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INmune Bio, Inc. (NASDAQ: INMB) is a clinical-stage biotechnology company focused on developing innovative therapies that target the innate immune system to treat diseases such as cancer, neurodegenerative disorders, and chronic inflammation. The company specializes in reprogramming the immune system to address immune dysfunction, offering precision medicine approaches through its proprietary platforms. INmune Bio's product candidates are currently in clinical trials and aim to provide safer and more effective treatment options for unmet medical needs.
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Dominant-Negative Tumor Necrosis Factor (DN-TNF) Platform - Develops therapies that selectively neutralize soluble TNF to treat neurodegenerative diseases, cancer, and treatment-resistant depression. Key product candidates include XPro™ for Alzheimer’s disease and INB03™ for cancer.
- XPro™ - Targets Mild Alzheimer’s disease, Mild Cognitive Impairment, and treatment-resistant depression.
- INB03™ - Focuses on cancer treatment by addressing immune dysfunction.
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Natural Killer Cell Priming Platform - Enhances the function of natural killer (NK) cells to eliminate cancer cells, with applications in hematologic malignancies and solid tumors. The platform's lead product, INKmune™, is in clinical trials for metastatic castration-resistant prostate cancer and other NK-resistant tumors.
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CORDStrom™ Platform - Utilizes human umbilical cord-derived mesenchymal stromal/stem cells (hucMSCs) for therapeutic applications. Recently completed a trial for recessive dystrophic epidermolysis bullosa.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Raymond J. Tesi ExecutiveBoard | President and Chief Executive Officer | Board Member at Bexion Pharmaceuticals | Raymond J. Tesi has served as the President and Chief Executive Officer of INMB since its formation in September 2015 and is also the Principal Executive Officer and a board member. | View Report → |
David J. Moss Executive | Chief Financial Officer | David J. Moss is the co-founder and Chief Financial Officer at INmune Bio since September 2015, and he also serves as Secretary and Treasurer. He was on the board of directors from September 15, 2015 until April 2018. | ||
J. Kelly Ganjei Board | Director | CEO and President of AmplifyBio, LLC | J. Kelly Ganjei has been a director at INmune Bio since September 2016 and serves as the chairman of the Nominating and Corporate Governance Committee, bringing nearly 30 years of experience in the life sciences, venture capital, and IT sectors. | |
Scott Juda Board | director | Co-Founder of Fossick Capital | Scott Juda has served as a director at INMB since March 2018 and is the chairman of the Audit Committee. He brings extensive capital markets experience from roles including CEO and Co-Founder of The Juda Group, Inc. and Managing Director at SMH Capital. | |
Tim Schroeder Board | Independent Director | Chairman, CEO, and Founder of CTI Clinical Trial & Consulting Services; Founding Executive Vice President of Clinical Development at SangStat Medical Corporation; Board member at Xavier University; Board member at Bexion Pharmaceuticals; Board member at Cognitive Research; Board member at Covington Life Sciences Partners; Board member at Gravity Diagnostics; Board member at Lepton Pharmaceuticals | Tim Schroeder has been an Independent Director at INmune Bio since December 2016 and serves on its Audit Committee. He brings extensive experience as Chairman, CEO, and Founder of CTI Clinical Trial & Consulting Services, as well as having served as the Founding Executive Vice President of Clinical Development at SangStat Medical Corporation and holding multiple board roles. |
- Given the complexities around your CORDStrom BLA filing and the ongoing need to address both CMC and regulatory feedback, how do you plan to mitigate delays while ensuring compliance with both U.S. and U.K. requirements?
- With EMACC as your primary endpoint in the AD02 trial, what concrete assurances or regulatory feedback have you received from the FDA regarding its validation and potential acceptance for demonstrating efficacy?
- Considering the inherent challenges of enrolling elderly patients in clinical trials, what specific strategies are you employing to manage the anticipated dropout rate so that it does not compromise the statistical power of the AD02 study?
- If the FDA demands a larger safety database for your asset progression, how prepared is the company to adjust the design and enrollment targets for a potential Phase III trial, and what impact might that have on your timelines and costs?
- With available warrant accelerations potentially raising additional capital, what are the anticipated impacts on shareholder dilution, and how is management planning to balance capital needs with protecting shareholder value?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
This company is developing products that involve replacing or supplementing NK cells of the patient for the treatment of cancer, which may include gene therapy as part of their extensive ex-vivo cell manipulations. | |
This company is involved in the NK cell therapy business, focusing on replacing or supplementing NK cells for cancer treatment. | |
This company is part of the NK cell therapy business, working on products that involve ex-vivo cell manipulations for cancer treatment. | |
This company is developing NK cell therapies that may include gene therapy as part of their ex-vivo cell manipulations for cancer treatment. | |
Glycostem | This company is engaged in the NK cell therapy business, focusing on ex-vivo cell manipulations for cancer treatment. |
This company is involved in the personalized immuno-oncology business, particularly in CAR-T cell therapies, which are patient-specific ex-vivo gene therapy approaches. | |
Juno Therapeutics | This company focuses on CAR-T cell therapies, a patient-specific ex-vivo gene therapy approach in the personalized immuno-oncology business. |
This company is part of the personalized immuno-oncology business, specializing in CAR-T cell therapies. | |
This company has in-licensed CAR-T cell therapies with marketing authorization in the US, focusing on personalized immuno-oncology. | |
This company has in-licensed CAR-T cell therapies with marketing authorization in the US, focusing on personalized immuno-oncology. | |
Genentech/Roche | This company drove the growth of monoclonal antibody therapies, which are disease-specific and aim to illuminate cancer to the innate immune system. |
This company is involved in monoclonal antibody therapies and poly-specific antibodies that connect cancer with activated T-cells. | |
This company is a leader in checkpoint inhibitors, including pembrolizumab, which block mechanisms shielding cancers from T-cell killing. | |
This company is involved in checkpoint inhibitors, including ipilimumab and nivolumab, which block mechanisms shielding cancers from T-cell killing. | |
BMS | This company is actively developing checkpoint inhibitors, a promising therapeutic area in immuno-oncology. |
This company is engaged in the development of immune checkpoint inhibitors, which are rapidly expanding in the immuno-oncology field. | |
This company is developing immune checkpoint inhibitors, contributing to the rapidly growing immuno-oncology field. | |
This company is involved in the development of immune checkpoint inhibitors, which are expanding in the immuno-oncology field. | |
Tesaro | This company is active in the immune checkpoint inhibitor field, contributing to the rapidly growing immuno-oncology space. |
This company is engaged in the immune checkpoint inhibitor field, which is rapidly expanding in immuno-oncology. | |
Theravectys | This company is developing immune checkpoint inhibitors, contributing to the rapidly growing immuno-oncology field. |
ToleroTech | This company is active in the immune checkpoint inhibitor field, contributing to the rapidly growing immuno-oncology space. |
| Customer | Relationship | Segment | Details |
|---|---|---|---|
One customer in the United Kingdom | Sale of mesenchymal stem cells (MSCs) | All | $0.014 million in 2024 (100% of total revenue) , $0.155 million in 2023 (100% of total revenue) |
Recent press releases and 8-K filings for INMB.
- Favorable patent milestone: The USPTO issued a favorable written opinion on all claims in INmune Bio’s international patent application PCT/US25/17028 for the CORDStrom platform, confirming the claims' novelty, inventive step, and industrial applicability.
- Product innovation details: The CORDStrom platform features pooled, culture-expanded human umbilical cord-derived mesenchymal stromal cells for injection or infusion, offering batch-to-batch consistency and potential IP exclusivity through at least 2045.
- Fast-track approach: The company plans to accelerate its U.S. national patent application via the Patent Prosecution Highway (PPH), building on this positive patentability opinion.
- Inmune Bio announced a collaboration with the Cell and Gene Therapy Catapult to scale up commercial-ready manufacturing for its CORDStrom cell therapy, targeting treatment for recessive dystrophic epidermolysis bullosa (RDEB).
- The partnership leverages existing facilities in the UK and US and is expected to support clinical trials and future regulatory submissions, with further plans to transition production of the INKmune therapy.
- Clinical Milestone: INmune Bio is on track to release top-line Phase II AD02 trial results for early Alzheimer's treatment, utilizing biomarker enrichment and the novel EMACC endpoint with data expected this June .
- Financial Performance: The company reported a net loss of approximately $42.1 million, maintained a cash position of $20.9 million at year-end, raised $29.9 million through equity and warrant financing, and secured an additional $5.4 million via an ATM .
- Pipeline Progress: Advancing its DN-TNF, INKmune, and CORDStrom platforms with successful enrollment and interim analysis in the AD02 Alzheimer’s trial, while planning a BLA filing for RDEB in Q1 2026 and expanding clinical programs in metastatic castration-resistant prostate cancer .
- Inmune Bio, Inc. presented preliminary phase I/II trial results showing in vivo activation of mlNK cells targeting metastatic, castration‐resistant prostate cancer.
- The presentation details the trial design, dosing strategy, and safety endpoints, while including forward-looking statements on clinical and operational milestones.
- Inmune Bio Inc. announced the completion of the third and highest dose cohort in its Phase I trial of INKmune™ therapy for metastatic castration-resistant prostate cancer, with the safety review committee authorizing the opening of the Phase II high dose cohort.
- The trial employs a Bayesian design with three ascending dose cohorts, and initial data showed an exemplary safety profile and immunologic effects, supporting the advancement to Phase II.
- The press release also notes that trial data will be presented at the 10th Annual Innate Killer Summit, underscoring robust patient recruitment and continued clinical progress.
- Inmune Bio, Inc. is advancing three novel platforms: CORDStrom for pediatric RDEB, XPro for Alzheimer’s, and INKmune for cancer immunotherapy, showcasing robust clinical and regulatory progress .
- CORDStrom has demonstrated significant itch reduction and clinical improvements in a randomized, placebo-controlled, double-blinded MissionEB study .
- The company plans to submit a BLA for CORDStrom to the FDA, with a targeted submission in December 2025, supported by compelling clinical data .
- A highly reproducible, scalable manufacturing process using pooled umbilical cords ensures cost-effective production while maintaining CORDStrom’s potency .
- Additional milestones include top-line cognition data for XPro expected in June 2025, and the attainment of Rare Pediatric Disease and Orphan Drug designations with plans for EU and UK marketing authorizations .