0001213900-19-017870.txt : 20190912 0001213900-19-017870.hdr.sgml : 20190912 20190912163017 ACCESSION NUMBER: 0001213900-19-017870 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20190912 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190912 DATE AS OF CHANGE: 20190912 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Inmune Bio, Inc. CENTRAL INDEX KEY: 0001711754 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 475205835 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38793 FILM NUMBER: 191090689 BUSINESS ADDRESS: STREET 1: 1200 PROSPECT STREET STREET 2: SUITE 525 CITY: LA JOLLA STATE: CA ZIP: 92037 BUSINESS PHONE: 8589643720 MAIL ADDRESS: STREET 1: 1200 PROSPECT STREET STREET 2: SUITE 525 CITY: LA JOLLA STATE: CA ZIP: 92037 8-K 1 f8k091219_inmunebioinc.htm CURRENT REPORT

 

 

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): September 12, 2019

 

  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.)

 

1200 Prospect Street, Suite 525 La Jolla, CA 92037

(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   INMB   NASDAQ

 

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 7.01 Regulation FD Disclosure

 

On September 12, 2019, INmune Bio, Inc. (the “Company”) published a press release (the “Press Release”) announcing that that the United States Patent and Trademark Office (USPTO) has given formal notice of allowance to Patent Application Serial No. 15/776,061, titled “CANCER PREVENTION AND THERAPY BY INHIBITING SOLUBLE TUMOR NUCROSIS FACTOR”, which covers the Company’s INB03 Program utilizing dominant negative TNFα (DN-TNFα) technology for treating cancer.

 

A copy of the Press Release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. Exhibits 99.1 shall not be deemed “filed” for purposed 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 into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.

 

Item 9.01 Financial statements and Exhibits

 

(d) Exhibits.

 

Exhibit Number   Description
99.1   INmune Bio Press Release

 

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SIGNATURE

 

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: September 12, 2019 By: /s/ David Moss
    David Moss
    Chief Financial Officer

 

 

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EX-99.1 2 f8k091219ex99-1_inmunebio.htm INMUNE BIO PRESS RELEASE

Exhibit 99.1

 

INMUNE BIO INC. ANNOUNCES USPTO ALLOWANCE OF KEY PATENT COVERING ITS DN-TNFα PLATFORM TECHNOLOGY FOR TREATING CANCER

 

La Jolla, CA September 12, 2019 INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that reprogram the patient’s innate immune system to fight disease, announced today that the United States Patent and Trademark Office (USPTO) has given formal notice of allowance to Patent Application Serial No. 15/776,061, titled “CANCER PREVENTION AND THERAPY BY INHIBITING SOLUBLE TUMOR NUCROSIS FACTOR”, which covers INmune’s INB03 Program utilizing dominant negative TNFα (DN-TNFα) technology for treating cancer.

 

“This is an important patent for INmune Bio, Inc. and provides exclusivity for use of our DN-TNFα technology for the treatment of cancer,” said Joshua Schoonover, Assoc. General Counsel of INmune Bio. “With the approval from the USPTO, and the positive indication of allowable subject matter in the international preliminary report on patentability for the corresponding international PCT patent application, published as WO/2017/106278, we expect this patent family should develop into global intellectual property rights.”

 

INMB has presented preliminary data from the Phase I trial using INB03 in patients with advanced cancer. The study demonstrated the safety of INB03 in cancer patients and showed that INB03 lowered IL6 levels – a biomarker that correlates with neutralization of soluble TNF.

 

“The inventors of this patent have made an important contribution to the field of cancer biology and cancer therapy,” said RJ Tesi, MD, CEO of INmune Bio. “With the successful completion of the Phase I trial, the company has already begun planning of a Phase II clinical trial in cancer patients where INB03 is used as part of combination immunotherapy.”

 

The allowed patent application is owned by the University of Pittsburgh and is licensed exclusively to INmune Bio, Inc.

 

 

 

 

About INB03

 

INB03, a novel dominant-negative TNFα inhibitor, is a selective second-generation TNFα inhibitor that neutralizes soluble TNFα (sTNFα) without blocking the function of trans-membrane TNFα or TNFα receptors. In animal studies, INB03 neutralization of sTNFα alters the immunobiology of the tumor microenvironment (TME) to improve tumor killing by decreasing populations of cells in the TME that protect the tumor from the patient’s immune system and immunotherapy - myeloid derived suppressor cells, T regulatory cells and tumor activated macrophages. The unique mechanism of action suggests INB03 may have safety and efficacy advantages over currently approved non-selective TNFα inhibitors in the treatment of cancer and other diseases.

 

About INmune Bio, Inc.

 

INmune Bio, Inc. is a publicly traded (NASDAQ: INMB) clinical-stage immunology company developing therapies targeting the innate immune system to fight disease. INmune Bio is developing two product platforms, the DN-TNFα Platform and an Immune Priming Platform, as well as multiple products related to these platforms that reengineer the patient’s innate immune system’s response to disease.

 

In addition to INB03, the DN-TNFα Platform includes XPRO1595, a DN-TNFα protein biologic that targets soluble TNFα (sTNFα) and may have many beneficial effects in patients with Alzheimer’s disease by decreasing neuroinflammation; and NeuLiv, also a DN-TNFα protein biologic that may enable targeting of the underlying cause of non-alcoholic steatohepatitis (NASH), to help stop the disease and allow the liver to heal.

 

The Immune Priming Platform includes INKmune, which is a natural killer (NK) cell therapeutic that primes the patient’s NK cells to attack minimal residual disease, the remaining cancer cells that are difficult to detect, which often cause relapse.

 

INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and neurodegenerative diseases. To learn more, please visit www.inmunebio.com.

 

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Forward Looking Statements

 

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. INBO3 is still in clinical trials and has not been approved and there cannot be any assurance that it will be approved. 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 for the year ended December 31, 2018, 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.

 

Contact

 

David Moss, CFO

(858) 964-3720

DMoss@INmuneBio.com

 

Media Contact:

Antenna Group

Holly Dugan

(201) 465-8019

INmuneBio@AntennaGroup.com

 

Investor Contact:

KCSA Strategic Communications

Valter Pinto / Daniela Guerrero

PH: (212) 896-1254 / (347) 487-6187

INmune@KCSA.com

 

 

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