Financial Performance - The company incurred net losses of $24.5 million and $21.6 million for the nine months ended September 30, 2022 and 2021, respectively[130]. - The accumulated deficit of the company reached $91.8 million as of September 30, 2022[130]. - The net loss for Q3 2022 was $11.9 million, compared to a net loss of $3.4 million in Q3 2021, reflecting a 248% increase in losses[147]. - The company recognized a net loss of $24.5 million for the nine months ended September 30, 2022, compared to a net loss of $21.6 million for the same period in 2021, a 13% increase in losses[156]. - The company has incurred significant losses and negative cash flows from operations since inception, indicating a substantial doubt about its ability to continue as a going concern[131]. Cash Position - As of September 30, 2022, the company had cash and cash equivalents of $51.0 million, which is insufficient to fund operations in the foreseeable future[131]. - As of September 30, 2022, cash and cash equivalents totaled $51.0 million, with no outstanding debt[189]. - Net cash used in operating activities was $33.2 million for the nine months ended September 30, 2022, compared to $19.1 million for the same period in 2021[173]. - Cash provided by financing activities was less than $0.1 million for the nine months ended September 30, 2022, compared to $101.9 million in 2021[178][179]. Research and Development - The lead product candidate, JSP191, is in clinical development and aims to initiate a registrational clinical study in acute myeloid leukemia (AML) patients by the end of Q1 2023[116]. - Initial results from a Phase 1 clinical trial of JSP191 showed that 0.6 mg/kg conditioning was well-tolerated, with all 24 patients achieving successful primary engraftment[121]. - The FDA granted rare pediatric disease designation and orphan drug designation to JSP191 for conditioning treatment prior to hematopoietic stem cell transplantation[120]. - The company plans to evaluate JSP191 as a therapeutic for lower-risk myelodysplastic syndrome (MDS) patients who are refractory to erythropoiesis-stimulating agents[123]. - The company has entered into a clinical collaboration with Stanford University to study JSP191 in patients with Fanconi anemia, with initial results showing 100% donor chimerism[122]. - The company intends to expand its pipeline to include other novel stem cell therapies based on immune modulation, graft engineering, and cell or gene therapies[116]. Operating Expenses - Research and development expenses increased by $1.8 million, from $7.2 million in Q3 2021 to $9.0 million in Q3 2022, representing a 26% increase[149]. - General and administrative expenses rose by $0.8 million, from $2.9 million in Q3 2021 to $3.7 million in Q3 2022, a 27% increase[152]. - Total operating expenses for Q3 2022 were $12.7 million, up from $10.1 million in Q3 2021, marking a 26% increase[147]. - Total operating expenses increased by $12.7 million, from $24.8 million for the nine months ended September 30, 2021, to $37.4 million for the same period in 2022, representing a 51% increase[156]. - Research and development expenses rose by $8.6 million, from $16.8 million for the nine months ended September 30, 2021, to $25.3 million for the same period in 2022, a 51% increase[158]. - General and administrative expenses increased by $4.1 million, from $8.0 million for the nine months ended September 30, 2021, to $12.1 million for the same period in 2022, a 52% increase[161]. Other Financial Information - Other income, net increased by $9.8 million, from $3.2 million for the nine months ended September 30, 2021, to $13.0 million for the same period in 2022, a 309% increase[162]. - The change in fair value of earnout liability decreased by 93%, from $6.2 million in Q3 2021 to $0.4 million in Q3 2022[147]. - The company has contractual obligations of $1.1 million within the next 12 months and $3.4 million for the remainder of the lease term under the amended lease agreement[183]. - The company does not currently have a marketing or sales organization, which will lead to significant commercialization expenses if regulatory approval is obtained[135]. - The ongoing COVID-19 pandemic may disrupt clinical trials and supply chains, impacting the company's financial performance and operations[138]. Market and Economic Conditions - Historical fluctuations in interest rates have not been significant, and a hypothetical 10% change would not materially affect the financial statements[189]. - Foreign currency transaction gains and losses have not been material, and the company does not have a formal hedging program[190]. - Inflation has not had a material effect on the interim condensed consolidated financial statements[191].
Jasper Therapeutics(JSPR) - 2022 Q3 - Quarterly Report