0001213900-19-019987.txt : 20191008 0001213900-19-019987.hdr.sgml : 20191008 20191008163020 ACCESSION NUMBER: 0001213900-19-019987 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20191008 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20191008 DATE AS OF CHANGE: 20191008 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: 191142945 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 f8k100719_inmunebio.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): October 8, 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 October 8, 2019, INmune Bio, Inc. (the “Company”) published a press release (the “Press Release”) announcing that RJ Tesi, M.D., Co-Founder and CEO will present at the 2nd Annual Advances in Immuno-Oncology USA Congress in San Diego taking place on October 8 and October 9, 2019, and that Dr. Tesi and CJ Barnum, Ph.D., Director of Neuroscience for the Company, will also present at the World Immunotherapy Congress taking place in Basel Switzerland from October 15 through October 17, 2019.

 

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

  

 

 

 

 

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: October 8, 2019 By:   /s/ David Moss
    David Moss
    Chief Financial Officer

 

 

 

EX-99.1 2 f8k100719ex99-1_inmunebio.htm INMUNE BIO PRESS RELEASE

 

Exhibit 99.1

 

INmune Bio Inc. to Present at Advances in Immuno-Oncology USA Congress and at World Immunotherapy Congress in October

LA JOLLA, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today that RJ Tesi, M.D., Co-Founder and CEO, will present at the 2nd Annual Advances in Immuno-Oncology USA Congress in San Diego taking place on Oct. 8 and Oct. 9. Dr. Tesi and CJ Barnum, Ph.D., Director of Neuroscience, will also present at the World Immunotherapy Congress taking place in Basel, Switzerland from Oct. 15 through 17.

“The immuno-oncology field is rapidly growing, and emerging new therapies are at the center of attention,” said Dr. Tesi. “With 30% of breast cancer patients being HER2+, trastuzumab has made significant strides in the treatment of breast cancer. Yet, many HER2+ breast cancer patients have shown resistance to the drug. In my presentation during the Advances in Immuno-Oncology USA Congress, I will address one of the reasons for the resistance – specifically the presence of the MUC4 biomarker – and how we may be able to use a soluble TNF inhibitor, such as our drug candidate INB03, to increase the efficacy of trastuzumab in those women who have shown resistance.”

Advances in Immuno-Oncology USA Congress brings together global pharmaceutical organizations, leading biotech companies and presents a unique chance to connect scientists on the latest innovations in immuno-oncology therapy development, research and more.

“Our approach to treating patients with Alzheimer's disease is focused on targeting the root of the disease, chronic inflammation and how we can leverage biomarkers,” said Dr. Barnum. “It’s an honor to have the opportunity to present alongside some of the most prominent leaders in the immunotherapy community to approach the field from a non-oncology perspective.”

The World Immunotherapy Congress is one of four conferences coordinated by the Festival of Biologics. The vision of the World Immunotherapy Congress is to bring together the full community and provide a single meeting point for where science meets business to make immunotherapy the cornerstone of the fight against cancer and other diseases.

Details on each speaking engagement can be found below:

Advances in Immuno-Oncology USA Congress:
Tuesday, October 8 at 5:20 p.m.
“Targeting Soluble TNF To Reverse Trastuzumab Resistance”
Dr. Tesi will address trastuzumab resistance in breast cancer patients due to the presence of MUC4, and the role of soluble TNF in MUC4 expression in HER2+ breast cancer. He will discuss how using INB03 as part of combination therapy may have positive effects in reversing trastuzumab resistance.

 

 

 

Wednesday, October 9 at 8:00 a.m.
“Alternative Therapeutic Strategies Beyond Checkpoint Inhibitors”
Serving as a moderator, Dr. Tesi will lead a table discussion of notable company spokespeople, covering the latest advances in immunotherapy.

World Immunotherapy Congress:
Tuesday, October 15 at 3:10 p.m.
“Targeting Protector Cells of the TME to Improve Efficacy of Immunotherapy”
Dr. Tesi will lead a discussion around “protector cells” of the TME and how they promote resistance to immunotherapy, and how eliminating MDSC and TAM will improve response to therapy. He will also discuss how INmune’s drug, INB03 targets sTNF as an effective strategy for eliminating MDSC and TAM.

The “Tumor microenvironment” session of the conference will be chaired by Dr. Tesi.

Wednesday, October 16 at 4:40 p.m.
“Approaching Alzheimer’s disease as an immunological disease: role of biomarkers”
Dr. Barnum will discuss how innate immune regulation causes chronic inflammation and development of Alzheimer’s disease, and how approaching AD as an immunological disease changes the clinical strategy, especially when developing biomarkers.

Dr. Barnum will also chair the “Immunotherapy for non-oncology” session of the conference.

About INmune Bio, Inc.
INmune Bio, Inc. is a publicly traded (NASDAQ: INMB) clinical-stage biotechnology company developing therapies targeting the innate immune system to fight disease. INmune Bio is developing three product platforms: two products that reengineer the patient’s innate immune system’s response to cancer and one product to treat neuroinflammation that is currently focused on Alzheimer’s disease. INKmune 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. INB03 inhibits myeloid-derived suppressor cells (MDSC), which often cause resistance to immunotherapy, such as anti-PD-1 checkpoint inhibitors. XPro1595 targets neuroinflammation, which causes microglial activation and neuronal cell death. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.

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, XPro1595, INKmune and NeuLiv are still in clinical trials and have not been approved and there cannot be any assurance that they 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.

 

 

 

INmune Bio 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 / Scott Eckstein 
PH: (212) 896-1254 / (212) 896-1210
INmune@KCSA.com