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ZLNA – Issuance of shares through set-off of option exercise fee
Globenewswire· 2025-05-24 06:38
Oslo, 24 May 2025: Zelluna ASA (the "Company") refers to the resolution by the Company's Annual General Meeting held on 29 April 2025 to grant the Company's Board of Directors an authorisation to issue new shares, each with a subscription price of NOK 26, to settle an amount of EUR 500,000 of an already triggered option exercise fee towards Inven2. The Company's Board of Directors has today resolved to issue 227,096 new shares in the Company to Inven2 against set-off of such amount of EUR 500,000. After the ...
Century Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-15 20:01
Core Insights - Century Therapeutics is advancing its pipeline of induced pluripotent stem cell (iPSC)-derived therapies for autoimmune diseases and cancer, with significant progress reported in the first quarter of 2025 [1][2]. Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $185.8 million, down from $220.1 million at the end of 2024, which is expected to support operations into Q4 2026 [11]. - Collaboration revenue for the first quarter of 2025 was $109.2 million, a substantial increase from $0.9 million in the same period of 2024, attributed to a collaboration agreement with Bristol-Myers Squibb, which was terminated on March 12, 2025 [11]. - Research and Development (R&D) expenses rose to $26.6 million in Q1 2025 from $23.4 million in Q1 2024, primarily due to increased clinical trial costs [11]. - General and Administrative (G&A) expenses decreased slightly to $8.4 million from $8.7 million year-over-year [11]. - The company reported a net income of $76.6 million for Q1 2025, compared to a net loss of $28.1 million in Q1 2024 [11]. Pipeline Developments - The company is on track to initiate Investigational New Drug (IND)-enabling studies for its lead preclinical program, CNTY-308, in mid-2025 [2][11]. - Patient dosing has commenced in the Phase 1 CALiPSO-1 trial for CNTY-101, with plans to expand into additional U.S. and European sites [5][6]. - Presentations at the ASGCT 28th Annual Meeting highlighted advancements in the preclinical pipeline, including improvements in anti-tumor activity of iPSC-derived immunotherapies [4][5]. Strategic Focus - Century Therapeutics is committed to developing off-the-shelf cell therapies to enhance patient access and improve treatment outcomes for autoimmune diseases and cancers [9]. - The company is leveraging its expertise in cellular reprogramming and genetic engineering to create scalable and accessible CAR-T cell therapies [7][11].
MiNK Therapeutics Reports Q1 2025 Results and Highlights Clinical & Strategic Progress
GlobeNewswire News Room· 2025-05-15 11:30
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].
Cabaletta Bio Announces 2027 Rese-cel BLA Submission Anticipated in Myositis Following Recent FDA Alignment on Registrational Cohorts
GlobeNewswire News Room· 2025-05-15 11:00
– 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 ...
Nkarta Reports First Quarter 2025 Financial Results and Corporate Highlights
GlobeNewswire News Room· 2025-05-14 20:01
Core Insights - Nkarta, Inc. is focused on developing engineered natural killer (NK) cell therapies for autoimmune diseases and has reported its financial results for Q1 2025 [1][9] - The company has restructured to enhance its clinical trial success and ensure sufficient cash flow to support operations until 2029 [2][8] Financial Performance - As of March 31, 2025, Nkarta had a cash balance of $351.9 million, which is expected to fund operations into 2029 [6][10] - Research and development (R&D) expenses for Q1 2025 were $24.2 million, while general and administrative (G&A) expenses were $12.4 million, including $5.1 million in restructuring costs [17][22] - The net loss for Q1 2025 was $32.0 million, or $0.43 per share, compared to a net loss of $29.5 million, or $0.58 per share, in Q1 2024 [17][23] Clinical Development Updates - Nkarta is advancing its NKX019 clinical programs, with preliminary data from the Ntrust-1 and Ntrust-2 trials expected in the second half of 2025 [4][6] - The Ntrust-1 trial has been expanded to include a cohort for primary membranous nephropathy, while the Ntrust-2 trial continues to enroll patients for systemic sclerosis and other conditions [7][12] - A modified lymphodepletion regimen using fludarabine and cyclophosphamide has been implemented across trials, with the option for eligible patients to continue with cyclophosphamide alone [6][7] Corporate Developments - Dr. Robert Ortmann has joined Nkarta as Vice President of Clinical Development, bringing over 20 years of experience in autoimmune diseases [8] - The company has undergone a restructuring plan that included a workforce reduction of 34% to extend its cash runway and prioritize clinical execution [8][10] Future Outlook - Nkarta aims to provide initial clinical updates for its Ntrust studies in the latter half of 2025, which will include clinical responses from enrolled patients [4][6] - The company is committed to achieving key clinical milestones while maintaining sufficient funds for ongoing operations [2][10]
Allogene's Q1 Earnings In Line With Estimates, Sales Nil
ZACKS· 2025-05-14 11:30
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]
CARsgen Announces Preliminary Clinical Data for Allogeneic BCMA CAR-T CT0596, Demonstrating Favorable Safety and Efficacy
Prnewswire· 2025-05-12 00:00
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]
Autolus(AUTL) - 2025 Q1 - Earnings Call Presentation
2025-05-08 12:38
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 ...
Autolus Therapeutics Reports First Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-05-08 11:00
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 ...
Zelluna ASA Reports First Quarter 2025 Financial Results and Provides General Business Update
Globenewswire· 2025-05-08 05:00
Core Viewpoint - Zelluna ASA, a company focused on allogeneic T Cell Receptor based Natural Killer (TCR-NK) cells for cancer treatment, announced its first quarter 2025 results, highlighting significant advancements in its manufacturing process and financial performance [1][2]. Financial Update - Total operating expenses for Q1 2025 were MNOK 22.2 [5]. - The net negative cash flow from operations was MNOK 36.0 [5]. - Proceeds from equity issuance amounted to MNOK 51.7, while net cash acquired from the business combination was MNOK 92.3, leading to a net increase in cash and cash equivalents of MNOK 108.0 during Q1 2025 [5]. - Cash and cash equivalents stood at MNOK 135.3 as of March 31, 2025 [5]. - A reverse share split was executed on March 31, 2025, resulting in 20,227,066 outstanding shares, each with a par value of NOK 1 [5]. Business Development - Zelluna successfully completed a business combination with Ultimovacs ASA and Zelluna Immunotherapy AS, along with a private placement that raised gross proceeds of MNOK 51.7 [5]. - The company has developed, scaled, and automated its proprietary manufacturing process for TCR-NK cell therapies, which allows for the production of hundreds of doses from a single batch, enhancing scalability and cost efficiency [5][6]. - The lead program targets MAGE-A4 for the treatment of various solid cancers, marking a significant innovation in the TCR-NK therapeutic field [6].