EMERYVILLE, Calif., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that Warner Biddle, Chief Executive Officer of Kyverna, will present at the following upcoming conferences: 2025 Wells Fargo Healthcare ConferenceFormat: Fireside ChatDate: Wednesday, September 3rd, 2025Time: 11:00 a.m. ET Morgan Stanley 23rd Annual Global Healthcare ConferenceFo ...

Core Insights - Immix Biopharma is focused on advancing its lead candidate, NXC-201, a BCMA-targeted CAR-T cell therapy, for relapsed/refractory AL Amyloidosis, with plans for a Biologics License Application (BLA) submission [1][2][3] - The company is also exploring partnerships to license out its Other Serious Disease (OSD) programs, leveraging promising clinical results from NXC-201 [2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases [3] - NXC-201 is currently being evaluated in a U.S. multi-center study (NEXICART-2) for relapsed/refractory AL Amyloidosis, with interim results presented at ASCO 2025 [3] - The therapy has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3]

Core Insights - Bio-Techne (TECH) reported fourth-quarter fiscal 2025 adjusted earnings per share (EPS) of 53 cents, exceeding the Zacks Consensus Estimate by 6% and improving from 49 cents in the previous year [1][9] - The company experienced a GAAP loss per share of 11 cents compared to an EPS of 25 cents in the prior-year quarter [2] - For the full year, adjusted EPS was $1.92, surpassing the Zacks Consensus Estimate by 1.1% and reflecting an 8.5% increase from fiscal 2024 [2] Revenue Performance - In the fiscal fourth quarter, Bio-Techne's net sales reached $316.9 million, marking a 3.5% year-over-year increase on a reported basis and 3% on an organic basis, surpassing the Zacks Consensus Estimate by 0.48% [3][9] - Full-year revenues totaled $1.22 billion, a 5.2% improvement from fiscal 2024 on a reported basis and a 5% increase organically, matching the Zacks Consensus Estimate [3] Segment Analysis - Within the Protein Sciences segment, revenues were $226.5 million, up 6% year over year (4% organically) [4] - In the Diagnostics and Spatial Biology segment, sales decreased by 1% year over year to $89.7 million, with an impairment loss of $83.1 million incurred during the quarter due to the Exosome Diagnostics business being classified as held-for-sale [5] Margin and Expense Overview - Bio-Techne's gross profit fell by 2.2% to $198.8 million, with gross margin contracting by 371 basis points to 62.7% due to a 15% rise in the cost of sales [6][9] - Selling, general and administrative expenses increased by 47.2% to $196.6 million, while research and development expenses rose by 8.5% to $26 million [6] Operating Performance - The company reported an operating loss of $23.9 million in the fiscal fourth quarter, a significant decline from the $45.8 million operating profit in the same quarter of the previous year [7][9] Capital Structure - At the end of the fiscal fourth quarter, Bio-Techne had cash and equivalents of $162.2 million, up from $151.8 million at the end of fiscal 2024, while long-term debt obligations increased to $346 million from $319 million [10] Strategic Outlook - Despite market uncertainties, Bio-Techne's results aligned with company expectations, with strong performance in cell therapy and protein analysis instrumentation [11] - The decision to divest the Exosome Diagnostics business is anticipated to enhance profitability and allow a greater focus on high-growth areas, particularly in research and precision diagnostics [11]

Summary of Nkarta (NKTX) Conference Call - July 30, 2025 Company Overview - Nkarta is focused on developing allogeneic CAR NK cell therapies for autoimmune diseases, particularly targeting B cell mediated immune diseases, having pivoted from oncology to autoimmune indications due to the potential of cell therapy in these areas [2][3][4] Key Points and Arguments Industry and Market Context - The cell therapy landscape is evolving, with significant interest in CAR NK therapies for autoimmune diseases, inspired by successful CAR T cell data [3][20] - The safety profile of NK cells is favorable compared to CAR T cells, with no high-grade cytokine release syndrome (CRS) or neurotoxicity observed in trials [4][21][56] Product Pipeline - Nkarta's lead program, NKX019, targets CD19 and is currently in IND studies for lupus nephritis, primary membranous nephropathy, systemic sclerosis, myositis, and onc-associated vasculitis [6][25] - The company is conducting a phase one trial for NKX019, focusing on dose escalation and early safety and pharmacology [24][51] Clinical Efficacy and Safety - Early readouts from the NKX019 trial will focus on clinical markers such as creatinine levels, protein in urine, and glomerular filtration rate (GFR), which are critical for assessing kidney function in autoimmune renal diseases [25][26] - The updated lymphodepletion regimen now includes fludarabine, aligning with standard practices in cell therapy to enhance B cell depletion [27][28] Competitive Advantages - CAR NK cells are designed to be off-the-shelf, scalable, and do not require leukapheresis, making them more accessible for patients compared to CAR T therapies [4][14][21] - The potential for outpatient administration of CAR NK therapies could significantly broaden access and reduce the burden on healthcare facilities [67][70] Future Outlook - Initial data from NKX019 is expected in the second half of 2025, with ongoing enrollment in the trial [51][72] - The company has a strong cash position of approximately $350 million, providing a runway into 2029 to support ongoing trials without immediate capital raising pressures [71][72] Additional Important Insights - The shift from oncology to autoimmune diseases is seen as a strategic move, with the need for accessible therapies in the rheumatology and nephrology fields being emphasized [20][66] - The potential for durable responses and immune reset in treatment-refractory autoimmune conditions represents a significant advancement in the field [37][39] - Nkarta is exploring additional indications beyond lupus nephritis, including myositis and systemic sclerosis, indicating a broadening of their therapeutic focus [46][48] Conclusion - Nkarta is positioned to leverage its CAR NK cell therapy platform to address significant unmet needs in autoimmune diseases, with a focus on safety, accessibility, and clinical efficacy. The upcoming data readouts and ongoing trials will be critical in determining the future trajectory of the company's product offerings and market positioning [76]

Core Viewpoint - Adaptimmune Therapeutics has entered into a definitive agreement to sell its cell therapy assets, including TECELRA, lete-cel, afami-cel, and uza-cel, to US WorldMeds for $55 million in cash, with potential future payments of up to $30 million based on milestone achievements [1][2][5] Group 1: Transaction Details - The sale includes all intellectual property rights related to the Assigned Assets, and Adaptimmune will retain rights to its preclinical assets such as PRAME and CD70 [1][2] - The transaction is expected to be completed before the end of the week, and Adaptimmune will provide transition services to US WorldMeds [1][4] - US WorldMeds plans to continue the development of lete-cel and other therapies, ensuring that patients have uninterrupted access to TECELRA [1][5] Group 2: Strategic Rationale - Adaptimmune's Board of Directors concluded that this transaction is in the best interest of all stakeholders after a comprehensive review of strategic alternatives [1][2] - The CEO of Adaptimmune emphasized the importance of securing the right strategic option to maximize value for stakeholders and ensure continued patient access to TECELRA [2][5] - US WorldMeds' CEO highlighted the acquisition as a significant step in their mission to innovate and provide hope to patients [2][5] Group 3: Financial Aspects - The transaction will be financed through debt led by Oaktree Capital Management and Athyrium Capital Management [6] - Adaptimmune will receive an initial payment of $55 million upon sale consummation, with additional milestone payments potentially reaching $30 million [1][2]

Core Insights - FibroBiologics has made significant progress in its cartilage repair program, confirming that CYWC628 spheroids can differentiate into chondrocytes, which are essential for cartilage formation [1][2] - The company plans to utilize its CYWC628 master cell bank to create a working cell bank for manufacturing CybroCell™, its investigational cell therapy for degenerative disc disease (DDD), and is moving forward with amending its IND clearance with the FDA for a Phase I clinical trial [2][3] - The use of the current master cell bank is expected to streamline the manufacturing process for CybroCell, reducing development time and costs, while demonstrating the scalability of FibroBiologics' fibroblast-based platform for multiple indications [3] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials [5][6] - The company holds over 275 patents issued and pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer, positioning itself as a leader in cell therapy and tissue regeneration [6]

Core Insights - Immix Biopharma is advancing its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, expanding to 18 sites in the U.S. [1][2] - The company is on track for the first Biologics License Application (BLA) for a cell therapy targeting an unaddressed orphan indication [1][2] - Interim results from the NEXICART-2 trial were presented at ASCO 2025, showcasing the progress of the therapy [1][2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [3] - The lead candidate is NXC-201, a BCMA-targeted CAR-T cell therapy, currently evaluated in a multi-center study [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3] Market Context - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [5] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [5]

Core Insights - Capricor Therapeutics Inc is advancing its Biologics License Application (BLA) for Deramiocel, aimed at treating Duchenne Muscular Dystrophy (DMD)-associated cardiomyopathy [1][3] - DMD affects around 15,000 individuals in the U.S., primarily boys, due to the absence of functional dystrophin [2] Regulatory Updates - The FDA has indicated that an Advisory Committee meeting is not necessary at this time, with the BLA under Priority Review and a PDUFA target action date set for August 31, 2025 [3][4] - Capricor has been informed of a potential Advisory Committee meeting on July 30, 2025, pending FDA confirmation, with no significant issues noted during the mid-cycle review [4] Company Performance - CEO Linda Marbán stated that the company has successfully met all key regulatory milestones, including a pre-license inspection and mid-cycle review [5] - Capricor recently presented four-year data from its HOPE-2 Open-Label Extension study, showcasing one of the longest treatment datasets in DMD, focusing on cardiac and skeletal muscle function [6] Market Reaction - Following these updates, CAPR stock experienced a 20% increase, reaching $9.22 [6]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials [1][5] - The company presented research on the immunomodulatory potential of human dermal fibroblast spheroids in psoriasis therapy at the Society for Investigative Dermatology Annual Meeting [2][3] Company Overview - FibroBiologics holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [5] - The company aims to advance innovative, cell-based treatments for chronic inflammatory diseases, with a focus on providing durable therapeutic options with lower adverse side effects [3][5] Research Highlights - The poster presentation titled "Immunomodulatory Potential of Human Dermal Fibroblast Spheroids in Psoriasis Therapy" demonstrated the potential of HDF spheroids to reduce psoriasis severity in preclinical models [2] - The research indicates that fibroblast-based candidates may offer sustained remission and reduced relapse rates in psoriasis treatment [3]

Financial Data and Key Metrics Changes - Total expenses increased by $396,000 quarter over quarter to $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [15] - Research and development expenses rose by $289,000 to $1,500,000 in Q1 2025 from $1,200,000 in Q1 2024 [15] - Net loss was $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [16] - Net cash used in operations was $1,600,000 for Q1 2025, comparable to $1,500,000 in Q1 2024 [17] Business Line Data and Key Metrics Changes - The CARDI Amp heart failure trial demonstrated safety and meaningful benefits for heart failure patients [6] - The CardioM Heart Failure II trial is actively enrolling patients at three clinical sites, with expectations for full enrollment over the next two years [7] - The Helix biotherapeutics delivery system is preparing for submission for approval, with potential value for therapeutic partners [9] Market Data and Key Metrics Changes - The electrophysiology market is valued at over $10 billion per year and is expanding to treat arrhythmias in the ventricles of the heart [12] - The company is focused on the Japanese market, with expectations for regulatory approval processes similar to the FDA [30] Company Strategy and Development Direction - The company aims to align with the FDA and Japan's PMDA to make CARDI Amp therapy available to physicians and patients [6] - Business development efforts are focused on partnerships that enhance shareholder value across all four platforms: CardiAmp, Cardiallo, Helix, and MorphDNA [10] - The company is open to partnerships in various indications not currently pursued, particularly in the allogeneic cell therapy space [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their therapies, emphasizing the importance of generating additional clinical evidence [40] - The company is optimistic about the potential for significant market opportunities in Japan, particularly with the CARDI Amp therapy [35] - Management noted that they are not significantly impacted by tariffs due to the domestic manufacturing of most components [49] Other Important Information - The company completed a small financing with minimal dilution to support upcoming milestones [14] - Management highlighted the importance of physician outreach and training for the introduction of new therapies into commercial channels [32] Q&A Session Summary Question: Discussion on business development maturity levels - Management indicated that while deal discussions can be lengthy, they have established products and ongoing discussions with large strategic partners [20] Question: Importance of Japan PMDA submission for CARDI Amp - Management confirmed that receiving permission to submit for approval in Japan is critical and aligns with their strategy for market entry [30] Question: Interaction between ongoing trials and FDA submission - Management clarified that they are continuously developing evidence while submitting for FDA approval, focusing on patient enrollment and data generation [40]