Curis Shares Drop On Safety Issues From Leukemia Study With CA-4948; Q1 Earnings Missing Estimates

Curis Inc CRIS stock gained momentum yesterday in reaction to updated data from its Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
Four objective responses were recorded with signs of hematologic recovery.
The data published from 15 patients showed bone marrow blast reductions in all tested doses - 200 milligrams, 300 milligrams, and 400 milligrams twice daily.
But today, in its Q1 earnings release, the company updated that the 500mg twice daily dosing regimen in the AML/MDS study has exceeded the maximum tolerated dose according to protocol guidelines.
Two patients in the cohort were observed to have dose-limiting toxicities, one of whom had severe rhabdomyolysis (breakdown of muscle tissue), and the other experienced severe syncope (fainting or passing ou caused by a temporary drop in the amount of blood that flows to the brain).
Both the adverse events resolved after discontinuation of dosing, said the company.
Also, the company reported non-clinical data to be presented in a poster at EHA demonstrating synergistic antitumor activity of CA-4948 in combination with azacitidine and venetoclax in leukemia cells.
Earnings Update: Curis reported a Q1 EPS loss of $(0.11), which missed the analyst consensus loss estimate of $(0.09) but is narrower than the loss of $(0.280 reported a year ago.
Sales of $2.19 million also missed the analyst consensus estimate of $2.64 million and were down 19.2% Y/Y.
Cash and equivalents totaled $168.4 million, which is expected to fund its planned operations into 2024.
Price Action: CRIS shares dropped 14.9% at $13.85 during the premarket session on the last check Thursday.

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