ZUG, Switzerland, April 01, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (NASDAQ:OCS) ("Oculis" or the "Company"), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced that it will host an in-person and virtual R&D Day on Tuesday, April 15, 2025 from 10:00 AM to 12:00PM ET at the Intercontinental New York Barclay hotel. To register for the event, click here. About OCS-01 eye drops and the OPTIREACH® ...

Financial Data and Key Metrics Changes - INmune Bio raised $29.9 million from the sale of common stock and warrants in 2024, issuing a total of 4,145,978 shares and warrants for 3,898,852 shares [37][38] - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023 [40] - Research and development expenses totaled approximately $33.2 million for 2024, up from approximately $20.3 million in 2023 [40] - Cash and cash equivalents at December 31, 2024, were approximately $20.9 million, with an additional $5.4 million raised since year-end [41] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease is expected to announce top-line data in less than 100 days, focusing on neuroinflammation as a primary driver of the disease [8][14] - The INmune platform has pivoted to target solid tumors, with ongoing trials for castrate-resistant metastatic prostate cancer [17][18] - CORDStrom, a new therapeutic platform, is positioned to address systemic disease modification for RDEB, differentiating itself from local wound management therapies [22][24] Market Data and Key Metrics Changes - The ADO2 trial enrolled 208 patients across eight countries, with a focus on those with neuroinflammation driving their Alzheimer's disease [15] - The CaRe PC trial for prostate cancer is progressing, with completion of dosing in the Phase 1 part and ongoing Phase 2 dosing expected to complete by 2025 [18][43] Company Strategy and Development Direction - INmune Bio aims to challenge the amyloid-centric paradigm of Alzheimer's treatment by focusing on neuroinflammation [14][33] - The company is committed to advancing its three therapeutic platforms, with a focus on achieving regulatory milestones and potential commercialization [36][45] - The management emphasizes a precision medicine approach in clinical trials, particularly in the ADO2 trial [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [34][35] - The company believes that addressing neuroinflammation could have broader implications for various CNS diseases [35] - Management highlighted the importance of safety in treating elderly patients with Alzheimer's, noting no significant adverse events reported thus far [31] Other Important Information - The company plans to file a BLA for CORDStrom in the first quarter of 2026, which would mark its first market therapeutic [44][112] - Management is focused on ensuring the quality of regulatory submissions to facilitate successful approvals [113] Q&A Session Summary Question: Is the 12-month open label trial for RDEB required for filing? - Management indicated that they believe the current data is adequate for a BLA submission, but the FDA will ultimately decide [50][51] Question: Will EMACC and CDR results be released at the same time? - Management confirmed that both EMACC and CDR results will be available at the time of data release [56][60] Question: Are there any dropouts in the EXPAREL Phase 2 trial? - Management reported that dropouts are within expected ranges, primarily due to typical issues associated with elderly patients [86] Question: How does the company plan to commercialize CORDStrom? - Management aims to move towards commercialization independently but may seek a partner closer to the launch [93] Question: Will the BLA for CORDStrom be filed in the UK and US? - Management confirmed that they expect to have all necessary data ready for filing in both regions by early 2026 [101][102]

Financial Data and Key Metrics Changes - The company ended the year with a cash balance of $4.6 million, with cash used in operations for Q4 2024 at $1.7 million and for the full year at $9.6 million, compared to $3 million and $15.8 million for the same periods in 2023, reflecting efforts to contain spending while advancing programs [27][28] - The net loss for the year ended 2024 was $10.8 million or $2.86 per share, compared to a net loss of $22.5 million or $6.54 per share in the prior year [28] Business Line Data and Key Metrics Changes - The company made significant progress in its clinical programs, particularly with the iNKT cell therapy, which has shown effectiveness in treating solid tumors and immune-driven diseases [11][12] - The collaboration with Autonomous Therapeutics aims to enhance the efficacy of iNKT cell therapy by integrating their encrypted RNA technology, targeting metastatic cancer with greater precision [9][10] Market Data and Key Metrics Changes - The company presented data at major conferences, demonstrating that its iNKT cell therapy enhances immune activation and overcomes resistance in challenging cancers, including gastric cancer [12][13] - The Phase 1 study of AgenT-797 in patients with severe acute respiratory distress showed an 80% survival rate, significantly higher than the 10% survival rate of in-hospital controls [20][21] Company Strategy and Development Direction - The company is focused on delivering scalable, durable, and effective allogeneic iNKT cell therapy to patients, with plans to advance multiple clinical programs in 2025, including gastric cancer and GvHD [5][31] - The addition of Dr. Robert Kadlec to the Board of Directors is expected to enhance the company's strategic depth in biodefense and pandemic preparedness [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's momentum entering 2025, highlighting a differentiated technology and a clear plan to reach the next value inflection point [26][32] - The company remains committed to operational efficiency and fiscal responsibility while advancing its innovative therapies [32] Other Important Information - The company has received probable funding from the National Institute of Allergy and Infectious Diseases (NIAID) to explore the activity of 797 in acute GvHD, with plans for a Phase 1 trial [23][24] - The company is advancing its PRAME-TCR program, which targets intracellular tumor antigens, demonstrating high specificity and potent tumor killing [15][18] Q&A Session Summary Question: Status of the Phase 2 study and focus for 2025 - Management confirmed that the majority of patients are enrolled in the Phase 2 study for gastric cancer, with data expected in the second half of the year, and emphasized the importance of advancing both gastric cancer and GvHD programs in 2025 [36][41] Question: KOL investigator feedback and potential for approval - Management noted positive feedback from key opinion leaders and emphasized the goal of accumulating data to demonstrate clinical benefits, with plans for regulatory discussions [47][53] Question: Timing of funding for GvHD study and cash runway - Management indicated that funding for the GvHD study is fluid but expressed optimism about securing it, while confirming that the company has cash runway through the end of 2025 [66][78]

Summary of InMed Pharmaceuticals (INM) Update / Briefing Industry Overview - The discussion centers around the Alzheimer's disease research and development landscape, highlighting the recent advancements in disease-modifying therapies and the challenges faced in clinical trials and drug development [6][7][15]. Key Points and Arguments Advances in Alzheimer's Research - There has been a significant increase in understanding Alzheimer's disease over the past decade, with the first disease-modifying therapies launched in the U.S., Japan, and China [6][7]. - The removal of amyloid from the brains of patients has been achieved, impacting tau levels and disease progression, although the average clinical impact remains limited [15][16][18]. Challenges with Mouse Models - Current mouse models primarily focus on amyloidosis and tauopathy, which do not fully replicate the complexity of Alzheimer's disease [8][9][10]. - The efficacy of treatments is often tested in younger mice, which may not accurately reflect the disease's progression in older adults [10][11]. - Advanced-stage models are necessary to better understand the safety and efficacy of treatments [11][13]. Importance of Biomarkers - The selection of patients for clinical trials has evolved from clinical criteria to biomarker-based criteria, improving the ability to demonstrate clinical efficacy [21][22]. - There is a need for better biomarkers for neuroinflammation, which is still in early development compared to amyloid biomarkers [47][48]. Neuroinflammation as a Target - Chronic neuroinflammation is recognized as a significant factor in Alzheimer's disease, with potential drug targets being explored [32][33][36]. - InMed's compound, INM901, shows promise in modulating neuroinflammation and promoting neurogenesis, with positive results in animal studies [30][51][52]. Diversity in Clinical Trials - Current clinical trials have been criticized for lacking racial and ethnic diversity, which may affect the understanding of drug efficacy across different populations [18][20][60]. Future Directions - The panelists express optimism about the future of Alzheimer's research, emphasizing the need for combination therapies and the potential for repurposing existing drugs [41][65]. - The goal is to transform Alzheimer's from a terminal disease to a chronic condition, improving the quality of life for patients [88][89]. Other Important Content - The discussion highlights the iterative learning process in selecting patients for trials based on biomarkers rather than solely on clinical diagnosis [21][22]. - The role of inflammation in Alzheimer's is complex, with both beneficial and harmful effects depending on the disease stage [40][76]. - The importance of accurate diagnosis and the distinction between Alzheimer's disease and dementia is emphasized [103]. This summary encapsulates the key discussions and insights from the InMed Pharmaceuticals update, focusing on the current state and future directions of Alzheimer's disease research and treatment.