CURIS INC Q3 FY2024 earnings call

• PCNSL Study: The TakeAim Leukemia Study evaluating emavusertib in combination with ibrutinib in relapsed/refractory PCNSL patients showed 3 complete responses, 1 unconfirmed complete response, and 2 partial responses in 10 evaluable patients. Enrollment continues, and engagement with regulatory authorities is ongoing to align on the registrational path.
• AML Study: The TakeAim Leukemia Study evaluating emavusertib as monotherapy in relapsed/refractory AML showed 6 of 11 evaluable FLT3-mutated patients achieved an objective response. Upcoming data will be presented at ASH and a poster on MDS will be presented at EHA.
• Financing Update: Completed a registered direct offering and private placement in October 2024, with net proceeds of ~$10.8 million, and cash position at $31.6 million.

Curis reported a net loss of $10.1 million or $1.70 per share for the third quarter of 2024 compared to a net loss of $12.2 million or $2.13 per share for the same period in 2023. For the 9 months ended September 30, 2024, the net loss was $33.8 million or $5.77 per share compared to $35.7 million or $6.96 per share in the same period of 2023. Research and development expenses were $9.7 million for the third quarter of 2024, down from $10.4 million in the same period of 2023, primarily due to lower consulting and employee-related costs. General and administrative expenses were $3.8 million for the third quarter of 2024, down from $4.8 million in the same period of 2023, primarily due to lower legal and employee-related costs. For the 9 months ended September 30, 2024, R&D expenses were $29.6 million compared to $29.5 million in the same period of 2023, and G&A expenses were $13.4 million compared to $13.8 million in the same period of 2023. In October 2024, Curis completed a registered direct offering and concurrent private placement of unregistered warrants with net proceeds of approximately $10.8 million. With cash and cash equivalents totaling $31.6 million, Curis expects its existing cash to enable planned operations into mid-2025.

• Curis' existing cash and cash equivalents are expected to enable planned operations into mid-2025.

• Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from expectations. Risks related to clinical trial outcomes, regulatory approvals, and market acceptance of products.

Q: Ed White asks about aligning with the FDA for PCNSL and the ideal approval pathway.

A: Jim Dentzer states they are engaging in discussions, seeking an accelerated path due to high unmet need and positive early data, and discussing the registrational design with the FDA.

Q: Ed White inquires about future expenses.

A: Diantha Duvall mentions historical burn was in the $10-12 million range, expects 2025 burn to stay around $10 million, varying due to manufacturing timing.

Q: Billal Jahangiri asks about the MDS program and combination with aza/ven.

A: Jim Dentzer says MDS data is upcoming at ASH, exploring dosing and combinations, with the VERONA readout being important.

Q: Daniel Bronder asks about the PCNSL trial contribution and BTK historical data.

A: Jim Dentzer notes the FDA may question study design, references literature on ibrutinib in PCNSL, and highlights salvage data outperforming second line in early stages.

Q: Daniel Bronder asks about program prioritization.

A: Jim Dentzer states PCNSL is a high priority due to unmet need and data, with AML/MDS data upcoming and solid tumors next in line for data readouts.

Q: Sean McCutcheon asks about the PCNSL data package and triplet study enrollment.

A: Jim Dentzer discusses FDA discussions on PCNSL registrational path and challenges in triplet study enrollment related to finding MRD-positive CR AML patients on aza/ven.