On March 10, 2020 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported financial results for the fourth quarter and full year ended December 31, 2019 and discussed recent corporate updates (Press release, Bicycle Therapeutics, MAR 10, 2020, View Source [SID1234555346]).
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"Last year was transformational for Bicycle as the completion of our initial public offering and the strengthening of corporate leadership enabled successful execution against our pipeline development strategy," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This year is already off to a strong start, with two new immuno-oncology collaborations designed to expand upon our wholly owned portfolio of systemic immune cell agonists and tumor-targeted immune cell agonists (TICAs). We look forward to the momentum continuing as we progress multiple Bicycle Toxin Conjugates through the clinic this year and prepare to begin clinical development of our first TICA. We believe our anticipated near-term milestones will further demonstrate the role Bicycles could play in creating a much-needed new treatment paradigm for people living with cancer and other serious diseases."
Fourth Quarter 2019 and Recent Highlights
Entered into Strategic Collaboration with Genentech to Discover, Develop and Commercialize Novel Bicycle-based Immuno-oncology Therapies. In February 2020, Bicycle entered into a strategic collaboration agreement with Genentech. Under the terms of the agreement, Bicycle will be responsible for discovery research and early preclinical development up to candidate selection. Bicycle will receive a $30 million upfront payment. The upfront payment and potential milestone payments could total up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties. None of Bicycle’s wholly owned oncology assets, including its immuno-oncology candidates, are included in the collaboration.
Announced Collaboration with Cancer Research UK to Develop New Bicycle Immuno-oncology Candidate, BT7401. In January 2020, Bicycle announced a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research. Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase I/IIa clinical study.
Dosed First Patient in Phase I/II Trial of BT5528, a Second-generation Bicycle Toxin Conjugate (BTC) Targeting EphA2, in Patients with Advanced Solid Tumors. In November 2019, Bicycle announced that the first patient had been dosed in the Phase I dose escalation portion of its Phase I/II trial of BT5528 in patients with advanced solid tumors associated with EphA2 expression. BT5528 is the first second-generation BTC to enter the clinic and has demonstrated promising anti-tumor activity and tolerability across a broad range of preclinical studies.
Presented New Preclinical Data for Novel, Fully Synthetic TICAs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. In an oral presentation at SITC (Free SITC Whitepaper), Bicycle presented 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.
Anticipated Key Events in 2020
Initiation of Phase IIa trial of BT1718, a BTC targeting MT1-MMP, in patients with solid tumors expressing MT1 (trial sponsored by Cancer Research UK)
Interim BT5528 Phase I data readout from the ongoing Phase I/II trial
Initiation of nivolumab arm in BT5528 Phase I portion of the ongoing Phase I/II trial
Initiation of a Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4, a tumor antigen shown to be overexpressed in tumor cells, in patients with solid tumors
Financial Results
Cash was $92.1 million as of December 31, 2019, compared with $63.4 million as of December 31, 2018. Cash at December 31, 2019 does not include the $30 million upfront payment from Genentech.
Research and development expenses were $6.6 million for the three months ended December 31, 2019 and $25.5 million for the year ended December 31, 2019, compared to $6.5 million for the three months ended December 31, 2018 and $20.8 million for the year ended December 31, 2018. The increase of $0.1 million for the three months ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $0.4 million of incremental non-cash share-based compensation expense, offset by a decrease of $0.9 million in direct program spending. The increase of $4.8 million for the year ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase of $2.1 million in direct program spending as well as an increase in personnel-related expenses, including $0.8 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $3.4 million for of the three months ended December 31, 2019 and $14.6 million for the year ended December 31, 2019, compared to $2.1 million for of the three months ended December 31, 2018 and $8.1 million for the year ended December 31, 2018. The increase of $1.3 million for the three months ended December 31, 2019 as compared to the same period in the prior year is primarily due $0.9 million in personnel-related costs, including $0.4 million of incremental non-cash share-based compensation expense, as well as $1.6 million in professional fees and costs related to operations as a public company, offset by a $1.2 million favorable effect of foreign exchange rates. The increase of $6.4 million for the year ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $1.2 million of incremental non-cash share-based compensation expense, as well as an increase in professional fees and costs related to operations as a public company, offset by a $0.6 million favorable effect of foreign exchange rates.
Net loss was $4.4 million, or $(0.25) basic and diluted net loss per share, for the three months ended December 31, 2019 and net loss was $30.6 million, or $(2.77) basic and diluted net loss per share for the year ended December 31, 2019, compared to net loss of $6.6 million, or $(13.19) basic and diluted net loss per share for the three months ended December 31, 2018, and net loss of $21.8 million, or $(49.78) basic and diluted net loss per share for the year ended December 31, 2018.