Jasper Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update
- First patient dosed in a sponsored trial of JSP191 conditioning in patients with Fanconi Anemia
- On schedule to initiate a registrational study in AML in the first quarter of 2023
- On schedule to initiate a new study of JSP191 as a therapeutic in second-line therapy for lower-risk, transplant ineligible MDS patients later this year
“During our second quarter, we continued to advance multiple clinical programs for our anti-CD117 monoclonal antibody, JSP191, announcing the first patient enrolled in a trial in Fanconi Anemia, advancing our new registration trial in older patients with AML and MDS, advancing our new trial as a therapeutic agent in lower-risk transplant ineligible MDS patients and making progress on a potential BLA filing for the SCID re-transplant population,” said
Second Quarter 2022 and Recent Highlights:
- Announced Treatment of First Patient in Study of JSP191 Conditioning in Patients with Fanconi Anemia: The first patient in the sponsored research of the Center for Definitive and Curative Medicine (CDCM) at the Stanford University School of Medicine for the study of JPS191 as a conditioning agent in the treatment of Fanconi Anemia was dosed in May. In accordance with the sponsored research agreement, Stanford Medicine is conducting a Phase 1/2 clinical trial (NCT04784052) utilizing JSP191 to treat Fanconi Anemia patients in bone marrow failure requiring allogeneic transplant with non-sibling donors.
- Continued progress on the registrational study of JSP191 in older, transplant-eligible patients with MDS or AML: Jasper held a Type B meeting with the FDA during which a review of the trial comparator arm, population, size, statistical assumptions, and primary endpoints were discussed. The Company agreed with the FDA to submit a trial protocol that will allow a potential initiation of registrational studies in either myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) patients undergoing stem cell transplant. The Company is finalizing the MDS/AML protocol details and plans to submit to the FDA in the coming months.
Upcoming clinical and corporate milestones:
- Initiate a new study of JSP191 as second-line therapy for transplant ineligible patients with low to intermediate risk MDS expected to start in the second half of 2022
- Initiate the registrational study of JSP191 in MDS or AML patients undergoing stem cell transplant in the first quarter of 2023 with the initial focus on the AML population
Second Quarter 2021 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents as of
Research and Development (“R&D”) Expenses: R&D expenses for the quarter ended
General and Administrative (“G&A”) Expenses: G&A expenses for the quarter ended
Net Loss: Net loss for the quarter ended
About JSP191
JSP191 is a humanized monoclonal antibody that blocks stem cell factor receptor signaling leading to the clearance of hematopoietic stem and progenitor cells from the bone marrow. JSP191 is in clinical development as a stem cell transplant conditioning agent where it helps create an empty space for the donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Three clinical trials for myelodysplastic syndromes (MDS)/ acute myeloid leukemia (AML), severe combined immunodeficiency (SCID) and Fanconi anemia (FA) undergoing allogeneic transplant are currently enrolling. JSP191 is also planned to enter clinical development as a second-line therapeutic in transfusion-dependent, lower risk MDS patients to preferentially drive recovery of healthy hematopoietic stem cells in order to help restore normal hematopoiesis.
About
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 the potential initiation of a registrational study of JSP191 in older, transplant-eligible patients with AML or MDS, the potential for JSP191 to significantly improve transplantation and its safety and efficacy, the potential for JSP191 to address the limitations of transplant conditioning, the Company’s plans to submit a trial protocol to the FDA for registrational studies of JSP191 in either MDS or AML patients undergoing stem cell transplant, the potential initiation of a new study of JSP191 as a second-line therapy for transplant ineligible patients with low to intermediate risk MDS, the expected timing for initiating clinical studies and trials and the Company’s expectations regarding its cash and cash equivalents and planned operating and capital expenditures. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of
Contacts:
617-429-3548
jmullaly@lifesciadvisors.com
650-549-1403
jmahal@jaspertherapeutics.com
---tables to follow---
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses | |||||||||||||||
Research and development(1) | $ | 8,135 | $ | 5,156 | $ | 16,323 | $ | 9,576 | |||||||
General and administrative(1) | 3,828 | 3,262 | 8,418 | 5,096 | |||||||||||
Total operating expenses | 11,963 | 8,418 | 24,741 | 14,672 | |||||||||||
Loss from operations | (11,963 | ) | (8,418 | ) | (24,741 | ) | (14,672 | ) | |||||||
Change in fair value of earnout liability | 625 | — | 5,218 | — | |||||||||||
Change in fair value of common stock warrants liability | 845 | — | 6,895 | — | |||||||||||
Change in fair value of derivative liability | — | — | — | (3,501 | ) | ||||||||||
Other income, net | 89 | 4 | 17 | 5 | |||||||||||
Total other income (expense), net | 1,559 | 4 | 12,130 | (3,496 | ) | ||||||||||
Net loss and comprehensive loss | $ | (10,404 | ) | $ | (8,414 | ) | $ | (12,611 | ) | $ | (18,168 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.29 | ) | $ | (4.00 | ) | $ | (0.35 | ) | $ | (8.89 | ) | |||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 36,397,822 | 2,104,899 | 36,353,509 | 2,043,247 | |||||||||||
(1) Amounts include non-cash stock based compensation expense as follows (in thousands): | |||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Research and development | $ | 585 | $ | 166 | $ | 807 | $ | 365 | |||||||
General and administrative | 480 | 129 | 1,036 | 257 | |||||||||||
Total | $ | 1,065 | $ | 295 | $ | 1,843 | $ | 622 | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
Assets | 2022 | 2021 | |||||
Current assets: | |||||||
Cash and cash equivalents | $ | 60,814 | $ | 84,701 | |||
Prepaid expenses and other current assets | 2,472 | 3,130 | |||||
Total current assets | 63,286 | 87,831 | |||||
Property and equipment, net | 4,016 | 3,686 | |||||
Operating lease right-of-use assets | 2,070 | 1,147 | |||||
Restricted cash | 417 | 345 | |||||
Other non-current assets | 577 | 645 | |||||
Total assets | $ | 70,366 | $ | 93,654 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,997 | $ | 3,919 | |||
Current portion of operating lease liabilities | 784 | 505 | |||||
Accrued expenses and other current liabilities | 2,841 | 3,596 | |||||
Total current liabilities | 6,622 | 8,020 | |||||
Non-current portion of operating lease liabilities | 3,234 | 2,380 | |||||
Common stock warrant liability | 455 | 7,350 | |||||
Earnout liability | 525 | 5,743 | |||||
Other non-current liabilities | 749 | 643 | |||||
Total liabilities | 11,585 | 24,136 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock | — | — | |||||
Common stock | 4 | 4 | |||||
Additional paid-in capital | 138,838 | 136,964 | |||||
Accumulated deficit | (80,061 | ) | (67,450 | ) | |||
Total stockholders’ equity | 58,781 | 69,518 | |||||
Total liabilities and stockholders’ equity | $ | 70,366 | $ | 93,654 |

Source: Jasper Therapeutics