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:
- INmune Bio’s management team rang the NASDAQ closing bell on
Tuesday, April 9, 2019, to celebrate the Company’s successful
initial public offering (“IPO”) in February 2019.
- In May, the Company closed a private placement of approximately
$4.7M of Common Stock priced led by Insiders and existing
shareholders.
- The Company published data on INmune Bio’s INB16 (INKmune) cell
line in peer-reviewed journal PLOS ONE.
- Reported positive preliminary data from INB03 Phase I clinical
trial in cancer followed by a final report later this year as the
Company advances the program into a Phase II study.
- Edguardo (Ed) Baracchini a biotech business development veteran
joined the board of directors.
“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:
- Received preliminary positive data on INB03’s Phase I study in
patients with advanced solid tumors. The trial was successful in
determining, in order of priority, the safety of INB03 in cancer
patients, the adequate dosage of INB03, and evidence of a biologic
effect, as the Company begins planning a Phase II trial in cancer
patients using INB03 as part of their combination immunotherapy.
The target INB03 trough level was reached in three of three
patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a
biomarker of soluble TNF function, decreased by more than 50% in
half of the patients, suggesting a pharmacodynamic effect of
INB03.
- INmune anticipates it will start patient enrollment in the
Phase I study of XPro1595 for the treatment of Alzheimer’s disease
and INKmune, INmune Bio’s NK cell therapy focused on eliminating
residual disease after cancer therapy, in the second half of
2019.
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.INmune
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
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.
INmune Bio Contact: David Moss,
CFO(858) 964-3720DMoss@INmuneBio.com
Media Contact: Antenna
GroupSharon Golubchik(201) 465-8008INmuneBio@AntennaGroup.com
Investor Contact: KCSA Strategic
Communications Valter Pinto / Daniela Guerrero PH: (212)
896-1254 / (347) 487-6187INmune@KCSA.com
The following table summarizes our results of
operations for the periods indicated:
INmune Bio, Inc.BALANCE
SHEETS(Unaudited)
|
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 |
|
INmune Bio,
Inc.CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited)
|
For the Three MonthsEnded June
30, |
|
|
For the Six MonthsEnded 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 |
) |
INmune Bio,
Inc.CONSOLIDATED STATEMENTS OF CASH
FLOWS(Unaudited)
|
For the Six MonthsEnded 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 |
|
|
$ |
- |
|
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