Ventyx Biosciences, Inc. (VTYX
Ventyx Biosciences, Inc. (VTYX Q1 FY2022 earnings call
May 13, 2022 · fiscal period ended 2022-03
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-05-13
Management highlights
• Raju Mohan started by running through the conference agenda, introducing Bill Sandborn as the new President and Chief Medical Officer. • Pipeline updates: - VTX958: Completed Phase 1 single-ascending dose trial, Phase 1 multiple-ascending dose trial ongoing with plan to complete dosing by end of second quarter and provide data update in early Q3; expects to commence Phase 2 trials in second half of 2022. - VTX002: Phase 2 randomized, placebo-controlled clinical trial for moderate-to-severe ulcerative colitis initiated in fourth quarter of 2021, plans to enroll 180 patients with primary endpoint of clinical remission at 13-week time point. - VTX2735: Phase 1 SAD/MAD trial ongoing in healthy volunteers, recently completed dosing, expects top line data by end of Q2; VTX3232, a CNS-penetrant NLRP3 inhibitor, advanced into IND-enabling studies with plan to file IND in fourth quarter of 2022.
Segment performance
In the first quarter of 2022, R&D expenses were $17.4 million compared to $24.6 million in the first quarter of 2021 (the 2021 amount included a $21.7 million noncash in-process R&D expense related to the acquisition of Oppilan and Zomagen subsidiaries). G&A expenses were $5.3 million for the first quarter of 2022 compared to $0.7 million in the first quarter of 2021. Net loss for the first quarter of 2022 was $22.7 million compared to $37.6 million in the first quarter of 2021. Cash, cash equivalents and marketable securities were $273.1 million as of March 31, 2022, and are sufficient to fund operations into the first half of 2024.
Guidance
• Expect R&D expenses to generally trend upwards in 2022 as preparing and launching three Phase 2 trials for VTX958 in second half of the year. • Current cash, cash equivalents and marketable securities sufficient to fund operations into first half of 2024. • Expect to report Phase 2 readouts for psoriasis for VTX958 and ulcerative colitis readout for VTX002 in 2023.
Risks
• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ, including factors discussed in filings with the Securities & Exchange Commission. • Risks related to clinical trial outcomes, such as not achieving expected efficacy or safety profiles, and market competition impacting the success of products.
Q&A highlights
Q: Yasmeen Rahimi of Piper Sandler asked Bill Sandborn about why he joined Ventyx and thoughts on etrasimod's placebo responses and Ventyx's mitigation of placebo response in Phase 2.
A: Bill Sandborn responded that he joined due to belief in transition from biologics to small molecules and Ventyx's potential for best-in-class molecules; on etrasimod, data not fully presented yet, but mentioned variations in trial conduct can affect placebo rates and importance of well-powered trials with close monitoring.
Q: Josh Schimmer of Evercore ISI asked about optimal time to partner each clinical stage program.
A: Raju Mohan stated Ventyx is well capitalized to reach key proof-of-concept readouts and has flexibility to partner or commercialize on own as they move forward.
Q: Michael Yee of Jefferies asked about differentiation of TYK2 in Phase 1 and coverage of IL-12 and IL-23 relative to Stelara.
A: Raju Mohan said they're looking forward to disclosing data in early Q3, focusing on maximizing exposures, covering not just IC50 but IC90 for TYK2 pathways including IL-12, IL-23, and interferon-alpha.
Q: Tiago Fauth of Credit Suisse asked about interpreting safety and tolerability of TYK2 in Phase 1.
A: Raju Mohan explained the molecule's non-JAK activity and focus on maximizing exposures while ensuring safety, expecting to avoid signals seen in other less selective inhibitors.
Q: Oliver McCammon of LifeSci Capital asked about pharmacodynamic markers for NLRP3 inhibitor VTX2735 and benefits vs IL-1 beta blockade.
A: Raju Mohan and Bill Sandborn discussed looking at markers like IL-1beta, SAA, and noted NLRP3 inhibition goes beyond IL-1 beta to include IL-18, potentially with less infection risk than broad IL-1 inhibition.
Q: Jeff Jones of Oppenheimer asked about what makes another S1P program stand out.
A: Raju Mohan mentioned VTX002's potential to differentiate on efficacy and safety, with Bill Sandborn elaborating on dose titration, onset/off rate, and meticulous trial conduct as key factors.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
May 13, 2022Full transcript unavailable for redistribution
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