Viking Therapeutics' Q3 2025 Earnings Call: Shifting Narratives on Oral Formulation, Dose Ranges, and Phase 3 Timelines Spark Investor Scrutiny

The above is the analysis of the conflicting points in this earnings call

Date of Call: October 22, 2025

Financials Results

• EPS: $0.81 loss per share for Q3 2025, compared to $0.22 loss per share in Q3 2024; nine‑month 2025 loss $1.80 per share vs $0.69 per share in nine months 2024

Guidance:

• Vanquish One enrollment expected to complete by end of 2025; Vanquish Two expected to complete enrollment in Q1 2026.
• End-of-phase‑2 meeting request for oral VK2735 to be submitted in coming days; meeting expected later in Q4 2025 (timing could slip).
• Phase 1 maintenance dosing study initiated; results expected mid‑2026.
• IND filing for amyloid receptor agonist targeted in Q1 2026.
• Cash of $715M at Sept 30, 2025 believed sufficient to complete planned phase 3 trials and advance additional programs.

Business Commentary:

• Research and Development Expenses:
• Viking Therapeutics reported research and development expenses of $90 million for the three months ended September 30, 2025, compared to $22.8 million in Q3 2024, representing an increase of 384%.

• The rise in expenses was primarily due to increased costs related to clinical studies, manufacturing for drug candidates, salaries, and benefits, offset partially by a decrease in stock-based compensation.

• Financial Performance:

• The company reported a net loss of $90.8 million or $0.81 per share for the three months ended September 30, 2025, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024.

• The loss was mainly due to the increase in research and development expenses, reflecting the progress in their clinical studies and development activities.

• Clinical Progress and Initiatives:

• The completion of the phase 2 Venture Oral Dosing Study led to positive top-line results, with participants experiencing statistically significant reductions in body weight.

• These results encouraged the initiation of a phase one study to evaluate maintenance dosing strategies, indicating the company's continued focus on weight loss and maintenance therapies.

• Cash Position and Financial Management:

• As of September 30, 2025, Viking Therapeutics held $715 million in cash, cash equivalents, and short-term investments, down from $903 million as of December 31, 2024.
• Despite the decrease, the cash position remains robust, ensuring the company's financial capability to complete phase three trials and pursue additional development programs.

Sentiment Analysis:

Overall Tone: Positive

• Management described Q3 as “busy and productive,” announced positive top-line phase II oral VK2735 results with statistically significant weight reductions up to 12.2%, reported Vanquish phase III enrollment is proceeding well (Vanquish One ahead of schedule), and emphasized $715M cash supporting planned phase III and pipeline INDs.

Q&A:

• Question from Steve Seedhouse (Cantor): Obviously, enrollment’s going very well in phase three. We wanted to ask if you had any sense of early signs of patient persistence, discontinuation rate, and if you’re happy with what you see there on the trial execution side. On the maintenance study, hoping you could expand on just the 19-week induction versus 12-week maintenance. What are you doing during that induction phase? How fast are you titrating patients up? What doses are being contemplated there? ... Can I follow up on the maintenance study? Are you making any changes to just the tablets, like the size or dose in the tablets for the maintenance phase, or is the auto-injector for the subcutaneous formulation available for this study?
  Response: Enrollment is ahead of schedule with no early persistence issues observed; the maintenance study titrates subjects up over ~19 weeks to target SQ doses (15–22.5 mg cohorts) and includes tablet sizes (daily 17.5/27.5 mg; weekly oral ~110 mg); no auto‑injector (vial/syringe).

• Question from June Lee (Truist Securities): Following up on the maintenance study, are you able to share what the doses for the monthly sub-Q, daily oral, and the weekly oral that are being tested? ... What are some of the key considerations as you’re screening for multiple compounds? Is it just the efficacy and tox profile or potential compatibility with VK2735? Will it be a small molecule, peptide, or will it be subcutaneous or orally dosed?
  Response: Planned maintenance doses: monthly SQ 15, 17.5, 20, 22.5 mg; daily oral 17.5, 20, 27.5 mg; weekly oral 110 mg; compound selection considers efficacy, tox, formulation and compatibility (lead is a peptide).

• Question from Ryan Fechner (Raymond James): If the maintenance study shows compelling evidence supporting one or more regimens, what’s the next clinical step for validating a maintenance regimen and potentially getting it on a future label? Is it a realistic option at all to add an expansion arm to the Vanquish study? Have you noticed any impact from the government shutdown on either the enrollment for the Vanquish studies, or has it had any impact on the timing of the amyloid program?
  Response: Adding a monthly maintenance arm to Vanquish is unlikely; next step would be a longer dedicated study (phase 2b or phase 3) depending on results, and the government shutdown has not materially affected enrollment or FDA communication yet but could impact meeting timing.

• Question from Jim Patel for Thomas Smith (Leerink): For the daily maintenance regimen, it’ll be two doses: 17.5 mg and 27.5 mg, and the weekly oral will be 100–110 mg—are those the only doses you’ll be testing? For the 27.5 mg, will there be any up‑titration from 17.5 to 27.5, or will it be directly to 27.5?
  Response: Daily oral maintenance doses are 17.5 mg and 27.5 mg and weekly oral is ~110 mg; there is no titration from subQ to oral because subQ exposures are much higher than oral.

• Question from Annabelle Femimi (CFOL): When you move from the weekly injectable to the weekly oral at 110 mg, you don’t believe there needs to be any titration, and there shouldn’t be any tolerability issue jumping from the weekly injection to the weekly oral? In any cohorts, are you having any kind of down‑titration for maintenance like you did in the phase two study? How can you best leverage the maintenance data given there’s no real regulatory path to get that maintenance on the label—will you use it with payers to support persistence and reimbursement?
  Response: They do not expect major tolerability issues switching to weekly oral 110 mg and are not planning further down‑titration; management expects maintenance data to be persuasive to payers to support persistence and reimbursement strategies.

• Question from Hardik Parikh (JP Morgan): Could you give your high‑level thoughts on the Pfizer‑MedSera deal? Do you think you could have a green light on whether the oral proceeds to a phase 2b or phase 3 by the end of the year after the FDA meeting?
  Response: They will not comment on other companies' deals; the end‑of‑phase‑2 meeting should inform whether to proceed to phase 2b/3 but timing and final minutes are uncertain and may slip into January.

• Question from Jay Olson (Oppenheimer): What lessons or read‑across have you taken from recent dynamics in the oral GLP‑1 space regarding attrition and tolerability, and can you comment on the DACRA IND filing rate‑limiting steps?
  Response: VK2735’s oral safety/tolerability profile looks strong and they plan to start lower and extend titration windows; the DACRA agonist shows promising potency that could enable oral dosing and they’re working toward an IND targeted in Q1 2026.

• Question from Biank Mamthani (B. Riley FBR): What topics will you discuss at the end‑of‑phase‑2 meeting for the oral—how relevant is the subQ package, and what doses are you contemplating for the next study? Also, regarding broader financials, is a CV outcome trial still part of consideration and are there other studies you expect to spend on in the next two years?
  Response: End‑of‑phase‑2 will focus on study design, duration and safety and they can leverage subQ long‑term tox data for oral; doses haven’t been disclosed; expected pre‑NDA studies include renal/hepatic impairment and DDI studies, with no additional phase‑3 planned currently.

• Question from Mike Ols (Morgan Stanley): Can you talk about expectations for OpEx moving forward—should R&D continue to rise? Also, given renewed interest in MASH, are there plans to partner VK2809?
  Response: OpEx is elevated due to phase‑3 activity and is expected to remain at higher levels through the trials; there is renewed partner interest in the MASH asset (VK2809).

• Question from Yale Jen (Laidlaw & Company): If the next step for the oral is phase 3, would you consider an oral‑to‑oral high‑dose to low‑dose maintenance or subQ‑to‑oral transition like the maintenance study? Also, will Vanquish One and Two be reported together or sequentially?
  Response: A pivotal oral program would likely follow a conventional titrate‑to‑dose 52‑week design rather than complex transitions; Vanquish studies will be reported when each readout is available and likely separately if timing differs.

• Question from Roger Song (Jefferies): Will you provide the four‑week off‑treatment follow‑up and PK data from the phase 2 oral study in coming months? How likely is testing weekly dosing in a potential pivotal given weekly is in the maintenance study?
  Response: Final PK report from the Venture Oral Dosing Study is expected in the next couple of weeks; inclusion of weekly dosing in pivotal work depends on maintenance and other data and will be decided after reviewing results.

• Question from Andy Shea (William Blair): How do you think about the dose required to maintain weight loss during the active loss period versus after reaching maximum weight loss—will 19‑week induction generalize to long‑term maintenance? Also thoughts on recent Eli Lilly CV results?
  Response: Primary objective is to identify doses that prevent weight regain (signal should be informative even if subjects haven't reached maximal loss); they cannot fully interpret Lilly’s CV results without complete data.

• Question from Justin Zelen (BTIG): How are you thinking about partnership versus going alone for commercialization in obesity?
  Response: The company is open to partnering and believes a larger partner would be helpful commercially but is fully prepared to proceed alone if necessary.