Carisma Therapeutics (US:CARM)2020-03-16 20:03Product Development and Clinical Trials - The company is advancing targeted fusion protein therapeutics (TFPTs) for cancer treatment, with its most advanced product candidate, Vicinium, targeting high-risk NMIBC[268] - As of May 29, 2019, the complete response rate (CRR) for Cohort 1 (n=86) at 3 months was 39% (95% CI: 28%-50%) and at 12 months was 17% (95% CI: 10%-27%) in evaluable patients[268] - The median duration of response (DoR) for patients in Cohorts 1 and 2 combined (n=93) is 287 days, with 52% remaining disease-free for 12 months or longer after treatment[275] - The company estimates that over 75% of patients treated with Vicinium in the VISTA Trial will remain cystectomy-free at 2.5 years[277] - The median time to disease recurrence for patients in Cohort 3 (n=40) is 402 days (95% CI: 170-NE)[277] - 90% of all patients treated with Vicinium are estimated to remain progression-free for 2 years or more[277] - The company received Fast Track designation from the FDA for Vicinium in August 2018 and reached agreement on an accelerated approval pathway in June 2019[279] - The first full commercial-scale cGMP run for Vicinium was completed at Fujifilm in April 2019, supporting the ability to produce the drug substance for commercial purposes upon regulatory approval[282] - The company has deferred further development of Vicinium for the treatment of SCCHN and VB6-845d to focus on Vicinium for high-risk NMIBC[286] Financial Performance - As of December 31, 2019, the company had cash and cash equivalents of $48.1 million and a net working capital of $45.9 million[286] - The company incurred negative cash flows from operating activities of $37.5 million, $22.8 million, and $17.8 million for the years ended December 31, 2019, 2018, and 2017, respectively[286] - The net loss for 2019 was $107.5 million, compared to a net loss of $33.7 million in 2018, reflecting a 219% increase in losses[295] - Cash and cash equivalents as of December 31, 2019, were $48.1 million, with a net working capital of $45.9 million and an accumulated deficit of $293.5 million[302] - Negative cash flows from operating activities were $37.5 million in 2019, compared to $22.8 million in 2018[302] - The company raised $27.8 million in net proceeds from a public offering in June 2019, selling 20.4 million shares of common stock[302] - The company anticipates continued operating losses as it progresses through the Phase 3 VISTA Trial for Vicinium and seeks FDA marketing approval[302] - The company reported a net cash increase of $(2.3) million in 2019, compared to an increase of $35.8 million in 2018[308] Research and Development Expenses - Research and development expenses for Vicinium for the treatment of high-risk NMIBC were $16.0 million in 2019, up from $8.9 million in 2018 and $7.0 million in 2017, indicating a 79% increase year-over-year[290] - Total research and development expenses for the company were $24.7 million in 2019, compared to $14.1 million in 2018 and $12.5 million in 2017[290] - The company expects research and development expenses for Vicinium for the treatment of high-risk NMIBC to continue increasing in subsequent periods[288] - Research and development expenses increased to $24.7 million in 2019 from $14.1 million in 2018, a rise of $10.6 million or 75%[296] Operating Expenses and Losses - Total operating expenses surged to $108.5 million in 2019 from $34.5 million in 2018, an increase of $73.99 million or 214%[295] - The non-cash change in fair value of contingent consideration was $71.6 million in 2019, up from $8.8 million in 2018, representing a 714% increase[298] - General and administrative expenses rose to $12.2 million in 2019 from $11.6 million in 2018, an increase of $0.6 million or 5%[297] - The net loss for 2019 was $107.5 million, adjusted for non-cash items including a change in the fair value of contingent consideration of $71.6 million[309] Funding and Agreements - The company has received a total of $30.0 million in payments from Roche under the License Agreement, including a $7.5 million upfront payment and a $22.5 million milestone payment[284] - The company is entitled to receive up to an additional $240.0 million upon achieving specified regulatory, development, and commercial milestones from Roche[284] - The company has no committed external funding sources other than amounts payable under the License Agreement with Roche[307] Assets and Liabilities - The company has indefinite-lived intangible assets related to in-process research and development for Vicinium, which will be amortized upon product launch if approved[313] - Goodwill on the balance sheet, resulting from the Viventia Acquisition, was tested for impairment and found not to be impaired for the years ended December 31, 2019, 2018, and 2017[314] - Contingent consideration related to the Viventia Acquisition is measured at fair value and is subject to fluctuations based on future sales and milestones[315] Tax and Off-Balance Sheet Arrangements - The company did not have any uncertain tax positions as of December 31, 2019, and 2018[319] - There were no off-balance sheet arrangements during the periods presented[321]