Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Jasper Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On July 7, 2025, Jasper Therapeutics released updated data from its BEACON Phase 1b/2a study of briquilimab, indicating issues with a specific drug product lot that affected results in certain patient cohorts [3] - The stock price of Jasper Therapeutics fell by $3.73 per share, or 55.1%, closing at $3.04 per share following the announcement of the study results [3] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4]

Core Viewpoint - Jasper Therapeutics, Inc. is under investigation for potential securities fraud and unlawful business practices following a significant drop in stock price due to issues related to a drug product lot in a clinical study [1][2]. Group 1: Company Overview - Jasper Therapeutics, Inc. is publicly traded on NASDAQ under the ticker symbol JSPR [1]. - The company recently reported updated data from its BEACON Phase 1b/2a study of briquilimab, which is intended for adult participants with chronic spontaneous urticaria (CSU) [2]. Group 2: Recent Developments - On July 7, 2025, Jasper announced that results from certain dose cohorts of its clinical study were confounded by issues with a specific drug product lot, affecting 10 out of 13 patients in those cohorts [2]. - Following this announcement, Jasper's stock price plummeted by $3.73 per share, representing a 55.1% decrease, closing at $3.04 per share on the same day [2]. Group 3: Legal Context - Pomerantz LLP is investigating claims on behalf of Jasper investors, focusing on potential securities fraud and misconduct by the company and its officers or directors [1]. - The Pomerantz Firm has a long history in corporate and securities class litigation, having recovered significant damages for victims of securities fraud [3].

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, 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]

Summary of Jasper Therapeutics Spotlight Data Update Conference Call Company Overview - **Company**: Jasper Therapeutics - **Focus**: Development of briquilimab for chronic inducible urticaria (Sindu) and other mast cell diseases Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting mast cell-driven diseases - **Condition**: Chronic inducible urticaria (Sindu) is a debilitating skin condition with significant quality of life impacts and no approved treatments globally beyond antihistamines [6][8] Core Findings and Data - **Clinical Trial**: Phase Ib/IIa Spotlight clinical trial evaluating briquilimab in chronic inducible urticaria - **Cohort Data**: - 180 mg cohort: 100% clinical response rate, with 92% achieving complete response [11][12] - 120 mg cohort: 92% clinical response rate, with 83% achieving complete response [11][15] - Overall, 96% of patients across all doses achieved a clinical response, and 81% achieved a complete response [5] - **Safety Profile**: - Briquilimab was well tolerated with no serious adverse events reported at the 180 mg dose level [18][21] - Adverse events included nasopharyngitis, fatigue, and headache, all mild and transient [19][20] - **Efficacy Timeline**: - 67% of participants in the 180 mg cohort achieved a clinical response by week two [12] - 58% maintained clinical response at week eight [12][21] Additional Important Insights - **Unmet Medical Need**: Chronic inducible urticaria has a high unmet medical need, with significant impacts on patients' quality of life [6][8] - **Mechanism of Action**: Briquilimab targets KIT on mast cells, potentially offering a new treatment paradigm for mast cell diseases [21] - **Future Studies**: Plans for registrational studies in Sindu and chronic spontaneous urticaria (CSU) are underway, with a focus on advancing briquilimab into further clinical trials [22][23] - **Upcoming Milestones**: Full results from the Spotlight study are expected to be presented at a medical conference in the second half of 2025 [23] Conclusion - Jasper Therapeutics is making significant progress in developing briquilimab for chronic inducible urticaria, demonstrating robust efficacy and a favorable safety profile. The company is poised to advance its clinical programs, addressing a critical gap in treatment options for patients suffering from mast cell-driven diseases.

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]