Core Insights - Eli Lilly (LLY) has entered into a definitive agreement to acquire Orna Therapeutics for $2.4 billion, which includes both upfront and milestone-based payments [1][8] - The acquisition will enhance Eli Lilly's portfolio with Orna's in vivo CAR-T pipeline, particularly the lead asset ORN-252, aimed at treating B-cell-driven autoimmune diseases [2][8] - Eli Lilly will also gain access to Orna's proprietary circular RNA platform, which may enable new therapeutic applications [3][8] Financial Performance - Eli Lilly's financial performance is currently strong, bolstered by the success of its GLP-1 therapies, Mounjaro and Zepbound, contributing to its market capitalization reaching $1 trillion [9][10] - The acquisition of Orna Therapeutics is seen as a long-term strategy for pipeline diversification rather than a response to immediate revenue pressures [10] Strategic Fit - The deal aligns with Eli Lilly's intent to diversify its therapeutic areas beyond metabolic diseases, as evidenced by recent regulatory approvals in immunology, oncology, and neuroscience [10] - Orna Therapeutics benefits from the acquisition as it lacks the commercial infrastructure to bring its advanced therapies to market, which Eli Lilly can provide [11] Recent M&A Activity - This acquisition marks Eli Lilly's second deal in 2023, following its offer to acquire Ventyx Biosciences for $1.2 billion, aimed at enhancing its portfolio in oral small-molecule therapies for inflammatory-mediated diseases [12]

Core Insights - The World Health Organization (WHO) has recognized "etaroleucel" (CELZ-101) as the proposed International Nonproprietary Name (INN), marking a significant regulatory achievement for Creative Medical Technology Holdings, Inc. [1][2] - This recognition builds on the prior approval of "olastrocel" (CELZ-201), reinforcing the credibility of the company's platform and supporting its multi-program execution strategy [1][4] Regulatory Milestones - The proposed INN "etaroleucel" for CELZ-101 was published in Proposed INN List 134 following expert review during the 80th WHO INN Consultation held from March 18 to 21, 2025 [2] - The INN recognition process includes a formal objection period before final confirmation, which is a standard procedure by the WHO [2] Product Development - CELZ-101 (etaroleucel) is designed to induce immune tolerance in complex autoimmune conditions, particularly Type 1 diabetes related to pancreatic islet transplantation [3] - CELZ-201 (olastrocel) is being developed for chronic lower back pain and degenerative disc disease, showcasing the company's diverse therapeutic focus [5] Executive Commentary - The CEO of Creative Medical emphasized that achieving proposed INN status for two independent clinical programs validates the company's scientific and regulatory capabilities [6] - The recognition of both olastrocel and etaroleucel highlights the differentiation of the company's technologies and the maturity of its clinical pipeline [6] Strategic Momentum - Creative Medical is advancing both programs through internationally recognized regulatory pathways, aligning with its strategy to translate innovative cell technologies into clinical applications [7] - The company aims to deliver scalable, disease-modifying solutions targeting large, underserved markets across various medical fields, including orthopedics and immunotherapy [8]

As filed with the Securities and Exchange Commission on February 9, 2026. Registration No. 333-_________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Nevada 8099 30-1341024 4 ...

Thank you very much. It's really a privilege to be and to be able to give this talk today. Um, but before I start, a quick show of hands.Who here has a smartphone. That's what I thought. Pretty much everyone here.Smartphones are omnipresent in the same way that we kind of, you know, all have a heart or a liver. But there are important differences between smartphones and organs that we need to keep in mind. When a smartphone breaks or malfunctions, it's an inconvenience. When it's an organ, it's an emergency ...

Core Viewpoint - Ernexa Therapeutics Inc. has announced a public offering of 21 million shares of common stock at a price of $0.50 per share, aiming to raise approximately $10.5 million before expenses [1][4]. Group 1: Offering Details - The offering includes warrants to purchase up to 21 million shares at an exercise price of $0.68, which will expire either five years after issuance or 180 days after the release of clinical trial data for ERNA-101 [2]. - The closing of the offering is expected around February 10, 2026, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance development programs, support working capital, and cover general corporate purposes [3]. Group 3: Financial Projections - The total gross proceeds from the offering are estimated at approximately $10.5 million, with potential additional proceeds of about $14.3 million from the exercise of the warrants if fully exercised [4]. Group 4: Company Overview - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create allogeneic synthetic mesenchymal stem cells (iMSCs) [7]. - The lead product, ERNA-101, is designed to enhance the immune system's ability to target cancer cells, with an initial focus on ovarian cancer treatment [8].

Core Viewpoint - Coeptis Therapeutics Holdings, Inc. has received shareholder approval for its merger with Z Squared Inc., which will result in Z Squared becoming a wholly owned subsidiary of Coeptis [1][2]. Company Overview - Coeptis is a biopharmaceutical and technology company focused on developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases [4]. - The company operates through its subsidiaries, including Coeptis Pharmaceuticals, GEAR Therapeutics, SNAP Biosciences, and Coeptis Technologies [4]. Therapeutic Portfolio - Coeptis's therapeutic portfolio includes assets licensed from Deverra Therapeutics, featuring an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage natural killer cell therapy technology [5]. - The company is also developing a universal, multi-antigen CAR technology licensed from the University of Pittsburgh, alongside GEAR cell therapy and companion diagnostic platforms in collaboration with VyGen-Bio and the Karolinska Institute [5]. Technology Division - Coeptis has established a Technology Division aimed at enhancing operational capabilities through advanced technologies, including AI-powered marketing software and robotic process automation tools acquired from NexGenAI Solutions Group [6]. Z Squared Overview - Z Squared is a digital infrastructure company focused on securing the Dogecoin and Litecoin networks through institutional-scale mining operations [8]. - Upon merger completion, Z Squared plans to deploy 9,800 ASIC miners across facilities in North Carolina, South Carolina, and Iowa, positioning itself as the largest publicly traded pure-play Dogecoin miner in the U.S. [8]. Operational Model - Z Squared emphasizes efficiency and risk management, converting mined assets to USD or stablecoins typically within 24 hours, aligning with a cash-flow-focused strategy [9]. - The company is led by a team with extensive expertise in cryptocurrency mining operations and infrastructure management [9].

Core Insights - Ernexa Therapeutics is advancing its lead cell therapy, ERNA-101, towards a first-in-human trial for ovarian cancer following a successful Pre-IND meeting with the FDA [2][3] - The FDA's regulatory alignment provides a clear pathway for Ernexa to submit an Investigational New Drug application and initiate clinical testing in the second half of 2026 [3] - The company is currently engaged in technology transfer for clinical-grade manufacturing, enhancing operational readiness for its synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies [3] Company Overview - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs) [5] - The company's lead product, ERNA-101, is designed to activate and regulate the immune system's response to cancer cells, while ERNA-201 targets inflammation for autoimmune disease treatment [6] - Ernexa's allogeneic synthetic iMSCs offer a scalable, off-the-shelf treatment solution without the need for patient-specific cell harvesting [5]

Core Insights - Kyverna Therapeutics has appointed Mayo Pujols as Chief Technology Officer, effective February 9, 2026, to support the launch of its CAR T-cell therapy, miv-cel [1][2][3] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate being miv-cel (mivocabtagene autoleucel, KYV-101) [7] - The company aims to revolutionize treatment for B-cell-driven autoimmune diseases and is advancing its neuroimmunology franchise with ongoing registrational trials [7] Leadership Transition - Mayo Pujols brings over 30 years of experience in technical operations, particularly in cell and gene therapies, succeeding Karen Walker, who is retiring but will assist in the transition [2][3] - Pujols has held significant roles in various biopharmaceutical companies, including COO at Castle Creek Biosciences and CTO at Rocket Pharmaceuticals, where he guided gene therapy programs through regulatory milestones [3][4] Miv-cel Therapy - Miv-cel is a fully human, autologous CAR T-cell therapy targeting CD19, designed for potency and tolerability, and is under investigation for B-cell-driven autoimmune diseases [6] - The therapy has the potential to achieve deep B-cell depletion and reset the immune system, aiming for durable, drug-free remission in autoimmune conditions [6] Inducement Grant - In connection with Pujols' appointment, Kyverna will grant him an option to purchase 300,000 shares of common stock, which will vest over four years [5]

Core Insights - Protara Therapeutics, Inc. is set to present updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) at the ASCO Genitourinary Cancers Symposium in February 2026 [1][4] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with TARA-002 as its lead candidate for NMIBC and lymphatic malformations [8] - TARA-002 is an investigational cell therapy derived from genetically distinct group A Streptococcus pyogenes, which has been granted Rare Pediatric Disease Designation by the FDA [5][8] Clinical Trial Details - The ADVANCED-2 trial (NCT05951179) is an open-label Phase 2 study assessing TARA-002 in NMIBC patients, specifically those who are BCG-Unresponsive or BCG-Naïve [3] - Approximately 25 patients will be evaluated for updated safety and efficacy data in the upcoming presentation [2] - The trial includes an induction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course [3] Presentation Information - The poster presentation titled "ADVANCED-2: Interim efficacy and safety data in BCG-Unresponsive participants with high-grade non-muscle invasive bladder cancer" will take place on February 27, 2026 [4] - Another poster titled "Interim safety and tolerability of TARA-002 in patients with BCG-Naïve and Unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2" will also be presented on the same day [5] Mechanism of Action - TARA-002 acts as a first-in-class TLR2/NOD2 agonist, activating both innate and adaptive immune pathways within the bladder wall, leading to a pro-inflammatory response and direct tumor cell death [6] Market Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases diagnosed annually [8]

Core Insights - ImmunityBio's shares increased by 39.8% on Friday and an additional 9.4% in after-hours trading following the release of updated efficacy and safety data from the QUILT-106 clinical study [2][8] - The QUILT-106 study is assessing an allogeneic CD19 CAR-NK therapy in combination with Roche's Rituxan for patients with Waldenström non-Hodgkin's lymphoma, showing promising results [3][4] Study Results - Updated data from the QUILT-106 study indicate durable complete responses and sustained disease control in patients with Waldenström NHL, with 100% disease control observed to date and responses extending up to 15 months [4][8] - The treatment regimen involves off-the-shelf CD19 CAR-NK cells combined with Rituxan, administered in an outpatient setting without the need for chemotherapy-based lymphodepletion [5][9] - Four patients have been enrolled in the study, all of whom remain in clinical disease control, with two patients demonstrating durable complete remission at seven and 15 months, respectively [6][10] Market Performance - Over the past six months, ImmunityBio's shares have surged by 106%, significantly outperforming the industry average growth of 22.1% [7] Future Developments - Enrollment and follow-up in the QUILT-106 study are ongoing, with further clinical updates expected as more patients become evaluable [10] - A follow-up study is planned to evaluate the combination of NK-CAR with ImmunityBio's IL-15 superagonist, Anktiva, and Roche's Rituxan to enhance current results in indolent lymphoma [10] Additional Programs - ImmunityBio is making progress in its first-line BCG-naïve NMIBC program, with enrollment in the QUILT-2.005 study exceeding expectations, targeting full enrollment by Q2 2026 [12] - The QUILT-2.005 study is evaluating Anktiva in combination with BCG, showing statistically significant improvements in complete response duration compared to BCG alone [14]