Viking Therapeutics, Inc. (NASDAQ:VKTX) is a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders. The company has made significant strides in advancing its pipeline, with positive results reported across multiple clinical programs in the first half of 2024.

Financials

For the fiscal year ended December 31, 2023, Viking Therapeutics reported an annual net loss of $85.9 million and no revenue. The company's annual operating cash flow and free cash flow were both negative $73.4 million. As of June 30, 2024, Viking Therapeutics held $942.3 million in cash, cash equivalents, and short-term investments, providing a strong financial foundation to support the advancement of its pipeline.

In the second quarter of 2024, the company reported a net loss of $22.3 million, compared to a net loss of $19.2 million in the same period of 2023. Research and development expenses increased to $23.8 million from $13.9 million, primarily due to increased expenses related to manufacturing, clinical studies, preclinical studies, salaries and benefits, and stock-based compensation. General and administrative expenses rose to $10.3 million from $9.8 million, driven by higher stock-based compensation and third-party consulting costs, partially offset by lower legal and patent expenses.

For the six months ended June 30, 2024, Viking Therapeutics reported a net loss of $49.6 million, compared to a net loss of $38.8 million in the same period of 2023. Research and development expenses increased to $47.9 million from $24.9 million, while general and administrative expenses rose to $20.3 million from $19.4 million, driven by similar factors as the quarterly results.

Business Overview

Viking Therapeutics was incorporated in 2012 and is headquartered in San Diego, California, with a subsidiary located in Adelaide, Australia. The company's focus is on the development of novel therapies for metabolic and endocrine disorders, with a pipeline that includes several promising drug candidates.

VK2735: Dual GLP-1/GIP Agonist for Obesity

VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, which are key regulators of metabolism and food intake. In the first quarter of 2024, Viking reported positive top-line results from the Phase 2 VENTURE trial, which evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 administered subcutaneously once weekly for 13 weeks. Patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%, as well as statistically significant reductions in body weight relative to placebo, ranging up to 13.1%.

In addition to the subcutaneous formulation, Viking is also developing an oral tablet formulation of VK2735. In the first quarter of 2024, the company reported positive results from a Phase 1 study evaluating the safety, tolerability, and pharmacodynamics of the oral formulation. Subjects receiving oral VK2735 demonstrated dose-dependent reductions in body weight ranging up to 5.3% from baseline, with placebo-adjusted reductions reaching up to 3.3%. Based on these promising results, Viking plans to initiate a Phase 2 trial of the oral formulation in the fourth quarter of 2024.

VK2809: Thyroid Hormone Receptor Beta Agonist for NASH

VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta (TRβ). In the second quarter of 2024, Viking announced positive 52-week histology results from the Phase 2b VOYAGE study, which evaluated the efficacy, safety, and tolerability of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. The study demonstrated that patients receiving VK2809 experienced clinically and statistically significant improvements in NASH resolution rate, fibrosis stage, and the combination of NASH resolution and fibrosis improvement, compared to placebo.

Specifically, up to 75% of VK2809-treated patients achieved NASH resolution without worsening of fibrosis, up to 57% achieved at least a one-stage improvement in fibrosis with no worsening of NASH, and up to 50% achieved both NASH resolution and fibrosis improvement. VK2809 also demonstrated an encouraging safety and tolerability profile through 52 weeks of treatment. Based on these positive results, Viking plans to schedule an end-of-Phase 2 meeting with the FDA to discuss the registration path for VK2809 in NASH.

VK0214: Thyroid Hormone Receptor Beta Agonist for X-ALD

VK0214 is Viking's second TRβ agonist in clinical development, and it is being evaluated for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare and debilitating metabolic disorder. The company recently completed enrollment in a Phase 1b study in patients with the adrenomyeloneuropathy (AMN) form of X-ALD and expects to announce top-line results from this trial later in 2024.

Amylin Receptor Agonist Program for Obesity

In the second quarter of 2024, Viking presented preclinical data on a series of internally developed dual agonists of the amylin and calcitonin receptors at the American Diabetes Association's scientific sessions. These compounds demonstrated reductions in food intake and body weight in animal models, and the company plans to advance this program into clinical development in 2025.

Risks and Challenges

Despite the promising progress across its pipeline, Viking Therapeutics faces several risks and challenges that investors should consider. The company's drug candidates are still in clinical development, and there is no guarantee that they will successfully obtain regulatory approval or be commercialized. The biopharmaceutical industry is highly competitive, and Viking may face challenges from competitors with more resources or more advanced drug candidates. Additionally, the company's ability to raise additional capital in the future to fund its operations and development activities is critical, as it currently has no revenue and is reliant on its cash reserves.

Outlook

The first half of 2024 has been a transformative period for Viking Therapeutics, with the company reporting positive results across multiple clinical programs. The successful Phase 2 trial of VK2735 in obesity, the positive 52-week histology data for VK2809 in NASH, and the introduction of a new amylin receptor agonist program have all contributed to the company's momentum.

Looking ahead, Viking is well-positioned to advance its pipeline, with plans to initiate a Phase 3 trial for VK2735 in obesity and schedule end-of-Phase 2 meetings with the FDA for both VK2735 and VK2809. The company's strong financial position, with $942.3 million in cash, cash equivalents, and short-term investments as of June 30, 2024, provides the resources needed to execute on its development strategy.

Conclusion

Overall, Viking Therapeutics' diverse pipeline of novel therapies, positive clinical data, and strong financial foundation make it a compelling investment opportunity in the metabolic and endocrine disease space. As the company continues to advance its programs and navigate the regulatory landscape, investors will be closely watching for further updates and milestones.