Inmune Bio Inc Stock Price, News & Analysis

INmune Bio (NASDAQ: INMB) has achieved a significant intellectual property milestone for its CORDStrom™ platform technology. The USPTO has issued a favorable written opinion on all claims in the company's international patent application PCT/US25/17028, confirming novelty, inventive step, and industrial applicability for their next-generation mesenchymal stromal cell (MSC) product.

CORDStrom™, comprising pooled, culture-expanded human umbilical cord-derived MSCs, is designed for infusion or injection across various inflammatory and degenerative diseases. The patent, once granted, will provide IP exclusivity through at least 2045. The company plans to expedite the U.S. application via the Patent Prosecution Highway program.

Recent Phase 2 trial data showed promising results, with CORDStrom™ demonstrating reductions in pain and itch, along with early signals of improved skin integrity and disease activity.

INmune Bio (NASDAQ: INMB) has partnered with Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms. The collaboration focuses initially on scaling production of CORDStrom™, a therapy for recessive dystrophic epidermolysis bullosa (RDEB).

Recent Phase 2 trial results showed CORDStrom™ reduced pain and itch while potentially improving skin integrity and disease activity. The company estimates approximately 4,000 children with intermediate to severe RDEB in the US, UK, and EU could benefit from this treatment.

Following CORDStrom™, INmune Bio plans to transition production of INKmune®, its NK-priming cell medicine for solid tumors, to the same facility. The partnership leverages CGT Catapult's expertise at its Stevenage Manufacturing Innovation Centre, building on INmune Bio's existing manufacturing base at the Royal Free Hospital.

INmune Bio (NASDAQ: INMB) has presented baseline demographics for its MINDFuL Phase II trial studying XPro™ in early Alzheimer's disease (AD) patients. The study includes 208 participants, with 44% diagnosed with MCI and 56% with mild AD, averaging 72 years of age.

The trial features a 2:1 randomization of XPro™ 1.0 mg/kg versus placebo, administered weekly for 23 weeks. All enrolled patients exhibited biomarkers of inflammation, with 69.2% being APOE ε4 carriers and 64.4% meeting multiple enrichment biomarker criteria. The study's primary endpoint is the change in cognitive scores measured by EMACC, with secondary endpoints including CDR-SB, E-Cog, ADL, and Neuropsychiatric Inventory.

The screen failure rate was 72%, primarily due to disease severity measured by MMSE. Topline results are expected in June 2025.

INmune Bio Inc. (NASDAQ: INMB) has released its financial results for the year ended December 31, 2024. The company reported significant progress across its three platform technologies:

For its DN-TNF Platform, the company completed enrollment of 208 patients in its Phase 2 AD02 trial for Early Alzheimer's Disease, with topline results expected in June 2025. The trial demonstrated strong performance of its EMACC cognitive measure tool.

The CORDStrom Platform showed positive results in treating Recessive Dystrophic Epidermolysis Bullosa (RDEB), receiving both Rare Pediatric Disease and Orphan Drug Designations from the FDA. The company plans to file a BLA in 2025 or early 2026.

The INKmune Platform demonstrated safety and increased NK-Cell activity in its Phase I/II trial for metastatic Castration-Resistant Prostate Cancer.

Financially, the company reported a net loss of $42.1 million for 2024, with R&D expenses of $33.2 million. The company raised approximately $27.5 million through securities purchase agreements and had cash and cash equivalents of $20.9 million as of December 31, 2024.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, has scheduled its Fourth Quarter 2024 financial results conference call for March 27, 2025, at 4:30 PM EDT. The company will present its financial performance for the quarter ended December 31, 2024, along with a corporate update.

Investors and interested parties can join via phone using the dial-in numbers 1-800-225-9448 or 1-203-518-9708 with Conference ID: INMUNE. A live audio webcast will be available, and a transcript will be provided approximately 24 hours after the call. A replay option will also be accessible.

INmune Bio (NASDAQ: INMB) has successfully completed the Phase I portion of its CaRe PC trial for INKmune™, a Natural Killer (NK) cell therapy treating metastatic castration-resistant prostate cancer (mCRPC). The Scientific Review Committee (SRC) unanimously approved opening all Phase II cohorts after reviewing safety data from the third and highest dose cohort.

The trial, which follows a Bayesian design with three ascending dose cohorts, has demonstrated an exemplary safety profile in outpatient settings. Initial data from the low dose cohort has shown immunologic effects. The Phase II extension will include six patients at the two higher dose levels, with patient recruitment progressing as expected.

The company's CSO, Mark Lowdell, will present the trial data at the 10th Annual Innate Killer Summit in San Diego on March 4th.

INmune Bio (NASDAQ: INMB) announces plans to submit a Biologics License Application (BLA) to the FDA for CORDStrom, targeting the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in pediatric patients. The decision follows positive results from the MissionEB clinical trial, a double-blind, placebo-controlled study involving 30 pediatric patients.

CORDStrom demonstrated significant efficacy, particularly in reducing itch severity by over 27% at 6-months in severe cases, with improvements in skin integrity for younger patients. The treatment received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA. The company estimates approximately 4,500 children with intermediate or severe RDEB in the US, UK, and EU could benefit from this therapy.

The company plans to submit the BLA in 2025, followed by Marketing Authorization Applications in the EU and UK in 2026. A 12-month open-label study is planned to continue supporting patients from the MissionEB trial.

INmune Bio (NASDAQ: INMB) has expanded its Phase I/II trial for metastatic castration-resistant prostate cancer (mCRPC) to include the West Los Angeles VA Medical Center, with the first patient treated in the Phase II portion. The trial, known as CarePC, represents a novel NK-targeted biologic therapy approach using INKmune treatment.

The patient received the 'medium' dose of INKmune as an outpatient under Dr. Matthew Rettig's care, who serves as Chief of Hematology-Oncology at VA Greater Los Angeles Healthcare System. The VA system treats approximately 15,000 Veterans diagnosed with prostate cancer annually, with over 200,000 Veterans being prostate cancer survivors. Under Dr. Rettig's leadership, 900 patients have participated in over two dozen clinical trials at the West LA VA Medical Center.

This treatment activates NK cells, which target tumor cells abundant in prostate cancer, and is administered on an outpatient basis with minimal reported side effects.

INmune Bio (NASDAQ: INMB) has announced the complete repayment of its $15.0 million Term Loan from Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. The loan, borrowed in 2021, was fully repaid on December 2, 2024, ahead of its January 1, 2025 maturity date. The company's CFO, David Moss, noted that this repayment will reduce quarterly cash burn and strengthen the balance sheet before upcoming Phase 2 Alzheimer's Disease trial data.

The company also mentioned the over-enrollment of its AD02 Trial in Alzheimer's Disease, focusing on Early AD patients with elevated neuroinflammation biomarkers. Top-line cognitive data from this six-month phase 2 trial is expected in Q2 2025.