Curis(US:CRIS)2021-08-02 16:00Financial Performance - As of June 30, 2021, the company has an accumulated deficit of $1.1 billion and incurred a net loss of $20.8 million for the six months ended June 30, 2021[131]. - Total revenues for the three months ended June 30, 2021, were $2.3 million, a decrease of 3% compared to the same period in 2020, primarily due to decreased royalty revenues from Genentech and Roche's sales of Erivedge[159]. - The net loss for the three months ended June 30, 2021, was $10.8 million, a 62% increase compared to a net loss of $6.7 million in the same period in 2020[159]. - Total revenues for the six months ended June 30, 2021, were $4.5 million, a decrease of 12% compared to the same period in 2020, mainly due to the absence of a milestone payment received in 2020[159]. - The company reported a net cash used in operating activities of $19.8 million for the six months ended June 30, 2021, primarily due to a net loss of $20.8 million[183]. - The company incurred cash used in investing activities of $32.8 million for the six months ended June 30, 2021, compared to cash provided of $4.6 million for the same period in 2020[186]. - Financing activities used cash of $1.9 million for the six months ended June 30, 2021, primarily due to the payment of liabilities under the Oberland Purchase Agreement[186]. Research and Development - The company is focusing on the development of CA-4948 and CI-8993, with initial data from the combination study of CA-4948 and ibrutinib expected in the first half of 2022[126]. - CA-4948 has been granted Orphan Drug Designation for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) by the FDA[126]. - The company is evaluating future studies for fimepinostat and CA-170 after observing no significant efficacy signals in previous trials[126]. - The company expects research and development expenses to increase substantially over the next several years as it conducts clinical trials and prepares regulatory filings[153]. - Research and development expenses increased to $15.5 million for the six months ended June 30, 2021, up from $12.8 million in the same period in 2020, representing a 22% increase[164]. - The company expects to incur a majority of its research and development expenses in connection with advancing its programs, including clinical and preclinical development costs[165]. Collaborations and Partnerships - The company has entered into collaborations with Genentech for the commercialization of Erivedge and with Aurigene for various oncology programs[127]. - The company has an option to license CI-8993 from ImmuNext, which is currently in a Phase 1 trial for solid tumors[126]. - The company received aggregate milestone payments totaling $59.0 million under its collaboration with Genentech since 2012[180]. - Curis Royalty is entitled to receive milestone payments of $17.2 million if aggregate royalty payments exceed $18.0 million in 2021 and $53.5 million if payments exceed $117.0 million by December 31, 2026[145]. Financial Position and Capital Needs - The company expects its cash, cash equivalents, and investments of $160.7 million as of June 30, 2021, to sustain operations into 2024[131]. - The company anticipates needing substantial additional capital to fund ongoing research and development activities and general administrative costs[189]. - The company has $21.6 million remaining available under its common stock purchase agreement with Aspire Capital as of June 30, 2021[173]. - The company plans to use proceeds from stock sales for general corporate purposes, including research and development and clinical trial activities[173]. - The company may face significant financial obligations under collaboration agreements, including milestone and royalty payments to Aurigene and ImmuNext[189]. - The company has historically derived a portion of operating cash flow from milestone payments under collaboration agreements, but future payments are uncertain[188]. Impact of COVID-19 - The company has faced delays in clinical trials due to COVID-19, impacting patient recruitment and trial timelines[134]. - The company acknowledges that the COVID-19 pandemic may continue to adversely affect its business, financial condition, and results of operations[139]. Expenses - Research and development expenses increased by 66% to $8.8 million for the three months ended June 30, 2021, compared to $5.3 million in the same period in 2020, driven by increased clinical and manufacturing costs[163]. - General and administrative expenses increased by 70% to $4.1 million for the three months ended June 30, 2021, compared to $2.4 million in the same period in 2020[159]. - Total general and administrative expenses for the six months ended June 30, 2021, were $8.2 million, an increase of 37% from $6.0 million in the same period in 2020[166]. - Other expenses decreased by $1.1 million, or 85%, for the three months ended June 30, 2021, primarily due to the forgiveness of the PPP Loan[169]. Miscellaneous - The company has no off-balance sheet arrangements as of June 30, 2021[194]. - There have been no material changes to the company's contractual obligations since the last annual report[193].