Viking Therapeutics, Inc. Q3 FY2024 earnings call

• Clinical highlights: Positive results from Phase 2 VENTURE trial for VK2735 subcutaneous, initial Phase 1 trial for oral VK2735, Phase 2b VOYAGE study for VK2809 in NASH/fibrosis, Phase 1b trial for VK0214 in X-ALD, and new amylin agonist program for obesity.
• Pipeline progress: Preparing for end of Phase 2 meeting with FDA for VK2735 subcutaneous, planning Phase 3 study; preparing to present oral VK2735 data at ObesityWeek and initiate 13-week Phase 2 study; evaluating next steps for VK2809 post-FDA responses; awaiting full data on VK0214.
• Staff expansion: Actively adding personnel in regulatory affairs, clinical development, manufacturing, etc., to support trials.

For the three months ended September 30, 2024, research and development expenses were $22.8 million, compared to $18.4 million in the same period of 2023. General and administrative expenses were $13.8 million, versus $8.9 million in 2023. Net loss was $24.9 million or $0.22 per share. For the nine months ended September 30, 2024, research and development expenses were $70.7 million compared to $43.3 million in 2023. General and administrative expenses were $34 million versus $28.2 million in 2023. Net loss was $74.5 million or $0.69 per share. Cash, cash equivalents, and short-term investments at September 30, 2024, were $930 million, up from $362 million on December 31, 2023.

• For subcutaneous VK2735: Actively preparing for end of Phase 2 meeting with FDA later this quarter, then planning to initiate Phase 3 study.
• For oral VK2735: Preparing to present data at ObesityWeek and initiate 13-week Phase 2 study later in the year.
• For VK2809: Evaluating next steps following recent FDA responses regarding registration path.
• For VK0214: Awaiting full data review to determine next steps.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from reported results, as mentioned in the opening remarks about forward-looking statements under the safe harbor provisions.

Q: Regarding the end of Phase 2 meeting for subcu VK2735, what are things to iron out with FDA and how quickly start Phase 3? Also, amylin agonist type.

A: With end of Phase 2 meeting, will review proposed protocol, doses, trial size; monthly dosing PK data supports feasibility, amylin agonist is dual amylin and calcitonin receptor agonist benchmarked against pramlintide/cagrilintide.

Q: Will we see PK data for monthly dosing in VK2735 and incorporate into Phase 3? Oral dosing regimens?

A: PK data on monthly dosing in VENTURE poster supports monthly dosing, Phase 3 likely standalone for monthly; oral dosing regimen details to be disclosed closer to 13-week Phase 2 study initiation.

Q: Protocol questions on Phase 3 study for VK2735 subcu, active control arm, amylin clinical development strategy, oral dosing longer dosing periods.

A: Phase 3 planned as placebo-controlled; amylin development to combine with other mechanisms for enhanced efficacy; oral dosing longer periods based on Phase 1 study observations of continued activity post-dosing.

Q: Clarification on oral 2735 dose escalation, manufacturing capacity for trials and commercial, auto-injector for subcu Phase 3, X-ALD study phase and next steps.

A: Oral 2735 dosed up to 100 mg, manufacturing has sufficient supplies for current trials and working on long-term agreements; subcu Phase 3 will use auto-injector; X-ALD study is Phase 1b, next step likely registration study focusing on functional/quality of life endpoints.