Our common stock and the warrants issued
in our initial public offering are listed on the NASDAQ Capital Market under the symbols “ADIL” and “ADILW.”
On July 10, 2020, the last reported sale price of our common stock on the NASDAQ Capital Market was $1.42 per share. The last
reported sale price of our warrants on July 10, 2020 was $0.3898 per warrant. We urge prospective purchasers of our common stock
to obtain current information about the market prices of our common stock and our warrants issued in connection with our initial
public offering in July 2018.
PROSPECTUS SUMMARY
This summary
highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider
in making your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including
our financial statements and the related notes that are incorporated by reference into this prospectus and the information set
forth under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” in each case included elsewhere in this prospectus. In this prospectus, unless the context otherwise
requires, the terms “we,” “us,” “our,” “Adial” and the “Company” refer
to Adial Pharmaceuticals, Inc. Except as disclosed in the prospectus, the financial statements and selected historical financial
data and other financial information included in, or incorporated by reference into, this prospectus are those of Adial Pharmaceuticals,
Inc.
Overview
We are a clinical-stage
biopharmaceutical company currently focused on the development of a therapeutic agent for the treatment of alcohol use disorder
(“AUD”) using our lead investigational new drug product, AD04, a selective serotonin-3 antagonist (i.e., a “5-HT3
antagonist”). The active ingredient in AD04 is ondansetron, which is also the active ingredient in Zofran®, an approved
drug for treating nausea and emesis. AUD is characterized by an urge to consume alcohol and an inability to control the levels
of consumption. We have commenced a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain
target genotypes. We believe our approach is unique in that it targets the serotonin system and individualizes the treatment of
AUD, through the use of genetic screening (i.e., a companion diagnostic genetic biomarker). We have created an investigational
companion diagnostic biomarker test for the genetic screening of patients with certain biomarkers that, as reported in the American
Journal of Psychiatry (Johnson, et. al. 2011 & 2013), we believe will benefit from treatment with AD04. Our strategy
is to integrate the pre-treatment genetic screening into AD04’s label to create a patient-specific treatment in one integrated
therapeutic offering. Our goal is to develop a genetically targeted, effective and safe product candidate to treat AUD by reducing
or eliminating the patients’ consumption of alcohol. We are also exploring expanding or portfolio in the field of addiction.
We have a worldwide, exclusive license from the University of Virginia
Patent Foundation (d.b.a the Licensing & Venture Group) (“UVA LVG”), which is the licensing arm of the University
of Virginia, to commercialize our investigational drug candidate, AD04, subject to Food and Drug Administration (“FDA”)
approval of the product, based upon three separate patent application families, with patents issued in over 40 jurisdictions,
including three issued patents in the U.S. Our investigational agent has been used in several investigator-sponsored trials and
we possess or have rights to use toxicology, pharmacokinetic and other preclinical and clinical data that supports our Phase 3
clinical trial. Our therapeutic agent was the product candidate used in a University of Virginia investigator sponsored Phase
2b clinical trial of 283 patients. In this Phase 2b clinical trial, ultra-low dose ondansetron, the active pharmaceutical agent
in AD04, showed a statistically significant difference between ondansetron and placebo for both the primary endpoint and secondary
endpoint, which were reduction in severity of drinking measured in drinks per drinking day (1.71 drinks/drinking day; p=0.0042),
and reduction in frequency of drinking measured in days of abstinence/no drinking (11.56%; p=0.0352), respectively. Additionally,
and importantly, the Phase 2b results showed a significant decrease in the percentage of heavy drinking days (11.08%; p=0.0445)
with a “heavy drinking day” defined as a day with four (4) or more alcoholic drinks for women or five (5) or more
alcoholic drinks for men consumed in the same day.
The active pharmaceutical agent in AD04, our lead investigational new
drug product, is ondansetron (the active ingredient in Zofran®), which was granted FDA approval in 1991 for nausea and vomiting
post-operatively and after chemotherapy or radiation treatment and is now commercially available in generic form. In studies of
Zofran®, conducted as part of its FDA review process, ondansetron was given acutely at dosages up to almost 100 times the
dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously (“i.v.”),
which results in approximately 160% of the exposure level as oral dosing. Even at high doses given i.v. the studies found that
ondansetron is well-tolerated and results in few adverse side effects at the currently marketed doses, which reach more than 80
times the AD04 dose and are given i.v. The formulation dosage of ondansetron used in our drug candidate (and expected to be used
by us in our future Phase 3 clinical trials) has the potential advantage that it contains a much lower concentration of ondansetron
than the generic formulation/dosage that has been used in prior clinical trials, is dosed orally, and is available with use of
a companion diagnostic genetic biomarker. Our development plan for AD04 is designed to demonstrate both the efficacy of AD04 in
the genetically targeted population and the safety of ondansetron when administered chronically at the AD04 dosage. However, to
the best of our knowledge, no comprehensive clinical study has been performed to date that has evaluated the safety profile of
ondansetron at any dosage for long-term use as anticipated in our Phase 3 clinical trial.
According to the
National Institute of Alcohol Abuse and Alcoholism (the “NIAAA”) and the Journal of the American Medical Association
(“JAMA”), in the United States alone, approximately 35 million people each year have AUD (such number is based upon
the 2012 data provided in Grant et. al. the JAMA 2015 publication and has been adjusted to reflect a compound annual growth rate
of 1.13%, which is the growth rate reported by U.S. Census Bureau for the general adult population from 2012-2017), resulting
in significant health, social and financial costs with excessive alcohol use being the third leading cause of preventable death
and is responsible for 31% of driving fatalities in the United States (NIAAA Alcohol Facts & Statistics). AUD contributes
to over 200 different diseases and 10% of children live with a person that has an alcohol problem. According to the American Society
of Clinical Oncologists, 5-6% of new cancers and cancer deaths globally are directly attributable to alcohol. And, The
Lancet published that alcohol is the leading cause of death in people ages 15-49 globally. The Centers for Disease Control
(the “CDC”) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting
for greater than 75% of the social and health related costs. Despite this, according to the article in the JAMA 2015 publication,
only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only
3.6% by a physician (i.e., approximately 1.3 million people). In addition, according to the JAMA 2017 publication, the problem
in the United States appears to be growing with almost a 50% increase in AUD prevalence between 2002 and 2013.
We have devoted substantially all of our resources
to development efforts relating to AD04, including preparation for conducting clinical trials, providing general and administrative
support for these operations and protecting our intellectual property. We currently do not have any products approved for sale
and we have not generated any significant revenue since our inception. From our inception through the date of this prospectus,
we have funded our operations primarily through the private placement of debt and equity securities and most recently, our initial
public offering and follow-on offering.
We have incurred net losses in each year since our inception, including net losses
of approximately $8.6 million and $11.6 million for the years ended December 31, 2019 and 2018, respectively and net losses of
$2.3 million and $2.7 million in the three months ended March 31, 2020 and 2019, respectively. We had an accumulated deficit of
approximately $22.9 million and $20.6 million as of March 31, 2020 and December 31, 2019, respectively. Substantially all our
operating losses in these periods resulted from costs incurred in connection with our research and development programs and from
general and administrative costs associated with our operations.
The ongoing Covid-19 pandemic risks delay to our development
efforts, disruption to our business operations, and other economic injuries. We may be eligible for a variety of United State
Federal government loans, some forgivable, to help support our operations during the pandemic. We have not, at this time, received
any such funding, but may in the future
Recent Business
Developments
In January 2020, we announced that we had received favorable opinions from the Finnish Medicines
Agency (FIMEA) and National Committee on Medical Research Ethics (TUKIJA) to commence our Phase 3 clinical trial to investigate
AD04 as a genetically targeted therapeutic agent for the treatment of AUD.
In February 2020, we were informed by our CRO
that the first site initiation visit had taken place and that subsequently the first potential trial participant had been screened.
On May 26, 2020, we reached an understanding on terms to purchase COVID-19 IgG / IgM Rapid Test kits, which test for the
antibodies indicating potential previous exposure and possible resistance to COVID-19, from BioLab Sciences, Inc. (“BioLab”).
We have purchased 500 Rapid Result COVID-19 IgG / IgM antibody tests from BioLab, which are intended to be used to test participants
in our landmark ONWARD™ pivotal Phase 3 clinical trial of the Company’s lead drug candidate, AD04, for the treatment
of Alcohol Use Disorder (AUD) to improve safety and enhance trial retention rates.
On June 8, 2020, we announced that we
had entered into a Distribution Agreement with BioLab providing us with exclusive rights to sell its Rapid Result COVID-19 IgG/IgM
antibody test kits to designated channel partners.
On June 11,
2020, we closed a registered direct offering of 2,820,000 shares of our common stock at a purchase price of $1.85 per share
for gross proceeds of $5,217,000 priced at-the-market under Nasdaq Capital Market rules. In a concurrent private
placement, we also issued warrants to purchase 2,115,000 shares of common stock, which warrants are immediately exercisable,
will expire five years from the date of issuance and will have an exercise price of $2.00 per share of common stock.
Corporate Information
ADial Pharmaceuticals, L.L.C. was formed as a Virginia
limited liability company in November 2010. ADial Pharmaceuticals, L.L.C. converted from a Virginia limited liability company
into a Virginia corporation on October 3, 2017, and reincorporated in Delaware on October 11, 2017 by merging the Virginia corporation
with and into Adial Pharmaceuticals, Inc., a Delaware corporation that was incorporated on October 5, 2017 and as a wholly owned
subsidiary of the Virginia corporation. We refer to this as the corporate conversion/reincorporation. In connection with the corporate
conversion/reincorporation, each unit of ADial Pharmaceuticals, L.L.C. was first converted into shares of common stock of the
Virginia corporation and then converted into shares of common stock of Adial Pharmaceuticals, Inc., the members of ADial Pharmaceuticals,
L.L.C. became stockholders of Adial Pharmaceuticals, Inc. and Adial Pharmaceuticals, Inc. succeeded to the business of ADial Pharmaceuticals,
L.L.C.
Our principal executive
offices are located at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901, and our telephone number is (434) 422-9800.
Our website address is www.adialpharma.com. Information contained in our website does not form part of the prospectus
and is intended for informational purposes only. This prospectus contains references to our trademarks and to trademarks
belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos,
artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended
to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the
applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names
or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Emerging Growth
Company
We are an emerging growth company under the JOBS ACT, which was enacted
in April 2012. We shall continue to be deemed an emerging growth company until the earliest of:
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(i)
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the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more;
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(ii)
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the last day of the fiscal year of the issuer following
the fifth anniversary of the date of the first sale of common equity securities of the issuer pursuant to an effective registration
statement;
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(iii)
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the date on which we have issued more than $1.0 billion
in non-convertible debt, during the previous 3-year period, issued; or
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(iv)
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the date on which we are deemed to be a large accelerated
filer.
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As an emerging growth company, we are subject to reduced public company reporting requirements and are exempt from Section
404(b) of Sarbanes Oxley. Section 404(a) requires issuers to publish information in their annual reports concerning the scope
and adequacy of the internal control structure and procedures for financial reporting. Section 404(b) requires that the registered
accounting firm shall, in the same report, attest to and report on the assessment on the effectiveness of the internal control
structure and procedures for financial reporting.
As an emerging growth company, we are also exempt from Section 14A (a)
and (b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which requires the shareholder approval,
on an advisory basis, of executive compensation and golden parachutes.
We have elected to use the extended transition period
for complying with new or revised accounting standards under Section 102(b)(2) of the Jobs Act, that allows us to delay the adoption
of new or revised accounting standards that have different effective dates for public and private companies until those standards
apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply
with public company effective dates.
Additional Information
For additional information
related to our business and operations, please refer to the reports incorporated herein by reference, including our Annual Report
on Form 10-K for the year ended December 31, 2019 as filed with the SEC on March 20, 2020, or the 2019 Form 10-K, our Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2020 as filed with the SEC on May 14, 2020, or the 2020 Form 10-Q,
and our Current Reports on Form 8-K as filed with the SEC, as described in the section entitled “Incorporation of Documents
by Reference” in this prospectus.
Registered Direct
Offering of Common Stock and Concurrent Private Placement of Warrants
On June
9, 2020, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors named therein
(the “Investors”), pursuant to which we agreed to issue and sell, in a registered direct offering directly to the
Investors (the “Registered Offering”), an aggregate of 2,820,000 shares (the “Shares”) of our common stock
at an offering price of $1.85 per share for gross proceeds of approximately $5.2 million before deducting the placement agent
fee and related offering expenses.
In a concurrent private placement (the “Private Placement” and together
with the Registered Offering, the “Offerings”), we agreed to issue to the Investors who participated in the Registered
Offering warrants (the “Warrants” and collectively with the Shares and the Warrants, the “Securities”)
exercisable for an aggregate of 2,115,000 shares of common stock at an exercise price of $2.00 per share. Each Warrant was immediately
exercisable and will expire five years from the issuance date. The Warrants and the shares of our common stock issuable upon the
exercise of the Warrants were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule
506(b) promulgated thereunder. We closed the Offerings on June 11, 2020.
THE
OFFERING
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Securities
offered by the Selling Stockholders
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2,115,000
shares of common stock
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Common
Stock Outstanding prior to this offering
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13,449,603
shares of common stock
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Common
Stock to be outstanding after this offering, assuming exercise of the Warrants issued pursuant to the Purchase Agreement
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15,564,603
shares (assuming full exercise of the warrants issued in our initial public offering)
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Terms
of the offering
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The
Selling Stockholders and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all
of their shares covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which
the shares are traded or in private transactions. These sales may be at fixed or negotiated prices. See “Plan of Distribution.”
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Use
of Proceeds
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We
may receive up to approximately $4.23 million in aggregate gross proceeds from cash exercises of the Warrants, based on the
per share exercise price of the Warrants. Any proceeds we receive from the exercise of the Warrants will be used for working
capital and other general corporate purposes. See “Use of Proceeds.”
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Risk
Factors
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Investment
in our securities involves a high degree of risk and could result in a loss of your entire investment. See “Risk Factors”
beginning on page 5 and the similarly entitled sections in the documents incorporated by reference into this prospectus.
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NASDAQ
Capital Markets Symbols
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Our
common stock and the warrants issued in the Offering are listed on the NASDAQ Capital Market under the symbol “ADIL”
and the warrants issued in our initial public offering are listed under the symbol “ADILW”.
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Except
as otherwise indicated herein, the number of shares of our common stock to be outstanding after this offering is based on 13,449,603
shares of common stock outstanding as of June 11, 2020 and excludes:
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●
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6,669,274 shares of Common Stock issuable as of the date
hereof upon the exercise of common stock warrants outstanding at a weighted average exercise price of $5.38 per share;
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●
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2,115,000 shares of Common Stock issuable as of the date
hereof upon the exercise of the Warrants at a weighted average exercise price of $2.00 per share;
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2,678,533
shares of Common Stock issuable upon the exercise of stock options outstanding at a weighted-average exercise price of $2.48
per share; and
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●
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346,715
shares of Common Stock available for future issuance under the 2017 Equity Incentive Plan.
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RISK
FACTORS
Investing
in our securities involves a high degree of risk. Before investing in our securities, you should carefully consider the risks,
uncertainties and assumptions contained in this prospectus and discussed under the heading “Risk Factors” included
in the 2019 Form 10-K, as revised or supplemented by subsequent filings, which are on file with the SEC and are incorporated herein
by reference, and which may be amended, supplemented or superseded from time to time by other reports we file with the SEC in
the future. Our business, financial condition, results of operations and future growth prospects could be materially and adversely
affected by any of these risks. In these circumstances, the market price of our common stock could decline, and you may lose all
or part of your investment.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference into this prospectus include forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that relate to
future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may
cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels
of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited
to, “anticipate,” “aim,” “believe,” “contemplate,” “continue,” “could,”
“design,” “estimate,” “expect,” “intend,” “may,” “might,”
“plan,” “predict,” “poise,” “project,” “potential,” “suggest,”
“should,” “strategy,” “target,” “will,” “would,” and similar expressions
or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. Although we believe that we have a reasonable basis for each forward-looking
statement contained in this prospectus and incorporated by reference into this prospectus, we caution you that these statements
are based on our projections of the future that are subject to known and unknown risks and uncertainties and other factors that
may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements,
to differ. The section in this prospectus entitled “Risk Factors” and the sections in our periodic reports,
including the 2019 Form 10-K entitled “Business,” and in the 2019 Form 10-K and the 2020 Form 10-Q entitled “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” as well as other sections in this prospectus
and the documents or reports incorporated by reference into this prospectus, discuss some of the factors that could contribute
to these differences. These forward-looking statements include, among other things, statements about:
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the
extent to which our business may be adversely affected by the recent COVID-19 outbreak;
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our
projected financial position and estimated cash burn rate;
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our
estimates regarding expenses, future revenues and capital requirements;
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our
need to raise substantial additional capital to fund our operations;
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the
success, cost and timing of our clinical trials;
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our
dependence on third parties in the conduct of our clinical trials;
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our
ability to obtain the necessary regulatory approvals to market and commercialize our product candidates;
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the
potential that results of preclinical and clinical trials indicate our current product candidates or any future product candidates
we may seek to develop are unsafe or ineffective;
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the
results of market research conducted by us or others;
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our
ability to obtain and maintain intellectual property protection for our current product candidates;
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our
ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce
or protect our intellectual property rights;
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●
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the
possibility that a third party may claim we have infringed, misappropriated or otherwise violated their intellectual property
rights and that we may incur substantial costs and be required to devote substantial time defending against these claims;
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our
reliance on third-party suppliers and manufacturers;
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the
success of competing therapies and products that are or become available;
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our
ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;
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the
potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these
product liability lawsuits to cause us to limit our commercialization of our product candidates;
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market
acceptance of our product candidates, the size and growth of the potential markets for our current product candidates and
any future product candidates we may seek to develop, and our ability to serve those markets; and
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the
successful development of our commercialization capabilities, including sales and marketing capabilities.
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Our
current product candidates are undergoing clinical development and have not been approved by the FDA or the European Commission.
These product candidates have not been, nor may they ever be, approved by any regulatory agency or competent authorities nor marketed
anywhere in the world.
We
may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Forward-looking statements should be regarded solely as our current plans,
estimates and beliefs. We have included important factors in the cautionary statements included in this document, particularly
in the section entitled “Risk Factors” beginning on page 5 of this prospectus that we believe could cause actual results
or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a very competitive and
rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks,
nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these risks
and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements
are qualified in their entirety by this cautionary statement. Our forward-looking statements do not reflect the potential impact
of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. You should read this prospectus
and the documents that we have filed as exhibits to this prospectus and incorporated by reference herein completely and with the
understanding that our actual future results may be materially different from the plans, intentions and expectations disclosed
in the forward-looking statements we make. The forward-looking statements contained in this prospectus are made as of the date
of this prospectus and 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 required by applicable law.
USE
OF PROCEEDS
We
will not receive any proceeds upon the sale of Selling Stockholders Shares by the Selling Stockholders in this offering. We will
receive approximately $4.23 million of proceeds if all the Warrants are exercised for cash. We currently intend to use these proceeds
for working capital and other general corporate purposes.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT
The following table sets forth
certain information, as of July 2, 2020, with respect to the beneficial ownership of our common stock by each of the following:
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each person who is known by us to be the beneficial owner of more than 5% of our outstanding common stock;
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●
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each of our named executive officers; and
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●
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all of our directors and executive officers as a group.
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As of July 2, 2020, we had 13,449,603
shares of common stock outstanding.
We
have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership
of securities to persons who possess sole or shared voting power or investment power with respect to those securities. In addition,
the rules include shares of common stock issuable pursuant to the exercise of profits interest units, warrants or other rights
that are either immediately exercisable or exercisable on or before September 2, 2020, which is approximately 60 days after the
date of this prospectus. These shares are deemed to be outstanding and beneficially owned by the person holding those options or
warrants for the purpose of computing the percentage ownership of that person, but they are not treated as outstanding for the
purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the persons or entities identified
in this table have sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to
applicable community property laws.
Except as otherwise noted below,
the address for each of the individuals and entities listed in this table is c/o Adial Pharmaceuticals, Inc., 1001 Research Park
Blvd., Suite 100, Charlottesville, Virginia 22911.
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Number of shares
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Percentage of
shares
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Name and address of beneficial owner
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beneficially
owned
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beneficially
owned
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Directors and named executive officers
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William B. Stilley, III (Chief Executive Officer, President and Director) (1)
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1,353,810
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9.6
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%
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Joseph Truluck (Chief Operating Officer and Chief Financial Officer) (2)
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277,587
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2.0
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%
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J. Kermit Anderson (Director) (3)
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17,247
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*
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Robertson H. Gilliland, MBA (Director) (4)
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17,247
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*
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%
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Bankole Johnson, DSc, MD (Chief Medical Officer) (5)
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1,572,587
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11.4
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%
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James W. Newman, Jr. (Director) (6)
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717,165
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5.2
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%
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Kevin Schuyler, CFA (Director) (7)
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1,460,934
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10.1
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%
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Tony Goodman (Director) (8)
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38,582
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*
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Jack Reich (Director) (9)
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12,500
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*
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All current executive officers and directors as a group (9 persons)
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5,467,657
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33.9
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%
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5% or greater stockholders
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En Fideicomiso De Mi Vida 11/23/2010 (Trust) (5)
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848,336
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6.3
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%
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Armistice Capital Master Fund Ltd. (10)
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712,500
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5.0
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%
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(1)
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Includes (i) 558,796 shares of common stock, a warrant to acquire 10,829 shares of our common stock having an exercise price of $.0054 per share, a warrant to acquire 36,800 shares of our common having an exercise price of $5.00 per share, a warrant to acquire 5,452 shares of our common stock having an exercise price of $7.63 per share, a warrant to acquire 205,827 shares of our common stock having an exercise price of $6.25 per share; (ii) 132,141 shares of common stock and a warrant to acquire 9,824 shares of our common stock having an exercise price of $7.63 per share owned by Mr. Stilley and his wife Anne T. Stilley. Does not include (x) 5,580 shares of our common stock owned by the Meredith A. Stilley Trust dtd 11/23/2010; (y) 5,580 shares of our common stock owned by the Morgan J. Stilley Trust dtd 11/23/2010; and (z) 5,580 shares of our common stock owned by the Blair E. Stilley Trust dtd 11/23/2010. The trusts are for the benefit of Mr. Stilley’s children and Mr. Stilley is not the trustee. Mr. Stilley disclaims beneficial ownership of these shares except to the extent of any pecuniary interest he may have in such shares. The number of shares reported for Mr. Stilley represents the number of shares he and the trusts received in connection with the corporate conversion/reincorporation and subsequent stock issuances. Includes 369,141 shares of common stock which will have been vested within 60 days of July 2, 2020, which shares were part of total option grants to purchase 957,474 shares of our common stock.
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(2)
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Comprised of 107,639 shares of our common stock. The number of shares also includes 5,927 warrants to purchase shares of common stock at an exercise price of $6.25 per share. Includes 164,021 shares of common stock, which will vest within 60 days of July 2, 2020, which shares were part of a total option grant to purchase 410,132 shares of our common stock.
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(3)
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Includes 17,247 shares of common stock which will vest within 60 days of July 2, 2020, which shares were part of total option grants to purchase 65,580 shares of our common stock.
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(4)
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Includes 17,247 shares of common stock which will vest within 60 days of July 2, 2020, which shares were part of total option grants to purchase 65,580 shares of our common stock.
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(5)
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Includes (i) 848,336 shares of our common stock owned by En Fideicomiso De Mi Vida 11/23/2010 (Trust); (ii) 93,000 shares of our common stock owned by En Fidecomiso de Todos Mis Suenos Grantor Retained Annuity Trust dated June 27, 2017; (iii) 201,055 shares of our common stock, a warrant to purchase 3,275 shares of our common stock having an exercise price of $7.63, warrants to purchase 189,714 shares of our common stock having an exercise price of $6.25, a warrant to purchase 17,600 shares of our common stock having an exercise price of $5.00 per share, all owned directly by Bankole A. Johnson; (iv) 22,320 shares of our common stock owned by En Fideicomiso De Mis Suenos 11/23/2010 (Trust); (v) 10,000 shares of our common stock owned by De Mi Amor 11/23/2010 (Trust); (vi) an aggregate of 9,300 shares of our common stock owned by Efunbowale Johnson, Ade Johnson, Lola Johnson, Lina Tiouririne, and Aida Tiouririne from whom Dr. Johnson has an voting proxy, (vi) 40,463 shares of our common stock owned by Medico -Trans Company, LLC. Medico -Trans Company, LCC is controlled by Bankole Johnson. Dr. Johnson is the Trustee of each Trust. Includes 137,524 shares of common stock which will have been vested within 60 days of July 2, 2020, which shares were part of total option grants to purchase 255,580 shares of our common stock. Dr. Johnson executed a guaranty, dated December 12, 2019, of PEPCO’s performance under the Master Services Agreement, dated July 5, 2019, and statement of work (the “Guaranty”), together with a pledge and security agreement, dated December 12, 2019 (the “Pledge and Security Agreement”), to secure the Guaranty with 600,000 shares our common stock beneficially owned by him and a lock-up agreement, dated December 12, 2019 (the “Lock-Up”), pursuant to which he agreed not to transfer or dispose of, directly or indirectly, any shares of our common stock, as currently owned by him, until after January 1, 2021.
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(6)
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Includes (i) 150,419 shares of common stock, a warrant to purchase 5,415 shares of our common stock having an exercise price of $.0054 per share, a warrant to purchase 4,974 shares of our common stock having an exercise price of $7.63 per share, a warrant to acquire 205,715 shares of our common stock having an exercise price of $6.25 per share, and a warrant to acquire 92,000 shares of common stock having an exercise price of $5.00 per share, all owned by Virga Ventures, LLC; (ii) 41,160 shares of our common stock a warrant to acquire 29,931 shares of our common stock at an exercise price of $6.25 per share and a warrant to acquire 2,372 shares of our common stock having an exercise price of $7.63 per share, all owned by Newman GST Trust FBO James W. Newman Jr; (iii) 35,221 shares of our common stock, a warrant to acquire 1,186 shares of our common stock having an exercise price of $7.63 per share and a warrant to acquire 45,178 shares of our common stock having an exercise price of $6.25 per share, and a warrant to acquire 20,000 shares of our common stock having an exercise price of $5.00 per share, all owned by Ivy Cottage Group, LLC.; (iv) 3,288 shares of our common stock, a warrant to acquire 2,707 shares of our common stock having an exercise price of $.0054 per share, a warrant to acquire 708 shares of our common stock having an exercise price of $7.63 per share, all owned by Rountop Limited Partnership, LLP; (v) 10,000 shares of common stock and a warrant to acquire 10,000 shares of common stock having an exercise price of $6.25 per share held in a Roth IRA for the benefit of Mr. Newman; and (vi) 10,000 shares of common stock and a warrant to acquire 10,000 shares of common stock having an exercise price of $6.25 per share, all owned directly by Mr. Newman. Mr. Newman is the sole member of Virga Ventures, LLC, the general partner of Ivy Cottage Group, LLC and Rountop Limited Partnership, LLP, and Trustee of the Newman GST Trust. Includes 17,247 shares of common stock which will vest within 60 days of July 2, 2020, which shares were part of total option grants to purchase 65,580 shares of our common stock.
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(7)
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Includes (i) 312,990 shares of common stock, warrants to acquire 1,010 shares of common stock at an exercise price of $.0054 per share, warrants to acquire 351,661 shares of our common stock having an exercise price of $6.25 per share issued upon consummation of our initial public offering, warrant to acquire 8,649 shares common stock at an exercise price of $7.63 per share, and a warrant to acquire 89,600 shares of our common stock having an exercise price of $5.00 per share, all owned directly by Mr. Schuyler (ii) 3,042 shares of our common stock and a warrant to acquire 1,963 shares of our common stock at an exercise price of $.0054 per share, and a warrant to acquire 1,172 shares of common stock at exercise price of $7.63, owned by Carolyn M. Schuyler, his wife, and (iii) 144,200 shares of common stock, warrants to acquire 336,800 shares of common stock having an exercise price of $6.25 per share, and a warrant to acquire 192,600 shares of our common stock having an exercise price of $5.00 per share, all owned directly by MVA 151 Investors, LLC. MVA 151 Investors, LLC is an entity under Mr. Schuyler’s control. Includes 17,247 shares of common stock which will vest within 60 days of July 2, 2020, which shares were part of total option grants to purchase 65,580 shares of our common stock.
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(8)
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Includes 8,755 shares of our common stock our common stock and a warrant to acquire 7,000 shares of our common stock having an exercise price of price of $6.25 per share issued upon consummation of our initial public offering. Mr. Goodman has also been granted an option to purchase 71,160 shares of our common stock, of which 22,827 are vested and exercisable within 60 days of July 2, 2020.
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(9)
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Includes 12,500 shares of common stock which will vest within 60 days of July 2, 2020, which shares were part of total option grants to purchase 90,000 shares of our common stock.
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(10)
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Comprised of a warrant to purchase 712,500 shares of common stock, exercisable immediately. Armistice Capital, LLC, the investment manager of Armistice Capital Master Fund Ltd. (“Armistice”), and Steven Boyd, the managing member of Armistice Capital, LLC, hold shared voting and dispositive power over the shares held by Armistice. Each of Armistice Capital, LLC and Steven Boyd disclaims beneficial ownership of the securities listed except to the extent of their pecuniary interest therein. The principal business address of Armistice is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, New York 10022
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SELLING
STOCKHOLDERS
The
shares of common stock being offered by the Selling Stockholders are those issuable upon the exercise of the Warrants. For additional
information regarding the issuance of these securities, see “Prospectus Summary—Registered Direct Offering of Common
Stock and Concurrent Private Placement of Warrants” on page 3 of this prospectus. We are registering the shares of common
stock issuable upon exercise of the Warrants in order to permit the Selling Stockholders to offer the shares for resale from time
to time. Except for the ownership of the Warrants, the transactions contemplated pursuant to the Purchase Agreement and other
financings completed by us, the Selling Stockholders have not had any material relationship with us within the past three years.
The
following table sets forth certain information with respect to each selling stockholder, including (i) the shares of our common
stock beneficially owned by the selling stockholder prior to this offering, (ii) the number of shares being offered by the selling
stockholder pursuant to this prospectus and (iii) the selling stockholder’s beneficial ownership after completion of this
offering. The registration of the shares of common stock issuable to the Selling Stockholders upon the exercise of the Warrants
does not necessarily mean that the Selling Stockholders will sell all or any of such shares, but the number of shares and percentages
set forth in the final two columns below assume that all shares of common stock being offered by the Selling Stockholders are
sold.
The
table is based on information supplied to us by the Selling Stockholders, with beneficial ownership and percentage ownership determined
in accordance with the rules and regulations of the SEC, and includes voting or investment power with respect to shares of stock.
This information does not necessarily indicate beneficial ownership for any other purpose. In computing the number of shares beneficially
owned by a Selling Stockholder and the percentage ownership of that Selling Stockholder, shares of common stock subject to warrants
held by that Selling Stockholder that are exercisable within 60 days after June 30, 2020, are deemed outstanding. Such shares,
however, are not deemed outstanding for the purposes of computing the percentage ownership of any other person. The percentage
of beneficial ownership after this offering is based on 13,449,603 shares of common stock outstanding on June 30, 2020.
This
prospectus covers the resale of 2,115,000 shares of our common stock that may be sold or otherwise disposed of by the Selling
Stockholders. Such shares are issuable to the Selling Stockholders upon the exercise of the Warrants. The Warrants are immediately
exercisable on the date of their issuance and expire five (5) years from the date they became exercisable. All of the Warrants
have an exercise price of $2.00 per share. See “Prospectus Summary — Registered Direct Offering of Common Stock and
Concurrent Private Placement of Warrants” above for a complete description of the Warrants. The Selling Stockholders may
sell all, some or none of their shares in this offering, but the number of shares and percentages set forth in the final two columns
below assume that all shares of common stock being offered by the Selling Stockholders are sold. See “Plan of Distribution.”
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Shares of Common Stock
Beneficially Owned
Prior to this Offering(1)
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Maximum
Number of
Shares of
Common Stock
to be Offered for
Resale in this
Offering(2)(3)
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Shares of Common Stock Beneficially Owned
Immediately
Following This Offering(1)(2)(4)
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Name
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Number
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|
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Percentage
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Number
|
|
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Number
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|
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Percentage
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Armistice Capital Master Fund Ltd.(5)
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712,500
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5.0
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%
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712,500
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—
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—
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CVI Investments, Inc. (6)
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450,000
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3.2
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%
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450,000
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|
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—
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—
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Empery Asset Master, LTD(7)(8)
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361,665
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2.6
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%
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299,604
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62,061
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*
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Empery Tax Efficient, LP(7)(9)
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140,505
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1.0
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%
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87,442
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53,063
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*
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Empery Tax Efficient III, LP(7)
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115,454
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*
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115,454
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—
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—
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Intracoastal Capital, LLC(10)
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470,000
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3.4
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%
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450,000
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20,000
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*
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(1)
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This
table and the information in the notes below are based upon information supplied by the
Selling Stockholders, including reports and amendments thereto filed with the SEC on
Schedule 13G.
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(2)
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The
shares of common stock underlying the Warrants held by the Selling Stockholders are exercisable
immediately. In addition, the terms of the Warrants held by the Selling Stockholders
include a blocker provision that restricts exercise to the extent the securities beneficially
owned by the Selling Stockholder and its affiliates would represent beneficial ownership
in excess of 4.99% (or, in the case of Armistice Capital Master Fund Ltd. and Intracoastal
Capital, LLC, 9.99%) of our common stock outstanding immediately after giving effect
to such exercise, subject to the holder’s option upon notice to us to increase
or decrease this beneficial ownership limitation; provided that any increase of such
beneficial limitation percentage shall only be effective upon 61 days’ prior notice
to us and such increased beneficial ownership percentage shall not exceed 9.99% of our
common shares.
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(3)
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The
actual number of shares of common stock offered hereby and included in the registration
statement of which this prospectus forms a part includes, in accordance with Rule 416
under the Securities Act, such indeterminate number of additional shares of our common
stock as may become issuable in connection with any proportionate adjustment for any
stock splits, stock combinations, stock dividends, recapitalizations or similar events
with respect to the common stock.
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(4)
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Assumes
the exercise in full of the Warrants and sale of all warrant shares registered pursuant
to this prospectus, although the Selling Stockholders are under no obligation known to
us to sell any shares of common stock at this time.
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(5)
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Armistice
Capital, LLC, the investment manager of Armistice Capital Master Fund Ltd. (“Armistice”),
and Steven Boyd, the managing member of Armistice Capital, LLC, hold shared voting and
dispositive power over the shares held by Armistice. Each of Armistice Capital, LLC and
Steven Boyd disclaims beneficial ownership of the securities listed except to the extent
of their pecuniary interest therein. The principal business address of Armistice is c/o
Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, New York 10022.
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(6)
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Heights
Capital Management, Inc. the authorized agent of CVI Investments, Inc. (“CVI”),
has discretionary authority to vote and dispose of the shares held by CVI and may be
deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity as
Investment Manager of Heights Capital Management, Inc., may also be deemed to have investment
discretion and voting power over the shares held by CVI. Mr. Kobinger disclaims any such
beneficial ownership of the shares. CVI Investments, Inc. is affiliated with one or more
FINRA members, none of whom are currently expected to participate in the sale pursuant
to the prospectus contained in the Registration Statement of Shares purchased by the
Investor in this Offering. The principal business address of Heights is PO Box 309GT,
Ugland House, South Church Street, George Town, Grand Cayman, Cayman Islands.
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(7)
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Empery
Asset Management LP (“EAM”), the authorized agent of Empery Asset Master
LTD, Empery Tax Efficient, LP and Empery Tax Efficient III, LP (collectively the “Empery
Entities”), has discretionary authority to vote and dispose of the shares held
by the Empery Entities and may be deemed to be the beneficial owner of these shares.
Martin Hoe and Ryan Lane, in their capacity as investment managers of EAM, may also be
deemed to have investment discretion and voting power over the shares held by EAM. The
Empery Entities, Mr. Hoe and Mr. Lane each disclaim any beneficial ownership of these
shares. The principal business address of the Empery Entities is 1 Rockefeller Plaza,
Suite 1205, New York, New York 10020.
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(8)
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The
number of shares of common stock owned prior to this offering by Empery Asset Master
LTD and the number of shares of common stock owned following this offering by Empery
Asset Master LTD each include 62,061 shares of common stock issuable upon exercise of
other warrants held by Empery Asset Master LTD, which warrants contain a 4.99% beneficial
ownership blocker substantially similar to those described in footnote (2) above.
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(9)
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The
number of shares of common stock owned prior to this offering by Empery Tax Efficient,
LP and the number of shares of common stock owned following this offering by Empery Tax
Efficient, LP each include 53,063 shares of common stock issuable upon exercise of other
warrants held by Empery Tax Efficient, LP, which warrants contain a 4.99% beneficial
ownership blocker substantially similar to those described in footnote (2) above.
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(10)
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Mitchell
P. Kopin (“Mr. Kopin”) and Daniel B. Asher (“Mr. Asher”), each
of whom are managers of Intracoastal Capital LLC (“Intracoastal”), have shared
voting control and investment discretion over the securities reported herein that are
held by Intracoastal. As a result, each of Mr. Kopin and Mr. Asher may be deemed to have
beneficial ownership (as determined under Section 13(d) of the Exchange Act) of the securities
reported herein that are held by Intracoastal. The principal business address of Intracoastal
Capital LLC is 245 Palm Trail, Delray Beach, Florida 33483. The number of shares of common
stock owned prior to this offering by this Selling Stockholder and the number of shares
of common stock owned following this offering by this Selling Stockholder each include
20,000 shares of common stock issuable upon exercise of other warrants held by the Selling
Shareholder, which warrants contain a 4.99% beneficial ownership blocker substantially
similar to those described in footnote (2) above.
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PLAN
OF DISTRIBUTION
Each
selling stockholder of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time,
sell any or all of their securities covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading
facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A selling
stockholder may use any one or more of the following methods when selling securities:
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●
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ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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●
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block
trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
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●
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purchases
by a broker-dealer as principal and resale by the broker-dealer for its account;
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●
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an
exchange distribution in accordance with the rules of the applicable exchange;
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●
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privately
negotiated transactions;
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●
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settlement
of short sales;
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●
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in
transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities
at a stipulated price per security;
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●
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through
the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
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●
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a
combination of any such methods of sale; or
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●
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any
other method permitted pursuant to applicable law.
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The
Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act,
if available, rather than under this prospectus.
Broker-dealers
engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive
commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities,
from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an
agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a
principal transaction, a markup or markdown in compliance with FINRA IM-2440.
In
connection with the sale of the securities or interests therein, the Selling Stockholders may enter into hedging transactions
with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of
hedging the positions they assume. The Selling Stockholders may also sell securities short and deliver these securities to close
out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling
Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one
or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered
by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus
(as supplemented or amended to reflect such transaction).
The
Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. Each selling stockholder has informed the Company that it does not have any written or oral agreement
or understanding, directly or indirectly, with any person to distribute the securities.
The
Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The
Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
We
agreed to keep this prospectus effective until no Selling Stockholders owns any Warrants or any shares of our common stock issuable
upon exercise of the Warrants. In addition, in certain states, the resale securities covered hereby may not be sold unless they
have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement
is available and is complied with.
Pursuant
to applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may
not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as
defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject
to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit
the timing of purchases and sales of the common stock by the Selling Stockholders or any other person. We will make copies of
this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus
to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
DESCRIPTION
OF OUR SECURITIES
The
following description of our capital stock and the provisions of our certificate of incorporation and our bylaws are summaries
and are qualified by reference to the certificate of incorporation and the bylaws. We have filed copies of these documents with
the SEC as exhibits to our registration statement of which this prospectus forms a part.
General
Our
authorized capital stock consists of 50,000,000 shares of common stock, par value $0.001 per share, and 5,000,000 shares of preferred
stock, par value $0.001 per share.
Common
Stock
Common
stock outstanding. There are 13,449,603 shares of our common stock outstanding on the date hereof.
Voting
rights. The holders of common stock are entitled to one vote per share on all matters to be voted upon by the stockholders,
except on matters relating solely to terms of preferred stock.
Dividend
rights. Subject to preferences that may be applicable to any outstanding preferred stock, the holders of common stock are
entitled to receive ratably such dividends, if any, as may be declared from time to time by the board of directors out of funds
legally available therefor. See “Dividend Policy.”
Rights
upon liquidation. In the event of our liquidation, dissolution or winding up, the holders of common stock are entitled to
share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights of preferred stock, if
any, then outstanding.
Other
rights. The holders of our common stock have no preemptive or conversion rights or other subscription rights. There are no
redemption or sinking fund provisions applicable to our common stock.
Preferred
Stock
Our
board of directors has the authority to issue preferred stock in one or more classes or series and to fix the designations, powers,
preferences and rights, and the qualifications, limitations or restrictions thereof, including dividend rights, conversion right,
voting rights, terms of redemption, liquidation preferences and the number of shares constituting any class or series, without
further vote or action by the stockholders. Although we have no present plans to issue any other shares of preferred stock, the
issuance of shares of preferred stock, or the issuance of rights to purchase such shares, could decrease the amount of earnings
and assets available for distribution to the holders of common stock, could adversely affect the rights and powers, including
voting rights, of the common stock, and could have the effect of delaying, deterring or preventing a change of control of us or
an unsolicited acquisition proposal. To date, no preferred stock has been issued.
Warrants
We
have outstanding warrants to purchase 8,784,274 shares of common stock with exercise prices ranging from $.0054 to $7.63 and expiration
dates from July 31, 2023 to December 31, 2031.
On
July 31, 2018, we consummated our IPO and issued an aggregate of 1,464,000 units, each unit consisting of one share of common
stock, par value $0.001 per share, and one warrant to purchase one share of common stock, at a public offering price of $5.00
per unit, before underwriting discounts and expenses. The warrants issued in the IPO are exercisable at any time after their original
issuance and at any time up to the date that is five years after their original issuance. The warrants will be exercisable, at
the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration
statement registering the issuance of the shares of common stock underlying the warrants under the Securities Act is effective
and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the
issuance of such shares, by payment in full in immediately available funds for the number of shares of common stock purchased
upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying the warrants
under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not available
for the issuance of such shares, the holder may, in its sole discretion, elect to exercise the warrant through a cashless exercise,
in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the
formula set forth in the warrant. No fractional shares of common stock will be issued in connection with the exercise of a warrant.
In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise
price. A holder will not have the right to exercise any portion of the warrant if the holder (together with its affiliates) would
beneficially own in excess of 4.99% of the number of shares of our common stock outstanding immediately after giving effect to
the exercise, as such percentage ownership is determined in accordance with the terms of the warrants. However, any holder may
increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage
shall not be effective until 61 days following notice from the holder to us. The exercise price per whole share of common stock
purchasable upon exercise of the warrants is $6.25 per share (based on the initial public offering price of $5.00 per unit) or
125 % of public offering price of the common stock. The exercise price is subject to appropriate adjustment in the event of certain
stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common
stock and also upon any distributions of assets, including cash, stock or other property to our stockholders. Subject to applicable
laws, the warrants may be offered for sale, sold, transferred or assigned without our consent. The warrants issued in the IPO
are trading on The NASDAQ Capital Market under the symbol “ADILW.” The warrants were issued in registered form under
a warrant agent agreement between VStock Transfer, LLC, as warrant agent, and us. The warrants shall initially be represented
only by one or more global warrants deposited with the warrant agent, as custodian on behalf of The Depository Trust Company (DTC)
and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC. In the event of a fundamental
transaction, as described in the warrants and generally including any reorganization, recapitalization or reclassification of
our Common Stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation
or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group
becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the warrants
will be entitled to receive upon exercise of the warrants the kind and amount of securities, cash or other property that the holders
would have received had they exercised the warrants immediately prior to such fundamental transaction.
The
representative of the underwriters in the IPO were issued warrants to purchase up to a total of 58,560 shares of common stock
(4% of the shares of common stock sold in this offering, excluding the over-allotment). The warrants are exercisable at any time,
and from time to time, in whole or in part, during the four-year period commencing one year from the effective date of the offering,
which period shall not extend further than five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(i).
The warrants are exercisable at a per share price equal to $6.25 per share, or 125% of the public offering price per unit in the
offering (based on the initial offering price of $5.00 per unit). The representative (or permitted assignees under Rule 5110(g)(1))
will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will they
engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition
of the warrants or the underlying securities for a period of 180 days from the effective date of the offering. In addition, the
warrants provide for registration rights upon request, in certain cases. In addition, the warrants provide for registration rights
upon request, in certain cases. The demand registration right provided will not be greater than five years from the effective
date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(iv). The piggyback registration right provided will not
be greater than seven years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(v). We will bear
all fees and expenses attendant to registering the securities issuable on exercise of the warrants other than underwriting commissions
incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the warrants may be adjusted
in certain circumstances including in the event of a stock dividend, extraordinary cash dividend or our recapitalization, reorganization,
merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuances of shares
of common stock at a price below the warrant exercise price.
As
of the date of this prospectus, 1,575,112 shares of common stock remain issuable upon the exercise of the warrants issued in the
IPO, including representatives warrants.
On
February 25, 2019, we closed a firm commitment underwritten public offering pursuant to which we issued and sold 2,845,000 shares
of our common stock together with a number of warrants to purchase 2,133,750 shares of our common stock. The combined public offering
price was $3.25 per share of common stock and accompanying warrant. The warrants are exercisable upon issuance at a price of $4.0625
per share of common stock, subject to adjustment in certain circumstances, and will expire on February 26, 2024. The warrants
will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and,
at any time a registration statement registering the issuance of the shares of common stock underlying the warrants under the
Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities
Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of
common stock purchased upon such exercise. If a registration statement registering the issuance of the shares of common stock
underlying the warrants under the Securities Act is not effective or available and an exemption from registration under the Securities
Act is not available for the issuance of such shares, the holder may, in its sole discretion, elect to exercise the warrant through
a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined
according to the formula set forth in the warrant. Except as otherwise provided in the warrants or by virtue of such holder’s
ownership of shares of common stock, the holder of a warrant does not have the rights or privileges of a holder of our common
stock, including any voting rights, until the holder exercises the warrant. No fractional shares of common stock will be issued
in connection with the exercise of a warrant. In lieu of fractional shares, at our election, we will pay the holder an amount
in cash equal to the fractional amount multiplied by the fair market value of any such fractional shares or round up to the next
whole share. The warrants also provide that in the event of a fundamental transaction we are required to cause any successor entity
to assume its obligations under the warrants. In addition, the holder of the warrant will be entitled to receive upon exercise
of the warrant the kind and amount of securities, cash or property that the holder would have received had the holder exercised
the warrant immediately prior to such fundamental transaction. A holder will not have the right to exercise any portion of the
warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% (or, upon election of the holder,
9.99%) of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage
ownership is determined in accordance with the terms of the warrants. However, any holder may increase or decrease such percentage,
provided that any increase will not be effective until the 61st day after such election.
On
June 9, 2020, we entered into the Purchase Agreement pursuant to which we issued: (i) 2,820,000 shares of our common stock, and
(ii) Warrrants, with a term of five years, to purchase an aggregate of up to 2,115,000 shares of Common Stock at an exercise price
of $2.00 per share.
Stockholder
Registration Rights
The
Warrant that was issued to the Selling Stockholders, provided that as soon as practicable after the issuance of such Warrants
(and in any event within 60 calendar days of the date of the Purchase Agreement), we would file a registration statement We agreed
to use commercially reasonable efforts to cause such registration to become effective within 181 days following the Closing Date
(as defined in the Purchase Agreement) and to keep such registration statement effective at all times until no Selling Stockholder
owns any Warrants or shares of our common stock issuable upon exercise thereof.
Anti-Takeover
Effects of Delaware Law
The
provisions of Delaware law, our certificate of incorporation and our bylaws described below may have the effect of delaying, deferring
or discouraging another party from acquiring control of us.
Section
203 of the Delaware General Corporation Law
We
are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any
business combination with any interested stockholder for a period of three years after the date that such stockholder became an
interested stockholder, with the following exceptions:
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before
such date, the board of directors of the corporation approved either the business combination or the transaction that resulted
in the stockholder becoming an interested stockholder;
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upon
completion of the transaction that resulted in the stockholder becoming an interested
stockholder, the interested stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction began, excluding for purposes of
determining the voting stock outstanding (but not the outstanding voting stock owned
by the interested stockholder) those shares owned (i) by persons who are directors and
also officers and (ii) employee stock plans in which employee participants do not have
the right to determine confidentially whether shares held subject to the plan will be
tendered in a tender or exchange offer; or
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on
or after such date, the business combination is approved by the board of directors and authorized at an annual or special
meeting of the stockholders, and not by written consent, by the affirmative vote of at least sixty-six and two-thirds percent
(66 2/3%) of the outstanding voting stock that is not owned by the interested stockholder.
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In
general, Section 203 defines business combination to include the following:
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any
merger or consolidation involving the corporation and the interested stockholder;
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any
sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;
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subject
to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder;
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any
transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class
or series of the corporation beneficially owned by the interested stockholder; or
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the
receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits
by or through the corporation.
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Certificate
of Incorporation and Bylaws
Our
certificate of incorporation and bylaws provide that:
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our
board of directors is divided into three classes, one class of which is elected each year by our stockholders with the directors
in each class to serve for a three-year term;
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the
authorized number of directors can be changed only by resolution of our board of directors;
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directors
may be removed only by the affirmative vote of the holders of at least 60% of our voting stock, whether for cause or without
cause;
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our
bylaws may be amended or repealed by our board of directors or by the affirmative vote of sixty-six and two-thirds percent
(66 2/3%) of our stockholders;
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stockholders
may not call special meetings of the stockholders or fill vacancies on the board of directors;
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our
board of directors will be authorized to issue, without stockholder approval, preferred stock, the rights of which will be
determined at the discretion of the board of directors and that, if issued, could operate as a “poison pill” to
dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors does not
approve;
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our
stockholders do not have cumulative voting rights, and therefore our stockholders holding a majority of the shares of common
stock outstanding will be able to elect all of our directors; and
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our
stockholders must comply with advance notice provisions to bring business before or nominate directors for election at a stockholder
meeting.
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Board
Classification
Our
board of directors is divided into three classes, one class of which is elected each year by our stockholders. The directors in
each class will serve for a three-year term. For more information on the classified board, see “Management—Board of
Directors and Executive Officers.” The classification of our board of directors and the limitations on the ability of our
stockholders to remove directors could make it more difficult for a third-party to acquire, or discourage a third-party from seeking
to acquire, control of us.
Potential
Effects of Authorized but Unissued Stock
We
have shares of common stock and preferred stock available for future issuance without stockholder approval. We may utilize these
additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate
corporate acquisitions or payment as a dividend on the capital stock.
The
existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons
friendly to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party
attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity
of our management. In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges
and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences
of each series of preferred stock, all to the fullest extent permissible under the Delaware General Corporation Law and subject
to any limitations set forth in our certificate of incorporation. The purpose of authorizing the board of directors to issue preferred
stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with a
stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with
possible financings, acquisitions and other corporate purposes, could have the effect of making it more difficult for a third
party to acquire, or could discourage a third party from acquiring, a majority of our outstanding voting stock.
Limitations
of Director Liability and Indemnification of Directors, Officers and Employees
Our
certificate of incorporation, limits the liability of directors to the maximum extent permitted by Delaware law. Delaware law
provides that directors of a corporation will not be personally liable for monetary damages for breach of their fiduciary duties
as directors, except for liability for any:
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breach
of their duty of loyalty to us or our stockholders;
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act
or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
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unlawful
payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the Delaware General Corporation
Law; or
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transaction
from which the directors derived an improper personal benefit.
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These
limitations of liability do not apply to liabilities arising under the federal or state securities laws and do not affect the
availability of equitable remedies such as injunctive relief or rescission.
Our
bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by law, and may indemnify employees
and other agents. Our bylaws also provide that we are obligated to advance expenses incurred by a director or officer in advance
of the final disposition of any action or proceeding.
We
have obtained a policy of directors’ and officers’ liability insurance.
We
have entered into separate indemnification agreements with our directors and officers. These agreements, among other things, require
us to indemnify our directors and officers for any and all expenses (including reasonable attorneys’ fees, retainers, court
costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone
charges, postage, delivery service fees) judgments, fines and amounts paid in settlement actually and reasonably incurred by such
directors or officers or on his or her behalf in connection with any action or proceeding arising out of their services as one
of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services
at our request provided that such person follows the procedures for determining entitlement to indemnification and advancement
of expenses set forth in the indemnification agreement. We believe that these bylaw provisions and indemnification agreements
are necessary to attract and retain qualified persons as directors and officers.
The
limitation of liability and indemnification provisions in our certificate of incorporation and bylaws may discourage stockholders
from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative
litigation against directors and officers, even though an action, if successful, might provide a benefit to us and our stockholders.
Our results of operations and financial condition may be harmed to the extent we pay the costs of settlement and damage awards
against directors and officers pursuant to these indemnification provisions.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling
us, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities
Act and is therefore unenforceable.
At
present, there is no pending litigation or proceeding involving any of our directors or officers as to which indemnification is
required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification.
Requirements
for Advance Notification of Stockholder Nominations and Proposals
Our
Bylaws establish advance notice procedures with respect to stockholder proposals and nomination of candidates for election as
directors.
Limits
on Special Meetings
Special
meetings of the stockholders may be called at any time only by the board of directors, Chairman or our Chief Executive Officer,
subject to the rights of the holders of any series of preferred stock.
Election
and Removal of Directors
Directors
are elected by a plurality of the votes of shares present in person or represented by proxy at a meeting and entitled to vote
generally on the election of directors. Our stockholders may remove directors only with the vote of sixty percent (60%) of the
stockholders, whether for cause or without cause. Our board of directors may appoint a director to fill a vacancy, including vacancies
created by the expansion of the board of directors. This system of electing and removing directors may discourage a third party
from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders
to replace a majority of our directors. Our certificate of incorporation and bylaws do not provide for cumulative voting in the
election of directors.
Amendments
to Our Governing Documents
Generally,
the amendment of our certificate of incorporation requires approval by our board of directors and a majority vote of stockholders.
Any amendment to our bylaws requires the approval of either a majority of our board of directors or approval of at least sixty-six
and two-thirds (66 2/3%) of the votes entitled to be cast by the holders of our outstanding capital stock in elections of our
board of directors.
Exclusive Forum Selection
Our certificate of incorporation provides
that to the fullest extent permitted by law, unless we consent in writing to the selection of an alternative forum, the Court of
Chancery of the State of Delaware shall be the sole and exclusive forum for (1) any derivative action or proceeding brought
on behalf of our company, (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers,
employees or stockholders to our company or our stockholders, (3) any action asserting a claim against our company or any
director, officer or employee of our company arising pursuant to any provision of the General Corporation Law of the State of Delaware
or our certificate of incorporation or bylaws, or (4) any action asserting a claim arising against our company or any director
or officer or other employee of our company governed by the internal affairs doctrine. This exclusive forum provision would not
apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim for
which the federal courts have exclusive jurisdiction. To the extent that any such claims may be based upon federal law claims,
Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules
and regulations thereunder. Although our certificate contains the choice of forum provision described above, it is possible that
a court could rule that such a provision is inapplicable for a particular claim or action or that such provision is unenforceable.
Investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.
Listing
Our
common stock is listed for trading on The NASDAQ Capital Market under the symbol “ADIL.” Our warrants issued in connection
with our initial public offering in July 2018 are currently listed on The NASDAQ Capital Market under the symbol “ADILW.”
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock offered in this offering is VStock Transfer, LLC. Its address is 18 Lafayette
Place, Woodmere, New York 11598. Its telephone number is (212)
828-8436.
LEGAL
MATTERS
The
validity of the securities being offered by this prospectus have been passed upon for us by Gracin & Marlow, LLP, New York,
New York.
EXPERTS
The
financial statements of Adial Pharmaceuticals, Inc. as of December 31, 2019 and 2018 and for each of the years in the two year
period ended December 31, 2019 incorporated by reference in this Registration Statement have been so included in reliance on the
report of Friedman LLP, an independent registered public accounting firm, (such report includes an explanatory paragraph regarding
the Company’s ability to continue as a going concern), given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
are a reporting company and file annual, quarterly and current reports, proxy statements and other information with the SEC. We
have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the securities we are offering
to sell. This prospectus, which constitutes part of the registration statement, does not include all of the information contained
in the registration statement and the exhibits, schedules and amendments to the registration statement. For further information
with respect to us and our common stock, we refer you to the registration statement and to the exhibits and schedules to the registration
statement. Statements contained in this prospectus about the contents of any contract, agreement or other document are not necessarily
complete, and, in each instance, we refer you to the copy of the contract, agreement or other document filed as an exhibit to
the registration statement. Each of these statements is qualified in all respects by this reference.
The
SEC maintains an Internet website, which is located at www.sec.gov, that contains reports, proxy and information statements
and other information regarding issuers that file electronically with the SEC. You may access the registration statement of which
this prospectus is a part at the SEC’s Internet website. Upon completion of this offering, we will be subject to the information
reporting requirements of the Securities Exchange Act of 1934, as amended, and we will file reports, proxy statements and other
information with the SEC.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The
SEC allows us to incorporate by reference the information we file with it, which means that we can disclose important information
to you by referring you to another document that we have filed separately with the SEC. You should read the information incorporated
by reference because it is an important part of this prospectus. Information in this prospectus supersedes information incorporated
by reference that we filed with the SEC prior to the date of this prospectus, while information that we file later with the SEC
will automatically update and supersede the information in this prospectus. We incorporate by reference into this prospectus and
the registration statement of which this prospectus is a part the information or documents listed below that we have filed with
the SEC (Commission File No. 001-38323):
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2019 filed with the SEC on March 20, 2020;
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Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 14, 2020;
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Our
Current Reports on Form 8-K filed with the SEC on February 6, 2020, March 6, 2020, May 20, 2020, May 27, 2020, June 8, 2020, June 10, 2020, June 11, 2020 and June 12, 2020; and
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The
description of our Common Stock set forth in our registration statement on Form
8-A12B, filed with the SEC on December 11, 2017 and Form
8-A12B/A filed with the SEC on July 23, 2018.
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We also incorporate by reference any future
filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed 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 this prospectus and 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.
We
will furnish without charge to each person, including any beneficial owner, to whom a prospectus is delivered, upon written or
oral request, a copy of any or all of the documents incorporated by reference into this prospectus but not delivered with the
prospectus, including exhibits that are specifically incorporated by reference into such documents. You should direct any requests
for documents to:
Adial
Pharmaceuticals, Inc.
1180
Seminole Trail, Suite 495
Charlottesville,
VA 22901
Telephone
(434) 422-9800
Attention:
Corporate Secretary
You
should rely only on information contained in, or incorporated by reference into, this prospectus and any prospectus supplement.
We have not authorized anyone to provide you with information different from that contained in this prospectus or incorporated
by reference into this prospectus. We are not making offers to sell the securities in any jurisdiction in which such an offer
or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so or to anyone
to whom it is unlawful to make such offer or solicitation.
2,115,000
SHARES OF COMMON STOCK UNDERLYING WARRANTS
PROSPECTUS
July 10, 2020
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