Viking Therapeutics (VKTX) Q3 2025: R&D Spend Quadruples as Phase III Obesity Enrollment Accelerates

October 22, 2025 | By EarningsIQ Research

Viking Therapeutics ramped R&D investment over 4x year-over-year to drive rapid Phase III enrollment for its dual GLP-1/GIP agonist, VK2735, in obesity. Positive Phase II oral results and a pioneering maintenance dosing study position Viking for multiple inflection points in 2026, but the sharp increase in operating loss underscores the scale of its late-stage ambitions. Investors now face a pivotal period as Viking balances clinical execution, regulatory milestones, and strategic optionality in a competitive obesity market.

Summary

• Obesity Program Momentum: Dual subcutaneous and oral VK2735 programs advance, with Phase III enrollment ahead of plan and positive oral Phase II data.
• Cash Burn Surges: R&D expenses quadrupled as Viking funds multiple late-stage trials and novel maintenance dosing studies.
• Regulatory and Commercial Pathways: End-of-Phase II FDA meetings and payer engagement will shape next steps for oral and maintenance regimens.

Performance Analysis

Viking’s third quarter was defined by an aggressive scale-up in clinical operations, with R&D spending reaching $90 million, up sharply from $22.8 million in Q3 2024. This surge reflects the simultaneous advancement of multiple late-stage obesity trials, including the Vanquish Phase III registration program for VK2735 and a new maintenance dosing study. General and administrative (G&A) expenses declined versus the prior year, driven by lower legal and patent costs, but were partially offset by higher salaries and benefits.

The net loss widened to $90.8 million for the quarter, primarily due to the expanded R&D footprint. For the first nine months of 2025, cumulative R&D spend reached $191.5 million, nearly tripling year-over-year, and net loss escalated to $202 million. Viking exited the quarter with $715 million in cash and equivalents, down from $903 million at year end, providing a runway to complete planned Phase III trials and advance additional pipeline assets.

• Clinical Investment Spike: R&D spend quadrupled year-over-year, reflecting late-stage trial ramp and new studies.
• Cash Position Remains Robust: $715 million in liquidity supports current development plans, but burn rate has materially increased.
• Operational Leverage in Focus: G&A cost discipline partially offset by higher headcount and commercial readiness initiatives.

The financial profile signals Viking’s commitment to rapid clinical execution, but also highlights the need for continued capital discipline as pivotal trial costs mount and the company approaches major regulatory milestones.

Executive Commentary

Strategic Positioning

1. Dual Modality Obesity Franchise

Viking is building a differentiated obesity platform through parallel development of subcutaneous and oral VK2735 formulations. Both forms use the same molecule, reducing transition risk and enabling flexible treatment paradigms. The subcutaneous program is in Phase III (Vanquish-1 and Vanquish-2), targeting both general obesity and obesity with type 2 diabetes, while the oral program delivered positive Phase II results and is advancing toward regulatory dialogue for next-phase studies.

2. Maintenance Dosing Innovation

The launch of a first-of-its-kind maintenance study for VK2735 positions Viking at the forefront of chronic weight management strategies. By evaluating monthly subcutaneous, daily oral, and weekly oral regimens for weight loss maintenance, Viking aims to address payer and patient needs for persistence and long-term efficacy. Early data suggest low-dose oral or less frequent dosing may sustain weight loss, a key differentiator in a market where therapy discontinuation undermines outcomes.

3. Pipeline Optionality and Amylin Expansion

Beyond VK2735, Viking is advancing novel amylin receptor agonists, with IND-enabling work on a peptide candidate expected to yield a Phase I filing in early 2026. The company is also evaluating the optimal route of administration based on potency data, which could unlock new oral or subcutaneous franchise opportunities. Meanwhile, the MASH (metabolic dysfunction-associated steatohepatitis) asset VK2809 has attracted renewed external interest, providing potential for partnership or monetization.

4. Regulatory and Commercial Readiness

Viking is actively engaging with the FDA and payers, with an end-of-Phase II meeting for the oral program and ongoing dialogue about maintenance regimens’ real-world value. The company is preparing for pivotal data readouts, NDA-enabling studies, and is open to strategic partnerships for commercialization, though it retains the option to go it alone if necessary.

Key Considerations

This quarter marks a strategic inflection for Viking as it transitions from proof-of-concept to late-stage execution across multiple obesity modalities. The company’s ability to efficiently enroll and execute large, global Phase III trials, while also pioneering maintenance strategies, will be a central determinant of future value creation.

Key Considerations:

• Clinical Execution Pace: Vanquish Phase III enrollment is ahead of schedule, reflecting strong investigator and patient interest.
• Maintenance Regimen as Differentiator: Payer feedback underscores the commercial importance of persistence and weight maintenance—Viking’s study may support future reimbursement and adoption.
• Cash Burn and Capital Allocation: The step-change in R&D spend is sustainable for now but will require careful monitoring as pipeline breadth expands and commercial readiness costs rise.
• Regulatory Timing Risk: FDA meeting schedules could be impacted by government shutdowns, potentially delaying oral program advancement.
• Partnership Optionality: Viking remains open to strategic collaborations, especially for commercialization, but is prepared to proceed independently if needed.

Risks

Viking faces significant execution, regulatory, and market risks as it advances multiple late-stage trials in a highly competitive obesity landscape. Delays in enrollment, safety or tolerability signals, or regulatory feedback could impact timelines and capital needs. The company’s increasing cash burn heightens exposure to funding risk if timelines extend or additional studies are required. Competition from established GLP-1 players and evolving payer requirements may also challenge commercial adoption and pricing power.

Forward Outlook

For Q4 2025 and early 2026, Viking guided to:

• Completion of Vanquish-1 Phase III enrollment by year-end, and Vanquish-2 in Q1 2026.
• End-of-Phase II FDA meeting for oral VK2735, with potential decision on Phase III initiation timing.

For full-year 2025, management maintained its focus on:

• Executing Phase III trials and advancing the maintenance study, with sufficient cash to fund these through key milestones.

Management highlighted several factors that will shape the next quarters:

• Results from the maintenance study in mid-2026 could inform future label and payer strategy.
• Ongoing pipeline progress, including amylin agonist IND filing and potential MASH asset partnership discussions.

Takeaways

Viking’s Q3 marks a transition to late-stage, high-burn clinical execution with multiple shots on goal in obesity. The company’s dual subcutaneous and oral approach, plus maintenance innovation, could set it apart if efficacy, safety, and persistence data hold up through pivotal trials.

• Obesity Franchise Expansion: Simultaneous advancement of subcutaneous and oral VK2735, with positive Phase II oral data, increases the probability of platform success.
• Financial Discipline Needed: Surging R&D spend is justified by pipeline breadth, but Viking must carefully manage capital as it approaches key data and regulatory events.
• Future Watchpoints: Maintenance dosing results, regulatory feedback on the oral program, and partnership activity will be decisive for valuation and strategic direction in 2026.

Conclusion

Viking Therapeutics is executing a bold, high-investment strategy to establish itself as a differentiated obesity player, with dual modality development and a focus on long-term treatment persistence. The next twelve months will be pivotal as enrollment, regulatory milestones, and maintenance data converge, determining whether Viking can translate clinical promise into commercial reality.

Industry Read-Through

Viking’s aggressive late-stage push and maintenance study innovation signal intensifying competition and rising clinical standards in the obesity and metabolic disease sector. The willingness to invest heavily in both subcutaneous and oral programs, and to address payer needs for persistence, will likely pressure smaller players and raise the bar for new entrants. The focus on weight loss maintenance and payer engagement could shape future reimbursement frameworks across the industry. Additionally, renewed MASH asset interest and amylin receptor pipeline expansion highlight the growing convergence of metabolic and liver disease franchises, with implications for deal-making and portfolio strategy among larger biopharma peers.

VKTX Healthcare Biotechnology Obesity GLP-1 Clinical Trials R&D