Bicycle Therapeutics(BCYC) - 2025 Q2 - Quarterly Results

Executive Summary Bicycle Therapeutics advanced R&D, initiated trial, strengthened leadership, and realigned costs, extending financial runway Recent Business Highlights Bicycle Therapeutics advanced its R&D pipeline, initiated a key clinical trial, enhanced leadership, and strategically realigned costs to extend its financial runway - Key program updates are expected in the second half of 2025[1] - The Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer is open and actively recruiting patients[1] - The company strengthened clinical leadership and bolstered its roster of scientific advisors with additions to the Board of Directors and the creation of a Research and Innovation Advisory Board[1] - A strategic cost realignment of approximately 30% was implemented, primarily through a workforce reduction[1] Cash and Financial Runway | Metric | Value | | :-------------------- | :-------------------- | | Cash and cash equivalents (as of June 30, 2025) | $721.5 million | | Expected financial runway | Extended into 2028 | CEO Statement and Strategic Focus CEO Kevin Lee emphasized the company's strategy grounded in scientific rigor, focusing on next-generation precision-guided therapeutics, pipeline progress, disciplined capital allocation, and organizational streamlining - The company's strategy is grounded in scientific rigor and focused on developing next-generation precision-guided therapeutics to help patients[2] - Bicycle Therapeutics remains committed to disciplined capital allocation while advancing pipeline programs[2] - Organizational streamlining efforts provide operational flexibility to deliver value-generating datasets and strengthen the financial position in uncertain market conditions[2] Recent Business Progress and Pipeline Updates This section details Bicycle Therapeutics' R&D pipeline advancements, including BRC and BDC program updates, corporate governance changes, and upcoming investor conferences Research and Development Pipeline Bicycle Therapeutics provided updates on its BRC and BDC programs, including new imaging data, trial progress, and strategic adjustments to its clinical development plan Bicycle Radioconjugates (BRC) Additional human imaging data for an early BRC molecule targeting MT1-MMP were presented, validating MT1-MMP as a cancer target and demonstrating positive BRC properties - Presented additional human imaging data for an early BRC molecule targeting MT1-MMP at AACR 2025, validating MT1-MMP as a novel cancer target and demonstrating positive properties of BRC molecules for radiopharmaceutical imaging[3] - Imaging data from two patients are representative of data generated in 12 out of 14 patients with various solid tumors[3] - Initial EphA2 human imaging data are expected in 2H 2025, and company-sponsored clinical trials are planned for 2026[3] Bicycle Drug Conjugates (BDC) - Zelenectide Pevedotin Two abstracts highlighting zelenectide pevedotin development for metastatic urothelial cancer (mUC) were presented at ASCO 2025, with updates on dose selection and accelerated approval pathway expected in 4Q 2025 - Presented two abstracts at ASCO 2025 highlighting the development of zelenectide pevedotin for metastatic urothelial cancer (mUC), including topline combination data from Duravelo-1 and an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial[4] - An update on dose selection from the Duravelo-2 trial and the accelerated approval pathway for zelenectide pevedotin in mUC is expected following an FDA meeting planned for 4Q 2025[4] - The Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer (NSCLC) is open and actively recruiting patients, leveraging NECTIN4 gene amplification as a biomarker[5] - The previously announced Phase 1/2 Duravelo-5 trial in multiple tumors has been paused[6] Corporate Governance and Leadership Bicycle Therapeutics expanded its Board of Directors, formed a new Research and Innovation Advisory Board (RAB), and welcomed new clinical development leadership Board of Directors Expansion The Board of Directors was expanded with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, recognized for his research on tumor evolution and cancer diversity - Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, was added to the Board of Directors[6] - Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute and is known for his research on how tumors evolve[6] Research and Innovation Advisory Board (RAB) Formation A new Research and Innovation Advisory Board (RAB) was formed to support scientific advancement and strategic growth across preclinical programs, replacing the previous Scientific Advisory Board - A Research and Innovation Advisory Board (RAB) was formed to support scientific advancement and strategic growth across preclinical programs, replacing the Scientific Advisory Board[6] - Inaugural RAB members include Jose-Carlos Gutierrez-Ramos, Ph.D., Jason Lewis, Ph.D., Robert Lutz, Ph.D., and Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD[6][8] New Clinical Development Leadership Michael Method, M.D., joined as Senior Vice President of Clinical Development, bringing extensive drug development experience from Karyopharm Therapeutics, ImmunoGen, and Eli Lilly - Michael Method, M.D., joined as Senior Vice President of Clinical Development[8] - Dr. Method brings extensive drug development experience from previous roles at Karyopharm Therapeutics, ImmunoGen, Inc., and Eli Lilly[8] Upcoming Investor Conferences Bicycle Therapeutics management is scheduled to participate in two investor conferences in September: the Cantor Global Healthcare Conference on September 4th and the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9th - Bicycle Therapeutics management will participate in the Cantor Global Healthcare Conference on Thursday, Sept. 4, with a fireside chat at 3:55 p.m. ET[8] - The company will also participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, Sept. 9, with a fireside chat at 7:45 a.m. ET[8] Second Quarter 2025 Financial Results This section provides an overview of Bicycle Therapeutics' Q2 2025 financial performance, highlighting strategic cost realignment, key financial metrics, and changes in operating expenses and net loss Financial Overview and Strategic Cost Realignment Bicycle Therapeutics implemented a workforce reduction and operational optimizations, expecting approximately 30% in total operational savings and extending the financial runway into 2028 - Bicycle Therapeutics is implementing a workforce reduction and other steps to optimize operations and extend its financial runway[10] - These strategic cost realignment efforts prioritize high-impact programs, including zelenectide pevedotin, BT5528, next-generation BDCs, and wholly-owned BRCs[10] - The company anticipates total operational savings of approximately 30% over the financial runway period[10] - These actions are expected to extend the financial runway into 2028[10] Key Financial Highlights For Q2 2025, Bicycle Therapeutics reported decreased cash and cash equivalents due to increased operational and clinical program expenses, leading to a higher net loss per share Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $721.5 million | $879.5 million | -$158.0 million | - The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities[12] Selected Operating Expenses (Three Months Ended June 30) | Expense Category | 2025 (Millions) | 2024 (Millions) | Change (Millions) | Change (%) | | :------------------------ | :-------------- | :-------------- | :---------------- | :--------- | | Research and development | $71.0 | $40.1 | +$30.9 | +77.1% | | General and administrative | $18.5 | $15.9 | +$2.6 | +16.4% | - The increase in R&D expenses was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform, and other expenses, and increased personnel-related costs, partially offset by decreased clinical program expenses for Bicycle TICA molecules and higher U.K. R&D tax