BCYC

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 co...

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...

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 Me...

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 o...

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 da...

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 unders...

Revenue: US$9.98m (down 49% from 1Q 2024). Net loss: US$60.8m (loss widened by 129% from 1Q 2024). US$0.88 loss per share (further deteriorated from US$0.62 loss in 1Q 2024). Our free stock report includes 2 warning signs investors should be aware of before investing in Bicycle Therapeutics. Read for free now. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 15%. Earnings per share (EPS) missed analyst estimates by 3.8%. Looking ahead, revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 10% from a week ago. We should say that we've discovered 2 warning signs for Bicycle Therapeutics (1 is potentially serious!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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...