Jasper Therapeutics Reports First Quarter 2022 Financial Results and Provides a Corporate Update
- Successful meeting with the FDA; the Company intends to initiate registrational studies in MDS and AML in Q1-2023
- Clinical data from the Phase 1 study of JSP191 as a conditioning regimen in patients with MDS or AML presented at the 2022 Transplantation & Cellular Therapy (TCT) Annual Meeting
- Clinical data from the Phase 1/ 2 study of JSP191 as single agent conditioning in SCID patients presented at the 2022
Clinical Immunology Society(CIS) Annual Meeting
- Jasper to initiate a new study of JSP191 as a second-line therapy for patients with lower-risk MDS later this year
“We had a productive first quarter advancing our clinical programs for JSP191, our anti-CD117 monoclonal antibody, including a successful meeting with the FDA to advance JSP191 into a registrational study for AML and MDS patients, and positive data readouts presented at both the Transplantation & Cellular Therapy (“TCT”) and
First Quarter 2022 and Recent Highlights:
- Announced plans for the registrational study of JSP191 in patients with MDS/AML: Jasper held a Type B meeting with the FDA during which a review of the registrational trial comparator arm, patient population, size of the study, statistical assumptions and primary endpoints were discussed. The Company agreed with the FDA to submit a protocol that will allow the initiation of registrational studies in MDS or AML patients. Jasper plans to initiate the registrational study by the end of the first quarter of 2023.
- Announced updated data from Phase 1 clinical trial of JSP191 as targeted stem conditioning agent in AML and MDS patients: Data were presented from the Phase 1 clinical trial of JSP191, on top of a standard course of NMA conditioning, in older patients with MDS or AML undergoing allogeneic hematopoietic (blood) cell transplantation as a late-breaking abstract at the 2022 TCT Meetings of the
American Society for Transplantationand Cellular Therapy(ASTCT) and the Center for International Blood & Marrow Transplant Research(CIBMTR). JSP191 was shown to be well tolerated with no treatment-related severe adverse events. All 24 patients achieved successful engraftment with neutrophil recovery and 20 of 24 patients were determined to be free from morphologic relapse or disease progression at last follow up.
- Announced updated data from Phase 1/ 2 clinical trial of JSP191 as targeted, single agent conditioning in SCID patients: Updated data from an ongoing study of JSP191 as single-agent conditioning prior to allogeneic hematopoietic stem cell (HSC) re-transplant in patients with severe combined immunodeficiency (“SCID”) were presented as a late-breaking poster at the 2022
Clinical Immunology Society(CIS) Annual Meeting. Data indicated that JSP191 at a dose of 0.6mg/kg can deplete blood stem cells in the bone marrow, leading to long-term donor cell engraftment and immune reconstitution, which positively affects the clinical status of SCID patients who suffer from poor T cell and negligible B cell immunity due to a failed first transplant.
- Hosted a KOL event on transforming hematopoietic stem cell therapies:
Lori Muffly, M.D., M.S. of Stanford Universityand David Sallman, M.D. of Moffitt Cancer Centerprovided an overview of the current landscape and unmet medical need in hematopoietic stem cell transplant conditioning as well as MDS treatment. Jasper’s management discussed how JSP191 may address the limitations of transplant conditioning, and Jasper’s management also outlined the potential new therapeutic approach for disease modification in lower-risk MDS patients with JSP191.
Ronald Martellas Chief Executive Officer and made other leadership changes: Mr. Martellbrings valuable expertise and a proven track record of leading public biopharmaceutical companies in all phases of development. He is focusing his efforts on accelerating the clinical-stage targeted conditioning program and Jasper’s research stage novel cellular therapeutics pipeline. Additionally, Jeet Mahalwas promoted to Chief Operating Officer and Chief Financial Officer and Dr. Wendy Pangwas promoted to Senior Vice President of Research and Translational Medicine.
Upcoming clinical and corporate milestones:
- Initiation of a new study with JSP191 as a second-line therapy for patients with lower-risk MDS is expected to commence in the second half of 2022
- Initiation of a registrational study in AML patients in the first quarter of 2023
First-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: For the quarter ended
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 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.
Jasper is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective, and potentially curative, allogeneic hematopoietic cell transplants and gene therapies. A clinical study of JSP191 as a novel, disease-modifying, therapeutic for patients with lower risk MDS is also planned to begin in 2022. In parallel, Jasper is advancing its preclinical mRNA hematopoietic stem cell grafts platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.
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 patients with AML and 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 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 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. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
|Three Months Ended
|Research and development(1)||$||8,188||$||4,420|
|General and administrative(1)||4,590||1,834|
|Total operating expenses||12,778||6,254|
|Loss from operations||(12,778||)||(6,254||)|
|Change in fair value of earnout liability||4,593||—|
|Change in fair value of common stock warrants liability||6,050||—|
|Change in fair value of derivative liability||—||(3,501||)|
|Other income (expense), net||(72||)||1|
|Total other income (expense), net||10,571||(3,500||)|
|Net loss and comprehensive loss||$||(2,207||)||$||(9,754||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.06||)||$||(4.92||)|
|Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted||36,309,683||1,980,910|
|(1) Amounts include non-cash stock based compensation expense as follows (in thousands):|
|Three Months Ended
|Research and development||$||222||$||199|
|General and administrative||556||128|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||70,400||$||84,701|
|Prepaid expenses and other current assets||3,399||3,130|
|Total current assets||73,799||87,831|
|Property and equipment, net||3,499||3,686|
|Operating lease right-of-use assets||2,222||1,147|
|Other non-current assets||611||645|
|Liabilities and Stockholders’ Equity|
|Current portion of operating lease liabilities||521||505|
|Accrued expenses and other current liabilities||3,982||3,596|
|Total current liabilities||5,969||8,020|
|Non-current portion of operating lease liabilities||3,383||2,380|
|Common stock warrant liability||1,300||7,350|
|Other non-current liabilities||641||643|
|Commitments and contingencies|
|Additional paid-in capital||137,758||136,964|
|Total stockholders’ equity||68,105||69,518|
|Total liabilities and stockholders’ equity||$||80,548||$||93,654|
Source: Jasper Therapeutics, Inc.