Summary of Adicet's Conference Call Company Overview - **Company**: Adicet - **Industry**: Biotech, specifically focused on gamma delta CAR T cell therapies - **Key Executive**: Chen Schor, President and CEO Core Points and Arguments - **Leadership in CAR T Cell Therapies**: Adicet is positioned as a leader in gamma delta CAR T cell therapies, which are advantageous for treating autoimmune diseases and solid tumors due to their off-the-shelf availability and tissue penetration capabilities [3][4] - **Progress in Autoimmune Program**: The company is currently enrolling patients for seven different indications, with significant proof of concept data announced recently [4][6] - **Efficacy and Safety Data**: - In a recent study involving lupus nephritis (LN) and systemic lupus erythematosus (SLE), the safety profile was excellent, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) observed [6][7] - Efficacy results showed that out of five LN patients, three achieved complete renal response, and all patients reduced their steroid use significantly [7][8] - **Durability of Responses**: The data suggests promising durability of responses, with immune reset observed in patients, indicating long-term effectiveness of the therapy [11][12][14] - **Regulatory Plans**: Adicet plans to meet with the FDA in Q1 next year to discuss pivotal studies for LN and SLE, with expectations to start these studies in Q2 [23][24] Additional Important Information - **Enrollment and Interest**: The company has opened 25 centers for patient enrollment and is seeing robust interest, particularly in systemic sclerosis (SSC) and other autoimmune conditions [19][28] - **Manufacturing and Cost of Goods**: Adicet has a robust manufacturing process with a cost of goods sold (COGS) expected to be less than 10% of pricing, allowing for flexibility in pricing strategies [43][44] - **Financial Position**: As of September 30, Adicet has nearly $180 million in cash, which is projected to fund operations into the second half of 2027, covering multiple clinical updates and regulatory milestones [51] Conclusion Adicet is making significant strides in the field of gamma delta CAR T cell therapies, with promising safety and efficacy data in autoimmune diseases. The company is well-positioned for future growth with a solid financial foundation and strategic regulatory plans.

Financial Performance - The company reported a net loss of $26.9 million for the three months ended September 30, 2025, a decrease of 12% compared to a net loss of $30.5 million in the same period of 2024[143]. - Net loss for the nine months ended September 30, 2025, was $86.3 million, a decrease of $2.1 million, or 2%, from $88.4 million in 2024[151]. - Total operating expenses for the nine months ended September 30, 2025, were $90.2 million, a decrease of $6.6 million, or 7%, from $96.9 million in 2024[151]. - Interest income decreased by $1.6 million, or 57%, to $1.2 million for the three months ended September 30, 2025, compared to $2.8 million in 2024[148]. - Interest income for the nine months ended September 30, 2025, decreased by $4.4 million, or 51%, to $4.3 million compared to $8.6 million in 2024[154]. Research and Development - Research and development expenses were $22.9 million for the three months ended September 30, 2025, down 13% from $26.3 million in 2024[143]. - Research and development expenses for the nine months ended September 30, 2025, were $74.1 million, a decrease of $2.0 million, or 3%, from $76.1 million in 2024[152]. - ADI-001 has shown a favorable safety profile with no reported cases of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and no Grade 2 or higher Cytokine Release Syndrome (CRS) observed in the ongoing Phase 1 trial[131]. - The potential market opportunity for ADI-001 in B cell mediated autoimmune diseases is substantial, with over 1.7 million patients in the U.S., EU5, China, and Japan[125]. - ADI-212 is designed to enhance potency in solid tumors and has shown improved activity in preclinical studies, targeting prostate specific membrane antigen (PSMA)[127]. Expenses and Cash Flow - General and administrative expenses decreased by 26% to $5.1 million in the third quarter of 2025, compared to $6.9 million in the same quarter of 2024[143]. - General and administrative expenses decreased by $1.8 million, or 26%, to $5.1 million for the three months ended September 30, 2025, compared to $6.9 million in 2024[147]. - Cash, cash equivalents, and short-term investments as of September 30, 2025, totaled $103.1 million, with an additional $74.8 million raised from the 2025 Offering[161][160]. - The company expects its cash resources to fund operations into the second half of 2027, based on current estimates[163]. - Net cash used in operating activities was $68.0 million for the nine months ended September 30, 2024, with a net loss offset by non-cash adjustments of $26.2 million[171]. Regulatory and Compliance - The company received FDA clearance for the IND application of ADI-001 in lupus nephritis in December 2023, expanding its clinical development program to include additional autoimmune diseases[125]. - The company plans to submit a regulatory filing for ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the first quarter of 2026[127]. - The company has been granted an additional 180 days until April 6, 2026, to regain compliance with the minimum $1.00 per share listing requirement on the Nasdaq Capital Market[130]. - The company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, as the stock closed below $1.00 for thirty consecutive business days[176]. - Following the failure to regain compliance by the deadline, the company transferred its stock listing to the Nasdaq Capital Market, gaining an additional 180-day grace period[178]. Market and Economic Conditions - The company does not believe that foreign currency exchange rate fluctuations have significantly impacted its results of operations[186]. - Inflation has not materially affected the company's business, financial condition, or results of operations during the three months ended September 30, 2025[187].

Ongoing enrollment of patients in Phase 1 study with LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) Adicet Bio Reports Third Quarter 2025 Financial Results and Provides Business Updates Announced positive preliminary safety and efficacy data from Phase 1 clinical trial of ADI-001 in patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE); data highlighted rapid a ...

Core Insights - The company announced promising safety and efficacy results from its ongoing Phase I study of ADI-001 in patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) [2]. Group 1 - The conference call was held to discuss the clinical data from the Phase I study [2][3]. - The Chief Medical Officer will summarize the clinical data to date, followed by the Chief Scientific Officer who will present evidence of immune reset observed in the study [3]. Group 2 - The Chief Financial Officer will participate in the Q&A session following the presentation of clinical data [3].

Core Insights - The company announced promising safety and efficacy results from its ongoing Phase I study of ADI-001 in patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) [2]. Group 1: Clinical Data - The presentation will include a summary of clinical data to date, led by the Chief Medical Officer [3]. - The study demonstrated clear evidence of immune reset observed in the patients [3]. Group 2: Leadership and Structure - The conference call features key executives including the CEO, Chief Medical Officer, Chief Scientific Officer, and Chief Financial Officer, indicating a structured approach to discussing the study results [2][3].

Core Viewpoint - Adicet Bio Inc. has experienced a decline in share price following the announcement of an $80 million direct offering, despite positive early safety and efficacy data from its Phase 1 trial of ADI-001 for autoimmune diseases [1][7]. Financial Offering - The company has priced a registered direct offering of 70 million shares and pre-funded warrants for 10 million shares at $1.00 per share and $0.9999 per warrant, aiming for gross proceeds of approximately $80 million [1]. Clinical Trial Results - Initial safety and efficacy data from the first seven patients treated with ADI-001 showed promising results, with 100% of patients in the lupus nephritis cohort achieving a renal response, including three complete responses [3][4]. - All patients experienced rapid and sustained reductions in SLEDAI-2K and PGA scores, indicating the potential for a durable effect on a wide range of lupus symptoms [4]. Safety Profile - ADI-001 was generally well-tolerated, with no serious adverse events reported among the seven patients, suggesting a favorable safety profile that may allow for outpatient dosing [5]. Future Development Plans - The company plans to request a meeting with the FDA in Q1 2026 to discuss the design of a potentially pivotal Phase 2 trial, which is expected to start in Q2 2026 [6].

Group 1: Company Overview - Exact Sciences (EXAS) is a notable stock within the Medical sector, which consists of 960 companies and currently ranks 6 in the Zacks Sector Rank [2] - The company has a Zacks Rank of 1 (Strong Buy), indicating strong potential for outperforming the market in the near term [3] Group 2: Performance Metrics - Over the past 90 days, the Zacks Consensus Estimate for EXAS' full-year earnings has increased by 125%, reflecting improved analyst sentiment and earnings outlook [4] - Year-to-date, EXAS has returned approximately 2.6%, outperforming the Medical sector average return of 1.5% [4] Group 3: Industry Context - Exact Sciences is part of the Medical - Biomedical and Genetics industry, which includes 472 stocks and currently ranks 89 in the Zacks Industry Rank [6] - The average return for the Medical - Biomedical and Genetics industry so far this year is 8.1%, indicating that EXAS is slightly underperforming its industry [6] Group 4: Comparison with Peers - Another stock in the Medical sector, Adicet Bio, Inc. (ACET), has a year-to-date return of 4% and a Zacks Rank of 2 (Buy) [5] - The consensus estimate for Adicet Bio's current year EPS has increased by 2.4% over the past three months, showcasing its positive outlook [5]

Group 1 - The article does not provide any specific information or data regarding companies or industries [1]

Summary of Adaset Bio Conference Call Company and Industry - **Company**: Adaset Bio - **Industry**: Biotechnology, specifically focusing on autoimmune diseases such as Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) Key Points and Arguments Phase I Study Results - The Phase I study of ADI-one shows promising safety and efficacy results for patients with LN and SLE, indicating a potential paradigm shift in treatment approaches for autoimmune diseases [2][4][41] - All patients (5 LN and 2 SLE) experienced rapid and sustained reductions in SLEDAI scores and physician global assessment (PGA) scores [6][14] - The study demonstrated a complete renal response (CRR) rate exceeding 40%, which is the regulatory benchmark for success in pivotal studies for B cell depleting therapies [6][24][41] Safety Profile - ADI-one was well tolerated with no serious adverse events (SAEs) reported, no cytokine release syndrome (CRS) events greater than grade one, and only one grade one infection [5][15][20] - The favorable safety profile supports the potential for ADI-one to be administered as an outpatient therapy, which could significantly reduce the burden on healthcare systems [22][41] Immune Reset Evidence - There is clear evidence of an immune reset, characterized by deep B cell depletion followed by the emergence of a new, less antigen-experienced B cell repertoire [30][32][36] - The study's findings align with the definition of an immune reset, indicating a potential for long-term disease remission without the need for chronic immunosuppressants [30][41] Future Plans and Milestones - Adaset Bio plans to request a meeting with the FDA in Q1 2026 to discuss the design of a Phase II pivotal trial, anticipated to start in Q2 2026 [9][43] - The company has activated over 25 clinical sites globally and is seeing increased interest in patient enrollment across multiple autoimmune indications [42][43] - Expected milestones throughout 2026 include clinical updates in SLE and LN, alignment with the FDA on pivotal study design, and initiation of pivotal studies [44][45] Market Opportunity - The data suggests significant commercial potential for ADI-one as an off-the-shelf therapy, which could transform treatment practices for autoimmune diseases [8][41][42] - The company is exploring additional indications, including rheumatoid arthritis (RA) and systemic cirrhosis, indicating a robust pipeline for future growth [10][43] Other Important Content - The study highlights the unmet medical need for effective treatments for LN and SLE, where current therapies often involve chronic immunosuppressants and steroids with significant side effects [16][29] - The demographic characteristics of the study participants are consistent with other clinical trials, reinforcing the validity of the findings [19][68] - The potential for ADI-one to provide a one-time treatment option with minimal side effects is emphasized as a major advantage over existing therapies [29][41] This summary encapsulates the critical insights from the Adaset Bio conference call, focusing on the promising results of the ADI-one Phase I study, its safety profile, the evidence of immune reset, future plans, and the significant market opportunity in the autoimmune disease sector.

ADI-001 Clinical Data and Safety Profile - ADI-001 demonstrated rapid and sustained reductions in SLEDAI-2K and PGA across all patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)[5,18] - All five LN patients achieved renal responses, including three complete renal responses and Definition of Remission in Systemic Lupus Erythematosus (DORIS) remissions[5,34] - ADI-001 showed a well-tolerated safety profile, with no ≥Grade 2 Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)[5,18] - All seven patients discontinued immunosuppressants and tapered corticosteroids to zero or physiological levels[5,18] - Clear evidence of immune reset was observed, with subsequent emergence of naïve B cell repertoire following a single treatment[5,18] ADI-001 Autoimmune Program and Pipeline - Adicet Bio is developing a broad pipeline of allogeneic γδ1 T cell therapies for autoimmune diseases and cancer[8] - ADI-001 is currently in clinical trials for LN & SLE, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)/Stiff Person Syndrome (SPS), Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis (AAV), and Rheumatoid Arthritis (RA)[8] - Adicet Bio anticipates SLE and LN clinical updates in the first half of 2026 and plans to initiate a pivotal study in LN or LN/SLE in the same period[11] ADI-212 Oncology Program - ADI-212, a PSMA-targeted therapy, is planned for regulatory filing in the first quarter of 2026, with initial clinical data expected in the second half of 2026 for metastatic castration-resistant prostate cancer (mCRPC)[8] Financial Status - As of June 30, 2025, Adicet Bio had approximately $125 million in cash and cash equivalents[12]