8-K
Inmune Bio, Inc. (INMB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date of earliest event reported):
December 18, 2023
| 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<br>Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under<br>the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under<br>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 8.01. Other Events.
On December 18, 2023, INmune Bio Inc. (the “Company”), issued a press release announcing that the Company received notification by the FDA that the US Phase II trial remains on full clinical hold pending a request for additional information on long-term potency.
A copy of the press release is attached herewith as Exhibit 99.1.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release dated December 18, 2023 |
|---|---|
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
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: December 18, 2023 | By: | /s/ David Moss |
| David Moss | ||
| Chief Financial Officer |
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Exhibit99.1
INmuneBio Provides Update Regarding Global Alzheimer’s Phase II Clinical Trial and Clinical Hold Issued by the United States FDA
Enrollmentin the Company’s Phase II study using XPro^TM^ to treat patients with Alzheimer’s Disease with neuroinflammationis accelerating in sites outside the US and the Company is maintaining its timeline to successfully conclude the trial.
Inthe US, the previously identified clinical hold issues have been successfully addressed however the Phase II study remains on clinicalhold pending additional information on long-term stability which the Company will provide before the end of 2023.
BocaRaton, Florida, Dec. 18, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XPro^TM^ (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, is on track to complete enrollment of its Phase II clinical trial in patients with early Alzheimer’s Disease and biomarkers of inflammation in 2024. The Company received notification by the FDA that the US Phase II trial remains on full clinical hold pending a request for additional information on long-term potency.
The request came following the most recent submission to the FDA that showed a possible increase in the long-term potency of XPro^TM^. The Company will provide clarification to the FDA in a response before the end of the year that it believes will resolve the remaining questions. “We remain discussion with the FDA regarding the clinical hold,” said RJ Tesi, CEO of INmune Bio. “The hold will not impact our progress in completing the Phase II AD study on schedule, as our patient recruitment projections are solely reliant on sites outside of the US.”
The trial is open in Australia, Canada, the United Kingdom, Poland, France, Spain and is expected to open soon in several additional EU countries. To date, the FDA remains the only regulatory agency to put the Phase II clinical trial on hold.
AboutINmune 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. XPro^TM^ is in a blinded randomized placebo controlled clinical trial to treat Early Alzheimer’s disease in patients with biomarkers of neuroinflammation. The Natural Killer Cell Priming Platform, INKmune™, primes patient’s NK cells to eliminate minimal residual disease in patients with cancer. INKmune is in early phase clinical trials in MDS/AML and metastatic Castration Resistant Prostate 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.
ForwardLooking 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.
INmuneBio Contact:
David Moss, CFO (858) 964-3720
info@inmunebio.com
Investor Contact:
Jason Nelson
Core IR
(516) 842-9614 x-823