Core Viewpoint - Coeptis Therapeutics Holdings, Inc. and Z Squared Inc. have entered into a definitive merger agreement, resulting in Z Squared becoming a wholly-owned subsidiary of Coeptis, with a focus on Dogecoin mining and a planned spin-out of Coeptis' biopharmaceutical operations [1][5][10] Company Overview - Coeptis Therapeutics is a biopharmaceutical and technology company that develops innovative cell therapy platforms for cancer, autoimmune, and infectious diseases [1][6] - Z Squared Inc. specializes in digital asset mining, primarily focusing on Dogecoin, which has a market capitalization exceeding $20 billion [2][10] Merger Details - The merger will involve a wholly-owned subsidiary of Coeptis merging with Z Squared, with Z Squared shareholders receiving equity in Coeptis in exchange for 9,000 U.S.-based Dogecoin mining machines [1] - The transaction is expected to close in the third quarter of 2025, pending regulatory approvals and shareholder consent [1] Leadership Changes - Post-merger, Z Squared executives will lead the combined entity, with David Halabu as CEO and Michelle Burke as COO [3][4] - Current Coeptis CEO Dave Mehalick will exit the Board of Directors upon closing [3] Strategic Focus - The combined company aims to create the largest publicly-traded entity in the U.S. focused on Dogecoin mining, targeting both retail and institutional investors [5] - Coeptis plans to maintain its biopharmaceutical operations separately after the merger, allowing continued involvement in both sectors [5]

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [7] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [4][7] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [4][8] Clinical Trials - The NEXICART-2 trial is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis, expected to enroll 40 patients with preserved heart function [3] - The primary endpoint of the Phase 1 portion is safety, while the Phase 2 portion focuses on efficacy [3] - Initial data from an ex-U.S. study, NEXICART-1, has shown high complete response rates in relapsed/refractory AL Amyloidosis [4] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [6] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Events - Phase 1/2 interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago on June 3, 2025 [1][2] - The presentation will be led by Dr. Heather Landau, Director of the Amyloidosis Program at Memorial Sloan-Kettering Cancer Center [1]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [8] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [5][8] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [5][9] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis [4] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy [4] - The primary endpoint for Phase 1 is safety, while for Phase 2 it is efficacy [4] Upcoming Presentation - Interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago [2] - The presentation is scheduled for June 3, 2025, and will be led by Dr. Heather Landau from Memorial Sloan-Kettering Cancer Center [2][3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [7] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [7]

Wa'el Hashad Wa'el Hashad, CEO, Longeveron MIAMI, April 22, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders. Dear Fellow Shareholders, Twenty twenty-four was a year of execution for Longeveron. We made significant progress advancing Longeve ...

Core Viewpoint - NKGen Biotech, Inc. is actively participating in the 7th China International Biotechnology Conference & Exhibition, showcasing its innovative NK cell therapeutics, particularly focusing on the treatment of neurodegenerative diseases like Alzheimer's and Parkinson's [1][2][3] Company Overview - NKGen is a clinical-stage biotechnology company based in Santa Ana, California, specializing in the development and commercialization of autologous and allogeneic natural killer (NK) cell therapeutics [6] - The company is developing a novel cell-based immunotherapeutic drug candidate named troculeucel, aimed at treating neurodegenerative disorders and various cancers [5] Conference Participation - Paul Y. Song, M.D., the CEO of NKGen, will present at BIOTEC-CHINA 2025, discussing the use of troculeucel for Alzheimer's and Parkinson's diseases [1][3] - The presentation will highlight promising results from Phase 1 clinical trials and ongoing Phase 1/2a trials for moderate Alzheimer's disease, with favorable clinical outcomes and biomarker data [3] Product Details - Troculeucel is recognized as the International Nonproprietary Name (INN) for SNK01, marking a significant milestone in NKGen's journey to market [5] - The therapy is designed to be patient-specific and is expanded ex vivo, indicating a tailored approach to immunotherapy [5]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean in Rome, highlighting a fibroblast cell-based therapeutic approach targeting chronic inflammation-mediated diseases [1][2] Company Overview - FibroBiologics is based in Houston and represents a new generation of medical advancements in cell therapy and tissue regeneration [3] - The company is actively engaged in the development of a pipeline of treatments aimed at chronic diseases, leveraging its extensive patent portfolio [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community from Europe and beyond [1][2]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean, highlighting a fibroblast cell-based therapeutic approach [1][2] Company Overview - FibroBiologics is based in Houston and is engaged in the development of a pipeline of treatments aimed at chronic diseases [3] - The company represents advancements in cell therapy and tissue regeneration, with a focus on innovative medical solutions [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community in Europe [1][2]

Company Overview - MaxCyte, Inc. is a leading company focused on cell engineering, providing platform technologies to advance the discovery, development, and commercialization of next-generation cell therapeutics [1][3] - The company has over 25 years of expertise in building best-in-class platforms and innovating solutions for the cell therapy market [3] Financial Results Announcement - MaxCyte will release its financial results for the first quarter of 2025 after the U.S. market closes on May 7, 2025 [1] - A conference call to discuss these financial results will be hosted by company management at 4:30 p.m. Eastern Time on the same day [1] Conference Call Registration - Investors interested in the conference call must register online, with a recommendation to do so at least a day in advance [2] - A live and archived webcast of the event will be available on the MaxCyte website [2]

HOUSTON, April 08, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics") , a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the opening of a new laboratory facility that will expand the company's ability to pioneer additional candidates for chronic disease-focused indications leveraging its novel fibroblast-based ...