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].

Financial Performance - The company reported a net loss of $28.2 million for the three months ended March 31, 2025, compared to a net loss of $28.0 million for the same period in 2024, representing a 1% increase in loss [139]. - Total operating expenses for the three months ended March 31, 2025, were $29.9 million, a decrease of $986,000, or 3%, compared to the same period in 2024 [139]. - General and administrative expenses increased by less than $0.1 million, or 1%, to $7.1 million for the three months ended March 31, 2025 [141]. - The company reported losses of $28.2 million for the three months ended March 31, 2025, with an accumulated deficit of $526.1 million as of the same date [150]. - Net cash used in operating activities was $25.4 million for the three months ended March 31, 2025, compared to $22.8 million for the same period in 2024 [158][159]. - The company incurred net cash used in investing activities of $2.9 million for the three months ended March 31, 2025, primarily due to purchases of short-term treasury securities and lab equipment [160]. Research and Development - Research and development expenses decreased by $1.1 million, or 5%, to $22.8 million for the three months ended March 31, 2025, primarily due to a decrease in expenses related to contract development and manufacturing organizations (CDMOs) [140]. - The company received FDA clearance for its IND application for ADI-001 in lupus nephritis in December 2023 and expanded its clinical development program to include additional autoimmune diseases in August 2024 [123]. - ADI-270, targeting CD70 for renal cell carcinoma (RCC), received FDA clearance for its IND application in June 2024 and Fast Track Designation in July 2024 [126]. - The company plans to file one new Investigational New Drug (IND) application every 12-18 months as part of its ongoing development strategy [122]. - The company has incurred significant losses and does not expect to generate substantial product revenue until regulatory approvals are obtained for its product candidates [152]. Capital and Funding - The company raised approximately $19.3 million in net proceeds through the JonesTrading ATM Program in January 2024 before transitioning to the Jefferies ATM Program [146]. - The company completed a public offering of 32,379,667 shares at a price of $2.40 per share, resulting in net proceeds of approximately $91.7 million after underwriting discounts and expenses [147]. - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $150.4 million, which is expected to cover operational needs for at least the next twelve months [148][151]. - The company anticipates needing to raise substantial additional capital to fund operations and product development in the foreseeable future [153]. Compliance and Regulations - The company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, with a deadline to regain compliance by October 6, 2025 [164]. - The company is classified as a "smaller reporting company," allowing it to take advantage of reduced disclosure requirements [168]. Economic Factors - Inflation has generally affected the company by increasing labor, clinical trial, and manufacturing costs [175]. - The company does not believe that inflation had a material effect on its business, financial condition, or results of operations during the three months ended March 31, 2025 [175]. - The company intends to retain and continue using its equipment, furniture, fixtures, and office equipment, which mitigates the impact of inflation on operations [175]. - Foreign currency exchange rate fluctuations have not had a significant impact on the company's results of operations for any periods presented [174]. Cash Management - As of March 31, 2025, the company had $2.9 million of restricted cash held in cash collateral accounts following the termination of a loan agreement [127]. - The company has restricted cash of $2.9 million held in cash collateral accounts as of March 31, 2025 [149]. - The company's assets are primarily monetary, consisting of cash, cash equivalents, and short-term investments in treasury securities [175]. - The company incurs a majority of its general and administrative expenses and research and development costs in U.S. Dollars [174].

Financial Performance - Adicet Bio reported a net loss of $28.2 million for Q1 2025, or $0.31 per share, compared to a net loss of $28.0 million, or $0.35 per share, in Q1 2024[8][12] - Research and Development (R&D) expenses decreased to $22.8 million in Q1 2025 from $23.9 million in Q1 2024, primarily due to a $1.4 million reduction in expenses related to contract development manufacturing organizations[8][12] - Cash and cash equivalents were $150.4 million as of March 31, 2025, down from $176.3 million as of December 31, 2024, with expectations to fund operations into the second half of 2026[8][12] Clinical Trials and Development - Enrollment is ongoing for the Phase 1 clinical trial of ADI-001 in autoimmune diseases, with preliminary data expected in 2H 2025[3][7] - The Phase 1 clinical trial of ADI-270 in metastatic/advanced clear cell renal cell carcinoma (ccRCC) is also underway, with preliminary data anticipated in 2H 2025[7][8] - Adicet has received Fast Track Designation from the FDA for ADI-001 targeting refractory systemic lupus erythematosus and systemic sclerosis[3][8] - Adicet plans to initiate enrollment for additional autoimmune disease patients in the Phase 1 trial by Q3 2025[3][8] - The company aims to leverage its allogeneic gamma delta CAR T cell therapy platform, identifying two promising programs targeting PSMA and autoimmune diseases[2][3] - Adicet will present preclinical data for ADI-270 at the ASGCT Annual Meeting in May 2025, highlighting its anti-tumor activity[7][8] Leadership Changes - The company appointed Michael Grissinger to its Board of Directors, bringing over 40 years of experience in biopharmaceutical business development and strategy[5]

Financial Performance - The company has incurred a net loss of $117.1 million for the year ended December 31, 2024, with an accumulated deficit of $497.9 million as of the same date[208]. - As of December 31, 2024, the company has $176.3 million in cash, cash equivalents, restricted cash, and short-term investments, which is expected to sustain operations into the second half of 2026[277]. - The company anticipates needing substantial additional financing to develop product candidates and implement operating plans, particularly for clinical trials and commercial production[276]. - The company has federal net operating loss carryforwards of approximately $339.9 million as of December 31, 2024, which may be limited by potential ownership changes[352]. Clinical Development and Regulatory Approval - The company plans to report preliminary clinical data for ADI-001 in lupus nephritis (LN) in the first half of 2025 and for other autoimmune diseases in the second half of 2025[211]. - The company received FDA clearance for its IND application for ADI-270 in renal cell carcinoma (RCC) in June 2024 and dosed its first patient in December 2024[211]. - The company received FDA clearance for IND applications for ADI-001 in December 2023 and for additional indications in 2024, with plans to file new INDs every 12-18 months[232]. - The FDA has indicated that companion diagnostics may be required for the approval of product candidates, which could materially impair revenue generation if not obtained[224]. - The FDA's guidance suggests that if a companion diagnostic is essential for a therapeutic product, approval of the therapeutic product may be contingent on the companion diagnostic being approved[225]. - The company anticipates challenges in demonstrating the safety and efficacy of its product candidates to regulatory authorities[397]. - The regulatory approval process for the company's novel product candidates may be more complex and expensive than for established therapies[217]. - The company may seek orphan drug designation for its product candidates, which could provide market exclusivity but is subject to regulatory uncertainties[398]. - The FDA may require post-marketing studies for products receiving accelerated approval, which could impact the timeline for commercialization[396]. - The company has received fast track designation for ADI-001 for the treatment of LN and for ADI-270 in metastatic/advanced clear cell RCC[401]. Research and Development Challenges - The company expects to incur significant expenditures for research and development related to its gamma delta T cell platform, including ADI-001 and ADI-270[209]. - The company faces significant challenges in developing its gamma delta T cell product candidates, including potential negative results from clinical trials and manufacturing difficulties[214]. - Clinical trials are costly and time-consuming, with a high attrition rate; many product candidates fail to demonstrate safety and efficacy[228][229]. - Clinical trials for gamma delta T cell product candidates are expected to incur significantly higher costs than conventional therapies due to extensive R&D and manufacturing requirements[244]. - The company anticipates challenges in manufacturing and processing product candidates at a commercial scale, which could affect inventory creation and cost[368]. - The company has not yet estimated the cost of commercial manufacturing, which could adversely impact the viability of its product candidates[369]. Market and Competitive Landscape - The company faces significant competition from other biotechnology and pharmaceutical companies, which may impact its market position[259]. - The potential target populations for the company's product candidates may be small, limiting the opportunity for profitability[253]. - The company is in the early stages of developing its allogeneic gamma delta T cell therapy, and there is no assurance that it will successfully demonstrate efficacy and safety[216]. Operational Risks and Dependencies - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[208]. - The company currently has no marketing and sales organization and lacks experience in marketing products, which may hinder revenue generation[256]. - The company relies on third-party suppliers for manufacturing, which increases the risk of delays and insufficient product quantities[263]. - The company is highly dependent on key personnel, and the loss of any executive officers or key employees could delay product development[271]. - The company conducts operations in a competitive market for skilled personnel, which may limit its ability to hire and retain qualified staff[272]. - The company relies on independent organizations and consultants for critical operational functions, which may not always be available or effective[281]. Regulatory and Compliance Issues - The company is subject to regulatory changes in China that could impact the development and commercialization of its product candidates, particularly regarding human genetic resources[286]. - The 2024 Negative List in China prohibits foreign investment in certain technologies, which may affect the company's research and development activities[290]. - The company may face compliance risks under the Human Genetic Resources Regulation, which restricts the collection and export of genetic resources by foreign entities[308]. - The evolving interpretation and enforcement of laws and regulations in China could increase operational costs and affect the company's ability to provide services[309]. - Compliance with the FCPA and similar anti-bribery laws may limit the company's ability to compete in foreign markets, potentially leading to material adverse effects on its business and reputation[311]. - The company is subject to extensive healthcare regulations, and violations could result in substantial penalties, impacting clinical research and sales programs[322]. Internal Control and Financial Reporting - The company is required to maintain effective internal control over financial reporting, with potential material weaknesses leading to financial statement restatements[343]. - The company must assess its internal controls annually and disclose changes quarterly, which can be costly and challenging[344]. - As of December 31, 2024, the company identified a material weakness in internal control over financial reporting related to cash disbursements, which was not adequately designed to prevent unauthorized cash disbursements[349]. - The company may incur additional costs in efforts to improve internal control processes, with no assurance of success in avoiding future material weaknesses[347]. Strategic Partnerships and Collaborations - Regeneron has provided a non-refundable upfront payment of $25.0 million and an additional $20.0 million for research funding as of December 31, 2024, under the collaboration agreement[355]. - If the collaboration with Regeneron is terminated, the company may face significant delays in development and commercialization efforts, potentially harming its financial condition[355]. - The company may face challenges in maintaining collaborations with other companies, which are crucial for its business operations[358]. - The company may need to seek additional funding or collaborations if existing agreements do not yield expected results, impacting its development and commercialization efforts[360]. Data Protection and Cybersecurity - The company is subject to cybersecurity threats that could disrupt operations and result in significant costs if data is lost or compromised[376]. - The company must implement new safeguards for data transfers outside the EEA or UK, which will require significant effort and cost[331]. - The company may face potential fines of up to €20 million or 4% of global annual revenues for non-compliance with GDPR or UK GDPR regulations[332]. - The UK GDPR may lead to additional compliance costs and legal risks, with potential penalties of up to £17.5 million or 4% of worldwide revenue for violations[330]. Economic and Market Conditions - Inflation and rising interest rates have decreased the trading value of government securities, posing risks to financial stability[339]. - The company may face adverse impacts from liquidity issues in the financial services industry, as seen with the closure of Silicon Valley Bank in March 2023[338]. - Changes in political and economic policies between China and the United States may adversely affect the company's business, financial condition, and results of operations[318].