Curis Inc (NASDAQ: CRIS)

Curis is a biotechnology company focused on the development of emavusertib (CA 4948) an orally available small molecule inhibitor of IRAK4 and FLT3. The company advances this compound through clinical programs in hematologic malignancies including relapsed refractory primary central nervous system lymphoma chronic lymphocytic leukemia and acute myeloid leukemia. Curis holds orphan drug designations from the U S Food and Drug Administration and the European Commission for emavusertib in the treatment of primary central nervous system lymphoma acute myeloid leukemia and myelodysplastic syndromes. The firm maintains a worldwide exclusive license to emavusertib through its 2015 collaboration with Aurigene Discovery Technologies Limited. Curis also retains rights to additional programs under the Aurigene alliance such as the PD1 TIM3 immune checkpoint program and an undisclosed immuno oncology program. The company’s principal executive office is located in Lexington Massachusetts.

Curis generates revenue primarily through its collaboration and licensing arrangements. Under the Aurigene agreement the company is eligible to receive milestone payments tied to regulatory approval and commercial sales as well as tiered royalties on net sales of any resulting products. Aurigene may also provide supplemental funding for certain program activities. Curis is entitled to a percentage of Aurigene’s sublicensing revenues and to royalties on potential future sales of compounds such as CA 170. In addition the company has monetized existing royalty interests by selling portions of its rights to third parties for upfront cash as seen in the Oberland and TPC Investments transactions. While no product is currently commercialized the pipeline could yield future sales of emavusertib or other candidates which would create a direct revenue stream. Until such sales occur the company depends on partnership related payments and occasional equity financing to fund operations.

Curis occupies a niche within the biotechnology sector as a developer of dual targeting kinase inhibitors for blood cancers. Its lead molecule emavusertib simultaneously inhibits IRAK4 and FLT3 a mechanism that aims to overcome resistance seen with single agent FLT3 inhibitors. The company faces competition from established BTK inhibitors such as ibrutinib and zanubrutinib from FLT3 directed therapies like gilteritinib and midostaurin and from other IRAK4 focused programs emerging in the industry. Curis differentiates itself through the orphan drug designations that may confer market exclusivity if approval is achieved and through preclinical data showing synergy between IRAK4 and FLT3 blockade. The firm’s strategy of combining emavusertib with BTK inhibitors in clinical trials seeks to leverage existing standard of care while adding a novel mechanism of action.

The company’s customers are primarily patients with hematologic disorders who receive treatment in clinical trial settings or eventually through commercial channels. Curis collaborates with pharmaceutical partners such as Aurigene for drug discovery and development and has previously worked with Genentech on the Hedgehog pathway asset Erivedge. Clinical trial sites investigators and health care providers also represent customers as they conduct the studies that generate data for regulatory review. Should emavusertib reach market the end users would include oncology specialists hematologists and hospitals treating lymphoma leukemia and related conditions.