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Item 7.01. Regulation FD Disclosure.
Jasper Therapeutics, Inc. (the “Company”) is furnishing an updated corporate presentation, attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Corporate Presentation”), which the Company intends to post on the Company’s website. The Corporate Presentation is current as of October 10, 2023, and the Company disclaims any obligation to update this material in the future.
The information in this Item 7.01, including the Corporate Presentation attached hereto as Exhibit 99.1, is being furnished under Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Corporate Presentation, dated October 2023. | |
| 104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: October 10, 2023 | JASPER THERAPEUTICS, INC. | ||
| By: | /s/ Herb Cross | ||
| Name: | Herb Cross | ||
| Title: | Chief Financial Officer | ||
2
Exhibit 99.1
Briquilimab is an investigative drug and is not approved for any indication 1 Jasper Therapeutics NASDAQ: JSPR October 2023 Exhibit 99.1
2 Briquilimab is an investigative drug and is not approved for any indication Safe Harbor Statements Forward - Looking Statements This investor presentation and any accompanying oral presentation (together, this “Presentation”) contain forward - looking statements. All statements other than statements of historical fact contained in this Presentation, including statements regarding the future opportunities and prospects of Jasper Therapeutics, Inc. (together with its subsidiary, "Jasper" or the "Company"), including milestones, potential regulatory filings and the anticipated timing thereof, patient enrollment, future timelines, business strategy, and plans and objectives for future operations, are forward - looking statements. Jasper has based these forward - looking statements on its estimates and assumptions and its current expectations and projections about future events. These forward - looking statements are subject to a number of risks, uncertainties and assumptions, including those contained in the "Risk Factors" section of the Company's Annual Report on Form 10 - K for the year ended December 31, 2022, Quarterly Reports on Form 10 - Q and Current Reports on Form 8 - K that the Company has subsequently filed or may subsequently file with the SEC. In light of these risks, uncertainties and assumptions, the forward - looking events and circumstances discussed in this Presentation are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward - looking statements. Accordingly, you should not rely upon forward - looking statements as predictions of future events. Jasper undertakes no obligation to update publicly or revise any forward - looking statements for any reason after the date of this Presentation or to conform these statements to actual results or to changes in Jasper's expectations. Industry and Market Data Certain data in this Presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or undertakes any obligation to update such data after the date of this Presentation. Such data involves risks and uncertainties and is subject to change based on various factors. Trademarks The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of the Company.
3 Briquilimab is an investigative drug and is not approved for any indication Jasper is focused on the development of new therapeutics targeting significant unmet clinical needs in diseases driven by mast or stem cells • Jasper is developing briquilimab across multiple mast cell mediated diseases, including Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CIndU) • Mast cells are potent inflammatory drivers in a number of allergic and dermatological diseases affecting millions of patients, with limited treatment options • c - Kit inhibition is the only therapeutic mechanism that has been shown to significantly deplete mast cells, potentially delivering durable disease control • Anti - c - Kit potency and PK properties of briquilimab allow for mast cell depletion while minimizing unwanted adverse effects on other cell types • Multiple company - sponsored clinical studies of briquilimab with key data read outs expected in 2024
4 Briquilimab is an investigative drug and is not approved for any indication SCF blockade drives differential impact on mast cells and stem cells MAST CELLS (MC) STEM CELLS (HSC) MC Apoptosis HSC Differentiation APOPTOTIC MC MC MC MC Apoptotic MC Apoptotic MC Apoptotic MC Stem Cell Factor (SCF) Briquilimab Apoptosis Programmed Cell Death ckit Durable Depletion MC P13K AKT FOXO3A BIM MEGAKARYOCYTE Quiescent HSC Quiescent HSC Quiescent HSC Quiescent HSC Quiescent HSC Quiescent HSC Stem Cell Factor (SCF) Briquilimab Differentiation ckit Exit BM Niche CYCLING HSC SCF Signaling Self - Renewal Growth Factor Signaling TPO MPL FLT3 Briquilimab is an investigative drug and is not approved for any indication
5 Briquilimab is an investigative drug and is not approved for any indication Mast cells are key drivers of the inflammatory response in a number of allergic and dermatologic diseases Theoharides et al. N Engl J Med. (2015) • Mast cells are the most potent drivers of inflammatory response in skin, lungs and gut • Activated mast cells release pro - inflammatory compounds that drive diseases such as Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Asthma and many others • Current approved therapies targeting mast cell driven diseases have limited efficacy and limited durability of response
6 Briquilimab is an investigative drug and is not approved for any indication Depletion of mast cells by anti - c - Kit monoclonal antibody blockade is a novel approach to treat urticarias and other mast cell mediated diseases 1 Moller C et al. Blood (2005) 2 Hundley TR et al. Blood (2004) 3 Arnold JN et al. Annu Rev Immunol (2007) • SCF signaling through c - Kit prevents mast cells apoptosis via the Bim - mediated pathway 1 • Blockade of c - Kit signaling on mast cells leads to organized cell death and phagocytic clearance 2 • Partial c - Kit inhibition blunts mast cell activation • Aglycosylated c - Kit antibodies avoid indiscriminate ADCC driven killing of other c - Kit expressing cells 3 • Unwanted effects on other c - Kit expressing cells can be minimized by the recovery of c - Kit signaling once the mast cells are depleted Briquilimab - Mediated Mast Cell Apoptosis
7 Briquilimab is an investigative drug and is not approved for any indication Briquilimab potently blocks c - Kit signaling leading to durable mast cell depletion 1 Jasper internal data • Briquilimab is an aglycosylated IgG1 anti c - Kit antibody with high affinity to c - Kit (Kd <5pm) • Briquilimab potently blocks c - Kit signaling by blocking the SCF ligand binding site on the receptor and triggering apoptosis • Mast cell depletion occurs within hours to days Mast cell survival assay 1
8 Briquilimab is an investigative drug and is not approved for any indication Briquilimab delivered with a single subcutaneous injection significantly depletes mast cells in humans above 0.8 mg/kg threshold 1 Jasper internal data (Phase 1a, healthy volunteer study); Dose is adjusted to body weight (mg/kg) on graph. Skin biopsies were used to count mast cells. 2 Maurer et al, GA²LEN Global Urticaria Forum – Berlin, December 6, 2022 • A single subcutaneous dose above ~0.8 mg/kg potently depletes mast cells in the skin of healthy volunteers • Skin mast cell depletion highly correlated to serum briquilimab exposure after subcutaneous administration • Significant depletion by day 7, with durable response lasting at least 29 days • Once depleted with an anti - c - Kit antibody, skin mast cells take at least 3 months to recover, potentially leading to durable disease control 2 0.8 mg/kg Skin mast cell depletion 4 weeks after single dose (≥42 mg) 1 Briquilimab Healthy Volunteer Phase 1 Subcutaneous Study
9 Briquilimab is an investigative drug and is not approved for any indication Briquilimab’s favorable pharmacokinetic properties may enable optimal biologic dosing 1 Jasper internal data (Phase 1a, healthy volunteer study) • Briquilimab is designed to minimize unwanted c - Kit - related effects • Subcutaneous dosing leads to predictable PK profile • Low frequency of ADAs and do not appear to affect PK • Drug elimination profile is favorable for minimizing off target effects • Clearance to allow for return of c - Kit signaling once the mast cells are depleted • No modifications to extend FcRn recycling Pharmacokinetics (≥10 mg) 1 Briquilimab Healthy Volunteer Phase 1 Subcutaneous Study
10 Briquilimab is an investigative drug and is not approved for any indication Briquilimab safety profile to - date supports development in a wide variety of mast cell diseases • c - Kit is expressed on mast cells, hemopoietic stem cells, melanocytes, taste buds, spermatogonia and Cajal (GI) cells, which all may be impacted by anti - c - Kit agents • However, briquilimab’s favorable elimination kinetics may allow for an improved safety profile on these other cell types Relevant Preclinical & Clinical Experience • NHP Chronic Toxicology Study • Paleness in skin & fur, depletion of colonic mast cells, decrease in reticulocytes and RBC mass, impact on spermatogenesis • All effects reversible at highest dose of 300 mg/kg weekly for 26 weeks • Healthy Volunteer Subcutaneous Studies (n=77 briquilimab - treated) • Various Grade 1/2 AEs including headache, decreased neutrophils, injection site reaction, infection, urticaria, dysgeusia (280 mg only) • One Grade 3 allergic reaction reported
Briquilimab is an investigative drug and is not approved for any indication 11 11 Briquilimab in Chronic Urticaria
12 Briquilimab is an investigative drug and is not approved for any indication Briquilimab Phase 1b/2a in patients with Chronic Spontaneous Urticaria (CSU) Study Goal: identify the optimal therapeutic doses & dosing frequency of subcutaneous briquilimab to inform future registrational trials Key Objectives: • Study multiple briquilimab dose levels, and intervals ranging from 4 to 12+ weeks to study the effects of: • Mast cell depletion and disease symptom/disease modifications • Briquilimab drug clearance • Time to return of disease symptoms • Briquilimab on other c - Kit expressing cell lineages • Part 1 intended to identify the minimally effective dose • Treat the highest unmet need population for clearest efficacy signal Status: IND cleared (US), CTA submitted (EU), with FPI targeted by year - end 2023
13 Briquilimab is an investigative drug and is not approved for any indication Phase 1b/2a dose levels selected to generate data below and above mast cell depletion threshold observed in Phase 1 healthy volunteer study *Jasper internal data (Phase 1a, healthy volunteer study); Skin biopsies were used to count mast cells. 240 mg Dose (mg) 10 mg 40 mg 80 mg 120 mg 180 mg Briquilimab CSU Phase 1b/2a study doses Briquilimab Healthy Volunteer Phase 1 Subcutaneous Study Skin mast cell depletion 4 weeks after single 42, 84, 158 and 280 mg dose*
14 Briquilimab is an investigative drug and is not approved for any indication Phase 1b/2a dose frequencies selected to align with mast cell recovery in the skin, which typically takes 3 months or longer 1 Maurer et al, GA²LEN Global Urticaria Forum – Berlin, December 6, 2022 • Single administration of anti - c - Kit leads to deep depletion of skin mast cells • Following depletion, mast cell recovery in the skin takes at least three months 1 • Serum tryptase recovery precedes return of urticarial symptoms and skin mast cells • Likely due to earlier recovery of lung and gut mast cells Single Dose of Barzolvolimab in CIndU (3 mg/kg IV) Minimal recovery of skin mast cells by week 36 following single administration of barzolvolimab IV in CIndU patients 1
15 Briquilimab is an investigative drug and is not approved for any indication Part 1 (n=6) Part 2 (n=28) Part 3 (n=4) • CSU diagnosis ≥ 6 mos. • UAS7 ≥ 16 • 18+ years • H1 - antihistamine - failed • Inadequate response to omalizumab UAS7 measured at 12 weeks (Primary Endpoint) • US Lead: Tom Casale, MD • EU Lead: Marcus Maurer, MD • ~30 sites in the US & EU • N = ~38 x Disease Scores: UAS7, UCT x Mast Cell Depletion & Recovery: Serum Tryptase, Skin Biopsies, Skin Codeine Skin Tests x Safety: TEAEs, SAEs 24 - Week Follow - Up Dose W0, 4, 12, 20 Dose W0, 4, 12, 20 10 mg 40 mg Dose W0, 8, 16, 24 80 mg Q8W 24 - Week Follow - Up Dose W0, 8, 16, 24 Dose W0, 12, 24 120 mg Q8W 120 mg Q12W Dose W0, 12, 24 180 mg Q12W 36 - Week Follow - Up Single Dose 240 mg Briquilimab Phase 1b/2a Chronic Spontaneous Urticaria Study Randomized, Double - Blind, Placebo - Controlled, Multiple Ascending Dose Study Screening/Eligibility Study Operations Key Assessments
16 Briquilimab is an investigative drug and is not approved for any indication Briquilimab Phase 1b/2a in patients with Chronic Inducible Urticaria (CIndU) Study Goal: identify therapeutic doses of subcutaneous briquilimab to inform future registrational trials Key Objectives: • Demonstration of efficacy and safety in a second dermatological indication • Study design intended to identify minimally effective dose • Provocation study enables a clear demonstration of potential drug effect • Assess the effects of single dose briquilimab on mast cell depletion and disease symptoms/disease modification Status: CTA submitted (EU), FPI targeted Q1 2024
17 Briquilimab is an investigative drug and is not approved for any indication 40 mg 120 mg Single Dose 36 - Week Follow - Up N=15 • Diagnosis of Cold Urticaria (ColdU) or Symptomatic Dermographism (SD) for ≥ 3 mos. • H1 - antihistamine - failed • 18+ years Provocation test measured at 12 weeks (Primary Endpoint) • EU Lead: Marcus Maurer, MD • ~5 sites in the EU • N = ~15 • Provocation Test: TempTest (ColdU), FricTest (SD) • Disease Scores: UCT • Mast Cell Depletion & Recovery: Serum Tryptase, Skin Biopsies, Codeine Skin Tests • Safety: TEAEs, SAEs Symptomatic Dermographism FricTest Cold Urticaria TempTest Provocation Tests Used for Clinical Evaluation Briquilimab Phase 1b/2a Chronic Inducible Urticaria Study Open - Label, Cold Urticaria & Symptomatic Dermographism, Single Ascending Dose Study Screening/Eligibility Study Operations Key Assessments
18 Briquilimab is an investigative drug and is not approved for any indication Mast cell depletion may provide deep and durable disease control with a convenient dosing schedule 1 Kolkhir P et al. Nature Reviews Disease Primers (2022) 2 Characterized by complete response and overall effects on disease control, as demonstrated in published clinical trials. Maurer et al, GA²LEN Global Urticaria Forum – Berlin, December 6, 2022 (Barzolvolimab); Xolair prescribing information; Maurer M et al. JACI 2022 (Dupilumab); Maurer M et al. JACI 2022 (Remibrutinib); Altrichter S et al. JACI 2022 (Lirentelimab) CIndU Efficacy 2 CSU Efficacy 2 Dosing Frequency Mast Cell Depletion Mechanisms Target 1 +++ +++ 8 to 12+ weeks (SQ) Mast cell depletion c - Kit + 4 weeks (SQ) Signal inhibition IgE* + 2 weeks (SQ) Cytokine inhibition IL - 4/IL - 13 ? ++ Twice daily (Oral) Signal inhibition BTK + + 2 weeks (SQ) Signal inhibition Siglec - 8 ? ? Unknown (Oral) Signal inhibition MRGPRX2 *Xolair (omalizumab) is FDA Approved
19 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is designed for differentiated mast cell depletion Potency • Binding affinity : K d < 5pM • Target epitope : Direct blockade of SCF binding pocket on c - Kit triggers mast cell apoptosis through the Bim pathway • Durable depletion : Mast cell depletion drives deep clinical response with dosing every two or three months Pharmacokinetics • Antibody design : Aglycosylated, no FcRn engineering to extend recycling • Safety profile : Favorable elimination kinetics allow for restoration of c - Kit signaling on other cell types once mast cells depleted Path to Market • Clinical experience : Encouraging efficacy and safety profile in >145 participants across six clinical trials to - date; initial CSU trial designed to determine the optimal biologic dose and prepare for a registrational trial • Potential 1 st BLA: FDA has granted briquilimab Fast Track, Orphan and Rare Pediatric Disease designations in SCID
20 Briquilimab is an investigative drug and is not approved for any indication Engineering c - Kit enables direct in vivo testing of briquilimab in mast cell mediated disease models • c - Kit antibodies designed against human receptor do not bind to wild type mouse c - Kit, thereby limiting disease model testing • Jasper transgenic mouse allows for direct testing of briquilimab in vivo • Jasper mouse engineered with human c - Kit ectodomain and mouse c - Kit intracellular domain • Briquilimab binds to Jasper mouse c - Kit, blocks signaling leading to mast cell apoptosis • Multiple diseases models that can be tested with briquilimab and Jasper c - Kit Mouse • Allergy • Anaphylaxis • Asthma Human extracellular domain binds to briquilimab and mouse SCF Mouse intracellular domain retains normal signaling Jasper c - Kit Mouse TM • Atopic Dermatitis • IBD • Transplant
21 Briquilimab is an investigative drug and is not approved for any indication Briquilimab’s ability to deplete mast cells may drive significant therapeutic benefits across a broad range of diseases Kolkhir P et al. Nature Reviews (2022) Mast Cell Driven Diseases These diseases are specifically caused by mast cell dysfunction • Chronic Spontaneous Urticaria • Chronic Inducible Urticaria Mast Cell Associated Diseases Fundamental role of mast cells in atopic and allergic diseases • Asthma, Chronic Obstructive Pulmonary Disease (COPD) • Atopic Dermatitis, Prurigo Nodularis • Allergic Rhinitis, Conjunctivitis • Food Allergies, Eosinophilic Esophagitis (EoE) Other Chronic Inflammatory & Autoimmune Diseases High numbers of mast cells and mast - cell mediators are seen in tissues and blood (correlate with severity of inflammation) • Multiple Sclerosis • Rheumatoid Arthritis • Bullous Pemphigoid
Briquilimab is an investigative drug and is not approved for any indication 22 22 Briquilimab in Low - to - Intermediate Risk MDS & Bone Marrow Transplant
23 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 low - to - intermediate risk MDS patients 1 Greenberg PL, et al. Blood (2012) 2 Ma X, et al. Am J Med (2012); GlobalData. 3 de Swart et al. BJHaem (2015) • 70% of myelodysplastic syndrome (MDS) patients have low to intermediate risk (LR - MDS) disease and are typically treated with ESA, other growth factors and/ or transfusions 1 • Current treatments only treat symptoms and do not delay disease progression to AML or High Risk MDS • By directly targeting c - Kit - reliant MDS stem cells, briquilimab may be the first disease modifying therapeutic for LR - MDS patients • Jasper’s ongoing study is designed to examine the impact of briquilimab to shift towards healthier bone marrow and restoration of normal hemopoiesis MDS Prevalence (US/EU) 2 >150K patients Low - to - Intermediate Risk MDS (IPSSR ≤3.5) 1 >100K patients (70%) RBC - Transfusion Dependent 3 >50K patients (50%) Erythropoietin Stimulating Agent (ESA) Market
24 Briquilimab is an investigative drug and is not approved for any indication Briquilimab Phase 1 trial in patients with LR - MDS Normal HSCs MDS HSCs Briquilimab Restoration of healthy bone marrow following briquilimab treatment Single Arm, MAD, Open Label Design (Enrolling) • Dosing: Up to 4 cohorts – 0.3, 0.6, 0.9 and 1.2 mg/kg; Every 8 weeks • Size: 3 - 6 per cohort Briquilimab Bone Marrow Evaluation S S c c r r e e e e n n i i n n g g / / E E l l i i g g i i b b i i l l i i t t y y • IPSS - R very low, low or intermediate risk MDS patients • RBC transfusion dependence, thrombocytopenia or neutropenia Screening/Eligibility • Primary: Safety, tolerability • Secondary: PK, Efficacy by HI - E/HI - P/HI - N, duration of response, reduction in RBC transfusions, ORR, progression free survival • Exploratory: Depletion of leukemic MDS and normal stem & progenitor cells, molecular characteristics of LSCs/HSCs/HPCs, cytokine profile, immunogenicity
25 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is also being tested as a novel conditioning agent for bone marrow transplant • Briquilimab c - Kit inhibition temporarily creates space in specialized bone marrow niches • May drive non - quiescent HSCs to differentiate • Combination with radiation required for full depletion • Briquilimab based bone marrow transplant conditioning regimens has been tested in SCID, Sickle Cell Disease, Fanconi Anemia, CGD, AML and MDS • Large unmet need for reduced toxicity bone marrow conditioning regimens • No briquilimab - related SAEs. Patients range in age from 3 months to 79 years • NIH sponsorship of studies in Sickle Cell, Beta Thalassemia, CGD, GATA - 2 MDS; Stanford sponsorship in Fanconi • Potential approval in SCID provides strategic opportunity for early product launch and Priority Review Voucher
26 Briquilimab is an investigative drug and is not approved for any indication Expanded portfolio presents exciting new opportunities in mast cell diseases Program Milestones Clinical Preclinical Research Sponsor Indication Briquilimab Mast Cell Diseases (Subcutaneous) • IND cleared; EU CTA submitted • FPI expected by YE 2023 • Initial clinical data expected in mid - 2024 Chronic Spontaneous Urticaria • EU CTA submitted • FPI expected in Q1 2024 • Initial clinical data expected in mid - 2024 Chronic Inducible Urticaria Stem Cell Diseases (Intravenous) • Enrolling • Initial clinical data expected late 2023/early 2024 Low - to - Intermediate Risk MDS • Enrolling • Potential BLA filing SCID • First 4 patients achieved full chimerism & count recovery • Expansion to Phase 2a (enrolling) Fanconi Anemia • First 3 patients with full chimerism & Hb increase (enrolling) Sickle Cell Disease • Enrolling Chronic Granulomatous Disease • Study start up GATA2 MDS Investigator Sponsored Studies Jasper maintains full worldwide rights to develop and commercialize briquilimab in all indications
27 Briquilimab is an investigative drug and is not approved for any indication Key milestones & financials • $115.8M cash and cash equivalents as of June 30, 2023 • $16.1M net loss for Q2 2023 • 110.8M outstanding shares as of June 30, 2023 • 43 employees 2023 2024 Briquilimab (c - Kit) CSU CIndU LR - MDS Phase 1b/2a first patient dosed Initial clinical data Initial clinical data Initial clinical data IND clearance; Submit CTA Submit CTA Phase 1b/2a first patient dosed
28 Briquilimab is an investigative drug and is not approved for any indication Jasper is developing briquilimab across multiple disease areas affecting millions of patients with key data read outs expected in 2024 • c - Kit mediated depletion of mast cells is a novel therapeutic approach that has the potential to benefit millions of patients in the US and EU • Briquilimab’s potency and PK properties allows for mast cell depletion while minimizing unwanted adverse effects on other cell types • Briquilimab is in development for multiple diseases with significant mast or stem cell involvement • Chronic Spontaneous Urticaria • Chronic Inducible Urticaria • Low - to - Intermediate Risk MDS • Bone Marrow Transplant Conditioning • Multiple clinical data read outs expected in 2024 across various indications in development
Briquilimab is an investigative drug and is not approved for any indication 29 Jasper Therapeutics NASDAQ: JSPR October 2023