Bioage Labs, Inc.(BIOA) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Unaudited H1 2025 financial statements reveal a net loss of $34.5 million, increased operating expenses, and initial collaboration revenue Condensed Consolidated Balance Sheets As of June 30, 2025, total assets decreased to $322.1 million due to reduced cash, while liabilities also declined and the accumulated deficit grew to $287.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $220,330 | $354,349 | | Marketable securities (current & non-current) | $93,073 | $0 | | Total current assets | $301,697 | $357,103 | | Total assets | $322,148 | $358,234 | | Liabilities & Equity | | | | Total current liabilities | $22,837 | $27,775 | | Total liabilities | $27,367 | $35,107 | | Accumulated deficit | $(287,302) | $(252,811) | | Total stockholders' equity | $294,781 | $323,127 | Condensed Consolidated Statements of Operations and Comprehensive Loss The company reported increased net losses of $21.6 million and $34.5 million for the three and six months ended June 30, 2025, primarily due to higher operating expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,412 | $0 | $3,863 | $0 | | Research and development | $19,844 | $10,471 | $30,953 | $19,792 | | General and administrative | $7,339 | $4,798 | $14,127 | $8,290 | | Loss from operations | $(24,771) | $(15,269) | $(41,217) | $(28,082) | | Net loss | $(21,563) | $(13,581) | $(34,491) | $(26,573) | | Net loss per share | $(0.60) | $(7.94) | $(0.96) | $(15.70) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $37.3 million for H1 2025, with significant cash used in investing for marketable securities and financing for loan payments Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,332) | $(31,453) | | Net cash used in investing activities | $(93,629) | $(35) | | Net cash (used in) provided by financing activities | $(3,000) | $165,614 | | Net (decrease) increase in cash | $(134,019) | $134,128 | Notes to Unaudited Condensed Consolidated Financial Statements The notes detail the company's business, liquidity, the Novartis collaboration, term loan, and a pending securities class action lawsuit - The company is a biopharmaceutical firm focused on developing therapies for metabolic diseases like obesity by targeting the biology of aging[22] - As of June 30, 2025, the company had an accumulated deficit of $287.3 million but believes its current cash, cash equivalents, and marketable securities of $313.4 million are sufficient to fund operations for at least one year[25][26] - In December 2024, the company entered into a collaboration agreement with Novartis, recognizing $3.9 million in revenue for the six months ended June 30, 2025, with potential future milestones up to $530.0 million[90][92][94] - A securities class action lawsuit was filed against the company and its directors/officers on January 7, 2025, alleging false and misleading statements in connection with the IPO[81] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's metabolic disease focus, increased R&D expenses for H1 2025, and strong liquidity projected to fund operations through 2029 Overview The company is a biopharmaceutical firm focused on metabolic diseases, with lead programs BGE-102 and APJ agonists, and has accumulated a deficit of $287.3 million - The lead program is BGE-102, an oral NLRP3 inhibitor for obesity, with a Phase 1 clinical trial planned for H2 2025 and initial data expected by year-end 2025[109][110] - The company is also developing novel oral and parenteral APJ agonists for obesity, with plans to file INDs for both programs by the end of 2026[111] - The company has incurred significant operating losses since inception, with an accumulated deficit of $287.3 million as of June 30, 2025[115] Results of Operations Net loss for H1 2025 increased to $34.5 million, driven by higher R&D and G&A expenses, partially offset by initial collaboration revenue Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $3,863 | $0 | $3,863 | 100% | | Research and development | $30,953 | $19,792 | $11,161 | 56% | | General and administrative | $14,127 | $8,290 | $5,837 | 70% | | Loss from operations | $(41,217) | $(28,082) | $(13,135) | 47% | R&D Expense Breakdown for the Six Months Ended June 30 (in thousands) | Program | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | azelaprag | $2,800 | $7,215 | $(4,415) | | BGE-102 | $5,158 | $0 | $5,158 | | Other programs | $10,626 | $2,078 | $8,548 | | Indirect costs | $12,369 | $10,499 | $1,870 | | Total R&D | $30,953 | $19,792 | $11,161 | - The increase in G&A expenses was primarily driven by a $3.5 million increase in personnel-related costs (largely stock-based compensation) and a $1.4 million increase in legal fees[154] Liquidity and Capital Resources As of June 30, 2025, the company held $313.4 million in liquidity, projected to fund operations through 2029, with significant cash used in operations and investing activities - The company possessed $313.4 million in cash, cash equivalents, and marketable securities as of June 30, 2025[156] - Based on the current operating plan, existing cash is estimated to be sufficient to fund operations and capital expenses through 2029[166] Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,332) | $(31,453) | | Net cash used in investing activities | $(93,629) | $(35) | | Net cash (used in) provided by financing activities | $(3,000) | $165,614 | Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the company is exempt from providing quantitative and qualitative market risk disclosures - As a smaller reporting company, BioAge Labs is exempt from providing quantitative and qualitative disclosures about market risk[191] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report (June 30, 2025)[192] - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[193] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is subject to a securities class action lawsuit filed January 7, 2025, alleging IPO-related violations, which it intends to vigorously defend - A securities class action lawsuit was filed against the company on January 7, 2025, alleging false and misleading statements in connection with its initial public offering[81] Item 1A. Risk Factors The company faces significant risks including limited operating history, ongoing losses, capital needs, clinical development uncertainties, third-party reliance, and intense market competition - The company has a history of significant operating losses ($287.3 million accumulated deficit as of June 30, 2025) and will require substantial additional capital to finance operations[203][208] - The business is highly dependent on the successful development and commercialization of its lead product candidate, BGE-102, which is in early development and faces an uncertain clinical and regulatory pathway[214] - The company relies on third-party manufacturers in China and India, exposing it to geopolitical risks, supply chain disruptions, and potential impacts from legislation like the BIOSECURE Act[308][309] - The company is subject to a securities class action lawsuit, which could result in substantial costs and divert management's attention[428] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered equity sales and detailed the use of $217.2 million net proceeds from its September 2024 IPO and concurrent private placement Use of Proceeds from September 2024 Offerings | Offering | Gross Proceeds | Net Proceeds | | :--- | :--- | :--- | | Initial Public Offering | $227.7 million | $207.3 million | | Concurrent Private Placement | $10.6 million | $9.9 million | | Total | $238.3 million | $217.2 million | Item 3. Defaults Upon Senior Securities No defaults upon senior securities occurred during the reporting period Item 4. Mine Safety Disclosures This item is not applicable to the company's operations Item 5. Other Information No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the quarter Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL data files