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Bicycle Therapeutics Reports Second Quarter 2020 Financial Results and Provides Corporate Update

05/08/2020

Bicycle Therapeutics, a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles®) technology, today reported financial results for the second quarter ended June 30, 2020 and discussed recent corporate updates.

“Despite the challenges presented by the ongoing COVID-19 pandemic, we have made significant progress towards achieving our 2020 objectives,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “In the coming months, we look forward to initiating the Phase IIa trial of BT1718 and the Phase I/II trial of BT8009. We are also continuing to advance BT5528 in the dose escalation portion of a Phase I/II trial, and we will be deploying our proprietary EphA2 immunohistochemistry, or IHC, assay to select and enroll EphA2-positive patients in the Phase I trial. We remain confident in our ability to achieve our near-term milestones, which should help enable our vision of pioneering the development of novel therapies for patients suffering from cancer and other serious diseases.”

Second Quarter 2020 and Recent Highlights

  • Appointed Sir Keith Peters FRS as Chairman of the Company’s Scientific Advisory Board (SAB). Sir Keith Peters is a renowned expert in the field of clinical immunology and was appointed Chairman of Bicycle’s SAB in June 2020. He has worked closely with the Company’s leadership team as a member of the SAB since its inception in 2018.
  • Presented New Translational Data for BT5528 and Preclinical Data for Tumor-Targeted Immune Cell Agonists (TICAs™) at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. Translational data presented at AACR describe the development of Bicycle’s proprietary IHC assay for use in the Phase I/II trial of BT5528, a second-generation BTC that targets EphA2. This assay will be used to support patient selection and assess EphA2 expression levels in tumor samples collected in the ongoing Phase I/II trial. New preclinical data presented for BT7480, a TICA targeting Nectin-4 and agonizing CD137, demonstrate that anti-tumor responses in a syngeneic mouse model can be achieved with an intermittent dosing regimen, indicating that continuous target coverage may be unnecessary for efficacy.
  • Presented Trials in Progress Poster for BT5528 at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program. The poster describes the design of the ongoing Phase I/II trial of BT5528 in advanced solid tumors associated with EphA2 expression.
  • Announced Publication of BT5528 Mechanism of Action in AACR Journal Molecular Cancer Therapeutics. The manuscript, titled “MMAE delivery using the Bicycle toxin conjugate BT5528,” describes the physiochemical properties and preclinical profile of BT5528 that have enabled BT5528 to demonstrate a more favorable safety and efficacy profile than that of antibody drug conjugates (ADCs) with the same tumor antigen target and similar cytotoxic payload.

Upcoming Investor Conferences

Bicycle will be participating in the following virtual investor conferences in the third quarter of 2020:

  • Canaccord Genuity 40th Annual Growth Conference, August 11-13, 2020
  • Citi 15th Annual BioPharma Conference, September 9-10, 2020
  • Goldman Sachs 10th Annual Biotech Symposium, September 11, 2020
  • H.C. Wainwright 22nd Annual Global Investment Conference, September 13-15, 2020
  • Cantor Global Healthcare Conference, September 15-17, 2020
  • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, September 21-23, 2020

Financial Results

  • Cash and cash equivalents were $96.9 million as of June 30, 2020, compared to $92.1 million as of December 31, 2019. Cash at June 30, 2020 does not include $17.6 million in net proceeds from the Company’s "at the market" (ATM) offering program or $6.7 million UK research and development tax credit reimbursement, both of which were received in July 2020.
  • Research and development expenses totaled $8.0 million for the three months ended June 30, 2020, compared to $6.5 million for the three months ended June 30, 2019. The increase of $1.4 million is primarily due to increased clinical and TICA program development expenses, partially offset by lower development expenses of other programs due to timing, and an increase in personnel related costs, including $0.2 million of incremental non-cash share-based compensation expense.
  • General and administrative expenses were $6.2 million for the three months ended June 30, 2020, compared to $3.0 million for the three months ended June 30, 2019. The increase of $3.2 million is primarily due to an increase in professional fees and costs related to operations as a public company, an unfavorable effect of foreign exchange rates, and an increase in personnel related costs, including $0.2 million of incremental non-cash share-based compensation expense.
  • Net loss was $12.1 million, or $(0.67) basic and diluted net loss per share, for the three months ended June 30, 2020, compared to net loss of $10.2 million, or $(1.40) basic and diluted net loss per share, for the three months ended June 30, 2019.

 


Published on: 05.08.20

Article sourced from Business Wire