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**【CEO Summary Section】**
- Announced positive top-line results from the Phase II VENTURE-Oral Dosing Study, showing 12.2% mean weight loss from baseline with VK2735 oral tablet formulation.
- Initiated a Phase I maintenance study evaluating monthly subcutaneous, weekly oral, and daily oral dosing regimens for VK2735.
- Enrolled over 4,500 patients in the Phase III VANQUISH-1 trial and 1,100 patients in VANQUISH-2 trial for obesity and obesity with type 2 diabetes.
- Advanced IND filing for a novel amylin receptor agonist program targeting appetite regulation.

**【CFO Financial Commentary】**
- Research and development expenses increased to $191.5 million for the first 9 months of 2025, driven by clinical trials and manufacturing costs.
- General and administrative expenses rose to $37.1 million, partially offset by decreased legal and patent expenses.
- Maintained strong cash position of $715 million as of September 30, 2025, supporting ongoing clinical development.

**【Q&A Key Highlights】**
- Enrollment in Phase III trials proceeding well, with no significant safety or tolerability issues observed.
- Maintenance study will test dose titration strategies (e.g., 17.5 mg to 27.5 mg oral, 110 mg weekly subcutaneous).
- FDA end-of-Phase II meeting planned for late 2025 to discuss potential Phase III pathway for oral VK2735.
- Payer engagement focused on demonstrating long-term weight maintenance benefits for reimbursement justification.
- No material impact from government shutdown on trial timelines or regulatory interactions.

Viking Therapeutics, Inc. (VKTX) Q3 2025 Earnings Call Transcript

- **Phase III Trials Launched**: VK2735 subcutaneous formulation enters Phase III with 4,500-patient obesity trial and 1,100-patient diabetes trial.
- **Oral Study Completion**: Phase II oral tablet trial enrollment finalized; results expected Q3 2025.
- **Amylin Program IND Filing**: New amylin receptor agonist IND filed for Q4 2025 Phase I trials.
- **Financial Strength**: $808 million cash balance supports Phase III execution despite Q2 net loss of $65.6 million.
- **Key Risk**: Placebo attrition in long-term trials could impact Phase III success.

**【CEO Summary Section】**
- Viking Therapeutics advanced its VK2735 obesity program into Phase III clinical trials (VANQUISH-1 and VANQUISH-2), targeting enrollment of 4,500 and 1,100 patients, respectively. The trials evaluate weekly subcutaneous dosing at 7.5mg, 12.5mg, and 17.5mg for 78 weeks.
- The Phase II oral tablet study (VENTURE-Oral) completed enrollment of 280 patients, with results expected in Q3 2025. The study evaluates doses up to 120mg daily.
- The company filed an IND for a novel amylin receptor agonist program, targeting a Q4 2025 start for Phase I trials.
- Viking secured a manufacturing agreement for VK2735 API and fill/finish services to support commercialization.

**【CFO Financial Commentary】**
- Q2 2025 net loss: $65.6 million ($0.58/share), up 193% YoY, driven by R&D (+153%) and G&A (+40%) expenses.
- R&D expenses: $60.2 million (vs. $23.8 million in Q2 2024), due to clinical trials, manufacturing, and stock-based compensation.
- G&A expenses: $14.4 million (vs. $10.3 million), driven by salaries and benefits.
- Cash balance: $808 million as of June 30, 2025, providing runway for Phase III trials.

**【Q&A Key Highlights】**
- **Oral Program Progress**: CEO expects Phase II oral data to inform potential Phase III plans, with a focus on 60-90mg doses. A maintenance cohort (90mg → 30mg) will test durability.
- **Manufacturing Timeline**: Sufficient API supply for Phase III is secured, with no delays anticipated.
- **Amylin Program Differentiation**: Early in vivo data shows comparable efficacy to VK2735, with potential for combination therapies.
- **Competitive Landscape**: CEO believes multiple oral GLP-1 agonists can coexist in the market, citing Lilly's orforglipron Phase III data as complementary.
- **Placebo Retention Strategy**: Open-label extensions and clinician engagement will mitigate attrition in Phase III trials.


Viking Therapeutics, Inc. (VKTX) Q2 2025 Earnings Call Transcript

- **Phase 3 Imminent**: Subcutaneous VK2735 Phase 3 trials set to begin Q2 2025 with 4,500+ patient enrollment.
- **Oral VK2735 Momentum**: Phase 2 trial fully enrolled (~280 patients), targeting H2 2025 weight loss data.
- **Manufacturing Scale**: $1B+ annual capacity secured via 5-year agreement with CordenPharma.
- **Amylin Pipeline Expansion**: IND filing expected late 2025 for weekly subcutaneous amylin receptor agonist.
- **Financial Strength**: $852M cash balance provides runway for Phase 3 trials and pipeline expansion.


**【CEO Opening Remarks】**
- Viking achieved record productivity in 2024, with positive data from 4 clinical programs (VK2735 subcutaneous, oral, VK2809, VK0214). 
- Phase 3 trials for subcutaneous VK2735 obesity program set to begin Q2 2025.
- Phase 2 oral VK2735 trial completed enrollment of ~280 patients with obesity, targeting 13-week weight loss data readout in H2 2025.
- Signed multi-year manufacturing agreement with CordenPharma for $1B+ annual supply of VK2735 API and finished products.

**【CFO Financial Review】**
- Q1 2025 R&D expenses: $41.4M (vs $21.4M YoY), driven by manufacturing costs (+$15M), clinical trials (+$5M), and stock comp (+$1M).
- G&A expenses: $14.1M (vs $10M YoY), due to legal/patent costs (+$2M) and insurance (+$1M).
- Net loss: $45.6M (-$0.41/share) vs $27.4M (-$0.26/share) YoY.
- Cash balance: $852M as of March 31, 2025 (down $51M QoQ).

**【Pipeline Updates】**
1. **VK2735 Subcutaneous**
- Phase 2 VENTURE study showed 14.7% weight loss at 13 weeks, with 90% retention at 7-week follow-up.
- Planning Phase 3 trials targeting 4,500+ patients (obesity & obese diabetics) with 52-week dosing.
- Exploring monthly dosing regimen in separate PK study later this year.

2. **VK2735 Oral**
- Phase 1 trial showed 8.2% weight loss at 28 days, with 8.3% retention at 4-week follow-up.
- Phase 2 trial evaluating 6 dose levels (30-120mg) in 280 patients, targeting H2 2025 data.
- Exploring step-down maintenance regimen (titrate to 90mg, then step down to 30mg).

3. **Amylin Receptor Agonist Program**
- Preclinical data shows weight loss and metabolic benefits.
- IND filing expected late 2025 for weekly subcutaneous formulation.

**【Q&A Highlights】**
- Phase 2 oral trial top-line data will include 13-week results only; 4-week follow-up data to follow.
- Auto-injector introduction planned for Q1 2026, with bridging study comparing vial/syringe vs auto-injector in Q3 2025.
- Manufacturing agreement includes redundancy across API, fill/finish, and packaging.
- No current plans to test oral VK2735 in Type 2 diabetes; Phase 3 will focus on obesity indications.
- Actively monitoring potential tariffs impact, but expects minimal near-term impact.


Viking Therapeutics (VKTX)-23 Apr 25-2025 Q1 Earnings call transcript

- **Clinical Success**: VK2735 subcutaneous Phase II achieved 14.7% weight loss, with 90% maintenance 7 weeks post-treatment.
- **Financial Strength**: $903M cash balance supports Phase III trials for obesity, NASH, and rare disease programs.
- **Pipeline Momentum**: 
  - VK2735 Phase III starts Q2 2025; oral Phase II data expected H2 2025.
  - VK2809 NASH resolution rate 58%, fibrosis improvement 43%.
  - New amylin agonist IND filing planned for 2025.
- **Strategic Focus**: Prioritizing obesity programs while exploring partnerships for NASH and rare diseases.

**【CEO Opening Remarks】**
- Viking reported 4 successful clinical trials in 2024, including VK2735 (obesity), VK2809 (NASH), VK0214 (X-ALD), and a new amylin receptor agonist program.
- VK2735 subcutaneous Phase II trial showed 14.7% weight loss at 13 weeks, with 90% weight loss maintained 7 weeks post-treatment.
- Completed $630M public offering, providing $903M cash balance to fund Phase III trials for VK2735 and other programs.

**【CFO Financial Review】**
- Q4 2024: R&D expenses $31M (vs. $20.5M 2023), G&A $15.3M (vs. $8.8M 2023), net loss $35.4M ($0.32/share).
- Full Year 2024: R&D $101.6M (vs. $63.8M), G&A $49.3M (vs. $37M), net loss $110M ($1.01/share).
- Cash balance $903M (vs. $362M 2023), supporting aggressive pipeline development.

**【CEO Clinical Program Updates】**
- **VK2735**: 
  - Subcutaneous Phase III expected Q2 2025; exploring monthly dosing for maintenance.
  - Oral Phase II trial (VENTURE-Oral Dosing) enrolling 280 patients, targeting 13-week weight loss data in H2 2025.
- **VK2809**: 
  - NASH Phase IIb VOYAGE trial showed best-in-class NASH resolution (58%) and fibrosis improvement (43%).
  - FDA-endorsed Phase III plan; exploring partnerships.
- **VK0214**: 
  - X-ALD Phase Ib trial showed 38% VLCFA reduction vs. placebo, with mild safety profile.
  - Seeking partners for rare disease development.
- **Amylin Agonist**: 
  - IND filing planned for 2025; Phase I targeting obesity indication.

**【Q&A Highlights】**
- **Phase III Design**: Requires ~4,500 patients across 2 trials (obesity & diabetes cohorts), 52-week treatment window.
- **Manufacturing**: API secured for Phase III; auto-injector bridging study planned.
- **Oral Dosing**: Phase II trial testing 6 doses (up to 120mg), targeting 13-week weight loss data.
- **Partnerships**: Actively engaging with pharma for NASH, X-ALD, and other programs.


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