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NANOBIOTIX Announces Presentation of Data From Two Phase 1 Studies Evaluating JNJ-1900 (NBTXR3) at the European Lung Cancer Conference
Globenewswire· 2025-03-20 20:15
Core Insights - Nanobiotix announced poster presentations from two Phase 1 studies evaluating JNJ-1900 (NBTXR3) for lung cancer at the 2025 European Lung Cancer Conference [1] Group 1: Study Presentations - The first study focuses on reirradiation with NBTXR3 for inoperable locoregional recurrent non-small cell lung cancer (NSCLC) [2] - The second study evaluates NBTXR3 activated by stereotactic body radiotherapy (SBRT) in combination with immune checkpoint inhibitors for lung metastases from NSCLC or other solid tumors [3] Group 2: Product Overview - NBTXR3 is a novel oncology product made of functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection and activated by radiotherapy [4] - The product aims to induce significant tumor cell death and trigger an adaptive immune response, potentially applicable across various solid tumors treated with radiotherapy [4] Group 3: Regulatory and Development Strategy - NBTXR3 is being evaluated in multiple solid tumor indications, including a global Phase 3 study in head and neck squamous cell cancers [5] - The FDA granted Fast Track designation for NBTXR3 activated by radiation therapy for patients with locally advanced head and neck squamous cell carcinoma [5] Group 4: Collaboration and Licensing - Nanobiotix has engaged in a collaboration with The University of Texas MD Anderson Cancer Center to expand the development of NBTXR3 [6] - In 2023, a license agreement for global co-development and commercialization of NBTXR3 was established with Janssen Pharmaceutica NV, a Johnson & Johnson company [7] Group 5: Company Background - Nanobiotix is a late-stage clinical biotechnology company focused on innovative therapeutic approaches to improve treatment outcomes for patients [8] - The company was incorporated in 2003 and is headquartered in Paris, France, with listings on Euronext Paris and Nasdaq [9]
Century Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-03-19 20:01
Core Insights - Century Therapeutics, Inc. reported financial results and business highlights for the full year 2024, emphasizing a pipeline re-prioritization to focus on transformative candidates in high unmet need diseases [1][2] Financial Performance - Cash, cash equivalents, and marketable securities were $220.1 million as of December 31, 2024, down from $261.8 million as of December 31, 2023 [8] - Net cash used in operations was $110.1 million for the year ended December 31, 2024, compared to $88.3 million for the same period in 2023 [8] - Collaboration revenue was $6.6 million, an increase from $2.2 million in 2023 [8] - Research and Development (R&D) expenses rose to $107.2 million from $92.7 million in 2023, primarily due to increased research and laboratory costs [8] - General and Administrative (G&A) expenses decreased to $33.2 million from $34.7 million in 2023 [8] - The net loss for 2024 was $126.6 million, compared to a net loss of $136.7 million in 2023 [8] Clinical Pipeline Developments - The company has decided to discontinue the Phase 1 ELiPSE-1 trial early, focusing instead on CNTY-101, which is positioned to impact B-cell-mediated autoimmune diseases [2][6] - The CALiPSO-1 Phase 1 trial is set to expand in the U.S. and Europe, with the first patient enrolled and scheduled for dosing in March 2025 [6] - The CARAMEL Phase 1 investigator-initiated trial is expected to commence in mid-2025, focusing on CNTY-101 for B-cell mediated autoimmune diseases [6] Strategic Focus - The company is prioritizing four transformative programs, including CNTY-308, which targets B-cell mediated autoimmune diseases and malignancies [5][9] - CNTY-308 is engineered with Allo-Evasion™ 5.0 technology, aiming for comparable or better performance than approved autologous CAR-T therapies [7][9] - The company aims to launch allogeneic cell therapies at antibody-like scale and cost, expanding access to cell therapies [7][9]
Absci(ABSI) - 2024 Q4 - Earnings Call Transcript
2025-03-18 21:32
Absci (ABSI) Q4 2024 Earnings Call March 18, 2025 04:30 PM ET Company Participants Alexander Khan - VP of Finance & Head of Investor RelationsSean McClain - Founder, CEO & DirectorZach Jonasson - Chief Financial Officer & Chief Business OfficerChristian Stegmann - Senior Vice President of Drug CreationArseniy Shabashvili - Vice PresidentJacqueline Kisa - Equity Research AssociateDebanjana Chatterjee - Director Conference Call Participants None - AnalystVikram Purohit - AnalystGil Blum - Senior AnalystRamaka ...
Quantum BioPharma Unaware of Any Material Change
Newsfile· 2025-03-17 19:33
Company Overview - Quantum BioPharma Ltd. is a biopharmaceutical company focused on developing innovative assets and biotech solutions for neurodegenerative and metabolic disorders, as well as alcohol misuse disorders [2] - The company is advancing its lead compound, Lucid-MS, which is designed to prevent and reverse myelin degradation, a key factor in multiple sclerosis, demonstrated in preclinical models [2] - Quantum BioPharma owns 25.71% of Celly Nutrition Corp., which markets the product unbuzzd™, and has a royalty agreement that includes 7% of sales until total payments reach $250 million, after which the royalty rate drops to 3% [2] Recent Market Activity - The Canadian Investment Regulatory Organization has requested confirmation from Quantum BioPharma regarding recent market activity, to which the company stated that management is unaware of any material changes in operations that would explain this increase [1]
Scinai to Connect with Investors, Showcase its Innovative I&I pipeline and its Boutique cGMP Biologics CDMO during BIO-Europe Spring 2025
Prnewswire· 2025-03-17 11:00
Core Insights - Scinai Bioservices, a CDMO unit launched by Scinai in 2024, operates from a facility in Jerusalem, Israel, featuring 1,850 square meters of clean rooms and laboratories compliant with cGMP standards [2][3] - The CDMO unit has engaged in drug development projects for various biotech companies, including upstream and downstream process development, scale-up, and drug manufacturing for clinical trials [3] - Scinai's U.S. subsidiary, Scinai Bioservices Inc., aims to support early-stage biotech companies in the U.S. by providing essential CDMO services that are currently in short supply [4] Company Overview - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) operates two business units: one focused on developing biological therapeutic products for inflammation and immunology, and the other providing CDMO services to early-stage biotech companies [5] - The company is actively seeking partnerships with potential pharma partners in the fields of inflammation and immunology, as well as institutional and private investors interested in its value proposition [7]
Why Ocular Therapeutix Was Bumping Higher This Week
The Motley Fool· 2025-03-14 12:36
Core Viewpoint - Ocular Therapeutix is experiencing positive market sentiment, leading to a nearly 5% increase in stock price week to date, driven by a bullish analyst coverage initiation [1] Group 1: Analyst Coverage - Needham's analyst Serge Belanger initiated coverage on Ocular Therapeutix, rating the stock as a buy with a price target of $15 per share, nearly double its current level [2] - Belanger believes in Ocular's potential primarily due to its investigational drug Axpaxli, which targets wet age-related macular degeneration (AMD) [3] Group 2: Drug Potential - Axpaxli is noted for its longer duration compared to comparable medications, positioning it as a standout treatment option [4] - The drug has the potential to become a blockbuster, especially for patients requiring a maintenance regime [4] Group 3: Market Opportunity - There is a significant patient base for wet AMD in the U.S., with approximately 200,000 new cases diagnosed annually, indicating a strong market opportunity for Axpaxli [5]
Polyrizon Signs Non– Binding LOI to Expand its Innovative Intranasal Drug Delivery Platform for Psychedelic-Based Treatments
Globenewswire· 2025-03-14 12:35
Core Viewpoint - Polyrizon Ltd. has signed a non-binding Letter of Intent with a biotech company focused on psychedelic-derived therapeutics to develop a novel intranasal formulation for psychedelic-based treatment applications [1][2]. Group 1: Collaboration Details - The agreement aims to leverage Polyrizon's proprietary platform to optimize the delivery of innovative psychedelic treatments, emphasizing the potential of intranasal drug delivery in enhancing bioavailability, efficacy, and patient accessibility [2][4]. - Polyrizon will lead the formulation's development using its mucoadhesive drug delivery technology, while the psychedelic company will fund the research and development process, including feasibility studies [4]. Group 2: Technology and Innovation - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, which create a barrier in the nasal cavity to protect against viruses and allergens [5]. - The company's proprietary Capture and Contain (C&C) hydrogel technology aims to improve bioadhesion and prolonged retention at the nasal deposition site for drug delivery [5]. Group 3: Future Prospects - If the collaboration is successful, it could lead to further clinical development and commercialization, with plans to negotiate a definitive agreement outlining intellectual property ownership, commercialization rights, and financial terms [4]. - Polyrizon is expected to receive royalty payments for any future commercialization of the product by the psychedelic company [4].
Intensity Therapeutics Reports 2024 Year End Financial Results and Provides Corporate Update
Prnewswire· 2025-03-13 20:07
Core Viewpoint - Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies, with recent updates on clinical trials and financial results for 2024 [1][6]. Corporate Update - The INVINCIBLE-3 Study is a Phase 3 trial testing INT230-6 as a monotherapy against standard of care drugs for certain soft tissue sarcoma subtypes, with an expected enrollment of 333 patients across eight countries [2]. - The INVINCIBLE-4 Study is a Phase 2 trial analyzing the safety and efficacy of INT230-6 in early-stage triple-negative breast cancer patients, with an expected enrollment of approximately 54 patients in Switzerland and France [4]. - The company has initiated and dosed its first patient in both the INVINCIBLE-3 and INVINCIBLE-4 studies, with ongoing patient recruitment and site activation [3][5]. Financial Results - Research and development expenses for 2024 were $10.5 million, up from $4.8 million in 2023, primarily due to costs associated with the INVINCIBLE-3 Study [7]. - General and administrative expenses increased to $6.1 million in 2024 from $3.5 million in 2023, driven by higher salaries, legal fees, and insurance costs [9]. - The net loss for 2024 was $16.3 million, compared to a net loss of $10.5 million in 2023, with a loss per share of $1.17 [9][15]. Cash Position - As of December 31, 2024, the company reported cash and cash equivalents totaling $2.6 million, a decrease from $14.8 million in 2023 [10][16]. Product Information - INT230-6 is the company's lead investigational product, designed for direct intratumoral injection, combining cisplatin and vinblastine with a penetration enhancer to improve drug distribution within tumors [11][12]. - The drug aims to elicit an immune response while maintaining a favorable safety profile, representing a potential shift in cancer treatment paradigms [12].
Tempus Stock May Rise on the Acquisition of AI-Driven Deep 6 AI
ZACKS· 2025-03-13 17:45
Core Viewpoint - Tempus AI, Inc. has acquired Deep 6 AI to enhance its precision medicine capabilities through AI-driven insights, aiming to improve patient recruitment and trial efficiency [1][4]. Company Developments - The acquisition of Deep 6 AI will streamline the process of connecting patients with relevant clinical trials, expediting the development of new treatments [2][6]. - Tempus integrates Deep 6 AI's advanced machine learning algorithms into its existing platform, allowing for real-time analysis of patient data to optimize trial outcomes [9]. - Tempus has a market capitalization of $7.85 billion and expects 42% earnings growth over the next five years, compared to the industry's 20.8% growth [5]. Industry Context - The acquisition strengthens Tempus' position in the rapidly growing AI-driven healthcare market, potentially boosting its stock price in the long run [4]. - Deep 6 AI's technology mitigates risks in clinical trials and enhances patient recruitment by analyzing both structured and unstructured electronic medical record data [8].
NKGen Biotech To Present on Potential of Troculeucel for the Treatment of Neurodegenerative Diseases at the 13th Annual Alzheimer’s & Parkinson’s Drug Development Summit
Globenewswire· 2025-03-13 12:00
Core Insights - NKGen Biotech, Inc. is focused on developing innovative NK cell therapeutics, with a presentation at the upcoming Alzheimer's & Parkinson's Drug Development Summit highlighting their autologous NK cell therapy, troculeucel, for neurodegenerative diseases [1][2] Company Overview - NKGen Biotech is a clinical-stage biotechnology company headquartered in Santa Ana, California, specializing in autologous and allogeneic NK cell therapeutics [6] - Troculeucel, the company's novel cell-based immunotherapeutic drug candidate, is being developed for neurodegenerative disorders and various cancers, with its International Nonproprietary Name (INN) assigned as SNK01 by the WHO [5] Presentation Details - Dr. Paul Y. Song will present on March 20, 2025, at 12:00 PM ET, focusing on the potential of enhanced NK cell therapies for neurodegenerative diseases, specifically introducing troculeucel [3] - The presentation will include data from a Phase 1 clinical trial showing early signs of clinical benefit, leading to FDA Fast Track designation for moderate Alzheimer's Disease and a new Investigational New Drug application for Parkinson's Disease [3] Summit Information - The Alzheimer's & Parkinson's Drug Development Summit is the only industry-focused event covering the entire drug development process, featuring over 150 experts discussing advancements in neurodegenerative therapeutics [2]