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].

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]

Summary of Jasper Therapeutics Conference Call Company Overview - **Company**: Jasper Therapeutics (NasdaqCM: JSPR) - **Date of Conference**: November 12, 2025 Key Points Industry and Product Insights - **Product**: Bromelamab, a drug under investigation for conditions related to mast cell-mediated diseases, including Chronic Spontaneous Urticaria (CSU) and asthma [1][2] - **Clinical Trials**: Ongoing studies to evaluate the efficacy and safety of bromelamab in various cohorts, particularly focusing on patient responses and dosing strategies [4][20] Clinical Data and Findings - **Patient Response Rates**: In a recent study, only 2 out of 10 patients showed complete responses, contrasting with previous studies where response rates were around 60-70% [3][4] - **Investigation of Anomalous Results**: The company is investigating the patient selection process and study conduct at a specific site that enrolled five patients, which may have skewed results [5][6] - **Pharmacokinetics (PK) and Tryptase Levels**: Serum concentrations of bromelamab were consistent with previous studies, indicating that the drug was effectively administered [2] Future Actions and Studies - **Redosing Strategy**: All patients will receive at least three doses to identify any late responders and gather safety data on repeat dosing [6][26] - **Enhanced Patient Selection**: Stricter inclusion-exclusion criteria are being implemented to ensure accurate diagnosis of CSU by expert physicians [8][9] - **Asthma Study Update**: The asthma study was halted due to concerns over the drug lot used, but data from 12-15 patients will be available by the end of the year [10][11] Upcoming Data and Expectations - **Phase 2B Study Plans**: The company plans to initiate a Phase 2B study in mid-2026, based on the data collected from ongoing studies [20] - **Data Availability**: A significant amount of data, including redosing results and safety profiles, is expected to be available in early Q1 of the following year [22][26] Safety and Efficacy Considerations - **Safety Data Importance**: The safety of repeat dosing at 240 mg is a critical focus, as previous data indicated a high efficacy rate with this dosage [6][24] - **Long-term Follow-up**: The company will conduct long-term follow-up on patients to assess the safety and efficacy of the treatment [26] Conclusion - **Overall Sentiment**: The company remains optimistic about the potential of bromelamab, emphasizing the importance of understanding patient selection and drug efficacy in future studies [19][20]

Summary of Jasper Therapeutics Conference Call Company Overview - **Company**: Jasper Therapeutics (NasdaqCM:JSPR) - **Industry**: Biotechnology - **Lead Asset**: Bricillimab, a monoclonal antibody in clinical trials for chronic spontaneous urticaria (CSU), chronic inducible urticaria, and asthma - **Mechanism**: Bricillimab binds to Kit, a primary survival pathway on mast cells, leading to mast cell apoptosis [1][1][1] Key Points on Urticaria Landscape - Recent launches of Remibrutinib and Dupixent provide new options for CSU patients, who previously had limited choices [2][2][2] - Current treatment approaches can either inhibit mast cells or deplete them, with bricillimab being one of the few that can deplete mast cells [4][4][4] Efficacy and Safety of Bricillimab - Bricillimab shows a nine-day half-life, allowing for a superior safety profile due to its ability to clear and restore signaling to other cells [8][8][8] - Initial clinical data indicates that at the 240 mg dose, there were 100% complete responses in a small cohort, suggesting strong efficacy [23][23][23] - Safety data shows a lower incidence and severity of Kit-related adverse events compared to Barzolvolimab, with a median time to resolution of neutrophil decreases being only 15 days [28][28][28] Clinical Trials and Future Data - The Beacon study is a dose escalation study that has shown promising results, with plans for repeat dosing data to be released in Q4 [24][24][24] - An investigation into anomalous patient responses in July led to a thorough audit and confirmed that the drug product was not at fault [32][32][32] - Upcoming data in Q1 will include results from new patients and longer-term follow-up on existing cohorts [56][56][56] Competitive Landscape - Bricillimab is positioned as a potentially superior option compared to Barzolvolimab, with a focus on both efficacy and safety [16][16][16] - The company is also monitoring other targets like MRGPRX2, which may not deplete mast cells but could play a role in treatment [77][77][77] Financial Outlook - Jasper Therapeutics has sufficient cash to fund operations into Q3 of the following year, but will need additional capital for the phase 2B study [93][93][93] - Potential funding strategies include capital raises or clinical co-development partnerships [102][102][102] Future Directions - The company plans to start a phase 2B study in CSU by mid-2026, aiming to optimize dosing for both efficacy and safety [66][66][66] - There is interest in expanding into asthma, with initial results expected in Q4, which could lead to strategic partnerships [112][112][112]

Core Insights - Celldex announced positive data from the Phase 1 study of CDX-622, a bispecific antibody targeting inflammation and fibrosis pathways [1][2] - The study demonstrated good tolerability, a favorable pharmacokinetic profile, and significant reductions in serum tryptase levels, indicating effective mast cell inhibition [1][6] - The company plans to advance the study to the next phase, testing multiple ascending doses and initiating a Phase 1b study in asthma patients [2][4] Study Design and Results - The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CDX-622 [4][7] - Part 1 enrolled 32 participants across 4 cohorts, receiving single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0, and 9.0 mg/kg) over a 12-week observation period [4][6] - Data from Part 1 were presented, and enrollment for Part 2 is ongoing, with results from Parts 2 and 3 expected in Q3 2026 [4][6] Mechanism and Therapeutic Potential - CDX-622 targets two validated pathways: neutralizing TSLP and depleting mast cells via SCF starvation, potentially offering enhanced therapeutic benefits for inflammatory and fibrotic disorders [5][6] - The antibody showed a serum half-life of approximately 18 days at 9 mg/kg, with no evidence of immunogenicity or dose-limiting toxicities observed [6][2] - A single dose led to a rapid and sustained decrease of about 50% in circulating tryptase, consistent with systemic mast cell inhibition [6]

Financial Data and Key Metrics Changes - Jasper Therapeutics is a clinical stage biotech company with a focus on briquelimab, a monoclonal antibody targeting KIT on mast cells, currently conducting multiple clinical trials in urticarias [2][3] - The company reported a favorable safety profile for briquelimab, with all KIT related adverse events being mild, transient, and self-resolving before the next dose [28] Business Line Data and Key Metrics Changes - The BEACON study for chronic spontaneous urticaria (CSU) showed that at a dose of 180 mg every eight weeks, 73% of patients achieved a complete response, and 82% had well-controlled disease [26][29] - The study indicated that the optimal dosing schedule for briquelimab is every eight weeks, with significant clinical relief observed within two weeks [13][26] Market Data and Key Metrics Changes - The competitive landscape includes small molecule approaches that only inhibit mast cells, whereas briquelimab depletes them, providing a superior clinical benefit [8][29] - Compared to Barzolumab, briquelimab demonstrated more than a double-digit improvement in complete response rates at 12 weeks [29] Company Strategy and Development Direction - The company aims to select doses for a Phase IIb study based on the totality of data from ongoing studies, with a focus on maintaining a favorable safety and efficacy profile [43] - Future data presentations are planned, including results from the open-label extension study and the asthma study, to further validate the drug's effectiveness [39][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for a deeper response and rapid response with higher doses, indicating a strategic approach to dosing regimens [26][43] - The company is investigating the reasons behind confounding results in specific cohorts and is committed to ensuring the integrity of the drug administration process [31][41] Other Important Information - The company is currently redosing patients from cohorts with compromised drug lots and enrolling new patients to gather more data [33][39] - Management emphasized that there is no evidence of compromise in the drug substance or product from their manufacturing facility [41] Q&A Session Summary Question: What are the key value-creating accomplishments for Jasper in the next year? - Management highlighted the importance of generating significant data to address existing questions and selecting doses for the Phase IIb study [43] Question: What is the rationale behind allowing patients a drug holiday? - The original design aimed to assess how long it would take for the disease to return after stopping briquelimab, ensuring patients had moderate to severe disease before re-dosing [22] Question: How does briquelimab compare to Barzolumab in terms of efficacy and safety? - Briquelimab showed a complete response rate of 73% at 12 weeks, significantly outperforming Barzolumab's rates, while also maintaining a favorable safety profile [29]

Core Insights - Celldex Therapeutics reported topline results from a Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating that while the primary endpoint of mast cell depletion was met, there was no improvement in EoE symptoms or endoscopic assessments compared to placebo [1][4][5] - The company will not pursue further development of barzolvolimab for EoE but will continue to explore its potential in other gastrointestinal indications [1][2] Study Design and Results - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 65 patients with moderate to severe EoE, assessing the efficacy and safety of subcutaneous barzolvolimab [4][6] - The primary endpoint was the reduction in peak esophageal intraepithelial mast cell count at 12 weeks, which was achieved with a significant reduction of -36.0 in the barzolvolimab group compared to -2.7 in the placebo group (p=<0.0001) [5][6] - Despite the significant mast cell depletion, no clinical improvement was observed in EoE symptoms (p=0.33) or endoscopic scoring (p=0.95) [5][6] Safety Profile - Barzolvolimab demonstrated a favorable safety profile at the 300 mg Q4 weekly dosing regimen, consistent with previous studies [5][6] - An unblinded review of data through the full treatment period (28 weeks) showed consistent clinical and safety outcomes [5] Future Development Plans - Celldex is focusing on advancing barzolvolimab's pipeline, with ongoing enrollment in four studies, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis [2][8] - Plans are also being finalized to initiate a Phase 3 program in inducible urticaria, which will include cold urticaria and symptomatic dermographism [2][8]

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]