INmune Bio Inc. Announces Second Quarter 2023 Results and Provides Business Update
07 August 2023 - 10:00PM
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 June 30, 2023 and provides a business update.
Q2 2023 Corporate Highlights:
DN-TNF Platform Highlights (XPro™ and
INB03™):
- AD02
blinded randomized program 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. Discussions with the FDA have provided a
clear pathway to lifting the clinical hold before the
end-of-year.
-
Announced expansion of novel MRI biomarker data to include gray
matter. Gray matter, the portion of the brain containing nerve cell
bodies, has historically been the focus of Alzheimer’s disease
research and drug development. Previous MRI biomarker analysis from
patients receiving XPro™ for treatment of AD has demonstrated early
changes in white matter that predict presence of neuroinflammation
and response to XPro™ therapy. The new data, reported at the annual
Alzheimer’s Association International Conference (AAIC) in
Amsterdam, Netherlands in July, demonstrates improvement in gray
matter in patients with AD. The results demonstrate a dose
dependent enhancement in gray matter measures in the brain in AD
patients treated with XPro™. The data confirm that
neuroinflammation affects white and gray matter of the brain.
Treatment with XPro™ resulted in improvements in both white and
gray matter microstructural elements that may predict improvements
in cognition. The data further validate the biomarker package
associated with the on-going Phase II trial in patients with Early
AD.
-
Presented data in early July at the 16th European Meeting on Glial
Cells in Health and Disease in Berlin that show that XPro™ promotes
remyelination by affecting astroglial and microglial biology.
Myelin is a specialized lipid produced by oligodendrocytes that
forms the myelin sheath of axons. Axons are the projections that
allow neurons to communicate with each other and with other tissues
such as muscle, skin, retina, nose, and the ear for sight, smell,
and hearing respectively. An intact and healthy myelin sheath is
necessary for axons to allow neurons to communicate with each other
and work properly. Drug therapies to prevent demyelination are
available, but there are no therapies that promote remyelination.
Therapies that promote remyelination will be needed to effectively
treat many neurodegenerative diseases and is increasingly
recognized as part of the pathology associated with Alzheimer’s
disease. The Company plans a webinar on highlighting
the importance of remyelination therapy in patients with MS and AD
before the end-of-year.
-
Presented additional data on combination of INB03™ 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™
reduced MUC4 expression to decrease resistance to immunotherapy
including tyrosine kinase inhibitors (TKI), trastuzumab and TDxd. A
pSar DN-TNF compound with new composition-of-matter IP is in animal
testing in preparation for a strategic partnering program in
oncology.
- The
polysarcosine (pSar) DN-TNF program converts XPro™ from a single
drug into a DN-TNF drug platform. Polysarcosine is a novel
half-life extender that effectively replaces the PEG half-life
extender used in XPro™. The pSar program is an essential part of
INmune Bio’s business development efforts. XPro™ has been
designated for the CNS programs, including AD, TRD, ALS and other
neurological diseases. The pSar program provides at least three new
DN-TNF biologics that are eligible for composition-of-matter IP and
have unique biologic characteristics that allow partnering DN-TNF
opportunities beyond CNS, such as oncology (INB03™), Duchenne’s
Muscular Dystrophy (DMD), and other disease indications. Each drug
is a novel DN-TNF compound that will require a unique development
program.
INKmune™ Platform:
- IND
cleared by the Food & Drug Administration (FDA) in May for
INKmune™ for a Phase I/II open label trial in metastatic
Castration-Resistant Prostate Cancer (mCRPC). The trial is expected
to enroll the first of 30 patients in the final quarter of 2023.
Patients will receive three infusions of INKmune™ as out-patient
treatment during the six-month trial. Three doses of INKmune™
are being tested in a modified Bayesian Phase I/II trial to answer
four questions:
- Is
INKmune™ safe in patients with mCRPC?
- What
dose of INKmune™ should be used in a blinded randomized pivotal
trial in men with mCRPC?
- How long
can the effects of INKmune™ be sustained, (Determined by measuring
tumor killing NK cells in the blood called memory like NK
cells).
- Is there
a tumor response to INKmune™ therapy? Measures of tumor
response include blood PSA and tumor DNA levels in the patient’s
blood and PMSA PET scan. The results of the open label study
should allow the Company to design a pivotable trial.
- LAUREL,
the INKmune™ trial in high risk MDS and AML has opened a third
clinical site in Athens, Greece. The site is screening patients and
expects to enroll patients soon. Changing management of high risk
MDS patients in the UK has resulted in screen failures. The cause
of these screen failures has been identified and addressed to help
increase recruiting of patient into LAUREL. The Company is seeking
to modify the trial enrollment criteria to increase the pool of
potential patients to drive recruitment.
- CSO Dr.
Mark Lowdell gave the opening plenary presentation in the
Presidential Session at the annual International Society of Cell
& Gene Therapy (ISCT) where he presented the scientific
discovery of INKmune™ and development to clinical trials. His talk
highlighted that NK cells primed by INKmune™ have the ability to
alter their phenotype to a cancer-killing population of memory-like
NK cells that differ from single-cytokine or multiple-cytokine
(IL-12, IL-15, IL-18) primed NK cells. This innovation avoids the
cost and complications associated with cytokine therapy and
produces NK cells ideally suited for attacking cancer.
Upcoming Events and Milestones:
-
Top-line results for the Phase II XPro™ trial for treatment of
neuroinflammation as a cause of Alzheimer’s Disease are expected
towards the end of 2024.
-
Initiate a Phase II trial of XPro™ in patients with
Treatment-Resistant Depression upon resolution of the ongoing FDA
manufacturing review.
-
Webinar on using XPro™ to promote remyelination in AD and MS before
end-of-year.
-
Additional open-label Phase I trial data of INKmune™ in high-risk
MDS/AML in 2023.
-
Opening of a Phase I/II trial in a prostate cancer in the second
half of 2023.
Financial Results for the Quarter Ended June
30, 2023:
- Net loss
attributable to common stockholders for the quarter ended June 30,
2023, was approximately $6.5 million, compared to approximately
$6.8 million during the quarter ended June 30, 2022.
- Research and
development expenses totaled approximately $4.1 million for the
quarter ended June 30, 2023, compared to approximately $4.2 million
during the quarter ended June 30, 2022.
- General and
administrative expense were approximately $2.3 million for the
quarter ended June 30, 2023, compared to approximately $2.2 million
during the quarter ended June 30, 2022.
- Other expense
was approximately $0.1 million for the quarter ended June 30, 2023,
compared to approximately $0.5 million during the quarter ended
June 30, 2022.
- As of June 30,
2023, the Company had cash and cash equivalents of approximately
$47.8 million.
- As of August 7,
2023, the Company had approximately 18.0 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: August 7, 2023Time: 4:30 PM Eastern TimeParticipant
Dial-in: 1-877-404-0784 Participant Dial-in (international):
1-201-689-8560 Conference ID: 13739436
A live audio webcast of the call can be accessed using this link
or clicking here:
https://viavid.webcasts.com/starthere.jsp?ei=1621197&tp_key=3e16bba085
A transcript will follow approximately 24 hours from the
scheduled call. A replay will also be available through August 14
by dialing 1-844-512-2921 or 1-412-317-6671 (international) and
entering PIN no. 13739436.
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
(mlNK cells). INKmune™ treatment converts the patient’s own
NK cells into mlNK cells. In patients, INKmune™ primed tumor
killing NK cells persist for more than 100 days and function in the
hypoxic TME because due to upregulated nutrient and mitochondrial
survival proteins. INKmune™ is a patient friendly that does
not require pre-medication, conditioning or additional cytokine
therapy given to the patients. INKmune™ is easily transported,
stored and delivered to the patient by a simple intravenous
infusion as an out-patient. 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) |
|
|
|
June 30,2023 |
|
|
December 31,2022 |
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
47,825 |
|
|
$ |
52,153 |
|
Research and development tax credit receivable |
|
|
1,934 |
|
|
|
8,099 |
|
Other tax receivable |
|
|
112 |
|
|
|
362 |
|
Prepaid expenses and other current assets |
|
|
2,707 |
|
|
|
4,027 |
|
Prepaid expenses – related party |
|
|
30 |
|
|
|
34 |
|
TOTAL CURRENT ASSETS |
|
|
52,608 |
|
|
|
64,675 |
|
|
|
|
|
|
|
|
|
|
Operating lease – right of use asset |
|
|
468 |
|
|
|
507 |
|
Other assets |
|
|
130 |
|
|
|
99 |
|
Acquired in-process research and development intangible assets |
|
|
16,514 |
|
|
|
16,514 |
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
69,720 |
|
|
$ |
81,795 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
2,385 |
|
|
$ |
5,206 |
|
Accounts payable and accrued liabilities – related parties |
|
|
9 |
|
|
|
9 |
|
Deferred liabilities |
|
|
560 |
|
|
|
616 |
|
Current portion of long-term debt |
|
|
10,000 |
|
|
|
5,000 |
|
Operating lease, current liabilities |
|
|
101 |
|
|
|
87 |
|
TOTAL CURRENT LIABILITIES |
|
|
13,055 |
|
|
|
10,918 |
|
|
|
|
|
|
|
|
|
|
Long-term debt, net |
|
|
4,822 |
|
|
|
9,697 |
|
Long-term operating lease liabilities |
|
|
463 |
|
|
|
526 |
|
Accrued liability – long-term |
|
|
726 |
|
|
|
550 |
|
TOTAL LIABILITIES |
|
|
19,066 |
|
|
|
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 |
|
|
155,399 |
|
|
|
151,799 |
|
Accumulated other comprehensive loss |
|
|
(712 |
) |
|
|
(699 |
) |
Accumulated deficit |
|
|
(104,051 |
) |
|
|
(91,014 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
50,654 |
|
|
|
60,104 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
69,720 |
|
|
$ |
81,795 |
|
|
INMUNE BIO INC.CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(In thousands,
except share and per share
amounts)(Unaudited) |
|
|
|
For the Three Months EndedJune
30, |
|
|
|
|
|
|
For the Six Months EndedJune
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
REVENUE |
|
$ |
46 |
|
|
$ |
16 |
|
|
$ |
84 |
|
|
$ |
179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
2,309 |
|
|
|
2,215 |
|
|
|
4,637 |
|
|
|
4,547 |
|
Research and development |
|
|
4,148 |
|
|
|
4,189 |
|
|
|
8,281 |
|
|
|
8,498 |
|
Total operating expenses |
|
|
6,457 |
|
|
|
6,404 |
|
|
|
12,918 |
|
|
|
13,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(6,411 |
) |
|
|
(6,388 |
) |
|
|
(12,834 |
) |
|
|
(12,866 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE, NET |
|
|
(90 |
) |
|
|
(450 |
) |
|
|
(203 |
) |
|
|
(875 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(6,501 |
) |
|
$ |
(6,838 |
) |
|
$ |
(13,037 |
) |
|
$ |
(13,741 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.73 |
) |
|
$ |
(0.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding – basic and diluted |
|
|
17,945,995 |
|
|
|
17,945,995 |
|
|
|
17,945,995 |
|
|
|
17,908,349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,501 |
) |
|
$ |
(6,838 |
) |
|
$ |
(13,037 |
) |
|
$ |
(13,741 |
) |
Other comprehensive loss – foreign currency translation |
|
|
(4 |
) |
|
|
(757 |
) |
|
|
(13 |
) |
|
|
(702 |
) |
Total comprehensive loss |
|
$ |
(6,505 |
) |
|
$ |
(7,595 |
) |
|
$ |
(13,050 |
) |
|
$ |
(14,443 |
) |
|
INMUNE BIO INC.CONSOLIDATED STATEMENTS OF
CASH FLOWS(In
thousands) (Unaudited) |
|
|
|
For the Six Months EndedJune
30, |
|
|
|
2023 |
|
|
2022 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(13,037 |
) |
|
$ |
(13,741 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
3,600 |
|
|
|
3,422 |
|
Accretion of debt discount |
|
|
125 |
|
|
|
113 |
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Research and development tax credit receivable |
|
|
6,165 |
|
|
|
(13 |
) |
Other tax receivable |
|
|
250 |
|
|
|
457 |
|
Prepaid expenses |
|
|
1,320 |
|
|
|
(1,944 |
) |
Prepaid expenses – related party |
|
|
4 |
|
|
|
(37 |
) |
Other assets |
|
|
(31 |
) |
|
|
- |
|
Accounts payable and accrued liabilities |
|
|
(2,821 |
) |
|
|
(2,046 |
) |
Accounts payable and accrued liabilities – related parties |
|
|
- |
|
|
|
(71 |
) |
Deferred liabilities |
|
|
(56 |
) |
|
|
2 |
|
Accrued liability – long-term |
|
|
176 |
|
|
|
176 |
|
Operating lease liabilities |
|
|
(10 |
) |
|
|
58 |
|
Net cash used in operating
activities |
|
|
(4,315 |
) |
|
|
(13,624 |
) |
|
|
|
|
|
|
|
|
|
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 |
|
|
(13 |
) |
|
|
(702 |
) |
|
|
|
|
|
|
|
|
|
NET DECREASE IN CASH AND CASH
EQUIVALENTS |
|
|
(4,328 |
) |
|
|
(13,597 |
) |
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD |
|
|
52,153 |
|
|
|
74,810 |
|
CASH AND CASH EQUIVALENTS AT
END OF PERIOD |
|
$ |
47,825 |
|
|
$ |
61,213 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURE OF CASH FLOWS INFORMATION: |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
- |
|
|
$ |
- |
|
Cash paid for interest expense |
|
$ |
930 |
|
|
$ |
601 |
|
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