\nBicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle\u00ae<\/i>) technology, today reported financial results for the second quarter ended June 30, 2021 and provided recent corporate updates.\n<\/p>\n
\n\u201cWe have made significant progress executing on our ongoing company-sponsored clinical programs over the first half of the year and, looking forward, intend to announce interim clinical data from the Phase I portion of our Phase I\/II clinical trials of BT5528 and BT8009, along with the expected Phase I\/II BT7840 trial initiation, in the second half of the year,\u201d said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. \u201cAdditionally, we believe our recent license and collaboration agreement with Ionis provides further validation for our contention that Bicycles<\/i> have the potential to become a leading technology for the development of precision medicines. We remain well-funded and look forward to announcing multiple upcoming key clinical milestones in the second half of the year.\u201d\n<\/p>\n
Second Quarter 2021 and Recent Highlights<\/b><\/p>\n Financial Results<\/b><\/p>\n About Bicycle Therapeutics<\/b><\/p>\n \nBicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles<\/i>, for diseases that are underserved by existing therapeutics. Bicycles<\/i> 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<\/i> attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle<\/i> Toxin Conjugate (BTC\u2122) targeting EphA2, and BT8009, a second-generation BTC\u2122 targeting Nectin-4, a well-validated tumor antigen, in company-sponsored Phase I\/II trials. In addition, BT1718, a BTC\u2122 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.<\/a><\/p>\n Forward Looking Statements<\/b><\/p>\n \nThis 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 \u201caims,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201ccould,\u201d \u201cestimates,\u201d \u201cexpects,\u201d \u201cforecasts,\u201d \u201cgoal,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201cplans,\u201d \u201cpossible,\u201d \u201cpotential,\u201d \u201cseeks,\u201d \u201cwill\u201d 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\u2019s expected cash runway; the availability and timing of data from clinical trials; the initiation of clinical trials; the therapeutic potential of Bicycle\u2019s product candidates; statements regarding Bicycle\u2019s collaboration with Ionis; the development and potential commercialization of potential product candidates using Bicycle\u2019s technology and under its license and collaboration agreement with Ionis; the therapeutic potential for Bicycles<\/i> in multiple applications; the potential of Bicycle\u2019s platform to develop potential precision medicines; and Bicycle\u2019s ability to achieve planned 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\u2019s and its collaboration partners\u2019 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\u2019s 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\u2019s product candidates; risks related to Bicycle\u2019s 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 our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled \u201cRisk Factors\u201d in our in our 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 because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.\n<\/p>\n Bicycle Therapeutics plc \n\u00a0\n<\/p>\n<\/td>\n Three Months Ended Six Months Ended \n\u00a0\n<\/p>\n<\/td>\n 2021<\/b><\/p>\n<\/td>\n 2020<\/b><\/p>\n<\/td>\n 2021<\/b><\/p>\n<\/td>\n 2020<\/b><\/p>\n<\/td>\n<\/tr>\n \nCollaboration revenues\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n1,785\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n1,571\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n3,593\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n2,700\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nOperating expenses:\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nResearch and development\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n11,722\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n7,958\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n21,415\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n15,728\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nGeneral and administrative\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n7,340\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n6,196\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n15,479\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n11,197\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal operating expenses\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n19,062\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n14,154\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n36,894\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n26,925\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nLoss from operations\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(17,277\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(12,583\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(33,301\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(24,225\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nOther income (expense):\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nInterest income\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n23\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n371\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n38\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n583\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nInterest expense\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(819\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u2014\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(1,341\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u2014\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nTotal other expense, net\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(796\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n371\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(1,303\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n583\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \nNet loss before income tax provision\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(18,073\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(12,212\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(34,604\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(23,642\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nBenefit from income taxes\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(160\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(97\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(500\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(204\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nNet loss\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(17,913\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(12,115\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(34,104\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(23,438\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nNet loss per share, basic and diluted\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(0.74\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(0.67\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(1.48\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(1.30\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \nWeighted average ordinary shares outstanding, basic and diluted\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n24,052,168\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n18,077,770\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n23,047,745\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n18,024,314\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n June 30, \n\u00a0\n<\/p>\n<\/td>\n December 31, \nCash\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$198,738\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$135,990\n<\/p>\n<\/td>\n<\/tr>\n \nWorking capital\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n194,515\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n132,594\n<\/p>\n<\/td>\n<\/tr>\n \nTotal assets\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n226,048\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n161,152\n<\/p>\n<\/td>\n<\/tr>\n \nTotal shareholders’ equity\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n142,050\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n95,460\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210805005135\/en\/<\/a><\/span><\/p>\n Investors:\n
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Condensed Consolidated Statements of Operations and Comprehensive Loss
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(In thousands, except share and per share data)
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(Unaudited)<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n
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June 30, <\/b><\/p>\n<\/td>\n\n \n
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June 30, <\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
\n Balance Sheets Data
(In thousands)
(Unaudited)<\/b><\/td>\n<\/tr>\n\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n
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2021<\/b><\/p>\n<\/td>\n\n \n
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2020<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n <\/p>\n
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David Borah, CFA
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VP, Capital Markets & Investor Relations
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david.borah@bicycletx.com
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617-203-8300\n<\/p>\n