Full Press Release Details
INmune Bio Inc. Announces Second Quarter 2025
Results, Provides Business Update and Announces Management Changes
BOCA RATON, Fla., Aug.
07, 2025 (GLOBE NEWSWIRE) -- INmune
Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments
that harness the patient's innate immune system to fight disease, today announces its financial results for the quarter ended June
30, 2025 and provides a business update.
Q2 2025 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro ):
Figure Legend: With the enriched
population underpowered for detecting statistically significant changes, the Company and third-party statisticians relied
on Cohen's d effect sizes to evaluate the meaningfulness of observed changes. These effect sizes, though small, consistently favored
XPro over placebo on the primary endpoint and multiple secondary and exploratory endpoints (see figure). Across most endpoints,
XPro showed favorable trends, with effect sizes approaching the 0.2 threshold for clinical relevance.
The clinical endpoints shown in the forest
Upcoming Events and Milestones:
Financial Results for the Second
Quarter Ended June 30, 2025:
Earnings Call Information
To participate in this
event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call
when reaching the operator.
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448 Participant
Dial-in (international): +1-203-518-9783
Conference ID: INMUNE
A live audio webcast of the call can be accessed
by clicking here or using
A transcript will follow
approximately 24 hours from the scheduled call. A replay will also be available through August 21, 2025 by dialing 1-844-512-2921 or 1-412-317-6671
(international) and entering pin no. 11159128.
XPro is a next-generation
inhibitor of tumor necrosis factor (TNF) that acts differently than currently available TNF inhibitors in that it neutralizes soluble
TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects
in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation
in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio's website.
patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in
suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and
expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom
products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular
medicines that can be produced at low cost and with repeatable specification independent of donor characteristics. The CORDStrom
product platform shares many similarities, including reagents, equipment, and procedures, with the Company's INKmune oncology
product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically manufacture both
products in a rotational campaign with resource and environmental efficiencies.
Initially developed at the INKmune manufacturing
facilities utilizing UK academic grant funding, CORDStrom is an MSC product platform that shows promise as a first systemic therapy
for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom product is agnostic
to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory,
immunomodulatory, wound healing, and other characteristics.
INKmune is a pharmaceutical-grade,
replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to
convert the cancer patient's resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune treatment
converts the patient's own NK cells into mlNK cells. In patients, INKmune primed tumor killing NK cells have persisted for
more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.
INKmune is a patient
friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients.
INKmune is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune
is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast,
renal and nasopharyngeal cancer. INKmune is treating patients in an open label Phase I/II trial in metastatic castration-resistant
prostate cancer in the US this year.
About INmune Bio Inc.
INmune Bio Inc. is a
publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system
to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes
dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver
of many diseases. DN-TNF product candidates are in clinical development to determine if they can treat Alzheimer's disease and other
indications (XPro ). The Natural Killer Cell Priming Platform includes INKmune developed to prime a patient's NK cells
to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic castration-resistance prostate
cancer. The third program, CORDStrom , is a proprietary allogeneic, pooled, human umbilical cord-derived mesenchymal Stromal cell
(hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. INmune Bio's
product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer.
Forward Looking Statements
Clinical trials are in
early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related
to the development or commercialization of product candidates and other business and financial matters, including without limitation,
trial results and data, including the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations
for the treatment of XPro , and the prospects for receiving regulatory approval or commercializing or selling any product or drug
candidates may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties.
Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements
because of these risks and uncertainties. CORDstrom , XPro1595 (XPro , pegipanermin), and INKmune
have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved
by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the
FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ
materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability
to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations
through 2026 and to conduct research and development, clinical studies and future product commercialization; and, the Company's
business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors
are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the
Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports
on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may
arise after the date of this release.
Chief Executive Officer
Head of Investor Relations
The following tables summarize our results
of operations for the periods indicated:
CONDENSED CONSOLIDATED BALANCE
(In thousands, except share and per share amounts)