Ventyx Biosciences(VTYX) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents Ventyx Biosciences, Inc.'s unaudited condensed consolidated financial statements for Q1 2025, including key financial statements and notes Condensed Consolidated Balance Sheets 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 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 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] Condensed Consolidated Statements of Cash Flows 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 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] - A securities class action and a shareholder derivative action filed against the company were both voluntarily dismissed without prejudice in February 2025[51][52] - 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][56] - 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] 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 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] - 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] 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] - 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][117] Quantitative and Qualitative Disclosures About Market Risk 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] Controls and Procedures 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] - No material changes in internal control over financial reporting were identified during the quarter ended March 31, 2025[139] PART II. OTHER INFORMATION Legal Proceedings 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] - A shareholder derivative action filed on December 6, 2024, was voluntarily dismissed without prejudice on February 24, 2025[52] Risk Factors 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] - 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][156] - 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][231][234] - The company faces intense competition from well-established pharmaceutical companies with substantially greater financial, scientific, and commercial resources[185] - 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][430][476] Unregistered Sales of Equity Securities and Use of Proceeds 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] Defaults Upon Senior Securities None - None[478] Mine Safety Disclosures Not applicable - Not Applicable[479] Other Information 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] Exhibits 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]