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 reported its financial results for
the quarter ended June 30, 2022 and provides a business update.
Q2 2022 and
Recent Corporate
Highlights
DN-TNF Platform Highlights (XPro™ and
INB03):
- Dosed
the first patient in the Phase II trial using XPro™ (XPro1595) to
treat patients with mild Alzheimer’s Disease (AD) in April. The
primary endpoint will examine cognition using the Early AD/MCI
Alzheimer's Cognitive Composite (EMACC). Multiple secondary
endpoints of cognition will also be measured, including CDR-SB,
ADAS-COG13 and other endpoints. Data is anticipated in the second
half of 2023.
- FDA
review of Chemistry Manufacturing and Controls (CMC) associated
with a recently placed clinical hold on XPro1595 AD trials is
ongoing. The Company is addressing the FDA’s manufacturing
procedure query to alleviate the current hold and start the US
trials sites for XPro1595 in AD as a soon as possible. While trials
in the United States are on hold, INmune continues to enroll and
open additional treatment sites in Australia.
- INmune
completed the manufacture of new doses of XPro™ during the quarter,
enough to supply all Phase 2 programs and continue the expansion of
our pre-clinical research in new disease targets for XPro
therapy.
- The
Company presented data demonstrating XPro™ promotes remyelination
in white matter in rodent models of Multiple Sclerosis at European
Conference on Neuroinflammation.
- INB03 – presented
data at the AACR Conference and HER2+ Targeted Therapy Summit
showing INB03’s ability to reverse Mucin 4 (MUC4) expression, a
negative predictor of treatment success, in HER2 breast cancer cell
line (JIMIT-1) to re-establish sensitivity to trastuzumab and
tyrosine kinase inhibitors.
- Patent
issued for use of XPro™ for central nervous systems diseases:
“METHODS OF TREATING NEUROLOGICAL DISEASES,” a patent directed to
use of Dominant Negative Tumor Necrosis Factor variants, such as
the Company’s XPro™, by peripheral administration for crossing the
blood-brain barrier and treating diseases of the Central Nervous
System. This patent provides protection for XPro treatment in CNS
diseases to 2033 with possible patent term extension of up to five
additional years if requested by the Company and approved by the
USPTO under 35 U.S.C. 156.
INKmune™ Platform:
- The
Company continues to monitor the high-risk myelodysplastic syndrome
(MDS) cancer patient and the two compassionate use acute myeloid
leukemia (AML) patients who have been treated with INKmune™ in a
Phase 1 open label dose escalation trial.
- Two
weeks ago, a young patient with refractory AML after failed BMT was
treated with INKmune. She received three doses of INKmune without
side effects. We will be monitoring her progress closely. She is
another patient with a high level of disease burden.
-
Received national registration for the INKmune™ MDS trial in the UK
which allows for patients from any hospital to be enrolled in the
trial at Southampton University Hospital. Additionally, the Company
will be expanding its INKmune™ MDS trial into the EU with a new
site in Athens, Greece.
-
Expanded ongoing INKmune™ treatment in MDS Phase 1 trial to include
patients with AML. The Company has recently treated a new patient
with AML on a compassionate basis who failed the inclusion criteria
for AML patients in the trial.
Upcoming Milestones:
- Initiate Xpro™ Phase
2 program for AD02 (mild AD) and AD03 (mild cognitive impairment)
in US patients once clinical hold is lifted.
- Initiate XPro™ Phase
2 program for treatment resistant depression (TRD), funded in part
by a $2.9 million NIH grant, once clinical hold is lifted.
- Initiate INKmune™
Phase I program in a solid tumor in 1H 2023.
- Additional
open-label Phase 1 trial data of INKmune™ in high-risk MDS/AML by
1H 2023.
- Report top-line data
from Phase 2 trial of Xpro™ in AD03 patients in 2H 2023.
- Report top-line data
from Phase 2 trial of XPro™ in AD02 patients in late 2023 or early
2024.
- Report pre-clinical
INKmune™ data in at least two new solid tumor indications, renal
cell carcinoma and nasopharyngeal carcinoma.
“In April, we announced the dosing of our first
patient treated with XPro™1595 in the treatment of
neuroinflammation as a cause of mild Alzheimer’s disease (AD) in
Phase II clinical trial, AD02,” stated RJ Tesi, M.D., CEO of INmune
Bio. “The trial is a blinded, randomized, placebo-controlled
multicenter study in Australia, in Canada and in the United States.
Although the trial in the United States is currently on hold
pending conclusion of the FDA’s manufacturing inquiry, we continue
to enroll patients in Australia where the trial is proceeding as
planned. Additionally, our plan to launch additional blinded,
randomized, placebo-controlled Phase II trials in patients with
mild cognitive impairment (MCI) and TRD will occur after the
clinical hold is lifted.
“Our INKmune™ platform continues to make positive strides. We
are actively expanding the INKmune program towards the treatment of
solid tumors. INKmune primed NK cells have unique biologic
characteristics that should make the therapy effective in solid
tumors,” concluded Dr. Tesi.
Financial Results
for the Quarter
Ended June 30,
2022:
Net loss attributable to common stockholders for
the quarter ended June 30, 2022 was approximately $6.8 million,
compared to approximately $6.7 million for the quarter ended June
30, 2021.
Research and development expense totaled
approximately $4.2 million for the recent quarter compared to
approximately $4.5 million during the quarter ended June 30,
2021.
General and administrative expense was
approximately $2.2 million for the quarter compared to
approximately $2.1 million during the quarter ended June 30,
2021.
Other expense was approximately $0.5 million for
the quarter ended June 30, 2022 compared to approximately $ 0.1
million during the quarter ended June 30, 2021.
As of June 30, 2022, the Company had cash and
cash equivalents of approximately $61.2 million. As of August 3,
2022, 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.
Date: August 3, 2022Time: 4:30 PM Eastern TimeParticipant
Dial-in: 1-877-407-0784Participant Dial-in (international):
1-201-689-8560Conference ID: 13728540
A live audio webcast of the call can be accessed using this
link:
https://services.choruscall.com/mediaframe/webcast.html?webcastid=Z4P1Gioe
A transcript will follow approximately 24 hours from the
scheduled call. A replay will also be available through August 10,
2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international)
and entering PIN no. 13728540.
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 akin to treatment with
at least three cytokines in combination. INKmune™ is stable at
-80oC and is delivered by a simple IV infusion. The INKmune:NK
interaction ligates multiple activating and co-stimulatory
molecules on the NK cell and enhances its avidity of binding to
tumor cells; notably those resistant to normal NK-mediated lysis.
Tumor-primed NK (TpNK) cells can lyse a wide variety of
NK-resistant tumors including leukemias, lymphomas, myeloma,
ovarian cancer, breast cancer.
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, 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)
964-3720DMoss@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 30,2022 |
|
|
December 31,2021 |
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
61,213 |
|
|
$ |
74,810 |
|
Research and development tax credit receivable |
|
|
4,926 |
|
|
|
4,913 |
|
Other tax receivable |
|
|
134 |
|
|
|
591 |
|
Prepaid expenses |
|
|
4,222 |
|
|
|
2,278 |
|
Prepaid expenses – related party |
|
|
51 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT ASSETS |
|
|
70,546 |
|
|
|
82,606 |
|
|
|
|
|
|
|
|
|
|
Operating lease – right of use asset |
|
|
650 |
|
|
|
726 |
|
Other assets |
|
|
99 |
|
|
|
99 |
|
Acquired in-process research and development intangible assets |
|
|
16,514 |
|
|
|
16,514 |
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
87,809 |
|
|
$ |
99,945 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
1,687 |
|
|
$ |
3,733 |
|
Accounts payable and accrued liabilities – related parties |
|
|
9 |
|
|
|
80 |
|
Deferred liabilities |
|
|
476 |
|
|
|
474 |
|
Operating lease, current liabilities |
|
|
113 |
|
|
|
72 |
|
TOTAL CURRENT LIABILITIES |
|
|
2,285 |
|
|
|
4,359 |
|
|
|
|
|
|
|
|
|
|
Long-term debt, less debt discount |
|
|
14,571 |
|
|
|
14,458 |
|
Long-term operating lease liabilities |
|
|
645 |
|
|
|
704 |
|
Accrued liability – long-term |
|
|
375 |
|
|
|
199 |
|
TOTAL LIABILITIES |
|
|
17,876 |
|
|
|
19,720 |
|
|
|
|
|
|
|
|
|
|
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 and 17,843,303
shares issued and outstanding, respectively |
|
|
18 |
|
|
|
18 |
|
Additional paid-in capital |
|
|
148,072 |
|
|
|
143,921 |
|
Accumulated other comprehensive (loss) income |
|
|
(701 |
) |
|
|
1 |
|
Accumulated deficit |
|
|
(77,456 |
) |
|
|
(63,715 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
69,933 |
|
|
|
80,225 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
87,809 |
|
|
$ |
99,945 |
|
|
|
INMUNE BIO, INC. |
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
FOR THE QUARTERS ENDED JUNE 30, 2022 AND 2021 |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
For the Three Months EndedJune
30, |
|
|
For the Six Months EndedJune
30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
REVENUE |
|
$ |
16 |
|
|
$ |
- |
|
|
$ |
179 |
|
|
$ |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
2,215 |
|
|
|
2,090 |
|
|
|
4,547 |
|
|
|
4,151 |
|
Research and development |
|
|
4,189 |
|
|
|
4,464 |
|
|
|
8,498 |
|
|
|
6,955 |
|
Total operating expenses |
|
|
6,404 |
|
|
|
6,554 |
|
|
|
13,045 |
|
|
|
11,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(6,388 |
) |
|
|
(6,554 |
) |
|
|
(12,866 |
) |
|
|
(11,102 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE |
|
|
(450 |
) |
|
|
(101 |
) |
|
|
(875 |
) |
|
|
(109 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(6,838 |
) |
|
$ |
(6,655 |
) |
|
$ |
(13,741 |
) |
|
$ |
(11,211 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.77 |
) |
|
$ |
(0.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
|
17,945,995 |
|
|
|
14,974,953 |
|
|
|
17,908,349 |
|
|
|
14,650,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,838 |
) |
|
$ |
(6,655 |
) |
|
$ |
(13,741 |
) |
|
$ |
(11,211 |
) |
Other comprehensive loss - foreign currency translation |
|
|
(757 |
) |
|
|
(62 |
) |
|
|
(702 |
) |
|
|
(61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(7,595 |
) |
|
$ |
(6,717 |
) |
|
$ |
(14,443 |
) |
|
$ |
(11,272 |
) |
|
|
INMUNE BIO, INC. |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
FOR THE QUARTERS ENDED JUNE 30, 2022 AND 2021 |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
For the Six Months EndedJune
30, |
|
|
|
2022 |
|
|
2021 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(13,741 |
) |
|
$ |
(11,211 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
3,422 |
|
|
|
1,668 |
|
Accretion of debt discount |
|
|
113 |
|
|
|
16 |
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Research and development tax credit receivable |
|
|
(13 |
) |
|
|
(1,382 |
) |
Other tax receivable |
|
|
457 |
|
|
|
62 |
|
Prepaid expenses |
|
|
(1,944 |
) |
|
|
(1,175 |
) |
Prepaid expenses – related party |
|
|
(37 |
) |
|
|
(15 |
) |
Accounts payable and accrued liabilities |
|
|
(2,046 |
) |
|
|
843 |
|
Accounts payable and accrued liabilities – related parties |
|
|
(71 |
) |
|
|
(25 |
) |
Deferred liabilities |
|
|
2 |
|
|
|
393 |
|
Accrued liability – long-term |
|
|
176 |
|
|
|
24 |
|
Operating lease liabilities |
|
|
58 |
|
|
|
1 |
|
Net cash used in operating
activities |
|
|
(13,624 |
) |
|
|
(10,801 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Cash paid to Xencor to settle
warrant for acquired research and development intangible
assets |
|
|
- |
|
|
|
(15,000 |
) |
Net cash used in investing
activities |
|
|
- |
|
|
|
(15,000 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock |
|
|
699 |
|
|
|
28,446 |
|
Net proceeds from the exercise of warrants |
|
|
30 |
|
|
|
18 |
|
Net proceeds from the issuance of debt |
|
|
- |
|
|
|
14,951 |
|
Net cash provided by financing
activities |
|
|
729 |
|
|
|
43,415 |
|
|
|
|
|
|
|
|
|
|
Impact on cash from foreign
currency translation |
|
|
(702 |
) |
|
|
(61 |
) |
|
|
|
|
|
|
|
|
|
NET (DECREASE) INCREASE IN
CASH |
|
|
(13,597 |
) |
|
|
17,553 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD |
|
|
74,810 |
|
|
|
21,967 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT
END OF PERIOD |
|
$ |
61,213 |
|
|
$ |
39,520 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURE OF CASH FLOWS INFORMATION: |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
- |
|
|
$ |
- |
|
Cash paid for interest expense |
|
$ |
601 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
NONCASH INVESTING AND
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Common stock issued to Xencor
to settle warrant issued for acquired research and development
intangible assets |
|
$ |
- |
|
|
$ |
3,300 |
|
Warrants issued as debt
inducement |
|
$ |
- |
|
|
$ |
619 |
|
|
|
|
|
|
|
|
|
|
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