Over 100 patients treated with AlloNK across autoimmune and oncology indications Refractory rheumatoid arthritis (RA) prioritized as lead indication following FDA Fast Track Designation for AlloNK®, the first known therapy within the emerging deep B-cell depletion category to receive this designation in RA Company to host webcast later this morning to discuss initial safety and translational data from clinical trials evaluating AlloNK in combination with anti-CD20 monoclonal antibodies across autoimmune dis ...

Core Insights - Ernexa Therapeutics is set to present at Cell 2025, focusing on innovations in cell therapies for advanced cancer and autoimmune diseases [1][3] - The presentations will emphasize the importance of smart trial design and early regulatory engagement to accelerate clinical progress in cell therapy development [1][2] Company Overview - Ernexa Therapeutics (NASDAQ: ERNA) specializes in developing innovative cell therapies, particularly through engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs) [4] - The company’s lead product, ERNA-101, aims to activate the immune system to target cancer cells, with a specific focus on ovarian cancer treatment [5] Event Details - The Cell 2025 event will take place on November 11-12, 2025, in London, UK, and is a key gathering for professionals in bioprocessing and advanced therapies [3] - Sanjeev Luther, President and CEO of Ernexa, will participate in a panel discussion addressing funding, innovation, and regulatory strategies for advancing their iMSC platform [2]

Core Viewpoint - ProKidney Corp. reported promising results from its Phase 2 REGEN-007 study, indicating that rilparencel may effectively stabilize kidney function in patients with advanced chronic kidney disease (CKD) and diabetes, supporting the ongoing Phase 3 PROACT 1 study [2][3][4]. Financial Highlights - As of September 30, 2025, ProKidney had cash, cash equivalents, and marketable securities totaling $271.7 million, down from $358.3 million at the end of 2024, which is expected to fund operations into mid-2027 [5][6]. - Research and development expenses for Q3 2025 were $26.8 million, a decrease from $31.3 million in Q3 2024, primarily due to reduced clinical operation costs [8]. - General and administrative expenses decreased to $11.9 million in Q3 2025 from $17.7 million in Q3 2024, mainly due to lower non-cash impairment charges [9]. - The net loss before noncontrolling interest was $35.8 million for Q3 2025, compared to $41.1 million for the same period in 2024 [10]. Clinical Updates - The Phase 2 REGEN-007 study showed a 4.6 mL/min/1.73m improvement in the annual decline in eGFR slope for Group 1, representing a 78% improvement, which was statistically significant (p<0.001) [7]. - Among Group 1 patients, 63% met the key PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m improvement in eGFR slope observed in this subgroup, indicating an 85% improvement (p=0.005) [7]. - The FDA has confirmed that the eGFR slope can serve as a surrogate endpoint for the accelerated approval pathway for rilparencel, with topline data readout expected in Q2 2027 [4][6]. Company Overview - ProKidney is focused on developing rilparencel, a first-in-class autologous cell therapy for patients with Stage 3b/4 CKD and diabetes, addressing a significant unmet need in the treatment of CKD [11][15].

Core Insights - Ernexa Therapeutics reported a significant reduction in operating losses, with a 44% decline year-over-year, indicating effective operational execution and financial discipline [1][11] - The company is advancing its lead program, ERNA-101, towards a first-in-human Phase 1 study in platinum-resistant ovarian cancer, expected to commence in the second half of 2026 [1][6] - Ernexa has established a partnership with Cellipont Bioservices to enhance the development of ERNA-101, alongside reporting substantial year-over-year financial performance improvements [3][4] Financial Performance - The operating loss for the three months ended September 30, 2025, decreased by $0.3 million, or 12%, from $2.3 million in the same period of 2024 to $2.0 million [11] - For the nine months ended September 30, 2025, the operating loss decreased by $5.8 million, or 44%, from $13.0 million in 2024 to $7.2 million [11] - General and administrative expenses saw a significant reduction, with a 72% decrease from $3.4 million to $1.0 million for the three-month period, primarily due to a decrease in rent and legal fees [11] Development Programs - Ernexa is utilizing synthetic, allogeneic induced mesenchymal stem cells (iMSCs) for scalable, off-the-shelf treatments, focusing on ovarian cancer and autoimmune diseases [4][8] - ERNA-101 is designed to secrete pro-inflammatory fusion cytokines and is currently in preclinical development for platinum-resistant ovarian cancer [5][9] - ERNA-201 targets inflammation and is in preclinical development for rheumatoid arthritis and other inflammatory diseases [5][9] Strategic Collaborations - The partnership with Cellipont Bioservices is a strategic move to advance ERNA-101 towards clinical trials [3][4] - A sponsored research agreement with MD Anderson Cancer Center aims to leverage MSCs' tumor-homing ability to enhance anti-tumor activity while minimizing systemic toxicity [6]

Core Insights - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [3] - The CEO, Warner Biddle, will present at the Jefferies Global Healthcare Conference on November 17, 2025 [1] - The company’s lead CAR T-cell therapy candidate, KYV-101, is in late-stage clinical development for stiff person syndrome and myasthenia gravis, with ongoing trials for lupus nephritis [3] Company Overview - Kyverna Therapeutics is dedicated to liberating patients through the curative potential of cell therapy [3] - The company is advancing next-generation CAR T-cell therapies in both autologous and allogeneic formats, aiming to expand into broader autoimmune indications [3] - The proprietary whole blood rapid manufacturing process is expected to increase patient reach with KYV-102 [3] Upcoming Events - A live webcast of the CEO's presentation will be available on the company's website, with a replay accessible for approximately 90 days post-conference [2]

Core Insights - Protara Therapeutics reported significant advancements in its clinical programs, particularly in the development of TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][5][10] - The company is on track to report interim results from its ADVANCED-2 trial in NMIBC patients in Q1 2026 and expects to provide updates on its STARBORN-1 trial for pediatric LMs in Q4 2025 [6][7] Clinical Development Updates - TARA-002 is being evaluated in the ADVANCED-2 trial for NMIBC, with interim results expected from approximately 25 BCG-Unresponsive patients in early 2026 [6][7] - The STARBORN-1 trial for TARA-002 in pediatric patients with LMs is progressing, with an interim update anticipated in Q4 2025 [5][6] - The THRIVE-3 trial for IV Choline Chloride is set to dose its first patient by the end of 2025, focusing on patients dependent on parenteral support [6][7] Financial Performance - As of September 30, 2025, Protara had approximately $134 million in cash and investments, expected to fund operations into mid-2027 [6][15] - Research and development expenses increased to $9.6 million in Q3 2025 from $8.1 million in the same period of 2024, primarily due to startup costs for the THRIVE-3 trial [15][23] - The company reported a net loss of $13.3 million, or $0.31 per share, for Q3 2025, compared to a net loss of $11.2 million, or $0.50 per share, in Q3 2024 [15][23] Corporate Recognition - Protara was recognized as one of BioSpace's Best Places to Work in November 2025, highlighting its strong culture and commitment to innovation [8]

Financial Data and Key Metrics Changes - As of September 30, 2025, the overall cash position was $40.5 million, expected to support operations into Q2 2027, one quarter longer than previously guided [25] - Total revenues for Q3 2025 were $3.7 million, a decrease of approximately $0.1 million compared to $3.8 million for the same period in 2024, primarily driven by lower royalty revenue [26] - Operating expenses for Q3 2025 were $7.5 million, a decrease of $0.1 million compared to $7.6 million for the same period in 2024 [27] - The net loss was $29.8 million, or $0.13 per share, compared to a net loss of $3 million, or $0.02 per share, for the same period in 2024, primarily driven by non-cash fair value remeasurement of warrant liabilities [28] Business Line Data and Key Metrics Changes - The R&D expenses for Q3 2025 were $3.3 million, an increase of $0.1 million compared to $3.2 million for the same period in 2024, driven by costs associated with the OPC1 program and preclinical programs [27] - G&A expenses were $4.2 million, a decrease of $0.2 million compared to $4.4 million for the same period in 2024, primarily due to stock-based compensation expenses [27] Market Data and Key Metrics Changes - The company reported a significant potential cash source of approximately $37 million from warrant capital if Roche and Genentech advance OpRegen into a clinical trial [26] Company Strategy and Development Direction - The company aims to create a basket of cell therapy assets, some developed internally and others partnered, focusing on generating multiple product candidates from its platform [18] - The strategic goals include entering into deals to fund existing product candidates, creating new assets to attract external funding, and capitalizing on unique manufacturing capabilities [10][12][13] - The company is optimistic about the OpRegen program's potential to drive positive clinical outcomes and is encouraged by partner commitments [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for OpRegen to advance into a controlled clinical trial, supported by positive indicators from clinical site expansions and independent validations of clinical findings [10][30] - The company anticipates that the favorable biotech market will improve the cost of capital, allowing for judicious expansion [17] Other Important Information - The company has preserved the right to enter into future clinical or commercial deals with pharmaceutical partners, demonstrating flexibility in its strategic approach [11] - The company is awaiting a decision on a CIRM CLIN2 grant, which could provide up to approximately $7 million in non-dilutive funding [15] Q&A Session Summary Question: Considerations for the iLET Cell program and internal decision-making - Management indicated that the biological ceiling in differentiation protocols limits the opportunity for significant process changes, focusing on maximizing early steps to achieve necessary outputs [32][33] Question: Future partnerships and collaborations - Management highlighted the importance of finding suitable partners, emphasizing that partnerships should align with the company's capabilities and strategic goals [35][36] Question: Updates on the OPC-1 program and patient dosing - Management confirmed that multiple doses could be administered at different sites, and the safety profile for OPC1 remains strong [39][40] Question: Impact of potential CIRM grant funding - Management stated that while the grant would provide significant support, the program would continue regardless of the outcome [59] Question: Future business model considerations - Management expressed a preference to avoid becoming a fee-for-service company, focusing instead on partnerships that allow for significant ownership in the upside [46][47]

Core Insights - Ernexa Therapeutics is advancing its lead cell therapy ERNA-101 for ovarian cancer through a partnership with Cellipont Bioservices [3] - The company specializes in innovative cell therapies targeting advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) [4] Company Overview - Ernexa Therapeutics (NASDAQ: ERNA) focuses on developing novel cell therapies for advanced cancer and autoimmune diseases [4] - The company's technology involves engineering iPSCs into induced mesenchymal stem cells (iMSCs), providing scalable treatment solutions without the need for patient-specific cell harvesting [4] Product Details - ERNA-101 is designed to activate and regulate the immune system's response to recognize and attack cancer cells [5] - ERNA-201 targets inflammation to treat autoimmune diseases, with the initial focus on developing ERNA-101 for ovarian cancer [5]

Financial Data and Key Metrics Changes - Organic revenue declined 1% in Q1, primarily due to clinical stage timing from large customers in the cell therapy business and ongoing softness in biotech funding [4][19] - Adjusted EPS for the quarter was $0.42, flat year-over-year, while GAAP EPS increased to $0.24 from $0.21 in the prior year [18][19] - Total revenue for Q1 was $286.6 million, representing a 1% year-over-year decline on both an organic and reported basis [19] - Adjusted gross margin improved to 70.2%, up from 69.5% last year, driven by the exosome diagnostics divestiture and ongoing productivity initiatives [20] - Adjusted operating margin reached 29.9%, up 90 basis points year-over-year [20] Business Line Data and Key Metrics Changes - Protein sciences segment reported sales of $202.2 million, down 1% year-over-year, with organic revenue declining 3% [22] - Diagnostics and spatial biology segment sales were $79.5 million, down 4% year-over-year, but achieved 3% organic growth [22] - The protein analytical tools business showed notable strength from large pharma customers, contributing to organic growth [22] Market Data and Key Metrics Changes - Revenue from large pharma customers increased low double digits, while biotech spending continued to decline, resulting in high single-digit declines in Q1 [5][19] - North America experienced mid-single digit revenue decline, while Europe and Asia posted low single-digit growth [19][22] - China achieved its second consecutive quarter of growth, driven by strong performance in ProteinSimple analytical instruments and spatial biology portfolio [7][19] Company Strategy and Development Direction - The company is focused on productivity and cost management while investing in strategic growth pillars [5][17] - The acquisition of Wilson Wolf is expected to enhance the company's position in the cell therapy market, with plans to complete the acquisition by the end of calendar 2027 [9][10] - The company anticipates a return to positive organic growth in the second half of the fiscal year, driven by improving conditions in the biopharma sector and stabilization in U.S. academic markets [25][39] Management's Comments on Operating Environment and Future Outlook - Management noted that underlying market trends remain constructive, with early signs of stabilization in biotech activity levels [6][18] - The company expects Q2 organic growth to be consistent with Q1, reflecting continued strength in pharma and renewed growth in China [25] - Management expressed optimism about the recovery in biotech funding and the potential for lower interest rates to support investment levels in emerging biotech companies [6][35] Other Important Information - The company achieved an estimated 40% reduction in Scope 1 and 2 emissions during fiscal 2025, transitioning to 100% renewable electricity at its largest site [17] - The diagnostics business grew mid-single digits in Q1, supported by balanced performance across core diagnostic controls and kits [15] Q&A Session Summary Question: How long might the air pocket persist for GMP proteins? - Management indicated that the headwind from two large customers would be approximately 400 basis points in Q2, but they remain positive about the underlying recovery in the biotech markets [28][30] Question: Are growth plans for fiscal 2026 still low single-digit? - Management confirmed that plans remain unchanged, with a commitment to the cell therapy market and expectations for low single-digit growth for the year [30] Question: What is the outlook for the second half of the fiscal year? - Management expects a return to positive organic growth in the second half, driven by easing headwinds and improved market conditions [25][39] Question: Can you provide an update on Wilson Wolf? - Wilson Wolf had a flat quarter, but management remains optimistic about its potential to accelerate growth in the cell therapy market [43][44] Question: What are the assumptions for government shutdown impacts? - Management noted no significant changes in academic customer buying patterns due to the government shutdown, indicating stability in the academic market [52]

Core Viewpoint - Marker Therapeutics, Inc. has appointed Kathryn Penkus Corzo to its Board of Directors, effective November 1, 2025, to strengthen its leadership as it advances its clinical programs, particularly the APOLLO program for CAR-relapsed Diffuse Large B Cell Lymphoma (DLBCL) [1][4]. Company Overview - Marker Therapeutics is a clinical-stage immuno-oncology company based in Houston, TX, focusing on next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [6]. - The company was founded at Baylor College of Medicine and has conducted clinical trials involving over 200 patients, demonstrating that its autologous and allogeneic MAR-T cell products are well tolerated and show durable clinical responses [6]. Leadership Appointment - Kathryn Penkus Corzo brings over 30 years of experience in biopharma, including roles in R&D, clinical trials, regulatory approvals, and commercialization [2]. - Prior to joining Marker, she served as President and COO at bit.bio Ltd, where she expanded the company's product portfolio and established scalable operations [2]. - Corzo has held senior positions at Takeda Ventures, Sanofi Genzyme, Hoffmann-La Roche, Eli Lilly, and Syndax Pharmaceuticals, contributing to the development and launch of multiple global blockbuster cancer therapies [3]. Clinical Development Focus - Marker Therapeutics is committed to advancing its lead asset MT-601 and the APOLLO program, which targets CAR-relapsed DLBCL [4]. - The company emphasizes the potential of its Multi-Antigen Recognizing (MAR) T cell platform, which aims to address limitations of current treatments and improve clinical outcomes for patients with limited options [5]. MAR-T Cell Platform - The MAR-T cell platform is a novel, non-genetically modified cell therapy that selectively expands tumor-specific T cells capable of recognizing a broad range of tumor antigens [5]. - This approach allows recognition of hundreds of different epitopes within up to six tumor-specific antigens, potentially reducing the risk of tumor escape [5]. - Marker believes that its MAR-T cell products will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell therapies [5].