CURIS INC Q1 FY2025 earnings call

• Welcomed Dr. Ahmed Hamdy to the Curis Executive team, who will advance emavusertib towards regulatory filings in primary CNS lymphoma and expand its use to other indications.
• TakeAim lymphoma study: 27 patients treated, 9 BTKI experienced patients with tumor burden reduction, 6 objective responses, etc. Expect additional data at ASH later this year and aim to enroll 30-40 patients for NDA submission.
• AML update: Emavusertib monotherapy in FLT3 mutation AML showed 38% composite CR rate, novel mechanism blocking IRAK4 and FLT3. Triplet study in frontline AML: Phase I study ongoing, 7-day dosing cohort completed, 14-day cohort enrollment ongoing.

No detailed product segment financial performance provided in the transcript. Curis reported a net loss of $10.6 million or $1.25 per share for the first quarter of 2025 compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024. Research and development expenses were $8.5 million for the first quarter of 2025 as compared to $9.6 million for the same period in 2024. General and administrative expenses were $4.0 million for the first quarter of 2025 as compared to $4.9 million for the same period in 2024.

• Focus on enrolling 30-40 additional patients for lymphoma NDA submission, aiming for 6-8 responses in that data set.
• Progressing with frontline AML study to evaluate safety and tolerability of emavusertib added to venetoclax and azacitidine in frontline AML.

• General risks associated with forward-looking statements, where actual results may differ materially from expectations. Potential industry challenges and concerns about FDA regulatory changes, though Jim Dentzer noted no immediate concerns regarding Curis' FDA collaboration timing.

Q: Wanted to welcome Dr. Hamdy, big picture on lymphoma vs AML and enrollment acceleration.

A: Jim discussed focus on PCNSL enrollment with more resources, AML frontline study progress; Jonathan mentioned 37 sites opened for lymphoma enrollment.

Q: Lymphoma site count, enrollment timeline, FDA concerns.

A: Jonathan stated 37 sites opened, Jim talked about FDA collaboration timing before current industry turmoil concerns.

Q: Question about ASCO presentation on mutations in lymphoma, AML development steps.

A: Jim discussed NF-kappaB pathway role in lymphoma, Jonathan mentioned AML development plans after completing ongoing triplet study safety assessment