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
September 30, 2022 and provides a business update.
Q3 2022 and
Recent Corporate
Highlights
DN-TNF Platform Highlights (XPro™ and
INB03):
- FDA
review of Chemistry Manufacturing and Controls (CMC) associated
with a recently placed clinical hold on XPro1595 AD trials is
ongoing. The Company has addressed the FDA’s manufacturing
procedure query and is in ongoing discussion to alleviate the
current hold and start the US trials sites for XPro1595 in AD as a
soon as possible.
- The
Phase 2 trial in Mild AD patients continues to enroll in Australia.
The first patient treated in the trial has completed the six-month
study and has enrolled in the open label extension study.
- Opened a Special Access Scheme (SAS) in
AUS for patients in the Phase I AD trial based on the demand from
our patients that completed the 12-month extension trial.
INKmune™ Platform:
- The
Company announced positive solid tumor data in multiple cancer
lines resistant to natural killer (NK) killing that can be overcome
with administration of INKmune by converting patient’s normal
resting NK cells into potent memory-like NK cells that target solid
tumors directly, even in the presence of immunosuppressive
immunoregulatory cells and hypoxia associated with the tumor
microenvironment (TME).
- The
second UK clinical site is due to be initiated in November 2022 and
a third UK site is under evaluation.
- The
company completed a pre-IND discussion with the FDA and is
preparing the IND to file with the FDA on a solid tumor
indication.
Upcoming Events and 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 1/2 program in a solid tumor in 1H 2023.
- Additional
open-label Phase 1 trial data of INKmune™ in high-risk MDS/AML in
2023.
- Report top-line data
from Phase 2 trial of Xpro™ in AD03 patients. Timelines to be
updated following resolution of FDA clinical hold.
- Report top-line data
from Phase 2 trial of XPro™ in AD02 patients. Timelines to be
updated following resolution of FDA clinical hold.
- Presentation at
Society of Immunotherapy Conference (SITC) on the use of DN-TNF to
reshape the TME of trastuzumab resistant HER2+ breast cancer from a
cancer protecting immunosuppressive TME to a TME that makes the
tumor sensitive to immunotherapy.
- Presentation at San
Antonio Breast Cancer Symposium (SABCS) demonstrating the addition
of DN-TNF to Antibody Drug Conjugates (ADC) in HER2+ breast cancer
improves the response of ADCs and suggests addition of DN-TNF may
improve results in resistant tumors.
- Presentation of
clinical data at ASH (American Society of Hematology) from the
INKmune trial.
“The first patient enrolled in the AD02 trial, a
randomized, blinded, placebo-controlled study of XPro™ in patients
with Mild Alzheimer’s Disease (AD) with biomarkers of
neuroinflammation, has completed the six-month study,” stated RJ
Tesi, M.D., CEO of INmune Bio. “All patients that complete the
six-month study will be eligible to receive XPro under a separate
open label extension study. Our international, multicenter trial
strategy has not changed and pending conclusion of the FDA’s XPro™
manufacturing inquiry, our plan to launch additional blinded,
randomized, placebo-controlled Phase 2 trials in patients with mild
cognitive impairment (MCI) and TRD will commence.”
“Our INKmune™ platform continues to pivot
towards solid tumors. Data presented at the Innate Killer Europe
conference demonstrated the ability of INKmune-primed NK cells to
fight solid tumors in the hostile environment of the
TME. Improving NK cell therapeutic effectiveness in
solid tumors such as prostate, renal cell, and nasopharyngeal
cancer is an important unmet need in cancer therapy,” concluded Dr.
Tesi.
Two presentations using DN-TNF (INB03) to reverse resistance to
immunotherapy will occur this quarter. In the animal models, DN-TNF
changes the immunobiology of the tumor and TME to make them more
susceptible to immunotherapy such as ADCs. Although much of the
data are in MUC4+/HER2+ breast cancer, the data are relevant in
gastric, pancreatic, and other malignancies expressing MUC4.
“Despite advances in the treatment of HER2+ breast cancer with
ADCs, 50% of women relapse after 24 months,” added Dr. Tesi.
“Combination with DN-TNF may provide these patients with additional
therapeutic opportunities.”
Financial Results
for the Quarter
Ended September
30, 2022:
Net loss attributable to common stockholders for
the quarter ended September 30, 2022 was approximately $7.7
million, compared to approximately $9.5 million for the quarter
ended September 30, 2021.
Research and development expense totaled
approximately $5.2 million for the recent quarter compared to
approximately $6.5 million during the quarter ended September 30,
2021.
General and administrative expense was
approximately $2.4 million for the quarter compared to
approximately $2.5 million during the quarter ended September 30,
2021.
Other expense was approximately $0.3 million for
the quarter ended September 30, 2022 compared to approximately $0.4
million during the quarter ended September 30, 2021.
As of September 30, 2022, the Company had cash
and cash equivalents of approximately $57.4 million. As of November
2, 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: November 2, 2022Time: 4:30 PM Eastern TimeParticipant
Dial-in: 1-877-407-0784Participant Dial-in (international):
1-201-689-8560Conference ID: 13728541
A live audio webcast of the call can be accessed using this
link:
https://services.choruscall.com/mediaframe/webcast.html?webcastid=B2yQCYB2
A transcript will follow approximately 24 hours from the
scheduled call. A replay will also be available through November
19, 2022 by dialing 1-844-512-2921 or 1-412-317-6671
(international) and entering PIN no. 13728541.
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)
964-3720info@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)
|
September 30,2022 |
|
|
December 31,2021 |
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
57,405 |
|
|
$ |
74,810 |
|
Research and development tax credit receivable |
|
4,417 |
|
|
|
4,913 |
|
Other tax receivable |
|
114 |
|
|
|
591 |
|
Prepaid expenses |
|
4,599 |
|
|
|
2,278 |
|
Prepaid expenses – related party |
|
123 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
TOTAL CURRENT ASSETS |
|
66,658 |
|
|
|
82,606 |
|
|
|
|
|
|
|
|
|
Operating lease – right of use asset |
|
529 |
|
|
|
726 |
|
Other assets |
|
99 |
|
|
|
99 |
|
Acquired in-process research and development intangible assets |
|
16,514 |
|
|
|
16,514 |
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
$ |
83,800 |
|
|
$ |
99,945 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
$ |
3,465 |
|
|
$ |
3,733 |
|
Accounts payable and accrued liabilities – related parties |
|
8 |
|
|
|
80 |
|
Deferred liabilities |
|
778 |
|
|
|
474 |
|
Current portion of long-term debt |
|
2,500 |
|
|
|
- |
|
Operating lease, current liabilities |
|
144 |
|
|
|
72 |
|
TOTAL CURRENT LIABILITIES |
|
6,895 |
|
|
|
4,359 |
|
|
|
|
|
|
|
|
|
Long-term debt, net |
|
12,129 |
|
|
|
14,458 |
|
Long-term operating lease liabilities |
|
607 |
|
|
|
704 |
|
Accrued liability – long-term |
|
463 |
|
|
|
199 |
|
TOTAL LIABILITIES |
|
20,094 |
|
|
|
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 |
|
150,011 |
|
|
|
143,921 |
|
Accumulated other comprehensive (loss) income |
|
(1,142 |
) |
|
|
1 |
|
Accumulated deficit |
|
(85,181 |
) |
|
|
(63,715 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
63,706 |
|
|
|
80,225 |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
83,800 |
|
|
$ |
99,945 |
|
|
|
|
|
|
|
|
|
INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(In thousands,
except share and per share
amounts)(Unaudited)
|
For the Three Months EndedSeptember
30, |
|
|
For the Nine Months Ended September
30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
REVENUE |
$ |
98 |
|
|
$ |
14 |
|
|
$ |
277 |
|
|
$ |
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
2,382 |
|
|
|
2,515 |
|
|
|
6,929 |
|
|
|
6,666 |
|
Research and development |
|
5,159 |
|
|
|
6,520 |
|
|
|
13,657 |
|
|
|
13,475 |
|
Total operating expenses |
|
7,541 |
|
|
|
9,035 |
|
|
|
20,586 |
|
|
|
20,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
(7,443 |
) |
|
|
(9,021 |
) |
|
|
(20,309 |
) |
|
|
(20,123 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE, NET |
|
(282 |
) |
|
|
(437 |
) |
|
|
(1,157 |
) |
|
|
(546 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
$ |
(7,725 |
) |
|
$ |
(9,458 |
) |
|
$ |
(21,466 |
) |
|
$ |
(20,669 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
$ |
(0.43 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.20 |
) |
|
$ |
(1.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
17,945,995 |
|
|
|
17,329,379 |
|
|
|
17,921,036 |
|
|
|
15,553,344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(7,725 |
) |
|
$ |
(9,458 |
) |
|
$ |
(21,466 |
) |
|
$ |
(20,669 |
) |
Other comprehensive loss - foreign currency translation |
|
(441 |
) |
|
|
(68 |
) |
|
|
(1,143 |
) |
|
|
(129 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
$ |
(8,166 |
) |
|
$ |
(9,526 |
) |
|
$ |
(22,609 |
) |
|
$ |
(20,798 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF CASH
FLOWS(In
thousands) (Unaudited)
|
For the Nine Months EndedSeptember
30, |
|
|
2022 |
|
|
2021 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
Net loss |
$ |
(21,466 |
) |
|
$ |
(20,669 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
Stock-based compensation |
|
5,361 |
|
|
|
3,274 |
|
Accretion of debt discount |
|
171 |
|
|
|
69 |
|
Impairment of operating lease – right of use asset |
|
89 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Research and development tax credit receivable |
|
496 |
|
|
|
(3,272 |
) |
Other tax receivable |
|
477 |
|
|
|
(75 |
) |
Prepaid expenses |
|
(2,321 |
) |
|
|
(1,080 |
) |
Prepaid expenses – related party |
|
(109 |
) |
|
|
(14 |
) |
Other assets |
|
- |
|
|
|
(99 |
) |
Accounts payable and accrued liabilities |
|
(268 |
) |
|
|
2,703 |
|
Accounts payable and accrued liabilities – related parties |
|
(72 |
) |
|
|
(24 |
) |
Deferred liabilities |
|
304 |
|
|
|
351 |
|
Accrued liability – long-term |
|
264 |
|
|
|
111 |
|
Operating lease liabilities |
|
83 |
|
|
|
1 |
|
Net cash used in operating activities |
|
(16,991 |
) |
|
|
(18,724 |
) |
|
|
|
|
|
|
|
|
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 |
|
|
|
80,253 |
|
Net proceeds from exercise of stock options |
|
- |
|
|
|
1,135 |
|
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 |
|
|
|
96,357 |
|
|
|
|
|
|
|
|
|
Impact on cash from foreign currency translation |
|
(1,143 |
) |
|
|
(129 |
) |
|
|
|
|
|
|
|
|
NET (DECREASE) INCREASE IN CASH |
|
(17,405 |
) |
|
|
62,504 |
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
|
74,810 |
|
|
|
21,967 |
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD |
$ |
57,405 |
|
|
$ |
84,471 |
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS
INFORMATION: |
|
|
|
|
|
|
|
Cash paid for income taxes |
$ |
- |
|
|
$ |
- |
|
Cash paid for interest expense |
$ |
962 |
|
|
$ |
265 |
|
|
|
|
|
|
|
|
|
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 |
|
INmune Bio (NASDAQ:INMB)
Historical Stock Chart
From Aug 2024 to Sep 2024
INmune Bio (NASDAQ:INMB)
Historical Stock Chart
From Sep 2023 to Sep 2024