Ventyx Biosciences, Inc. Q1 FY2024 earnings call

• Pipeline updates:
  • VTX3232: Phase I results in adult healthy volunteers showed positive top-line, CNS-penetrant, once-daily dosing, Phase II-ready; plans for Phase IIa in early Parkinson's disease and obese patients with cardiovascular risk factors.
  • VTX2735: Phase II results in CAPS showed efficacy comparable to IL-1 biologics, favorable safety profile; plans for cardiovascular and other indications.
  • IBD assets: VTX002 Phase II data positive, open-label extension reinforcing results, Phase III ready; VTX958 Phase II trial in Crohn's disease ongoing, protocol amended, enrollment completed, results expected in early second half of 2024.

R&D expenses in Q1 2024 were $33.7 million compared to $35.4 million in Q1 2023. G&A expenses in Q1 2024 were $8 million vs $7.1 million in Q1 2023. Net loss in Q1 2024 was $38.6 million vs $38.9 million in Q1 2023. Cash, cash equivalents, and marketable securities balance was $302.6 million as of March 31, 2024. Net cash used in operating activities in Q1 was $47.6 million, primarily due to prepaid expenses increase and accrued expenses decrease. Expect operating expenses and cash flows to decrease in Q2 2024 and remain lower for rest of 2024.

• Operating expenses and cash flows expected to decrease in Q2 2024 and beyond due to wind-down of Phase II trial programs.
  • Current cash reserves sufficient to support operations into at least the second half of 2026.

Forward-looking statements subject to risks and uncertainties, detailed in Form 10-Q for the quarter ended March 31, 2024.

Q: On CNS NLRP3 program, what's promising for 28-day study, bar, and comparison to other options; mouse data presentation plans?

A: Raju Mohan said data to be reported in late second quarter, mouse study results to be compiled, stay tuned; 28-day study expects measurable weight loss like competitor data.

Q: Tox package for VTX3232, steps for Phase II trial in obese patients, rate-limiting steps for VTX2735 cardiovascular trials, partnership interest in VTX002, End of Phase 2 meeting details?

A: Tox supports 28-day study, cardiovascular trial planning standard process, positive End of Phase 2 meeting with FDA, partnerships being pursued.

Q: Parkinson's neurodegenerative markers, obesity study design, patient exclusion?

A: Planning biomarker and imaging components, 28-day trial not expecting motor symptom effects, longer trial later; obesity study to report results, biomarkers like IL-1 beta, neurofilament light chain.

Q: CD program VTX958, Phase II data expectations?

A: Primary endpoint change in CDAI score, secondary endpoints endoscopic response, aiming for statistical significance in line with approved drugs.

Q: Human dose equivalent in mouse study, 2735 potential in HS?

A: Mouse studies for proof-of-concept, not for human dose determination; potential for 2735 in HS due to NLRP3 mechanism.

Q: Phase IIb de-risking for 3232, differentiation from Natera in Parkinson's?

A: VTX3232 well-behaved, QD dosing, low doses, expected biomarker effects, own calibration for Phase IIa.

Q: Obesity preclinical study methodology vs Natera, conclusions?

A: No learnings from competitor mouse study, standard obese mouse models, secondary endpoints like liver weight, lipids; models used for drug development.

Q: 2735 in recurrent pericarditis, MACE prevention, unmet need?

A: Oral option for recurrent pericarditis, better than injectable therapies, addressing unmet need in cardiovascular indications.