Curis (CRIS) 1 Aug 24 2024 Q2 Earnings call transcript
AInvestFriday, Aug 2, 2024 6:04 pm ET
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Curis Inc.'s recent earnings call provided valuable insights into the company's ongoing clinical trials and regulatory discussions for its drug candidate, emavusertib. With a focus on its TakeAim Lymphoma and TakeAim Leukemia studies, Curis has demonstrated promising results, setting the stage for potential breakthroughs in the treatment of relapsed/refractory primary central nervous system lymphoma (PCNSL) and relapsed/refractory acute myeloid leukemia (AML).

Emavusertib's Progress in Lymphoma: A Potential Game Changer

Curis' TakeAim Lymphoma study, which evaluates emavusertib in combination with ibrutinib for relapsed/refractory PCNSL patients, has shown significant potential. The study's thesis is centered on the idea that blocking both the TLR pathway with emavusertib and the BCR pathway with ibrutinib can enhance patients' response to treatment. The initial data from the study, presented at the American Society of Hematology (ASH) conference in December 2023, reported an objective response rate of over 50%, indicating a promising outlook for this combination therapy.

The company's recent discussions with regulatory authorities, particularly the FDA, are a critical next step in emavusertib's development. These discussions center around defining the registrational path for emavusertib in combination with ibrutinib, a crucial move that could significantly impact the drug's future in the primary CNSL market. The positive momentum continues with the European Commission's recent granting of orphan drug designation for primary CNS lymphoma, providing several benefits, including 10 years of market exclusivity and reduced fees.

Emavusertib's Role in Leukemia: A Versatile Approach

Curis' TakeAim Leukemia study, which evaluates emavusertib in monotherapy for relapsed/refractory AML, has also shown promising results. The study's data, presented at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) earlier in 2024, revealed that four out of 18 evaluable patients with a splicing factor mutation achieved an objective response, with one complete remission and two CRs with partial hematologic recovery. Additionally, six out of 11 evaluable patients with a FLT3 mutation achieved an objective response, highlighting the drug's potential in treating this subpopulation of AML patients.

The company's strategic approach to emavusertib's development in leukemia is multifaceted. Emavusertib's unique targeting of IRAK4, which is expressed in nearly all patients with AML, opens up various opportunities. The potential for monotherapy applications in leukemia, in combination with azacitidine and venetoclax, and in non-Hodgkin's lymphoma with ibrutinib, showcases the drug's versatility and broad applicability. The recent initiation of a study of emavusertib in combination with azacitidine and venetoclax in frontline AML underscores Curis' commitment to exploring the full potential of emavusertib.

Financial Outlook and Future Prospects

Curis reported a net loss for the second quarter and six-month ended June 30, 2024, primarily driven by higher research and development and general administrative expenses. Despite the financial challenges, the company remains optimistic about its future, with a focus on enrolling 30 clinical sites in the US and Europe and anticipating initial data for 15 to 20 patients by year-end. The company's existing cash, cash equivalents, and investments are expected to sustain operations into the first quarter of 2025.

Conclusion

Curis' second quarter 2024 business update call provided a comprehensive overview of the company's ongoing efforts to advance emavusertib in the treatment of relapsed/refractory PCNSL and relapsed/refractory AML. With promising results from the TakeAim Lymphoma and TakeAim Leukemia studies, Curis is poised to make significant strides in addressing unmet needs in these patient populations. The company's strategic approach to emavusertib's development, coupled with its ongoing discussions with regulatory authorities, positions Curis for potential breakthroughs in the treatment of primary CNS lymphoma and acute myeloid leukemia. As the company moves forward, investors and stakeholders will be closely watching the progress of emavusertib, with high hopes for its potential to revolutionize the treatment landscape for these critical indications.

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