Inmune Bio Inc Stock Price, News & Analysis

INmune Bio (NASDAQ: INMB) has reported results from its Phase 2 MINDFuL trial evaluating XPro™, a selective soluble TNF inhibitor, in early Alzheimer's Disease (AD). While the modified intent-to-treat population (n=200) did not meet the primary cognitive endpoint, a predefined subgroup of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100) showed positive results.

Key findings in the subgroup demonstrated:

• Clinical benefit on the primary endpoint EMACC (effect size: 0.27)
• Improvement on the Neuropsychiatric Inventory (effect size: -0.24)
• Biological benefit in blood levels of pTau217 (effect size: -0.20)

The treatment was well-tolerated with no occurrences of ARIA-E or ARIA-H, even in high-risk ApoE4+/+ patients. The most common adverse events were injection site reactions, affecting 80% of the XPro™ group. The company plans to file for Breakthrough Therapy Designation with the FDA and schedule an End-of-Phase 2 meeting in Q4 2025 to define the path for a pivotal trial.

INmune Bio (NASDAQ: INMB), a clinical-stage inflammation and immunology company, has announced a registered direct offering of 3,000,000 shares of common stock priced at $6.30 per share. The offering, expected to close around June 30, 2025, aims to raise approximately $19 million in gross proceeds.

The offering is priced at-the-market under Nasdaq rules, with A.G.P./Alliance Global Partners serving as the sole placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The offering is being made through an effective shelf registration statement previously filed with the SEC.

INmune Bio (NASDAQ: INMB), a clinical-stage inflammation and immunology company, has scheduled a conference call to present top line data from their Phase 2 MINDFuL trial in early Alzheimer's Disease. The call will take place on June 30, 2025, at 8:00 AM EDT.

Investors can access the presentation through a dial-in number (+1-800-267-6316 for US, +1-203-518-9783 for international) or via webcast. A transcript will be available within 24 hours, and a replay will be accessible through July 30, 2025.

INmune Bio announced positive results from a study showing XPro (pegipanermin) effectively reduces amyloid formation and improves brain function after traumatic brain injury (TBI) in an Alzheimer's disease model. The research, presented at Keystone Symposia's Neurodegeneration section, demonstrated that XPro administration 30 minutes post-injury inhibited solTNF/TNFR1 activity and prevented increases in key markers associated with Alzheimer's progression. The study revealed TBI triggers increased expression of TNFR1, BACE1, and Aβ42 in the hippocampus. XPro treatment successfully reduced intracellular neuronal amyloid accumulation and improved neurological outcomes in treated animals. This research is particularly significant as TBI from falls is a major concern for elderly populations at risk for Alzheimer's disease, potentially accelerating dementia onset.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company focused on inflammation and immunology through innate immune system targeting, has announced its participation in the 2025 RBC Capital Markets Global Healthcare Conference. The event will take place on May 20-21, 2025, at the InterContinental Barclay NY. The company will participate in a fireside chat and conduct one-on-one virtual meetings, with their presentation scheduled for 11:00 AM EDT.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company focused on treating Alzheimer's Disease through targeting microglial activation and neuroinflammation, has scheduled its Q1 2025 earnings conference call for May 8th, 2025, at 4:30 PM EDT. The call will cover financial results for the quarter ended March 31, 2025, and provide a corporate update.

Participants can join via phone using the domestic dial-in (1-800-267-6316) or international dial-in (+1-203-518-9783) 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 will be accessible through May 22nd, 2025.

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.