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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):
August 1, 2024
INMUNE
BIO INC.
(Exact name of registrant as specified in charter)
Nevada |
|
001-38793 |
|
47-5205835 |
(State or other jurisdiction |
|
(Commission File Number) |
|
(IRS Employer |
of incorporation) |
|
|
|
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 share |
|
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 1, 2024, INmune
Bio Inc. issued a press release announcing its financial results and to provide a business update for the quarter ended June 30, 2024.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item
2.02.
The information furnished
under this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section and shall not be
deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise
expressly stated by specific reference in any 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 2, 2024 |
By: |
/s/ David Moss |
|
|
David Moss |
|
|
Chief Financial Officer |
2
Exhibit 99.1
INmune Bio Inc. Announces Second Quarter 2024 Results and Provides Business Update
Company to Host Conference Call Today,
August 1, at 4:30pm ET
BOCA RATON, Fla., Aug. 01, 2024 (GLOBE NEWSWIRE)
-- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company developing
treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter
ended June 30, 2024 and provides a business update.
Q2 2024 and Recent
Corporate Highlights
DN-TNF Platform Highlights (XPro™):
| ● | The
Phase 2 randomized, blinded clinical trial for patients with Early Alzheimer’s Disease is on schedule to reach its final enrollment before
the end of Q3 followed by top-line data approximately six months from the last patient enrolled. |
| ● | Announced
completion of blinded interim analysis of the ongoing Phase II Alzheimer’s Disease trial, confirming that the trial is appropriately
powered to assess its primary and secondary cognitive endpoints, the Early Mild Alzheimer’s Cognitive Composite (EMACC) and CDR.
The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest
quality. |
| ● | New
Phase 1b analysis of proteomic data presented at AAIC shows XPro’s™ significant effects on a broad range of synaptic proteins and
pathways. The analysis revealed that a 12-week treatment with XPro™ resulted in a significant change in synaptic proteins, which
are essential for communication between neurons. The formation and elimination of synapses is executed by cells of the innate immune
system such as astrocytes. When these cells are in a dysregulated inflammatory/immune state, synapse formation is reduced and synapse
elimination is increased, resulting in loss of communication between neurons which, in the case of AD, results in cognitive impairment.
Restoring synapses requires a normally functioning innate immune system. |
| ● | The
Company successfully completed extended stability validation for XPro™ at continuous storage in solution at 2C-8C. The 24
and 30-month stability test samples passed all chemistry and potency assays allowing the Company to make a conservative claim of 24-month
stability and positioning it to meet the dosing demands envisioned in the Phase III trial. |
| ● | Shared
the progress of two early patients in the Phase 1b AD trial in Australia who have continued to receive XPro™ treatment under
an open-label program administered by their treating physician. The video testimonials underscore XPro’s™ unique
attributes that may halt progression of cognitive impairment versus existing treatments that slow the pace of, but do not stop the
progression of, cognitive decline. |
INKmune™ Platform:
| ● | Announced
a new formulation of INKmune™ that supports single bag administration at the highest trial dose, and expansion of bioreactor capacity
in preparation of scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA that also includes
additional validation data supporting an alternative critical reagent used in INKmune™ manufacturing, improving supply chain redundancy. |
| ● | Completed
the first cohort in the Phase I/II open label trial (the “CarePC” trial) of INKmune™ in metastatic castration-resistant
prostate cancer (mCRPC). Following review by the Safety Review Committee (SRC), approval was granted to proceed with the second dose
level (cohort 2) and two patients have been enrolled. Data from this open-label trial is expected to be released intermittently as it
becomes available. |
| ● | Patient
enrollment in CarePC remains robust and on schedule. The first patient of the middle dose cohort will complete treatment this month and
the 2nd patient of the middle dose cohort is about to be screened. The safety of INKmune™ remains excellent and all patients in
the CarePC trial have been treated as an out-patient. Data from the trial is expected to be released later this year. |
| ● | The
most recent pre-clinical data and early clinical results with INKmune™ have been published in the peer-reviewed Journal
for ImmunoTherapy of Cancer this month. The study demonstrates that memory-like natural killer (mlNK) cells, generated by either
cytokine or INKmune™ priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer
immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from
cancer patients are equally as potent as those generated from healthy volunteers, further supporting INKmune™’s in vivo treatment
methodology. The research also provides new insights into the metabolic and physiological mechanisms underlying NK cell memory, paving
the way for innovative treatments in both hematological malignancies and solid tumors. |
Corporate:
| ● | The
Company is presenting at BTIG’s Virtual Biotechnology Conference 2024 on Tuesday, August 6, 2024 at 8AM ET and will host one-on-one
meetings August 5/6. This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading,
investment banking, research and related brokerage services. To join the conference, email. |
| ● | Joined
the broad-market Russell 3000® Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective as of Monday,
July 1st, 2024. |
| ● | The
Company successfully raised a combined $14.5 million of equity capital before placement agent fees and expenses in two separate transactions
in late April. Of note, in the first $4.8 million offering, management and members of the Board of Directors purchased approximately
20% of the offering. Excluding shares and warrants acquired by insiders, both offerings were priced at-the-market. |
| ● | Received
a research and development rebates from Australia in July of approximately $2.5 million USD. |
Upcoming Events and Milestones:
| ● | Full
enrollment in the Phase II XPro™ trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected before
the end of Q3 followed by top-line data approximately six months from the last patient enrolled. |
| ● | Initiate
a Phase II trial of XPro™ in patients with Treatment-Resistant Depression 2H 2024. |
| ● | Expect
to complete enrollment in the Phase I portion of INKmune™ in metastatic castration-resistant prostate cancer trial in Q4 2024.
The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic
and therapeutic response to INKmune as data becomes available. |
Financial Results for the First
Quarter Ended June 30, 2024:
| ● | Net
loss attributable to common stockholders for the quarter ended June 30, 2024 was approximately $9.7 million, compared to approximately
$6.5 million during the quarter ended June 30, 2023. |
| ● | Research
and development expenses totaled approximately $7.1 million for the quarter ended June 30, 2024, compared to approximately $4.1 million
during the quarter ended June 30, 2023. |
| ● | General
and administrative expenses were approximately $2.8 million for the quarter ended June 30, 2024, compared to approximately $2.3 million
during the quarter ended June 30, 2023. |
| ● | Other
income (expense), net was approximately $0.1 million for the quarter ended June 30, 2024, compared to approximately ($0.1) million during
the quarter ended June 30, 2023. |
| ● | As
of June 30, 2024, the Company had cash and cash equivalents of approximately $31.1 million. |
| ● | As
of August 1, 2024, the Company had approximately 19.8 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 Second Quarter Conference Call when reaching an operator.
Date: August 1, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448
Participant Dial-in (international): 1-203-518-9708
Conference ID: INMUNE
A live audio webcast of the call can be accessed
by clicking here or using this link:
https://viavid.webcasts.com/starthere.jsp?ei=1679432&tp_key=8a15b560a4
A transcript will follow approximately 24
hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international)
and entering PIN no. 11156467.
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 have persisted for more than
100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.
INKmune™ is a patient friendly drug
treatment that does not require pre-medication, conditioning or additional cytokine therapy to be 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/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 inflammation and immunology 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™), Early Alzheimer’s disease 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
Chief Financial Officer
(858) 964-3720
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
The following tables summarize our results of operations for the periods indicated:
INMUNE BIO INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | |
| |
CURRENT ASSETS | |
| | |
| |
Cash and cash equivalents | |
$ | 31,069 | | |
$ | 35,848 | |
Research and development tax credit receivable | |
| 3,143 | | |
| 1,905 | |
Other tax receivable | |
| 270 | | |
| 537 | |
Prepaid expenses and other current assets | |
| 1,013 | | |
| 1,510 | |
Prepaid expenses – related party | |
| - | | |
| 142 | |
TOTAL CURRENT ASSETS | |
| 35,495 | | |
| 39,942 | |
| |
| | | |
| | |
Operating lease – right of use asset | |
| 363 | | |
| 414 | |
Other assets | |
| 81 | | |
| 131 | |
Acquired in-process research and development intangible assets | |
| 16,514 | | |
| 16,514 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 52,453 | | |
$ | 57,001 | |
| |
| | | |
| | |
LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 9,282 | | |
$ | 7,901 | |
Accounts payable and accrued liabilities – related parties | |
| 139 | | |
| 35 | |
Deferred liabilities | |
| 521 | | |
| 489 | |
Current portion of long-term debt | |
| 4,979 | | |
| 9,921 | |
Operating lease, current liability | |
| 130 | | |
| 119 | |
TOTAL CURRENT LIABILITIES | |
| 15,051 | | |
| 18,465 | |
| |
| | | |
| | |
Long-term operating lease liability | |
| 322 | | |
| 397 | |
TOTAL LIABILITIES | |
| 15,373 | | |
| 18,862 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES | |
| | | |
| | |
| |
| | | |
| | |
Redeemable common stock, $0.001 par value; 75,697 shares issued and outstanding (Note 9) | |
| 799 | | |
| 799 | |
| |
| | | |
| | |
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, and 19,706,732 and 17,950,776 shares issued and outstanding, respectively | |
| 20 | | |
| 18 | |
Additional paid-in capital | |
| 178,767 | | |
| 159,143 | |
Accumulated other comprehensive loss | |
| (713 | ) | |
| (799 | ) |
Accumulated deficit | |
| (141,793 | ) | |
| (121,022 | ) |
TOTAL STOCKHOLDERS’ EQUITY | |
| 36,281 | | |
| 37,340 | |
| |
| | | |
| | |
TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY | |
$ | 52,453 | | |
$ | 57,001 | |
INMUNE BIO INC.
CONDENSED 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, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
REVENUE | |
$ | - | | |
$ | 46 | | |
$ | 14 | | |
$ | 84 | |
| |
| | | |
| | | |
| | | |
| | |
OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
| 2,812 | | |
| 2,309 | | |
| 5,150 | | |
| 4,637 | |
Research and development | |
| 7,053 | | |
| 4,148 | | |
| 15,746 | | |
| 8,281 | |
Total operating expenses | |
| 9,865 | | |
| 6,457 | | |
| 20,896 | | |
| 12,918 | |
| |
| | | |
| | | |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (9,865 | ) | |
| (6,411 | ) | |
| (20,882 | ) | |
| (12,834 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER INCOME (EXPENSE), NET | |
| 119 | | |
| (90 | ) | |
| 111 | | |
| (203 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (9,746 | ) | |
$ | (6,501 | ) | |
$ | (20,771 | ) | |
$ | (13,037 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share – basic and diluted | |
$ | (0.50 | ) | |
$ | (0.36 | ) | |
$ | (1.11 | ) | |
$ | (0.73 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding – basic and diluted | |
| 19,307,323 | | |
| 17,945,995 | | |
| 18,666,898 | | |
| 17,945,995 | |
| |
| | | |
| | | |
| | | |
| | |
COMPREHENSIVE LOSS | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (9,746 | ) | |
$ | (6,501 | ) | |
$ | (20,771 | ) | |
$ | (13,037 | ) |
Other comprehensive income (loss) – foreign currency translation | |
| (44 | ) | |
| (4 | ) | |
| 86 | | |
| (13 | ) |
Total comprehensive loss | |
$ | (9,790 | ) | |
$ | (6,505 | ) | |
$ | (20,685 | ) | |
$ | (13,050 | ) |
INMUNE BIO INC.
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
(In thousands)
(Unaudited)
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss | |
$ | (20,771 | ) | |
$ | (13,037 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| 4,129 | | |
| 3,600 | |
Accretion of debt discount | |
| 58 | | |
| 125 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Research and development tax credit receivable | |
| (1,238 | ) | |
| 6,165 | |
Other tax receivable | |
| 267 | | |
| 250 | |
Prepaid expenses | |
| 497 | | |
| 1,320 | |
Prepaid expenses – related party | |
| 142 | | |
| 4 | |
Other assets | |
| 50 | | |
| (31 | ) |
Accounts payable and accrued liabilities | |
| 1,381 | | |
| (2,821 | ) |
Accounts payable and accrued liabilities – related parties | |
| 104 | | |
| - | |
Deferred liabilities | |
| 32 | | |
| (56 | ) |
Accrued liability – long-term | |
| - | | |
| 176 | |
Operating lease liabilities | |
| (13 | ) | |
| (10 | ) |
Net cash used in operating activities | |
| (15,362 | ) | |
| (4,315 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Net proceeds from sale of common stock and warrants | |
| 15,497 | | |
| - | |
Repayments of debt | |
| (5,000 | ) | |
| - | |
Net cash provided by financing activities | |
| 10,497 | | |
| - | |
| |
| | | |
| | |
Impact on cash from foreign currency translation | |
| 86 | | |
| (13 | ) |
| |
| | | |
| | |
NET DECREASE IN CASH AND CASH EQUIVALENTS | |
| (4,779 | ) | |
| (4,328 | ) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | |
| 35,848 | | |
| 52,153 | |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | |
$ | 31,069 | | |
$ | 47,825 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | |
| | | |
| | |
Cash paid for income taxes | |
$ | - | | |
$ | - | |
Cash paid for interest expense | |
$ | 523 | | |
$ | 930 | |
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INmune Bio (NASDAQ:INMB)
過去 株価チャート
から 8 2024 まで 9 2024
INmune Bio (NASDAQ:INMB)
過去 株価チャート
から 9 2023 まで 9 2024