Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks in recent months [1] - Bicycle Therapeutics plc (BCYC) was previously analyzed in December, with a conclusion that it warranted a small "watch item" holding at that time [2] - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade ideas and weekly market commentary [2] Group 2 - The analyst has a beneficial long position in BCYC shares through various financial instruments [3] - Seeking Alpha emphasizes that past performance does not guarantee future results and does not provide specific investment recommendations [4]

Financial Performance - The company has incurred net losses of $50.8 million and $117.2 million for the three and nine months ended September 30, 2024, respectively, with an accumulated deficit of $628.9 million [193]. - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future [198]. - The net loss before income tax provision was $54.3 million for the three months ended September 30, 2024, compared to a net loss of $47.6 million in the same period of 2023 [221]. - Net loss for Q3 2024 was $50.8 million, compared to a net loss of $49.9 million in Q3 2023, reflecting an increase in operational losses [221]. - Net loss for the nine months ended September 30, 2024, was $117.2 million, a decrease in loss compared to $131.6 million in the same period of 2023 [229]. Revenue and Collaboration - The company has received gross proceeds of $1.4 billion from the sale of ordinary shares and $233.6 million from collaboration arrangements since its inception in 2009 [192]. - Collaboration revenues decreased by $2.7 million to $2.7 million for the three months ended September 30, 2024, down from $5.4 million in the same period of 2023 [220]. - Collaboration revenues increased by $9.9 million to $31.6 million for the nine months ended September 30, 2024, driven by collaborations with Novartis, Genentech, and Bayer [228]. Expenses and Costs - Total operating expenses increased by $10.4 million to $66.5 million for the three months ended September 30, 2024, compared to $56.1 million in the same period of 2023 [221]. - Research and development expenses increased by $8.4 million to $48.3 million for the three months ended September 30, 2024, compared to $39.9 million in the same period of 2023 [221]. - General and administrative expenses increased by $2.0 million to $18.3 million for the three months ended September 30, 2024, primarily due to a $0.7 million increase in personnel-related costs and a $0.7 million increase in share-based compensation [224]. - Total operating expenses for the nine months ended September 30, 2024, were $173.8 million, an increase of $16.4 million compared to the same period in 2023 [229]. - Research and development expenses rose by $11.4 million to $123.2 million for the nine months ended September 30, 2024, primarily due to increased clinical program expenses for zelenectide pevedotin [232]. - General and administrative expenses increased by $5.0 million to $50.6 million for the nine months ended September 30, 2024, mainly due to higher personnel-related costs and share-based compensation [234]. Cash and Financing - As of September 30, 2024, the company had cash and cash equivalents of $890.9 million, which is expected to fund operations for at least 12 months [197]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $155.3 million, compared to $13.3 million for the same period in 2023 [239]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $519.5 million, up from $249.6 million in the same period of 2023, representing a 108.3% increase [243][244]. - The company repaid a total of $31.9 million related to the Loan Agreement on July 9, 2024, which included $30.0 million in outstanding borrowings [246]. Research and Development - The company is focusing on advancing its product candidates, including conducting future clinical trials for zelenectide pevedotin, BT5528, BT7480, and BT1718 [194]. - The ongoing Phase II expansion of the clinical trial for zelenectide pevedotin contributed to a $10.2 million increase in clinical program expenses [222]. - The company has incurred approximately $129.3 million in direct external expenses for the development of zelenectide pevedotin since its candidate nomination [223]. - The increase in R&D expenses was primarily due to $28.1 million in clinical program expenses for zelenectide pevedotin and $9.0 million in employee-related expenses [232]. Regulatory and Tax Considerations - Zelenectide pevedotin and BT5528 have both been granted Fast Track Designation by the FDA for the treatment of locally advanced or metastatic urothelial cancer [186]. - The U.K. research and development tax credit allows for a cash rebate of up to 33.35% of qualifying expenditures incurred prior to April 1, 2023 [216]. - The company is subject to potential changes in U.K. R&D tax credit regulations that may impact future claims for subcontracted R&D activities [217]. - The U.K. research and development tax credit is fully refundable and recorded as a reduction to research and development expenses, benefiting the company's financial position [214]. Future Outlook and Challenges - The company anticipates significant increases in expenses and capital requirements as it advances its product candidates into later-stage clinical trials [194]. - The company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates [249]. - The company is facing challenges due to high inflation rates and rising interest rates, which may impact operating results and capital raising efforts [260]. - The company may need to delay or reduce research and development programs if capital cannot be raised on attractive terms [260]. - There is a risk of dilution for existing shareholders if additional capital is raised through equity sales [256].

Financial Performance - The net loss for Q3 2024 was $50.8 million, or $(0.74) per share, compared to a net loss of $49.9 million, or $(1.26) per share, in Q3 2023[1][20]. - Collaboration revenues for September 30, 2024, were $2,676,000, a decrease of 50% from $5,352,000 for the same period in 2023[24]. - Total operating expenses increased to $66,522,000 for the quarter ended September 30, 2024, compared to $56,149,000 for the same quarter in 2023, representing an 18.5% increase[24]. - Net loss for the quarter ended September 30, 2024, was $50,802,000, slightly higher than the net loss of $49,898,000 for the same period in 2023[24]. - Interest and other income for the quarter was $10,583,000, significantly higher than $3,985,000 for the same period in 2023, indicating a strong increase in income sources[24]. Cash and Assets - The company has cash and cash equivalents of $890.9 million as of September 30, 2024, compared to $526.4 million as of December 31, 2023[1][17]. - Cash and cash equivalents as of September 30, 2024, were $890,862,000, up from $526,423,000 as of December 31, 2023, indicating a significant increase in liquidity[25]. - Total assets increased to $996,746,000 as of September 30, 2024, compared to $595,344,000 as of December 31, 2023, reflecting a growth of 67.4%[25]. - Total shareholders' equity rose to $831,032,000 as of September 30, 2024, compared to $370,932,000 as of December 31, 2023, marking an increase of 124.1%[25]. Research and Development - Research and Development (R&D) expenses increased to $48.3 million for Q3 2024, up from $39.9 million in Q3 2023, primarily due to increased clinical program expenses[1][18]. - Research and development expenses for the quarter were $48,265,000, up from $39,868,000 in the same quarter of 2023, representing a 21.5% increase[24]. - General and administrative expenses rose to $18.3 million for Q3 2024, compared to $16.3 million in Q3 2023, mainly due to higher personnel-related expenses[1][19]. - General and administrative expenses increased to $18,257,000 for the quarter ended September 30, 2024, compared to $16,281,000 for the same period in 2023, a rise of 12.1%[24]. Clinical Trials and Pipeline - Bicycle Therapeutics reported a 45% overall response rate (ORR) for both zelenectide pevedotin and BT5528 in metastatic urothelial cancer[1][8][10]. - The company is advancing its radiopharmaceuticals pipeline, with first human imaging data validating MT1-MMP as a novel cancer target[1][3]. - Bicycle Therapeutics is currently enrolling patients in the global Phase 2/3 Duravelo-2 trial for zelenectide pevedotin in metastatic urothelial cancer[1][9]. - The company plans to provide additional updates on clinical data for zelenectide pevedotin and BT5528 later this year[1][2]. - Bicycle Therapeutics has selected EphA2 as its second BRC target and is collaborating with Eckert & Ziegler for isotope supply and development[1][6]. Future Outlook - The company expects its financial runway to extend into the second half of 2027[1][17]. - Weighted average ordinary shares outstanding increased to 68,988,858 for the quarter ended September 30, 2024, compared to 39,576,467 for the same period in 2023[24].

Company Overview - Bicycle Therapeutics PLC shares increased by 5.7% to close at $26.46, following a period of 8.1% loss over the past four weeks, indicating a significant rebound in investor interest [1] - The rise in share price is driven by investor expectations regarding the company's pipeline of novel molecules developed through proprietary technology [1] - The company is currently evaluating its lead drug, zelenectide pevedotin, in the registrational phase II/III Duravelo-2 study for metastatic urothelial cancer [1] Financial Expectations - Bicycle Therapeutics is projected to report a quarterly loss of $0.78 per share, reflecting a year-over-year change of +38.1% [1] - Expected revenues for the upcoming report are $8.16 million, which represents a 52.5% increase from the same quarter last year [1] Industry Context - Bicycle Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Voyager Therapeutics [2] - Voyager Therapeutics has a Zacks Rank of 1 (Strong Buy) and reported a 4.5% increase in its stock price, closing at $7.18 [2][3] - The consensus EPS estimate for Voyager Therapeutics has remained unchanged at -$0.52, showing an 11.9% improvement from the previous year [3]

Core Viewpoint - RBC Capital initiated coverage on Bicycle Therapeutics PLC (BCYC), highlighting its competitive edge in oncology, particularly with its lead program Zelenectide pevedotin (zele) in metastatic urothelial cancer (mUC) [1][2] Group 1: Product and Market Potential - Zelenectide shows potential to compete with Pfizer's Padcev in mUC, demonstrating similar objective response rates and fewer adverse events [1] - The improved safety profile of Zelenectide could lead to greater antitumor durability, distinguishing it from Padcev [1] - The analyst estimates Zelenectide could achieve peak global sales of approximately $2 billion by 2033 [1] - Commercialization opportunities in non-mUC indications are expected to be less competitive, providing additional upside for Zelenectide [1] Group 2: Regulatory and Clinical Insights - The regulatory path for Zelenectide is considered de-risked following FDA alignment on the Duravelo-2 trial [2] - Strong demand for a safer Nectin-4 drug conjugate is indicated by RBC's proprietary oncologist survey [2] - Zelenectide has potential therapeutic applications in additional solid tumor indications, including triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC), which are not addressed by Padcev [2] Group 3: Financial Position and Future Prospects - Bicycle Therapeutics has generated over $200 million in non-dilutive capital through its internal pipeline and external partnerships [3] - Future value creation is anticipated from next-generation Bicycle Toxin Conjugates (BTCs), radiopharmaceutical applications, and expansion beyond oncology [3] - As of June 30, 2024, the company reported cash and cash equivalents of $961.4 million, expected to sustain operations into the second half of 2027 [3] Group 4: Stock Performance - BCYC stock experienced a 1.27% increase, reaching $20.69 in the latest trading session [3]

Company Overview - Bicycle Therapeutics was founded by Nobel laureate Dr. Greg Winter, known for his work on humanizing monoclonal antibodies, which initiated the mAb revolution in medicine [3] - The company's core technology, "bicycles," are small protein structures that offer advantages over monoclonal antibodies, including size, stability, and production efficiency [3] - Bicycles are smaller (9 to 20 amino acids) compared to mAbs (1200 to 1500 amino acids), leading to improved stability and faster tissue penetration [3] - Bicycles are recognized as small molecule new chemical entities by regulatory authorities, resulting in lower production costs and a broader target spectrum [3] Pipeline - BCYC's lead internal program, BT8009, is a bicycle toxin conjugate targeting tumors overexpressing Nectin-4, currently in phase 1/2 and phase 2/3 trials [4][5] - Other internal programs include BT5528, targeting EphA2, and BT7480, targeting Nectin-4/CD137, both in phase 1/2 trials [4][5] - A partnered program, BT1718, is targeting high MT1-MMP expressing tumors in collaboration with Cancer Research UK [5] Clinical Data - BT8009 demonstrated a 38% objective response rate (ORR) in a phase 1/2 trial among 26 patients with metastatic urothelial cancer, with a median duration of response of 11.1 months [6] - BT5528 achieved a 39% ORR among 18 patients with metastatic urothelial cancer, with a median duration of response of four months [7] - Both BT8009 and BT5528 exhibited a favorable safety profile, with low frequency and severity of treatment-related adverse events [7] Competitive Landscape - Bicycle Therapeutics operates in a novel therapeutic space with no direct competitors developing bicycles [8] - Competing molecules include PACDEV, an approved Nectin-4 targeting antibody drug conjugate by Pfizer, and MedImmune's MEDI-547 targeting EphA2 [8] Financials and Collaborations - BCYC has a market cap of $1.54 billion and a cash balance of $961 million, with a cash runway projected through 2027 [9] - The company holds over 344 patents and has collaborations with major pharmaceutical companies including Bayer, Genentech, and Novartis [10]

Investors might want to bet on Bicycle Therapeutics PLC Sponsored ADR (BCYC) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and f ...

Bicycle Therapeutics PLC Sponsored ADR (BCYC) closed the last trading session at $22.96, gaining 3.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $43.38 indicates an 88.9% upside potential.The mean estimate comprises eight short-term price targets with a standard deviation of $12.91. While the lowest estimate of $28 indicates a 22% increase from the current price level, the mos ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Ordinary shares, nominal value £0.01 per share* n/a The Nasdaq Stock Market LLC American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share BCYC The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ...

Exhibit 99.1 Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2024 Financial Results Four abstracts containing data updates across clinical pipeline accepted for poster presentation at ESMO Congress 2024 Focused R&D pipeline on clinical programs and research areas that have the highest potential to maximize value creation Streamlined leadership team to better align with strategic and pipeline priorities, and enhanced oncology expertise with formation of Clinical Advisory Board Streng ...