Jasper Therapeutics Faces Critical Phase 2b Junction in CSU Amid Financial & Regulatory Pressure

Jasper Therapeutics’ post-merger journey reveals a high-risk, high-reward path typical of biotech firms moving from SPAC transition towards late-stage development. The company’s original rationale—leveraging cash from Amplitude Healthcare’s trust (~US$100 million less redemptions) plus committed PIPE funding of US$100 million—provided what appeared to be a strong launch pad toward advancing its conditioning agent JSP191 and engineered hematopoietic stem cell platform. ([businesswire.com](https://www.businesswire.com/news/home/20210506005725/en/Jasper-Therapeutics-and-Amplitude-Healthcare-Acquisition-Corporation-Announce-Merger-to-Create-a-Publicly-Listed-Leading-Biotechnology-Company-in-Hematopoietic-Stem-Cell-Transplantation?utm_source=openai))

However, the strategy suffered a material blow in 2025 when Jasper reported that one drug product lot used in two key dose cohorts (240mg Q8W and 240mg followed by 180mg Q8W) in the BEACON CSU trial, plus its asthma (ETESIAN) study, appeared to be defective. This led to confounding of results for 10 of 13 patients dosed with the suspect lot. As a consequence, it halted non-urticaria development (asthma, SCID), halted enrollment in impacted cohorts, and began investigations into manufacturing, site practices, and patient selection. The impact included an approximately 55% drop in stock price. ([prnewswire.com](https://www.prnewswire.com/news-releases/pomerantz-law-firm-announces-the-filing-of-a-class-action-against-jasper-therapeutics-inc–and-certain-officers–jspr-302596646.html?utm_source=openai))

Amid this crisis, Jasper still demonstrated strong signals in its urticaria programs. In its BEACON study and SPOTLIGHT cohorts, observed complete response rates reach ~89% in higher single dose cohorts (240–360 mg), 73% at 12 weeks in the open-label extension (180 mg Q8W), and 92% in CIndU (180 mg SPOTLIGHT cohort). Safety has so far been tolerable with no dose-limiting safety signals arising from the problematic cohorts. This gives hope that statistical separation and regulatory evidence for a blockbuster‐style therapy remain attainable, though final dose selection depends on upcoming data. ([ir.jaspertherapeutics.com](https://ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-reports-second-quarter-2025-financial?utm_source=openai))

Financially, Jasper is under pressure. Cash and equivalents dropped from approximately $48.8 million at end-March 2025 to ~$39.5 million by end-June, before rising to ~$50.9 million at end-September following a US$30 million common stock and warrants offering. R&D expenses increased, general expenses remain substantial, and net losses continue. The workforce cut of ~50 % and leadership changes (new acting CMO) are symptomatic of a company tightening its focus to survive. ([ir.jaspertherapeutics.com](https://ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-reports-first-quarter-2025-financial-results/?utm_source=openai))

Strategic implications are multi-fold:

• If Jasper can resolve the confounded lot issue and show clean, reproducible efficacy and safety in BEACON/SPOTLIGHT, it could still establish a strong licensure path in CSU/CIndU—indications with sizable unmet need and favorable reimbursement potential. Delays and dose re-selection, however, will push commercialization further into the future.
• The decision to halt asthma and SCID efforts both concentrates resources but reduces diversification; if urticaria programs stumble, risk is concentrated.
• Manufacturing controls, lot consistency, and third-party oversight will likely draw regulatory scrutiny, and investors will be sensitive to any further deviations or undisclosed risks.
• Cash runway likely extends only through mid-2026; further fundraising will need to be executed without diluting trust in the pipeline or leadership metrics.

Open questions include: What are the root causes of the anomalous dosing lot—manufacturing, handling, storage, administration? Will data from new and redosed patients support superior dose selection and regulatory submission? How competitively differentiated is briquilimab vs existing and emerging therapies in urticarias? Can Jasper rekindle investor confidence given past overhangs and litigation exposure? And finally, when should the Phase 2b trial be officially initiated?