Bicycle Therapeutics(BCYC) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents unaudited condensed consolidated financial statements, showing increased net loss, decreased cash, and an accumulated deficit from higher R&D Condensed Consolidated Balance Sheets The balance sheet shows decreased total assets and shareholders' equity, driven by reduced cash and increased accumulated deficit Balance Sheet Summary (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $721,451 | $879,520 | | Total current assets | $804,262 | $928,605 | | Total assets | $832,184 | $956,868 | | Total current liabilities | $77,422 | $67,230 | | Total liabilities | $163,269 | $163,808 | | Total shareholders' equity | $668,915 | $793,060 | | Accumulated deficit | $(820,497) | $(680,791) | Condensed Consolidated Statements of Operations and Comprehensive Loss Net loss significantly increased for Q2 and H1 2025, driven by higher R&D expenses and decreased collaboration revenue Financial Performance (in thousands, except per share data) | 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 | $2,920 | $9,361 | $12,897 | $28,891 | | Research and development | $71,029 | $40,059 | $130,087 | $74,923 | | General and administrative | $18,493 | $15,949 | $39,616 | $32,331 | | Total operating expenses | $89,522 | $56,008 | $169,703 | $107,254 | | Loss from operations | $(86,602) | $(46,647) | $(156,806) | $(78,363) | | Net loss | $(78,952) | $(39,812) | $(139,706) | $(66,375) | | Net loss per share (basic & diluted) | $(1.14) | $(0.77) | $(2.02) | $(1.40) | Condensed Consolidated Statements of Shareholders' Equity Shareholders' equity decreased to $668.9 million by June 30, 2025, due to net loss and negative foreign currency adjustments Changes in Shareholders' Equity (in thousands) | Item | Balance at Dec 31, 2024 | Q1 2025 Activity | Q2 2025 Activity | Balance at Jun 30, 2025 | | :--------------------------------------- | :---------------------- | :--------------- | :--------------- | :---------------------- | | Ordinary Shares (Amount) | $890 | $2 | $1 | $893 | | Additional Paid-in Capital | $1,472,842 | $9,605 | $9,435 | $1,491,882 | | Accumulated Other Comprehensive (Loss) Income | $119 | $(1,580) | $(1,902) | $(3,363) | | Accumulated Deficit | $(680,791) | $(60,754) | $(78,952) | $(820,497) | | Total Shareholders' Equity | $793,060 | $740,333 | $668,915 | $668,915 | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $159.2 million for H1 2025, driven by higher clinical program expenses Cash Flow Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :---------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(159,156) | $(115,496) | | Net cash used in investing activities | $(1,102) | $(432) | | Net cash (used in) provided by financing activities | $(86) | $551,477 | | Effect of exchange rate changes | $2,275 | $(608) | | Net (decrease) increase in cash | $(158,069) | $434,941 | | Cash, cash equivalents and restricted cash at end of period | $721,998 | $961,911 | Notes to Condensed Consolidated Financial Statements Notes detail the company's clinical-stage oncology focus, $721.5 million cash, recurring losses, and subsequent workforce reduction - Bicycle Therapeutics plc is a clinical-stage pharmaceutical company developing Bicycle® molecules for underserved diseases, primarily oncology. Key product candidates include zelenectide pevedotin (Nectin-4), BT5528 (EphA2), and BT7480 (Nectin-4 and CD137)[25] - As of June 30, 2025, the company had cash and cash equivalents of $721.5 million and an accumulated deficit of $820.5 million, expecting to fund operations for at least 12 months[27][30] - The company recognized collaboration revenue of $2.9 million and $12.9 million for the three and six months ended June 30, 2025, respectively, a decrease from the prior year due to completion of certain performance obligations and expiration of material rights in collaborations with Ionis, Novartis, and Genentech[82][169][176] - Research and development expenses increased significantly by $31.0 million (QoQ) and $55.2 million (YoY) due to advancing clinical trials for zelenectide pevedotin (Duravelo-2 and NECTIN4 amplified breast cancer trials) and pipeline development, partially offset by R&D incentives[170][177] - In August 2025, the company announced cost reduction initiatives, including a workforce reduction of approximately 25%, expected to reduce planned operating costs by 30% and incur $5.3 million in severance charges[128][139][477] - Genentech provided notice of termination for the Genentech Collaboration Agreement, effective August 2025, leading to an expected recognition of $6.5 million in deferred revenue in Q3 2025[94][127] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition, highlighting oncology pipeline, increased net losses from R&D, and future funding needs - Bicycle Therapeutics is a clinical-stage pharmaceutical company developing Bicycle® molecules, a novel therapeutic modality combining biologic pharmacology with small molecule properties, primarily for oncology indications[131] - Key product candidates include zelenectide pevedotin (Nectin-4 BDC), BT5528 (EphA2 BDC), and BT7480 (Nectin-4/CD137 Bicycle TICA), all in Phase I/II or Phase II/III clinical trials[133] - The company incurred net losses of $79.0 million and $139.7 million for the three and six months ended June 30, 2025, respectively, with an accumulated deficit of $820.5 million as of June 30, 2025[141] - Collaboration revenue decreased by $6.4 million (QoQ) and $16.0 million (YoY) due to the completion of performance obligations and expiration of material rights in agreements with Ionis, Novartis, and Genentech[169][176] - Research and development expenses increased by $31.0 million (QoQ) and $55.2 million (YoY), primarily due to increased clinical program expenses for zelenectide pevedotin, pipeline development, and higher employee-related costs[170][177] - As of