CURIS INC Q4 FY2024 earnings call

NHL Progress

• TakeAim Lymphoma study evaluating emavusertib with ibrutinib in PCNSL received encouraging feedback from EMA and FDA on potential accelerated approvals. Clinical data showed responses in BTKI experienced and naïve patients. Emavusertib granted Orphan Drug Designation for primary CNS lymphoma in US and EU.

AML Progress

• Data from ASH conference on emavusertib monotherapy in FLT3 mutated AML patients in salvage line setting showed compelling composite CR rate. Triplet Study in Frontline AML has completed 7-day cohort enrollment and ongoing 14-day cohort enrollment.

No detailed product segment financial performance with revenue contributions provided; focus on clinical progress in NHL and AML. In NHL, TakeAim Lymphoma study with emavusertib and ibrutinib in PCNSL showed positive clinical data, EMA and FDA feedback on accelerated approvals, and Orphan Drug Designation. In AML, data from ASH conference on emavusertib monotherapy in FLT3 mutated AML and progress in Triplet Study in Frontline AML.

Cash Runway

• Proceeds from offerings extended cash runway from mid-2024 to Q4 2025. Burn rate is approximately $10 million per quarter.

Partnerships

• Expect continuing discussions on partnering to move NHL and AML programs forward, with anticipation of partnering with major players in relevant spaces.

Q: Can you just talk a little bit more about cash runway, and how we should speak into that expenses going forward, and any additional cost modulations we should be considering, as we update our models?

A: Burn is about $10 million a quarter. Proceeds from offerings extend cash runway from mid '24 to 4Q of '25.

Q: Can you just talk a little bit about any potential inbound interest from partners in this environment? Are there any additional hurdles for partnerships other than fitting into the landscape?

A: Given utility seen in NHL and AML, we're on radar screens. Expect continuing discussions on how to best move programs forward, potentially involving partnering with major players in NHL or AML space.

Q: Can you remind us how many primary central nervous system lymphoma patients have been given the 100 milligram BID dose of emavusertib to-date, either as monotherapy or in combination with ibrutinib. And perhaps walk us through the necessary steps to meet the FDA's requirement on the individual component contributions. And obviously, based on your commentary, it's a review issue for the number of patients you'll need. But would you anticipate the number, at a go forward dose being roughly in line with what the EMA expects?

A: To-date, 13 patients have been dosed at 100 mg BID. Agencies look for consistent and compelling data, with expectation that number of patients needed will be in line with EMA expectations.

Q: You just had mentioned the agency's looking for north of 25% ORR. Is this a bit of a change? I think in the past you mentioned that they're looking for a CR rate above 20%?

A: We're looking to ensure consistent data. 20% CR rate beats null hypothesis of 10%, and we're seeing higher than that, with aim for north of 25% ORR to have cushion over 95% confidence interval.

Q: How should we be thinking about TakeAim Leukemia? It seems like you're focusing on PCNSL patients. Should we expect to see more enrollment in the leukemia study, and also should we expect to see more data later this year?

A: Focus on Triplet Study in Frontline AML with enrollment in 7-day cohort completed and 14-day cohort ongoing. Interest in monotherapy extension for FLT3 population, with hope to have better sense of timelines and data as year progresses when studies are initiated