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bicycle therapeutics Bicycle Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 4 , 2021 - Announced interim BT5528 Phase I clinical trial results and preliminary results from ongoing BT8009 Phase I clinical trial - First Patient Dosed in Phase I / II Trial of Bicycle® Tumor - targeted Immune Cell AgonistTM BT7480 in Patients with Advanced Solid Tumors Associated with Nectin - 4 Expression - Cash was $ 259.5 million , which excludes $ 201.3 million in gross proceeds from Q4'21 public offering - Genentech exercised an option in Q4'21 to initiate an additional program under the 2020 collaboration agreement CAMBRIDGE , England , & BOSTON -- ( BUSINESS WIRE ) -- Nov . 4 , 2021-- 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 third quarter ended September 30 , 2021 and provided recent corporate updates . " We recently provided a clinical update for our ongoing Phase 1 dose escalation trials in BT5528 and BT8009 , the data from which support our conviction that the Bicycle platform offers a potentially differentiated approach to traditional targeted payload delivery , " said Kevin Lee , Ph.D. , Chief Executive Officer of Bicycle Therapeutics . " We were encouraged to see preliminary anti - tumor activity in both trials and across two tumor types , providing further insights as we continue to expand the application of our technology . We look forward to providing additional clinical data on BT5528 and BT8009 next year . " " Beyond our Bicycle Toxin Conjugates ( BTC ) , we are also making progress across our other programs , including BT7480 , our novel , fully synthetic Bicycle tumor - targeted immune cell agonist ( Bicycle TICATM ) , which recently entered the clinic , as well as in our partnership withGenentech , which is now being expanded to include a new program under the collaboration . In addition , we recently entered into a collaboration agreement with lonis Pharmaceuticals to develop targeted oligonucleotide therapeutics , which we believe further demonstrates the potential of the platform outside of oncology . Our plans to advance our programs and platform in oncology and beyond are supported by a strong balance sheet that has been further enhanced by the recent proceeds from an upsized public equity offering completed in October . " Third Quarter 2021 and Recent Highlights • Presented Interim BT5528 Phase I Clinical Trial Results at AACR - NCI - EORTC Conference . In October 2021 , Bicycle presented interim Phase I results for BT5528 , a BTC targeting EphA2 , a target for which prior antibody - based approaches have been unsuccessful . A total of 24 patients were dosed both prior to , and after , the implementation of the EphA2 immunohistochemistry ( IHC ) assay , with a median of seven prior lines of therapy . Among these patients , preliminary anti - tumor activity , including three partial responses , as defined by Response Evaluation Criteria in Solid Tumors ( RECIST ) version 1.1 , was observed in seven EphA2 positive urothelial and ovarian cancer patients . Based on the totality of the findings , Bicycle expects the recommended Phase 2 dose to be in the range of 6.5mg / m² to 8.5mg / m² every other week , a dose that Bicycle believes is within the therapeutic range based on both preclinical studies and preliminary clinical anti - tumor activity . Bicycle plans to initiate expansion cohorts in urothelial and ovarian cancers , as well as a basket cohort that includes head and neck , non - small cell lung , gastroesophageal and triple negative breast cancers in 2022 . • Announced Preliminary Results from Ongoing BT8009 Phase I Clinical Trial . In October 2021 , Bicycle announced preliminary Phase I results for BT8009 , a Nectin - 4 targeting BTC with a potentially differentiated profile as compared to an FDA approved , Nectin - 4 targeting antibody - drug conjugate . As of September 30 , a total of 11 response evaluable urothelial cancer patients had been dosed in monotherapy cohorts , including four patients in the 2.5mg / m² dose cohort and seven in the 5.0mg / m² dose cohort . Among the four patients dosed at 2.5mg / m² weekly , three patients were observed to have at least stable disease , with a disease control rate of 75 % , and one patient ( 25 % ) was observed to have a tumor reduction of 37 % , meeting the criteria of a partial response under RECIST 1.1 . Among the seven patients dosed at 5.0mg / m² , five were observed to have at least stable disease , with a disease control rate of 71 % , and three patients ( 43 % ) were observed to have tumor reductions meeting the criteria of a partial response under RECIST 1.1 . The magnitude of tumor reductions ranged from 44 % to 89 % . In both cohorts , BT8009 has been tolerated , with no dose limiting toxicities observed to - date . Dose escalation remains ongoing , and patients are currently being enrolled in 7.5mg / m² weekly and every other week cohorts . A total of 14 clinical sites are active globally , including nine outside of the United States , and Bicycle expects to I have up to 21 sites active this year . • Announced First Patient Dosed in Phase I / II Trial of Bicycle® Tumor - targeted Immune Cell Agonist ™ BT7480 in Patients with Advanced Solid Tumors Associated with Nectin - 4 Expression . This is the Company's fourth product