Core Viewpoint - Cabaletta Bio, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aiming to raise capital for its clinical-stage biotechnology operations focused on autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes shares of common stock and pre-funded warrants, with an option for underwriters to purchase an additional 15% of the offering [1][2]. - The offering is expected to close around June 12, 2025, subject to market conditions and customary closing conditions [2]. Group 2: Company Overview - Cabaletta Bio is a clinical-stage biotechnology company dedicated to developing curative targeted cell therapies for autoimmune diseases [5]. - The company’s CABA™ platform employs two strategies to advance engineered T cell therapies, with a focus on the CARTA strategy and its lead investigational therapy, rese-cel [5]. - Rese-cel is currently being evaluated in the RESET™ clinical development program, which spans multiple therapeutic areas including rheumatology, neurology, and dermatology [5].

Core Insights - Cabaletta Bio, Inc. announced promising clinical data from its ongoing RESET clinical trials for autoimmune diseases, highlighting the potential of rese-cel to provide drug-free, symptom-free lives for patients [1][2][6] Clinical Trial Results - In the RESET-Myositis trial, 7 out of 8 patients achieved clinically meaningful total improvement scores (TIS) while off all immunomodulators and steroids, with 4 patients experiencing grade 1 cytokine release syndrome (CRS) [1][2][3] - All systemic lupus erythematosus (SLE) patients without nephropathy achieved remission as per DORIS criteria, with 7 out of 7 patients responding clinically while off immunomodulators and glucocorticoids [1][2] - Both patients in the RESET-SSc trial showed significant improvements in modified Rodnan Skin Score (mRSS) after discontinuing immunomodulatory drugs, with one patient meeting the revised Composite Response Index in Systemic Sclerosis (CRISS) criteria [1][8] Safety Profile - Among 18 patients with follow-up of 4 weeks or more, 94% experienced no CRS or only Grade 1 CRS, and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS) [1][2] - In the RESET-SLE trial, 2 out of 8 patients experienced grade 1 CRS, and one ICANS event was reported [3][8] Regulatory and Development Plans - Cabaletta plans to initiate enrollment in two registrational myositis cohorts in 2025 and has scheduled discussions with the FDA regarding registrational pathways for SLE/LN in 3Q25, scleroderma in 4Q25, and myasthenia gravis in 1H26 [1][9] - The RESET clinical trial program is accelerating, with 51 patients actively enrolled across over 65 clinical sites as of May 30, 2025 [1][2][6] Company Overview - Cabaletta Bio is focused on developing curative targeted cell therapies for autoimmune diseases, with rese-cel being a key investigational therapy designed to deplete CD19-positive B cells [5][6] - The company aims to change treatment paradigms for autoimmune diseases through its innovative CARTA platform, which includes multiple disease-specific clinical trials [5][6]

Cabaletta Bio (CABA) 2025 Conference June 04, 2025 11:05 AM ET Speaker0 morning, everyone. Thank you for attending Jefferies Global Healthcare Conference. My name is Kelly Xu, one of the equity analysts on the biotech team. We are very pleased to have Steven, CEO Caballetta Bio join us today for this fireside chat session. Welcome, Steven. Speaker1 Thanks. Thanks for having me. Speaker0 Maybe we can start a question with the great news from Caballetta. You've aligned with FDA on the registrational trial des ...

Core Insights - Cabaletta Bio, Inc. is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 [1] - The lead strategy, CARTA, is centered on the investigational therapy rese-cel, which is currently in the RESET clinical development program [3] Company Overview - Cabaletta Bio is dedicated to advancing engineered T cell therapies that may provide deep and durable, potentially curative treatments for a variety of autoimmune diseases [3] - The company is headquartered in Philadelphia, PA, and has a comprehensive platform that includes two complementary strategies for therapy development [3] - Rese-cel is a fully human CD19-CAR T cell therapy that contains 4-1BB and is being evaluated across multiple therapeutic areas, including rheumatology, neurology, and dermatology [3]

Patient dosing initiated in Phase 1 CALiPSO-1 trial evaluating CNTY-101 in autoimmune disease; expanding to additional U.S. and European sites following CTA authorizations in Germany, France, and Italy CNTY-308 expected to enter IND-enabling studies in mid-2025 to support anticipated clinical trials in B-cell-mediated autoimmune diseases and malignancies Presentations at ASGCT 28th Annual Meeting highlight preclinical pipeline anchored by advanced iPSC-derived ’tunable’ CD4+/CD8+ ab T cells and Allo-Evasion ...

Core Viewpoint - MiNK Therapeutics is making significant progress in its clinical-stage biopharmaceutical development of allogeneic invariant natural killer T (iNKT) cell therapies, with a focus on oncology and immune-mediated diseases, while also enhancing its financial position through strategic partnerships and non-dilutive capital [2][3][6]. Financial Highlights - As of March 31, 2025, MiNK Therapeutics reported a cash balance of $3.2 million, with cash used in operations amounting to $1.3 million, a decrease from $2.5 million in the same period of 2024 [6][10]. - The net loss for Q1 2025 was $2.8 million, or $0.70 per share, compared to a net loss of $3.8 million, or $1.10 per share, for Q1 2024 [6][10]. Clinical Progress - MiNK is advancing its iNKT platform in treating solid tumors and immune-mediated diseases, with notable developments including a complete remission case in metastatic testicular cancer and ongoing enrollment in a Phase 2 gastric cancer trial [8][12]. - The company presented new data at AACR IO and ASCO GI, demonstrating the efficacy of agenT-797 in combination with other therapies for PD-1–resistant gastroesophageal cancers [8][12]. - MiNK's iNKT therapy has shown survival benefits in acute respiratory distress syndrome (ARDS) and is pursuing broader patient access through clinical trials [8][12]. Strategic Developments - The company is engaged in late-stage strategic discussions to expand its reach in oncology, immune-mediated diseases, and next-generation engineered cell therapies, aiming to enhance shareholder value [2][3]. - MiNK has been selected for probable funding by NIAID to support its allogeneic iNKT program in graft-versus-host disease (GvHD), expected to provide critical non-dilutive capital [8][12].

– SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 – – New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June – – Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – As of March 31, 2025, the Company had cash and cash equivalents of $131.8 million, per our Form 10-Q being filed ...

Core Viewpoint - Allogene Therapeutics reported a first-quarter 2025 loss of 28 cents per share, which aligns with the Zacks Consensus Estimate, showing an improvement from a loss of 38 cents per share in the same period last year [1] Financial Performance - The company did not report any sales during the quarter, as it lacks a marketed product, compared to collaboration revenues of $0.02 million in the year-ago period [1] - Research and development (R&D) expenses were $50.2 million, down 4% year over year, while general and administrative (G&A) expenses decreased by 13% to $15.0 million [5] - As of March 31, 2025, Allogene had $335.5 million in cash, cash equivalents, and investments, down from $373.1 million as of December 31, 2024 [5] 2025 Guidance - Allogene revised its 2025 guidance, expecting operating expenses to be around $230 million, including nearly $45 million in non-cash stock-based compensation, an improvement from the previous forecast of $250 million [6] - Cash burn for 2025 is now expected to be around $150 million, reduced from the previous guidance of $170 million, allowing the company to extend its cash runway into the second half of 2027 [7] Pipeline Updates - The pivotal phase II ALPHA3 study is evaluating lead drug cema-cel for treating newly diagnosed large B cell lymphoma patients, with the timeline for analysis pushed back to the first half of 2026 [9] - Allogene plans to initiate the phase I RESOLUTION basket study with ALLO-329 for autoimmune diseases in mid-2025, with the first data readout now expected in the first half of 2026 [10] - Updated data from the phase I TRAVERSE study evaluating ALLO-316 in advanced renal cell carcinoma will be presented at the 2025 ASCO Annual Meeting on June 1 [11] Stock Performance - Year to date, Allogene's shares have declined by 47%, contrasting with a 6% decline in the industry [2]

Core Insights - CARsgen Therapeutics Holdings Limited announced preliminary clinical data for CT0596, an allogeneic BCMA-targeted CAR-T therapy, currently in exploratory clinical studies for relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (R/R PCL) [1][2] Group 1: Clinical Data and Efficacy - As of May 6, 2025, 8 patients with R/R MM were infused with CT0596 after lymphodepletion, showing favorable tolerability and encouraging efficacy signals across all predefined dose levels [2] - Among 5 patients who completed the first efficacy assessment at Week 4, 3 patients (60%) achieved stringent complete response/complete response (sCR/CR), and 4 patients (80%) achieved minimal residual disease (MRD)-negativity in the bone marrow [5] - Early efficacy data from 2 patients at Day 14 indicated reductions in measurable lesions by ≥92% and ≥65%, respectively [5] Group 2: Technology and Platform - CARsgen developed the THANK-u Plus™ platform to enhance CAR-T technology, demonstrating sustained expansion regardless of NKG2A expression levels on NK cells, with improved antitumor efficacy compared to the previous THANK-uCAR® [3] - The platform shows potential for developing diverse allogeneic CAR-T therapies, with CAR-T cells exhibiting robust antitumor activity in the presence of NK cells [3] Group 3: Company Overview - CARsgen is focused on innovative CAR T-cell therapies for unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [4] - The company has established end-to-end capabilities for CAR T-cell research and development, covering target discovery, preclinical research, clinical development, and commercial-scale production [4] - CARsgen aims to improve safety profiles, enhance efficacy in treating solid tumors, and reduce treatment costs, positioning itself as a global leader in biopharmaceuticals [4]

Q1 2025 Financial Results and Business Updates May 8, 2025 For Investor communication only. Not for use in product promotion. Not for further distribution. Autolus.com Developing and Delivering a New Generation of T Cell Therapies Disclaimer These slides contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by te ...