Filed Pursuant to Rule 424(b)(5)
Registration No. 333-254221
PROSPECTUS SUPPLEMENT
(To the Prospectus Dated May 5, 2021)
$28,701,161.61
Common Stock
INMUNE BIO INC.
This
prospectus supplement and the accompanying base prospectus, which together we sometimes refer to as the prospectus, relate to the
offer and sale, from time to time, of shares of our common stock having an aggregate gross sales price of up to $28,701,161.61,
through BTIG, LLC, or BTIG, acting as our sales agent, in accordance with the terms of a sales agreement we have entered into with
BTIG. On August 16, 2023, we entered into an amendment to the sales agreement in order to update
the registration statement that this prospectus forms a part of. As of the date of this prospectus we have sold $16,298,838.39 of
shares of our common stock pursuant to the sales agreement and issued 788,889 shares of our common stock and may sell up to an
additional $28,701,161.61 of shares of our common stock.
Sales
of our common stock, if any, under this prospectus supplement will be made by any method that is deemed to be an “at the market
offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, or the Securities Act. BTIG is not required
to sell any specific amount of securities, but will act as our sales agent using commercially reasonable efforts consistent with its normal
trading and sales practices, on mutually agreed terms between BTIG and us. There is no arrangement for funds to be received in any escrow,
trust or similar arrangement.
BTIG
will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of our common stock on our behalf
pursuant to the sales agreement. In connection with the sale of the common stock on our behalf, BTIG will be deemed to be an “underwriter”
within the meaning of the Securities Act, and the compensation of BTIG will be deemed to be underwriting commissions or discounts. We
have agreed to provide indemnification and contribution to BTIG against certain civil liabilities, including liabilities under the Securities
Act or the Securities Exchange Act of 1934, as amended, or the Exchange Act.
Our
common stock is currently traded on the Nasdaq Capital Market, or Nasdaq, under the symbol “INMB.” On August 14, 2023, the
last reported sales price for our common stock was $8.21 per share.
We
are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act,
and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus supplement, the accompanying
prospectus and our filings with the Securities and Exchange Commission.
Investing
in our common stock involves a high degree of risk. See “Risk Factors” beginning on page S-5 of this prospectus supplement
and page 5 of the accompanying prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
if this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is August 16, 2023.
TABLE OF CONTENTS
PROSPECTUS
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement
and the accompanying prospectus relate to the offering of our common stock. Before buying any of the common stock that we are offering,
we urge you to carefully read this prospectus supplement and the accompanying prospectus, together with the information incorporated by
reference as described under the headings “Where You Can Find More Information” and “Incorporation of Certain Information
by Reference” in this prospectus supplement. These documents contain important information that you should consider when making
your investment decision.
This document is in two parts.
The first part is this prospectus supplement, which describes the specific terms of this offering and also adds to and updates information
contained in the accompanying prospectus and the documents incorporated by reference herein or therein. The second part, the accompanying
prospectus, provides more general information. Generally, when we refer to this prospectus, we are referring to both parts of this document
combined. To the extent there is a conflict between the information contained in this prospectus supplement, on the one hand, and the
information contained in any document incorporated by reference into this prospectus supplement that was filed with the Securities and
Exchange Commission (the “SEC”), before the date of this prospectus supplement, on the other hand, you should rely on the
information in this prospectus supplement. If any statement in one of these documents is inconsistent with a statement in another document
having a later date—for example, a document incorporated by reference into this prospectus supplement—the statement in the
document having the later date modifies or supersedes the earlier statement.
We further note that the representations,
warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference herein
or in the accompanying prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreement, and should not be deemed to be a representation, warranty or covenant
to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations,
warranties and covenants should not be relied on as accurately representing the current state of our affairs.
You should rely only on the
information contained or incorporated by reference in this prospectus supplement and the accompanying prospectus and any free writing
prospectuses we may provide to you in connection with this offering. We have not, and BTIG has not, authorized any other person to provide
you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. We are not,
and BTIG is not, making an offer to sell or seeking an offer to buy our common stock under this prospectus in any jurisdiction where the
offer or sale is not permitted. Persons outside the United States who come into possession of this prospectus must inform themselves about,
and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside the United States.
Furthermore, you should not consider this prospectus to be an offer or solicitation relating to the securities if the person making the
offer or solicitation is not qualified to do so, or if it is unlawful for you to receive such an offer or solicitation. You should not
assume that the information contained in this prospectus or any free writing prospectus is accurate as of any date other than the date
on the front cover of those documents, or that the information contained in any document incorporated by reference is accurate as of any
date other than the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any sale
of a security. Our business, financial condition, results of operations and prospects may have changed since those dates. It is important
for you to read and consider all information contained in this prospectus supplement, the accompanying prospectus, the documents incorporated
by reference herein and therein, and any free writing prospectus prepared by or on behalf of us that we may authorize for use in connection
with this offering, in their entirety, before making an investment decision. You should also read and consider the information in the
documents to which we have referred you in the sections entitled “Where You Can Find More Information” and “Incorporation
of Certain Information by Reference” in this prospectus supplement and in the accompanying prospectus.
In this prospectus supplement
and the accompanying prospectus, unless the context otherwise requires, references to “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.
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights
certain information about this offering and selected information contained elsewhere in or incorporated by reference into this prospectus
supplement and the accompanying prospectus. This summary is not complete and does not contain all of the information that you should consider
before deciding whether to invest in our shares of common stock. You should carefully read this entire prospectus supplement and accompanying
prospectus, including the information incorporated herein and therein, including the “Risk Factors” section contained in this
prospectus supplement and the other documents incorporated by reference into this prospectus supplement.
Overview
We are a clinical-stage immunology
company focused on developing drugs that may reprogram the patient’s innate immune system to treat disease. We believe this may
be done by targeting cells of the innate immune system that cause acute and chronic inflammation and are involved in immune dysfunction
associated with chronic diseases such as cancer and neurodegenerative diseases. The Company’s drugs are in clinical trials and have
not been approved by a regulatory authority. The Company has two therapeutic platforms – a dominant-negative TNF platform (“DN-TNF”,
“XPro™”, “XPro1595™” or “pegipanermin and pSar DN-TNF”) and a Natural Killer (“NK”,
or “INKmune™”) 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-selective TNF inhibitors that inhibit both sTNF and tmTNF. Protecting the function of tmTNF and TNF receptors while neutralizing
the function of sTNF is a potent anti-inflammatory strategy that does not cause immunosuppression or demyelination which occur in the
currently approved non-selective TNF inhibitors. Currently approved non-selective TNF inhibitors treat autoimmune disease, but are contraindicated
in patients with 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
natural killer cells in patients with cancer. NK cells are part of the normal immunologic response to cancer with important roles in immunosurveillance
to prevent cancer and in preventing relapse by eliminating residual disease. Residual disease is the cancer left behind after therapy
is finished. Residual disease can grow to cause relapse. The mechanism by which INKmune improves the ability of the patient’s NK
cells to kill their cancer is complex. The NK cells of cancer patients lose the ability to bind and kill cancer cells. A measure of NK
cell binding to cancer cells is avidity. The higher the avidity, the greater the bond between the NK cell to cancer cell and thus the
greater NK killing of cancer cells. INKmune increases NK avidity and further improves mitochondrial function and upregulates nutrient
receptors. These metabolic changes may help the INKmune primed NK cell to function in the hostile tumor microenvironment and persist much
longer in the patient. 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-TNF platform and the INKmune platform can be used to treat multiple diseases. The DN-TNF platform will be used as an immunotherapy
for the treatment of cancer and neurodegenerative disease. INKmune is being developed to treat NK sensitive hematologic malignancies and
solid tumors.
We
believe our DN-TNF platform can be used as a cancer therapy to reduce resistance in immunotherapy and as a CNS (“central nervous
system”) therapy to target glial activation to prevent progression of Alzheimer’s disease (“AD”), and to target
neuroinflammation in treatment resistant depression (“TRD”) and as a drug to prevent muscle degeneration, prevent fibrosis
and promote muscle regeneration in Duchene muscular dystrophy (“DMD”). The drug is named differently for the oncology and
CNS indications; INB03™ or XPro™, respectively, but it is the same drug product. For DMD, the company is exploring pSar DN-TNF
compounds optimized for the treatment of DMD. The pSar DN-TNF compound has the same mechanism of action, a different half-life extender
and novel IP protection. In each case, we believe neutralizing sTNF is a cornerstone to the treatment of these diseases. As an immunotherapy
for cancer, we are using INB03 to neutralize sTNF produced by HER2+ trastuzumab resistant breast cancers to reverse resistance to targeted
therapy. sTNF produced by the tumor causes an up-regulation of MUC4 expression causing steric hindrance of trastuzumab binding to the
HER receptor on HER2+ breast cancer cells. Without binding, trastuzumab based therapies are not effective. Neutralizing sTNF reverses
MUC4 expression converting a trastuzumab resistant breast cancer cell into a trastuzumab sensitive breast cancer cell. In addition, INB03
changes the immunobiology of the tumor microenvironment by decreasing the number of immunosuppressive myeloid cells, both myeloid derived
suppressor cells and tumor active macrophages, and increasing the number of cytotoxic lymphocytes and phagocytic macrophages in the TME.
Recently, the Company has shown the combination for INB03 with trastuzumab-deruxtecan (Enhertu), decreases tumor growth in the multi-resistant
JIMT-1 tumor model. The Company has completed an open label dose escalation trial in cancer patients with metastatic solid tumors that
have failed multiple lines of therapy. The trial informs the design of the Phase II trial by demonstrating that INB03 was safe and well
tolerated, defined the dose of INB03 to carry into Phase II trials, and demonstrated a pharmacodynamic endpoint – a decrease in
inflammatory cytokines in the blood. A Phase II trial is planned in patients with advanced MUC4+ expressing cancer.
Likewise,
we believe the DN-TNF platform can be used to treat selected neurodegenerative diseases by modifying the brain microenvironment (“BME”).
The Company believes the core pathology of cognitive decline is a combination of neurodegeneration and synaptic dysfunction. Neurodegeneration
is nerve cell death that may include demyelination. Synaptic dysfunction means the connections between nerve cells stop working efficiently
and may decrease in number or become disconnected. The combination of neurodegeneration and synaptic dysfunction causes cognitive decline
and behavioral changes associated with Alzheimer’s disease (“AD”). XPro completed a Phase I trial treating patients
with Alzheimer’s disease that was partially funded by a Part-the-Clouds Award from the Alzheimer’s Association. We believe
XPro targets activated microglia and astrocytes of the brain that produce sTNF that promotes nerve cell loss and synaptic dysfunction,
key elements in the development of dementia. In animal models, elimination of sTNF prevents nerve cell dysfunction and reverses synaptic
pruning. The Phase I trial in patients with biomarkers of inflammation with AD has been completed. The open label, dose escalation trial
was designed to demonstrate that XPro can safely decrease neuroinflammation in patients with ADi. ADi is the term used to delineate patients
with AD with biomarkers of inflammation. This appears to be more than 40% of patients with AD. The endpoints of the trial are measures
of neuroinflammation and neurodegeneration in blood and cerebral spinal fluid by measuring changes in inflammatory cytokine levels in
the CNS and using MRI-DTI to measure white matter free water. White matter free water is a validated measure of neuroinflammation in the
brain. XPro, at the 1mg/kg/week dose decreased inflammatory cytokines in the CSF and decreased white matter free water in the brain demonstrating
that XPro can decrease neuroinflammation in patients with ADi. We also studied downstream benefits of decreasing neuroinflammation by
measuring changes in the CSF proteome and quantifying changes in novel white matter MRI biomarkers. XPro significantly decreases biomarkers
of neurodegeneration as measured 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 proteome including a 222% increase in Contactin 2 and a 56% decrease neurogranin, changes that contribute to improved
synaptic function.
The
successful completion of the Phase I trial in AD has informed the design of a blinded randomized, placebo-controlled Phase II trials in
patients with early ADi. Early ADi includes patients with AD and MCI who have at least one biomarker of inflammation (ADi and MCI2 respectively).
The early ADi trial is a blinded randomized trial to test if treatment of early AD patients with neuroinflammation with XPro will affect
cognitive decline. The Phase II trial in early ADi has six important elements. Two hundred and ten patients are being enrolled in a 2:1
ratio (XPro vs placebo). The patients will receive 1mg/kg/week as a subcutaneous injection for six months. An enrichment strategy identical
to the successful strategy used in the Phase I trial will be used to ensure patients have neuroinflammation. Patients will need to have
one or more enrichment criteria: elevated blood level of at least one of C-reactive protein, hemoglobin A1c, erythrocyte sedimentation
and/or at least one allele of ApoE4. The primary endpoint will be Early/ild 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 trial
is open in Australia and Canada and will open in the US pending the lift of a clinical hold by the US FDA. All patients will be offered
to stay on therapy for at least 12 months in an extension trial. Clinical and biomarker data will be collected during the extension trial.
Effective
therapy for TRD is a large unmet need. Twenty percent of patients with a Major Depressive Disorder have TRD. Once third of TRD patients
have peripheral biomarkers to inflammation (elevated CRP). This is a large patient population. The role of TNF and anti-TNF therapeutics
was explored in a small open label clinical trial by Prof. Andrew Miller, MD of Emory University demonstrated the patients have elevated
TNF levels and treatment with infliximab treated their depression (Miller, 2011). The Company received a $2.9M USD award from the National
Institute of Mental Health (“NIMH”) to treat TRD with XPro. The blinded, randomized Phase II trial will use biomarkers of
peripheral inflammation to select patients with TRD for enrollment. Patients will be treated for 6 weeks. Primary endpoints include both
clinical and neuroimaging measures. The final trial design is ongoing and discussions with the FDA are not complete. The Company anticipates
receiving authorization to initiate the clinical trial once the pending clinical hold is lifted.
The
Company completed an extensive series of studies in murine models of DMD. The data shows DN-TNF decreases muscle fiber inflammation and
degeneration, increases muscle fiber regeneration in an acute model of DMD. Cardiac function was studied using echocardiography after
30 weeks of treatment. Cardiac function did not change compared to placebo treated or prednisone treated animals. These data strongly
suggest DN-TNF may be a therapy for treatment of patients with DMD that may have unique biologic attributes, muscle fiber regeneration,
without corticosteroid associated metabolic toxicity – insulin resistance, diabetes, obesity, hirsutism, short stature and muscle
weakness.
We
believe that INKmune improves the ability of the patient’s own NK cells to attack their tumor. INKmune interacts with the patient’s
NK cells to convert them from inert resting NK cells into memory-like NK cells that kill the patient’s cancer cells. INKmune is
a replication incompetent proprietary cell line that is given to the patient after determining that i) the patient has adequate NK cells
in their circulation and ii) those NK cells are functional when exposed to INKmune in vitro. INKmune is designed to be given to patients
after their immune system has recovered after cytotoxic chemotherapy to target the residual disease the remains after treatment with cytotoxic
therapy. We believe INKmune can be used to treat numerous hematologic malignancies and solid tumors including leukemia, multiple myeloma,
lymphoma, lung, ovary, breast, renal, nasopharyngeal and prostate cancer. The Company has initiated a Phase I trial using INKmune to treat
patients with high risk MDS/AML, a form of leukemia. Two patients have been treated in the Phase I trial for MDS and three patients have
been treated compassionately in AML. In the five patients, INKmune therapy is safe, produces memory-like NK cells that kill cancer in
vitro, promotes development of cancer killing memory-like NK cells that can be found in the patient’s circulation of 4 months. The
Company will continue to enroll patients in the Phase I trial. The Company intends to initiate a separate Phase I/II trial of INKmune
in a metastatic castration resistant prostate cancer (“mCRPC”) tumor during 2024. An IND for a Phase I/II trial in men with
mCRPC was opened in May 2023. The trial will treat up to 30 patients with mCRPC in a open label trial. The trial has four goals: i) demonstrate
safety of INKmune in men with mCRPC; ii) determine what dose of INKmune should be used in a blinded randomized Phase II trial on men with
mCRPC; iii) determine tumor response using traditional biomarkers of mCRPC including blood PSA level and iv) use exploratory biomarkers
of tumor response including circulating tumor DNA and PET PMSA imaging studies. The first patients should be treated 9 months after the
IND is open.
Corporate Information
Our principal executive offices
are located at 225 NE Mizner Blvd., Suite 640, Boca Raton, Florida 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 our website address in this prospectus as an inactive textual reference only and not as an active hyperlink.
THE OFFERING
Common stock offered by us |
Shares of our common stock having an aggregate offering price of up to $28,701,161.61. |
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Manner of offering |
“At the market offering” that may be made from time to time to or through our sales agent, BTIG, LLC. Please see “Plan of Distribution” on page S-8. |
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Use of Proceeds |
We intend to use the net proceeds from this offering for general corporate purposes, including to support research and development, including clinical trials. |
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Risk Factors |
See “Risk Factors” beginning on page S-5 of this prospectus supplement and in the documents incorporated by reference herein for a discussion of factors you should consider carefully before investing in our common stock. |
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Nasdaq Capital Market symbol |
“INMB” |
RISK FACTORS
An investment in our common
stock involves a high degree of risk. Prior to making a decision about investing in our common stock, you should carefully consider the
risk factors described below and the risk factors discussed in the sections entitled “Risk Factors” contained in our most
recent Annual Report on Form 10-K, and our other filings with the SEC and incorporated by reference in this prospectus supplement, together
with all of the other information contained in this prospectus supplement. Our business, financial condition and results of operations
could be materially and adversely affected as a result of these risks. This could cause the trading price of our common stock to decline,
resulting in a loss of all or part of your investment.
Risks Related to this Offering
We will have broad discretion in the use
of the net proceeds from this offering and, despite our efforts, we may use the net proceeds in a manner that does not increase the value
of your investment.
We currently intend to use
the net proceeds from this offering for general corporate purposes, including to support research and development, including clinical
trials. However, we have not determined the specific allocation of the net proceeds among these potential uses. Our management will have
broad discretion over the use and investment of the net proceeds from this offering, and, accordingly, investors in this offering will
need to rely upon the judgment of our management with respect to the use of proceeds, with only limited information concerning our specific
intentions. We may use the net proceeds in ways that do not improve our operating results or increase the value of your investment.
Certain shares previously sold under our ATM
Sales Agreement may have been sold in violation of federal and state securities laws and may be subject to rescission rights and other
penalties, requiring us to repurchase shares sold thereunder.
In connection with our At-the-Market-Sales
Agreement, dated March 10, 2021 (the “Sales Agreement”), we recently became aware that our shelf registration statement on
Form S-3 (file number 333-237368) (the “Registration Statement”) expired on April 2, 2023. Prior to becoming aware of
the expiration, we sold an aggregate of 75,697 shares of our common stock following the expiration of the Registration Statement and through
July 17, 2023 at an average price of approximately $10.56 per share for an aggregate of approximately $799,212 under the Registration
Statement pursuant to the Sales Agreement (the “Sales”). Because the Registration Statement had already expired, the Sales
could be determined to be unregistered sales of securities and, in accordance with Section 5 of the Securities Act, direct purchasers
in the Sales may have rescission rights pursuant to which they may be entitled to recover the amount paid for such shares, plus statutory
interest, upon returning the shares to us within one year from the transaction date. In addition, we could be subject to enforcement actions
or penalties and fines by federal and/or state regulatory authorities. We cannot predict the likelihood of any claims or actions being
brought against us or the amount of any penalties or fines in connection with the Sales.
You may experience immediate and substantial
dilution in the net tangible book value per share of the common stock you purchase in the offering. In addition, we may issue additional
equity or convertible debt securities in the future, which may result in additional dilution to you.
The offering price per share
in this offering may exceed the pro forma net tangible book value per share of our common stock outstanding as of June 30, 2023. Assuming
that we sell an aggregate of 3,495,878 shares of our common stock at a price of $8.21 per share, the last reported sale price of our common
stock on Nasdaq on August 14, 2023, for aggregate gross proceeds of approximately $28,701,161, and after deducting commissions and estimated
aggregate offering expenses payable by us, you will experience immediate dilution of $5.32 per share, representing the difference between
our pro forma as adjusted net tangible book value per share as of June 30, 2023, after giving effect to this offering and the assumed
offering price. See the section titled “Dilution” below for a more detailed illustration of the dilution you would incur if
you participate in this offering. In addition, to the extent we need to raise additional capital in the future and we issue additional
shares of common stock or securities convertible or exchangeable for our common stock, our then existing stockholders may experience dilution
and the new securities may have rights senior to those of our common stock offered in this offering.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement,
the accompanying prospectus and the information incorporated by reference herein and therein contain or incorporate forward-looking statements
within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements reflect
management’s beliefs and assumptions. In addition, these forward-looking statements reflect management’s current views with
respect to future events or our financial performance, and involve certain known and unknown risks, uncertainties and other factors, including
those identified below, which may cause our or our industry’s actual or future results, levels of activity, performance or achievements
to differ materially from those expressed or implied by any forward-looking statements or from historical results. We intend the forward-looking
statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act. Forward-looking statements include information concerning our possible or assumed future results of operations
and statements preceded by, followed by, or that include the words “may,” “will,” “could,” “would,”
“should,” “believe,” “expect,” “plan,” “anticipate,” “intend,”
“estimate,” “predict,” “potential” or similar expressions.
Forward-looking statements
are inherently subject to risks and uncertainties, many of which we cannot predict with accuracy and some of which we might not even anticipate.
Although we believe that the expectations reflected in the forward-looking statements are based upon reasonable assumptions at the time
made, we can give no assurance that the expectations will be achieved. Future events and actual results, financial and otherwise, may
differ materially from the results discussed in the forward-looking statements. Readers are cautioned not to place undue reliance on these
forward-looking statements.
The factors described under
“Risk Factors” in this prospectus supplement and in any documents incorporated by reference herein, and other factors could
cause our or our industry’s future results to differ materially from historical results or those anticipated or expressed in any
of our forward-looking statements. We operate in a continually changing business environment, and new risk factors emerge from time to
time. Other unknown or unpredictable factors also could have material adverse effects on our future results, performance or achievements.
We cannot assure you that projected results or events will be achieved or will occur.
You should read this prospectus
supplement, the accompanying prospectus and the information incorporated by reference herein and therein completely and with the understanding
that our actual future results may be materially different from what we expect. Any forward-looking statement speaks only as of the date
of this prospectus supplement. We do not assume any obligation to update any forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required by law.
USE OF PROCEEDS
We may issue and sell shares
of our common stock having aggregate gross sales proceeds of up to $28,701,161.61 from time to time. Because there is no minimum offering
amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any,
are not determinable at this time.
We will retain broad discretion
over the use of the net proceeds from the sale of the securities offered hereby. We currently intend to use the net proceeds from this
offering for general corporate purposes, including to support research and development, including clinical trials. The precise amount
and timing of the application of such proceeds will depend upon our funding requirements and the availability and cost of other capital.
As of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses for the net proceeds that we
will have from the sale of the shares of our common stock. Pending the use of the net proceeds from this offering, if any, we may invest
the net proceeds in investment grade, short-term interest-bearing obligations, such as money-market funds, certificates of deposit, or
direct or guaranteed obligations of the United States government, or hold the net proceeds as cash.
DILUTION
If you purchase shares of
our common stock in this offering, your interest will be diluted to the extent of the difference between the public offering price per
share and the net tangible book value per share of our common stock after this offering. We calculate net tangible book value per share
by dividing our net tangible assets (tangible assets less total liabilities) by the number of shares of our common stock issued and outstanding
as of June 30, 2023.
Our historical net tangible
book value at June 30, 2023 was $34,140,000 or approximately $1.90 per share of our common stock. After giving effect to the sale of our
common stock in the aggregate amount of approximately $28,701,161 in this offering, at an assumed offering price of $8.21 per share, the
last reported sale price of our common stock on Nasdaq on August 14, 2023, and after deducting estimated offering expenses and commissions
payable by us, our adjusted net tangible book value as of June 30, 2023 would have been approximately $61,890,000 or approximately $2.89
per share of our common stock. This represents an immediate increase in the net tangible book value of $0.99 per share of our common stock
to our existing stockholders and an immediate dilution in net tangible book value of approximately $5.32 per share of our common stock
to new investors. The following table illustrates per share dilution:
Assumed public offering price per share | |
$ | 8.21 | |
Net tangible book value per share as of June 30, 2023 | |
$ | 1.90 | |
Increase in net tangible book value per share attributable to this offering | |
$ | 0.99 | |
Adjusted net tangible book value per share as of June 30, 2023, after giving effect to this offering | |
$ | 2.89 | |
Dilution per share to new investors purchasing shares in this offering | |
$ | 5.32 | |
The table above assumes for
illustrative purposes that an aggregate of 3,495,878 shares of our common stock are sold at a price of $8.21 per share, the last reported
sale price of our common stock on Nasdaq on August 14, 2023, for aggregate gross proceeds of approximately $28,701,161. The shares sold
in this offering, if any, will be sold from time to time at various prices. An increase of $2.00 per share in the price at which the shares
are sold from the assumed offering price of $8.21 per share shown in the table above, assuming all of our common stock in the aggregate
amount of $28,701,161 is sold at that price, would increase our adjusted net tangible book value per share after the offering to $2.98
per share and would increase the dilution in net tangible book value per share to new investors in this offering to $7.23 per share, after
deducting estimated offering expenses and commissions payable by us. A decrease of $2.00 per share in the price at which the shares are
sold from the assumed offering price of $8.21 per share shown in the table above, assuming all of our common stock in the aggregate amount
of $28,701,161 is sold at that price, would decrease our adjusted net tangible book value per share after the offering to $2.74 per share
and would decrease the dilution in net tangible book value per share to new investors in this offering to $3.47 per share, after deducting
estimated offering expenses and commissions payable by us. This information is supplied for illustrative purposes only.
The information above is based
on 17,945,995 shares of our common stock outstanding as of June 30, 2023, and excludes:
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5,501,000 shares of our common stock issuable upon the exercise of stock options outstanding at June 30, 2023, at a weighted average exercise price of $8.73 per share (4,058,832 of which are exercisable at a weighted average exercise price of $7.81 per share); |
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74,074 shares of our common stock issuable upon the exercise of warrants outstanding at June 30, 2023, at a weighted average exercise price of $12.33 per share; |
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1,932,475 additional shares of our common stock available for future issuance as of June 30, 2023, under our amended and restated INmune Bio Inc. 2021 stock incentive plan; |
In addition, the above discussion
and table do not include 75,697 shares of the Company’s common stock sold during July 2023 pursuant to the Sales Agreement.
To the extent that outstanding
options or warrants are exercised, or we issue other shares, investors purchasing shares in this offering could experience further dilution.
In addition, to the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of
those securities could result in further dilution to our stockholders.
PLAN OF DISTRIBUTION
We have entered into the sales
agreement with BTIG under which we may issue and sell shares of our common stock having an aggregate offering price of up to $45,000,000
from time to time through BTIG, acting as our sales agent. On August 16, 2023, we entered into an amendment
to the sales agreement in order to update the registration statement that this prospectus forms a part of. As the date of this prospectus
we have sold $16,298,838.39 of shares of our common stock pursuant to the sales agreement and issued 788,889 shares of our common stock
and may sell up to an additional $28,701,161.61 of shares of our common stock. The sales of our common stock, if any, under this prospectus
supplement will be made at market prices by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4)
under the Securities Act, including sales made directly on The Nasdaq Capital Market, on any other existing trading market for our common
stock, or to or through a market maker.
Each time that we wish to
issue and sell shares of our common stock under the sales agreement, we will provide BTIG with a placement notice describing the amount
of shares to be sold, the time period during which sales are requested to be made, any limitation on the amount of shares of common stock
that may be sold in any single day, any minimum price below which sales may not be made or any minimum price requested for sales in a
given time period and any other instructions relevant to such requested sales. Upon receipt of a placement notice, BTIG, acting as our
sales agent, will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and
federal laws, rules and regulations and the rules of the Nasdaq Capital Market, to sell shares of our common stock under the terms and
subject to the conditions of the placement notice and the sales agreement. We or BTIG may suspend the offering of common stock pursuant
to a placement notice upon notice and subject to other conditions. BTIG, in its sole discretion, may decline to accept any placement notice.
BTIG will provide written
confirmation to us no later than the opening of the trading day on the Nasdaq Capital Market following the trading day on which shares
of our common stock are sold through BTIG as sales agent under the sales agreement. Each confirmation will include the number of shares
sold on the preceding day, the net proceeds to us and the commissions payable by us to BTIG in connection with the sales.
Settlement for sales of common
stock under the sales agreement will occur on the second trading day following the date on which such sales are made (or on such other
date as is industry practice for regular-way trading), unless otherwise specified in the applicable placement notice, in return for payment
of the net proceeds to us. There are no arrangements to place any of the proceeds of this offering in an escrow, trust or similar account.
Sales of our common stock as contemplated in this prospectus supplement will be settled through the facilities of The Depository Trust
Company or by such other means as we and BTIG may agree upon.
We will pay BTIG commissions
for its services in acting as our sales agent in the sale of our common stock pursuant to the sales agreement. BTIG will be entitled to
compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of our common stock on our behalf pursuant to the
sales agreement. We also have agreed to reimburse BTIG for its reasonable out-of-pocket expenses, including the fees and disbursements
of BTIG’s counsel, incurred in connection with entering into the sales agreement, in an amount not to exceed $50,000, plus additional
amounts, not to exceed $7,500 per calendar quarter during which shares of our common stock have been sold under the sales agreement, to
reimburse BTIG for additional out-of-pocket expenses it may incur after the date of this prospectus supplement in connection with this
offering.
We estimate that the total
expenses for this offering, excluding compensation payable to BTIG and certain expenses reimbursable to BTIG under the terms of the sales
agreement, will be approximately $90,000. The remaining sales proceeds, after deducting any expenses payable by us and any transaction
fees imposed by any governmental, regulatory, or self-regulatory organization in connection with the sales, will equal our net proceeds
for the sale of such common stock.
Because there are no minimum
sale requirements as a condition to this offering, the actual total public offering price, commissions and net proceeds to us, if any,
are not determinable at this time. The actual dollar amount and number of shares of common stock we sell through this prospectus supplement
will be dependent, among other things, on market conditions and our capital raising requirements.
We will report at least quarterly
the number of shares of common stock sold through BTIG under the sales agreement, the net proceeds to us and the compensation paid by
us to BTIG in connection with the sales of common stock.
In connection with the sale
of the common stock on our behalf, BTIG will be deemed to be an “underwriter” within the meaning of the Securities Act, and
the compensation of BTIG will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution
to BTIG against certain civil liabilities, including liabilities under the Securities Act or the Exchange Act.
BTIG will not engage in any
market making activities involving our common stock while the offering is ongoing under this prospectus supplement if such activity would
be prohibited under Regulation M or other anti-manipulation rules under the Securities Act. As our sales agent, BTIG will not engage in
any transactions that stabilizes our common stock.
The offering pursuant to the
sales agreement will terminate upon the earlier of (i) the sale of all shares of common stock subject to the sales agreement and (ii)
termination of the sales agreement as permitted therein. We may terminate the sales agreement in our sole discretion at any time by giving
10 days’ prior notice to BTIG. BTIG may terminate the sales agreement under the circumstances specified in the sales agreement and
in its sole discretion at any time by giving 10 days’ prior notice to us.
The sales agreement has been
filed as an exhibit to a current report on Form 8-K that we filed with the SEC in connection with this offering and is incorporated into
this prospectus supplement by reference.
BTIG has provided, and BTIG
and/or its affiliates may in the future provide, various investment banking and other financial services for us, for which BTIG has received,
and BTIG and/or its affiliates may in the future receive, customary fees and commissions.
LEGAL MATTERS
The validity of the securities
offered by this prospectus will be passed upon by Sichenzia Ross Ference LLP, New York, New York. Certain matters will be passed upon
for BTIG by Lowenstein Sandler LLP, New York, New York.
EXPERTS
The consolidated financial
statements of INmune Bio Inc. as of and for the years ended December 31, 2022 and 2021 appearing in INmune Bio Inc.’s Annual Report
on Form 10-K for the year ended December 31, 2022 have been audited by Marcum LLP, as set forth in its report thereon, included therein,
and incorporated herein by reference. Such consolidated financial statements are incorporated herein by reference in reliance upon such
report given on the authority of such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly
and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public at the SEC’s
web site at http://www.sec.gov.
We make available free of
charge on or through our Internet website www.inmunebio.com, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8–K, and amendments to those reports filed or furnished pursuant to Section 13(a), 14 or 15(d) of the Exchange Act
as soon as reasonably practicable after we electronically file the material with, or furnish it to, the SEC. The references to www.inmunebio.com in
this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein or therein are inactive textual
references only, and the information found on our internet website is not incorporated by reference into, and should not be considered
part of, this prospectus supplement, the accompanying base shelf prospectus or the documents incorporated by reference herein or therein.
Investors should not rely on any such information in deciding whether to invest in our common stock.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate
by reference information contained in documents we file with it, which means that we can disclose important information to you by referring
you to those documents already on file with the SEC that contain that information. The information incorporated by reference is considered
to be part of this prospectus supplement, and later information that we file with the SEC will automatically update and supersede this
information. We incorporate by reference the documents listed below and any future information filed (rather than furnished) with the
SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, between the date of this prospectus supplement and the termination of
the offering of the securities covered by this prospectus supplement, provided, however, that we are not incorporating any information
furnished under any of Item 2.02 or Item 7.01 of any Current Report on Form 8-K (and exhibits filed on such form that are related to such
items):
|
● |
Our Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the SEC on March 2, 2023;
|
|
● |
Our Quarterly Report on Form 10-Q for the period ended March 31, 2023, filed with the SEC on May 3, 2023; and our Quarterly Report on Form 10-Q for the period ended June 30, 2023 filed with the SEC on August 7, 2023; |
|
● |
our Current Reports on Form 8-K or Form 8-K/A filed with the SEC on January 25, 2023, February 10, 2023, February 22, 2023, February 22, 2023, March 3, 2023, March 15, 2023, April 3, 2023, April 11, 2023, April 20, 2023, April 24, 2023, May 8, 2023, May 12, 2023, June 1, 2023, July 12, 2023, July 27, 2023, August 1, 2023, and August 2, 2023. |
|
● |
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), including any amendment or report filed for the purpose of updating such description. In addition, a Form 8-A filed on December 30, 2020, contains a description of certain rights attributable to the common stock. |
The information 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., 225 NE Mizner Blvd, Suite
640, Boca Raton, Florida 33432, telephone number (858) 964-3720.
PROSPECTUS
$250,000,000
INMUNE BIO Inc.
Common Stock
Preferred Stock
Warrants
Units
We may from time to time,
in one or more offerings at prices and on terms that we will determine at the time of each offering, sell common stock, preferred stock,
warrants, or a combination of these securities, or units, for an aggregate initial offering price of up to $250,000,000. This prospectus
describes the general manner in which our securities may be offered using this prospectus. Each time we offer and sell securities, we
will provide you with a prospectus supplement that will contain specific information about the terms of that offering. Any prospectus
supplement may also add, update, or change information contained in this prospectus. You should carefully read this prospectus and the
applicable prospectus supplement as well as the documents incorporated or deemed to be incorporated by reference in this prospectus before
you purchase any of the securities offered hereby.
We
are an “emerging growth company” under applicable Securities and Exchange Commission, or the SEC, rules and, as such, have
elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.
This prospectus may not be
used to offer and sell securities unless accompanied by a prospectus supplement.
Our common stock is currently
traded on the NASDAQ Capital Market under the symbol “INMB.” On March 9, 2021, the last reported sales price for our common
stock was $13.73 per share. The applicable prospectus supplement will contain information, where applicable, as to any other listing of
the securities on the NASDAQ Capital Market or any other securities market or exchange covered by the prospectus supplement. Prospective
purchasers of our securities are urged to obtain current information as to the market prices of our securities, where applicable.
We may offer the securities
directly or through agents 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 calculable from the information set forth, in an accompanying prospectus supplement. We can sell the securities through agents, underwriters
or dealers only 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-affiliates was approximately $238.5 million which was calculated based on 8,882,870 shares
of outstanding common stock held by non-affiliates as of March 9, 2021, and a price per share of $26.85, the closing price of our common
stock on January 19, 2021.
The securities offered
by this prospectus involve a high degree of risk. See “Risk Factors” beginning on page 5, in addition to Risk Factors contained
in the applicable prospectus supplement.
Neither the Securities
and Exchange Commission nor 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 May 5, 2021
Table of Contents
You should rely only on
the information contained or incorporated by reference in this prospectus or any prospectus supplement. We have not authorized anyone
to provide you with information different from that contained or incorporated by reference into this prospectus. If any person does provide
you with information that differs from what is contained or incorporated by reference in this prospectus, you should not rely on it. No
dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus. You
should assume that the information contained in this prospectus or any prospectus supplement is accurate only as of the date on the front
of the document and that any information contained 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 not an offer to sell or a solicitation of an offer to buy these securities in any circumstances under
which the offer or solicitation is unlawful.
ABOUT THIS PROSPECTUS
This prospectus is part of
a registration statement that we filed with the Securities and Exchange Commission, or SEC, using a “shelf” registration process.
Under this shelf registration process, we may sell any combination of the securities described in this prospectus in one of more offerings
up to a total dollar amount of proceeds of $250,000,000. This prospectus describes the general manner in which our securities may be offered
by this prospectus. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about
the terms of that offering. The prospectus supplement may also add, update or change information contained in this prospectus or in documents
incorporated by reference in this prospectus. The prospectus supplement that contains specific information about the terms of the securities
being offered may also include a discussion of certain U.S. Federal income tax consequences and any risk factors or other special considerations
applicable to those securities. To the extent that any statement that we make in a prospectus supplement is inconsistent with statements
made in this prospectus or in documents incorporated by reference in this prospectus, you should rely on the information in the prospectus
supplement. You should carefully read both this prospectus and any prospectus supplement together with the additional information described
under “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.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus and the documents
and information incorporated by reference in this prospectus include forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the
Exchange Act. These statements are based on our management’s beliefs and assumptions and on information currently available to our
management. All statements, other than statements of historical fact, included regarding our strategy, future operations, financial position,
future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “expect,”
“anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,”
“think,” “may,” “could,” “will,” “would,” “should,” “continue,”
“potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended
to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements. Examples of our forward-looking
statements include:
| ● | our
ability to raise funds for general corporate purposes and operations, including our research activities and clinical trials; |
| ● | our
ability to recruit qualified management and technical personnel; |
| ● | the
success of our clinical trials; |
| ● | our
ability to obtain and maintain required regulatory approvals for our trials; |
| ● | our
expectations regarding the use of our existing cash and the expected net proceeds of this offering; |
| ● | the
other factors discussed in the “Risk Factors” section and elsewhere in this prospectus. |
Because forward-looking statements
are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control,
you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our
forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking
statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is
not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly
update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances
or otherwise.
This prospectus and the documents
incorporated herein by reference also refer to estimates and other statistical data made by independent parties and by us relating to
market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned
not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future
performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
ABOUT INMUNE BIO INC.
We are a clinical-stage immunotherapy
company focused on reprogramming the patient’s innate immune system to treat disease. We do this by targeting four key cells of
the innate immune system, natural killer, or NK cells, and myeloid derived suppressor cells, or MDSC, hepatic stellate cells of the liver,
or HSC, and microglial cells of the central nervous system. NK cells are the body’s first line of defense due to their innate ability
to rapidly seek and destroy abnormal cells, such as cancer or virally-infected cells, without prior exposure or activation by other support
molecules required to activate adaptive immune cells such as T-cells. NK cells play a key role in the immune-surveillance that prevents
people from getting cancer and in eliminating residual disease which may cause people to relapse after cytotoxic therapy. MDSC are myeloid
cells produced in the bone marrow, take up residence in the tumor microenvironment, the tissue associated with the cancerous cells, to
protect the tumor from immunological attack by the patient’s immune system. MDSC play a critical role in making the cancer resistant
to immunotherapy such as currently approved checkpoint inhibitors. Microglial cells are the primary immune cells of the central nervous
system responsible for protecting the neural unit of microglia, astrocytes, oligodendrocytes and neurons from infection. In the setting
of chronic inflammation, microglial cells become activated and cause dysfunction of the other three cells types in the neural unit resulting
in neurodegenerative and neuropsychiatric diseases. Hepatic stellate cells are immunologically active cells that are part of the liver
architecture that support hepatocyte function in health and disease. INB03, LivNate and XPro1595 are the identical drug used in different
therapeutic arenas. INB03 is the name of the drug for cancer targeted applications. XPro1595 in the name of the drug for neurology and
psychiatric indications. LivNate is the name of the drug for treatment of liver diseases.
We believe INKmune, our NK
cell directed therapy, and INB03, our MDSC directed therapy, and XPro1595, our microglial directed therapy and LivNate, our HSC directed
therapy offer unique strategies to improve the response of patients’ innate immune system to their cancer, neurologic and liver
disease respectively. These therapies will use a precision medicine approach to select patients who will benefit from the therapy and
monitor the response to the therapy. For oncology, neither INB03 nor INKmune therapy is cancer specific. The decision to use either INKmune
or INB03 as part of cancer therapies, or with each other, depends on immunologic parameters that can be tested in patients before treatment.
The type of cancer is not important. This means that both therapies can be used to treat patients with a variety of hematologic malignancies
and solid tumors that have the immunologic profile needed to respond. Put simply, we are treating the immune system to attack the patients’
cancer, not targeting the patient’s cancer directly.
We believe that INKmune improves
the ability of the patient’s own NK cells to attack their tumor. INKmune itself will not kill cancer cells. INKmune interacts with
the patient’s NK cells to convert them from inert resting NK cells that ignores the cancer into primed NK cells that kill the cancer
cell. INKmune is a replication incompetent proprietary cell line we have named INB16 that is given to the patient after determining that
i) the patient has adequate NK cells in their circulation and ii) those NK cells are functional when exposed to INKmune in vitro. INKmune
is designed to be given to patients after their immune system has recovered after cytotoxic chemotherapy to target the residual disease
the remains after treatment with cytotoxic therapy.
Likewise, we believe XPro1595,
our microglial directed therapy, offers a unique strategy to decrease neuroinflammation, a key pathophysiology in neurodegenerative and
neuropsychiatric diseases. XPro1595 will use a precision medicine approach to select patients who will benefit from the therapy and monitor
the response to the therapy. The therapy is not diagnosis specific but will be used in patients who have biomarkers of neuroinflammation.
Our initial program with XPro1595 will be treating patients with Alzheimer’s disease with biomarkers inflammation.
Likewise, we believe LivNate,
our HSC directed therapy, offers a unique strategy to treat NASH by decreasing peripheral , regional and local inflammatory cycles that
results in hepatocyte ballooning and death, hepatitis and fibrosis, the core pathophysiology of many inflammatory liver diseases. Our
initial program with LivNate will be treating patients with NASH.
We reported a net loss of
$12,099,159 and $7,678,313 for the years ended December 31, 2020 and 2019, respectively. We have an accumulated deficit of $33,375,340
as of December 31, 2020.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company
As a company with less than
$1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company,” as defined in the Jumpstart
Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of reduced reporting requirements that
are otherwise applicable to public companies. These provisions include, but are not limited to:
| ● | being
permitted to present only two years of audited financial statements and two years of related Management’s Discussion and Analysis
of Financial Condition and Results of Operations; |
| ● | not
being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended,
or the Sarbanes-Oxley Act; |
| ● | reduced
disclosure obligations regarding executive compensation in periodic reports, proxy statements and registration statements; and |
| ● | exemptions
from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute
payments not previously approved. |
We may take advantage of these
provisions until the last day of our fiscal year following the fifth anniversary of our initial public offering. However, if certain events
occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue
exceeds $1.07 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to
be an emerging growth company prior to the end of such five-year period.
We have elected to take advantage
of certain of the reduced disclosure obligations in this prospectus and may elect to take advantage of other reduced reporting requirements
in future filings. As a result, the information that we provide to our stockholders may be different from what you might receive from
other public reporting companies in which you hold equity interests.
In addition, under the JOBS
Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private
companies.
We are also a “smaller
reporting company,” as that term is defined in Rule 12b-2 under the Exchange Act. As a result, many of the same exemptions
from reporting requirements available to us as an emerging growth company are also available to us as a smaller reporting company, including
not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act and reduced disclosure
obligations regarding executive compensation. To the extent that we continue to qualify as a smaller reporting company, after we cease
to qualify as an emerging growth company, those exemptions may continue to be available to us.
Corporate Information
Our principal executive offices
are located at 1200 Prospect Street, Suite 525, La Jolla, California 92037. 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 our website address in this prospectus as an inactive textual reference only and not as an active hyperlink.
RISK FACTORS
Investing in our securities
involves a high degree of risk. Before making an investment decision, you should consider carefully the risks, uncertainties and other
factors described in our most recent Annual Report on Form 10-K, as supplemented and updated by subsequent quarterly reports on Form 10-Q
and current reports on Form 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 more
information about our SEC filings, please see “Where You Can Find More Information”.
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 support research and development, including clinical trials, and general corporate purposes.
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, summarizes the material terms and provisions of our common stock and the preferred stock that we may offer under this
prospectus. While the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer,
we will describe the particular terms of any class or series of these securities in more detail in the applicable prospectus supplement.
For the complete terms of our common stock and preferred stock, please refer to our articles of incorporation and our bylaws that are
incorporated by reference into the registration statement of which this prospectus is a part. The summary below and that contained in
any applicable prospectus supplement or 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 shares of common stock, $0.001 par value per share. As of the date of this prospectus, there are 14,932,638 shares of
common stock issued and outstanding. The outstanding shares of common stock are validly issued, fully paid and nonassessable.
Holders of common stock are
entitled to one vote for each share on all matters submitted to a stockholder vote. Holders of common stock do not have cumulative voting
rights. Therefore, holders of a majority of the shares of common stock voting for the election of directors can elect all of the directors.
Holders of common stock representing a majority of the voting power of our capital stock issued, outstanding and entitled to vote, represented
in person or by proxy, are necessary to constitute a quorum at any meeting of stockholders. A vote by the holders of a majority of the
Company’s outstanding shares is required to effectuate certain fundamental corporate changes such as liquidation, merger or an amendment
to the Company’s certificate of incorporation.
Holders of common stock are
entitled to share in all dividends that our Board of Directors, in its discretion, declares from legally available funds. In the event
of a liquidation, dissolution or winding up, each outstanding share entitles its holder to participate pro rata in all assets that remain
after payment of liabilities and after providing for each class of stock, if any, having preference over the common stock. The common
stock 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 shares of preferred stock, par value $0.001 per share, from time to time in one or more series. On December 30, 2020,
we filed a Certificate of Designation of Series A Junior Preferred Stock with the Secretary of State of the State of Delaware to designate
45,000 shares as Series A 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 Board of 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 as shall be determined by the Board of Directors for each class or series of stock. Preferred stock is available for possible
future financings or acquisitions and for general corporate purposes without further authorization of stockholders unless such authorization
is required by applicable law, the rules of the NASDAQ Capital Market or other securities exchange or market on which our stock is then
listed or admitted to trading.
Our Board of Directors may
authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights
of the holders of common stock. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions
and other corporate purposes could, under some circumstances, have the effect of delaying, deferring or preventing a change-in-control
of the Company.
A prospectus supplement relating
to any series of preferred stock being offered will include specific terms relating to the offering. Such prospectus supplement will include:
| ● | the
title and stated or par value of the preferred stock; |
| ● | the
number of shares of the preferred stock offered, the liquidation preference per share and the offering price of the preferred stock; |
| ● | the
dividend rate(s), period(s) and/or payment date(s) or method(s) of calculation thereof applicable to the preferred stock; |
| ● | whether
dividends shall be cumulative or non-cumulative and, if cumulative, the date from which dividends on the preferred stock shall accumulate; |
| ● | the
provisions for a sinking fund, if any, for the preferred stock; |
| ● | any
voting rights of the preferred stock; |
| ● | the
provisions for redemption, if applicable, of the preferred stock; |
| ● | any
listing of the preferred stock on any securities exchange; |
| ● | the
terms and conditions, if applicable, upon which the preferred stock will be convertible into our common stock, including the conversion
price or the manner of calculating the conversion price and conversion period; |
| ● | if
appropriate, a discussion of Federal income tax consequences applicable to the preferred stock; and |
| ● | any
other specific terms, preferences, rights, limitations or restrictions of the preferred stock. |
The terms, if any, on which
the preferred stock may be convertible into or exchangeable for our common stock will also be stated in the preferred stock prospectus
supplement. The terms will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our
option, and may include provisions pursuant to which the number of shares of our common stock to be received by the holders of preferred
stock would be subject to adjustment.
Transfer Agent and Registrar
The transfer agent for our
common stock is VStock Transfer, LLC. The transfer agent’s address is 18 Lafayette Place, Woodmere, New York 11598.
Listing
Our common stock is currently
traded on the NASDAQ Capital Market under the symbol “INMB”.
DESCRIPTION OF WARRANTS
We may issue warrants for
the purchase of preferred stock or common stock. Warrants may be issued independently or together with any preferred stock or common stock,
and may be attached to or separate from any offered securities. Each series of warrants will be issued under a separate warrant agreement
to be entered into between a warrant agent specified in the agreement and us. The warrant agent will act solely as our agent in connection
with the warrants of 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, including the forms of securities warrant certificate representing the securities warrants, relating to the specific securities
warrants being offered for the complete terms of the securities warrant agreement and the securities warrants. The securities warrant
agreement, together with the terms of the securities warrant certificate and securities warrants, will be filed with the SEC in connection
with the offering of the specific warrants.
The applicable prospectus
supplement will describe the following terms, where applicable, of the warrants in respect of which this prospectus is being delivered:
| ● | the
title of the warrants; |
| ● | the
aggregate number of the warrants; |
| ● | the
price or prices at which the warrants will be issued; |
| ● | the
designation, amount and terms of the offered securities purchasable upon exercise of the warrants; |
| ● | if
applicable, the date on and after which the warrants and the offered securities purchasable upon exercise of the warrants will be separately
transferable; |
| ● | the
terms of the securities purchasable upon exercise of such warrants and the procedures and conditions relating to the exercise of such
warrants; |
| ● | any
provisions for adjustment of the number or amount of securities receivable upon exercise of the warrants or the exercise price of the
warrants; |
| ● | the
price or prices at which and currency or currencies in which the offered securities purchasable upon exercise of the warrants may be
purchased; |
| ● | the
date on which the right to exercise the warrants shall commence and the date on which the right shall expire; |
| ● | the
minimum or maximum amount of the warrants that may be exercised at any one time; |
| ● | information
with respect to book-entry procedures, if any; |
| ● | if
appropriate, a discussion of Federal income tax consequences; and |
| ● | any
other 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 preferred stock 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 certificate properly completed and duly executed at the corporate trust office of the warrant agent or any other office indicated
in the applicable prospectus supplement, we will, as soon as practicable, forward the purchased securities. If less than all of the warrants
represented by the warrant certificate are exercised, a new warrant certificate will be issued for the remaining warrants.
Prior to the exercise of any
securities warrants to purchase preferred stock or common stock, holders of the warrants will not have any of the rights of holders of
the common stock or preferred stock purchasable upon exercise, including in the case of securities warrants for the purchase of common
stock or preferred stock, the right to vote or to receive any payments of dividends on the preferred stock or common stock purchasable
upon exercise.
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 specify the 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 this prospectus (i) to or through underwriters or dealers, (ii) directly to purchasers, including our affiliates,
(iii) through agents, or (iv) through a combination of any these methods. The securities may be distributed at a fixed price or prices,
which may be changed, market prices prevailing at the time of sale, prices related to the prevailing market prices, or negotiated prices.
The prospectus supplement will include the following information:
| ● | the
terms of the offering; |
| ● | the
names of any underwriters or agents; |
| ● | the
name or names of any managing underwriter or underwriters; |
| ● | the
purchase price of the securities; |
| ● | any
over-allotment options under which underwriters may purchase additional securities from us; |
| ● | the
net proceeds from the sale of the securities |
| ● | any
delayed delivery arrangements |
| ● | any
underwriting discounts, commissions and other items constituting underwriters’ compensation; |
| ● | any
initial public offering price; |
| ● | any
discounts or concessions allowed or reallowed or paid to dealers; |
| ● | any
commissions paid to agents; and |
| ● | any
securities exchange or market on which the securities may be listed. |
Sale Through Underwriters or Dealers
Only underwriters named in
the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If underwriters are used in
the sale, the underwriters will acquire the securities for their own account, including through underwriting, purchase, security lending
or repurchase agreements with 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 prospectus or otherwise), including other public or private transactions and short sales. Underwriters may offer securities to
the public either through 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 subject to certain conditions, and the underwriters will be obligated to purchase all the offered securities if they purchase
any of them. The underwriters may change from time to time any initial public offering price and any discounts or concessions allowed
or reallowed or paid to dealers.
If dealers are used in the
sale of securities offered through this prospectus, we will sell the securities to them as principals. They may then resell those securities
to the public at varying prices determined by the dealers at the time of resale. The prospectus supplement will include the names of the
dealers and the terms of the transaction.
Direct Sales and Sales Through Agents
We may sell the securities
offered through this prospectus directly. In this case, no underwriters or agents would be involved. Such securities may also be sold
through agents designated from time to time. The prospectus supplement will name any agent involved in the offer or sale of the offered
securities and will describe any commissions payable to the agent. Unless otherwise indicated in the prospectus supplement, any agent
will agree to use its reasonable best efforts to solicit purchases for the period of its appointment.
We may sell the securities
directly to institutional investors or others who may be deemed to be underwriters within the meaning of the Securities Act with respect
to any sale of those securities. The terms of any such sales will be described in the prospectus supplement.
Delayed Delivery Contracts
If the prospectus supplement
indicates, we may authorize agents, underwriters or dealers to solicit offers from certain types of institutions to purchase securities
at the public offering price under delayed delivery contracts. These contracts would provide for payment and delivery on a specified date
in the future. The contracts would be subject only to those conditions described in the prospectus supplement. The applicable prospectus
supplement will describe 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 sell shares 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 the shares of common stock, if any, will be made by means of ordinary brokers’ transactions on the NASDAQ Capital Market
at market prices, block transactions and such other transactions as agreed upon by us and the broker-dealer. Under the terms of such a
program, we also may sell shares of common 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 common stock to such broker-dealer as principal, we will enter into a separate terms agreement with
such broker-dealer, and we will describe this agreement in a separate prospectus supplement or pricing supplement.
Market Making, Stabilization and Other Transactions
Unless the applicable prospectus
supplement states otherwise, other than our common stock all securities we offer under this prospectus will be a new issue and will have
no established trading market. We may elect to list offered securities on an exchange or in the over-the-counter market. Any underwriters
that we use in 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 stabilizing transactions, syndicate covering transactions and penalty bids in accordance with Rule 104 under the Securities Exchange
Act. Stabilizing transactions involve bids to purchase the underlying security in the open market for the purpose of pegging, fixing or
maintaining the price of the securities. Syndicate covering transactions involve purchases of the securities in the open market after
the distribution has been completed in order to cover syndicate short positions.
Penalty bids permit the underwriters
to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicate member are purchased in a
syndicate covering transaction to cover syndicate short positions. Stabilizing transactions, syndicate covering transactions and penalty
bids may cause the price of the securities to be higher than it would be in the absence of the transactions. The underwriters may, if
they commence these 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 Securities Act. Our agents, underwriters, and dealers, or their affiliates, may be customers of, engage in transactions with
or perform services for us, in the ordinary course of business.
LEGAL MATTERS
The validity of the issuance
of the securities offered by this prospectus will be passed upon for us by Sichenzia Ross Ference LLP, New York, New York.
EXPERTS
The consolidated financial
statements of INmune Bio Inc. as of and for the years ended December 31, 2020 and 2019 appearing in INmune Bio Inc.’s Annual
Report on Form 10-K for the year ended December 31, 2020, have been audited by Marcum LLP, as set forth in its report thereon, included
therein, and incorporated herein by reference. Such consolidated financial statements are incorporated herein by reference in reliance
upon such report given on the authority of such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly
and special reports, along with other information with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s
website at http://www.sec.gov. You may also read and copy any document we file at the SEC’s Public Reference Room at 100 F Street,
NE, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room.
This prospectus is part of
a registration statement on Form S-3 that we filed with the SEC to register the securities offered hereby under the Securities Act of
1933, as amended. This prospectus does not contain all of the information included in the registration statement, including certain exhibits
and schedules. You may obtain the registration statement and exhibits to the registration statement from the SEC at the address listed
above or from the SEC’s internet site.
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE
This prospectus is part of
a registration statement filed with the SEC. The SEC allows us to “incorporate by reference” into this prospectus the information
that we file with them, which means that we can disclose important information to you by referring you to those documents. The information
incorporated by reference is considered to be part of this prospectus, and information that we file later with the SEC will automatically
update and supersede this information. The following documents are incorporated by reference and made a part of this prospectus:
| ● | our
Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March
4, 2021; |
| ● | our
Current Report on Form 8-K/A filed with the SEC on January 4, 2021, and our Current Reports
on Form 8-K filed with the SEC on January 19, 2021, January 21, 2021, January 25, 2021, March 2, 2021, March 5, 2021, March 9, 2021 and March 11, 2021; |
| ● | 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), including any amendment or 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. |
We also incorporate by reference
any future filings (other than information furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits furnished on
such form that are related to such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a),
13(c), 14 or 15(d) of the Exchange Act, including those made after the date of the initial 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 and will become a part of this prospectus from the
date that such documents are filed with the SEC. Information in such future filings updates and supplements the information provided in
this prospectus. Any statements in any such future filings will automatically be deemed to modify and supersede any information in any
document we previously filed with the SEC that is incorporated or deemed to be incorporated herein by reference to the extent that statements
in the later filed document modify or replace such earlier statements.
Notwithstanding the foregoing,
information furnished under Items 2.02 and 7.01 of any Current Report on Form 8-K, including the related exhibits, is not incorporated
by reference in this prospectus.
The information 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., 1200 Prospect Street, Suite 525,
La Jolla, CA 92037, telephone number (858) 964-3720.
$28,701,161.61
Common Stock
INMUNE BIO INC.
PROSPECTUS SUPPLEMENT
The date of this prospectus supplement is August
16, 2023
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