What are the baseline characteristics for VANQUISH-1 and VANQUISH-2, and are they consistent with expectations? How should investors think about expected weight loss in type 2 diabetic versus non-diabetic obese patients?

Brian Lian stated that baseline demographics for VANQUISH-1 and VANQUISH-2 will be presented at upcoming conferences (European Congress of Obesity and EASD, respectively). He noted that type 2 diabetic patients are generally more resistant to weight loss than non-type 2 patients, so it would not be surprising to see less robust effects in the T2D cohort. “But generally, type 2 patients are a little bit more resistant to weight loss than non-type 2 patients. So I don't think that would be surprising to see in the weight loss data from these studies.”

What changed regarding the Phase III initiation of oral VK2735, now expected in Q4 2026, versus prior expectations for earlier in 2026?

Brian Lian clarified that nothing fundamentally changed. The timing is a result of scaling up manufacturing processes from small-batch production to large-scale commercial production, which involves optimizing engineering processes for efficiency and cost-effectiveness. He expressed confidence in initiating the program as early as possible in Q4. “Nothing really changed. We're moving incredibly fast and scaling up dramatically here. And as you do that, you learn a lot about the process and efficiencies, making 100 tablets is different than making 1 million tablets.”

What is the purpose of having 8 additional maintenance cohorts, and how will they be used in the VANQUISH extension trial? Will the extension study have a defined set of cohorts drawn from this data, and will this data be used for label inclusion or just for physician guidance?

Brian Lian explained that the expanded cohorts are to better inform the selection of multiple dosing arms for the VANQUISH extension studies. He confirmed that a very defined set of cohorts from this Phase I data will be included in the extension study. At a minimum, the extension data would be published to provide valuable information to clinicians and patients, with the potential for label inclusion. “And so we thought to better inform the cohorts that would go into the extension of VANQUISH, and there will be more than 1 dosing arm in the extension studies for maintenance and Vanquish. It just made sense to expand the subcu cohorts and then defer the oral since we went as time sensitive on the oral to a separate part of the study.”

VKTX

Viking Therapeutics (VKTX) Q1 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q1 FY26)· Health Care· Apr 29, 2026

Source: earnings call transcript

Executive summary

Viking Therapeutics Q1 FY26 — Pipeline Advancements and Oral Program Expansion

Viking Therapeutics reported significant progress in its obesity franchise during Q1 FY26, completing enrollment for both subcutaneous VK2735 Phase III trials and the maintenance dosing study. The company plans to initiate Phase III development for oral VK2735 in Q4 FY26, emphasizing optionality in treatment regimens. An IND was filed for the novel amylin receptor agonist VK3019, with Phase I initiation expected shortly, further diversifying the pipeline. The company also strengthened its commercialization strategy with a new Chief Commercial Officer and maintains a strong balance sheet to fund ongoing programs.

Highlights

Completed enrollment in the Phase III VANQUISH-2 trial for subcutaneous VK2735 in Q1 2026.
Completed enrollment in the VK2735 maintenance dosing study in Q1 2026, less than 3 months after initiation.
Successfully introduced an auto-injector device into both VANQUISH-1 and VANQUISH-2 studies in Q1 2026.
Oral VK2735 Phase II VENTURE-Oral study achieved up to 12.2% mean body weight reduction after 13 weeks, with 98% of drug-related adverse events being mild or moderate.

Concerns

Net loss increased to $158.3 million ($1.37 per share) for Q1 FY26, compared to $45.6 million ($0.41 per share) in Q1 FY25.
Research and development expenses significantly increased to $115.2 million for Q1 FY26, up from $41.4 million in Q1 FY25.
Cash, cash equivalents, and short-term investments decreased to $603 million as of March 31, 2026, from $706 million as of December 31, 2025.

Guidance & targets

Category	Target	Timeline	Confidence
Oral VK2735 Phase III Initiation	Initiate Phase III clinical development high materiality	Q4 · FY26	High
VK2735 Subcutaneous Maintenance Study Results	Report results medium materiality	Q3 · FY26	High
VK2735 Oral Maintenance Study Results	Report results medium materiality	H1 FY27	High
VK3019 Phase I Initiation	Initiate Phase I clinical trial medium materiality	Q2 · FY26	High

Risks & headwinds

Increased R&D expenses and net loss Q1 FY26

R&D expenses increased to $115.2M in Q1 FY26 from $41.4M in Q1 FY25; Net loss increased to $158.3M in Q1 FY26 from $45.6M in Q1 FY25.

Mitigation:Company expects R&D costs to taper down in H2 FY26 and maintains sufficient cash to fund operations into 2028.

Higher-than-anticipated cash usage Q1 FY26

Cash, cash equivalents and short-term investments decreased from $706M (Dec 31, 2025) to $603M (Mar 31, 2026).

Mitigation:Management expects cash usage to be around Q1 levels in Q2, then taper down in H2, remaining on track with projections to fund into 2028.

Lower efficacy in Type 2 Diabetes patients Long-term (VANQUISH-2 trial results)

Type 2 diabetic patients are generally more resistant to weight loss.

Mitigation:Not explicitly stated, but acknowledged as a general trend in obesity studies.

Scaling up manufacturing for oral VK2735 Leading up to Q4 FY26 Phase III initiation

Making 100 tablets is different than making 1 million tablets.

Mitigation:Company is actively learning and optimizing engineering processes to ensure efficient and cost-effective methods for large-scale production.

What to watch in Q2 FY26

VK3019 Phase I Initiation

Q2 FY26

Current IND filed in Q1 2026

Target Initiation of Phase I trial

Why it matters

Initiation of clinical development for a novel amylin receptor agonist, diversifying the pipeline and offering a potential new mechanism for obesity treatment.

Pending clearance, we expect to initiate a Phase I clinical trial for VK3019 later this quarter.

Find out whether VKTX delivers this. Inve re-checks your case every morning.

Q&A highlights

What are the doses and intervals for the new 8 subcu maintenance cohorts? And can you clarify R&D expenses, given the Q1 increase, and if they will come down next quarter?

Brian Lian detailed the new subcu maintenance cohorts: 15mg monthly, 10mg monthly, 10mg every other week, and 5mg every other week, in addition to the prior 22.5mg monthly, 20mg monthly, 17.5mg monthly, and 7.5mg every other week. Greg Zante explained that Q1 R&D and cash usage were higher due to timing, expecting similar levels in Q2, then tapering in H2, with cash projected to last into 2028.

“So we'll retain those first 4 cohorts that we had earlier, which were 22.5, 20 17.5 mg monthly as well as 7.5 mg every other week. But we've added 15 monthly, 10 monthly 10 every other week and 5 every other week. So we got a nice range of every other week and a broader range of monthly doses.”

asked by Steven Seedhouse · answered by Brian Lian

2 min read 5 chapters

Detailed narrative

VK2735 Subcutaneous Program Progress

Viking Therapeutics made significant strides in its subcutaneous VK2735 program, a dual GLP-1 and GIP receptor agonist. Enrollment for the Phase III VANQUISH-1 trial (obesity) was completed in Q4 2025, and the VANQUISH-2 trial (obesity and type 2 diabetes) completed enrollment in Q1 2026.

Both studies are designed to assess efficacy and safety over 78 weeks. A key operational achievement was the successful introduction of an auto-injector device into both VANQUISH studies in Q1 2026, following a bioequivalence study in Q4 2025, aiming to provide a more convenient administration method for patients.

VK2735 Oral Program Advancement

The company is advancing its oral VK2735 program into Phase III clinical development, with initiation planned for Q4 2026. This decision follows positive top-line results from the Phase II VENTURE-Oral dosing study, which demonstrated statistically significant weight reductions up to 12.2% after 13 weeks and a favorable tolerability profile.

Management highlighted the importance of oral optionality for patients who prefer non-injectable therapies or for weight maintenance, noting the recent success of another oral peptide in expanding the obesity market.

Novel Maintenance Dosing Strategy

Viking initiated a maintenance dosing study for VK2735 in Q4 2025, with enrollment completed in Q1 2026. This study explores various regimens (monthly, every other week, weekly) to support long-term weight management, leveraging VK2735's potency and PK profile. The subcutaneous cohorts were expanded from 4 to 8 to provide a robust dataset for inclusion in the upcoming 52-week VANQUISH extension studies.

Results for the subcutaneous portion are expected in Q3 2026, with oral maintenance results anticipated in H1 2027.

Amylin Receptor Agonist (VK3019) Development

Viking is progressing its earlier-stage pipeline with VK3019, a novel amylin receptor agonist. An Investigational New Drug (IND) application was filed in Q1 2026, and the company expects to initiate a Phase I clinical trial for VK3019 later in Q2 2026.

Preclinical data suggest VK3019 could offer better efficacy than VK2735 and cagrilintide in weight loss, potentially targeting patients with lower BMI or those intolerant to GLP-1s. Initial studies will focus on single-agent safety and pharmacokinetics, with future consideration for combination therapy with VK2735.

Organizational Growth and Financial Position

As VK2735 advances towards potential approval and commercialization, Viking is strategically expanding its organization, adding staff across scientific, operational, supply chain, manufacturing, and quality roles. Neil Aubuchon was appointed as the first Chief Commercial Officer in Q1 2026, bringing extensive cardiometabolic commercial experience.

The company reported $603 million in cash, cash equivalents, and short-term investments as of March 31, 2026, which management believes is sufficient to fund operations through key milestones, including the completion of ongoing Phase III obesity trials and development of additional programs into 2028.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.