Executive Summary / Key Takeaways

• Viking Therapeutics is rapidly advancing its lead asset, VK2735, a dual GLP-1/GIP agonist, into Phase 3 clinical trials for obesity, with both subcutaneous and oral formulations demonstrating compelling efficacy and tolerability in earlier studies.
• The company maintains a robust cash position of $715 million as of September 30, 2025, providing a substantial financial runway to fund its ongoing Phase 3 trials for VK2735 and further pipeline development through at least December 31, 2026.
• Viking's diversified pipeline, including VK2809 for NASH and a novel Dual Amylin and Calcitonin Receptor Agonist (DACRA) program, offers multiple future value inflection points and strategic partnering opportunities in large, unmet medical need areas.
• Strategic multi-year manufacturing agreements for VK2735 are in place, securing commercial-scale supply for both injectable and oral formulations, thereby mitigating a critical operational risk for future market entry.
• Despite intense competition from established pharmaceutical giants, Viking's differentiated mechanisms, strong clinical data, and flexible dosing strategies position it as a formidable challenger poised for significant market capture in the rapidly expanding metabolic health sector.

A New Era in Metabolic Health: Viking's Strategic Ascent

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for metabolic and endocrine disorders. The company's strategic focus is sharply aligned with the burgeoning global health crisis of obesity and related metabolic conditions, a market projected to reach hundreds of billions of dollars in the coming years. Viking's overarching strategy centers on developing first-in-class or best-in-class therapies, leveraging dual-action mechanisms and a diversified pipeline to address significant unmet medical needs.

The company, incorporated in 2012, laid its intellectual property foundation in 2014 through an exclusive Master License Agreement with Ligand Pharmaceuticals , securing rights to key drug candidates. This early strategic move enabled Viking to build a robust pipeline, including VK5211 for muscle recovery, VK2809 for NASH, and VK0214 for X-linked adrenoleukodystrophy (X-ALD). The competitive landscape for metabolic disorders is intense, dominated by pharmaceutical giants such as Eli Lilly and Novo Nordisk , which possess extensive resources and established market presence. However, Viking has strategically positioned itself as a potent challenger through innovative science and a focus on differentiated clinical profiles.

Technological Edge: Dual Agonism and Receptor Selectivity Drive Differentiation

Viking's core competitive advantage stems from its innovative therapeutic platforms, particularly its dual agonist and receptor-subtype selective approaches. The company's lead drug candidate, VK2735, exemplifies this with its mechanism as a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This dual agonism is designed to offer enhanced efficacy in weight reduction and metabolic improvement.

Clinical data for VK2735 have been compelling. In the Phase 2 VENTURE study, the subcutaneous formulation demonstrated statistically significant reductions in mean body weight, reaching up to 14.7% from baseline after just 13 weeks of weekly dosing. Furthermore, follow-up visits indicated impressive durability, with over 90% of the initial weight loss maintained seven weeks after the last 2.5mg dose. The oral tablet formulation of VK2735 also showed strong results in its Phase 2 VENTURE-Oral Dosing trial, achieving up to 12.2% mean body weight reduction after 13 weeks of daily dosing. Importantly, both formulations have demonstrated encouraging safety and tolerability profiles, with 98% of drug-related adverse events for the oral formulation categorized as mild or moderate. This strong safety and efficacy profile positions VK2735 as a potentially best-in-class treatment, offering a compelling value proposition for investors through its potential for significant market share and favorable patient outcomes.

Beyond obesity, Viking's pipeline features VK2809 and VK0214, both orally available, tissue and receptor-subtype selective agonists of the thyroid hormone receptor beta (TRß). VK2809, targeting NASH and fibrosis, achieved "best-in-class" histologic improvements in its Phase 2b VOYAGE study, with up to 75% of patients achieving NASH resolution without worsening of fibrosis (compared to 29% for placebo) and up to 57% showing a one-stage improvement in fibrosis without worsening of NASH (compared to 34% for placebo). VK0214, for the rare neurological disorder X-ALD, demonstrated significant reductions of approximately 38% in plasma levels of the important 26-carbon very long chain fatty acid in a Phase 1b trial. These programs highlight Viking's ability to develop targeted therapies for conditions with high unmet medical needs, contributing to a diversified value proposition.

Viking is also advancing a novel Dual Amylin and Calcitonin Receptor Agonist (DACRA) program for obesity. Preclinical data suggest that balanced activity on both amylin and calcitonin receptors could lead to a "best in the industry efficacy profile" when combined with other mechanisms, such as GLP-1/GIP agonism. This R&D initiative aims to further enhance weight loss and metabolic benefits, with an Investigational New Drug (IND) application planned for the first quarter of 2026.

Operational Momentum: Advancing a Multi-Modal Pipeline

Viking's operational execution has been robust, marked by significant progress across its clinical pipeline. The company initiated its pivotal Phase 3 VANQUISH Registration program for subcutaneous VK2735 in June 2025. This program includes two large-scale, 78-week studies: VANQUISH-1, targeting approximately 4,500 obese or overweight adults with co-morbidities, and VANQUISH-2, enrolling approximately 1,100 obese or overweight adults with type 2 diabetes. Enrollment for VANQUISH-1 is expected to conclude by the end of 2025, with VANQUISH-2 following in the first quarter of 2026. These trials are evaluating weekly subcutaneous doses of 7.5 mg, 12.5 mg, and 17.5 mg, alongside placebo.

The oral formulation of VK2735 also saw significant advancement with positive top-line results from the Phase 2 VENTURE-Oral Dosing trial announced in August 2025. Following these results, Viking plans to submit an end of Phase 2 meeting request to the FDA in the fourth quarter of 2025 to discuss potential next steps, including a possible direct transition to Phase 3. A key differentiating strategy for Viking is the development of both subcutaneous and oral formulations using the same molecule, which management believes could mitigate safety and tolerability challenges during patient transitions between therapies.

Further enhancing its strategic depth, Viking initiated an exploratory Phase 1 study in October 2025 to evaluate various maintenance dosing strategies for VK2735, including monthly subcutaneous, weekly oral, and daily oral regimens. Results from this study are anticipated in mid-2026. This initiative is particularly important for payers, who are keenly interested in data supporting long-term treatment adherence and weight loss maintenance.

To support its ambitious clinical programs and future commercialization, Viking entered into broad, multi-year manufacturing agreements with CordenPharma in March 2025. These agreements secure dedicated capacity for the annual manufacture and supply of multiple metric tons of VK2735 API, as well as fill-and-finish capacity for 100 million autoinjectors, 100 million vial and syringe products, and over one billion oral tablets annually. These prepayments, made from 2025 to 2028, will be fully credited against future orders, ensuring a robust supply chain for a potential blockbuster product. The company has also aggressively expanded its internal staff across critical functions like regulatory affairs, clinical development, manufacturing, and market access, preparing for the complexities of late-stage clinical trials and commercial launch.

Financial Fortitude and Investment Implications

Viking Therapeutics, as a clinical-stage biopharmaceutical company, has not generated any revenue since its inception and continues to incur significant operating losses. For the three months ended September 30, 2025, the company reported a net loss of $90.8 million, or $0.81 per share, a notable increase from $24.9 million, or $0.22 per share, in the corresponding period of 2024. For the nine months ended September 30, 2025, the net loss was $202 million, or $1.80 per share, compared to $74.5 million, or $0.69 per share, in the prior year.

This widening net loss is primarily attributable to a substantial increase in research and development (R&D) expenses, which rose to $90 million for Q3 2025 from $22.8 million in Q3 2024, and to $191.5 million for the nine months ended September 30, 2025, from $70.7 million in the same period of 2024. These increased R&D costs are driven by the accelerated pace of clinical studies, particularly the Phase 3 VANQUISH program, and increased manufacturing activities for its drug candidates. General and administrative (G&A) expenses also increased for the nine-month period, primarily due to higher stock-based compensation and insurance costs, though they saw a quarterly decrease due to reduced legal and patent services.

Despite these losses, Viking maintains a strong financial position. As of September 30, 2025, the company held $715 million in cash, cash equivalents, and short-term investments. Management believes this capital is sufficient to fund operations through at least December 31, 2026, covering the completion of its planned Phase 3 obesity trials for VK2735 and the advancement of its additional programs. This robust liquidity provides a critical runway, enabling Viking to aggressively pursue its development goals without immediate pressure for additional financing. Management expects R&D expenses to continue increasing, projecting a 25% to 33% rise from Q2 2025 levels for the third and fourth quarters of 2025, reflecting sustained investment in its late-stage pipeline.

Competitive Dynamics and Strategic Positioning

Viking operates in highly competitive therapeutic areas, particularly the rapidly expanding obesity market. Key competitors include established pharmaceutical leaders such as Eli Lilly (LLY) and Novo Nordisk (NVO), which have approved GLP-1/GIP agonists like Zepbound and Wegovy, respectively. Other significant players with late-stage programs include Amgen (AMGN) (MariTide) and Boehringer Ingelheim (survodutide). In the NASH market, Madrigal Pharmaceuticals (MDGL) has an approved therapy, Resmetirom (Rezdiffra), and numerous other companies are developing treatments.

Viking's strategic positioning hinges on the differentiated profile of its drug candidates. VK2735's dual GLP-1/GIP agonism, coupled with its impressive efficacy and tolerability, positions it as a strong contender. The company's unique approach of developing both subcutaneous and oral formulations using the same molecule is a significant differentiator, potentially offering patients and clinicians greater flexibility and reducing the risks associated with transitioning between different therapeutic agents. The ongoing maintenance dosing study further aims to provide data crucial for payer discussions and long-term patient adherence, a key factor in market success. While management views the injectable formulation as the primary opportunity (80% of the obesity market), the oral formulation represents a substantial 20% opportunity.

In NASH, VK2809's "best-in-class" histologic data provides a strong foundation, and Viking is actively exploring partnering opportunities to leverage the resources of larger pharmaceutical collaborators for complex Phase 3 trials. Similarly, VK0214 for X-ALD, a first-in-class pharmacologic treatment, is also being positioned for partnering with organizations specializing in rare disorders. The emerging DACRA program, with its potential for superior efficacy, further diversifies Viking's competitive offerings. Despite the formidable competition, Viking's innovative pipeline, strong clinical data, and strategic manufacturing and partnering initiatives enable it to carve out a significant position in these high-value markets.

Risks and Challenges

Investing in Viking Therapeutics carries inherent risks typical of a clinical-stage biopharmaceutical company. The most significant risk is clinical trial failure, particularly for VK2735, which would have a devastating impact on the company's valuation. Regulatory hurdles, including potential delays or denials of approval by the FDA or comparable foreign authorities, pose a constant threat. The company's dependence on technologies licensed from Ligand Pharmaceuticals (LGND) also presents a risk, as loss of this license would severely impair its development capabilities.

Viking relies heavily on third-party contract research organizations (CROs) and manufacturers, and any failure by these partners to meet contractual obligations, deadlines, or regulatory requirements could delay or terminate drug development. The competitive landscape is intense, with larger, more financially resourced competitors potentially bringing faster, more effective, or better-tolerated therapies to market. Undesirable side effects from Viking's drug candidates could also delay or prevent regulatory approval or commercialization. Furthermore, the company will require additional capital beyond its current runway to fund future operations and complete planned clinical trials, which may not be available on acceptable terms. Macroeconomic factors, government shutdowns, healthcare reform measures, and global geopolitical conflicts could also adversely impact operations and financial performance.

Conclusion

Viking Therapeutics stands at a pivotal juncture, poised to unlock significant value in the metabolic health revolution. The company's robust pipeline, spearheaded by the dual GLP-1/GIP agonist VK2735, demonstrates compelling efficacy and tolerability in both subcutaneous and oral formulations, positioning it as a strong contender in the burgeoning obesity market. Supported by a substantial cash reserve of $715 million and strategic manufacturing agreements, Viking is well-equipped to advance its Phase 3 VANQUISH program and explore innovative maintenance dosing strategies.

Beyond obesity, the diversified portfolio, including the "best-in-class" VK2809 for NASH and the first-in-class VK0214 for X-ALD, offers multiple avenues for future growth and strategic partnerships. While the path ahead is marked by inherent clinical and competitive risks, Viking's commitment to scientific innovation, strong operational execution, and a clear strategic vision for market differentiation underscore its potential for long-term value creation in addressing critical unmet medical needs.