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INmune Bio Inc. Presents Baseline Demographics and Disease Profiles of Participants in the MINDFuL Phase II Study
Globenewswire· 2025-04-01 11:00
Core Insights - INmune Bio, Inc. is presenting data from the MINDFuL Phase II trial at the International Conference on Alzheimer's and Parkinson's Diseases, focusing on early Alzheimer's disease (AD) and inflammation biomarkers [1][5] - The trial enrolled 208 patients, with 44% diagnosed with Mild Cognitive Impairment (MCI) and 56% with mild AD, averaging 72 years of age [2] - The primary endpoint is the change in cognitive scores measured by the Early and Mild Alzheimer's Cognitive Composite (EMACC), which is designed for sensitivity in early AD trials [3] Patient Demographics and Trial Design - The enrolled patients met criteria for inflammation biomarkers, including hsCRP > 1.5 mg/L, ESR > 10 mm/hr, HbA1c > 6.0%, or at least one APOE ε4 allele [2] - Patients were randomized in a 2:1 ratio to receive XPro™ (1.0 mg/kg) or placebo weekly for 23 weeks [2] - The screen failure rate was 72%, primarily due to disease severity as measured by the MMSE [4] Preliminary Findings - Preliminary analyses indicate a well-characterized cohort with 69.2% being APOE ε4 carriers and 64.4% meeting criteria for multiple enrichment biomarkers [5] - Secondary endpoints include CDR-SB, E-Cog, ADL, and Neuropsychiatric Inventory (NPI), along with blood biomarker and neuroimaging outcomes [5] - Topline results from the MINDFuL trial are expected to be reported in June 2025 [6] Company Overview - INmune Bio is a clinical-stage biotechnology company focused on treatments targeting the innate immune system, with three product platforms including DN-TNF, NK Cell Priming, and CORDStrom™ [7] - The company is developing therapies for Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [7]
INmune Bio(INMB) - 2024 Q4 - Earnings Call Transcript
2025-03-27 20:30
INmune Bio (INMB) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Moss - Chief Financial OfficerRaymond Tesi - CEO & ChairmanGeorge Farmer - Managing DirectorMark Lowdell - Chief Scientific Officer & Chief Manufacturing OfficerCJ Barnum - Head of NeuroscienceDenis Reznik - Senior Equity Research AssociateElemer Piros - Senior Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Ph ...
Oncocyte(OCX) - 2024 Q4 - Earnings Call Presentation
2025-03-24 21:20
Investment Highlights - Oncocyte is taking a disruptive approach to molecular diagnostic testing by empowering local labs with kits, contrasting the central lab model[14] - The company has secured a go-to-market strategic partner and equity investment[14] - Oncocyte has a science-driven team experienced in molecular diagnostics and rapid growth[14] - The company possesses a full R&D pipeline to fuel growth and portfolio expansion over the next decade[14] - Oncocyte's IP portfolio is attractive to partners and enables value protection[14] Transplant Market - Kidney transplant patients face a 20.2% chance of developing Antibody-Mediated Rejection (AMR) within 10 years of transplant, and up to 70% of those patients will progress to graft failure[43] - The US market supports $500 million in annual revenue for Laboratory Developed Tests (LDTs), which is currently generated by competitors[79] - The global transplant testing market is currently a $1 billion Total Addressable Market (TAM) and can expand to approximately $2 billion with claims expansion[67, 79] - Global transplants are growing at approximately 9% per year[68] Oncology Market - The estimated Total Addressable Market (TAM) for oncology in the US alone is $2 billion[97, 98] - The estimated Total Addressable Market (TAM) for Copy Number Instability (CNI) in the US Market is $4 billion[101] - There are 26 million estimated annual global testing opportunities for oncology[97] - There are 78 million estimated annual global testing opportunities for Copy Number Instability (CNI)[101]
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].
Tevogen Bio’s CIO & Head of Tevogen.AI, Mittul Mehta, Featured Speaker at Proskauer’s AI Discussion Panel
Globenewswire· 2025-03-07 21:09
Group 1 - Tevogen Bio, a clinical-stage specialty immunotherapy biotech company, is leveraging AI to enhance precision medicine and operational efficiencies [2][3][5] - The company has reported positive safety data from its proof-of-concept clinical trial and owns key intellectual property assets, including three granted patents and multiple pending patents related to AI [5][6] - Tevogen Bio aims to make advanced therapies more accessible and affordable by combining proprietary datasets with generative AI models [3][5] Group 2 - The recent AI discussion panel featured industry leaders discussing the transformative impact of AI across finance, biotech, and legal sectors [2][4] - The event highlighted the importance of tailoring AI applications to address unique challenges within each industry [3][4] - Tevogen Bio's leadership emphasizes the need for disruptive business models to sustain medical innovation and ensure patient accessibility [5][6]
Renovaro Completes First Milestone Payment to Finalize Definitive Agreement with Predictive Oncology
Globenewswire· 2025-03-03 14:15
Core Insights - Renovaro Biosciences Inc. has initiated the first tranche of financing to Predictive Oncology, Inc. to integrate AI/ML platform technologies and core laboratory capabilities in Europe and the United States [1][3] - The merger with Predictive Oncology and BioSymetrics significantly enhances Renovaro's capabilities in biomarker and drug discovery, particularly in oncology [1][2] Company Developments - The combined entity will leverage Predictive's AI-driven drug discovery platform, which includes a biobank of over 150,000 patient tumor samples and 200,000 pathology slides, to commercialize drug discovery and diagnostic platforms [2][4] - Renovaro has committed an additional $15 million in equity to accelerate its focus on revolutionizing healthcare through advanced diagnostics and drug discovery [3] Strategic Goals - The integration aims to create a comprehensive AI stack and an end-to-end solution for biomarker discovery and validation for precision medicine [3] - The transaction involves issuing an 18-month $3 Redeemable Preferred share to each Predictive Oncology shareholder, with further developments to be disclosed upon Board approval [3] Industry Context - Predictive Oncology is at the forefront of using AI and machine learning for early biomarker and drug discovery, with a scientifically validated platform that predicts drug response with 92% accuracy [4] - The company offers one of the industry's broadest AI-based drug discovery solutions, supported by its CLIA lab and GMP facilities [4][5]
Relay Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Updates
Globenewswire· 2025-02-26 21:05
Core Insights - Relay Therapeutics is advancing its RLY-2608 breast cancer program, with a Phase 3 trial (ReDiscover-2) expected to start in mid-2025, focusing on patients with PI3Kα mutations who have been pre-treated with CDK4/6 inhibitors [1][5][2] - The interim data for RLY-2608 combined with fulvestrant shows a median progression-free survival (PFS) of 11.4 months in second-line patients with PI3Kα mutations [1][11] - The company reported approximately $781.3 million in cash, cash equivalents, and investments as of December 31, 2024, which is expected to fund operations into the second half of 2027 [7][19] Clinical Development - The ReDiscover-2 trial will be a randomized, open-label, multicenter study evaluating the safety and efficacy of RLY-2608 + fulvestrant against capivasertib + fulvestrant in advanced breast cancer patients [5] - Key inclusion criteria for the trial include prior treatment with a CDK4/6 inhibitor and frontline endocrine therapy for over six months [5] - The primary endpoint is progression-free survival, with overall survival as a key secondary endpoint [5] Financial Performance - Relay Therapeutics reported no revenue for Q4 2024, with total revenue for the full year at $10 million, down from $25.5 million in 2023, primarily due to timing of milestones [8] - Research and development expenses decreased to $68.1 million in Q4 2024 from $77.5 million in Q4 2023, and total R&D expenses for 2024 were $319.1 million compared to $330 million in 2023 [9] - The net loss for Q4 2024 was $76 million, or $0.45 per share, an improvement from a net loss of $83.5 million, or $0.67 per share, in Q4 2023 [12] Future Outlook - The company plans to continue advancing its clinical programs, including the initiation of the RLY-2608 + fulvestrant Phase 3 trial and exploring additional triplet combinations for earlier treatment settings [2][11] - Upcoming milestones include additional Phase 1b data for RLY-2608 and the initiation of clinical trials for vascular malformations in Q1 2025 [11]
Renovaro and BioSymetrics Announce Definitive Merger Agreement to Advance AI-Driven Biomarker Discovery and Precision Medicine
Globenewswire· 2025-02-26 18:25
Core Insights - Renovaro Biosciences Inc. has announced a definitive agreement to merge with BioSymetrics to enhance biomarker identification and drug discovery capabilities in precision medicine for cancer and other diseases [1][3][4] Group 1: Merger Details - The merger aims to integrate BioSymetrics' AI-driven Elion platform, which accelerates the discovery of diagnostics and therapeutics by uncovering complex biological relationships [2][4] - The transaction is expected to close in March 2025, pending customary closing conditions and regulatory approvals [5] Group 2: Technological Advancements - BioSymetrics' Phenograph provides a translational engine that maps clinical signals to therapeutic targets, improving target and biomarker identification [2] - The combined entity will leverage advanced AI in vivo modeling and machine vision systems for high throughput phenotypic screening, enhancing research efficiency [2][4] Group 3: Strategic Goals - The merger is positioned as a pivotal step in advancing precision medicine and improving patient outcomes through enhanced diagnostic capabilities and therapeutic interventions [3][4] - The collaboration emphasizes a commitment to harnessing AI and data-driven approaches to accelerate the journey from discovery to clinical application [4]
Palisade Bio (PALI) Conference Transcript
2024-06-26 12:00
Palisade Bio (PALI) Conference June 26, 2024 08:00 AM ET Speaker0 Okay. We're ready to get started. Welcome, everyone, and thank you for joining us for today's virtual investor closing bell. My name is Janine Thomas. I am CEO of JTCIR, and I will be the moderator for this event. So the closing bell series starts at market close and allows for companies to share an overview of their story and connect with investors. For this session, I am very pleased to be joined by JD Finley, chief executive officer, and d ...
Alumis Inc.(ALMS) - Prospectus(update)
2024-06-24 10:39
TABLE OF CONTENTS As filed with the Securities and Exchange Commission on June 24, 2024. Registration No. 333-280068 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Alumis Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-1771129 (I.R.S. Employer Identifica ...