Full Press Release Details
INmune Bio, Inc. Announces 2022 Results and Provides Business Update
Company to Host Conference Call Today, March 2, at 4:30pm ET
BOCA RATON, Fla., March 02, 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 year ended December
31, 2022 and provides a business update.
Q4 2022 and 2022 Corporate Highlights:
DN-TNF Platform Highlights (XPro and INB03 ):
Upcoming Events and Milestones:
Financial Results for the Year Ended December
Net loss attributable to common stockholders for the year ended December
31, 2022 was approximately $27.3 million, compared to approximately $ 30.3 million for the year ended December 31, 2021.
Research and development expense totaled approximately $17.1 million
for the year ended December 31, 2022 to approximately $20.5 million during the year ended December 31, 2021.
General and administrative expense was approximately $9.3 million for
the year ended December 31, 2022 compared to approximately $8.8 million during the year ended December 31, 2021.
Other expense was approximately $1.3 million for the year ended December
31, 2022 compared to approximately $1.2 million during the year ended December 31, 2021.
As of December 31, 2022, the Company had cash and cash equivalents
of approximately $52.2 million.
As of March 2, 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 Fourth Quarter Conference Call when reaching an operator.
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13735978
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 March 9 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no.
About Metastatic Castration-Resistant Prostate Cancer (mCPRC)
Prostate cancer is the second most commonly diagnosed cancer in
men and the fifth leading cause of cancer death in men globally, with an incidence of 1.4 million and 375,000 deaths in 2020. In
the United States, it is estimated that there were 268,490 new cases and 34,500 deaths in 2022. Development of prostate cancer is often
driven by male sex hormones called androgens, including testosterone. In patients with mCRPC, the prostate cancer grows and spreads to
other parts of the body, despite the use of androgen deprivation therapy (ADT) to block the action of male sex hormones. Approximately
10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at
least 84% of these patients presenting with metastases at the time of CRPC diagnosis. Of patients with no metastases at CRPC diagnosis,
33% are likely to develop metastases within two years.
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.
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 ),
Early Alzheimer's disease, 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)
| December 31, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $52,153 | $74,810 | ||||||
| Research and development tax credit receivable | 8,099 | 4,913 | ||||||
| Other tax receivable | 362 | 591 | ||||||
| Prepaid expenses and other current assets | 4,027 | 2,278 | ||||||
| Prepaid expenses - related party | 34 | 14 | ||||||
| TOTAL CURRENT ASSETS | 64,675 | 82,606 | ||||||
| Operating lease - right of use assets | 507 | 726 | ||||||
| Other assets | 99 | 99 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 81,795 | $ | 99,945 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 5,206 | $ | 3,733 | ||||
| Accounts payable and accrued liabilities - related parties | 9 | 80 | ||||||
| Deferred liabilities | 616 | 474 | ||||||
| Current portion of long-term debt | 5,000 | - | ||||||
| Operating lease, current liabilities | 87 | 72 | ||||||
| TOTAL CURRENT LIABILITIES | 10,918 | 4,359 | ||||||
| Long-term debt, less debt discount | 9,697 | 14,458 | ||||||
| Long-term operating lease liabilities | 526 | 704 | ||||||
| Accrued liability - long-term | 550 | 199 | ||||||
| TOTAL LIABILITIES | 21,691 | 19,720 | ||||||
| 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 and 17,843,303 shares issued and outstanding, respectively | 18 | 18 | ||||||
| Additional paid-in capital | 151,799 | 143,921 | ||||||
| Accumulated other comprehensive (loss) income | (699 | ) | 1 | |||||
| Accumulated deficit | (91,014 | ) | (63,715 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 60,104 | 80,225 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 81,795 | $ | 99,945 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(In thousands, except share and per share amounts)
| 2022 | 2021 | |||||||
| REVENUE | $ | 374 | $ | 181 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 9,258 | 8,791 | ||||||
| Research and development | 17,067 | 20,543 | ||||||
| Total operating expenses | 26,325 | 29,334 | ||||||
| LOSS FROM OPERATIONS | (25,951 | ) | (29,153 | ) | ||||
| OTHER EXPENSE, NET | ||||||||
| Other expense, net | (1,348 | ) | (1,187 | ) | ||||
| Total other expense, net | (1,348 | ) | (1,187 | ) | ||||
| NET LOSS | $ | (27,299 | ) | $ | (30,340 | ) | ||
| Net loss per common share - basic and diluted | $ | (1.52 | ) | $ | (1.88 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 17,927,327 | 16,130,539 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (27,299 | ) | $ | (30,340 | ) | ||
| Other comprehensive loss - foreign currency translation | (700 | ) | (10 | ) | ||||
| Total comprehensive loss | $ | (27,999 | ) | $ | (30,350 | ) |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| 2022 | 2021 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (27,299 | ) | $ | (30,340 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 7,149 | 4,796 | ||||||
| Impairment of right of use asset | 89 | - | ||||||
| Accretion of debt discount | 239 | 126 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (3,186 | ) | (3,227 | ) | ||||
| Other tax receivable | 229 | (478 | ) | |||||
| Prepaid expenses and other current assets | (1,749 | ) | (2,058 | ) | ||||
| Prepaid expenses - related party | (20 | ) | (14 | ) | ||||
| Other assets | - | (99 | ) | |||||
| Accounts payable and accrued liabilities | 1,473 | 2,215 | ||||||
| Accounts payable and accrued liabilities - related parties | (71 | ) | 46 | |||||
| Deferred liabilities | 142 | 284 | ||||||
| Accrued liability - long-term | 351 | 199 | ||||||
| Operating lease liabilities | (33 | ) | 46 | |||||
| Net cash used in operating activities | (22,686 | ) | (28,504 | ) | ||||
| CASH FROM INVESTING ACTIVITIES | ||||||||
| Cash paid to Xencor to settle warrant for acquired research and development intangible assets | - | (15,000 | ) | |||||
| Net cash used in investing activities | - | (15,000 | ) | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of debt | - | 14,951 | ||||||
| Net proceeds from sale of common stock | 699 | 80,253 | ||||||
| Net proceeds from the exercise of stock options | - | 1,135 | ||||||
| Net proceeds from the exercise of warrants | 30 | 18 | ||||||
| Net cash provided by financing activities | 729 | 96,357 | ||||||
| Impact on cash from foreign currency translation | (700 | ) | (10 | ) | ||||
| NET (DECREASE) INCREASE IN CASH | (22,657 | ) | 52,843 | |||||
| CASH AT BEGINNING OF YEAR | 74,810 | 21,967 | ||||||
| CASH AT END OF YEAR | $ | 52,153 | $ | 74,810 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | 1,372 | $ | 559 | ||||
| NONCASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Common stock issued to Xencor to settle warrant issued for acquired research and development intangible assets | $ | - | $ | 3,300 | ||||
| Warrants issued to lenders as debt inducement | $ | - | $ | 619 |