Akero Therapeutics Delivers Significant Financial Results Update

Akero Therapeutics Announces Third Quarter Financial Results and Progress Update

Akero Therapeutics, Inc. (NASDAQ: AKRO), a clinical-stage biotechnology company focused on developing transformative treatments for serious metabolic diseases, has announced its financial results for the third quarter of 2024, along with exciting updates on its operations. This pivotal quarter saw the initiation of patient dosing for the Phase 3 SYNCHRONY Outcomes study of Efruxifermin (EFX), a leading candidate in the battle against metabolic dysfunction-associated steatohepatitis (MASH).

Exciting Developments in EFX Clinical Trials

Andrew Cheng, the president and CEO of Akero Therapeutics, shared the company’s enthusiasm over the recent advancements, stating, "The third quarter of 2024 marked an important milestone for EFX with the first patient dosed in the Phase 3 SYNCHRONY Outcomes study. This marks full enrollment in all three of our Phase 3 studies, allowing us to further evaluate the safety and efficacy of EFX, bringing us closer to providing a much-needed treatment option for MASH patients."

Phase 3 SYNCHRONY Program Overview

The SYNCHRONY program consists of three randomized, placebo-controlled trials focusing on the efficacy and safety of EFX for both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) resulting from MASH. With an ongoing commitment to patient safety and study integrity, the SYNCHRONY trials underscore Akero's dedication to high standards in clinical research.

Details on SYNCHRONY Studies

• SYNCHRONY Outcomes: This study targets patients with compensated cirrhosis (F4). Patients will receive either EFX (50mg) or placebo weekly, with primary endpoints focusing on fibrosis improvement and clinical event occurrences.
• SYNCHRONY Histology: Enrolling patients with pre-cirrhotic MASH (F2-F3), this study aims for accelerated approval, with primary outcomes based on fibrosis improvement and MASH resolution.
• SYNCHRONY Real-World: This ongoing study evaluates the safety and tolerability of EFX in a real-world setting, assessing outcomes over 52 weeks.

Phase 2b SYMMETRY Study Update

In addition to the SYNCHRONY studies, Akero continues to make strides with its Phase 2b SYMMETRY study focused on patients with compensated cirrhosis (F4). This trial, which incorporates EFX dosages of 28mg and 50mg, is expected to yield results by February 2025. All necessary biopsies have been collected, signaling robust adherence to the study protocol.

Financial Insights for the Third Quarter of 2024

As of September 30, 2024, Akero reported having $787.1 million in cash, cash equivalents, and marketable securities. This financial strength positions Akero well to continue funding its ambitious clinical programs, particularly the ongoing SYNCHRONY studies, through their primary endpoint readouts and beyond.

Operational Expenses Overview

• Research and development expenses for this quarter amounted to $72.2 million, a reflection of aggressive investment in key clinical studies.
• General and administrative expenses totaled $9.5 million, consistent with operational growth. Akero's commitment to advancing MASH treatment necessitates these investments in talent and resources.
• Total operating expenses reached $81.7 million this quarter, highlighting the company's active pace of development and clinical evaluation.

Understanding Efruxifermin and MASH

Efruxifermin (EFX) has emerged as a breakthrough therapy aimed at treating MASH, a condition affecting millions of individuals globally. Designed as an Fc-FGF21 fusion protein, EFX seeks to improve metabolic health by decreasing liver fat, enhancing insulin sensitivity, and addressing inflammation. Its convenient once-weekly dosing regimen signals a future of improved treatment adherence for patients.

The Burden of MASH

MASH is characterized by dangerous fat accumulation in the liver, which can lead to severe complications, including cirrhosis and increased risk for liver transplants. Akero's targeted approach through EFX aims to tackle this growing health crisis, offering hope to many impacted individuals.

About Akero Therapeutics

Headquartered in South San Francisco, Akero Therapeutics is dedicated to developing innovative treatments for patients with serious metabolic diseases. With its lead candidate EFX currently in pivotal Phase 3 trials, the company strives to become a front-runner in the treatment landscape for MASH, providing much-needed solutions to patients in distress.

Frequently Asked Questions

What is the significance of the SYNCHRONY studies for Akero Therapeutics?

The SYNCHRONY studies are crucial as they will allow Akero to assess the safety and efficacy of Efruxifermin (EFX) in treating MASH, potentially leading to commercial approval.

When are the results for the SYMMETRY study expected?

Results from the SYMMETRY study are anticipated to be reported in February 2025.

What financial position is Akero Therapeutics in?

Akero reported $787.1 million in cash and equivalents as of the end of the third quarter of 2024, which is sufficient to support its ongoing clinical programs.

How does Efruxifermin work?

Efruxifermin functions as an Fc-FGF21 fusion protein, aiming to alleviate cellular stress, regulate metabolism, and reduce liver fat and inflammation in patients with MASH.

Why is the research on MASH so critical?

MASH is rapidly becoming a prevalent cause of liver disease, making effective treatments a pressing necessity to improve patient outcomes and alleviate public health burdens.

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