Full Press Release Details
Bio Inc. Announces Second Quarter 2023 Results and Provides Business Update
Company to Host Conference Call Today, August 7, at 4:30pm ET
BOCA RATON, Fla., Aug. 07, 2023 (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, 2023 and provides a business update.
Q2 2023 Corporate Highlights:
DN-TNF Platform Highlights (XPro and INB03 ):
Upcoming Events and Milestones:
Financial Results for the Quarter Ended June 30, 2023:
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 an operator.
Date: August 7, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-404-0784 Participant
Dial-in (international): 1-201-689-8560 Conference ID: 13739436
A live audio webcast of the call can be accessed using this link or
A transcript will follow approximately 24 hours from the scheduled
call. A replay will also be available through August 14 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no.
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 persist for more than 100 days and function in the hypoxic
TME because due to upregulated nutrient and mitochondrial survival proteins. INKmune is a patient friendly that does not require
pre-medication, conditioning or additional cytokine therapy 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 trial in high-MDS/AML in the UK and Europe. The company plans 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 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.
David Moss, CFO (858) 964-3720
(516) 842-9614 x-823
The following tables summarize our results of operations for the
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
| June 30, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 47,825 | $ | 52,153 | ||||
| Research and development tax credit receivable | 1,934 | 8,099 | ||||||
| Other tax receivable | 112 | 362 | ||||||
| Prepaid expenses and other current assets | 2,707 | 4,027 | ||||||
| Prepaid expenses - related party | 30 | 34 | ||||||
| TOTAL CURRENT ASSETS | 52,608 | 64,675 | ||||||
| Operating lease - right of use asset | 468 | 507 | ||||||
| Other assets | 130 | 99 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 69,720 | $ | 81,795 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 2,385 | $ | 5,206 | ||||
| Accounts payable and accrued liabilities - related parties | 9 | 9 | ||||||
| Deferred liabilities | 560 | 616 | ||||||
| Current portion of long-term debt | 10,000 | 5,000 | ||||||
| Operating lease, current liabilities | 101 | 87 | ||||||
| TOTAL CURRENT LIABILITIES | 13,055 | 10,918 | ||||||
| Long-term debt, net | 4,822 | 9,697 | ||||||
| Long-term operating lease liabilities | 463 | 526 | ||||||
| Accrued liability - long-term | 726 | 550 | ||||||
| TOTAL LIABILITIES | 19,066 | 21,691 | ||||||
| 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, 17,945,995 shares issued and outstanding | 18 | 18 | ||||||
| Additional paid-in capital | 155,399 | 151,799 | ||||||
| Accumulated other comprehensive loss | (712 | ) | (699 | ) | ||||
| Accumulated deficit | (104,051 | ) | (91,014 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 50,654 | 60,104 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 69,720 | $ | 81,795 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(In thousands, except share and per share amounts)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| REVENUE | $ | 46 | $ | 16 | $ | 84 | $ | 179 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| General and administrative | 2,309 | 2,215 | 4,637 | 4,547 | ||||||||||||
| Research and development | 4,148 | 4,189 | 8,281 | 8,498 | ||||||||||||
| Total operating expenses | 6,457 | 6,404 | 12,918 | 13,045 | ||||||||||||
| LOSS FROM OPERATIONS | (6,411 | ) | (6,388 | ) | (12,834 | ) | (12,866 | ) | ||||||||
| OTHER EXPENSE, NET | (90 | ) | (450 | ) | (203 | ) | (875 | ) | ||||||||
| NET LOSS | $ | (6,501 | ) | $ | (6,838 | ) | $ | (13,037 | ) | $ | (13,741 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.36 | ) | $ | (0.38 | ) | $ | (0.73 | ) | $ | (0.77 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 17,945,995 | 17,945,995 | 17,945,995 | 17,908,349 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (6,501 | ) | $ | (6,838 | ) | $ | (13,037 | ) | $ | (13,741 | ) | ||||
| Other comprehensive loss - foreign currency translation | (4 | ) | (757 | ) | (13 | ) | (702 | ) | ||||||||
| Total comprehensive loss | $ | (6,505 | ) | $ | (7,595 | ) | $ | (13,050 | ) | $ | (14,443 | ) |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (13,037 | ) | $ | (13,741 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 3,600 | 3,422 | ||||||
| Accretion of debt discount | 125 | 113 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 6,165 | (13 | ) | |||||
| Other tax receivable | 250 | 457 | ||||||
| Prepaid expenses | 1,320 | (1,944 | ) | |||||
| Prepaid expenses - related party | 4 | (37 | ) | |||||
| Other assets | (31 | ) | - | |||||
| Accounts payable and accrued liabilities | (2,821 | ) | (2,046 | ) | ||||
| Accounts payable and accrued liabilities - related parties | - | (71 | ) | |||||
| Deferred liabilities | (56 | ) | 2 | |||||
| Accrued liability - long-term | 176 | 176 | ||||||
| Operating lease liabilities | (10 | ) | 58 | |||||
| Net cash used in operating activities | (4,315 | ) | (13,624 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock | - | 699 | ||||||
| Net proceeds from the exercise of warrants | - | 30 | ||||||
| Net cash provided by financing activities | - | 729 | ||||||
| Impact on cash from foreign currency translation | (13 | ) | (702 | ) | ||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (4,328 | ) | (13,597 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 52,153 | 74,810 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 47,825 | $ | 61,213 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | 930 | $ | 601 |