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Sep 30, 2020
MacroGenics Q3 2020 Earnings Report
MacroGenics advanced its portfolio of clinical molecules and reported financial results.
Key Takeaways
MacroGenics reported third quarter financial results, with total revenue of $18.2 million and a net loss of $36.0 million. The company continued to advance its clinical programs, with three investigational programs currently in pivotal studies.
Continued advancement of multiple clinical molecules during the third quarter of 2020.
Three investigational programs currently in pivotal studies: margetuximab, flotetuzumab and retifanlimab.
PDUFA action date for margetuximab in breast cancer is December 18, 2020.
Presentation of flotetuzumab clinical data at ASH in December.
MacroGenics
MacroGenics
Forward Guidance
MacroGenics anticipates providing a clinical update on Module A of the MAHOGANY study in the first half of 2021 and expects to initiate a Phase 2 study of enoblituzumab in the first quarter of 2021.
Positive Outlook
- Margetuximab BLA being reviewed by the FDA with a PDUFA target action date of December 18, 2020.
- Enrollment of the global Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade is ongoing.
- MacroGenics anticipates accrual of the 385th OS event in the second half of 2021.
- MacroGenics expects to provide an update on the MGC018 study in the first half of 2021.
- MacroGenics expects to initiate a Phase 2 study of enoblituzumab in the first quarter of 2021.
Challenges Ahead
- Uncertainties inherent in the initiation and enrollment of future clinical trials.
- Availability and timing of data from ongoing clinical trials.
- Expectations for the timing and steps required in the regulatory review process.
- Impact of competitive products.
- Business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as COVID-19.