EDINBURGH, Scotland, June 11, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology company pioneering gamma delta T cell therapies for the treatment of cancer, today announced the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008. The response was achieved after the patient's second dose of 250,000,000 gamma delta t-cells, two we ...

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 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].

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]

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 ...

Company reports Q1 2025 AUCATZYL® net product revenue of $9.0 millionU.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for AUCATZYL® for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)Encouraging preliminary data reported in Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE); planned Phase 2 pivotal clinical trial in lupus nephritis (LN) and Phase 1 clinical trial in prog ...

Core Insights - Autolus Therapeutics plc is advancing its development pipeline, particularly focusing on the expansion of its programmed T cell therapy, obe-cel, into autoimmune diseases such as lupus nephritis (LN) and multiple sclerosis (MS) [1][2][5] Development Plans - The company aims to establish a potential registrational path for obe-cel in LN, supported by insights from key opinion leaders in the field [2][3] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) indicate a strong rationale for progressing to a pivotal Phase 2 study, with the first patient expected to be dosed by the end of 2025 [5][6] Clinical Data - In the Phase 1 CARLYSLE trial, three out of six patients achieved complete renal response by month three, and all patients showed normalization of complement levels by month one [6] - The trial reported no dose-limiting toxicities or severe neurotoxicity, with only mild cytokine release syndrome observed in some patients [6] Future Trials - Autolus plans to initiate a Phase 1 trial for obe-cel in progressive forms of MS, with the first patient expected to be dosed by year-end 2025 [5][6] - The company has aligned with the U.S. FDA on the Phase 2 trial design and anticipates further data presentation at a medical conference in the second half of 2025 [6] Regulatory Updates - Autolus is awaiting notifications from the UK MHRA and EU EMA regarding the approval of obe-cel for adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL) in 2025 [7][11] - The company is actively launching AUCATZYL, its FDA-approved product, with 38 centers fully activated as of April 2025 [11][13] Market Potential - The company believes that obe-cel represents a significant opportunity for value creation across multiple B cell-driven malignancies and autoimmune diseases, addressing substantial unmet medical needs [3][5]

Company outlined potential for value creation driven by obe-cel across multiple B cell driven malignancies and autoimmune diseases, including acute lymphoblastic leukemia (ALL), lupus nephritis (LN) and multiple sclerosis (MS)Preliminary data in initial six patient cohort treated in Phase 1 trial in systemic lupus erythematosus (SLE) support progressing obe-cel into a planned Phase 2 pivotal study in lupus nephritis; first patient expected to be dosed in Phase 2 trial by year-end 2025Company plans to advanc ...

LONDON, April 02, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in the 24th Annual Needham Virtual Healthcare Conference. Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Wednesday, April 9, 2025 at 9:30am EDT / 14:30pm BST. A webcast of the fireside chat will be available ...