BCYC Bicycle Therapeutics plc

20.4
+0.49  (+2%)
Previous Close 19.91
Open 19.82
52 Week Low 7.5
52 Week High 21.6757
Market Cap $434,617,940
Shares 21,304,801
Float 20,776,345
Enterprise Value $305,432,044
Volume 26,562
Av. Daily Volume 74,958
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Drug Pipeline

Drug Stage Notes
BT8009
Solid tumors
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing announced September 10, 2020.
BT1718
Solid tumors
Phase 2
Phase 2
Phase 2a initiation of dosing announced September 2, 2020.
THR-149 (KALAHARI)
Diabetic Macular Edema
Phase 2
Phase 2
Phase 2 initiation of dosing announced September 1, 2020.
BT5528 and Nivolumab
Solid tumors
Phase 1/2
Phase 1/2
Phase 1 dosing has commenced - noted May 5, 2020.

Latest News

  1. Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that management will participate in a fireside chat at the 2020 Piper Sandler Healthcare Conference, which is scheduled to take place from December 1 – 3, 2020. The conference will be held in a virtual meeting format.

    A recording of the fireside chat will be accessible in the Investors & Media section of Bicycle's website at www.bicycletherapeutics.coma at 9:00 a.m. ET on Tuesday, December 1. An archived replay of the webcast will be available for 90 days following the fireside chat date.

    About Bicycle Therapeutics

    Bicycle Therapeutics (NASDAQ…

    Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that management will participate in a fireside chat at the 2020 Piper Sandler Healthcare Conference, which is scheduled to take place from December 1 – 3, 2020. The conference will be held in a virtual meeting format.

    A recording of the fireside chat will be accessible in the Investors & Media section of Bicycle's website at www.bicycletherapeutics.coma at 9:00 a.m. ET on Tuesday, December 1. An archived replay of the webcast will be available for 90 days following the fireside chat date.

    About Bicycle Therapeutics

    Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles 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 Bicycles attractive candidates for drug development. Bicycle's lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

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  2. Bicycle Therapeutics plc (NASDAQ:BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that it has entered into a settlement and license agreement with Pepscan Systems B.V. regarding Bicycle's use of Pepscan's CLIPS peptide technology.

    The companies have agreed to settle all intellectual property disputes worldwide. Under the terms of the settlement, Bicycle has been granted a license to use CLIPS peptide technology in the development of its product candidates BT1718 and THR-149. Bicycle will pay €3 million upfront, will pay €1 million on the first anniversary of the date of settlement, and will make potential…

    Bicycle Therapeutics plc (NASDAQ:BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that it has entered into a settlement and license agreement with Pepscan Systems B.V. regarding Bicycle's use of Pepscan's CLIPS peptide technology.

    The companies have agreed to settle all intellectual property disputes worldwide. Under the terms of the settlement, Bicycle has been granted a license to use CLIPS peptide technology in the development of its product candidates BT1718 and THR-149. Bicycle will pay €3 million upfront, will pay €1 million on the first anniversary of the date of settlement, and will make potential additional payments to Pepscan based on achievement of specified clinical, regulatory and commercial milestones.

    About Bicycle Therapeutics

    Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles 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 Bicycles attractive candidates for drug development. Bicycle's lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. 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's use of CLIPS peptide technology in the development of its product candidates BT1718 and THR-149, Bicycle's future payment obligations to Pepscan, and Bicycle's contemplated achievement of specified clinical, regulatory and commercial milestones. Bicycle 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: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to Bicycle's abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials by Bicycle or its collaboration partners and in the clinical development of Bicycle's product candidates; availability and timing of results from clinical trials; expectations for regulatory approvals to conduct trials or to market product; and other important factors, any of which could cause our 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's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, as well as in other filings Bicycle 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 expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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  3. Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that management will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 1:10 p.m. ET.

    A live webcast of the fireside chat will be accessible in the Investors & Media section of Bicycle's website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the presentation date.

    About Bicycle Therapeutics

    Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred…

    Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that management will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 1:10 p.m. ET.

    A live webcast of the fireside chat will be accessible in the Investors & Media section of Bicycle's website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the presentation date.

    About Bicycle Therapeutics

    Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles 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 Bicycles attractive candidates for drug development. Bicycle's lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

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  4. Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that preclinical data for BT7480, a tumor-targeted immune cell agonist (TICA™), and an EphA2/CD137 TICA will be presented during an e-poster session at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting on November 9-14, 2020.

    "We continue to produce compelling data characterizing the preclinical profiles of our novel, fully synthetic immuno-oncology, or IO, candidates," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "The data presented at SITC provide further evidence of the potential…

    Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that preclinical data for BT7480, a tumor-targeted immune cell agonist (TICA™), and an EphA2/CD137 TICA will be presented during an e-poster session at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting on November 9-14, 2020.

    "We continue to produce compelling data characterizing the preclinical profiles of our novel, fully synthetic immuno-oncology, or IO, candidates," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "The data presented at SITC provide further evidence of the potential advantages of our TICAs over conventional, biologic-based IO therapies. Our molecules are able to fully engage the local tumor microenvironment with intermittent systemic exposure. Furthermore, because our TICAs are fully synthetic, we can customize each molecule's pharmacokinetic profile and easily swap tumor-targeting and/or immune cell agonizing Bicycles for a generalizable approach. We believe our TICAs represent a major innovation in precision targeted immune modulation, and we look forward to initiating a clinical trial for our lead IO program, BT7480, in 2021."

    In preclinical models, BT7480 exhibited potent, target-dependent anti-tumor activity, and facilitated the development of immunogenic memory. New data presented at SITC demonstrate that treatment with BT7480 leads to significant modulation of the tumor microenvironment, including immune checkpoints. This finding supports potential dosing of BT7480 in combination with checkpoint inhibitors. At dose levels tested, BT7480 has been shown to be well-tolerated in non-human primates. IND-enabling activities for BT7480 are ongoing.

    Based on new data presented at SITC, one of Bicycle's EphA2/CD137 TICAs demonstrated potent EphA2-dependent activity in both CD137 reporter and primary immune cell assays. As with BT7480, intermittent dosing was associated with robust anti-tumor activity in an MC38 syngeneic mouse model that expresses human CD137. There, complete responder animals became resistant to rechallenge with MC38 tumor cells, implying an immunogenic memory response. Bicycle also showed a potential ability to induce significant modulation of the tumor immune microenvironment, including immune checkpoints. Bicycle announced earlier this year that it has selected an EphA2/CD137 TICA candidate, BT7455.

    Together, data to be presented at SITC demonstrate the potential generalizability of the TICA platform, with a Nectin-4/CD137 TICA and an EphA2/CD137 TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle's poster presentations at SITC are as follows:

    Poster Title: BT7480, a fully synthetic tumor-targeted immune cell agonist (TICA™) induces tumor localized CD137 agonism and modulation of tumor immune microenvironment

    Abstract #: 706

    Live Q&A: Thursday, November 12, 4:50 p.m. – 5:20 p. m. ET and Saturday, November 14, 1:00 p.m. –1:30 p.m. ET

    Poster Title: EphA2/CD137 Bicycle tumor-targeted immune cell agonists (TICAs™) induce tumor regressions, immunogenic memory, and reprogramming of the tumor immune microenvironment

    Abstract #: 700

    Live Q&A: Thursday, November 12, 4:50 p.m. – 5:20 p. m. ET and Saturday, November 14, 1:00 p.m. –1:30 p.m. ET

    About Bicycle Therapeutics

    Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles 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 Bicycles attractive candidates for drug development. Bicycle's lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. 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 and the therapeutic potential and potential advantages of Bicycle's product candidates, Bicycle's ability to customize its TICAs, Bicycle's plans to initiate clinical trials for BT7480 and BT7455, Bicycle's ability to advance its product candidates through clinical development. Bicycle 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: risks presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycle's product candidates; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that trials and studies may be delayed and may not have satisfactory outcomes; expectations for regulatory approvals to conduct trials or to market product; and other important factors, any of which could cause our 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's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, as well as in other filings Bicycle 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 expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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  5. OXURION NV Confirms New Patents for THR-687 Issued by European and US Patent Offices

    Composition-of-matter patents protect THR-687 until 2039-2044

    Leuven, Belgium and Boston, MA, November 9, 2020 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing potential next generation standard-of-care therapies to better preserve the vision of patients with diabetic macular edema (DME), today announces a further strengthening of its intellectual property (IP) portfolio governing THR-687, an integrin antagonist being developed for the treatment of DME.

    The European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) have both issued new composition-of-matter patents covering THR-687…

    OXURION NV Confirms New Patents for THR-687 Issued by European and US Patent Offices

    Composition-of-matter patents protect THR-687 until 2039-2044

    Leuven, Belgium and Boston, MA, November 9, 2020 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing potential next generation standard-of-care therapies to better preserve the vision of patients with diabetic macular edema (DME), today announces a further strengthening of its intellectual property (IP) portfolio governing THR-687, an integrin antagonist being developed for the treatment of DME.

    The European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) have both issued new composition-of-matter patents covering THR-687. Patents EP3613739 and US10703752 were issued in November 2020 and July 2020 respectively, and expire in 2039, with possible patent extensions of up to 5 additional years (2044). An international application is still pending.

    THR-687 is a potential best-in-class small molecule pan-RGD integrin antagonist being developed to treat DME holding potential of becoming the standard of care for DME patients.

    Data from a Phase 1 trial showed that THR-687 is well-tolerated and safe with no dose-limiting toxicities and no serious adverse events reported at any of the doses evaluated in the study. Early signs of efficacy were also observed across all doses, with a rapid onset of action in mean Best Corrected Visual Acuity (BCVA) from Day 1. Following a single injection of the highest dose of THR-687, this activity was maintained at Month 3 with a mean BCVA improvement of 12.5 letters.

    Oxurion pre-clinical data show that THR-687 has the potential to be developed for additional significant indications, including wet Age-related Macular Degeneration (wAMD) and Retinal Vein Occlusion (RVO).

    Patrik De Haes, M.D., CEO of Oxurion, said: "We are delighted that by using our in-house expertise to chemically optimize THR-687, we have generated an improved molecule for clinical development and extended its composition-of-matter patent coverage. The new patents that have been granted will ensure exclusivity until at least 2039 in the most important US and European markets for THR-687. These patents are a key element in securing the potentially significant commercial opportunity for THR-687, given our initial aim to make it the standard of care for all DME patients."

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 16 75 13 10 / +32 478 33 56 32





     
    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/ Frazer Hall

    Tel: +44 20 7638 9571

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing potential next generation standard of care therapies to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.

    Oxurion is building a leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME.  The Company is currently conducting a Phase 2 clinical trial evaluating THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

       
    • THR-687, a pan-RGD integrin inhibitor, initially being developed as a potential new standard of care for DME patients. Positive topline results in a Phase 1 clinical study assessing it as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021.  THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG).

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.

    More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

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