Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-221492
Prospectus
Supplement
(To
prospectus dated December 15, 2017)
7,058,824
shares of common stock
Pursuant
to this prospectus supplement and the accompanying prospectus, we are offering 7,058,824 shares of our common stock, $0.001
par value per share, at a price of $1.0625 per share, to certain institutional investors pursuant to this prospectus
supplement and the accompanying prospectus and a securities purchase agreement with such investors. In a concurrent private
placement, we are selling to such investors warrants to purchase up to 3,529,412 shares which represent 50% of the number of
shares of our common stock being purchased in this offering (the “Warrants”). The Warrants and the shares of our
common stock issuable upon the exercise of the Warrants are being offered pursuant to the exemption provided in Section
4(a)(2) under the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506(b) promulgated
thereunder, and they are not being offered pursuant to this prospectus supplement and the accompanying prospectus.
Our
common stock is listed on the Nasdaq Capital Market and traded under the symbol “CTXR.” The last reported sale price
of our common stock on the Nasdaq Capital Market on May 13, 2020 was $1.11 per share. The Warrants being issued in the concurrent
private placement are not listed on any securities exchange, and we do not expect to list the Warrants.
We
have retained H.C. Wainwright & Co., LLC to act as our exclusive placement agent in connection with the shares of common stock
offered by this prospectus supplement and the accompanying prospectus. The placement agent has agreed to use its reasonable best
efforts to sell the shares of common stock offered by this prospectus supplement and the accompanying prospectus.
We
have agreed to pay the placement agent the placement agent fees set forth in the table below, which assumes that we sell all of
the shares of common stock we are offering.
|
|
|
Per
Share
|
|
|
Total
|
|
|
Offering price
|
|
$
|
1.0625
|
|
|
$
|
7,500,000
|
|
|
Placement agent fees
(1)
|
|
$
|
0.0744
|
|
|
$
|
525,000
|
|
|
Proceeds, before expenses,
to us (2)
|
|
$
|
0.9881
|
|
|
$
|
6,975,000
|
|
|
|
(1)
|
We
have agreed to pay the placement agent for certain of its expenses and to issue
warrants to purchase shares of common stock to the placement agent (or its designees) as further described
under the “Plan of Distribution” on page S-15 of this prospectus supplement.
|
|
|
(2)
|
The
amount of the offering proceeds to us presented in this table does not give effect to
any exercise of the Warrants being issued in the concurrent private placement.
|
You
should read carefully this prospectus supplement and the documents incorporated by reference in this prospectus supplement before
you invest. Please see “Risk Factors” on page S-10 of this prospectus supplement and the risk factors incorporated
by reference into this prospectus supplement and the accompanying prospectus for more information.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus supplement or the accompanying prospectus. Any representation to the contrary
is a criminal offense.
As
of May 13, 2020, the aggregate market value of the voting and non-voting common equity held by non-affiliates, computed by reference
to the closing price of the common stock on May13, 2020, was $28,660,336, based on 38,128,062 shares of outstanding common stock
as of May 13, 2020, of which 25,820,123 shares were held by non-affiliates. Pursuant to General Instruction I.B.6 of Form S-3,
in no event will we sell securities in a public primary offering with a value exceeding more than one-third of our public float
in any 12-calendar month period so long as our public float remains below $75.0 million. During the 12 calendar months prior to
and excluding the date of this prospectus supplement, we sold no securities pursuant to General Instruction I.B.6 of Form S-3.
We
anticipate delivery of the shares will take place on or about May 18, 2020, subject to the satisfaction of certain conditions.
H.C.
Wainwright & Co.
The
date of this prospectus supplement is May 14, 2020.
TABLE
OF CONTENTS
Prospectus
Supplement
Prospectus
You
should rely only on the information incorporated by reference or provided in this prospectus supplement and the accompanying prospectus.
We have not authorized anyone to provide you with different information. If anyone provides you with different or inconsistent
information, you should not rely on it. This prospectus supplement and the accompanying prospectus do not constitute an offer
to sell, or a solicitation of an offer to purchase, the shares of common stock offered by this prospectus supplement and the accompanying
prospectus in any jurisdiction where it is unlawful to make such offer or solicitation. You should not assume that the information
contained in this prospectus supplement or the accompanying prospectus, or any document incorporated by reference in this prospectus
supplement or the accompanying prospectus, is accurate as of any date other than the date on the front cover of the applicable
document. Neither the delivery of this prospectus supplement nor any distribution of shares of common stock pursuant to this prospectus
supplement shall, under any circumstances, create any implication that there has been no change in the information set forth or
incorporated by reference into this prospectus supplement or in our affairs since the date of this prospectus supplement. Our
business, financial condition, results of operations and prospects may have changed since that date.
ABOUT
THIS PROSPECTUS SUPPLEMENT
This
document is in two parts, both of which are part of a registration statement that we filed with the Securities and Exchange Commission,
or SEC, using a “shelf” registration process. Under this shelf process, we may currently from time to time offer up
to approximately $50.0 million of shares of our common stock, $0.001 par value per share, under this prospectus at prices and
on terms to be determined at the time of sale.
We
provide information to you about this offering of shares of our common stock in two separate documents: (1) this prospectus supplement,
which describes the specific details regarding this offering; and (2) the accompanying prospectus, which provides a general description
of the securities we may offer, some of which may not apply to this offering. Generally, when we refer to this “prospectus,”
we are referring to both documents combined. If information in this prospectus supplement is inconsistent with the accompanying
prospectus, you should rely on this prospectus supplement. You should read this prospectus supplement together with the additional
information described below under the heading “Where You Can Find Additional Information” and “Incorporation
of Documents by Reference.”
The
registration statement that contains this prospectus, including the exhibits to the registration statement and the information
incorporated by reference, contains additional information about the shares of common stock offered under this prospectus. That
registration statement can be read at the SEC website or at the SEC offices mentioned below under the heading “Where You
Can Find Additional Information.”
We
are responsible for the information contained and incorporated by reference in this prospectus supplement, the accompanying prospectus
and any related free writing prospectus we prepare or authorize. We have not authorized anyone to provide you with different information,
and we take no responsibility for any other information that others may give you.
This
prospectus supplement and the accompanying prospectus do not constitute an offer to sell or the solicitation of an offer to buy
any securities other than the registered shares of common stock to which this prospectus supplement relates, nor do this prospectus
supplement and the accompanying prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any
jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.
You
should not assume that the information in this prospectus supplement and the accompanying prospectus is accurate at any date other
than the date indicated on the cover page of this prospectus supplement or that any information we have incorporated by reference
is correct on any date subsequent to the date of the document incorporated by reference.
Unless
the context otherwise requires, “Citius,” “the Company,” “we,” “us,” “our”
and similar terms refer to Citius Pharmaceuticals, Inc.
We
own or have rights to various U.S. federal trademark registrations and applications, and unregistered trademarks and servicemarks,
including Mino-Lok®. All other trade names, trademarks and service marks appearing in this prospectus are the property of
their respective owners. We have assumed that the reader understands that all such terms are source-indicating. Accordingly, such
terms, when first mentioned in this prospectus, appear with the trade name, trademark or service mark notice and then throughout
the remainder of this prospectus without trade name, trademark or service mark notices for convenience only and should not be
construed as being used in a descriptive or generic sense.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
The
SEC encourages companies to disclose forward-looking information so that investors can better understand a company’s future
prospects and make informed investment decisions. This prospectus supplement, the accompanying prospectus and the documents we
have filed with the SEC that are incorporated herein and therein by reference contain such “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995.
Words
such as “may,” “might,” “should,” “anticipate,” “estimate,” “expect,”
“projects,” “intends,” “plans,” “believes” and words and terms of similar substance
used in connection with any discussion of future operating or financial performance, identify forward-looking statements. Forward-looking
statements represent management’s current judgment regarding future events and are subject to a number of risks and uncertainties
that could cause actual results to differ materially from those described in the forward-looking statements. These risks include,
but are not limited to: the commercial success and market acceptance of any of our products and product candidates that are approved
for marketing in the United States or other countries; the accuracy of our estimates of the size and characteristics of the markets
that may be addressed by our products and product candidates; our ability to manufacture sufficient amounts of our product candidates
for clinical trials and our products for commercialization activities; our need for, and ability to raise, additional capital;
the number, designs, results and timing of our clinical trials; the regulatory review process and any regulatory approvals that
may be issued or denied by the FDA or other regulatory agencies; our need to secure collaborators to license, manufacture, market
and sell any products for which we receive regulatory approval in the future; our ability to protect our intellectual property
and operate our business without infringing upon the intellectual property rights of others; the medical benefits, effectiveness
and safety of our products and product candidates; the safety and efficacy of medicines or treatments introduced by competitors
that are targeted to indications which our products and product candidates have been or are being developed to treat; our current
or prospective collaborators’ compliance or non-compliance with their obligations under our agreements with them; and other
factors discussed elsewhere in this prospectus supplement, the accompanying prospectus and the documents incorporated herein and
therein by reference. Please also see the discussion of risks and uncertainties under “Risk Factors” below, and contained
in the accompanying prospectus and otherwise incorporated by reference herein, and in our most recent annual report on Form 10-K
and our most recent quarterly report on Form 10-Q as well as any amendments thereto, as filed with the SEC and which are incorporated
herein by reference.
In
light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained
in this prospectus supplement, the accompanying prospectus or in any document incorporated herein or therein by reference might
not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the respective
dates of this prospectus supplement, the accompanying prospectus or the date of the document incorporated by reference in this
prospectus supplement or the accompanying prospectus. We expressly disclaim any obligation to update or alter any forward-looking
statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
PROSPECTUS
SUPPLEMENT SUMMARY
The
following is a summary of what we believe to be the most important aspects of our business and the offering of our shares of common
stock under this prospectus supplement and the accompanying prospectus. We urge you to read this entire prospectus supplement
and the accompanying prospectus, including the more detailed consolidated financial statements, notes to the consolidated financial
statements and other information incorporated herein or therein by reference from our other filings with the SEC. Investing in
our securities involves risks. Therefore, carefully consider the risk factors set forth in this prospectus supplement, the accompanying
prospectus and in our most recent annual and quarterly filings with the SEC, as well as other information in this prospectus supplement,
the accompanying prospectus and the documents incorporated by reference herein or therein, before purchasing our securities. Each
of the risk factors could adversely affect our business, operating results and financial condition, as well as adversely affect
the value of an investment in our securities.
Overview
Citius
Pharmaceuticals, Inc., headquartered in Cranford, New Jersey, is a specialty pharmaceutical company dedicated to the development
and commercialization of critical care products targeting important medical needs with a focus on anti-infective products in adjunct
cancer care and unique prescription products. Our goal is to achieve leading market positions by providing therapeutic products
that address unmet medical needs yet have a lower development risk than new chemical entities have. New formulations of previously
approved drugs with substantial safety and efficacy data are a core focus as we seek to reduce development and clinical risks
associated with drug development. Our strategy centers on products that have intellectual property and regulatory exclusivity
protection, while providing competitive advantages over other existing therapeutic approaches.
Since
its inception, we have devoted substantially all of our efforts to business planning, research and development, recruiting management
and technical staff, and raising capital. We are developing two proprietary products: Mino-Lok®, an antibiotic lock solution
used to treat patients with catheter-related bloodstream infections by salvaging the infected catheter, and a hydrocortisone-lidocaine
topical formulation that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids.
We believe the markets for our products are large, growing and underserved by the current prescription products or procedures.
Mino-Lok
Mino-Lok
is a patented solution containing minocycline, disodium ethylenediaminetetraacetic acid (edetate) and ethyl alcohol, all of which
act synergistically to treat and salvage infected central venous catheters (“CVCs”) in patients with catheter related
bloodstream infections (“CRBSIs”). Mino-Lok breaks down biofilm barriers formed by bacterial colonies, eradicates
the bacteria, and provides anti-clotting properties to maintain patency in CVCs.
The
administration of Mino-Lok consists of filling the lumen of the catheter with 0.8 ml to 2.0 ml of Mino-Lok solution. The catheter
is then “locked”, meaning that the solution remains in the catheter without flowing into the vein. the lock is maintained
for a dwell-time of two hours while the catheter is not in use. If the catheter has multiple lumens, all lumens may be locked
with the Mino-Lok solution either simultaneously or sequentially. If patients are receiving continuous infusion therapy, the catheters
alternate between being locked with the Mino-Lok solution and delivering therapy. The Mino-Lok therapy is two hours per day for
at least five days, usually with two additional locks in the subsequent two weeks. After locking the catheter for two hours, the
Mino-Lok solution is aspirated, and the catheter is flushed with normal saline. At that time, either the infusion will be continued,
or will be locked with the standard-of-care lock solution until further use of the catheter is required. In a clinical study conducted
by MD Anderson Cancer Center (“MDACC”), there were no serum levels of either minocycline or edetate detected in the
sera of several patients who underwent daily catheter lock solution with minocycline and edetate (“M-EDTA”) at the
concentration level proposed in Mino-Lok treatment. Thus, it has been demonstrated that the amount of either minocycline or edetate
that leaks into the serum is very low or none at all.
Phase
2b Results
From
April 2013 to July 2014, 30 patients with CVC-related bloodstream infection were enrolled at MDACC in a prospective Phase 2b study.
Patients received Mino-Lok therapy for two hours once daily for a minimum of five days within the first week followed by two additional
locks within the next two weeks. Patients were followed for one month post lock therapy. Demographic information, clinical characteristics,
laboratory data, therapy, as well as adverse events and outcome were collected for each patient. Median age at diagnosis was 56
years (range: 21-73 years). In all patients, prior to the use of lock therapy, systemic treatment with a culture-directed, first-line
intravenous antibiotic was started. Microbiological eradication was achieved at the end of therapy in all cases. None of the patients
experienced any serious adverse event related to the lock therapy.
The
active arm, which is the Mino-Lok treated group of patients, was then compared to 60 patients in a matched cohort that experienced
removal and replacement of their CVCs within the same contemporaneous timeframe. The patients were matched for cancer type, infecting
organism and level of neutropenia. All patients were cancer patients and treated at the MDACC. The efficacy of Mino-Lok therapy
was 100% in salvaging CVCs, demonstrating equal effectiveness to removing the infected CVC and replacing with a new catheter.
The
main purpose of the study was to show that Mino-Lok therapy was at least as effective as the removal and replacement of CVCs when
CRBSIs are present, and that the safety was better, that is, the complications of removing an infected catheter and replacing
with a new one could be avoided. In addition to having a 100% efficacy rate with all CVCs being salvaged, Mino-Lok therapy had
no significant adverse events (“SAEs”), compared to an 18% SAE rate in the matched cohort where patients had the infected
CVCs removed and replaced (“R&R”) with a fresh catheter. There were no overall complication rates in the Mino-Lok
arm group compared to 11 patients with events (18%) in the control group. These events included bacterial relapse (5%) at four
(4) weeks post-intervention, and a number of complications associated with mechanical manipulation in the removal or replacement
procedure for the catheter (10%) or development of deep-seated infections such as septic thrombophlebitis and osteomyelitis (8%).
As footnoted, six (6) patients had more than one (1) complication in the control arm group.
|
|
|
Mino-Lok
Arm
|
|
|
Control
Arm
|
|
|
Parameter
|
|
N
|
|
|
(%)
|
|
|
N
|
|
|
(%)
|
|
|
Patients
|
|
|
30
|
|
|
|
(100
|
)%
|
|
|
60
|
|
|
|
(100
|
)%
|
|
Cancer type
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Hematologic
|
|
|
20
|
|
|
|
(67
|
)
|
|
|
48
|
|
|
|
(80
|
)
|
|
- Solid tumor
|
|
|
10
|
|
|
|
(33
|
)
|
|
|
12
|
|
|
|
(20
|
)
|
|
ICU Admission
|
|
|
4
|
|
|
|
(13
|
)
|
|
|
4
|
|
|
|
(7
|
)
|
|
Mech. Ventilator
|
|
|
3
|
|
|
|
(10
|
)
|
|
|
0
|
|
|
|
(0
|
)
|
|
Bacteremia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Gram+
|
|
|
17
|
|
|
|
(57
|
)*
|
|
|
32
|
|
|
|
(53
|
)
|
|
- Gram-
|
|
|
14
|
|
|
|
(47
|
)*
|
|
|
28
|
|
|
|
(47
|
)
|
|
Neutropenia (<500)
|
|
|
19
|
|
|
|
(63
|
)
|
|
|
36
|
|
|
|
(60
|
)
|
|
Microbiologic Eradication
|
|
|
30
|
|
|
|
(100
|
)
|
|
|
60
|
|
|
|
(100
|
)
|
|
- Relapse
|
|
|
0
|
|
|
|
(0
|
)
|
|
|
3
|
|
|
|
(5
|
)
|
|
Complications
|
|
|
0
|
|
|
|
(0
|
)
|
|
|
8
|
|
|
|
(13
|
)
|
|
SAEs related to R&R
|
|
|
0
|
|
|
|
(0
|
)
|
|
|
6
|
|
|
|
(10
|
)
|
|
Overall Complication
Rate
|
|
|
0
|
|
|
|
(0
|
)%
|
|
|
11
|
**
|
|
|
(18
|
)%
|
|
|
*
|
1
polymicrobial patient had a Gram+ and a Gram- organism cultured
|
|
|
**
|
6
patients had > 1 complication
|
Source:
Dr. Issam Raad, Antimicrobial Agents and Chemotherapy, June 2016, Vol. 60 No. 6, Page 3429
Phase
3 Initiation
In
November 2016, we initiated site recruitment for Phase 3 clinical trials. From initiation through first quarter 2017, we received
input from several sites related to the control arm as being less than standard of care for some of the respective institutions.
We worked closely with the FDA with respect to the design of the phase 3 trial, and received feedback on August 17, 2017. The
FDA stated that they recognized that there is an unmet medical need in salvaging infected catheters and agreed that an open label,
superiority design would address our concerns and would be acceptable to meet the requirements of a new drug application. We amended
the phase 3 study design to remove the saline and heparin placebo control arm and to use an active control arm that conforms with
today’s current standard of care. Patient enrollment commenced in February 2018.
The
Mino-Lok phase 3 trial was originally planned to enroll 700 patients in 50 participating institutions, all located in the U.S.
There will be interim analyses at both the 50% and 75% points of the trial as measured by the number of patients treated. As of
February 29, 2020, there are 30 active sites currently enrolling patients including such academic centers as MDACC, Henry Ford
Health Center, Georgetown University Medical Center, University of Chicago, and others. There are five additional well renowned
medical centers in startup mode. There are no other remaining sites in feasibility.
In
September 2019, the Company announced that the FDA agreed to a new primary efficacy endpoint of “time to catheter failure”
in comparing Mino-Lok to the antibiotic lock control arm. This change in the trial design reduced the required patient sample
size of the trial from 700 subjects to approximately 144 available subjects to achieve the pre-specified 92 catheter failure events
needed to conclude the trial. Additionally, the Company submitted a response to the FDA that it will implement this change in
the primary endpoint and expected it to result in less than 150 subjects needed in its Phase 3 trial, which the FDA is reviewing.
In
October 2019, the FDA agreed that the patient sample size of approximately 144 patients was acceptable.
In
October 2019, the Company announced that the Phase 3 trial had reached the 40% completion triggering an interim futility analysis.
That analysis showed a positive outcome, as it met the prespecified interim futility analysis criteria. The next major milestone
in the Mino-Lok trial, expected to be achieved in the first half of 2020, will be the 75% interim analysis for superior efficacy.
The endpoints for this analysis require that the time to catheter failure be at least 38 days for Mino-Lok vs. 21 days for SOC
antibiotic locks.
Fast
Track Designation
In
October 2017, we received official notice from FDA that the investigational program for Mino-Lok was granted “Fast Track”
status. Fast Track is a designation that expedites FDA review to facilitate development of drugs which treat a serious or life-threatening
condition and fill an unmet medical need. A drug that receives Fast Track designation is eligible for the following:
|
|
●
|
More
frequent meetings with FDA to discuss the drug’s development plan and ensure collection
of appropriate data needed to support drug approval;
|
|
|
●
|
More
frequent written correspondence from FDA about the design of the clinical trials;
|
|
|
●
|
Priority
review to shorten the FDA review process for a new drug from ten months to six months;
and
|
|
|
●
|
Rolling
Review, which means Citius can submit completed sections of its New Drug Application
(NDA) for review by FDA, rather than waiting until every section of the application is
completed before the entire application can be reviewed.
|
Mino-Lok
International Study
In
October 2017, data from an international study on Mino-Lok was presented at the Infectious Disease Conference, (“ID Week”),
in San Diego, California. The 44-patient study was conducted in Brazil, Lebanon and Japan and showed Mino Lok therapy was an effective
intervention to salvage long term, infected central venous catheters (CVCs) in catheter related bloodstream infections in patients
who had cancer with limited vascular access. This study showed 95% effectiveness for Mino-Lok therapy in achieving microbiological
eradication of the CVCs as compared to 83% for the control.
Stability
Patent Application for Mino-Lok
In
October 2018, the U.S. Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 10,086,114, entitled “Antimicrobial
Solutions with Enhanced Stability.” The new invention overcomes limitations in mixing antimicrobial solutions in which components
have precipitated because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions. The scientists
and technologists at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed
pH of the solution. This may allow for longer storage time of the ready-to-use solution. Citius holds the exclusive worldwide
license which provides access to this patented technology for development and commercialization of Mino-Lok.
On
October 9, 2019, the European Patent Office (“EPO”) granted European Patent No. 3370794, entitled “Antimicrobial
Solutions with Enhanced Stability.” The grant of this European patent strengthens the intellectual property protection for
Mino-Lok through November of 2036. The new invention overcomes limitations in mixing antimicrobial solutions, in which components
have precipitated because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions. The scientists
and technologists at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed
pH of the solution. This may allow for longer storage time of the ready-to-use solution.
Mino-Wrap
On
January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas
System on behalf of the MDACC, whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses
relating to breast implants, specifically the Mino-Wrap technology. This includes rights to U.S. Patent No. 9,849,217, which was
issued on December 16, 2017. We intend to develop Mino-Wrap as a liquefying, gel-based wrap containing minocycline and rifampin
for the reduction of infections associated with breast implants following breast reconstructive surgeries. We are required to
use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated
with these regulatory options leading to an approval from the FDA. Mino-Wrap will require pre-clinical development prior to any
regulatory pathway. In July 2019, we announced that we intend to pursue the FDA’s Investigational New Drug (“IND”)
regulatory pathway for the development of Mino-Wrap.
Halo-Lido
Overview
Halo-Lido
is a topical formulation of halobetasol propionate, a corticosteroid and lidocaine that is intended for the treatment of hemorrhoids.
To our knowledge, there are currently no FDA-approved prescription drug products for the treatment of hemorrhoids. Some physicians
are known to prescribe topical steroids for the treatment of hemorrhoids. In addition, there are various topical combination prescription
products containing halobetasol propionate along with lidocaine or pramoxine, each a topical anesthetic, that are prescribed by
physicians for the treatment of hemorrhoids. These products contain drugs that were in use prior to the start of the Drug Efficacy
Study Implementation (“DESI”) program and are commonly referred to as DESI drugs. However, none of these single-agent
or combination prescription products have been clinically evaluated for safety and efficacy and approved by the FDA for the treatment
of hemorrhoids. Further, many hemorrhoid patients use over the counter (“OTC”) products as their first line therapy.
OTC products contain any one of several active ingredients including glycerin, phenylephrine, pramoxine, white petrolatum, shark
liver oil and/or witch hazel, for symptomatic relief.
Development
of Hemorrhoids Drugs
Hemorrhoids
are a common gastrointestinal disorder, characterized by anal itching, pain, swelling, tenderness, bleeding and difficulty defecating.
In the U.S., hemorrhoids affect nearly 5% of the population, with approximately 10 million persons annually admitting to having
symptoms of hemorrhoidal disease. Of these persons, approximately one third visit a physician for evaluation and treatment of
their hemorrhoids. The data also indicate that for both sexes a peak of prevalence occurs from age 45 to 65 years with a subsequent
decrease after age 65 years. Caucasian populations are affected significantly more frequently than African Americans, and increased
prevalence rates are associated with higher socioeconomic status in men but not women. Development of hemorrhoids before age 20
is unusual. In addition, between 50% and 90% of the general U.S., Canadian and European population will experience hemorrhoidal
disease at least once in life. Although hemorrhoids and other anorectal diseases are not life-threatening, individual patients
can suffer from agonizing symptoms which can limit social activities and have a negative impact on the quality of life.
Hemorrhoids
are defined as internal or external according to their position relative to the dentate line. Classification is important for
selecting the optimal treatment for an individual patient. Accordingly, physicians use the following grading system, referred
to as the Goligher’s classification of internal hemorrhoids:
|
Grade I
|
Hemorrhoids not prolapsed
but bleeding.
|
|
Grade II
|
Hemorrhoids prolapse and reduce spontaneously
with or without bleeding.
|
|
Grade III
|
Prolapsed hemorrhoids that require reduction
manually.
|
|
Grade IV
|
Prolapsed and cannot be reduced including both
internal and external hemorrhoids that are confluent from skin tag to inner anal canal.
|
Development
Activities to Date
In
the fall of 2015, we completed dosing patients in a double-blind dose ranging placebo controlled Phase 2a study where six different
formulations containing hydrocortisone and lidocaine in various strengths were tested against the vehicle control. The objectives
of this study were to: (1) demonstrate the safety and efficacy of the formulations when applied twice daily for two weeks in subjects
with Grade I or II hemorrhoids, and (2) assess the potential contribution of lidocaine hydrochloride and hydrocortisone acetate,
alone or in combination for the treatment of symptoms of Goligher’s Classification Grade I or II hemorrhoids.
Symptom
improvement was observed based on a global score of disease severity (“GSDS”), and based on some of the individual
signs and symptoms of hemorrhoids, specifically itching and overall pain and discomfort. Within the first few days of treatment,
the combination products (containing both hydrocortisone and lidocaine) were directionally favorable versus the placebo and their
respective individual active treatment groups (e.g., hydrocortisone or lidocaine alone) in achieving ‘almost symptom free’
or ’symptom free’ status according to the GSDS scale. These differences suggest the possibility of a benefit for the
combination product formulation.
Overall,
results from adverse event reporting support the safety profile of all test articles evaluated in this study and demonstrate similar
safety profiles as compared to the vehicle. The safety findings were unremarkable. There was a low occurrence of adverse events
and a similar rate of treatment related adverse events across all treatment groups. The majority of adverse events were mild and
only one was severe. None of the adverse events were an SAE and the majority of adverse events were recovered/resolved at the
end of the study. There were only two subjects who were discontinued from the study due to adverse events.
In
addition to the safety and dose-ranging information, information was obtained relating to the use of the GSDS as an assessment
tool for measuring the effectiveness of the test articles. Individual signs and symptoms were also assessed but can vary from
patient to patient. Therefore, the goal of the GSDS was to provide an assessment tool that could be used for all patients regardless
of which signs and symptoms they are experiencing. The GSDS proved to be a more effective tool for assessing the severity of the
disease and the effectiveness of the drug when compared to the assessment of the individual signs and symptoms. Citius believes
that we can continue to develop this assessment tool as well as other patient reported outcome endpoints for use in the next trials
and in the pivotal trial.
Information
was also obtained about the formulation of the drug and the vehicle. As a result of this study, we believe that the performance
of the active arms of the study relative to the vehicle can be improved by re-formulating our topical preparation. Therefore,
we have initiated work on vehicle formulation and evaluation of higher potency steroids.
In
June and July 2016, we engaged the Dominion Group, a leading provider of healthcare and pharmaceutical marketing research services.
The primary market research was conducted to understand the symptoms that are most bothersome to patients better in order to develop
meaningful endpoints for the clinical trials. We also learned about the factors that drive patients to seek medical attention
for hemorrhoids in an effort to understand the disease impact on quality of life. The results of this survey are able to help
us develop patient reported outcome evaluation tools. These tools can be used in clinical trials to evaluate the patients’
conditions and to assess the performance of the test articles.
In
March 2018, we announced that we had selected a higher potency corticosteroid in our steroid/anesthetic topical formulation program
for the treatment of hemorrhoids. The original topical preparation, which we referred to as Halo-Lido or CITI-001, which was used
in the Phase 2a study, was a combination of hydrocortisone acetate and lidocaine hydrochloride. The new formulation, CITI-002,
which we refer to as Halo-Lido, will combine lidocaine with the higher potency corticosteroid halobetasol propionate for symptomatic
relief of the pain and discomfort of hemorrhoids.
We
held a Type C meeting with the FDA in December 2017 to discuss the results of the Phase 2a study and to obtain the FDA’s
view on development plans to support the potential formulation change for the planned Phase 2b study. We also requested the FDA’s
feedback on our Phase 2b study design, including target patient population, inclusion/exclusion criteria, and efficacy endpoints.
The pre-clinical and clinical development programs for CITI-002 are planned to be similar to those conducted for the development
of CITI-001 to support the design for a planned Phase 3 clinical trial.
Citius/Novellus
Program
On
March 31, 2020, we entered into an option agreement with a subsidiary of Novellus, Inc. (“Novellus”) whereby for the
duration of the option agreement we will have the exclusive opportunity to in-license from Novellus on a worldwide basis, a novel
cellular therapy for acute respiratory distress syndrome (ARDS). The option exercise period runs for six months, during which
period, if and when we exercise the option, we and Novellus must negotiate a mutually acceptable definitive license agreement.
The option agreement contains the agreed upon financial terms for the license. Novellus also agreed to allow us access to such
records as we deem necessary for our due diligence to determine whether to exercise the option. In April we paid Novellus $100,000
for the option.
Corporate
History and Information
The
Company was founded as Citius Pharmaceuticals, LLC, a Massachusetts limited liability company, on January 23, 2007. On September
12, 2014, Citius Pharmaceuticals, LLC entered into a Share Exchange and Reorganization Agreement, with Citius Pharmaceuticals,
Inc. (formerly Trail One, Inc.), a publicly traded company incorporated under the laws of the State of Nevada. Citius Pharmaceuticals,
LLC became a wholly-owned subsidiary of Citius. On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. as a wholly-owned
subsidiary. LMB was a pharmaceutical company focused on the development and commercialization of critical care products with a
concentration on anti-infectives.
Our
principal executive offices are located at 11 Commerce Drive, First Floor, Cranford, New Jersey 07016 and our telephone number
is (908) 976-6677.
THE
OFFERING
|
Common stock
offered
|
|
7,058,824 shares
|
|
|
|
|
|
Offering price
|
|
$1.0625
|
|
|
|
|
|
Common stock
to be outstanding after this offering (1)
|
|
45,186,886 shares
|
|
|
|
|
|
Concurrent private
placement
|
|
Unregistered
Warrants to purchase up to 3,529,412 shares of common stock at an exercise price of $1.00 which are immediately exercisable with
a term of five and one-half years after the initial exercise date.
|
|
|
|
|
|
Use of proceeds
|
|
We estimate that
the net proceeds from this offering, after deducting the placement agent fees and estimated offering expenses, will be approximately
$6,820,000, which excludes the proceeds, if any, from the exercise of the Warrants offered in the concurrent private placement.
We intend to use the net proceeds for general corporate purposes, including our Phase 3 clinical Mino-Lok® trial for the
treatment of catheter related bloodstream infections, development of Mino-Wrap and our Phase 2b trial of Halo-Lido cream for
the treatment of hemorrhoids and working capital and capital expenditures. See “Use of Proceeds” on page S-12
of this prospectus supplement.
|
|
|
|
|
|
Risk factors
|
|
Your investment
in shares of our common stock involves substantial risks. You should read “Risk Factors” on page S-10 of this
prospectus supplement and in the documents incorporated by reference in this prospectus supplement for a discussion of factors
to consider before deciding to purchase shares of our common stock.
|
|
|
|
|
|
Nasdaq Capital
Market symbol
|
|
“CTXR”
|
|
|
(1)
|
The
number of shares of our common stock that will be issued and outstanding immediately after this offering as shown above is based
on 38,078,062 shares of common stock issued and outstanding as of March 31, 2020 and excludes as of that date:
|
|
|
●
|
warrants
for 23,501,050 shares of our common stock, with a weighted average exercise price of
$1.675 per share;
|
|
|
●
|
options
to purchase an aggregate of 2,751,838 shares of our common stock issued to our officers,
directors and non-employee consultants under our 2014 and 2018 Stock Incentive Plans,
with a weighted average exercise price of $2.831 per share;
|
|
|
●
|
100,667
shares of common stock and warrants to purchase 100,667 shares of common stock, at an
exercise price of $9.00 per share, each issued or issuable pursuant to certain units,
in the form of a unit purchase option agreement, with a price of $9.00 per unit;
|
|
|
●
|
3,110,000
shares of common stock available for future grants under our 2020 Stock Incentive Plan;
|
|
|
●
|
3,529,412
shares of our common stock issuable upon the exercise of the Warrants offered in the
concurrent private placement, with an exercise price of $1.00 per share; and
|
|
|
●
|
494,118
shares of our common stock issuable upon the exercise of warrants offered as compensation
to H.C. Wainwright & Co., LLC, which represent 7.0% of the aggregate number of shares
placed in this offering, with an exercise price of $1.3281 per share.
|
Except
as otherwise indicated, all information included or incorporated by reference in this prospectus supplement assumes no
exercise of the outstanding options and warrants described above or the Warrants offered in the concurrent private placement
or the warrants to be issued to our placement agent as compensation in connection with this offering.
RISK
FACTORS
Investing
in our shares of common stock involves a high degree of risk. You should carefully consider and evaluate all of the
information contained in this prospectus supplement, the accompany prospectus and in the documents we incorporate by
reference into this prospectus supplement and accompanying prospectus before you decide to purchase our shares of common
stock pursuant to this prospectus supplement. In particular, you should carefully consider and evaluate the risks and
uncertainties described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year
ended September 30, 2019 and in our Quarterly Report on Form 10-Q for the quarter ended March 31. 2020. Any of the risks and
uncertainties set forth in that report, as updated by annual, quarterly and other reports and documents that we file with the
SEC and incorporate by reference into this prospectus supplement, or the accompanying prospectus, could materially and
adversely affect our business, results of operations and financial condition, which in turn could materially and adversely
affect the value of any securities offered by this prospectus supplement. As a result, you could lose all or part of your
investment.
Risk
Related to this Offering
We
may be required to raise additional financing by issuing new securities with terms or rights superior to those of our existing
securityholders, which could adversely affect the market price of shares of our common stock and our business.
We
will require additional financing to fund future operations, including our research and development activities and any possible
sales and marketing activities. We may not be able to obtain financing on favorable terms, if at all. If we raise additional funds
by issuing equity securities, the percentage ownership of our current stockholders will be reduced, and the holders of the new
equity securities may have rights superior to those of our existing securityholders, which could adversely affect the market price
of our common stock and the voting power of shares of our common stock. If we raise additional funds by issuing debt securities,
the holders of these debt securities would similarly have some rights senior to those of our existing securityholders, and the
terms of these debt securities could impose restrictions on operations and create a significant interest expense for us which
could have a materially adverse effect on our business.
Issuances
of shares of our common stock or securities convertible into or exercisable for shares of our common stock following this offering,
as well as the exercise of outstanding options and warrants, will dilute your ownership interests and may adversely affect the
future market price of our common stock.
The
issuance of additional shares of our common stock or securities convertible into or exchangeable for our common stock could be
dilutive to stockholders if they do not invest in future offerings. We intend to use the net proceeds from this offering for the
continued clinical development of our product candidates, Mino-Lok®, Mino-Wrap and Halo-Lido, and for other general corporate
purposes, which may include working capital, research and development expenditures, the funding of in-licensing agreements for
product candidates, additional technologies or other forms of intellectual property, expenditures relating to manufacturing infrastructure
and other capital expenditures and general and administrative expenses. We may seek additional capital through a combination of
private and public equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements, which may
cause your ownership interest to be diluted.
In
addition, we have a substantial number of options and warrants to purchase shares of our common stock outstanding, which will
be significantly increased by the number of Warrants issued in the concurrent private placement. If these securities are converted
or exercised, you may incur further dilution. Moreover, to the extent that we issue in the future more options or warrants to
purchase shares of our common stock, or other securities convertible into or exchangeable for shares of our common stock such
as convertible notes or convertible preferred stock, and those options, warrants or other securities are exercised, converted
or exchanged, stockholders may experience further dilution.
You
will experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase.
The
offering price per share of our common stock being offered is substantially higher than the net tangible book value per share
of our outstanding common stock. As a result, the investors purchasing shares of our common stock in this offering will incur
immediate dilution of $(0.8817) per share, after giving effect to the sale of an aggregate of 7,058,824 shares of our common
stock at an offering price of $1.06250 per share, and after deducting the placement agent fees and estimated offering
expenses payable by us. See “Dilution” on page S-14 of this prospectus supplement for a more detailed discussion
of the dilution you will incur if you purchase shares in this offering.
A
substantial number of shares of our common stock may be sold in this offering, which could cause the price of our common stock
to decline.
In
this offering we are selling 7,058,824 shares of common stock, which represents approximately18.5% of our outstanding common stock
as of May 13, 2020, after giving effect to the sale of the shares of common stock in this offering. In addition, the investors
in this offering will receive unregistered Warrants in a concurrent private placement to purchase up to 3,529,412 shares of common
stock which represent 50% of the number of shares purchased in this offering and the placement agent will receive unregistered
warrants to purchase up to 7.0% of the aggregate number of shares of common stock sold in this offering (494,118 shares). This
sale and any future sales of a substantial number of shares of our common stock in the public market, or the perception that such
sales may occur, could adversely affect the price of our common stock on the Nasdaq Capital Market. We cannot predict the effect,
if any, that market sales of those shares of common stock or the availability of those shares of common stock for sale will have
on the market price of our common stock.
Our
management will have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
Our
management will have broad discretion in the application of the net proceeds from this offering, and our stockholders will not
have the opportunity as part of their investment decision to assess whether the net proceeds are being used appropriately. Because
of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use
may vary substantially from their currently intended use. The failure by our management to apply these funds effectively could
harm our business. See “Use of Proceeds” on page S-12 of this prospectus supplement for a description of our proposed
use of proceeds from this offering.
The
COVID-19 pandemic may materially and adversely affect our clinical trial operations and our financial results.
The COVID-19
pandemic has adversely impacted hospitals and medical facilities where we are currently conducting our Mino-Lok phase 3 trial.
The full extent to which COVID-19 may impact this trial is not known at this time, but it has slowed the estimated completion
date for the trial, which we now expect to be in the September 2021 through December 2021 timeframe. The exact duration of
the delay and any other impact will depend on future developments, which are highly uncertain and cannot be predicted with
confidence, such as the duration of the outbreak, the severity of COVID-19, or the effectiveness of actions to contain and
treat for COVID-19. The continued spread of COVID-19 also could adversely impact our ability to recruit and retain patients
and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, which could
further negatively impact the Mino-Lok trial. In addition, if the FDA elects to delay face-to-face meetings for an extended
period of time due to COVID-19, it could have a material adverse effect on our Mino-Lok trial and our other product candidates.
Any or all of these events could increase our operating expenses and the length of time to complete the trial and have a material
adverse effect on our financial results.
USE
OF PROCEEDS
We
estimate that the proceeds from this offering will be approximately $6,820,000, after deducting the placement agent fees and estimated
offering expenses payable by us and excluding any proceeds we may receive upon exercise of the Warrants being offered in the concurrent
private placement.
We
intend to use the net proceeds from the sale of our securities by us under this prospectus supplement for general corporate purposes,
including our Phase 3 clinical Mino-Lok® trial for the treatment of catheter related bloodstream infections, development of
Mino-Wrap and our Phase 2b trial of Halo-Lido cream for the treatment of hemorrhoids and working capital and capital expenditures.
DIVIDEND
POLICY
We
have never declared dividends on our equity securities, and currently do not plan to declare dividends on shares of our common
stock in the foreseeable future. We expect to retain our future earnings, if any, for use in the operation and expansion of our
business. The payment of cash dividends in the future, if any, will be at the discretion of our Board of Directors and will depend
upon such factors as earnings levels, capital requirements, our overall financial condition and any other factors deemed relevant
by our Board of Directors.
PRIVATE
PLACEMENT OF WARRANTS
Concurrently
with the closing of the sale of shares of common stock in this offering, we also expect to issue and sell to the investors,
Warrants to purchase up to an aggregate of 3,529,412 shares of our common stock, at an exercise price equal to $1.00 per
share.
Each
Warrant will be initially exercisable on the issuance date and have a term of exercise equal to five and one-half years from the
initial exercise date. Subject to limited exceptions, a holder of Warrants will not have the right to exercise any portion of
its Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99%, or 9.99% at the investor’s
election, of the number of shares of our common stock outstanding immediately after giving effect to such exercise, provided that
the holder may increase or decrease the beneficial ownership limitation up to 9.99%, provided, further, that any increase in the
beneficial ownership limitation shall not be effective until 61 days following notice of such change to the Company.
In
the event of a Fundamental Transaction (as defined in the Warrant), we or any successor entity shall, at the holder’s option,
purchase the holder’s Warrants for an amount of cash equal to the value of the Warrants as determined in accordance with
the Black Scholes option pricing model, provided that if the Fundamental Transaction is not within our control, including not
approved by our Board of Directors or the consideration is not in all stock of the successor entity, a holder shall only be entitled
to receive the same type or form of consideration at the Black Scholes Value (as defined in the Warrant) of the unexercised portion
of the Warrant, that is being offered and paid to the holders of our common stock in connection with the Fundamental Transaction.
The
Warrants will be issued and sold without registration under the Securities Act, or state securities laws, in reliance on the exemptions
provided by Section 4(a)(2) of the Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under
applicable state laws. Accordingly, the investors may exercise those Warrants and sell the underlying shares of common stock only
pursuant to an effective registration statement under the Securities Act covering the resale of those shares, an exemption under
Rule 144 under the Securities Act or another applicable exemption under the Securities Act.
DILUTION
If
you invest in our common stock and Warrants, you will experience dilution to the extent of the difference between the
offering price per share (attributing no value to the Warrants sold in the concurrent private placement) and the net tangible book
value per share of our common stock immediately after this offering.
Our
net tangible book value on March 31, 2020 was $1,338,189 or $0.0351 per share of our common stock. “Net tangible book value”
is total assets minus the sum of liabilities and intangible assets. “Net tangible book value per share” is net tangible
book value divided by the total number of shares outstanding. Dilution in net tangible book value per share represents the difference
between the amount per share paid by purchasers of shares of common stock in this offering and the net tangible book value per
share of our common stock immediately after this offering. For purposes of this calculation, the shares of our common stock issuable
upon exercise of the Warrants have not been included.
After
giving effect to the sale of 7,058,824 shares of our common stock in this offering at the offering price of $1.0625 per share,
and after deducting the placement agent’s fees and estimated offering expenses payable by us, and excluding the proceeds,
if any, from the exercise of Warrants offered in the concurrent private placement, our as adjusted net tangible book value as
of March 31, 2020, would have been approximately $8,160,289, or $0.1808 per share. This represents an immediate increase in net
tangible book value of $0.1456 per share to existing stockholders and immediate dilution in net tangible book value of $(0.8817)
per share to new investors purchasing our common stock in this offering at the offering price. The following table illustrates
this dilution on a per share basis:
|
Offering price per share of common stock
|
|
|
|
|
|
$
|
1.0625
|
|
|
Net tangible book value per share as of March 31, 2020
|
|
$
|
0.0351
|
|
|
|
|
|
|
Increase in net tangible book value per share attributable to new investors
|
|
$
|
0.1456
|
|
|
|
|
|
|
As adjusted net tangible book value per share as of March 31, 2020 after giving effect to this offering
|
|
|
|
|
|
$
|
0.1808
|
|
|
Dilution in net tangible book value per share to investors in this offering
|
|
|
|
|
|
$
|
0.8817
|
|
The
above discussion and table are based on 38,078,062 shares of our common stock outstanding as of March 31, 2020 and excludes as
of that date:
|
|
●
|
warrants
for 23,501,050 shares of our common stock with a weighted average exercise price of $1.675
per share;
|
|
|
●
|
options
to purchase an aggregate of 2,751,838 shares of our common stock issued to our officers,
directors and non-employee consultants under our 2014 and 2018 Incentive Stock Plans,
with a weighted average exercise price of $2.831 per share;
|
|
|
●
|
100,667
shares of common stock and warrants to purchase 100,667 shares of common stock, at an
exercise price of $9.00 per share, each issued or issuable pursuant to certain units,
in the form of a unit purchase option agreement, with a price of $9.00 per unit; and
|
|
|
●
|
3,110,000
shares of common stock available for future grants under our 2020 Stock Incentive Plan.
|
Because
there is no minimum offering amount required as a condition to the closing of this offering, the dilution per share to the new
investors may be more than that indicated above in the event that the actual number of shares sold, if any, is less than the maximum
number of shares of our common stock we are offering.
The
above illustration of dilution per share to the investors participating in this offering assumes no exercise of outstanding options
to purchase our common stock or warrants to purchase shares of our common stock that will be outstanding after this offering.
The exercise of outstanding options and warrants that will be outstanding after this offering having an exercise price less than
the offering price will increase dilution to the new investors.
Investors
that acquire additional shares of common stock through the exercise of the Warrants offered in the concurrent private placement
may experience additional dilution depending on our net tangible book value at the time of exercise.
PLAN
OF DISTRIBUTION
Pursuant
to an engagement letter agreement dated February 14, 2020, we have engaged H.C. Wainwright & Co., LLC, or Wainwright or
the placement agent, to act as our exclusive placement agent in connection with this offering of our shares of common stock
pursuant to this prospectus supplement and accompanying prospectus and Warrants in a concurrent private placement. Under the
terms of the engagement agreement, the placement agent has agreed to be our exclusive placement agent, on a reasonable best
efforts basis, in connection with the issuance and sale by us of our shares of common stock in this takedown from our shelf
registration statement and Warrants in a concurrent private placement. The terms of this offering were subject to market
conditions and negotiations between us, the placement agent and prospective investors. The engagement agreement does not give
rise to any commitment by the placement agent to purchase any of our shares of common stock or Warrants, and the placement
agent will have no authority to bind us by virtue of the engagement agreement. Further, the placement agent does not
guarantee that it will be able to raise new capital in any prospective offering. The placement agent may engage sub-agents or
selected dealers to assist with the offering. We will enter into securities purchase agreements directly with investors who
purchase shares of common stock in this offering. We will only sell to such investors who have entered into the securities
purchase agreement with us.
We
expect to deliver the shares of our common stock being offered pursuant to this prospectus supplement and accompanying prospectus
on or about May 18, 2020.
We
have agreed to pay the placement agent a total cash fee equal to 7.0% of the gross proceeds of this offering. We will also
pay the placement agent $85,000 for non-accountable expenses and clearing expense in the amount of $12,900. We estimate the
total expenses payable by us for this offering will be approximately $153,000, which amount excludes the placement
agent’s fees. In addition, we have agreed to issue to the placement agent or its designees warrants to purchase up to
7.0% of the aggregate number of shares of common stock sold in this offering (or up to 494,118 shares). The placement agent
warrants will have substantially the same terms as the Warrants issued to the investors in the concurrent private placement,
except that the placement agent warrants will have an exercise price equal to $1.3281 or 125% of the offering price per share
and will be exercisable for five years from the date of the effective date of this offering. Pursuant to FINRA Rule 5110(g),
the placement agent warrants and any shares issued upon exercise of the placement agent warrants shall not be sold,
transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put or call
transaction that would result in the effective economic disposition of the securities by any person for a period of 180 days
immediately following the date of effectiveness or commencement of sales of this offering, except the transfer of any
security: (i) by operation of law or by reason of our reorganization; (ii) to any FINRA member firm participating in the
offering and the officers or partners thereof, if all securities so transferred remain subject to the lock-up restriction set
forth above for the remainder of the time period; (iii) if the aggregate amount of our securities held by the placement agent
or related persons do not exceed 1% of the securities being offered; (iv) that is beneficially owned on a pro-rata basis by
all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by
the fund and the participating members in the aggregate do not own more than 10% of the equity in the fund; or (v) the
exercise or conversion of any security, if all securities remain subject to the lock-up restriction set forth above for the
remainder of the time period.
We
have granted the placement agent a 12-month right of first refusal to act as our exclusive underwriter or placement agent for
any further capital raising transactions undertaken by us and for any acquisition or disposition of assets or any merger or other
business combination or any financing or refinancing of debt.
We
also have granted the placement agent a tail cash fee equal to 7.0% of the gross proceeds and warrants to purchase shares of common
stock equal to 7.0% of the aggregate number of shares of common stock sold in any offering, within 12 months of August 14, 2020,
to investors whom the placement agent contacted or introduced to us directly or indirectly in connection with this offering.
We
have agreed to indemnify the placement agent and specified other persons against certain liabilities relating to or arising out
of the placement agent’s activities under the placement agency agreement and to contribute to payments that the placement
agent may be required to make in respect of such liabilities.
The
placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions
received by it and any profit realized on the resale of the securities sold by it while acting as principal might be deemed to
be underwriting discounts or commissions under the Securities Act. As an underwriter, the placement agent would be required to
comply with the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the
Securities Act and Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases
and sales of shares of common stock and Warrants by the placement agent acting as principal. Under these rules and regulations,
the placement agent:
|
|
●
|
may
not engage in any stabilization activity in connection with our securities; and
|
|
|
●
|
may
not bid for or purchase any of our securities or attempt to induce any person to purchase
any of our securities, other than as permitted under the Exchange Act, until it has completed
its participation in the distribution.
|
From
time to time, the placement agent may provide in the future various advisory, investment and commercial banking and other services
to us in the ordinary course of business, for which they have received and may continue to receive customary fees and commissions.
However, except as disclosed in this prospectus supplement, we have no present arrangements with the placement agent for any further
services. H.C. Wainwright & Co., LLC acted as our exclusive placement agent in connection with a warrant exchange offering
we consummated in February 2020, as sole book-running manager in connection our underwritten public offering we consummated in
September 2019, as sole book-running manager in connection our underwritten public offering we consummated in August 2018 and
as our exclusive placement agent in connection with our registered direct offering we consummated in March 2018, in each case
for which it received compensation.
LEGAL
MATTERS
The
validity of the shares of common stock being offered hereby have been passed upon by Wyrick Robbins Yates & Ponton LLP, Raleigh,
North Carolina.
EXPERTS
The
financial statements of Citius Pharmaceuticals, Inc. appearing in its Annual Report on Form 10-K for the fiscal year ended September
30, 2019, have been incorporated herein by reference in reliance on the report of Wolf & Company, P.C., independent registered
public accounting firm, given upon the authority of such firm as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
have filed a registration statement on Form S-3 with the SEC for the securities we are offering by this prospectus supplement.
This prospectus supplement does not include all of the information contained in the registration statement. You should refer to
the registration statement and its exhibits for additional information. We will provide to each person, including any beneficial
owner, to whom a prospectus supplement is delivered, a copy of any or all of the information that has been incorporated by reference
in this prospectus supplement but not delivered with this prospectus supplement. We will provide this information upon oral
or written request, free of charge. Any requests for this information should be made by calling or sending a letter to the
Secretary of the Company, c/o Citius Pharmaceuticals, Inc., at our office located at 11 Commerce Drive, 1st Floor,
Cranford, NJ 07016.
We
are required to file annual and quarterly reports, current reports, proxy statements and other information with the SEC. We make
these documents publicly available, free of charge, on our website at www.citiuspharma.com as soon as reasonably practicable after
filing such documents with the SEC. You can read our SEC filings, including the registration statement, on the SEC’s website
at http://www.sec.gov.
INCORPORATION
OF DOCUMENTS BY REFERENCE
The
SEC allows us to “incorporate by reference” information that we file with them. Incorporation by reference allows
us to disclose important information to you by referring you to those other documents. The information incorporated by reference
is an important part of this prospectus supplement and the accompanying prospectus, and information that we file later with the
SEC will automatically update and supersede this information. We filed a registration statement on Form S-3 under the Securities
Act of 1933, as amended, with the SEC with respect to the securities being offered pursuant to this prospectus supplement and
the accompanying prospectus. This prospectus supplement and the accompanying prospectus omit certain information contained in
the registration statement, as permitted by the SEC. You should refer to the registration statement, including the exhibits, for
further information about us and the securities being offered pursuant to this prospectus supplement and the accompanying prospectus.
Statements in this prospectus supplement and the accompanying prospectus regarding the provisions of certain documents filed with,
or incorporated by reference in, the registration statement are not necessarily complete, and reference is made to the actual
documents for complete information. Copies of all or any part of the registration statement, including the documents incorporated
by reference or the exhibits, may be obtained upon payment of the prescribed rates at the offices of the SEC listed above in “Where
You Can Find Additional Information.” The documents we are incorporating by reference into this prospectus supplement are:
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the
description of our common stock contained in our Registration Statement on Form 8-A,
filed on July 28, 2017;
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our
Annual Report on Form 10-K for the fiscal year ended September 30, 2019, filed with
the SEC pursuant to Section 13 of the Exchange Act on December 16, 2019;
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our
Quarterly Report on Form 10-Q for the quarter ended December 31, 2019, filed with the
SEC pursuant to Section 13 of the Exchange Act on February 13, 2020;
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our
Current Reports on Form 8-K, filed with the SEC pursuant to Section 13 of the Exchange
Act on October 7, November 1, November 5 and December 19, 2019, and January 22, February 3, February 4, February 10, February 14, February 19, February 25, April 1, April 7,
April 28, April 29, and May 12, 2020; and
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our
definitive proxy statement on Schedule 14A for the annual meeting of stockholders held
on February 12, 2020, filed with the SEC pursuant to Section 14 of the Exchange Act on
December 20, 2019.
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In
addition, all documents subsequently filed by us pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act of 1934, as amended, before the date our offering is terminated or completed are deemed to be incorporated by reference into,
and to be a part of, this prospectus supplement.
Any
statement contained in this prospectus supplement and the accompanying prospectus or in a document incorporated or deemed to be
incorporated by reference into this prospectus supplement and the accompanying prospectus will be deemed to be modified or superseded
for purposes of this prospectus supplement and the accompanying prospectus to the extent that a statement contained in this prospectus
supplement and the accompanying prospectus or any other subsequently filed document that is deemed to be incorporated by reference
into this prospectus supplement and the accompanying prospectus modifies or supersedes the statement. Any statement so modified
or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement and
the accompanying prospectus.
We
will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference,
including exhibits to these documents. You should direct any requests for documents to Citius Pharmaceuticals, Inc., Attention:
Secretary, 11 Commerce Drive, 1st Floor, Cranford, New Jersey 07016, (908) 967-6677.
You
should rely only on information contained in, or incorporated by reference into, this prospectus supplement and the accompanying
prospectus. We have not authorized anyone to provide you with information different from that contained in this prospectus supplement
and the accompanying prospectus or incorporated by reference in this prospectus supplement and the accompanying 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.
Prospectus
$50,000,000
Common
Stock
Preferred
Stock
Warrants
Units
We
may offer and sell from time to time common stock, preferred stock and warrants to purchase common stock or preferred stock, in
one or more transactions. We may also offer and sell from time to time, in one or more transactions, such securities as may be
issuable upon the conversion, exercise or exchange of preferred stock or warrants. Any securities registered hereunder may be
sold separately or as units with the other securities registered hereunder.
This
prospectus provides you with a description of our common stock and a general description of the other securities we may offer.
A prospectus supplement containing specific information about the terms of the securities being offered and the offering, including
the compensation of any underwriter, agent or dealer, will accompany this prospectus to the extent required. Any prospectus supplement
may also add, update or change information contained in this prospectus. If information in any prospectus supplement is inconsistent
with the information in this prospectus, then the information in that prospectus supplement will apply and will supersede the
information in this prospectus. You should carefully read both this prospectus and any prospectus supplement, together with additional
information described in “Where You Can Find More Information” and “Incorporation of Certain Information by
Reference,” before you invest in our securities.
Investing
in our securities involves a high degree of risk. See “Risk Factors” beginning on page 5 of this prospectus,
in any accompanying prospectus supplement and in the documents incorporated by reference into this prospectus, to read about factors
you should consider before investing in our securities.
Our
common stock is listed on the Nasdaq Capital Market under the symbol “CTXR”.
Neither
the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed
upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is December 15, 2017
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a Registration Statement on Form S-3 that we filed with the Securities and Exchange Commission, or the SEC,
using a “shelf” registration process or continuous offering process. By using a shelf registration statement, we may
from time to time, sell common stock, preferred stock and warrants to purchase common stock or preferred stock in one or more
offerings. Each time that we sell securities under this Registration Statement, we will provide a prospectus supplement that will
contain specific information about the terms of that offering. A prospectus supplement may also add, update or change information
contained in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus
and an applicable prospectus supplement, you should rely on the prospectus supplement. Before purchasing any securities, you should
carefully read both this prospectus and any applicable prospectus supplement or free writing prospectus we file with the SEC,
together with the additional information described under the headings “Where You Can Find More Information” and “Incorporation
of Documents by Reference”.
The
rules of the SEC allow us to incorporate by reference information into this prospectus. This means that important information
is contained in other documents that are considered to be a part of this prospectus. Additionally, information that we file later
with the SEC will automatically update and supersede this information. You should carefully read both this prospectus and the
applicable prospectus supplement together with the additional information that is incorporated or deemed incorporated by reference
in this prospectus. See “Incorporation of Documents by Reference” before making an investment in our common stock.
This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is
made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.
Copies of the documents referred to herein have been filed or will be filed or incorporated by reference as exhibits to the Registration
Statement of which this prospectus is a part. The Registration Statement, including the exhibits and documents incorporated or
deemed incorporated by reference in this prospectus, can be read on the SEC website or at the SEC offices mentioned under the
heading “Where You Can Find More Information”.
THIS
PROSPECTUS MAY NOT BE USED TO SELL ANY SHARES OF OUR COMMON STOCK UNLESS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
Neither
the delivery of this prospectus or any applicable prospectus supplement nor any sale made using this prospectus or any applicable
prospectus supplement implies that there has been no change in our affairs or that the information in this prospectus or in any
applicable prospectus supplement is correct as of any date after their respective dates. You should not assume that the information
included in or incorporated by reference in this prospectus or any applicable prospectus supplement or any free writing prospectus
prepared by us, is accurate as of any date other than the date(s) on the front covers of those documents. Our business, financial
condition, results of operations and prospects may have changed since those dates.
You
should rely only on the information contained in or incorporated by reference in this prospectus or a prospectus supplement. We
have not authorized anyone to give you different information, and if you are given any information that is not contained or incorporated
by reference in this prospectus or a prospectus supplement, you must not rely on that information. We are not making an offer
to sell securities in any jurisdiction where the offer or sale of such securities is not permitted.
We
have filed or incorporated by reference exhibits to the Registration Statement of which this prospectus is a part. You should
read the exhibits carefully for provisions that may be important to you.
Unless
the context otherwise requires, we use the terms “Citius”, “the Company”, “our company”, “we”,
“us”, and “our” in this prospectus to refer to the consolidated operations of Citius Pharmaceuticals,
Inc. and its consolidated subsidiaries as a whole.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
prospectus contains forward-looking statements that are based on our management’s belief and assumptions and on information
currently available to our management. Although we believe that the expectations reflected in these forward-looking statements
are reasonable, these statements 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 be materially
different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking
statements. Forward-looking statements in this prospectus include, but are not limited to, statements about:
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the
commercial success and market acceptance of any of our products and product candidates that are approved for marketing in
the United States or other countries;
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the
accuracy of our estimates of the size and characteristics of the markets that may be addressed by our products and product
candidates;
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our
ability to manufacture sufficient amounts of our product candidates for clinical trials and our products for commercialization
activities;
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our
need for, and ability to raise, additional capital;
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the
number, designs, results and timing of our clinical trials;
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the
regulatory review process and any regulatory approvals that may be issued or denied by the FDA or other regulatory agencies;
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our
need to secure collaborators to license, manufacture, market and sell any products for which we receive regulatory approval
in the future;
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our
ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights
of others;
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the
medical benefits, effectiveness and safety of our products and product candidates;
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the
safety and efficacy of medicines or treatments introduced by competitors that are targeted to indications which our products
and product candidates have been developed to treat;
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our
current or prospective collaborators’ compliance or non-compliance with their obligations under our agreements with
them; and
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other
factors discussed elsewhere in this prospectus.
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In
some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,”
“expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology.
These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve
known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially
affect results. Factors that may cause actual results to differ materially from current expectations include, among other things,
those listed under “Risk Factors” and elsewhere in this prospectus. Actual events or results may vary significantly
from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
You should read this prospectus and the documents that we reference in this prospectus and have filed with the Securities and
Exchange Commission as exhibits to this prospectus completely and with the understanding that our actual future results may be
materially different from any future results expressed or implied by these forward-looking statements.
The
forward-looking statements in this prospectus represent our views as of the date of this prospectus. We anticipate that subsequent
events and developments will cause our views to change. However, while we may elect to update these forward-looking statements
at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should
therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this
prospectus.
This
prospectus and the documents incorporated by reference into this prospectus contain “forward-looking statements” that
involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results
to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this prospectus
and the documents incorporated by reference into this prospectus that are not purely historical are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities
Exchange Act of 1934, as amended, or Exchange Act.
This
prospectus, the documents incorporated by reference into this prospectus and the documents that we have filed as exhibits to the
Registration Statement, of which this prospectus is a part, includes statistical and other industry and market data that we obtained
from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party
research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable,
although they do not guarantee the accuracy or completeness of such information. We believe that the data obtained from these
industry publications and third-party research, surveys and studies are reliable. We are ultimately responsible for all disclosure
included in this prospectus.
You
should rely only on the information contained in this prospectus, as supplemented and amended. We have not authorized anyone to
provide you with information that is different. This prospectus may only be used where it is legal to sell these securities. The
information in this prospectus may only be accurate on the date of this prospectus.
In
addition, projections, assumptions, and estimates of our future performance and the future performance of the industry in which
we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described
in “Risk Factors”. These and other factors could cause results to differ materially from those expressed in the estimates
made by the independent parties and by us.
THE
COMPANY
Citius
Pharmaceuticals, Inc., headquartered in Cranford, New Jersey, is a specialty pharmaceutical company dedicated to the development
and commercialization of critical care products targeting important medical needs with a focus on anti-infective products in adjunct
cancer care and unique prescription products. Our goal is to achieve leading market positions by providing therapeutic products
that address unmet medical needs yet have a lower development risk than new chemical entities have. New formulations of previously
approved drugs with substantial safety and efficacy data are a core focus as we seek to reduce development and clinical risks
associated with drug development. Our strategy centers on products that have intellectual property and regulatory exclusivity
protection, while providing competitive advantages over other existing therapeutic approaches.
The
Company was founded as Citius Pharmaceuticals, LLC, a Massachusetts limited liability company, on January 23, 2007. On September
12, 2014, Citius Pharmaceuticals, LLC entered into a Share Exchange and Reorganization Agreement, with Citius Pharmaceuticals,
Inc. (formerly Trail One, Inc.), a publicly traded company incorporated under the laws of the State of Nevada. Citius Pharmaceuticals,
LLC became a wholly-owned subsidiary of Citius. On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. as a wholly-owned
subsidiary. LMB was a pharmaceutical company focused on the development and commercialization of critical care products with a
concentration on anti-infectives.
Since
its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting
management and technical staff, and raising capital. We are developing two proprietary products: Mino-Lok™, an antibiotic
lock solution used to treat patients with catheter-related bloodstream infections by salvaging the infected catheter, and a hydrocortisone-lidocaine
topical formulation that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids.
We believe the markets for our products are large, growing, and underserved by the current prescription products or
procedures.
In
July 2016, the Company decided to discontinue Suprenza, its FDA-approved phentermine-based product for weight loss, due to a strategic
change in direction following the acquisition of LMB and the Mino-Lok product. In September 2016, Citius notified the FDA of its
decision to voluntarily withdraw both the Investigative New Drug Application and New Drug Application for commercial reasons and
not due to safety concerns, effective immediately. The Company had received no royalties from Suprenza and believed costs associated
with the ongoing regulatory expenses were depleting resources from our more promising Mino-Lok and Hydro-Lido product candidates.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. You should consider carefully the risks and uncertainties described in “Risk
Factors” and elsewhere in our most recently filed Annual Report on Form 10-K filed with the SEC, in each case as these risk
factors are amended or supplemented by subsequent Annual Reports on Form 10-K or Quarterly Reports on Form 10-Q that have been
or will be incorporated by reference in this prospectus. The prospectus supplement relating to a particular offering of common
stock may also discuss certain risks of investing in that offering. The occurrence of any of such risks may materially and adversely
affect our business, financial condition, results of operations and future prospects. In such an event, the market price of our
common stock could decline, and you could lose part or all of your investment.
USE
OF PROCEEDS
We
cannot assure you that we will receive any proceeds in connection with securities offered by us pursuant to this prospectus. Unless
otherwise provided in the applicable prospectus supplement, we intend to use the net proceeds from the sale of our securities
by us under this prospectus for general corporate purposes, including clinical trials, research and development expenses, and
general and administrative expenses. We will set forth in the applicable prospectus supplement our intended use for the net proceeds
received from the sale of any securities by us. Pending the application of the net proceeds, we intend to invest the net proceeds
generally in short-term, investment grade, interest-bearing securities.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or
a combination of these methods. We may sell the securities to or through underwriters or dealers, through agents, or directly
to one or more purchasers. We may distribute securities from time to time in one or more transactions:
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a fixed price or prices, which may be changed;
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at
market prices prevailing at the time of sale;
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at
prices related to such prevailing market prices; or
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A
prospectus supplement or supplements (and any related free writing prospectus that we may authorize to be provided to you) will
describe the terms of the offering of the securities, including, to the extent applicable:
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the
name or names of the underwriters, if any;
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the
purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale;
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any
over-allotment options under which underwriters may purchase additional securities from us;
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any
agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation;
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any
public offering price;
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any
discounts or concessions allowed or reallowed or paid to dealers; and
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any
securities exchange or market on which the securities may be listed.
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Only
underwriters named in the prospectus supplement will be underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the securities for their own account and may resell the securities from time
to time in one or more transactions at a fixed public offering price or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through underwriting syndicates represented by managing underwriters or by
underwriters without a syndicate. Subject to certain conditions, the underwriters will be obligated to purchase all of the securities
offered by the prospectus supplement, other than securities covered by any over-allotment option. Any public offering price and
any discounts or concessions allowed or reallowed or paid to dealers may change from time to time. We may use underwriters with
whom we have a material relationship. We will describe in the prospectus supplement, naming the underwriter, the nature of any
such relationship.
We
may sell securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by certain types of institutional investors to purchase securities from
us at the public offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment
and delivery on a specified date in the future. We will describe the conditions to these contracts and the commissions we must
pay for solicitation of these contracts in the prospectus supplement.
We
may provide agents and underwriters with indemnification against civil liabilities, including liabilities under the Securities
Act, or contribution with respect to payments that the agents or underwriters may make with respect to these liabilities. Agents
and underwriters may engage in transactions with, or perform services for, us in the ordinary course of business.
All
securities we may offer, other than common stock, will be new issues of securities with no established trading market. Any underwriters
may make a market in these securities, but will not be obligated to do so and may discontinue any market making at any time without
notice. We cannot guarantee the liquidity of the trading markets for any securities.
Any
underwriter may engage in over-allotment, stabilizing transactions, short-covering transactions and penalty bids in accordance
with Regulation M under the Exchange Act. Over-allotment involves sales in excess of the offering size, which create a short
position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed
a specified maximum price. Syndicate-covering or other short-covering transactions involve purchases of the securities, either
through exercise of the over-allotment option or in the open market after the distribution is completed, to cover short positions.
Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the
dealer are purchased in a stabilizing or covering transaction to cover short positions. Those activities may cause the price of
the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at
any time.
Our
common stock and certain warrants are listed on the NASDAQ Capital Market. To facilitate the offering of securities, certain persons
participating in the offering may engage in transactions that stabilize, maintain or otherwise affect the price of the securities.
This may include over-allotments or short sales of the securities, which involve the sale by persons participating in the offering
of more securities than were sold to them. In these circumstances, these persons would cover such over-allotments or short positions
by making purchases in the open market or by exercising their over-allotment option, if any. In addition, these persons may stabilize
or maintain the price of the securities by bidding for or purchasing securities in the open market or by imposing penalty bids,
whereby selling concessions allowed to dealers participating in the offering may be reclaimed if securities sold by them are repurchased
in connection with stabilization transactions. The effect of these transactions may be to stabilize or maintain the market price
of the securities at a level above that which might otherwise prevail in the open market. These transactions may be discontinued
at any time.
DESCRIPTION
OF OUR CAPITAL STOCK
The
following description summarizes the material terms of Citius capital stock as of the date of this Prospectus. Because it is only
a summary, it does not contain all the information that may be important to you. For a complete description of our capital stock,
you should refer to our certificate of incorporation and our bylaws, and to the provisions of applicable Nevada law.
General
Our
authorized capital stock consists of 200,000,000 shares of Common Stock, par value $0.001, 8,423,391 shares of which are issued
and outstanding as of December 1, 2017, and 10,000,000 shares of preferred stock, none of which are issued and outstanding. Our
preferred stock and/or Common Stock may be issued from time to time without prior approval by our stockholders. Our preferred
stock and/or Common Stock may be issued for such consideration as may be fixed from time to time by our Board of Directors. Our
Board of Directors may issue such shares of our preferred stock and/or Common Stock in one or more series, with such voting powers,
designations, preferences and rights or qualifications, limitations or restrictions thereof as shall be stated in the resolution
or resolutions.
Common
Stock
The
Company, a Nevada corporation, is authorized to issue 200,000,000 shares of Common Stock, $0.001 par value. Each share of Common
Stock shall have one (1) vote per share for all purposes. The holders of a majority of the shares entitled to vote, present in
person or represented by proxy shall constitute a quorum at all meetings of our stockholders. Our Common Stock does not provide
preemptive, subscription or conversion rights and there are no redemption or sinking fund provisions or rights. Our Common Stock
holders are not entitled to cumulative voting for election of the Board of Directors.
Holders
of Common Stock are entitled to receive ratably such dividends as may be declared by the Board of Directors out of funds legally
available therefore as well as any distributions to the security holder. We have never paid cash dividends on our Common Stock,
and do not expect to pay such dividends in the foreseeable future.
In
the event of a liquidation, dissolution or winding up of our company, holders of Common Stock are entitled to share ratably in
all of our assets remaining after payment of liabilities. Holders of Common Stock have no preemptive or other subscription or
conversion rights. There are no redemption or sinking fund provisions applicable to the Common Stock.
Preferred
Stock
Our
Board of Directors is authorized to cause us to issue, from our authorized but unissued shares of preferred stock, one or more
series of preferred stock, to establish from time to time the number of shares to be included in each such series, as well as
to fix the designation and any preferences, conversion and other rights and limitations of such series. These rights and limitations
may include voting powers, limitations as to dividends, and qualifications and terms and conditions of redemption of the shares
of each such series.
Units
In
a private offering commenced in October 2016 (the “2016 Offering”), we sold 128,017 Units, each Unit consisting
of (i) one share of Common Stock and (ii) a Warrant to purchase one share of Common Stock (a “Warrant Share”). Each
Warrant has an exercise price of $8.25 and is exercisable for a period of five years from the date of issuance.
Warrants
Issued as Part of the Units
Each
Warrant issued to investors in the 2016 Offering entitles the registered holder to purchase one share of our Common Stock at a
price of $8.25 per share, with such exercise price to be subject to adjustment as set forth in the warrant agreement. The
Warrants have a five-year term and a cashless exercise if there is no effective registration statement covering the resale of
the shares underlying the warrants. The Warrants are redeemable at the Company’s option provided the shares underlying
the warrants can be sold pursuant to an effective registration statement filed with the SEC, upon the date the Company’s
Common Stock has traded for $30.00 per share for any 17 out of 20 consecutive days and the aggregate trading volume per day during
that period is a minimum of 6,667 shares. The Warrants shall not provide for price or share based adjustments due to dilutive
issuances of equity securities, other than stock splits, cash dividends, or the like.
Options
On
September 12, 2014, our stockholders approved the Company’s 2014 Stock Incentive Plan, which provides for the award of stock
options, stock appreciation rights, restricted stock and other equity awards for up to an aggregate of 866,667 shares of common
stock. The shares of common stock underlying any awards that are forfeited, canceled, reacquired by us prior to vesting, satisfied
without any issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2014 Plan will be added back
to the shares of common stock available for issuance under the 2014 Plan.
As
of September 30, 2017, we had outstanding options to purchase an aggregate of 861,039 shares of our common stock at a weighted
average exercise price of $6.69 per share. Of these, an aggregate of 513,997 are exercisable. The remainder have vesting requirements.
The
2014 Plan is administered by our Board or a committee designated by the Board (as applicable, the Administrator). The Administrator
has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make
any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions
of the 2014 Plan. The Administrator may delegate to our Chief Executive Officer the authority to grant stock options and other
awards to employees who are not subject to the reporting and other provisions of Section 16 of the Exchange Act and not subject
to Section 162(m) of the Code, subject to certain limitations and guidelines.
Persons
eligible to participate in the 2014 Plan are full or part-time officers, employees, non-employee directors, directors and other
key persons (including consultants and prospective officers) of our company and its subsidiaries as selected from time to time
by the Administrator in its discretion.
Warrants
On
August 8, 2017 the Company closed an underwritten public offering of 1,648,484 shares of common stock and warrants to
purchase 1,648,484 shares of common stock at an offering price of $4.125 per share and $0.01 per warrant. In addition, the
Company’s underwriter in that offering, Aegis Capital Corp., exercised its over-allotment to purchase an additional
247,272 warrants for a total of 1,895,753 warrants issued (the “Offering Warrants”). The Company also issued a
representative’s warrant to purchase an aggregate of 65,940 shares of common stock with an exercise price of $4.5375
(the “Bankers Warrants”).
Exercisability.
The Offering Warrants are exercisable at any time after August 8, 2017, and up to August 8, 2022, with all Bankers Warrants
exercisable at any time after February 2, 2018 until August 2, 2022. 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 or round up to
the next whole share.
Exercise
Limitation. 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% upon at least 61 days’ prior notice
from the holder to us.
Exercise
Price. The exercise price per whole share of common stock purchasable upon exercise of the warrants is expected to be
$4.125 per share, which is equal to 100% of public offering price of common stock at a public offering price of $4.125 share).
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 shareholders.
Transferability.
Subject to applicable laws, the warrants may be offered for sale, sold, transferred or assigned without our consent.
Fundamental
Transactions. 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.
Listing
The
shares of our Common Stock were previously quoted on the OTCQB under the symbol “CTXR.” Our common stock and warrants
are listed on Nasdaq Capital Market under the symbols “CTXR” and “CTXRW”, respectively.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock and warrants is VStock Transfer, LLC. The transfer agent’s address is
18 Lafayette Place, Woodmere, New York 11598 and its telephone number is (212) 828-8436.
Nevada’s
Anti-Takeover Law and Provisions of Our Articles of Incorporation and Bylaws
Acquisition
of Controlling Interest Statutes. Nevada’s “acquisition of controlling interest” statutes
contain provisions governing the acquisition of a controlling interest in certain Nevada corporations. These
“control share” laws provide generally that any person that acquires a “controlling interest” in
certain Nevada corporations may be denied certain voting rights, unless a majority of the disinterested stockholders of the
corporation elects to restore such voting rights. These statutes provide that a person acquires a “controlling
interest” whenever a person acquires shares of a subject corporation that, but for the application of these provisions
of the Nevada Revised Statutes, would enable that person to exercise (1) one-fifth or more, but less than one-third, (2)
one-third or more, but less than a majority or (3) a majority or more, of all of the voting power of the corporation in the
election of directors. Once an acquirer crosses one of these thresholds, shares which it acquired in the transaction taking
it over the threshold and within the 90 days immediately preceding the date when the acquiring person acquired or offered to
acquire a controlling interest become “control shares” to which the voting restrictions described above apply.
Our articles of incorporation and bylaws currently contain no provisions relating to these statutes, and unless our articles
of incorporation or bylaws in effect on the tenth day after the acquisition of a controlling interest were to provide
otherwise, these laws would apply to us if we were to (i) have 200 or more stockholders of record (at least 100 of which have
addresses in the State of Nevada appearing on our stock ledger) and (ii) do business in the State of Nevada directly or
through an affiliated corporation. As of December 1, 2017, we have 115 record stockholders and do not have 100 stockholders
of record with Nevada addresses appearing on our stock ledger. If these laws were to apply to us, they might discourage
companies or persons interested in acquiring a significant interest in or control of the Company, regardless of whether such
acquisition may be in the interest of our stockholders.
Combination
with Interested Stockholders Statutes. Nevada’s “combinations with interested stockholders” statutes prohibit
certain business “combinations” between certain Nevada corporations and any person deemed to be an “interested
stockholder” for two years after such person first becomes an “interested stockholder” unless (i) the corporation’s
Board of Directors approves the combination (or the transaction by which such person becomes an “interested stockholder”)
in advance, or (ii) the combination is approved by the Board of Directors and sixty percent of the corporation’s voting
power not beneficially owned by the interested stockholder, its affiliates and associates. Furthermore, in the absence of prior
approval certain restrictions may apply even after such two-year period. For purposes of these statutes, an “interested
stockholder” is any person who is (x) the beneficial owner, directly or indirectly, of ten percent or more of the voting
power of the outstanding voting shares of the corporation, or (y) an affiliate or associate of the corporation and at any time
within the two previous years was the beneficial owner, directly or indirectly, of ten percent or more of the voting power of
the then outstanding shares of the corporation. The definition of the term “combination” is sufficiently broad to
cover most significant transactions between the corporation and an “interested stockholder”. Subject to certain timing
requirements set forth in the statutes, a corporation may elect not to be governed by these statutes. We have not included any
such provision in our articles of incorporation.
The
effect of these statutes may be to potentially discourage parties interested in taking control of the Company from doing so if
it cannot obtain the approval of our Board of Directors
Articles
of Incorporation and Bylaws. Provisions of our certificate of incorporation and bylaws may delay or discourage transactions
involving an actual or potential change of control or change in our management, including transactions in which stockholders might
otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests.
Therefore, these provisions could adversely affect the price of our common stock. Among other things, these provisions include:
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the
authorization of 10,000,000 shares of “blank check” preferred stock, the rights, preferences and privileges of
which may be established and shares of which may be issued by our Board of Directors at its discretion from time to time and
without stockholder approval;
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limiting
the removal of directors by the stockholders;
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allowing
for the creation of a staggered Board of Directors;
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eliminating
the ability of stockholders to call a special meeting of stockholders; and
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establishing
advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted
upon at stockholder meetings.
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DESCRIPTION
OF WARRANTS
We
may issue warrants for the purchase of common stock or preferred stock. Warrants may be issued independently or together with
other securities and may be attached to or separate from any offered securities. We may issue the warrants directly or under warrant
agreements to be entered into between a warrant agent and us. Any warrant agent will act solely as our agent in connection with
the warrants and will not have any obligation or relationship of agency or trust for or with any holders or beneficial owners
of warrants.
The
following outlines some of the general terms and provisions of the warrants that we may issue. A prospectus supplement will describe
the particular terms of any warrants offered from time to time, and may supplement or change the terms outlined below. We will
file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from reports
that we file with the SEC, a form of the warrant or form of the warrant agreement and warrant certificate that sets forth the
terms of the particular warrants we are offering. The summary of such terms contained in this prospectus and in the applicable
prospectus supplement is qualified in its entirety by reference to such warrant or warrant agreement and warrant certificate.
We urge you to read the warrant or warrant agreement and warrant certificate and the additional description of the terms of the
warrants included in the prospectus supplement.
General
The
prospectus supplement relating to a particular issue of warrants will describe the terms of the warrants, including the following:
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the
title of the warrants;
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the
offering price for the warrants, if any;
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the
aggregate number of the warrants;
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the
designation and terms of the common stock, preferred stock or other class of security that may be purchased upon exercise
of the warrants;
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if
applicable, the date from and after which the warrants and any securities issued with the warrants will be separately transferable;
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the
number of shares and price of common stock or preferred stock that may be purchased upon exercise of a warrant;
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the
dates on which the right to exercise the warrants commence and expire;
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if
applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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if
applicable, a discussion of material U.S. federal income tax considerations;
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anti-dilution
provisions of the warrants, if any;
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redemption
or call provisions, if any, applicable to the warrants; and
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any
additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the
warrants.
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Exercise
of Warrants
Each
warrant will entitle the holder of the warrant to purchase at the exercise price set forth in the applicable prospectus supplement
the principal amount of debt securities or shares of common stock or preferred stock being offered. Holders may exercise warrants
at any time up to the close of business on the expiration date set forth in the applicable prospectus supplement. After the close
of business on the expiration date, unexercised warrants will be void. Holders may exercise warrants as set forth in the prospectus
supplement relating to the warrants being offered.
Until
a holder exercises the warrants to purchase any securities underlying the warrants, the holder will not have any rights as a holder
of the underlying securities by virtue of ownership of warrants.
DESCRIPTION
OF THE UNITS
We
may issue units comprised of one or more of the other classes of securities offered hereby in any combination. Each unit will
be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit
will have the rights and obligations of a holder of each included security.
The
units may be, but are not required to be, issued under unit agreements to be entered into between us and a unit agent, as detailed
in the prospectus supplement relating to the units being offered. We will file as an exhibit to the registration statement of
which this prospectus is a part, or will incorporate by reference from reports that we file with the SEC, a form of the unit agreement
and unit certificate, if any, that sets forth the terms of the particular units we are offering. The summary of such terms contained
in this prospectus and in the applicable prospectus supplement is qualified in its entirety by reference to such unit agreement
and unit certificate. We urge you to read the unit agreement and unit certificate, if any, and the additional description of the
terms of the units included in the prospectus supplement.
The
prospectus supplement will describe the units and the price or prices at which we will offer the units. The description will include:
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the
designation and terms of the units and of the securities comprising the units, including whether and under what circumstances
the securities comprising the units may be held or transferred separately;
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a
description of the terms of any unit agreement governing the units;
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a
description of the provisions for the payment, settlement, transfer or exchange of the units;
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a
discussion of material federal income tax considerations, if applicable; and
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whether
the units if issued as a separate security will be issued in fully registered or global form.
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The
descriptions of the units in this prospectus and in any prospectus supplement are summaries of the material provisions of the
applicable agreements.
LEGAL
MATTERS
The
validity of the securities being offered hereby will be passed upon by Wyrick Robbins Yates & Ponton LLP, Raleigh, North Carolina.
EXPERTS
The
financial statements of Citius Pharmaceuticals, Inc. appearing in the Company’s Annual Report on Form 10-K for the fiscal
year ended September 30, 2017 have been audited by Wolf & Company, P.C., independent registered public accounting firm, as
set forth in their report thereon appearing elsewhere herein, and are included in reliance upon such report given on the authority
of such firm as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and file annual, quarterly and current
reports, proxy statements and other information with the SEC. You can read our SEC filings, including the registration statement,
over the Internet at the SEC’s website at http://www.sec.gov. We also maintain a website at http://www.citiuspharma.com,
at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with,
or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not part of this prospectus.
You
may also read and copy any document we file with the SEC at its public reference facilities at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You may also obtain copies of these documents at prescribed rates by writing to the Public Reference Section
of the SEC at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the
operation of the public reference facilities. You may also request a copy of these filings, at no cost, by writing or telephoning
us at: 11 Commerce Drive, First Floor, Cranford, New Jersey 07016, (908) 967-6677.
INCORPORATION
OF DOCUMENTS BY REFERENCE
The
SEC allows us to “incorporate by reference” information that we file with them. Incorporation by reference allows
us to disclose important information to you by referring you to those other documents. The information incorporated by reference
is an important part of this prospectus and any applicable accompanying prospectus, and information that we file later with the
SEC will automatically update and supersede this information. We filed a registration statement on Form S-3 under the Securities
Act of 1933, as amended, with the SEC with respect to the securities being offered pursuant to this prospectus and any applicable
accompanying prospectus. This prospectus omits certain information contained in the registration statement, as permitted by the
SEC. You should refer to the registration statement, including the exhibits, for further information about us and the securities
being offered pursuant to this prospectus and any applicable accompanying prospectus. Statements in this prospectus and any applicable
accompanying prospectus regarding the provisions of certain documents filed with, or incorporated by reference in, the registration
statement are not necessarily complete and each statement is qualified in all respects by that reference. Copies of all or any
part of the registration statement, including the documents incorporated by reference or the exhibits, may be obtained upon payment
of the prescribed rates at the offices of the SEC listed above in “Where You Can Find More Information.” The documents
we are incorporating by reference into this prospectus are:
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our
Annual Report on Form 10-K for the fiscal year ended September 30, 2017 filed on December 13, 2017;
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our
Quarterly Reports on Form 10-Q for the fiscal quarter ended December 31, 2016 filed February 14, 2017, for the fiscal quarter
ended March 31, 2017 filed on May 15, 2017, and for the fiscal quarter ended June 30, 2017 filed on August 14, 2017;
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our
Current Reports on Form 8-K filed on October 10, 2017, October 24, 2017, October 31, 2017, November 7, 2017, November 7, 2017, November 9, 2017, and December 1, 2017;
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our definitive proxy statement on Schedule 14A, filed on December
13, 2017, for our annual meeting of stockholders scheduled to be held on February 7, 2018;
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the
description of our common stock contained in our registration statement on Form 8-A filed on July 28, 2017; and
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all
of the filings pursuant to the Exchange Act after the date of the filing of the registration statement and prior to the effectiveness
of the registration statement.
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In addition, all documents subsequently
filed by us pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act before the date our offering is terminated
or completed are deemed to be incorporated by reference into, and to be a part of, this prospectus, provided that we are not incorporating
by reference any information furnished to, but not filed with, the SEC.
Any
statement contained in this prospectus and any applicable prospectus supplement or in a document incorporated or deemed to be
incorporated by reference into this prospectus and any applicable prospectus supplement will be deemed to be modified or superseded
for purposes of this prospectus and any prospectus supplement to the extent that a statement contained in this prospectus and
any applicable prospectus supplement or any other subsequently filed document that is deemed to be incorporated by reference into
this prospectus and any applicable prospectus supplement modifies or supersedes the statement. Any statement so modified or superseded
will not be deemed, except as so modified or superseded, to constitute a part of this prospectus and any applicable prospectus
supplement.
We
will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference,
including exhibits to these documents. You should direct any requests for documents to Citius Pharmaceuticals, Inc. 11 Commerce
Drive, First Floor, Cranford, New Jersey 07016, (908) 967-6677.
You
should rely only on information contained in, or incorporated by reference into, this prospectus and any applicable prospectus
supplement. We have not authorized anyone to provide you with information different from that contained in this prospectus and
any applicable prospectus supplement or incorporated by reference in this prospectus and any applicable prospectus supplement.
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.
7,058,824
shares of common stock
PROSPECTUS
SUPPLEMENT
H.C.
Wainwright & Co.
The
date of this prospectus supplement is May 14, 2020
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