Jasper Therapeutics(US:JSPR)2022-03-18 20:16Financial Performance - The company reported net losses of $30.6 million and $31.7 million for the years ended December 31, 2021 and 2020, respectively, with an accumulated deficit of $67.5 million as of December 31, 2021[475]. - The company has not generated any revenue from product sales and expects to incur significant losses as it continues to seek regulatory approvals for its product candidates[474]. - The company reported a net loss of $30.6 million for 2021, a slight improvement from a net loss of $31.7 million in 2020, reflecting a 3% decrease[509]. - Total operating expenses for 2021 were $36.8 million, up from $20.7 million in 2020, marking a 78% increase[509]. - The company incurred net cash used in operating activities of $33.7 million for the year ended December 31, 2021, compared to $18.3 million for 2020[531][532]. - The company had net operating loss carryforwards of approximately $53.1 million for federal income tax purposes and $45.4 million for state income tax purposes as of December 31, 2021[558]. Cash Position and Financing - Cash and cash equivalents were $84.7 million as of December 31, 2021, which may not be sufficient to fund operations in the foreseeable future, indicating substantial doubt about the company's ability to continue as a going concern[476]. - As of December 31, 2021, the company had $84.7 million in cash and cash equivalents, following net cash proceeds of $95.3 million from the Business Combination[519]. - The company raised $101.0 million in financing activities for the year ended December 31, 2021, primarily from the Business Combination and PIPE Financing, compared to $11.3 million in 2020[536][537]. - The company expects to finance future cash needs through public or private equity or debt financings, collaborations, or a combination of these approaches[522]. - The company anticipates that its ability to raise additional funds may be adversely impacted by negative global economic conditions and disruptions in credit and financial markets[522]. Research and Development - The lead product candidate, JSP191, is in clinical development for severe combined immunodeficiency (SCID) and has shown promising preliminary results, with six out of nine patients achieving donor engraftment[464]. - JSP191 has received rare pediatric disease designation and orphan drug designation from the FDA for its use as a conditioning treatment prior to hematopoietic stem cell transplantation[465]. - The company is also evaluating JSP191 in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), with initial results showing successful engraftment in all patients[466]. - The company plans to expand its pipeline to include other novel stem cell therapies based on immune modulation and gene therapies, aiming to improve the efficacy and safety of treatments[461]. - The eHSC platform is designed to enhance stem cell engraftment and survival, with initial preclinical experiments indicating potential advantages over existing therapies[470]. - The company has entered into collaborations with Stanford University and the National Institutes of Health to study JSP191 in various conditions, including Fanconi anemia and sickle cell disease[467]. - The company experienced slower patient enrollment in clinical trials due to the COVID-19 pandemic, impacting its clinical development timelines[482]. - The company anticipates significant future research and development expenses as it advances product candidates and expands its pipeline[504]. Expenses and Costs - Research and development expenses increased by $9.5 million, from $15.9 million in 2020 to $25.4 million in 2021, representing a 60% increase[511]. - External costs for CRO, CMO, and other third-party preclinical studies and clinical trials rose by $6.5 million, from $8.8 million in 2020 to $15.3 million in 2021, a 74% increase[511]. - General and administrative expenses increased by $6.6 million, from $4.8 million in 2020 to $11.4 million in 2021, a 138% increase[513]. - The company expects significant commercialization expenses if regulatory approval is obtained for product candidates, including costs related to sales, marketing, manufacturing, and distribution[480]. - The company expects general and administrative expenses to continue rising due to increased personnel and compliance costs associated with being a public company[507]. Stock and Equity - The PIPE Financing raised $100 million through the issuance of 10,000,000 shares of Class A Common Stock at $10.00 per share[484]. - The company has authorized 490,000,000 shares of voting common stock, with 36,559,092 shares issued and outstanding as of December 31, 2021[489]. - Stock-based compensation expense recorded was $1.0 million for the year ended December 31, 2021, compared to $1.2 million for 2020[553]. - As of December 31, 2021, total unrecognized stock-based compensation expense was $1.5 million, expected to be recognized over a remaining weighted-average period of 2.6 years[553]. Agreements and Obligations - The company has a license agreement with Amgen for JSP191, which includes an option to negotiate a definitive license with Stanford for related intellectual property[491][492]. - Under the Stanford License Agreement, the company is obligated to pay up to $9.0 million in milestone payments and low single-digit royalties on net sales of licensed products[496]. - The company has entered into various collaboration and clinical trial agreements, including with Stanford University and the National Cancer Institute, to study JSP191 for different indications[498][500]. - The company has lease commitments of $0.7 million for the next 12 months and $2.7 million for the remainder of the lease term, with an additional commitment of $1.8 million for newly leased space[525]. - The company entered into a sponsored research agreement with Stanford, committing to pay a total of $0.9 million over approximately three years upon achieving clinical milestones[526]. - The company has a contingent earnout liability estimated at $5.7 million as of December 31, 2021, down from an estimated fair value of $15.0 million at the closing of the Business Combination[544]. - The company has contractual obligations with CROs and CMOs for clinical trials and manufacturing, with no non-cancellable obligations as of December 31, 2021[523][524]. Market and Economic Conditions - The company will remain an emerging growth company until certain revenue or market value thresholds are met[562]. - Foreign currency transaction gains and losses have not been material to the consolidated financial statements[564]. - The fair value of common stock is estimated based on the closing quoted market price on the Nasdaq Capital Market[555]. - The company intends to maintain its portfolio of cash equivalents in institutional market funds composed of U.S. Treasury securities to minimize interest rate risk[563].