On November 7, 2019 Bicycle Therapeutics plc (NASDAQ:BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported financial results for the third quarter ended September 30, 2019 and discussed recent corporate updates (Press release, Bicycle Therapeutics, NOV 7, 2019, View Source [SID1234550656]).
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"The significant progress we have made in the past few months is instrumental to our goal of advancing our novel pipeline of Bicycle drug candidates through the clinic," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We’ve bolstered all three areas of the pipeline, namely, our wholly-owned Bicycle Toxin Conjugate and immuno-oncology programs, as well as our collaborations to develop new Bicycle-based therapies for indications beyond oncology. We have also continued to strengthen our leadership team both at the corporate and Board levels. These efforts further position the Company to evaluate the potential of Bicycles to enable possible first-in-class medicines that transform the treatment paradigm for people living with a broad range of serious diseases, in ways that existing modalities cannot."
Third Quarter 2019 and Recent Highlights
Presenting New Preclinical Data for Novel, Fully Synthetic Bicycle Tumor-targeted Immune Cell Agonists (TICAs) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. This week, Bicycle is presenting new data showing that its lead immuno-oncology candidate, BT7480, a TICA targeting Nectin-4 and agonizing CD137, rapidly penetrates tumors and effects powerful anti-tumor activity in preclinical models. In addition to data on BT7480, the Company will present preclinical research at SITC (Free SITC Whitepaper) on other emergent Bicycle TICA strategies. Details of the Company’s poster presentations on Saturday, November 9, 2019 can be found in the News section of bicycletherapeutics.com.
Enhanced Executive Team and Board of Directors. In October 2019, Bicycle announced the appointment of Nigel Crockett, Ph.D., as Chief Business Officer and of Veronica Jordan, Ph.D., to the Company’s Board of Directors.
Expanded Neuroscience Collaborations to Include Oxford University’s Oxford Drug Discovery Institute (ODDI). Bicycle announced that it will collaborate with ODDI to use Bicycle technology for the development of novel therapeutics for dementia. This expands upon the collaboration announced in May 2019 between Bicycle and the Dementia Discovery Fund (DDF), a specialized venture capital fund focused on discovering and developing novel therapies for dementia. If promising lead compounds are identified, Bicycle will have rights to the development of the resulting intellectual property and, with DDF, will have the option to jointly establish a new company to develop those compounds.
Presented New Translational Data for Lead Asset BT1718 and Preclinical Data for Other Bicycle Toxin Conjugates at AACR (Free AACR Whitepaper)-NCI-EORTC 2019. Bicycle presented new translational data for BT1718 and preclinical data for BT5528 and BT8009 during poster sessions at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The translational data for BT1718 characterize enrollment criteria for identifying expansion cohorts in the Phase IIa part of the ongoing Phase I/IIa trial.
Presented Updated Data from Phase I/IIa Trial Evaluating BT1718 in Patients with Advanced Solid Tumors at ESMO (Free ESMO Whitepaper) 2019 Annual Congress. Bicycle and Cancer Research UK presented updated data from the ongoing Phase I portion of the Phase I/IIa trial evaluating BT1718 in patients with advanced solid tumors. As of August 7, 2019, 54% of evaluable patients dosed had stable disease at the eight-week timepoint, including a patient who experienced a 45% reduction in a target lesion, and BT1718 appeared tolerable with once-weekly dosing.
Upcoming Investor Presentations
Bicycle will present at the following investor conferences in the fourth quarter of 2019:
Jefferies London Healthcare Conference on Wednesday, November 20, 2019 at 2:40 p.m. GMT (9:40 a.m. ET) in London, England
Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 3:30 p.m. ET in New York, NY
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.
Financial Results
Cash was $96.0 million as of September 30, 2019, compared with $63.4 million as of December 31, 2018. The September 30, 2019 cash balance excludes a UK research and development incentive payment of approximately $6.0 million received in October 2019.
Research and development expenses were $6.1 million for the three months ended September 30, 2019, compared to $5.6 million for the three months ended September 30, 2018. The increase of $0.4 million is primarily due to $0.3 million of incremental non-cash share-based compensation expense, as well as other personnel related costs.
General and administrative expenses were $4.8 million for the three months ended September 30, 2019, compared to $2.3 million for the three months ended September 30, 2018. The increase of $2.5 million is primarily due to a $0.9 million unfavorable effect of foreign exchange rates, $0.7 million in personnel related costs, including $0.3 million of incremental non-cash share-based compensation expense, as well as increased professional fees related to operations as a public company.
Net loss was $9.5 million, or $(0.53) basic and diluted net loss per share, for the three months ended September 30, 2019, compared to net loss of $7.7 million, or $(17.73) basic and diluted net loss per share, for the quarter ended September 30, 2018.