BCYC Bicycle Therapeutics plc

30.94
-0.24  -1%
Previous Close 31.18
Open 30.86
52 Week Low 14.26
52 Week High 33.2
Market Cap $744,962,955
Shares 24,077,665
Float 23,589,560
Enterprise Value $588,071,594
Volume 60,528
Av. Daily Volume 145,002
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Upcoming Catalysts

Drug Stage Catalyst Date
BT8009
Solid tumors
Phase 1/2
Phase 1/2
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BT1718
Solid tumors
Phase 2
Phase 2
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BT5528 and Nivolumab
Solid tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
BT7480
Oncology
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.
THR-149 (KALAHARI)
Diabetic Macular Edema
Phase 2
Phase 2
Phase 2 initiation of dosing announced September 1, 2020.

Latest News

  1. - BT7480, the lead Bicycle tumor-targeted immune cell agonist, presented at AACR Annual Meeting 2021 "New Drugs on the Horizon" session; remains on-track for 2H'21 clinical trial start

    - Achieved significant recent progress across pipeline of Bicycle®-based therapies beyond oncology

    - Raised $75.0 million through at-the-market offering program; cash of $195.9 million as of March 31, 2021 expected to provide financial runway through multiple clinical milestones and into 2024

    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 reported financial results for the first quarter ended March 31, 2021 and discussed…

    - BT7480, the lead Bicycle tumor-targeted immune cell agonist, presented at AACR Annual Meeting 2021 "New Drugs on the Horizon" session; remains on-track for 2H'21 clinical trial start

    - Achieved significant recent progress across pipeline of Bicycle®-based therapies beyond oncology

    - Raised $75.0 million through at-the-market offering program; cash of $195.9 million as of March 31, 2021 expected to provide financial runway through multiple clinical milestones and into 2024

    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 reported financial results for the first quarter ended March 31, 2021 and discussed recent corporate updates.

    "We've had a great start to 2021, as we advance multiple Bicycle Toxin Conjugates® (BTCs) in the clinic, prepare for BT7480, our lead tumor-targeted immune cell agonist, to enter the clinic later this year and continue to expand the use of our platform outside of oncology, while also significantly strengthening our balance sheet," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We plan to build on this momentum during the year, and our presentation of preclinical data at AACR serves to highlight the potential therapeutic benefits that Bicycles may offer toward improving the treatment paradigms for people living with cancer and other serious diseases."

    First Quarter 2021 and Recent Highlights

    • Presented at the American Association for Cancer Research (AACR) Annual Meeting 2021. In April 2021, Bicycle presented new preclinical data describing the discovery of BT7480, a novel Nectin-4/CD137 Bicycle tumor-targeted immune cell agonistTM (Bicycle TICA) during a "New Drugs on the Horizon" session. The Company expects BT7480 to enter the clinic in the second half of 2021. Additionally, the Company presented five posters and one presentation highlighting preclinical data across multiple programs in Bicycle's oncology pipeline. The posters and presentations are available on the Publications section of bicycletherapeutics.com.



    • Provided Pipeline Progress Update Across Multiple Therapeutic Programs Beyond Oncology. In March 2021, Bicycle announced progress updates for its Bicycle programs outside of oncology:



      • Achieved first milestone in the collaboration with Dementia Discovery Fund (DDF) and the University of Oxford's Alzheimer's Research UK Oxford Drug Discovery Institute (ODDI): The Company identified and optimized nM affinity Bicycles to transferrin receptor 1 (TfR1), a molecular shuttle. The three parties are collaborating to identify and characterize Bicycles that bind to and activate TREM2, a genetically validated dementia target.



      • Advanced the platform in multiple anti-infective areas, including antimicrobials and antivirals: Innovate UK's Biomedical Catalyst (BMC) awarded the Company funding to advance a Bicycle inhibitor for a key cell wall biosynthesis target in Enterobacterales, Penicillin Binding Protein 3 (PBP3). Bicycle, working with investigators at the University of Warwick, intends to progress these PbP3 inhibitors, potentially the first novel class of antibiotics identified in decades, to candidate and initial toxicology testing. Additionally, under a specific Innovate UK program targeting key technologies to rapidly respond to the challenge of the COVID-19 pandemic, Bicycle received funding to support its efforts to discover new healthcare solutions to SARS-CoV-2.



      • Made significant progress through partnerships: Bicycle successfully discovered and advanced targets outside of oncology through its ongoing collaboration with AstraZeneca, a global biopharmaceutical company, to discover novel agents for the treatment of respiratory and cardiometabolic diseases. Two assets were transitioned to AstraZeneca's pipeline for further development. Bicycle also identified targets in its collaboration with Bioverativ (acquired by Sanofi) for the treatment of rare hematological diseases. The collaborations successfully identified nM multi-valent inhibitors to P-Selectin, which inhibited neutrophil binding and rolling, with potential applications in sickle cell disease and other inflammatory diseases. The Bioverativ collaboration also identified the first small molecule Factor VIII mimetic for the potential treatment of Hemophilia A. Upon termination of the collaboration in 2019, these "lead stage" assets have been returned to Bicycle.



    • Appointed Jose-Carlos Gutierrez-Ramos, Ph.D., to its Board of Directors: In March 2021, Bicycle announced the appointment of industry veteran Dr. Gutierrez-Ramos to its Board of Directors. Dr. Gutierrez-Ramos previously served as Chair of Bicycle's Scientific Advisory Board and has extensive experience in leading biopharmaceutical companies and in academia.



    • Continued to Strengthen the Balance Sheet in 2021. Since January 2021, Bicycle has completed the sale of $75.0 million through its at-the-market (ATM) offering program. Gross proceeds during the first quarter of 2021 totaled $60.6 million, with an additional $14.4 million in gross proceeds recognized in April 2021. Also during the second quarter of 2021, the Company received $2.0 million from Genentech for achieving specified criteria under the collaboration research plan. Cash as of March 31, 2021 does not include the April 2021 ATM proceeds or Genentech proceeds. In addition, in March 2021, the Company drew an additional $15.0 million available under its debt facility with Hercules Capital, Inc. and amended the loan and security agreement to extend the interest-only payment period until the second half of 2023, with the potential to further extend it into 2024, contingent on the satisfaction of performance milestones.

    Financial Results

    • Cash was $195.9 million as of March 31, 2021, compared to $136.0 million as of December 31, 2020. The increase in cash was primarily due to net proceeds of $58.8 million from the ATM offering and net proceeds of $15.0 million from the debt facility with Hercules Capital Inc., offset by cash used in operating activities. Cash at March 31, 2021 does not include net proceeds from the ATM offering received in April 2021. Cash of $195.9 million at March 31, 2021 is expected to provide financial runway through multiple clinical milestones and into 2024.
    • Research and development expenses were $9.7 million for the three months ended March 31, 2021, compared to $7.8 million for the three months ended March 31, 2020. The increase in expense of $1.9 million for the three months ended March 31, 2021 as compared to the same period in the prior year was primarily due to increased clinical program expenses for BT8009, a second-generation Bicycle Toxin Conjugate (BTC) targeting Nectin-4, and increased other unallocated discovery and platform related expenses due to the timing of development activities, and increased personnel-related expenses, including $0.5 million of incremental non-cash share-based compensation expense.
    • General and administrative expenses were $8.1 million for the three months ended March 31, 2021, compared to $5.0 million for the three months ended March 31, 2020. The increase of $3.1 million for the three months ended March 31, 2021 as compared to the same period in the prior year was primarily due to an unfavorable effect of foreign exchange rates and an increase in personnel-related costs, including $1.2 million of incremental non-cash share-based compensation expense for the three months ended March 31, 2021.
    • Net loss was $16.2 million, or $(0.73) basic and diluted net loss per share, for the three months ended March 31, 2021, compared to net loss of $11.3 million, or $(0.63) basic and diluted net loss per share for three months ended March 31, 2020.

    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 is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2, and BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Centre for Drug Development of Cancer Research UK. 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 anticipated advancement and expansion of its pre-clinical and clinical pipelines; Bicycle's collaboration partners' pre-clinical development efforts; Bicycle's expected cash runway; the expected initiation of Bicycle's clinical trial of BT7480; the therapeutic potential of Bicycle's product candidates; and the potential extension of the interest-only period under Bicycle's debt facility. 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 and its collaboration partners' abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Bicycle's product candidates by Bicycle or its collaboration partners; the risk that Bicycle may not realize the intended benefits of its technology; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates; risks related to Bicycle's ability to maintain existing collaborations and realize the benefits thereof; expectations for regulatory approvals to conduct trials or to market products; risks related to Bicycle's ability to achieve performance milestones applicable to its debt facility; 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 our in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 11, 2021, 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 because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

    Bicycle Therapeutics plc

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

     

    March 31,

     

     

    2021

     

    2020

    Collaboration revenues

     

    $

    1,808

     

     

    $

    1,129

     

    Operating expenses:

     

     

     

     

     

     

    Research and development

     

     

    9,693

     

     

     

    7,774

     

    General and administrative

     

     

    8,139

     

     

     

    4,998

     

    Total operating expenses

     

     

    17,832

     

     

     

    12,772

     

    Loss from operations

     

     

    (16,024

    )

     

     

    (11,643

    )

    Other income (expense):

     

     

     

     

     

     

    Interest income

     

     

    15

     

     

     

    212

     

    Interest expense

     

     

    (522

    )

     

     

     

    Total other income (expense), net

     

     

    (507

    )

     

     

    212

     

    Net loss before income tax provision

     

     

    (16,531

    )

     

     

    (11,431

    )

    Benefit from income taxes

     

     

    (340

    )

     

     

    (107

    )

    Net loss

     

    $

    (16,191

    )

     

    $

    (11,324

    )

    Net loss per share, basic and diluted

     

    $

    (0.73

    )

     

    $

    (0.63

    )

    Weighted average ordinary shares outstanding, basic and diluted

     

     

    22,100,840

     

     

     

    17,997,929

     

    Balance Sheets Data

    (In thousands)

    (Unaudited)

     

     

     

     

     

     

     

     

     

    March 31,

     

    December 31,

     

     

    2021

     

    2020

    Cash

     

    $

    195,901

     

    $

    135,990

    Working capital

     

     

    194,687

     

     

     

    132,594

     

    Total assets

     

     

    223,942

     

     

     

    161,152

     

    Total shareholders' equity

     

     

    142,091

     

     

     

    95,460

     

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  2. Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the appointment of Maria Koehler, M.D., Ph.D. to its Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she led the development of Ibrance® (palbociclib) and contributed to the strategic direction of the oncology portfolio.

    "We are extremely pleased to welcome Maria to our Board of Directors at this important next stage of Ikena's evolution," said Mark Manfredi, President…

    Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the appointment of Maria Koehler, M.D., Ph.D. to its Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she led the development of Ibrance® (palbociclib) and contributed to the strategic direction of the oncology portfolio.

    "We are extremely pleased to welcome Maria to our Board of Directors at this important next stage of Ikena's evolution," said Mark Manfredi, President & Chief Executive Officer of Ikena. "Maria is a highly accomplished biopharmaceutical veteran. During her distinguished career, she has led the development of numerous oncology drugs from early- to late-stage clinical investigation, through to commercialization. Her leadership and strategic expertise will be invaluable as we advance IK-930, our lead targeted oncology candidate, into clinical development, followed thereafter by our other pipeline programs targeting cancers with high unmet need."

    "It is a privilege to join Ikena's Board of Directors during such an exciting period of growth following the Company's recent IPO, and as Ikena advances IK-930 towards clinical development during the second half of 2021," said Dr. Koehler. "I look forward to working alongside Ikena's current Board members and executive management to advance Ikena's innovative drug candidates through clinical development and toward commercialization where they can truly benefit patients."

    Dr. Koehler brings deep experience in both early drug development and bringing new drugs to global markets, having developed strategies for product candidates at all stages of development. Dr. Koehler currently serves as the Chief Medical Officer at Repare Therapeutics (NASDAQ:RPTX), where she leads clinical strategy and oversees all operations. Dr. Koehler joined Repare from Bicycle Therapeutics (NASDAQ:BCYC) where she was Chief Medical Officer. Prior to Bicycle, she was Vice President of Strategy, Innovation and Collaborations for the Oncology Business Unit at Pfizer. Prior to Pfizer, she served in leadership roles at GlaxoSmithKline and at AstraZeneca. She is board certified in hematology and oncology. She began her career as a practicing physician and served as the clinical director of Bone Marrow Transplantation at University Hospital in Pittsburgh as well as the director of the Bone Marrow Transplant Program and associate professor at St. Christopher's Hospital in Philadelphia. Dr. Koehler received her M.D. and Ph.D. from the Silesian Medical School in Poland and has co-authored over 150 publications, book chapters, and patents.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  3. Leuven, BE, Boston, MA, US – April 13th, 2021 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in retinal vascular disorders, today announces that Grace Chang, M.D., Ph.D., Chief Medical Officer (CMO) of Oxurion, will be presenting at the Wet AMD and DME Drug Development Summit, taking place from April 13 to 15, 2021.

    Dr. Chang will be joining the Summit as a presenter and a panelist:

    •   Presentation on New Therapeutics Target RGD Integrins and The Plasma Kallikrein System: Overview of First Clinical Findings
    Date & Time: April 15, 2021 at 9:55 am EDT
           
    •   Participation in Q&A session entitled Targeting

    Leuven, BE, Boston, MA, US – April 13th, 2021 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in retinal vascular disorders, today announces that Grace Chang, M.D., Ph.D., Chief Medical Officer (CMO) of Oxurion, will be presenting at the Wet AMD and DME Drug Development Summit, taking place from April 13 to 15, 2021.

    Dr. Chang will be joining the Summit as a presenter and a panelist:

    •   Presentation on New Therapeutics Target RGD Integrins and The Plasma Kallikrein System: Overview of First Clinical Findings

    Date & Time: April 15, 2021 at 9:55 am EDT

           

    •   Participation in Q&A session entitled Targeting New Therapeutic Pathways & Looking Beyond Anti-VEGF

    Date & Time: April 15, 2021 at 10:35 am EDT

    •   Participation in Panel Discussion on the Topic Searching for Novel Therapeutic Targets – Addressing Developmental Challenges for New Drug Candidates in Wet AMD & DME

    Date & Time: April 15, 2021 at 11:10 am EDT

    For more information and registration details:  https://wet-amd-drugdevelopment.com

    Under the leadership of Dr. Chang, Oxurion is advancing a pipeline of innovative clinical drug candidates with distinct and complementary modes of action, for treatment of retinal vascular disorders, including DME but also wet AMD.

    THR-149 is a potential first in class plasma kallikrein inhibitor with the possibility to become the treatment of choice for the 40% DME patients who respond sub-optimally to anti-VEGF therapy. Oxurion is currently recruiting patients in a Phase 2 and is on track to readout Part A data later this year. 

    THR-687 is a potential best in class small molecule pan-RGD integrin antagonist initially being developed to treat DME with the possibility to become the standard of care for most DME patients. The Company is currently preparing an IND to start a Phase 2 study evaluating THR-687 as a new therapy for most DME patients. This Phase 2 is expected to start in mid-year.

    Beyond DME, THR-687 also has development possibilities in additional retinal vascular disorders including for wet age-related macular degeneration (Wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12 billion.

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32







     
    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571





     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with retinal vascular disorders including diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

    Oxurion is aiming to build the leading global franchise in the treatment of retinal vascular disorders 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 the 40% of 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 multiple injections of THR-149 in 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 is a pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO. THR-487 is an optimized compound derived from a broader library of integrin antagonists 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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  4. - BT7480 to be presented in a "New Drugs on the Horizon" session; on-track to enter the clinic in 2H'21

    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 for the first time, preclinical work describing the discovery of BT7480, a novel Nectin-4/CD137 tumor-targeted immune cell agonist (TICATM), will be presented virtually in a "New Drugs on the Horizon" session at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 10-15, 2021. Additional work covering TICAs and Bicycle Toxin Conjugates® (BTCs), will also be covered in a late-breaking mini-symposium…

    - BT7480 to be presented in a "New Drugs on the Horizon" session; on-track to enter the clinic in 2H'21

    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 for the first time, preclinical work describing the discovery of BT7480, a novel Nectin-4/CD137 tumor-targeted immune cell agonist (TICATM), will be presented virtually in a "New Drugs on the Horizon" session at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 10-15, 2021. Additional work covering TICAs and Bicycle Toxin Conjugates® (BTCs), will also be covered in a late-breaking mini-symposium, as well as in five e-posters.

    "Our TICA platform has made significant progress, and we are thrilled to present information about the discovery of BT7480, as well as preclinical data across multiple programs in our immuno-oncology pipeline," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "These presentations highlight the potential utility of Bicycle-based therapeutic candidates for treating multiple tumor types via diverse mechanisms as we pursue our goal of improving the treatment paradigm for patients with cancer."

    Bicycle TICAs are potent, fully synthetic compounds that represent an immuno-oncology approach engineered to overcome the limitations of other immunomodulatory mechanisms. Bicycles are small, structurally constrained peptides discovered via phage display and optimized using structure-driven design and medicinal chemistry approaches. Bicycle has applied this disruptive technology by identifying CD137 Bicycles and chemically linking these to tumor antigen binding Bicycles to generate multifunctional molecules that induce tumor antigen-dependent, tumor-localized agonism of CD137. Bicycle expects BT7480 to enter the clinic in the second half of 2021.

    Details on Bicycle's presentations and posters at AACR are as follows:

    Poster Title: Molecular-based enrichment strategy for Nectin-4 targeted Bicycle toxin conjugate BT8009

    Abstract #: 391

    Session, Date and Time: Biomarkers Predictive of Therapeutic Benefit, April 10, 8:30 AM

    Poster Title: Nectin-4-dependent immune cell stimulation and anti-tumor efficacy by BT7480, a Nectin-4/CD137 Bicycle® tumor-targeted immune cell agonist (TICA™)

    Poster #: 1728

    Session, Date and Time: Immunomodulatory Agents and Interventions, April 10, 8:30 AM

    Poster Title: Microinjection of Nectin-4/CD137 tumor-targeted immune cell agonist (TICA™) activates the local tumor microenvironment

    Poster #: 1724

    Session, Date and Time: Immunomodulatory Agents and Interventions, April 10, 8:30 AM

    Poster Title: A multi tumor survey of Nectin-4 expression to guide BT8009 indication selection

    Poster #: 1197

    Session, Date and Time: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes, April 10, 8:30 AM

    Poster Title: Rapid Accumulation of Cytotoxic Payload in Tumor Tissue Drives BT5528 Activity in Tumor Models

    Poster #: 1319

    Session, Date and Time: Novel Drug Delivery Systems, April 10, 8:30 AM

    Presentation Title: BT7480, a novel Nectin-4 dependent agonist of the immune cell costimulatory receptor CD137

    Session, Date and Time: New Drugs on the Horizon: Part 1, April 10, 1:30 – 3:15 OM, Channel 1

    Presentation Title: Integrative surfaceome profiling identifies immunotherapeutic targets in osteosarcoma and preclinical testing of BT1769, an MT1-MMP-targeted Bicycle® toxin conjugate, in osteosarcoma by the Pediatric Preclinical Testing Consortium (PPTC)

    Session, Date and Time: Late-Breaking Mini-symposium 2, April 12, 1:35 – 1:45 OM, Channel 7

    The posters will be available on the Publications section of bicycletherapeutics.com following each session.

    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 trial. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated in 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 anticipated initiation of a clinical trial of BT7480 and the therapeutic potential of Bicycle's pre-clinical targets and product candidates. 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 Bicycle's and its collaboration partners' abilities to meet anticipated deadlines and milestones presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Bicycle's product candidates by Bicycle or its collaboration partners; the risk that Bicycle or its collaboration partners may not realize the intended benefits of Bicycle's technology; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that studies and trials may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates; risks related to Bicycle's ability to maintain existing collaborations and realize the benefits thereof; expectations for regulatory approvals to conduct trials or to market products; and other important factors, any of which could cause Bicycle's actual results to differ from those contained in the forward-looking statements, and which are described in greater detail in the section entitled "Risk Factors" in Bicycle's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 11, 2021, 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 is a leader in the development of pan-RGD integrin antagonists for retinal vascular disorders - THR-687 on track to enter Phase 2 development by mid-year

    Leuven, BE, Boston, MA, US – April 7, 2021 – 05.45 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care therapies for retinal vascular disorders, announces the publication of a review article describing the cutting-edge science and rationale for the design and development of THR-687. The article entitled: Targeting RGD-binding integrins as an integrative therapy for diabetic retinopathy and neovascular age-related macular degeneration' (I Van Hove et al, reference below) was published in Progress in Retinal Eye Research

    Oxurion is a leader in the development of pan-RGD integrin antagonists for retinal vascular disorders - THR-687 on track to enter Phase 2 development by mid-year

    Leuven, BE, Boston, MA, US – April 7, 2021 – 05.45 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care therapies for retinal vascular disorders, announces the publication of a review article describing the cutting-edge science and rationale for the design and development of THR-687. The article entitled: Targeting RGD-binding integrins as an integrative therapy for diabetic retinopathy and neovascular age-related macular degeneration' (I Van Hove et al, reference below) was published in Progress in Retinal Eye Research.

    Integrins are a class of transmembrane receptors that are involved in a wide range of biological functions. The authors describe how RGD integrins affect a multitude of disease-related proteins and molecular pathways in relation to retinal vascular disorders. RGD integrins have been demonstrated to play an important role in diabetic retinopathy (DR), age-related macular degeneration (AMD), glaucoma, dry eye disease and retinal vein occlusion (RVO).

    Based on these findings, the authors conclude that therapies that engage integrin-linked pathways, including THR-687, have the potential to block all of these pathways and to deliver important clinical benefits to patients with these vision threatening conditions. 

    Oxurion is a leader in the development of pan-RGD integrin antagonists for retinal vascular disorders, with THR-687, a potential best-in-class molecule on track to enter a Phase 2 study in patients with diabetic macular edema (DME) in mid-2021. Oxurion is initially developing THR-687 as a first line therapy for DME. THR-687 also holds potential for development in wet AMD and RVO.

    Prof Alan Stitt, Ph.D., Chief Scientific Officer (CSO) of Oxurion, said, "We are pleased to have made this important scientific contribution to retinal eye research. Selective integrin antagonists are becoming an ever-more attractive option to block key processes such as vasopermeability, neovascularisation and inflammation to prevent sight-loss, a therapeutic area in which Oxurion is well placed. The review highlights the potential of our pioneering pan-RGD integrin antagonist THR-687 to deliver important clinical benefits to patients with retinal vascular disorders. We are on track to start a Phase 2 study in patients with DME in mid-year, and we are excited by the significant potential of THR-687 to provide a broad therapeutic alternative for retinal vascular diseases including DME, wet AMD and RVO."  

    References

    I Van Hove, et al. Targeting RGD-binding integrins as an integrative therapy for diabetic retinopathy and neovascular age-related macular degeneration in Progress in Retinal Eye research

    Article abstract can be accessed at: https://www.sciencedirect.com/science/article/abs/pii/S1350946221000276

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32







    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571





     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

    Oxurion is aiming to build the 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 multiple injections of THR-149 in 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 is a pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, which is an optimized compound derived from a broader library of integrin antagonists in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG), also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.

    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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