INmune Bio, Inc. (NASDAQ: INMB), an immunology
company focused on developing treatments that harness the patient’s
innate immune system to fight disease, today reported its financial
results and is providing a business update for the first quarter
ended March 31, 2019.
Corporate Highlights in 2019:
- First biotechnology company to close initial public offering in
2019 and commence trading on The Nasdaq Capital Market.
- Received the Part the Cloud Award from the Alzheimer’s
Association, including a $1 million grant to advance XPro1595, a
novel therapy targeting neuroinflammation as a cause of Alzheimer’s
disease.
“2019 has marked a transformative period for INmune Bio, as the
first biotech of the year to close its IPO and list on the Nasdaq,”
stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We
are focused on advancing our clinical programs for the foreseeable
future.”
Our clinical programs continue to advance:
- INB03, our program targeting resistance to immunotherapy caused
by myeloid derived suppressor ells (MDSC), completing a monotherapy
Phase I trial in patients with advanced solid tumors, will
transition into a combination therapy clinical program this summer
in preparation for a Phase II trial in patients resistant to
checkpoint inhibitors due to increased MDSC that should begin in
2020. INB03 targets MDSC - one of the causes of resistance to
checkpoint inhibitors. Treatment with INB03 should eliminate
the MDSC in the tumor microenvironment to allow CPI to be
therapeutically effective.
- INKmune, our NK cell therapy focused on eliminating residual
disease after cancer therapy will start enrolling patients in a
Phase I/II trial in women with relapsed refractory ovarian cancer
later this year. In many patients, cancer relapse after
seemingly effective cancer therapy is due to a failure of their NK
cells to eliminate minimal residual disease (MRD). INKmune,
by priming the patient’s NK cells to attack their tumor, should
eliminate MRD to prevent relapse.
- The Phase I clinical trial in patients with Alzheimer’s disease
(AD) should enroll its first patient this summer. The open
label dose escalation trial in patients with mild to moderate AD
has a novel biomarker strategy to determine if XPro1595 will
eliminate neuroinflammation in patients after 3 months of
therapy. XPro1595 targets microglial cells, the immune cells
of the brain, that are activated in many patients with AD and is a
cause of neuroinflammation that can kill nerve cells and promote
synaptic dysfunction – the cause of dementia in AD. If
successful, the company will consider initiating a Phase II trial
in AD patients who have neuroinflammation as a cause of their
dementia.
Financial Results for the First Quarter Ended March 31,
2019:Net loss attributable to common stockholders for the
first quarter ended March 31, 2019 was $1.9 million, compared to
$2.8 million for the quarter ended March 31, 2018. Net loss
incurred during the quarter ended March 31, 2019 included noncash
stock-based compensation expense of $1.0 million.
Research and development expense totaled approximately $0.1
million for the first quarter ended March 31, 2019, compared with
approximately $0.1 million for the quarter ended March 31, 2018.
During the three months ended March 31, 2019, research and
development expense included $0.4 million of research and
development expense incurred for our clinical trials, partially
offset by a grant received from the Alzheimer’s Association of
which $0.3 million was recorded as contra-research and development
expense.
General and administrative expense was approximately $1.8
million in the quarter ended March 31, 2019, compared to
approximately $2.7 million in the quarter ended March 31,
2018. The $0.9 million decline in general and administrative
expense is due to lower noncash stock-based compensation ($1.0
million for the quarter ended March 31, 2019 compared to $2.5
million for the quarter ended March 31, 2018), partially offset by
higher general and administrative expenses including professional
fees and payroll expense.
At March 31, 2019, the Company had cash and cash equivalents of
approximately $6.0 million with no debt. Subsequently, the Company
received proceeds of $4.7 million at a purchase price of $9.00 per
share led by RJ Tesi, CEO, David Moss, CFO, and existing
shareholders.
As of May 10, 2019 the Company had 10.3 million common and 13.3
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 / Scott Eckstein PH: (212)
896-1254 / (212) 896-1210INmune@KCSA.com
The following table summarizes our results of operations for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2019 |
|
2018 |
|
Change |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
101,592 |
|
|
|
$ |
104,011 |
|
|
$ |
( 2,419 |
) |
|
General and administrative |
|
1,809,495 |
|
|
|
|
2,742,373 |
|
|
|
(932,878 |
) |
|
Total operating expenses |
|
1,911,087 |
|
|
|
|
2,846,384 |
|
|
|
(935,297 |
) |
|
Loss from operations |
|
(1,911,087 |
) |
|
|
|
(2,846,384 |
) |
|
|
(935,297 |
) |
|
Other income |
|
10,042 |
|
|
|
|
- |
|
|
|
10,042 |
|
|
Net loss |
$ |
(1,901,045 |
) |
|
|
$ |
(2,846,384 |
) |
|
$ |
(945,339 |
) |
|
The following table summarizes our cash flows for the periods
indicated:
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
|
|
|
|
Net cash and cash equivalents
(used in) provided by: |
|
|
|
Operating activities |
$ |
(1,387,702 |
) |
|
$ |
(328,841 |
) |
Financing activities |
|
7,251,142 |
|
|
|
900,000 |
|
Change in cash and cash
equivalents |
|
5,863,440 |
|
|
|
571,159 |
|
Impact on cash from foreign
currency translation |
|
(722 |
) |
|
|
14,430 |
|
Cash and cash equivalents,
beginning of period |
|
186,204 |
|
|
|
1,370,711 |
|
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