Core Viewpoint - Adicet Bio, Inc. has announced a registered direct offering of 70,001,000 shares of its common stock, along with pre-funded warrants for an additional 10,000,000 shares, indicating a significant capital raise to support its clinical stage biotechnology initiatives [1] Company Summary - Adicet Bio, Inc. is a clinical stage biotechnology company focused on discovering and developing allogeneic gamma delta T cell therapies aimed at treating autoimmune diseases and cancer [1]

Summary of Adicet Bio FY Conference Call Company Overview - **Company**: Adicet Bio (NasdaqGM:ACET) - **Industry**: Biotechnology, specifically focused on CAR T cell therapies for autoimmune diseases and cancer [2][3] Core Points and Arguments - **Leadership in CAR T Therapies**: Adicet Bio is recognized as a leader in developing off-the-shelf gamma delta one CAR T cell therapies for autoimmune diseases and cancer [2] - **Clinical Validation**: The platform has been clinically validated, showing high complete response (CR) rates and overall response rates in oncology studies, particularly in non-Hodgkin lymphoma (NHL) [3] - **Safety Profile**: Gamma delta one CAR T cells exhibit a more favorable safety profile compared to traditional alpha beta T cell therapies, with reduced incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [4] - **Lead Program**: The lead program, ADI-001, is in phase one for six autoimmune indications, with clinical data expected in the second half of the year [5][6] - **Pipeline Expansion**: The company is also targeting solid tumors, specifically prostate cancer, with enhanced potency through gene editing and armoring technologies [5][6] Clinical Study Insights - **Key Learnings from Clinical Studies**: The studies have shown robust exposure comparable to autologous CAR T therapies, with complete depletion of CD19 positive B cells in both blood and lymph nodes [8][9] - **Importance of Lymph Node Depletion**: Effective depletion of B cells in lymph nodes is crucial for demonstrating clinical activity in autoimmune diseases [12][13] - **Unmet Medical Need**: There is a significant unmet medical need in autoimmune diseases, with patients often relying on immunosuppressants and experiencing severe side effects [14][15] Target Product Profile - **Efficacy and Safety Goals**: The target product profile for ADI-001 aims for efficacy similar to autologous CD19 CAR T therapies, with a better safety profile to allow outpatient administration [16][17] - **Regulatory Expectations**: For lupus nephritis, a complete response (CR) rate of 40% or above is expected to meet regulatory thresholds for pivotal studies [23][32] Future Milestones - **Upcoming Data Releases**: Significant updates on the programs for lupus nephritis and systemic lupus erythematosus (SLE) are anticipated in the near future, with additional updates for systemic sclerosis and other indications expected [34][35] - **Oncology Program**: The company is also excited about its oncology program targeting prostate cancer, with plans to file an IND and start clinical development early next year [35] Additional Considerations - **Challenges in Solid Tumors**: The company acknowledges challenges in penetrating solid tumors, referred to as "cold tumors," and is working on enhancing the activity of gamma delta one T cells in these environments [37][38] - **Comparative Data**: The presentation referenced data from other companies, highlighting the competitive landscape and the need for objective endpoints in clinical studies [26][29][30] This summary encapsulates the key points discussed during the Adicet Bio FY Conference Call, focusing on the company's innovative approaches, clinical insights, and future directions in the biotechnology sector.

Summary of Adicet Bio (ACET) FY Conference Call - August 12, 2025 Company Overview - **Company**: Adicet Bio (ACET) - **Focus**: Leader in off-the-shelf gamma delta CAR T cell therapies, particularly for autoimmune diseases and solid tumors [3][4] Core Points and Arguments Allogeneic Approach - Adicet's gamma delta CAR T cell therapies are off-the-shelf, providing a differentiated safety profile compared to autologous therapies [4][8] - The ability to dose in outpatient settings is a significant advantage, especially for autoimmune diseases that often lead to organ damage [4][9] Autoimmune Disease Programs - Current programs include enrollment for systemic lupus erythematosus (SLE), lupus nephritis (LN), and systemic sclerosis [5][28] - The company is targeting CD20 instead of CD19 or CD22 due to its stable antigen presence on B cells, which has shown similar efficacy in B cell depletion [12][13] Safety and Efficacy - Gamma delta T cells have a lower frequency of cytokine release syndrome (CRS) and neurotoxicity compared to alpha beta T cells, allowing for safer outpatient administration [9][10] - The potential for patients to avoid prolonged immunosuppression before treatment is a key benefit of the allogeneic approach [17][18] Clinical Study Design - The lupus nephritis study is designed to enroll patients and report outcomes at various intervals, with a focus on safety and B cell depletion [29][39] - Initial readout expected to include at least six patients with three months of follow-up, assessing safety, immune reset, and renal function [38][40] Comparison of Study Types - Investigator-sponsored studies (ISTs) are more subjective and less rigorous compared to company-sponsored studies, which are multisite and have defined protocols [20][22] - Company-sponsored studies are viewed as more reliable for understanding patient benefits [23] Future Developments - The prostate cancer program (ADI 212) is in development, focusing on enhancing gamma delta T cell efficacy in solid tumors through gene editing and other technologies [45][46] - Manufacturing capabilities are robust, with a 14-day process and multiple sources for donor material, allowing for significant scalability [49][52] Important but Overlooked Content - The mean age of death for patients with SLE is 55, highlighting the urgent need for effective therapies that can reduce reliance on immunosuppressants and steroids [25] - The potential for patients to achieve immunosuppressant-free remission is a significant therapeutic goal, representing a major advancement in treatment [25][26] Conclusion Adicet Bio is positioned to make significant advancements in the treatment of autoimmune diseases and solid tumors through its innovative allogeneic gamma delta CAR T cell therapies, with ongoing clinical trials and a strong focus on safety and efficacy. The company’s approach addresses critical challenges in current therapies, particularly in terms of patient management and treatment accessibility.

Core Viewpoint - Adicet Bio, Inc. (ACET) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system tracks the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts, and changes in these estimates are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for Adicet Bio indicate an improvement in the company's underlying business, which is expected to positively influence its stock price [5][10]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7][9]. - Adicet Bio's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2025, Adicet Bio is expected to earn -$1.15 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 35.3% over the past three months [8].

PART I. FINANCIAL INFORMATION [Item 1. Consolidated Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(Unaudited)) Adicet Bio's unaudited financials for Q2 2025 show total assets decreased to **$163.0 million**, with a **net loss of $31.2 million** and a **30% workforce reduction** [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$163.0 million** by June 30, 2025, primarily due to a **$51.3 million decline** in cash and short-term investments Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $34,720 | $56,495 | | Short-term investments | $90,243 | $119,808 | | Total current assets | $127,740 | $180,136 | | Total assets | $162,972 | $220,219 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $17,079 | $19,392 | | Total liabilities | $29,600 | $33,610 | | Total stockholders' equity | $133,372 | $186,609 | | Total liabilities and stockholders' equity | $162,972 | $220,219 | [Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a **net loss of $31.2 million** for Q2 2025 and **$59.4 million** for the first six months, driven by increased R&D expenses Consolidated Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $28,424 | $25,901 | $51,238 | $49,797 | | General and administrative | $3,968 | $6,948 | $11,039 | $13,922 | | Total operating expenses | $32,392 | $32,849 | $62,277 | $63,719 | | Loss from operations | ($32,392) | ($32,849) | ($62,277) | ($63,719) | | Net loss | ($31,217) | ($29,901) | ($59,431) | ($57,917) | | Net loss per share | ($0.34) | ($0.33) | ($0.65) | ($0.68) | [Consolidated Statements of Cash Flows](index=12&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$52.0 million** for H1 2025, resulting in a **$21.8 million decrease** in cash and equivalents Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($52,030) | ($46,271) | | Net cash provided by (used in) investing activities | $30,092 | ($541) | | Net cash provided by financing activities | $163 | $111,170 | | **Net change in cash, cash equivalents and restricted cash** | **($21,775)** | **$64,358** | | Cash, cash equivalents and restricted cash at end of period | $37,623 | $224,069 | [Notes to Unaudited Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail liquidity, Nasdaq non-compliance, and a July 2025 strategic pipeline prioritization with a **30% workforce reduction** and **$2.3 million** in restructuring charges - The company believes its cash, cash equivalents, and short-term investments are sufficient to fund operations for at least the **next twelve months** from the financial statement issuance date[45](index=45&type=chunk) - On April 7, 2025, the company received a Nasdaq notification for its stock bid price falling below **$1.00** for 30 consecutive business days, with a deadline of October 6, 2025, to regain compliance[48](index=48&type=chunk) - In July 2025, the company announced a strategic pipeline prioritization focusing on ADI-001 and ADI-212, discontinued ADI-270, and implemented a **workforce reduction of approximately 30%**[124](index=124&type=chunk)[127](index=127&type=chunk) - The company expects to incur approximately **$2.3 million** in personnel-related restructuring charges in Q3 2025 due to the workforce reduction[124](index=124&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses pipeline focus on ADI-001 and ADI-212, with **Q2 2025 R&D up 10%** and **G&A down 43%**, ending with **$125.0 million** in cash [Overview](index=36&type=section&id=Overview) Adicet Bio focuses on allogeneic gamma delta T cell therapies, with lead candidate ADI-001 in Phase 1 and ADI-212 advancing, while ADI-270 development is discontinued - Lead product candidate ADI-001 is in a Phase 1 clinical trial for autoimmune diseases, with preliminary data from at least **6 patients** expected in H2 2025[132](index=132&type=chunk) - The company is advancing ADI-212 for mCRPC and expects to submit a regulatory filing in **Q1 2026**[134](index=134&type=chunk) - Development of ADI-270 has been discontinued as part of a strategic pipeline prioritization[135](index=135&type=chunk) - In July 2025, the company reduced its workforce by approximately **30%** in connection with its strategic pipeline prioritization[136](index=136&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Q2 2025 R&D expenses increased **10% to $28.4 million**, while G&A expenses decreased **43% to $4.0 million**, resulting in a **$59.4 million** net loss for H1 2025 Comparison of Operating Expenses (in thousands) | Expense Category | Q2 2025 | Q2 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $28,424 | $25,901 | $2,523 | 10% | | General and administrative | $3,968 | $6,948 | ($2,980) | (43%) | | **Total operating expenses** | **$32,392** | **$32,849** | **($457)** | **(1%)** | Comparison of Operating Expenses - Six Months (in thousands) | Expense Category | H1 2025 | H1 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $51,238 | $49,797 | $1,441 | 3% | | General and administrative | $11,039 | $13,922 | ($2,883) | (21%) | | **Total operating expenses** | **$62,277** | **$63,719** | **($1,442)** | **(2%)** | - The decrease in G&A expenses for both the three and six-month periods was primarily due to a decrease in **stock-based compensation expense**[149](index=149&type=chunk)[156](index=156&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$125.0 million** in cash and investments, sufficient for 12 months, with an accumulated deficit of **$557.3 million** as of June 30, 2025 - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling **$125.0 million**[162](index=162&type=chunk) - The company expects its current cash position to be sufficient to fund operations for at least the **next twelve months**[162](index=162&type=chunk)[164](index=164&type=chunk) - In January 2024, the company raised net proceeds of approximately **$91.7 million** from an underwritten public offering and **$19.3 million** from its ATM program[160](index=160&type=chunk)[161](index=161&type=chunk) - The company's accumulated deficit was **$557.3 million** as of June 30, 2025[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its **$125.0 million** in investments, but foreign currency and inflation risks are not currently material - The company's primary market risk is interest rate risk on its cash and short-term investments of **$125.0 million**, but a **10% change** in rates is not expected to be material[185](index=185&type=chunk) - Foreign currency exchange risk and inflation risk are not considered to have had a material impact on the company's results for the period[187](index=187&type=chunk)[188](index=188&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective as of June 30, 2025, with a previously identified material weakness in cash disbursements remediated - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2025[189](index=189&type=chunk) - A material weakness in internal controls over financial reporting related to unauthorized cash disbursements, identified in **Q4 2024**, was successfully **remediated** as of March 6, 2025[189](index=189&type=chunk)[191](index=191&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings or claims expected to have a material adverse effect - As of the report date, the company is not subject to any **material legal proceedings**[193](index=193&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include dependence on ADI-001, substantial net losses, need for financing, clinical and manufacturing challenges, regulatory hurdles, and potential Nasdaq delisting - The business is highly dependent on the success of its most advanced product candidate, **ADI-001**[202](index=202&type=chunk) - The company has incurred net losses since inception, with an accumulated deficit of **$557.3 million** as of June 30, 2025, and anticipates substantial future losses[197](index=197&type=chunk) - Substantial additional financing is required to develop product candidates and implement operating plans[260](index=260&type=chunk) - The company's common stock is at risk of being **delisted from Nasdaq** for failing to maintain a minimum bid price of **$1.00 per share**[470](index=470&type=chunk) - The July 2025 workforce reduction may not result in anticipated savings and could disrupt business operations[272](index=272&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=147&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - No unregistered sales of equity securities occurred during the period[497](index=497&type=chunk) [Item 5. Other Information](index=147&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during the fiscal quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the quarter[500](index=500&type=chunk) [Item 6. Exhibits](index=147&type=section&id=Item%206.%20Exhibits) The report includes key exhibits such as corporate governance documents, license agreements, and officer certifications - Key exhibits filed include license and collaboration agreements with CRISPR Therapeutics AG and City of Hope, along with standard corporate governance documents and officer certifications[503](index=503&type=chunk)

[Adicet Bio Second Quarter 2025 Business Updates](index=1&type=section&id=Adicet%20Bio%20Second%20Quarter%202025%20Business%20Updates) [Autoimmune Diseases Program (ADI-001)](index=1&type=section&id=Autoimmune%20Diseases%20Program%20(ADI-001)) Adicet is actively enrolling patients in its Phase 1 trial for ADI-001 across multiple autoimmune diseases, with preliminary data anticipated in H2 2025 - Actively enrolling patients in a Phase 1 trial for ADI-001 in lupus nephritis (LN), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc)[1](index=1&type=chunk) - The first patient with systemic sclerosis (SSc) was dosed in July 2025[3](index=3&type=chunk) - Enrollment has been expanded to include patients with idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV)[1](index=1&type=chunk)[3](index=3&type=chunk) - Preliminary clinical data from the Phase 1 trial, with at least 6 patients having at least 3 months' follow-up, is on track to be reported in the **second half of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) [Solid Tumor Indications Program (ADI-212)](index=2&type=section&id=Solid%20Tumor%20Indications%20Program%20(ADI-212)) Adicet prioritizes preclinical development of ADI-212 for prostate cancer, targeting a Q1 2026 regulatory filing and H2 2026 initial clinical data - Prioritizing development of ADI-212, a next-generation gene-edited candidate targeting prostate specific membrane antigen (PSMA) for solid tumors[4](index=4&type=chunk) - Preclinical studies of ADI-212 have shown enhanced activity, suggesting potential for improved potency and tumor-cell killing capacity[4](index=4&type=chunk) - A regulatory filing for ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) is expected in **Q1 2026**[4](index=4&type=chunk) - Initial clinical data from the ADI-212 program is anticipated in the **second half of 2026**, subject to regulatory clearance[4](index=4&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Adicet discontinued the ADI-270 program and reduced its workforce by **30%**, extending its cash runway into **Q4 2026** - Discontinued the development of ADI-270 for patients with metastatic/advanced clear renal cell carcinoma (ccRCC) and closed enrollment in its Phase 1 trial[5](index=5&type=chunk) - Reduced its workforce by approximately **30%** in connection with the strategic pipeline prioritization[5](index=5&type=chunk) - The workforce reduction and other expense reductions are expected to extend the Company's cash runway into the **fourth quarter of 2026**[5](index=5&type=chunk) [Financial Results for Second Quarter 2025](index=2&type=section&id=Financial%20Results%20for%20Second%20Quarter%202025) [Q2 2025 Financial Performance Summary](index=2&type=section&id=Q2%202025%20Financial%20Performance%20Summary) Adicet reported a **Q2 2025 net loss of $31.2 million**, with R&D expenses increasing to **$28.4 million** and G&A decreasing to **$4.0 million**, ending with **$125.0 million** in cash Q2 2025 Financial Performance Summary | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $28.4 million | $25.9 million | | G&A Expenses | $4.0 million | $6.9 million | | Net Loss | $31.2 million | $29.9 million | | Net Loss per Share | $0.34 | $0.33 | | Cash, Cash Equivalents & Short-term Investments | $125.0 million | N/A | - The increase in R&D expenses was primarily driven by a **$1.4 million** increase in costs related to contract development and manufacturing organizations and a **$1.6 million** increase in facility-related expenses[6](index=6&type=chunk) - The decrease in G&A expenses was mainly due to a **$1.8 million** decrease in payroll and personnel expenses and a **$1.1 million** decrease in facility-related expenses[10](index=10&type=chunk) - The company's cash, cash equivalents, and short-term investments of **$125.0 million** as of June 30, 2025, are expected to be sufficient to fund operating expenses into the **fourth quarter of 2026**[10](index=10&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Adicet reported **Q2 2025 total operating expenses of $32.4 million** and a **net loss of $31.2 million**, or **$0.34 per share**, compared to **Q2 2024's $32.8 million** operating expenses and **$29.9 million** net loss Consolidated Statements of Operations | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $28,424 | $25,901 | | General and administrative | $3,968 | $6,948 | | **Total operating expenses** | **$32,392** | **$32,849** | | Loss from operations | $(32,392) | $(32,849) | | Interest income | $1,398 | $2,999 | | **Net loss** | **$(31,217)** | **$(29,901)** | | **Net loss per share, basic and diluted** | **$(0.34)** | **$(0.33)** | [Consolidated Balance Sheets Information](index=5&type=section&id=Consolidated%20Balance%20Sheets%20Information) As of June 30, 2025, Adicet reported **$125.0 million** in cash, equivalents, and short-term investments, **$163.0 million** in total assets, and **$133.4 million** in total stockholders' equity Consolidated Balance Sheets Information | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents, and short term investments | $124,963 | $176,303 | | Working Capital | $110,661 | $160,744 | | Total assets | $162,972 | $220,219 | | Total stockholders' equity | $133,372 | $186,609 |

ADI-001 for Autoimmune Diseases - Adicet's ADI-001 targets CD20 and has demonstrated complete CD19+ B cell depletion in blood and secondary lymphoid tissue[8, 17] - ADI-001 is under clinical development for 6 autoimmune indications, with initial clinical data expected in the second half of 2025[8, 9] - ADI-001's Cmax, D28 Persistence, and AUC are consistent with approved autologous CD19 CAR T therapies[19] - In preclinical studies, ADI-001 exhibited potent killing of patient-derived CD19+ B cells in multiple autoimmune diseases, including SLE, SSc, RA, Multiple Sclerosis, and Sjogren's Syndrome[25] - A Phase 1 autoimmune study is underway, with primary endpoints focused on safety and secondary endpoints including cellular kinetics, pharmacodynamics, and efficacy endpoints specific to each indication[57, 59] - The company is expanding ADI-001 autoimmune development across six indications with a US prevalence of ~242 thousand patients for SLE, ~85 thousand for Systemic Sclerosis, ~60 thousand for IIM, ~60 thousand for AAV and so on[50, 51] ADI-270 for Oncology - Adicet's ADI-270 targets CD70 and is designed to address multiple refractory cancers, with a Phase 1 clinical update expected in the second half of 2025[8, 62, 64] - ADI-270 incorporates a TGFβ receptor II to mitigate immunosuppressive effects and is engineered to increase persistence[8, 65] - Preclinical data shows ADI-270 retains potent activity in CD70-low tumors compared to clinically relevant CD70-targeting αβ CAR T cell benchmarks[79] - In ccRCC xenograft models, a single dose of ADI-270 demonstrated potent regression and sustained systemic anti-tumor activity[92] Financial Status - As of March 31, 2025, Adicet Bio has approximately $1504 million in cash and cash equivalents, projected to provide a cash runway into the second half of 2026[101]

Summary of Adicet Bio (ACET) Conference Call Company Overview - Adicet Bio is a leader in off-the-shelf gamma delta one CAR T cell therapy, focusing on autoimmune diseases and solid tumors [3][4] Clinical Programs - **Clinical Programs**: - Off-the-shelf gamma delta one CAR T cell therapy targeting CD20 for lupus and other autoimmune diseases [3][4] - Gamma delta one CAR T targeting CD70 for renal cell carcinoma [4][37] - **Preclinical Programs**: Two preclinical programs are in development, with data expected later this year [4][46] Advantages of Gamma Delta T Cells - **Autoimmune Diseases**: - Off-the-shelf availability eliminates the need for leukapheresis and personalized manufacturing [5][6] - Better tolerability with lower incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [5][6] - Complete depletion of CD19 positive B cells in blood and lymph nodes, which is crucial for durable therapy [11][12] - **Solid Tumors**: - Innate and adaptive anti-tumor activity helps address tumor heterogeneity [7][8] - Tissue tropism allows activity in nutrient-poor and hypoxic environments [7][8] Targeting Strategy - **CD20 Targeting in Autoimmune Diseases**: - Strong proof of concept for CAR T efficacy leading to significant disease score improvements [19][20] - Enrollment includes patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) [17][18] - **CD70 Targeting in Renal Cell Carcinoma**: - Targeting CD70 using CD27 receptor for potentially more potent activity [38][39] - Expected to have data in the second half of the year, focusing on patients who have progressed on PD-1 and VEGF therapies [41][42] Enrollment and Study Design - Enrollment criteria for SLE include patients who have progressed on at least two therapies [25][26] - Initial data set for SLE and LN expected to include at least six patients with three months follow-up [28][41] Key Learnings and Market Potential - Recent developments in cell therapy for autoimmune diseases indicate significant improvements in disease scores, suggesting a new class of therapies could emerge [35][36] - The potential for gamma delta T cell therapies to address unmet medical needs in multiple autoimmune diseases and solid tumors presents a significant commercial opportunity [35][36] Future Plans and Milestones - Data expected in the second half of the year for both autoimmune and oncology programs [48][49] - Continued focus on expanding clinical data and preclinical programs, with multiple milestones anticipated over the next 18 months [49][50]

Core Viewpoint - Adicet Bio, Inc. (ACET) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [3][5]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [3]. Company Performance Indicators - The upgrade for Adicet Bio reflects an improvement in the company's underlying business, which is expected to drive the stock price higher [4]. - For the fiscal year ending December 2025, Adicet Bio is projected to earn -$1.71 per share, representing a -28.6% change from the previous year [7]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have averaged a +25% annual return since 1988 [6]. - Adicet Bio's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [9].

Summary of Adicet Bio (ACET) Conference Call Company Overview - Adicet Bio is a leader in gamma delta CAR T cell therapies, which have several advantages over traditional therapies, including being off-the-shelf, better safety profiles, and effective tissue distribution [3][4][5][6][7]. Key Advantages of Gamma Delta CAR T Cells - **Off-the-Shelf Availability**: Gamma delta CAR T cells can be administered without prior patient-specific modifications, reducing preparation time [3]. - **Safety Profile**: These cells are associated with lower rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) compared to alpha beta T cells [4]. - **Tissue Distribution**: Gamma delta T cells effectively localize to tissues, which is beneficial for treating autoimmune diseases and solid tumors [5][6]. - **Innate Antitumor Activity**: They can target tumor cells even if they do not express the specific target, enhancing their therapeutic potential [7]. Clinical Programs and Data - Adicet Bio is currently running two clinical programs and has two preclinical programs in development [8]. - In clinical trials for diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL), the complete response (CR) rates were comparable to autologous therapies, with a notable safety advantage [11][12]. - The company is focusing on autoimmune diseases, particularly lupus nephritis (LN) and systemic lupus erythematosus (SLE), with plans to expand to other conditions like systemic sclerosis and ANCA vasculitis [19][21]. Market Potential and Unmet Needs - The market for autoimmune diseases is significant, with high unmet medical needs, particularly in conditions like lupus nephritis, where patients face severe long-term health risks [25]. - The company aims to provide a one-time therapy that could lead to complete responses, reducing the need for ongoing immunosuppressants [25]. Data Expectations and Patient Selection - Investors are looking for data from at least six patients with three months of follow-up to assess efficacy [27]. - The ideal patient profile includes younger individuals with recent diagnoses and minimal existing tissue damage [31]. Competitive Landscape - The cell therapy space is competitive, with many companies pivoting from oncology to autoimmune diseases based on promising academic data [33]. - Adicet Bio differentiates itself by offering off-the-shelf therapies that do not require leukapheresis or personalized manufacturing, which can complicate treatment [36][39]. Future Developments - The company is also exploring renal cell carcinoma (RCC) as a new target, leveraging its unique advantages in tissue targeting and safety [44][46]. - Data from RCC trials is expected in the second half of the year, with a focus on achieving better outcomes than existing therapies [49]. Financial Position - Adicet Bio has approximately $150 million in cash, which is expected to fund operations into the second half of the following year [52]. - The company is open to business development opportunities to enhance its pipeline and financial stability [52]. Regulatory Environment - Interactions with regulatory agencies have been positive, with a collaborative approach noted in discussions about innovative therapies [53][54]. - The company believes that therapies demonstrating significant patient benefits will receive favorable attention from regulators [54]. Conclusion - Adicet Bio is positioned to make significant advancements in both autoimmune and oncology sectors with its gamma delta CAR T cell therapies, addressing critical unmet needs while navigating a competitive landscape and regulatory challenges [56].