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3 Stocks to Buy Under $10 That Could Triple From Here
Yahoo Finance· 2025-09-15 11:30
Group 1: Company Overview - Sana Biotechnology (SANA) is valued at $837.6 million and focuses on creating modified cells and gene therapies to repair or replace damaged cells and control gene expression [4] - The company has significantly expanded its financial runway, ending Q2 with $72.7 million in cash, which increased to a pro forma $177.2 million after capital raises, expected to fund operations until the second half of 2026 [1] Group 2: Product Development and Clinical Trials - Sana is developing a functional treatment for diabetes that does not require lifelong immunosuppression, which is considered a promising initiative [1] - The company is also working on allogeneic CAR T therapies, including SC291 for autoimmune diseases and SC262 for relapsed/refractory B-cell malignancies, with results from Phase 1 trials expected by 2025 [2] - The UP421 trial, using hypoimmune-modified pancreatic islet cells for type 1 diabetes, has shown success, leading to a 100% increase in stock price year-to-date [3] Group 3: Market Sentiment and Analyst Ratings - Wall Street rates SANA stock as a "Strong Buy," with seven out of nine analysts recommending it, and an average target price of $9.17, indicating a potential upside of 169.7% [6] - The highest estimate for the stock is $15, suggesting a possible increase of 341.2% in the next 12 months [6]
Bicycle Therapeutics plc (BCYC) Presents at Morgan Stanley 23rd
Seeking Alpha· 2025-09-09 16:06
Group 1 - Bicycle Therapeutics announced new board appointments, including Roger Dansey and Hervé Hoppenot, who are recognized for their contributions in the oncology biotech sector [2] - The recent appointments follow earlier additions of Charles Swanton and Alessandro Riva to the board, indicating a strategic focus on enhancing leadership in oncology [2] - The company aims to establish itself as a leading oncology powerhouse by building a strong board and senior management team [3]
Bicycle Therapeutics Plc (BCYC) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-09 16:06
Group 1 - Bicycle Therapeutics announced new board appointments, including Roger Dansey and Hervé Hoppenot, who are recognized for their contributions in the oncology biotech sector [2] - The recent appointments follow earlier additions of Charles Swanton and Alessandro Riva to the board, indicating a strategic focus on enhancing leadership in oncology [2] - The company aims to establish itself as a leading oncology powerhouse by building a strong board and senior management team [3]
Bicycle Therapeutics(BCYC) - 2025 Q2 - Quarterly Report
2025-08-08 11:14
[PART I - FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements.) 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](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) 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](index=25&type=chunk) - 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](index=27&type=chunk)[30](index=30&type=chunk) - 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](index=82&type=chunk)[169](index=169&type=chunk)[176](index=176&type=chunk) - 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](index=170&type=chunk)[177](index=177&type=chunk) - 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](index=128&type=chunk)[139](index=139&type=chunk)[477](index=477&type=chunk) - 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](index=94&type=chunk)[127](index=127&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) 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](index=131&type=chunk) - 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](index=133&type=chunk) - 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](index=141&type=chunk) - 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](index=169&type=chunk)[176](index=176&type=chunk) - 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](index=170&type=chunk)[177](index=177&type=chunk) - As of
Bicycle Therapeutics(BCYC) - 2025 Q2 - Quarterly Results
2025-08-08 11:05
[Executive Summary](index=1&type=section&id=Executive%20Summary) Bicycle Therapeutics advanced R&D, initiated trial, strengthened leadership, and realigned costs, extending financial runway [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) 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](index=1&type=chunk) - 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](index=1&type=chunk) - 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](index=1&type=chunk) - A strategic cost realignment of approximately **30%** was implemented, primarily through a workforce reduction[1](index=1&type=chunk) 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](index=1&type=section&id=CEO%20Statement%20and%20Strategic%20Focus) 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](index=2&type=chunk) - Bicycle Therapeutics remains committed to disciplined capital allocation while advancing pipeline programs[2](index=2&type=chunk) - Organizational streamlining efforts provide operational flexibility to deliver value-generating datasets and strengthen the financial position in uncertain market conditions[2](index=2&type=chunk) [Recent Business Progress and Pipeline Updates](index=1&type=section&id=Recent%20Business%20Progress%20and%20Pipeline%20Updates) 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](index=1&type=section&id=Research%20and%20Development%20Pipeline) 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)](index=1&type=section&id=Bicycle%20Radioconjugates%20%28BRC%29) 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](index=3&type=chunk) - Imaging data from two patients are representative of data generated in **12 out of 14 patients** with various solid tumors[3](index=3&type=chunk) - Initial EphA2 human imaging data are expected in **2H 2025**, and company-sponsored clinical trials are planned for **2026**[3](index=3&type=chunk) [Bicycle Drug Conjugates (BDC) - Zelenectide Pevedotin](index=2&type=section&id=Bicycle%20Drug%20Conjugates%20%28BDC%29%20-%20Zelenectide%20Pevedotin) 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](index=4&type=chunk) - 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](index=4&type=chunk) - 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](index=5&type=chunk) - The previously announced Phase 1/2 Duravelo-5 trial in multiple tumors has been paused[6](index=6&type=chunk) [Corporate Governance and Leadership](index=2&type=section&id=Corporate%20Governance%20and%20Leadership) 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](index=2&type=section&id=Board%20of%20Directors%20Expansion) 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](index=6&type=chunk) - 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](index=6&type=chunk) [Research and Innovation Advisory Board (RAB) Formation](index=2&type=section&id=Research%20and%20Innovation%20Advisory%20Board%20%28RAB%29%20Formation) 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](index=6&type=chunk) - 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](index=6&type=chunk)[8](index=8&type=chunk) [New Clinical Development Leadership](index=3&type=section&id=New%20Clinical%20Development%20Leadership) 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](index=8&type=chunk) - Dr. Method brings extensive drug development experience from previous roles at Karyopharm Therapeutics, ImmunoGen, Inc., and Eli Lilly[8](index=8&type=chunk) [Upcoming Investor Conferences](index=3&type=section&id=Upcoming%20Investor%20Conferences) 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](index=8&type=chunk) - 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](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Results) 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](index=4&type=section&id=Financial%20Overview%20and%20Strategic%20Cost%20Realignment) 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](index=10&type=chunk) - These strategic cost realignment efforts prioritize high-impact programs, including zelenectide pevedotin, BT5528, next-generation BDCs, and wholly-owned BRCs[10](index=10&type=chunk) - The company anticipates total operational savings of approximately **30%** over the financial runway period[10](index=10&type=chunk) - These actions are expected to extend the financial runway into **2028**[10](index=10&type=chunk) [Key Financial Highlights](index=4&type=section&id=Key%20Financial%20Highlights) 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](index=12&type=chunk) 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
Bicycle Therapeutics (BCYC) Earnings Call Presentation
2025-06-27 11:44
Zelenectide Pevedotin (Nectin-4 Targeting Bicycle Drug Conjugate) - Zelenectide pevedotin targets Nectin-4, which is highly expressed in many tumors, and is being studied as a potential treatment for multiple solid tumors including mUC, TNBC, and NSCLC[19, 20] - In the Duravelo-1 Ph1 study, zelenectide has shown a promising response and differentiated safety profile in 2L+ EV-naïve mUC, with an ORR of 45% (17/38 patients)[22, 26] - In the Duravelo-1 Ph1 study, zelenectide + pembrolizumab has shown an encouraging response in 1L cisplatin-ineligible mUC, with an ORR of 65% (13/20 patients) including a Complete Response of 25% (5/20 patients)[36, 38] - Patients with NECTIN4 gene amplification show an enhanced response to zelenectide in 2L+ TNBC and NSCLC, with ORRs of 57% (4/7) and 40% (2/5) respectively in NECTIN4-amplified patients[49, 55] - The company initiated the Duravelo-3 trial in March 2025 in NECTIN4-amplified breast cancer and plans to initiate Duravelo-4 and Duravelo-5 trials in 2H 2025 in NECTIN4-amplified NSCLC and multi-tumor respectively[60, 62] Bicycle Radioconjugates (BRC) - BRC molecules show selective tumor uptake and ideal PK across a range of targets and tumor models, including MT1-MMP, EphA2, and CD38[71, 72] - Early MT1-MMP-targeting BRC molecules show high tumor enrichment in PET imaging studies, with first human MT1-MMP imaging representative of data seen in 12 patients with various solid tumors[80, 83] - EphA2 is a tumor antigen that is widely expressed in many cancers, with 60% of pancreatic cancer and 58% of bladder cancer cases testing positive[101, 93] BT5528 (EphA2 Targeting BDC Molecule) - BT5528 demonstrated anti-tumor activity in patients with advanced solid tumors, particularly in mUC, with an ORR of 34% (10/29 patients) in all monotherapy dose escalation and expansion[119] - BT5528 delivers 10x more drug to the tumor compared to plasma in patients, demonstrating efficient and durable tumor MMAE delivery[112, 113] - In clinical trials, treatment-related adverse events of interest were of low frequency and severity, with peripheral neuropathy occurring in 20% (26/128) of patients and neutropenia in 10% (13/128) of patients[131] BT7480 (Bicycle TICA Molecule) - BT7480 was generally well-tolerated, with any grade treatment-related AEs occurring in 49% (19/39) of patients, the most common being fatigue (23%)[157, 159] - BT7480 showed preliminary antitumor activity in patients with advanced Nectin-4–associated solid tumors, with a clinical benefit rate of 38% (15/40 patients)[160, 161]
Bicycle Therapeutics(BCYC) - 2025 Q1 - Earnings Call Presentation
2025-05-01 15:04
Zelenectide Pevedotin (Nectin-4 Targeting Bicycle Drug Conjugate) - In the Duravelo-1 Ph1 study, 45% ORR (17/38) was observed in 2L+ EV-naïve mUC patients treated with zelenectide [26] - In the Duravelo-1 Ph1 study, 65% ORR (13/20) was observed in 1L cisplatin-ineligible mUC patients treated with zelenectide + pembrolizumab [38] - In TNBC patients with NECTIN4 gene amplification, 57% ORR (4/7) and 100% DCR (7/7) were observed with zelenectide monotherapy [56] - In NSCLC patients with NECTIN4 gene amplification, 40% ORR (2/5) and 100% DCR (5/5) were observed with zelenectide monotherapy [56] - The company plans to initiate the Duravelo-4 trial in NECTIN4-amplified NSCLC and the Duravelo-5 trial in NECTIN4-amplified multi-tumor in 2H 2025 [63] BT5528 (EphA2 Targeting Bicycle Drug Conjugate) - In all cancers, 12% ORR (14/113) was observed with BT5528 monotherapy at 6.5 mg/m2 Q2W dose esc+exp [120] - In urothelial cancer, 34% ORR (10/29) was observed with BT5528 monotherapy at 6.5 mg/m2 Q2W dose esc+exp [120] - BT5528 delivers 10x more drug to the tumor compared to plasma in patients [114] BT7480 (Tumor-Targeted Immune Cell Agonist) - 49% of patients experienced any grade treatment-related AEs (TRAEs) with BT7480, the most common being fatigue (23%) and headache (10%) [159] - 5% ORR (2/40) was observed with BT7480 in all patients [161] Financial Position - The company had $793 million in cash and cash equivalents as of March 31, 2025, with expected financial runway into 2H 2027 [6]
Bicycle Therapeutics(BCYC) - 2025 Q1 - Quarterly Report
2025-05-01 11:10
PART I - FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis of Bicycle Therapeutics plc [Item 1. Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) This section presents the unaudited condensed consolidated financial statements for Bicycle Therapeutics plc, including the balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, and statements of cash flows, along with their accompanying notes - Financial Position (in thousands) | Financial Metric (in thousands) | March 31, 2025 | December 31, 2024 | Change (vs. Dec 31, 2024) | | :------------------------------ | :------------- | :---------------- | :------------------------ | | Cash and cash equivalents | $792,973 | $879,520 | $(86,547) | | Total current assets | $856,086 | $928,605 | $(72,519) | | Total assets | $883,894 | $956,868 | $(72,974) | | Total current liabilities | $57,623 | $67,230 | $(9,607) | | Total liabilities | $143,561 | $163,808 | $(20,247) | | Total shareholders' equity | $740,333 | $793,060 | $(52,727) | - Statements of Operations (in thousands, except per share) | Financial Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Collaboration revenue | $9,977 | $19,530 | $(9,553) | | Research and development expenses | $59,058 | $34,864 | $24,194 | | General and administrative expenses | $21,123 | $16,382 | $4,741 | | Total operating expenses | $80,181 | $51,246 | $28,935 | | Loss from operations | $(70,204) | $(31,716) | $(38,488) | | Net loss | $(60,754) | $(26,563) | $(34,191) | | Net loss per share, basic and diluted | $(0.88) | $(0.62) | $(0.26) | - Cash Flow Activities (in thousands) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | $(86,370) | $(70,869) | $(15,501) | | Net cash used in investing activities | $(604) | $(12) | $(592) | | Net cash (used in) provided by financing activities | $(41) | $1,871 | $(1,912) | | Net decrease in cash, cash equivalents and restricted cash | $(86,547) | $(69,426) | $(17,121) | | Cash, cash equivalents and restricted cash at end of period | $793,520 | $457,544 | $335,976 | - The company had an **accumulated deficit of $741.5 million** as of March 31, 2025, reflecting recurring losses since inception[28](index=28&type=chunk) [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, including assets, liabilities, and equity, as of March 31, 2025, and December 31, 2024 [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss for the three months ended March 31, 2025 and 2024 [Condensed Consolidated Statements of Shareholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) This section outlines changes in the company's shareholders' equity for the three months ended March 31, 2025 and 2024 [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1. Nature of the business and basis of presentation](index=11&type=section&id=Note%201.%20Nature%20of%20the%20business%20and%20basis%20of%20presentation) Bicycle Therapeutics is a clinical-stage pharmaceutical company focused on developing novel Bicycle® molecules for underserved diseases, primarily oncology - Bicycle Therapeutics is a clinical-stage pharmaceutical company developing Bicycle® molecules for oncology, including zelenectide pevedotin (Nectin-4 BDC), BT5528 (EphA2 BDC), and BT7480 (Nectin-4/CD137 Bicycle TICA®)[24](index=24&type=chunk) - The company has incurred net losses of **$60.8 million** (Q1 2025) and **$26.6 million** (Q1 2024), with an accumulated deficit of **$741.5 million** as of March 31, 2025[28](index=28&type=chunk) - Cash and cash equivalents totaled **$793.0 million** as of March 31, 2025, projected to fund operations for at least 12 months[26](index=26&type=chunk)[28](index=28&type=chunk) [Note 2. Summary of significant accounting policies](index=13&type=section&id=Note%202.%20Summary%20of%20significant%20accounting%20policies) This note outlines the company's significant accounting policies, including the use of estimates, economic uncertainties, and R&D incentives - The company benefits from U.K. government R&D tax reliefs, recognizing incentives as a reduction to R&D expenses[42](index=42&type=chunk) - R&D Incentives (in thousands) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Reduction to R&D expenses from incentives | $9,300 | $15,300 | | R&D incentives receivable (as of March 31, 2025) | $46,200 | N/A | - The company adopted ASU No. 2023-07 (Segment Reporting) with no impact on reportable segments and is evaluating ASU No. 2024-03 (Expense Disaggregation) and ASU No. 2023-09 (Income Tax Disclosures) for future impact[43](index=43&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) [Note 3. Fair value of financial assets and liabilities](index=17&type=section&id=Note%203.%20Fair%20value%20of%20financial%20assets%20and%20liabilities) This note details the fair value classification of financial assets and liabilities, primarily cash equivalents and restricted cash - Cash equivalents of **$593.1 million** (Mar 31, 2025) and **$664.9 million** (Dec 31, 2024) consist of money market funds primarily invested in U.S. Treasury securities, classified as Level 1 assets[49](index=49&type=chunk) - Restricted cash of **$0.5 million** is held as collateral for a lease in Cambridge, Massachusetts[50](index=50&type=chunk) [Note 4. Property and equipment, net](index=18&type=section&id=Note%204.%20Property%20and%20equipment%2C%20net) Property and equipment, net, decreased to $8.7 million as of March 31, 2025, with $1.6 million in depreciation and amortization expense for Q1 2025 - Property and Equipment, Net (in thousands) | Category (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------- | :------------- | :---------------- | | Laboratory equipment | $15,655 | $14,658 | | Leasehold improvements | $11,262 | $10,903 | | Total Property and equipment, net | $8,736 | $9,516 | - Depreciation and amortization expense was **$1.6 million** for the three months ended March 31, 2025, down from **$1.7 million** in the prior year period[51](index=51&type=chunk) [Note 5. Accrued expenses and other current liabilities](index=18&type=section&id=Note%205.%20Accrued%20expenses%20and%20other%20current%20liabilities) Accrued expenses and other current liabilities decreased to $34.0 million as of March 31, 2025, primarily due to lower employee compensation - Accrued Expenses and Other Current Liabilities (in thousands) | Category (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------- | :------------- | :---------------- | | Accrued employee compensation and benefits | $6,234 | $16,272 | | Accrued external R&D expenses | $17,412 | $14,978 | | Total Accrued expenses and other current liabilities | $33,992 | $41,246 | - The company paid **$0.3 million** in severance and termination benefits during Q1 2025, related to consolidating discovery research activities in August 2024[52](index=52&type=chunk) [Note 6. Debt](index=18&type=section&id=Note%206.%20Debt) The company fully repaid and terminated its Loan Agreement with Hercules Capital, Inc. in July 2024, resulting in zero interest expense for Q1 2025 - The Loan Agreement with Hercules Capital, Inc. was fully repaid and terminated in July 2024, including **$30.0 million** in outstanding borrowings[53](index=53&type=chunk) - Interest Expense (in thousands) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :------------- | :----------------------------------------------- | :----------------------------------------------- | | Interest expense | $0 | $800 | [Note 7. Ordinary shares](index=20&type=section&id=Note%207.%20Ordinary%20shares) The company has ordinary and non-voting ordinary shares, with 47.7 million and 21.5 million outstanding, respectively, as of March 31, 2025 - The company's share capital includes ordinary shares (voting) and non-voting ordinary shares, with **47.7 million** ordinary shares and **21.5 million** non-voting ordinary shares outstanding as of March 31, 2025[54](index=54&type=chunk)[57](index=57&type=chunk) - Non-voting ordinary shares can be re-designated as ordinary shares under specific conditions, primarily to avoid exceeding 9.99% beneficial ownership for Section 13(d) of the Exchange Act[58](index=58&type=chunk) [Note 8. Share-based compensation](index=21&type=section&id=Note%208.%20Share-based%20compensation) Share-based compensation expense for Q1 2025 was $9.6 million, with significant unrecognized compensation expense for unvested options and RSUs - Share-based Compensation Expense (in thousands) | Expense Category (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development | $4,352 | $4,531 | | General and administrative | $5,253 | $4,751 | | Total share-based compensation | $9,605 | $9,282 | - As of March 31, 2025, total unrecognized compensation expense for unvested employee and director share options was **$54.9 million**, to be recognized over a weighted average period of 2.6 years[74](index=74&type=chunk) - As of March 31, 2025, total unrecognized compensation expense for unvested RSUs was **$28.2 million**, to be recognized over a weighted-average period of 3.1 years[77](index=77&type=chunk) [Note 9. Significant agreements](index=25&type=section&id=Note%209.%20Significant%20agreements) Collaboration revenue decreased to $9.98 million in Q1 2025, primarily due to the completion of the Ionis obligation and termination of Genentech Program 4 - Collaboration Revenue (in thousands) | Collaboration Partner | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------- | :----------------------------------------------- | :----------------------------------------------- | | Bayer | $848 | $818 | | Novartis | $1,405 | $1,247 | | Ionis | $0 | $5,854 | | Genentech | $7,724 | $11,611 | | Total | $9,977 | $19,530 | - The decrease in collaboration revenue is mainly due to the completion of the Ionis combined licenses and research and discovery performance obligation in Q2 2024 and the termination of Genentech Collaboration Program 4 in Q1 2025[122](index=122&type=chunk)[143](index=143&type=chunk) - Deferred Revenue (in thousands) | Collaboration Partner | Deferred Revenue as of March 31, 2025 (in thousands) | Deferred Revenue as of December 31, 2024 (in thousands) | | :-------------------- | :--------------------------------------------------- | :---------------------------------------------------- | | Bayer | $40,427 | $39,960 | | Novartis | $44,054 | $44,073 | | Ionis | $3,694 | $3,587 | | Genentech | $6,562 | $14,038 | | Total | $94,737 | $101,658 | [Note 10. Income taxes](index=51&type=section&id=Note%2010.%20Income%20taxes) The company recorded an income tax benefit of $1.1 million for Q1 2025, primarily from U.S. operations, maintaining a full valuation allowance against U.K. deferred tax assets - Benefit from Income Taxes (in thousands) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--------------------- | :----------------------------------------------- | :----------------------------------------------- | | Benefit from income taxes | $(1,087) | $(350) | - The income tax benefit is mainly from U.S. operating activities, which generate taxable income through intercompany service arrangements[148](index=148&type=chunk) - A full valuation allowance is maintained against U.K. deferred tax assets due to the company's history of cumulative net losses in the U.K[149](index=149&type=chunk)[150](index=150&type=chunk) [Note 11. Commitments and contingencies](index=52&type=section&id=Note%2011.%20Commitments%20and%20contingencies) The company has total lease liabilities of $8.1 million for operating leases and $1.0 million for finance leases, plus potential future milestone payments of $166.2 million - Total Lease Liabilities (in thousands) | Lease Type | Total Lease Liabilities (in thousands) as of March 31, 2025 | | :--------------- | :-------------------------------------------------------- | | Operating Leases | $8,141 | | Finance Leases | $977 | - Lease Cost (in thousands) | Lease Cost (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Operating lease cost | $1,251 | $1,341 | | Finance lease cost | $74 | $0 | - The company has potential future milestone payments of **$166.2 million** under third-party agreements, contingent on future events not considered probable as of March 31, 2025[161](index=161&type=chunk) [Note 12. Net loss per share](index=56&type=section&id=Note%2012.%20Net%20loss%20per%20share) Basic and diluted net loss per share for Q1 2025 was $(0.88), based on 69.2 million weighted average ordinary shares outstanding - Net Loss Per Share | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss per share, basic and diluted | $(0.88) | $(0.62) | | Weighted average ordinary shares outstanding | 69,196,945 | 42,560,091 | - Potentially dilutive securities (RSUs and options) were excluded from diluted EPS calculation due to their anti-dilutive effect[165](index=165&type=chunk) [Note 13. Related party transactions](index=58&type=section&id=Note%2013.%20Related%20party%20transactions) The company engaged Stone Atlanta Estates LLC for consulting services, totaling $0.1 million in Q1 2025, with an amendment effective June 2025 - Consulting Services (in thousands) | Consulting Services (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Stone Atlanta Estates LLC | $100 | $48 | - An amendment to the consulting agreement with Stone Atlanta Estates LLC, effective June 17, 2025, modifies compensation and sets an expiration date of no later than June 30, 2028[166](index=166&type=chunk) [Note 14. Segments and geographic information](index=59&type=section&id=Note%2014.%20Segments%20and%20geographic%20information) The company operates as a single operating segment in the U.S. and U.K., with most long-lived assets located in the United Kingdom - The company operates as a single operating segment, with its CEO as the chief operating decision maker, reviewing consolidated results[168](index=168&type=chunk) - Long-Lived Assets by Geographic Region (in thousands) | Geographic Region | Long-Lived Assets (in thousands) as of March 31, 2025 | Long-Lived Assets (in thousands) as of December 31, 2024 | | :---------------- | :---------------------------------------------------- | :---------------------------------------------------- | | United States | $2,529 | $3,037 | | United Kingdom | $12,919 | $14,152 | | Total | $15,448 | $17,189 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=61&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on the company's financial condition and results of operations, highlighting its focus on Bicycle® molecules, significant operating losses, and reliance on collaborations and equity financing - 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[174](index=174&type=chunk) - The company has incurred significant operating losses, with net losses of **$60.8 million** in Q1 2025 and an accumulated deficit of **$741.5 million** as of March 31, 2025[184](index=184&type=chunk) - The company's cash and cash equivalents of **$793.0 million** as of March 31, 2025, are expected to fund operating expenses and capital expenditure requirements for at least 12 months[188](index=188&type=chunk)[234](index=234&type=chunk) [Overview](index=61&type=section&id=Overview) This section provides a high-level summary of the company's business, strategy, and financial performance [Components of Our Results of Operations](index=67&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section details the key revenue and expense categories that comprise the company's financial results [Results of Operations](index=74&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the reporting period, comparing current and prior year results [Liquidity and Capital Resources](index=77&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and ability to meet its short-term and long-term obligations [Critical Accounting Estimates](index=83&type=section&id=Critical%20Accounting%20Estimates) This section describes the significant judgments and assumptions used in preparing the company's financial statements [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=85&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's market risk exposure primarily relates to interest rate sensitivity and foreign currency exchange risk, with a foreign exchange loss of $0.2 million in Q1 2025 - The company's investment portfolio is conservative, primarily in U.S. Treasury obligations, minimizing material impact from a one percentage point change in interest rates[242](index=242&type=chunk) - The company is exposed to foreign currency exchange risk, particularly between the pound sterling and the U.S. dollar, recording a foreign exchange loss of **$0.2 million** in Q1 2025[244](index=244&type=chunk) - The company does not currently engage in currency hedging activities[246](index=246&type=chunk) [Item 4. Controls and Procedures](index=85&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - The CEO and CFO concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025[249](index=249&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during Q1 2025[250](index=250&type=chunk) PART II - OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=87&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[252](index=252&type=chunk) [Item 1A. Risk Factors](index=87&type=section&id=Item%201A.%20Risk%20Factors) This section outlines various risks that could materially affect the company's business, financial condition, and future growth, including financial, operational, and intellectual property risks - The company has a history of significant operating losses and expects to incur increasing losses, requiring substantial additional funding to support product discovery and development programs[256](index=256&type=chunk)[268](index=268&type=chunk) - Success is heavily dependent on the BDC and Bicycle TICA programs, which are in early clinical stages and face high risks of failure in trials, regulatory approval, and commercialization[275](index=275&type=chunk)[276](index=276&type=chunk)[284](index=284&type=chunk) - The company relies on third parties for clinical trials and manufacturing, increasing risks of delays, insufficient supplies, and potential intellectual property misappropriation[452](index=452&type=chunk)[459](index=459&type=chunk)[470](index=470&type=chunk) - The market price of the company's ADSs is highly volatile, influenced by clinical trial results, funding needs, regulatory decisions, competition, and broader economic conditions[525](index=525&type=chunk)[526](index=526&type=chunk) [Summary of Selected Risk Factors](index=87&type=section&id=Summary%20of%20Selected%20Risk%20Factors) This section provides a high-level overview of the most significant risks facing the company's business and operations [Risks Related to Our Financial Position and Need for Additional Capital](index=91&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section details risks associated with the company's financial health, including operating losses and future funding requirements [Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates](index=98&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) This section outlines risks inherent in the drug development process, from discovery to clinical trials and regulatory approvals [Risks Related to Commercialization of Our Product Candidates and Other Regulatory Compliance Matters](index=120&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates%20and%20Other%20Regulatory%20Compliance%20Matters) This section covers risks related to market acceptance, pricing, reimbursement, and compliance with post-approval regulations for product candidates [Risks Related to Our Business and Our International Operations](index=150&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Our%20International%20Operations) This section addresses general business risks, including operational challenges, cybersecurity, and complexities of international activities [Risks Related to Our Dependence on Third Parties](index=157&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section highlights risks arising from reliance on third-party collaborators, contract research organizations, and manufacturers [Risks Related to Our Intellectual Property](index=167&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section discusses risks concerning the protection, enforcement, and potential infringement of the company's intellectual property rights [Risks Related to Employee Matters and Managing Growth](index=181&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) This section addresses risks related to attracting and retaining key personnel, managing organizational growth, and maintaining company culture [Risks Related to Ownership of Our Securities](index=185&type=section&id=Risks%20Related%20to%20Our%20Securities) This section outlines risks for investors, including stock price volatility, limited liquidity, and potential dilution [Risks Related to Our Incorporation Under the Laws of England and Wales](index=191&type=section&id=Risks%20Related%20to%20Our%20Incorporation%20Under%20the%20Laws%20of%20England%20and%20Wales) This section details specific risks arising from the company's legal structure and jurisdiction of incorporation [General Risks](index=199&type=section&id=General%20Risks) This section covers broad, overarching risks that could impact the company's operations and financial stability [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=201&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) This item is not applicable for the reporting period [Item 3. Defaults Upon Senior Securities.](index=201&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This item is not applicable for the reporting period [Item 4. Mine Safety Disclosures.](index=201&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable for the reporting period [Item 5. Other Information.](index=201&type=section&id=Item%205.%20Other%20Information.) No directors or officers adopted or terminated insider trading arrangements (Rule 10b5-1 plans) during the three months ended March 31, 2025 - No directors or officers adopted or terminated insider trading arrangements (Rule 10b5-1 plans) during the three months ended March 31, 2025[569](index=569&type=chunk) [Item 6. Exhibits.](index=201&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the Quarterly Report, including Articles of Association, various consulting and separation agreements, and certifications from the Principal Executive Officer and Principal Financial Officer - Key exhibits include Articles of Association, consulting agreements with Santiago Arroyo and Stone Atlanta Estates LLC, and certifications required by the Sarbanes-Oxley Act[570](index=570&type=chunk)
Bicycle Therapeutics(BCYC) - 2025 Q1 - Quarterly Results
2025-05-01 11:05
[Q1 2025 Business Progress and Financial Results](index=1&type=section&id=Bicycle%20Therapeutics%20Reports%20Recent%20Business%20Progress%20and%20First%20Quarter%202025%20Financial%20Results) Bicycle Therapeutics highlights Q1 2025 clinical progress, corporate developments, and financial results, projecting a strong cash runway into 2027 [CEO's Remarks](index=1&type=section&id=CEO's%20Remarks) The CEO highlighted significant Q1 progress, validating MT1-MMP as a novel cancer target and advancing clinical trials, supported by a strong financial position - Human imaging data continues to validate MT1-MMP as a novel cancer target and demonstrates the positive properties of Bicycle Radioconjugate (BRC) molecules[2](index=2&type=chunk) - The Phase 1/2 Duravelo-3 trial for NECTIN4 gene-amplified breast cancer has been initiated[2](index=2&type=chunk) - Dose selection in the Phase 2/3 Duravelo-2 trial for metastatic urothelial cancer is on track for the second half of 2025[2](index=2&type=chunk) - The company has an expected financial runway extending to the second half of 2027[2](index=2&type=chunk) [Key Business and Clinical Updates](index=1&type=section&id=First%20Quarter%202025%20and%20Recent%20Events) The company presented positive BRC imaging data, advanced the zelenectide pevedotin program, and strengthened its leadership team with key appointments and promotions [Pipeline Progress](index=1&type=section&id=Pipeline%20Progress) The company presented additional BRC imaging data, advanced zelenectide pevedotin with ASCO abstract acceptances, and initiated the Phase 1/2 Duravelo-3 trial - Presented additional human imaging data for a Bicycle Radioconjugate (BRC) targeting MT1-MMP at the AACR 2025 meeting, reinforcing its potential. Initial human imaging data for EphA2 is expected in 2H 2025[3](index=3&type=chunk) - Two abstracts on zelenectide pevedotin for metastatic urothelial cancer (mUC) were accepted for presentation at ASCO 2025, covering Phase 1 combination data and the ongoing Phase 2/3 Duravelo-2 trial[6](index=6&type=chunk) - The Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer is now open and actively recruiting patients, following FDA Fast Track designation for this indication[6](index=6&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) The company strengthened its leadership team by appointing a new Chairman, adding new Board and Clinical Advisory Board members, and promoting key internal talent - Felix J. Baker, Ph.D., will succeed Pierre Legault as chairman of the Board of Directors[6](index=6&type=chunk) - World-renowned oncology experts Alessandro Riva, M.D., and Fabrice André, M.D., Ph.D., have joined the company's Board of Directors and Clinical Advisory Board, respectively[6](index=6&type=chunk) - Key leadership promotions include Eric Westin, M.D., to Chief Medical Officer and Jim MacDonald-Clink to SVP, Head of Business Development[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Bicycle Therapeutics reported a Q1 2025 net loss of **$60.8 million**, primarily due to increased R&D expenses and decreased collaboration revenue, while maintaining a strong cash position [Financial Summary](index=2&type=section&id=Financial%20Summary) Key financial metrics for Q1 2025 show an increased net loss and higher R&D and G&A expenses, alongside a decrease in cash and cash equivalents compared to Q4 2024 Q1 2025 Financial Summary (in millions) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Cash & Cash Equivalents** | $793.0M | - | -$86.5M (vs Q4'24) | | **R&D Expenses** | $59.1M | $34.9M | +$24.2M | | **G&A Expenses** | $21.1M | $16.4M | +$4.7M | | **Net Loss** | $60.8M | $26.6M | +$34.2M | | **Net Loss Per Share** | $(0.88) | $(0.62) | +$0.26 | [Statement of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statement of operations for Q1 2025 reflects a significant increase in net loss and operating loss, driven by higher expenses and reduced collaboration revenue Q1 2025 Statement of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $ 9,977 | $ 19,530 | | Research and development | 59,058 | 34,864 | | General and administrative | 21,123 | 16,382 | | **Loss from operations** | **(70,204)** | **(31,716)** | | **Net loss** | **$ (60,754)** | **$ (26,563)** | | **Net loss per share, basic and diluted** | **$ (0.88)** | **$ (0.62)** | [Balance Sheet Data](index=5&type=section&id=Balance%20Sheets%20Data) The balance sheet highlights a decrease in cash and cash equivalents, working capital, total assets, and total shareholders' equity as of March 31, 2025, compared to December 31, 2024 Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 792,973 | $ 879,520 | | Working capital | 798,463 | 861,375 | | Total assets | 883,894 | 956,868 | | Total shareholders' equity | 740,333 | 793,060 | [Outlook and Future Events](index=1&type=section&id=Outlook%20and%20Future%20Events) The company projects a strong financial position with a cash runway into the second half of 2027 and plans to participate in the RBC Capital Markets Global Healthcare Conference - The company possesses cash and cash equivalents of **$793.0 million** as of March 31, 2025, which is expected to fund operations into the second half of 2027[1](index=1&type=chunk)[5](index=5&type=chunk) - Management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference on May 20, 2025[4](index=4&type=chunk)
Bicycle Therapeutics: Maybe Underwhelming, But I Don't Think They Should Be This Discounted
Seeking Alpha· 2025-04-22 07:47
Company Overview - Bicycle Therapeutics (NASDAQ: BCYC) is a developmental biotech company focused on novel conjugated targeted therapies aimed at exploiting cell surface targets in cancer [1] Analyst Insights - Analysts, including those from Avisol Capital Partners, have been evaluating Bicycle Therapeutics over the past two years, indicating a growing interest in the company's potential within the biotech sector [1]