PresentationThank you for standing by. Welcome to the Jasper Therapeutics Chronic Urticaria Data Update Webinar. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Jasper Investor Relations website following the conclusion of the event. I'd now like to hand the call over to Jasper's Head of Investor Relations, Alex Gray. Please go ahead, Alex.Alex Gray Thank you, Tara, and thank you to those listening in today. Joining us for the prepared remarks a ...

Summary of Jasper Therapeutics Chronic Urticaria Data Update Webinar Company Overview - **Company**: Jasper Therapeutics (NasdaqCM: JSPR) - **Focus**: Development of briquilimab for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) Key Points and Arguments Industry and Product Development - **Briquilimab**: An antibody targeting the KIT receptor, showing promise in treating mast cell-driven diseases, including CSU and CIndU [4][5] - **Clinical Trials**: Updated data from the BEACON study and an open-label extension study were presented, indicating positive outcomes for briquilimab [4][5] Efficacy and Safety Data - **BEACON Study Results**: - Six out of eight patients receiving briquilimab achieved complete response (CR) by week three, and four out of six by week 12 [6][9] - Mean reduction of UAS7 scores was 31 points at week 12, indicating significant symptom relief [9][12] - Rapid onset of disease control was observed, with most patients showing improvement within two weeks [9][10] - **Open-Label Extension Study**: - 63 patients treated with briquilimab showed durable clinical responses, with 65% of CIndU patients achieving CR or partial response (PR) at week 16 [9][15] - A favorable chronic safety profile was reported, with low incidence of KIT-related adverse events [7][20] Future Plans - **Phase 2b Study**: - Expected to commence in the second half of 2026, involving 75 to 100 adult patients with CSU [8][20] - The study will evaluate two effective dose regimens versus placebo [20] - **Dose Selection**: - Ongoing analysis of current data will inform the final dose selection for the phase 2b study [24][55] - Consideration of weight-adjusted dosing to optimize efficacy [48][55] Competitive Positioning - **Differentiated Product Profile**: - Briquilimab's unique mechanism of action and favorable safety profile position it competitively against other therapies targeting the KIT receptor [18][19] - The company believes the data supports a compelling product profile for chronic urticarias [20] Financial Considerations - **Capital Requirements**: - Current capital is sufficient to support operations through mid-2026, but additional funding will be necessary for future studies [28] - **Partnership Opportunities**: - The company is open to potential partnerships to support broader development across multiple indications [34] Additional Important Information - **CEO Transition**: The change in leadership was driven by the need for a new direction as the company progresses into pivotal studies [24] - **Regulatory Considerations**: The company is preparing to engage with regulatory bodies regarding the phase 2b study design and dose selection [25][46] This summary encapsulates the critical insights from the Jasper Therapeutics webinar, highlighting the company's advancements in chronic urticaria treatment and future strategic directions.

67% of additional patients (n=6) enrolled in the BEACON study achieved a complete response at 12 weeks with a mean UAS7 reduction of 31 points 75% of CSU participants (n=36) enrolled in the open label extension study achieved a complete response or well controlled disease at 12 weeks With a median duration of follow up of more than 200 days on 63 participants in the open label extension study, KIT related AEs were low in frequency and predominantly low-grade events that resolved while on study BEACON and o ...

Company Leadership Changes - Jasper Therapeutics has appointed Jeet Mahal as President and Chief Executive Officer, effective January 5, 2026, succeeding Ronald Martell [2][3] - Thomas Wiggans has been appointed as the Executive Chairperson of the Board of Directors [2][3] Strategic Focus and Development - The company is preparing to commence the registrational program for briquilimab, targeting mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [3][4] - Mr. Mahal brings over thirty years of experience in the life sciences industry, with a focus on developing therapeutics and leading biotech companies through clinical trials [3][4] Upcoming Events - Jasper will host an investor webinar on January 8, 2026, at 8:00 a.m. ET to present updated data from the BEACON study and the open-label extension study in CSU and CIndU [2][5] - A live question and answer session will follow the formal presentation during the webinar [5][6] Product Development - Briquilimab is a targeted monoclonal antibody that inhibits signaling through the KIT receptor, aiming to deplete mast cells and address inflammatory responses in diseases like CSU and asthma [7][8] - The drug has shown efficacy and safety in clinical studies involving patients and healthy volunteers, with positive outcomes reported in CSU, CIndU, and allergic asthma [8]

Summary of Jasper Therapeutics FY Conference Call Company Overview - **Company**: Jasper Therapeutics (NasdaqCM:JSPR) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company specializing in monoclonal antibodies, particularly briquilimab (BRIC) for chronic spontaneous urticaria (CSU) and asthma [3][2] Key Findings and Updates Chronic Spontaneous Urticaria (CSU) - **Investigation Results**: An internal investigation was initiated after unexpected results in cohorts eight and nine, where 10 out of 13 patients showed no clinical response. The investigation concluded that the drug product was not at fault; rather, many patients did not have mast cell-mediated CSU [4][5][6] - **Misdiagnosis Rate**: It was noted that 20%-25% of CSU patients may be misdiagnosed, emphasizing the challenges in clinical diagnosis without biomarkers [7][8] - **New Measures**: To prevent future misdiagnoses, additional measures have been implemented, including a third clinical reviewer and requiring a minimum six-month history of CSU diagnosis for new patients [8][9] Upcoming Data and Expectations - **Data Milestones**: Significant data is expected in the first half of Q1, including results from new patients in cohorts eight and nine. A complete response rate similar to Celldex's 50% would be considered a success [10][11] - **Safety Profile**: The safety profile of briquilimab is a primary focus, with positive results noted in previous dosing [11][12] Open Label Extension (OLE) Study - **Patient Enrollment**: Most patients from the Beacon study opted to roll over into the OLE, indicating perceived benefits from the treatment. Data from 35-40 patients in the OLE will be available early next year [17][18] Phase 2B Study Design - **Study Structure**: The upcoming phase 2B study will be a three-arm trial with two dosing regimens and a placebo arm, estimated to cost $40-$50 million [19][30] Asthma Research - **Allergen Challenge Study**: The asthma study involved a classic design measuring FEV1 and eosinophil levels post-allergen challenge. Initial findings showed a significant reduction in eosinophils in treated patients [20][24] - **Future Studies**: Discussions are ongoing regarding the next steps in asthma research, including potential multi-dose studies and patient selection criteria [27][28] Financial Overview - **Capital Raise**: Jasper Therapeutics raised $30 million, providing a cash runway into Q3 of the following year, allowing for the initiation of the phase 2B study [30][31] Additional Insights - **Expert Consultation**: The company plans to consult with experts in asthma drug development to refine patient selection and study design for future trials [28][29] - **Focus on Eosinophils**: The reduction of eosinophils in the asthma study suggests potential implications for both T2 high and T2 low patient groups [28]

Group 1 - The webinar is hosted by Jasper Therapeutics, featuring key executives including the CEO, acting CMO, and a professor from Charite in Berlin [2] - The event includes a presentation of slides that are accessible via a webinar link and posted on the Investor Relations website [2] - Forward-looking statements will be made during the event, based on estimates and assumptions regarding future events [3]

Summary of Jasper Therapeutics Data Update Webinar Company Overview - **Company**: Jasper Therapeutics (NasdaqCM:JSPR) - **Date of Call**: December 2, 2025 Key Points Industry and Company Focus - **Industry**: Biotechnology, specifically focusing on treatments for chronic spontaneous urticaria (CSU) and allergic asthma - **Core Product**: Briquilimab, a drug targeting mast cells BEACON Trial Findings - **Unexpected Results**: In the BEACON trial for CSU, none of the 10 U.S. patients in Cohort 8 achieved complete response by week 12, contrasting with two out of three patients in EU sites who did respond, indicating potential issues with drug lot A34954 used in the U.S. [4][5] - **Investigation**: An internal investigation was launched, reviewing manufacturing records, drug handling, and patient data. No significant deviations were found in drug production or handling [5][10][11]. - **Patient-Specific Factors**: The investigation concluded that patient-specific factors likely caused the unexpected results, with many patients possibly not having CSU [11][17]. Redosing Data from BEACON - **Cohorts 8 and 9**: Patients were switched to a new drug lot (34955) during the trial, showing no changes in pharmacokinetics (PK) or pharmacodynamics (PD) measures after redosing [12][15]. - **Clinical Outcomes**: The drug effectively depleted mast cells, as indicated by reduced tryptase levels, but clinical responses were not observed in many patients, suggesting misdiagnosis [15][17]. ATESIAN Study Results - **Study Design**: The ATESIAN trial assessed briquilimab's safety and efficacy in patients with mild allergic asthma, focusing on allergen challenges [20][21]. - **Efficacy Observations**: A single 180 mg dose resulted in significant reductions in serum tryptase levels and improved FEV1 responses, indicating a sustained effect on both early and late asthmatic responses [22][24]. - **Safety Profile**: Briquilimab was well tolerated with no serious treatment-related adverse events reported, reinforcing its safety in asthmatic populations [24][26]. Future Directions - **Next Steps**: Jasper plans to report additional BEACON data and open-label extension data in Q1 2026, including efficacy and safety data from new patients [26][27]. - **Broader Asthma Studies**: The company is evaluating further studies to explore briquilimab's effects across different asthma endotypes, including T2 high and T2 low diseases [25][27]. Recommendations for Future Trials - **Patient Selection**: Emphasis on quality patient selection is crucial, with recommendations to involve certified specialists in diagnosing CSU to avoid misdiagnosis [18][49]. - **Larger Sample Sizes**: Increasing sample sizes in trials may help mitigate the impact of non-mast cell-driven patients [18][67]. Conclusion - **Overall Outlook**: Jasper Therapeutics is optimistic about briquilimab's potential in treating both CSU and asthma, with ongoing investigations and upcoming data expected to support its clinical efficacy and safety [72].

BEACON Trial Investigation Results - Internal investigation indicates anomalous efficacy results in the BEACON trial are likely due to patient-specific factors rather than issues with the drug product or study conduct[23] - A KOL panel review suggested that 9 out of 10 patients who did not respond in the US may not have had CSU, highlighting potential misdiagnosis issues common in CSU studies where 25%-30% of patients are incorrectly diagnosed[40] - Redosing Cohort 8 & 9 patients with a different drug product lot did not significantly change efficacy outcomes, with no incremental efficacy observed in 8 of 9 patients redosed[27, 31] - In the BEACON trial, 7 of 10 US patients in Cohorts 8 & 9 were switched to a different drug product lot by week 16[27, 31] ETESIAN Trial Interim Results - A single 180mg dose of Briquilimab in the ETESIAN study demonstrated a reduction in serum tryptase levels at 6 weeks, consistent with previous observations[45] - Briquilimab mitigated the effects of allergen challenge on FEV1 response, showing a sustained impact on asthmatic response at 6 and 12 weeks[47] - Briquilimab dramatically reduced airway hyper-responsiveness, increasing the concentration of methacholine needed to drive a 20% drop in FEV1 (PD20)[51] - Sputum eosinophil response was suppressed by Briquilimab at both 6-week and 12-week allergen challenge timepoints[53] Program Status and Next Steps - In CSU, single doses of 240mg and 360mg of Briquilimab led to more than a 24-point drop in UAS7, with 82% CR and 91% WC disease by week 4 (n=11)[60] - In an OLE study for CSU, 180mg Q8W of Briquilimab resulted in 73% CR and 82% WC disease at 12 weeks (n=11)[60]

Core Insights - Jasper Therapeutics reported positive preliminary clinical data from the ETESIAN Phase 1b study of briquilimab, showing significant reductions in airway hyperresponsiveness and eosinophilic response in asthma patients [2][4][5] Group 1: ETESIAN Study Findings - A single subcutaneous 180mg dose of briquilimab resulted in substantial reductions in sputum eosinophils at both 6 weeks (1.88% to 0.44%) and 12 weeks (1.88% to 0.38%) [2][12] - Improvements in FEV1 were observed in both Early Asthmatic Response (EAR) and Late Asthmatic Response (LAR), with LAR %Max FEV1 improving by 10.4% at 6 weeks and 8.7% at 12 weeks compared to baseline [7][10] - The study demonstrated a favorable safety profile for briquilimab, with no dose-limiting toxicities and infrequent low-grade adverse events [14] Group 2: BEACON Study Investigation - Jasper completed an internal investigation into the lack of clinical response in the BEACON study, concluding that the unexpected results were likely due to patient selection issues rather than problems with the drug product [3][16] - The investigation revealed that 9 out of 10 patients did not have chronic spontaneous urticaria (CSU) as their symptoms were not mast cell-driven, which affected the efficacy results [16][17] - The company is confident that insights from this investigation will help minimize enrollment of patients without mast cell-driven diseases in future studies [17] Group 3: Future Developments - Jasper plans to further develop briquilimab for asthma treatment, supported by the positive data from the ETESIAN study and the favorable safety profile observed [4][20] - The company anticipates additional data from the BEACON study in Q1 2026, which will inform dose selection for the Phase 2b CSU study planned for mid-2026 [17][20]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant gains in after-hours trading due to corporate updates and upcoming event announcements [1] Company Updates - Jasper Therapeutics, Inc. (JSPR) saw a 21.51% increase to $2.09 after hours, following the announcement of a webinar on December 2 to present findings from the BEACON study and preliminary data from the ETESIAN study [2] - NRx Pharmaceuticals, Inc. (NRXP) rose 13.39% to $2.71 after hours, with the CEO scheduled to present at NobleCon21 on December 3, discussing the company's expanded focus and clinical revenue progress [3] - Unicycive Therapeutics, Inc. (UNCY) increased by 5.42% to $6.33, with the CEO participating in two upcoming events, although no new announcements were made on Monday [4] - Spruce Biosciences, Inc. (SPRB) shares rose 4.68% to $87.00 after reporting a net loss of $8.2 million for the quarter ending September 30, 2025, an improvement from a net loss of $8.7 million in the previous year [5] - Evaxion A/S (EVAX) added 3.96% to $5.65, announcing progress in its CMV vaccine program with new protective data and ongoing preclinical development [6] - Solana Company (HSDT) gained 3.48% to $3.87, reporting a net loss of $352.8 million for the third quarter, a significant increase from a net loss of $3.7 million in the prior-year period, with revenue totaling $697,000 [7] - Protara Therapeutics, Inc. (TARA) rose 5.04% to $7.08, planning a conference call on December 3 to review interim data from its Phase 2 trial of TARA-002 in bladder cancer patients [8]