The reverse stock split is intended to enable Adicet to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf†gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patie ...

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].

Financial Performance - Adicet Bio reported a net loss of $26.9 million for Q3 2025, a decrease from a net loss of $30.5 million in Q3 2024, resulting in a net loss per share of $0.29 compared to $0.34 in the prior year[9]. - Research and Development (R&D) expenses were $22.9 million for Q3 2025, down from $26.3 million in Q3 2024, primarily due to reductions in payroll and personnel expenses[9]. - General and Administrative (G&A) expenses decreased to $5.1 million in Q3 2025 from $6.9 million in Q3 2024, mainly due to lower payroll and personnel costs[9]. - Adicet's accumulated deficit reached $584.2 million as of September 30, 2025, compared to $497.9 million at the end of 2024[15]. Cash Position - Cash, cash equivalents, and short-term investments totaled $103.1 million as of September 30, 2025, down from $176.3 million at the end of 2024, with additional funding expected to extend the cash runway into the second half of 2027[9][8]. - The company raised $74.8 million in net proceeds from a registered direct offering in October 2025, enhancing its financial position[8]. Clinical Trials and Regulatory Plans - Positive preliminary data from the Phase 1 trial of ADI-001 showed rapid and sustained reductions in SLEDAI-2K scores and improved renal function in all patients with lupus nephritis[4]. - The company plans to request a meeting with the FDA in Q1 2026 to discuss the design of a potentially pivotal trial for ADI-001, with study initiation anticipated in Q2 2026[1]. - Adicet is actively enrolling patients in the Phase 1 study of ADI-001 for treatment-refractory rheumatoid arthritis, evaluating the potential to reduce the need for conditioning[6]. - A regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer is planned for Q1 2026, with initial clinical data expected in the second half of 2026[3][7].

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.