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)

Core Viewpoint - Ventyx Biosciences, Inc. reported its second quarter financial results and highlighted advancements in its clinical pipeline, focusing on innovative oral therapies for autoimmune, inflammatory, and neurodegenerative diseases [1] Pipeline Updates and Anticipated Milestones - The Phase 2 trial of VTX2735 for recurrent pericarditis is ongoing, with expectations to release topline results in Q4 2025 [2][4] - VTX3232 has completed enrollment in a Phase 2 study for obese participants with cardiometabolic risk factors, with topline results anticipated in early Q4 2025 [2][6] - Positive Phase 2a data for VTX3232 in early-stage Parkinson's disease demonstrated safety, tolerability, and significant biomarker suppression, leading to plans for further clinical trials [3][5] Financial Results - As of June 30, 2025, Ventyx reported cash, cash equivalents, and marketable securities totaling $209.0 million, sufficient to fund operations into at least H2 2026 [5][9] - Research and Development (R&D) expenses for Q2 2025 were $22.3 million, down from $27.8 million in Q2 2024, while General and Administrative (G&A) expenses decreased to $7.1 million from $7.9 million [11][17] - The net loss for Q2 2025 was $27.0 million, compared to a net loss of $32.0 million in Q2 2024 [11][17] Inflammatory Bowel Disease (IBD) Portfolio - Ventyx is exploring development options for VTX958 in Crohn's disease, including potential partnerships [8][12] - Tamuzimod (VTX002) has shown promising Phase 2 induction data in ulcerative colitis, indicating potential for combination therapies [11][12]

Core Viewpoint - Ventyx Biosciences, Inc. (VTYX) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][4]. Earnings Estimates and Stock Ratings - The Zacks rating system is primarily driven by changes in a company's earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [2]. - The correlation between earnings estimate revisions and stock price movements is strong, making the Zacks rating system valuable for investors [3][5]. Impact of Institutional Investors - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to significant buying or selling activity that affects stock prices [5]. - An increase in earnings estimates typically results in a higher fair value for a stock, prompting institutional investors to act accordingly [5]. Ventyx Biosciences' Earnings Outlook - The recent upgrade for Ventyx Biosciences reflects an improvement in the company's underlying business, which is expected to drive the stock price higher [6]. - Over the past three months, the Zacks Consensus Estimate for Ventyx has increased by 6%, with expectations for the fiscal year ending December 2025 set at -$1.85 per share, unchanged from the previous year [9]. Zacks Rank System Performance - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - Ventyx's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].

Core Insights - The study successfully established the safety and tolerability of VTX3232 in patients with early-stage Parkinson's disease, with no drug-related treatment-emergent adverse events reported [1][2] - VTX3232 demonstrated significant reductions in NLRP3-related biomarkers in both cerebrospinal fluid (CSF) and plasma, indicating sustained target engagement [1][3] - The company plans to initiate a placebo-controlled Phase 2 trial for VTX3232 in Parkinson's disease and potentially in other neurodegenerative disorders like Alzheimer's disease [3][6] Study Details - The Phase 2a study evaluated a 40mg oral daily dose of VTX3232 in ten patients over a 28-day treatment period, focusing on safety and tolerability [3][4] - Key secondary objectives included pharmacokinetic profiling and measuring effects on biomarkers of NLRP3 inhibition, with significant reductions observed in IL-1, IL-6, and hsCRP [3][4] - The study showed that VTX3232 maintained plasma and CSF levels above the IC90 for IL-1b for 24 hours [3][9] Biomarker Findings - VTX3232 treatment resulted in reductions of biomarkers such as IL-1β, IL-18, IL-6, and hsCRP, with some approaching the limit of quantitation [9] - Statistically significant improvements were noted in motor and non-motor symptoms of Parkinson's disease, as measured by MDS-UPDRS [9] - No acute changes were observed in exploratory PET imaging, consistent with the short duration of the study [9] Future Development - Ventyx intends to present the complete dataset at a future medical meeting and publish full results in a peer-reviewed journal [5] - The company is also conducting a 12-week Phase 2 trial of VTX3232 in participants with obesity and cardiometabolic risk factors, with topline results expected in H2 2025 [1][8] - Planning for a double-blind, placebo-controlled, dose-ranging Phase 2 trial in Parkinson's disease is underway [6]

Summary of Ventyx Biosciences (VTYX) Conference Call Company Overview - **Company**: Ventyx Biosciences (VTYX) - **Date**: June 5, 2025 - **Key Speakers**: Raju Mohan (CEO), Matt Moore (COO) Key Programs and Trials - Ventyx is focused on its pipeline, particularly in the field of inflammasomes, specifically NLRP3 [7][8] - Three Phase II readouts are anticipated: 1. **Parkinson's Disease Trial**: In early Parkinson's patients using CNS molecule VTX-3232, with results expected in June 2025 [8][9][10] 2. **Recurrent Pericarditis Trial**: An open-label trial modeled after Arcalist, with results expected in the second half of 2025 [13][15] 3. **Obesity and Cardiometabolic Risk Trial**: A placebo-blinded trial using VTX-3232, with results expected in the fall of 2025 [14][15] Financial Position - Ventyx is in a strong cash position with approximately $200 million available, allowing for continued execution of trials without immediate pressure to seek partnerships or sales [19][81][84] Strategic Partnerships - Sanofi has a right of first negotiation (ROFIN) for VTX-3232, which will be triggered after the cardiometabolic readout [21][25] - The interest from Sanofi is heightened due to their commitment to neurodegenerative diseases and previous successes in the field [26][27] Market Interest and Valuation - The stock is currently trading at a low valuation, around cash levels, attracting interest from various investors [20][21] - The upcoming data releases are expected to significantly impact investor sentiment and stock valuation [20][22] Data Expectations and Success Criteria - For the Parkinson's trial, success is defined by: - Safety of the treatment - Evidence of drug exposure in cerebrospinal fluid (CSF) - Biomarker modulation in CSF, particularly suppression of IL-1 beta and downstream effects [42][43][62][72] - The obesity trial is designed to detect weight loss and other metabolic markers, with a focus on safety and activity [113][125] Competitive Landscape - Roche is also conducting trials related to NLRP3 in Parkinson's, but has not released data, creating uncertainty in the competitive landscape [91][97] - Other companies are exploring similar pathways, indicating a growing interest in inflammasome inhibitors [98][108] Conclusion - Ventyx is positioned for significant developments in the coming months with multiple trials and potential strategic partnerships on the horizon. The focus remains on executing trials effectively while maintaining a strong financial position to support long-term growth and value creation for shareholders [84][90][135]

Company Overview - Ventyx Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for patients with autoimmune, inflammatory, and neurodegenerative diseases [3] - The company leverages expertise in medicinal chemistry, structural biology, and immunology to discover differentiated oral small molecule therapeutics for conditions with high unmet medical need [3] Product Pipeline - Ventyx's portfolio includes NLRP3 inhibitors such as VTX2735, which is in Phase 2 development for recurrent pericarditis, and VTX3232, a CNS-penetrant NLRP3 inhibitor in Phase 2 development for neurodegenerative and cardiometabolic diseases [4] - The inflammatory bowel disease portfolio features two Phase 2 compounds: tamuzimod (VTX002), an S1P1R modulator, and VTX958, a TYK2 inhibitor [4] Upcoming Events - Company executives will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, from 12:50 to 1:20 PM ET [2] - A webcast of the event will be available on the Ventyx website, with a replay accessible for ninety days post-event [2]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Ventyx Biosciences, Inc.'s unaudited condensed consolidated financial statements for Q1 2025, including key financial statements and notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$276.6 million** to **$253.5 million** in Q1 2025, driven by a reduction in marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $28,076 | $27,260 | | Marketable securities | $200,731 | $225,683 | | Total current assets | $242,558 | $229,625 | | **Total assets** | **$253,480** | **$276,563** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $12,394 | $12,776 | | **Total liabilities** | **$21,847** | **$22,518** | | **Total stockholders' equity** | **$231,633** | **$254,045** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss decreased to **$27.4 million** in Q1 2025 from **$38.6 million** in Q1 2024, primarily due to lower R&D expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $22,898 | $33,747 | | General and administrative | $7,199 | $8,021 | | **Total operating expenses** | **$30,097** | **$41,768** | | Loss from operations | ($30,097) | ($41,768) | | Interest income | ($2,666) | ($3,227) | | **Net loss** | **($27,440)** | **($38,572)** | | Net loss per share, basic and diluted | ($0.39) | ($0.62) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to **$231.6 million** in Q1 2025, primarily due to the net loss, partially offset by stock-based compensation - The primary drivers for the change in stockholders' equity during Q1 2025 were the **net loss of $27.4 million** and **stock-based compensation of $5.0 million**[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased to **$25.7 million** in Q1 2025, with no financing activities this quarter Summary of Cash Flows (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($25,718) | ($47,625) | | Net cash provided by investing activities | $26,415 | $41,765 | | Net cash provided by financing activities | $— | $96,184 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed disclosures on Ventyx's business, accounting policies, financial assets, legal proceedings, equity, and R&D expenses by program - Ventyx is a clinical-stage biopharmaceutical company focused on developing oral therapies for autoimmune, inflammatory, and neurodegenerative diseases[29](index=29&type=chunk) - A securities class action and a shareholder derivative action filed against the company were both voluntarily dismissed without prejudice in February 2025[51](index=51&type=chunk)[52](index=52&type=chunk) - In September 2024, the company issued **70,601 shares of Series A non-voting convertible preferred stock** to a subsidiary of Sanofi for gross proceeds of approximately **$27.0 million**, granting Sanofi a right of first negotiation (ROFN) for VTX3232[55](index=55&type=chunk)[56](index=56&type=chunk) - In March 2024, the company raised approximately **$100.0 million** in gross proceeds through a private placement of **11,174,000 shares of common stock**[54](index=54&type=chunk) R&D Expenses by Program (in thousands) | Program | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | VTX2735 | $1,914 | $990 | | VTX3232 | $5,471 | $1,846 | | Tamuzimod | $3,821 | $10,793 | | VTX958 | $1,992 | $10,215 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, clinical pipeline, and capital resources, noting decreased R&D expenses and sufficient liquidity for the next 12 months - The company is advancing its NLRP3 inhibitor portfolio, with **VTX2735** in a Phase 2 trial for recurrent pericarditis and **VTX3232** in Phase 2 trials for Parkinson's disease and obesity[88](index=88&type=chunk) - Following Phase 2 results, the company intends to find a partner for the future development of tamuzimod and does not plan to commit significant internal resources to the further development of VTX958[88](index=88&type=chunk) Change in R&D Expenses by Program (Q1 2025 vs Q1 2024, in thousands) | Program | Change | | :--- | :--- | | VTX2735 | $924 increase | | VTX3232 | $3,625 increase | | Tamuzimod | ($6,972) decrease | | VTX958 | ($8,223) decrease | | **Total R&D Expenses** | **($10,849) decrease** | - The decrease in G&A expenses by **$0.8 million** in Q1 2025 compared to Q1 2024 was primarily due to lower compensation-related expenses and professional service fees[112](index=112&type=chunk) - As of March 31, 2025, the company had **$228.8 million** in cash, cash equivalents, and marketable securities and believes these funds are sufficient for at least the next twelve months[114](index=114&type=chunk)[117](index=117&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Ventyx Biosciences is a smaller reporting company and, as such, is not required to provide the information requested under this item - As a smaller reporting company, Ventyx is not required to provide quantitative and qualitative disclosures about market risk[137](index=137&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Interim Principal Financial Officer, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025 - The company's management concluded that disclosure controls and procedures were effective as of the end of the reporting period[138](index=138&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended March 31, 2025[139](index=139&type=chunk) [PART II. OTHER INFORMATION](index=31&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) Details two legal actions against the company, a securities class action and a shareholder derivative action, both voluntarily dismissed without prejudice - A putative securities class action complaint filed on March 1, 2024, was voluntarily dismissed without prejudice on February 10, 2025[51](index=51&type=chunk) - A shareholder derivative action filed on December 6, 2024, was voluntarily dismissed without prejudice on February 24, 2025[52](index=52&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Details significant risks including operating losses, financing needs, product candidate dependence, clinical development uncertainties, supply chain risks, and intense competition - The company has a history of significant operating losses, with an accumulated deficit of **$581.7 million** as of March 31, 2025, and expects to continue incurring losses[145](index=145&type=chunk) - The business is entirely dependent on the success of its product candidates, which face a high risk of failure in development, as exemplified by the termination of VTX958 development for psoriasis[155](index=155&type=chunk)[156](index=156&type=chunk) - The company relies on suppliers in China for manufacturing and research, making it subject to risks from U.S.-China trade relations, political instability, and potential legislation like the BIOSECURE Act[230](index=230&type=chunk)[231](index=231&type=chunk)[234](index=234&type=chunk) - The company faces intense competition from well-established pharmaceutical companies with substantially greater financial, scientific, and commercial resources[185](index=185&type=chunk) - The company's stock price has been and may continue to be volatile, and the company has previously been subject to securities class action litigation following periods of volatility[144](index=144&type=chunk)[430](index=430&type=chunk)[476](index=476&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=110&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no sales of unregistered equity securities during the quarter ended March 31, 2025, that had not been previously disclosed in a Current Report on Form 8-K - No unregistered sales of equity securities were made during the quarter that were not previously reported[477](index=477&type=chunk) [Defaults Upon Senior Securities](index=110&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - None[478](index=478&type=chunk) [Mine Safety Disclosures](index=110&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not Applicable[479](index=479&type=chunk) [Other Information](index=110&type=section&id=Item%205.%20Other%20Information) During the last fiscal quarter, no directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No officers or directors adopted or terminated a Rule 10b5-1 trading plan during the last fiscal quarter[480](index=480&type=chunk) [Exhibits](index=111&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with Form 10-Q, including corporate governance documents and officer certifications - The report includes key corporate governance documents and required officer certifications as exhibits[481](index=481&type=chunk)