Jasper Therapeutics, Inc. — FY2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. Jasper is a clinical-stage biotechnology company developing conditioning agents and engineered hematopoietic stem cell therapies. The September 24, 2021 business combination with Amplitude Healthcare Acquisition Corporation was accounted for as a reverse recapitalization; FY2020 comparisons primarily reflect Old Jasper.
Financial results and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | No product revenue | No product revenue |
| Research and development expense | $25.4 million | $15.9 million |
| General and administrative expense | $11.4 million | $4.8 million |
| Total operating expenses | $36.8 million | $20.7 million |
| Operating loss | $36.8 million | $20.7 million |
| Net loss | $30.6 million | $31.7 million |
| Net loss per share, basic and diluted | $2.69 | $18.31 |
| Net cash used in operating activities | $33.7 million | $18.3 million |
| Cash and cash equivalents at year-end | $84.7 million | $19.8 million |
Gross margin is not applicable because Jasper had no product sales. Operating expenses rose 78%, driven largely by clinical, manufacturing, personnel, and public-company costs. Net loss narrowed slightly despite higher operating costs, mainly because FY2021 included $9.3 million of non-cash income from a lower estimated sponsor earnout liability; FY2020 included $10.9 million of non-cash expense from remeasurement of a preferred-stock derivative liability.
FY2021 financing cash flow was $101.0 million, including $95.3 million in net proceeds from the business combination and PIPE financing. Investing cash outflow was $2.4 million, primarily for lab equipment and leasehold improvements. Jasper reported no outstanding debt at year-end. Current assets were $87.8 million and current liabilities $8.0 million; cash and cash equivalents were $84.7 million. The balance sheet also included $7.4 million of warrant liability and $5.7 million of earnout liability.
Business, pipeline, and material developments
- Lead candidate JSP191: An anti-CD117 antibody being tested as a targeted conditioning agent before stem cell transplantation. In the SCID Phase 1/2 trial, the company reported donor engraftment, immune-cell production, and clinical improvement in some patients; six of the first nine non-IL2RG patients with prior transplants achieved engraftment and related reported outcomes. No JSP191 treatment-related serious adverse events had been reported through year-end. Enrollment was expected to finish by mid-2023.
- MDS/AML: In early Phase 1 results, all 17 reported patients achieved successful engraftment; 12 of 15 patients with measurable residual disease at screening achieved MRD clearance. Four patients had left the study at the time of reporting: two for relapse or progression, one for late-onset Grade 3 acute graft-versus-host disease, and one for secondary graft failure. These are preliminary, small-cohort results, not evidence of established efficacy.
- Additional studies: JSP191 collaborations cover Fanconi anemia, sickle cell disease, chronic granulomatous disease, GATA-2 deficiency, and investigational gene therapies. A study in ESA-refractory low-risk MDS was planned, with enrollment anticipated in early 2023.
- Engineered HSC platform: Preclinical program using mRNA delivery and gene editing to improve engraftment and potentially reduce conditioning toxicity and graft-versus-host disease. Jasper planned to present in-vivo data in 2022 and file an IND in 2023.
Outlook, risks, and unusual items
Management expects substantial ongoing losses and higher R&D and administrative spending as it advances clinical programs, develops its platform, and operates as a public company. The company has no approved products, product-sales revenue, or established commercial infrastructure. Management stated that year-end cash was insufficient to fund operations for at least one year from the financial statements’ issuance date and that additional financing would be required. The financial statements and auditor’s report identify substantial doubt about the company’s ability to continue as a going concern.
- Additional capital may be unavailable or dilutive; failure to obtain it could force delays, reductions, or termination of programs.
- Clinical findings are preliminary and may not predict later trial outcomes; enrollment, safety, regulatory review, and transplant-related complications could affect development.
- Jasper relies on third parties for trials and manufacturing, including Lonza as a single-source manufacturer for clinical supply; alternatives may be difficult to secure.
- COVID-19 had slowed SCID trial enrollment in 2020 and could continue to disrupt enrollment, supply chains, trial sites, or regulatory timelines.
- JSP191 depends on licensed intellectual property from Amgen and Stanford. The Stanford agreement includes up to $9.0 million in development and sales milestones plus low-single-digit royalties if products are approved.
- The CIRM award was $2.3 million, payable upon milestones; $0.6 million had been received by year-end and $1.7 million remained available subject to milestones. The award carries repayment or revenue-sharing terms.
- The auditor issued an unqualified opinion on the financial statements, while highlighting the going-concern uncertainty. Management reported effective disclosure controls and internal control over financial reporting; no auditor attestation on internal controls was included under the emerging-growth-company exemption.
- No material legal proceedings were reported. The Redwood City lease was expanded in January 2022, adding estimated lease payments of $1.8 million.
Important facts for investors to verify
- Cash runway, quarterly operating cash burn, and timing and terms of any additional financing.
- Final and updated JSP191 trial data, including follow-up, MRD response, durability of engraftment, adverse events, and reasons for study discontinuations.
- Enrollment and timing against management’s stated SCID, low-risk MDS, and eHSC development milestones.
- Manufacturing capacity, supply continuity, and any constraints or costs under the Lonza arrangements.
- Potential dilution from warrants, equity plans, and registered resale shares; confirm current share counts and warrant status.
- Cash, clinical obligations, and the status of CIRM and Stanford milestone commitments following the filing date.