BCYC Bicycle Therapeutics plc

29.41
-0.24  -1%
Previous Close 29.65
Open 29.81
52 Week Low 15.25
52 Week High 36.99
Market Cap $708,124,128
Shares 24,077,665
Float 23,589,560
Enterprise Value $598,184,214
Volume 149,618
Av. Daily Volume 129,507
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Upcoming Catalysts

Drug Stage Catalyst Date
BT5528 and OPDIVO (nivolumab)
Solid tumors
Phase 1/2
Phase 1/2
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BT8009
Solid tumors
Phase 1/2
Phase 1/2
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BT1718
Solid tumors
Phase 2
Phase 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. - Bicycle to receive a total of $45 million upfront from Ionis and is eligible for development, regulatory and commercial milestone payments and royalties

    - The agreement provides Ionis an exclusive license to Bicycles that bind with high specificity to the transferrin receptor without modifying natural function

    - Bicycle retains rights to use transferrin binding bicycles to deliver all molecular payloads outside of oligonucleotides

    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 Ionis Pharmaceuticals has exercised its option and entered into an exclusive worldwide license and collaboration…

    - Bicycle to receive a total of $45 million upfront from Ionis and is eligible for development, regulatory and commercial milestone payments and royalties

    - The agreement provides Ionis an exclusive license to Bicycles that bind with high specificity to the transferrin receptor without modifying natural function

    - Bicycle retains rights to use transferrin binding bicycles to deliver all molecular payloads outside of oligonucleotides

    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 Ionis Pharmaceuticals has exercised its option and entered into an exclusive worldwide license and collaboration agreement for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor (TfR1).

    Ionis had an option for an exclusive license under the terms of a December 2020 evaluation and option agreement. The agreement granted Ionis the right to evaluate tissue-targeting TfR1 binding Bicycles as vehicles to deliver oligonucleotide therapeutics to specific organ systems and an option to obtain an exclusive license at the end of the evaluation period.

    Bicycle receives a total of $45 million upfront, which includes a license fee, an option fee, and an $11 million equity investment. Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for each program developed under the collaboration.

    "This agreement stems from a highly successful collaboration with Ionis that began earlier in the year, during which Bicycles were shown to selectively deliver oligonucleotide payloads into TfR1-expressing tissue," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "These data build upon our own work, and that of our partners, which have shown Bicycles targeted to tumor antigens can rapidly and selectively deliver a variety of payloads into solid tumors. This tissue-targeting payload-delivery capability is facilitated by the unique nature of Bicycles that inherently enables the conjugation of a diverse range of molecular cargos without impacting the pharmacology of the target. We believe Bicycles have the potential to become the targeting technology of choice for the development of precision medicines."

    Bicycle has identified binders that it believes to be the first small molecules to target TfR1 with high specificity without modifying TfR1's natural function. These binders present broad conjugation potential across multiple payloads, thereby resulting in the potential to treat diseases in multiple therapeutic areas, including those of the skeletal and cardiac muscles and of the central nervous system. Bicycle is currently also collaborating with the Dementia Discovery Fund (DDF) to advance potential TfR1 Bicycles for treating dementia.

    Under the terms of the license and collaboration agreement, Ionis and Bicycle will collaborate to develop a pipeline of oligonucleotide therapeutic product candidates delivered using the tissue-targeting TfR1 Bicycle technology, while Bicycle retains the rights to use TfR1 Bicycles for all non-oligonucleotide therapeutic purposes, including within its existing collaboration with DDF targeting dementia.

    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 collaboration with Ionis; the development and potential commercialization of potential product candidates using Bicycle's technology and under the license and collaboration agreement; the therapeutic potential for Bicycles in multiple applications; the potential of Bicycle's platform to develop potential precision medicines; Bicycle's continued collaboration with DDF; and the potential to receive milestone payments and royalties under the license and collaboration agreement. 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, 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 May 6, 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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  2. CARLSBAD, Calif., July 13, 2021 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that it has entered into an exclusive licensing agreement with Bicycle Therapeutics plc (NASDAQ:BCYC) to increase the delivery capabilities of Ionis' advanced LIgand Conjugated Antisense (LICA) medicines. The agreement provides Ionis exclusive access to Bicycle's proprietary macrocyclic peptides, referred to as Bicycles, to design LICAs that target transferrin receptor 1 for use with oligonucleotides. This LICA strategy has demonstrated both the improved delivery of antisense medicines to muscle tissue, including cardiac muscle, as well as the potential to cross the blood brain barrier.

    CARLSBAD, Calif., July 13, 2021 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that it has entered into an exclusive licensing agreement with Bicycle Therapeutics plc (NASDAQ:BCYC) to increase the delivery capabilities of Ionis' advanced LIgand Conjugated Antisense (LICA) medicines. The agreement provides Ionis exclusive access to Bicycle's proprietary macrocyclic peptides, referred to as Bicycles, to design LICAs that target transferrin receptor 1 for use with oligonucleotides. This LICA strategy has demonstrated both the improved delivery of antisense medicines to muscle tissue, including cardiac muscle, as well as the potential to cross the blood brain barrier.

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, 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.

    "One of our key strategic objectives is to expand our drug discovery capabilities. The agreement with Bicycle Therapeutics represents a strategic addition to our expanding LICA platform, giving us the potential to meaningfully expand our drug discovery capabilities and deliver many more transformational medicines to the market," said Brett P. Monia, Ph.D., Ionis' chief executive officer. "We believe that investing in technologies like Bicycle's cutting-edge transferrin receptor 1-targeting peptides will enhance our ability to design medicines to tackle devastating diseases in need of better treatment options."

    "Our collaboration with Bicycle will accelerate Ionis' progress toward creating best-in-class, low molecular weight ligands for muscle-specific targeted delivery," said Eric E. Swayze, Ph.D., executive vice president of research at Ionis. "This approach offers several potential advantages over related strategies in development, including increased potency, more convenient administration, less complex manufacturing processes and reduced cost of goods." Dr. Swayze added, "We are pleased with the data we have generated to date and look forward to incorporating optimized Bicycle peptides into our LICA delivery platform."

    Under terms of the agreement, Ionis obtained an exclusive license to Bicycle's technology covering the entire class of transferrin receptor 1 Bicycles for use in targeted delivery of oligonucleotide drugs. Ionis made a $45 million upfront payment to Bicycle which included a license fee, an option fee, and an $11 million equity investment in Bicycle. Bicycle will be eligible to earn development and regulatory milestone payments on a program-by-program basis and royalties on product sales.

    About Ionis Pharmaceuticals, Inc.

    For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.

    To learn more about Ionis visit www.ionispharma.com and follow us on Twitter @ionispharma.

    Ionis' Forward-looking Statement

    This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of Ionis' technologies and products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2020, and the most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of these and other documents are available from the Company.

    In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to Ionis Pharmaceuticals and its subsidiaries.

    Ionis Pharmaceuticals® is a trademark of Ionis Pharmaceuticals, Inc.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ionis-enters-exclusive-licensing-agreement-with-bicycle-therapeutics-aimed-at-further-advancing-lica-technology-301332026.html

    SOURCE Ionis Pharmaceuticals, Inc.

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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 an update regarding shareholder attendance at its 2021 Annual General Meeting (the "AGM") to be held on June 28, 2021.

    As noted in Bicycle's Notice of 2021 Annual General Meeting (the "Meeting Notice") and the accompanying proxy statement (the "Proxy Statement"), there are currently restrictions on movements and gatherings in the United Kingdom imposed by the U.K. government in response to the ongoing COVID-19 pandemic. The U.K. government had indicated in its "roadmap" published in February 2021 that these restrictions may be removed by the…

    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 an update regarding shareholder attendance at its 2021 Annual General Meeting (the "AGM") to be held on June 28, 2021.

    As noted in Bicycle's Notice of 2021 Annual General Meeting (the "Meeting Notice") and the accompanying proxy statement (the "Proxy Statement"), there are currently restrictions on movements and gatherings in the United Kingdom imposed by the U.K. government in response to the ongoing COVID-19 pandemic. The U.K. government had indicated in its "roadmap" published in February 2021 that these restrictions may be removed by the time of Bicycle's AGM. However, the removal of such restrictions remained subject to later review. On June 14, 2021, the U.K. Prime Minister announced that the date for removal of these restrictions had been pushed back to July 19, 2021. Therefore, these restrictions will remain in place as of the date of Bicycle's AGM on June 28, 2021.

    Accordingly, ordinary shareholders (other than those company representatives necessary to form a quorum) are not permitted to attend the AGM in person. Anyone seeking to attend the AGM will be refused entry. Shareholders should submit their vote on the matters to be considered at the AGM by proxy as previously requested in the Proxy Statement and related materials mailed to ordinary shareholders and holders of Bicycle's American Depositary Shares ("ADSs") on or about April 30, 2021. In addition, all shareholders are urged to appoint the Chairman of the AGM as their proxy, as any other proxy will not be able to attend the AGM and vote on the shareholder's behalf.

    The date, time and place of the AGM, and all other arrangements for the AGM, remain unchanged from that set out in the Meeting Notice and Proxy Statement. The AGM will be held on Monday, June 28, 2021 at 1:00 p.m. London time (8:00 a.m. Eastern Daylight Time), at Bicycle's principal executive offices, located at Building 900 Babraham Research Campus, Babraham, Cambridge, CB22 3AT, United Kingdom.

    As shareholders will be unable to attend the AGM in person, shareholders who have questions for Bicycle's Board of Directors can submit them in advance of the AGM to . The Board will endeavor, where appropriate, to answer such questions by publishing responses to Bicycle's website as soon as practical after the AGM.

    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.

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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 management will participate in the following virtual investor conferences in June:

    • Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021; fireside chat at 11:00 a.m. ET
    • Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021; fireside chat at 8:00 a.m. ET
    • The JMP Securities Life Sciences Conference on Thursday, June 17, 2021; fireside chat at 12:00 p.m. ET

    A live webcast of the fireside chats will be accessible in the Investors & Media section of Bicycle's website at www.bicycletherapeutics.com

    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 the following virtual investor conferences in June:

    • Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021; fireside chat at 11:00 a.m. ET
    • Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021; fireside chat at 8:00 a.m. ET
    • The JMP Securities Life Sciences Conference on Thursday, June 17, 2021; fireside chat at 12:00 p.m. ET

    A live webcast of the fireside chats will be accessible in the Investors & Media section of Bicycle's website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 30 days following the presentation dates.

    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.

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  5. - 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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