UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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The |
Item 1.01 Entry into a Material Definitive Agreement.
As previously disclosed in its filings with the Securities and Exchange Commission, on October 29, 2015, INmune Bio Inc. (the “Company”) entered into an exclusive license agreement (as subsequently amended, the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”). Pursuant to the INKmune License Agreement, the Company was granted an exclusive worldwide, sub-licensable, royalty-bearing license to commercialize INKmune (the “INKmune License”). In consideration for the INKmune License, the Company was obligated to pay Immune Ventures certain milestone and royalty payments.
On April 17, 2023, the Company entered into an additional amendment to the INKmune License Agreement (the “INKmune Amendment”) to remove the due diligence requirements of the INKmune License Agreement, including using reasonable commercial efforts to bring licensed products and services to market, removing all initiation of clinical trial requirements, and the filing of an NDA or equivalent upon successful completion of Phase III clinical trials. Except as specifically modified or amended by the terms of the INKmune Amendment, the INKmune License Agreement and all provisions contained therein are, and shall continue, in full force and effect.
As previously disclosed in the Company’s filing with the Securities and Exchange Commission, the Company and the University of Pittsburgh entered into an Exclusive License Agreement on June 26, 2017 (the “PITT Agreement), which was amended on September 20, 2017 (the First PITT Amendment”).
On April 17, 2023, the Company entered into the Second Amendment to Exclusive License Agreement to the PITT Agreement (the “Second PITT Amendment”). Under the Second PITT Amendment, certain due diligence requirements were removed under the PITT Agreement and replaced with the following: (i) the dose of the first patient in a Phase II Clinical Trial or foreign equivalent using the licensed technology under the PITT Agreement would occur by June 26, 2026, and (ii) the requirement to obtain marketing authorization from the FDA or foreign equivalent for a product making use of the licensed technology by June 26, 2031. In addition, the patent rights disclosure was updated. Except as specifically modified or amended by the terms of the PITT Amendment, the PITT Agreement and all provisions contained therein are, and shall continue, in full force and effect.
The information set forth above is qualified in its entirety by reference to the Assignment Agreement, the INKmune License Agreement, the PITT Agreement, the First PITT Amendment, the INKmune Amendment and the Second PITT Amendment, attached hereto as Exhibit 10.1 and 10.2, each of which are incorporated herein by reference.
Item 8.01. Other Events
On April 19, 2023, the Company issued a press release announcing pre-clinical data detailing research led by Kirsty J. Dixon of the Department of Surgery, Virginia Commonwealth University (VCU), and Elliott Mufson, Barrow Neurological Institute. A copy of this press release is attached herewith as Exhibit 99.1.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
10.1 | First Amendment to Exclusive License Agreement between INmune Bio Inc. and Immune Ventures LLC dated April 17, 2023. | |
10.2 | Second Amendment to Exclusive License Agreement by and between the University of Pittsburgh of the Commonwealth system of Higher Education and Immune Ventures, LLC dated April 17, 2023 | |
99.1 | Press Release dated April 19, 2023 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
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.
Date: April 20, 2023 | INMUNE BIO INC. | |
By: | /s/ David Moss | |
David Moss | ||
Chief Financial Officer |
2
Exhibit 10.1
FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (“First Amendment”) is made as of April 17, 2023 by and between Immune Ventures, LLC (“Licensor”) and INmune Bio, Inc., a Nevada corporation, having a principal place of business at 225 NE Mizner Blvd., STE 640, Boca Raton, FL 33432 (“Licensee”), each a “Party” and collectively the “Parties”.
RECITALS
WHEREAS, Licensor and Licensee previously entered into an Exclusive License Agreement with effective date of October 29, 2015 (the “Agreement”); and
WHEREAS, the parties now wish to amend the Agreement as further set forth herein.
NOW, THEREFORE, in consideration of the foregoing and for good and valuable consideration, the receipt and sufficiency which are hereby acknowledged, the parties hereby agree as follows:
1. Definitions. Each initially capitalized term used herein without definition shall have the meaning ascribed to such term in the Agreement.
2. Amendments.
2.1 It is hereby agreed that Article 6 of the Agreement, including each of Sections 6.1, 6.2, and 6.3 therein, shall be deleted, and all obligations therein shall be removed, effective as of the date hereof.
3. Full Force and Effect. Except as specifically modified or amended by the terms of this First Amendment, the Agreement and all provisions contained therein are, and shall continue, in full force and effect and are hereby ratified and confirmed.
4. Counterparts. This First Amendment may be executed in any number of separate counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same instrument. Alternatively, this First Amendment may be executed by electronic signatures.
5. Miscellaneous. This First Amendment shall be binding upon all the parties to the Agreement and their respective successors and assigns.
[Signature Page Follows]
IN WITNESS WHEREOF, the parties hereto have caused this FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT to be duly executed and delivered by their proper and duly authorized officers as of the day and year first above written.
IMMUNE VENTURES, LLC | ||
By | /s/ David Moss | |
Name: | David Moss | |
Title: | Managing Member | |
Date: | 4/17/2023 | |
INMUNE BIO, INC. | ||
By | /s/ David Moss | |
Name: | David Moss | |
Title: | CFO | |
Date: | 4/17/2023 |
Exhibit 10.2
SECOND AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This SECOND AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (this “Second Amendment”) is made as of April 6, 2023, by and between the University of Pittsburgh – Of the Commonwealth System of Higher Education, a non-profit corporation organized and existing under the laws of the Commonwealth of Pennsylvania (“University”) and INmune Bio, Inc (“Licensee”).
WHEREAS, University and Licensee have previously entered into an Exclusive License Agreement with effective date of June 26, 2017, as previously amended by the parties on September 20, 2017 (the “Agreement”); and
WHEREAS, the parties wish to further amend the Agreement as set forth herein.
NOW, THEREFORE, in consideration of the foregoing and for good and valuable consideration, the receipt and sufficiency which are hereby acknowledged, the parties hereby agree as follows:
1. | Amendments to Agreement. |
(a) | Section 3.2 (b)-(c) of the Agreement is hereby deleted in its entirety and replaced as follows: |
“(b) Dose the first patient in a Phase II Clinical Trial or foreign equivalent using the Licensed Technology by June 26, 2026; and
(c) Obtaining marketing authorization from the FDA or foreign equivalent for a product making use of the Licensed Technology by June 26, 2031.”
(b) | Exhibit A in the Agreement is hereby replaced in its entirety with the Exhibit A attached hereto. |
2. | Miscellaneous. |
(a) | Except as specifically amended above, all terms of the Agreement shall remain in full force and effect. To the extent that there are any inconsistencies between the terms of the Agreement and the terms of this Second Amendment, the terms of this Second Amendment shall prevail in effect. |
(b) | The parties acknowledge that this Second Amendment and the Agreement set forth the entire understanding and intentions of the parties hereto as to the subject matter hereof and supersedes all previous understandings between the parties, written or oral, regarding such subject matter. |
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IN WITNESS WHEREOF, the parties represent and warrant that each has the authority to bind the party to this Agreement and hereto have executed this Second Amendment as of the date first written above.
UNIVERSITY OF PITTSBURGH – OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION | ||
By | /s/ Evan Facher | |
Evan Facher, Ph.D., MBA | ||
Director, Innovation Institute | ||
Vice Chancellor for Innovation and Entrepreneurship | ||
LICENSEE | ||
By | /s/ David Moss | |
Name: | David Moss | |
Title: | CFO |
2
Exhibit 99.1
XPro1595 Improves Outcomes in a Mouse Model of TBI-induced Alzheimer’s Disease
TNF is involved in the development of Alzheimer’s Disease pathology following traumatic brain injury and is prevented by neutralization of soluble TNF by XPRO™
Boca Raton, Florida, April 19, 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, announced pre-clinical data detailing research led by Kirsty J. Dixon of the Department of Surgery, Virginia Commonwealth University (VCU), and Elliott Mufson, Barrow Neurological Institute. In the pre-clinical study, Alzheimer’s Disease related amyloid pathology increased after Traumatic Brain Injury (TBI) in an at-risk mouse model. Treatment with XPro™ one hour after TBI prevents the development of amyloid pathology in the brain. These data show that soluble TNF drives the development of amyloid pathology after TBI, which can be prevented by neutralizing sTNF with XPro™.
“The unfortunate reality of TBI is that the acute injury often overshadows the long-term consequences, which includes the potential for later developing Alzheimer’s disease,” said Kirsty Dixon, Assoc. Prof. of Surgery at VCU. “My team that includes Ph.D. student Michelle Taylor, and MD/Ph.D. student Chelsie Poffenberger investigate the role of soluble TNF in both the acute injury setting and chronically following TBI. We hope this research may determine the relationship between TBI and AD.”
“TBI remains a major health problem affecting more than 50 million people worldwide per year,” said RJ Tesi MD, CEO of INmune Bio, “Few realize that the elderly have the greatest risk of hospitalizations and death due to TBI. The ability of XPro to prevent amyloid formation after head injury suggests early intervention may help to prevent the development of AD in the elderly with TBI.”
The Company provided XPro1595 to Kirsty Dixon and her research team through an MTA collaboration with VCU. The Company, and its research partners continue to investigate the involvement of soluble TNF and potential applications of XPro1595 for treating disease. The data was presented in a poster at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Disease in Gothenburg, Sweden on 1 April 2023.
About XPro1595
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials 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 potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation and restoring innate immune cell function. 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 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™), 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, CFO (858) 964-3720
info@inmunebio.com
Investor Contact:
Jason Nelson
Core IR
(516) 842-9614 x-823
Cover |
Apr. 17, 2023 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Apr. 17, 2023 |
Entity File Number | 001-38793 |
Entity Registrant Name | INMUNE BIO INC. |
Entity Central Index Key | 0001711754 |
Entity Tax Identification Number | 47-5205835 |
Entity Incorporation, State or Country Code | NV |
Entity Address, Address Line One | 225 NE Mizner Boulevard |
Entity Address, Address Line Two | Suite 640 |
Entity Address, City or Town | Boca Raton |
Entity Address, State or Province | FL |
Entity Address, Postal Zip Code | 33432 |
City Area Code | 858 |
Local Phone Number | 964-3720 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.001 per share |
Trading Symbol | INMB |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
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