Full Press Release Details
INmune Bio Inc. Announces First Quarter
2025 Results and Provides Business Update
Conference Call Today at 4:30pm ET
BOCA RATON, Fla., May 08, 2025 (GLOBE NEWSWIRE)
Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage biotechnology company targeting inflammation and immunology
through the innate immune system, today announces its financial results for the quarter ended March 31, 2025 and provides a business update.
Corporate Highlights
DN-TNF Platform Highlights (XPro ):
Upcoming Events and Milestones:
Financial Results for the First
Quarter Ended March 31, 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: 1-800-267-6316 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 May 22nd, 2025, by dialing 1-844-512-2921 or 1-412-317-6671 (international)
and entering pin no. 11158539.
XPro is a next-generation inhibitor
of tumor necrosis factor (TNF) that is currently in clinical trial and 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.
CORDStrom is a 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 the treatment of 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 and other solid tumors.
INKmune is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this
About INmune Bio Inc.
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 trials to determine if they can treat Mild Alzheimer's disease,
Mild Cognitive Impairment and treatment-resistant depression (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 pooled, allogeneic, human umbilical cord-derived
mesenchymal Stromal/Stem 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.
To learn more, please visit www.inmunebio.com.
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 that do not describe historical
facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements
contained in this press release that do not describe historical facts 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 a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially
from those described by the forward-looking statements as a result of these risks and uncertainties. CORDstrom , XPro1595 (XPro ),
and INKmune are still in clinical trials or 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 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 in order to reflect any event or circumstance that may arise after the date of this release.
Co-founder and Chief Financial Officer
Head of Investor Relations
The following tables summarize our results
of operations for the periods indicated:
| INMUNE BIO INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 19,337 | $ | 20,922 | ||||
| Research and development tax credit receivable | 1,283 | 1,181 | ||||||
| Other tax receivable | 133 | 228 | ||||||
| Prepaid expenses and other current assets | 207 | 331 | ||||||
| TOTAL CURRENT ASSETS | 20,960 | 22,662 | ||||||
| Operating lease - right of use asset | 278 | 307 | ||||||
| Other assets | 49 | 79 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 37,801 | $ | 39,562 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 7,198 | $ | 6,539 | ||||
| Accounts payable and accrued liabilities - related parties | 103 | 25 | ||||||
| Deferred liabilities | 480 | 517 | ||||||
| Operating lease, current liabilities | 146 | 140 | ||||||
| TOTAL CURRENT LIABILITIES | 7,927 | 7,221 | ||||||
| Long-term operating lease liability | 201 | 244 | ||||||
| TOTAL LIABILITIES | 8,128 | 7,465 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 22,930,411 and 22,280,451 shares issued and outstanding, respectively | 23 | 22 | ||||||
| Additional paid-in capital | 203,103 | 195,754 | ||||||
| Accumulated other comprehensive loss | (610 | ) | (575 | ) | ||||
| Accumulated deficit | (172,843 | ) | (163,104 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 29,673 | 32,097 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 37,801 | $ | 39,562 |
| INMUNE BIO INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| REVENUE | $ | 50 | $ | 14 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 2,316 | 2,338 | ||||||
| Research and development | 7,639 | 8,693 | ||||||
| Total operating expenses | 9,955 | 11,031 | ||||||
| LOSS FROM OPERATIONS | (9,905 | ) | (11,017 | ) | ||||
| OTHER INCOME (EXPENSE), NET | 166 | (8 | ) | |||||
| NET LOSS | $ | (9,739 | ) | $ | (11,025 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.43 | ) | $ | (0.61 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 22,496,191 | 18,026,473 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (9,739 | ) | $ | (11,025 | ) | ||
| Other comprehensive income (loss) - foreign currency translation | (35 | ) | 130 | |||||
| Total comprehensive loss | $ | (9,774 | ) | $ | (10,895 | ) |
| INMUNE BIO INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (9,739 | ) | $ | (11,025 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 2,076 | 1,779 | ||||||
| Accretion of debt discount | - | 34 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (102 | ) | (228 | ) | ||||
| Other tax receivable | 95 | (20 | ) | |||||
| Prepaid expenses | 124 | 401 | ||||||
| Prepaid expenses - related party | - | 119 | ||||||
| Other assets | 30 | 25 | ||||||
| Accounts payable and accrued liabilities | 659 | 1,393 | ||||||
| Accounts payable and accrued liabilities - related parties | 78 | 21 | ||||||
| Deferred liabilities | (37 | ) | 31 | |||||
| Operating lease liabilities | (8 | ) | (6 | ) | ||||
| Net cash used in operating activities | (6,824 | ) | (7,476 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Sale of common stock for cash | 5,273 | - | ||||||
| Exercise of warrants for cash | 1 | - | ||||||
| Repayments of debt | - | (2,500 | ) | |||||
| Net provided by (used in) financing activities | 5,274 | (2,500 | ) | |||||
| Impact on cash from foreign currency translation | (35 | ) | 130 | |||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (1,585 | ) | (9,846 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 20,922 | 35,848 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 19,337 | $ | 26,002 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | - | $ | 302 |