Full Press Release Details
INmune Bio Inc. Announces First Quarter
2023 Results and Provides Business Update
Company to Host Conference Call Today, May 3, at 4:30pm ET
BOCA RATON, Fla., May 03, 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 March 31, 2023
and provides a business update.
Q1 2023 Corporate Highlights:
DN-TNF Platform Highlights (XPro and INB03 ):
Upcoming Events and Milestones:
Financial Results for the Quarter Ended March
Net loss attributable to common stockholders for the quarter ended
March 31, 2023 was approximately $6.5 million, compared to approximately $6.9 million during the quarter ended March 31, 2022.
Research and development expense totaled approximately $4.1 million
for the quarter ended March 31, 2023 compared to approximately $4.3 million during the quarter ended March 31, 2022.
General and administrative expenses were approximately $2.3 million
for the quarter ended March 31, 2023 compared to approximately $2.3 million during the quarter ended March 31, 2022.
Other expense was approximately $0.1 million for the quarter ended
March 31, 2023 compared to approximately $0.4 million during the quarter ended March 31, 2022.
In addition, the Company received research and development rebates
from Australia and the United Kingdom during the three months ended March 31, 2023 that totaled approximately $6.5 million.
As of March 31, 2023, the Company had cash and cash equivalents of
approximately $51.0 million.
As of May 3, 2023, the Company had approximately 17.9 million common
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.
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-844-826-3035 Participant Dial-in (international): 1-412-317-5195
Conference ID: 10177985
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 May 10 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. INKmune treatment's effect on NK cells is akin to treatment
with at least three cytokines in combination (IL-12, IL-15, IL-18) to form memory-like NK cells. In patients, INKmune primed
tumor killing NK cells persist for more than 100 days and function in the in the hypoxic TME because due to upregulated nutrient and mitochondrial
survival proteins. INKmune is a patient friendly therapy that can be easily transported, stored and delivered to the patient
by a simple intravenous infusion without the need for patient conditioning or premedication. 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
following tables summarize our results of operations for the periods indicated:
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
| March 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 51,003 | $ | 52,153 | ||||
| Research and development tax credit receivable | 1,814 | 8,099 | ||||||
| Other tax receivable | 396 | 362 | ||||||
| Prepaid expenses and other current assets | 3,633 | 4,027 | ||||||
| Prepaid expenses - related party | 35 | 34 | ||||||
| TOTAL CURRENT ASSETS | 56,881 | 64,675 | ||||||
| Operating lease - right of use asset | 485 | 507 | ||||||
| Other assets | 99 | 99 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 73,979 | $ | 81,795 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 2,077 | $ | 5,206 | ||||
| Accounts payable and accrued liabilities - related parties | 9 | 9 | ||||||
| Deferred liabilities | 591 | 616 | ||||||
| Current portion of long-term debt | 7,500 | 5,000 | ||||||
| Operating lease, current liabilities | 106 | 87 | ||||||
| TOTAL CURRENT LIABILITIES | 10,283 | 10,918 | ||||||
| Long-term debt, net | 7,264 | 9,697 | ||||||
| Long-term operating lease liabilities | 498 | 526 | ||||||
| Accrued liability - long-term | 638 | 550 | ||||||
| TOTAL LIABILITIES | 18,683 | 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 | 153,536 | 151,799 | ||||||
| Accumulated other comprehensive loss | (708 | ) | (699 | ) | ||||
| Accumulated deficit | (97,550 | ) | (91,014 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 55,296 | 60,104 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 73,979 | $ | 81,795 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(In thousands, except share and per share amounts)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| REVENUE | $ | 38 | $ | 163 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 2,328 | 2,332 | ||||||
| Research and development | 4,133 | 4,309 | ||||||
| Total operating expenses | 6,461 | 6,641 | ||||||
| LOSS FROM OPERATIONS | (6,423 | ) | (6,478 | ) | ||||
| OTHER EXPENSE | ||||||||
| Other expense, net | (113 | ) | (425 | ) | ||||
| Total other expense, net | (113 | ) | (425 | ) | ||||
| NET LOSS | $ | (6,536 | ) | $ | (6,903 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.36 | ) | $ | (0.39 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 17,945,995 | 17,870,285 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (6,536 | ) | $ | (6,903 | ) | ||
| Other comprehensive (loss) income - foreign currency translation | (9 | ) | 55 | |||||
| Total comprehensive loss | $ | (6,545 | ) | $ | (6,848 | ) |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (6,536 | ) | $ | (6,903 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,737 | 1,536 | ||||||
| Accretion of debt discount | 67 | 56 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 6,285 | (236 | ) | |||||
| Other tax receivable | (34 | ) | 92 | |||||
| Prepaid expenses | 394 | (2,390 | ) | |||||
| Prepaid expenses - related party | (1 | ) | - | |||||
| Accounts payable and accrued liabilities | (3,129 | ) | (1,182 | ) | ||||
| Accounts payable and accrued liabilities - related parties | - | (71 | ) | |||||
| Deferred liabilities | (25 | ) | 110 | |||||
| Accrued liability - long-term | 88 | 88 | ||||||
| Operating lease liabilities | 13 | 35 | ||||||
| Net cash used in operating activities | (1,141 | ) | (8,865 | ) | ||||
| 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 | (9 | ) | 55 | |||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (1,150 | ) | (8,081 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 52,153 | 74,810 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 51,003 | $ | 66,729 |