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]

Core Insights - VTX3232 demonstrated significant reductions in cardiovascular risk factors, particularly in inflammation markers, with additional benefits when combined with semaglutide [2][4][6] Study Results - The Phase 2 study involved 175 participants and focused on the safety, tolerability, and effects of VTX3232 on inflammation and cardiovascular risk factors [2][12] - VTX3232 monotherapy achieved a 78% reduction in hsCRP at week 12 compared to a 3% increase in the placebo group (p<0.0001) [2][14] - In the full analysis set, VTX3232 showed a 64% reduction in hsCRP at week 12 compared to the placebo [2][14] - 69% of participants reached target hsCRP levels of less than 2 mg/L [14] - Statistically significant reductions in IL-6, Lp(a), fibrinogen, and liver inflammation were observed [2][14] - VTX3232 did not result in weight loss as a monotherapy or in combination with semaglutide [2][14] Safety and Tolerability - VTX3232 was found to be safe and well tolerated, with adverse event rates comparable to placebo [3][9][14] - Treatment emergent adverse events (TEAEs) were balanced between the VTX3232 and placebo groups [14] Implications for Cardiovascular Disease - VTX3232 represents a transformative opportunity in treating cardiovascular disease by targeting the NLRP3 inflammasome, which is linked to atherosclerosis and related disorders [11] - The combination of VTX3232 and semaglutide may serve as a powerful adjunct therapy to GLP-1 treatment [6][11] Future Developments - The company plans to provide updates on the continued development of VTX3232 in future disclosures [11]

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Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - AGM Group Holdings Inc. (AGMH) increased by 185% to $6.36 [3] - AlphaVest Acquisition Corp (ATMV) rose by 77% to $26.80 [3] - Brera Holdings PLC (BREA) saw a 20% increase to $30.00 [3] - Asset Entities Inc. (ASST) gained 18% to $4.54 [3] - 22nd Century Group, Inc. (XXII) also increased by 18% to $2.08 [3] - Millennium Group International Holdings Limited (MGIH) rose by 16% to $2.84 [3] - Robo.ai Inc. (AIIO) increased by 11% to $2.17 [3] - Butterfly Network, Inc. (BFLY) saw a 10% rise to $2.10 [3] - GrafTech International Ltd. (EAF) increased by 9% to $13.91 [3] - Cardlytics, Inc. (CDLX) rose by 8% to $2.99 [3] Premarket Losers - ECD Automotive Design, Inc. (ECDA) decreased by 14% to $3.70 [4] - Champions Oncology, Inc. (CSBR) fell by 8% to $6.11 [4] - Beam Global (BEEM) saw an 8% decline to $2.79 [4] - Fathom Holdings Inc. (FTHM) decreased by 8% to $2.19 [4] - Ventyx Biosciences, Inc. (VTYX) fell by 7% to $2.20 [4] - SciSparc Ltd. (SPRC) decreased by 6% to $4.35 [4] - Lightwave Logic, Inc. (LWLG) fell by 6% to $3.45 [4] - Jasper Therapeutics, Inc. (JSPR) decreased by 6% to $2.43 [4] - StableX Technologies, Inc. (SBLX) fell by 5% to $5.67 [4] - Galecto, Inc. (GLTO) decreased by 5% to $2.70 [4]

Financial Data and Key Metrics Changes - The company is focusing on the inflammasome space, particularly targeting NLRP3, with two compounds in clinical development [4][6] - VTX2735 has completed a successful trial in early Parkinson's patients and is moving towards a longer phase two efficacy trial [5][6] Business Line Data and Key Metrics Changes - VTX2735 is being developed for multiple indications, including recurrent pericarditis (RP) and obesity, with readouts expected in the fourth quarter [5][6] - The company has seen a successful drop in inflammatory markers such as HSCRP in trials, indicating the efficacy of their compounds [11][14] Market Data and Key Metrics Changes - The market for NLRP3 inhibitors is heating up, with increased competition indicating a resurgence of interest in this target [8][25] - The company is positioning itself to capture market share by offering an oral alternative to existing biologics, which are often expensive and require injections [32][33] Company Strategy and Development Direction - The company aims to establish itself as a leader in NLRP3 biology, with a focus on developing oral therapies that can compete with existing treatments [52][54] - Future expansion opportunities include exploring indications such as myocarditis and potentially other rheumatic diseases [38][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of their compounds, particularly in the context of unmet medical needs in inflammatory diseases [53][54] - The company believes that the data generated will help educate investors and the market about the potential of NLRP3 inhibitors [55] Other Important Information - The company is conducting a weight loss trial with VTX2735, which was not initially planned but has shown promising results in preclinical studies [50][51] - The company is also exploring partnerships to enhance the development and commercialization of its compounds [49] Q&A Session Summary Question: How does VTX2735 compare to other NLRP3 inhibitors? - The company believes VTX2735 is the best peripheral compound available, designed to avoid issues seen with earlier compounds [8][9] Question: What are the key learnings from the CAPS trial? - The trial demonstrated that VTX2735 effectively reduced inflammatory markers and improved patient symptoms, validating its mechanism of action [14][17] Question: What endpoints are critical for the phase two trial? - The primary endpoints include a significant drop in HSCRP and pain scores, with a focus on achieving competitive results compared to existing therapies [26][28] Question: What is the expected timeline for moving into the next phase of trials? - The company anticipates a typical transition from phase two to phase three trials to take about six to nine months [30][31] Question: How does the company plan to differentiate its product in the market? - The company aims to provide an oral alternative to existing biologics, which could appeal to patients seeking less invasive treatment options [32][33]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Ventyx Biosciences, Inc., including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, statements of cash flows, and accompanying notes, covering the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's total assets decreased from $276.6 million at December 31, 2024, to $230.0 million at June 30, 2025, primarily due to a reduction in marketable securities. Total liabilities also decreased, while total stockholders' equity saw a decline | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Total Assets | $230,009 | $276,563 | | Current Marketable Securities | $176,658 | $190,062 | | Long-term Marketable Securities| $— | $35,621 | | Total Liabilities | $20,626 | $22,518 | | Total Stockholders' Equity | $209,383 | $254,045 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $27.0 million for the three months ended June 30, 2025, an improvement from $32.0 million in the prior year period. For the six months, net loss was $54.4 million, down from $70.5 million, driven by reduced research and development expenses | Metric | Three months ended June 30, 2025 (in thousands) | Three months ended June 30, 2024 (in thousands) | | :------------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | Total Operating Expenses | $29,333 | $35,712 | | Net Loss | $(26,987) | $(31,950) | | Net Loss Per Share (Basic and Diluted) | $(0.38) | $(0.45) | | Metric | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :------------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | Total Operating Expenses | $59,430 | $77,480 | | Net Loss | $(54,427) | $(70,522) | | Net Loss Per Share (Basic and Diluted) | $(0.76) | $(1.07) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $254.0 million at December 31, 2024, to $209.4 million at June 30, 2025, primarily due to the accumulated net loss, partially offset by stock-based compensation expense and foreign currency translation adjustments | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Total Stockholders' Equity | $209,383 | $254,045 | | Accumulated Deficit | $(608,736) | $(554,309) | - Stock-based compensation expense for the six months ended June 30, 2025, was **$9,606 thousand**[72](index=72&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to $47.0 million for the six months ended June 30, 2025, from $72.2 million in the prior year. Investing activities provided $51.6 million in cash in 2025, a significant change from using $33.8 million in 2024, mainly due to marketable securities maturities. Financing activities provided minimal cash in 2025 compared to $95.3 million in 2024 due to a private placement | Cash Flow Activity (Six months ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :-------------------------------------------- | :------------------ | :------------------ | | Net cash used in operating activities | $(46,995) | $(72,163) | | Net cash provided by (used in) investing activities | $51,607 | $(33,755) | | Net cash provided by financing activities | $68 | $95,278 | | Cash, cash equivalents and restricted cash, end of period | $33,276 | $41,900 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the unaudited condensed consolidated financial statements, covering the company's organization, significant accounting policies, fair value measurements, balance sheet details, commitments, stockholders' equity, leases, stock-based compensation, net loss per share, related party transactions, and segment information [1. Organization and Business](index=10&type=section&id=1.%20Organization%20and%20Business) Ventyx Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for autoimmune, inflammatory, and neurodegenerative diseases, incorporated in Delaware in November 2018 - Ventyx Biosciences, Inc. is a clinical-stage biopharmaceutical company[31](index=31&type=chunk) - The company develops innovative oral therapies for **autoimmune, inflammatory, and neurodegenerative diseases**[31](index=31&type=chunk) - Ventyx was incorporated in Delaware in November 2018[31](index=31&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) The financial statements are prepared in accordance with U.S. GAAP and SEC regulations for interim information, with no changes to significant accounting policies from the prior annual report. The company provides specific reconciliations for cash and cash equivalents and details on net loss per share calculation - Financial statements are prepared in accordance with U.S. GAAP and SEC rules for interim financial information[33](index=33&type=chunk) - There have been no changes to the company's significant accounting policies from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[34](index=34&type=chunk) | Cash, Cash Equivalents and Restricted Cash (in thousands) | June 30, 2025 | June 30, 2024 | | :-------------------------------------------------------- | :------------ | :------------ | | Cash and cash equivalents | $32,301 | $40,925 | | Restricted cash | $975 | $975 | | Total cash, cash equivalents and restricted cash | $33,276 | $41,900 | [Recent Accounting Pronouncements](index=11&type=section&id=Recent%20Accounting%20Pronouncements) The company is evaluating the impact of ASU 2023-09 (Income Tax Disclosures) and ASU 2024-03 (Expense Disaggregation Disclosures), both not yet adopted. ASU 2023-07 (Segment Reporting) was adopted in January 2024 with no significant impact - ASU 2023-09 (Income Taxes): Effective for annual periods beginning after December 15, **2024**; impact on financial statements is currently under assessment[39](index=39&type=chunk) - ASU 2024-03 (Expense Disaggregation Disclosures): Effective for annual periods beginning after December 15, **2026**; impact on financial statement disclosures is currently under evaluation[40](index=40&type=chunk) - ASU 2023-07 (Segment Reporting): Adopted for the annual reporting period beginning January 1, **2024**; had no significant impact on financial statement disclosures[41](index=41&type=chunk) [3. Fair Value Measurements](index=11&type=section&id=3.%20Fair%20Value%20Measurements) The company measures financial assets and liabilities at fair value on a recurring basis, primarily categorizing cash equivalents and marketable securities into Level 1 (quoted prices in active markets) and Level 2 (observable inputs other than Level 1). There were no transfers between fair value levels during the reported periods - Fair value hierarchy categorizes inputs into Level 1 (quoted prices in active markets), Level 2 (observable inputs), and Level 3 (unobservable inputs)[42](index=42&type=chunk)[43](index=43&type=chunk) | Total Assets at Fair Value (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Level 1 | $85,337 | $72,949 | | Level 2 | $113,980 | $166,272 | | Total Assets | $199,317 | $239,221 | - No transfers between Level 1, Level 2, and Level 3 occurred during the six months ended June 30, 2025, and 2024[44](index=44&type=chunk) [Fair Value Measurements-Recurring Basis](index=12&type=section&id=Fair%20Value%20Measurements-Recurring%20Basis) As of June 30, 2025, marketable securities totaled $176.7 million, with U.S. Treasury securities ($67.7M) and commercial paper ($73.2M) being the largest components. The company held 26 marketable securities in an unrealized loss position, all for less than 12 months, and determined these losses were not credit-related | Marketable Securities (in thousands) | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------------- | :----------------------- | :--------------------------- | | U.S. Treasury securities | $67,670 | $59,411 | | U.S. government agency securities | $20,753 | $34,882 | | Corporate debt securities | $8,012 | $18,882 | | Commercial paper | $73,208 | $104,588 | | Asset backed securities | $7,015 | $7,920 | | Total marketable securities | $176,658 | $225,683 | - As of June 30, 2025, **twenty-six** available-for-sale marketable securities were in an unrealized loss position, all for less than **12 months**[47](index=47&type=chunk) - The company believes none of the unrealized losses are the result of a credit loss as of June 30, 2025, and did not record an allowance for credit losses[49](index=49&type=chunk) [4. Consolidated Balance Sheet Details](index=14&type=section&id=4.%20Consolidated%20Balance%20Sheet%20Details) This section provides details on property and equipment, net, and accrued expenses. Property and equipment, net, decreased to $0.5 million at June 30, 2025, from $0.6 million at December 31, 2024. Accrued expenses increased to $9.4 million from $8.6 million, primarily due to higher accrued clinical trial costs | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Property and equipment, net | $549 | $614 | | Accrued expenses | $9,418 | $8,594 | [Property and Equipment, net](index=14&type=section&id=Property%20and%20Equipment,%20net) Property and equipment, net, decreased to $0.5 million at June 30, 2025, from $0.6 million at December 31, 2024. Construction in progress increased significantly from $15 thousand to $82 thousand | Property and Equipment (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Property and equipment, net | $549 | $614 | | Construction in progress | $82 | $15 | [Accrued Expenses](index=14&type=section&id=Accrued%20Expenses) Accrued expenses increased to $9.4 million at June 30, 2025, from $8.6 million at December 31, 2024. This increase was primarily driven by a substantial rise in accrued clinical trial costs from $1.6 million to $4.2 million, partially offset by a decrease in accrued payroll liabilities | Accrued Expenses (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Accrued research and development costs | $802 | $646 | | Accrued clinical trial costs | $4,176 | $1,575 | | Accrued payroll liabilities | $3,403 | $5,347 | | Other accrued liabilities | $873 | $943 | | Accrued related party liabilities | $164 | $83 | | Total accrued expenses | $9,418 | $8,594 | [5. Commitments and Contingencies](index=15&type=section&id=5.%20Commitments%20and%20Contingencies) The company is not aware of any pending legal proceedings expected to materially impact its financial position. Two previously filed lawsuits, a securities class action and a shareholder derivative action, both related to the VTX958 trial results, were voluntarily dismissed in February 2025 - The company is not aware of any pending legal proceedings expected to have a material impact on its financial position or results of operations[53](index=53&type=chunk) - A putative securities class action (Yuksel v. Ventyx Biosciences, Inc., et al.) was voluntarily dismissed without prejudice on February 10, **2025**[54](index=54&type=chunk) - A shareholder derivative action (Schwing v. Mohan, et al.) was voluntarily dismissed without prejudice on February 24, **2025**[55](index=55&type=chunk) [6. Stockholders' Equity](index=15&type=section&id=6.%20Stockholders'%20Equity) This section details changes in stockholders' equity, including a March 2024 private placement of common stock raising $95.0 million net, and a September 2024 private placement of Series A non-voting convertible preferred stock to Sanofi, generating $26.6 million net proceeds | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total Stockholders' Equity | $209,383 | $254,045 | [March 2024 Private Placement](index=15&type=section&id=March%202024%20Private%20Placement) In March 2024, the company issued 11,174,000 shares of common stock at $8.95 per share, generating approximately $95.0 million in net proceeds - Date of private placement: March 11, **2024**[56](index=56&type=chunk) - Issued **11,174,000 shares** of common stock at **$8.95 per share**[56](index=56&type=chunk) - Received approximately **$95.0 million** in net proceeds[56](index=56&type=chunk) [September 2024 Issuance of Series A Non-Voting Convertible Preferred Stock from Private Placement](index=15&type=section&id=September%202024%20Issuance%20of%20Series%20A%20Non-Voting%20Convertible%20Preferred%20Stock%20from%20Private%20Placement) In September 2024, the company issued 70,601 shares of Series A non-voting convertible preferred stock to Sanofi for gross proceeds of $27.0 million ($26.6 million net). Each share is convertible into 100 common shares at $3.8243 per common share. Sanofi also received a right of first negotiation for VTX3232 - Date of private placement: September 23, **2024**[57](index=57&type=chunk) - Issued **70,601 shares** of Series A non-voting convertible preferred stock to Aventis Inc. (Sanofi)[57](index=57&type=chunk) - Gross proceeds of approximately **$27.0 million**; net proceeds of approximately **$26.6 million**[57](index=57&type=chunk)[58](index=58&type=chunk) - Each preferred share is convertible into **100 shares** of common stock at an as-converted price of **$3.8243 per common share**[57](index=57&type=chunk) - Granted Sanofi a right of first negotiation (ROFN) for VTX3232, the company's CNS-penetrant NLRP3 inhibitor[58](index=58&type=chunk) [ATM Sales Agreement](index=16&type=section&id=ATM%20Sales%20Agreement) The company has an At-The-Market (ATM) Sales Agreement with Jefferies for up to $150.0 million in common stock sales. No shares were issued under this agreement during the six months ended June 30, 2025, or the year ended December 31, 2024 - Sales Agreement with Jefferies allows for up to **$150.0 million** in common stock sales[59](index=59&type=chunk) - No **shares** of common stock were issued under the Sales Agreement during the six months ended June 30, 2025, or the year ended December 31, 2024[59](index=59&type=chunk) [Common Stock](index=16&type=section&id=Common%20Stock) The company is authorized to issue up to 900,000,000 shares of common stock with a $0.0001 par value. As of June 30, 2025, 71,234,510 shares were issued and outstanding - Authorized to issue up to **900,000,000 shares** of common stock with a par value of **$0.0001**[60](index=60&type=chunk) - **71,234,510 shares** of common stock were issued and outstanding as of June 30, 2025[17](index=17&type=chunk) [Series A Preferred Stock](index=16&type=section&id=Series%20A%20Preferred%20Stock) The company is authorized to issue up to 100,000,000 shares of preferred stock. As of June 30, 2025, 70,601 shares of Series A non-voting convertible preferred stock were issued and outstanding, with specific powers, preferences, rights, qualifications, limitations, and restrictions detailed in the Certificate of Designations - Authorized to issue up to **100,000,000 shares** of preferred stock with a par value of **$0.0001**[61](index=61&type=chunk) - **70,601 shares** of Series A non-voting convertible preferred stock were issued and outstanding as of June 30, 2025[17](index=17&type=chunk) - The powers, preferences, rights, qualifications, limitations, and restrictions of the Series A Preferred Stock are set forth in the Certificate of Designations[61](index=61&type=chunk) [7. Leases](index=16&type=section&id=7.%20Leases) The company's headquarters lease in San Diego commenced in July 2023, with a term ending July 2031, involving annual payments of approximately $2.0 million with 3% annual increases. A Ghent, Belgium lease expired in June 2024 but was extended to June 2026. Two Encinitas, California leases were terminated in February 2024 - San Diego headquarters lease commenced July 2023, term ends July 31, 2031, with approximately **$2.0 million** annual payments and **3%** annual increases[62](index=62&type=chunk) - Ghent, Belgium lease expired June 30, 2024, and was extended through June 30, 2026[63](index=63&type=chunk) - Two non-cancellable leases for office facilities in Encinitas, California, were terminated in February 2024[64](index=64&type=chunk) - Weighted average remaining lease term was approximately **6.1 years** and the discount rate was **10.1%** at June 30, 2025[66](index=66&type=chunk) [Lease Terminations](index=16&type=section&id=Lease%20Terminations) In February 2024, the company terminated two non-cancellable leases for office facilities in Encinitas, California, writing off $0.8 million in ROU assets and $0.9 million in operating lease liabilities - In February 2024, the company entered into two separate lease termination agreements for Encinitas office facilities[64](index=64&type=chunk) - Wrote off **$0.8 million** in ROU assets and **$0.9 million** in operating lease liabilities associated with the terminated leases[65](index=65&type=chunk) [Future minimum payments under non-cancellable leases](index=18&type=section&id=Future%20minimum%20payments%20under%20non-cancellable%20leases) As of June 30, 2025, total future minimum lease payments are $13.8 million, with a present value of lease liabilities of $10.3 million | Lease Payments (in thousands) | Amount | | :---------------------------- | :----- | | Total future minimum lease payments | $13,810 | | Less: imputed interest | $(3,515) | | Present value of lease liabilities | $10,295 | | Less: lease liabilities, current | $(1,138) | | Lease liabilities, net of current portion | $9,157 | [8. Stock-Based Compensation](index=18&type=section&id=8.%20Stock-Based%20Compensation) Total stock-based compensation expense for the six months ended June 30, 2025, was $9.6 million, down from $12.3 million in the prior year. The 2021 Equity Incentive Plan saw an automatic increase of 3,556,502 shares on January 1, 2025 | Stock-Based Compensation Expense (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :---------------------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $4,561 | $5,434 | | General and administrative | $5,045 | $6,880 | | Total stock-based compensation expense | $9,606 | $12,314 | - On January 1, 2025, the number of **shares** available for issuance under the **2021 Plan** automatically increased by **3,556,502 shares**[70](index=70&type=chunk) [Equity Incentive Plans](index=18&type=section&id=Equity%20Incentive%20Plans) The company operates under the 2021 Equity Incentive Plan, which automatically increases available shares annually. On January 1, 2025, 3,556,502 shares were added, bringing total authorized shares under the plans to 15,968,281, with 3,514,879 remaining available for grant - The **2021 Equity Incentive Plan** automatically increases **shares** available for issuance annually[70](index=70&type=chunk) - On January 1, 2025, **3,556,502 shares** were added to the **2021 Plan**[70](index=70&type=chunk) | Equity Incentive Plan Shares | June 30, 2025 | December 31, 2024 | | :--------------------------- | :------------ | :---------------- | | Total authorized for issuance | 15,968,281 | 12,366,264 | | Remaining available for grant | 3,514,879 | 3,454,152 | [Stock Options](index=19&type=section&id=Stock%20Options) Stock options outstanding increased to 13,342,969 shares at June 30, 2025, from 9,838,142 at December 31, 2024, with a weighted average exercise price of $8.51. The weighted average grant date fair value for options granted in the six months ended June 30, 2025, was $1.75 per share | Stock Option Activity | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Outstanding Shares | 13,342,969 | 9,838,142 | | Weighted Average Exercise Price | $8.51 | $11.52 | - Weighted average grant date fair value of stock options granted during the six months ended June 30, 2025, was **$1.75 per share** (compared to **$2.50** in 2024)[73](index=73&type=chunk) - Unrecognized stock-based compensation for stock options was **$23.4 million** as of June 30, 2025, expected to be recognized over a weighted average period of **3.0 years**[75](index=75&type=chunk) [Restricted Stock Awards](index=20&type=section&id=Restricted%20Stock%20Awards) All previously granted restricted stock awards were fully vested by December 31, 2024, and no new awards were granted during the six months ended June 30, 2025, resulting in no unvested restricted stock awards - All restricted stock awards granted were fully vested by December 31, 2024[76](index=76&type=chunk) - No restricted stock awards were granted during the six months ended June 30, 2025[76](index=76&type=chunk) - There were no unvested restricted stock awards as of June 30, 2025[76](index=76&type=chunk) [Restricted Stock Units](index=20&type=section&id=Restricted%20Stock%20Units) Unvested restricted stock units decreased to 219,775 shares at June 30, 2025, from 266,815 at December 31, 2024. Unrecognized compensation cost for RSUs was $2.3 million, to be recognized over 0.8 years | Restricted Stock Units | June 30, 2025 | December 31, 2024 | | :--------------------- | :------------ | :---------------- | | Unvested balance | 219,775 | 266,815 | - Unrecognized stock-based compensation cost for restricted stock units was approximately **$2.3 million** as of June 30, 2025, to be recognized over a weighted average period of **0.8 years**[77](index=77&type=chunk) [Employee Stock Purchase Plan](index=20&type=section&id=Employee%20Stock%20Purchase%20Plan) The 2021 ESPP allows employees to purchase stock at a discount. On January 1, 2025, 711,300 shares were added to the plan. During the six months ended June 30, 2025, 66,468 shares were issued at an average price of $1.03 - On January 1, 2025, **711,300 shares** were automatically added to the **2021 ESPP**[78](index=78&type=chunk) | ESPP Shares Issued (Six months ended June 30) | 2025 | 2024 | | :-------------------------------------------- | :----- | :----- | | Shares Issued | 66,468 | 56,903 | | Average Share Price | $1.03 | $2.01 | [9. Net Loss Per Share](index=21&type=section&id=9.%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share were $(0.38) for the three months and $(0.76) for the six months ended June 30, 2025, an improvement from $(0.45) and $(1.07) respectively in 2024. Potentially dilutive securities, totaling 20.7 million shares, were excluded due to the net loss position | Net Loss Per Share (Basic and Diluted) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :------------------------------------- | :------------------------------- | :------------------------------- | | Net loss per share | $(0.38) | $(0.45) | | Net Loss Per Share (Basic and Diluted) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------- | :----------------------------- | :----------------------------- | | Net loss per share | $(0.76) | $(1.07) | | Potentially Dilutive Securities (in common stock equivalent shares) | June 30, 2025 | June 30, 2024 | | :---------------------------------------------------------------- | :------------ | :------------ | | Shares issuable upon exercise of stock options | 13,342,969 | 10,793,201 | | Shares issuable upon conversion of Series A non-voting preferred stock | 7,060,100 | — | | Unvested restricted stock units | 219,775 | 444,718 | | Shares purchasable under the 2021 Employee Stock Purchase Plan | 91,398 | 56,879 | | Total | 20,714,242 | 11,294,798 | - Potentially dilutive securities were not included in the diluted net loss per share calculation because the company was in a net loss position, making them anti-dilutive[38](index=38&type=chunk)[80](index=80&type=chunk) [10. Related Party Transactions](index=21&type=section&id=10.%20Related%20Party%20Transactions) The company has a Research and Development Support Services Agreement with Bayside Pharma, LLC, a related party owned by an employee. Expenses recognized under this agreement were $0.252 million for the three months and $0.501 million for the six months ended June 30, 2025, consistent with the prior year - The company has a Research and Development Support Services Agreement with Bayside Pharma, LLC, a related party owned by an employee[81](index=81&type=chunk) | Related Party R&D Expense (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Research and development - Bayside | $252 | $249 | | Related Party R&D Expense (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Research and development - Bayside | $501 | $503 | - Accounts payable and accrued expenses due to related parties were **$0.2 million** at June 30, 2025, and **$0.1 million** at December 31, 2024[82](index=82&type=chunk) [11. Segment Information](index=21&type=section&id=11.%20Segment%20Information) The company operates as a single operating segment, focusing on pre-clinical and clinical research and development for inflammatory diseases. Resource allocation decisions are based on program-specific R&D expenses and clinical trial progression - The company views its operations and manages its business as one operating segment[83](index=83&type=chunk) - The Chief Operating Decision Maker (CODM) is the chief executive officer, who assesses performance and allocates resources based on research and development expenses incurred at the program-specific level[83](index=83&type=chunk)[84](index=84&type=chunk) | Operating Expenses by Program (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :------------------------------------------- | :------------------------------- | :------------------------------- | | VTX2735 | $3,156 | $1,654 | | VTX3232 | $7,442 | $3,359 | | Tamuzimod (formerly VTX002) | $1,667 | $9,232 | | VTX958 | $991 | $6,362 | | Other segment items | $16,077 | $15,105 | | Total operating expenses | $29,333 | $35,712 | | Operating Expenses by Program (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------- | :----------------------------- | :----------------------------- | | VTX2735 | $5,069 | $2,644 | | VTX3232 | $12,913 | $5,205 | | Tamuzimod (formerly VTX002) | $5,487 | $20,025 | | VTX958 | $2,983 | $16,577 | | Other segment items | $32,978 | $33,029 | | Total operating expenses | $59,430 | $77,480 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its status as a clinical-stage biopharmaceutical company, its product pipeline, financial performance, liquidity, and critical accounting policies. It details the decrease in net loss and R&D expenses, while emphasizing the ongoing need for substantial funding [Overview](index=23&type=section&id=Overview) Ventyx Biosciences is a clinical-stage biopharmaceutical company developing oral therapies for autoimmune, inflammatory, and neurodegenerative diseases. The company has incurred significant operating losses since inception, with a net loss of $54.4 million for the six months ended June 30, 2025. Key product candidates include NLRP3 inhibitors (VTX2735, VTX3232) and IBD therapies (tamuzimod, VTX958). VTX958 development is being de-emphasized due to Phase 2 trial results. The company expects to need substantial additional funding - Ventyx Biosciences is a clinical-stage biopharmaceutical company developing innovative oral therapies for **autoimmune, inflammatory, and neurodegenerative diseases**[88](index=88&type=chunk) - Key clinical product candidates include VTX2735 (peripheral NLRP3 inhibitor), VTX3232 (CNS-penetrant NLRP3 inhibitor), tamuzimod (S1P1R modulator for UC), and VTX958 (allosteric TYK2 inhibitor)[88](index=88&type=chunk) - VTX2735: Reported positive topline Phase 2 results in CAPS (Q1 2024); initiated Phase 2 trial in recurrent pericarditis (Jan 2025), with topline results anticipated in Q4 2025[88](index=88&type=chunk) - VTX3232: Reported positive topline Phase 1 results in healthy adults (Q1 2024); initiated Phase 2a trial in early Parkinson's disease (Aug 2024) with positive topline results (June 2025); initiated Phase 2 trial in obesity (Dec 2024), with topline results anticipated in early Q4 2025[88](index=88&type=chunk) - Tamuzimod: Announced positive Phase 2 results in UC (Q4 2023) and long-term extension (Oct 2024); seeking a partner for future development[88](index=88&type=chunk) - VTX958: Phase 2 Crohn's disease trial did not meet its primary endpoint (Q3 2024); company does not anticipate committing significant internal resources to further development[88](index=88&type=chunk)[89](index=89&type=chunk) | Metric | Three months ended June 30, 2025 (in millions) | Three months ended June 30, 2024 (in millions) | | :----- | :--------------------------------------------- | :--------------------------------------------- | | Net Loss | $(27.0) | $(32.0) | | Metric | Six months ended June 30, 2025 (in millions) | Six months ended June 30, 2024 (in millions) | | :----- | :------------------------------------------- | :------------------------------------------- | | Net Loss | $(54.4) | $(70.5) | - Accumulated deficit of **$608.7 million** as of June 30, 2025[91](index=91&type=chunk) - The company expects to incur significant operating losses for the foreseeable future and will need substantial additional funding[91](index=91&type=chunk)[92](index=92&type=chunk) - Received approximately **$26.6 million** in net proceeds from a September 2024 private placement of Series A non-voting convertible preferred stock to Sanofi, granting Sanofi a right of first negotiation for VTX3232[93](index=93&type=chunk)[94](index=94&type=chunk) - Received **$95.0 million** in net proceeds from a March 2024 private placement of common stock[95](index=95&type=chunk) - Macroeconomic factors, including global economic uncertainty, military conflicts, and changes in trade policy (e.g., OBBBA tax changes), could materially and adversely affect the business[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Research and Development Expense](index=26&type=section&id=Research%20and%20Development%20Expense) R&D expenses decreased by $5.5 million (15.5%) to $22.3 million for the three months ended June 30, 2025, and by $16.4 million (26.6%) to $45.2 million for the six months, primarily due to the close-out of Phase 2 trials for tamuzimod and VTX958, partially offset by increased spending on VTX2735 and VTX3232 | R&D Expense (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Change | | :------------------------- | :------------------------------- | :------------------------------- | :----- | | VTX2735 | $3,156 | $1,654 | $1,502 | | VTX3232 | $7,442 | $3,359 | $4,083 | | Tamuzimod (formerly VTX002)| $1,667 | $9,232 | $(7,565)| | VTX958 | $991 | $6,362 | $(5,371)| | Compensation-related expenses | $6,828 | $6,836 | $(8) | | Indirect expenses | $2,182 | $362 | $1,820 | | Total R&D expenses | $22,266 | $27,805 | $(5,539)| | R&D Expense (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | | :------------------------- | :----------------------------- | :----------------------------- | :----- | | VTX2735 | $5,069 | $2,644 | $2,425 | | VTX3232 | $12,913 | $5,205 | $7,708 | | Tamuzimod (formerly VTX002)| $5,487 | $20,025 | $(14,538)| | VTX958 | $2,983 | $16,577 | $(13,594)| | Compensation-related expenses | $14,221 | $14,413 | $(192) | | Indirect expenses | $4,491 | $2,688 | $1,803 | | Total R&D expenses | $45,164 | $61,552 | $(16,388)| - Expected R&D costs to increase for VTX2735 and VTX3232 due to continued development, and decrease for tamuzimod and VTX958 due to close-out of Phase 2 trials[105](index=105&type=chunk) - Indirect expenses for the three and six months ended June 30, 2025, increased by **$1.8 million**, partly due to a **$2.1 million** UK R&D tax credit received in the prior year period (2024) that did not recur[111](index=111&type=chunk)[117](index=117&type=chunk) [General and Administrative Expense](index=29&type=section&id=General%20and%20Administrative%20Expense) G&A expenses decreased by $0.8 million (10.5%) to $7.1 million for the three months ended June 30, 2025, and by $1.7 million (10.4%) to $14.3 million for the six months, primarily due to lower compensation-related expenses and professional service fees | G&A Expense (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Change | | :------------------------- | :------------------------------- | :------------------------------- | :----- | | General and administrative | $7,067 | $7,907 | $(840) | | G&A Expense (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | | :------------------------- | :----------------------------- | :----------------------------- | :----- | | General and administrative | $14,266 | $15,928 | $(1,662)| - The decrease in G&A expenses was primarily due to lower compensation-related expenses and professional service fees[122](index=122&type=chunk)[125](index=125&type=chunk) [Other (Income) Expense](index=30&type=section&id=Other%20(Income)%20Expense) Total other income decreased by $1.4 million to $(2.3) million for the three months ended June 30, 2025, and by $2.0 million to $(5.0) million for the six months, primarily due to lower interest income from reduced average cash balances and interest rates | Other (Income) Expense (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Change | | :------------------------------------ | :------------------------------- | :------------------------------- | :----- | | Interest income | $(2,367) | $(3,783) | $1,416 | | Other expense | $21 | $21 | $— | | Total other (income) expense | $(2,346) | $(3,762) | $1,416 | | Other (Income) Expense (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | | :------------------------------------ | :----------------------------- | :----------------------------- | :----- | | Interest income | $(5,033) | $(7,010) | $1,977 | | Other expense | $30 | $52 | $(22) | | Total other (income) expense | $(5,003) | $(6,958) | $1,955 | - The decrease in interest income was primarily due to lower average cash balances and interest rates[126](index=126&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company has funded operations primarily through equity and debt, holding $209.0 million in cash, cash equivalents, and marketable securities as of June 30, 2025. It anticipates needing substantial additional funding for ongoing development and potential commercialization, expecting current funds to last at least 12 months - Operations have been funded primarily through the issuance of equity and debt securities[127](index=127&type=chunk) - As of June 30, 2025, the company had **$209.0 million** in cash, cash equivalents, and marketable securities (excluding **$1.0 million** restricted cash)[127](index=127&type=chunk) - The company believes existing cash, cash equivalents, and marketable securities will be sufficient to fund obligations for at least **12 months** from the issuance of the condensed consolidated financial statements[131](index=131&type=chunk) - Substantial additional funding will be needed for ongoing development activities, clinical trials, regulatory approval, and potential commercialization[130](index=130&type=chunk) [Sources of Liquidity and Capital Resources](index=30&type=section&id=Sources%20of%20Liquidity%20and%20Capital%20Resources) Since inception, Ventyx has raised significant capital through various equity and debt financings, including a $158.8 million IPO in October 2021, a $165.2 million private placement in September 2022, a $95.0 million private placement in March 2024, and a $26.6 million Series A preferred stock private placement in September 2024 - Initial Public Offering (October 2021): Received approximately **$158.8 million** in net proceeds[127](index=127&type=chunk) - Private Placement (September 2022): Received approximately **$165.2 million** in net proceeds[127](index=127&type=chunk) - Private Placement (March 2024): Received approximately **$95.0 million** in net proceeds[127](index=127&type=chunk) - Series A Private Placement (September 2024): Received approximately **$26.6 million** in net proceeds from the sale of Series A non-voting convertible preferred stock[127](index=127&type=chunk) [Future Funding Requirements](index=31&type=section&id=Future%20Funding%20Requirements) The company expects significant increases in expenses for R&D, clinical trials, regulatory approvals, and potential commercialization. It will need substantial additional funding, likely through equity, debt, or collaborations, as it does not generate product revenue - Expenses are expected to increase significantly due to ongoing development activities, clinical trials, regulatory approval, and potential commercialization[130](index=130&type=chunk) - Anticipates needing substantial additional funding for continuing operations[130](index=130&type=chunk) - Future cash needs are expected to be financed through a combination of equity, equity-linked, and debt financings, collaborations, strategic alliances, and/or licensing arrangements[136](index=136&type=chunk) - Short-term liquidity needs for operating leases are approximately **$2.3 million**; long-term needs are approximately **$11.7 million**[133](index=133&type=chunk) [Cash Flows](index=32&type=section&id=Cash%20Flows) Net cash used in operating activities decreased to $47.0 million for the six months ended June 30, 2025, from $72.2 million in 2024. Investing activities provided $51.6 million in 2025, a significant shift from using $33.8 million in 2024. Financing activities provided $0.1 million in 2025, down from $95.3 million in 2024 | Cash Flow Activity (Six months ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :-------------------------------------------- | :------------------ | :------------------ | | Net cash used in operating activities | $(46,995) | $(72,163) | | Net cash provided by (used in) investing activities | $51,607 | $(33,755) | | Net cash provided by financing activities | $68 | $95,278 | - Net cash used in operating activities decreased primarily due to a lower net loss and changes in operating assets and liabilities[139](index=139&type=chunk)[141](index=141&type=chunk) - Net cash provided by investing activities in 2025 was primarily from proceeds from maturities of marketable securities, offsetting purchases[142](index=142&type=chunk) - Net cash provided by financing activities in 2024 was significantly higher due to **$95.0 million** net proceeds from a common stock private placement[145](index=145&type=chunk) [Critical Accounting Policies and Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's financial statements rely on estimates and judgments for areas like clinical trial costs, fair value measurements, and stock-based awards. No material changes to these policies were reported for the six months ended June 30, 2025 - Key estimates and judgments include prepaid and accrued clinical trial and R&D costs, fair value of stock-based awards and marketable securities, operating lease assets and liabilities, and impairment evaluation of long-lived assets[146](index=146&type=chunk) - No material changes to critical accounting policies and estimates occurred during the six months ended June 30, 2025[147](index=147&type=chunk) [Other Company Information](index=34&type=section&id=Other%20Company%20Information) Ventyx regained "smaller reporting company" (SRC) status as of June 30, 2024, due to its market value falling below $560 million and no revenue, allowing for scaled disclosure relief - The company regained qualification as a "smaller reporting company" (SRC) as of June 30, 2024[148](index=148&type=chunk) - Qualification was based on the market value of stock held by non-affiliates being less than **$560 million** and no revenue generated[148](index=148&type=chunk) - As an SRC, the company elected to comply with scaled disclosure relief[148](index=148&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Ventyx Biosciences is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[150](index=150&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with CEO and Interim Principal Financial Officer participation, concluded that disclosure controls and procedures were effective as of June 30, 2025. No material changes in internal control over financial reporting occurred during the quarter [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The CEO and Interim Principal Financial Officer evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, providing reasonable assurance for timely and accurate reporting - Management, including the CEO and Interim Principal Financial Officer, evaluated disclosure controls and procedures as of June 30, 2025[151](index=151&type=chunk) - Concluded that disclosure controls and procedures were effective to provide reasonable assurance that required information is recorded, processed, summarized, and reported timely[151](index=151&type=chunk) [Changes in Internal Control over Financial Reporting](index=34&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No changes in internal control over financial reporting were identified during the quarter ended June 30, 2025, that materially affected or are reasonably likely to materially affect the company's internal control over financial reporting - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[152](index=152&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the information on commitments and contingencies from Note 5 of the financial statements, which details the voluntary dismissal of a securities class action and a shareholder derivative action - Information regarding legal proceedings is incorporated by reference from Note 5, "Commitments and Contingencies," in Part I, Item 1 of this Form 10-Q[154](index=154&type=chunk) - A securities class action and a shareholder derivative action, both related to VTX958 trial results, were voluntarily dismissed in February 2025[54](index=54&type=chunk)[55](index=55&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Investing in Ventyx Biosciences common stock involves a high degree of risk, including a history of operating losses, the need for substantial additional financing, dependence on product candidate success, and intense competition. The company's clinical trials face uncertainties, and its stock price is volatile - Investing in the company's common stock involves a high degree of risk[155](index=155&type=chunk) - Key risks include operating losses, need for additional financing, dependence on product candidate success, clinical trial failures, intense competition, and stock price volatility[156](index=156&type=chunk) [Risk Factors Summary](index=35&type=section&id=Risk%20Factors%20Summary) The company's business faces numerous risks, including a history of operating losses, the need for substantial additional financing, dependence on product candidate success, potential clinical trial failures, significant competition, reliance on Chinese suppliers, and stock price volatility - The company has a history of operating losses and expects to continue incurring significant losses, potentially never achieving profitability[156](index=156&type=chunk)[158](index=158&type=chunk) - Substantial additional financing is required for product candidate development and commercialization, with failure to obtain capital potentially forcing delays or termination of efforts[156](index=156&type=chunk)[160](index=160&type=chunk) - Business success is entirely dependent on the successful development, regulatory approval, and commercialization of product candidates, which is not guaranteed[156](index=156&type=chunk)[168](index=168&type=chunk) - Clinical trials are lengthy, expensive, and have uncertain outcomes, with a high risk of failure to demonstrate adequate safety and efficacy[156](index=156&type=chunk)[177](index=177&type=chunk)[179](index=179&type=chunk) - The company faces significant competition from other biotechnology and pharmaceutical companies with greater resources[156](index=156&type=chunk)[198](index=198&type=chunk) - Reliance on suppliers located in China for manufacturing and non-clinical research exposes the business to economic, political, and legal risks[156](index=156&type=chunk)[243](index=243&type=chunk) - The company's stock price has been and may continue to be volatile, leading to potential investment losses[156](index=156&type=chunk)[445](index=445&type=chunk) [Risks Related to Our Business](index=36&type=section&id=Risks%20Related%20to%20Our%20Business) The company has a limited operating history, has incurred significant losses, and expects to continue doing so. Its business is entirely dependent on the successful development and commercialization of its product candidates, which face high risks of failure in clinical trials and require substantial additional funding. The company also faces risks related to manufacturing, supply chain, and competition - The company has incurred significant operating losses since inception, with an accumulated deficit of **$608.7 million** as of June 30, 2025[158](index=158&type=chunk) - Existing cash, cash equivalents, and marketable securities (**$209.0 million** as of June 30, 2025) are expected to fund obligations for at least **12 months**, but substantial additional financing will be required[161](index=161&type=chunk) - The business is entirely dependent on the successful development, regulatory approval, and commercialization of product candidates, including VTX2735, VTX3232, and tamuzimod, with VTX958 development being de-emphasized[168](index=168&type=chunk)[169](index=169&type=chunk) - Clinical trials are lengthy, expensive, and uncertain, with risks of delays, failure to demonstrate safety/efficacy, and unexpected adverse events[173](index=173&type=chunk)[177](index=177&type=chunk)[179](index=179&type=chunk)[182](index=182&type=chunk) - Manufacturing of product candidates is complex and relies on third-party CMOs, posing risks related to production difficulties, quality control, and supply chain disruptions[233](index=233&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Reliance on suppliers in China for manufacturing and non-clinical research exposes the company to economic, political, legal, and trade policy risks, including potential impacts from the proposed BIOSECURE Act[243](index=243&type=chunk)[247](index=247&type=chunk) - The company faces significant competition from other biotechnology and pharmaceutical companies with greater resources and established products[198](index=198&type=chunk)[200](index=200&type=chunk) - Even if approved, product candidates may not achieve broad market acceptance among physicians, patients, and third-party payors, limiting revenue generation[280](index=280&type=chunk) - The company faces an inherent risk of product liability lawsuits from clinical testing and commercialization, which could result in substantial liabilities[274](index=274&type=chunk) - Success is highly dependent on attracting and retaining highly skilled executive officers, key scientific personnel, and employees, for whom competition is intense[304](index=304&type=chunk) - Future growth may be difficult to manage, imposing significant responsibilities on management and potentially disrupting operations[307](index=307&type=chunk)[309](index=309&type=chunk) - Future acquisitions or strategic partnerships may increase capital requirements, dilute stockholders, and entail numerous integration and operational risks[313](index=313&type=chunk) - Reliance on trade secrets increases the possibility of discovery, misappropriation, or unauthorized disclosure by competitors or third parties[248](index=248&type=chunk)[398](index=398&type=chunk) [Risks Related to Government Regulation](index=78&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company faces a lengthy, unpredictable, and costly FDA regulatory approval process, with no guarantee of success. Post-approval, it remains subject to extensive ongoing regulatory obligations, including surveillance and compliance with healthcare fraud and abuse laws, and changes in government policies or funding could cause delays or increased costs - The FDA regulatory approval process is lengthy, time-consuming, and unpredictable, with no prior NDA submission experience[328](index=328&type=chunk) - Clinical development can be delayed or terminated due to regulatory disagreements, enrollment difficulties, safety concerns, or manufacturing issues[329](index=329&type=chunk)[331](index=331&type=chunk) - Product candidates may cause undesirable side effects, leading to clinical trial halts, more restrictive labeling, or denial of regulatory approval[226](index=226&type=chunk)[227](index=227&type=chunk) - Obtaining regulatory approval in one jurisdiction does not guarantee approval in others, and foreign regulatory requirements can vary significantly and be costly[333](index=333&type=chunk)[334](index=334&type=chunk) - Post-approval, the company and its contractors are subject to ongoing regulatory obligations, including surveillance, cGMP compliance, labeling, advertising, and adverse event reporting[340](index=340&type=chunk)[342](index=342&type=chunk) - Changes in FDA policies, potentially influenced by Supreme Court rulings (e.g., Loper Bright), executive orders, or agency reorganization, could delay approvals or increase compliance burdens[345](index=345&type=chunk)[347](index=347&type=chunk) - The company is subject to federal and state healthcare fraud and abuse laws (e.g., AKS, FCA, HIPAA), pharmaceutical marketing, and price reporting requirements, with non-compliance leading to significant penalties[357](index=357&type=chunk)[358](index=358&type=chunk)[360](index=360&type=chunk) - Impermissible promotion of off-label uses for approved products can lead to substantial liability and government fines[362](index=362&type=chunk)[363](index=363&type=chunk) - Sales of product candidates depend on adequate coverage and reimbursement from third-party payors, a costly and uncertain process that may limit profitability[366](index=366&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk) - May not obtain or maintain orphan drug designation benefits, including market exclusivity, which could be impacted by judicial interpretations[324](index=324&type=chunk)[326](index=326&type=chunk)[327](index=327&type=chunk) - Subject to U.S. and foreign export and import controls, with non-compliance potentially leading to penalties and limitations on international market access[348](index=348&type=chunk)[349](index=349&type=chunk) - Subject to U.S. FCPA and foreign anti-corruption laws; non-compliance can result in criminal/civil liability and harm to business[350](index=350&type=chunk)[351](index=351&type=chunk) - Failure to comply with environmental, health, and safety laws, particularly regarding hazardous materials, could lead to fines or penalties[352](index=352&type=chunk)[354](index=354&type=chunk) [Risks Related to Intellectual Property](index=93&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success depends on obtaining, maintaining, protecting, and enforcing patents and other proprietary rights, which is expensive, time-consuming, and uncertain. Risks include failure to obtain patents, challenges to validity, infringement by third parties, and difficulties in protecting trade secrets - Success is dependent on obtaining, maintaining, protecting, and enforcing patents and other proprietary rights in the U.S. and other countries[389](index=389&type=chunk)[390](index=390&type=chunk) - Patentability in the biotechnology field is evolving and uncertain; pending applications may not result in issued patents, or issued patents may be challenged, invalidated, or circumvented[390](index=390&type=chunk)[391](index=391&type=chunk)[395](index=395&type=chunk) - Obtaining and enforcing patents is expensive and time-consuming, with risks of failing to identify patentable aspects or maintain protection[392](index=392&type=chunk) - Competitors or third parties may infringe patents, leading to costly and time-consuming litigation that diverts management attention[415](index=415&type=chunk) - Risk of being sued for infringing third-party intellectual property, potentially leading to injunctions, monetary damages, or the need to obtain licenses on unfavorable terms[418](index=418&type=chunk)[419](index=419&type=chunk) - Reliance on trade secrets and proprietary know-how is difficult to trace and enforce, with risks of disclosure, misappropriation, or independent development by competitors[398](index=398&type=chunk)[438](index=438&type=chunk)[440](index=440&type=chunk) - Patent rights are national/regional; protecting IP globally is expensive, and foreign laws may offer less protection, impairing competitive advantage[402](index=402&type=chunk)[404](index=404&type=chunk) - Changes in U.S. patent law (e.g., America Invents Act) or laws in other countries (e.g., European Unified Patent Court) could diminish the value of patents[425](index=425&type=chunk)[427](index=427&type=chunk)[428](index=428&type=chunk) - May be subject to claims challenging the inventorship or ownership of patents and other intellectual property, potentially leading to loss of rights[433](index=433&type=chunk)[435](index=435&type=chunk) - Inability to license or acquire new or necessary intellectual property rights or technology from third parties could materially impact product development[431](index=431&type=chunk) - Patent terms may be inadequate to protect competitive position for a sufficient duration, leading to earlier competition from generic products[432](index=432&type=chunk) - Failure to adequately protect trademarks and trade names could hinder brand recognition and adversely affect the business[442](index=442&type=chunk) [Risks Related to Our Common Stock](index=106&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock trading market may not be liquid or orderly, and its price has been and is expected to remain volatile due to various factors, including clinical trial results, financing efforts, and market conditions. Future equity offerings could cause dilution, and certain charter provisions may hinder acquisition attempts - An active, liquid, and orderly trading market for common stock may not develop or be sustained, making it difficult to sell **shares**[444](index=444&type=chunk) - The market price of common stock has been and is likely to remain volatile due to factors such as clinical trial results, financing efforts, regulatory developments, and general market conditions[445](index=445&type=chunk)[446](index=446&type=chunk) - Failure to comply with Nasdaq's continued listing standards could lead to delisting, adversely affecting liquidity and ability to raise funds[447](index=447&type=chunk)[448](index=448&type=chunk) - Management has broad discretion in using capital raise proceeds, which may not be effective or align with stockholder expectations[449](index=449&type=chunk) - Future equity offerings or other equity issuances will result in substantial dilution to existing stockholders[450](index=450&type=chunk) - Sales of a substantial number of common stock shares in the public market could cause the stock price to decline[451](index=451&type=chunk)[459](index=459&type=chunk) - The board of directors is authorized to issue preferred stock with rights senior to common stock, potentially causing dilution[460](index=460&type=chunk) - The company does not anticipate paying cash dividends for the foreseeable future, requiring investors to rely on stock price appreciation for returns[461](index=461&type=chunk) - Provisions in the amended and restated certificate of incorporation and bylaws may prevent or frustrate attempts by stockholders to change management or acquire a controlling interest[462](index=462&type=chunk)[464](index=464&type=chunk) - Bylaws designate Delaware courts and federal district courts as exclusive forums for certain disputes, potentially limiting stockholders' ability to choose a favorable judicial forum[465](index=465&type=chunk)[468](index=468&type=chunk)[469](index=469&type=chunk) - Claims for indemnification by directors and officers may reduce available funds to satisfy

[Report Introduction and Executive Summary](index=1&type=section&id=Report%20Introduction%20and%20Executive%20Summary) [Q2 2025 Highlights and Corporate Progress](index=1&type=section&id=Q2%202025%20Highlights%20and%20Corporate%20Progress) Ventyx announced Q2 2025 results, highlighting clinical pipeline progress and a robust financial position [Company Overview](index=1&type=section&id=Company%20Overview) 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](index=2&type=chunk)[11](index=11&type=chunk) [CEO Commentary and Key Progress](index=1&type=section&id=CEO%20Commentary%20and%20Key%20Progress) 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](index=3&type=chunk) - VTX3232 Phase 2 study in obese participants with cardiometabolic risk factors is **fully enrolled**, with topline results anticipated in **early Q4 2025**[3](index=3&type=chunk) - 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](index=3&type=chunk) [Summary of Anticipated Milestones and Financial Position](index=1&type=section&id=Summary%20of%20Anticipated%20Milestones%20and%20Financial%20Position) 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](index=6&type=chunk) - Data from the Phase 2 study of VTX2735 in recurrent pericarditis is **expected in Q4 2025**[6](index=6&type=chunk) - Phase 2 study of VTX3232 in obesity and cardiometabolic risk factors is fully-enrolled, with topline data **expected in early Q4 2025**[6](index=6&type=chunk) - Current cash balance is expected to fund planned operations into **at least H2 2026**[6](index=6&type=chunk) Cash, Cash Equivalents and Marketable Securities | As of Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $209.0 | [Pipeline Updates and Anticipated Milestones](index=1&type=section&id=Pipeline%20Updates%20and%20Anticipated%20Milestones) [NLRP3 Inhibitor Portfolio](index=1&type=section&id=NLRP3%20Inhibitor%20Portfolio) 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](index=4&type=chunk) [VTX3232 in Parkinson's Disease](index=1&type=section&id=VTX3232%20in%20Parkinson's%20Disease) 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](index=4&type=chunk) - 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](index=4&type=chunk) - 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](index=4&type=chunk) - VTX3232 treatment was associated with **improved motor and non-motor symptoms** of Parkinson's disease, as measured by the MDS-UPDRS[4](index=4&type=chunk) - 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](index=4&type=chunk) - 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](index=5&type=chunk) [VTX2735 in Recurrent Pericarditis](index=1&type=section&id=VTX2735%20in%20Recurrent%20Pericarditis) 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](index=7&type=chunk) - Key endpoints include safety, change in the numerical rating scale (NRS) pain score, and change in hsCRP[7](index=7&type=chunk) - Ventyx expects to release **topline results** from this study in **Q4 2025**[6](index=6&type=chunk)[7](index=7&type=chunk) - 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](index=7&type=chunk) [VTX3232 in Cardiometabolic Diseases](index=2&type=section&id=VTX3232%20in%20Cardiometabolic%20Diseases) 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](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=6&type=chunk)[7](index=7&type=chunk) [Inflammatory Bowel Disease (IBD) Portfolio](index=2&type=section&id=Inflammatory%20Bowel%20Disease%20(IBD)%20Portfolio) 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](index=13&type=chunk) [Tamuzimod (Ulcerative Colitis)](index=2&type=section&id=Tamuzimod%20(Ulcerative%20Colitis)) 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](index=12&type=chunk) - 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](index=12&type=chunk) - The Company is **exploring partnership opportunities** for tamuzimod in ulcerative colitis[12](index=12&type=chunk) [VTX958 (Crohn's Disease)](index=2&type=section&id=VTX958%20(Crohn's%20Disease)) 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](index=12&type=chunk) - 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](index=12&type=chunk) - Showed a **greater magnitude of reduction** in two key biomarkers of inflammation, CRP and fecal calprotectin[12](index=12&type=chunk) - Ventyx is exploring multiple options for continued development of VTX958 in Crohn's disease, including **partnership opportunities**[9](index=9&type=chunk) [Second Quarter Financial Results](index=2&type=section&id=Second%20Quarter%20Financial%20Results) [Key Financial Highlights](index=2&type=section&id=Key%20Financial%20Highlights) 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](index=12&type=chunk) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=4&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) 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](index=2&type=section&id=About%20Ventyx%20Biosciences) 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](index=11&type=chunk) - 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](index=11&type=chunk) - Extensive experience in clinical development allows for the rapid progression of drug candidates through clinical trials[11](index=11&type=chunk) - The portfolio includes NLRP3 inhibitors (VTX2735, VTX3232) and inflammatory bowel disease compounds (tamuzimod, VTX958)[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=15&type=chunk) - 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](index=15&type=chunk) - 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](index=16&type=chunk) [Investor Relations Contact](index=3&type=section&id=Investor%20Relations%20Contact) This section provides contact information for investor relations inquiries - Investor Relations Contact: Joyce Allaire, Managing Director, LifeSci Advisors, IR@ventyxbio.com[17](index=17&type=chunk)