Full Press Release Details
Bio Inc. Announces Third Quarter 2024 Results and Provides Business Update
BOCA RATON, Fla., Oct. 31, 2024 (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 quarter ended September 30, 2024 and provides a business update.
Corporate Highlights
DN-TNF Platform Highlights (XPro ):
Upcoming Events and Milestones:
Financial Results for the Third
Quarter Ended September 30, 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 Second Quarter Conference Call when reaching an operator.
Date: October 31, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): 1-203-518-9843
Conference ID: INMUNE
A live audio webcast of the call can be accessed
by clicking here or using this link: INmune Bio, Inc. Third Quarter 2024 Earnings Call - 1692115
A transcript will follow approximately 24
hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international)
and entering PIN no. 11156467.
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.
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.
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 two product platforms that are both in clinical trials: 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 cancer (INB03 ),
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. INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic
and solid tumor malignancies, and chronic inflammation. 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.
Co-founder and Chief Financial Officer
Head of Investor Relations
Managing Director - LifeSci Advisors
The following tables summarize our results
of operations for the periods indicated:
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
| September 30, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 33,552 | $ | 35,848 | ||||
| Research and development tax credit receivable | 1,109 | 1,905 | ||||||
| Other tax receivable | 311 | 537 | ||||||
| Prepaid expenses and other current assets | 864 | 1,510 | ||||||
| Prepaid expenses - related party | 15 | 142 | ||||||
| TOTAL CURRENT ASSETS | 35,851 | 39,942 | ||||||
| Operating lease - right of use asset | 335 | 414 | ||||||
| Other assets | 82 | 131 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 52,782 | $ | 57,001 | ||||
| LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 10,590 | $ | 7,901 | ||||
| Accounts payable and accrued liabilities - related parties | 55 | 35 | ||||||
| Deferred liabilities | 549 | 489 | ||||||
| Current portion of long-term debt | 2,494 | 9,921 | ||||||
| Operating lease, current liability | 135 | 119 | ||||||
| TOTAL CURRENT LIABILITIES | 13,823 | 18,465 | ||||||
| Long-term operating lease liability | 284 | 397 | ||||||
| TOTAL LIABILITIES | 14,107 | 18,862 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| Redeemable common stock, $0.001 par value; no shares and 75,697 shares issued and outstanding at September 30, 2024 and December 31, 2023, 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, and 22,172,451 and 17,950,776 shares issued and outstanding, respectively | 22 | 18 | ||||||
| Additional paid-in capital | 193,575 | 159,143 | ||||||
| Accumulated other comprehensive loss | (1,036 | ) | (799 | ) | ||||
| Accumulated deficit | (153,886 | ) | (121,022 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 38,675 | 37,340 | ||||||
| TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' EQUITY | $ | 52,782 | $ | 57,001 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| REVENUE | $ | - | $ | 43 | $ | 14 | $ | 127 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| General and administrative | 2,219 | 2,586 | 7,369 | 7,223 | ||||||||||||
| Research and development | 10,067 | 5,985 | 25,813 | 14,266 | ||||||||||||
| Total operating expenses | 12,286 | 8,571 | 33,182 | 21,489 | ||||||||||||
| LOSS FROM OPERATIONS | (12,286 | ) | (8,528 | ) | (33,168 | ) | (21,362 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET | 193 | (35 | ) | 304 | (238 | ) | ||||||||||
| NET LOSS | $ | (12,093 | ) | $ | (8,563 | ) | $ | (32,864 | ) | $ | (21,600 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.60 | ) | $ | (0.48 | ) | $ | (1.71 | ) | $ | (1.20 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 20,185,676 | 18,008,295 | 19,176,853 | 17,966,990 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (12,093 | ) | $ | (8,563 | ) | $ | (32,864 | ) | $ | (21,600 | ) | ||||
| Other comprehensive loss - foreign currency translation | (323 | ) | (23 | ) | (237 | ) | (36 | ) | ||||||||
| Total comprehensive loss | $ | (12,416 | ) | $ | (8,586 | ) | $ | (33,101 | ) | $ | (21,636 | ) |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (32,864 | ) | $ | (21,600 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 5,848 | 5,489 | ||||||
| Accretion of debt discount | 73 | 179 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 796 | 6,012 | ||||||
| Other tax receivable | 226 | 186 | ||||||
| Prepaid expenses | 646 | 2,492 | ||||||
| Prepaid expenses - related party | 127 | 34 | ||||||
| Other assets | 49 | (30 | ) | |||||
| Accounts payable and accrued liabilities | 2,689 | (1,531 | ) | |||||
| Accounts payable and accrued liabilities - related parties | 20 | 70 | ||||||
| Deferred liabilities | 60 | (120 | ) | |||||
| Accrued liability - long-term | - | 254 | ||||||
| Operating lease liabilities | (18 | ) | (14 | ) | ||||
| Net cash used in operating activities | (22,348 | ) | (8,579 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock and warrants | 27,789 | 775 | ||||||
| Repayments of debt | (7,500 | ) | (2,500 | ) | ||||
| Net cash provided by financing activities | 20,289 | (1,725 | ) | |||||
| Impact on cash from foreign currency translation | (237 | ) | (36 | ) | ||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (2,296 | ) | (10,340 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 35,848 | 52,153 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 33,552 | $ | 41,813 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | 661 | $ | 1,394 |