BCYC

Data presented at AACR and ASCO provide further validation of the potential of Bicycle® technology to deliver oncology therapeutics with improved benefit/risk profiles compared to existing modalities Expanded Clinical Advisory Board with the addition of Thomas Powles, MBBS, MRCP, M.D. Cash and cash equivalents of $510.1 million as of June 30, 2026, with expected cash runway into 2030 CAMBRIDGE, England & BOSTON, July 30, 2026--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the second quarter ended June 30, 2026, and provided recent corporate updates. "We are pleased with the progress we made during the second quarter. Our financial discipline with refined focus on nuzefatide pevedotin and our next-generation Bicycle conjugate pipeline, including Bicycle® Radioconjugates (BRC®), leaves us well capitalized to pursue our mission to help patients to not only live longer, but also live well," said Bicycle CEO Kevin Lee, Ph.D. "The encouraging data we presented during the quarter continue to deepen our belief in the potential of our technology to deliver oncology therapeutics with a superior benefit/risk profile against high-value targets like EphA2 and Nectin-4, the former being historically considered undruggable using antibody-based approaches. We believe this profile provides a strong rationale for developing nuzefatide in recurrent pancreatic cancer, where we successfully dosed our first patient in the ongoing Phase 2 trial in April. We remain on track to begin the Phase 1 trial for BT1702, our MT1-MMP targeting BRC, in 2027, backed by compelling human imaging data validating the targeting precision and translatability of our Bicycle® technology." Dr Lee added: "It is an honor to welcome world-renowned oncologist Professor Thomas Powles to our Clinical Advisory Board. His deep clinical insights and distinguished leadership in urothelial cancers will be instrumental as we accelerate our efforts to deliver precision-targeted therapies for patients." Second Quarter 2026 and Recent Events Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 highlights significant opportunities for nuzefatide pevedotin (nuzefatide), a potentially first-in-class EphA2 targeting Bicycle® Drug Conjugate (BDC®), in EphA2 expressing cancers. Altogether, Bicycle Therapeutics believes that these data underscore the therapeutic potential for nuzefatide in EphA2-expressing cancers, including pancreatic cancer. Bicycle Therapeutics is actively enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC. The first patient was successfully dosed in April 2026 at the 8mg/m2 Q2W preferred dose for the trial. Additional human imaging data of a Bicycle® Imaging Agent (BIA) targeting EphA2 in patients with PDAC presented at AACR Annual Meeting 2026. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle® molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA) in seven patients with histologically confirmed PDAC. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle® molecules for targeted radioligand therapies and radiopharmaceutical imaging.Bicycle Therapeutics continues to advance its emerging radioligand pipeline, with the initiation of the first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP targeting BRC, expected in 2027. Initial Duravelo-2 data presented at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrates encouraging response rates comparable to published data for standard of care (SOC) and a potentially differentiated safety profile in previously untreated patients with mUC. Zelenectide pevedotin (zelenectide) is a BDC targeting Nectin-4, a well-validated tumor antigen. The dose optimization stage of the randomized Phase 2 Duravelo-2 trial evaluated two doses of zelenectide – 5mg/m2 weekly (5mg dose) and 6mg/m2 (6mg dose) two weeks on, one week off – in combination with 200mg of pembrolizumab once every three weeks in previously untreated patients with mUC (Cohort 1). Bicycle Therapeutics reached regulatory alignment on the zelenectide 6mg dose as optimal both in combination with pembrolizumab and as a monotherapy. Cohort 1 data were extracted for the interim analysis at Week 27, on July 23, 2025. At the time of the data cut, the median progression-free survival (PFS) was not mature, and the results at the optimal dose showed: Updated Duravelo-1 data presented at 2026 ASCO Annual Meeting demonstrates encouraging median PFS comparable to published data for SOC in previously untreated, cisplatin-ineligible mUC patients. Updated Phase 1 Duravelo-1 results as of the August 1, 2025 data cutoff evaluating zelenectide at the 5mg dose in combination with pembrolizumab in previously untreated cisplatin-ineligible patients, 45% of whom were classified as Eastern Cooperative Oncology Group (ECOG) performance status of 2, showed: Across all patients, the safety and tolerability profile was consistent with other zelenectide data to date. No new safety signals were observed and there were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest reported. Expanded Clinical Advisory Board with the addition of Thomas Powles, MBBS, MRCP, M.D. Dr. Powles is a Professor of Genitourinary Oncology and Director of Barts Cancer Centre at St Bartholomew’s Hospital, and Lead for Solid Tumor Research at Barts Cancer Institute, London. Dr. Powles is an international leader in the treatment of urothelial cancers, with a research focus spanning from Phase 1 to randomized Phase 3 clinical trials, particularly in translational Phase 2 studies investigating novel targeted and immune therapies. He has played a critical role in leading over twenty randomized clinical trials, resulting in multiple U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals. Second Quarter 2026 Financial Results Cash and cash equivalents were $510.1 million as of June 30, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily due to cash used in operations, including cash payments for clinical program activities. Research and development (R&D) expenses were $41.2 million for the three months ended June 30, 2026, compared to $71.0 million for the three months ended June 30, 2025. The decrease in expense of $29.8 million was primarily due to decreased clinical program expenses for zelenectide, decreased personnel-related costs and share-based compensation due to our recent workforce reduction announced in March 2026, as well as decreased discovery, platform and other expenses, offset by lower U.K. R&D tax credits period over period. General and administrative (G&A) expenses were $14.0 million for the three months ended June 30, 2026, compared to $18.5 million for the three months ended June 30, 2025. The decrease in expense of $4.5 million was primarily due to decreased professional and consulting fees and decreased personnel-related costs and share-based compensation due to our recent workforce reduction announced in March 2026. Net loss was $50.3 million, or $(0.72) basic and diluted net loss per share, for the three months ended June 30, 2026, compared to net loss of $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025. About Bicycle TherapeuticsBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating nuzefatide pevedotin, formerly BT5528, a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of other bicycle-based conjugate molecules, including Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Mass. For more information, visit bicycletherapeutics.com. Forward Looking StatementsThis press release 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,", "promising", "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential therapeutic benefit of nuzefatide pevedotin, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials, and the potential development of nuzefatide pevedotin in a number of cancers, including pancreatic cancer; the progress of Bicycle Therapeutics’ clinical trials, reporting data from Bicycle Therapeutics’ clinical trials, including for nuzefatide pevedotin, the timing of EphA2 human imaging data and updates on future clinical development plans for nuzefatide pevedotin; the potential of EphA2 as a novel cancer target and the positive properties of Bicycle® radioligand molecules for radiopharmaceutical use; the development of the Bicycle® radioligands pipeline, including BRCs and BIAs; communications with and feedback from the FDA and other regulatory agencies; Bicycle Therapeutics’ expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the workforce reduction may take longer or result in more significant charges or cash expenditures than anticipated or otherwise negatively impact Bicycle Therapeutics’ and its business plans during and after the period during which the workforce reduction is being executed; uncertainties related to the benefits of the strategic reprioritization; uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its technology or partnerships; the risk that Bicycle Therapeutics may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics’ projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in Bicycle Therapeutics’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 17, 2026, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260730302807/en/ Contacts Investors: Matthew DeYoungArgot [email protected] 212-600-1902Media: Argot [email protected]

Presentations at AACR Annual Meeting 2026 underscore significant opportunities for nuzefatide pevedotin in EphA2 expressing cancers, including pancreatic cancer Human imaging data provides further evidence of the potential of EphA2 as a novel cancer target and the positive properties of Bicycle® radioligand molecules for radiopharmaceutical use Initial dose selection data from Duravelo-2 trial evaluating zelenectide pevedotin plus pembrolizumab in metastatic urothelial cancer to be presented at 2026 ASCO Annual Meeting Cash and cash equivalents of $559.5 million as of March 31, 2026, with expected cash runway into 2030 CAMBRIDGE, England & BOSTON, April 30, 2026--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the first quarter ended March 31, 2026, and provided recent corporate updates. "The data we reported in the first quarter continues to provide further validation of the potential of our Bicycle technology to deliver oncology therapeutics with improved benefit/risk profiles compared to existing modalities," said Bicycle CEO Kevin Lee, Ph.D. "We are excited by the emerging profile of our EphA2 drug conjugate, nuzefatide pevedotin, which we have now tested in over 150 patients to date, both as a monotherapy and in combination with a checkpoint inhibitor. Nuzefatide has been shown to be generally well tolerated at clinically active doses, in contrast to previous attempts to drug this target with other modalities. We believe these data, together with those presented at AACR, provide a strong rationale for advancing the development of nuzefatide in pancreatic cancer, and we are pleased to have recently dosed our first patient in our Phase 2 trial. In addition to this, the preliminary data we have reported from our Duravelo-2 program demonstrate zelenectide pevedotin to also be clinically active with a differentiated safety profile, providing convincing evidence that Bicycle drug conjugates may exhibit a fundamentally different tolerability profile to that seen with antibody-based approaches, and support our mission of helping patients not only to live longer but also to live well." Dr. Lee added: "Following a strategic reprioritization in the first quarter, we are converting the Duravelo-2 trial into a randomized Phase 2 trial, allowing us to focus our internal resources on our emerging pipeline of next-generation therapeutics, including nuzefatide and Bicycle-based radiotherapeutics and imaging agents. We look forward to presenting initial dose selection data from our Duravelo-2 trial at the upcoming 2026 ASCO Annual Meeting and will continue to evaluate the best path for this program as the data continues to mature." First Quarter 2026 and Recent Events Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 demonstrates significant opportunities for nuzefatide pevedotin (nuzefatide), formerly BT5528, a potentially first-in-class EphA2 targeting Bicycle® Drug Conjugate (BDC®), in EphA2 expressing cancers. Nuzefatide Phase 1/2 data show a differentiated safety profile in combination with nivolumab in metastatic urothelial cancer (mUC) patients as well as promising anti-tumor activity. As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2 once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with mUC who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed: 40% confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumors and 100% confirmed ORR (3/3) among patients with EphA2+ tumors that were monomethyl auristatin E (MMAE)-naïve. Patients who achieved a partial response (PR) or at least 16 weeks of stable disease (SD) were on treatment for a minimum of 56 weeks and most continued on treatment at the time of the data cut-off. Nuzefatide in combination with nivolumab was generally well tolerated with no Grade ≥3 treatment-related adverse events (TRAEs) of clinical interest and no TRAEs of hemorrhage observed. Only one dose-limiting toxicity of Grade 3 fatigue that lasted for five days was reported and improved to Grade 1 without dose reduction. Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of pancreatic ductal adenocarcinoma (PDAC). Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models were sensitive to nuzefatide, six of which showed high sensitivity. Preclinical assessment of nuzefatide anti-tumor activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma (HNSCC). Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing CDX models of HNSCC. Altogether, Bicycle Therapeutics believes that these data highlight significant opportunities for nuzefatide in EphA2 expressing cancers, including pancreatic cancer. In March 2026, Bicycle Therapeutics began enrolling a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC, and the first patient was successfully dosed in April 2026. Bicycle Therapeutics has determined 8mg/m2 Q2W as the preferred dose for the trial. Additional human imaging data of a Bicycle® Imaging Agent (BIA) targeting EphA2 in patients with PDAC presented at AACR Annual Meeting 2026. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA). Seven patients with histologically confirmed PDAC underwent PET/CT imaging up to three hours post injection of the EphA2 BIA. Data demonstrated rapid tumor uptake in six out of seven patients with excretion primarily via the kidneys. EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node, and peritoneal metastases. These data are representative of the results seen in 15 out of 18 patients with PDAC who have undergone EphA2 BIA imaging to date. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle® molecules for targeted radioligand therapies and radiopharmaceutical imaging. Promising Duravelo-2 data and multiple potential regulatory pathways provide a range of options for a Phase 3 trial and potential commercialization of zelenectide pevedotin (zelenectide) in mUC. Initial dose selection data from the Duravelo-2 trial demonstrate response rates comparable to those published for existing standards of care, with physician assessed ORR of 65%, blinded independent central review (BICR) confirmed ORR of 58% at the 27-week cutoff and a differentiated safety profile. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62%. Zelenectide at 6mg/m2 two weeks on, one week off demonstrated a differentiated safety profile with only one patient discontinuing therapy due to a TRAE at the 27-week cutoff. While Bicycle Therapeutics evaluates preliminary regulatory feedback from the European Medicines Agency, U.S. Food and Drug Administration (FDA), and Medicines and Healthcare products Regulatory Agency, and the potential paths for this program, the company is converting the ongoing Duravelo-2 trial to a randomized Phase 2 trial and deprioritized the program for internal development. Bicycle Therapeutics will present initial Duravelo-2 dose selection data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2 in Chicago. Strategic reprioritization focuses on promising pipeline of next-generation therapeutics. In March 2026, Bicycle Therapeutics initiated a strategic reprioritization in order to focus its resources on its promising pipeline of next-generation therapeutics, including nuzefatide, as well as its emerging Bicycle conjugate pipeline, including BRCs. As part of the reprioritization, Bicycle Therapeutics seeks to discontinue the Phase 1/2 Duravelo-3 trial for zelenectide in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide in NECTIN4-amplified non-small cell lung cancer. Enrollment for these trials is closed, and patients currently enrolled will complete their course of treatment. In addition, Bicycle Therapeutics announced a workforce reduction pursuant to which it expects to reduce its workforce by approximately 30%. Anticipated annual operational savings related to the workforce reduction and strategic reprioritization are expected to reduce annual operating expenses by approximately 50% based on the company’s current plans. These actions are expected to extend Bicycle Therapeutics’ cash runway by approximately two years, into 2030. First Quarter 2026 Financial Results Cash and cash equivalents were $559.5 million as of March 31, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily due to cash used in operations, including cash payments for clinical program activities. Collaboration revenue was $0.9 million for the three months ended March 31, 2026, compared to $10.0 million for the three months ended March 31, 2025. The decrease in collaboration revenue of $9.1 million was primarily due to the termination of our collaboration programs with Genentech and Novartis. Research and development (R&D) expenses were $48.9 million for the three months ended March 31, 2026, compared to $59.1 million for the three months ended March 31, 2025. The decrease in expense of $10.2 million was primarily due to decreased clinical program expenses for zelenectide and share-based compensation due to our workforce reduction, offset by lower U.K. R&D tax credits period over period. General and administrative (G&A) expenses were $17.5 million for the three months ended March 31, 2026, compared to $21.1 million for the three months ended March 31, 2025. The decrease in expense of $3.6 million was primarily due to decreased professional and consulting fees and decreased share-based compensation due to our workforce reduction. Net loss was $60.8 million, or $(0.87) basic and diluted net loss per share, for the three months ended March 31, 2026, compared to net loss of $60.8 million, or $(0.88) basic and diluted net loss per share, for the three months ended March 31, 2025. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating nuzefatide pevedotin, formerly BT5528, a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of other bicycle-based conjugate molecules, including Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137; and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Mass. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release 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, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential therapeutic benefit of nuzefatide pevedotin, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials, and the potential development of nuzefatide pevedotin in a number of cancers, including pancreatic cancer; the progress of Bicycle Therapeutics’ clinical trials, reporting data from Bicycle Therapeutics’ clinical trials, including for nuzefatide pevedotin, the timing of EphA2 human imaging data and updates on future clinical development plans for nuzefatide pevedotin; the potential of EphA2 as a novel cancer target and the positive properties of Bicycle® radioligand molecules for radiopharmaceutical use; the development of the Bicycle® radioligands pipeline, including BRCs and BIAs; the potential benefits of Bicycle Therapeutics’ strategic reprioritization, including the potential extension of financial runway; the workforce reduction and its impact on Bicycle Therapeutics’ expenditures; communications with and feedback from the FDA and other regulatory agencies including the potential for multiple regulatory pathways for zelenectide pevedotin in mUC; the existence of a range of options for a Phase 3 trial and potential commercialization of zelenectide pevedotin in mUC; Bicycle Therapeutics’ expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the workforce reduction may take longer or result in more significant charges or cash expenditures than anticipated or otherwise negatively impact Bicycle Therapeutics’ and its business plans during and after the period during which the workforce reduction is being executed; uncertainties related to the benefits of the strategic reprioritization; uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its technology or partnerships; the risk that Bicycle Therapeutics may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics’ projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in Bicycle Therapeutics’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 17, 2026, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260430332492/en/ Contacts Investors: Matthew DeYoung Argot Partners [email protected] 212-600-1902 Media: Argot Partners [email protected]

Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin (zelenectide) plus pembrolizumab in metastatic urothelial cancer (mUC) successfully identifies 6mg/m2 zelenectide two weeks on, one week off dose (6mg dose) as optimal, demonstrating response rates comparable to published rates for standards of care with a differentiated tolerability profile Bicycle to convert Duravelo-2 to a randomized Phase 2 trial while determining appropriate next steps for the program Strategic reprioritization to focus on BT5528 and next generation Bicycle® conjugates, including Bicycle® Radioconjugates (BRC®); additional EphA2 human imaging data and Phase 1 BT5528 combination data planned for the first half of 2026 Strategic partnerships established to enable an end-to-end isotope agnostic strategy to support the potential discovery, development and commercial supply of a portfolio of BRCs Cash and cash equivalents of $628 million as of December 31, 2025, with expected cash runway extended into 2030 following a strategic reprioritization, including a proposed workforce reduction of approximately 30% CAMBRIDGE, England & BOSTON, March 17, 2026--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent corporate updates. "We have successfully completed the dose selection portion of the Duravelo-2 trial and received regulatory alignment that the 6mg dose and schedule is optimal for zelenectide in mUC based on strong anti-tumor activity and its differentiated safety profile. We look forward to sharing these data at an upcoming scientific conference. Based on the regulatory feedback we have received, the existing Duravelo-2 trial design is no longer considered acceptable as an approval path for zelenectide in mUC. Preliminary discussions with regulatory agencies have outlined several potential paths for zelenectide’s approval in mUC. While we believe the strength of these data and the clear medical need justify continued development of zelenectide, we have reached the difficult decision to deprioritize this program for internal development at this time. We have initiated a process to convert our ongoing Duravelo-2 trial to a randomized Phase 2 study. Once we have these randomized Phase 2 data in hand, we will determine the most appropriate path for zelenectide," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We believe these data provide further validation of the ability of our Bicycle technology to deliver oncology therapeutics with a potentially improved benefit/risk profile compared to existing modalities. In view of this, we have decided to conduct a strategic reprioritization, which includes a proposed workforce reduction, to best position the company to focus our resources on our promising pipeline of next-generation therapeutics." Fourth Quarter 2025 and Recent Events Promising Duravelo-2 data and multiple potential regulatory pathways provide a range of options for a Phase 3 trial and potential commercialization of zelenectide in mUC. Initial dose selection data from the Duravelo-2 trial demonstrate response rates comparable to those published for existing standards of care, with physician assessed overall response rate (ORR) of 65%, blinded independent central review (BICR) confirmed ORR of 58% at the 27-week cutoff and a differentiated safety profile. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62%. The 6mg dose demonstrated a differentiated safety profile with only one patient discontinuing therapy due to a treatment-related adverse event (TRAE) at the 27-week cutoff. Bicycle Therapeutics expects to present initial dose selection data from the Duravelo-2 trial at an upcoming scientific conference. While Bicycle Therapeutics evaluates preliminary regulatory feedback from the European Medicines Agency, U.S. Food and Drug Administration (FDA), and Medicines and Healthcare products Regulatory Agency, and the potential paths for this program, the company plans to convert the ongoing Duravelo-2 trial to a randomized Phase 2 trial and deprioritize this program for internal development at this time. Once available, data from the randomized Phase 2 trial will be shared with the scientific and medical community. Strategic reprioritization focuses on promising pipeline of next-generation therapeutics. Bicycle Therapeutics has initiated a strategic reprioritization in order to focus its resources on its promising pipeline of next-generation therapeutics, including BT5528, a potentially first-in-class EphA2 targeting Bicycle® Drug Conjugate (BDC®), as well as its emerging bicycle conjugate pipeline, including BRCs. As part of the reprioritization, Bicycle Therapeutics will seek to discontinue the Phase 1/2 Duravelo-3 trial for zelenectide in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide in NECTIN4-amplified non-small cell lung cancer. Further enrollment for these trials will be closed, and patients already enrolled will complete their course of treatment. In addition, Bicycle Therapeutics is proposing to implement a workforce reduction pursuant to which it would reduce its workforce by approximately 30%. Anticipated annual operational savings related to the workforce reduction and strategic reprioritization are expected to reduce annual operating expenses by approximately 50% based on the company’s current plans. These actions are expected to extend Bicycle Therapeutics’ cash runway by approximately two years, into 2030. Established multiple strategic partnerships to create end-to-end supply chain to support wholly owned radiopharmaceutical pipeline. Bicycle Therapeutics entered into a 15-year contract including an option to renew with the UK Nuclear Decommissioning Authority (NDA) for access to up to 400 tonnes of reprocessed uranium (RepU). RepU continually regenerates providing a potentially sustainable supply of 212Pb. In addition, Bicycle Therapeutics announced a collaboration with United Kingdom National Nuclear Laboratory (UKNNL), pursuant to which it plans to extract 228Th from the RepU obtained from NDA. The extracted 228Th will then be further processed into 224Ra and loaded into bespoke 212Pb generators being developed exclusively for Bicycle Therapeutics by SpectronRx. Collectively, this bespoke set of arrangements is designed to support the potential discovery, development, and commercial supply of a portfolio of BRCs containing 212Pb. These arrangements build on a previously announced agreement with Eckert & Ziegler to supply a range of radioisotopes for the manufacture and development of BRCs and Bicycle Imaging Agents (BIA), enabling an isotope agnostic strategy. Data for an early BIA targeting MT1-MMP presented at European Association of Nuclear Medicine (EANM) 2025 Congress. An e-poster presentation outlined the first clinical experience with an early BIA targeting MT1-MMP. An additional e-poster presented by the German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), highlighted preclinical BRC data demonstrating the potential of this approach for radiotheranostic use. Altogether, these data build on preclinical and first human imaging data previously disclosed at the American Association for Cancer Research (AACR) Annual Meeting 2025 and EANM 2024 Congress. Bicycle Therapeutics believes these data further support the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrate the translatability of BRC preclinical data and highlight the potential of Bicycle® molecules for targeted radionuclide therapies and radiopharmaceutical imaging. Bicycle Therapeutics continues to advance its emerging radioligand pipeline, with additional EphA2 human imaging data expected in the first half of 2026 and the initiation of the first company-sponsored radioligand clinical trial, for BT1702, an MT1-MMP targeting BRC, expected in 2027. BT5528, a potential first-in-class EphA2 targeting BDC molecule. Bicycle Therapeutics announced nuzefatide pevedotin (nuzefatide) as the International Nonproprietary Name for BT5528. Phase 1 nuzefatide combination data with nivolumab in mUC patients will be presented at a scientific conference in the first half of 2026. In March 2026, Bicycle Therapeutics began enrolling a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent pancreatic ductal adenocarcinoma (PDAC). Additional information regarding this indication will be presented at a scientific conference in the first half of 2026. BT7480, a Bicycle tumor-targeted immune cell agonist® (Bicycle TICA®), is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Phase 1 BT7480 combination data with nivolumab will be presented at a scientific conference in the first half of 2026. After reporting combination data, Bicycle Therapeutics will no longer develop BT7480 internally and intends to seek a potential partner for future development. Evolving leadership team strengthens transition to next phase of innovation across oncology pipeline. Bicycle Therapeutics has appointed Jennifer Perry, Pharm.D. as chief operating officer (COO), and Alistair Milnes as chief corporate development officer (CCDO). In her role as COO, Jennifer will oversee portfolio and new product strategy, business development, commercial and medical affairs, while in his role as CCDO, Alistair will oversee government affairs, human resources and information technology. Bicycle Therapeutics also recently promoted Travis Thompson as chief financial officer, overseeing the finance, accounting and investor relations functions and Michael Method, M.D., MPH, MBA, to chief medical officer, overseeing all clinical development and the relationship with Bicycle Therapeutics’ Clinical Advisory Board. In addition, Michael Skynner, Ph.D., now serves as chief scientific officer, overseeing scientific discovery, early-stage pipeline development and the relationship with Bicycle Therapeutics’ Research and Innovation Advisory Board. Fourth Quarter and Year End 2025 Financial Results Cash and cash equivalents were $628.1 million as of December 31, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. Collaboration revenue was $48.0 million for the three months ended December 31, 2025 and $72.6 million for the year ended December 31, 2025, compared to $3.7 million for the three months ended December 31, 2024 and $35.3 million for the year ended December 31, 2024. The increases in collaboration revenue of $44.3 million and $37.3 million for the three months and year ended December 31, 2025, respectively, were primarily due to the recognition of all remaining revenue under Bicycle Therapeutics’ collaboration with Novartis Pharma AG upon a notice of termination of the collaboration agreement, as well as the recognition of revenue under Bicycle Therapeutics’ collaboration with Bayer Consumer Care AG upon a notice of termination of one of the target programs under the collaboration agreement. R&D expenses were $51.8 million for the three months ended December 31, 2025, and $240.3 million for the year ended December 31, 2025, compared to $49.8 million for the three months ended December 31, 2024, and $173.0 million for the year ended December 31, 2024. The increase in expense of $2.0 million for the three months ended December 31, 2025 was primarily due to increased discovery, platform and other expenses and lower U.K. R&D tax credits period over period, offset by decreased clinical program expenses for zelenectide development and Bicycle TICA® molecules. The increase in expense of $67.3 million for the year ended December 31, 2025 was primarily due to increased clinical program expenses for zelenectide development, discovery, platform and other expenses, higher personnel-related costs, including severance-related expenses of the workforce reduction completed in August 2025, and lower U.K. R&D tax credits period over period, offset by decreased clinical program expenses for Bicycle TICA® molecules. General and administrative expenses were $20.9 million for the three months ended December 31, 2025, and $79.4 million for the year ended December 31, 2025, compared to $21.6 million for the three months ended December 31, 2024, and $72.2 million for the year ended December 31, 2024. The decrease in expense of $0.7 million for the three months ended December 31, 2025 was primarily due to decreased professional and consulting fees. The increase in expense of $7.2 million for the year ended December 31, 2025 was primarily due to increased personnel-related costs including share-based payments, offset by a favorable impact of foreign exchange rates. Net loss was $20.2 million, or $(0.29) basic and diluted net loss per share, for the three months ended December 31, 2025, and net loss was $219.0 million, or $(3.16) basic and diluted net loss per share, for the year ended December 31, 2025, compared to net loss of $51.9 million, or $(0.75) basic and diluted net loss per share, for the three months ended December 31, 2024, and net loss was $169.0 million, or $(2.90) basic and diluted net loss per share, for the year ended December 31, 2024. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating nuzefatide pevedotin, formerly BT5528, a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of other bicycle-based conjugate molecules, including Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137; and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Mass. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release 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, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: Bicycle Therapeutics’ efforts to identify partners to help advance its product candidates, such as BT7480; the potential benefits of Bicycle Therapeutics’ strategic reprioritization, including the potential extension of financial runway; the proposed workforce reduction and its impact on Bicycle Therapeutics’ expenditures; Bicycle Therapeutics’ expectations with respect to the benefits of its agreements and collaborations with the NDA, UKNNL and SpectronRx, respectively; Bicycle Therapeutics’ ability to leverage its agreements with NDA and SpectronRx and collaboration with UKNNL to support the potential discovery, development and commercial supply of a portfolio of BRCs containing 212Pb; the initiation of new clinical trials, including for BT1702, an MT1-MMP targeting BRC, the progress of Bicycle Therapeutics’ clinical trials, reporting data from Bicycle Therapeutics’ clinical trials, including for BT5528 and BT7480, the timing of EphA2 human imaging data and updates on future clinical development plans for BT5528 and approval pathway; the development of the Bicycle® radioligands pipeline, including BRCs and BIAs; the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; communications with and feedback from the FDA and other regulatory agencies including the potential for multiple regulatory pathways for zelenectide pevedotin in mUC; the existence of a range of options for a Phase 3 trial and potential commercialization of zelenectide pevedotin in mUC; Bicycle Therapeutics’ expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the proposed workforce reduction may take longer or result in more significant charges or cash expenditures than anticipated or otherwise negatively impact Bicycle Therapeutics’ and its business plans during and after the period during which the proposed workforce reduction is being executed; uncertainties related to the benefits of the strategic reprioritization; uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its technology or partnerships; the risk that Bicycle Therapeutics may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics’ projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in Bicycle Therapeutics’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 30, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260317342933/en/ Contacts Investors: Matthew DeYoung Argot Partners [email protected] 212-600-1902 Media: Argot Partners [email protected]

Dose selection from Phase 2/3 Duravelo-2 trial and update on potential approval pathway expected in 1Q 2026 as company seeks feedback from multiple regulatory agencies Enhanced clinical leadership team with appointments to Board of Directors and Research and Innovation Advisory Board Cash and cash equivalents of $648.3 million as of September 30, 2025, excluding $38.2 million U.K. R&D tax credit received in October 2025; expected financial runway into 2028 CAMBRIDGE, England & BOSTON, October 30, 2025--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate updates. "We are currently seeking broad regulatory feedback to make an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer. We look forward to providing updates in the first quarter of 2026," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We have also been executing across the rest of our pipeline with the goal of helping patients live longer and live well. The development of zelenectide pevedotin for multiple Nectin-4 associated cancers is ongoing, with the Phase 1/2 Duravelo-3 trial for NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for NECTIN4-amplified non-small cell lung cancer open and actively enrolling. Additionally, we were pleased to welcome additional esteemed global oncology leaders to the Bicycle Board of Directors and to our Research and Innovation Advisory Board to further strengthen our innovation and strategic growth." Third Quarter 2025 and Recent Events Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in patients with metastatic urothelial cancer (mUC). Bicycle Therapeutics is currently seeking regulatory feedback on zelenectide pevedotin, a Bicycle® Drug Conjugate (BDC®). The company now expects to provide an update on dose selection for Duravelo-2 and zelenectide pevedotin’s potential approval pathway in mUC following meetings with multiple regulatory agencies in the first quarter of 2026. Data for an early Bicycle® Radioconjugate (BRC®) molecule targeting MT1-MMP presented at European Association of Nuclear Medicine (EANM) 2025 Congress. An e-poster presentation outlined the first clinical experience with an early Bicycle Imaging Agent (BIA) targeting MT1-MMP. An additional e-poster presented by the German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), highlighted preclinical BRC data demonstrating the potential of this approach for radiotheranostic use. Altogether, the data build on preclinical and first human imaging data previously disclosed at the American Association for Cancer Research (AACR) Annual Meeting 2025 and EANM 2024. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle® molecules for targeted radionuclide therapies and radiopharmaceutical imaging. The company continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in the first half of 2026 and the initiation of the first company-sponsored clinical trial expected in 2026. Trial in Progress data for Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and tissue sample data in patients with NECTIN4-amplified non-small cell lung cancer (NSCLC) presented at the European Society for Medical Oncology (ESMO) Congress 2025. The Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified NSCLC are open and actively enrolling. Data from post-hoc analyses of late-line breast cancer and lung cancer patients enrolled in Duravelo-1 showed enhanced anti-tumor activity of zelenectide pevedotin in patients with NECTIN4 amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration (FDA) previously granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and NSCLC. BT5528, a potential first-in-class EphA2 targeting BDC molecule. Phase 1 BT5528 combination data with nivolumab in mUC patients will now be presented at a scientific conference in the first half of 2026. BT7480, a Bicycle tumor-targeted immune cell agonist® (Bicycle TICA®), is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Phase 1 BT7480 combination data with nivolumab will now be presented at scientific conference in the first half of 2026. Strengthened Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, Roger Dansey, M.D. and Hervé Hoppenot. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. Dr. Dansey currently serves on the Boards of Directors of Inovio Inc. and Ottimo Pharma. Mr. Hoppenot is an advisor to the CEO and serves on the Board of Directors of Incyte, after serving 11 years as its chairman and CEO. He is also Chairman of the Board of Directors of Maze Therapeutics. Expanded Research and Innovation Advisory Board (RAB) with the appointment of additional esteemed global leaders in oncology to further support scientific advancement and strategic growth across the company’s discovery research programs. The new RAB members are as follows: Steve Davidsen, Ph.D., is a biotech executive with over 35 years of experience in drug discovery and development. Dr. Davidsen currently serves as the founder and president of Predawn Discovery Advisors LLC, providing technical and strategic input to organizations engaged in therapeutic drug discovery. He also serves on the Scientific Advisory Boards of Nitrase Therapeutics and BioLoomics. Previously, Dr. Davidsen served as vice president, oncology discovery research at AbbVie, where he was responsible for discovery efforts across all of AbbVie’s oncology programs and sites. He held various positions of increasing responsibility at Abbott prior to the separation of AbbVie. Dr. Davidsen has directed research teams and partnerships leading to more than 40 first-in-human clinical trials across a broad range of platforms and biology targeting both hematologic and solid tumor indications. He has more than 70 scientific publications across a diverse range of topics including metalloproteinase inhibitors, kinase inhibitors and the discovery of histone deacetylase inhibitors. Dr. Davidsen earned a Ph.D. in organic chemistry from the University of Texas at Austin and a B.S. in chemistry from the University of Maryland. Gilles Gallant, B.Pharm, Ph.D., FOPQ, is an advisor and a consultant to biotechnology and pharmaceutical companies developing oncology drugs. He recently served as chief development officer at Mythic Therapeutics, responsible for the strategy, direction and execution of the company’s clinical development program. He also serves as a scientific advisor for Iteru Systems and is the founder and principal consultant of GG Biotech Consulting LLC. Previously, Dr. Gallant was senior vice president, global head of oncology clinical development at Daiichi Sankyo, leading the development of the company’s global oncology portfolio. At Daiichi, he led the clinical development and global approval of the antibody-drug conjugate (ADC) Enhertu® (fam-trastuzumab deruxtecan-nxki) for the treatment of advanced breast cancer, gastric cancer and non-small cell lung cancer. Dr. Gallant also held leadership roles of increasing responsibility at Bristol-Myers-Squibb, Human Genome Sciences and BioMarin. Dr. Gallant earned a Ph.D. in medicinal chemistry and a B.Pharm from the Université de Montréal and is a Fellow of the Order of Pharmacists of Québec. Ken Herrmann, M.D., MBA, is a well-known leader in oncologic nuclear medicine with more than a decade of experience in clinical investigation. He currently serves on the Board of Directors of Aktis Oncology and as the chair of Aktis’ Scientific Advisory Board. Dr. Herrmann also serves as chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen in Germany, member of Pentixapharm Holding AG’s Supervisory Board and associate editor of the Journal of Nuclear Medicine. Previously, he served as chair of the European Associates of Nuclear Medicine Oncology & Theranostics Committee, vice chair of the Department of Nuclear Medicine at the Universitätsklinikum Würzburg and associate professor in the Ahmanson Translational Imaging Division at the University of California, Los Angeles. To date, he has authored more than 700 peer-reviewed publications. Dr. Herrmann earned his M.D. from Humboldt Universität Berlin and his MBA from the Universität Zurich. John Lambert, Ph.D., is a recognized global leader in ADC discovery and development, currently serving as a consultant/advisor to biopharma and pharma on ADC technologies. He serves on the Avipep Therapeutics Board of Directors and is a scientific advisor to Cureteq AG, Synaffix BV, CytomX Therapeutics and Mythic Therapeutics, among other companies. Previously, Dr. Lambert was chief scientific officer and executive vice president of research at ImmunoGen. During his tenure in leadership roles there, ImmunoGen invented the ADC technology that resulted in Kadcyla® (ado-trastuzumab emtansine) and Elahere® (mirvetuximab soravtansine-gynx) for the treatment of HER2+ breast cancer and platinum-resistant ovarian cancers, respectively. He is a fellow of the American Institute for Medical and Biological Engineering and an honorary professor at Queen’s University Belfast. Dr. Lambert earned a Ph.D. in biochemistry from the University of Cambridge. Participation in Upcoming Investor Conference Bicycle Therapeutics management will participate in the following investor conference in November: Jefferies Global Healthcare Conference in London on Tuesday, Nov. 18; fireside chat at 10:30 a.m. GMT A live webcast of the fireside chat will be accessible in the Investor section of the company’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available following the event. Third Quarter 2025 Financial Results Cash and cash equivalents were $648.3 million as of September 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. In October 2025, we received $38.2 million related to our U.K. research and development (R&D) tax credit claim for the year ended December 31, 2024. R&D expenses were $58.4 million for the three months ended September 30, 2025, compared to $48.3 million for the three months ended September 30, 2024. The increase in expense of $10.1 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, discovery, platform and other expenses, and higher personnel-related costs, including severance-related expenses of our workforce reduction in August 2025, offset by decreased clinical program expenses for Bicycle TICA® molecules. General and administrative expenses were $18.9 million for the three months ended September 30, 2025, compared to $18.3 million for the three months ended September 30, 2024. The increase in expense of $0.6 million was primarily due to increased personnel-related costs, offset by decreased professional and consulting fees. Net loss was $59.1 million, or $(0.85) basic and diluted net loss per share, for the three months ended September 30, 2025, compared to net loss of $50.8 million, or $(0.74) basic and diluted net loss per share, for three months ended September 30, 2024. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release 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, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the initiation of new clinical trials, the progress of Bicycle’s clinical trials, reporting data from Bicycle’s clinical trials, including for BT5528 and BT7480, the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; communications with and feedback from the FDA and other regulatory agencies; Bicycle’s expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle’s projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in Bicycle Therapeutics’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251030686670/en/ Contacts Investors: Matthew DeYoung Argot Partners [email protected] 212-600-1902 Media: Jim O’Connell Weber Shandwick [email protected] 312-988-2343

Bicycle Therapeutics plc (NASDAQ:BCYC) is one of the Top 10 Stocks Under $10 That Could Triple. On August 11, RBC Capital increased its price target on Bicycle Therapeutics plc (NASDAQ:BCYC) from $25 to $27 and kept an Outperform rating after the company reported its Q2 2025 results. The research firm pointed out that the update on the Duravelo-2 dose selection is still expected in the fourth quarter of 2025. However, updates on Duravelo-1 are now expected in 2026, later than initially planned. RBC Capital also highlighted Bicycle Therapeutics plc’s (NASDAQ:BCYC) efforts to reduce costs, mainly through a workforce reduction. This will help the company extend its cash runway into 2028. The company is focused on advancing its clinical programs through key milestones. The firm is also confident that Bicycle Therapeutics plc’s (NASDAQ:BCYC) zelenectide could offer competitive efficacy compared to Padcev with an improved safety profile. RBC Capital indicated that the market is currently undervaluing the $2 billion oncology opportunity for zelenectide. Previously, on August 8, Needham had also reiterated a Buy rating on Bicycle Therapeutics plc (NASDAQ:BCYC) with a $28 price target following the company’s Q2 2025 results. Needham’s Buy rating reflects the company’s new plan to reduce costs by 30%. This move provides a stable foundation for Bicycle Therapeutics plc’s (NASDAQ:BCYC) ongoing projects and improves investor confidence about the company’s future. Overall, analysts are bullish on Bicycle Therapeutics plc (NASDAQ:BCYC). The 12-month median price target of $25.50 set by analysts suggests a potential upside of 256% from the current stock price. Bicycle Therapeutics plc (NASDAQ:BCYC) is a clinical-stage pharmaceutical company focused on developing a novel class of medicines, called Bicycle molecules, for diseases that are underserved by existing therapeutics, especially solid tumor cancers. While we acknowledge the potential of BCYC as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Hot Mid Cap Stocks to Buy Now and 10 Best Affordable Stocks Under $50 to Buy. Disclosure: None. This article is originally published at Insider Monkey.

Continued advancement across research and development pipeline, with key program updates expected in 2H 2025 Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer open and actively recruiting patients Strengthened clinical leadership and bolstered roster of scientific advisors with additions to Board of Directors and creation of Research and Innovation Advisory Board Strategic cost realignment of approximately 30%, primarily through a workforce reduction Cash and cash equivalents of $721.5 million as of June 30, 2025, with expected financial runway extended into 2028 CAMBRIDGE, England & BOSTON, August 08, 2025--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. "We continue to execute on our strategy, which is grounded in scientific rigor and focused on fulfilling our mission to develop next-generation precision-guided therapeutics that have the potential to help patients live longer and live well," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We are energized by the progress we are making across our pipeline, and with this momentum, we are pleased to welcome our new Research and Innovation Advisory Board members, as well as new Board member Charles Swanton, to further our innovation and strategic growth." Dr. Lee continued: "As we advance our various pipeline programs that hold strong potential for changing the treatment paradigm for patients with cancer and creating value for shareholders, Bicycle remains committed to disciplined capital allocation. Today we announced organizational streamlining efforts that provide us with operational flexibility to deliver potentially value-generating datasets while strengthening our financial position in uncertain market conditions. Saying goodbye to talented team members is very difficult, and we sincerely thank them for their dedication to our company. We believe Bicycle is strongly positioned to realize our strategic priorities and milestones and look forward to providing key program updates over the second half of this year." Second Quarter 2025 and Recent Events Presented additional human imaging data for an early Bicycle Radioconjugate® (BRC®) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical imaging. Imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors. Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026. Presented two abstracts highlighting the development of Bicycle® Drug Conjugate (BDC®) zelenectide pevedotin for metastatic urothelial cancer (mUC) at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. The abstracts outlined previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1/2 Duravelo-1 trial and provided an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC. Bicycle Therapeutics is on track to provide an update on dose selection from the Duravelo-2 trial and the accelerated approval pathway for zelenectide pevedotin in mUC following a meeting with the U.S. Food and Drug Administration planned for 4Q 2025. Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer (NSCLC) open and actively recruiting patients. Duravelo-4 is Bicycle Therapeutics’ second trial to leverage NECTIN4 gene amplification as a biomarker for patient selection and to expand the development of zelenectide pevedotin for additional solid tumors. With several trials underway assessing the potential for zelenectide pevedotin to treat mUC, breast cancer and lung cancer, the company has decided to pause the previously announced Phase 1/2 Duravelo-5 trial in multiple tumors. Expanded Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, current chair of Bicycle Therapeutics’ Clinical Advisory Board. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. His research focuses on how tumors evolve over space and time, developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation and the impact of cancer diversity on effective immune surveillance and clinical outcomes. Dr. Swanton is a fellow of the Royal Society, a fellow of the Royal College of Physicians and a fellow of the Academy of Medical Sciences. He completed his M.D. and Ph.D. training at the Imperial Cancer Research Fund Laboratories. Formed Research and Innovation Advisory Board (RAB) to support scientific advancement and strategic growth across preclinical programs. The RAB replaces Bicycle’s Scientific Advisory Board. Inaugural RAB members include: Jose-Carlos Gutierrez-Ramos, Ph.D., is a director on the Bicycle Therapeutics Board of Directors. He also serves as the chief science officer at Danaher Corporation, leading the Danaher Innovation Centers and the Danaher Scientific Advisory Board. Previously, Dr. Gutierrez-Ramos was head of global drug discovery at AbbVie Inc., group senior vice president of biotherapeutics research and development (R&D) at Pfizer Inc., and senior vice president and CEDD head of immuno-inflammation at GlaxoSmithKline plc. He was also the founding CEO and president of Repertoire Immune Medicine, where he built and led a team focused on decoding the human immunome. Prior to that, he served as president and CEO of Synlogic, Inc. Dr. Gutierrez-Ramos earned a Ph.D. from the immunology department of the Center for Molecular Biology at the Universidad Autonoma de Madrid, and a B.S., summa cum laude, in chemistry with a minor in biochemistry from the Universidad Complutense de Madrid. Jason Lewis, Ph.D., is the Emily Tow Chair at Memorial Sloan Kettering Cancer Center (MSKCC) and currently serves as the deputy director at the Sloan Kettering Institute, overseeing the Office of Scientific Education and Training. He is also the scientific director of the Radiochemistry and Molecular Imaging Probe Core Facility at MSKCC. Dr. Lewis is a laboratory head in Sloan-Kettering Institute’s molecular pharmacology program and serves as a professor at the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences and at Weill-Cornell Medical College. He earned a Ph.D. in biochemistry from the University of Kent and an M.S. and B.S. in chemistry from the University of Essex. Robert Lutz, Ph.D., is a consultant/advisor to biotech and pharma with more than 30 years of experience with a significant focus on the development of antibody-drug conjugates (ADCs). He currently serves as chief scientific officer of Iksuda Therapeutics and is a board member and chief development officer of Synthis Therapeutics. Prior to his consulting practice, Dr. Lutz was vice president of translational research and development at ImmunoGen, where he was responsible for the advancement of multiple ADC programs, including KADCYLA® (ado-trastuzumab emtansine), the first ADC to be approved for solid tumor indications, and ELAHERE® (mirvetuximab soravtansine). He earned a Ph.D. in biochemistry from Brandeis University and a B.S. in biochemistry from the University of New Hampshire. Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD, is a nuclear medicine physician and professor at the Sir Peter MacCallum Department of Oncology at the University of Melbourne in Australia. His research has been instrumental in advancing PSMA PET imaging and PSMA radioligand therapy, helping to revolutionize the diagnosis and treatment of prostate cancer. He was named Australia’s top researcher in nuclear medicine, radiotherapy and molecular imaging in both 2024 and 2025. Professor Hofman leads the PET/CT program and the Prostate Cancer Theranostics and Imaging Centre of Excellence at Peter MacCallum Cancer Centre. He earned a degree in medicine and surgery from Monash University in Australia and undertook a PET/CT fellowship at St. Thomas’ Hospital in London. Welcomed Michael Method, M.D., as senior vice president of clinical development. Dr. Method is an academic and clinical gynecologic oncologist with extensive drug development experience. He most recently served as a senior vice president of clinical development at Karyopharm Therapeutics, Inc., after his time as an executive medical director at ImmunoGen, Inc. where he led global clinical development for gynecologic and female malignancies. Previously, Dr. Method was a senior medical advisor for global medical affairs at Eli Lilly, focused on breast cancer. He earned his M.D. and MPH from Northwestern University, and his B.S. in biochemistry and MBA from the University of Notre Dame. Participation in Upcoming Investor Conferences Bicycle Therapeutics management will participate in the following investor conferences in September: Cantor Global Healthcare Conference on Thursday, Sept. 4; fireside chat at 3:55 p.m. ET Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, Sept. 9; fireside chat at 7:45 a.m. ET Live webcasts of the fireside chats will be accessible in the Investor section of the company’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available following the fireside chat dates. Second Quarter 2025 Financial Results Cash and cash equivalents were $721.5 million as of June 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. R&D expenses were $71.0 million for the three months ended June 30, 2025, compared to $40.1 million for the three months ended June 30, 2024. The increase in expense of $30.9 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform and other expenses, and increased personnel-related costs, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) molecules as well as higher U.K. R&D tax credits period over period. General and administrative expenses were $18.5 million for the three months ended June 30, 2025, compared to $15.9 million for the three months ended June 30, 2024. The increase in expense of $2.6 million was primarily due to increased personnel-related costs, as well as increased professional and consulting fees. Net loss was $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025, compared to net loss of $39.8 million, or $(0.77) basic and diluted net loss per share, for three months ended June 30, 2024. In recognition of the evolving macroeconomic environment and the importance of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and extend the company’s expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle® Drug Conjugates and the company’s wholly owned pipeline of Bicycle® Radioconjugates. Bicycle Therapeutics anticipates total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the financial runway into 2028 and strengthen the company’s ability to weather continued market uncertainty as it advances clinical programs through key milestones. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release 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, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle’s ongoing clinical trials and the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the outcome of Bicycle’s strategic cost realignment efforts and Bicycle’s expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle’s projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in Bicycle Therapeutics’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250808838184/en/ Contacts Investors: Stephanie Yao SVP, Investor Relations and Corporate Communications [email protected] 857-523-8544 Matthew DeYoung Argot Partners [email protected] 212-600-1902 Media: Jim O’Connell Weber Shandwick [email protected] 312-988-2343

Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Eckert & Ziegler SE (XTER:EUZ) reiterated its optimistic outlook for achieving its 2025 guidance of 320 million in net sales and 78 million in adjusted EBIT. The company has secured new supply agreements for isotopes, including Actinium and Luitium, which are crucial for future growth. A new partnership with Bicycle Therapeutics highlights the growing importance of CMO activities in the company's portfolio. The company successfully executed a license deal with a Chinese company, generating $10 million plus royalties, demonstrating its strategic expansion in the Chinese market. Despite challenges, the company's EBIT margin improved from 22% to 24%, indicating better profitability management. A cyberattack in February significantly disrupted operations, affecting production, shipping, and invoicing, leading to delays in revenue recognition. The temporary stop in generator production further impacted the company's ability to meet customer demand in the first quarter. The isotope segment experienced a weaker product mix, resulting in a lower gross margin of 44% compared to 46% last year. Currency effects and higher inflation continue to influence net income negatively. The company's reliance on a single competitor in the generator market poses a risk if similar disruptions occur in the future. Warning! GuruFocus has detected 7 Warning Sign with XTER:EUZ. Q: Can you provide guidance on the one-off payments from tech transfers for 2025 and 2026? A: The one-off payment from tech transfers is not a recurring business like generators. We aim to be a full-service provider, and while we strive for continuous license deals, it's challenging to predict exact timings. The current deal with the Chinese joint venture is worth 5 million euros for this year, with the rest to be shown over time. (Unidentified_1 and Unidentified_3) Q: What was the impact of the cyberattack on your revenue, particularly in the medical segment? A: The cyberattack blocked our systems, affecting production and shipping, mainly in the medical segment. We expect to recover the lost revenue in the following months, with April's shipments confirming this recovery. (Unidentified_1) Q: How did your customers react to the delays caused by the cyberattack? A: Customers were understandably upset but appreciated our proactive communication and efforts to resolve the issue. The feedback was generally understanding, and complaints were minimal. (Unidentified_1) Q: What are the expected capital expenditures for the full year, and what is the potential revenue from the CDMO partnership with Bicycle Therapeutics? A: We expect capital expenditures to be around 40 million euros. The CDMO partnership with Bicycle Therapeutics has significant potential, with commercial production possibly reaching double-digit million euros in the future, depending on the project's success. (Unidentified_1 and Unidentified_3) Q: What measures have you taken following the cyberattack to prevent future incidents? A: We are migrating to cloud solutions for better security, standardizing our firewall systems, and increasing employee training to prevent phishing attacks. These steps aim to enhance our cybersecurity posture. (Unidentified_1) For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.

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 management team Cash and cash equivalents of $793.0 million as of March 31, 2025, with expected financial runway into 2H 2027 CAMBRIDGE, England & BOSTON, May 01, 2025--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported recent business progress and financial results for the first quarter ended March 31, 2025. "In the first quarter, we continued to advance our business priorities and our pipeline of oncology therapeutics. We were pleased to share additional human imaging data that continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of our Bicycle Radioconjugate molecules for radiopharmaceutical use," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "Our work to develop zelenectide pevedotin for various Nectin-4 associated cancers continues to progress, as we recently initiated our Phase 1/2 Duravelo-3 trial for NECTIN4 gene-amplified breast cancer and remain on track for dose selection in our Phase 2/3 Duravelo-2 trial for metastatic urothelial cancer in the second half of this year. Additionally, with new members on our leadership team, Board of Directors and Clinical Advisory Board, and expected financial runaway extending to the second half of 2027, we remain focused on continuing to execute our strategy and make meaningful advances for patients." First Quarter 2025 and Recent Events Additional human imaging data for an early Bicycle® Radioconjugate (BRC®) molecule targeting MT1-MMP presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical use. Importantly, the imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors. Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026. Two abstracts accepted for poster presentation at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. Bicycle Therapeutics will present two abstracts highlighting the development of zelenectide pevedotin for metastatic urothelial cancer (mUC). The first abstract outlines previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1 Duravelo-1 trial, while the second abstract provides an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC. Dose selection in Duravelo-2 remains on track for the second half of the year. Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer open and actively recruiting patients. Bicycle Therapeutics previously announced a development strategy leveraging NECTIN4 amplification for zelenectide pevedotin in breast cancer, lung cancer and multiple tumor types. The strategy is based on the company’s discovery that the NECTIN4 gene sits on a commonly amplified chromosomal site in cancer, creating more copies of the gene and often translating to more protein expression. Data from post-hoc analyses of late-line breast cancer and lung cancer patients enrolled in Duravelo-1 showed enhanced anti-tumor activity of zelenectide pevedotin in patients with NECTIN4 amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and non-small cell lung cancer. The Duravelo-3 breast cancer trial is the first of several planned trials to expand the development of zelenectide pevedotin for additional solid tumors. Announced new Board of Directors and key clinical leadership appointments. Felix J. Baker, Ph.D., will succeed Pierre Legault, MBA, CPA, as chairman of the Bicycle Therapeutics Board of Directors as Mr. Legault and Richard Kender, MBA, will retire from the Board following the company’s Annual General Meeting on June 17, 2025. In addition, 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. Furthermore, Eric Westin, M.D., has been promoted to chief medical officer and Jim MacDonald-Clink has been promoted to senior vice president, head of business development, following the transitions of Santiago Arroyo, M.D., Ph.D., chief development officer, and Nigel Crockett, Ph.D., chief business officer, to advisor roles as distinguished fellows. Participation in Upcoming Investor Conferences Bicycle Therapeutics management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference on Tuesday, May 20, at 2:05 p.m. ET. A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event. First Quarter 2025 Financial Results Cash and cash equivalents were $793.0 million as of March 31, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. Research and development (R&D) expenses were $59.1 million for the three months ended March 31, 2025, compared to $34.9 million for the three months ended March 31, 2024. The increase in expense of $24.2 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased personnel-related expenses and lower U.K. R&D tax credits period over period. General and administrative expenses were $21.1 million for the three months ended March 31, 2025, compared to $16.4 million for the three months ended March 31, 2024. The increase in expense of $4.7 million was primarily due to increased professional and consulting fees as well as increased personnel-related costs, including incremental share-based compensation expense of $0.5 million for the three months ended March 31, 2025. Net loss was $60.8 million, or $(0.88) basic and diluted net loss per share, for the three months ended March 31, 2025, compared to net loss of $26.6 million or $(0.62) basic and diluted net loss per share, for three months ended March 31, 2024. About Bicycle TherapeuticsBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC™) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com. Forward Looking StatementsThis press release 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, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRCs having positive properties for radiopharmaceutical use; the initiation of new clinical trials, the progress of Bicycle’s ongoing clinical trials and the timing of dose selection in the Duravelo-2 clinical trial; Bicycle’s expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its partnerships; the risk that Bicycle Therapeutics may the risk that Bicycle’s projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in Bicycle Therapeutics’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 25, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.   View source version on businesswire.com: https://www.businesswire.com/news/home/20250501958606/en/ Contacts Investors: Stephanie YaoSVP, Investor Relations and Corporate [email protected] 857-523-8544 Matthew DeYoungArgot [email protected] 212-600-1902 Media: Jim O’ConnellWeber [email protected] 312-988-2343