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Item 8.01. Other Events.
On January 8, 2025, Jasper Therapeutics, Inc. (the “Company”), issued a press release reporting positive preliminary data from the Company’s ongoing BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with chronic spontaneous urticaria and disclosing that the Company will hold a conference call and webinar at 8:00 am EST on January 8, 2025 to present the preliminary data from the BEACON Phase 1b/2a study.
A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the presentation to be used in connection with the conference call and webinar on January 8, 2025 is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Number |
Description | |
| 99.1 | Press Release, dated January 8, 2025. | |
| 99.2 | Presentation—Jasper Therapeutics: Preliminary BEACON Results, dated January 8, 2025. | |
| 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.
|
JASPER THERAPEUTICS, INC. | ||
| Date: January 8, 2025 | By: | /s/ Herb Cross |
| Name: Herb Cross | ||
| Title: Chief Financial Officer | ||
2
Exhibit 99.1
Jasper Therapeutics Reports Positive Data from BEACON Study of Briquilimab in Chronic Spontaneous Urticaria
Rapid onset of deep and durable clinical responses observed across multiple dosing cohorts with a favorable safety profile
Mean change in UAS7 from baseline of -26.6 observed in the 240mg single dose cohort at 8 weeks, multiple dosing regimens ≥120mg demonstrated UAS7 change of more than -25 points
100% (N=3) Complete Responses (UAS7 = 0) observed in the 240mg single dose cohort at 8 weeks and 66% maintained Well Controlled disease at 12 weeks
Serum tryptase reductions below the lower limit of quantification observed at multiple dose levels
Data supports commencement of CSU registrational program expected to commence second half of 2025
Company to host conference call and webinar today at 8:00 a.m. EDT
REDWOOD CITY, Calif., January 8, 2025 (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 positive preliminary data from Jasper’s ongoing BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU. Substantial reductions in UAS7 were reported, with a mean change from baseline at 8 weeks of -26.6 in the 240mg single-dose cohort and multiple dosing regimens at or above 120mg demonstrating UAS7 changes of more than -25 points. Clinical responses were observed as early as 1-week post-first dose, and Complete Responses (UAS7 = 0) were achieved by patients at each therapeutic dose level (80mg, 120mg, 180mg and 240mg), most notably, all patients in the 240mg single-dose cohort (N=3) maintained Complete Responses through the 8-week time-point. Durability of response was generally dose dependent and reductions in serum tryptase to levels below the lower limit of quantification were observed at multiple dose levels. Briquilimab was well tolerated in the study with a favorable safety profile.
“I am excited to see the preliminary clinical data which demonstrated that treatment with briquilimab led to rapid and durable symptom control in patients with CSU, especially given the omalizumab-experienced population enrolled in the BEACON study,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics, University of South Florida Morsani College of Medicine. “I am also very encouraged by the safety and tolerability profile observed thus far in both the BEACON and SPOTLIGHT studies. I believe these data support advancing briquilimab into a registrational program following the completion of BEACON, and I look forward to participating in additional studies of briquilimab in chronic urticaria.”
“We are very pleased to present the positive preliminary data from the BEACON study, which demonstrates the potential of briquilimab as a leading therapeutic for CSU patients,” said Edwin Tucker, Chief Medical Officer of Jasper. “The profound reduction in UAS7 from baseline in multiple cohorts, the dose dependent durability of response and the significant and prolonged drops in mean serum tryptase from baseline demonstrate the potential for deep and durable efficacy of briquilimab in CSU. Combined with the favorable safety profile enabled by our optimal biologic dosing approach, we believe briquilimab has demonstrated the potential to be a leading therapeutic option for patients with CSU. On behalf of the entire Jasper team, I’d like to thank the investigators and the patients who are participating in the study, along with their families and caregivers.”
BEACON Study Design and Data Summary:
The BEACON study is a randomized, double-blind, and placebo-controlled Phase 1b/2a trial evaluating multiple ascending doses of subcutaneous briquilimab as a treatment for adult patients with moderate to severe CSU despite high dose antihistamines and treatment with, or who cannot tolerate, omalizumab. The primary endpoints are safety and tolerability of briquilimab and secondary endpoints are focused on clinical activity and PK/PD, including measurement of serum tryptase and mast cells in skin. Primary measurements used to assess clinical activity were the sum of the Hives Severity Score and the daily Itch Severity Score (ISS), as measured via the Urticaria Activity Score over 7 days (UAS7) on a 0 to 42-point scale.
The preliminary data, as of December 31, 2024, includes the results from 49 participants (N=3 at 10mg, N=3 at 40mg, N=6 at 80mg, N=8 at 120mg, N=14 at 180mg, N=3 at 240mg, and N=12 placebo) who completed at least 12 weeks of follow-up following initial dosing with investigational product. Participants had high disease burden as assessed by UAS7 score with mean baseline score of 27.9 in the 120mg dose group, 25.9 in the 180mg dose group, 26.6 in the 240mg dose group, and 28.6 in the placebo group.
Substantial reductions in UAS7 score were reported with multiple dosing regimens at or above 120mg demonstrating mean change from baseline of greater than -25 points at 12 weeks, as well as a mean change from baseline at 8 weeks of -26.6 points in the 240mg single-dose cohort. Complete responses (UAS7 = 0) were achieved by patients treated at each therapeutic dose level (80mg, 120mg, 180mg and 240mg), and all patients in the 240mg single-dose cohort (N=3) maintained Complete Responses through the 8-week time-point. In general, clinical responses following first dose at the 120mg and 180mg dose levels showed durability out to 4-6 weeks, while clinical responses at the 240mg level showed durability out to 8-12 weeks. These data demonstrate that treatment with briquilimab leads to rapid onset of durable and dose-dependent symptom control in patients with CSU.
Single-Dose Clinical Activity Assessments Summary at Week 8
|
|
240 mg Single-Dose (N=3) |
Placebo (N=12) | ||
| UAS7 Changes | ||||
| Baseline mean UAS7 (SD) | 26.6 (10.9) | 28.6 (9.4) | ||
| Mean change at Week 8 | -26.6 | -12.4 | ||
| Mean difference from placebo | -14.2 | - | ||
| Clinical Responses | ||||
| UAS7≤6 (Well Controlled) | 100% | 25% | ||
| UAS7=0 (Complete Response) | 100% | 17% | ||
2
Q8W Dose Clinical Activity Assessments Summary at Week 12
|
|
80mg Q8W (N=6) |
120 mg Q8W (N=4) |
180mg Q8W (N=7) |
Placebo (N=12) | ||||
| UAS7 Changes | ||||||||
| Baseline mean UAS7 (SD) | 31.0 (7.9) | 27.0 (7.5) | 26.5 (8.0) | 28.6 (9.4) | ||||
| Mean change at Week 12 | -9.3 | -27.2 | -13.2 | -9.2 | ||||
| Mean difference from placebo | -0.1 | -18.0 | -4.0 | - | ||||
| Clinical Responses | ||||||||
| UAS7≤6 (Well Controlled) | 33% | 75% | 43% | 8% | ||||
| UAS7=0 (Complete Response) | 17% | 50% | 29% | 8% | ||||
Q12W Dose Clinical Activity Assessments Summary at Week 16
|
|
120 mg Q12W (N=4) |
180mg Q12W (N=7) |
Placebo (N=12) | |||
| UAS7 Changes | ||||||
| Baseline mean UAS7 (SD) | 28.8 (10.6) | 27.8 (7.8) | 28.6 (9.4) | |||
| Mean change at Week 16 | -29.8 | -21.7 | -10.1 | |||
| Mean difference from placebo | -19.7 | -11.6 | - | |||
| Clinical Responses | ||||||
| UAS7≤6 (Well Controlled) | 75% | 57% | 25% | |||
| UAS7=0 (Complete Response) | 50% | 57% | 17% | |||
Mean baseline serum tryptase for participants in the enrolled in the study was within the normal range in all cohorts. Substantial reductions in tryptase were observed as early as the week 1 assessment and were correlated with the onset of clinical responses. Tryptase levels below the lower limit of quantification were reported for 86% (6 of 7) of participants in the 180mg Q8W cohort at week 2, and for 100% (3 of 3) of participants in 240mg single dose cohort at week 1.
Briquilimab was well tolerated in the study, with no dose limiting toxicities observed. Safety observations potentially related to c-Kit blockade were infrequent and generally limited to low grade events, none of which resulted in discontinuations or dose delays and the majority of which resolved during repeat dosing. Predictable decreases in neutrophil counts were observed upon dosing, with counts generally recovering prior to subsequent dose and no association to fever or infection. A single Grade 3 neutropenia event was reported in a participant with prior history of idiopathic neutropenia and thrombocytopenia.
3
Patients enrolled in the study will continue to be dosed and assessed for safety/tolerability and clinical activity, and Jasper has commenced an open-label extension study in chronic urticarias that will roll over patients from the BEACON to a 180mg Q8W dose upon completion of their initial follow up period. Consistent with the Company’s clinical development plan, Jasper submitted for regulatory review of two additional BEACON cohorts, 240mg Q8W (N=8) and 180mg Q8W following a 240mg induction dose (N=8).
Jasper expects to begin a registrational program in CSU with a Phase 2b study expected to commence in the second half of 2025. Final selection of doses for the Phase 2b study will be further informed by additional data at 180mg Q8W from the open-label extension study, as well as by further data from BEACON cohorts evaluating a 360mg single dose, a 240mg Q8W dose and a 180mg Q8W dose following a 240mg loading dose. Data from these additional cohorts are expected to be presented by mid-2025.
“We are very happy to report preliminary data from the BEACON study,” said Ronald Martell, President and Chief Executive Officer of Jasper. “The favorable safety profile, rapid onset of durable responses, the pharmacokinetic profile, and the depth and durability of tryptase reductions observed, all support advancing a 240mg dosing regimen into the Phase 2b portion of a CSU registrational program that we plan to commence in the second half of 2025. With positive data in both SPOTLIGHT and BEACON studies and preliminary data on the ETESIAN study in asthma expected in the second half of 2025, we continue to rapidly advance our briquilimab franchise in mast cell driven diseases.”
Conference Call / Webinar
Jasper will host a conference call and webinar today at 8:00 a.m. EDT, including remarks from Dr. Thomas B. Casale, M.D., the lead US investigator for the BEACON study. A live question and answer session with management will follow the formal presentations. A link to the webinar, including presentation slides, can be found here.
The presentation slides and a link to the live and archived webcast will also be available on the Events & News – Events page of Jasper’s Investor Relations website.
About Briquilimab
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 c-Kit, also known as CD117, 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 conducting clinical studies of briquilimab as a treatment in patients with CSU, CIndU or asthma. Briquilimab has a demonstrated efficacy and safety profile in patients and healthy volunteers, with positive clinical outcomes in CSU and CIndU. For more information, please visit us at www.jaspertx.com.
4
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 potential in mast cell driven diseases such as CSU, CIndU, and asthma and as a leading therapeutic for CSU patients; the potential for deep and durable efficacy of briquilimab in CSU; briquilimab’s safety profile; the advancement of briquilimab into a registrational program; additional studies of briquilimab in chronic urticaria; patient enrollment in an open-label extension study in chronic urticarias that will roll over patients from the BEACON to a 180mg Q8W dose; regulatory review of two additional BEACON cohorts, 240mg Q8W (N=8) and 180mg Q8W following a 240mg induction dose (N=8); Jasper’s expectations regarding a registrational program in CSU, including the expected timing of the Phase 2b study and dose selection; Jasper’s expected timing for presenting data from additional BEACON cohorts; and Jasper’s expectations regarding rapidly advancing its briquilimab franchise in mast cell driven diseases. 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, including preliminary results for the BEACON study reported in this press release, may not be replicated in continuing or future studies and trials; 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, 2023 and subsequent Quarterly Reports on Form 10-Q. 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@jaspertherapeutics.com
Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
jallaire@lifesciadvisors.com
Lauren Walker (media)
Real Chemistry
646-564-2156
lbarbiero@realchemistry.com
5
Exhibit 99.2
1 Briquilimab is an investigative drug and is not approved for any indication Jasper Therapeutics: Preliminary BEACON Results NASDAQ: JSPR January 8 th , 2025
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 statem ents. All statements other than statements of historical fact contained in this Presentation, including statements regarding the future opportunities an d p rospects of Jasper Therapeutics, Inc. (together with its subsidiary, "Jasper" or the "Company"), including milestones, potential regulatory fili ngs and the anticipated timing thereof, patient enrollment, future timelines, business strategy, and plans and objectives for future operations, are forward - lo oking statements. Jasper has based these forward - looking statements on its estimates and assumptions and its current expectations and projections about futur e events. These forward - looking statements are subject to a number of risks, uncertainties and assumptions, including those contained in the "Risk Fa cto rs" section of the Company's Annual Report on Form 10 - K for the year ended December 31, 2023, 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 - lo oking events and circumstances discussed in this Presentation are inherently uncertain and may not occur, and actual results could differ materially and adv ers ely from those anticipated or implied in the forward - looking statements. Accordingly, you should not rely upon forward - looking statements as predictions of fu ture events. Jasper undertakes no obligation to update publicly or revise any forward - looking statements for any reason after the date of this Prese ntation 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, adv ise rs or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or represen tat ives 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 Prese nta tion. 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 shou ld 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 Briquilimab is an investigative drug and is not approved for any indication Today’s agenda and presenters Title (Affiliation) Presenter Topic Chief Executive Officer Ronald Martell Opening Remarks and Topline Summary Chief Medical Officer Edwin Tucker, MD, MRCP BEACON Preliminary Results Summary Prof of Medicine and Pediatrics, University of South Florida Thomas B Casale, MD Briquilimab for Chronic Urticaria Chief Executive Officer Ronald Martell Upcoming Milestones and Closing Remarks
4 Briquilimab is an investigative drug and is not approved for any indication 4 BEACON Preliminary Results Summary Edwin Tucker, MD, MRCP
5 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication 80mg 120mg 120mg 180mg 180mg 240mg 360mg 10 mg 40 mg Open Label Double - Blind Placebo - Controlled Screening/Eligibility • CSU diagnosis ≥ 6 mos. • UAS7 ≥ 16 • 18+ years • H1 - antihistamine - failed • Intolerant or refractory to omalizumab Study Operations • US Lead: Thomas Casale , MD • EU Lead: Martin Metz, MD • ~30 sites in the US & EU • n = ~77 x Disease Scores: UAS7, UCT x Mast Cell Depletion & Recovery: Serum Tryptase, Skin Biopsies x Safety: TEAEs, SAEs x PK Key Assessments Weeks 0, 4, 12, 20 Phase 1b/2a BEACON study in chronic spontaneous urticaria Randomized, double - blind, placebo - controlled, multiple ascending dose study N=3 N=3 Participants ( Randomization ) N=8 (3:1) N=6 (2:1) N=6 (2:1) N=10 (3:1) N=9 (3:1) N=4 (3:1) N=4 (3:1) Treatment Period (24 weeks ) Dose Group Q8W Q8W Q8W Q12W Q12W Single Dose Single Dose (ongoing, data not available)
6 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Baseline demographics were generally balanced across the cohorts Representative of a population of moderate to severe patients with CSU Pooled Placebo (N=12) 240mg 2 (N=3) 180mg pooled (N=14) 120mg pooled (N=8) 80mg Q8W (N=6) 10mg / 40mg 1 (N=6) 39 (26 - 60) 44 (29 - 64) 38 (18 - 73) 43 (23 - 82) 63 (22 - 77) 55 (31 - 63) Age (years), median (range) 10 (83%) 3 (100%) 7 (50%) 5 (63%) 3 (50%) 6 (100%) Female Sex, n (%) 78 (66 - 110) 76 (67 - 84) 84 (64 - 131) 88 (63 - 122) 98 (77 - 129) 66 (55 - 93) Weight (kg), median (range) 27 (24 - 42) 27 (27 - 31) 31 (22 - 41) 29 (22 - 43) 34 (24 - 50) 25 (22 - 30) BMI, median (range) 28.6 (9.4) 26.6 (10.9) 25.9 (7.8) 27.9 (8.6) 31.0 (7.9) 26.1 (9.5) UAS7 (0 - 42), mean (SD) 3.7 (3.6) 3.7 (1.5) 4.5 (3.1) 3.7 (1.5) 3.3 (2.4) 3.6 (2.8) UCT (0 - 16), mean (SD) 8.5 (4.7) 4.5 (1.0) 6.0 (3.2) 7.8 (5.1) 8.4 (2.6) 6.6 (1.4) Serum Tryptase (ug/L), mean (SD) All participants were refractory or intolerant to omalizumab, representing a CSU population of highest unmet medical need 1 Briquilimab 10mg and 40 mg doses were administered at Week 0, 4, 12 and 20; 2 Briquilimab 240 mg was administered as a single dose
7 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Briquilimab demonstrated deep reductions in UAS7 scores >25pt reduction in UAS7 noted in multiple dosing regimens ≥120mg Q8W regimens UAS7 Mean Change from Baseline at Week 12 - 29.8 - 21.7 - 10.1 -30 -25 -20 -15 -10 -5 0 Q12W regimens UAS7 Mean Change from Baseline at Week 16 Placebo n=9 120mg n=3 180mg n=6 - 9.3 - 27.2 - 13.2 - 9.2 -30 -25 -20 -15 -10 -5 0 80mg n=6 Placebo n=11 120mg n=3 180mg n=5 △ - 18.0 △ - 19.7 △ - 11.6 240mg SD UAS7 Mean Change from Baseline at Week 8 - 26.6 - 12.4 -30 -25 -20 -15 -10 -5 0 Placebo n=11 240mg SD n=3 △ - 14.2 Data cut - off 31 Dec 2024
8 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Dose dependent increase in patients achieving Complete Response (UAS7=0) Complete responses noted at all doses ≥ 80mg Q8W Complete Response at Week 12 (UAS7=0) 16.7% 50.0% 28.6% 8.3% 0% 20% 40% 60% 80% 100% 80mg n =6 Placebo n =12 120mg n =4 180mg n =7 Q12W Complete Response at Week 16 (UAS7=0) 240 mg Complete Response at Week 8 (UAS7=0) 100.0% 16.7% 0% 20% 40% 60% 80% 100% Placebo n =12 240 mg n = 3 Data cut - off 31 Dec 2024 Placebo n=12 120mg n=4 180mg n=7 The last observation carried forward (LOCF) method was used for data imputation 50.0% 57.1% 16.7% 0% 20% 40% 60% 80% 100%
9 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Dose dependent increase in patients achieving Well Controlled Disease 50% or more of patients achieved well - controlled disease 4 weeks post - dosing in multiple dose regimens Well Controlled at Week 12 (UAS7 < 6) 33.3% 75.0% 42.9% 66.7% 8.3% 0% 20% 40% 60% 80% 100% 80mg Q8W n =6 Placebo n =12 120mg Q8W n =4 180mg Q8W n =7 Well Controlled at Week 16 (UAS7 < 6) Well Controlled at Week 8 (UAS7 < 6) Placebo n=12 120mg Q12W n=4 180mg Q12W n=7 The last observation carried forward (LOCF) method was used for data imputation 100.0% 25.0% 0% 20% 40% 60% 80% 100% Placebo n =12 240 mg SD n = 3 Data cut - off 31 Dec 2024 240 mg SD n =3 75.0% 57.1% 25.0% 0% 20% 40% 60% 80% 100%
10 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication All patients in the 240mg single - dose cohort maintained CR to 8 weeks All patients achieving CR by week 2, with 66% Well Controlled at Week 12 0% 20% 40% 60% 80% 100% 0 1 2 3 4 5 6 7 8 9 10 11 12 Placebo 240mg Week 240mg Complete Response Weeks 1 - 12 (UAS7=0) 0% 20% 40% 60% 80% 100% 0 1 2 3 4 5 6 7 8 9 10 11 12 240mg Placebo Week 240mg Well Controlled Weeks 1 - 12 (UAS7 6) n=3 n=12 Data cut - off 31 Dec 2024
11 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Dose dependent UAS7 reductions observed over 26 weeks Deeper UAS7 reductions observed in subsequent doses 0 10 20 30 40 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 240mg SD 180mg Q8W 120mg Q8W Weeks Weekly UAS7 Score Placebo Data cut - off 31 Dec 2024
12 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Data cut - off 31 Dec 2024 Weeks Serum Tryptase ( n g/mL) 240mg SD 180mg pooled 120mg pooled Placebo 80mg Q8W LLOQ – 1.6 ng/mL 0 2 4 6 8 10 12 0 1 2 4 6 8 Dose dependent reductions in serum tryptase Reduction to LLOQ seen in multiple patients at 180mg Q8W and all patients at 240mg dose levels * All values below LLOQ (1.6 ng/ml) are represented as 50% of LLOQ (0.8 ng/ml)
13 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Briquilimab PK demonstrates early Cmax consistent with rapid onset of response in patients with CSU • Preliminary PK data in patients with CSU indicates briquilimab PK is comparable to historical data in healthy volunteers • 240mg briquilimab SC Tmax is 4 - 7 days with a half - life of approximately 9 days • No accumulation predicted for repeat dosing of 240mg SC briquilimab on a Q8W dosing schedule • Preliminary data indicate 34% incidence of anti - drug antibodies (ADA) and no clinically meaningful effect of ADAs on briquilimab PK in CSU patients Briquilimab Serum Concentration over Time in CSU Patients Following SC Administration Data cut - off 31 Dec 2024
14 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Briquilimab was well tolerated and demonstrated a favorable safety profile >24 - week exposure for 10mg - 180mg doses, 12 - weeks for 240mg dose as of 31Dec24 data cut Pooled Placebo (N=12) n (%) Pooled Briquilimab (N=37) n (%) Number of Participants With 0 (0) 0 (0) Any DLT 8 (66.7) 26 (70.3) Any TEAE 0 (0) 1 (2.7) 1 Any Treatment - Related Serious TEAE 0 (0) 1 (2.7) 1 Any Hypersensitivity 0 (0) 0 (0) Any Anaphylaxis 0 (0) 1 (2.7) 1 Any TEAE Leading to Discontinuation of IP 1 (8.3) 3 1 (2.7) 2 Adverse Event > Grade 3 1 Single participant, 180mg Q8W, CoFAR grade 2 hypersensitivity reaction 2 Single participant, 180mg Q12W, CTCAE grade 3 AE: neutropenia, unrelated - prior history of idiopathic neutropenia, thrombocytopenia 3 Single participant , placebo, CTCAE grade 3 bronchitis Most commonly reported AEs (≥5 participants): nasopharyngitis, fatigue, hair color change, taste changes Data cut - off 31 Dec 2024
15 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Safety observations possibly related to c - Kit blockade were infrequent and generally limited to low grade events Majority resolved during repeat dosing and none resulted in discontinuations or dose delays Data cut - off 31 Dec 2024 CTCAE Grade / Comments Pooled Placebo N=12 (%) Pooled Briquilimab N=37 (%) Adverse Event as reported term • 4 reported as Grade 1, 1 Grade unreported • 2 cases reported to be resolved/resolving 1 (8.3) 4 (10.8) Hair color changes • No skin discoloration observed with patient exposure up to 24 weeks 1 (8.3) 0 (0) Skin discoloration • All mild, Grade 1 occurring on first dose, 1 recurrence (resolved) • Taste reductions: bitter, salt, umami • Resolved in 4 patients: Median time to resolution of 31 days 0 (0.0) 6 (16.2) Taste change/ Hypogeusia • Grade 3 neutropenia in a single participant with prior history of idiopathic neutropenia and thrombocytopenia • Grade 1 neutropenia in 3 participants, all resolved prior to subsequent dose • No fevers or infections associated 1 (8.3) 3 (8.1) Neutropenia • 2 Grade 1 decreases in neutrophil counts resolved prior to subsequent dose • No fevers or infections associated 0 (0.0) 2 (5.4) Neutrophil count decreased
16 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication 0 2 4 6 8 10 12 14 16 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 240mg SD 180mg Q8W 120mg Q8W Weeks Mean Neutrophils (10 9 /L) Placebo Data cut - off 31 Dec 2024 Neutrophil counts generally remained stable, with predictable reduction which subsequently recovered No discontinuations or dose delays due to reductions in neutrophil counts Source: Figure 14.3.4.1 ULN LLN
17 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Preliminary BEACON study results demonstrate briquilimab achieved rapid, deep and durable responses in patients with moderate to severe CSU • Participants had moderate to severe CSU and were omalizumab experienced • Clinical responses in this hard - to - treat population are encouraging for a broader CSU population • Briquilimab demonstrated rapid and deep disease control • Rapid onset of effect – Clinical responses as early as 1 week post first dose • Deep dose - dependent response: – Multiple dosing regimens ≥120mg demonstrated UAS7 changes of more than - 25 points – Deepest responses shown of - 29 on the UAS7 scale • Complete and durable control demonstrated – Complete responses seen at all dose cohorts ≥ 80mg – 100% complete control with 240mg by week 2, durable to 8 weeks – Repeat dosing shows deepening clinical responses across multiple dose cohorts • Rapid, dose - dependent tryptase reductions correlated with early onset of clinical response • Reduction to LLOQ observed in multiple dose cohorts
18 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Efficacy, safety and PK informs an optimal biologic dose selection for briquilimab CSU registrational program expected to be initiated in 2H 2025 • Briquilimab was well tolerated and had a favorable safety profile in the study • Low and comparable frequency of Grade 1 hair color changes – in both active and placebo • Mild taste changes observed on first dose with majority resolving by a median of 31 days • No dose delays or discontinuations due to neutrophil reductions and no association with infection – Neutrophil recovery between doses • Single discontinuation due to AE • Registrational program in CSU expected to commence second half of 2025 • Deep and durable efficacy to 240mg dose, combined with the favorable safety profile observed support advancing into Phase 2b portion of a registrational program • Ongoing trials continue to generate clinical data to support registrational program • Expansion of 240mg and 360mg single dose cohorts ongoing • Additional cohorts of 240mg Q8W and 240mg induction dose followed by 180mg Q8W • Additional 180mg Q8W data from BEACON and SPOTLIGHT Open Label Extension study • These data will further inform final dose selection for the Phase 2b portion of our registrational program
19 Briquilimab is an investigative drug and is not approved for any indication 19 Briquilimab for Chronic Urticaria Thomas B Casale, MD Prof of Medicine and Pediatrics, University of South Florida
20 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Severe CSU Moderate CSU Presentation Persistent or severe full - body hives 3 - 5 mod - severe flair - ups weekly UAS7 28+ Severe itch and 50+ wheals UAS7 16 - 27 Moderate itch and 20 - 50 wheals Severity Score 14.3* 10.9 Quality of Life (DLQI) 15% of all CSU 25% of all CSU Prevalence Moderate - to - severe CSU may lead to significant impact to patient’s lives and is associated with poorer outcomes * Comparable to DLQI in moderate - severe psoriasis (Average DLQI of 14.8); other QoL measures (MCS, PCS) are similar across CSU, AD, and PsO (Nikolaev I, et al. EAACI Hybrid Congress, July 1 - 3, 2022) 1 Lambert et al. 2021; 2 Weller K, et al. EADV 2023; 3 Kolkhir et al. 2025; 4 Balp MM, et al., EADV 2023, Jasper Market Research and Expert Interviews • CSU is a recurring inflammatory condition of the skin lasting 6 weeks or more, characterized by the development of itchy wheals (hives), angioedema, or both 1 • CSU has a significant negative impact on daily life including sleep, relationships and ability to work 2 • CSU is associated with higher risk of suicide, depression, anxiety and all - cause mortality 3 • Approximately 1.4m patients in the US, Germany, France, Italy, Spain and the UK have moderate to severe CSU 4 • Current approved therapies limited to anti - histamines and a single anti - IgE biologic (omalizumab)
21 Briquilimab is an investigative drug and is not approved for any indication Preliminary BEACON data in CSU show that briquilimab leads to deep and durable efficacy with a favorable safety profile 1 Moller C et al. Blood (2005) 2 Hundley TR et al. Blood (2004) 3. Arnold JN et al. Annu Rev Immunol (2007) • Mast cell degranulation is the central pathogenic driver of chronic urticarias • Briquilimab blocks c - Kit signaling and may lead to depletion of mast cells • Preliminary BEACON efficacy results show multiple regimens associated with clinically meaningful declines in UAS7 • Preliminary efficacy results show rapid onset of action, with the 240mg dose showing high 100% CR, durable to 8 weeks • Preliminary BEACON safety results show low incidence of manageable AEs • Based on these data, briquilimab appears to a promising new therapy for moderate to severe CSU patients • Advancement to registrational trials is warranted
22 Briquilimab is an investigative drug and is not approved for any indication 22 Upcoming Milestones and Closing Remarks Ronald Martell
23 Briquilimab is an investigative drug and is not approved for any indication • Briquilimab demonstrated rapid onset of action with disease control observed as early as one week after initial dose • Complete responses were observed at doses as low as 80mg Q8W and 240mg dose demonstrated 100% Complete Responses with durability out to 8 weeks • Serum tryptase reductions below the lower limit of quantification were observed in multiple dose cohorts • Favorable safety profile observed in preliminary data support the potential of optimal biologic dosing o On target adverse events seen were low - grade and at low incidence rates o Many of the possible on - target AEs resolved between doses • Additional BEACON cohorts and the open label extension study will further inform final dose selection for Phase 2b study planned to commence 2H 2025 Positive preliminary BEACON study results support commencing briquilimab registrational program in CSU in 2H 2025
24 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Briquilimab has the potential to be a major immunology franchise by delivering control to millions of patients with mast - cell driven diseases • Eosinophilic Esophagitis • IBD • Food Allergies • Asthma • COPD • Chronic Rhinosinusitis with Nasal Polyps • Chronic Spontaneous Urticaria • Chronic Inducible Urticaria 2 million 20 million 30+ million Moderate - to - Severe Disease (US/EU 1,2 ) Chronic Atopic and Mast Cell Driven Diseases • Prurigo Nodularis • Atopic Dermatitis 1 EvaluatePharma ; 2 Databridge Market Research (allergic rhinitis)
25 Briquilimab is an investigative drug and is not approved for any indication Key milestones 2024 CSU CIndU Asthma Conferences PHASE 1B/2A = Completed = Future events/milestones 2025 2026 Registrational Phase 1b/2a a. Initial clinical data Clinical data all cohorts Open Label Extension Phase 1b/2a Phase 1b/2aa. Open Label Extension Clinical data all patients Registrational Next Mast Cell Indication Initial clinical data Phase 1b/2a ase 1b/2aa. First patient dosed Initial clinical data Phase 2b Phase 1b/2a EADV ACAAI AAAAI EAACI EADV GA 2 LEN ATS ACAAI AAD AAAAI EAACI ATS AAD ERS EADV GA 2 LEN ACAAI ERS
26 Briquilimab is an investigative drug and is not approved for any indication Briquilimab is an investigative drug and is not approved for any indication Q&A
27 Briquilimab is an investigative drug and is not approved for any indication Jasper Therapeutics: Preliminary BEACON Results NASDAQ: JSPR January 8 th , 2025