On May 12, 2020 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 12, 2020, View Source [SID1234557641]).
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"We are pleased with our first quarter progress which included advancing the Phase 1/2 clinical trial of our lead product candidate BDTX-189 and completing our successful initial public offering," said David M. Epstein, Ph.D., President and CEO. "All companies are being impacted by the COVID-19 pandemic and Black Diamond is no exception. Our priority is the safety and well-being of our patients, as well as employees and their families, and we have adjusted our operations accordingly. We have also put in place contingency plans and additional resources from third-party service providers to minimize the impact on our business and strategy. We believe we are well positioned not only to execute on the clinical development of BDTX-189 as planned, but also to continue to invest in our proprietary MAP platform and to progress our early stage pipeline of small molecule, tumor-agnostic precision medicine programs. We will continue to closely monitor the global COVID-19 situation and its impact on our business as it evolves."
Recent Developments
•In February 2020, Black Diamond completed an initial public offering (IPO) pursuant to which it issued and sold 12,174,263 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $231.3 million before deducting underwriting discounts and commissions and other offering expenses.
•Black Diamond continued to enroll and dose patients in the Phase 1 portion of a Phase 1/2 clinical trial of BTDX-189 (MasterKey-01; NCT04209465) and expects to complete the Phase 1 portion of the trial by the first half of 2021. BDTX-189 is Black Diamond’s mutation spectrum-selective, oral, irreversible small molecule inhibitor product candidate, which targets cancer-causing driver mutations in human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) that have not yet been drugged.
•Black Diamond continued to advance its program in glioblastoma multiforme (GBM) toward nomination of a development candidate targeting a range of driver mutations in GBM, as well as its earlier-stage programs derived from the Company’s Mutation-Allostery-Pharmacology (MAP) platform.
•Black Diamond implemented risk mitigation measures and adjusted operations in response to the COVID-19 pandemic.
Financial Highlights
•Black Diamond ended the first quarter of 2020 with $357.2 million in cash and cash equivalents, which included net proceeds from the Company’s IPO of $212.1 million, compared to $44.7 million for the first quarter of 2019. Net cash used in operations was $11.3 million for the first quarter of 2020 compared to $6.9 million for the first quarter of 2019.
•Research and development (R&D) expenses were $7.4 million for the first quarter of 2020 compared to $3.0 million for the first quarter of 2019. The increase in R&D expenses was primarily related to an increase in headcount, preclinical development, and advancement of the BDTX-189 Phase 1/2 clinical trial.
•General and administrative (G&A) expenses were $5.5 million for the first quarter of 2020 compared to $0.8 million for the first quarter of 2019. The increase in G&A expenses was primarily due to an increase in personnel and costs associated with operations as a public company.
Upcoming Events
•The Company will present a poster about the MasterKey-01 Phase 1/2 clinical trial design at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program:
◦Abstract Title: Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies (Abstract TPS3665; Poster 395)
◦Poster Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
•David M. Epstein, Ph.D., President and CEO, is scheduled to present at the following upcoming conferences:
◦Bank of America Global Research Health Care Conference 2020, on Tuesday, May 12, 2020, at 4:20 PM ET
◦Jefferies Global Healthcare Conference, on Wednesday, June 3, 2020, at 1:30 PM ET
◦BMO 2020 Prescriptions for Success Healthcare Virtual Conference, on Tuesday, June 23, 2020