Bicycle Therapeutics(BCYC) - 2024 Q1 - Quarterly Results

Executive Summary & Highlights Bicycle Therapeutics reported significant preclinical and clinical progress, with multiple abstracts accepted for major oncology meetings, continued R&D pipeline advancements, and a strong cash position projected to fund operations into 2026 Recent Business Progress Highlights Bicycle Therapeutics reported multiple preclinical and clinical abstracts accepted for major oncology meetings, continued R&D pipeline progress with numerous data readouts expected in 2H 2024, and a key executive promotion - Multiple preclinical and clinical abstracts accepted for presentation at 2024 ASCO Annual Meeting and AACR Annual Meeting, underscoring the breadth of Bicycle platform technology and pipeline[1] - Continued progress across research and development (R&D) pipeline, with numerous clinical data readouts and updates expected in 2H 2024[1] - Mike Hannay, D.Sc., FRPharmS, promoted to Chief Product and Supply Chain Officer[1] First Quarter 2024 Financial Highlights The company ended Q1 2024 with $457.0 million in cash and cash equivalents, which is projected to fund operations into 2026 Cash and Cash Equivalents (Q1 2024 vs. Q4 2023) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $457.0 million | $526.4 million | - Expected to provide financial runway into 2026[1] First Quarter 2024 and Recent Events The company initiated the Phase 2/3 Duravelo-2 trial, presented clinical and preclinical data at major oncology conferences, promoted a key executive, and scheduled investor relations activities Clinical and Preclinical Development Updates The company initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009 in metastatic urothelial cancer and presented clinical and preclinical data at ASCO and AACR, highlighting the versatility of its Bicycle platform ASCO Annual Meeting Presentations Two abstracts were accepted for poster presentation at the 2024 ASCO Annual Meeting, detailing clinical pharmacokinetics and the ongoing Duravelo-2 trial for BT8009 - Two abstracts accepted for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting[2] - First abstract to examine clinical pharmacokinetics and safety of Bicycle Toxin Conjugates (BTC molecules)[2] - Second abstract to outline the ongoing Phase 2/3 clinical trial, Duravelo-2, of BT8009 in metastatic urothelial cancer (mUC)[2] AACR Annual Meeting Presentations Three posters were presented at the AACR Annual Meeting 2024, showcasing preclinical data on BTC, NK-TICA, and Bicycle TICA molecules for solid tumors, emphasizing platform versatility - Three posters presented at the American Association for Cancer Research (AACR) Annual Meeting 2024[3] - Shared preclinical data on BTC molecules for solid tumors, Natural Killer Tumor-Targeted Immune Cell Agonist (NK-TICA) molecules, and Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) molecules[3] - Posters underscore the breadth of the company's platform technology and its capabilities to produce different modalities to target cancer[3] R&D Pipeline Progress The company initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009 and continues to assess BT8009, BT5528, and BT7480 in Phase 1/2 clinical trials, with updates planned for its BRC™ pipeline - Initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC, with patient enrollment ongoing[4] - Continues to assess BT8009, BT5528, and BT7480 in Phase 1/2 clinical trials across a variety of tumor types[4] - Plans to provide updates from its wholly owned Bicycle Radio Conjugate (BRC™) pipeline[4] Corporate Updates Mike Hannay was promoted to Chief Product and Supply Chain Officer, recognized for significantly advancing the company's manufacturing capabilities and priorities, including preparations for the potential commercial launch of BT8009 - Mike Hannay, D.Sc., FRPharmS, promoted to Chief Product and Supply Chain Officer[5] - Advanced the company's chemistry, manufacturing and controls (CMC) capabilities and drug manufacturing priorities, including preparations and buildout for the potential commercial launch of BT8009[5] Investor Relations Bicycle Therapeutics management will participate in a fireside chat at the Citizens JMP Life Sciences Conference on May 13, 2024 - Bicycle Therapeutics management will participate in a fireside chat at the Citizens JMP Life Sciences Conference on May 13, 2024[6] First Quarter 2024 Financial Results Bicycle Therapeutics reported a net loss of $26.6 million for Q1 2024, an improvement from the prior year, driven by increased collaboration revenues and controlled operating expenses, while cash and cash equivalents decreased to $457.0 million Cash and Liquidity Cash and cash equivalents decreased to $457.0 million as of March 31, 2024, from $526.4 million at the end of 2023, primarily due to cash used in operating activities, including upfront payments for the Duravelo-2 trial Cash and Cash Equivalents (Q1 2024 vs. Q4 2023) | Metric | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $456,997 | $526,423 | - Decrease primarily due to cash used in operating activities, including upfront payments associated with the initiation of the Phase 2/3 Duravelo-2 registrational trial[7] Operating Expenses R&D expenses increased to $34.9 million in Q1 2024, mainly due to higher clinical program expenses for BT8009 and personnel costs, partially offset by decreased expenses for other programs and a one-time tax credit. G&A expenses also rose to $16.4 million due to increased personnel-related costs Operating Expenses (Q1 2024 vs. Q1 2023) | Expense Category | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (Q1 2024 vs Q1 2023) | | :--- | :--- | :--- | :--- | | Research and development | $34,864 | $32,211 | +$2,653 | | General and administrative | $16,382 | $14,488 | +$1,894 | | Total operating expenses | $51,246 | $46,699 | +$4,547 | - R&D increase primarily due to increased clinical program expenses for BT8009 development and increased personnel-related expenses, offset by decreased expenses for Bicycle TICA and BT5528 development, and $8.2 million of one-time, incremental retroactive U.K. R&D tax credits[7] - G&A increase primarily due to an increase in personnel-related costs[8] Net Loss and EPS Bicycle Therapeutics reported a net loss of $26.6 million, or $(0.62) per share, for Q1 2024, an improvement compared to a net loss of $39.1 million, or $(1.30) per share, in Q1 2023 Net Loss and EPS (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net loss | $(26,563) | $(39,064) | | Net loss per share, basic and diluted | $(0.62) | $(1.30) | Collaboration Revenues and Interest Income (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Collaboration revenues | $19,530 | $4,896 | | Interest income | $5,624 | $2,929 | About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing novel Bicycle molecules, which are synthetic peptides designed for high-affinity and selective target binding, with a pipeline focused on oncology and partnerships exploring other therapeutic areas Company Overview and Technology Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing Bicycle molecules, which are fully synthetic short peptides constrained with small molecule scaffolds to form two loops, enabling high-affinity and selective target binding - Clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics[9] - Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry, facilitating target binding with high affinity and selectivity[9] Pipeline and Partnerships The company's pipeline includes BT8009 (targeting Nectin-4), BT5528 (targeting EphA2), and BT7480 (targeting Nectin-4 and agonizing CD137) in clinical trials. It is also developing Bicycle Radio Conjugates (BRC™) and collaborating on therapies beyond oncology - Evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4; BT5528, a BTC targeting EphA2; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials[9] - Developing Bicycle Radio Conjugates (BRC™) for radiopharmaceutical use[9] - Through various partnerships, exploring the use of Bicycle technology to develop therapies for diseases beyond oncology[9] Forward Looking Statements This section contains standard forward-looking statements regarding anticipated R&D progress, clinical trial advancements, data timing, therapeutic potential, and financial runway, along with disclaimers about inherent uncertainties and risks that could cause actual results to differ - Statements regarding anticipated progress across R&D pipeline, advancement of product candidates (BT8009, BT5528, BT7480), progression of clinical trials, and timing of data announcements[11] - Includes statements on the development of potential radiopharmaceutical or other product candidates through partnerships, therapeutic potential in oncology and other applications, and expected financial runway[11] - Disclaims obligation to update forward-looking statements and highlights various factors and risks that could cause actual results to differ materially, as described in SEC filings[11] Financial Statements This section presents the unaudited condensed consolidated statements of operations and comprehensive loss, along with key balance sheet data, for the periods ended March 31, 2024, and December 31, 2023 Condensed Consolidated Statements of Operations and Comprehensive Loss The unaudited condensed consolidated statements of operations detail collaboration revenues, operating expenses (R&D, G&A), loss from operations, other income/expense, net loss before income tax, benefit from income taxes, and net loss for the three months ended March 31, 2024, and 2023 Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | | :--- | :--- | :--- | | Collaboration revenues | $19,530 | $4,896 | | Operating expenses: | | | | Research and development | 34,864 | 32,211 | | General and administrative | 16,382 | 14,488 | | Total operating expenses | 51,246 | 46,699 | | Loss from operations | (31,716) | (41,803) | | Other income (expense): | | | | Interest income | 5,624 | 2,929 | | Interest expense | (821) | (808) | | Total other income (expense), net | 4,803 | 2,121 | | Net loss before income tax provision | (26,913) | (39,682) | | Benefit from income taxes | (350) | (618) | | Net loss | $(26,563) | $(39,064) | | Net loss per share, basic and diluted | $(0.62) | $(1.30) | | Weighted average ordinary shares outstanding, basic and diluted | 42,560,091 | 30,001,725 | Balance Sheets Data The unaudited balance sheets data provides key financial positions including cash and cash equivalents, working capital, total assets, and total shareholders' equity as of March 31, 2024, and December 31, 2023 Balance Sheets Data (Unaudited) | | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $456,997 | $526,423 | | Working capital | 466,452 | 492,331 | | Total assets | 547,143 | 595,344 | | Total shareholders' equity | 356,048 | 370,932 | Contacts This section provides contact information for investor relations and media inquiries - Investor Relations Contact: Stephanie Yao, SVP, Investor Relations and Corporate Communications, ir@bicycletx.com, 857-523-8544[15] - Media Contact: Deborah Elson, Argot Partners, media@bicycletx.com, 212-600-1902[15]