Ventyx Biosciences(VTYX) - 2025 Q2 - Quarterly Results

Report Introduction and Executive Summary Q2 2025 Highlights and Corporate Progress Ventyx announced Q2 2025 results, highlighting clinical pipeline progress and a robust financial position Company Overview Ventyx is a clinical-stage biopharmaceutical firm developing oral therapies for autoimmune and neurodegenerative diseases - Ventyx Biosciences is a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for autoimmune, inflammatory, and neurodegenerative diseases[2][11] CEO Commentary and Key Progress The CEO highlighted key trial enrollments and positive Phase 2a data for the company's NLRP3 inhibitor programs - VTX2735 Phase 2 trial in recurrent pericarditis continues patient enrollment, targeting NLRP3 and Caspase-1 inflammasome inhibition[3] - VTX3232 Phase 2 study in obese participants with cardiometabolic risk factors is fully enrolled, with topline results anticipated in early Q4 2025[3] - VTX3232 Phase 2a trial in early-stage Parkinson's disease met primary objectives, showing safety, tolerability, high CSF drug exposure, and potent suppression of NLRP3-related biomarkers[3] Summary of Anticipated Milestones and Financial Position The company anticipates key data readouts in Q4 2025 and has a cash runway into at least H2 2026 - Positive topline Phase 2a biomarker data position VTX3232 as a potential disease-modifying therapy for Parkinson's disease[6] - Data from the Phase 2 study of VTX2735 in recurrent pericarditis is expected in Q4 2025[6] - Phase 2 study of VTX3232 in obesity and cardiometabolic risk factors is fully-enrolled, with topline data expected in early Q4 2025[6] - Current cash balance is expected to fund planned operations into at least H2 2026[6] Cash, Cash Equivalents and Marketable Securities | As of Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $209.0 | Pipeline Updates and Anticipated Milestones NLRP3 Inhibitor Portfolio The NLRP3 inhibitor portfolio features two Phase 2 candidates with significant data readouts expected in Q4 2025 - Ventyx's NLRP3 inhibitor portfolio includes VTX2735, a peripherally restricted NLRP3 inhibitor, and VTX3232, a central nervous system (CNS)-penetrant NLRP3 inhibitor[4] VTX3232 in Parkinson's Disease The Phase 2a trial for VTX3232 in Parkinson's disease demonstrated safety, high CSF exposure, and robust biomarker reductions - Phase 2a trial of VTX3232 in early-stage Parkinson's disease met safety and tolerability goals, with no drug-related treatment-emergent adverse events observed[4] - VTX3232 demonstrated high drug exposures with steady state concentrations in CSF and plasma exceeding the IC90 for NLRP3 inhibition by ≥3-fold for 24-hours post-dose[4] - Showed clear evidence of target engagement in plasma and CSF with robust reductions in downstream biomarkers of NLRP3 inhibition, such as IL-1β, IL-6 and high-sensitivity C-reactive protein (hsCRP)[4] - VTX3232 treatment was associated with improved motor and non-motor symptoms of Parkinson's disease, as measured by the MDS-UPDRS[4] - The Company initiated planning discussions for a placebo-controlled, Phase 2 trial in Parkinson's disease and potentially in additional neurodegenerative disorders such as Alzheimer's disease[4] - Ventyx will present the Phase 2a VTX3232 results at the International Congress of Parkinson's Disease and Movement Disorders (Oct 5-9) and the Michael J Fox Foundation's Parkinson's Disease Therapeutics Conference (Oct 16)[5] VTX2735 in Recurrent Pericarditis The ongoing Phase 2 trial for VTX2735 in recurrent pericarditis has topline results expected in Q4 2025 - The ongoing Phase 2, multicenter, 30-patient, open-label trial is evaluating VTX2735, dosed twice daily, in patients with recurrent pericarditis over a 6-week primary treatment period[7] - Key endpoints include safety, change in the numerical rating scale (NRS) pain score, and change in hsCRP[7] - Ventyx expects to release topline results from this study in Q4 2025[6][7] - VTX2735 has the potential to streamline treatment for patients with recurrent pericarditis by treating active flares and preventing future recurrences with an oral agent[7] VTX3232 in Cardiometabolic Diseases The fully enrolled Phase 2 trial of VTX3232 in cardiometabolic diseases will yield data in Q4 2025 - The Phase 2, multicenter, double-blind, placebo-controlled trial of VTX3232 in participants with obesity and cardiometabolic risk factors is fully-enrolled[7] - Subjects are randomized to one of four groups for a 12-week primary treatment period: monotherapy placebo, monotherapy VTX3232, combination semaglutide + placebo, or combination semaglutide + VTX3232[7] - Key endpoints include safety and change in hsCRP, with exploratory endpoints assessing biomarkers of inflammation and cardiometabolic disease, as well as imaging for body composition and liver fat[7] - Data from the Phase 2 trial are expected in early Q4 2025 and will guide future development of the Company's NLRP3 inhibitors in cardiometabolic diseases[6][7] Inflammatory Bowel Disease (IBD) Portfolio The IBD portfolio includes two Phase 2 compounds with positive data, for which the company is exploring partnerships - Ventyx's inflammatory bowel disease portfolio includes two Phase 2 compounds: tamuzimod (VTX002), an S1P1R modulator, and VTX958, a TYK2 inhibitor[13] Tamuzimod (Ulcerative Colitis) Phase 2 data for Tamuzimod showed robust remission rates, and Ventyx is exploring partnership opportunities - Phase 2 induction data for Tamuzimod (S1P1R Modulator) in ulcerative colitis, published in The Lancet (January 2025), showed robust clinical and endoscopic remission rates compared to placebo[12] - Tamuzimod's efficacy and safety profile could position it as the backbone of future combination regimens with another oral or biologic agent in IBD[12] - The Company is exploring partnership opportunities for tamuzimod in ulcerative colitis[12] VTX958 (Crohn's Disease) Phase 2 data for VTX958 indicated disease-modifying benefits, and the company is exploring development options - Phase 2 data suggest that VTX958 (TYK2 Inhibitor) may have disease-modifying benefits in Crohn's disease[12] - Presentation of results at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO) in February 2025 demonstrated a robust, dose-dependent endoscopic response at Week 12 for VTX958 compared to placebo[12] - Showed a greater magnitude of reduction in two key biomarkers of inflammation, CRP and fecal calprotectin[12] - Ventyx is exploring multiple options for continued development of VTX958 in Crohn's disease, including partnership opportunities[9] Second Quarter Financial Results Key Financial Highlights The company reported a reduced net loss for Q2 2025, driven by lower expenses, and maintains a strong cash position - Current cash, cash equivalents, and marketable securities are believed to be sufficient to fund planned operations into at least H2 2026[12] Key Financial Highlights (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and Development (R&D) expenses | $22.3 | $27.8 | -$5.5 (-19.8%) | | General and Administrative (G&A) expenses | $7.1 | $7.9 | -$0.8 (-10.1%) | | Net loss | $27.0 | $32.0 | -$5.0 (-15.6%) | Cash Position | As of Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $209.0 | Condensed Consolidated Statements of Operations and Comprehensive Loss The company's net loss decreased for both the second quarter and first half of 2025 compared to the prior year Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | Metric | Three months ended June 30, 2025 (in thousands) | Three months ended June 30, 2024 (in thousands) | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,266 | $27,805 | $45,164 | $61,552 | | General and administrative | $7,067 | $7,907 | $14,266 | $15,928 | | Total operating expenses | $29,333 | $35,712 | $59,430 | $77,480 | | Loss from operations | $(29,333) | $(35,712) | $(59,430) | $(77,480) | | Interest income | $(2,367) | $(3,783) | $(5,033) | $(7,010) | | Other expense | $21 | $21 | $30 | $52 | | Total other (income) expense | $(2,346) | $(3,762) | $(5,003) | $(6,958) | | Net loss | $(26,987) | $(31,950) | $(54,427) | $(70,522) | | Unrealized loss on marketable securities | $(152) | $(119) | $(266) | $(181) | | Foreign currency translation | $246 | $(8) | $357 | $(17) | | Comprehensive loss | $(26,893) | $(32,077) | $(54,336) | $(70,720) | | Net loss per share (basic and diluted)| $(0.38) | $(0.45) | $(0.76) | $(1.07) | | Shares used to compute net loss per share | 71,198,652 | 70,554,718 | 71,165,440 | 66,192,348 | Selected Condensed Consolidated Balance Sheet Data The balance sheet shows a decrease in cash, total assets, and stockholders' equity as of June 30, 2025 Selected Condensed Consolidated Balance Sheet Data (Unaudited) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $208,959 | $252,943 | | Working capital | $207,853 | $216,849 | | Total assets | $230,009 | $276,563 | | Total liabilities | $20,626 | $22,518 | | Accumulated deficit | $(608,736) | $(554,309) | | Total stockholders' equity | $209,383 | $254,045 | About Ventyx Biosciences Ventyx is a clinical-stage biopharmaceutical company developing oral therapies for autoimmune and inflammatory diseases - Ventyx Biosciences is a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for patients with autoimmune, inflammatory, and neurodegenerative diseases[11] - The company utilizes expertise in medicinal chemistry, structural biology, and immunology for the discovery of differentiated oral small molecule therapeutics for conditions with high unmet medical need[11] - Extensive experience in clinical development allows for the rapid progression of drug candidates through clinical trials[11] - The portfolio includes NLRP3 inhibitors (VTX2735, VTX3232) and inflammatory bowel disease compounds (tamuzimod, VTX958)[13] Forward-Looking Statements This section outlines forward-looking statements and associated risks and uncertainties that could affect future results - Statements in this press release regarding matters that are not historical facts are forward-looking statements, based on Ventyx's current beliefs and expectations[14] - Forward-looking statements include the potential of Ventyx's product candidates (VTX2735, VTX3232) to emerge as best-in-class NLRP3 inhibitors, the timing of reporting data from Phase 2 trials in Q4 2025, and the expected timeframe for funding Ventyx's operating plan with current cash into at least H2 2026[14] - Actual results may differ from those set forth due to risks and uncertainties inherent in Ventyx's business, including potential delays in clinical trials, dependence on third parties, disruptions in the supply chain, and regulatory developments[15] - Other risks include economic uncertainty, unexpected adverse side effects or inadequate efficacy, Ventyx's ability to obtain and maintain intellectual property protection, and the use of capital resources sooner than expected, as described in SEC filings[15] - Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of the report, and Ventyx undertakes no obligation to update such statements[16] Investor Relations Contact This section provides contact information for investor relations inquiries - Investor Relations Contact: Joyce Allaire, Managing Director, LifeSci Advisors, IR@ventyxbio.com[17]