This presentation may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts", "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements other than stateme ...

Table of Contents 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 ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38916 Bicycle Therapeutics plc (Exact Name of Registrant as Specified in its Charter) England and Wales Not App ...

Exhibit 99.1 Bicycle Therapeutics Reports Recent Business Progress and First Quarter 2025 Financial Results Multiple abstracts accepted for presentation at 2025 ASCO and AACR annual meetings underscore breadth of Bicycle technology and potential of oncology pipeline Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer open and actively recruiting patients Bolstered business and clinical expertise with appointments to Board of Directors, Clinical Advisory Board and company ...

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]

Financial Performance - The company has incurred net losses of $169.0 million, $180.7 million, and $112.7 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $680.8 million as of December 31, 2024[564]. - The net loss for the year ended December 31, 2024, was $169.031 million, a decrease of $11.633 million from a net loss of $180.664 million in 2023[596]. - The company does not expect to generate revenue from product sales for the foreseeable future, relying instead on collaboration revenue[571]. - The company has not generated revenue from product sales since inception and expects to continue incurring significant operating losses[605]. Revenue and Collaboration - The company has received gross proceeds of $1.4 billion from the sale of ordinary shares and $236.6 million from collaboration agreements since its inception in 2009[563]. - Collaboration revenue increased by $8.3 million in the year ended December 31, 2024, compared to 2023, primarily due to increases from collaborations with Novartis ($6.3 million), Genentech ($2.9 million), and Bayer ($2.2 million)[597]. - Collaboration revenue increased by $8.3 million to $35.3 million in 2024, driven by contributions from collaborations with Novartis, Genentech, and Bayer[596]. - The company has not recognized any sales-based royalty revenue from its collaboration agreements to date[643]. Expenses and Operating Costs - Total operating expenses for 2024 were $245.147 million, an increase of $28.225 million compared to $216.922 million in 2023[596]. - Research and development expenses for the year ended December 31, 2024, were $172.966 million, an increase of $16.470 million from $156.496 million in 2023[596]. - General and administrative expenses rose to $72.181 million in 2024, up by $11.755 million from $60.426 million in 2023[596]. - The company anticipates substantial increases in expenses and capital requirements as it continues its development activities and seeks marketing approvals[565]. - General and administrative expenses are anticipated to rise as the company increases headcount to support research and development and potential commercialization efforts[586]. Cash and Financing - As of December 31, 2024, the company had cash and cash equivalents of $879.5 million, which is expected to fund operations for at least 12 months[570]. - Net cash used in operating activities was $164.72 million in 2024, an increase of $104.1 million compared to 2023, largely due to higher cash payments for ongoing development activities[608]. - Net cash provided by financing activities was $519.75 million in 2024, primarily from net proceeds of $544.1 million from a private placement[610]. - The company expects to finance its cash needs through equity offerings, debt financings, collaborations, and other strategic transactions, which may dilute existing shareholders' ownership[622]. Research and Development - The company is evaluating multiple product candidates, including zelenectide pevedotin and BT5528, in ongoing clinical trials[559]. - The company expects research and development expenses to continue increasing due to an expanded portfolio of product candidates and ongoing clinical trials[579]. - Research and development expenses increased by $16.5 million to $172.97 million in 2024, primarily due to a $38.6 million increase in clinical program expenses for zelenectide pevedotin[599]. - The company incurred approximately $156.6 million in direct external expenses for the development of zelenectide pevedotin since its candidate nomination[600]. Obligations and Liabilities - Total contractual obligations as of December 31, 2024, amounted to $11.18 million, with $6.07 million due within one year[615]. - The company has entered into agreements with third parties for future milestone payments totaling $166.2 million, contingent upon achieving specific milestones[618]. - Future debt financing may involve covenants that restrict the company's operations or ability to incur additional debt[622]. Economic and Market Conditions - High inflation rates and increased costs of clinical trial materials and supplies may adversely affect the company's operating results and cash flows[623]. - The company faces challenges in raising capital due to unfavorable global economic and political conditions, which may impact its development programs[621]. - The company is subject to potential downward pressure on share prices due to economic uncertainty and volatility in capital markets[623].

Financial Performance - The company reported a net loss of $51.9 million, or $(0.75) basic and diluted net loss per share, for the fourth quarter of 2024, compared to a net loss of $49.1 million, or $(1.16) per share, for the same period in 2023[12]. - Collaboration revenue for Q4 2024 was $3.708 million, compared to $5.331 million in Q4 2023, representing a decrease of 30.4%[16]. - Total operating expenses for Q4 2024 were $71.371 million, up from $59.566 million in Q4 2023, an increase of 19.8%[16]. - Net loss for Q4 2024 was $51.854 million, compared to a net loss of $49.099 million in Q4 2023, reflecting an increase in loss of 5.6%[16]. - General and administrative expenses for the year ended December 31, 2024, were $72.2 million, an increase from $60.4 million in 2023, driven by higher personnel-related expenses[12]. - Research and development expenses for the year ended December 31, 2024, were $173.0 million, up from $156.5 million in 2023, primarily due to increased clinical program expenses for zelenectide pevedotin[12]. Cash and Assets - As of December 31, 2024, cash and cash equivalents were $879.5 million, an increase from $526.4 million as of December 31, 2023, providing a financial runway into the second half of 2027[12]. - Cash and cash equivalents increased to $879.520 million as of December 31, 2024, from $526.423 million in 2023, a growth of 67.0%[18]. - Total assets rose to $956.868 million in 2024, compared to $595.344 million in 2023, marking an increase of 60.6%[18]. Clinical Trials and Research - In the Phase 1 Duravelo-1 trial, a 65% overall response rate (ORR) was achieved among 20 efficacy evaluable patients treated with zelenectide pevedotin plus pembrolizumab for first-line metastatic urothelial cancer[3]. - Bicycle Therapeutics is conducting the Phase 2/3 Duravelo-2 trial evaluating the efficacy of zelenectide pevedotin in combination with pembrolizumab versus chemotherapy in first-line metastatic urothelial cancer[4]. - Among 38 breast cancer patients evaluated, a 62.5% ORR was observed in those with NECTIN4 gene amplification compared to a 14.3% ORR in all efficacy-evaluable patients[4]. - Bicycle Therapeutics plans to initiate several additional Phase 1/2 trials for zelenectide pevedotin in NECTIN4 gene-amplified cancers, including breast cancer in 1H 2025 and lung cancer in 2H 2025[6]. - The company received FDA Fast Track designations for zelenectide pevedotin in the treatment of adult patients with previously treated, NECTIN4 gene-amplified, advanced or metastatic triple-negative breast cancer and non-small cell lung cancer[5]. - The company anticipates additional MT1-MMP human imaging data in mid-2025 and initial EphA2 human imaging data in 2H 2025 as part of its radiopharmaceuticals pipeline[7]. Shareholder Information - The company reported a weighted average of 69,051,745 ordinary shares outstanding for Q4 2024, compared to 42,419,326 in Q4 2023, an increase of 62.8%[16]. Strategic Focus - The company anticipates the initiation of clinical trials for its product candidates in various cancers, including breast and lung cancer, in the near future[14]. - Bicycle Therapeutics expects to leverage its technology through partnerships to develop therapies beyond oncology, indicating a strategic expansion of its research focus[14].

Group 1 - Bicycle Therapeutics (NASDAQ: BCYC) presented two sets of data since August 20, with the first set at ESMO in September 2024 from its phase 1/2 trial of BT8009 or zelenectide pevedotin [1] - The second set of data was not detailed in the provided content [1] Group 2 - The Total Pharma Tracker offers tools for DIY investors, including a software for entering any ticker to access extensive curated research material [2] - In-house experts provide hands-on support to find the best investible stocks, along with buy/sell strategies and alerts [2]

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].