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BOCA RATON, Florida – INmune Bio Inc. (NASDAQ:INMB), a biotechnology firm with a market capitalization of $171 million engaged in developing treatments targeting inflammation and immunology, has received a favorable written opinion from the United States Patent and Trademark Office (USPTO) concerning its international patent application for its novel cell therapy product, CORDStrom™. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, positioning it well for continued research and development efforts. The USPTO’s written opinion, dated April 8, 2025, validates all claims regarding the innovation, novelty, and industrial applicability of the CORDStrom™ platform, which utilizes pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs).
CORDStrom™ stands out from traditional mesenchymal stromal cell (MSC) products by offering a tunable and consistent therapeutic performance for a variety of inflammatory and degenerative diseases. The platform is designed for scalable production and ensures batch-to-batch consistency, potentially providing a significant advance in the field of cell therapy.
The company’s General Counsel, Joshua Schoonover, expressed encouragement by the USPTO’s examination results and the favorable opinion on patentability of the submitted claims. He emphasized that the CORDStrom™ product, once patented, is expected to secure IP exclusivity through at least 2045, subject to patent term adjustments or extensions. The market has responded positively to these developments, with INmune Bio’s stock showing a remarkable 60% gain year-to-date, though InvestingPro analysis indicates significant price volatility. Analysts maintain an optimistic outlook, with price targets ranging from $20 to $30.
In pursuit of expedited U.S. patent approval, INmune Bio plans to engage the Patent Prosecution Highway (PPH), a program that allows for more efficient patent reviews based on favorable international rulings. This strategy follows the promising outcomes from a recent Phase 2 trial, which indicated that CORDStrom™ may reduce pain and itch while showing early signs of improving skin integrity and disease activity.
CORDStrom™ is a patent-pending cell medicine that leverages proprietary techniques to create off-the-shelf, allogeneic pooled hucMSCs. Initially developed at INKmune® manufacturing facilities with UK academic grant funding, CORDStrom™ has shown potential as a systemic therapy for recessive dystrophic epidermolysis bullosa (RDEB) and other challenging conditions.
INmune Bio, known for its focus on the innate immune system, has several other products in clinical trials, including candidates for Alzheimer’s disease, mild cognitive impairment, treatment-resistant depression, and cancer. However, it is important to note that CORDStrom™, along with the company’s other products, has not yet been approved by the FDA or any regulatory body, and the outcomes of ongoing clinical trials are not guaranteed.
This report is based on a press release statement and reflects the latest developments in INmune Bio’s efforts to advance its CORDStrom™ platform within the biotechnology industry. With the next earnings announcement scheduled for April 30, 2025, investors seeking deeper insights can access comprehensive analysis through InvestingPro, which offers exclusive financial health scores, valuation metrics, and additional ProTips for over 1,400 US stocks, including INmune Bio’s detailed Pro Research Report.
In other recent news, INmune Bio Inc. reported its Q4 2024 earnings, revealing a net loss of $42.1 million, up from $30 million in 2023, with increased investments in research and development. The company raised $29.9 million through the sale of common stock and warrants, emphasizing its commitment to advancing clinical trials, particularly for Alzheimer’s disease. The company is preparing to release top-line data from its Phase II Alzheimer’s trial in June 2025. Raymond James maintained an Outperform rating on INmune Bio, with a $23 price target, highlighting the anticipated results from the Alzheimer’s trial as a potential catalyst for value creation.
Additionally, INmune Bio presented data from its MINDFuL Phase II trial at a recent conference, detailing the patient demographics and biomarker status for its XPro™ treatment for early Alzheimer’s disease. The trial includes 208 participants with mild cognitive impairment or mild Alzheimer’s disease. The company is also addressing a slight delay in its CORDStrom program for RDEB, with the BLA submission now expected in Q1 2026. Meanwhile, INKmune is progressing in Phase 1/2 trials for mCRPC, with results anticipated in 2025.
INmune Bio’s financial runway is projected to last through Q3 2025, with potential extensions through warrants and ATM offerings. The company’s strategic focus remains on neuroinflammation, with aspirations to halt cognitive decline in Alzheimer’s patients through precision medicine.
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