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Apr 30, 2024
Engene Q2 2024 Earnings Report
Announced second quarter 2024 financial results and provided a business update, including plans for initial indication expansion for EG-70 into high-risk papillary only NMIBC.
Key Takeaways
enGene reported its second quarter 2024 financial results, highlighting a net loss of $15.0 million, or $0.38 per share, and cash and cash equivalents of $264.8 million. The company is expanding the LEGEND study to include a cohort focused on enrollment of patients with high-risk, BCG-unresponsive papillary-only NMIBC.
Plans to expand LEGEND study to include a cohort focused on patients with high-risk, BCG-unresponsive papillary-only NMIBC.
Expects to release interim data from the LEGEND study’s BCG-unresponsive cohort by the end of September 2024.
Enrollment in the second cohort of LEGEND study has been temporarily paused, with enrollment in both groups expected to resume in the fourth quarter of 2024.
Cash and cash equivalents were $264.8 million as of April 30, 2024, expected to fund operations into 2027.
Engene
Engene
Forward Guidance
enGene anticipates releasing interim data from LEGEND Cohort 1 by the end of September and expects to file a BLA for EG-70 in mid-2026. The company plans to expand the LEGEND study to include a third cohort targeting high-risk BCG-unresponsive papillary-only NMIBC patients and modifying the second cohort to include BCG-exposed patients.
Positive Outlook
- Release of interim data from LEGEND Cohort 1 by the end of September.
- Expansion of LEGEND study to include a third cohort targeting high-risk BCG-unresponsive papillary-only NMIBC patients.
- Modification of the second cohort of LEGEND study to include BCG-exposed patients.
- Existing cash and cash equivalents will fund operating expenses, debt obligations and capital expenditures into 2027.
- Planned initial expansion of the LEGEND study will include a cohort focused on enrollment of patients with high-risk, BCG-unresponsive papillary-only NMIBC.
Challenges Ahead
- Temporary pause in enrollment in the second cohort of LEGEND study.
- Deprioritization of pre-clinical development of EG-i08 for cystic fibrosis.
- Increase in operating expenses due to increasing manufacturing and clinical costs related to the EG-70 study.
- Increase in general and administrative expenses due to headcount costs and professional fees.
- Net loss attributable to common shareholders was approximately $15.0 million.