Jasper Therapeutics Internal Investigation - No Drug Product Issues
Summary
Jasper Therapeutics filed an SEC Form 8-K exhibit disclosing completion of an internal investigation into anomalous clinical response data from the July 2025 BEACON study cohorts 8 and 9. The investigation confirmed no issues with the drug product (briquilimab), and a key opinion leader panel recommended enhanced site selection and patient screening criteria for future studies.
What changed
Jasper Therapeutics, a clinical-stage biotech company, disclosed completion of an internal investigation regarding anomalous lack of clinical response observed in July 2025 BEACON study data for cohort 8 (240mg Q8W) and cohort 9 (240mg/180mg Q8W). The investigation, which included switching US patients to a new drug product lot, confirmed no issues with the drug product itself. A key opinion leader panel generated recommendations to enhance site selection and patient screening criteria for the planned Phase 2b/3 study in chronic spontaneous urticaria.
This is an informational disclosure with no regulatory implications. Companies conducting clinical trials should note that internal investigations into unexpected study outcomes, even when cleared, warrant documentation and enhanced protocols going forward. Jasper remains on track to commence Phase 2b patient enrollment in H2 2026 pending capital availability.
Source document (simplified)
EX-99.1 2 ea028336401ex99-1.htm PRESS RELEASE, DATED MARCH 30, 2026 Exhibit
99.1
Jasper
Therapeutics Reports Fourth Quarter and Year-End 2025 Financial Results and Provides Corporate Update
REDWOOD
CITY, Calif., March 30, 2026 (GLOBE NEWSWIRE) – Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology
company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases
such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today reported results for the fiscal quarter
and year ended December 31, 2025 and provided a corporate update.
“Briquilimab
has demonstrated the potential for a compelling and differentiated profile in both CSU and CIndU, along with proof of concept in asthma,”
said Jeet Mahal, President and Chief Executive Officer of Jasper. “We are very pleased with the chronic urticaria data we reported
in January from the BEACON study as well the open-label extension study, which reaffirmed the potential of briquilimab to drive rapid
and durable disease control in patients. We are finalizing dose selection for the Phase 2b portion of our planned Phase 2b/3 study in
CSU where we will evaluate two efficacious doses versus placebo to demonstrate the differentiated profile based on briquilimab’s
unique biological properties. We remain on track to commence patient enrollment in the second half of 2026, pending capital availability.”
Highlights
for Fourth Quarter 2025 and Recent Weeks
| | ● | Jeet
Mahal appointed as Chief Executive Officer to lead next phase of clinical growth. |
| | ● | Reported
positive updated data from briquilimab studies in chronic spontaneous urticaria: |
| | ○ | 67%
of additional patients (n=6) enrolled in Cohort 9.1 (240mg/180mg Q8W) of the BEACON study
achieved a complete response at 12 weeks with a mean UAS7 reduction of 31 points, |
| | ○ | 75%
of CSU participants (n=36) enrolled in the open label extension study (180mg Q8W) achieved
a complete response or well controlled disease at 12 weeks, |
| | ○ | With
a median duration of follow up of more than 200 days on 63 participants in the open label
extension study, KIT related AEs were predominantly low-grade events that resolved while
on study, and |
| | ○ | BEACON
and open label extension data sets are now sufficient to select doses for the Phase 2b study
of briquilimab in CSU planned to commence in the second half of 2026. |
| | ● | Announced
the completion of the Company’s internal investigation into the anomalous lack of clinical
response observed in the July 2025 BEACON data for cohort 8 (240mg Q8W) and cohort 9 (240mg/180mg
Q8W). Results indicated there were no issues with the drug product utilized in the study,
and the key opinion leader panel convened generated recommendations to enhance site selection
and patient screening criteria going forward. Jasper’s internal investigation included: |
| | ○ | Switching
all US patients to a new lot of drug product for the remainder of their doses on study to
determine if drug product played a role, |
| | ○ | A
comprehensive review of all manufacturing records, drug handling, site training/ logs and
data handling, |
| | ○ | Recovery
and testing by Jasper and independent labs of drug product samples from across the supply
chain, |
| | ○ | A
review of all US sites and all US patients, including protocol adherence patient medical
histories, patient screening and all pharmacokinetics, pharmacodynamics and efficacy data,
and |
| | ○ | Assembling
a KOL panel to review the internal investigation findings, including full patient dossiers,
which provided its input and conclusions from the findings. |
| | ● | Reported
positive preliminary data from ETESIAN study of briquilimab in asthma: |
| | ○ | Reductions
in airway hyperresponsiveness and suppressed eosinophilic response at both 6 weeks and 12
weeks observed after a single 180mg dose of Briquilimab in the ETESIAN Study, and |
| | ○ | The
positive proof of concept data generated in the ETESIAN study supports further development
in the broader asthma population; however, advancing any future clinical studies in asthma
would be based on an evaluation of the competitive landscape, the potential for strategic
partnerships and capital availability. |
Fourth
Quarter Fiscal 2025 Financial Results
| | ● | Cash
and cash equivalents as of December 31, 2025, totaled $28.7 million. |
| | ● | Research
and development expense for the three months ended December 31, 2025, was $11.4 million. |
| | ● | General
and administrative expense for the three months ended December 31, 2025, was $4.5 million. |
| | ● | Jasper
reported a net loss of $9.1 million and $75.8 million, or basic and diluted net loss per
share attributable to common stockholders of $0.32 and $3.95, for the three months and year
ended December 31, 2025, respectively. |
About
Jasper
Jasper
is a clinical-stage biotechnology company focused on developing briquilimab as a therapeutic for chronic mast cell diseases. Briquilimab
is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor KIT, thereby inhibiting
signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via
apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria and
asthma. Jasper is currently evaluating briquilimab as a treatment in patients with CSU, CIndU and asthma. Briquilimab has a demonstrated
efficacy and safety profile in patients and healthy volunteers, with positive clinical outcomes in CSU, CIndU and allergic asthma. For
more information, please visit us at www.jaspertx.com.
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Forward-Looking
Statements
Certain statements
included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions
under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words
such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,”
“seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate
future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited
to, statements regarding briquilimab’s potential, including with respect to its compelling and differentiated profile in both CSU
and CIndU and proof of concept in asthma; the potential of briquilimab to drive rapid and durable disease control in patients; the Phase
2b portion of Jasper’s planned Phase 2b/3 study in CSU, including dose selection, expected timing of patient enrollment, pending
capital availability, and planned commencement of the study; Jasper’s next phase of clincal growth; briquilimab’s differentiated
profile and any potential advancement of future clinical studies in asthma. These statements are based on various assumptions, whether
or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These
forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by
an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances
are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general
economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through
clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may
not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that prior test,
study and trial results may not be replicated in continuing or future studies and trials; Jasper’s ability to continue as a going
concern and the risk that Jasper may be unable to raise capital to continue its operations and continue its Phase 2b/3 study in CSU;
the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study
results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized;
patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition
on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and
other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development
plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable
to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual
property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC,
including its Annual Report on Form 10-K for the year ended December 31, 2025 to be filed with the SEC on or about the date hereof. If
any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results
implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future,
Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s
assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking
statements.
Contacts:
Alex Gray
(investors)
Jasper Therapeutics
650-549-1454
agray@jaspertx.com
Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
jallaire@lifesciadvisors.com
Media:
3
JASPER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
(unaudited)
| | | Three Months Ended December 31, | | | | | | | | Twelve Months Ended December 31, | | | | | | |
| | | 2025 | | | | 2024 | | | | 2025 | | | | 2024 | | |
| Operating expenses | | | | | | | | | | | | | | | | |
| Research and development (1) | | $ | 11,360 | | | $ | 19,772 | | | $ | 63,104 | | | $ | 55,821 | |
| General and administrative (1) | | | 4,479 | | | | 5,513 | | | | 20,779 | | | | 20,418 | |
| Total operating expenses | | | 15,839 | | | | 25,285 | | | | 83,883 | | | | 76,239 | |
| Loss from operations | | | (15,839 | ) | | | (25,285 | ) | | | (83,883 | ) | | | (76,239 | ) |
| Interest income | | | 338 | | | | 938 | | | | 1,741 | | | | 5,058 | |
| Change in fair value of warrant liability | | | 6,429 | | | | — | | | | 8,528 | | | | — | |
| Other income/(expense), net | | | (29 | ) | | | 26 | | | | (2,187 | ) | | | (88 | ) |
| Total other income, net | | | 6,738 | | | | 964 | | | | 8,082 | | | | 4,970 | |
| Net loss and comprehensive loss | | $ | (9,101 | ) | | $ | (24,321 | ) | | $ | (75,801 | ) | | $ | (71,269 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | | $ | (0.32 | ) | | $ | (1.62 | ) | | $ | (3.95 | ) | | $ | (4.89 | ) |
| Weighted-average shares used in computing net loss per share attributable to
common stockholders, basic and diluted | | | 28,663,484 | | | | 15,008,473 | | | | 19,168,110 | | | | 14,584,870 | |
| | (1) | Amounts include non-cash stock based compensation expense as
follows (in thousands): |
| | | Three Months Ended
December 31, | | | | | | | | Twelve Months Ended
December 31, | | | | | | |
| | | 2025 | | | | 2024 | | | | 2025 | | | | 2024 | | |
| | | | | | | | | | | | | | | | | |
| Research and development | | $ | 395 | | | $ | 639 | | | $ | 1,995 | | | $ | 2,039 | |
| General and administrative | | | 1,266 | | | | 1,331 | | | | 4,718 | | | | 4,580 | |
| Total | | $ | 1,661 | | | $ | 1,970 | | | $ | 6,713 | | | $ | 6,619 | |
4
JASPER THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| | | December 31, | | | | December 31, | | |
| Assets | | 2025 | | | | 2024 | | |
| Current assets: | | | | | | | | |
| Cash and cash equivalents | | $ | 28,692 | | | $ | 71,637 | |
| Prepaid expenses and other current assets | | | 5,953 | | | | 4,174 | |
| Total current assets | | | 34,645 | | | | 75,811 | |
| Property and equipment, net | | | 102 | | | | 1,875 | |
| Operating lease right-of-use assets | | | 502 | | | | 976 | |
| Restricted cash | | | 417 | | | | 417 | |
| Other non-current assets | | | 113 | | | | 820 | |
| Total assets | | $ | 35,779 | | | $ | 79,899 | |
| | | | | | | | | |
| Liabilities and Stockholders’ Equity | | | | | | | | |
| Current liabilities: | | | | | | | | |
| Accounts payable | | $ | 6,220 | | | $ | 4,027 | |
| Current portion of operating lease liabilities | | | 1,235 | | | | 1,089 | |
| Accrued expenses and other current liabilities | | | 5,745 | | | | 10,121 | |
| Total current liabilities | | | 13,200 | | | | 15,237 | |
| Non-current portion of operating lease liabilities | | | — | | | | 724 | |
| Warrant liability | | | 16,164 | | | | — | |
| Other non-current liabilities | | | 2,264 | | | | 2,264 | |
| Total liabilities | | | 31,628 | | | | 18,225 | |
| | | | | | | | | |
| Commitments and contingencies | | | — | | | | — | |
| Stockholders’ equity: | | | | | | | | |
| Preferred stock | | | — | | | | — | |
| Common stock | | | 3 | | | | 2 | |
| Additional paid-in capital | | | 320,818 | | | | 302,541 | |
| Accumulated deficit | | | (316,670 | ) | | | (240,869 | ) |
| Total stockholders’ equity | | | 4,151 | | | | 61,674 | |
| Total liabilities and stockholders’ equity | | $ | 35,779 | | | $ | 79,899 | |
5
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