Clinical Trials and Product Development - Bempikibart (ADX-914) has completed two Phase 2a clinical trials, with topline results announced in December 2024, and further data expected in mid-2026[165][170] - In the SIGNAL-AA Part A trial, 44 patients were dosed for 24 weeks, showing more hair regrowth compared to placebo, with continued improvement observed during a 12-week follow-up[166] - The FDA granted Fast Track designation to bempikibart for the treatment of alopecia areata in April 2025, facilitating expedited development and review[171] - A corporate restructuring in February 2025 focused on advancing bempikibart, resulting in the discontinuation of the Phase 2 renal basket clinical trial of ADX-097[175] - Legacy Q32 retained full development and commercial rights to bempikibart after terminating the collaboration agreement with Horizon Therapeutics[177] Financial Performance and Expenses - As of September 30, 2025, the company had cash and cash equivalents of $49.0 million, expected to fund operations into 2027[183] - The company does not expect to generate revenue from product sales in the foreseeable future, as it has not generated any revenue since inception[186] - Research and development expenses for the three months ended September 30, 2025, were $3.6 million, a decrease of $10.8 million compared to $14.3 million for the same period in 2024[204] - General and administrative expenses were $4.0 million for the three months ended September 30, 2025, down from $4.5 million in the same period in 2024[206] - The total operating expenses for the three months ended September 30, 2025, were $7.6 million, a decrease of $11.2 million from $18.8 million in 2024[203] - For the nine months ended September 30, 2025, total operating expenses were $28.977 million, a decrease of $22.599 million from $51.576 million in 2024[208] - Research and development expenses decreased to $15.841 million in 2025 from $37.598 million in 2024, primarily due to reduced clinical costs for the Bempikibart program[209] - General and administrative expenses were $13.136 million for the nine months ended September 30, 2025, down from $13.978 million in 2024, reflecting lower consulting expenses and costs associated with the prior year's merger[211] - Net loss for the nine months ended September 30, 2025, was $27.909 million, an improvement of $5.635 million compared to a net loss of $33.544 million in 2024[208] Cash Flow and Capital Requirements - Cash and cash equivalents as of September 30, 2025, were $49.0 million, expected to fund operations into 2027[218] - Net cash used in operating activities was $27.363 million for the nine months ended September 30, 2025, compared to $56.287 million in 2024[219] - The company raised $136.0 million in aggregate cash proceeds from the sale of convertible preferred stock and convertible notes since inception[215] - The company expects to continue incurring significant operating losses and negative cash flows as it invests in research and development[216] - The company anticipates needing to raise additional capital to advance its programs through regulatory approval and potential commercialization[184] - The company requires substantial additional capital to complete the development of product candidates and build necessary sales, marketing, and distribution infrastructure[230] - Management expects to seek additional capital through private or public equity or debt financings, which may dilute stockholder ownership[231] Obligations and Agreements - The company made an upfront payment of $8 million to Bristol-Myers Squibb for the license agreement related to bempikibart, with potential milestone payments totaling up to $215 million based on net sales[237] - Under the Horizon Agreements, the company received $55 million in initial consideration and staged development funding for bempikibart, which was retained after the termination of the agreements[240][241] - The company is obligated to pay up to $75.1 million in regulatory and sales milestone payments to Horizon upon achieving certain milestones for bempikibart[241] - The company has a license agreement with The Regents of the University of Colorado, which includes potential milestone payments of up to $2.2 million per licensed product and tiered royalty rates on cumulative net sales[244] Accounting and Reporting - Legacy Q32 recognized a noncash gain of $15.9 million on the change in fair value of convertible notes prior to their conversion[199] - The company’s critical accounting policies have not materially changed during the three months ended September 30, 2025, from those discussed in the Annual Report for the year ended December 31, 2024[247] - The company is not required to provide market risk disclosures as it qualifies as a smaller reporting company[249]

Clinical Trial Updates - Enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial was completed, increasing the trial size to 33 patients due to strong patient demand, with topline data readout expected in mid-2026[3] - The Part B trial is designed to evaluate the efficacy of bempikibart, with treatment duration of 36 weeks and follow-up through week 52[3] - Emerging signs of clinical activity are being observed among early-enrolling patients in Part B of the trial[4] - The company initiated an open-label extension (OLE) for eligible patients from Part A to enable longer-term follow-up, with dosing ongoing[4] - The company expects to report topline results from the Part B trial in mid-2026[4] Financial Performance - Cash and cash equivalents were $49.0 million as of September 30, 2025, expected to fund operations into 2027[7] - Research and development expenses decreased to $3.6 million for Q3 2025, down from $14.3 million in Q3 2024, a reduction of 74.9%[7] - General and administrative expenses were $4.0 million for Q3 2025, compared to $4.5 million in Q3 2024, a decrease of 11.1%[7] - Net loss for Q3 2025 was $7.4 million, or $0.60 per share, compared to a net loss of $17.6 million, or $1.46 per share, in Q3 2024[7] - Total operating expenses for Q3 2025 were $7.6 million, down from $18.8 million in Q3 2024, a decrease of 59.7%[14]

Accessibility StatementSkip Navigation -- Completed enrollment in Part B of SIGNAL-AA Phase 2a clinical trial and increased trial size to 33 patients based on patient demand; topline data readout expected in mid-2026 -- -- Dosing of patients in Part A open-label extension (OLE) ongoing -- -- Cash and cash equivalents of $49.0 million as of September 30, 2025 expected to provide financial runway into 2027 -- Financial Results Completed enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial and inc ...

Core Insights - Q32 Bio has completed enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial for bempikibart, exceeding the initial target of approximately 20 patients, with a total of 33 patients enrolled due to high demand [1][3] - Bempikibart is a fully human anti-IL-7R antibody aimed at treating severe alopecia areata (AA) by re-regulating adaptive immune function [1][3] - The trial is designed to evaluate the efficacy of bempikibart over a 36-week treatment period, with follow-up extending to 52 weeks, and aims to support advancement into pivotal trials based on the results [2][3] Company Overview - Q32 Bio is a clinical stage biotechnology company focused on developing therapies for alopecia areata and other autoimmune diseases, targeting the adaptive immune system [3] - Approximately 700,000 individuals in the United States are affected by alopecia areata, highlighting the need for new treatment options [3] Clinical Trial Details - Part B of the SIGNAL-AA trial includes a loading regimen of 200mg of bempikibart administered weekly for four doses, followed by a maintenance dose every other week for a total of 36 weeks [2] - Efficacy will be assessed using the Severity of Alopecia Tool (SALT) scores, with the goal of observing significant improvements in patients' conditions [2] Future Expectations - Preliminary data from early-enrolling patients in Part B indicate emerging signs of clinical activity, with a faster achievement of steady-state drug concentration compared to Part A [2] - Q32 Bio anticipates reporting topline data from Part B in mid-2026, which could lead to further development of bempikibart pending positive results [3]

Financial Data and Key Metrics Changes - The company has extended its cash runway into Q1 2027, providing sufficient margin to allow ongoing trials to complete [47][48] - The company reported a 20% reduction in SALT score at week 36 in part A, with expectations to improve upon this in part B [28][29] Business Line Data and Key Metrics Changes - The company is advancing bempikibart, focusing on alopecia areata, with ongoing enrollment in phase 2 part B after positive results from part A [5][36] - In part A, statistically significant hair improvement was observed at week 24, with no grade 3 or higher related events reported [8][12] Market Data and Key Metrics Changes - The competitive landscape includes other IL-7 receptor alpha programs, with the company believing it has a best-in-class asset due to its pharmacology and dosing advantages [43][44] Company Strategy and Development Direction - The company is focusing on immunomodulating agents rather than immunosuppressants, aiming for clinically meaningful efficacy with durable responses [31][32] - Future trials may include registrational studies, with potential for seamless phase 2 part B/3 trials [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiated profile of bempikibart, emphasizing its safety and potential for durable effects [49][51] - Early signs in part B indicate improved responsiveness compared to part A, suggesting that changes made to the trial design are effective [52][53] Other Important Information - The company has made significant changes to trial design in part B, including a loading dose regimen and modified inclusion criteria to enhance patient responsiveness [9][25] - Management noted that the atopic dermatitis trial did not yield expected results, but it provided valuable insights for future indications [42] Q&A Session Summary Question: What are the next steps for bempikibart? - The next steps could include registrational trials, with various options being considered for the trial design [36] Question: How does the company plan to fund operations moving forward? - The company has sufficient cash runway into 2027 and is exploring strategic options for further funding [47][48] Question: What differentiates bempikibart from competitors? - The company believes its pharmacology and dosing regimen provide a competitive edge over other IL-7 receptor alpha programs [43][44] Question: What are the expectations for part B results? - Management hopes to see improved efficacy and responsiveness in part B compared to part A, with a focus on clinically meaningful outcomes [52][53]

Bempikibart (ADX-914) for Alopecia Areata (AA) - Bempikibart demonstrated proof of concept in alopecia areata with favorable safety profile and robust changes in Th2 clinical biomarkers[9] - SIGNAL-AA Phase 2a Part A showed continued benefit through Week 36, supporting potential for durable effect following dosing cessation[25] - In SIGNAL-AA Part A, patients with baseline SALT 50-100 showed a mean SALT score percentage change of 163% at Week 24 and 199% at Week 36[29] - In SIGNAL-AA Part A, patients with baseline SALT 50-95 showed a mean SALT score percentage change of 245% at Week 24 and 278% at Week 36[29] - The company anticipates Bempikibart SIGNAL-AA Phase 2a Part B topline results in the first half of 2026[10, 71] - The company has received FDA Fast Track designation for Bempikibart for the treatment of AA[11] Alopecia Areata Market and Unmet Need - There are approximately 700,000 AA patients in the US[9, 45, 49] - The expected market size for AA is $26 billion by 2030[9] - Approximately 300,000 US Alopecia Areata (AA) Patients have Severe (SALT > 50)[49] - Currently available therapies for AA lack the desired profile, and doctors and patients seek alternatives to currently approved agents including JAK inhibitors which carry significant safety risks[9, 45, 46] ADX-097 and Complement Platform - ADX-097 is Phase 2 ready and the company is evaluating strategic next steps for ADX-097 and the complement inhibitor platform[11] - ADX-097 Phase 1 study achieved primary goals, demonstrating dose-dependent PK/PD and a favorable safety profile[62] Financial Overview - The company's Q2 2025 cash balance was $548 million, providing expected cash runway into 2027[71]

Core Viewpoint - Q32 Bio reported a significantly reduced GAAP net loss of $0.78 per share for Q2 2025, with no revenue, reflecting its pre-commercial status and a focus on its lead drug candidate, bempikibart [1][5][10] Financial Performance - The net loss (GAAP) decreased to $9.5 million in Q2 2025 from $17.0 million in Q2 2024, primarily due to an $8.2 million reduction in research and development expenses [5] - Research and development expenses were $5.2 million in Q2 2025, down 61.2% from $13.4 million in Q2 2024 [2] - General and administrative expenses decreased to $4.0 million in Q2 2025 from $4.5 million in Q2 2024, reflecting lower staffing and legal costs [2][5] - Cash and cash equivalents at the end of the period were $54.8 million, expected to fund operations into 2027 [2][7] Business Focus and Strategy - Q32 Bio is concentrating on bempikibart, an experimental therapy for autoimmune diseases, and has halted development on its ADX-097 project [3][4] - The company underwent a restructuring in February 2025 to conserve resources and accelerate progress on bempikibart [4] Clinical Development - The bempikibart program is currently in the SIGNAL-AA Phase 2a trial, with ongoing enrollment and topline results expected in the first half of 2026 [6][10] - Bempikibart received Fast Track designation from the U.S. FDA for alopecia areata, which may expedite its development and review process [8] Future Outlook - Management does not anticipate revenue in the near term and has prioritized completing the SIGNAL-AA trial [10]

PART I—FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements.) The unaudited statements show a clinical-stage company with no revenue, a net loss of $20.5 million, and the financial impact of a recent merger Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $54,832 | $77,965 | | Total assets | $66,117 | $92,332 | | Total liabilities | $78,352 | $86,657 | | Total stockholders' equity (deficit) | $(12,235) | $5,675 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $12,286 | $23,252 | | General and administrative | $9,114 | $9,510 | | Loss from operations | $(21,400) | $(32,762) | | Net loss | $(20,520) | $(15,949) | | Net loss per share—basic | $(1.68) | $(2.46) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Account | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,133) | $(36,765) | | Net cash provided by investing activities | $0 | $9,985 | | Net cash provided by financing activities | $0 | $93,824 | | Net (decrease) increase in cash | $(23,133) | $67,044 | - The company completed a **reverse recapitalization merger** with Homology Medicines, Inc. on March 25, 2024, which included a **$42.0 million Pre-Closing Financing**[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) - As of June 30, 2025, the company had **$54.8 million in cash** and cash equivalents and an accumulated deficit of **$255.3 million**, with management believing cash is sufficient for at least one year[39](index=39&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic focus on bempikibart, the financial impact of its recent merger, and its current liquidity position and future capital needs - The company is advancing **bempikibart for Alopecia Areata (AA)** after completing a Phase 2a trial, with topline data expected in H1 2026 and an FDA Fast Track designation[162](index=162&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - A strategic restructuring in February 2025 discontinued the ADX-097 trial to focus on bempikibart, resulting in severance-related charges of approximately **$0.9 million**[171](index=171&type=chunk) Comparison of Results of Operations (in thousands) | Period | Research & Development Expense | General & Administrative Expense | Net Loss | | :--- | :--- | :--- | :--- | | **Three Months Ended June 30, 2025** | $5,161 | $4,010 | $(9,489) | | **Three Months Ended June 30, 2024** | $13,411 | $4,508 | $(16,978) | | **Six Months Ended June 30, 2025** | $12,286 | $9,114 | $(20,520) | | **Six Months Ended June 30, 2024** | $23,252 | $9,510 | $(15,949) | - The decrease in R&D expenses was primarily due to **lower clinical and manufacturing costs** for the bempikibart program and the discontinuation of the ADX-097 trial[199](index=199&type=chunk)[205](index=205&type=chunk) - The company's **$54.8 million in cash** and cash equivalents is expected to fund operations into 2027, but **substantial additional capital** will be needed for future development[180](index=180&type=chunk)[213](index=213&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=68&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures about market risk - As a **smaller reporting company**, Q32 Bio Inc. is not required to provide quantitative and qualitative disclosures about market risk[246](index=246&type=chunk) [Controls and Procedures](index=68&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Management evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they were **effective**[248](index=248&type=chunk) - **No material changes** in internal control over financial reporting occurred during the quarter ended June 30, 2025[249](index=249&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=69&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is **not involved in any material legal proceedings**[251](index=251&type=chunk) [Risk Factors](index=69&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of losses, capital requirements, dependence on its lead product, and regulatory challenges - The company has a history of significant losses (**$20.5 million for H1 2025**), has no products for sale, and may **never achieve profitability**[253](index=253&type=chunk)[254](index=254&type=chunk) - **Substantial additional capital is required** to finance future operations beyond the current cash runway projected into 2027[258](index=258&type=chunk)[259](index=259&type=chunk) - The company is **substantially dependent on the success** of its most advanced product candidate, bempikibart, whose clinical trials may not be successful[272](index=272&type=chunk) - The company's ability to protect its patents is uncertain and it relies on **key licenses from third parties** like Bristol-Myers Squibb[298](index=298&type=chunk)[306](index=306&type=chunk) - The company relies on third parties for manufacturing and clinical trials, including foreign CDMOs like WuXi Biologics which could be impacted by the **BIOSECURE Act**[395](index=395&type=chunk)[406](index=406&type=chunk)[410](index=410&type=chunk) - The company received a **Nasdaq non-compliance notice** on May 19, 2025, for failing to meet the minimum stockholders' equity requirement, which could result in delisting[467](index=467&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=148&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the covered period - The company reports **no unregistered sales of equity securities** for the period covered by the report[483](index=483&type=chunk) [Defaults Upon Senior Securities](index=148&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities during the period - The company reports **no defaults upon senior securities**[484](index=484&type=chunk) [Mine Safety Disclosures](index=148&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable as the company is not engaged in mining operations - Mine safety disclosures are **not applicable** to the company's operations[485](index=485&type=chunk) [Other Information](index=148&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading plans were adopted, modified, or terminated by officers or directors during the quarter - No officers or directors adopted, modified, or terminated any **Rule 10b5-1 trading plans** during the quarter ended June 30, 2025[486](index=486&type=chunk) [Exhibits](index=149&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including merger agreements and officer certifications - The report includes a list of filed exhibits, such as the Merger Agreement, corporate governance documents, and **Sarbanes-Oxley Act certifications**[488](index=488&type=chunk)

[Corporate Update and Business Highlights](index=1&type=section&id=Corporate%20Update%20and%20Business%20Highlights) Q32 Bio advanced bempikibart development for alopecia areata with ongoing Phase 2a dosing, a new interim CMO, and FDA Fast Track designation [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Bempikibart's SIGNAL-AA Phase 2a trial continues patient dosing in Part B and OLE, with Part B topline data expected in H1 2026 - Dosing of patients in Part B of the SIGNAL-AA Phase 2a clinical trial is ongoing, with topline data readout on track for the first half of 2026[1](index=1&type=chunk)[3](index=3&type=chunk) - The Part B trial will evaluate bempikibart in approximately **20 patients** with severe AA over a **36-week dosing period**, with efficacy measured by changes in SALT scores[3](index=3&type=chunk) - Patient dosing is also ongoing in the Part A open-label extension (OLE), initiated due to emerging data suggesting durable responses and strong patient demand for continued treatment[6](index=6&type=chunk) [Corporate Developments](index=1&type=section&id=Corporate%20Developments) Q32 Bio appointed Dr. Adrien Sipos as Interim CMO and secured FDA Fast Track designation for bempikibart in alopecia areata - Appointed Adrien Sipos, M.D., Ph.D., a seasoned Immunology and Inflammation (I&I) drug developer, as **Interim Chief Medical Officer**[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - Bempikibart received **FDA Fast Track designation**, potentially allowing more frequent FDA interactions, rolling review, and eligibility for Accelerated Approval and Priority Review[6](index=6&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Q32 Bio reported a reduced net loss of **$9.5 million** in Q2 2025, driven by lower R&D, with **$54.8 million** cash extending its runway to 2027 [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Q32 Bio's cash and equivalents totaled **$54.8 million**, funding operations into 2027, with reduced R&D and G&A expenses narrowing net loss to **$9.5 million** - Cash and cash equivalents were **$54.8 million** as of June 30, 2025, expected to fund operations into **2027** through key clinical milestones for bempikibart[1](index=1&type=chunk)[6](index=6&type=chunk) Expense Summary (in millions USD) | Expense Category | Q2 2025 (USD) | Q2 2024 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | R&D Expenses | $5.2M | $13.4M | -$8.2M | | G&A Expenses | $4.0M | $4.5M | -$0.5M | - The decrease in R&D expenses was primarily due to lower costs for bempikibart development and the discontinuation of the ADX-097 Phase 2 trial, while G&A decreased mainly due to lower personnel and legal costs following restructuring[6](index=6&type=chunk)[7](index=7&type=chunk) Net Loss Summary (in millions USD, except per share) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $9.5M | $17.0M | | Net Loss Per Share (basic & diluted) | $0.78 | $1.42 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total operating expenses decreased to **$9.2 million** in Q2 2025 from **$17.9 million** in Q2 2024, resulting in a reduced net loss of **$9.5 million** Condensed Consolidated Statements of Operations (in thousands USD, except per share amounts) | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | | Research and development | $5,161 | $13,411 | | General and administrative | $4,010 | $4,508 | | **Total operating expenses** | **$9,171** | **$17,919** | | **Loss from operations** | **($9,171)** | **($17,919)** | | **Net loss** | **($9,489)** | **($16,978)** | | **Net loss per share—basic & diluted** | **($0.78)** | **($1.42)** | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$66.1 million**, down from **$92.3 million** in 2024, with total liabilities at **$78.4 million** and a stockholders' deficit of **$12.2 million** Condensed Consolidated Balance Sheets (in thousands USD) | (in thousands) | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $54,832 | $77,965 | | **Total assets** | **$66,117** | **$92,332** | | **Liabilities and Stockholders' Equity (Deficit)** | | | | Total Liabilities | $78,352 | $86,657 | | Stockholders' equity (deficit) | ($12,235) | $5,675 | | **Total liabilities and stockholders' equity (deficit)** | **$66,117** | **$92,332** |

Clinical Trial Results - The SIGNAL-AA Phase 2a trial studied bempikibart in patients with severe or very severe Alopecia Areata [1] - The study included patients with SALT scores between 50 and 100 [15] - At Week 24, patients with baseline SALT 50-100 showed a mean SALT score change of 163% with bempikibart treatment [20] - In patients with baseline SALT 50-95, the mean SALT score change at Week 24 was 245% with bempikibart [20] - Some patients experienced continued response even 7 months post last dose [23, 24] Safety and Tolerability - In the bempikibart group, 70% of participants experienced at least one treatment-emergent adverse event (TEAE) [27] - In the placebo group, 38% of participants experienced at least one TEAE [27] - No Grade 3 or higher related adverse events were reported in the bempikibart group [27] Study Design and Demographics - The study randomized patients in a 3:1 ratio to bempikibart (n=33) or placebo (n=81) [15] - The mean baseline SALT score in the bempikibart group was 749, while in the placebo group it was 819 [16]