Proprietary master cell bank of fibroblast-based spheroids product candidate, CYWC628, completed in accordance with Good Manufacturing Practices after successfully passing all required safety testing Preparations for Phase 1/2 clinical trial in Australia utilizing CYWC628 to treat diabetic foot ulcers are proceeding with plans to initiate in the second quarter of 2025 Cash and cash equivalents of approximately $14.0 million at December 31, 2024 HOUSTON, March 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc ...

Lead program investigating MT-601 in patients with refractory lymphomas, including anti-CD19 CAR-T cell therapy, demonstrated safety and efficacy in 9 patients with 78% having objective responses, including durable complete responses "In 2024, we made substantial progress advancing MT-601, our lead multi antigen recognizing (MAR)-T cell therapy, and laid the groundwork for continued momentum in 2025," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "Preliminary data from ...

HOUSTON, March 21, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, will present on FibroBiologics' unique fibroblast cell-based approach for the potential treatment of chronic di ...

Maravai LifeSciences (MRVI) Q4 2024 Earnings Call March 20, 2025 05:00 PM ET Company Participants Deb Hart - Head of Investor RelationsKevin Herde - Executive VP & CFOTrey Martin - CEODoug Schenkel - Managing DirectorRicki Levitus - Equity Research Associate - Life Sciences Tools & DiagnosticsDan Arias - Managing DirectorBrandon Couillard - Managing Director Conference Call Participants Matt Stanton - AnalystMatt Larew - Research Analyst - HealthcareTejas Savant - Executive Director & Senior Healthcare Equi ...

Financial Data and Key Metrics Changes - The company reported Q4 product revenue of $1.2 million from TECELRA, with expectations to invoice approximately six to eight patients in Q1 2025, significantly higher than the previous quarter [9][10][17] - The consensus analyst forecast for 2025 sales is approximately $25 million, which the company believes is achievable based on current performance metrics [17][30] Business Line Data and Key Metrics Changes - The launch of TECELRA has seen strong momentum, with 20 authorized treatment centers (ATCs) established, ahead of the planned 30 by the end of 2025 [6][8] - The company has a pipeline of around 20 biomarker-positive patients expected to be treated in Q2 and Q3 2025, with over 80 patients having completed MAGE-A4 testing [11][12] Market Data and Key Metrics Changes - Over 70% of commercial and Medicare lives have established reimbursement policies for TECELRA, with no denials reported to date [12] - The company anticipates that Lete-cel will expand the sarcoma franchise, potentially doubling the number of treatable patients annually in the US [25] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven by 2027, with a focus on building a successful business around two FDA-approved products in sarcoma [26][30] - The company is exploring strategic options, including partnerships and collaborations, to optimize shareholder value and ensure financial stability [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating sales of TECELRA and the anticipated launch of Lete-cel, which is expected to leverage existing commercial infrastructure [17][30] - The company is focused on managing costs effectively while pushing towards profitability in 2027, with a commitment to exploring all financial opportunities [30][56] Other Important Information - The company has paused spending on preclinical programs targeting PRAME and CD70, which is expected to reduce cash flow demands by approximately $75 million to $100 million through 2028 [27][68] - The company is part of the PRIME scheme in Europe for TECELRA and plans to submit a marketing application based on comprehensive trial results [80] Q&A Session Summary Question: Can you comment on the pace of apheresis during Q1? - The pace of apheresis has been increasing, with more patients being treated as additional ATCs come online [35] Question: What are the assumptions for profitability in 2027? - The company has not provided specific revenue guidance but expects to achieve profitability through the combination of TECELRA and Lete-cel sales [36][50] Question: What is the status of the ex-US strategy? - The primary focus remains on establishing a commercially viable business in the US, with discussions ongoing for potential partnerships in ex-US markets [66] Question: Can you provide insights on the financials for the quarter? - The company is finalizing its 10-K filing and expects to publish it soon, with anticipated cost reductions from restructuring [68] Question: Are there any capacity constraints affecting patient infusions? - There are currently no capacity limitations reported, and the company is confident in meeting its goals [111][112]

Start Time: 16:30 January 1, 0000 5:12 PM ET MaxCyte, Inc. (NASDAQ:MXCT) Q4 2024 Earnings Conference Call March 11, 2025, 16:30 PM ET Company Participants Maher Masoud - President and CEO Doug Swirsky - CFO Erik Abdo - IR Conference Call Participants Matt Larew - William Blair Julie Simmonds - Panmure Liberum Brendan Smith - TD Cowen Mark Massaro - BTIG Matt Hewitt - Craig-Hallum Operator Thank you for standing by and welcome to MaxCyte's Fourth Quarter Earnings Conference Call. At this time, all participan ...

Legend Biotech Corporation (NASDAQ:LEGN) Q4 2024 Earnings Conference Call March 11, 2025 8:00 AM ET Company Participants Caroline Paul - Associate Director, IR Ying Huang - CEO Jessie Yeung - Interim CFO Mythili Koneru - Chief Medical Officer Guowei Fang - President, R&D Alan Bash - President, CARVYKTI Conference Call Participants Jon Miller - Evercore Hang Hu - Barclays Yaron Werber - TD Cowen Jessica Fye - JPMorgan Ziyi Chen - Goldman Sachs Leonid Timashev - RBC Capital Markets Vikram Purohit - Morgan Sta ...

Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q4 2024 Earnings Conference Call March 10, 2025 4:30 PM ET Company Participants Ioana Hone - Head of Investor Relations Brian Culley - Chief Executive Officer Jill Howe - Chief Financial Officer Conference Call Participants Jack Allen - Baird Joseph Pantginis - H.C. Wainwright Michael Okunewitch - Maxim Group Mayank Mamtani - Riley Securities Albert Lowe - Craig-Hallum Sean McCutcheon - Raymond James Operator Thank you for standing by. My name is Rochelle and I wi ...

Core Viewpoint - NKGen Biotech has initiated the administration of troculeucel, an autologous NK cell therapy, to a stroke patient under a compassionate use IND approved by the FDA, marking a significant step in exploring its therapeutic potential in post-stroke treatment [1][3]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [7]. Product Development - Troculeucel is a novel, patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate, being developed for neurodegenerative disorders and various cancers. The WHO has assigned the International Nonproprietary Name (INN) "troculeucel" for SNK01, which is a significant milestone for the company [6]. Clinical Collaboration - NKGen is collaborating with Dr. Dimitri Sigounas and Dr. Amarendra K. Neppalli from George Washington University Medical Center to explore the potential of troculeucel in reducing chronic neuroinflammation and damage in stroke patients [3][5]. Clinical Assessment - The stroke patient receiving troculeucel will undergo regular independent assessments by Dr. Sigounas at GWU Medical Center to evaluate the treatment's effectiveness [4]. Research Insights - Neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) are identified as markers of brain injury, and previous trials have shown that troculeucel can cross the blood-brain barrier to reduce cerebrospinal fluid levels of these markers, indicating its potential to improve outcomes in stroke patients [5].

Longeveron Inc. (NASDAQ:LGVN) Q4 2024 Earnings Conference Call February 28, 2025 4:30 PM ET Company Participants Derek Cole - IR, Advisory Solutions Wa'el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Conference Call Participants Boobalan Pachaiyappan - ROTH Capital Partners Ram Selvaraju - H.C. Wainwright Michael Okunewitch - Maxim Group Operator Good day, and welcome to the Longeveron 2024 and Full Year Financial Results Conference Call. At this time all participants are in a listen-only mode. ...