Jasper Therapeutics, Inc. annual report, FY2022

Jasper Therapeutics, Inc. — FY2022 Form 10-K

Reporting period: Fiscal year ended December 31, 2022. This is an annual report, not a standalone fourth-quarter filing. Jasper is a clinical-stage biotechnology company with no approved products and no product-sales revenue. Its lead candidate, briquilimab, is being developed for mast-cell and stem-cell disorders and as a conditioning agent before stem-cell transplant; its mRNA stem-cell platform remains preclinical.

Financial performance and liquidity

MetricFY2022 / Dec. 31, 2022FY2021 / Dec. 31, 2021
Revenue from product salesNoneNone
Research and development expense$34.6 million$25.4 million
General and administrative expense$16.6 million$11.4 million
Total operating expenses$51.2 million$36.8 million
Operating loss$51.2 million$36.8 million
Net loss$37.7 million$30.6 million
Net loss per share, basic and diluted$1.03$2.69
Net cash used in operating activities$45.9 million$33.7 million
Cash and cash equivalents$38.3 million$84.7 million
Total assets / total liabilities$48.4 million / $12.4 million$93.7 million / $24.1 million
DebtNo outstanding debtNot stated here as a comparable metric

Margins are not meaningful because the company had no product-sales revenue. Cash, cash equivalents and restricted cash totaled $38.7 million at year-end; restricted cash was $0.4 million. The company reported a $105.1 million accumulated deficit.

Material changes and unusual items

  • Operating expenses increased 39% year over year, led by higher R&D costs (up 36%) and G&A costs (up 45%). R&D growth reflected increased personnel, facilities and overhead, consulting, and laboratory costs; external CRO/CMO and other study costs declined.
  • Net loss increased 23%, while operating cash use rose by $12.2 million. Year-end cash fell by $46.5 million.
  • Other income of $13.5 million included non-cash gains of $7.2 million from a decline in warrant liability fair value and $5.7 million from a decline in earnout liability fair value. These gains reduced reported net loss but did not represent operating revenue or cash generated from operations.
  • In January 2023, Jasper raised estimated net proceeds of $101.4 million: $96.9 million from an underwritten offering of 69 million shares and $4.5 million from ATM sales. The offering materially diluted existing shareholders. Management said year-end cash plus these proceeds would fund its operating plan for at least 12 months from the filing date.

Pipeline, outlook and key risks

  • SCID: In an ongoing Phase 1/2 study, 7 of the first 10 transplanted T-B- SCID patients showed donor engraftment and functional immune-cell production; no briquilimab treatment-related serious adverse events were reported through year-end. Enrollment was expected to complete in 2023.
  • MDS/AML transplant conditioning: The Phase 1 study enrolled 31 patients; all achieved neutrophil recovery after transplant, and no briquilimab-related serious adverse events were reported. In a preliminary analysis of 12 AML patients, one-year overall survival was 75%, relapse-free survival 67%, and non-relapse mortality 8%. These small, early and non-randomized results are preliminary and may change with further data.
  • Other transplant collaborations: Early reports described donor myeloid chimerism and blood-count recovery in the first two Fanconi anemia patients, and full myeloid chimerism in the first three sickle-cell patients. These are limited early observations, not established efficacy.
  • Planned development: Jasper planned to file an IND for CSU in Q2 2023, with a potential study start in Q3, and anticipated starting a lower-risk MDS monotherapy study in the first half of 2023. It expected additional MDS/AML trial data in 2023. The mRNA platform was preclinical, with further in-vivo assessment and data expected in 2023.
  • Portfolio focus: In January 2023, Jasper announced prioritization of briquilimab in chronic mast- and stem-cell diseases and as a transplant-conditioning agent for rare diseases, including CSU, LR-MDS, sickle-cell disease, Fanconi anemia and SCID.
  • Principal risks: substantial future financing needs and ongoing losses; clinical, regulatory and safety uncertainty; dependence on briquilimab; reliance on third parties for trials and single-source clinical manufacturing; and intellectual-property risk. Some licensed briquilimab patents were expected to expire in 2027, absent extensions, and two Stanford European patents were under opposition. Management reported that the January financing removed the previously identified substantial doubt about going concern as of the financial-statement issuance date, but additional financing will be needed over the longer term.

The company reported effective disclosure controls and effective internal control over financial reporting as of December 31, 2022. The auditor did not attest to internal-control effectiveness because Jasper qualified for the emerging-growth-company exemption. No material legal proceedings were reported.

Important facts for investors to verify

  • Whether the January 2023 financing proceeds and subsequent cash burn support the stated operating runway, and what additional capital may be required.
  • Updated, final clinical data—including patient follow-up, durability, safety, relapse and immune recovery—for the SCID and MDS/AML studies and partner trials.
  • Whether planned CSU and LR-MDS studies began on schedule and whether the 2023 milestones were achieved.
  • The extent of share dilution from the January offering, ATM sales, equity awards and outstanding warrants; the filing reported 109,383,173 common shares outstanding as of February 28, 2023.
  • Manufacturing continuity and supply terms with Lonza, briquilimab patent coverage and challenges to licensed patents, and the clinical and technical progress of the preclinical mRNA platform.