738,325 | 535,306 | ||||||||||||||
| Total liabilities and stockholders' equity | $ | 817,547 | $ | 580,271 | ||||||||||||
| Akero Therapeutics, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended September30, | Nine Months Ended September30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 72,232 | $ | 38,634 | $ | 178,204 | $ | 88,406 | ||||||||
| General and administrative | 9,471 | 7,981 | 29,194 | 22,591 | ||||||||||||
| Total operating expenses | 81,703 | 46,615 | 207,398 | 110,997 | ||||||||||||
| Loss from operations | (81,703 | ) | (46,615 | ) | (207,398 | ) | (110,997 | ) | ||||||||
| Interest expense | (1,246 | ) | (888 | ) | (3,468 | ) | (2,202 | ) | ||||||||
| Interest and other income, net | 10,244 | 7,844 | 28,830 | 16,626 | ||||||||||||
| Net loss | $ | (72,705 | ) | $ | (39,659 | ) | $ | (182,036 | ) | $ | (96,573 | ) | ||||
| Comprehensive loss | $ | (70,341 | ) | $ | (39,914 | ) | $ | (180,203 | ) | $ | (97,116 | ) | ||||
| Net loss per common share, basic and diluted | $ | (1.05 | ) | $ | (0.71 | ) | $ | (2.76 | ) | $ | (1.87 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 69,442,136 | 55,613,120 | 65,982,798 | 51,506,766 | ||||||||||||
FAQ
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