Jasper Therapeutics, Inc. · NASDAQ:JSPR
Jasper Therapeutics — Investor Presentation (June 2023)
55 slides from Jasper Therapeutics's investor presentation, Jun 2, 2023
Slide 1: Harnessing the Power of Jasper's Differentiated c-Kit Therapeutic Approach
Harnessing the Power of Jasper’s Differentiated c - Kit Therapeutic Approach Nasdaq: JSPR June 2023
Slide 2: Safe Harbor Statements
Safe Harbor Statements Briquilimab is an investigative drug and is not approved for any indication 2 Forward - Looking Statements This investor presentation and any accompanying oral presentation (together, this “Presentation”) contain forward - looking statements . All statements other than stateme
Slide 3: Briquilimab is an anti c-Kit antibody for mast and stem cell diseases
Briquilimab is an anti c - Kit antibody for acute and chronic therapy in multiple mast and stem cell diseases Clinical validation in 5 for 5 transplant indications Therapeutic development in chronic disease Chronic Spontaneous Urticaria (CSU) Expected Start Q4 2023 Low to Int. Risk MDS Enrollment on
Slide 4: Tyrosine kinase KIT plays a central role in regulating mast and stem cell survival
Tyrosine kinase KIT plays a central role in regulating mast and stem cell survival Play a key role in immune system through the release of compounds that induce inflammation (degranulation) Unregulated mast cell activation may cause episodes of hives and inflammation (i.e. Chronic Urticaria) Mast Ce
Slide 5: Briquilimab blocks SCF binding to c-Kit (CD117)
SCF c - KIT (CD117) Briquilimab Briquilimab Blocks SCF binding to c - Kit (CD117) to directly inhibit receptor signaling Validated Mechanism of Action Briquilimab is designed to directly block SCF from binding to c - Kit (CD117) with high affinity and avidity • Aglycoslyated IgG1 antibody directly i
Slide 6: Briquilimab Therapeutic Development
Briquilimab Therapeutic Development Briquilimab is an investigative drug and is not approved for any indication 6
Slide 7: Briquilimab for Chronic Urticaria
7 Briquilimab for Chronic Urticaria
Slide 8: Briquilimab c-Kit and mast cell activity
8 Briquilimab is an investigative drug and is not approved for any indication Briquilimab c - Kit and mast cell activity Result Activity Assay Kd < 5 pM Binding affinity to human c - Kit Fc dimer Ki 70pM Biacore assessment of c - Kit signaling neutralization IC 50 1.8nM Human mast cell c - Kit phosp
Slide 9: Briquilimab mast cell depletion in non-human primates following cutaneous wound injury
9 Briquilimab is an investigative drug Source: Amgen Research Report 2006488 Briquilimab mast cell depletion in non - human primates following cutaneous wound injury and is not approved for any indication
Slide 10: Briquilimab mast cell depletion in lungs of non-human primates
Briquilimab mast cell depletion in lungs of non - human primates Briquilimab is an investigative drug and is not approved for any indication 10 Source: Amgen research report R2006481
Slide 11: Briquilimab can be dosed IV or subcutaneously
Briquilimab can be dosed IV or subcutaneously (SQ) Briquilimab IV serum concentrations Concentration of JSP191 in Serum (ng/mL) 0 7 14 Time (days) 21 1 10 100 1000 10000 100000 - 0001 (0.1 mg/kg) - 0002 (0.1 mg/kg) - 0003 (0.1 mg/kg) - 0004 (0.3 mg/kg) - 0006 (0.3 mg/kg) - 0008 (0.3 mg/kg) - 0013 (0
Slide 12: Phase I: Briquilimab depletes tryptase and c-Kit positive skin mast cells
12 Briquilimab is an investigative drug and is not approved for any indication Phase I: Briquilimab robustly depletes tryptase and c - Kit positive skin mast cells *Punch Biopsy Wound Model Source: Amgen Phase 1a (SAD = 71 briquilimab patients; MAD = 8 briquilimab patients) Briquilimab Phase 1a (N=7
Slide 13: Celldex's barzolvolimab has demonstrated proof-of-concept of c-Kit blockade in CSU
13 Briquilimab is an investigative drug and is not approved for any indication Celldex’s barzolvolimab has demonstrated proof - of - concept of c - Kit signal blockade for Chronic Spontaneous Urticaria patients Source: Celldex AAAAI February Presentation (February 2023) Barzolvolimab Phase 1b MAD (I
Slide 14: Potential initial clinical study for Briquilimab in Chronic Spontaneous Urticaria
14 Briquilimab is an investigative drug Potential initial clinical study for Briquilimab in Chronic Spontaneous Urticaria Chronic Spontaneous Urticaria (CSU) • H1 - antihistamines refractory • Xolair - naïve and/or Xolair - failed Patient Population • 20 - 40 patients Expected Enrollment • 12 - 18 m
Slide 15: Key points of differentiation between Briquilimab and Barzolvolimab
15 Briquilimab is an investigative drug and is not approved for any indication Key points of differentiation between Briquilimab and Barzolvolimab (CDX - 0159) Key Similarities Key Differences 1 c. Kit (CD117) signal blockade o Both antibodies block c - Kit signaling on mast cells 2 On - target depl
Slide 16: Chronic urticaria represents a significant and expanding market
16 Briquilimab is an investigative drug and is not approved for any indication Chronic urticaria represents a significant and expanding market, with estimated 1+ million potential patients Given Xolair’s low penetration, experts believe the antihistamine - failed market is poised for significant gro
Slide 17: Significant unmet need for Chronic Urticaria patients who fail antihistamines
17 Briquilimab is an investigative drug and is not approved for any indication There is a significant unmet need for Chronic Urticaria patients who fail antihistamines – safer, more effective therapies are needed *Montelukast = Leukotriene receptor antagonist; cyclosporine = immunosuppressant; dapso
Slide 18: Potential to expand beyond Chronic Urticaria into other mast cell-mediated diseases
18 Briquilimab is an investigative drug and is not approved for any indication Briquilimab has the potential to expand beyond Chronic Urticaria into other mast cell - mediated and inflammatory diseases Chronic Inducible Urticaria Patients are inadequately controlled by antihistamines; only approved
Slide 19: Briquilimab for Lower to Intermediate Risk MDS
19 Briquilimab for Lower to Intermediate Risk MDS
Slide 20: Briquilimab may deplete cancerous stem cells in lower to intermediate risk MDS
20 Briquilimab is an investigative drug and is not approved for any indication Briquilimab’s ability to directly deplete cancerous stem cells may be leveraged as a disease - modifying therapeutic in lower to intermediate risk MDS patients LR - MDS: Lower - Risk Myelodysplastic syndromes Normal HSCs
Slide 21: Briquilimab depletion may enable healthy HSCs to take over the bone marrow niche
21 Briquilimab is an investigative drug and is not approved for any indication Briquilimab depletion may enable healthy HSCs to take over the bone marrow niche and restore functional hematopoiesis 1 Kwon et al, Blood 2019 2 Amgen Phase I healthy volunteer data (unpublished) Briquilimab depletion and
Slide 22: Phase I study of briquilimab in lower-risk MDS
22 Briquilimab is an investigative drug A Phase I open - label, dose - escalation, safety and tolerability study of briquilimab as a second line therapy in patients with lower - risk myelodysplastic syndrome HI - E: Hematologic Improvement - Erythroid; Hematologic Improvement - Platelet; Hematologic
Slide 23: Lower to intermediate risk MDS market opportunity
Lower to intermediate risk MDS market opportunity MDS INCIDENCE (G7) 1 ~32,000 Lower to Intermediate Risk MDS (IPSSR ≤3.5)* 2,3 ~22,500 (70%) RBC - Transfusion Dependent 4,5 ~11,250 (50%) Erythropoietin Stimulating Agent (ESA) Market Briquilimab is an investigative drug and is not approved for any i
Slide 24: Briquilimab Transplant Development
Briquilimab Transplant Development Briquilimab is an investigative drug and is not approved for any indication 24
Slide 25: Sickle Cell & Beta Thalassemia
25 Sickle Cell & Beta Thalassemia
Slide 26: Phase I: Briquilimab in non-myeloablative transplant for Sickle Cell Disease and Beta-Thalassemia
26 Briquilimab is an investigative drug and is not approved for any indication ► Sickle cell disease (SCD) is a group of inherited red blood cell / hemoglobin disorders; patients with SCD have misshapen red blood cells, which prevents normal cell function / behavior ► Patients typically develop chro
Slide 27: SCID
¢j Jasper per THERAPEUTICS ING. SCID
Slide 28: Briquilimab conditioning for severe combined immunodeficiency (SCID)
28 Briquilimab is an investigative drug Briquilimab conditioning for severe combined immunodeficiency (SCID) T - B - : A form of severe combined immunodeficiency (SCID) is the T cell - negative (T - ), B cell - negative (B - ) SCID phenotype Jasper SCID Strategy: • Establish Single Agent Activity PO
Slide 29: Briquilimab SCID Phase I results: safety and tolerability to date
29 Briquilimab is an investigative drug and is not approved for any indication Briquilimab SCID phase I results: Safety and tolerability to date Clinical Safety • No briquilimab - related serious adverse events (SAEs) • No myelosuppression • No significant infusion reactions Clinical Setting • Proto
Slide 30: Potential BLA and PRV opportunity for briquilimab in SCID
Potential biologics license application (BLA) and PRV opportunity for briquilimab in SCID SCID is a lethal genetic immune disorder where HCT is the only proven cure Briquilimab is an investigative drug and is not approved for any indication 30 T - B - : A form of severe combined immunodeficiency (SC
Slide 31: Fanconi Anemia
¢j Jasper per THERAPEUTICS ING. Fanconi Anemia
Slide 32: Fanconi anemia: briquilimab-based conditioning regimen at Stanford
32 Briquilimab is an investigative drug Fludarabine Cyclophosphamide ► Fanconi is an inherited DNA repair deficiency that leads to progressive failure of hematopoietic stem and progenitor cells and transfusion dependency ► Allogeneic stem cell transplant is the only current cure, however Fanconi pat
Slide 33: Potential Fanconi Anemia development path for briquilimab
33 Briquilimab is an investigative drug Potential Fanconi Anemia development path for briquilimab Allogeneic stem cell transplant can restore bone marrow and blood formation in Fanconi Anemia patients Development strategy Continue to enroll under current protocol (n up to 12) Discuss path to BLA wit
Slide 34: Briquilimab development plan
Briquilimab development plan 2023 2024 2025 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q LR - MDS SCID Urticaria Additional LR - MDS Study (n=12 - 16) LR - MDS Expansion (n=40 - 50) Natural History Follow - Up BLA Submission (Rolling) IND Phase I /II MAD study (n=40) Sickle Cell Disease, Fanconi Anemia and Other S
Slide 35: Harnessing the Power of Jasper's Differentiated c-Kit Therapeutic Approach
Harnessing the Power of Jasper’s Differentiated c - Kit Therapeutic Approach Nasdaq: JSPR June 2023
Slide 36: Additional Slides
36 Briquilimab is an investigative drug and is not approved for any indication Additional Slides
Slide 37: AML/MDS
THERAPEUTICS ING. AML/ MDS
Slide 38: AML/MDS Study: Single agent briquilimab depletes diseased stem and progenitor cells
38 Briquilimab is an investigative drug and is not approved for any indication AML/MDS Study: Single agent briquilimab depletes diseased stem & progenitor cells in bone marrow in 5 to 7 days Muffly L et al. Tandem Meetings Transplantation and Cellular Therapy (TCT) 2022 April 23 - 26; Salt Lake City
Slide 39: Briquilimab-based conditioning demonstrates donor cell takeover and elimination of detectable cancer
39 Briquilimab is an investigative drug and is not approved for any indication Briquilimab based conditioning demonstrates donor cell takeover of bone marrow stem cells and elimination of detectable cancer in older patients Donor cell takeover of the bone marrow (Median donor chimerism) Clearance of
Slide 40: Multimodality Measurable Residual Disease in AML patients
TD360 TD180 TD90 TD56 TD28 SCRN NEG C NEG NEG MRD+ MRD+ MRD+ Relapse MRD+ NEG MRD+ MRD+ MRD+ NRM (acu NEG MRD+ MRD+ MRD+ MRD+ MRD+ * C MRD+ MRD+ NEG MRD+ NEG C NEG NEG NEG MRD+ NEG C NEG NEG MRD+ MRD+ Relapse QNS NEG NEG NEG C NEG NEG NEG MRD+ NEG C MRD+ NEG NEG NEG C NEG NEG NEG MRD+ Relapse MRD+ M
Slide 41: Outcomes in AML patients
Outcomes in AML patients N = 12, complete 1 year follow - up Patients with AML (N=12) 8 (67%) Alive without AML @ 1 yr 8 (67%) Alive and AML MRD negative @ 1 yr 6 (50%) Alive without AML and off immunosuppression @ 1 yr Days Post - HCT Days Post - HCT 8 10 12 No. at risk: 8 11 12 No. at risk: Overal
Slide 42: GVHD in AML patients
GVHD in AML patients N = 12, complete 1 year follow - up Patients with AML (N=12) Acute GVHD (per MAGIC) 3 (25%) Grade 2 - 4 2 (17%) Grade 2 1 (8%) Grade 3 0 (0%) Grade 4 Chronic GVHD (per NIH Consensus) 0 (0%) Mild 4 (33%) Moderate 0 (0%) Severe Grade 2 - 4 aGVHD Moderate - Severe cGVHD 0 Briquilim
Slide 43: Summary: Subanalysis of AML Patients Enrolled in Phase I Trial
Summary: Subanalysis of AML Patients (N=12) Enrolled in Phase I Trial with Full 1 Year Follow - up • 0.6 mg/kg briquilimab demonstrated predictable clearance, allowing safe and effective donor cell infusion 9 - 14 days after briquilimab • RFS 67%, OS 75%, NRM 8% @ 1 yr post - HCT, with low rates of
Slide 44: No briquilimab-related SAEs and proof of concept for outpatient stem cell transplant
44 Briquilimab is an investigative drug and is not approved for any indication No briquilimab - related SAEs, no 100 - day transplant related mortality and proof of concept for outpatient stem cell transplant Clinical Safety • No briquilimab - related SAEs • No significant briquilimab infusion react
Slide 45: 0.6 mg/kg IV Briquilimab Pharmacokinetics
45 Briquilimab is an investigative drug and is not approved for any indication 0.6 mg/kg IV Briquilimab Pharmacokinetics: consistent and predictable clearance 300 100 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Time (days) 30000 10000 3000 1000 Concentration of JSP191 in Serum (ng/mL) Muffly L et al. Tand
Slide 46: Preclinical
jy Jasper per THERAPEUTICS ING. Preclinical
Slide 47: Briquilimab 6-month non-human primate toxicology study
Briquilimab 6 - month non - human primate (NHP) toxicology study Briquilimab is an investigative drug and is not approved for any indication 47 Source: Amgen Report 109076 • 4 groups (control, 1, 30, 300 mg/kg weekly subcutaneous), n=8 to 12 per group, 50% female • Dosing for 26 weeks followed by 32
Slide 48: Reticulocytes and Hemoglobin Levels – 6mo NHP toxicology study
Reticulocytes and Hemoglobin Levels – 6mo NHP toxicology study Briquilimab is an investigative drug and is not approved for any indication 48 Source: Amgen Report 109076
Slide 49: White Blood Cells – 6mo NHP toxicology study
White Blood Cells – 6mo NHP toxicology study 0 5 10 15 20 25 WBC E3/uL Males 0 mg/kg 1 mg/kg 30 mg/kg Pre 15 Pre 22 Dose Dose Dose Dose Dose Dose Dose Dose Post 29Post 57Post 85 Post Post Pose Post Post 15 29 57 85 113 141 169 183 113 141 169 197 225 300 mg/kg 0 5 10 15 20 25 Pre 15 Pre 22 Dose 15 D
Slide 50: Phase I Healthy Volunteers
50 Phase I Healthy Volunteers
Slide 51: Briquilimab Phase I SAD Study: Adverse events of interest
* All mild (Grade 1) AEs except for two Grade 2 events Briquilimab is an investigative drug and is not approved for any indication 51 Briquilimab (JSP191/AMG191) Phase I SAD Study: Adverse events of interest
Slide 52: Phase I – Human SAD
Phase I – Human SAD Briquilimab is an investigative drug and is not approved for any indication 52
Slide 53: Phase I – Human SAD Study Day
Phase I – Human SAD Study Day Briquilimab is an investigative drug and is not approved for any indication 53
Slide 54: MAD – Grade adverse event
MAD – Grade 3 adverse event Briquilimab is an investigative drug and is not approved for any indication 54 One subject reported an allergic reaction 36 hours after 2nd dose in cohort 1 (14 mg q2w) • Urticaria, facial angioedema, no respiratory symptoms, no clinically relevant changes in vital signs
Slide 55: Phase I: Healthy volunteer immunogenicity summary
Phase I: Healthy volunteer immunogenicity summary Briquilimab is an investigative drug and is not approved for any indication 55 • Pre - existing ADAs: 2/77 (Briquilimab (AMG191) treated subjects) • Developing ADAs: 13/77 • Neutralizing ADAs: 8/77 • Post - dose ADAs seen in subjects given 20mg SC or
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