8-K

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): May 12, 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 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, 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 May 12, 2023, INmune Bio Inc. (the “Company”) is filing as Exhibit 99.1 to this Current Report on Form 8-K a slide deck that the Company intends to use in a presentation. By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.

The information contained in the presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure

Item 9.01 Financial statements and Exhibits

(d) Exhibits.

99.1	Presentation
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: May 12, 2023	By:	/s/ David Moss
		David Moss
		Chief Financial Officer

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EX-99.1

Exhibit 99.1

HARNESSING THE POWER OF THE INNATE IMMUNE SYSTEM INMB Webinar Phase I/II Trial of INKmune ʳ in Metastatic Castration - Resistant Prostate Cancer

FORWARD LOOKING STATEMENTS This presentation contains “forward - looking statements . ” Forward - looking statements reflect our current view about future events . When used in this presentation, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward - looking statements . Such statements, include, but are not limited to, statements contained in this presentation relating to our business strategy, our future operating results and liquidity and capital resources outlook . Forward - looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions . Because forward – looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict . Our actual results may differ materially from those contemplated by the forward - looking statements . They are neither statements of historical fact nor guarantees of assurance of future performance . We caution you therefore against relying on any of these forward - looking statements . Important factors that could cause actual results to differ materially from those in the forward - looking statements include, without limitation, our ability to raise capital to fund continuing operations ; our ability to protect our intellectual property rights ; the impact of any infringement actions or other litigation brought against us ; competition from other providers and products ; our ability to develop and commercialize products and services ; changes in government regulation ; our ability to complete capital raising transactions ; and other factors relating to our industry, our operations and results of operations . There is no guarantee that any specific outcome will be achieved . Investment results are speculative and there is a risk of loss, potentially all loss of investments . Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned . Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them . We cannot guarantee future results, levels of activity, performance or achievements . Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward - looking statements to conform these statements to actual results . INB 03 w , XPro 1595 , and INKmune w 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 . 2 2

INKmune Primed mlNK cell Therapy ( TpNK ) for mCRPC Participants • Matt Rettig MD - Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer at UCLA • Mark Lowdell, PhD – Chief Scientific Officer of INmune Bio, inventor of INKmune technology • RJ Tesi MD – CEO of INmune Bio Agenda 1. Introductions 2. Therapeutic options for men with mCRPC 3. Frustrating history of immunotherapy in mCRPC 4. INKmune MOA 5. Why target NK cells for prostate cancer 6. Why NK cell immunotherapy for mCRPC 7. Unique problems of a NK cell immunotherapy program in mCRPC 8. Unique trial design elements 9. Summary 10. Q&A

Prostate Cancer 2018 2019 2020 2021 2022 Incidence 164,690 174,650 191,930 248,530 268,490 Mortality 29,430 31,620 33,330 34,130 34,500 0 50,000 100,000 150,000 200,000 250,000 300,000 350,000 2018 2019 2020 2021 2022 Incidence: Prostate vs. Breast Cancer Breast Cancer Prostate Cancer Prostate Cancer Incidence and Mortality

2004: Docetaxel 2010: Cabazitaxel 2010: Sipuleucel - T 2011: Abiraterone (post - chemo) 2012: Enzalutamide (post - chemo) 2013: Abiraterone (pre - chemo) 2013: Radium 223 2014: Enzalutamide (post - chemo) Timeline of Drug Development in mCRPC 2004 2010 2012 2014 2016 2018 2020 2022 2020: PARPi ( olaparib , rucaparib) 2017: Pembrolizumab 2022: PSMA radioligand

Agent Sipuleucel - T Abiraterone Enzalutamide Docetaxel Cabazitaxel Radium - 223 PSMA RLT Olaparib Median OS benefit (months) 4.1 Post - doc: 4.6 Pre - doc: 4.4 Post - doc: 4.8 Pre - doc: 4.0 2.4 2.4 3.6 5.3 2.3 Monthly Median OS Benefit of Drugs Approved for mCRPC

WHY NK CELLS AND WHY INKmune? Why NK cells? ▪ NK cells are central to immune surveillance and innately kill cancer cells – people with low NK function have increased lifetime risk of all cancers – ▪ MEN WITH CaPros WITH LOW NK FUNCTION HAVE LOWER OS ▪ NKs help expand the immune response (interact with DCs & initiate T cells response) Why INKmune? ▪ INKmune activates patient’s own NK cells to attack their resistant cancer cells ▪ Tumour - mediated priming generates memory - like NK cells ( TpNK ) which have with enhanced cancer killing function ▪ TpNK upregulate mitochondrial survival proteins which may facilitate survival and anti - cancer function in TME ▪ TpNK upregulate nutrient receptors which may promote proliferation and survival of patient’s NK cells ▪ Induces persistent NK activation in patients beyond 100 days INKmune Logistical advantages: ▪ Off - the - shelf product suitable for local storage for immediate use ▪ No need for patient conditioning , pre - medication or cytokines ▪ Well tolerated and easy to administer as an out - patient

NK cell function in prostate cancer Wu et al 2020 Pasero et al 2015 Peripheral Blood NK cell number Prostate cancer TME NK cell phenotype Reality : Lots of NK cells in TME of prostate cancer Problem: NK cells in TME are resting NK cells (rNK unable to lyse NK - resistant cancer cells) Reality: men with activated NK cells in blood survive longer Solution: convert rNK in blood and TME to tumor killing activated NK cells (TpNK) Resting NK cells Activated NK cells NK - Tumor TROGOCYTOSIS Tumor - derived Inhibitory signals Activating signals NK - resistant tumour Activating signals Add INKmune Tumor - derived Inhibitory signals Activating signals Lysis of NK - resistant tumour INKmune converts patient’s rNK cells to tumor killing TpNK cells

Lymphoma Myeloma Myeloma Prostate INKmune Ρ primes NK to lyse NK - resistant DU145 cells TpNK function in the hostile environment of the TME Problem: patient’s rNK cells do not kill NK resistant CaPros Solution: INKmune primed rNK cells become memory - like TpNK cells that kill NK resistant CaPros Problem: hypoxic immunosuppressive TME inhibits function of cytokine activated NK cells Solution: TpNK kill tumor cells normally in hostile TME TpNK “fitter” than cytokine primed NK hours

TpNK “fitter” than cytokine primed NK Only INKmune induces changes which protect NK in TME rNK LAK - 15 CIML - NK INKMUNE - TpNK proteomics G A T B G A T C G F M 2 H A R S 1 H A R S 2 L A R S 2 M R P L 1 0 M R P L 1 6 M R P L 2 M R P L 2 3 M R P L 4 7 M R P L 5 1 M R P L 5 7 M R P S 1 1 M R P S 1 2 M R P S 1 5 M R P S 1 6 M R P S 1 7 M R P S 1 8 A M R P S 1 8 B M R P S 1 8 C M R P S 2 M R P S 2 1 M R P S 2 4 M R P S 3 4 M R P S 6 M R P S 7 N D U F A 7 N O A 1 P T C D 3 Q R S L 1 R A R S 2 -2 -1 0 1 2 3 Change in mitochondrial survival proteins following priming Mitochondrial survival proteins L o g c h a n g e f r o m r N K ( A v e r a g e L o g r a t i o ) TpNK CIML IL15 R e s t i n g N K c e l l s T p N K C i M L - N K 0.00 0.05 0.10 0.15 0.20 O C R ( p m o l e s / m i n ) Basal Mitochondria Respiration R e s t i n g N K c e l l s T p N K C i M L - N K 0.0 0.1 0.2 0.3 O C R ( p m o l e s / m i n ) Maximal Mitochondria Respiration

mCRPC Phase I/II protocol • FDA “must haves” for trial design: • Understand short and long - term safety of product in target population • Justify dose to be used in pivotal trial • INmune Bio “must haves” for trial design: • Safety in target population • Evidence of Proof - of - Biology – evidence of anti - tumor effect • A dose that is practical for commercialization ( eg : manufacturing cost) • Unique Problem: • measures of NK function in blood may not correlate with NK activity in TME • Solution: modified BOIN12 trial design ( www.trialdesign.org ) • Bayesian Optimal Interval Phase I/II trial for utility dose finding • Allows for continuous safety and dosing evaluation to optimize dosing decision

mCPRC mBOIN12 – a two step trial • Step 1: 3X3 dose escalation “run - in” to demonstrate: • short - term safety (28 days) • short - term immunologic efficacy • Step 2: simultaneous testing of multiple doses to: • Demonstrate long - term safety (6 month) • Demonstrate proof - of - biology (PO = anti - tumor effects) • POB “efficacy” measures - PSA, ctDNA and PSMA PET • Quantify long - term immunologic efficacy - persistence Desired Outcome: clear safety and POB to support dose selection and investment decision for blinded randomized trial

mBION12 mCRPC • Inclusion criteria: mCRPC without contraindications or recent chemo or immunotherapy • Exclusions: chronic viral infection, short life expectancy • Definition of effective dose • Safe • Evidence of anti - tumor effects • Manufacturing efficiency low dose middle dose high dose 1 1 1 1 1 1 1 1 1 Short term safety Immunologic efficacy 6 patients 6 patients long term safety Immunologic efficacy Anti tumor effects 6 patients 6 patient confirmatory group In this example: SRC choses middle dose for pivotal trial Definitions: • Short and long - term safety – no drug related AEs • Short - term immunologic efficacy – converts patient’s NK cells to TpNK cells that kill tumor cells (ex vivo assay) • Long - term immunologic efficacy – persistence of TpNK cells in patient’s circulation • Anti - tumor effects – evidence of control of tumor burden by PSA, PSMA and/or ctDNA Step 1 Step 2

14 Thank you Contact: mlowdell@inmunebio.com

XML

Cover	May 12, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 12, 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 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