Core Viewpoint - Jasper Therapeutics is focused on developing briquilimab, a novel antibody therapy targeting mast cell-driven diseases, with promising clinical results reported for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [1][2]. Clinical Development - Briquilimab demonstrated a complete response rate of 89% in the BEACON study for CSU patients receiving 240 mg and 360 mg single doses [2][3]. - In the open-label extension study, 73% of patients maintained a complete response at 12 weeks with 180 mg dosed every 8 weeks [3]. - The SPOTLIGHT study showed a 92% complete response rate in CIndU patients at the 180 mg dose, with rapid onset of action observed [3]. Safety and Tolerability - Briquilimab has shown a favorable safety profile, with no dose-limiting toxicities reported and adverse events being low grade and infrequent [3][4]. - Ongoing investigations are being conducted to understand the lack of UAS7 reduction in certain cohorts, with no safety signals observed that would impede further dosing [3][6]. Financial Performance - For the second quarter of fiscal 2025, Jasper reported a net loss of $26.7 million, with a basic and diluted net loss per share of $1.74 [6][10]. - Research and development expenses for the quarter were $21.2 million, while general and administrative expenses totaled $5.9 million [6][10]. Corporate Restructuring - The company implemented a workforce reduction of approximately 50% to focus resources on its urticaria programs and preserve capital [6]. - Non-mast cell focused clinical and preclinical programs have been halted to concentrate on briquilimab development [6]. Cash Position - As of June 30, 2025, Jasper had cash and cash equivalents totaling $39.5 million, down from $71.6 million at the end of 2024 [6][13].

Core Viewpoint - Jasper Therapeutics is undergoing a significant corporate reorganization, including a workforce reduction of approximately 50%, to extend its cash runway and focus on the development of briquilimab for chronic urticaria [1][6]. Company Updates - The company is halting all other clinical and preclinical programs to concentrate resources on briquilimab, which targets mast cell-driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [1][6]. - Dr. Edwin Tucker is departing as Chief Medical Officer, with Dr. Daniel Adelman stepping in as Acting Chief Medical Officer [1][6]. Product Development - Briquilimab is a novel antibody therapy that inhibits signaling through the KIT receptor, leading to the depletion of mast cells and addressing the inflammatory response in mast cell-driven diseases [5][7]. - The company has reported rapid, deep, and durable responses along with a favorable safety profile for briquilimab in both CSU and CIndU [2][6]. Future Plans - Jasper plans to share additional data from the BEACON and open label extension studies later in the year, indicating ongoing commitment to briquilimab's development despite the operational streamlining [2][6].

Core Viewpoint - Jasper Therapeutics faced a significant setback due to issues with a batch of its investigational antibody drug, briquilimab, which interfered with the clinical trial results for chronic spontaneous urticaria (CSU), leading to a 55% drop in its stock price [1][2]. Group 1: Drug Batch Issue - A problematic batch of briquilimab affected the BEACON Ib/IIa clinical trial results, which involved approximately 40 patients in a randomized, double-blind, placebo-controlled study [1]. - Data from 13 patients indicated that those using the problematic batch showed "lower than expected" improvement in tryptase levels, a key pharmacodynamic outcome for the trial [1]. - The primary efficacy measure, urticaria activity score, showed "no significant impact" for the 10 patients using the affected batch [1]. Group 2: Market Reaction and Financial Impact - Following the announcement, Jasper's stock plummeted by 55%, prompting the company to consider cost-cutting measures, including potential strategic restructuring [2]. - As of March 31, Jasper had $48.8 million in cash and cash equivalents, which may be impacted by the current market environment and investor sentiment [2]. - Analysts from BMO Capital Markets suggested that the batch issue would make it harder for Jasper to attract investors in the current market climate [2]. Group 3: Future Plans and Adjustments - Jasper is investigating the specific reasons behind the batch issue and plans to provide new medication to the affected patients from an earlier cohort that showed efficacy [2]. - The company intends to add 10 to 12 new patients to the affected dosage groups to ensure data robustness, with results expected in Q4 [2]. - The initiation of the IIb clinical trial for briquilimab in CSU has been delayed to mid-2026, and the company will no longer pursue the drug for asthma indications [2][3].

Core Viewpoint - Jasper Therapeutics, Inc. is facing a significant decline in stock price, dropping nearly 55% amid high trading volume, following the release of updated data from its BEACON study on briquilimab for chronic spontaneous urticaria (CSU) [1][10]. Group 1: Study Results - The BEACON Phase 1b/2a study reported briquilimab's safety, tolerability, and clinical activity, with primary endpoints focusing on these aspects [2]. - In the study, 89% of participants achieved a complete response, and 78% achieved a clinical response by week 2 [4]. - Mean changes in Urticaria Activity Score over 7 days (UAS7) showed reductions of 28.3 points in the 240mg cohort and 22.9 points in the 360mg cohort at 4 weeks [4]. Group 2: Ongoing Investigations and Adjustments - The company is investigating issues related to a specific drug product lot that affected results in certain cohorts, with findings expected in the coming weeks [6]. - Additional patient enrollment is planned to strengthen the data set for the Phase 2b CSU study, with results anticipated in Q4 2025 and study commencement expected in mid-2026 [7]. Group 3: Strategic Changes - To prioritize resources for briquilimab in CSU, the company is halting the asthma study and pausing development in severe combined immunodeficiency (SCID) [8]. - Cost-cutting measures, including potential restructuring, are being implemented to extend the company's financial runway [8].

Summary of Jasper Therapeutics (JSPR) Update / Briefing July 07, 2025 Company Overview - **Company**: Jasper Therapeutics (JSPR) - **Focus**: Development of therapies for chronic spontaneous urticaria (CSU) using the drug vaprolimab Key Points Industry and Company Context - The conference call was focused on updated data from the BEACON trial and initial data from the open label extension study evaluating vaprolimab in patients with CSU [4][20] Core Findings from the BEACON Trial - **Efficacy**: - A greater than 25 drop in UAS7 (Urticaria Activity Score over 7 days) was observed in the 240 mg and 360 mg single dose cohorts, with 78% complete response and 89% well-controlled disease by week four [4][21] - In the open label extension study, 73% of patients achieved complete response and 82% well-controlled disease at the 12-week assessment with a mean reduction in UAS7 scores of greater than 25 points [17][22] - **Safety Profile**: - Vaprolimab demonstrated a favorable safety profile with no dose-limiting toxicities reported. Treatment emergent adverse events were similar in both active and placebo groups [13][22] - Mild transient adverse events were observed, including taste changes and neutrophil count reductions, but these were self-resolving and did not lead to discontinuations [14][15] Issues Identified - **Confounding Results**: - Two cohorts (240 mg Q8 weeks and 240 mg followed by 180 mg Q8 weeks) showed confounded results due to an issue with a specific drug product lot (lot A34954), which resulted in lower than expected drops in mean tryptase levels and no discernible effect on UAS7 in 10 out of 10 patients dosed with this lot [5][12] - An investigation into the affected lot is ongoing, with results expected in the coming weeks [6][20] - **Next Steps**: - Additional 10 to 12 patients will be enrolled in the affected cohorts to ensure a robust data set for the Phase IIb CSU study expected to commence mid-2026 [6][20] Financial and Operational Insights - **Cash Runway**: - Current guidance into the fourth quarter remains unchanged, but the company is evaluating its cost structure and may need to raise additional capital to extend its runway [54] - **Regulatory Communication**: - The company is in communication with the FDA regarding the lot issue, but there are no safety concerns associated with the affected lot [48][41] Additional Observations - **Durability of Responses**: - The data suggests that the depth of triptase reduction correlates with the depth of UAS7 reductions, indicating a potential for durable effects with the 180 mg dosing regimen [55] - **Patient Management**: - Patients who received the inactive dose from the compromised lot will be transitioned to a new drug product that has demonstrated efficacy in other cohorts [20][48] Conclusion - Jasper Therapeutics is optimistic about the potential of vaprolimab as a differentiated therapeutic option for CSU, despite the setback from the compromised drug lot. The company is taking proactive steps to address the issue and continue its clinical development program.

Core Insights - Jasper Therapeutics, Inc. reported updated data from the BEACON Phase 1b/2a study of briquilimab, showing high efficacy in treating chronic spontaneous urticaria (CSU) with 89% of participants in the 240mg and 360mg cohorts achieving a complete response [1][5] - The study faced confounding results due to issues with a specific drug product lot, prompting an investigation and a halt in the ETESIAN asthma study [2][4] - The company plans to transition affected patients to a new drug product and enroll additional participants to strengthen the data set for the upcoming Phase 2b study [3][5] Study Results - In the BEACON study, 8 of 9 participants (89%) in the 240mg and 360mg single-dose cohorts achieved a complete response, while 73% of participants in the 180mg Q8W open-label extension study achieved a complete response at 12 weeks [1][11] - The 240mg Q8W and 240mg followed by 180mg Q8W cohorts showed confounding results due to the drug product lot issue, with 10 of 13 patients affected [2][5] - Substantial reductions in UAS7 scores were observed, with a mean change of 28.3 points in the 240mg single-dose cohort and 22.9 points in the 360mg single-dose cohort [10] Safety and Tolerability - No grade 3 or higher treatment-related adverse events were reported, indicating a favorable safety profile for briquilimab [1][13] - Mild and predictable decreases in neutrophil counts were observed, but these resolved during the study without leading to discontinuations [13] Future Plans - The company is investigating the drug product lot issue and expects results in the coming weeks, while also planning to enroll an additional 10-12 patients in the affected cohorts [2][3] - The commencement of the Phase 2b study is now expected in mid-2026, with data from additional BEACON patients anticipated in Q4 2025 [3][5] Company Overview - Jasper Therapeutics focuses on developing briquilimab, a monoclonal antibody targeting mast cell-driven diseases such as CSU and chronic inducible urticaria (CIndU) [16][17] - The company aims to address the underlying inflammatory responses in these conditions through its innovative therapeutic approach [16]

Efficacy of Briquilimab 180mg - A single 180mg dose of briquilimab demonstrated a 100% clinical response in participants with Chronic Inducible Urticaria (CIndU) [31] - 92% (11 out of 12) of participants in the 180mg cohort achieved a Complete Response (CR) by week 8 [21] - 83% (10 out of 12) of participants at 180mg had tryptase measurements below the Lower Limit of Quantification (LLOQ) [16] - 67% (8 out of 12) of patients in the 180mg group achieved a clinical response by week 2 [24] - Durability was shown with 58% (7 out of 12) clinical response maintained at 8 weeks (5 CRs and 2 PRs) in the 180mg dose [31] Safety and Tolerability - Briquilimab was well-tolerated in participants with CIndU [31] - Possibly KIT-related adverse events observed were low-grade and transient [31] - A reduction to below Lower Limit of Quantification (LLOQ) (1 µg/L) was seen in 833% (10/12) participants at 180mg [18] Study Design and Demographics - The SPOTLIGHT study is a Phase 1b/2a open-label, single ascending dose study in Chronic Inducible Urticaria [12] - The study included approximately 27 participants across ~5 sites in the EU [12] - The study evaluated briquilimab at 40mg (n=3), 120mg (n=12), and 180mg (n=12) single doses [12]

Core Insights - Jasper Therapeutics, Inc. presented promising data from the 180mg cohort of its SPOTLIGHT Phase 1b/2a study, showing that 100% of participants achieved a clinical response and 92% achieved a complete response [1][2][5] - The study demonstrated rapid and durable efficacy, with significant improvements observed as early as week 1, and 66% of participants achieving clinical response by week 2 [1][5][10] - Briquilimab was well tolerated, with no serious adverse events reported in the 180mg cohort, indicating a potentially differentiated safety profile [1][9][10] Study Design and Results - The SPOTLIGHT study is an open-label clinical trial evaluating briquilimab in adult participants with cold urticaria or symptomatic dermographism who are refractory to antihistamines, enrolling 27 participants across three dose cohorts: 40mg, 120mg, and 180mg [3][4] - Among the 12 participants in the 180mg cohort, 25% were diagnosed with cold urticaria and 75% with symptomatic dermographism, with a high disease burden indicated by provocation threshold testing [4][5] - Overall, 81% of participants in the study achieved a complete response, and 96% achieved either a complete or partial response [6][7] Safety and Tolerability - The mean baseline serum tryptase for the 180mg cohort was 5.1 ng/ml, with significant reductions observed, correlating with clinical responses [8] - No serious adverse events or grade 3 or higher adverse events were reported, with mild, transient drops in neutrophil counts observed in some participants [9][10] - The safety profile of briquilimab appears favorable, with low frequency and low-grade adverse events that resolved quickly [10] Company Information - Jasper Therapeutics is focused on developing briquilimab as a therapeutic for chronic mast cell diseases, including chronic spontaneous urticaria and asthma [13] - The company is conducting clinical studies to further evaluate briquilimab's efficacy and safety profile in patients with chronic urticaria and asthma [13]

Summary of Jasper Therapeutics Conference Call Company Overview - **Company**: Jasper Therapeutics - **Lead Program**: Briquilimab, targeting mast cell-mediated diseases [2][4] Industry Context - **Focus Area**: Mast cell-driven diseases, including chronic spontaneous urticaria, chronic inducible urticaria, and asthma [2][6] - **Market Opportunity**: Significant potential in treating over 3.5 million patients with urticaria and a large asthma market [39] Core Insights and Arguments 1. **Mechanism of Action**: Briquilimab targets the KIT receptor on mast cells, leading to apoptosis and depletion of these cells, which are implicated in various diseases [4][5] 2. **Clinical Trials**: Currently conducting trials for chronic spontaneous urticaria, chronic inducible urticaria, and asthma [6][35] 3. **Efficacy in Urticaria**: Briquilimab demonstrated rapid onset of clinical activity, with significant responses observed within the first week [9][18] 4. **Dosing Strategy**: The company is exploring optimal dosing intervals to maximize efficacy while minimizing adverse effects [7][8] 5. **Safety Profile**: Favorable safety profile with transient adverse events, including hair color changes and taste alterations, which resolved before the next dose [20][25][30] 6. **Comparative Efficacy**: Briquilimab shows competitive efficacy compared to other drugs in development for urticaria [19][28] Additional Important Points 1. **Upcoming Data Releases**: Mid-year data expected from ongoing studies, including the BEACON study and the asthma challenge study [32][38] 2. **Phase 2b Clinical Trial**: Planned initiation in the second half of the year, leading to phase 3 registrational trials [40] 3. **Market Differentiation**: Briquilimab and barzolimab are the only drugs aimed at depleting mast cells, while others only inhibit them [39] Conclusion - **Transformative Year Ahead**: 2025 is projected to be pivotal for Jasper Therapeutics with significant data readouts and trial initiations [40]

Company Overview - Jasper Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing briquilimab, a novel antibody therapy targeting KIT to treat mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma [2] Product Development - Briquilimab is a targeted aglycosylated monoclonal antibody that inhibits the binding of stem cell factor to the cell-surface receptor KIT, leading to the depletion of mast cells through apoptosis, which addresses the inflammatory response in mast cell driven diseases [2] - The company is currently conducting clinical studies of briquilimab for patients with CSU, CIndU, or asthma, demonstrating efficacy and safety in previous trials [2] Investor Engagement - Jasper Therapeutics will participate in the RBC Capital Markets 2025 Global Healthcare Conference on May 21, 2025, and the Jefferies 2025 Global Healthcare Conference on June 5, 2025, with live webcasts available on their Investor Relations website [1]