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Dec 31, 2020
Black Diamond Therapeutics Q4 2020 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.
Key Takeaways
Black Diamond Therapeutics reported its fourth quarter and full year 2020 financial results, highlighting key progress in its clinical programs, including the ongoing Phase 1/2 trial of BDTX-189 and the advancement of BDTX-1535 into IND-enabling studies. The company's cash position is expected to fund operations into 2023.
Patient enrollment and dosing in the Phase 1/2 clinical trial of BDTX-189 continue to track in line with projections.
BDTX-1535 is on track to enter the clinic in 2022.
Pre-clinical data for MasterKey inhibitors targeting proprietary families of BRAF and FGFR2/3 mutations were presented at ESMO TAT.
Cash, cash equivalents, and investments of $315.1 million as of December 31, 2020, expected to be sufficient to fund operations into 2023
Black Diamond Therapeutics
Black Diamond Therapeutics
Forward Guidance
Black Diamond Therapeutics is focused on advancing its pipeline of MasterKey therapies and anticipates several milestones in the coming year.
Positive Outlook
- Completion of dose-escalation portion of the Phase 1 clinical trial of BDTX-189 in the first half of 2021.
- Initiation of safety expansion cohort anticipated in the second quarter of 2021.
- Start of Phase 2 portion of MasterKey-01 study planned for second half of 2021.
- Filing an Initial New Drug (IND) application for BDTX-1535 in the first half of 2022.
- IND filings for both BRAF and FGFR programs in 2022.
Challenges Ahead
- The Phase 2 portion of the MasterKey-01 study is potentially registrational and may support a new drug application, the Company may only enroll up to 50 patients in Phase 2 before results of routine three-month good laboratory practice (GLP) toxicology studies have been submitted and accepted by the FDA.
- This partial clinical hold on Phase 2 enrollment is not based on any safety findings from the MasterKey-01 trial and has no impact on completion of our Phase 1 study (including the planned safety expansion cohort).
- The Company has initiated the three-month GLP toxicology studies and does not anticipate any delays to its clinical trial timelines for BDTX-189.
- Success of clinical trials is subject to regulatory developments.
- The impact that the current COVID-19 pandemic will have on the Company’s clinical trials and pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in its 2019 annual report on Form 10-K filed with the United States Securities and Exchange Commission and its other filings filed with the United States Securities and Exchange Commission.