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 ...

CAMBRIDGE, Mass., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics Inc. (Nasdaq: ERNA) (“Ernexa” or the “Company”), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the pricing of a best-efforts registered public offering of 21,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 21,000,000 shares of common stock, at a combined public offering price of $0.50 per s ...

WEXFORD, Pa., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Coeptis Therapeutics Holdings, Inc. (Nasdaq: COEP) (“Coeptis” or the “Company”), a next-gen technology and biopharmaceutical company, today announced that its shareholders have voted to approve the previously announced merger with Z Squared Inc. The transaction was approved on January 30, 2026, by Coeptis’ shareholders. In connection with the consummation of the business combination, Z Squared will become a wholly owned subsidiary of Coeptis. The transaction r ...

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]

Mr. Pujols brings more than 30 years of technical operations expertise to role, scaling commercial manufacturing for CAR T-cell therapies and complex biologics, as Kyverna advances towards launch of miv-celEMERYVILLE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the appointment of Mayo Pujols as its Chief Technology Officer (CTO), effective Febru ...

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]

Summary of Sana Biotechnology FY Conference Call Company Overview - **Company**: Sana Biotechnology (NasdaqGS:SANA) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 14, 2026 - **Presenter**: Steve Harr, President and CEO Core Industry Focus - **Industry**: Biotechnology, specifically in cell therapy and gene editing - **Target Disease**: Type 1 diabetes and potential applications in blood cancers and autoimmune diseases Key Points and Arguments Goals and Progress - **Main Goals**: - Overcome allogeneic rejection in cell therapy to make it universally available - Develop effective delivery methods for genetic payloads to cells [2][3] - **Focus Area**: Type 1 diabetes, a significant unmet medical need with high demand for better treatment options [3][9] Achievements - **Cell Transplantation**: Successfully demonstrated the ability to transplant cells that evade the immune system [4] - **Master Cell Bank**: Established a master cell bank for consistent production of pancreatic beta cells [4][28] - **Regulatory Engagement**: Engaged with global regulators to align on future plans, including filing an Investigational New Drug (IND) application [4][29] Clinical Development - **Phase One Study**: Plans to file IND and begin Phase One study within the year, aiming for quick proof of concept regarding immune evasion and functional insulin production [4][30] - **Patient Outcomes**: A patient who received the therapy has shown no adverse events and continued insulin production for over a year [16][21] Scientific Insights - **Mechanism of Action**: - Knocking out MHC class I and II to prevent immune rejection, combined with overexpression of CD47 to evade both adaptive and innate immunity [13][14] - Evidence of survival and function of transplanted cells through C-peptide levels and PET MRI scans [17][21] Market Potential - **Unmet Need**: Curing type 1 diabetes could equate to curing both HIV and multiple sclerosis in the U.S., highlighting the vast market potential [9] - **Scalability**: The goal is to create a scalable therapy that can treat millions of patients, with a focus on manufacturing efficiency [28][58] Future Directions - **In Vivo CAR T Cells**: Development of a best-in-class in vivo CAR T platform, with plans to initiate trials in cancer and autoimmune diseases [43][60] - **Partnership Strategy**: Considering partnerships to accelerate development in competitive areas like B cell cancers and autoimmune diseases [60] Regulatory and Manufacturing Challenges - **Regulatory Complexity**: Navigating the complexities of novel immunology, gene editing, and stem cell biology with regulators [51] - **Manufacturing Scale**: Challenges in scaling production from Phase One to commercial levels, focusing on maintaining genomic stability and purity [45][47] Investment and Financial Outlook - **Investment Needs**: Significant investment required for manufacturing scale-up and clinical development, with ongoing financial commitments expected [56][58] Additional Important Insights - **Patient Population for Trials**: Initial trials will focus on adults with type 1 diabetes, with plans to expand to younger populations as data is gathered [52][53] - **Global Reach**: The Phase One study will not be limited to the U.S. but will include other geographies [54] This summary encapsulates the key points discussed during the conference call, highlighting Sana Biotechnology's strategic focus, achievements, and future plans in the biotechnology sector.

CARVYKTI Market Leadership - CARVYKTI achieved $1.7 billion in Last Twelve Months (LTM) net trade sales[10, 91] - Over 10,000 patients have been treated with CARVYKTI[11, 22] - CARVYKTI has a manufacturing success rate of 97%[24] - CARVYKTI has a median turnaround time (TAT) of less than 30 days[24] - The company expects 3/4 of CARVYKTI orders to come from 2L-4L (second to fourth line) patients[92] Financial Performance and Profitability - Revenue has scaled nearly 4x since Q2 2023[16] - The company anticipates achieving company-wide operating profit in 2026[13, 92] - Operating margin improved from -142% in Q2 2023 to -16% in Q3 2025[14] - The company has $1 billion in cash, cash equivalents, and time deposits as of September 2025[13, 90] Innovation and Pipeline - The company plans to present in vivo data in the second half of 2026[92] - The company aims to file 1-2 US INDs (Investigational New Drug applications) in the second half of 2026[92]

NASDAQ PROK Transforming the Future of Chronic Kidney Disease Treatment Preserving Kidney Function in Patients at High Risk of Kidney Failure 44th Annual J.P. Morgan Healthcare Conference Bruce Culleton, MD Chief Executive Officer January 14, 2026 Copyright © 2026 ProKidney Corp. All rights reserved. Forward-looking Statements This presentation includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. ProKidney's actual ...