As filed with the Securities and
Exchange Commission on October 23, 2018
Registration No. 333-207248
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No.
1
to
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES
ACT OF 1933
Relmada
Therapeutics, Inc.
(Exact name of registrant as specified in
its charter)
Nevada
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45-5401931
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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750 Third Avenue,
9
th
Floor
New York, NY 10017
(212) 547-9591
(Address, including zip code, and telephone
number, including area code, of registrant’s principal executive offices)
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
750 3rd Avenue,
9
th
Floor
New York, New York 10017
(212) 547-9591
(Name, address, including zip code, and
telephone number, including area code, of agent for service)
Copies of all communications, including
communications sent to agent for service, should be sent to:
Thomas Slusarczyk, Esq.
The Matt law
Firm, PLLC
1701 Genesee
Street
Utica, New
York 13501
Tel. (315) 235-2299
Fax (315) 624-7359
Approximate date of commencement of proposed
sale to the public:
From time to time after this Registration Statement becomes effective.
If the only securities being registered
on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box: ☐
If any of the securities being registered
on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than
securities offered only in connection with dividend or interest reinvestment plans, check the following box: ☒
If this Form is filed to register additional
securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities
Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment
filed pursuant to Rule 462 I under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ☐
If this Form is a registration statement
filed pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the
Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment
to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes
of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the Registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2
of the Exchange Act.
Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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(Do not check if a smaller reporting
company)
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If an emerging growth company, indicate by check mark if
the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
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EXPLANATORY
NOTE
This Amendment No. 1 to the Registration
Statement on Form S-3 (File No. 333-216748) of Relmada Therapeutics, Inc. is being filed solely to update the Registration on
Form S-3 originally filed on October 2, 2015 in order to update the registration statement to comply with the applicable requirements
of the Securities Act of 1933, the rules and regulations under the Act, and the requirements of Form S-3. Accordingly this Amendment
No. 1 contains an update of the two prospectuses filed in the Registration Statement filed on October 2, 2015, and includes:
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a base prospectus which covers the offering, issuance and sale by us of up to a maximum aggregate offering price of $200,000,000 of our shares of common stock, shares of preferred stock, debt securities, warrants, rights, purchase contracts, and/or units; and
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a sales agreement prospectus covering the offering, issuance and sale by us of up to a maximum aggregate offering price of $75,000,000 of our common stock that may be issued and sold under a sales agreement with Cantor Fitzgerald & Co.
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The base prospectus immediately follows this explanatory
note. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement
to the base prospectus. The sales agreement prospectus immediately follows the base prospectus. The $75,000,000 of common stock
that may be offered, issued and sold under the sales agreement prospectus is included in the $200,000,000 of securities that may
be offered, issued and sold by us under the base prospectus.
The information in this prospectus is not
complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these
securities in any state or other jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION,
DATED OCTOBER 23, 2018
PROSPECTUS
$200,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Rights
Purchase Contracts
Units
We may offer and sell from time to time, in one or more series
or issuances and on terms that we will determine at the time of the offering, any combination of the securities described in this
prospectus, up to an aggregate amount of $200,000,000.
We will provide specific terms of any offering in a supplement
to this prospectus. Any prospectus supplement may also add, update, or change information contained in this prospectus. You should
carefully read this prospectus and the applicable prospectus supplement as well as the documents incorporated or deemed to be incorporated
by reference in this prospectus before you purchase any of the securities offered hereby.
THIS PROSPECTUS MAY NOT BE USED TO OFFER AND SELL SECURITIES
UNLESS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
These securities may be offered and sold in the same offering
or in separate offerings; to or through underwriters, dealers, and agents; or directly to purchasers. The names of any underwriters,
dealers, or agents involved in the sale of our securities, their compensation and any over-allotment options held by them will
be described in the applicable prospectus supplement. See “Plan of Distribution.”
Our common stock is presently traded on the OTCQB under
the symbol “RLMD.” On October 15, 2018, the last reported sale price of our common stock was $1.13 per share. We recommend
that you obtain current market quotations for our common stock prior to making an investment decision. We will provide information
in any applicable prospectus supplement regarding any listing of securities other than shares of our common stock on any securities
exchange.
INVESTING IN OUR SECURITIES INVOLVES A HIGH DEGREE OF
RISK. YOU SHOULD CAREFULLY READ AND CONSIDER THE RISK FACTORS DESCRIBED IN THIS PROSPECTUS, ANY ACCOMPANYING PROSPECTUS SUPPLEMENT,
AND IN THE DOCUMENTS INCORPORATED BY REFERENCE INTO THIS PROSPECTUS. SEE “RISK FACTORS” BEGINNING ON PAGE 9 AND IN
THE DOCUMENTS INCORPORATED BY REFERENCE INTO THIS PROSPECTUS.
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.
Any representation to the contrary is a criminal offense.
The date of this prospectus is October
, 2018
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 (the “SEC”) using a “shelf” registration
process. Under this shelf registration process, we may, from time to time, issue and sell to the public any combination of the
securities described in this prospectus in one or more offerings up to a total dollar amount of $200,000,000.
This prospectus provides you with a general description of the
securities we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information
about the terms of that offering. The prospectus supplement may also add to, update or change information contained in this prospectus
or in documents incorporated by reference in this prospectus and, accordingly, to the extent inconsistent, information in this
prospectus will be deemed modified or superseded by the information in the prospectus supplement.
The prospectus supplement to be attached to the front of this
prospectus may describe, as applicable: the terms of the securities offered; the public offering price; the price paid for the
securities; net proceeds; and the other specific terms related to the offering of the securities.
You should only rely on the information contained or incorporated
by reference in this prospectus and any prospectus supplement or issuer free writing prospectus relating to a particular offering.
No person has been authorized to give any information or make any representations in connection with this offering other than those
contained or incorporated by reference in this prospectus, any accompanying prospectus supplement and any related issuer free writing
prospectus in connection with the offering described herein and therein, and, if given or made, such information or representations
must not be relied upon as having been authorized by us. Neither this prospectus nor any prospectus supplement nor any related
issuer free writing prospectus shall constitute an offer to sell or a solicitation of an offer to buy offered securities in any
jurisdiction in which it is unlawful for such person to make such an offering or solicitation. This prospectus does not contain
all of the information included in the registration statement. For a more complete understanding of the offering of the securities,
you should refer to the registration statement, including its exhibits.
You should carefully read the entire prospectus and any prospectus
supplement and any related issuer free writing prospectus, as well as the documents incorporated by reference into this prospectus
or any prospectus supplement or any related issuer free writing prospectus, before making an investment decision. Neither the delivery
of this prospectus or any prospectus supplement or any issuer free writing prospectus nor any sale made hereunder shall under any
circumstances imply that the information contained or incorporated by reference herein or in any prospectus supplement or issuer
free writing prospectus is correct as of any date subsequent to the date hereof or of such prospectus supplement or issuer free
writing prospectus, as applicable. You should assume that the information appearing in this prospectus, any prospectus supplement
or any document incorporated by reference is accurate only as of the date of the applicable documents, regardless of the time of
delivery of this prospectus or any sale of securities. Our business, financial condition, results of operations and prospects may
have changed since that date.
THIS PROSPECTUS MAY NOT BE USED TO OFFER AND SELL SECURITIES
UNLESS IT IS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
The registration statement containing this prospectus, including
exhibits to the registration statement, provides additional information about us and the securities offered under this prospectus.
The registration statement can be read at the SEC’s website or at the SEC offices mentioned under the heading “Where
You Can Find More Information.”
PROSPECTUS SUMMARY
This summary provides an overview of selected information
contained elsewhere or incorporated by reference in this prospectus and does not contain all of the information you should consider
before investing in our securities. You should carefully read the prospectus, the information incorporated by reference and the
registration statement of which this prospectus is a part in their entirety before investing in our securities, including the information
discussed under “Risk Factors” in this prospectus and the documents incorporated by reference and our financial statements
and notes thereto that are incorporated by reference in this prospectus. As used in this prospectus, unless the context otherwise
indicates, the terms “we,” “our,” “us,” or “the Company” refer to Relmada Therapeutics,
Inc., a Nevada corporation, and its subsidiary taken as a whole.
The Company
Business Overview
We are a clinical-stage, publicly traded
biotechnology company focused on the development of d-methadone (dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor
antagonist. d-methadone is a new chemical entity that potentially addresses areas of high unmet medical need in the treatment
of central nervous system (CNS) diseases and other disorders.
Our lead product candidate, d-methadone,
is a New Chemical Entity (NCE) being developed as a rapidly acting, oral agent for the treatment of depression and other potential
indications. We have completed Phase I single and multiple ascending dose studies. A Phase II study in major depressive disorder
is ongoing, with first patient dosed in June 2018, and we expect to have top line results in the first half of 2019.
NMDA receptors are present in many parts
of the central nervous system and play important roles in regulating neuronal activity. We believe that dextromethadone acting
as a NMDA receptor antagonist can have potential applications in a number of disease indications which mitigates risk and offers
significant upside.
In addition, the Company has a portfolio
of three 505b2 product candidates at various stages of development. These products are: LevoCap ER (REL-1015), an abuse resistant,
sustained release dosage form of the opioid analgesic levorphanol; BuTab (oral buprenorphine, REL-1028), an oral dosage form of
the opioid analgesic buprenorphine; and MepiGel (topical mepivacaine, REL-1021), an orphan drug designated topical formulation
of the local anesthetic mepivacaine
d-methadone (dextromethadone, REL-1017)
and Treatment-Resistant Depression (TRD)
Background
In 2014, the National Institute of Mental
Health (NIMH) estimated that 15.7 million adults aged 18 or older in the United States had at least one major depressive episode
in the past year. According to data from nationally representative surveys supported by NIMH, only about half of Americans diagnosed
with major depression in a given year receive treatment. Of those receiving treatment with as many as four different standard
antidepressants, 33% of drug-treated depression patients do not achieve adequate therapeutic benefits according to the Sequenced
Treatment Alternatives to Relieve Depression (STAR*D) trial published in the American Journal of Psychiatry. Accordingly, we believe
that approximately 3 million patients with such treatment-resistant depression are in need of new treatment options.
In addition to the high failure rate,
none of the marketed products for depression can demonstrate rapid antidepressant effects and most of the products take up to
a month to show effectiveness. The urgent need for improved, faster acting antidepressant treatments is underscored by the fact
that severe depression can be life-threatening, due to heightened risk of suicide.
Recent studies have shown that ketamine,
a drug known previously as an anesthetic, can lift depression in many patients within hours. Like d-methadone, ketamine is an
NMDA receptor antagonist. However, it is unlikely that ketamine itself will become a practical treatment for most cases of depression.
It must be administered through intravenous infusion or intranasally, requiring a hospital setting, and more importantly can potentially
trigger adverse side effects including psychedelic symptoms (hallucinations, memory defects, panic attacks), nausea/vomiting,
somnolence, cardiovascular stimulation and, in a minority of patients, hepatoxicity. Ketamine also hasn’t been thoroughly
studied for long-term safety and effectiveness, and the U.S. Food and Drug Administration, or FDA, hasn’t approved it to
treat depression.
d-methadone Overview and Mechanism
of Action
d-methadone’s mechanism of action,
as a non-competitive NMDA channel blocker or antagonist, is fundamentally differentiated from all currently FDA-approved antidepressants,
as well as all atypical antipsychotics used adjunctively with standard, FDA-approved antidepressants. Working through the same
brain mechanisms as ketamine but potentially lacking its adverse side effects, Relmada’s d-methadone is being developed
as a rapidly acting, oral agent for the treatment of depression and/or other potential CNS pathological conditions.
In chemistry an enantiomer, also known
as an optical isomer, is one of two stereoisomers that are mirror images of each other that are non-superposable (not identical),
much as one’s left and right hands are the same except for being reversed along one axis. A racemic compound, or racemate,
is one that has equal amounts of left- and right-handed enantiomers of a chiral molecule. For racemic drugs, often only one of
a drug’s enantiomers is responsible for the desired physiologic effects, while the other enantiomer is less active or inactive.
Racemic methadone has been used since
the 1950s as a treatment for opioid addiction and has remained the primary therapy for this condition for more than 40 years.
Methadone is a highly lipophilic molecule that is suitable for a variety of administration routes, with oral bioavailability close
to 80%.
As a single isomer of racemic methadone,
d-methadone has been shown to possess NMDA antagonist properties with virtually no traditional opioid or ketamine-like adverse
events at the expected therapeutic doses. In contrast, racemic methadone is associated with common opioid side effects that include
anxiety, nervousness, restlessness, sleep problems (insomnia), nausea, vomiting, constipation, diarrhea, drowsiness, and others.
It has been shown that the left (levo) isomer, l-methadone, is largely responsible for methadone’s opioid activity, while
the right (dextro) isomer, d-methadone, is much less active as an opioid while maintaining affinity for the NMDA receptor.
NMDA receptors are present in many parts
of the central nervous system and play important roles in regulating neuronal activity and promoting synaptic plasticity in brain
areas important for cognitive functions such as executive function, learning and memory. Based on these premises, d-methadone
could show benefits in several different CNS indications.
d-methadone Phase 1 Clinical Safety
Studies
The safety data from two Company-funded
d-methadone Phase I clinical safety studies and a third study conducted by researchers at Memorial Sloan-Kettering Cancer Center
indicate that d-methadone was safe and well tolerated in both healthy subjects and cancer patients at all projected therapeutic
doses tested.
In November 2014, Health Canada approved
a Clinical Trial Application (“CTA”) to conduct the first Phase I study with d-methadone. This was a Single Ascending
Dose (“SAD”) study and was followed by a Multiple Ascending Dose (“MAD”) study, both in healthy volunteers.
The two studies were designed to assess the safety, tolerability and pharmacokinetics of d-methadone in healthy, opioid-naïve
subjects. The SAD study included single escalating oral doses of d-methadone to determine the maximum tolerated dose, defined
as the highest dose devoid of unacceptable adverse events. In the MAD study, healthy subjects received daily oral doses of d-methadone
for several days to assess its safety, pharmacokinetics and tolerability. In March 2015, we reported that d-methadone demonstrated
an acceptable safety profile with no dose limiting side effects after four cohorts were exposed to increasing higher doses. In
April 2015, the Company received clearance from Health Canada to continue with dose escalation and explore even higher single
doses of d-methadone. In June 2015, the Company successfully completed the SAD study identifying the maximum tolerated dose and
subsequently received a No Objection Letter (NOL) from Health Canada to conduct the MAD clinical study in August 2015. The MAD
study was completed in January 2016 and the results successfully demonstrated a potential therapeutic dosing regimen for d-methadone
with a favorable side effect and tolerability profile. The data from these studies was used to design a Phase 2a study in patients
with depression.
d-methadone In Vivo Studies for Depression
In May 2016, we announced the results
of an in vivo study showing that administration of d-methadone results in antidepressant-like effects in a well-validated animal
model of depression, known as the forced swim test (FST), providing preclinical support for its potential as a novel treatment
of depression.
According to the Journal of Visualized
Experiments, the FST is based on the assumption that when placing an animal in a container filled with water, it will first make
efforts to escape by swimming or climbing, but eventually will exhibit “immobility” that may be considered to reflect
a measure of behavioral despair. This test has been extensively used because it involves the exposure of the animals to stress,
which was shown to have a role in the tendency for major depression. Additionally, the FST has been shown to be influenced by
some of the factors that are altered by or worsen depression in humans, including changes in food consumption and sleep abnormalities.
The main advantages of this procedure are that it is relatively easy to perform and that its results are easily and quickly analyzed.
Importantly, the FST’s sensitivity to a broad range of antidepressant drugs makes it a suitable screening test and is one
of the most important features leading to its high predictive validity.
In the Company’s FST study, male
Sprague Dawley rats were administered single doses of placebo, ketamine, or d-methadone on day one (after habituation; 24 hours
prior to forced swim testing). At all doses tested, d-methadone significantly decreased immobility of the rats compared to the
placebo, suggesting antidepressant-like activity. In addition, the effect of d-methadone on immobility at the two highest doses
tested was larger than the effect seen with ketamine. Moreover, the effects of d-methadone in the forced swim test were not caused
by a stimulant effect on spontaneous locomotor activity of the rats. Locomotor activity of lab animals is often monitored to assess
the behavioral effects of drugs.
In September 2017 we completed two additional
in vivo studies to confirm and support the antidepressant-like effect of dextromethadone in validated animal models, the Novelty
Suppressed Feeding Test (NSFT) and the Female Urine-Sniffing test (FUST) test. The studies were performed by Professor Ronald
S. Duman, Ph.D. at Yale University School of Medicine.
For FUST, rats are first exposed to a
cotton tip dipped in tap water and later exposed to another cotton tip infused with fresh female urine. Male behavior was video
recorded and total time spent sniffing the cotton-tipped applicator is determined. For NSFT, rats were food deprived for 24 hr
and then placed in an open field with food pellets in the center; latency to eat is recorded in seconds. As a control, food consumption
in the home cage is quantified. Rats were administered vehicle, ketamine or d-methadone.
The results of the FUST demonstrate that
administration of ketamine significantly increases the time male rats spent engaged in sniffing female urine compared to vehicle
group. Similarly, a single dose of d-methadone significantly increased the time spent sniffing female urine compared to vehicle.
In contrast, ketamine or d-methadone had no effect on time sniffing water, demonstrating that the effect of drug treatment was
specific to the rewarding effects of female urine. The results of the NSFT demonstrate that a single dose of ketamine significantly
decreases the latency to eat in a novel open field. Similarly, a single dose of d-methadone also significantly decreased the latency
to enter and eat in the novel feed. In contrast, neither ketamine nor methadone influenced latency to feed in the home cage.
These findings demonstrate that ketamine
and d-methadone produce rapid antidepressant actions in the FUST and NSFT, effects that are only observed after chronic administration
of an SSRI antidepressant.
A separate in vitro electrophysiology
study of d-methadone was conducted using 2 subtypes of cloned human NMDA receptors.
The results of this study demonstrated
functional antagonist activity with d-methadone comparable to that of both racemic ketamine and the isomer [S]-ketamine.
Phase II Program for d-methadone in
Depression
Combined with the results of our Phase
I studies, the encouraging results of in vivo and in vitro studies strongly support further evaluation of d-methadone in a Phase
II study as a rapidly acting, oral agent for the treatment of major depressive disorder. Relmada filed an Investigational New
Drug (“IND”) application for the Phase II study with the FDA, which was accepted on January 25, 2017.
On April 13, 2017, we announced that the
FDA granted Fast Track designation for d-methadone (REL-1017 dextromethadone) for the adjunctive treatment of major depressive
disorder. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat
serious conditions and fill an unmet medical need. The purpose, according to the FDA, is to get important new drugs to the patient
earlier. Drugs that receive Fast Track designation may be eligible for more frequent meetings and written communications with
the FDA, accelerated review and priority approval, and rolling New Drug Application review.
On January 17, 2018 we announced that
Relmada had acquired the global rights to develop and market dextromethadone for the treatment of neurological conditions including
certain rare diseases with symptoms affecting the CNS.
In February 2018 Relmada initiated its
Phase II study of d-methadone in patients with major depressive disorder.
d-methadone (dextromethadone, REL-1017)
in other indications
In addition to developing dextromethadone
in major depression, Relmada is initiating work in additional indications. In particular, we have initiated a preclinical program
to test the potential efficacy of dextromethadone in Rett syndrome. Rett syndrome is an X-linked neurodevelopmental disorder with
high unmet need caused by Mecp2 gene mutation. Loss of Mecp2 disrupts synaptic function and structure and neuronal networks. Rett
syndrome is an Orphan Disease affecting ~15,000 in U.S., primarily girls, with no approved therapy. The disease begins with a
short period of developmental stagnation, then rapid regression in language and motor skills, followed by long-term stability.
Studies of ketamine, a NMDAR antagonist
with mechanistic similarities with dextromethadone, in Rett Syndrome mouse models show that low-dose ketamine acutely reverses
multiple disease manifestations and chronic administration of ketamine improves Rett Syndrome progression, providing a solid rationale
to pursue this indication with dextromethadone.
Other indications that Relmada may explore
in the future, potentially includes restless leg syndrome, ALS and ophthalmology.
In January 2018, we entered into an Intellectual
Property Assignment Agreement (the “Assignment Agreement”) and License Agreement (the “License Agreement”
and together with the Assignment Agreement, the “Agreements”) with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi
(collectively, the “Licensor”). Pursuant to the Agreements, Relmada assigned its existing rights, including patents
and patent applications, to d-methadone in the context of psychiatric use (the “Existing Invention”) to Licensor.
Licensor then granted Relmada under the License Agreement a perpetual, worldwide, and exclusive license to commercialize the Existing
Invention and certain further inventions regarding d-methadone in the context of other indications such as those contemplated
above.
LevoCap ER (REL-1015)
LevoCap ER (REL-1015) is a novel version
of a proven drug product. LevoCap ER -is an extended release, abuse deterrent, and proprietary formulation of levorphanol (levo-3-hydroxy-N-methyl-morphinan),
a unique, broad spectrum opioid with additional “non-opioid” mechanisms of action. In particular, levorphanol binds
to all three opioid receptor subtypes involved in analgesia (mu, kappa, and delta), the NMDA receptor, and the norepinephrine
and serotonin reuptake pumps, whereas morphine, oxycodone, hydrocodone, and other opioids are highly selective for the mu receptor
subtype. Due to its multi-modal mechanism of action, levorphanol could achieve analgesia in patients resistant to other strong
opioids. In clinical studies, levorphanol has demonstrated a remarkably broad spectrum of analgesic activity against many different
types of pain including neuropathic pain, post-surgical pain, and chronic pain in patients refractory to other opioids.
Levorphanol is a potent opioid analgesic
first introduced in the U.S. around 1953 for the treatment of moderate to severe pain where an opioid analgesic is appropriate.
Extended-release (long-acting opioid) agents may be preferable to immediate release formulations due to better patient adherence,
less dose-watching, and result in improved sleep. Both immediate- and extended-release opioids can potentially be crushed to produce
concentrated drug with greater appeal to abusers. Intentional crushing or extracting the active ingredient from the extended-release
dosage form by addicts and recreational drug users can destroy the timed-release mechanism and result in a rapid surge of drug
into the bloodstream for the purpose of achieving a high or euphoric feeling. Serious side effects and death have been reported
from such misuse.
LevoCap ER is the first product candidate
utilizing SECUREL™, Relmada’s proprietary abuse deterrent extended release technology for opioid drugs. SECUREL dosage
forms cannot be easily crushed for inhalation or to obtain rapid euphoria from high blood levels when swallowed. It is also exceedingly
difficult for intravenous abusers to extract the active drug from the dosage form using common solvents, including alcohol.
LevoCap ER can be developed under the
505(b)(2) regulatory pathway. Following an exchange of correspondence and meeting with the FDA in January 2017, we have defined
a path forward for the Phase 3 clinical study for LevoCap ER and a new drug application (“NDA”) filing. In light of
the promising data generated by Relmada’s d-methadone research program, and Relmada’s focus on the d-methadone program,
Relmada is currently limiting the investments in LevoCap ER.
BuTab (REL-1028)
BuTab (REL-1028) represents a novel formulation
of oral, modified release buprenorphine as a potential therapeutic for both chronic pain and opioid dependence. Buprenorphine
has been widely used by the sublingual and transdermal routes of administration, but was believed to be ineffective by the oral
route because of poor oral bioavailability. We have completed a preclinical program to better define the pharmacokinetic profile
of BuTab and to assess the time course of systemic absorption of buprenorphine using several different oral modified release formulations
of buprenorphine in dogs, compared to an intravenous administration. Based on the results of this work, we obtained approval from
Health Canada and initiated a Phase I pharmacokinetic study in healthy volunteers in the second quarter of 2015. This trial was
completed in the fourth quarter of 2015. The absolute bioavailability of BuTab relative to intravenous (IV) administration exceeded
published data with non-modified buprenorphine when administered orally and compares favorably with a currently marketed transdermal
patch. There were no safety or tolerability issues. The data generated by this study will guide formulation optimization and inform
the design of subsequent clinical pharmacology studies. BuTab can be developed under the 505(b)(2) regulatory pathway. In light
of the promising data generated by Relmada’s d-methadone research program, and Relmada’s focus on the d-methadone
program, Relmada is currently limiting the investments in BuTab.
MepiGel (REL-1021)
MepiGel (REL-1021), is a proprietary topical
dosage form of the local anesthetic mepivacaine for the treatment of painful peripheral neuropathies, such as painful diabetic
neuropathy, postherpetic neuralgia and painful HIV-associated neuropathy. Mepivacaine is an anesthetic (numbing medicine) that
blocks the nerve impulses that send pain signals to the brain. It is chemically related to bupivacaine but pharmacologically related
to lidocaine. Mepivacaine is currently indicated for infiltration, nerve block and epidural anesthesia. Relmada has received two
FDA Orphan Drug Designations for mepivacaine, one each for “the treatment of painful HIV-associated neuropathy” and
for “the management of postherpetic neuralgia,” or PHN. We have selected the formulations to be advanced into clinical
studies for MepiGel after the evaluation of results from in vitro and ex vivo studies comparing various topical prototypes of
mepivacaine that were conducted by MedPharm Ltd, a specialist formulation development company recognized internationally for its
expertise in topical and transdermal products. Multiple toxicology studies were successfully conducted and completed in 2015.
MepiGel can be developed under the 505(b)(2) regulatory pathway. In light of the promising data generated by Relmada’s d-methadone
research program, and Relmada’s focus on the d-methadone program, Relmada is currently limiting the investments in MepiGel.
Overview of the 505(b)(2) Pathway
Part of our strategy is the utilization
of FDA’s 505(b)(2) new drug application process, (“NDA”) for approval. The 505(b)(2) NDA is one of three FDA
drug approval pathways and represents an appealing regulatory strategy for many companies. The pathway was created by the Hatch-Waxman
Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2)
were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference”
or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.
A 505(b)(2) NDA contains full safety and
effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information
on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive
and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated
products with tremendous commercial value.
Overview of Orphan Drug Status
In accordance with laws and regulations
pertaining to the Regulatory Agencies, a sponsor may request that the Regulatory Agencies designate a drug intended to treat a
“Rare Disease or Condition” as an “Orphan Drug.” For example, in the United States, a “Rare Disease
or Condition” is defined as one which affects less than 200,000 people in the United States, or which affects more than
200,000 people but for which the cost of developing and making available the product is not expected to be recovered from sales
of the product in the United States. Upon the approval of the first NDA or BLA for a drug designated as an orphan drug for a specified
indication, the sponsor of that NDA or BLA is entitled to 7 years of exclusive marketing rights in the United States unless the
sponsor cannot assure the availability of sufficient quantities to meet the needs of persons with the disease. In Europe, this
exclusivity is 10 years, and in Australia it is 5 years. However, orphan drug status is particular to the approved indication
and does not prevent another company from seeking approval of an off-patent drug that has other labeled indications that are not
under orphan or other exclusivities. Orphan drugs may also be eligible for federal income tax credits for costs associated with
such as the disease state, the strength and complexity of the data presented, the novelty of the target or compound, risk-management
approval and whether multiple rounds of review are required for the agency to evaluate the submission. There is no guarantee that
a potential treatment will receive marketing approval or that decisions on marketing approvals or treatment indications will be
consistent across geographic areas.
Research and Development Expenses
A significant portion of our operating
expenses is related to research and development and we intend to maintain our strong commitment to research and development. Total
research and development spending for the year ended June 30, 2018 was approximately $2,942,600, as compared to $1,293,500 for
the same period of 2017, an increase of $1,649,100.
Our Corporate History and Background
We are a clinical-stage, publicly traded
biotechnology company focused on the development of d-methadone (dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor
antagonist. d-methadone is a new chemical entity that potentially addresses areas of high unmet medical need in the treatment
of central nervous system (CNS) diseases and other disorders. REL-1017 is in Phase II for the treatment of major depressive disorder.
Relmada Therapeutics, Inc. (“RTI”) was incorporated
in May 2004 as a privately held company. On December 31, 2014, RTI entered into a merger agreement with Medeor Inc. (“Medeor”),
through which all of Medeor’s shares of common stock were exchanged for shares of RTI’s common stock, based upon a
negotiated exchange ratio. Following the transaction, the corporate existence of Medeor ceased and RTI continued as the surviving
corporation. Prior to the merger, Medeor had been developing d-Methadone.
In May 2014, RTI completed a share exchange with Camp Nine,
Inc., a publicly traded Nevada corporation that was formed in May 2012. In July 2014, we changed the name of Camp Nine, Inc. to
Relmada Therapeutics, Inc. Pursuant to the share exchange, RTI shareholders exchanged 10 shares of RTI’s common stock for
one share of our common stock. Following the share exchange, RTI’s shareholders acquired the majority of our issued and outstanding
capital stock and RTI became our subsidiary.
The share exchange was accounted for as a
“reverse merger” rather than a business combination, wherein we are considered the acquirer for accounting and financial
reporting purposes. The statement of operations reflects the activities of RTI from the commencement of its operations since inception.
Unless the context suggests otherwise, when we refer to business and financial information for periods prior to the consummation
of the share exchange, we are referring to the business and financial information of RTI.
In 2014, we changed our fiscal year end
to June 30 and increased our authorized common stock to 500,000,000 shares and our authorized preferred stock to 200,000,000 shares,
of which 3,500,000 is designated as Class A preferred stock. In August 2015, we completed a one-for-five reverse stock split in
preparation for our proposed up-listing to the NASDAQ Capital Markets or the NYSE MKT, reducing the authorized common share to
100,000,000 common shares. This prospectus reflects a retroactive adjustment for the reverse stock split.
Currently, none of our drugs have been approved for sale in
the United States or elsewhere. We have no commercial products nor do we have a sales or marketing infrastructure. In order to
market and sell our products we must conduct clinical trials on patients and obtain regulatory approvals from appropriate regulatory
agencies, like the FDA in the United States, and similar organizations elsewhere in the world.
Corporate and Other Information
Our principal executive offices are located
at 750 3rd Avenue, 9
th
Floor, New York, New York 10017. Our telephone number is (212) 547-9591. Our website address
is www.relmada.com. Information accessed through our website is not incorporated into this prospectus and is not a part of this
prospectus.
The Securities We May Offer
We may offer our shares of common stock, shares of preferred
stock, debt securities, warrants, rights, purchase contracts or units, or any combination of the foregoing, with a total value
of up to $200,000,000 from time to time under this prospectus at prices and on terms to be determined by market conditions at the
time of the offering.
In this prospectus, we refer to the common stock, preferred
stock, debt securities, warrants, rights, purchase contracts or units, or any combination of the foregoing securities to be sold
by us in a primary offering collectively as “securities.” This prospectus provides you with a general description of
the securities we may offer. Each time we offer a type or series of securities, we will provide a prospectus supplement that will
describe the specific amounts, prices and other important terms of the securities, as described below under “Plan of Distribution.”
This prospectus may not be used to consummate a sale of securities
unless it is accompanied by a prospectus supplement.
RISK FACTORS
An investment in our securities involves a high degree of
risk. The prospectus supplement applicable to each offering of our securities will contain a discussion of the risks applicable
to an investment in our securities. Before deciding whether to invest in our securities, you should carefully consider the specific
factors discussed under the heading “Risk Factors” in the applicable prospectus supplement, together with all of the
other information contained or incorporated by reference in the prospectus supplement or appearing or incorporated by reference
in this prospectus. You should also consider the risks, uncertainties and assumptions discussed under Item 1A, “Risk Factors,”
in our Annual Report on Form 10-K for the fiscal year ended June 30, 2018, all of which are incorporated herein by reference,
as updated or superseded by the risks and uncertainties described under similar headings in the other documents that are filed
after the date hereof and incorporated by reference into this prospectus and any prospectus supplement related to a particular
offering. The risks and uncertainties we have described are not the only ones we face. Additional risks and uncertainties not
presently known to us or that we currently deem immaterial may also affect our operations. Past financial performance may not
be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future
periods. If any of these risks actually occurs, our business, business prospects, financial condition or results of operations
could be seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part
of your investment.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus, each prospectus supplement and the information
incorporated by reference in this prospectus and each prospectus supplement contain “forward-looking statements,” which
include information relating to future events, future financial performance, strategies, expectations, competitive environment
and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,”
“potential,” “continue,” “expects,” “anticipates,” “future,” “intends,”
“plans,” “believes,” “estimates,” and similar expressions, as well as statements in future
tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance
or results and will probably not be accurate indications of when such performance or results will be achieved. Forward-looking
statements are based on information we have when those statements are made or our management’s good faith belief as of that
time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to
differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such
differences include, but are not limited to:
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our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives;
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our ability to complete clinical trials as anticipated and obtain and maintain regulatory approvals for our products;
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our ability to adequately protect our intellectual property;
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disputes over ownership of intellectual property;
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the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our products is an attractive alternative to other products;
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intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
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entry of new competitors and products and potential technological obsolescence of our products;
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loss of a key customer or supplier;
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technical problems with our research and products and potential product liability claims;
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adverse economic conditions;
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adverse federal, state and local government regulation, in the United States;
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price increases for supplies;
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inability to carry out research, development and commercialization plans; and
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loss or retirement of key executives and research scientists.
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You should review carefully the section entitled “Risk
Factors” beginning on page 9 of this prospectus for a discussion of these and other risks that relate to our business and
investing in our securities. The forward-looking statements contained or incorporated by reference in this prospectus or any prospectus
supplement are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly
update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or
to reflect the occurrence of unanticipated events.
USE OF PROCEEDS
We intend to use the net proceeds from the sale of the securities
as set forth in the applicable prospectus supplement.
DESCRIPTION OF CAPITAL STOCK
The following description of common stock and preferred stock
summarizes the material terms and provisions of the common stock and preferred stock that we may offer under this prospectus, but
is not complete. For the complete terms of our common stock and preferred stock, please refer to our amended and restated certificate
of incorporation and our bylaws, which have been filed with the SEC as exhibits to our registration statement, of which this prospectus
forms a part. While the terms we have summarized below will apply generally to any future common stock or preferred stock that
we may offer, we will describe the specific terms of any series of preferred stock in more detail in the applicable prospectus
supplement. If we so indicate in a prospectus supplement, the terms of any preferred stock we offer under that prospectus supplement
may differ from the terms we describe below.
General
We have authorized 300,000,000
shares of capital stock, par value $0.001 per share, of which 100,000,000 are shares of common stock and 200,000,000 are
shares of preferred stock, 3,500,000 of which are designated Class A Convertible Preferred Stock. On October 19, 2018, there
were 26,925,986 shares of common stock issued and outstanding. There are no preferred issued and outstanding. The authorized
and unissued shares of common stock and the authorized and undesignated shares of preferred stock are available for issuance
without further action by our stockholders, unless such action is required by applicable law or the rules of any stock
exchange on which our securities may be listed. Unless approval of our stockholders is so required, our board of directors
does not intend to seek stockholder approval for the issuance and sale of our common stock or preferred stock.
We also have warrants that are outstanding, which are described
below.
The following is a summary of the material provisions of the
common stock and preferred stock provided for in our amended and restated certificate of incorporation and bylaws. For additional
detail about our capital stock, please refer to our certificate of incorporation and bylaws, each as amended.
Common Stock
The holders of our common stock are entitled to one vote per
share. Our certificate of incorporation does not provide for cumulative voting. Our directors are divided into three classes. At
each annual meeting of stockholders, directors elected to succeed those directors whose terms expire are elected for a term of
office to expire at the third succeeding annual meeting of stockholders after their election. The holders of our common stock are
entitled to receive ratably such dividends, if any, as may be declared by our board of directors out of legally available funds.
However, the current policy of our board of directors is to retain earnings, if any, for operations and growth. Upon liquidation,
dissolution or winding-up, the holders of our common stock are entitled to share ratably in all assets that are legally available
for distribution. The holders of our common stock have no preemptive, subscription or conversion rights and there are no redemption
or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of holders of our common stock
are subject to, and may be adversely affected by, the rights of the holders of any series of preferred stock, which may be designated
solely by action of our board of directors and issued in the future.
Our common stock is listed on the OTCQB under the symbol “RLMD.”
We have applied to list our common stock on the NASDAQ Capital Market. There can be no assurance, however, that our application
will be approved.
Preferred Stock
As of October 19, 2018, there were no
shares of Class A Convertible Preferred Stock issued and outstanding.
The rights and preferences of our Class A Convertible Preferred
Stock include the following:
Liquidation Preference
In the event of any dissolution, liquidation or winding up of
our Company, whether voluntary or involuntary, the holders of our Class A Convertible Preferred Stock are entitled to participate
in any distribution out of our assets of on an equal basis per share with the holders of our common stock.
Dividends
The Class A Convertible Preferred Stock is, with respect to
dividend rights, entitled to two times the amount of any dividend granted by our board of directors to the holders of our common
stock.
Conversion
Optional Conversion.
Subject to certain exceptions, each
share of Class A Convertible Preferred Stock is convertible at the option of the holder and without the payment of additional consideration
by the holder, at any time, into shares of our common stock at a conversion rate of one share of our common stock for every one
share of our Class A Convertible Preferred Stock. However, a holder of our Class A Convertible Preferred Stock cannot convert shares
of our Class A Convertible Preferred Stock to shares of our common stock if such conversion would cause the holder or any “group”
(within the meaning of Section 13(d) of the Securities Exchange Act of 1934 (the “Exchange Act”)) of which such holder
is or deemed to be a part, to “beneficially own” (within the meaning of Rule 13d-3 under the Exchange Act) more than
9.9% of the number of shares of our common stock listed as outstanding by in our most recent public filing with the SEC prior to
us receiving the conversion demand.
Automatic Conversion.
Subject to the limitation on conversion
described above, on the first day of each month until there are no shares of our Class A Convertible Preferred Stock outstanding,
each share of our Class A Convertible Preferred Stock will convert without the payment of additional consideration by a holder
into shares of our common stock on the automatic conversion date at a conversion rate of one share of our common stock for every
one share of our Class A Convertible Preferred Stock.
Voting
The holders of our Class A Convertible Preferred Stock are not
entitled to vote on any matter submitted to a vote of the holders of our common stock, including the election of directors.
The board of directors is authorized, subject to any limitations
prescribed by law, without further vote or action by our stockholders, to issue from time to time shares of preferred stock in
one or more series. Each such series of preferred stock shall have such number of shares, designations, preferences, voting powers,
qualifications and special or relative rights or privileges as determined by our board of directors, which may include, among others,
dividend rights, voting rights, liquidation preferences, conversion rights and preemptive rights. Issuance of preferred stock by
our board of directors may result in such shares having dividend and/or liquidation preferences senior to the rights of the holders
of our common stock and could dilute the voting rights of the holders of our common stock.
Prior to the issuance of shares of each series of preferred
stock, our board of directors is required by the Nevada Revised Law and our amended and restated certificate of incorporation to
adopt resolutions and file a certificate of designation with the Secretary of State of the State of Nevada. The certificate of
designation fixes for each class or series the designations, powers, preferences, rights, qualifications, limitations and restrictions,
including, but not limited to, some or all of the following:
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the number of shares constituting that series and the distinctive designation of that series, which number may be increased or decreased (but not below the number of shares then outstanding) from time to time by action of our board of directors;
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the dividend rate and the manner and frequency of payment of dividends on the shares of that series, whether dividends will be cumulative, and, if so, from which date;
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whether that series will have voting rights, in addition to any voting rights provided by law, and, if so, the terms of such voting rights;
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whether that series will have conversion privileges, and, if so, the terms and conditions of such conversion, including provision for adjustment of the conversion rate in such events as our board of directors may determine;
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whether or not the shares of that series will be redeemable, and, if so, the terms and conditions of such redemption;
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whether that series will have a sinking fund for the redemption or purchase of shares of that series, and, if so, the terms and amount of such sinking fund;
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whether or not the shares of the series will have priority over or be on a parity with or be junior to the shares of any other series or class in any respect;
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the rights of the shares of that series in the event of voluntary or involuntary liquidation, dissolution or winding up of the corporation, and the relative rights or priority, if any, of payment of shares of that series; and
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any other relative rights, preferences and limitations of that series.
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Once designated by our board of directors, each series of preferred
stock may have specific financial and other terms that will be described in a prospectus supplement. The description of the preferred
stock that is set forth in any prospectus supplement is not complete without reference to the documents that govern the preferred
stock. These include our amended and restated certificate of incorporation and any certificates of designation that our board of
directors may adopt.
All shares of our preferred stock will, when issued, be fully
paid and non-assessable, including shares of our preferred stock issued upon the exercise of preferred stock warrants or subscription
rights, if any.
Although our board of directors has no intention at the present
time of doing so, it could authorize the issuance of a series of preferred stock that could, depending on the terms of such series,
impede the completion of a merger, tender offer or other takeover attempt.
Warrants
Series A Preferred Warrants
In connection with our sale of Series A preferred stock
and 8% senior subordinated unsecured convertible notes in 2012 and 2013, we sold to the purchasers 498,437 warrants to purchase
common stock at an exercise price of $4.00 per share (the “Series A Preferred Warrants”). As of October 19, 2018,
there were 498,437 Series A Preferred Warrants outstanding. The Series A Preferred Warrants have a seven-year term from their issuance
dates, which occurred between July 10, 2012 and September 26, 2013. The exercise price of the Series A Preferred Warrants is subject
to adjustment upon certain events. If we at any time while the Series A Preferred Warrants remain outstanding and unexpired shall
declare a dividend or make a distribution on the outstanding common stock payable in shares of its capital stock, or split, subdivide
or combine the common stock into a different number of securities of the same class, the exercise price for the Series A Preferred
Warrants shall be proportionately decreased in the case of a dividend, split or subdivision or proportionately increased in the
case of a combination. The Series A Preferred Warrants contained an anti-dilution provision that was eliminated upon the Company
going public.
Notes Warrants
In connection with our 2013 notes financing, we sold to
the purchasers 42,750 warrants to purchase common stock at an exercise price of $4.00 per share. The note warrants have a seven-year term from their issuance dates and have substantially
the same terms as the Series A Preferred Warrants (as described above).
Advisory Firm Warrants
In connection with an agreement with an advisory firm, we
issued to such advisory firm warrants (“Advisory Firm Warrants”) to purchase 12% of the fully diluted shares of Relmada,
or 1,731,157 shares of common stock. As of October 19, 2018 there were 164,205 Advisory Firm Warrants outstanding. The Advisory
Firm Warrants are exercisable at $0.001 per share, provide for cashless exercise and expire seven years after the date of issuance.
Shares purchased by exercise of the Advisory Firm Warrants have unlimited piggyback registration rights should we have a public
offering registered with the SEC and are subject to lock-ups, if any, required by SEC regulations or other applicable law, or
by investors.
Series B Warrants
In connection with our sale of units in 2014, we sold to
the purchasers an aggregate of 1,716,379 Series B warrants to purchase common stock at an exercise price of $11.25 per share
(the “Series B Warrants”). As of October 19, 2018, there were 1,716,379 Series B Warrants outstanding. The Series B Warrants
have a five-year term from their respective issuance dates. There is a cashless exercise provision. We may call these Series B
Warrants for redemption upon written notice to all purchasers at any time the closing price of the common stock exceeds $18.75
for 20 consecutive trading days, as reported by Bloomberg, provided at such time there is an effective registration statement
covering the resale of the shares. In the 60 business days following the date the redemption notice is deemed given, investors
may choose to exercise their respective Series B Warrant or a portion of their Series B Warrant by paying the then applicable
exercise price. Any shares not exercised on the last day of the exercise period will be redeemed by us at $0.001 per share. The
Series B Warrants have an anti-dilution provision, which will terminate upon the issuance of a clearance letter for the up-listing
of our common stock to a senior stock exchange such as NASDAQ Capital Market or the NYSE MKT.
Placement Agent Warrants
In connection with our sale of Series A preferred
stock and 8% senior subordinated unsecured convertible notes in 2012 and 2013, we issued to a placement agent warrants to
purchase 250,000 shares of common stock at an exercise price of $4.00 per share (the “Placement Agent Warrants”).
As of October 19, 2018 there are 176,115 warrants to purchase common stock outstanding. These Placement Agent Warrants
include a cashless exercise provision and have substantially the same terms as the Series A Preferred Warrants. In connection
with the 2013 notes financing, the placement agent or its designees also received five-year warrants to purchase 28,125
shares of our common stock at a price of $4.00 per share.
In connection with our merger with Medeor in December 2013,
we issued to a placement agent 40,000 warrants exercisable for shares of our common stock at an exercise price of $5.50 per share.
In connection with our May 2014 offering, we also issued to
a placement agent warrants to purchase 858,190 shares of common stock at an exercise price of $7.50 per share (the “2014
Placement Agent Warrants”). The 2014 Placement Agent Warrants issued have substantially the same proportional adjustment
provisions as the Series A Preferred Warrants described above. The 2014 Placement Agent Warrants have an anti-dilution provision,
which will terminate upon the issuance of a clearance letter for the up-listing of our common stock to a senior stock exchange
such as NASDAQ Capital Market or the NYSE MKT.
Founder Warrants
During 2012, we issued our founder 173,643 warrants to purchase
common stock in connection with a transaction that exchanged debt for stock. The warrants have an exercise price of $4.00 per share
and will expire five years from their respective issuance dates.
2017 Note Warrants
In connection with our sale of notes in 2017, we sold to
the purchasers an aggregate of 4,803,330 warrants to purchase common stock at an exercise price of $1.50 per share (the “Note
Warrants”). As of October 19, 2018, there were 4,803,330 2017 Note Warrants outstanding. The 2017 Note Warrants have a seven-year
term from their respective issuance dates. There is no cashless exercise provision.
In connection with our sale of notes in 2017, we issued
to a placement agent warrants to purchase 804,000 shares of common stock at an exercise price of $1.50 per share. As of October
19, 2018 there are 804,000 warrants to purchase common stock outstanding.
2018 Warrants
In connection with our sale of units in October 2018, we sold
to the purchasers an aggregate of 2,368,887 warrants to purchase common stock at an exercise price of $1.50 per share, and
an additional 471,665 warrants to purchase common stock at an exercise price of $1.50 per share were issued to the placement agent
(the “2018 Warrants”). As of October 19, 2018, there were 2,840,552 2018 Warrants outstanding. The 2018 Warrants have
a five-year term from their respective issuance dates. There is no cashless exercise provision.
An additional 672,243 warrants have been issued to employees
and consultants, and are outstanding as at October 19, 2018. These warrants have a weighted average exercise price of $2.05
Registration Rights
In connection with our October 2018 private placement offering
that closed on October 12 and 18, 2018, we are obligated to file within 45 days of the final closing of the offering a registration
statement registering for resale all shares of our common stock issued as part of the units and all of our common shares issuable
upon exercise of the warrants issued in the offering.
Anti-takeover Effects of Our Articles of Incorporation and
By-laws
Our amended and restated articles of incorporation and bylaws
contain certain provisions that may have anti-takeover effects, making it more difficult for or preventing a third party from acquiring
control of us or changing our board of directors and management. According to our amended and restated articles of incorporation
and bylaws, neither the holders of our common stock nor the holders of our preferred stock have cumulative voting rights in the
election of our directors. The combination of the present ownership by a few stockholders of a significant portion of the issued
and outstanding shares of our common stock and lack of cumulative voting makes it more difficult for other stockholders to replace
our board of directors or for a third party to obtain control of us by replacing our board of directors.
Anti-takeover Effects of Nevada Law
Business Combinations
The “business combination” provisions of Sections
78.411 to 78.444, inclusive, of the Nevada Revised Statutes (“NRS”), generally prohibit a Nevada corporation with at
least 200 stockholders of record, a “resident domestic corporation,” from engaging in various “combination”
transactions with any “interested stockholder” unless certain conditions are met or the corporation has elected in
its articles of incorporation to not be subject to these provisions.
A “combination” is generally defined to include
(a) a merger or consolidation of the resident domestic corporation or any subsidiary of the resident domestic corporation with
the interested stockholder or affiliate or associate of the interested stockholder, (b) any sale, lease, exchange, mortgage, pledge,
transfer or other disposition, in one transaction or a series of transactions, by the resident domestic corporation or any subsidiary
of the resident domestic corporation to or with the interested stockholder or affiliate or associate of the interested stockholder
having: (i) an aggregate market value equal to 5% or more of the aggregate market value of the assets of the resident domestic
corporation, (ii) an aggregate market value equal to 5% or more of the aggregate market value of all outstanding shares of the
resident domestic corporation or (iii) 10% or more of the earning power or net income of the resident domestic corporation, (c)
the issuance or transfer in one transaction or series of transactions of shares of the resident domestic corporation or any subsidiary
of the resident domestic corporation having an aggregate market value equal to 5% or more of the resident domestic corporation
to the interested stockholder or affiliate or associate of the interested stockholder and (d) certain other transactions with an
interested stockholder or affiliate or associate of the interested stockholder.
An “interested stockholder” is generally defined
as a person who, together with affiliates and associates, owns (or within three years, did own) 10% or more of a corporation’s
voting stock. An “affiliate” of the interested stockholder is any person that directly or indirectly through one or
more intermediaries is controlled by or is under common control with the interested stockholder. An “associate” of
an interested stockholder is any (a) corporation or organization of which the interested stockholder is an officer or partner or
is directly or indirectly the beneficial owner of 10% or more of any class of voting shares of such corporation or organization,
(b) trust or other estate in which the interested stockholder has a substantial beneficial interest or as to which the interested
stockholder serves as trustee or in a similar fiduciary capacity or (c) relative or spouse of the interested stockholder, or any
relative of the spouse of the interested stockholder, who has the same home as the interested stockholder.
If applicable, the prohibition is for a period of two years
after the date of the transaction in which the person became an interested stockholder, unless such transaction is approved by
the board of directors prior to the date the interested stockholder obtained such status; or the combination is approved by the
board of directors and thereafter is approved at a meeting of the stockholders by the affirmative vote of stockholders representing
at least 60% of the outstanding voting power held by disinterested stockholders; and extends beyond the expiration of the two-year
period, unless (a) the combination was approved by the board of directors prior to the person becoming an interested stockholder,
(b) the transaction by which the person first became an interested stockholder was approved by the board of directors before the
person became an interested stockholder, (c) the transaction is approved by the affirmative vote of a majority of the voting power
held by disinterested stockholders at a meeting called for that purpose no earlier than two years after the date the person first
became an interested stockholder or (d) if the consideration to be paid to all stockholders other than the interested stockholder
is, generally, at least equal to the highest of: (i) the highest price per share paid by the interested stockholder within the
three years immediately preceding the date of the announcement of the combination or in the transaction in which it became an interested
stockholder, whichever is higher, plus compounded interest and less dividends paid, (ii) the market value per share of common shares
on the date of announcement of the combination and the date the interested stockholder acquired the shares, whichever is higher,
plus compounded interest and less dividends paid or (iii) for holders of preferred stock, the highest liquidation value of the
preferred stock, plus accrued dividends, if not included in the liquidation value. With respect to (i) and (ii) above, the interest
is compounded at the rate for one-year United States Treasury obligations from time to time in effect.
Applicability of the Nevada business combination law would discourage
parties interested in taking control of our company if they cannot obtain the approval of our board of directors. These provisions
could prohibit or delay a merger or other takeover or change in control attempt and, accordingly, may discourage attempts to acquire
our company even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the
prevailing market price. We have elected to not be governed by the Nevada business combination provisions.
Control Share Acquisitions
The “control share” provisions of Sections 78.378
to 78.3793, inclusive, of the NRS, apply to “issuing corporations,” which are Nevada corporations with at least 200
stockholders of record, including at least 100 stockholders of record who are Nevada residents, and which conduct business directly
or indirectly in Nevada, unless the corporation has elected to not be subject to these provisions.
The control share statute prohibits an acquirer of shares of
an issuing corporation, under certain circumstances, from voting its shares of a corporation’s stock after crossing certain
ownership threshold percentages, unless the acquirer obtains approval of the target corporation’s disinterested stockholders.
The statute specifies three thresholds: (a) one-fifth or more but less than one-third, (b) one-third but less than a majority and
(c) a majority or more, of the outstanding voting power. Generally, once a person acquires shares in excess of any of the thresholds,
those shares and any additional shares acquired within 90 days thereof become “control shares” and such control shares
are deprived of the right to vote until disinterested stockholders restore the right. These provisions also provide that if control
shares are accorded full voting rights and the acquiring person has acquired a majority or more of all voting power, all other
stockholders who do not vote in favor of authorizing voting rights to the control shares are entitled to demand payment for the
fair value of their shares in accordance with statutory procedures established for dissenters’ rights.
A corporation may elect to not be governed by, or “opt
out” of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that the
opt-out election must be in place on the 10th day following the date an acquiring person has acquired a controlling interest, that
is, crossing any of the three thresholds described above. We have opted out of the control share statutes, and, provided the “opt
out” election remains in place, we will not be subject to the control share statutes.
The effect of the Nevada control share statute is that the acquiring
person, and those acting in association with the acquiring person, will obtain only such voting rights in the control shares as
are conferred by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable,
could have the effect of discouraging takeovers of us.
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities from time to time, in one or more
series, as either senior or subordinated debt or as senior or subordinated convertible debt. While the terms we have summarized
below will apply generally to any debt securities that we may offer under this prospectus, we will describe the particular terms
of any debt securities that we may offer in more detail in the applicable prospectus supplement. The terms of any debt securities
offered under a prospectus supplement may differ from the terms described below. Unless the context requires otherwise, whenever
we refer to the indenture, we are also referring to any supplemental indentures that specify the terms of a particular series of
debt securities.
We will issue the debt securities under the indenture that
we will enter into with the trustee named in the indenture. The indenture will be qualified under the Trust Indenture Act of 1939,
as amended (“Trust Indenture Act”). We have filed the form of indenture as an exhibit to the registration statement
of which this prospectus is a part, and supplemental indentures and forms of debt securities containing the terms of the debt
securities being offered will be filed as exhibits to the registration statement of which this prospectus is a part or will be
incorporated by reference from reports that we file with the SEC.
The following summary of material provisions of the debt securities
and the indenture is subject to, and qualified in its entirety by reference to, all of the provisions of the indenture applicable
to a particular series of debt securities. We urge you to read the applicable prospectus supplements and any related free writing
prospectuses related to the debt securities that we may offer under this prospectus, as well as the complete indenture that contains
the terms of the debt securities.
General Terms of the Indenture
The indenture does not limit the amount of debt securities that
we may issue. It provides that we may issue debt securities up to the principal amount that we may authorize and may be in any
currency or currency unit designated by us. Except for the limitations on consolidation, merger and sale of all or substantially
all of our assets contained in the indenture, the terms of the indenture do not contain any covenants or other provisions designed
to afford holders of any debt securities protection with respect to our operations, financial condition or transactions involving
us.
We may issue the debt securities issued under the indenture
as “discount securities,” which means they may be sold at a discount below their stated principal amount. These debt
securities, as well as other debt securities that are not issued at a discount, may, for U.S. federal income tax purposes, be
treated as if they were issued with “original issue discount” (“OID”) because of interest payment and
other characteristics. Special U.S. federal income tax considerations applicable to debt securities issued with original issue
discount will be described in more detail in any applicable prospectus supplement.
We will describe in the applicable prospectus supplement the
terms of the series of debt securities being offered, including:
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the title of the series of debt securities;
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any limit upon the aggregate principal amount that may be issued;
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the maturity date or dates;
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the form of the debt securities of the series;
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whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;
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whether the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination;
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if the price (expressed as a percentage of the aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the method by which any such portion will be determined;
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the interest rate or rates, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates;
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our right, if any, to defer payment of interest and the maximum length of any such deferral period;
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if applicable, the date or dates after which, or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions;
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the date or dates, if any, on which, and the price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;
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the denominations in which we will issue the series of debt securities, if other than denominations of $1,000, and any integral multiple thereof;
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any and all terms, if applicable, relating to any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms which may be advisable in connection with the marketing of debt securities of that series;
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whether the debt securities of the series will be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which such global security or securities may be exchanged in whole or in part for other individual securities; and the depositary for such global security or securities;
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if applicable, the provisions relating to conversion or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and the manner of settlement for any conversion or exchange;
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if other than the full principal amount thereof, the portion of the principal amount of debt securities of the series which will be payable upon declaration of acceleration of the maturity thereof;
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additions to or changes in the covenants applicable to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant;
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additions to or changes in the events of default with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if any, with respect to such securities to be due and payable;
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additions to or changes in or deletions of the provisions relating to covenant defeasance and legal defeasance;
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additions to or changes in the provisions relating to satisfaction and discharge of the indenture;
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additions to or changes in the provisions relating to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture;
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the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars;
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whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made;
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the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any, and principal amounts of the debt securities of the series to any holder that is not a “United States person” for federal tax purposes;
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any restrictions on transfer, sale or assignment of the debt securities of the series; and
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any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may be required by us or advisable under applicable laws or regulations.
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Conversion or Exchange Rights
We will set forth in the prospectus supplement the terms on
which a series of debt securities may be convertible into or exchangeable for our common stock or our other securities. We will
include provisions as to settlement upon conversion or exchange and whether conversion or exchange is mandatory, at the option
of the holder or at our option. We may include provisions pursuant to which the number of shares of our common stock or our other
securities that the holders of the series of debt securities receive would be subject to adjustment.
Consolidation, Merger or Sale
Unless we provide otherwise in the prospectus supplement applicable
to a particular series of debt securities, the indenture will not contain any covenant that restricts our ability to merge or consolidate,
or sell, convey, transfer or otherwise dispose of our assets as an entirety or substantially as an entirety. However, any successor
to or acquirer of such assets, other than a subsidiary of ours, must assume all of our obligations under the indenture or the debt
securities, as appropriate.
Events of Default Under the Indenture
Unless we provide otherwise in the prospectus supplement applicable
to a particular series of debt securities, the following are events of default under the indenture with respect to any series of
debt securities that we may issue:
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if we fail to pay any installment of interest on any debt securities of that series, as and when the same will become due and payable, and such default continues for a period of 90 days, provided that a valid extension of an interest payment period by us in accordance with the terms of any indenture supplemental thereto will not constitute a default in the payment of interest for this purpose;
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if we fail to pay the principal of (or premium, if any) on any debt securities of that series as and when the same will become due and payable whether at maturity, upon redemption, by declaration or otherwise, or in any payment required by any sinking or analogous fund established with respect to that series, provided, that a valid extension of the maturity of such debt securities in accordance with the terms of any indenture supplemental thereto will not constitute a default in the payment of principal or premium, if any;
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if we fail to observe or perform any other covenant or agreement with respect to that series contained in the indenture or otherwise established with respect to that series pursuant to the indenture, other than a covenant or agreement specifically included solely for the benefit of one or more debt securities other than that series, and our failure continues for 90 days after we receive written notice of such failure, requiring the same to be remedied and stating that such is a notice of default thereunder, from the trustee or holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency or reorganization occur.
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If an event of default with respect to debt securities of any
series occurs and is continuing, other than an event of default described in the last bullet point above, the trustee or the holders
of at least 25% in aggregate principal amount of the outstanding debt securities of that series, by notice to us in writing, and
to the trustee if notice is given by such holders, may declare the unpaid principal of (premium, if any) and accrued and unpaid
interest, if any, due and payable immediately. If an event of default specified in the last bullet point above occurs with respect
to us, the principal amount of and accrued interest, if any, of that series will be automatically due and payable without any declaration
or other action on the part of the trustee or any holder.
The holders of a majority in principal amount of the outstanding
debt securities of an affected series may waive any default or event of default with respect to the series and its consequences,
except defaults or events of default regarding payment of principal, premium, if any, or interest, unless we have cured the default
or event of default in accordance with the indenture. Any waiver will cure the default or event of default.
Subject to the terms of the indenture, if an event of default
under an indenture occurs and is continuing, the trustee will be under no obligation to exercise any of its rights or powers under
such indenture at the request or direction of any of the holders of the applicable series of debt securities, unless such holders
have offered the trustee reasonable indemnity. The holders of a majority in principal amount of the outstanding debt securities
of any series will have the right to direct the time, method and place of conducting any proceeding for any remedy available to
the trustee, or exercising any trust or power conferred on the trustee, with respect to the debt securities of that series, provided
that:
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the direction so given by the holder is not in conflict with any law or the applicable indenture; and
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subject to its duties under the Trust Indenture Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding.
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A holder of the debt securities of any series will have the
right to institute a proceeding under the indenture or to appoint a receiver or trustee, or to seek other remedies only if:
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the holder has given written notice to the trustee of a continuing event of default with respect to that series;
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the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made written request;
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such holders have offered to the trustee indemnity satisfactory to it against the costs, expenses and liabilities to be incurred by the trustee in compliance with the request; and
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the trustee does not institute the proceeding, and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other inconsistent directions within 90 days after the notice, request and offer.
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These limitations do not apply to a suit instituted by a holder
of debt securities if we default in the payment of the principal, premium, if any, or interest on, the debt securities.
We will periodically file statements with the trustee regarding
our compliance with specified covenants in the indenture.
Modification of Indenture; Waiver
We and the trustee may change an indenture without the consent
of any holders with respect to specific matters:
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to cure any ambiguity, defect or inconsistency in the indenture or in the debt securities of any series;
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to comply with the provisions described above under “Description of Debt Securities—Consolidation, Merger or Sale”;
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to provide for uncertificated debt securities in addition to or in place of certificated debt securities;
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to add to our covenants, restrictions, conditions or provisions such new covenants, restrictions, conditions or provisions for the benefit of the holders of all or any series of debt securities, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default or to surrender any right or power conferred upon us in the indenture;
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to add to, delete from or revise the conditions, limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication and delivery of debt securities, as set forth in the indenture;
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to make any change that does not adversely affect the interests of any holder of debt securities of any series in any material respect;
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to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided above under “Description of Debt Securities—General” to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities;
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to evidence and provide for the acceptance of appointment under any indenture by a successor trustee; or
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to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act.
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In addition, under the indenture, the rights of holders of a
series of debt securities may be changed by us and the trustee with the written consent of the holders of at least a majority in
aggregate principal amount of the outstanding debt securities of each series that is affected. However, unless we provide otherwise
in the prospectus supplement applicable to a particular series of debt securities, we and the trustee may make the following changes
only with the consent of each holder of any outstanding debt securities affected:
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extending the fixed maturity of any debt securities of any series;
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reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any series of any debt securities; or
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reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver.
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Discharge
Each indenture provides that we can elect to be discharged from
our obligations with respect to one or more series of debt securities, except for specified obligations, including obligations
to:
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provide for payment;
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register the transfer or exchange of debt securities of the series;
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replace stolen, lost or mutilated debt securities of the series;
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pay principal of and premium and interest on any debt securities of the series;
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maintain paying agencies;
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hold monies for payment in trust;
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recover excess money held by the trustee;
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compensate and indemnify the trustee; and
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appoint any successor trustee.
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In order to exercise our rights to be discharged, we must deposit
with the trustee money or government obligations sufficient to pay all the principal of, any premium, if any, and interest on,
the debt securities of the series on the dates payments are due.
Form, Exchange and Transfer
We will issue the debt securities of each series only in fully
registered form without coupons and, unless we provide otherwise in the applicable prospectus supplement, in denominations of $1,000
and any integral multiple thereof. The indenture provides that we may issue debt securities of a series in temporary or permanent
global form and as book-entry securities that will be deposited with, or on behalf of, The Depository Trust Company, or DTC, or
another depositary named by us and identified in a prospectus supplement with respect to that series. To the extent the debt securities
of a series are issued in global form and as book-entry, a description of terms relating will be set forth in the applicable prospectus
supplement.
At the option of the holder, subject to the terms of the indenture
and the limitations applicable to global securities described in the applicable prospectus supplement, the holder of the debt securities
of any series can exchange the debt securities for other debt securities of the same series, in any authorized denomination and
of like tenor and aggregate principal amount.
Subject to the terms of the indenture and the limitations applicable
to global securities set forth in the applicable prospectus supplement, holders of the debt securities may present the debt securities
for exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed thereon duly executed if so required
by us or the security registrar, at the office of the security registrar or at the office of any transfer agent designated by us
for this purpose. Unless otherwise provided in the debt securities that the holder presents for transfer or exchange, we will impose
no service charge for any registration of transfer or exchange, but we may require payment of any taxes or other governmental charges.
We will name in the applicable prospectus supplement the security
registrar, and any transfer agent in addition to the security registrar, that we initially designate for any debt securities. We
may at any time designate additional transfer agents or rescind the designation of any transfer agent or approve a change in the
office through which any transfer agent acts, except that we will be required to maintain a transfer agent in each place of payment
for the debt securities of each series.
If we elect to redeem the debt securities of any series, we
will not be required to:
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issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or
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register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part.
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Information Concerning the Trustee
The trustee, other than during the occurrence and continuance
of an event of default under an indenture, undertakes to perform only those duties as are specifically set forth in the applicable
indenture. Upon an event of default under an indenture, the trustee must use the same degree of care as a prudent person would
exercise or use in the conduct of his or her own affairs. Subject to this provision, the trustee is under no obligation to exercise
any of the powers given it by the indenture at the request of any holder of debt securities unless it is offered reasonable security
and indemnity against the costs, expenses and liabilities that it might incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement,
we will make payment of the interest on any debt securities on any interest payment date to the person in whose name the debt securities,
or one or more predecessor securities, are registered at the close of business on the regular record date for the interest.
We will pay principal of and any premium and interest on the
debt securities of a particular series at the office of the paying agents designated by us, except that unless we otherwise indicate
in the applicable prospectus supplement, we will make interest payments by check that we will mail to the holder or by wire transfer
to certain holders. Unless we otherwise indicate in the applicable prospectus supplement, we will designate the corporate trust
office of the trustee as our sole paying agent for payments with respect to debt securities of each series. We will name in the
applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular series.
We will maintain a paying agent in each place of payment for the debt securities of a particular series.
All money we pay to a paying agent or the trustee for the payment
of the principal of or any premium or interest on any debt securities that remains unclaimed at the end of two years after such
principal, premium or interest has become due and payable (or such shorter period set forth in applicable escheat, abandoned or
unclaimed property law) will be repaid to us, and the holder of the debt security thereafter may look only to us for payment thereof.
Governing Law
The indenture and the debt securities will be governed by and
construed in accordance with the laws of the State of New York, except to the extent that the Trust Indenture Act is applicable.
DESCRIPTION
OF WARRANTS
As of October 19, 2018, there were 12,655,577 shares of our
common stock that may be issued upon exercise of outstanding warrants.
We
may issue warrants for the purchase of our debt securities, common stock or preferred stock in one or more series. We may issue
warrants independently or together with our debt securities, common stock or preferred stock, and the warrants may be attached
to or separate from these securities.
We
will evidence each series of warrants by warrant certificates that we may issue under a separate agreement. We may enter into
a warrant agreement with a warrant agent. Each warrant agent may be a bank that we select which has its principal office in the
United States. We may also choose to act as our own warrant agent. We will indicate the name and address of any such warrant agent
in the applicable prospectus supplement relating to a particular series of warrants.
We
will describe in the applicable prospectus supplement the terms of the series of warrants, including:
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the
offering price and aggregate number of warrants offered;
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if
applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such security;
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if
applicable, the date on and after which the warrants and the related securities will be separately transferable;
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in
the case of warrants to debt securities, purchase common stock or preferred stock, the number or amount of shares of common
stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which and currency
in which these shares may be purchased upon such exercise;
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the
manner of exercise of the warrants, including any cashless exercise rights;
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the
warrant agreement under which the warrants will be issued;
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the
effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants;
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anti-dilution
provisions of the warrants, if any;
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the
terms of any rights to redeem or call the warrants;
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any
provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the
dates on which the right to exercise the warrants will commence and expire or, if the warrants are not continuously exercisable
during that period, the specific date or dates on which the warrants will be exercisable;
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the
manner in which the warrant agreement and warrants may be modified;
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the
identities of the warrant agent and any calculation or other agent for the warrants;
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federal
income tax consequences of holding or exercising the warrants;
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the
terms of the securities issuable upon exercise of the warrants;
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any
securities exchange or quotation system on which the warrants or any securities deliverable upon exercise of the warrants
may be listed or quoted; and
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any
other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including, in the case of warrants to purchase shares of our common stock or preferred stock, the right to receive dividends,
if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement,
holders of the warrants may exercise the warrants at any time up to 5:00 P.M. eastern time, the close of business, on the expiration
date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together
with specified information, and paying the required exercise price by the methods provided in the applicable prospectus supplement.
We will set forth on the reverse side of the warrant certificate, and in the applicable prospectus supplement, the information
that the holder of the warrant will be required to deliver to the warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities
purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we
will issue a new warrant certificate for the remaining amount of warrants.
Enforceability
of Rights By Holders of Warrants
Any
warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship
of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue
of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement
or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us.
Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate
legal action the holder’s right to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance
with their terms.
Warrant
Agreement Will Not Be Qualified Under Trust Indenture Act
No
warrant agreement will be qualified as an indenture, and no warrant agent will be required to qualify as a trustee, under the
Trust Indenture Act. Therefore, holders of warrants issued under a warrant agreement will not have the protection of the Trust
Indenture Act with respect to their warrants.
Governing
Law
Each
warrant agreement and any warrants issued under the warrant agreements will be governed by New York law.
DESCRIPTION
OF RIGHTS
We
may issue rights to our stockholders to purchase shares of our common stock or preferred stock. We may offer rights separately
or together with one or more additional rights, debt securities, preferred stock, common stock or warrants or any combination
of those securities in the form of units, as described in the applicable prospectus supplement. Each series of rights will be
issued under a separate rights agreement to be entered into between us and a bank or trust company, as rights agent. The rights
agent will act solely as our agent in connection with the certificates relating to the rights of the series of certificates and
will not assume any obligation or relationship of agency or trust for or with any holders of rights certificates or beneficial
owners of rights. The following description sets forth certain general terms and provisions of the rights to which any prospectus
supplement may relate. The particular terms of the rights to which any prospectus supplement may relate and the extent, if any,
to which the general provisions may apply to the rights so offered will be described in the applicable prospectus supplement.
To the extent that any particular terms of the rights, rights agreement or rights certificates described in a prospectus supplement
differ from any of the terms described below, then the terms described below will be deemed to have been superseded by that prospectus
supplement. We encourage you to read the applicable rights agreement and rights certificate for additional information before
you decide whether to purchase any of our rights.
We
will provide in a prospectus supplement the following terms of the rights being issued:
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the
date on which stockholders entitled to the rights distribution will be determined;
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the
aggregate number of shares of common stock or preferred stock purchasable upon exercise of the rights;
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the
exercise price;
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the
aggregate number of rights issued;
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the
date, if any, on and after which the rights will be separately transferable;
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the
date on which the ability to exercise the rights will commence, and the date on which such ability will expire;
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the
conditions to the completion of the offering, if any;
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the
withdrawal, termination and cancellation rights, if any;
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any
applicable material U.S. federal income tax considerations; and
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any
other terms of the rights, including terms, procedures and limitations relating to the distribution, exchange and exercise
of the rights.
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Each
right will entitle the holder of rights to purchase, for cash, the number of shares of our common stock or preferred stock at
the exercise price provided in the applicable prospectus supplement. Rights may be exercised at any time up to the close of business
on the expiration date for the rights provided in the applicable prospectus supplement.
Holders
may exercise rights as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly
completed and duly executed at the corporate trust office of the rights agent or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the shares of our common stock or preferred stock, as applicable, purchasable
upon exercise of the rights. If less than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed
securities directly to persons other than stockholders, to or through agents, underwriters or dealers or through a combination
of such methods, including pursuant to standby arrangements, as described in the applicable prospectus supplement.
DESCRIPTION
OF PURCHASE CONTRACTS
We
may issue purchase contracts, including contracts obligating holders to purchase from us, and for us to sell to holders, a specific
or variable number of our debt securities, shares of common stock, preferred stock, warrants or rights, or securities of an entity
unaffiliated with us, or any combination of the above, at a future date or dates. Alternatively, the purchase contracts may obligate
us to purchase from holders, and obligate holders to sell to us, a specific or variable number of our debt securities, shares
of common stock, preferred stock, warrants, rights or other property, or any combination of the above. The price of the securities
or other property subject to the purchase contracts may be fixed at the time the purchase contracts are issued or may be determined
by reference to a specific formula described in the purchase contracts. We may issue purchase contracts separately or as a part
of units each consisting of a purchase contract and one or more of our other securities described in this prospectus or securities
of third parties, including U.S. Treasury securities, securing the holder’s obligations under the purchase contract. The
purchase contracts may require us to make periodic payments to holders or vice versa and the payments may be unsecured or pre-funded
on some basis. The purchase contracts may require holders to secure the holder’s obligations in a manner specified in the
applicable prospectus supplement.
The
applicable prospectus supplement will describe the terms of any purchase contracts in respect of which this prospectus is being
delivered, including, to the extent applicable, the following:
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whether
the purchase contracts obligate the holder or us to purchase or sell, or both purchase and sell, the securities subject to
purchase under the purchase contract, and the nature and amount of each of those securities, or the method of determining
those amounts;
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the purchase contracts are to be prepaid;
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whether
the purchase contracts are to be settled by delivery, or by reference or linkage to the value, performance or level of the
securities subject to purchase under the purchase contract;
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any
acceleration, cancellation, termination or other provisions relating to the settlement of the purchase contracts;
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applicable federal income tax considerations; and
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whether
the purchase contracts will be issued in fully registered or global form.
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The
preceding description sets forth certain general terms and provisions of the purchase contracts to which any prospectus supplement
may relate. The particular terms of the purchase contracts to which any prospectus supplement may relate and the extent, if any,
to which the general provisions may apply to the purchase contracts so offered will be described in the applicable prospectus
supplement. To the extent that any particular terms of the purchase contracts described in a prospectus supplement differ from
any of the terms described above, then the terms described above will be deemed to have been superseded by that prospectus supplement.
We encourage you to read the applicable purchase contract for additional information before you decide whether to purchase any
of our purchase contracts.
DESCRIPTION
OF UNITS
We
may issue units comprised of one or more of the other securities described in this prospectus or any prospectus supplement in
any combination. Each unit will be issued so that the holder of the unit is also the holder, with the rights and obligations of
a holder, of each security included in the unit. The unit agreement under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately, at any time or at any times before a specified date or upon the
occurrence of a specified event or occurrence.
The
applicable prospectus supplement will describe:
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the
designation and the terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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any
unit agreement under which the units will be issued;
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any
provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units;
and
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whether
the units will be issued in fully registered or global form.
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PLAN
OF DISTRIBUTION
We
may sell the securities being offered pursuant to this prospectus to or through underwriters, through dealers, through agents,
or directly to one or more purchasers or through a combination of these methods. The securities may be distributed at a fixed
price or prices, which may be changed, market prices prevailing at the time of sale, prices related to the prevailing market prices,
or negotiated prices. The applicable prospectus supplement will describe the terms of the offering of the securities, including:
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the
name or names of any underwriters, if any, and if required, any dealers or agents;
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name or names of any managing underwriter or underwriters;
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the
purchase price of the securities and the net proceeds we will receive from the sale;
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delayed delivery arrangements;
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underwriting discounts, commissions and other items constituting underwriters’ compensation;
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discounts or concessions allowed or re-allowed or paid to dealers;
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commissions paid to agents; and
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securities exchange or market on which the securities may be listed or traded.
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Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
Sale
Through Underwriters or Dealers
If
underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name
of each underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation
of the underwriters and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting
syndicates represented by managing underwriters or directly by one or more investment banking firms or others, as designated.
If an underwriting syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement.
If underwriters are used in the sale, the offered securities will be acquired by the underwriters for their own accounts and may
be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or
at varying prices determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed
or paid to dealers may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations
of the underwriters to purchase the offered securities will be subject to conditions precedent, and the underwriters will be obligated
to purchase all of the offered securities, if any are purchased.
We
may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering
price, with additional underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms
of any over-allotment option will be set forth in the prospectus supplement for those securities.
If
we use a dealer in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will
sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to
be determined by the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified
in a prospectus supplement.
Direct
Sales and Sales Through Agents
We
may sell the 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, any agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by 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.
At-the-Market
Offerings
To
the extent that we make sales through one or more underwriters or agents in at-the-market offerings, we will do so pursuant to
the terms of a sales agency financing agreement or other at-the-market offering arrangement between us, on the one hand, and the
underwriters or agents, on the other. If we engage in at-the-market sales pursuant to any such agreement, we will issue and sell
our securities through one or more underwriters or agents, which may act on an agency basis or a principal basis. During the term
of any such agreement, we may sell securities on a daily basis in exchange transactions or otherwise as we agree with the underwriters
or agents. Any such agreement will provide that any securities sold will be sold at prices related to the then prevailing market
prices for our securities. Therefore, exact figures regarding proceeds that will be raised or commissions to be paid cannot be
determined at this time. Pursuant to the terms of the agreement, we may agree to sell, and the relevant underwriters or agents
may agree to solicit offers to purchase blocks of our common stock or other securities. The terms of any such agreement will be
set forth in more detail in the applicable prospectus or prospectus supplement.
Market
Making, Stabilization and Other Transactions
Unless
otherwise specified in the applicable prospectus supplement, any common stock sold pursuant to a prospectus supplement will be
eligible for listing on a national securities exchange, such as the NYSE MKT or NASDAQ, subject to official notice of issuance.
Any underwriters to whom securities are sold by us for public offering and sale may make a market in the securities, but such
underwriters will not be obligated to do so and may discontinue any market making at any time without notice.
To
facilitate a public offering of a series of securities, persons participating in the offering may engage in transactions that
stabilize, maintain, or otherwise affect the market price of the securities. This may include over-allotments or short sales of
the securities, which involves the sale by persons participating in the offering of more securities than have been sold to them
by us. In addition, those 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 underwriters or dealers participating in
any such 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. Such transactions, if commenced, may be discontinued at any time. We make no representation
or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented, may have on
the price of our securities.
General
Information
In
connection with the sale of the securities, underwriters, dealers or agents may receive compensation from us or from purchasers
of the securities for whom they act as agents, in the form of discounts, concessions or commissions. Underwriters may sell the
securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions
from the underwriters or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that
participate in the distribution of the securities, and any institutional investors or others that purchase securities directly
for the purpose of resale or distribution, may be deemed to be underwriters, and any discounts or commissions received by them
from us and any profit on the resale of the common stock by them may be deemed to be underwriting discounts and commissions under
the Securities Act of 1933, as amended.
We
may provide agents, underwriters and other purchasers with indemnification against particular civil liabilities, including liabilities
under the Securities Act of 1933, as amended, or contribution with respect to payments that the agents, underwriters or other
purchasers may make with respect to such liabilities. Agents and underwriters may engage in transactions with, or perform services
for, us in the ordinary course of business.
In
order to comply with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus will
be sold in those states only through registered or licensed brokers or dealers. In addition, in some states securities may not
be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or
qualification requirement is available and complied with.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon by Fennemore Craig, P.C., Reno, Nevada. Additional legal
matters may be passed upon for us or any underwriters, dealers or agents by counsel that we will name in the applicable prospectus
supplement.
EXPERTS
The financial statements incorporated in this prospectus
by reference to the Annual Report on Form 10-K for the fiscal year ended June 30, 2018 have been so incorporated in reliance on
the reports of GBH CPAs, PC, and Marcum LLP, related to the consolidated financial statements for the years ended June 30, 2017
and 2018, respectively, each an independent registered public accounting firm, given on the authority of said firm as experts
in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and in accordance therewith
file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission
(the “SEC”). Such reports, proxy statements and other information can be read and copied at the SEC’s public
reference facilities at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-732-0330 for further information
on the operation of the public reference facilities. In addition, the SEC maintains a website that contains reports, proxy and
information statements and other information regarding registrants that file electronically with the SEC. The address of the SEC’s
website is www.sec.gov.
We
make available free of charge on or through our website at www.relmada.com, our Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material
with or otherwise furnish it to the SEC.
We
have filed with the SEC a registration statement under the Securities Act of 1933, as amended, relating to the offering of these
securities. The registration statement, including the attached exhibits, contains additional relevant information about us and
the securities. This prospectus does not contain all of the information set forth in the registration statement. You can obtain
a copy of the registration statement, at prescribed rates, from the SEC at the address listed above, or for free at www.sec.gov.
The registration statement and the documents referred to below under “Incorporation of Certain Information By Reference”
are also available on our website, www.relmada.com.
We
have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to incorporate by reference into this prospectus certain information we file with it, which means that we can disclose
important information to you by referring you to those documents. The information incorporated by reference is considered to be
a part of this prospectus, and information that we later file with the SEC will automatically update and supersede information
contained in this prospectus and any accompanying prospectus supplement. We incorporate by reference the documents listed below
and any future documents (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the SEC pursuant
to Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, subsequent to the date of this prospectus
and prior to the termination of the offering:
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Our
Annual Report on Form 10-K as of June 30, 2018, filed with the SEC on September 28, 2018;
and
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on October
18, 2018; and
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The
description of our common stock, which is contained in our Current Report on Form 8-K,
filed with the SEC on May 27, 2014.
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All
filings filed by us pursuant to the Securities Exchange Act of 1934, as amended, after the date of the initial filing of this
registration statement and prior to the effectiveness of such registration statement (excluding information furnished pursuant
to Items 2.02 and 7.01 of Form 8-K) shall also be deemed to be incorporated by reference into the prospectus. Any statements contained
in a previously filed document incorporated by reference into this prospectus is deemed to be modified or superseded for purposes
of this prospectus to the extent that a statement contained in this prospectus, or in a subsequently filed document also incorporated
by reference herein, modifies or supersedes that statement.
This
prospectus may contain information that updates, modifies or is contrary to information in one or more of the documents incorporated
by reference in this prospectus. You should rely only on the information incorporated by reference or provided in this prospectus.
We have not authorized anyone else to provide you with different information. You should not assume that the information in this
prospectus is accurate as of any date other than the date of this prospectus or the date of the documents incorporated by reference
in this prospectus.
We
will provide without charge to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, upon
written or oral request, a copy of any or all of the information that has been incorporated by reference in this prospectus but
not delivered with this prospectus (other than an exhibit to these filings, unless we have specifically incorporated that exhibit
by reference in this prospectus). Any such request should be addressed to us at: 750 3rd Avenue, 9
th
Floor, New York,
New York 10017, Attention: Sergio Traversa, Chief Executive Officer, or made by phone at (212) 547-9591. You may also access the
documents incorporated by reference in this prospectus through our website at www.relmada.com. Except for the specific incorporated
documents listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus
or the registration statement of which it forms a part.
The
information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we
are not soliciting offers to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED OCTOBER 19, 2018
PROSPECTUS
SUPPLEMENT
Up
to $75,000,000
Common
Stock
We
have entered into a Controlled Equity Offering
SM
sales agreement with Cantor Fitzgerald & Co. relating to
shares of our common stock offered by this prospectus supplement and the accompanying prospectus. In accordance with the terms
of the sales agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $75,000,000
from time to time through Cantor Fitzgerald & Co., acting as agent.
Our
common stock is listed on the OTCQB under the symbol “RLMD.” On October 15, 2018, the last reported sale price of
our common stock on the OTCQB was $1.13 per share.
Sales
of our common stock, if any, under this prospectus supplement and the accompanying prospectus may be made in sales deemed to be
“at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended,
or the Securities Act, including sales made directly on or through the NASDAQ Capital Market, the existing trading market for
our common stock, sales made to or through a market maker other than on an exchange or otherwise, in negotiated transactions at
market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted
by law. Cantor Fitzgerald & Co. will act as sales agent on a best effort basis and use commercially reasonable efforts to
sell on our behalf all of the shares of common stock requested to be sold by us, consistent with its normal trading and sales
practices, on mutually agreed terms between Cantor Fitzgerald & Co. and us. There is no arrangement for funds to be received
in any escrow, trust or similar arrangement.
Cantor
Fitzgerald & Co. will be entitled to compensation at a fixed commission rate of 3.0% of the gross sales price per share sold.
In connection with the sale of the common stock on our behalf, Cantor Fitzgerald & Co. will be deemed to be an “underwriter”
within the meaning of the Securities Act, and the compensation of Cantor Fitzgerald & Co. will be deemed to be underwriting
commissions or discounts.
Investing
in our securities involves a high degree of risk. Before making an investment decision, please read the information contained
in or incorporated by reference under the heading “Risk Factors” beginning on page S-9 of this prospectus supplement,
on page 6 of the accompanying prospectus and in the documents incorporated by reference into this prospectus supplement.
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. Any representation to the contrary is a criminal offense.
The
date of this prospectus supplement is , 2018
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS SUPPLEMENT
This
prospectus supplement and the accompanying prospectus relates to the offering of our common stock. Before buying any of the common
stock that we are offering, we urge you to carefully read this prospectus supplement, the accompanying prospectus, any free writing
prospectus that we have authorized for use in connection with this offering, together with the information incorporated by reference
as described under the heading “Where You Can Find More Information” and “Incorporation of Certain Information
by Reference.” These documents contain important information that you should consider when making your investment decision.
This
document is comprised of two parts. The first part is this prospectus supplement, which describes the specific terms of this offering
and also adds to, and updates information contained in, the accompanying prospectus and the documents incorporated by reference
into this prospectus supplement and the accompanying prospectus. The second part, the accompanying prospectus, including the documents
incorporated by reference into the accompanying prospectus, provides more general information, some of which may not apply to
this offering. Generally, when we refer to this prospectus, we are referring to the combined document consisting of this prospectus
supplement and the accompanying prospectus. In this prospectus supplement, as permitted by law, we “incorporate by reference”
information from other documents that we file with the Securities and Exchange Commission, or the Commission. This means that
we can disclose important information to you by referring to those documents. The information incorporated by reference is considered
to be a part of this prospectus supplement and the accompanying prospectus and should be read with the same care. When we make
future filings with the Commission to update the information contained in documents that have been incorporated by reference,
the information included or incorporated by reference in this prospectus supplement is considered to be automatically updated
and superseded. In other words, in case of a conflict or inconsistency between information contained in this prospectus supplement
and information in the accompanying prospectus or incorporated by reference into this prospectus supplement, you should rely on
the information contained in the document that was filed later.
You
should only rely on the information contained or incorporated by reference in this prospectus supplement, the accompanying prospectus,
and any free writing prospectus that we have authorized for use in connection with this offering. No person has been authorized
to give any information or make any representations in connection with this offering other than those contained or incorporated
by reference in this prospectus supplement, the accompanying prospectus, and any related free writing prospectus in connection
with the offering described herein and therein, and, if given or made, such information or representations must not be relied
upon as having been authorized by us. This prospectus supplement, the accompanying prospectus and any related free writing prospectus
shall not constitute offers to sell or solicitations of an offer to buy offered securities in any jurisdiction in which it is
unlawful for such person to make such an offering or solicitation. This prospectus supplement does not contain all of the information
included in the registration statement. For a more complete understanding of the offering of the securities, you should refer
to the registration statement, including its exhibits.
You
should read the entire prospectus supplement, the accompanying prospectus and any related free writing prospectus, as well as
the documents incorporated by reference into this prospectus supplement, the accompanying prospectus or any related free writing
prospectus, before making an investment decision. You should assume that the information appearing in this prospectus supplement,
the accompanying prospectus, the documents incorporated by reference into this prospectus supplement and the accompanying prospectus,
and in any free writing prospectus that we have authorized for use in connection with this offering, is accurate only as of the
date of those respective documents, regardless of the time of delivery of this prospectus supplement and accompanying prospectus
or any sale of securities. Our business, financial condition, results of operations and prospects may have changed since that
date.
Unless
the context otherwise requires, as used in this prospectus supplement, “we,” “us,” “Relmada,”
“the Company” and “our” refer to Relmada Therapeutics, Inc., a Nevada corporation.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary provides an overview of selected information contained elsewhere or incorporated by reference in this prospectus and does
not contain all of the information you should consider before investing in our common stock. You should carefully read the prospectus,
the information incorporated by reference and the registration statement of which this prospectus is a part in their entirety
before investing in our common stock, including the information discussed under “Risk Factors” in this prospectus
and the documents incorporated by reference and our financial statements and notes thereto that are incorporated by reference
in this prospectus. As used in this prospectus, unless the context otherwise indicates, the terms “we,” “our,”
“us,” or “the Company” refer to Relmada Therapeutics, Inc., a Nevada corporation, and its subsidiaries
taken as a whole.
The
Company
Business
Overview
We
are a clinical-stage, publicly traded biotechnology company focused on the development of d-methadone (dextromethadone, REL-1017),
an N-methyl-D-aspartate (NMDA) receptor antagonist. d-methadone is a new chemical entity that potentially addresses areas of high
unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.
Our
lead product candidate, d-methadone, is a New Chemical Entity (NCE) being developed as a rapidly acting, oral agent for the treatment
of depression and other potential indications. We have completed Phase I single and multiple ascending dose studies. A Phase II
study in major depressive disorder is ongoing, with first patient dosed in June 2018, and we expect to have top line results in
the first half of 2019.
NMDA
receptors are present in many parts of the central nervous system and play important roles in regulating neuronal activity. We
believe that dextromethadone acting as a NMDA receptor antagonist can have potential applications in a number of disease indications
which mitigates risk and offers significant upside.
In
addition, the Company has a portfolio of three 505b2 product candidates at various stages of development. These products are:
LevoCap ER (REL-1015), an abuse resistant, sustained release dosage form of the opioid analgesic levorphanol; BuTab (oral buprenorphine,
REL-1028), an oral dosage form of the opioid analgesic buprenorphine; and MepiGel (topical mepivacaine, REL-1021), an orphan drug
designated topical formulation of the local anesthetic mepivacaine
d-methadone
(dextromethadone, REL-1017) and Treatment-Resistant Depression (TRD)
Background
In
2014, the National Institute of Mental Health (NIMH) estimated that 15.7 million adults aged 18 or older in the United States
had at least one major depressive episode in the past year. According to data from nationally representative surveys supported
by NIMH, only about half of Americans diagnosed with major depression in a given year receive treatment. Of those receiving treatment
with as many as four different standard antidepressants, 33% of drug-treated depression patients do not achieve adequate therapeutic
benefits according to the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial published in the American Journal
of Psychiatry. Accordingly, we believe that approximately 3 million patients with such treatment-resistant depression are in need
of new treatment options.
In
addition to the high failure rate, none of the marketed products for depression can demonstrate rapid antidepressant effects and
most of the products take up to a month to show effectiveness. The urgent need for improved, faster acting antidepressant treatments
is underscored by the fact that severe depression can be life-threatening, due to heightened risk of suicide.
Recent
studies have shown that ketamine, a drug known previously as an anesthetic, can lift depression in many patients within hours.
Like d-methadone, ketamine is an NMDA receptor antagonist. However, it is unlikely that ketamine itself will become a practical
treatment for most cases of depression. It must be administered through intravenous infusion or intranasally, requiring a hospital
setting, and more importantly can potentially trigger adverse side effects including psychedelic symptoms (hallucinations, memory
defects, panic attacks), nausea/vomiting, somnolence, cardiovascular stimulation and, in a minority of patients, hepatoxicity.
Ketamine also hasn’t been thoroughly studied for long-term safety and effectiveness, and the U.S. Food and Drug Administration,
or FDA, hasn’t approved it to treat depression.
d-methadone
Overview and Mechanism of Action
d-methadone’s
mechanism of action, as a non-competitive NMDA channel blocker or antagonist, is fundamentally differentiated from all currently
FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively with standard, FDA-approved antidepressants.
Working through the same brain mechanisms as ketamine but potentially lacking its adverse side effects, Relmada’s d-methadone
is being developed as a rapidly acting, oral agent for the treatment of depression and/or other potential CNS pathological conditions.
In
chemistry an enantiomer, also known as an optical isomer, is one of two stereoisomers that are mirror images of each other that
are non-superposable (not identical), much as one’s left and right hands are the same except for being reversed along one
axis. A racemic compound, or racemate, is one that has equal amounts of left- and right-handed enantiomers of a chiral molecule.
For racemic drugs, often only one of a drug’s enantiomers is responsible for the desired physiologic effects, while the
other enantiomer is less active or inactive.
Racemic
methadone has been used since the 1950s as a treatment for opioid addiction and has remained the primary therapy for this condition
for more than 40 years. Methadone is a highly lipophilic molecule that is suitable for a variety of administration routes, with
oral bioavailability close to 80%.
As
a single isomer of racemic methadone, d-methadone has been shown to possess NMDA antagonist properties with virtually no traditional
opioid or ketamine-like adverse events at the expected therapeutic doses. In contrast, racemic methadone is associated with common
opioid side effects that include anxiety, nervousness, restlessness, sleep problems (insomnia), nausea, vomiting, constipation,
diarrhea, drowsiness, and others. It has been shown that the left (levo) isomer, l-methadone, is largely responsible for methadone’s
opioid activity, while the right (dextro) isomer, d-methadone, is much less active as an opioid while maintaining affinity for
the NMDA receptor.
NMDA
receptors are present in many parts of the central nervous system and play important roles in regulating neuronal activity and
promoting synaptic plasticity in brain areas important for cognitive functions such as executive function, learning and memory.
Based on these premises, d-methadone could show benefits in several different CNS indications.
d-methadone
Phase 1 Clinical Safety Studies
The
safety data from two Company-funded d-methadone Phase I clinical safety studies and a third study conducted by researchers at
Memorial Sloan-Kettering Cancer Center indicate that d-methadone was safe and well tolerated in both healthy subjects and cancer
patients at all projected therapeutic doses tested.
In
November 2014, Health Canada approved a Clinical Trial Application (“CTA”) to conduct the first Phase I study with
d-methadone. This was a Single Ascending Dose (“SAD”) study and was followed by a Multiple Ascending Dose (“MAD”)
study, both in healthy volunteers. The two studies were designed to assess the safety, tolerability and pharmacokinetics of d-methadone
in healthy, opioid-naïve subjects. The SAD study included single escalating oral doses of d-methadone to determine the maximum
tolerated dose, defined as the highest dose devoid of unacceptable adverse events. In the MAD study, healthy subjects received
daily oral doses of d-methadone for several days to assess its safety, pharmacokinetics and tolerability. In March 2015, we reported
that d-methadone demonstrated an acceptable safety profile with no dose limiting side effects after four cohorts were exposed
to increasing higher doses. In April 2015, the Company received clearance from Health Canada to continue with dose escalation
and explore even higher single doses of d-methadone. In June 2015, the Company successfully completed the SAD study identifying
the maximum tolerated dose and subsequently received a No Objection Letter (NOL) from Health Canada to conduct the MAD clinical
study in August 2015. The MAD study was completed in January 2016 and the results successfully demonstrated a potential therapeutic
dosing regimen for d-methadone with a favorable side effect and tolerability profile. The data from these studies was used to
design a Phase 2a study in patients with depression.
d-methadone
In Vivo Studies for Depression
In
May 2016, we announced the results of an in vivo study showing that administration of d-methadone results in antidepressant-like
effects in a well-validated animal model of depression, known as the forced swim test (FST), providing preclinical support for
its potential as a novel treatment of depression.
According
to the Journal of Visualized Experiments, the FST is based on the assumption that when placing an animal in a container filled
with water, it will first make efforts to escape by swimming or climbing, but eventually will exhibit “immobility”
that may be considered to reflect a measure of behavioral despair. This test has been extensively used because it involves the
exposure of the animals to stress, which was shown to have a role in the tendency for major depression. Additionally, the FST
has been shown to be influenced by some of the factors that are altered by or worsen depression in humans, including changes in
food consumption and sleep abnormalities. The main advantages of this procedure are that it is relatively easy to perform and
that its results are easily and quickly analyzed. Importantly, the FST’s sensitivity to a broad range of antidepressant
drugs makes it a suitable screening test and is one of the most important features leading to its high predictive validity.
In
the Company’s FST study, male Sprague Dawley rats were administered single doses of placebo, ketamine, or d-methadone on
day one (after habituation; 24 hours prior to forced swim testing). At all doses tested, d-methadone significantly decreased immobility
of the rats compared to the placebo, suggesting antidepressant-like activity. In addition, the effect of d-methadone on immobility
at the two highest doses tested was larger than the effect seen with ketamine. Moreover, the effects of d-methadone in the forced
swim test were not caused by a stimulant effect on spontaneous locomotor activity of the rats. Locomotor activity of lab animals
is often monitored to assess the behavioral effects of drugs.
In
September 2017 we completed two additional in vivo studies to confirm and support the antidepressant-like effect of dextromethadone
in validated animal models, the Novelty Suppressed Feeding Test (NSFT) and the Female Urine-Sniffing test (FUST) test. The studies
were performed by Professor Ronald S. Duman, Ph.D. at Yale University School of Medicine.
For
FUST, rats are first exposed to a cotton tip dipped in tap water and later exposed to another cotton tip infused with fresh female
urine. Male behavior was video recorded and total time spent sniffing the cotton-tipped applicator is determined. For NSFT, rats
were food deprived for 24 hr and then placed in an open field with food pellets in the center; latency to eat is recorded in seconds.
As a control, food consumption in the home cage is quantified. Rats were administered vehicle, ketamine or d-methadone.
The
results of the FUST demonstrate that administration of ketamine significantly increases the time male rats spent engaged in sniffing
female urine compared to vehicle group. Similarly, a single dose of d-methadone significantly increased the time spent sniffing
female urine compared to vehicle. In contrast, ketamine or d-methadone had no effect on time sniffing water, demonstrating that
the effect of drug treatment was specific to the rewarding effects of female urine. The results of the NSFT demonstrate that a
single dose of ketamine significantly decreases the latency to eat in a novel open field. Similarly, a single dose of d-methadone
also significantly decreased the latency to enter and eat in the novel feed. In contrast, neither ketamine nor methadone influenced
latency to feed in the home cage.
These
findings demonstrate that ketamine and d-methadone produce rapid antidepressant actions in the FUST and NSFT, effects that are
only observed after chronic administration of an SSRI antidepressant.
A
separate in vitro electrophysiology study of d-methadone was conducted using 2 subtypes of cloned human NMDA receptors.
The
results of this study demonstrated functional antagonist activity with d-methadone comparable to that of both racemic ketamine
and the isomer [S]-ketamine.
Phase
II Program for d-methadone in Depression
Combined
with the results of our Phase I studies, the encouraging results of in vivo and in vitro studies strongly support further evaluation
of d-methadone in a Phase II study as a rapidly acting, oral agent for the treatment of major depressive disorder. Relmada filed
an Investigational New Drug (“IND”) application for the Phase II study with the FDA, which was accepted on January
25, 2017.
On
April 13, 2017, we announced that the FDA granted Fast Track designation for d-methadone (REL-1017 dextromethadone) for the adjunctive
treatment of major depressive disorder. Fast Track designation is a process designed to facilitate the development and expedite
the review of drugs to treat serious conditions and fill an unmet medical need. The purpose, according to the FDA, is to get important
new drugs to the patient earlier. Drugs that receive Fast Track designation may be eligible for more frequent meetings and written
communications with the FDA, accelerated review and priority approval, and rolling New Drug Application review.
On
January 17, 2018 we announced that Relmada had acquired the global rights to develop and market dextromethadone for the treatment
of neurological conditions including certain rare diseases with symptoms affecting the CNS.
In
February 2018 Relmada initiated its Phase II study of d-methadone in patients with major depressive disorder.
d-methadone
(dextromethadone, REL-1017) in other indications
In
addition to developing dextromethadone in major depression, Relmada is initiating work in additional indications. In particular,
we have initiated a preclinical program to test the potential efficacy of dextromethadone in Rett syndrome. Rett syndrome is an
X-linked neurodevelopmental disorder with high unmet need caused by Mecp2 gene mutation. Loss of Mecp2 disrupts synaptic function
and structure and neuronal networks. Rett syndrome is an Orphan Disease affecting ~15,000 in U.S., primarily girls, with no approved
therapy. The disease begins with a short period of developmental stagnation, then rapid regression in language and motor skills,
followed by long-term stability.
Studies
of ketamine, a NMDAR antagonist with mechanistic similarities with dextromethadone, in Rett Syndrome mouse models show that low-dose
ketamine acutely reverses multiple disease manifestations and chronic administration of ketamine improves Rett Syndrome progression,
providing a solid rationale to pursue this indication with dextromethadone.
Other
indications that Relmada may explore in the future, potentially includes restless leg syndrome, ALS and ophthalmology.
In
January 2018, we entered into an Intellectual Property Assignment Agreement (the “Assignment Agreement”) and License
Agreement (the “License Agreement” and together with the Assignment Agreement, the “Agreements”) with
Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (collectively, the “Licensor”). Pursuant to the Agreements, Relmada
assigned its existing rights, including patents and patent applications, to d-methadone in the context of psychiatric use (the
“Existing Invention”) to Licensor. Licensor then granted Relmada under the License Agreement a perpetual, worldwide,
and exclusive license to commercialize the Existing Invention and certain further inventions regarding d-methadone in the context
of other indications such as those contemplated above.
LevoCap
ER (REL-1015)
LevoCap
ER (REL-1015) is a novel version of a proven drug product. LevoCap ER -is an extended release, abuse deterrent, and proprietary
formulation of levorphanol (levo-3-hydroxy-N-methyl-morphinan), a unique, broad spectrum opioid with additional “non-opioid”
mechanisms of action. In particular, levorphanol binds to all three opioid receptor subtypes involved in analgesia (mu, kappa,
and delta), the NMDA receptor, and the norepinephrine and serotonin reuptake pumps, whereas morphine, oxycodone, hydrocodone,
and other opioids are highly selective for the mu receptor subtype. Due to its multi-modal mechanism of action, levorphanol could
achieve analgesia in patients resistant to other strong opioids. In clinical studies, levorphanol has demonstrated a remarkably
broad spectrum of analgesic activity against many different types of pain including neuropathic pain, post-surgical pain, and
chronic pain in patients refractory to other opioids.
Levorphanol
is a potent opioid analgesic first introduced in the U.S. around 1953 for the treatment of moderate to severe pain where an opioid
analgesic is appropriate. Extended-release (long-acting opioid) agents may be preferable to immediate release formulations due
to better patient adherence, less dose-watching, and result in improved sleep. Both immediate- and extended-release opioids can
potentially be crushed to produce concentrated drug with greater appeal to abusers. Intentional crushing or extracting the active
ingredient from the extended-release dosage form by addicts and recreational drug users can destroy the timed-release mechanism
and result in a rapid surge of drug into the bloodstream for the purpose of achieving a high or euphoric feeling. Serious side
effects and death have been reported from such misuse.
LevoCap
ER is the first product candidate utilizing SECUREL™, Relmada’s proprietary abuse deterrent extended release technology
for opioid drugs. SECUREL dosage forms cannot be easily crushed for inhalation or to obtain rapid euphoria from high blood levels
when swallowed. It is also exceedingly difficult for intravenous abusers to extract the active drug from the dosage form using
common solvents, including alcohol.
LevoCap
ER can be developed under the 505(b)(2) regulatory pathway. Following an exchange of correspondence and meeting with the FDA in
January 2017, we have defined a path forward for the Phase 3 clinical study for LevoCap ER and a new drug application (“NDA”)
filing. In light of the promising data generated by Relmada’s d-methadone research program, and Relmada’s focus on
the d-methadone program, Relmada is currently limiting the investments in LevoCap ER.
BuTab
(REL-1028)
BuTab
(REL-1028) represents a novel formulation of oral, modified release buprenorphine as a potential therapeutic for both chronic
pain and opioid dependence. Buprenorphine has been widely used by the sublingual and transdermal routes of administration, but
was believed to be ineffective by the oral route because of poor oral bioavailability. We have completed a preclinical program
to better define the pharmacokinetic profile of BuTab and to assess the time course of systemic absorption of buprenorphine using
several different oral modified release formulations of buprenorphine in dogs, compared to an intravenous administration. Based
on the results of this work, we obtained approval from Health Canada and initiated a Phase I pharmacokinetic study in healthy
volunteers in the second quarter of 2015. This trial was completed in the fourth quarter of 2015. The absolute bioavailability
of BuTab relative to intravenous (IV) administration exceeded published data with non-modified buprenorphine when administered
orally and compares favorably with a currently marketed transdermal patch. There were no safety or tolerability issues. The data
generated by this study will guide formulation optimization and inform the design of subsequent clinical pharmacology studies.
BuTab can be developed under the 505(b)(2) regulatory pathway. In light of the promising data generated by Relmada’s d-methadone
research program, and Relmada’s focus on the d-methadone program, Relmada is currently limiting the investments in BuTab.
MepiGel
(REL-1021)
MepiGel
(REL-1021), is a proprietary topical dosage form of the local anesthetic mepivacaine for the treatment of painful peripheral neuropathies,
such as painful diabetic neuropathy, postherpetic neuralgia and painful HIV-associated neuropathy. Mepivacaine is an anesthetic
(numbing medicine) that blocks the nerve impulses that send pain signals to the brain. It is chemically related to bupivacaine
but pharmacologically related to lidocaine. Mepivacaine is currently indicated for infiltration, nerve block and epidural anesthesia.
Relmada has received two FDA Orphan Drug Designations for mepivacaine, one each for “the treatment of painful HIV-associated
neuropathy” and for “the management of postherpetic neuralgia,” or PHN. We have selected the formulations to
be advanced into clinical studies for MepiGel after the evaluation of results from in vitro and ex vivo studies comparing various
topical prototypes of mepivacaine that were conducted by MedPharm Ltd, a specialist formulation development company recognized
internationally for its expertise in topical and transdermal products. Multiple toxicology studies were successfully conducted
and completed in 2015. MepiGel can be developed under the 505(b)(2) regulatory pathway. In light of the promising data generated
by Relmada’s d-methadone research program, and Relmada’s focus on the d-methadone program, Relmada is currently limiting
the investments in MepiGel.
Overview
of the 505(b)(2) Pathway
Part
of our strategy is the utilization of FDA’s 505(b)(2) new drug application process, (“NDA”) for approval. The
505(b)(2) NDA is one of three FDA drug approval pathways and represents an appealing regulatory strategy for many companies. The
pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and
Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed
on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission
to rely on data not developed by the NDA applicant.
A
505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval,
such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant.
This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such
as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.
Overview
of Orphan Drug Status
In
accordance with laws and regulations pertaining to the Regulatory Agencies, a sponsor may request that the Regulatory Agencies
designate a drug intended to treat a “Rare Disease or Condition” as an “Orphan Drug.” For example, in
the United States, a “Rare Disease or Condition” is defined as one which affects less than 200,000 people in the United
States, or which affects more than 200,000 people but for which the cost of developing and making available the product is not
expected to be recovered from sales of the product in the United States. Upon the approval of the first NDA or BLA for a drug
designated as an orphan drug for a specified indication, the sponsor of that NDA or BLA is entitled to 7 years of exclusive marketing
rights in the United States unless the sponsor cannot assure the availability of sufficient quantities to meet the needs of persons
with the disease. In Europe, this exclusivity is 10 years, and in Australia it is 5 years. However, orphan drug status is particular
to the approved indication and does not prevent another company from seeking approval of an off-patent drug that has other labeled
indications that are not under orphan or other exclusivities. Orphan drugs may also be eligible for federal income tax credits
for costs associated with such as the disease state, the strength and complexity of the data presented, the novelty of the target
or compound, risk-management approval and whether multiple rounds of review are required for the agency to evaluate the submission.
There is no guarantee that a potential treatment will receive marketing approval or that decisions on marketing approvals or treatment
indications will be consistent across geographic areas.
Research
and Development Expenses
A
significant portion of our operating expenses is related to research and development and we intend to maintain our strong commitment
to research and development. Total research and development spending for the year ended June 30, 2018 was approximately $2,942,600,
as compared to $1,293,500 for the same period of 2017, an increase of $1,649,100.
Corporate
and Other Information
Our
principal executive offices are located at 750 3rd Avenue, 9
th
floor, New York, New York 10017. Our telephone number
is (212) 547-9591. Our website address is www.relmada.com. Information accessed through our website is not incorporated into this
prospectus and is not a part of this prospectus.
THE
OFFERING
Common
stock offered by us pursuant to this prospectus supplement
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Shares
of our common stock having an aggregate offering price of up to $75,000,000.
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Common
stock to be outstanding after this offering
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Up
to 93,297,668 shares (as more fully described in the notes following this table), assuming sales of 66,371,681 shares of our
common stock in this offering at an offering price of $1.13 per share, which was the last reported sale price of our
common stock on The OTCQB on October 15, 2018. The actual number of shares issued will vary depending on the sales price
under this offering.
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Manner
of offering
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“At-the-market
offering” that may be made from time to time through our sales agent, Cantor Fitzgerald & Co. See “Plan of
Distribution” on page S-14.
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Use
of Proceeds
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We
currently intend to use the net proceeds from this offering, if any, for general corporate purposes, including capital expenditures,
the advancement of our drug candidates in clinical trials, preclinical trials and working capital.
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See
the section entitled “Use of Proceeds” on page S-11.
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Risk
Factors
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Investing
in our securities involves a high degree of risk. Before making an investment decision, you should read the information contained
in or incorporated by reference under the heading “Risk Factors” beginning on page S-9 of this prospectus supplement,
on page 6 of the accompanying prospectus and in the documents incorporated by reference into this prospectus supplement.
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OTCQB
symbol
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Our
common stock currently trades on the OTCQB under the symbol “RLMD”. We have applied to list our common stock on
the NASDAQ Capital Market under the same symbol. There can be no assurance, however, that our application will be accepted.
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The
number of shares of common stock to be outstanding after this offering is based on 26,614,879 shares of common stock outstanding
as of October 19, 2018, and excludes, in each case as of October 19, 2019:
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3,068,865 shares of common stock issuable
upon the exercise of outstanding stock options having a weighted-average exercise price of $1.45 per share;
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12,655,577 shares of common stock issuable
upon the exercise of outstanding stock warrants having a weighted-average exercise price of $3.41 per share;
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3,542,903 shares of common stock reserved
for issuance pursuant to future awards under our Amended 2014 Stock and Equity Option Incentive Plan, as well as any automatic
increases in the number of shares of our common stock reserved for future issuance under this plan.
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Unless
otherwise stated, all information contained in this sales agreement prospectus supplement reflects an assumed public offering
price of $1.13 per share, which was the last reported sale price of our common stock on The OTCQB on October 15, 2018.
RISK
FACTORS
An
investment in our common stock involves a high degree of risk. Before deciding whether to invest in our common stock, you should
carefully consider the risks and uncertainties described below, together with the information under the heading “Risk Factors”
in our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2018, all of which are incorporated herein by
reference, as updated or superseded by the risks and uncertainties described under similar headings in the other documents that
are filed after the date hereof and incorporated by reference into this prospectus, together with all of the other information
contained or incorporated by reference in this prospectus. The risks and uncertainties we have described are not the only ones
we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our
operations. Past financial performance may not be a reliable indicator of future performance, and historical trends should not
be used to anticipate results or trends in future periods. If any of these risks actually occurs, our business, business prospects,
financial condition or results of operations could be seriously harmed. This could cause the trading price of our common stock
to decline, resulting in a loss of all or part of your investment. Please also read carefully the section below entitled “Special
Note Regarding Forward-Looking Statements.”
Additional
Risks Relating to this Offering
Our
management team may invest or spend the proceeds of this offering in ways with which you may not agree or in ways which may not
yield a significant return.
Our
management will have broad discretion over the use of proceeds from this offering. Our management will have broad discretion in
the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of
operations or enhance the value of our common stock. The failure by management to apply these funds effectively could result in
financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and
delay the development of our product candidates.
Purchasers
in this offering will likely experience immediate and substantial dilution in the book value of their investment.
Because the prices per share at which shares of our common
stock are sold in this offering may be substantially higher than the book value per share of our common stock, you may suffer
immediate and substantial dilution in the net tangible book value of the common stock you purchase in this offering. The shares
sold in this offering, if any, will be sold from time to time at various prices. After giving effect to the sale of our common
stock in the maximum aggregate offering amount of $75,000,000 at an assumed offering price of $1.13 per share, the last reported
sale price of our common stock on the OTCQB on October 15, 2018, and after deducting estimated offering commissions payable by
us, our net tangible book value as of June 30, 2018 would have been $67.0 million, or $0.85 per share of common stock. This represents
an immediate increase in the net tangible book value of $1.29 per share to our existing stockholders and an immediate and substantial
dilution in net tangible book value of $0.28 per share to new investors who purchase our common stock in the offering.
Sales of a substantial number of shares of our common
stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
Almost all of the 26,925,986 outstanding shares of our common
stock, as well as a substantial number of shares of our common stock underlying outstanding options and warrants, are available
for sale in the public market, either pursuant to Rule 144 under the Securities Act of 1933, as amended, or an effective registration
statement. Pursuant to our shelf registration statement on Form S-3, we may sell up to $200,000,000 of our equity securities over
the next several years. Sales of a substantial number of shares of our common stock, or the perception that such sales may occur,
may adversely impact the price of our common stock.
Risks Related to Our Organization and Our Common Stock
Our articles of incorporation and bylaws contain anti-takeover
provisions that could delay or discourage takeover attempts that stockholders may consider favorable.
Our
board of directors is authorized to issue shares of preferred stock in one or more series and to fix the voting powers, preferences
and other rights and limitations of the preferred stock. Accordingly, we may issue shares of preferred stock with a preference
over our common stock with respect to dividends or distributions on liquidation or dissolution, or that may otherwise adversely
affect the voting or other rights of the holders of common stock. Issuances of preferred stock, depending upon the rights, preferences
and designations of the preferred stock, may have the effect of delaying, deterring or preventing a change of control, even if
that change of control might benefit our stockholders.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus supplement, the accompanying prospectus, the documents we have filed with the Commission that are incorporated by reference
and any free writing prospectus that we have authorized for use in connection with this offering contain “forward-looking
statements,” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934,
as amended, or the Exchange Act, 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.
All statements contained in this prospectus supplement other than statements of historical fact, including statements relating
to future events, future financial performance, strategies, expectations, competitive environment and regulation, are forward-looking
statements. Words such as “may,” “should,” “could,” “would,” “predicts,”
“potential,” “continue,” “expects,” “anticipates,” “future,” “intends,”
“plans,” “believes,” “estimates,” and similar expressions, as well as statements in future
tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance
or results and will probably not be accurate indications of when such performance or results will be achieved. Forward-looking
statements are based on information we have when those statements are made or our management’s good faith belief as of that
time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results
to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause
such differences include, but are not limited to:
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our
history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
regarding the adequacy of our liquidity to pursue our complete business objectives;
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●
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our
ability to complete clinical trials as anticipated and obtain and maintain regulatory approvals for our products;
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●
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our
ability to adequately protect our intellectual property;
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●
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disputes
over ownership of intellectual property;
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●
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our
dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and
to increase production as necessary;
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●
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the
risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our products
are an attractive alternative to other procedures and products;
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●
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intense
competition in our industry, with competitors having substantially greater financial, technological, research and development,
regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
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●
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entry
of new competitors and products and potential technological obsolescence of our products;
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●
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loss
of a key customer or supplier;
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●
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adverse
economic conditions;
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●
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adverse
federal, state and local government regulation, in the United States;
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●
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price
increases for supplies and components;
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●
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inability
to carry out research, development and commercialization plans; and
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●
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loss
or retirement of key executives and research scientists.
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We
discuss in greater detail, and incorporate by reference into this prospectus supplement and the accompanying prospectus in their
entirety, many of these risks and uncertainties under the heading “Risk Factors” beginning on page S-9 of this prospectus
supplement. The forward-looking statements contained or incorporated by reference in this prospectus are expressly qualified in
their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement
to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated
events.
USE
OF PROCEEDS
The
amount of proceeds from this offering will depend upon the number of shares of our common stock sold and the market price at which
they are sold. There can be no assurance that we will be able to sell any shares under or fully utilize the sales agreement with
Cantor Fitzgerald & Co. as a source of financing.
Unless
otherwise indicated in the prospectus supplement, we currently intend to use the net proceeds from this offering, if any, for
general corporate purposes, including capital expenditures, the advancement of our drug candidates in clinical trials, preclinical
trials, and working capital.
Investors
are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of
our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing
of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount
of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this
offering for other purposes.
From
time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing
allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change
in the use of proceeds include:
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●
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a
change in development plan or strategy;
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●
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the
addition of new products or applications;
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●
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technical
delays;
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●
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delays
or difficulties with our clinical trials;
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●
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negative
results from our clinical trials;
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●
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difficulty
obtaining U.S. Food and Drug Administration approval;
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●
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failure
to achieve sales as anticipated; and
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●
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the
availability of other sources of cash including cash flow from operations and new bank debt financing arrangements, if any.
|
Pending
other uses, we intend to invest the proceeds to us in investment-grade, interest-bearing securities such as money market funds,
certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether
the proceeds invested will yield a favorable, or any, return.
DILUTION
If you invest in our common stock, your interest will be
diluted immediately to the extent of the difference between the public offering price per share of our common stock you pay in
this offering and the as adjusted net tangible book value per share of our common stock immediately after this offering. Our net
tangible book value of our common stock as of June 30, 2018 was approximately $(5.5 million), or approximately $(0.44) per share
of common stock based upon 12,549,870 shares and outstanding at that time, respectively. Net tangible book value represents the
amount of our total tangible assets less the sum of our total liabilities and intangible assets. Net tangible book value per share
represents the net tangible book value divided by the total number of shares of our common stock outstanding.
After giving effect to the sale of shares of our common
stock, $0.001 par value per share, in the aggregate amount of $75,000,000 at an assumed offering price of $1.13 per share, the
last reported sale price of our common stock on the OTCQB on October 15, 2018, and after deducting estimated aggregate offering
expenses payable by us, our as adjusted net tangible book value as of June 30, 2018 would have been approximately $67.0 million,
or approximately $0.85 per share of common stock. This represents an immediate increase in net tangible book value of approximately
$1.29 per share to our existing stockholders and an immediate dilution in as adjusted net tangible book value of approximately
$0.28 per share to purchasers of our common stock in this offering.
The
following table illustrates this calculation on a per share basis as of June 30, 2018:
Assumed public offering
price per share of common stock
|
|
|
|
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|
$
|
1.13
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|
Net tangible
book value per share of common stock
|
|
$
|
(0.44
|
)
|
|
|
|
|
Increase in
net tangible book value per share of common stock attributable to investors purchasing our common stock in this offering
|
|
$
|
1.29
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|
As adjusted net tangible book value per share
of common stock after giving effect to the offering
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|
|
|
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|
$
|
0.85
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|
Net dilution per share
of common stock to investors purchasing our common stock in this offering
|
|
|
|
|
|
$
|
(0.28
|
)
|
The foregoing table and calculations are based on the
number of shares of our common stock outstanding as of June 30, 2018. The foregoing table and calculations do not reflect the
October 2018 issuances of shares associated with the $3.3M capital raise, and the October 18 conversion of outstanding notes to
equity, which resulted in the issuance of 3,644,440 and 10,731,669 shares respectively.
DIVIDENDS
In
the past, we have not declared or paid cash dividends on our common stock, and we do not intend to pay any cash dividends on our
common stock. Rather, we intend to retain future earnings, if any, to fund the operation and expansion of our business and for
general corporate purposes.
PLAN
OF DISTRIBUTION
On
October 2, 2015, we entered into a Controlled Equity Offering
SM
Sales Agreement, or the sales agreement, with Cantor
Fitzgerald & Co., or Cantor, under which we may issue and sell shares of our common stock through Cantor acting as agent.
We may issue and sell shares through this prospectus supplement having an aggregate gross sales price of up to $75,000,000. The
following summary of the material provisions of the sales agreement does not purport to be a complete statement of its terms and
conditions. The sales agreement has been filed as an exhibit to our registration statement on Form S-3 of which this prospectus
forms a part.
Upon
delivery of a placement notice and subject to the terms and conditions of the sales agreement, Cantor may sell our common stock
by any method permitted by law that is deemed to be an “at-the-market” offering as defined in Rule 415 promulgated
under the Securities Act, including sales made directly on or through the NASDAQ Capital Market or any other existing trading
market for our common stock in the United States or to or through a market maker. Subject to the terms of a Placement Notice,
Cantor may also sell our common stock by any other method permitted by law, including in privately negotiated transactions.
Each
time we wish to issue and sell common stock under the sales agreement, we will notify Cantor of the number of shares to be issued,
the dates on which such sales are anticipated to be made, any limitation on the number of shares that may be sold in any one day
and any minimum price below which sales may not be made. Once we have so instructed Cantor, unless Cantor declines to accept the
terms of such notice, Cantor has agreed to use its commercially reasonable efforts consistent with its normal trading and sales
practices to sell such shares up to the amount specified on such terms. The obligations of Cantor under the sales agreement, to
sell our common stock are subject to a number of conditions that we must meet. We or Cantor may suspend the offering of our common
stock upon notice and, subject to other conditions, our prior approval.
The
settlement between us and Cantor is generally anticipated to occur on the third trading day following the date on which any sales
are made, or on some other date that is agreed upon by us and Cantor in connection with a particular transaction, in return for
payment of the net proceeds to us. Sales of our common stock as contemplated in this prospectus supplement will be settled through
the facilities of The Depository Trust Company or by such other means as we and Cantor may agree upon. There is no arrangement
for funds to be received in an escrow, trust or similar arrangement.
We
will pay Cantor a commission equal to an aggregate of 3.0% of the gross proceeds we receive from the sales of our common stock.
Because there is no minimum offering amount required as a condition to close this offering, the actual total public offering amount,
commissions and proceeds to us, if any, are not determinable at this time. In connection with the sale of the common stock on
our behalf, Cantor will be deemed to be an “underwriter” within the meaning of the Securities Act, and the compensation
of Cantor will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution
to Cantor with respect to certain civil liabilities, including liabilities under the Securities Act. We have also agreed to reimburse
Cantor for certain specified expenses, including the fees and disbursements of its legal counsel, in an amount not to exceed $50,000.
We estimate that the total expenses for the offering, but excluding any underwriter fees or expense reimbursement payable to Cantor
under the terms of the sales agreement, will be approximately $150,000.
The
offering of our common stock pursuant to this prospectus will terminate upon the termination of the sales agreement as permitted
therein. We and Cantor may each terminate the sales agreement at any time upon ten days’ prior notice.
Any
portion of the $75,000,000 included in this sales agreement prospectus supplement that is not previously sold or included in an
active placement notice pursuant to the sales agreement is available for sale in other offerings pursuant to the base prospectus,
and if no shares are sold under the sales agreement, the full $75,000,000 of securities may be sold in other offerings pursuant
to the base prospectus and a corresponding prospectus supplement.
Cantor
and its affiliates may in the future provide various investment banking, commercial banking and other financial services for us
and our affiliates, for which services they may in the future receive customary fees. To the extent required by Regulation M under
the Exchange Act, Cantor will not engage in any market making activities involving our common stock while the offering is ongoing
under this prospectus supplement.
This
prospectus supplement and the accompanying prospectus in electronic format may be made available on a website maintained by Cantor,
and Cantor may distribute this prospectus supplement and the accompanying prospectus electronically.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon by Fennemore Craig, P.C., Reno, Nevada. Cantor is being
represented in connection with this offering by Cooley, LLP, New York, New York.
EXPERTS
The financial statements incorporated in this prospectus
by reference to the Annual Report on Form 10-K for the fiscal year ended June 30, 2018 have been so incorporated in reliance on
the reports of GBH CPAs, PC, and Marcum LLP, related to the consolidated financial statements for the years ended June 30, 2017
and 2018, respectively, each an independent registered public accounting firm, given on the authority of said firm as experts
in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and in accordance therewith
file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission,
or the Commission. Such reports, proxy statements and other information can be read and copied at the Commission’s public
reference facilities at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-732-0330 for further information
on the operation of the public reference facilities. In addition, the Commission maintains a website that contains reports, proxy
and information statements and other information regarding registrants that file electronically with the Commission. The address
of the Commission’s website is www.sec.gov.
We
make available free of charge on or through our website at www.relmada.com, our Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material
with or otherwise furnish it to the Commission.
We
have filed with the Commission a registration statement under the Securities Act of 1933, as amended, relating to the offering
of these securities. The registration statement, including the attached exhibits, contains additional relevant information about
us and the securities. This prospectus supplement and the accompanying prospectus do not contain all of the information set forth
in the registration statement. You can obtain a copy of the registration statement, at prescribed rates, from the Commission at
the address listed above, or for free at www.sec.gov. The registration statement and the documents referred to below under “Incorporation
of Certain Information By Reference” are also available on our website, www.relmada.com.
We
have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
Commission allows us to “incorporate by reference” the information we have filed with it, which means that we can
disclose important information to you by referring you to those documents instead of having to repeat the information in this
prospectus supplement. The information incorporated by reference is considered to be part of this prospectus supplement and the
accompanying prospectus, and later information that we file with the Commission will automatically update and supersede prior
information. We incorporate by reference the documents listed below and any future documents (excluding information furnished
pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the Commission pursuant to Sections l3(a), l3(c), 14 or l5(d) of the
Securities Exchange Act of 1934, as amended, or the Exchange Act, subsequent to the date of this prospectus supplement and before
the sale of all the securities covered by this prospectus supplement:
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●
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Our
Annual Report on Form 10-K as of June 30, 2018, filed with the SEC on September 28, 2018; and
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●
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on October 18, 2018; and
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●
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The
description of our common stock, which is contained in our Current Report on Form 8-K, filed with the SEC on May 27, 2014.
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To
the extent that any information contained in any filings we have made or will make with the Commission under Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act, or any exhibit thereto, was furnished, rather than filed with the Commission, such information
or exhibit is specifically not incorporated by reference in this prospectus supplement.
We
will provide without charge to each person to whom a copy of this prospectus is delivered, upon written or oral request, a copy
of any or all of the information that has been incorporated by reference in this prospectus but not delivered with this prospectus
(other than an exhibit to these filings, unless we have specifically incorporated that exhibit by reference in this prospectus).
Any such request should be addressed to us at: 757 3rd Avenue, Suite 2018, New York, New York 10017, Attention: Sergio Traversa,
Chief Executive Officer, or made by phone at (212) 547-9591. You may also access the documents incorporated by reference in this
prospectus through our website at www.relmada.com. Except for the specific incorporated documents listed above, no information
available on or through our website shall be deemed to be incorporated in this prospectus or the registration statement of which
it forms a part.
Up
to $75,000,000
Common
Stock
PROSPECTUS
SUPPLEMENT
,
2018
PART
II
INFORMATION
NOT REQUIRED IN THE PROSPECTUS
Item
14.
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Other
Expenses of Issuance and Distribution.
|
The
fees and expenses, other than underwriting discounts and commissions, payable by us in connection with this registration statement
are estimated as follows:
Securities
and Exchange Commission registration fee
|
|
$
|
20,140
|
|
FINRA
filing fee
|
|
|
30,500
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|
The
supplemental listing fee
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|
|
*
|
|
Accounting
fees and expenses
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|
|
10,000
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|
Legal
fees and expenses
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|
|
40,000
|
|
Printing
fees and expenses
|
|
|
*
|
|
Transfer
Agent fees and expenses
|
|
|
*
|
|
Miscellaneous
fees and expenses
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|
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*
|
|
Total
|
|
$
|
100,640
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|
*
These fees are calculated based on the securities offered and the number of issuances and accordingly cannot be estimated at this
time.
Item
15.
|
Indemnification
of Directors and Officers.
|
We
are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes,
or NRS.
Section
78.138 of the NRS provides that, unless the corporation’s articles of incorporation provide otherwise, a director or officer
will not be individually liable unless it is proven that (i) the director’s or officer’s acts or omissions constituted
a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of
the law. Our amended and restated articles of incorporation provide that no director or officer shall be personally liable to
the corporation or any of its stockholders for damages for any breach of fiduciary duty as a director or officer except for liability
of a director or officer for (i) acts or omissions involving intentional misconduct, fraud, or a knowing violation of law or (ii)
payment of dividends in violation of Section 78-300 of the NRS.
Section
78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid
in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding,
if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or
director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding,
had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS also precludes
indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion
of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent
that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for
such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or
otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.
Section
78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending
a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination
by the stockholders, the disinterested board members, or by independent legal counsel. Section 78.751 of NRS requires a corporation
to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount
if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified
by the company if so provided in the corporations articles of incorporation, bylaws, or other agreement. Section 78.751 of the
NRS further permits the company to grant its directors and officers, additional rights of indemnification under its articles of
incorporation, bylaws, or other agreement.
Section
78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf
of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the
company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise,
for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee,
or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability
and expenses.
Our
amended and restated bylaws implement the indemnification and insurance provisions permitted by Chapter 78 of the NRS.
The
indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter
acquire under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person’s
official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased
to be a director, officer, employee, or agent and shall inure to the benefit of the heirs, executors, and administrators of such
person.
We
maintain a general liability insurance policy that covers liabilities of directors and officers of our corporation arising out
of claims based on acts or omissions in their capacities as directors or officers.
Item
16. Exhibits.
A
list of exhibits filed herewith is contained in the exhibit index that immediately precedes such exhibits and is incorporated
herein by reference.
Item
17. Undertakings
(a)
|
The
undersigned registrant hereby undertakes:
|
|
(1)
|
To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
|
(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low
or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration
statement; and
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(iii)
|
To
include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
|
provided,
however
, that paragraphs (a)(1)(i) and (a)(1)(ii) of this section do not apply if the information required to be included
in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
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(2)
|
That,
for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
|
|
(3)
|
To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
|
|
(5)
|
That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
|
(i)
|
If
the registrant is relying on Rule 430B,
|
|
(A)
|
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as
of the date the filed prospectus was deemed part of and included in the registration statement; and
|
|
(B)
|
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information
required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement
as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract
of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the
issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration
statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement
made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated
or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that
was made in the registration statement or prospectus that was part of the registration statement or made in any such document
immediately prior to the effective date; or
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|
(ii)
|
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance
on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such date of first use.
|
|
(6)
|
That,
for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer and sell such securities to such purchaser:
|
|
(i)
|
Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
|
|
(ii)
|
Any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
|
|
(iii)
|
The
portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
|
|
(iv)
|
Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
|
(b)
|
The
undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange
Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d)
of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to
be a new registration statement relating to the securities offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.
|
|
(h)
|
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the
opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities
Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding), is asserted by such director, officer or controlling person
in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has
been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of
such issue.
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(j)
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The
undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee
to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed
by the SEC under Section 305(b)(2) of the Trust Indenture Act.
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SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of New York, State of New York, on October 23, 2018.
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RELMADA
THERAPEUTICS, INC.
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By:
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/s/
Sergio Traversa
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Name:
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Sergio
Traversa
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Title:
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Chief
Executive Officer
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Pursuant
to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature
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Title
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Date
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/s/
Sergio Traversa
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Chief
Executive Officer, Interim CFO and Director
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October
23, 2018
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Sergio
Traversa
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(Principal
Executive Officer and Principal
Financial
and Accounting Officer))
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/s/
Charles J. Casamento*
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Chairman
of the Board
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October
23, 2018
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Charles
J. Casamento
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/s/
Paul Kelly*
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Director
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October
23, 2018
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Sandesh
Seth
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/s/
Maged Shenouda*
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Director
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October
23, 2018
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Maged
Shenouda
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*
Sergio Traversa
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Power
of Attorney
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Exhibit Index
Exhibit
No.
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Description
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1.1*
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Form of Underwriting Agreement
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1.2
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Controlled
Equity Offering Sales Agreement
SM
, dated October 2, 2015, by and between Relmada Therapeutics, Inc. and Cantor
Fitzgerald & Co. (incorporated by reference to Exhibit 1.2 of Relmada’s Form S-3 filed on October 2, 2015)
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3.1
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i)
Articles of Incorporation of Camp Nine, Inc. (incorporated by reference to Exhibit 3.1 of Relmada’s Registration Statement
on Form S-1 filed with the SEC on November 13, 2012).
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ii)
Certificate of Designation dated May 13, 2014 (incorporated by reference to Exhibit 4.1 to Relmada’s Report on Form
8-K filed with the SEC on May 19, 2014).
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(iii) Nevada Certificate of Amendment to Articles of Incorporation of Camp Nine, Inc., effective May 30, 2014 (incorporated by reference to Exhibit 3.1 of Relmada’s Form 8-K filed with the SEC on June 2, 2014).
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(iv)
Nevada Certificate of Amendment to Articles of Incorporation of Camp Nine, Inc., effective July 8, 2014 (incorporated by reference
to Exhibit 3.1 of Relmada’s Form 8-K filed with the SEC on July 14, 2014).
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(v)
Certificate of Amendment to Articles of Incorporation of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit
3.1 of Relmada’s Form 10-Q filed with the SEC on February 13, 2015).
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(vi)
Certificate of Change of Relmada Therapeutics, Inc. dated August 4, 2015 (incorporated by reference to Exhibit 3.1 of Relmada’s
Form 8-K filed with the SEC on August 10, 2015).
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3.2
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Amended
and Restated Bylaws of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 of Relmada’s Form 8-K filed
with the SEC on August 7, 2015).
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4.1
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Form
of Common Stock Certificate (incorporated by reference to Exhibit 4.1 of Relmada’s Form S-3 filed on October 2, 2015)
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4.2*
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Certificate of Designation of Preferred Stock
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4.3*
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Form of Indenture
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4.4*
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Form of Common Stock Warrant Agreement and
Warrant Certificate
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4.5*
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Form of Preferred Stock Warrant Agreement
and Warrant Certificate
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4.6*
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Form of Debt Securities Warrant Agreement
and Warrant Certificate
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4.7*
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Form of Subscription Rights Agreement and
Certificate
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4.8*
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Form of Purchase Contract
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4.9*
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Form of Unit Agreement
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5.1
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Opinion
of Fennemore Craig, P.C. (incorporated by reference to Exhibit 5.1 to Form S-3 filed on October 2, 2015)
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12.1
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Statement
Regarding the Computation of Ratio of Earnings to Fixed Charges (incorporated by reference to Exhibit 12.1 of Relmada’s
Form S-3 filed on October 2, 2015).
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23.1**
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Consent of GBH CPAs, PC
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23.2**
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Consent of Marcum LP
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23.2
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Consent
of Fennemore Craig, P.C. (included in Exhibit 5.1)
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24.1
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Power of Attorney (included
in signature page)
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25.1*
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Statement of Eligibility on Form T-1 under
the Trust Indenture Act of 1939, as amended, of the trustee, as trustee under the indenture filed herewith.
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* To be filed as an exhibit to a Current Report of the registrant
on Form 8-K or other document to be incorporated herein by reference.
** Filed herewith.