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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
|
INMUNE BIO INC. |
|
|
(Exact name of registrant as specified in charter) |
|
Nevada |
|
001-38793 |
|
47-5205835 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number)
|
|
(IRS Employer
Identification No.) |
225 NE Mizner Blvd., Suite 640
Boca Raton, Florida 33432
(Address of Principal Executive Offices) (Zip Code)
(858) 964 3720
(Registrant’s Telephone Number, Including
Area Code)
Not Applicable
(Former Name or Former Address, If Changed Since
Last Report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common Stock, par value $0.001 per shares |
|
INMB |
|
The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check
mart if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results
of Operations and Financial Condition.
On August 7, 2023, INmune
Bio Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023 and provided
a business update. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this
Current Report, including the exhibits hereto, is being furnished and shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2)
of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not
be incorporated by reference into any registration statement or other document filed by the Company with the Securities and Exchange Commission,
whether made before or after the date of this report, regardless of any general incorporation language in such filing (or any reference
to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
INMUNE BIO INC. |
|
|
Date: August 8, 2023 |
By: |
/s/ David Moss |
|
|
David Moss |
|
|
Chief Financial Officer |
Exhibit
99.1
INmune
Bio Inc. Announces Second Quarter 2023 Results and Provides Business Update
Company to Host Conference Call Today, August 7, at 4:30pm ET
BOCA RATON, Fla., Aug. 07, 2023 (GLOBE NEWSWIRE)
-- 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, 2023
Time: 4:30 PM Eastern Time
Participant 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) 964-3720
info@inmunebio.com
Investor Contact:
Jason Nelson
Core 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 Ended June 30, | | |
| | |
For the Six
Months
Ended June 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 Ended June 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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