Full Press Release Details
INmune Bio, Inc. Reports Fourth Quarter and Full Year 2019
Results - Drug Pipeline Expands to Now Include Cancer, Alzheimer's Disease and NASH
Company will host an investor conference call today at
LA JOLLA, Calif., March 11, 2020 (GLOBE NEWSWIRE) -- INmune
Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments
that harness the patient's innate immune system to fight disease, today reported its financial results for the fourth quarter
and full year ended December 31, 2019 and is providing a business update.
The Company will hold a conference call today at 11AM Eastern
(U.S.) time. To participate in the live conference call, please dial 1-877-407-2988 five minutes prior to the scheduled conference
call time and ask for the, "INmune Bio Conference Call." International callers should dial 1-201-389-0923. Participants
can also use this link for instant telephone access to the event.
2019 and Recent Corporate Highlights on the DN-TNF Platform
and NK Priming Platform:
DN-TNF Platform Highlights:
NK Priming Platform Highlights:
Professor Lowdell, CSO INmune Bio and Professor of Cell
Therapy at UCL, London, and creator of the INKmune product said, "2019 has been a landmark year for this product and
is the culmination of 20 years' of bench-to-bedside research. We have published the molecular basis of the mechanism of action
in a peer-reviewed journal, developed scaled manufacture adequate for full commercial delivery and validated an efficient and easily
delivered cold supply chain for the drug. I am extremely excited about our delivery of patients into two phase I trials this year
in high risk MDS cancer and ovarian cancer, two very different clinical applications."
"2019 and year to date, has been a period of substantial
progress," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We completed our first-in-man study of our
DN-TNF platform in cancer and have expanded that franchise to include Alzheimer's Disease and NASH. Additionally, we just
announced pre-clinical proof-of-concept studies in ALS. Both our NK cell priming platform and DN-TNF platform continue
to generate data in the laboratory and the clinic to allow us to expand the depth and breadth of our pipeline."
Upcoming Milestones:
Financial Results for the Fourth Quarter Ended December
Net loss attributable to common stockholders for the fourth
quarter ended December 31, 2019 was $2.3 million, compared to $1.9 million for the quarter ended December 31, 2018.
Research and development expense totaled approximately
$0.9 million for the fourth quarter ended December 31, 2019, compared with approximately $1.0 million for the quarter ended December
31, 2018. The decrease in research and development expense was due to the Company recording $0.3 million of contra research and
development expense as a result of the receipt of a grant from the Alzheimer's Association. Excluding the grant, research
and development expense increased during the three months ended December 31, 2019 as a result of the further advancement of our
General and administrative expense was approximately $1.5
million in the quarter ended December 31, 2019, compared to approximately $0.9 million in the quarter ended December 31, 2018.
The $0.6 million increase in general and administrative expense is largely due to the costs associated with being a public company
and due to higher compensation cost (including higher stock-based compensation).
At December 31, 2019, the Company had cash and cash equivalents
of approximately $7.0 million with no debt. During the quarter ending December 31, 2019, the Company received $0.4 million
of cash proceeds from Australia and $0.4 million of cash proceeds from the United Kingdom pursuant to research and development
As of March 10, 2020, the Company had 10.7 million common
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. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize
soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed
for cancer (INB03 ), Alzheimer's (XPro595), and NASH (LIVNate ). The Innate Immune Priming Platform includes
INKmune aimed at priming the 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
malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.
Information about Forward-Looking Statements
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 and XPro1595 are still in
clinical trials and have not been approved and there cannot be any assurance that they will be approved 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
David Moss, CFO (858) 964-3720
James Carbonara (646) 755-7412
CONSOLIDATED BALANCE SHEETS
| December 31, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 6,995,525 | $ | 186,204 | ||||
| Research and development tax credit receivable | 568,139 | 592,215 | ||||||
| Other tax receivable | 77,225 | 37,382 | ||||||
| Joint development cost receivable | - | 17,989 | ||||||
| Prepaid expenses | 97,623 | 15,552 | ||||||
| Prepaid expenses - related party | 26,266 | - | ||||||
| TOTAL CURRENT ASSETS | 7,764,778 | 849,342 | ||||||
| Operating lease - right of use asset - related party | 191,543 | - | ||||||
| Acquired in-process research and development intangible assets | 16,514,000 | 16,514,000 | ||||||
| TOTAL ASSETS | $ | 24,470,321 | $ | 17,363,342 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 401,989 | $ | 553,221 | ||||
| Accounts payable and accrued liabilities - related parties | 290,102 | 270,545 | ||||||
| Operating lease, current liability - related party | 8,288 | - | ||||||
| TOTAL CURRENT LIABILITIES | 700,379 | 823,766 | ||||||
| Long-term operating lease liability - related party | 160,164 | - | ||||||
| TOTAL LIABILITIES | 860,543 | 823,766 | ||||||
| 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, 10,770,948 and 8,719,441 shares issued and outstanding, respectively | 10,771 | 8,719 | ||||||
| Additional paid-in capital | 44,833,703 | 25,446,196 | ||||||
| Common stock issuable | 50,000 | 4,676,000 | ||||||
| Accumulated other comprehensive income (loss) | (8,515 | ) | 6,529 | |||||
| Accumulated deficit | (21,276,181 | ) | (13,597,868 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 23,609,778 | 16,539,576 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 24,470,321 | $ | 17,363,342 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
FOR THE YEARS ENDED DECEMBER 31, 2019 AND 2018
| 2019 | 2018 | |||||||
| REVENUE | $ | - | $ | - | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 6,016,056 | 9,085,100 | ||||||
| Research and development | 3,281,945 | 3,354,923 | ||||||
| Gain on waiver of common stock issuable | (1,542,000 | ) | - | |||||
| Total operating expenses | 7,756,001 | 12,440,023 | ||||||
| LOSS FROM OPERATIONS | (7,756,001 | ) | (12,440,023 | ) | ||||
| OTHER INCOME | ||||||||
| Interest income | 77,688 | - | ||||||
| Total other income | 77,688 | - | ||||||
| NET LOSS | $ | (7,678,313 | ) | $ | (12,440,023 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.75 | ) | $ | (1.43 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 10,272,641 | 8,676,701 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2019 AND 2018
| 2019 | 2018 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (7,678,313 | ) | $ | (12,440,023 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 4,096,538 | 10,001,359 | ||||||
| Gain on waiver of common stock issuable | (1,542,000 | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 24,076 | (485,349 | ) | |||||
| Other tax receivable | (39,843 | ) | 74,236 | |||||
| Joint development cost receivable | 17,989 | 91,135 | ||||||
| Prepaid expenses | (82,071 | ) | 27,095 | |||||
| Prepaid expenses - related party | (26,266 | ) | 158,504 | |||||
| Accounts payable and accrued liabilities | (151,232 | ) | 426,964 | |||||
| Accounts payable and accrued liabilities - related parties | 19,557 | 87,085 | ||||||
| Operating lease liability - related party | (23,091 | ) | - | |||||
| Net cash used in operating activities | (5,384,656 | ) | (2,058,994 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock | 12,209,021 | 900,000 | ||||||
| Net cash provided by financing activities | 12,209,021 | 900,000 | ||||||
| Impact on cash from foreign currency translation | (15,044 | ) | (25,513 | ) | ||||
| NET INCREASE (DECREASE) IN CASH | 6,809,321 | (1,184,507 | ) | |||||
| CASH AT BEGINNING OF YEAR | 186,204 | 1,370,711 | ||||||
| CASH AT END OF YEAR | $ | 6,995,525 | $ | 186,204 |