FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-40928 Ventyx Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2996852 (St ...

Financial Performance - Ventyx reported a net loss of $22.8 million for Q3 2025, a decrease from a net loss of $35.2 million in Q3 2024, representing a 35% improvement year-over-year [10]. - Total operating expenses for Q3 2025 were $24.9 million, compared to $38.6 million in Q3 2024, reflecting a 35% decrease [10]. - The company’s accumulated deficit increased to $631.6 million as of September 30, 2025, compared to $554.3 million at the end of 2024 [20]. - Ventyx's total assets decreased to $211.5 million as of September 30, 2025, from $276.6 million at the end of 2024 [20]. Research and Development - Research and Development (R&D) expenses for Q3 2025 were $17.7 million, down from $30.6 million in Q3 2024, indicating a 42% reduction [10]. - VTX3232 demonstrated an approximately 80% reduction in hsCRP levels within the first week of treatment in a Phase 2 study, with 70% of patients achieving target hsCRP levels of 2 mg/L or lower [4]. - The Phase 2 study of VTX2735 in recurrent pericarditis is expected to report topline data in Q4 2025 [5]. - VTX3232 showed statistically significant reductions in IL-6 to levels associated with reduced cardiovascular risk (IL-6 ≤1.65 ng/L) in the recent Phase 2 study [4]. Cash and Liquidity - Cash, cash equivalents, and marketable securities totaled $192.6 million as of September 30, 2025, expected to fund operations into at least H2 2026 [5]. - General and Administrative (G&A) expenses were $7.2 million for Q3 2025, slightly down from $7.9 million in Q3 2024 [10].

Core Insights - Ventyx Biosciences, Inc. reported third quarter financial results and highlighted significant progress in its clinical pipeline, particularly with its NLRP3 inhibitors VTX3232 and VTX2735 [1][4] Pipeline Updates and Anticipated Milestones - Ventyx's NLRP3 inhibitor portfolio includes VTX2735, a peripherally restricted NLRP3 inhibitor, and VTX3232, a CNS-penetrant NLRP3 inhibitor [3][10] - The Phase 2 study of VTX3232 in subjects with obesity and cardiovascular risk factors demonstrated a nearly 80% reduction in hsCRP levels within the first week, sustained through week 12, with approximately 70% of patients achieving target hsCRP levels of 2 mg/L or lower [3][4] - VTX3232 also showed significant reductions in IL-6, Lp(a), fibrinogen, and ESR, indicating its potential as a next-generation oral anti-inflammatory therapy for cardiovascular disease [4][5] - Topline data from the Phase 2 study of VTX2735 in recurrent pericarditis is expected in Q4 2025 [4][5] Financial Results - As of September 30, 2025, Ventyx had cash, cash equivalents, and marketable securities totaling $192.6 million, sufficient to fund operations into at least H2 2026 [4][20] - Research and Development (R&D) expenses for Q3 2025 were $17.7 million, a decrease from $30.6 million in Q3 2024 [13][18] - General and Administrative (G&A) expenses were $7.2 million for Q3 2025, compared to $7.9 million in Q3 2024 [13][18] - The net loss for Q3 2025 was $22.8 million, down from $35.2 million in Q3 2024 [13][19]

Core Insights - The biotech sector is experiencing significant momentum, with many clinical-stage and commercial biopharma stocks reaching new 52-week highs due to breakthrough trial data, strategic deals, and earnings surprises [1] Company Summaries - **Metsera Inc. (MTSR)**: A clinical-stage biopharmaceutical company focused on developing hormone analog peptides for obesity and related metabolic diseases. Recently, Novo Nordisk made a $9 billion unsolicited acquisition proposal, which Metsera's board considers superior to its existing agreement with Pfizer [2][3]. Metsera announced positive Phase 2b results for its GLP-1 receptor agonist MET-097i, showing up to 14.1% weight loss after 28 weeks, supporting Phase 3 initiation in late 2025 [4]. The stock rose from $32.35 to a 52-week high of $66.10, a gain of 104.3% [5]. - **Indivior Plc (INDV)**: Develops buprenorphine-based therapies for opioid dependence. The company reported Q3 net income of $42 million, up from $22 million a year ago, with adjusted earnings of $93 million, exceeding Wall Street's expectations [6][7]. The stock increased from $20.86 to a 52-week high of $30.55, reflecting a 46.5% gain [7]. - **Insmed Inc. (INSM)**: Focused on therapies for serious and rare diseases, Insmed reported a Q3 net loss of $370 million but saw net product revenue rise to $142.3 million from $93.4 million last year [8][9]. The company raised its full-year 2025 revenue guidance for ARIKAYCE to $420 million - $430 million, indicating 15% - 18% growth year-over-year [10]. The stock surged from $76.54 to a 52-week high of $194.70, marking a 154.4% gain [10]. - **Ventyx Biosciences Inc. (VTYX)**: A clinical-stage biotech company developing therapies for autoimmune and neurodegenerative diseases. Ventyx reported positive Phase 2 results for its NLRP3 inhibitor VTX3232, showing strong safety and tolerability [11][13]. The stock rose from $3.01 to a 52-week high of $8.52, a gain of over 183% [14]. - **Inhibrx Biosciences Inc. (INBX)**: Focuses on oncology and rare diseases, announcing positive topline results from its ChonDRAgon study for ozekibart in chondrosarcoma [15]. The stock increased from $18.35 to a 52-week high of $83.78, representing a gain of 356.6% [16]. - **ABIVAX Société Anonyme (ABVX)**: Developing therapies for chronic inflammatory diseases, ABIVAX presented positive Phase 3 data for obefazimod in ulcerative colitis [17]. The stock rose from $7.83 to an all-time high of $106.73, marking a significant gain of 1263% [18]. - **Arrowhead Pharmaceuticals Inc. (ARWR)**: Developing RNAi-based therapies, Arrowhead finalized a licensing agreement with Novartis for ARO-SNCA, with financial terms including a $200 million upfront payment [19][20][21]. The stock increased from $29.70 to a 52-week high of $43.33, representing a gain of over 45% [21]. - **Kodiak Sciences Inc. (KOD)**: Focused on retinal diseases, Kodiak announced positive Phase 1b data for KSI-101, showing significant vision improvements [22][23][24]. The stock climbed from $8.98 to a 52-week high of $21.17, delivering a 135.7% gain [22]. - **Arcutis Biotherapeutics Inc. (ARQT)**: Focused on dermatological treatments, Arcutis reported Q3 net income of $7.4 million, a turnaround from a net loss last year, with revenue up 122% year-over-year [25][26]. The stock rose from $14.99 to a 52-week high of $27.08, representing a gain of over 80% [27]. - **Maze Therapeutics Inc. (MAZE)**: Developing precision therapies for various diseases, Maze announced positive Phase 1 results for MZE782 and secured $150 million in a private placement [28][29]. The stock rose from $11.21 to a new 52-week high of $34.29, returning a gain of 206% [29]. - **Supernus Pharmaceuticals Inc. (SUPN)**: Focused on CNS disorders, Supernus is expected to report Q3 earnings of $0.82 per share and revenue of $180.22 million [30][31]. The stock increased from $38.21 to a 52-week high of $57.65, representing a gain of over 50% [31].

Core Insights - Ventyx Biosciences Inc. has announced positive topline results from its Phase 2 study of the oral drug VTX3232, which targets obesity and cardiovascular risk factors [1][3] - The study involved 175 participants and was designed as a randomized, double-blind, placebo-controlled trial [1] - VTX3232 demonstrated safety and tolerability comparable to placebo, with significant reductions in inflammation and other cardiovascular risk biomarkers [2][3] Company Overview - Ventyx Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing oral therapies for autoimmune, inflammatory, and neurodegenerative diseases [4] Study Details - The primary goal of the Phase 2 study was to assess safety and tolerability, while the secondary endpoint focused on the effect on high-sensitivity C-reactive protein (hsCRP) [2] - The drug was found to be safe and well-tolerated across all groups during the 12-week study period [2] - VTX3232 monotherapy showed significant efficacy in reducing inflammation [2][3] Future Plans - Ventyx Biosciences plans to provide updates on the continued development of VTX3232, emphasizing its potential to lower the risk of cardiovascular events by addressing underlying inflammation [3]

Group 1 - The VTX3232 results press release is now available on the company's website, indicating a focus on transparency and accessibility of information [2] - Slides presented during the call will be available on the webcast and subsequently posted on the company's website, emphasizing the company's commitment to providing detailed information to stakeholders [2] Group 2 - The call includes forward-looking statements under the Safe Harbor Act, highlighting the company's proactive approach to communicate potential future developments while acknowledging associated risks and uncertainties [3]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Ventyx Biosciences, Inc. (VTYX) increased by 108% to $8.05 - Brera Holdings PLC (SLMT) rose by 49% to $12.50 - Safe & Green Holdings Corp. (SGBX) gained 39% to $3.18 - American Rebel Holdings, Inc. (AREB) up by 26% to $2.71 - Tango Therapeutics, Inc. (TNGX) increased by 18% to $10.25 - Garrett Motion Inc. (GTX) rose by 14% to $14.30 - ETHZilla Corporation (ETHZ) gained 12% to $17.61 - D-Wave Quantum Inc. (QBTS) increased by 11% to $30.40 - IonQ, Inc. (IONQ) rose by 10% to $61.04 - Megan Holdings Limited (MGN) up by 7% to $2.31 [3] Premarket Losers - Splash Beverage Group, Inc. (SBEV) decreased by 21% to $2.06 - Molina Healthcare, Inc. (MOH) down by 18% to $158.44 - SCHMID Group N.V. (SHMD) fell by 18% to $3.18 - Beyond Meat, Inc. (BYND) decreased by 18% to $2.91 - Agencia Comercial Spirits Ltd (AGCC) down by 16% to $5.07 - Super League Enterprise, Inc. (SLE) fell by 13% to $2.25 - Armata Pharmaceuticals, Inc. (ARMP) decreased by 12% to $5.99 - Applied DNA Sciences, Inc. (BNBX) down by 12% to $4.19 - Ribbon Communications Inc. (RBBN) fell by 12% to $3.49 - Tamboran Resources Corporation (TBN) decreased by 11% to $21.81 [4]

Core Insights - Biotech stocks experienced significant gains in after-hours trading on October 22, 2023, primarily driven by Ventyx Biosciences' positive Phase 2 data, which led to an 88% surge in its stock price [1][2]. Company Performance - Ventyx Biosciences Inc. (VTYX) saw its shares increase by over 88% following the announcement of positive results from its Phase 2 study of VTX3232 for patients with obesity and cardiovascular risk factors [2]. - Medpace Holdings, Inc. (MEDP) reported better-than-expected Q3 results, resulting in an over 18% increase in its stock price during after-hours trading [2]. - Inhibrx Biosciences Inc. (INBX) shares rose over 10% to $34.98 after announcing a live webcast presentation to discuss topline results from the ChonDRAgon study [3]. - SCYNEXIS Inc. (SCYX) shares increased by over 11% to $0.87 [4]. - Acumen Pharmaceuticals Inc. (ABOS) experienced a notable rise of over 24.9% to $2.31 [4]. - Rani Therapeutics Holdings Inc. (RANI) shares were up over 9% at $2.64 [4]. - iBio Inc. (IBIO) shares increased by over 7% to $1.50 [4]. - Chemomab Therapeutics Ltd. (CMMB) shares rose over 7% to $3.32 [4]. - Nautilus Biotechnology Inc. (NAUT) shares increased by over 7% to $1.35 [4]. - ProQR Therapeutics N.V. (PRQR) shares were up over 7% at $2.92 [4]. - Tyra Biosciences Inc. (TYRA) shares increased by over 7% to $15.00 [4]. - Imunon Inc. (IMNN) shares rose over 4% to $4.90 [4].

Ventyx Biosciences Business Update Summary Company Overview - **Company**: Ventyx Biosciences (NasdaqGS: VTYX) - **Focus**: Development of VTX3232, an NLRP3 inhibitor targeting cardiovascular disease and inflammation Key Points from the Call Industry Context - **Cardiovascular Disease**: A significant health issue with over 25 million patients at elevated cardiovascular risk due to high CRP levels (>2 mg/L) [36] - **Market Opportunity**: VTX3232 is positioned as a first-line therapy for patients with atherosclerotic cardiovascular disease, addressing an unmet need for safer oral anti-inflammatory treatments [36][37] VTX3232 Phase 2 Trial Results - **Trial Design**: Double-blind, placebo-controlled trial assessing VTX3232 as a monotherapy and in combination with semaglutide [13] - **Primary Endpoint**: Safety and tolerability; secondary endpoint focused on changes in high-sensitivity C-reactive protein (HSCRP) levels [14] - **Participant Demographics**: 175 individuals, predominantly white and female, with a mean age of 45-50 years and a mean BMI of 36 [17][18] Efficacy Results - **HSCRP Reduction**: - Approximately 80% reduction in HSCRP within the first week, sustained over 12 weeks [6][21] - 69% of participants on VTX3232 monotherapy and 82% in combination with semaglutide achieved HSCRP levels <2 mg/L [26] - **IL-6 and Lipoprotein(a)**: Significant reductions in IL-6 levels to below cardiovascular risk thresholds and approximately 20% reduction in lipoprotein(a) [9][30] - **Liver Inflammation**: Statistically significant reductions in liver inflammation observed via MRI CT1 imaging [33] Safety Profile - **Adverse Events**: VTX3232 was well tolerated, with adverse events comparable to placebo [10][19] - **No Weight Loss**: VTX3232 did not promote weight loss, either alone or in combination with semaglutide [10][32] Mechanism of Action - **NLRP3 Inhibition**: VTX3232 targets the NLRP3 inflammasome, reducing inflammatory cytokines (IL-1, IL-6) and acute phase reactants associated with cardiovascular risk [12][27] Future Directions - **Strategic Partnerships**: Ventyx has a right of first negotiation agreement with Sanofi, which may influence future development and commercialization strategies [57] - **Next Steps**: Plans to explore further cardiovascular indications and potential partnerships for broader market access [57] Expert Commentary - **Clinical Implications**: Experts emphasized the importance of targeting inflammation in cardiovascular disease and the potential of VTX3232 to reduce clinical events by lowering CRP levels [42][43] - **Comparison with Other Treatments**: Discussion on the advantages of VTX3232 over existing treatments like colchicine, highlighting its targeted action and safety profile [44][47] Conclusion - **Overall Assessment**: VTX3232 demonstrates promising efficacy in reducing cardiovascular risk markers with a favorable safety profile, positioning it as a potential first-line therapy for patients with elevated inflammatory markers [34][37]

VTX3232 Phase 2 Trial Results - VTX3232 demonstrated statistically significant decrease in hsCRP of up to 80% within the first week of treatment[11] - A majority of participants achieved hsCRP levels of <2 mg/L at Week 12, a critical threshold for determining CV risk[11] - VTX3232 induced rapid and durable reductions in hsCRP, with ~80% decrease after 1 week of treatment sustained through Week 12[28, 31] - In the modified analysis set, a significant proportion of participants on VTX3232 had hsCRP of <2 mg/L at Week 12[37] - VTX3232 reduces IL-6 levels below CV risk threshold while maintaining immune homeostasis[45] - VTX3232 also Reduced Lipoprotein(a), Fibrinogen, and ESR[46] - VTX3232 decreased liver inflammation at Week 12, with greater effects observed when combined with semaglutide in participants with ≥ 5% baseline liver fat[55] Safety and Tolerability - VTX3232 was safe and well-tolerated in the Phase 2 study, with rates of adverse events comparable to placebo[11, 58] - There was no evidence of increased risk of infection with VTX3232[58] Market Opportunity - There is a vast market opportunity for residual inflammation reduction in CVD, with tens of millions of CV patients globally with residual inflammatory risk[60]