UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in charter) |
(State or other jurisdiction | (Commission File Number) | (IRS Employer | ||
of incorporation) | Identification No.) |
(Address of Principal Executive Offices) (Zip Code)
(
(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 | ||
The
|
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 October 27, 2021, INmune Bio Inc., a Nevada corporation (the “Company”), issued a press release announcing multiple poster presentations and a plenary talk at the upcoming 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting, being held in a hybrid format (in-person and virtual) from November 9-12 in Boston.
Details of the presentations are as follows:
Late-breaking oral presentation:
Title: The Early Mild Alzheimer’s Cognitive Composite (EMACC): a meaningful primary cognitive endpoint in a phase 2 trial of XPro1595 in Alzheimer’s Disease (AD) with inflammation (ADi)
Presenter: Dr. Judith Jaeger, Cognitionmetrics and Albert Einstein College of Medicine, Stamford, CT and Bronx, NY
Session: LB12
Date: Friday, November 12 (onsite)
Time: 9:55am ET
Late-breaking oral communication:
Title: Analyzing the CSF proteome to support decisions in an AD clinical trial program
Theme: Clinical trials: biomarkers including plasma
Poster (on-demand/virtual): LBR7
Date: Tuesday, November 9
Time: presentation will be available beginning at 8:00am ET
Poster presentations:
Title: Novel white matter imaging measures of neuroinflammation, axonal density and demyelination as potential biomarkers for trials in the AD spectrum: validation in the largescale longitudinal multicenter ADNI studies
Theme: Clinical trials: imaging
Poster (onsite): LP3
Time: all posters will be available beginning November 9 at 8:00am ET
1
Title: MRI measures of white matter pathology can replace CSF sampling in AD clinical trials – case study from the XProTM a phase 1 trial in Alzheimer’s patients with neuroinflammation
Theme: Clinical trials: imaging
Poster (onsite): LP4
Time: all posters will be available beginning November 9 at 8:00am ET
Title: Planning for Success: a Three-step process to Define Phase II Trial Size and Duration Using a Patient Enrichment Strategy using Phase I Data and Public Databases
Theme: Clinical trials: methodology
Poster (onsite): LP11
Time: all posters will be available beginning November 9 at 8:00am ET
A copy of this press release is attached as Exhibit 99.1
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
99.1 | Press Release dated October 27, 2021 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
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: October 28, 2021 | By: | /s/ David Moss |
David Moss | ||
Chief Financial Officer |
3
Exhibit 99.1
INmune Bio, Inc. Announces Multiple Oral and Poster Presentations at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting
Boca Raton, Florida, Oct. 27, 2021 (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, today announced multiple poster presentations and a plenary talk at the upcoming 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting, being held in a hybrid format (in-person and virtual) from November 9-12 in Boston.
Details of the presentations are as follows:
Late-breaking oral presentation:
Title: The Early Mild Alzheimer’s Cognitive Composite (EMACC): a meaningful primary cognitive endpoint in a phase 2 trial of XPro1595 in Alzheimer’s Disease (AD) with inflammation (ADi)
Presenter: Dr. Judith Jaeger, Cognitionmetrics and Albert Einstein College of Medicine, Stamford, CT and Bronx, NY
Session: LB12
Date: Friday, November 12 (onsite)
Time: 9:55am ET
Late-breaking oral communication:
Title: Analyzing the CSF proteome to support decisions in an AD clinical trial program
Theme: Clinical trials: biomarkers including plasma
Poster (on-demand/virtual): LBR7
Date: Tuesday, November 9
Time: presentation will be available beginning at 8:00am ET
Poster presentations:
Title: Novel white matter imaging measures of neuroinflammation, axonal density and demyelination as potential biomarkers for trials in the AD spectrum: validation in the largescale longitudinal multicenter ADNI studies
Theme: Clinical trials: imaging
Poster (onsite): LP3
Time: all posters will be available beginning November 9 at 8:00am ET
Title: MRI measures of white matter pathology can replace CSF sampling in AD clinical trials – case study from the XProTM a phase 1 trial in Alzheimer’s patients with neuroinflammation
Theme: Clinical trials: imaging
Poster (onsite): LP4
Time: all posters will be available beginning November 9 at 8:00am ET
Title: Planning for Success: a Three-step process to Define Phase II Trial Size and Duration Using a Patient Enrichment Strategy using Phase I Data and Public Databases
Theme: Clinical trials: methodology
Poster (onsite): LP11
Time: all posters will be available beginning November 9 at 8:00am ET
About XPro
XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and differentiates itself from existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have 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 please 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 akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.
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 DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trial to determine if it can treat for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and treatment resistant depression (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the 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 malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.
2
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™, Quellor™, XPro1595, LIVNate™, and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved 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
DMoss@INmuneBio.com
Investor Contact:
Chuck Padala
LifeSci Advisors
(646) 627-8390
3
Cover |
Oct. 27, 2021 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Oct. 27, 2021 |
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 Blvd. |
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 shares |
Trading Symbol | INMB |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
3MUX#-$$)!N!O&+T^*J,]9.7Z;+9Q4_Z@M)JP
M:'VWFC!C+U(;-\\/2J )^XB"1>2%,=@/FD=C(W=K*?VI8*6GQ^TEC\BYZ5E+
MV)\?-WM$ON,MLW<,ZYN/,9M)4K&@"Q&/-SFY8%I'!%]"G",%B[:Y?$3P>HLW
M];J!$Y*FPO6"5B)@]*.&$FY%9C6FZUFC-F6C3AFQ)G5ZT+@[)#+ 8#$3Y,+S
MG]I4,[UTD O\I+:(-I.D(VAF,V%/#KW(*[1#\=2_=3:*!Y"\-DMB "CI&(
MWOG_G &]<83YJ!RUM5'7"/"GV:A(KAWX[9FJ^&L73=7TQDWW@])I:ZI^/(J.
MU]T+E7HT0T=.TY5E9ML83]?J68Q%@=0FGC;B4SRB+(L;L.1"K)BUFA