Full Press Release Details
INmune Bio Inc. Announces Year End 2024
Results and Provides a Business Update
Company to Host Conference Call Today, March
Fla., March 27, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation
and immunology company focused on developing treatments that harness the patient's innate immune system to fight disease, today
announces its financial results for the year ended December 31, 2024 and provides a business update.
Full Year 2024 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro1595,
Upcoming Events and Milestones:
Financial Results for the Year
Ended December 31, 2024:
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 2024 Year End Conference Call when reaching an operator.
Date: March 27, 2025
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448 or 1-203-518-9708 (international): 1-203-518-9808
Conference ID: INMUNE
A live audio webcast of the call
can be accessed by clicking here or
A transcript will follow approximately 24
hours from the scheduled call. A telephone replay will also be available for approximately 30 days by dialing 1-844-512-2921 or 1-412-317-6671
(international) and entering PIN no. 11157984.
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
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 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. INB03 , 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.
Chief Financial Officer
Head of Investor Relations
The following tables summarize our results of operations for the periods indicated:
| INMUNE BIO INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 20,922 | $ | 35,848 | ||||
| Research and development tax credit receivable | 1,181 | 1,905 | ||||||
| Other tax receivable | 228 | 537 | ||||||
| Prepaid expenses and other current assets | 331 | 1,510 | ||||||
| Prepaid expenses - related party | - | 142 | ||||||
| TOTAL CURRENT ASSETS | 22,662 | 39,942 | ||||||
| Operating lease - right of use asset | 307 | 414 | ||||||
| Other assets | 79 | 131 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 39,562 | $ | 57,001 | ||||
| LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 6,539 | $ | 7,901 | ||||
| Accounts payable and accrued liabilities - related parties | 25 | 35 | ||||||
| Deferred liabilities | 517 | 489 | ||||||
| Current portion of long-term debt, net | - | 9,921 | ||||||
| Operating lease, current liability | 140 | 119 | ||||||
| TOTAL CURRENT LIABILITIES | 7,221 | 18,465 | ||||||
| Long-term operating lease liability | 244 | 397 | ||||||
| TOTAL LIABILITIES | 7,465 | 18,862 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| Redeemable common stock, $0.001 par value; 0 and 75,697 shares issued and outstanding, respectively (Note 9) | - | 799 | ||||||
| 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, 22,280,451 and 17,950,776 shares issued and outstanding, respectively | 22 | 18 | ||||||
| Additional paid-in capital | 195,754 | 159,143 | ||||||
| Accumulated other comprehensive loss | (575 | ) | (799 | ) | ||||
| Accumulated deficit | (163,104 | ) | (121,022 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 32,097 | 37,340 | ||||||
| TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' EQUITY | $ | 39,562 | $ | 57,001 |
| INMUNE BIO INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023 (In thousands, except share and per share amounts) | ||||||||
| 2024 | 2023 | |||||||
| REVENUE | $ | 14 | $ | 155 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 9,483 | 9,623 | ||||||
| Research and development | 33,166 | 20,273 | ||||||
| Total operating expenses | 42,649 | 29,896 | ||||||
| LOSS FROM OPERATIONS | (42,635 | ) | (29,741 | ) | ||||
| OTHER INCOME (EXPENSE), NET | ||||||||
| Other income (expense), net | 553 | (267 | ) | |||||
| Total other income (expense), net | 553 | (267 | ) | |||||
| NET LOSS | $ | (42,082 | ) | $ | (30,008 | ) | ||
| Net loss per common share - basic and diluted | $ | (2.11 | ) | $ | (1.67 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 19,944,304 | 17,980,791 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (42,082 | ) | $ | (30,008 | ) | ||
| Other comprehensive income (loss) - foreign currency translation | 224 | (100 | ) | |||||
| Total comprehensive loss | $ | (41,858 | ) | $ | (30,108 | ) |
| INMUNE BIO INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023 (In thousands) | ||||||||
| 2024 | 2023 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (42,082 | ) | $ | (30,008 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 7,605 | 7,368 | ||||||
| Accretion of debt discount | 79 | 224 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 724 | 6,194 | ||||||
| Other tax receivable | 309 | (175 | ) | |||||
| Prepaid expenses and other current assets | 1,179 | 2,517 | ||||||
| Prepaid expenses - related party | 142 | (108 | ) | |||||
| Other assets | 52 | (32 | ) | |||||
| Accounts payable and accrued liabilities | (1,362 | ) | 2,695 | |||||
| Accounts payable and accrued liabilities - related parties | (10 | ) | 26 | |||||
| Deferred liabilities | 28 | (127 | ) | |||||
| Accrued liability - long-term | - | (550 | ) | |||||
| Operating lease liability | (25 | ) | (4 | ) | ||||
| Net cash used in operating activities | (33,361 | ) | (11,980 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock and warrants | 27,789 | 775 | ||||||
| Repayment of debt | (10,000 | ) | (5,000 | ) | ||||
| Net proceeds from the exercise of stock options | 422 | - | ||||||
| Net cash provided by (used in) financing activities | 18,211 | (4,225 | ) | |||||
| Impact on cash from foreign currency translation | 224 | (100 | ) | |||||
| NET DECREASE IN CASH | (14,926 | ) | (16,305 | ) | ||||
| CASH AT BEGINNING OF YEAR | 35,848 | 52,153 | ||||||
| CASH AT END OF YEAR | $ | 20,922 | $ | 35,848 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | 1,690 | $ | 1,778 |