Contact Us Back to the Newsroom Exousia Pro, Inc. Completes Exclusive Licensing Agreement With the University of Central Florida for Novel Cancer Diagnostic and Therapy Platforms Tuesday, 02 December 2025 01:45 PM Topic:Â Company Update ORLANDO, FLORIDA / ACCESS Newswire / December 2, 2025 / Exousia Pro, Inc. (OTCID:MAJI), a clinical-stage biotechnology company focused on advanced exosome-based delivery systems, today announced the execution of an exclusive licensing agreement between its wholly owned subsi ...

Company Overview - Moderna is a leading developer of messenger RNA vaccines and medicines [2] - The company has faced pressure on its shares over the last couple of years, particularly due to decreasing immunization rates following its role in the COVID pandemic [2] Recent Challenges - There has been a notable decline in immunization rates, impacting Moderna's market performance [2] - The FDA and public figures have raised concerns about mRNA vaccines, contributing to a challenging environment for the company [2] - A recent setback related to a product has added to the difficulties faced by Moderna [2] Future Prospects - Moderna recently held an R&D Day, showcasing new vaccines and medicines in development, indicating a potentially exciting future for the company [2] - The financial strategies and developments discussed during the R&D Day suggest a focus on innovation and growth moving forward [2]

Core Insights - Q32 Bio's shares more than doubled following a strategic deal with Akebia Therapeutics, indicating strong market interest and validation of its complement inhibitor platform [1][3] - The deal involves an upfront payment of $12 million for the Phase complement inhibitor ADX-097, with potential total transaction value reaching $592 million through various milestones [1][3] - The transaction allows Q32 Bio to monetize a key asset while retaining rights to its broader tissue-targeted complement inhibitor platform, which includes ADX-096 for ophthalmologic indications [3] Financial Implications - The divestment of ADX-097 provides immediate cash flow and long-term revenue potential through tiered royalties ranging from low single-digit to mid-teen percentages on future sales [4] - The company plans to refocus on advancing Bempikibart, a treatment for alopecia areata, which represents a strategic pivot that may enhance stock value in 2026 [4] Market Reaction - At its peak, Q32 Bio stock traded nearly 350% above its year-to-date low, but closed the session at $3.82, reflecting a 75% increase on the day [2] - Despite the positive outlook from the Akebia deal, there are concerns regarding the sustainability of the stock's rapid price increase and inherent execution risks associated with biotech investments [5][6]

Core Insights - Exousia Bio, Inc. has completed the acquisition of Exousia AI, Inc. in an all-stock transaction, issuing 62,223,000 restricted shares to consolidate ownership of a promising preclinical oncology platform [1] - The acquisition strengthens Exousia Bio's position in the exosome technology space, with two exclusive worldwide licenses secured for critical areas in cancer therapy and targeted drug delivery [2] - The company has received Orphan Drug Designation (ODD) from the FDA for its Glioblastoma therapy, marking a significant regulatory milestone [3][4] Financial and Strategic Advantages - The ODD provides substantial financial and strategic benefits, including an estimated potential value in the tens of millions of dollars [6] - The designation guarantees seven years of market exclusivity post-approval, offering a competitive advantage and protecting future revenue streams [10] - The company will benefit from tax credits for qualified clinical research costs and a waiver of New Drug Application user fees [10] Research and Development Progress - A completed in-vivo mouse study has shown extremely positive results for using exosomes to treat Glioblastoma multiforme, with findings being prepared for peer-reviewed publication [7] - To support the advancement of its pipeline, the company plans to expand its executive leadership and Board of Directors, including the appointment of a Chief Science Officer and Chief Medical Officer [8] Company Overview - Exousia Bio, Inc. specializes in developing and manufacturing mammalian and plant-derived exosomes using proprietary technologies for nucleic acid loading and targeted delivery [9] - The platform aims to address significant unmet medical needs, particularly in targeting cancer stem cells and treating a broad spectrum of viral infections [11]

Core Insights - Inovio is currently awaiting the acceptance of its Biologics License Application (BLA) for INO-3107, which targets recurrent respiratory papillomatosis [2] - The company is developing a unique pipeline and in vivo protein production technology, which has the potential to significantly surpass the market opportunity presented by recurrent respiratory papillomatosis [2] Company Overview - Inovio's leadership includes Jacqueline Shea, PhD, serving as President and CEO, and Michael Sumner as Chief Medical Officer [2] - The company is positioned in the biotech sector, focusing on innovative treatments and technologies [2]

Summary of Fate Therapeutics FY Conference Call Company Overview - **Company**: Fate Therapeutics (NasdaqGM:FATE) - **Focus**: Development of induced pluripotent stem cells (iPSC)-derived cell therapies for immune diseases and oncology [1][2] Key Points and Arguments iPSC Technology - **Unique Properties**: iPSCs can grow indefinitely and differentiate into any of the 200 cell types in the body, allowing for the creation of a master cell bank [3][4] - **Off-the-Shelf Concept**: iPSCs enable the production of consistent and uniform drug products, reducing costs and improving accessibility [4][5] Transition to CAR iT Cells - **Shift from T Cells to CAR iT Cells**: The company transitioned from developing T cells to CAR iT cells due to the latter's superior response to stimulation and expansion, which is crucial for treating aggressive diseases [6][7][8] FT819 Development - **Target**: FT819 is a CD19 CAR iT cell therapy initially aimed at aggressive DLBCL, showing a 40% complete response (CR) rate in CAR-T naive patients [10][11] - **Lupus Indication**: The therapy has been adapted for lupus, demonstrating a favorable safety profile and significant efficacy improvements in various clinical metrics [12][13] Market Potential - **Patient Population**: The potential patient population for lupus is significantly larger than for DLBCL, with estimates of 200 million individuals affected [13][14] - **Manufacturing Capacity**: The company projects the ability to produce approximately 50,000 doses per year, with a cost of goods around $3,000 per dose [15][16] Clinical Development and Future Plans - **Next Steps**: The company aims to initiate pivotal registration studies for FT819 in lupus by 2026 and explore additional autoimmune diseases [20][21] - **Pipeline Expansion**: Future therapies include FT839 for more complex diseases and FT836 targeting MICA/MICB in oncology [21][27] Innovations in Treatment - **Reduced Conditioning**: The company is working towards outpatient treatment options with lighter conditioning regimens, enhancing patient experience and accessibility [24][26] - **Sophisticated Edits**: FT839 will include additional edits to target CD38, aiming for a broader approach in treating autoimmune diseases [22][23] Financial Position - **Cash Reserves**: Fate Therapeutics reported a cash position of approximately $226 million, extending its runway through the end of 2027, allowing for continued development of its therapies [35] Additional Important Information - **Partnerships**: The company is collaborating with Ono for the development of FT825, a HER2 CAR iT therapy, which has faced challenges in patient enrollment due to prior treatments affecting HER2 expression [33][34] - **Patient Enrollment**: The company is experiencing faster enrollment rates in lupus compared to competitors, with nearly 14 clinical sites activated [19][20] This summary encapsulates the critical insights and developments discussed during the Fate Therapeutics FY Conference Call, highlighting the company's innovative approaches and future directions in cell therapy.

Summary of Caribou Biosciences FY Conference Call Company Overview - **Company**: Caribou Biosciences (NasdaqGS:CRBU) - **Focus**: Development of CAR-T therapies, specifically the Vispacel product for treating large cell B-cell lymphoma and the CB-011 program for myeloma Key Points on Vispacel Program - **Clinical Updates**: - Vispacel has been evaluated in the clinic for approximately four and a half years, showing promising results that resemble autologous CAR-T therapies [4][5] - After treating 84 patients, response rates and duration of response for Vispacel are nearly identical to autologous CAR-T, with a notable safety profile [5][6] - 75% of large cell B-cell lymphoma patients do not receive autologous CAR-T, indicating a significant market opportunity [5] - **Safety Profile**: - Vispacel demonstrated low rates of cytokine release syndrome, high-grade neurotoxicity, and severe infections, making it comparable to Lysosel, a better-tolerated product [6][7] - **Target Patient Population**: - Focus on patients ineligible for autologous CAR-T and auto transplants, including those facing geographical, insurance, and manufacturing challenges [7][19] - Plans for a pivotal trial involving approximately 250 patients randomized against immunochemotherapy, which lacks curative intent [7][9] - **Durability of Outcomes**: - Data indicates a plateau in durability of responses similar to autologous CAR-T, with low relapse rates compared to immunochemotherapy [8][9] - **Regulatory Strategy**: - Anticipated label for Vispacel will include auto CAR-T ineligible and auto transplant ineligible populations, with no significant barriers expected [19][20] - **Community Center Access**: - There is a strong desire from community centers to treat patients with Vispacel, as many patients refuse to travel to academic centers [25][27] Key Points on CB-011 Program - **Market Positioning**: - CB-011 is positioned against bispecific antibodies, with a focus on the myeloma patient population, where only about 10% currently receive autologous CAR-T [30] - Physicians express interest in an allogeneic CAR-T that matches or exceeds the efficacy of bispecifics, highlighting the treatment burden associated with bispecific therapies [30][31] - **Clinical Development**: - Expansion of the 450 million cell cohort to approximately 30 patients to better estimate overall response rates and MRD negativity [33][41] - The goal is to achieve median progression-free survival (PFS) rates comparable to bispecifics, targeting around 15 months [33] - **Competitive Landscape**: - Other allogeneic CAR-T products and in vivo CAR-T therapies are seen as less competitive due to their current stage of development and regulatory challenges [42][44] Additional Insights - **Manufacturing and Cost Efficiency**: - Vispacel can be manufactured and stockpiled, allowing for immediate availability upon patient eligibility confirmation, with significantly lower costs of goods sold (COGS) compared to autologous CAR-T [45][46] - **Patient Access Challenges**: - A significant portion of patients in the second-line setting are dual ineligible for both transplant and autologous CAR-T, indicating a meaningful market for Vispacel [27][29] This summary encapsulates the critical insights from the conference call, highlighting Caribou Biosciences' strategic focus on expanding access to CAR-T therapies through innovative product development and addressing patient needs in underserved populations.

Bio-Techne FY Conference Summary Company Overview - **Company**: Bio-Techne (NasdaqGS: TECH) - **Date of Conference**: December 02, 2025 Key Industry Insights 1. Performance in Large Pharma - Large pharma accounts for approximately 30% of Bio-Techne's revenue and has shown double-digit growth for three consecutive quarters [3][6] - The company is optimistic about continued strength in this segment, particularly in China, which has seen organic growth for two consecutive quarters [3][4] 2. Biotech Market Dynamics - Smaller biotech represents roughly 20% of Bio-Techne's revenue, but funding in this sector has decreased by 30% year-over-year [7][8] - Despite a high single-digit decline in biotech revenue in the most recent quarter, there is a belief that the market is stabilizing, with increased funding observed in recent months [11][12] 3. Academic and Government Market - Academic and government sectors contribute about 20% of global revenues, with stable growth in Europe but uncertainty in the U.S. due to NIH funding concerns [12][13] - Recent signals from Congress suggest flat budgets, alleviating some anxiety among academic customers [13][14] Financial Performance 1. Revenue and Growth - The company reported an organic decline of 1% in the latest quarter, attributed to headwinds from two major cell therapy customers who received Fast Track designation from the FDA [3][6] - Despite this, Bio-Techne managed to achieve a 90 basis points margin expansion [6] 2. Future Guidance - The company maintains a soft guidance for low single-digit growth in fiscal 2026, with expectations for Q2 results to mirror Q1 [19][20] - The underlying strength of the business is improving, with projections for better performance in the second half of the fiscal year [20][24] Product and Market Highlights 1. Product Portfolio - The ProteinSimple franchise continues to perform well, with double-digit growth in consumables [4][20] - The spatial product line has stabilized and is expected to improve, with positive growth in reagents [5][20] 2. Cell Therapy Dynamics - The Fast Track designation for two major customers has led to a temporary reduction in orders, as these customers are combining phases in their clinical trials [32][36] - The potential revenue from these therapies could reach $40-$50 million each upon commercialization, with a base case for commercial ramp starting in fiscal year 2028 [51][55] Market Risks and Uncertainties 1. Academic Funding Concerns - The primary uncertainty affecting the biotech market is the outcome of academic funding, which could impact spending in the biotech sector [25][26] - There is a belief that even in a flat academic market, Bio-Techne can outperform due to its positioning and product offerings [26][29] 2. Pharma Market Stability - While the pharma market has shown double-digit growth, uncertainties regarding pricing and tariffs have largely subsided, leading to a more stable outlook [30][31] Conclusion - Bio-Techne is navigating a complex market landscape with a focus on innovation and strategic positioning in key growth areas such as large pharma, biotech, and cell therapy - The company is optimistic about future growth, particularly in fiscal year 2027, driven by its diverse product portfolio and improving market conditions [15][19][78]

Core Insights - StimCell Energetics Inc. has signed a service agreement with St. Boniface Hospital Albrechtsen Research Centre to study the effects of its eBalance® device on mitochondrial function in sensory neurons [1] Company Developments - The collaboration involves Principal Investigator Professor Paul Fernyhough and aims to further define the physiological action of microcurrents [1]

Core Insights - YD Bio Limited is expanding its OkaiDx platform for cancer detection, now including pancreatic and colorectal cancer tests in addition to breast cancer monitoring [1][2] - The company has established partnerships to integrate OkaiDx testing into primary care and women's health settings, enhancing accessibility for proactive cancer detection [3] - Recent clinical data shows the OkaiDx Detect Pancreatic Cancer Test has high sensitivity and specificity, indicating its potential effectiveness in early-stage cancer detection [4] Company Developments - YD Bio has broadened the availability of its OkaiDx blood-based testing services across 44 states in the U.S. through EG BioMed's accredited laboratory [2] - The company is leveraging a nationwide telehealth network to facilitate virtual consultations and streamline blood sample collection for patients [2] - New memorandums of understanding with medical groups aim to incorporate OkaiDx testing into routine clinical workflows [3] Clinical Advancements - The OkaiDx Detect Pancreatic Cancer Test demonstrated 93.8% sensitivity for early-stage pancreatic ductal adenocarcinoma and 100% sensitivity for late-stage cases [4] - The test also showed 97.3% specificity in healthy individuals and 97.7% overall accuracy in a study involving 100 PDAC patients and 500 healthy controls [4] - The findings highlight the potential of cfDNA methylation biomarkers, such as ZFP30, in improving early cancer detection [4]