Viking Therapeutics Releases Q3 2024 Financial Results and Corporate Update

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced its financial results for the third quarter and nine months ending September 30, 2024, alongside updates on its clinical pipeline. The company, focusing on novel therapies for metabolic and endocrine disorders, reported positive outcomes from various clinical trials and preclinical programs.

Brian Lian, Ph.D., CEO of Viking, highlighted the productive period for the company, announcing positive results from four clinical trials. In the first quarter, the Phase 2 VENTURE trial investigating subcutaneous VK2735 for obesity showed significant body weight reductions over 13 weeks. Additionally, a Phase 1 trial evaluating the oral formulation of VK2735 in healthy volunteers exhibited encouraging weight reduction and tolerability after 28 days. In the second quarter, the Phase 2b VOYAGE trial with VK2809 in NASH/MASH patients with fibrosis demonstrated successful primary, secondary, and exploratory endpoints. Recently, the Phase 1b trial for VK0214 in X-linked adrenoleukodystrophy patients indicated safety, tolerability, and significant reductions in very long-chain fatty acids and other lipids.

Key developments and future plans include an End-of-Phase 2 meeting for subcutaneous VK2735 scheduled for the fourth quarter of 2024, potentially leading to a Phase 3 program. Viking is also planning a Phase 2 study of oral VK2735 in obesity starting in the fourth quarter of 2024. The oral formulation aims to provide an alternative for patients preferring not to use injections or maintain achieved weight loss. The Phase 1 trial results for oral VK2735 showed safety, tolerability, and dose-dependent weight reductions over 28 days, with promising prospects for further dose escalation.

The successful Phase 2b VOYAGE trial for VK2809 in NASH/MASH patients reported its findings in the second quarter of 2024. This trial achieved its primary endpoint with significant liver fat reductions and high rates of NASH/MASH resolution and fibrosis improvement over 52 weeks. The VOYAGE data showcased best-in-class efficacy and potential cardiovascular benefits due to improved plasma lipids. The results will be presented at the upcoming Liver Meeting on November 19, 2024, in San Diego.

VK0214, a novel thyroid hormone receptor beta agonist, demonstrated safety and tolerability in a Phase 1b study for X-ALD patients, with significant reductions in plasma very long-chain fatty acids and other lipids over 28 days. The study enrolled patients across three cohorts, and the primary and secondary objectives were achieved. Viking is currently evaluating the complete data set to determine the next steps for this program.

The company's novel amylin agonist program also progressed, with preclinical data presented at the American Diabetes Association's annual Scientific Sessions. Viking's compounds showed significant body weight reductions in animal models, supporting further development for obesity treatment. The company plans to file an investigational new drug application for this program in 2025.

Financially, Viking reported increased research and development expenses for the third quarter of 2024, primarily due to manufacturing, stock-based compensation, and clinical studies. General and administrative expenses also rose, attributed to legal and patent services, third-party consultants, and insurance. The net loss for the third quarter of 2024 was $24.9 million, compared to $22.5 million in the same period in 2023. For the nine months ended September 30, 2024, research and development expenses increased due to manufacturing, clinical studies, and preclinical studies. General and administrative expenses rose due to stock-based compensation and consultant services. The net loss for the nine-month period was $74.5 million, compared to $61.3 million in the corresponding period in 2023.

As of September 30, 2024, Viking held $930 million in cash, cash equivalents, and short-term investments, compared to $362 million as of December 31, 2023. The company's management plans to discuss the third quarter financial results in a conference call scheduled for 4:30 p.m. ET today.