[Corporate Update and Business Highlights](index=1&type=section&id=Corporate%20Update%20and%20Business%20Highlights) The company provided updates on briquilimab's clinical efficacy and ongoing investigation into atypical results, alongside a significant corporate restructuring to focus on mast cell-driven diseases [Management Commentary](index=1&type=section&id=Management%20Commentary) Management expressed confidence in briquilimab's potential for mast cell-driven diseases, while addressing an ongoing investigation into atypical efficacy results in specific BEACON study cohorts - The CEO highlighted strong data showing briquilimab's potential, with complete responses in **89% of patients** in certain BEACON study cohorts, **73%** in an open-label extension, and **92%** in the SPOTLIGHT CIndU study[2](index=2&type=chunk) - An investigation is underway for two BEACON study cohorts (**240mg Q8W** and **240mg/180mg Q8W**) that did not show expected efficacy. The company is exploring various causes and plans to redose affected patients and enroll new ones, with an update expected later in the year[2](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Robust efficacy data for briquilimab in CSU and CIndU was presented, though an investigation into anomalous BEACON study results has delayed the Phase 2b CSU study and paused asthma trial enrollment Briquilimab Efficacy Data Highlights | Study/Cohort | Indication | Key Efficacy Result | | :--- | :--- | :--- | | BEACON (240mg & 360mg single-dose) | CSU | 89% (8 of 9) achieved complete response (UAS7=0) | | Open-Label Extension (180mg Q8W) | CSU | 73% (8 of 11) maintained complete response at 12 weeks | | SPOTLIGHT (180mg) | CIndU | 92% (11 of 12) achieved complete response | - An investigation was initiated for the **240mg Q8W** and **240mg/180mg Q8W** BEACON cohorts due to an atypical absence of UAS7 reduction. The company is assessing potential product lot variability, as all **10 patients** dosed from one specific lot failed to show a response[6](index=6&type=chunk) - Due to the ongoing investigation, the planned Phase 2b CSU study is now expected to commence in **mid-2026**. Enrollment in the ETESIAN asthma study has been halted pending the investigation's outcome[6](index=6&type=chunk) - Across studies, briquilimab was reported to be well-tolerated with no dose-limiting toxicities. Any adverse events were generally low-grade and did not lead to discontinuations[3](index=3&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Jasper implemented a significant corporate restructuring, including a **50% workforce reduction**, to preserve capital and focus resources on its core urticaria programs - The company executed a corporate restructuring, reducing its workforce by approximately **50%** to focus resources on its urticaria programs and preserve capital[6](index=6&type=chunk) - All non-mast cell focused clinical and preclinical programs, including investigator-sponsored trials and the SCID clinical program, have been halted[6](index=6&type=chunk) - As part of the reorganization, Dr. Edwin Tucker stepped down as Chief Medical Officer and was succeeded on an interim basis by Dr. Daniel Adelman[6](index=6&type=chunk) [Second Quarter Fiscal 2025 Financial Results](index=2&type=section&id=Second%20Quarter%20Fiscal%202025%20Financial%20Results) The company reported a widened net loss for Q2 2025, driven by increased R&D expenses, with a significant decrease in cash and total assets [Financial Highlights](index=2&type=section&id=Financial%20Highlights) For the second quarter of 2025, Jasper Therapeutics reported a net loss of **$26.7 million** and ended the period with **$39.5 million** in cash and cash equivalents Q2 2025 Financial Summary | Metric | Amount | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $39.5 million | | Research and development expense | $21.2 million | | General and administrative expense | $5.9 million | | Net loss | $26.7 million | | Net loss per share | $1.74 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's net loss widened to **$26,723 thousand** for the three months ended June 30, 2025, from **$14,583 thousand** in the same period of 2024, primarily due to a substantial increase in research and development expenses to **$21,196 thousand** from **$11,296 thousand** year-over-year Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | $37,353 | $21,594 | | General and administrative | $5,880 | $4,697 | $11,525 | $9,471 | | **Total operating expenses** | **$27,076** | **$15,993** | **$48,878** | **$31,065** | | Loss from operations | $(27,076) | $(15,993) | $(48,878) | $(31,065) | | **Net loss** | **$(26,723)** | **$(14,583)** | **$(47,964)** | **$(28,311)** | | Net loss per share | $(1.74) | $(0.97) | $(3.16) | $(2.00) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Jasper Therapeutics had total assets of **$46,466 thousand**, a significant decrease from **$79,899 thousand** at the end of 2024, primarily due to reduced cash and cash equivalents Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,510 | $71,637 | | Total current assets | $42,966 | $75,811 | | **Total assets** | **$46,466** | **$79,899** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $20,500 | $15,237 | | **Total liabilities** | **$22,965** | **$18,225** | | **Total stockholders' equity** | **$23,501** | **$61,674** | [About Jasper](index=2&type=section&id=About%20Jasper) Jasper is a clinical-stage biotechnology company focused on developing briquilimab for mast cell-driven diseases like CSU, CIndU, and asthma - Jasper is a clinical-stage biotechnology company focused on developing briquilimab, a monoclonal antibody targeting the c-Kit receptor to deplete mast cells[5](index=5&type=chunk) - The company's primary therapeutic areas of focus are mast cell-driven diseases, including chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma[5](index=5&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements regarding clinical development and timelines, which are subject to numerous risks and uncertainties - This report contains forward-looking statements regarding briquilimab's potential, clinical trial timelines, and the expected completion of investigations. These statements are subject to numerous risks and uncertainties[7](index=7&type=chunk) - Key risks include potential failures in clinical development, inconclusive investigation results, inability to raise capital, and the possibility that prior trial results may not be replicated in future studies[7](index=7&type=chunk)

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].

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section presents the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show a significant increase in net loss and cash used in operations compared to the prior year, with substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Items (in thousands) | Balance Sheet Items (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,510 | $71,637 | | Total current assets | $42,966 | $75,811 | | Total assets | $46,466 | $79,899 | | **Liabilities & Equity** | | | | Total current liabilities | $20,500 | $15,237 | | Total liabilities | $22,965 | $18,225 | | Accumulated deficit | $(288,833) | $(240,869) | | Total stockholders' equity | $23,501 | $61,674 | - Cash and cash equivalents decreased by **44.8%** from **$71.6 million** at the end of 2024 to **$39.5 million** as of June 30, 2025, reflecting significant cash burn from operations[10](index=10&type=chunk) - Total stockholders' equity declined by **61.9%** to **$23.5 million** from **$61.7 million** at year-end 2024, primarily driven by the net loss incurred during the first six months of 2025[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results (in thousands) | Operating Results (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | $37,353 | $21,594 | | General and administrative | $5,880 | $4,697 | $11,525 | $9,471 | | **Total operating expenses** | **$27,076** | **$15,993** | **$48,878** | **$31,065** | | Loss from operations | $(27,076) | $(15,993) | $(48,878) | $(31,065) | | **Net loss** | **$(26,723)** | **$(14,583)** | **$(47,964)** | **$(28,311)** | - Net loss for the second quarter of 2025 increased by **83.2%** year-over-year to **$26.7 million**, driven by an **87.6%** increase in Research and Development expenses[13](index=13&type=chunk) Per Share Data | Per Share Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss per share, basic and diluted | $(1.74) | $(0.97) | $(3.16) | $(2.00) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,295) | $(27,416) | | Net cash provided by (used in) investing activities | $5 | $(182) | | Net cash provided by financing activities | $6,163 | $47,530 | | **Net (decrease) increase in cash** | **$(32,127)** | **$19,932** | | Cash at beginning of period | $72,054 | $87,304 | | **Cash at end of period** | **$39,927** | **$107,236** | - Net cash used in operating activities increased by **39.7%** to **$38.3 million** for the first six months of 2025, compared to **$27.4 million** in the same period of 2024, reflecting higher operating losses[20](index=20&type=chunk) - Cash from financing activities was significantly lower in the first half of 2025 (**$6.2 million** from ATM offering) compared to the first half of 2024 (**$47.5 million** from an underwritten offering), contributing to the large net decrease in cash[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has concluded that substantial doubt exists about its ability to continue as a going concern, as existing cash and cash equivalents of **$39.5 million** are not sufficient to fund operating plans for at least twelve months from the financial statement issuance date[28](index=28&type=chunk)[30](index=30&type=chunk) - In July 2025, the company implemented a corporate reorganization, including a workforce reduction of approximately **50%**, to extend its cash runway, focusing on briquilimab clinical programs in chronic urticaria and halting other programs, with an estimated cost of **$1.9 million** for the reduction[100](index=100&type=chunk)[101](index=101&type=chunk) - The company operates as a single reportable segment focused on the research and development of therapeutic products for chronic urticaria and asthma, with total program costs of **$25.5 million** for the six months ended June 30, 2025, a **107%** increase from **$12.3 million** in the prior year period[98](index=98&type=chunk)[99](index=99&type=chunk) - The company entered into an Open Market Sale Agreement (ATM Offering) in March 2025, raising net proceeds of approximately **$5.9 million** by June 30, 2025, with **$94.1 million** remaining available under the ATM prospectus as of that date[76](index=76&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing briquilimab for mast cell driven diseases, highlighting recent clinical data, an investigation into a drug product lot, and a subsequent corporate reorganization to extend the cash runway, while reiterating substantial doubt about the company's ability to continue as a going concern [Overview and Recent Developments](index=26&type=section&id=Overview%20and%20Recent%20Developments) - The company is a clinical-stage biotech focused on developing briquilimab, a monoclonal antibody targeting the c-Kit receptor on mast cells for diseases like Chronic Spontaneous Urticaria (CSU), Chronic Inducible Urticaria (CIndU), and asthma[110](index=110&type=chunk)[111](index=111&type=chunk) - An investigation is underway for a specific drug product lot used in the BEACON (CSU) and ETESIAN (asthma) studies, which showed an atypical lack of efficacy in certain patient cohorts, leading to halting enrollment in the ETESIAN study[116](index=116&type=chunk)[119](index=119&type=chunk) - On July 8, 2025, the company implemented a corporate reorganization, reducing its workforce by approximately **50%** to extend its cash runway and focus resources on its chronic urticaria clinical development programs[122](index=122&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Expense Comparison (in thousands) | Expense Comparison (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | +88% | | General and administrative | $5,880 | $4,697 | +25% | | **Total operating expenses** | **$27,076** | **$15,993** | **+69%** | - The **88%** increase in Q2 2025 R&D expenses was driven by a **$9.6 million** rise in program costs, including a **$4.1 million** increase in CRO expenses and a **$5.1 million** increase in CMO manufacturing costs to support clinical programs[143](index=143&type=chunk)[146](index=146&type=chunk) Expense Comparison (in thousands) | Expense Comparison (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $37,353 | $21,594 | +73% | | General and administrative | $11,525 | $9,471 | +22% | | **Total operating expenses** | **$48,878** | **$31,065** | **+57%** | - For the first six months of 2025, R&D expenses grew by **$15.8 million** (**73%**) year-over-year, primarily due to a **$13.2 million** increase in program costs related to advancing the CSU and asthma trials and higher CMO manufacturing expenses[151](index=151&type=chunk)[154](index=154&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had cash and cash equivalents of **$39.5 million**[158](index=158&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern within one year, given recurring losses and the current cash position relative to its operating plan[163](index=163&type=chunk) - The company will need to raise substantial additional funding to continue operations, with future financing potentially coming from equity or debt offerings, collaborations, or other arrangements, though there is no assurance of success[162](index=162&type=chunk)[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risk during the six months ended June 30, 2025 - There have been no material changes to the company's market risk exposure during the first six months of 2025[182](index=182&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[184](index=184&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[185](index=185&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other important information including legal proceedings, updated risk factors, equity sales, other disclosures, and a list of exhibits [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[187](index=187&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section updates and reiterates key risks to the business, including financial concerns about going concern, operational risks from clinical trial delays and reorganization, reliance on third parties, and market-related risks - **Financial Risk:** The company has a history of significant net losses and negative cash flows, expects to incur losses for the foreseeable future, and has substantial doubt about its ability to continue as a going concern[189](index=189&type=chunk)[201](index=201&type=chunk) - **Clinical Development Risk:** Delays in clinical trials are a major risk, highlighted by the investigation into a drug product lot used in the BEACON and ETESIAN studies that demonstrated an atypical absence of efficacy[206](index=206&type=chunk)[208](index=208&type=chunk) - **Operational Risk:** The July 2025 corporate reorganization and **~50%** workforce reduction may have unintended consequences, such as loss of expertise and reduced morale, and may not achieve the anticipated benefits[203](index=203&type=chunk) - **Third-Party Reliance Risk:** The company relies heavily on third parties like CROs to conduct clinical trials, and failures by these parties, such as potential manufacturing variability in the investigated drug lot, could substantially harm the business[221](index=221&type=chunk)[224](index=224&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[242](index=242&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or officers adopted or terminated any Rule 10b5-1 trading plans or other non-Rule 10b5-1 trading arrangements - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the fiscal quarter ended June 30, 2025[245](index=245&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - The report includes a list of exhibits filed, such as corporate governance documents and officer certifications required by the Sarbanes-Oxley Act[246](index=246&type=chunk)

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.