Full Press Release Details
Reports Second Quarter 2019 Financial Results and Provides Shareholder Update
La Jolla, CA - August 12, 2019 -
INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company focused on developing treatments
that harness the patient's innate immune system to fight disease, today reported its financial results for the second quarter
ended June 30, 2019 and is providing a business update for the year-to-date.
2019 Year-to-Date Corporate Highlights:
"This year we remained focused on advancing
our pipeline," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "More recently we announced we have begun
planning a Phase II trial for INB03 after receiving positive preliminary data from its clinical Phase I study. This preliminary
data has allowed us to move forward with the development of INB03 as a combination immunotherapy for patients with cancer. We anticipate
our full data set to be reported later this year followed by a Phase II study."
Our clinical programs continue to advance:
Financial Results for the Second Quarter
Ended June 30, 2019:
Net loss attributable to common stockholders
for the second quarter ended June 30, 2019 was $0.4 million, compared to $6.2 million for the quarter ended June 30, 2018. Net
loss incurred during the quarter ended June 30, 2019 included a noncash waiver of common stock issuable of $1.5 million partially
offset by noncash stock-based compensation expense of $1.0 million.
Research and development expense totaled approximately
$0.3 million for the second quarter ended June 30, 2019, compared with approximately $0.3 million for the quarter ended June 30,
2018. During the three months ended June 30, 2019, research and development expense included $0.6 million of research and development
expense related to clinical trials, partially offset by $0.3 million of grants from the Alzheimer's Association which the
Company recognized as contra research and development expense.
General and administrative expense was approximately
$1.7 million in the quarter ended June 30, 2019, compared to approximately $5.9 million in the quarter ended June 30, 2018. The
$4.2 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the
quarter ended June 30, 2019 compared to $5.6 million for the quarter ended March 31, 2018), partially offset by higher general
and administrative expenses including investor relations and payroll expense.
At June 30, 2019, the Company had cash and
cash equivalents of approximately $9.4 million with no debt. In May, the Company closed a
private placement of approximately $4.7 million of Common Stock led by insiders and existing shareholders.
As of August 9, 2019 the Company had 10.8 million
common and 13.9 million fully diluted shares outstanding.
About INmune Bio, Inc.
Bio, Inc. is a publicly traded (NASDAQ: INMB) clinical-stage biotechnology company developing therapies targeting the innate immune
system to fight disease. INmune Bio is developing three product platforms: two products that reengineer the patient's innate
immune system's response to cancer and one product to treat neuroinflammation that is currently focused on Alzheimer's
disease. INKmune is a natural killer (NK) cell therapeutic that primes the patient's NK cells to attack minimal residual
disease, the remaining cancer cells that are difficult to detect, which often cause relapse. INB03 inhibits myeloid-derived suppressor
cells (MDSC), which often cause resistance to immunotherapy, such as anti-PD-1 checkpoint inhibitors. XPro1595 targets neuroinflammation,
which causes microglial activation and neuronal cell death. 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 in this press release relating to our drug candidates and our ability to optimize our opportunities for growth and other
statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
This release contains "forward-looking statements" Forward-looking statements reflect our current view about future
events. When used in this release, the words "anticipate," "believe," "estimate," "expect,"
"future," "intend," "plan," or the negative of these terms and similar expressions, as they
relate to us or our management, identify forward-looking statements. Forward-looking statements are based on our current expectations
and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate
to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our
actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of
historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking
statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements
include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual
property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers
and products; our ability to develop and commercialize products and services; changes in government regulation; and other factors
relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated,
believed, estimated, expected, intended or planned.
Factors or events that could cause our actual
results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future
results, levels of activity, performance or achievements. For a more detailed description
of the risk factors and uncertainties affecting the Company please refer to the Company's recent Securities and change Commission
filings, which are available at https://www.sec.gov/cgi-bin/browse-edgar?company=inmune&owner=exclude&action=getcompany.
The Company undertakes no obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise, unless otherwise required by law.
KCSA Strategic Communications
Valter Pinto / Daniela Guerrero
PH: (212) 896-1254 / (347) 487-6187
table summarizes our results of operations for the periods indicated:
| As of | ||||||||
| June 30, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,363,964 | $ | 186,204 | ||||
| Research and development tax credit receivable | 843,687 | 592,215 | ||||||
| Other tax receivable | 104,697 | 37,382 | ||||||
| Joint development cost receivable | 49,329 | 17,989 | ||||||
| Prepaid expenses | 200,024 | 15,552 | ||||||
| Prepaid expenses - related party | 244,882 | - | ||||||
| Total current assets | 10,806,583 | 849,342 | ||||||
| Operating lease - right of use asset - related party | 209,234 | - | ||||||
| Acquired in-process research and development intangible assets | 16,514,000 | 16,514,000 | ||||||
| Total assets | $ | 27,529,817 | $ | 17,363,342 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 438,217 | $ | 553,221 | ||||
| Accounts payable and accrued liabilities - related parties | 69,891 | 270,545 | ||||||
| Operating lease, current liability - related party | 7,530 | - | ||||||
| Total current liabilities | 515,638 | 823,766 | ||||||
| Long-term operating lease liability - related party | 177,051 | - | ||||||
| Total liabilities | 692,689 | 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, 10,762,473 and 8,719,441 shares issued and outstanding, respectively | 10,762 | 8,719 | ||||||
| Additional paid-in capital | 42,686,569 | 25,446,196 | ||||||
| Common stock issuable | 50,000 | 4,676,000 | ||||||
| Accumulated other comprehensive income (loss) | (19,207 | ) | 6,529 | |||||
| Accumulated deficit | (15,890,996 | ) | (13,597,868 | ) | ||||
| Total stockholders' equity | 26,837,128 | 16,539,576 | ||||||
| Total liabilities and stockholders' equity | $ | 27,529,817 | $ | 17,363,342 |
CONSOLIDATED STATEMENTS OF OPERATIONS
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 293,812 | 287,316 | 395,404 | 391,327 | ||||||||||||
| General and administrative | 1,676,611 | 5,886,547 | 3,486,106 | 8,628,920 | ||||||||||||
| Waiver of common stock issuable | (1,542,000 | ) | - | (1,542,000 | ) | - | ||||||||||
| Total operating expenses | 428,423 | 6,173,863 | 2,339,510 | 9,020,247 | ||||||||||||
| Loss from operations | (428,423 | ) | (6,173,863 | ) | (2,339,510 | ) | (9,020,247 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 36,340 | - | 46,382 | - | ||||||||||||
| Total | 36,340 | - | 46,382 | - | ||||||||||||
| Net loss | $ | (392,083 | ) | $ | (6,173,863 | ) | $ | (2,293,128 | ) | $ | (9,020,247 | ) | ||||
| Basic and diluted loss per common share | $ | (0.04 | ) | $ | (0.71 | ) | $ | (0.23 | ) | $ | (1.04 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 10,150,810 | 8,719,441 | 9,771,833 | 8,633,253 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (392,083 | ) | $ | (6,173,863 | ) | $ | (2,293,128 | ) | $ | (9,020,247 | ) | ||||
| Other comprehensive loss - loss on foreign currency translation | (25,014 | ) | (30,040 | ) | (25,736 | ) | (15,610 | ) | ||||||||
| Total comprehensive loss | $ | (417,097 | ) | $ | (6,203,903 | ) | $ | (2,318,864 | ) | $ | (9,035,857 | ) |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Six Months Ended June 30, | ||||||||
| 2019 | 2018 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (2,293,128 | ) | $ | (9,020,247 | ) | ||
| Adjustments to reconcile net loss to: | ||||||||
| Net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,949,395 | 8,066,986 | ||||||
| Waiver of common stock issuable | (1,542,000 | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (251,472 | ) | (155,816 | ) | ||||
| Other tax receivable | (67,315 | ) | 63,774 | |||||
| Joint development cost receivable | (31,340 | ) | 109,124 | |||||
| Prepaid expenses | (184,472 | ) | (208,344 | ) | ||||
| Prepaid expenses - related party | (244,882 | ) | 112,218 | |||||
| Accounts payable and accrued liabilities | (376,529 | ) | 22,534 | |||||
| Accounts payable and accrued liabilities - related parties | 60,871 | (136,917 | ) | |||||
| Operating lease liability - related party | (24,653 | ) | - | |||||
| Net cash used in operating activities | (3,005,525 | ) | (1,146,688 | ) | ||||
| 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 | (25,736 | ) | (15,610 | ) | ||||
| Net increase in cash and cash equivalents | 9,177,760 | (262,298 | ) | |||||
| Cash and cash equivalents - beginning | 186,204 | 1,370,711 | ||||||
| Cash and cash equivalents - ending | $ | 9,363,964 | $ | 1,108,413 | ||||
| Cash paid during the period for: | ||||||||
| Income Taxes | $ | - | $ | - | ||||
| Interest | $ | - | $ | - | ||||
| Noncash investing and financing activity: | ||||||||
| Issuance of warrants to placement agents | $ | 247,452 | $ | - | ||||
| Issuance of common stock issuable | $ | 3,084,000 | $ | - |