On August 4, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the second quarter ended June 30, 2022 and provided recent corporate updates (Press release, Bicycle Therapeutics, AUG 4, 2022, View Source [SID1234617570]).
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"We are pleased with the progress of our wholly owned clinical oncology pipeline of Bicycle Toxin Conjugate, or BTC, programs and Bicycle tumor-targeted immune cell agonist, or Bicycle TICA, programs," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "In the second quarter, we initiated the expansion cohorts of our Phase I/II study of BT5528, and development of BT8009 and BT7480 remains on track as these programs advance in their respective clinical trials."
"In addition, we were delighted to announce the second expansion of our immuno-oncology collaboration with Genentech last month, highlighting the potential of the platform beyond our BTCs and Bicycle TICAs," Dr Lee continued. "We are pleased to have a strong balance sheet which helps support the advancement of our programs and which we anticipate provides a financial runway into 2025."
Second Quarter 2022 and Recent Highlights
Announced First Patient Dosed in the Expansion Cohorts of Phase I/II Trial of BT5528. In June 2022, Bicycle announced that the first patient was dosed in the expansion cohorts of the Phase I/II study of BT5528, Bicycle’s second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2. Up to 56 patients will be enrolled in the initial expansion cohorts, with the ability to further expand enrollment based on the results from these cohorts. Bicycle intends to provide completed results of the dose escalation portion of the clinical trial during the third quarter of 2022.
Announced Expansion of Genentech Immuno-Oncology Collaboration. In July 2022, Bicycle announced that Genentech exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. This expansion represented the second option exercised by Genentech under the terms of the original February 2020 agreement and triggered a $10 million payment to Bicycle, which is expected to be received in the third quarter of 2022.
Presented Trials in Progress Poster Featuring BT7480 Phase I/II Clinical Trial at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In June 2022, Bicycle presented a Trials in Progress poster highlighting the Phase I/II clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137.
Announced Interim BT8009 Phase I Clinical Trial Results at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In April 2022, Bicycle announced interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4. As of March 7, 2022, 37 patients have been dosed in the Phase I/II trial of BT8009. A total of 12 response evaluable urothelial cancer (UC) patients have been dosed in monotherapy cohorts of 2.5mg/m2 and 5.0mg/m2 weekly in the ongoing trial. Four response evaluable UC patients were dosed at 2.5mg/m2 weekly, with one patient observed to have tumor reductions constituting a confirmed partial response (PR) and two patients observed to have stable disease (SD). Eight response evaluable UC patients were dosed at 5.0mg/m2 weekly, with four patients observed to have a confirmed complete response (CR) or PR, including one patient with a CR and three patients with a PR, and two patients with SD, reflecting a 50% overall response rate and 75% disease control rate. As of March 7, 2022, the median duration of response had not yet been reached in either the 2.5 mg/m2 or 5.0mg/m2 cohort, with four of the five responders in these cohorts still on therapy after at least 24 weeks.
Exploration of additional doses and frequencies continues, and Bicycle intends to provide further updates this year.
Financial Results
Cash and cash equivalents were $372.8 million as of June 30, 2022, compared to $438.7 million as of December 31, 2021. The decrease in cash is primarily due to cash used in operating activities.
Research and development expenses were $19.9 million for the three months ended June 30, 2022, compared to $11.7 million for the three months ended June 30, 2021. The increase in expense of $8.2 million was primarily due to increased clinical program expenses for BT5528 and BT8009, Bicycle TICA program development expenses, as well as increased personnel-related expenses, including $1.6 million of incremental non-cash share-based compensation expenses, and increased facilities-related expenses.
General and administrative expenses were $11.8 million for the three months ended June 30, 2022, compared to $7.3 million for the three months ended June 30, 2021. The increase of $4.5 million for the three months ended June 30, 2022 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $1.5 million of incremental non-cash share-based compensation expense, and an unfavorable effect of foreign exchange rates.
Net loss was $26.8 million, or $(0.90) basic and diluted net loss per share, for the three months ended June 30, 2022, compared to net loss of $17.9 million, or $(0.74) basic and diluted net loss per share, for the three months ended June 30, 2021.