INMB INmune Bio Inc

 

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): March 4, 2025

 

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 mark 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.

 

INmune Bio Inc. (the “Company”) has prepared a slide deck that the Company intends to use in presentations from time to time (the “Presentation”). The Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in any such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Investor Presentation
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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: March 4, 2025	By:	/s/ David Moss
	Name:	David Moss
	Title:	Chief Financial Officer

 

 

 

2

 

Exhibit 99.1

 

INMB Nasdaq In vivo activation of mlNK cells with INKmune Preliminary results from a phase I/II trial in metastatic, castration - resistant prostate cancer Mark Lowdell CSO INmuneBio Inc INMB Nasdaq Innate Killer Summit March 2025

2 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 e xpr essions, 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 a re 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 rel yin g 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 infri nge ment actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in go vernment regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. The re 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 re sults may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause our actual results to dif fer 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. Exc ept 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 stat ements to actual results. ​

3 Evidence for tumor - primed mlNK

4 NK - Tumor TROGOCYTOSIS Resting NK Resting NK o/n TpNK o/n MoA of INKmune

5 R a j i D A U D I S K O V 3 S K O V 3 S K O V 3 7 6 8 O 7 6 8 O 7 6 8 O 7 6 8 O 7 6 8 O 7 6 8 O 7 6 8 O 7 6 8 O 7 6 8 O M D S - L M D S - L M D S - L M D S - L M D S - L 0 20 40 60 80 100 % s p e c i f i c l y s i s rNK TpNK Ovarian cancer patients Renal Cell cancer patients MDS patients R a j i 7 8 6 O A C H N S K O V 3 N P C H 3 N P C C 1 7 U 2 6 6 M D S - L K 5 6 2 O V C A R 0 50 100 % o f s p e c i f i c l y s i s rNK TpNK Pt NK – primary tumors HD NK – tumor cell lines CaPr TiML NK target solid tumors Arellano Ballestero J Immunotherapy 2024

6 INKmune potential MoA 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 Arellano Ballestero J Immunotherapy 2024

7 Rapid proliferation of NK cells ex - vivo leads to reduced mitochondrial fitness; decreased membrane potential and increased levels of mitochondrial reactive oxygen species ( mtROS ) Mitochondrial fitness has to be restored for the persistence of long - term NK cell function; this is achieved by mitophagy or the removal of damaged mitochondria IL15 upregulated nutrient receptors = 1 INKmune - mediated effects on mitochondrial function and nutrient receptors SLC1A4 INKmune upregulated nutrient receptors = 37 SLC39A9, SLC30A9, SLC25A16, SLC1A5, SLC25A38, SLC2A1, SLC39A10, SLC5A3, SLC25A14, SLC16A3, SLC35B2, SLC27A4, SLC19A1, SLC25A33, SLC25A40, SLC37A4, SLC25A22, SLC37A4, SLC12A4, SLC6A6, SLC25A19, SLC16A3, SLC25A53, SLC17A5, SLC39A8, SLC29A1, SLC35A2, SLC7A6, SLC25A26, SLC30A1, SLC18B1, SLC6A6, SLC25A3, SLC25A53, SLC39A8, SLC9A6, SLC11A2, SLC35A2, SLC12A7, SLC25A29 R e s t i n g N K c e l l s T i M L - 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 i M L - 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 R e s t i n g N K c e l l s T i M L - N K C i M L - N K 0.0 0.1 0.2 0.3 E C A R ( m p H / m i n ) Spare respiratory capacity p=0.027 Arellano Ballestero J Immunotherapy 2024

8 INKmune mCRPC Phase I/II Trial Design Low - dose 1x10 8 Middle - dose 3x10 8 High - dose 5 x10 8 1 1 1 1 1 1 1 1 1 Step 1: Short term safety Immunologic efficacy 6 patients 6 patients Step 2: Long term safety Immunologic efficacy Anti - tumor effects 6 patients Confirmatory group In this example: SRC choses middle dose for pivotal trial Trial will determine: • Effective dose: safe with evidence of tumor effects • Short and long - term safety – no drug related serious adverse effects • Immunologic efficacy – converts patient’s NK cells to mlNK cells that kill tumor cells (ex vivo assay) with long - term persistence of mlNK cells in patient’s circulation • Anti - tumor effects – evidence of control of tumor burden by PSA, PSMA and/or ctDNA Now enrolling Now enrolling

CARE - PC – clinical sites PI Name Location Site Name Site Number Matthew Rettig Los Angeles, CA VA Greater Los Angeles Healthcare 101 Alexander Starodub Cincinnati, OH The Christ Hospital 102 Matthew Rettig Los Angeles, CA UCLA 103 Bruce Montgomery Seattle, WA Puget Sound VA 104 Mary Crow The Woodlands, TX Renovatio Clinical, The Woodlands 105 Mahamed Salkeni Fairfax, VA NEXT Virginia 106 Kyaw Thein Las Vegas, NV Comprehensive Cancer Centers of Nevada 107 Mary Crow El Paso, TX Renovatio Clinical, El Paso 108

CARE - PC – data to be presented Confidential 9.30.20 v3 10 Month 6 Month 3 Pre Dose Level Subject x x x 1 D1 - 001 x x x 1 D1 - 002 x x x 1 D1 - 003 PD x x 2 D2 - 001 Awaited x x 2 D2 - 002 PD x x 2 D2 - 003 PD x x 3 D3 - 001

CARE - PC March 2025 • All phase I doses administered – No AE/SAE/SAR after 29 infusions in 10 patients at all three doses – Primary safety end - point met • Phase II open at intermediate and high doses – 2 patients at intermediate level treated • CMC completed for all future doses • Immune response data being compiled for “unblinding” • PSMA - PET data received on 14 th Feb – Pre, Day 57 and Day 169 timepoints

12 Potency Assay Summary for Patient 102-001 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 1 1 0 1 2 0 1 3 0 1 4 0 1 5 0 1 6 0 1 7 0 0 10 20 30 40 50 60 70 80 90 100 0 50 100 150 200 250 300 NK/mL whole blood Raji KillingK562 Killing Day P e r c e n t a g e ( % ) N K / L w h o l e b l o o d Potency Assay Summary for Patient 105-002 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 1 1 0 1 2 0 1 3 0 1 4 0 1 5 0 1 6 0 1 7 0 0 10 20 30 40 50 60 70 80 90 100 0 50 100 150 200 250 300 Day P e r c e n t a g e ( % ) N K / L w h o l e b l o o d Potency Assay Summary for Patient 105-003 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 0 5 5 6 0 6 5 7 0 7 5 8 0 8 5 9 0 9 5 1 0 0 1 0 5 1 1 0 0 10 20 30 40 50 60 70 80 90 100 0 50 100 150 200 250 300 Day P e r c e n t a g e ( % ) N K / L w h o l e b l o o d Potency Assay Summary for Patient 106-001 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 0 5 5 6 0 0 10 20 30 40 50 60 70 80 90 100 0 50 100 150 200 250 300 Day P e r c e n t a g e ( % ) N K / L w h o l e b l o o d Potency Assay Summary for Patient 105-004 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 0 5 5 -20 -10 0 10 20 30 40 50 60 70 80 90 100 0 50 100 150 200 250 300 Day P e r c e n t a g e ( % ) N K / L w h o l e b l o o d

13 NK activation in vivo 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 0 10 20 30 40 50 CD16 low DAYS % o f N K D1-001 D1-002 D1-003 D2-001 D2-002 D2-003 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 0 50 100 150 NKG2D DAYS % o f N K D1-001 D1-002 D1-003 D2-001 D2-002 D2-003 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 18 1 5 2 9 5 7 8 5 1 1 3 1 4 1 1 6 9 0 20 40 60 80 100 CD69 DAYS % o f N K D1-001 D1-002 D1-003 D2-001 D2-002 D2-003

14 L1 L1 L1 L2 L2 L2 L3 Baseline Day 57 Day 169 L3 L1 L1 L1 L2 L2 L2 Whole body tumour volume Average tumour volume per site Baseline Day 57 Day 169

CARE - PC Conclusions • Primary safety end - point met • Evidence of NK activation in vivo even at lowest dose • Transient effects on tumor lesions – LN mets might be most sensitive • No consistent effect on PSA – immunoRx not expected to do so • ctDNA data awaited • High level disease burden probably unresponsive • Safety and response data suggest – repeat dosing strategy – Suitability for early intervention in disease management 15

Acknowledgements • INmuneBio – Dr Ben Weil – UK CMC/GMP team – CARE - PC clinical ops team • US investigators – Dr Matt Rettig - UCLA

v3.25.0.1

Cover	Mar. 04, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 04, 2025
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	false

---