Adicet Bio (ACET) FY Conference August 12, 2025 01:30 PM ET Speaker0Hi. Good afternoon, and thank you for joining us at the forty fifth Annual Canaccord Genuity Growth Conference here in Boston. I'm John Newman, one of the senior analysts at the firm on the biotech team. So we're very excited to have Adaset with us today and the CEO, Hin Schorr. Hin, welcome.Thank you for joining us today. You know, I'm wondering if you could give us an overview on Adaset's allogeneic approach and your current programs, esp ...

Adicet Bio, Inc. (ACET) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Since a changing ear ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38359 Adicet Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3305277 (State or other jurisdiction o ...

Second Quarter 2025 and Recent Operational Highlights: Autoimmune diseases · First SSc patient dosed in ongoing Phase 1 clinical trial in autoimmune diseases. In July 2025, Adicet announced that the first SSc patient was dosed in the second cohort of the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases, in addition to ongoing enrollment in LN and SLE. The Company recently opened enrollment in the Phase 1 trial to include patients with IIM, SPS and AAV. Adicet remains on track to share prelim ...

Industry and Market Information Information regarding market share, market position and industry data pertaining to Adicet's business contained in this presentation consists of estimates based on data and reports compiled by industry professional organizations and analysts and Adicet's knowledge of their industry. Although Adicet believes the industry and market data to be reliable, this information could prove to be inaccurate. You should carefully consider the inherent risks and uncertainties associated w ...

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]