Q4 2024 Earnings Summary
- Viking Therapeutics is advancing its lead obesity drug VK2735 into Phase III trials in both obese patients and obese patients with type 2 diabetes, potentially expanding its market reach and allowing for inclusion of glycemic control data in the label.
- The company is exploring more convenient dosing regimens for VK2735, including monthly subcutaneous injections and an oral tablet formulation, which could improve patient compliance and differentiate their product in the obesity market.
- VK2735 has shown positive safety and tolerability in Phase I studies, with potential to explore higher doses for increased efficacy, and the company is making good progress on manufacturing agreements to support commercialization.
- The company is experiencing delays in finalizing manufacturing agreements, which could impact development timelines for VK2735.
- Uncertainty about optimal dosing and safety at higher doses for VK2735 may pose challenges in defining appropriate doses for Phase III trials.
- The requirement for large Phase III trials involving over 4,500 participants could increase costs and extend timelines, potentially impacting financial resources.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Subcutaneous VK2735 Clinical Program | Not specified | Preparing for an end‐of‐Phase II meeting with the FDA and planning for Phase III initiation | no current guidance | no current guidance |
Oral VK2735 Clinical Program | Not specified | Planning to present additional data at ObesityWeek in November 2024 and to initiate a 13‑week Phase II study | no current guidance | no current guidance |
VK2809 (NASH & Fibrosis) Clinical Program | Not specified | Evaluating next steps after FDA feedback and planning to present additional data at the Liver Meeting | no current guidance | no current guidance |
VK0214 (X‑ALD) Clinical Program | Not specified | Awaiting final Phase Ib trial data to decide next steps | no current guidance | no current guidance |
Manufacturing | Not specified | Sufficient drug supplies with ongoing discussions with global peptide suppliers | no current guidance | no current guidance |
Phase III Trials for VK2735 | Q2 2025 | Qualitatively noted – planning for a Phase III trial initiation after the end‐of‐Phase II meeting | Initiation of Phase III trials in Q2 2025 | no change |
Auto‑Injector Introduction for VK2735 | Not specified | no prior guidance | Introduction of an auto‑injector for the Phase III program | no prior guidance |
Monthly Dosing Evaluation for VK2735 | FY 2025 | no prior guidance | Evaluation of monthly dosing in a maintenance setting later in FY 2025 | no prior guidance |
VENTURE‑Oral Dosing Trial for VK2735 | FY 2025 | no prior guidance | Ongoing Phase II trial evaluating an oral tablet (280 adults, 13‑week treatment; data in second half FY 2025) | no prior guidance |
IND Filing and Phase I Trial for Amylin Receptor Agonists | FY 2025 | no prior guidance | Filing of an IND and initiation of a Phase I trial later in FY 2025 | no prior guidance |
Partnering Opportunities for VK2809 and VK0214 | FY 2025 | no prior guidance | Exploration of partnering opportunities during FY 2025 | no prior guidance |
Financial Position | As reported | $930 million in cash, cash equivalents, and short‑term investments as of September 30, 2024 | Over $900 million in cash | lowered |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
VK2735 Phase III Development | Q3 discussions focused on obesity trial preparation with planned end‐of‐Phase II meetings and Q2 updates included both obesity and type 2 diabetes target populations , while Q1 did not mention Phase III development. | Q4 provided comprehensive details on initiating Phase III trials for obesity with an added inclusion of type 2 diabetes patients, detailed trial design (auto‐injector, two studies, monthly dosing study) and clarified timing. | Expanded focus: Evolved from an obesity‐only focus (Q3) and partial mention (Q2) to a more integrated design including type 2 diabetes and refined trial components. |
Dual Formulation and Dosing Optimization | Q3 emphasized both subcutaneous and oral formulations with discussions of monthly dosing and potential auto‐injector use. Q2 discussed dose escalation, tablet size, and the exploration of less frequent dosing. Q1 highlighted the VENTURE trial results, auto‐injector plans, and initial efforts to explore extended dosing. | Q4 detailed the dosing transition from weekly to monthly, introduction of an auto‐injector with bridging studies, and further supported the dual formulation strategy with additional PK data. | Consistent theme with refinement: The strategy remains central across periods with increasingly detailed design elements and optimized delivery approaches. |
Safety, Tolerability, and Dose Escalation Challenges | Q3 reported excellent safety with mild or moderate adverse events and successful dose escalation up to 100 mg orally. Q2 echoed favorable safety profiles for both oral and subcutaneous dosing with continued escalation. Q1 described robust tolerability in both Phase I (oral) and Phase II (subcutaneous) studies. | Q4 reiterated encouraging safety and tolerability in both oral and subcutaneous formulations, with careful balancing of dose escalation (up to 100 mg proposed) and continued support from the VENTURE study. | Stable and positive: The safety profile has remained consistently favorable with ongoing dose escalation without emerging major issues. |
Manufacturing and Supply Chain Constraints Impacting Commercialization Timelines | Q1 highlighted significant supply chain challenges (shortages, material constraints) that could affect commercial supply. Q2 and Q3 emphasized sufficient drug supplies for clinical studies and progress with external manufacturing agreements. | Q4 focused on active work toward comprehensive manufacturing agreements and noted logistical factors (e.g., clinical material production) that have narrowed Phase III start timelines. | Fluctuating focus: Early concerns reappeared in Q4 with renewed emphasis on refining manufacturing partnerships and logistics despite prior positive updates. |
Large-scale Phase III Trial Design and Escalating Financial Risks | Q2 provided details on planning two Phase III studies with a combined enrollment of at least 4,500 participants and an estimated cost of $300 million. Q3 discussed protocol design adjustments and noted rising clinical expenses. Q1 did not address large-scale Phase III design. | Q4 delivered the most comprehensive overview yet, outlining detailed trial structure (split studies, 52-week treatment, auto‐injector bridging) and highlighted increased R&D and G&A expenses along with higher net losses. | Increased detail and financial exposure: From minimal mention in Q1 to substantial elaboration and acknowledgment of escalating costs in Q4. |
Regulatory Uncertainties and Evolving FDA Feedback Including Trial Powering Issues | Q1 mentioned discussions with the FDA regarding study design, duration, and powering issues (e.g., VOYAGE study powering for NASH resolution). Q3 referenced receiving written FDA feedback and reviewing Phase II protocols. Q2 did not cover the topic. | Q4 did not include any specific discussion of regulatory uncertainties or trial powering issues. | Diminished discussion: Earlier periods (especially Q1 and Q3) addressed FDA feedback and uncertainties, whereas Q4 shows a shift away from these topics. |
VK2809 Development for NASH and Fibrosis with Partnership and Regulatory Uncertainties | Q1 noted that next steps depended on VOYAGE data and potential partnership decisions. Q2 provided detailed efficacy results from the VOYAGE study and expressed a preference for partnering for the NASH registration path. Q3 described submitting an end‐of‐Phase II meeting package and ongoing internal review of FDA responses with a view to partner collaboration. | Q4 reported a completed end‐of‐Phase II meeting with the FDA, highlighted strong VOYAGE outcomes (presented at a major conference) and mentioned active though non‐definitive partnership discussions. | Progressive clarity and forward momentum: Regulatory and partnership strategies have become more defined over time, with Q4 building on prior positive clinical and regulatory milestones. |
Pipeline Expansion through Combination Therapies and the New DACRA Program | Q2 discussed advancing dual agonists (DACRA) and potential combination strategies, highlighting promising preclinical data and plans to move into the clinic next year. Q3 reiterated the intention to combine amylin agonism with other mechanisms and referenced DACRA benchmark discussions. Q1 did not mention this topic. | Q4 did not reference any pipeline expansion through combination therapies or updates on the DACRA program. | Topic dropped: Previously active in Q2 and Q3, the subject is absent in Q4 discussions. |
Intense Market Competition in Obesity and Diabetes Treatments | Q1 had only minor indirect mentions via supply issues. Q2 did not feature the topic. Q3 explicitly acknowledged competition, citing major competitor readouts (e.g., from Novo Nordisk and Roche) and detailed market opportunity assessments. | Q4 did not include any discussion of intense market competition in obesity or diabetes. | Reduced emphasis: The competitive landscape was a focus in Q3 but was de-emphasized in Q4. |
Shifts in Financial Strategy and Resource Allocation Amid High Clinical Expenses | Q1 discussed rising R&D and G&A expenses, significant net losses, and the capital raise (public offering of $630 million) that strengthened their balance sheet substantially. Q2 and Q3 echoed rising clinical expenses and highlighted robust cash positions. | Q4 detailed further increases in clinical expenses (R&D and G&A), higher quarterly and annual net losses, yet underscored an even stronger cash position, enabling aggressive pipeline investment. | Consistent emphasis with escalation: Ongoing discussion of higher expenditures balanced by strong capital; the narrative deepened as programs scaled. |
De-emphasis of Early-Stage Chronic Toxicology Studies and Extended Dosing Duration Discussions | Only Q1 mentioned that chronic toxicology studies are complete and that there is flexibility for extended dosing durations in upcoming studies. | Q2, Q3, and Q4 did not reference these topics. | Diminished focus: Initially highlighted in Q1, this topic was not revisited in later periods. |
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Phase III Obesity Studies Timing
Q: Why has the timing for Phase III obesity study start narrowed to Q2?
A: The timing has been narrowed to Q2 2025 due to better visibility on timelines for production of the clinical material. This improvement in logistics for making the formulation and drug product allows for a more focused timeframe. Everything is going according to plan. -
Phase III Trial Design and Size
Q: Can you provide details on Phase III study design and size?
A: We will conform to guidance requiring at least 4,500 people in the Phase III program. There will be two studies: one in obese subjects and one in subjects with type 2 diabetes. Multiple doses will be used, and a 52-week treatment window is targeted. Further details will be provided when trials initiate. -
Manufacturing Updates
Q: Any updates on the manufacturing agreement and why it's taking so long?
A: We are spending significant time on manufacturing and working toward comprehensive agreements to enable the launch of a substantial commercial product. Discussions are complicated but progress is good, and we will provide more information at the appropriate time. -
Strategic Discussions for VK2809 (NASH)
Q: Any updates on partnering discussions for VK2809 in NASH?
A: It's hard to comment on partnering discussions at this time. We had a busy schedule at JPMorgan and are in the follow-up period now. The requirement for biopsies complicates Phase III trials in NASH, but we'll see where conversations lead. -
Transition from Subcutaneous to Oral Formulation
Q: Are you planning to transition from subcu to oral formulation in the same study?
A: Ideally, yes. We would transition some patients to a low-dose oral in the same study. We are currently working through the protocol, planning an initial PK exploratory study followed by a longer-term study to assess maintenance effects. -
Amylin Program Updates
Q: What needs to be completed for the amylin program IND submission this year?
A: All of the IND-enabling work, particularly the toxicology studies, needs to be completed. We hope to have this done to enable an IND filing this year. -
Cost of Goods Sold and Profitability
Q: Can you comment on cost of goods sold based on manufacturing contracts?
A: It's premature to discuss COGS as we're in a Phase II trial. We wouldn't want to target a product that isn't profitable, though. -
Auto-Injector Plans
Q: Is an auto-injector part of your material preparation, and will you need a bridging study?
A: Yes, we plan to introduce an auto-injector in the Phase III program and anticipate the product to launch as an auto-injector. We probably would do a bridging study to ensure bioequivalence with the auto-injector. -
Type 2 Diabetes Label Considerations
Q: Will you seek a label for diabetes alone, or just as part of obesity?
A: We wouldn't be submitting for approval for treatment of type 2 diabetes alone. It's for inclusion in an obesity label for people with obesity and type 2 diabetes. -
Scalability of Peptide API vs Small Molecules
Q: Thoughts on the benefits and scalability of peptide API compared to small molecules?
A: There's a misperception that small molecules are universally easier to make than peptides, which is totally false. Peptide chemistry is simple and low-tech; scalability is the challenge, not the chemistry. We are comfortable that we'll be able to produce scale that supports a multibillion-dollar franchise. -
Weight Regain and Lean Muscle Mass Preservation
Q: Any plans to study weight regain or lean muscle mass preservation in Phase II studies?
A: The maintenance study would target weight regain by dosing with the weekly regimen up to a high dose, then transitioning to a monthly injection or low-dose daily oral. The primary objective is to understand how weight regain manifests after transition. We will do DEXAs in the Phase III program, but no intention currently to evaluate our 5211 molecule for muscle preservation. -
Monthly Subcutaneous Dosing
Q: Can you discuss your plans for testing monthly subcu dosing?
A: Our long-term goal is to have monthly dosing in the label, though whether it's in the initial NDA is too early to tell. We plan to initiate a study where we rapidly titrate patients to a high dose, then transition from weekly to monthly dosing, looking at weight maintenance. -
Pharmacokinetic Data and Accumulation
Q: Is there a minimum plasma level needed to minimize weight regain?
A: At the 2.5 mg dose over 13 weeks, which leads to approximately 9% weight loss, maintaining plasma levels near that dose after 4 weeks from the prior dose may prevent significant weight gain. Our data suggest that even after 13 weeks, accumulation is ongoing, indicating that 13-week data may understate long-term efficacy. -
VENTURE Oral Phase II Trial Dose Range
Q: Why is the dose range in the Phase II oral VENTURE trial still broad?
A: We want to know if lower doses continue to mature in body weight reduction with longer treatment. In Phase I, lower doses showed promising results, but due to the short and small study, it's hard to tell. With further accumulation and longer-term dosing, we may see a maturing efficacy signal. -
Recruitment for Phase III Studies
Q: How long will it take to recruit patients for Phase III studies?
A: We can't provide guidance on that yet. We need to start the study and understand timelines to site initiation and the enrollment queue. We hope to start the studies as concurrently as possible. -
Testing Maximum Tolerability at Highest Dose
Q: Are you comfortable that you've tested maximum tolerability at the highest dose?
A: The Phase I study was well tolerated at 100 mg. We pushed a little higher to 120 mg. We could probably go higher, but we balance that against the slow accumulation rate and not being at steady state at 28 days. 120 mg seems like an interesting dose to look at. -
Securing API for Phase III Studies
Q: Have you secured API for both Phase III studies?
A: Yes, we have the API for both studies, though not enough to get through the entire Phase III program. -
Exploring Monthly Dosing in Maintenance Setting
Q: Is monthly dosing being explored for maintenance in the subcu formulation?
A: Yes, pharmacokinetic results support the feasibility of once-monthly dosing in the maintenance setting, and we plan to further evaluate monthly dosing later this year.