Traws Pharma, Inc.(US:TRAW)2021-11-15 22:24Financial Performance - Net losses for the nine months ended September 30, 2021, were $12.4 million compared to $18.7 million for the same period in 2020, with an accumulated deficit of $441.0 million as of September 30, 2021[110]. - Revenue for the three months ended September 30, 2021, was $57,000, a decrease of $9,000 compared to $66,000 in the same period of 2020[150]. - The net loss for the three months ended September 30, 2021, was $3,453,000, an improvement of $2,788,000 from a net loss of $6,241,000 in the same period of 2020[150]. - Revenues decreased by $9,000, or 14%, for the three months ended September 30, 2021, compared to the same period in 2020[151]. - Net cash used in operating activities was $15.2 million for the nine months ended September 30, 2021, compared to $17.6 million for the same period in 2020[170]. - Net cash provided by financing activities was $55.6 million for the nine months ended September 30, 2021, compared to $19.1 million for the same period in 2020[175]. - The accumulated deficit at September 30, 2021, was $441.0 million[168]. Cash and Financing - As of September 30, 2021, the company had $59.4 million in cash and cash equivalents, expected to fund operations and ongoing trials for more than two years[114]. - The company raised approximately $8.5 million from a common stock offering on January 12, 2021, and approximately $26.7 million from another offering on February 16, 2021[111]. - An at-the-market equity distribution agreement was entered on August 20, 2021, allowing for the sale of up to $25.0 million in common stock, with net proceeds of approximately $0.5 million from 109,523 shares sold by September 30, 2021[112]. - The company is exploring various funding sources for ongoing operations and development, emphasizing the need for additional financing to continue its clinical-stage programs[115]. - The company expects net cash expenditures in 2022 to be comparable to 2021, primarily due to ongoing clinical trials[177]. Research and Development - Narazaciclib (ON 123300) is a multi-kinase inhibitor targeting CDK4/6 and other tyrosine kinases, showing potential efficacy in various cancers[107]. - The IC50 values for narazaciclib against CDK4 and CDK6 are 3.87 nM and 9.82 nM, respectively, indicating its potency compared to palbociclib[118]. - A collaboration agreement with HanX for the development and commercialization of narazaciclib in China includes upfront payments, milestone payments, and royalties on future sales[122]. - The IND for narazaciclib was approved by the Chinese FDA on January 6, 2020, following a filing by HanX in the fourth quarter of 2019[124]. - Enrollment in the US Phase 1 study of narazaciclib commenced in May 2021, with 36 patients enrolled in the first cohort, showing no dose limiting toxicities[125]. - A complementary Phase 1 study for narazaciclib in China has been initiated, with the first patient enrolled on September 15, 2020, and no dose limiting toxicities observed to date[126]. - Narazaciclib is expected to provide preliminary safety data and the recommended Phase 2 dose and schedule upon completion of the Phase 1 studies[127]. - The safety profile of narazaciclib is anticipated to be similar to approved CDK4/6 inhibitors, with common adverse events including myelosuppression and gastrointestinal toxicity[137]. - Preliminary efficacy data from a study of rigosertib in combination with a PD-1 inhibitor in KRAS-mutated NSCLC showed a clinical benefit rate of 43%[141]. Operating Expenses - Total operating expenses for the three months ended September 30, 2021, were $4,047,000, down by $2,293,000 from $6,340,000 in the same period of 2020[150]. - Research and development expenses decreased by $2,430,000 to $1,763,000 for the three months ended September 30, 2021, compared to $4,193,000 in 2020[150]. - General and administrative expenses increased by $0.8 million, or 12%, to $7.4 million for the nine months ended September 30, 2021, from $6.5 million for the same period in 2020[161]. - Research and development expenses decreased by $6.8 million, or 55%, to $5.6 million for the nine months ended September 30, 2021, from $12.4 million for the same period in 2020[163]. - The change in fair value of warrant liability increased by $474,000, from $56,000 in 2020 to $530,000 in 2021[150]. - The fair value of the warrant liability decreased by $0.3 million for the nine months ended September 30, 2021, compared to an increase of $0.1 million for the same period in 2020[165].