As filed with the Securities and Exchange Commissionon May 1, 2024.
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
INMUNE BIO INC.
(Exact name of registrant as specified in its charter)
Nevada 47-5205835
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
225 NE Mizner Blvd., Suite 640
Boca Raton, Florida 33432
(858) 964-3720
(Address, including zip code, and telephone number,including area code of
registrant's principal executive offices)
David Moss
Chief Financial Officer
INmune Bio Inc.
225 NE Mizner Blvd., Suite 640
Boca Raton, Florida 33432
(858) 964-3720
(Name, address, including zip code, and telephonenumber, including area code,
of agent for service)
Copies to:
Marc Ross, Esq.
Thomas A. Rose, Esq.
David B. Manno, Esq.
Sichenzia Ross Ference Carmel LLP
1185 Avenue of the Americas, 31
st
Floor
New York, New York 10036
(212) 930-9700
Approximate date of commencement of proposed sale to the public: Fromtime to
time after the effective date of this registration statement.
If the only securities being registered on this Form are being offeredpursuant
to dividend or interest reinvestment plans, please check the following box:
If any of the securities being registered on this Form are to be offeredon a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connectionwith dividend or
interest reinvestment plants, check the following box:
If this Form is filed to register additional securities for an offeringpursuant
to Rule 462(b) under the Securities Act, please check the following and list
the Securities Act registration statement numberof the earlier effective
registration statement for the same offering.
If this Form is a post-effective amendment filed pursuant to Rule 462(c)under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registrationstatement
for the same offering./
If this Form is a registration statement pursuant to General InstructionI.D.
or a post-effective amendment thereto that shall become effective upon filing
with the Commission pursuant to Rule 462(e) under theSecurities Act, check the
following box.
If this Form is a post-effective amendment to a registration statementfiled
pursuant to General Instruction I.D. filed to register additional securities
or additional classes of securities pursuant to Rule413(b) under the
Securities Act, check the following box.
Indicate by check mark whether the registrant is a large acceleratedfiler, an
accelerated filer, a non-accelerated filer, a smaller reporting company or an
emerging growth company. See the definitions of"large accelerated filer,"
"accelerated filer," "smaller reporting company" and "emerging growthcompany"
in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer Accelerated filer
Non-accelerated filer Smaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registranthas
elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuantto Section
7(a)(2)(B) of Securities Act.
The registrant hereby amends this Registration Statementon such date or dates
as may be necessary to delay its effective date until the registrant shall
file a further amendment which specificallystates that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section
8(a),may determine.
EXPLANATORY NOTE
We are filing this registration statement on Form S-3 with the Securitiesand
Exchange Commission using a "shelf" registration process to replace our prior
registration statement on Form S-3 (FileNo. 333-254221) originally filed on
March 12, 2021, and declared effective on May 5, 2021 (the "Prior Registration
Statement"),in accordance with applicable Securities and Exchange Commission
regulations. Under this shelf registration statement, we may, from timeto
time, sell any combination of the securities described herein, in one or more
offerings, up to a maximum aggregate offering price of$250,000,000. Pursuant
to Rule 415(a)(5)(ii) under the Securities Act of 1933, as amended, by filing
this shelf registration statement,we may issue and sell securities covered by
the Prior Registration Statement until the earlier of (i) the effective date
of this shelfregistration statement and (ii) November 1, 2024, which is 180
days after the third-year anniversary of the effective date of the
PriorRegistration Statement.
The information in this prospectus isnot complete and may be changed. We may
not sell these securities until the registration statement relating to these
securities thathas been filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities andit is
not soliciting an offer to buy these securities in any state where the offer
or sale is not permitted.
(Subject to Completion,dated May 1, 2024)
PROSPECTUS
$250,000,000
INMUNE BIO Inc.
Common Stock
Preferred Stock
Warrants
Units
We may from time to time, in one or more offeringsat prices and on terms that
we will determine at the time of each offering, sell common stock, preferred
stock, warrants, or a combinationof these securities, or units, up to a total
offering price of $250,000,000.
This prospectus describes the general manner inwhich our securities may be
offered using this prospectus. Each time we offer and sell securities, we will
provide you with a prospectussupplement that will contain specific information
about the terms of that offering. Any prospectus supplement may also add,
update, orchange information contained in this prospectus. You should
carefully read this prospectus and the applicable prospectus supplement aswell
as the documents incorporated or deemed to be incorporated by reference in
this prospectus before you purchase any of the securitiesoffered hereby.
We are an"emerging growth company" under applicable Securities and Exchange
Commission, rules and, as such, have elected to complywith certain reduced
public company reporting requirements for this prospectus and future filings.
This prospectus may not be used to offer and sellsecurities unless accompanied
by a prospectus supplement.
Our common stock is currently traded on The NasdaqCapital Market ("Nasdaq")
under the symbol "INMB." On April 30, 2024, the last reported sales price for
our commonstock was $11.84 per share. The applicable prospectus supplement
will contain information, where applicable, as to any other listing ofthe
securities on Nasdaq or any other securities market or exchange covered by the
prospectus supplement. Prospective purchasers of oursecurities are urged to
obtain current information as to the market prices of our securities, where
applicable.
We may offer the securities directly or throughagents or to or through
underwriters or dealers. If any agents or underwriters are involved in the
sale of the securities their names,and any applicable purchase price, fee,
commission or discount arrangement between or among them, will be set forth,
or will be calculablefrom the information set forth, in an accompanying
prospectus supplement. We can sell the securities through agents, underwriters
or dealersonly with delivery of a prospectus supplement describing the method
and terms of the offering of such securities. See "Plan of Distribution."
The aggregate market value of our outstanding common stock held by
non-affiliateswas approximately $158.6 million which was calculated based on
19,760,985 shares of outstanding common stock held by non-affiliates asof
April 30, 2024, and a price per share of $11.84, the closing price of our
common stock on April 18, 2024.
Investing in our securities involves significantrisks. We strongly recommend
that you read carefully the risks we describe in this prospectus and in any
accompanying prospectus supplement,as well as the risk factors that are
incorporated by reference into this prospectus from our filings made with the
Securities and ExchangeCommission. See "Risk Factors" beginning on page 5 of
this prospectus.
Neither the Securities and Exchange Commissionnor any state securities
commission has approved or disapproved of these securities or determined if
this prospectus is truthful or complete.Any representation to the contrary is
a criminal offense.
This prospectus is dated ___________, 2024
Table of Contents
Page
ABOUT THIS PROSPECTUS ii
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS iii
PROSPECTUS SUMMARY 1
RISK FACTORS 5
USE OF PROCEEDS 6
DESCRIPTION OF CAPITAL STOCK 7
DESCRIPTION OF WARRANTS 9
DESCRIPTION OF UNITS 10
PLAN OF DISTRIBUTION 10
LEGAL MATTERS 13
EXPERTS 13
WHERE YOU CAN FIND MORE INFORMATION 13
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE 14
You should rely only on the information containedor incorporated by reference
in this prospectus or any prospectus supplement. We have not authorized anyone
to provide you with informationdifferent from that contained or incorporated
by reference into this prospectus. If any person does provide you with
information thatdiffers from what is contained or incorporated by reference in
this prospectus, you should not rely on it. No dealer, salesperson or
otherperson is authorized to give any information or to represent anything not
contained in this prospectus. You should assume that the informationcontained
in this prospectus or any prospectus supplement is accurate only as of the
date on the front of the document and that any informationcontained in any
document we have incorporated by reference is accurate only as of the date of
the document incorporated by reference,regardless of the time of delivery of
this prospectus or any prospectus supplement or any sale of a security. These
documents are notan offer to sell or a solicitation of an offer to buy these
securities in any circumstances under which the offer or solicitation is
unlawful.
i
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statementthat we filed with the
Securities and Exchange Commission, or SEC, using a "shelf" registration
process. Under this shelfregistration process, we may sell any combination of
the securities described in this prospectus in one of more offerings up to a
totaldollar amount of proceeds of $250,000,000. This prospectus describes the
general manner in which our securities may be offered by thisprospectus. Each
time we sell securities, we will provide a prospectus supplement that will
contain specific information about the termsof that offering. The prospectus
supplement may also add, update or change information contained in this
prospectus or in documents incorporatedby reference in this prospectus. The
prospectus supplement that contains specific information about the terms of
the securities beingoffered may also include a discussion of certain U.S.
Federal income tax consequences and any risk factors or other special
considerationsapplicable to those securities. To the extent that any statement
that we make in a prospectus supplement is inconsistent with statementsmade in
this prospectus or in documents incorporated by reference in this prospectus,
you should rely on the information in the prospectussupplement. You should
carefully read both this prospectus and any prospectus supplement together
with the additional information describedunder "Where You Can Find More
Information" before buying any securities in this offering.
The terms "INmune Bio", the "Company,""we," "our," or "us," in this prospectus
refer to INmune Bio Inc. and its wholly-owned subsidiaries,unless the context
suggests otherwise.
ii
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKINGSTATEMENTS
Some of the statements made under "ProspectusSummary," "Use of Proceeds," and
elsewhere in this prospectus, as well as the documents incorporated by
reference herein,including in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2023, constitute forward-looking statements withinthe
meaning of The Private Securities Litigation Reform Act of 1995. In some
cases, you can identify forward-looking statements by terminologysuch as
"may," "will," "should," "expects," "plans," "anticipates,""believes,"
"estimates," "predicts," "potential," "intends," or "continue,"or the negative
of these terms or other comparable terminology.
These forward-looking statements may include, butare not limited to,
statements related to our expected business, new product introductions,
results of clinical studies, expectationsregarding regulatory clearance and
the timing of FDA or non-US filings or approvals including meetings with FDA
or non-U.S. regulatorybodies, our ability to raise funds for general corporate
purposes and operations, including our research activities and clinical
trials,procedures and procedure adoption, future results of operations, future
financial position, our ability to generate revenues, our financingplans and
future capital requirements, anticipated costs of revenue, anticipated
expenses, the effect of recent accounting pronouncements,our anticipated cash
flows, our ability to finance operations from cash flows or otherwise, and
statements based on current expectations,estimates, forecasts, and projections
about the economies and markets in which we operate and intend to operate and
our beliefs and assumptionsregarding these economies and markets.
Forward-looking statements are not guarantees offuture performance and are
subject to risks and uncertainties. We have based these forward-looking
statements on assumptions and assessmentsmade by our management in light of
their experience and their perception of historical trends, current
conditions, expected future developments,and other factors they believe to be
appropriate.
Important factors that could cause actual results,developments and business
decisions to differ materially from those anticipated in these forward-looking
statements include, among others,those factors referred to in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2023, which is
incorporated by referenceherein.
These statements are only current predictions andare subject to known and
unknown risks, uncertainties, and other factors that may cause our or our
industry's actual results, levelsof activity, performance, or achievements to
be materially different from those anticipated by the forward-looking
statements. We discussmany of these risks in the documents incorporated by
reference herein. You should not rely upon forward-looking statements as
predictionsof future events.
Although we believe that the expectations reflectedin the forward-looking
statements are reasonable, we cannot guarantee future results, levels of
activity, performance, or achievements.Except as required by law, we are under
no duty to update or revise any of the forward-looking statements, whether as
a result of newinformation, future events or otherwise, after the date of this
prospectus.
iii
PROSPECTUS SUMMARY
This summary highlights certain informationabout us and selected information
contained in the prospectus. This summary is not complete and does not contain
all of the informationthat may be important to you. For a more complete
understanding of the Company, we encourage you to read and consider the more
detailedinformation included or incorporated by reference in this prospectus
and our most recent consolidated financial statements and relatednotes.
We are a clinical-stage immunology company focusedon developing drugs that may
reprogram the patient's innate immune system to treat disease. We believe this
may be done by targetingcells of the innate immune system that cause acute and
chronic inflammation and are involved in immune dysfunction associated with
chronicdiseases such as cancer and neurodegenerative diseases. The Company's
drugs are in clinical trials and have not been approved bya regulatory
authority. The Company has two therapeutic platforms - a dominant-negative TNF
platform ("DN-TNF", "XProTM","XPro1595TM" or "pegipanermin") and a Natural
Killer ("NK", or "INKmuneTM")platform. The DN-TNF platform neutralizes soluble
TNF ("sTNF") without affecting trans-membrane TNF ("tmTNF")or TNF receptors
-TNFR1 and TNFR2. This unique biologic mechanism differentiates the DN-TNF
drugs from currently approved non-selectiveTNF inhibitors that inhibit both
sTNF and tmTNF. Protecting the function of tmTNF and TNF receptors while
neutralizing the function ofsTNF is a potent anti-inflammatory strategy that
does not cause immunosuppression or demyelination which occur in the currently
approvednon-selective TNF inhibitors. Currently approved non-selective TNF
inhibitors treat autoimmune disease, but are contraindicated in patientswith
infection, cancer and neurologic diseases because they increase the risk of
infection, cancer and demyelinating neurologic diseases,respectively; these
safety problems are due to off-target effects on inhibiting tmTNF. The NK
platform targets the dysfunctional naturalkiller cells in patients with
cancer. NK cells are part of the normal immunologic response to cancer with
important roles in immunosurveillanceto prevent cancer and in preventing
relapse by eliminating residual disease. Residual disease is the cancer left
behind after therapyis finished. Residual disease can grow to cause relapse.
The mechanism by which INKmune improves the ability of the patient's NKcells
to kill their cancer is complex. The NK cells of cancer patients lose the
ability to bind and kill cancer cells. A measure of NKcell binding to cancer
cells is avidity. The higher the avidity, the greater the bond between the NK
cell to cancer cell and thus thegreater NK killing of cancer cells. INKmune
increases NK avidity and further improves mitochondrial function and
upregulates nutrientreceptors. These metabolic changes may help the INKmune
primed NK cell to function in the hostile tumor microenvironment and persist
muchlonger. These mechanisms improve the ability of INKmune primed NK cells to
overcome the immune evasion of the patient's cancer cells.We believe INKmune
is best used to eliminate residual disease after the patient has completed
other cancer therapies. Both the DN-TNFplatform and the INKmune platform can
be used to treat multiple diseases. The DN-TNF platform will be used as an
immunotherapy for thetreatment of cancer and neurodegenerative disease.
INKmune is being developed to treat NK sensitive hematologic malignancies and
solidtumors.
We believe our DN-TNF platformcan be used as a CNS ("central nervous system")
therapy to target glial activation to prevent progression of Alzheimer'sdisease
("AD"); to target neuroinflammation in treatment resistant depression ("TRD");
as a drug to prevent muscledegeneration, prevent fibrosis and promote muscle
regeneration in Duchene muscular dystrophy ("DMD"); and as a cancer therapyto
reduce resistance in immunotherapy. The primary focus of the company's
development efforts for XPro is AD. The next indicationto be developed with
XPro will be TRD. Treatment of DMD and cancer will occur when partners for the
programs are found. The drug is nameddifferently for the oncology and CNS
indications; INB03TM or XPro, respectively, but it is the same drug product.
For DMD, the companyis exploring DN-TNF compounds that is optimized for the
treatment of DMD. This novel compound has the same mechanism of action but
hasnovel IP protection. In each case, we believe neutralizing sTNF is a
cornerstone to the treatment of these diseases. As an immunotherapyfor cancer,
we are using INB03 to neutralize sTNF produced by HER2+ trastuzumab resistant
breast cancers to reverse resistance to targetedtherapy. sTNF produced by the
tumor causes an up-regulation of MUC4 express causing steric hindrance of
trastuzumab binding to the HERreceptor on HER2+ breast cancer cells. Without
binding, trastuzumab based therapies are not effective. Neutralizing sTNF
reverses MUC4expression converting a trastuzumab resistant breast cancer cell
into a trastuzumab sensitive breast cancer cell. In addition, INB03 maychange
the immunobiology of the tumor microenvironment by decreasing the number of
immunosuppressive myeloid cells, both myeloid derivedsuppressor cells and
tumor active macrophages, and increasing the number of cytotoxic lymphocytes
and phagocytic macrophages in the TME.The Company has completed an open label
dose escalation trial in cancer patients with metastatic solid tumors that
have failed multiplelines of therapy. The pre-clinical data in MUC4+
expressing tumors and the clinical trial informs the design of a future Phase
II trialby demonstrating that INB03 was safe and well tolerated, defined the
dose of INB03 to carry into Phase II trials, and demonstrated a pharmacodynamice
nd-point. The company does not plan to commence a Phase II trial in patients
with advanced MUC4+ expressing cancer until a partner canbe found.
1
Likewise, we believe the DN-TNFplatform can be used to treat selected
neurodegenerative diseases by modifying the brain microenvironment ("BME").
The Companybelieves the core pathology of cognitive decline is a combination
of neurodegeneration and synaptic dysfunction. Neurodegeneration isnerve cell
death that may include demyelination. Synaptic dysfunction means the
connections between nerve cells stop working efficientlyand may decrease in
number. The combination of neurodegeneration and synaptic dysfunction causes
cognitive decline and behavioral changesassociated with Alzheimer's disease
("AD"). XPro completed a Phase I trial treating patients with Alzheimer'sdisease
that was partially funded by a Part-the-Clouds Award from the Alzheimer's
Association. We believe XPro targets activatedmicroglia and astrocytes of the
brain that produce sTNF that promotes nerve cell loss, synaptic dysfunction
and prevents myelin repair- key elements in the development of dementia. In
animal models, elimination of sTNF prevents nerve cell dysfunction, reverses
synapticpruning and promotes myelin repair. The Phase I trial in patients with
biomarkers of inflammation with AD has been completed. The openlabel, dose
escalation trial was designed to demonstrate that XPro can safely decrease
neuroinflammation in patients with ADi. ADi isthe term used to delineate
patients with AD with biomarkers of inflammation. The endpoints of the trial
were measures of neuroinflammationand neurodegeneration in blood and cerebral
spinal fluid by measuring changes in inflammatory cytokine levels in the CNS
and using MRI-DTIto measure brain microstructural changes. XPro, at the
1mg/kg/week dose, decreased inflammatory cytokines in the CSF in the brain
demonstratingthat XPro can decrease neuroinflammation in patients with AD. We
also studied downstream benefits of decreasing neuroinflammation by
measuringchanges in the CSF proteome and quantifying changes in novel white
matter MRI biomarkers. XPro significantly decreases biomarkers of
neurodegeneration asmeasured by changes in the CSF proteome including
neurofilament light chain, phospho Tau 217 and VILIP-1; decreases of 84%, 46%
and 91%respectively after 3 months of therapy. Three months of XPro therapy
improved measures of synaptic function, as measured in the CSF proteomeincluding
a 222% increase in Contactin 2 and a 56% decrease neurogranin, changes that
contribute to improved synaptic function.
The successful completionof the Phase I trial in AD has informed the design of
a blinded randomized, placebo-controlled Phase II trial in patients with early
ADi.Early ADi includes patients with AD and MCI who have at least one
biomarker of inflammation (ADi and MCI
2
respectively).The early ADi trial is a blinded randomized trial to test if
treatment of early AD patients with neuroinflammation with XPro will
affectcognitive decline. The Phase II trial in early ADi has six important
elements. Two hundred and one patients are being enrolled in a 2:1ratio (XPro
vs placebo). The patients will receive 1mg/kg/week as a subcutaneous injection
for six months. An enrichment strategy identicalto the successful strategy
used in the Phase I trial will be used to ensure patients have neuroinflammation
. Patients will need to haveone or more enrichment criteria: elevated blood
level of at least one of C-reactive protein, hemoglobin A1c, erythrocyte
sedimentationand at least one allele of ApoE4. The primary end-point will be
Early/mild Alzheimer's Cognitive Composite ("EMACC"),a validated cognitive
measure that is more sensitive than traditional end-points used in many
studies of patients with early AD. The ADprogram is open in the United States,
Australia, Canada, the United Kingdom, France, Germany, Spain, Czech Republic
and Slovakia. Allpatients will be offered to stay on therapy for at least 12
months in an extension trial. Clinical and biomarker data will be
collectedduring the extension trial.
There are at least 4 clinicalmilestones associated with the Phase II trial in
AD. Enrollment of 201 patients in the Phase II AD trial should be complete by
mid-year.Six months after the last patient is enrolled, top line cognition
data with EMACC will be available. Secondary end-points which includeblood
biomarker, neuroimaging and additional neuropsychiatric end-points will be
available after data base lock 2-3 months after top linedata. Finally, several
months after all the data are analyzed, the Company plans an end-of-phase II
meeting with the FDA to finalize plansfor the pivotal Phase III trial. The
Company plans to apply for an accelerated pathway during 2024. XPro for
treatment of AD may be eligiblefor one or both accelerated approval pathways.
The Company plans to submit of Fast Track status in 2024. We expect to be
eligible forBreak Through status after completion of the Phase II in 2025.
Effective therapy for TRDis a large unmet need. Twenty percent of patients
with a Major Depressive Disorder have TRD. Once third of TRD patients have
peripheralbiomarkers to inflammation (elevated CRP). This is a large patient
population. The role of TNF and anti-TNF therapeutics was exploredin a small
open label clinical trial by Prof. Andrew Miller, MD of Emory University
demonstrated the patients have elevated TNF levelsand treatment with
infliximab treated their depression (Miller, 2011). The Company received a
$2.9M USD award from the National Instituteof Mental Health ("NIMH") to treat
TRD with XPro. The blinded, randomized Phase II trial will use biomarkers of
peripheralinflammation to select patients with TRD for enrollment. Patients
will be treated for 6 weeks. Primary end-points include both clinicaland
neuroimaging measures. The final trial design is ongoing and discussions with
the FDA are not complete. The Company received authorizationto initiate a
clinical trial in AD in the US during January 2024. The TRD trial is expected
to start enrollment after the AD Phase IItrial finishes patient enrollment.
2
We believe that INKmune improvesthe ability of the patient's own NK cells to
attack their tumor. INKmune interacts with the patient's NK cells to
convertthem from inert resting NK cells into memory-like NK cells that kill
the patient's cancer cells. INKmune is a replication incompetentproprietary
cell line that is given to the patient after determining that i) the patient
has adequate NK cells in their circulation andii) those NK cells are
functional when exposed to INKmune in vitro. INKmune is designed to be given
to patients after their immune systemhas recovered after cytotoxic
chemotherapy to target the residual disease that remains after treatment with
cytotoxic therapy. We believeINKmune can be used to treat numerous hematologic
malignancies and solid tumors including leukemia, multiple myeloma, lymphoma,
lung,ovary, breast, renal and prostate cancer. The Company had a Phase I trial
using INKmune to treat patients with high risk MDS/AML, a formof leukemia. Two
patients were treated in the Phase I trial for MDS, three patients have been
treated compassionately in AML and anotherMDS patient is expected to be
treated shortly. During March 2024, the Company decided to terminate further
enrollment in the MDS/AML trial.In the patients, INKmune therapy is safe,
produces memory-like NK cells that kill cancer in vitro, and promotes
development of cancerkilling memory-like NK cells that can be found in the
patient's circulation of 4 months. The Company initiated a separate PhaseI/2
trial of INKmune in a metastatic castrate resistant prostate cancer. The open
label trial enrolled the first patient in December 2023.
The Phase I/II trial usingINKmune to treat patients with metastatic castrate
resistant prostate cancer (mCPRC) is an open label trial. Biomarker data from
the patientswill be visible as patients are treated. The Company will report
data from each cohort as it becomes available. In addition to clinicaldata,
the Company will communicate when the Phase I portion of the trial has
completely enrolled. This is expected in September 2024.Because of the
modified Bayesian design, the Company estimates the trial will be completely
enrolled 1H25 with top-line data available6 months later. Topline data is
divided into immunologic and tumor response variables. The most important
immunologic response variableis related to memory like NK cell persistence.
This is how long are the number of mlNK cells in patients blood compared to
baseline. Thereare 3 important variables to tumor response: i) blood PSA
changes; ii) change in PMSA scan and iii) change in circulating tumor DNA
(ctDNA).Ideally, the levels of all three variables decrease with treatment. We
do not expect this 6 month trial to provide survival data.
We continue to incur significantdevelopment and other expenses related to our
ongoing operations. As a result, we are not and have never been profitable and
have incurredlosses in each period since our inception, resulting in
substantial doubt in our ability to continue as a going concern. We reported
anet loss of $30.0 million and $27.3 million for the years ended December 31,
2023 and 2022, respectively. As of December 31, 2023 and2022, we had cash and
cash equivalents of $35.8 million and $52.2 million, respectively. We expect
to continue to incur significant lossesfor the foreseeable future, and we
expect these losses to increase as we continue our research and development
of, and seek regulatoryapprovals for, our product candidates. The size of our
future net losses will depend, in part, on the rate of future growth of our
expensesand our ability to generate revenues, if any.
Our recurring net losses andnegative cash flows from operations raised
substantial doubt regarding our ability to continue as a going concern within
one year afterthe issuance of our consolidated financial statements for the
year ended December 31, 2023. Until we can generate sufficient revenue fromthe
commercialization of our product candidates, we expect to finance our
operations through the public or private sale of equity, debtfinancings or
other capital sources, such as government funding, collaborations, strategic
alliances, divestment of non-core assets, orlicensing arrangements with third
parties. To date, the Company has relied on equity and debt financing to fund
its operations.
3
Implications of Being an Emerging Growth Company and a Smaller Reporting Company
We qualify as an "emerging growth company"as defined in Section 2(a)(19) of
the Securities Act of 1933, as modified by the Jumpstart Our Business Startups
Act of 2012, orthe "JOBS Act." As such, we take advantage of certain
exemptions from various reporting requirements applicable to other
publiccompanies that are not emerging growth companies for as long as we
continue to be an emerging growth company, including (i) the exemptionfrom the
auditor attestation requirements with respect to internal control over
financial reporting under Section 404 of the Sarbanes-OxleyAct of 2002 (the
"Sarbanes-Oxley Act"), (ii) the exemptions from say-on-pay, say-on-frequency
and say-on-golden parachutevoting requirements and (iii) reduced disclosure
obligations regarding executive compensation in our periodic reports and proxy
statements.As a result, our stockholders may not have access to certain
information they deem important. We will remain an emerging growth
companyuntil the earliest of (i) the last day of the fiscal year (a) December
31, 2024, which is the last day of the fiscal year following thefifth
anniversary of the date of the first sale of the Company's common stock, (b)
in which we have total annual gross revenue ofat least $1.235 billion or (c)
in which INmune Bio is deemed to be a large accelerated filer, which means the
market value of our commonstock that are held by non-affiliates exceeds $700
million as of the last business day of our prior second fiscal quarter, and
(ii) thedate on which we have issued more than $1.0 billion in non-convertible
debt during the prior three-year period.
In addition, Section 107 of the JOBS Act alsoprovides that an emerging growth
company can take advantage of the exemption from complying with new or revised
accounting standards providedin Section 7(a)(2)(B) of the Securities Act of
1933, as long as it is an emerging growth company. An emerging growth
companycan therefore delay the adoption of certain accounting standards until
those standards would otherwise apply to private companies. The JOBSAct
provides that a company can elect to opt out of the extended transition period
and comply with the requirements that apply tonon-emerging growth companies,
but any such election to opt out is irrevocable. The Company has elected not
to opt out of such extendedtransition period, which means that when a standard
is issued or revised and it has different application dates for public or
privatecompanies, we, as an emerging growth company, can adopt the new or
revised standard at the time private companies adopt the new or revisedstandard.
This may make comparison of our financial statements with another public
company which is neither an emerging growth companynor an emerging growth
company which has opted out of using the extended transition period difficult
or impossible because of the potentialdifferences in accounting standards used.
Corporate Information
Our principal executive offices are located at225 NE Mizner Blvd, Suite 640,
Boca Raton, FL 33432. Our telephone number is (858) 964-3720. We maintain an
Internet website at www.inmunebio.com.The information contained on, connected
to or that can be accessed via our website is not part of this prospectus. We
have included ourwebsite address in this prospectus as an inactive textual
reference only and not as an active hyperlink.
4
RISK FACTORS
Investing in our securities involves a high degreeof risk. Before making an
investment decision, you should consider carefully the risks, uncertainties
and other factors described in ourmost recent Annual Report on Form 10-K, as
supplemented and updated by subsequent quarterly reports on Form 10-Q and
current reports onForm 8-K that we have filed or will file with the SEC, which
are incorporated by reference into this prospectus.
Our business, affairs, prospects,assets, financial condition, results of
operations and cash flows could be materially and adversely affected by these
risks. For moreinformation about our SEC filings, please see "Where You Can
Find More Information".
5
USE OF PROCEEDS
Unless otherwise indicated in a prospectus supplement,we intend to use the net
proceeds from the sale of the securities under this prospectus for general
corporate purposes, including to supportresearch and development, including
clinical trials, and general corporate purposes.
6
DESCRIPTION OF CAPITAL STOCK
General
The following description of our capital stock,together with any additional
information we include in any applicable prospectus supplement or any related
free writing prospectus, summarizesthe material terms and provisions of our
common stock and the preferred stock that we may offer under this prospectus.
While the termswe have summarized below will apply generally to any future
common stock or preferred stock that we may offer, we will describe the
particularterms of any class or series of these securities in more detail in
the applicable prospectus supplement. For the complete terms of ourcommon
stock and preferred stock, please refer to our articles of incorporation and
our bylaws that are incorporated by reference intothe registration statement
of which this prospectus is a part. The summary below and that contained in
any applicable prospectus supplementor any related free writing prospectus are
qualified in their entirety by reference to our articles of incorporation and
our bylaws.
Common Stock
We are authorized to issue 200,000,000 sharesof common stock, $0.001 par value
per share. As of the date of this prospectus, there are 19,760,985 shares of
common stock issuedand outstanding. The outstanding shares of common stock are
validly issued, fully paid and nonassessable.
Holders of common stock areentitled to one vote for each share on all matters
presented to the stockholders. Holders of common stock do not have cumulative
votingrights. Therefore, holders of a plurality of the shares of common stock
voting for the election of directors can elect all of the directors.Holders of
common stock representing 33.3 percent of our capital stock issued,
outstanding and entitled to vote, represented in personor by proxy, are
necessary to constitute a quorum at any meeting of stockholders.
Holders of common stock areentitled to share in all dividends that our Board
of Directors, in its discretion, declares from legally available funds. In the
eventof a liquidation, dissolution or winding up, each outstanding share
entitles its holder to participate pro rata in all assets that remainafter
payment of liabilities and after providing for each class of stock, if any,
having preference over the common stock. The commonstock has no pre-emptive,
subscription or conversion rights and there are no redemption provisions
applicable to the common stock.
Preferred Stock
We are authorized to issue up to 10,000,000 sharesof preferred stock, par
value $0.001 per share, from time to time in one or more series. On December
30, 2020, we filed a Certificateof Designation of Series A Junior Preferred
Stock with the Secretary of State of the State of Delaware to designate 45,000
shares as SeriesA Preferred Junior Participating Preferred Stock. As of the
date of this prospectus, there were no shares of our preferred stock
outstanding.
Our articles of incorporation authorizes our Boardof Directors to issue
preferred stock from time to time with such designations, preferences,
conversion or other rights, voting powers,restrictions, dividends or
limitations as to dividends or other distributions, qualifications or terms or
conditions of redemption asshall be determined by the Board of Directors for
each class or series of stock. Preferred stock is available for possible
future financingsor acquisitions and for general corporate purposes without
further authorization of stockholders unless such authorization is requiredby
applicable law, the rules of Nasdaq or other securities exchange or market on
which our stock is then listed or admitted to trading.
7
Our Board of Directors may authorize the issuanceof preferred stock with
voting or conversion rights that could adversely affect the voting power or
other rights of the holders of commonstock. The issuance of preferred stock,
while providing flexibility in connection with possible acquisitions and other
corporate purposescould, under some circumstances, have the effect of
delaying, deferring or preventing a change-in-control of the Company.
A prospectus supplement relating to any seriesof preferred stock being offered
will include specific terms relating to the offering. Such prospectus
supplement will include:
thetitle and stated or par value of the preferred stock;
thenumber of shares of the preferred stock offered, the liquidation
preference per share and the offering price of the preferred stock;
thedividend rate(s), period(s) and/or payment date(s) or method(s) of calculation thereof applicable to the preferred stock;
whetherdividends shall be cumulative or non-cumulative and, if cumulative,
the date from which dividends on the preferred stock shall accumulate;
theprovisions for a sinking fund, if any, for the preferred stock;
anyvoting rights of the preferred stock;
theprovisions for redemption, if applicable, of the preferred stock;
anylisting of the preferred stock on any securities exchange;
theterms and conditions, if applicable, upon which the preferred stock will be convertible into our common
stock, including the conversionprice or the manner of calculating the conversion price and conversion period;
ifappropriate, a discussion of Federal income tax consequences applicable to the preferred stock; and
anyother specific terms, preferences, rights, limitations or restrictions of the preferred stock.
The terms, if any, on which the preferred stockmay be convertible into or
exchangeable for our common stock will also be stated in the preferred stock
prospectus supplement. The termswill include provisions as to whether
conversion or exchange is mandatory, at the option of the holder or at our
option, and may includeprovisions pursuant to which the number of shares of
our common stock to be received by the holders of preferred stock would be
subjectto adjustment.
Transfer Agent and Registrar
The transfer agent for our common stock is VStockTransfer, LLC. The transfer
agent's address is 18 Lafayette Place, Woodmere, New York 11598.
Listing
Our common stock is currently traded on The NasdaqCapital Market under the
symbol "INMB".
8
DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of preferredstock or common stock.
Warrants may be issued independently or together with any preferred stock or
common stock, and may be attachedto or separate from any offered securities.
Each series of warrants will be issued under a separate warrant agreement to
be entered intobetween a warrant agent specified in the agreement and us. The
warrant agent will act solely as our agent in connection with the warrantsof
that series and will not assume any obligation or relationship of agency or
trust for or with any holders or beneficial owners of warrants.This summary of
some provisions of the securities warrants is not complete. You should refer
to the securities warrant agreement, includingthe forms of securities warrant
certificate representing the securities warrants, relating to the specific
securities warrants being offeredfor the complete terms of the securities
warrant agreement and the securities warrants. The securities warrant
agreement, together withthe terms of the securities warrant certificate and
securities warrants, will be filed with the SEC in connection with the
offering ofthe specific warrants.
The applicable prospectus supplement will describethe following terms, where
applicable, of the warrants in respect of which this prospectus is being
delivered:
thetitle of the warrants;
theaggregate number of the warrants;
theprice or prices at which the warrants will be issued;
thedesignation, amount and terms of the offered securities purchasable upon exercise of the warrants;
ifapplicable, the date on and after which the warrants and the offered securities
purchasable upon exercise of the warrants will be separatelytransferable;
theterms of the securities purchasable upon exercise of such warrants and
the procedures and conditions relating to the exercise of suchwarrants;
anyprovisions for adjustment of the number or amount of securities receivable
upon exercise of the warrants or the exercise price of thewarrants;
theprice or prices at which and currency or currencies in which the offered
securities purchasable upon exercise of the warrants may bepurchased;
thedate on which the right to exercise the warrants shall commence and the date on which the right shall expire;
theminimum or maximum amount of the warrants that may be exercised at any one time;
informationwith respect to book-entry procedures, if any;
ifappropriate, a discussion of Federal income tax consequences; and
anyother material terms of the warrants, including terms, procedures
and limitations relating to the exchange and exercise of the warrants.
Warrants for the purchase of common stock or preferredstock will be offered
and exercisable for U.S. dollars only. Warrants will be issued in registered
form only.
Upon receipt of payment and the warrant certificateproperly completed and duly
executed at the corporate trust office of the warrant agent or any other
office indicated in the applicableprospectus supplement, we will, as soon as
practicable, forward the purchased securities. If less than all of the
warrants representedby the warrant certificate are exercised, a new warrant
certificate will be issued for the remaining warrants.
Prior to the exercise of any securities warrantsto purchase preferred stock or
common stock, holders of the warrants will not have any of the rights of
holders of the common stock orpreferred stock purchasable upon exercise,
including in the case of securities warrants for the purchase of common stock
or preferredstock, the right to vote or to receive any payments of dividends
on the preferred stock or common stock purchasable upon exercise.
9
DESCRIPTION OF UNITS
As specified in the applicable prospectus supplement,we may issue units
consisting of shares of common stock, shares of preferred stock or warrants or
any combination of such securities.
The applicable prospectus supplement will specifythe following terms of any
units in respect of which this prospectus is being delivered:
the terms of the units and of any of the common stock, preferred stock and warrants comprising the units,
including whether and under what circumstances the securities comprising the units may be traded separately;
a description of the terms of any unit agreement governing the units; and
a description of the provisions for the payment, settlement, transfer or exchange of the units.
PLAN OF DISTRIBUTION
We may sell the securities offered through thisprospectus (i) to or through
underwriters or dealers, (ii) directly to purchasers, including our
affiliates, (iii) throughagents, or (iv) through a combination of any these
methods. The securities may be distributed at a fixed price or prices, which
may bechanged, market prices prevailing at the time of sale, prices related to
the prevailing market prices, or negotiated prices. The prospectussupplement
will include the following information:
theterms of the offering;
thenames of any underwriters or agents;
thename or names of any managing underwriter or underwriters;
thepurchase price of the securities;
anyover-allotment options under which underwriters may purchase additional securities from us;
thenet proceeds from the sale of the securities
anydelayed delivery arrangements
anyunderwriting discounts, commissions and other items constituting underwriters' compensation;
anyinitial public offering price;
anydiscounts or concessions allowed or reallowed or paid to dealers;
anycommissions paid to agents; and
anysecurities exchange or market on which the securities may be listed.
Sale Through Underwriters or Dealers
Only underwriters named in the prospectus supplementare underwriters of the
securities offered by the prospectus supplement.
10
If underwriters are used in the sale, the underwriterswill acquire the
securities for their own account, including through underwriting, purchase,
security lending or repurchase agreementswith us. The underwriters may resell
the securities from time to time in one or more transactions, including
negotiated transactions.Underwriters may sell the securities in order to
facilitate transactions in any of our other securities (described in this
prospectusor otherwise), including other public or private transactions and
short sales. Underwriters may offer securities to the public eitherthrough
underwriting syndicates represented by one or more managing underwriters or
directly by one or more firms acting as underwriters.Unless otherwise
indicated in the prospectus supplement, the obligations of the underwriters to
purchase the securities will be subjectto certain conditions, and the
underwriters will be obligated to purchase all the offered securities if they
purchase any of them. Theunderwriters may change from time to time any initial
public offering price and any discounts or concessions allowed or reallowed or
paidto dealers.
If dealers are used in the sale of securities offeredthrough this prospectus,
we will sell the securities to them as principals. They may then resell those
securities to the public at varyingprices determined by the dealers at the
time of resale. The prospectus supplement will include the names of the
dealers and the termsof the transaction.
Direct Sales and Sales Through Agents
We may sell the securities offered through thisprospectus directly. In this
case, no underwriters or agents would be involved. Such securities may also be
sold through agents designatedfrom time to time. The prospectus supplement
will name any agent involved in the offer or sale of the offered securities
and will describeany commissions payable to the agent. Unless otherwise
indicated in the prospectus supplement, any agent will agree to use its
reasonablebest efforts to solicit purchases for the period of its appointment.
We may sell the securities directly to institutionalinvestors or others who
may be deemed to be underwriters within the meaning of the Securities Act of
1933 with respect to any sale ofthose securities. The terms of any such sales
will be described in the prospectus supplement.
Delayed Delivery Contracts
If the prospectus supplement indicates, we mayauthorize agents, underwriters
or dealers to solicit offers from certain types of institutions to purchase
securities at the public offeringprice under delayed delivery contracts. These
contracts would provide for payment and delivery on a specified date in the
future. Thecontracts would be subject only to those conditions described in
the prospectus supplement. The applicable prospectus supplement willdescribe
the commission payable for solicitation of those contracts.
Continuous Offering Program
Without limiting the generality of the foregoing,we may enter into a
continuous offering program equity distribution agreement with a broker-dealer,
under which we may offer and sellshares of our common stock from time to time
through a broker-dealer as our sales agent. If we enter into such a program,
sales of theshares of common stock, if any, will be made by means of ordinary
brokers' transactions on Nasdaq at market prices, block transactionsand such
other transactions as agreed upon by us and the broker-dealer. Under the terms
of such a program, we also may sell shares ofcommon stock to the broker-dealer,
as principal for its own account at a price agreed upon at the time of sale.
If we sell shares of commonstock to such broker-dealer as principal, we will
enter into a separate terms agreement with such broker-dealer, and we will
describethis agreement in a separate prospectus supplement or pricing
supplement.
11
Market Making, Stabilization and Other Transactions
Unless the applicable prospectus supplement statesotherwise, other than our
common stock all securities we offer under this prospectus will be a new issue
and will have no establishedtrading market. We may elect to list offered
securities on an exchange or in the over-the-counter market. Any underwriters
that we usein the sale of offered securities may make a market in such
securities, but may discontinue such market making at any time without
notice.Therefore, we cannot assure you that the securities will have a liquid
trading market.
Any underwriter may also engage in stabilizingtransactions, syndicate covering
transactions and penalty bids in accordance with Rule 104 under the Securities
Exchange Act of 1934(the "Exchange Act"). Stabilizing transactions involve
bids to purchase the underlying security in the open market for thepurpose of
pegging, fixing or maintaining the price of the securities. Syndicate covering
transactions involve purchases of the securitiesin the open market after the
distribution has been completed in order to cover syndicate short positions.
Penalty bids permit the underwriters to reclaima selling concession from a
syndicate member when the securities originally sold by the syndicate member
are purchased in a syndicatecovering transaction to cover syndicate short
positions. Stabilizing transactions, syndicate covering transactions and
penalty bids maycause the price of the securities to be higher than it would
be in the absence of the transactions. The underwriters may, if they
commencethese transactions, discontinue them at any time.
General Information
Agents, underwriters, and dealers may be entitled,under agreements entered
into with us, to indemnification by us against certain liabilities, including
liabilities under the SecuritiesAct of 1933. Our agents, underwriters, and
dealers, or their affiliates, may be customers of, engage in transactions with
or perform servicesfor us, in the ordinary course of business.
12
LEGAL MATTERS
The validity of the issuanceof the securities offered by this prospectus will
be passed upon for us by Sichenzia Ross Ference Carmel LLP, New York, New York.
EXPERTS
The consolidated financialstatements of INmune Bio Inc. as of and for the
years ended December 31, 2023 and 2022 appearing in INmune Bio Inc.'s Annual
Reporton Form 10-K for the year ended December 31, 2023 have been audited by
Marcum LLP, as set forth in its report thereon, which includesan explanatory
paragraph as to the Company's ability to continue as a going concern, included
therein, and incorporated herein byreference. Such consolidated financial
statements are incorporated herein by reference in reliance upon such report
given on the authorityof such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed our registrationstatement on Form S-3 with the SEC under the
Securities Act of 1933, as amended. We also file annual, quarterly and current
reports, proxystatements and other information with the SEC. You may read and
copy any document that we file with the SEC, including the registrationstatement
and the exhibits to the registration statement, at the SEC's Public Reference
Room located at 100 F Street, N.E., WashingtonD.C. 20549. You may obtain
further information on the operation of the Public Reference Room by calling
the SEC at 1-800-SEC-0330. OurSEC filings are also available to the public at
the SEC's web site at www.sec.gov. These documents may also be accessed on our
website at www.amplitechinc.com. Information contained on our web site is not
incorporated by reference into this prospectus and you shouldnot consider
information contained on our web site to be part of this prospectus.
This prospectus and any prospectussupplement are part of a registration
statement filed with the SEC and do not contain all of the information in the
registration statement.The full registration statement may be obtained from
the SEC or us as indicated above. Other documents establishing the terms of
the offeredsecurities are filed as exhibits to the registration statement or
will be filed through an amendment to our registration statement onForm S-3 or
under cover of a Current Report on Form 8-K and incorporated into this
prospectus by reference.
13
INCORPORATION OF CERTAINDOCUMENTS BY REFERENCE
TheSEC allows us to "incorporate by reference" into this prospectus the
information we file with it, which means that we candisclose important
information to you by referring you to those documents. The information
incorporated by reference is considered tobe part of this prospectus. Any
statement contained herein or in a document incorporated or deemed to be
incorporated by reference intothis document will be deemed to be modified or
superseded for purposes of the document to the extent that a statement
contained in thisdocument or any other subsequently filed document that is
deemed to be incorporated by reference into this document modifies or
supersedesthe statement. We incorporate by reference in this prospectus the
following information (other than, in each case, documents or informationdeemed
to have been furnished and not filed in accordance with SEC rules):
our Annual Report on
Form 10-K
for the year ended December 31, 2023 filed with the SEC on March 28, 2024, and as amended by that
Form 10-K/A
on April 16, 2024;
our Current Reports on Form 8-K filed with the SEC on
January 2, 2024
,
March 27, 2024
,
April 9, 2024
,
April 22, 2024
,
April 25, 2024
,
April 26, 2024
and
April 30, 2024
.
the description of our common stock contained in our Registration Statement on
Form 8-A
filed with the SEC on February 1, 2019 (File No. 001-38793), as amended by
Exhibit 4.1
to our Annual Report on
Form 10-K
filed on March 3, 2022, including any subsequent amendment or any report filed for the purpose of updating such description; and
all reports and other documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d)
of the Exchange Act after the date of this prospectus and prior to the termination of this offering.
Wealso incorporate by reference any future filings (other than information
furnished under Item 2.02 or Item 7.01 of Form 8-Kand exhibits furnished on
such form that are related to such items unless such Form 8-K expressly
provides to the contrary) madewith the SEC pursuant to Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act, including those made after the date of
theinitial filing of the registration statement of which this prospectus is a
part and prior to effectiveness of such registration statement,until we file a
post-effective amendment that indicates the termination of the offering of the
common stock made by this prospectus andwill become a part of this prospectus
from the date that such documents are filed with the SEC. Information in such
future filings updatesand supplements the information provided in this
prospectus. Any statements in any such future filings will automatically be
deemed tomodify and supersede any information in any document we previously
filed with the SEC that is incorporated or deemed to be incorporatedherein by
reference to the extent that statements in the later filed document modify or
replace such earlier statements.
Notwithstandingthe foregoing, information furnished under Items 2.02 and 7.01
of any Current Report on Form 8-K, including the related exhibits, isnot
incorporated by reference in this prospectus.
Theinformation about us contained in this prospectus should be read together
with the information in the documents incorporated by reference.You may
request a copy of any or all of these filings, at no cost, by writing or
telephoning us at: David Moss, INmune Bio Inc., 225NE Mizner Blvd, Suite 640,
Boca Raton, FL 33432, telephone number (858) 964-3720.
14
$250,000,000
Common Stock
Preferred Stock
Warrants
Units
INMUNE BIO INC.
Prospectus
, 2024
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the costs and expensespayable by the Registrant
in connection with this offering, other than underwriting commissions and
discounts, all of which are estimatedexcept for the SEC registration fee.
Item
Amount
SEC registration fee $ 8,290.61 (1)
FINRA filing fee $ 38,000
Printing and engraving expenses $ *
Legal fees and expenses $ *
Accounting fees and expenses $ *
Transfer agent and registrar's fees and expenses $ *
Miscellaneous expenses $ *
Total $ *
(1) In accordance with Rule 415(a)(6) under the Securities Act, the filing fee previously paid in connection
with the securities registered in the registration statement on Form S-3 (File No. 333-254221) which remain
unsold will continue to be applied to the securities registered under this Registration Statement. Please see
the registration fee table contained in Exhibit 107 to this registration statement for more information.
* These fees are calculated based on the securities offered and the number
of issuances and accordingly cannot be estimated at this time. In
accordance with Rule 430B, the applicable prospectus supplement will set
forth the estimated amount of expenses of any offering of securities.
Item 15. Indemnification of Directors and Officers.
NRS 78.7502(1) provides that a corporation mayindemnify any person who was or
is a party or is threatened to be made a party to any threatened, pending or
completed action, suit orproceeding, whether civil, criminal, administrative
or investigative, except an action by or in the right of the corporation, by
reasonof the fact that he is or was a director, officer, employee or agent of
the corporation, or is or was serving at the request of the corporationas a
director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, against expenses,including
attorneys' fees, judgments, fines and amounts paid in settlement actually and
reasonably incurred by him in connectionwith the action, suit or proceeding if
he: (a) is not liable pursuant to NRS 78.138; or (b) acted in good faith and
in a manner whichhe reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding,had no reasonable cause to believe his conduct was unlawful.
NRS Section 78.7502(2) provides that a corporationmay indemnify any person who
was or is a party or is threatened to be made a party to any threatened,
pending or completed action or suitby or in the right of the corporation to
procure a judgment in its favor by reason of the fact that he is or was a
director, officer,employee or agent of the corporation, or is or was serving
at the request of the corporation as a director, officer, employee or agentof
another corporation, partnership, joint venture, trust or other enterprise
against expenses, including amounts paid in settlement andattorneys' fees
actually and reasonably incurred by him in connection with the defense or
settlement of the action or suit if he:(a) is not liable pursuant to NRS
78.138; or (b) acted in good faith and in a manner which he reasonably
believed to be in or not opposedto the best interests of the corporation.
Indemnification may not be made for any claim, issue or matter as to which
such a person hasbeen adjudged by a court of competent jurisdiction, after
exhaustion of all appeals there from, to be liable to the corporation or
foramounts paid in settlement to the corporation, unless and only to the
extent that the court in which the action or suit was brought orother court of
competent jurisdiction determines upon application that in view of all the
circumstances of the case, the person is fairlyand reasonably entitled to
indemnity for such expenses as the court deems proper.
II-
1
Our Articles of Incorporation provides that veryperson who was or is a party
to, or is threatened to be made a party to, or is involved in any action, suit
or proceeding, whether civil,criminal, administrative or investigative, by
reason of the fact that he, or a person of whom he is the legal representative,
is or wasa director or officer of the Company, or is or was serving at the
request of the Company as a director or officer of another corporation,or as
its representative in a partnership, joint venture, trust or other enterprise,
shall be indemnified and held harmless to the fullestextent legally
permissible under the laws of the State of Nevada from time to time against
all expenses, liability and loss (includingattorney's fees, judgements, fines
and amounts paid or to be paid in settlement) reasonably incurred or suffered
by him in connectiontherewith. Such right of indemnification shall be a
contract right which may be enforced in any matter desired by such person. The
expensesof the officers and directors incurred in defending a civil or
criminal action, suit or proceeding must be paid by the Company as theyare
incurred and in advance of the final disposition of the action, suit or
proceeding, upon receipt of an undertaking by or on behalfof the director or
officer to repay the amount if it is ultimately determined by a court of
competent jurisdiction that he is not entitledto be indemnified by the
Company. Such right of indemnification shall not be exclusive of any other
right which such directors, officersor representatives may have or hereafter
acquire, and, without limiting the generality of such statement, they shall be
entitled to theirrespective rights of indemnification under any bylaw,
agreement, vote of stockholders, provision of law, or otherwise, as well as
theirrights under this Article.
NRS Section 78.747 providesthat except as otherwise provided by specific
statute, no director or officer of a corporation is individually liable for a
debt or liabilityof the corporation, unless the director or officer acts as
the alter ego of the corporation. The court as a matter of law must
determinethe question of whether a director or officer acts as the alter ego
of a corporation.
Insofar as indemnification for liabilities arisingunder the Securities Act of
1933 may be permitted to directors, offices or controlling persons of ours,
pursuant to the foregoing provisions,or otherwise, we have been advised that,
in the opinion of the SEC, such indemnification is against public policy as
expressed in theSecurities Act of 1933, and is, therefore, unenforceable. In
the event that a claim for indemnification against such liabilities (otherthan
the payment by us of expenses incurred or paid by a director, officer or
controlling person of ours in the successful defense ofany action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registeredhereunder, we will, unless in
the opinion of our counsel the matter has been settled by controlling
precedent, submit to a court of appropriatejurisdiction the question whether
such indemnification by us is against public policy as expressed in the
Securities Act of 1933 and willbe governed by the final adjudication of such
issue.
II-
2
Item 16. Exhibits.
Exhibit
Number Description of Document
1.1 Form of Underwriting Agreement.*
4.1 Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the
Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
4.2 Bylaws incorporated by reference to Exhibit 3.2 to the Registration
Statement on Form S-1 filed with the SEC on August 30, 2018).
4.3 Certificate of Designation of Series A Junior Participating Preferred Stock of INmune Bio Inc.
(Incorporated by reference to Exhibit 3.1 to the Current Report filed with the SEC on December 30, 2020).
4.4 Form of Certificate of Designation.*
4.5 Form of Preferred Stock Certificate.*
4.6 Form of Warrant Agreement.*
4.7 Form of Warrant Certificate.*
4.8 Form of Stock Purchase Agreement.*
4.9 Form of Unit Agreement.*
5.1 Opinion of Sichenzia
Ross Ference Carmel LLP.
23.1 Consent of Marcum LLP.
23.2 Consent of Sichenzia Ross Ference
Carmel LLP (contained in Exhibit 5.1).
107 Filing Fee Table.
* To be filed by amendment or by a Current Report on Form 8-K and incorporated by reference herein.
II-
3
Item 17. Undertakings
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offersor sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required bysection 10(a)(3) of the Securities
Act of 1933;
(ii) To reflect in the prospectus any factsor events arising after the
effective date of the registration statement (or the most recent post-effective
amendment thereof) which,individually or in the aggregate, represent a
fundamental change in the information set forth in the registration statement.
Notwithstandingthe foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceedthat
which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in theform of prospectus
filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes
in volume and price represent no morethan 20 percent change in the maximum
aggregate offering price set forth in the "Calculation of Registration Fee"
table inthe effective registration statement.
(iii) To include any material informationwith respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such informationin the registration statement;
provided, however
, that paragraphs (a)(1)(i),(a)(1)(ii) and (a)(1)(iii) above do not apply if
the information required to be included in a post-effective amendment by those
paragraphsis contained in reports filed with or furnished to the SEC by the
registrant pursuant to Section 13 or Section 15(d) of the Exchange Actthat are
incorporated by reference in the registration statement, or is contained in a
form of prospectus filed pursuant to Rule 424(b)that is part of the
registration statement.
(2) That, for the purpose of determining anyliability under the Securities Act
of 1933, each such post-effective amendment shall be deemed to be a new
registration statement relatingto the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial
bona fide offeringthereof.
(3) To remove from registration by means ofa post-effective amendment any of
the securities being registered which remain unsold at the termination of the
offering.
(4) That, for the purpose of determining liabilityunder the Securities Act of
1933 to any purchaser:
(A) Each prospectus filed by the registrantpursuant to Rule 424(b)(3) shall be
deemed to be part of the registration statement as of the date the filed
prospectus was deemedpart of and included in the registration statement; and
(B) Each prospectus required to be filed pursuantto Rule 424(b)(2), (b)(5), or
(b)(7) as part of a registration statement in reliance on Rule 430B relating
to an offering madepursuant to Rule 415(a)(1)(i), (vii), or (x) for the
purpose of providing the information required by section 10(a) of the
SecuritiesAct of 1933 shall be deemed to be part of and included in the
registration statement as of the earlier of the date such form of prospectusis
first used after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus.As provided in Rule
430B, for liability purposes of the issuer and any person that is at that date
an underwriter, such date shallbe deemed to be a new effective date of the
registration statement relating to the securities in the registration
statement to which thatprospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
Provided,however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a
documentincorporated or deemed incorporated by reference into the registration
statement or prospectus that is part of the registration statementwill, as to
a purchaser with a time of contract of sale prior to such effective date,
supersede or modify any statement that was madein the registration statement
or prospectus that was part of the registration statement or made in any such
document immediately priorto such effective date; or
(5) That, for the purpose of determining liabilityof the registrant under the
Securities Act of 1933 to any purchaser in the initial distribution of the
securities, the undersigned registrantundertakes that in a primary offering of
securities of the undersigned registrant pursuant to this registration
statement, regardlessof the underwriting method used to sell the securities to
the purchaser, if the securities are offered or sold to such purchaser by
meansof any of the following communications, the undersigned registrant will
be a seller to the purchaser and will be considered to offer orsell such
securities to such purchaser:
(i) Any preliminary prospectus or prospectusof the undersigned registrant
relating to the offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relatingto the offering prepared by or on
behalf of the undersigned registrant or used or referred to by the undersigned
registrant;
II-
4
(iii) The portion of any other free writingprospectus relating to the offering
containing material information about the undersigned registrant or its
securities provided by oron behalf of the undersigned registrant; and
(iv) Any other communication that is an offerin the offering made by the
undersigned registrant to the purchaser.
(b) The undersigned registrant hereby undertakesthat for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuantto section 13(a) or section 15(d) of the
Exchange Act (and, where applicable, each filing of an employee benefit plan's
annual reportpursuant to section 15(d) of the Exchange Act) that is
incorporated by reference in the registration statement shall be deemed to be
anew registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemedto be the initial
bona fide offering thereof.
(c) Insofar as indemnification for liabilitiesarising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant tothe foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the SEC such indemnification is
againstpublic policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities(other
than the payment by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrantin the successful defense of
any action, suit or proceeding) is asserted by such director, officer or
controlling person in connectionwith the securities being registered, the
registrant will, unless in the opinion of its counsel the matter has been
settled by controllingprecedent, submit to a court of appropriate jurisdiction
the question whether such indemnification by it is against public policy as
expressedin the Act and will be governed by the final adjudication of such
issue.
(d) The undersigned registrant hereby undertakesthat:
(1) For purposes of determining any liabilityunder the Securities Act of 1933,
the information omitted from the form of prospectus filed as part of this
registration statement inreliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or497(h)
under the Securities Act of 1933 shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For the purpose of determining any liabilityunder the Securities Act of
1933, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registrationstatement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to
be the initialbona fide offering thereof.
II-
5
SIGNATURES
Pursuant to the requirements of the SecuritiesAct of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on FormS-3 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the Cityof Boca Raton, State of Florida, on May 1, 2024.
INmune Bio Inc.
By: /s/ Raymond J. Tesi, M. D.
Raymond J. Tesi, M. D.
Its: Chief Executive Officer
(Principal Executive Officer)
By: /s/ David J. Moss
David J. Moss
Its: Chief Financial Officer
(Principal Financial and Accounting Officer)
Each person whose signature appears below constitutesand appoints Raymond J.
Tesi and David J. Moss, and each of them severally, as his true and lawful
attorney in fact and agent, with fullpowers of substitution and re-substitution,
for him and in his name, place and stead, in any and all capacities, to sign
any or all amendments(including post effective amendments) to the Registration
Statement, and to sign any registration statement for the same offering
coveredby this Registration Statement that is to be effective upon filing
pursuant to Rule 462(b) under the Securities Act of 1933, as amended,and all
post effective amendments thereto, and to file the same, with all exhibits
thereto, and all documents in connection therewith,with the SEC, granting unto
said attorney-in-fact and agent, each acting alone, full power and authority
to do and perform each and everyact and thing requisite and necessary to be
done in and about the premises, as fully to all intents and purposes as he or
she might orcould do in person, hereby ratifying and confirming all that said
attorney-in-fact and agent, each acting alone, or his or her substituteor
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the SecuritiesAct of 1933, this registration
statement has been signed below by the following persons in the capacities and
on the dates indicated.
/s/ Raymond J. Tesi, M.D May 1, 2024
Raymond J. Tesi, M.D.
Chief Executive Officer and
Director (principal executive officer)
/s/ David J. Moss May 1, 2024
David J. Moss
Chief Financial Officer
(principal financial and accounting officer)
/s/ Timothy Schroeder May 1, 2024
Timothy Schroeder
Director
/s/ J. Kelly Ganjei May 1, 2024
J. Kelly Ganjei
Director
/s/ Scott Juda, JD May 1, 2024
Scott Juda, JD
Director
/s/ Edgardo Baracchini May 1, 2024
Edgardo Baracchini
Director
/s/ Marcia Allen May 1, 2024
Marcia Allen
Director
II-6
Exhibit 5.1
May 1, 2024
INmune Bio Inc.
225 NE Mizner Blvd, Suite 640
Boca Raton, FL 33432
Re: Registration Statement on Form S-3
Ladies and Gentlemen:
We have acted as counsel to INmune Bio Inc., aNevada corporation (the
"Company"), in connection with the filing of a registration statement on Form
S-3 (the "RegistrationStatement"), under the Securities Act of 1933, as
amended (the "Act"), relating to the offering and sale from time totime, as
set forth in the Registration Statement, the form of prospectus contained
therein (the "Prospectus"), and one ormore supplements to the Prospectus
(each, a "Prospectus Supplement"), by the Company of up to $250,000,000
aggregate initialoffering price of securities consisting of (i) shares of the
Company's common stock, par value $0.001 per share (the "CommonStock"), (ii)
shares of the Company's preferred stock, par value $0.001 per share (the
"Preferred Stock"), (iii)warrants ("Warrants") to purchase Common Stock or
Preferred Stock, or (iv) units consisting of Common Stock, Preferred Stock,or
Warrants, or any combination thereof, in one or more series (the "Units"). The
Common Stock, Preferred Stock, Warrantsand Units are collectively referred to
herein as the "Securities."
We have examined originals or certified copiesof such corporate records of the
Company and other certificates and documents of officials of the Company,
public officials and othersas we have deemed appropriate for purposes of this
letter. We have assumed the genuineness of all signatures, the legal capacity
of eachnatural person signing any document reviewed by us, the authority of
each person signing in a representative capacity (other than theCompany) any
document reviewed by us, the authenticity of all documents submitted to us as
originals and the conformity to authentic originaldocuments of all copies
submitted to us or filed with the Securities and Exchange Commission (the
"Commission") as conformedand certified or reproduced copies. As to any facts
material to our opinion, we have made no independent investigation of such
facts andhave relied, to the extent that we deem such reliance proper, upon
certificates of public officials and officers or other representativesof the
Company.
Based upon the foregoing and subject to the assumptions,exceptions,
qualifications and limitations set forth herein, we are of the opinion that:
1. With respect to Securities constituting CommonStock to be sold by the
Company, when (i) the Company has taken all necessary action to authorize and
approve the issuance of such CommonStock, the terms of the offering thereof
and related matters and (ii) such Common Stock has been issued and delivered,
with certificatesrepresenting such Common Stock having been duly executed,
countersigned, registered and delivered or, if uncertificated, valid
book-entrynotations therefor having been made in the share register of the
Company, in accordance with the terms of the applicable definitive
purchase,underwriting or similar agreement or, if such Common Stock is
issuable upon the exercise of Warrants, the applicable warrant agreementtherefor
, against payment (or delivery) of the consideration therefor provided for
therein, such Common Stock (including any Common Stockduly issued upon
exercise of Warrants that are exercisable to purchase Common Stock) will have
been duly authorized and validly issuedand will be fully paid and
non-assessable.
1185 Avenue of the Americas| 31
st
Floor | New York, NY | 10036
T (212) 930 9700 | F (212) 930 9725 | WWW.SRFC.LAW
2. With respect to Securities constituting PreferredStock, when (i) the
Company has taken all necessary action to authorize and approve the issuance
and terms of the shares of the seriesof such Preferred Stock, the terms of the
offering thereof and related matters, including the adoption of a resolution
fixing the numberof shares in any series of Preferred Stock and the
designation of relative rights, preferences and limitations in any series of
PreferredStock and the filing of a certificate of designation with respect to
the series with the Secretary of State of the State of Nevada asrequired by
78.1955 of the Nevada Revised Statutes and (ii) such Preferred Stock has been
issued and delivered, with certificates representingsuch Preferred Stock
having been duly executed, countersigned, registered and delivered or, if
uncertificated, valid book-entry notationstherefor having been made in the
share register of the Company, in accordance with the terms of the applicable
definitive purchase, underwritingor similar agreement or, if such Preferred
Stock is issuable upon the exercise of Warrants, the applicable warrant
agreement therefor,against payment (or delivery) of the consideration therefor
provided for therein, such Preferred Stock (including any Preferred Stockduly
issued upon exercise of Warrants that are exercisable to purchase Preferred
Stock) will have been duly authorized and validly issuedand will be fully paid
and non-assessable.
3. With respect to the Warrants, when (i) the Boardof Directors of the Company
(the "Board") has taken all necessary corporate action to approve the creation
of and the issuanceand terms of the Warrants, the terms of the offering
thereof and related matters; (ii) the warrant agreement or agreements relating
tothe Warrants have been duly authorized and validly executed and delivered by
the Company and the warrant agent appointed by the Company;and (iii) the
Warrants or certificates representing the Warrants have been duly executed,
countersigned, registered and delivered in accordancewith the appropriate
warrant agreement or agreements and the applicable definitive purchase,
underwriting or similar agreement approvedby the Board, upon payment of the
consideration therefor provided for therein, the Warrants will be validly
issued and will be valid andbinding obligations of the Company, enforceable
against the Company in accordance with their terms.
4. With respect to Securities constituting Units,when (i) the Board has taken
all necessary corporate action to approve the creation of and the issuance and
terms of the Units, termsof the offering thereof and related matters; (ii) the
agreement or agreements relating to the Securities comprising the Units have
beenduly authorized and validly executed and delivered by the Company; and
(iii) the certificates representing the Securities comprising theUnits have
been duly executed, countersigned, registered and delivered in accordance with
the appropriate agreements, the Units will bevalid and binding obligations of
the Company enforceable against the Company in accordance with the their terms.
The opinions and other matters in this letter arequalified in their entirety
and subject to the following:
A. With respect to the opinions above, we haveassumed that, in the case of
each offering and sale of Securities, (i) the Registration Statement, and any
amendments thereto (includingpost-effective amendments), will have become
effective under the Act and such effectiveness or qualification shall not have
been terminatedor rescinded; (ii) a Prospectus Supplement will have been
prepared and filed with the Commission describing such Securities; (iii)
suchSecurities will have been issued and sold in compliance with applicable
United States federal and state securities Laws (hereinafter defined)and
pursuant to and in the manner stated in the Registration Statement and the
applicable Prospectus Supplement; (iv) unless such Securitiesconstitute Common
Stock or Preferred Stock issuable upon exchange or conversion of Securities
constituting Common Stock or Preferred Stock,or Common Stock or Preferred
Stock issuable upon exercise of Warrants, a definitive purchase, underwriting
or similar agreement with respectto the issuance and sale of such Securities
will have been duly authorized, executed and delivered by the Company and the
other partiesthereto; (v) at the time of the issuance of such Securities, (a)
the Company will validly exist and be duly qualified and in good standingunder
the laws of its jurisdiction of incorporation and (b) the Company will have
the necessary corporate power and due authorization;(vi) the terms of such
Securities and of their issuance and sale will have been established in
conformity with and so as not to violate,or result in a default under or
breach of, the articles of incorporation and bylaws of the Company and any
applicable law or any agreementor instrument binding upon the Company and so
as to comply with any requirement or restriction imposed by any court or
governmental orregulatory body having jurisdiction over the Company; (vii) if
such Securities constitute Common Stock or Preferred Stock, (a) sufficientshares
of Common Stock or Preferred Stock will be authorized for issuance under the
articles of incorporation of the Company that havenot otherwise been issued or
reserved for issuance and (b) the consideration for the issuance and sale of
such Common Stock or PreferredStock established by the Board and provided for
in the applicable definitive purchase, underwriting or similar agreement (or,
if CommonStock or Preferred Stock is issuable upon exercise of Warrants, the
applicable warrant agreement) will not be less than the par valueof such
Common Stock or Preferred Stock; (viii) if such Securities constitute Common
Stock or Preferred Stock issuable upon exercise ofWarrants, the action with
respect to such Warrants referred to in Paragraph 3 above will have been
taken; and (ix) if such Securitiesconstitute Warrants that are exercisable for
Securities constituting Common Stock or Preferred Stock, the Company will have
then takenall necessary action to authorize and approve the issuance of such
Common Stock or Preferred Stock upon exercise of such Warrants, theterms of
such exercise and related matters and to reserve such Common Stock or
Preferred Stock for issuance upon such exercise.
1185 Avenue of the Americas| 31
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Floor | New York, NY | 10036
T (212) 930 9700 | F (212) 930 9725 | WWW.SRFC.LAW
2
B.This letter is limited to matters governed by the Nevada Revised Statutes
and by the laws of the State of New York ("Laws").
C. This letter is limited to the matters statedherein, and no opinion is
implied or may be inferred beyond the matters expressly stated. We assume
herein no obligation, and hereby disclaimany obligation, to make any inquiry
after the date hereof or to advise you of any future changes in the foregoing
or of any fact or circumstancethat may hereafter come to our attention.
D. The matters expressed in this letter are subjectto and qualified and
limited by (i) applicable bankruptcy, insolvency, fraudulent transfer and
conveyance, reorganization, moratoriumand similar laws affecting creditors'
rights and remedies generally, and (ii) general principles of equity,
including principlesof commercial reasonableness, good faith and fair dealing
(regardless of whether enforcement is sought in a proceeding at law or in
equity).
We hereby consent to the filing of this opinionas Exhibit 5.1 to the
Registration Statement and to the use of our name under the caption "Legal
Matters" in the RegistrationStatement and in the Prospectus and in any
supplement thereto. In giving this consent, we do not thereby admit that we
are within thecategory of persons whose consent is required under Section 7 of
the Act or the rules and regulations of the Commission promulgated thereunder.
Very truly yours,
/s/ Sichenzia Ross Ference Carmel LLP
Sichenzia Ross Ference Carmel LLP
1185 Avenue of the Americas| 31
st
Floor | New York, NY | 10036
T (212) 930 9700 | F (212) 930 9725 | WWW.SRFC.LAW
3
Exhibit 23.1
IndependentRegistered Public Accounting Firm's Consent
We consent to the incorporation by reference inthis Registration Statement of
INmune Bio Inc. on Form S-3 of our report dated March 28, 2024, which includes
an explanatory paragraphas to INmune Bio Inc.'s ability to continue as a going
concern, with respect to our audits of the consolidated financial statementsof
INmune Bio Inc. as of December 31, 2023 and 2022 and for the years ended
December 31, 2023 and 2022 appearing in the Annual Reporton Form 10-K of
INmune Bio Inc. for the year ended December 31, 2023. We also consent to the
reference to our firm under the heading "Experts"in the Prospectus, which is
part of this Registration Statement.
/s/ Marcum
llp
Marcum
llp
Houston, Texas
May 1, 2024
Exhibit 107
Calculationof Filing Fee Tables
Form S-3
(Form Type)
INmune Bio Inc.
(Exact name of Registrant as Specified in its Charter)
Security Security Fee Amount Proposed Maximum Fee Amount C
Type Class Calculation Registered Maximum Aggregate Rate of F
Title or Offering Offering Registration
Carry Price Price Fee
Forward Per
Rule Unit
Newly Registered Securities
Fees Equity Common - - - - - -
to Stock,
Be par
Paid value
$0.001
per
share
Equity Preferred - - - - - -
Stock,
par
value
$0.001
per
share
Other Warrants - - - - - -
Other Units - - - - - -
Total Unallocated Rule (1) (2 ) $ 56,169,401.90 0.00014760 $ 8,290.61
(Universal) 457(o)
Shelf
Carry Forward Securities
Carry Equity Common - - - - - -
Forward Stock,
Securities par
value
$0.001
per
share
Equity Preferred - - - - - -
Stock,
par
value
$0.001
per
share
Other Warrants - - - - - -
Other Units - - - - - -
Total Unallocated Rule (3) $ 193,830,598.10 (3)
(Universal) 415(a)(6)
Shelf
Total $ 250,000,000 $ 8,290.61
Offering
Amounts
Total -
Fees
Previously
Paid
Total -
Fee
Offsets
Net $ 8,290.61
Fee
Due
arry Carry Carry Filing
orward Forward Forward Fee
Form File Initial Previously
Type Number effective Paid
date In
Connection
with
Unsold
Securities
to
be
Carried
Forward
- - - -
- - - -
- - - -
- - - -
S-3 333-254221 May $ 21,146.92 (3)
5,
2021
(1) There are being registered hereunder such indeterminate numberof shares of common stock, such indeterminate number of
shares of preferred stock, such indeterminate number of units and such indeterminatenumber of warrants to purchase common
stock or preferred stock registered hereunder as shall have an aggregate initial offering pricenot to exceed $250,000,000.
The securities registered also include such indeterminate number of shares of common stock and preferredstock
as may be issued upon exercise of warrants or pursuant to the antidilution provisions of any such securities. In addition,
pursuantto Rule 416 under the Securities Act of 1933, as amended (the "Securities Act"), the shares being registered
hereunder includesuch indeterminate number of shares of common stock and preferred stock as may be issuable with
respect to the shares being registeredhereunder as a result of stock splits, stock dividends or similar transactions.
(2) The proposed maximum aggregate offering price per class of securitywill be determined from time to time
by INmune Bio Inc. (the "Registrant") in connection with the issuance by the Registrantof the securities
registered hereunder and is not specified as to each class of security pursuant to Instruction 2.A.iii.b
of the Instructionsto the Calculation of Filing Fee Tables and Related Disclosure on Form S-3.
(3) The Registrant previously filed a Registration Statement onForm S-3 with
the Securities and Exchange Commission (the "SEC") on March 12, 2021 (File
No. 333-254221) (the "PriorRegistration Statement"), which was declared
effective on May 5, 2021, that registered $250,000,000 of securities to
be offeredby the Registrant from time to time. Pursuant to Rule 415(a)(6)
under the Securities Act, this Registration Statement includes
$193,830,598.10of unsold securities (the "Unsold Securities") that were
previously registered on the Prior Registration Statement. In connectionwith the
registration of the Unsold Securities on the Prior Registration Statement,
the Registrant paid a filing fee of $27,275 (calculatedat the filing fee
rate in effect at the time of the filing of the Prior Registration Statement).
The Registrant is not required to payany additional fee with respect
to the Unsold Securities being included in this Registration Statement in
reliance on Rule 415(a)(6),because such Unsold Securities (and associated
fees) are being moved from the Prior Registration Statement to this
Registration Statement.Accordingly, the Amount of Registration Fee in the table
above reflects only the registration fee attributable to the $56,169,401.90of
new securities registered on this Registration Statement. The
registration fee previously paid by the Registrant relating to the UnsoldSecurities
included on this Registration Statement will continue to be applied
to such Unsold Securities. During the grace period affordedby Rule 415(a)(5)
under the Securities Act, the Registrant may continue to offer and
sell under the Prior Registration Statement theUnsold Securities being
registered hereunder. To the extent that, after the filing date hereof and
prior to the effectiveness of thisRegistration Statement, the Registrant sells
any such Unsold Securities pursuant to the Prior Registration Statement,
the Registrantwill identify in a pre-effective amendment to this Registration
Statement the updated amount of Unsold Securities from the Prior
RegistrationStatement to be included in this Registration Statement
pursuant to Rule 415(a)(6). Pursuant to Rule 415(a)(6), the offering of the
UnsoldSecurities under the Prior Registration Statement will be deemed
terminated as of the date of effectiveness of this Registration Statement.
{graphic omitted}