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 quarter ended March 31, 2023 and provides a business update.
Q1 2023 Corporate Highlights:
DN-TNF Platform Highlights (XPro™ and
INB03™):
- AD02
blinded randomized Phase 2 clinical trial in patients with early
Alzheimer’s Disease (AD) continues to enroll in Australia and
Canada. The company is actively pursuing other regulatory venues to
expand the clinical trial footprint. The company announced
consolidation of the mild ADi and Mild Cognitive Impairment Phase 2
programs into a single trial to improve the efficiency and align
the program with the most probable Phase 3 design. Discussions with
the FDA have provided a clear pathway to lifting the clinical hold
before the end of year.
-
Announced data in acute mdx model of Duchene’s Muscular Dystrophy
(DMD) and formed DN02, Inc. a wholly owned subsidiary to facilitate
partnering and development of DN-TNF in the treatment of DMD.
Results from the long-term D2.mdx model are expected soon. Data
presented to date suggests DN-TNF may improve treatment from boys
with DMD by promoting muscle fiber regeneration and eliminating the
need for corticosteroids. Corticosteroids, the current
standard-of-care, is responsible for many of the metabolic and
physical complications suffered by boys with DMD.
-
Presented additional data on combination of INB03™ DN-TNF with
trastuzumab-deruxtecan (Enhertu™, TDxd) at the American Association
for Cancer Research (AACR) annual scientific meeting in April
showing that triple negative breast cancer (TNBC) often express
MUC4. MUC4 expressing cancers, breast cancer, HER2+ breast cancer,
TNBC, gastric and pancreatic cancer, are candidates for combination
therapy with DN-TNF. In pre-clinical models, INB03™ DN-TNF reduced
MUC4 expression to decrease resistance to immunotherapy including
tyrosine kinase inhibitors (TKIs), trastuzumab and TDxd. The
Company is developing a novel DN-TNF-bioconjugate compound with
distinct intellectual property protections and testing in a variety
of animal models in preparation of launching a strategic partnering
program in oncology.
-
Announced pre-clinical, mouse model data that support the use of
XPro™ as an early treatment following Traumatic Brain Injury (TBI)
to prevent the development of amyloid pathology. Data shows
neuroinflammation drives the development of amyloid pathology after
TBI and can be prevented by neutralizing sTNF with XPro™. These
data implicated TBI as a contributing factor for the development of
AD.
INKmune™ Platform:
- IND
filed in April for the use of INKmune™ to treat patients with
metastatic castration-resistant prostate cancer (mCRPC) in the US.
Excluding skin cancer, prostate cancer is the most common
cancer in men. The Phase I/II design will enroll patients at
several medical centers in the US.
-
Additional sites have opened to support the ongoing Phase 1 trial
in high risk MDS/AML. A second site in the UK, The Royal
Hallamshire Hospital at Sheffield University Medical School treated
their first patient on March 9th. A third site in Europe, Attikon
University Hospital in Athens, Greece, has opened for recruitment
and INKmune™ is being imported into Greece in readiness for patient
enrollment.
- Our CSO
Mark Lowdell co-hosted a session at the Innate Killer Summit in La
Jolla in March focused on the expanding world of memory-like NK
cells in cancer immunotherapy and the ability of INKmune™ to
generate these cells in vivo.
- On June
1st, Dr Lowdell will present the opening plenary presentation in
the Presidential Session at the annual International Society of
Cell & Gene Therapy (ISCT) where he will share the latest data
on INKmune.
Upcoming Events and Milestones:
-
Top-line results for the Phase 2 XPro™ trial
for treatment of neuroinflammation as a cause of Alzheimer’s
Disease is expected in 2H 2024.
-
Initiate a Phase 2 trial of XPro™ in patients
with Treatment Resistant Depression that is partially funded by a
$2.9 million NIH grant upon resolution of the FDA manufacturing
review.
-
Additional open-label Phase 1 trial data of INKmune™ in high-risk
MDS/AML in 2023.
-
Opening of a Phase I/II trial studying INKmune™
in prostate cancer upon the acceptance of the IND by the
FDA.
Financial Results for the Quarter Ended March
31, 2023:
Net loss attributable to common stockholders for the quarter
ended March 31, 2023 was approximately $6.5 million, compared to
approximately $6.9 million during the quarter ended March 31,
2022.
Research and development expense totaled approximately $4.1
million for the quarter ended March 31, 2023 compared to
approximately $4.3 million during the quarter ended March 31,
2022.
General and administrative expenses were approximately $2.3
million for the quarter ended March 31, 2023 compared to
approximately $2.3 million during the quarter ended March 31,
2022.
Other expense was approximately $0.1 million for the quarter
ended March 31, 2023 compared to approximately $0.4 million during
the quarter ended March 31, 2022.
In addition, the Company received research and development
rebates from Australia and the United Kingdom during the three
months ended March 31, 2023 that totaled approximately $6.5
million.
As of March 31, 2023, the Company had cash and cash equivalents
of approximately $51.0 million.
As of May 3, 2023, the Company had approximately 17.9 million
common shares outstanding.
Earnings Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call. Please ask for the INmune Bio
First Quarter Conference Call when reaching an operator.
Date: May 3, 2023Time: 4:30 PM Eastern TimeParticipant Dial-in:
1-844-826-3035 Participant Dial-in (international):
1-412-317-5195Conference ID: 10177985
A live audio webcast of the call can be accessed using this link
or
clicking here:https://callme.viavid.com/?$Y2FsbG1lPXRydWUmcGFzc2NvZGU9JmluZm89Y29tcGFueSZyPXRydWUmYj0xNQ==
A transcript will follow approximately 24 hours from the
scheduled call. A replay will also be available through May 10 by
dialing 1-844-512-2921 or 1-412-317-6671 (international) and
entering PIN no. 10177985.
About XPro™
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.
About INKmune™
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 in the US this year.
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™), Mild Alzheimer’s
disease, Mild Cognitive Impairment 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.
INmune Bio Contact:David
Moss, CFO (858) 964-3720info@inmunebio.com
Investor Contact:Jason
NelsonCore IR(516) 842-9614 x-823
The following tables summarize our results of operations
for the periods indicated:
INMUNE BIO INC.
CONSOLIDATED BALANCE
SHEETS(In thousands, except share and per share
amounts)(Unaudited)
|
|
March 31,2023 |
|
|
December 31,2022 |
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
51,003 |
|
|
$ |
52,153 |
|
Research and development tax credit receivable |
|
|
1,814 |
|
|
|
8,099 |
|
Other tax receivable |
|
|
396 |
|
|
|
362 |
|
Prepaid expenses and other current assets |
|
|
3,633 |
|
|
|
4,027 |
|
Prepaid expenses – related party |
|
|
35 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT ASSETS |
|
|
56,881 |
|
|
|
64,675 |
|
|
|
|
|
|
|
|
|
|
Operating lease – right of use asset |
|
|
485 |
|
|
|
507 |
|
Other assets |
|
|
99 |
|
|
|
99 |
|
Acquired in-process research and development intangible assets |
|
|
16,514 |
|
|
|
16,514 |
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
73,979 |
|
|
$ |
81,795 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
2,077 |
|
|
$ |
5,206 |
|
Accounts payable and accrued liabilities – related parties |
|
|
9 |
|
|
|
9 |
|
Deferred liabilities |
|
|
591 |
|
|
|
616 |
|
Current portion of long-term debt |
|
|
7,500 |
|
|
|
5,000 |
|
Operating lease, current liabilities |
|
|
106 |
|
|
|
87 |
|
TOTAL CURRENT LIABILITIES |
|
|
10,283 |
|
|
|
10,918 |
|
|
|
|
|
|
|
|
|
|
Long-term debt, net |
|
|
7,264 |
|
|
|
9,697 |
|
Long-term operating lease liabilities |
|
|
498 |
|
|
|
526 |
|
Accrued liability – long-term |
|
|
638 |
|
|
|
550 |
|
TOTAL LIABILITIES |
|
|
18,683 |
|
|
|
21,691 |
|
|
|
|
|
|
|
|
|
|
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 shares issued and
outstanding |
|
|
18 |
|
|
|
18 |
|
Additional paid-in capital |
|
|
153,536 |
|
|
|
151,799 |
|
Accumulated other comprehensive loss |
|
|
(708 |
) |
|
|
(699 |
) |
Accumulated deficit |
|
|
(97,550 |
) |
|
|
(91,014 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
55,296 |
|
|
|
60,104 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
73,979 |
|
|
$ |
81,795 |
|
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(In thousands, except share and
per share amounts)(Unaudited)
|
|
Three months endedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
REVENUE |
|
$ |
38 |
|
|
$ |
163 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
General and administrative |
|
|
2,328 |
|
|
|
2,332 |
|
Research and development |
|
|
4,133 |
|
|
|
4,309 |
|
Total operating expenses |
|
|
6,461 |
|
|
|
6,641 |
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(6,423 |
) |
|
|
(6,478 |
) |
|
|
|
|
|
|
|
|
|
OTHER EXPENSE |
|
|
|
|
|
|
|
|
Other expense, net |
|
|
(113 |
) |
|
|
(425 |
) |
Total other expense, net |
|
|
(113 |
) |
|
|
(425 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(6,536 |
) |
|
$ |
(6,903 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.39 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding – basic and
diluted |
|
|
17,945,995 |
|
|
|
17,870,285 |
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,536 |
) |
|
$ |
(6,903 |
) |
Other comprehensive (loss) income – foreign currency
translation |
|
|
(9 |
) |
|
|
55 |
|
Total comprehensive loss |
|
$ |
(6,545 |
) |
|
$ |
(6,848 |
) |
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF CASH
FLOWS(In
thousands) (Unaudited)
|
|
For the Three Months EndedMarch
31, |
|
|
|
2023 |
|
|
2022 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(6,536 |
) |
|
$ |
(6,903 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
1,737 |
|
|
|
1,536 |
|
Accretion of debt discount |
|
|
67 |
|
|
|
56 |
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Research and development tax credit receivable |
|
|
6,285 |
|
|
|
(236 |
) |
Other tax receivable |
|
|
(34 |
) |
|
|
92 |
|
Prepaid expenses |
|
|
394 |
|
|
|
(2,390 |
) |
Prepaid expenses – related party |
|
|
(1 |
) |
|
|
- |
|
Accounts payable and accrued liabilities |
|
|
(3,129 |
) |
|
|
(1,182 |
) |
Accounts payable and accrued liabilities – related parties |
|
|
- |
|
|
|
(71 |
) |
Deferred liabilities |
|
|
(25 |
) |
|
|
110 |
|
Accrued liability – long-term |
|
|
88 |
|
|
|
88 |
|
Operating lease liabilities |
|
|
13 |
|
|
|
35 |
|
Net cash used in operating
activities |
|
|
(1,141 |
) |
|
|
(8,865 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock |
|
|
- |
|
|
|
699 |
|
Net proceeds from the exercise of warrants |
|
|
- |
|
|
|
30 |
|
Net cash provided by financing
activities |
|
|
- |
|
|
|
729 |
|
|
|
|
|
|
|
|
|
|
Impact on cash from foreign
currency translation |
|
|
(9 |
) |
|
|
55 |
|
|
|
|
|
|
|
|
|
|
NET DECREASE IN CASH AND CASH
EQUIVALENTS |
|
|
(1,150 |
) |
|
|
(8,081 |
) |
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD |
|
|
52,153 |
|
|
|
74,810 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT
END OF PERIOD |
|
$ |
51,003 |
|
|
$ |
66,729 |
|
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