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Jun 30, 2023
Agenus Q2 2023 Earnings Report
Agenus reported second quarter 2023 results with key accomplishments in botensilimab development and regulatory achievements.
Key Takeaways
Agenus reported Q2 2023 results, highlighting the promising clinical activity of botensilimab, particularly in colorectal cancer, and the FDA's Fast Track designation for the botensilimab/balstilimab combination. The company is advancing its clinical pipeline and preparing for a regulatory submission for botensilimab/balstilimab in colorectal cancer. The company ended the quarter with $157.6 million in cash, cash equivalents and short-term investments, and raised $20.3 million through sales of common stock since the end of Q2 2023. Revenue for the quarter was $25.3 million, and the net loss was $73.4 million.
Botensilimab/balstilimab combination demonstrated a median overall survival of 20.9 months and a 23% overall response rate in 3L+ Non-MSI-H colorectal cancer patients without active liver metastases.
The U.S. FDA granted Fast Track designation for the botensilimab/balstilimab combination in 3L+ Non-MSI-H CRC in patients without active liver metastases.
Phase 2 ACTIVATE trials in CRC and melanoma are expected to be fully enrolled by the end of the year.
AGEN2373 Phase 1 data showed promising monotherapy clinical responses in patients with advanced solid tumors.
Forward Guidance
Agenus is focused on expediting its first regulatory submission for the botensilimab/balstilimab combination in colorectal cancer and advancing its diverse clinical pipeline.
Positive Outlook
- Planning is underway for a Phase 3 CRC study.
- A Biologics License Application to the FDA is planned in 2024.
- Enrollment continues for a Phase 1b trial targeting PD-(L)1 +/- chemotherapy relapsed/refractory non-small-cell lung cancer (NSCLC); data update planned by year-end.
- Ongoing global enrollment in Phase 2 ACTIVATE trial with data update planned in 2024.
- Updated data for a Phase 1b cohort with advanced sarcomas to be presented at ESMO on October 21st 2023.
Challenges Ahead
- The design and timing for Phase 3 CRC study will be determined after discussions with the FDA.
- Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.
- Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in the release.
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