As
filed with the United States Securities and Exchange Commission on
February 5, 2019
Registration No.
333-226905
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
PALATIN TECHNOLOGIES, INC.
(Exact name of registrant as specified in its
charter)
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Delaware
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95-4078884
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(State or other jurisdiction of incorporation or
organization)
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(I.R.S. Employer Identification No.)
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4B Cedar Brook Drive
Cranbury, New Jersey 08512
(609) 495-2200
(Address, including zip code, and telephone number,
including area code, of Registrant’s principal executive
offices)
______________________
Stephen T. Wills, Executive Vice President, Chief Financial
Officer,
and Chief Operating Officer
4B Cedar Brook Drive
Cranbury, New Jersey 08512
(609) 495-2200
(Name, address, including zip code, and telephone
number,
including area code, of agent for service)
______________________
Please send copies of all communications to:
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Faith L. Charles, Esq.
Thompson Hine LLP
335 Madison Avenue, 12th Floor
New York, NY 10017
(212) 908-3905
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Stephen A. Slusher, Esq.
Chief Legal Officer
4B Cedar Brook Drive
Cranbury, NJ 08512
(609) 495-2200
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Approximate date of commencement of proposed sale to the public:
from time to time, following the effective date of this
registration statement.
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(c)
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 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, a
smaller reporting company or an emerging growth company. See the
definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer
☐
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Accelerated filer ☑
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| Smaller reporting company ☑ | |
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Emerging growth 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. ☐
______________________
The registrant hereby amends this registration statement on such
date or dates as may be necessary to delay its effective date until
the registrant shall file a further amendment which specifically
states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities
Act of 1933, as amended, or until the registration statement shall
become effective on such date as the U.S. Securities and Exchange
Commission, acting pursuant to said Section 8(a), may
determine.
EXPLANTORY
NOTE
This
Amendment No. 1 is being filed for the purpose of updating the
Registration Statement (File No. 333-226905) to reflect the filing
by Palatin Technologies, Inc. of its Annual Report on Form 10-K for
the fiscal year ended June 30, 2018, including filing a related
consent as an exhibit to such Registration Statement, and the
filing of its subsequent Quarterly Report on Form
10-Q.
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 U.S. Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any
jurisdiction where the offer or sale is not permitted.
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PROSPECTUS
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SUBJECT TO COMPLETION
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February 5, 2019
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PALATIN TECHNOLOGIES, INC.
4B
Cedar Brook Drive
Cranbury,
New Jersey 08512
(609)
495-2200
$100,000,000
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Units
We may
offer under this prospectus from time to time in one or more
offerings, at prices and on terms to be determined by market
conditions at the time we make the offer, up to an aggregate of
$100,000,000 of our:
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common stock, par
value $0.01 per share;
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preferred stock,
par value $0.01 per share;
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debt
securities;
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warrants to
purchase common or preferred stock, or debt securities;
or
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any combination of
the above, separately or as units.
This
prospectus may not be used to sell our securities unless
accompanied by a prospectus supplement. The prospectus supplement
will provide specific terms of the securities offered, will
describe the specific manner in which we will offer these
securities, and may also supplement, update or amend information
contained in this prospectus. Before you invest in our securities,
you should carefully read both this prospectus and any prospectus
supplement related to the offering of the securities, together with
any documents incorporated herein or therein.
Our
common stock is listed on the NYSE American under the symbol
“PTN.” On January 31, 2019, the closing price of our
common stock as reported on the NYSE American was $0.69 per share.
None of the other securities that we may offer under this
prospectus are currently publicly traded.
As of
January 31, 2019, the aggregate market value of our outstanding
common shares held by non-affiliates was approximately
$138,416,180, which was calculated based on 203,063,429 common
shares outstanding as of that date, of which 200,603,159 common
shares were held by non-affiliates, and a price per share of $0.69,
which was the closing price of our common stock as reported on the
NYSE American on such date.
Investing in our securities involves a high degree of risk. You
should purchase these securities only if you can afford a complete
loss of your investment. See “Risk Factors” beginning
on page 7.
Neither the United States 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.
If we
sell securities through agents or underwriters, we will include
their names and the fees, commissions and discounts they will
receive, as well as the net proceeds to us, in the applicable
prospectus supplement. The underwriters, if any, may over-allot a
portion of the securities.
The
date of this prospectus is , 2019
TABLE OF CONTENTS
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Page
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Prospectus
Summary
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5
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Risk
Factors
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9
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Note
Concerning Forward-Looking Statements
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10
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Incorporation
of Information by Reference
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12
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Where
You Can Find More Information
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13
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Use of
Proceeds
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13
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Dilution
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13
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Market
Information and Related Stockholder Matters
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13
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Description
of Securities
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14
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Anti-Takeover
Effects of Provisions of Delaware Law and Our Charter
Documents
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20
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Plan of
Distribution
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21
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Legal
Matters
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22
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Experts
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22
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PROSPECTUS SUMMARY
This summary highlights certain information appearing elsewhere in
this prospectus and in the information incorporated by reference.
This summary is not complete and does not contain all of the
information you should consider prior to investing in our
securities. After you read this summary, you should read and
consider carefully the more detailed information and financial
statements and related notes that we include in this prospectus or
incorporate by reference, especially the section entitled
“Risk Factors.” If you invest in our securities, you
are assuming a high degree of risk.
Unless we have indicated otherwise or the context otherwise
requires, references in the prospectus to “Palatin,”
the “Company,” “we,” “us” and
“our” or similar terms refer to the operations of
Palatin Technologies, Inc. and its subsidiary.
Overview
We are a
specialized biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin and natriuretic peptide receptor systems. Our product
candidates are targeted, receptor-specific therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential. Our most advanced product candidate is
Vyleesi™, the trade name for bremelanotide, a peptide
melanocortin receptor 4 (MC4r) agonist, for the treatment of
premenopausal women with acquired, generalized hypoactive sexual
desire disorder (“HSDD”), which is a type of female
sexual dysfunction (“FSD”), defined as low desire with
associated distress or interpersonal difficulty.
Vyleesi. Vyleesi is a subcutaneous
injectable product for the treatment of HSDD in premenopausal
women. Vyleesi is a synthetic peptide analog of the naturally
occurring hormone alpha-MSH (melanocyte-stimulating hormone). In
March 2018, our exclusive North American licensee for Vyleesi, AMAG
Pharmaceuticals, Inc. (“AMAG”), submitted a New Drug
Application (“NDA”) to the U.S. Food and Drug
Administration (“FDA”) for Vyleesi for the treatment of
HSDD in premenopausal women, which was accepted for filing and
review by the FDA. In November 2018, AMAG announced that the FDA
requested additional data assessing 24-hour ambulatory blood
pressure with short term daily use of Vyleesi, which study is
ongoing. The Prescription Drug User Fee Act (“PDUFA”)
date for completion of FDA review of the Vyleesi NDA was extended
by three months to June 23, 2019. We have also licensed rights to
bremelanotide to Shanghai Fosun Pharmaceutical Industrial
Development Co. Ltd. (“Fosun”) for the territories of
the People’s Republic of China, Taiwan, Hong Kong S.A.R. and
Macau S.A.R. (collectively, “Chinese Territories”), and
Kwangdong Pharmaceutical Co., Ltd. (“Kwangdong”) for
the Republic of Korea (“Korea”).
Our Phase 3 studies
for HSDD in premenopausal women, called the RECONNECT studies,
consisted of two double-blind placebo-controlled, randomized
parallel group studies comparing the on-demand use of 1.75 mg of
Vyleesi versus placebo, in each case, delivered via a subcutaneous
auto-injector. Each trial consisted of more than 600 patients
randomized in a 1:1 ratio to either the treatment arm or placebo
with a 24-week evaluation period. In both clinical trials, Vyleesi
met the pre-specified co-primary efficacy endpoints of improvement
in desire and decrease in distress associated with low sexual
desire as measured using validated patient-reported outcome
instruments.
After completing
the studies, patients had the option to continue in an open-label
safety extension study for an additional 52 weeks. Nearly 80% of
patients who completed the randomized portion of the study elected
to remain in the open-label portion of the study. In the Phase 3
clinical trials, the most frequent adverse events were nausea,
flushing, injection site reactions and headache, which were
generally mild-to-moderate in intensity and were
transient.
We
retain worldwide rights for Vyleesi for HSDD and all other
indications outside North America, Korea and the Chinese
Territories. We are actively seeking potential partners for
marketing and commercialization rights for Vyleesi for HSDD outside
the licensed territories. However, we may not be able to enter into
suitable agreements with potential partners on acceptable terms, if
at all.
Melanocortin Receptor Systems. There are
five melanocortin receptors, MC1r through MC5r. Modulation of these
receptors, through use of receptor-specific agonists, which
activate receptor function, or receptor-specific antagonists, which
block receptor function, can have significant pharmacological
effects. Our new product development activities primarily focus on
MC1r agonists, with potential to treat a number of inflammatory and
autoimmune diseases such as dry eye disease, also known as
keratoconjunctivitis sicca, uveitis, diabetic retinopathy and
inflammatory bowel disease. We believe that MC1r agonists,
including the MC1r agonist peptides we are developing, have broad
anti-inflammatory effects and appear to utilize mechanisms engaged
by the endogenous melanocortin system in regulation of the immune
system and resolution of inflammatory responses. We are also
developing peptides that are active at more than one melanocortin
receptor, and MC4r agonists, with potential utility in a number of
obesity and metabolic-related disorders, including rare disease and
orphan indications.
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PL-8177, a
selective MC1r agonist peptide, is our lead clinical development
candidate for inflammatory bowel diseases, with potential
applicability for a number of other diseases. We filed an
Investigational New Drug (“IND”) application on PL-8177
in late 2017 and have completed subcutaneous dosing of human
subjects in a Phase 1 single and multiple ascending dose clinical
safety study, with favorable results issued in a press release
dated November 8, 2018. We started a clinical study with oral
dosing of PL-8177 in human subjects in the fourth quarter of
calendar year 2018, with data expected in the first half of
calendar year 2019.
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PL-8331, a dual
MC1r and MC5r peptide agonist, is a preclinical development
candidate for treating ocular inflammation. We have initiated
IND-enabling preclinical activities with PL-8331, and if results
are favorable, anticipate filing an IND and initiating clinical
trials for treatment of dry eye disease in the second half of
calendar year 2019.
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We have initiated
preclinical programs with MC4r peptides and orally-active small
molecules for treatment of rare genetic metabolic and obesity
disorders, and if results are favorable, anticipate selecting a
lead clinical development candidate and completing IND-enabling
activities in calendar year 2019.
5
Natriuretic Peptide Receptor Systems.
The natriuretic peptide receptor (“NPR”) system has
numerous cardiovascular functions, and therapeutic agents
modulating this system may be useful in treatment of cardiovascular
diseases, including reducing cardiac hypertrophy and fibrosis,
heart failure, acute asthma, other pulmonary diseases and
hypertension. While the therapeutic potential of modulating this
system is well appreciated, development of therapeutic agents has
been difficult due, in part, to the short biological half-life of
native peptide agonists. We have designed and are developing
potential candidate drugs that are selective for one or more
different natriuretic peptide receptors, including natriuretic
peptide receptor-A (“NPR-A”), natriuretic peptide
receptor B (“NPR-B”), natriuretic peptide receptor C
(“NPR-C”).
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PL-3994 is an NPR-A
agonist we developed which has completed Phase 1 clinical safety
studies. It has potential utility in treatment of a number of
cardiovascular diseases, including genetic and orphan diseases
resulting from a deficiency of endogenous active NPR-A. We have
ongoing academic collaborations with several institutions with
PL-3994, and seek to enter into a development partnership by the
end of calendar year 2019.
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PL-5028, a dual
NPR-A and NPR-C agonist we developed, is in preclinical development
for cardiovascular diseases, including reducing cardiac hypertrophy
and fibrosis. We have ongoing academic collaborations with several
institutions with PL-5028, and seek to enter into a development
partnership by the end of calendar year 2019.
The
following chart illustrates the status of our drug development
programs.
6
Our
Strategy
Key
elements of our business strategy include:
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Using our
technology and expertise to develop and commercialize products in
our active drug development programs;
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Entering into
strategic alliances and partnerships with pharmaceutical companies
to facilitate the development, manufacture, marketing, sale and
distribution of product candidates that we are
developing;
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Partially funding
our product development programs with the cash flow generated from
existing license agreements, as well as any future research,
collaboration or license agreements; and
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Completing
development and seeking regulatory approval of certain of our other
product candidates.
Risks Related to Our Business
Our
business is subject to numerous risks and uncertainties, including
those incorporated by reference in the section of this prospectus
entitled “Risk Factors,” which you should read
carefully before deciding to invest in our securities. These risks
include, among others, the following:
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We have incurred
substantial losses since our inception and we anticipate that we
will not attain sustained profitability in the foreseeable future,
if ever. We expect to incur additional losses as we continue our
development of product candidates. Until bremelanotide for HSDD or
other product candidates receive regulatory approval under
applicable regulatory requirements, neither we nor our licensees
can sell products we have developed and we will not have product,
sales milestone or royalty revenues from them;
●
We are
substantially dependent on the clinical and commercial success of
our product candidates, primarily our lead product candidate,
bremelanotide for HSDD, for which AMAG, our North American
licensee, has filed an NDA with FDA. Neither we nor our licensees
may be able to obtain regulatory approval for bremelanotide for
HSDD or our other product candidates under applicable regulatory
requirements. The denial or delay of any such approval would delay
commercialization and have a material adverse effect on our
potential to generate revenue, our business and our results of
operations;
●
Our licensees
control the development and commercialization of bremelanotide in
North America, Chinese Territories and Korea, and as a result we
may not realize a significant portion of the potential value of the
license arrangements. We have limited control over development
activities, including regulatory approvals, and no direct control
over commercialization efforts;
●
Even if
bremelanotide for HSDD or our other product candidates receive
regulatory approval, the products may fail to achieve the level of
market acceptance needed for us to have commercial success. Our
product candidates, if approved, will face significant competition
and our failure, or the failure of our licensees, to effectively
compete may prevent us from achieving significant market
penetration and expansion;
●
We will require
substantial additional funding to achieve our goals, and a failure
to obtain this necessary capital when needed on acceptable terms,
or at all, could force us to delay, limit, reduce or terminate our
product development, other operations or commercialization
efforts;
●
If our efforts to
protect our intellectual property related to bremelanotide for HSDD
or any future product candidates are not adequate, we may not be
able to compete effectively in our market; and
●
We rely on a small
management team and staff as well as various contractors and
consultants to provide critical services to us, including services
related to our clinical programs for bremelanotide, PL-8177 and
PL-3994 and our preclinical programs for other NPR and MC1r and
MC4r peptide or small
molecule drug candidates. Such programs could be adversely affected
if we lose the services of existing key personnel.
7
Corporate
Information
We were
incorporated under the laws of the State of Delaware on November
21, 1986 and commenced operations in the biopharmaceutical area in
1996. Our corporate offices are located at 4B Cedar Brook Drive,
Cedar Brook Corporate Center, Cranbury, New Jersey 08512 and our
telephone number is (609) 495-2200. Our internet address is
www.palatin.com. The information on our website is not incorporated
by reference into this prospectus and should not be considered to
be part of this prospectus. Our website address is included in this
prospectus as an inactive textual reference only.
“Palatin
Technologies, Inc.” and the Palatin logo are our trademarks.
“Vyleesi” is a trademark of AMAG Pharmaceuticals, Inc.
in North America and of Palatin Technologies, Inc. elsewhere in the
world. All other trademarks and service marks appearing in this
prospectus are the property of their respective
owners.
The Offering
This
prospectus is part of a registration statement on Form S-3 that we
filed with the U.S. Securities and Exchange Commission
(“SEC”) utilizing a “shelf” registration
process. Under this process, we may sell any combination of the
securities described in this prospectus in one or more offerings up
to a total dollar amount of $100.0 million. This prospectus
provides you with a general description of the securities we may
offer. Each time we offer to sell securities under this prospectus,
we will provide a prospectus supplement containing specific
information about the terms of that offering. The prospectus
supplement may also add, update or change information contained in
this prospectus. To the extent that any information we provide in a
prospectus supplement is inconsistent with information in this
prospectus, the information in the prospectus supplement will
modify or supersede this prospectus. You should read both this
prospectus and any prospectus supplement together with the
additional information described under the headings
“Incorporation of Information by Reference” and
“Where You Can Find More Information.”
You
should rely only on the information contained or incorporated by
reference in this prospectus and in any prospectus supplement. We
have not authorized anyone to provide you with different
information. We are not offering the securities in any jurisdiction
where the offering is prohibited. You should not assume that the
information in this prospectus, any prospectus supplement or any
document incorporated by reference is truthful or complete at any
date other than the date mentioned on the cover page of those
documents.
8
RISK FACTORS
Investing in our
securities involves risks which you should consider carefully. We
have set forth below risk factors related specifically to this
offering. For risks related to our business operations, see
“Risk Factors” in our annual report, on Form 10-K for
the year ended June 30, 2018 and our quarterly report on Form 10-Q
for the quarter ended September 30, 2018, and all subsequent
reports that we file with the SEC under Sections 13(a), 13(c), 14
or 15(d) of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”). We have incorporated those reports by
reference into this prospectus. See “Incorporation of
Information by Reference” and “Where You Can Find More
Information” below.
RISKS RELATED TO THE OFFERING
We expect to sell additional equity securities, which will cause
dilution.
We
expect to sell more equity securities in the future to obtain
operating funds. We may sell these securities at a discount to the
market price. Any future sales of equity will dilute the holdings
of existing stockholders, possibly reducing the value of their
investment.
Investors in this offering may suffer immediate
dilution.
As of
September 30, 2018, we had a net book value of $25.2 million which
yields a pro forma net book value of $0.12 per share of common
stock, assuming the conversion of all then convertible preferred
stock and no exercise of any warrants or options. If you pay more
than the net tangible book value per share for stock in this
offering, you will suffer immediate dilution.
As of January 31, 2019, there were 44,803,050 shares of common
stock underlying outstanding convertible preferred stock, options,
restricted stock units and warrants. Stockholders may experience
dilution from the conversion of preferred stock, exercise of
outstanding options and warrants, vesting of restricted stock units
or delayed delivery of common stock pursuant to restricted stock
unit agreements.
As of
January 31, 2019, holders of our outstanding dilutive securities
had the right to acquire the following amounts of underlying common
stock:
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61,335 shares
issuable on the conversion of immediately convertible Series A
Convertible preferred stock, subject to adjustment, for no further
consideration;
●
12,512,461 shares
issuable on the exercise of stock options, at exercise prices
ranging from $0.37 to $2.80 per share;
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4,872,333 shares
issuable under restricted stock units which vest on dates between
June 20, 2019 and June 26, 2022, subject either to the fulfillment
of service conditions or attaining defined performance
conditions;
●
3,952,875 shares of
common stock which have vested under restricted stock unit
agreements, but are subject to provisions to delay delivery;
and
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23,404,046 shares
issuable on the exercise of warrants at exercise prices ranging
from $0.70 to $0.91 per share.
If the
holders convert, exercise or receive these securities, or similar
dilutive securities we may issue in the future, stockholders may
experience dilution in the net tangible book value of their common
stock. In addition, the sale or availability for sale of the
underlying shares in the marketplace could depress our stock price.
We have registered or agreed to register for resale substantially
all of the underlying shares listed above. Holders of registered
underlying shares could resell the shares immediately upon
issuance, which could result in significant downward pressure on
our stock price and could also negatively impact our ability to
raise equity capital.
We will have broad discretion over the use of the proceeds of this
offering and you may not realize a return.
We will
have considerable discretion in the application of the net proceeds
of this offering. We have not determined the amount of net proceeds
that we will apply to various corporate purposes, including
potential acquisitions. We may use the net proceeds for purposes
that do not yield a significant return, if any, for our
stockholders.
9
NOTE CONCERNING FORWARD-LOOKING STATEMENTS
In this
prospectus, references to “we”, “our”,
“us” or “Palatin” means Palatin
Technologies, Inc. and its subsidiary.
This
prospectus, and the information that we incorporate by reference,
as well as oral statements that may be made by us or by our
officers, directors, or employees acting on our behalf, that are
not historical facts constitute “forward-looking
statements”, which are made pursuant to the safe harbor
provisions of Section 27A of the Securities Act of 1933, as
amended (the “Securities Act”) and Section 21E of
the Exchange Act. The forward-looking statements in this prospectus
do not constitute guarantees of future performance. Investors are
cautioned that statements that are not strictly historical facts
contained in this prospectus, including, without limitation, the
following are forward looking statements:
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estimates of our
expenses, future revenue and capital requirements;
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our ability to
achieve and maintain profitability;
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our ability to
obtain additional financing on terms acceptable to us, or at
all;
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our ability to
advance product candidates into, and successfully complete,
clinical trials;
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the initiation,
timing, progress and results of future preclinical studies and
clinical trials, and our research and development
programs;
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the timing or
likelihood of regulatory filings and approvals;
●
our expectations
regarding completion of required clinical trials and studies and
validation of methods and controls used to manufacture
Vyleesi™ (the trade name for bremelanotide) for the treatment
of premenopausal women with hypoactive sexual desire disorder
(“HSDD”), which is a type of female sexual dysfunction
(“FSD”);
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our expectation
regarding the timing of our regulatory submissions for approval of
Vyleesi for HSDD in the United States and in certain other
jurisdictions outside the United States;
●
our expectation
regarding performance of our exclusive licensees of Vyleesi,
including;
o
AMAG
Pharmaceuticals, Inc. (“AMAG”) for North
America,
o
Shanghai Fosun
Pharmaceutical Industrial Development Co. Ltd.
(“Fosun”), a subsidiary of Shanghai Fosun
Pharmaceutical (Group) Co., Ltd., for the territories of the
People’s Republic of China, Taiwan, Hong Kong S.A.R. and
Macau S.A.R. (collectively, the “Chinese Territories”),
and
o
Kwangdong
Pharmaceutical Co., Ltd. (“Kwangdong”) for the Republic
of Korea (“Korea”);
10
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the potential for
commercialization of Vyleesi for HSDD in North America by AMAG and
other product candidates, if approved, by us;
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our expectations
regarding the potential market size and market acceptance for
Vyleesi for HSDD and our other product candidates, if approved for
commercial use;
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our ability to
compete with other products and technologies similar to our product
candidates;
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the ability of our
third-party collaborators to timely carry out their duties under
their agreements with us;
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the ability of our
contract manufacturers to perform their manufacturing activities
for us in compliance with applicable regulations;
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our ability to
recognize the potential value of our licensing arrangements with
third parties;
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the potential to
achieve revenues from the sale of our product
candidates;
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our ability to
obtain adequate reimbursement from Medicare, Medicaid, private
insurers and other healthcare payers;
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our ability to
maintain product liability insurance at a reasonable cost or in
sufficient amounts, if at all;
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the performance of
our management team, senior staff professionals, and third-party
contractors and consultants;
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the retention of
key management, employees and third-party contractors;
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the scope of
protection we are able to establish and maintain for intellectual
property rights covering our product candidates and technology in
the United States and throughout the world;
●
our compliance with
federal and state laws and regulations;
●
the timing and
costs associated with obtaining regulatory approval for our product
candidates;
●
the impact of
fluctuations in foreign exchange rates;
●
the impact of
legislative or regulatory healthcare reforms in the United
States;
●
our ability to
adapt to changes in global economic conditions as well as competing
products and technologies; and
●
our ability to
remain listed on the NYSE American stock exchange.
These
forward-looking statements involve risks, uncertainties and other
factors that could cause our actual results to be materially
different from our historical results or from any results expressed
or implied by forward-looking statements. Our future operating
results are subject to risks and uncertainties and are dependent
upon many factors, including, without limitation, the risks
identified under the caption “Risk Factors,” and in our
other SEC filings. The statements we make in this prospectus are as
of the date of this prospectus.
Although we believe
that the expectations reflected in the forward-looking statements
are reasonable, we cannot guarantee future results, levels of
activity, performance or achievements. Except as may be required by
law, we do not intend to update any of the forward-looking
statements for any reason after the date of this prospectus to
conform such statements to actual results or if new information
becomes available.
All
forward-looking statements attributable to us, or to persons acting
on our behalf, are expressly qualified in their entirety by these
cautionary statements.
You
should read this prospectus, together with the information
incorporated herein by reference as described under the section
entitled “Incorporation of Information by Reference,”
and the documents that we reference in this prospectus and have
filed with the SEC as exhibits to the registration statement on
Form S-3, of which this prospectus is a part, with the
understanding that our actual future results, levels of activity,
performance and achievements may be materially different from what
we expect. We qualify all of our forward-looking statements by
these cautionary statements.
11
INCORPORATION OF INFORMATION BY REFERENCE
We
incorporate into this prospectus information contained in documents
which we file with the SEC. We are disclosing important information
to you by referring you to those documents. The information which
we incorporate by reference is an important part of this
prospectus, and certain information that we file later with the SEC
will automatically update and supersede this information. We
incorporate by reference the documents listed below (other than, in
each case, any documents or information deemed to have been
furnished and not filed in accordance with SEC rules):
●
annual report on
Form 10-K for the fiscal year ended June 30, 2018, filed with the
SEC on September 13, 2018;
●
quarterly report on
Form 10-Q for the quarter ended September 30, 2018, filed with the
SEC on November 9, 2018;
●
current report on
Form 8-K, filed with the SEC on November 13, 2018;
●
current report on
Form 8-K, filed with the SEC on January 7, 2019; and
●
the description of
our common stock contained in our registration statement on Form
8-A, initially filed with the SEC on December 13, 1999, including
any amendment or report for the purpose of updating such
description.
We also
incorporate by reference any documents that we subsequently file
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Exchange Act, prior to the termination of the offering (other than,
in any case, any documents or information deemed to have been
furnished and not filed in accordance with SEC rules).
You may
obtain a free copy of any or all of the information incorporated by
reference by writing or calling us. Please direct your request
to:
|
|
Stephen
T. Wills
Executive
Vice President, Chief Financial Officer and Chief Operating
Officer
Palatin
Technologies, Inc.
4B
Cedar Brook Drive
Cranbury,
New Jersey 08512
Telephone:
(609) 495-2200
Fax:
(609) 495-2201
|
12
WHERE
YOU CAN FIND MORE INFORMATION
We file
annual, quarterly and current reports, proxy statements,
registration statements and other information with the SEC. You may
read and copy any materials we file at the SEC’s Public
Reference Room at 100 F St. NE, Washington, DC 20549. You may
obtain information on the operation of the Public Reference Room by
calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet
site that contains reports, proxy and information statements, and
other information regarding issuers that file electronically with
the SEC. The address of that website is http://www.sec.gov. You can
also access these documents free of charge and find information
about Palatin on our website at http://www.palatin.com. Information
found on our website is not part of this prospectus or any
prospectus supplement, and investors should not rely on any such
information in deciding whether to invest in our
securities.
USE OF PROCEEDS
Unless
we state otherwise in a prospectus supplement, we intend to use the
net proceeds from the sale of securities under this prospectus for
general corporate purposes, including capital expenditures. From
time to time, we evaluate the possibility of acquiring businesses,
products and technologies, and we may use a portion of the proceeds
as consideration for acquisitions. Until we use net proceeds for
these purposes, we may invest them in interest-bearing
securities.
DILUTION
We may
set forth in a prospectus supplement the following information
regarding any material dilution of the equity interests of
purchasers of securities in an offering under this
prospectus:
●
The net tangible
book value per share of our equity securities before and after the
offering;
●
The amount of the
increase in such net tangible book value per share attributable to
the cash payments made by the purchasers in the offering;
and
●
the amount of the
immediate dilution from the public offering price which will be
absorbed by such purchasers.
MARKET INFORMATION AND RELATED STOCKHOLDER MATTERS
Our
common stock has been listed on NYSE American under the symbol
“PTN” since December 21, 1999. It previously traded on
The Nasdaq SmallCap Market
under the symbol “PLTN.”
Holders of common stock. On January 31,
2019, we had approximately 145 record holders of common stock and
the closing sales price of our common stock as reported on the NYSE
American was $0.69 per share.
Dividends and dividend policy. We have
never declared or paid any dividends. We currently intend to retain
earnings, if any, for use in our business. We do not anticipate
paying dividends in the foreseeable future.
Dividend restrictions. Our outstanding
Series A Preferred Stock, consisting of 4,030 shares on January 31,
2019, provides that we may not pay a dividend or make any
distribution to holders of any class of stock unless we first pay a
special dividend or distribution of $100 per share to the holders
of the Series A Preferred Stock.
13
DESCRIPTION OF SECURITIES
General
The
following description of our capital stock is intended as a summary
only and is qualified in its entirety by reference to our amended
and restated certificate of incorporation and bylaws, which are
filed as exhibits to the registration statement of which this
prospectus forms a part. Our authorized capital stock consists
of:
●
300,000,000 shares
of common stock, par value $0.01 per share, and
●
10,000,000 shares
of preferred stock, par value $0.01 per share, of which 9,736,000
shares are undesignated.
As of
January 31, 2019, we had outstanding:
●
203,063,429 shares
of our common stock;
●
4,030 shares of
Series A Convertible Preferred Stock, convertible into 61,335
shares of common stock, subject to adjustment, for no further
consideration;
●
stock options to
purchase 12,512,461 shares of common stock at exercise prices
ranging from $0.37 to $2.80 per share;
●
restricted stock
units representing 4,872,333 shares of common stock which vest on
dates between June 20, 2019 and June 26, 2022, subject to the
fulfillment of service conditions or attaining defined performance
conditions;
●
restricted stock
unit agreements representing 3,952,875 shares of common stock which
have vested but are subject to provisions to delay delivery;
and
●
warrants to
purchase 23,404,046 shares of common stock issuable on the exercise
of warrants at exercise prices ranging from $0.70 to $0.91 per
share.
Common Stock
We have
the authority to issue 300,000,000 shares of common stock, par
value $0.01 per share. As of January 31, 2019, there were
203,063,429 shares of our common stock outstanding, and a maximum
of 44,803,050 shares of common stock were issuable on conversion of
outstanding convertible preferred stock, exercise of outstanding
options and warrants, vesting of restricted stock units and delayed
delivery pursuant to restricted stock unit agreements.
Holders
of our common stock are entitled to one vote per share for the
election of directors and on all other matters that require
stockholder approval. Holders of shares of common stock do not have
any cumulative voting rights. Subject to any preferential rights of
any outstanding preferred stock, in the event of our liquidation,
dissolution or winding up, holders of our common stock are entitled
to share ratably in the assets remaining after payment of
liabilities and the liquidation preferences of any outstanding
preferred stock. See “Preferred Stock” and
“Series A Convertible Preferred Stock,” below. Our
common stock does not carry any redemption rights or any preemptive
or preferential rights enabling a holder to subscribe for, or
receive shares of, any class of our common stock or any other
securities convertible into shares of any class of our common
stock. Holders of our common stock have the right to participate
ratably in dividend distributions. Our outstanding Series A
Preferred Stock, consisting of 4,030 shares on January 31, 2019,
provides that we may not pay a dividend or make any distribution to
holders of any class of stock unless we first pay a special
dividend or distribution of $100 per share to the holders of the
Series A Preferred Stock.
Market Information
Our
common stock is listed on the NYSE American under the symbol
“PTN.” On January 31, 2019, the closing price of the
common stock was $0.69 per share. We do not have any other class of
securities listed for trading.
Transfer Agent and Registrar
The
transfer agent for our common stock is American Stock Transfer
& Trust Company, located at 6201 15th Avenue, Brooklyn,
New York 11219. Their telephone number is (800)
937-5449.
14
Preferred
Stock
We have
the authority to issue 10,000,000 shares of preferred stock. As of
January 31, 2019, 264,000 shares of our preferred stock were
designated as a single class, Series A Convertible Preferred Stock,
of which 4,030 shares were outstanding (see “Series A
Convertible Preferred Stock” below). The description of
preferred stock provisions set forth below is not complete and is
subject to and qualified in its entirety by reference to our
amended and restated certificate of incorporation and the
certificate of designations relating to the Series A Convertible
Preferred Stock.
The
board of directors has the right, without the consent of holders of
common stock, to designate and issue one or more series of
preferred stock, which may be convertible into common stock at a
ratio determined by the board. A series of preferred stock may bear
rights superior to common stock as to voting, dividends,
redemption, distributions in liquidation, dissolution, or winding
up, and other relative rights and preferences. The board may set
the following terms of any series preferred stock (which will be
specified in the applicable prospectus supplement):
●
the number of
shares constituting the series and the distinctive designation of
the series;
●
dividend rates,
whether dividends are cumulative, and, if so, from what date and
the relative rights of priority of payment of
dividends;
●
voting rights and
the terms of the voting rights;
●
conversion
privileges and the terms and conditions of conversion, including
provision for adjustment of the conversion rate;
●
redemption rights
and the terms and conditions of redemption, including the date or
dates upon or after which shares may be redeemable, and the amount
per share payable in case of redemption, which may vary under
different conditions and at different redemption
dates;
●
sinking fund
provisions for the redemption or purchase of shares;
●
rights in the event
of voluntary or involuntary liquidation, dissolution or winding up
of the corporation, and the relative rights of priority of payment;
and
●
any other relative
powers, preferences, rights, privileges, qualifications,
limitations and restrictions of the series.
Dividends on
outstanding shares of preferred stock will be paid or declared and
set apart for payment before any dividends may be paid or declared
and set apart for payment on the common stock with respect to the
same dividend period.
If upon
any voluntary or involuntary liquidation, dissolution or winding up
of the corporation, the assets available for distribution to
holders of preferred stock are insufficient to pay the full
preferential amount to which the holders are entitled, then the
available assets will be distributed ratably among the shares of
all series of preferred stock in accordance with the respective
preferential amounts (including unpaid cumulative dividends, if
any) payable with respect to each series.
Holders
of preferred stock will not be entitled to preemptive rights to
purchase or subscribe for any shares of any class of capital stock
of the corporation. The preferred stock will, when issued, be fully
paid and non-assessable. The rights of the holders of preferred
stock will be subordinate to those of our general
creditors.
15
The
board of directors established a series of 264,000 shares of
preferred stock, designated Series A Convertible Preferred Stock,
par value $0.01 per share (the “Series A”). We issued
137,780 shares of Series A in 1997, of which 4,030 shares remain
outstanding as of January 31, 2019, the rest having been converted
into common stock. The Series A has the following rights and
preferences.
Optional conversion. Each share of
Series A is convertible at any time, at the option of the holder,
into the number of shares of common stock equal to $100 divided by
the conversion price, as defined in the Series A certificate of
designations. The current conversion price is $6.57, so each share
of Series A is currently convertible into approximately 15 shares
of common stock.
Mandatory conversion. We may, at our
option, cause the conversion of the Series A, in whole or in part,
on a pro rata basis, into common stock, if the closing bid price of
the common stock has exceeded 200% of the conversion price for at
least 20 trading days in any 30 consecutive trading day period,
ending three days prior to the date of mandatory
conversion.
Price protection provisions. The
conversion price decreases if we sell common stock (or equivalents)
for a price per share less than the conversion price or less than
the market price of the common stock, subject to certain
exceptions. The conversion price is also subject to adjustment upon
the occurrence of a merger, reorganization, consolidation,
reclassification, stock dividend or stock split which results in an
increase or decrease in the number of shares of common stock
outstanding.
Dividend and distribution preference.
We may not pay a dividend or make any distribution to holders of
any other capital stock unless and until we first pay a special
dividend or distribution of $100 per share to the holders of Series
A.
Liquidation preference. Upon (i)
liquidation, dissolution or winding up of the Company, whether
voluntary or involuntary, (ii) sale or other disposition of all or
substantially all of the assets of the Company, or (iii) any
consolidation, merger, combination, reorganization or other
transaction in which Palatin is not the surviving entity or in
which the shares of common stock constituting in excess of 50% of
the voting power of the Company are exchanged for or changed into
other stock or securities, cash and/or any other property, after
payment or provision for payment of the debts and other liabilities
of the Company, the holders of Series A will be entitled to
receive, pro rata and in preference to the holders of any other
capital stock, an amount per share equal to $100 plus accrued but
unpaid dividends, if any.
Voting rights. Each holder of Series A
has the number of votes equal to the number of shares of common
stock issuable upon conversion of the holder’s Series A at
the record date for determination of the stockholders entitled to
vote or, if no record date is established, at the date a vote is
taken. Except as provided above or as required by applicable law,
the holders of the Series A are entitled to vote together with the
holders of the common stock and not as a separate
class.
Debt
Securities
As of
the date of this prospectus, we have no debt securities issued and
outstanding other than a four-year senior secured term loan with a
group led by Horizon Technology Finance Corporation for an original
total face amount of $10,000,000 in the aggregate. As of September
30, 2018, the total of notes payable was $4,305,242 (including
unamortized discounts and issuance costs of $28,092), together with
final incremental payments of $1,000,000, all of which was
classified as a current liability.
The
following description, together with the additional information we
include in any applicable prospectus supplement, summarizes the
material terms and provisions of the debt securities that we may
offer under this prospectus. While the terms we have summarized
below will apply generally to any future debt securities we may
offer, 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 we offer under a
prospectus supplement may differ from the terms we describe
below.
We will
issue notes under an indenture, which we will enter into with the
trustee named in the indenture. Any indenture will be qualified
under the Trust Indenture Act of 1939. You should read the summary
below, the applicable prospectus supplement and the provisions of
the applicable indenture and any related security documents, if
any, in their entirety before investing in our debt
securities.
We will
describe in each prospectus supplement the following terms relating
to a series of debt securities:
●
the
title;
●
the principal
amount being offered, and if a series, the total amount authorized
and the total amount outstanding;
●
any limit on the
amount that may be issued;
●
whether or not we
will issue the series of debt securities in global form, and if so,
the terms and who the depository will be;
●
the maturity
date;
●
the principal
amount due at maturity, and whether the debt securities will be
issued with an original issue discount;
●
whether and under
what circumstances, if any, we will pay additional amounts on any
debt securities held by a person who is not a United States person
for tax purposes, and whether we can redeem the debt securities if
we have to pay such additional amounts;
●
the annual interest
rate, 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;
●
whether or not the
debt securities will be secured or unsecured, and the terms of any
secured debt;
16
●
the terms of the
subordination of any series of subordinated debt;
●
the place where
payments will be payable;
●
restrictions on
transfer, sale or other assignment, if any;
●
our right, if any,
to defer payment of interest and the maximum length of any such
deferral period;
●
the date, if any,
after which the conditions upon which, and the price 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 redemptions provisions;
●
the date, if any,
on which, and the price 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;
●
whether the
indenture will restrict our ability to pay dividends, or will
require us to maintain any asset ratios or reserves;
●
whether we will be
restricted from incurring any additional indebtedness, issuing
additional securities, or entering into a merger, consolidation or
sale of our business;
●
a discussion of any
material or special United States federal income tax considerations
applicable to the debt securities;
●
information
describing any book-entry features;
●
provisions for a
sinking fund purchase or other analogous fund, if any;
●
any provisions for
payment of additional amounts for taxes and any provision for
redemption, if we must pay such additional amount with respect to
any debt security;
●
whether the debt
securities are to be offered at a price such that they will be
deemed to be offered at an “original issue discount” as
defined in paragraph (a) of Section 1273 of the Internal Revenue
Code;
●
the denominations
in which we will issue the series of debt securities, if other than
denominations of $1,000 and any integral multiple
thereof;
●
the terms on which
a series of debt securities may be convertible into or exchangeable
for our common stock, any other of our securities or securities of
a third party, and whether conversion or exchange is mandatory, at
the option of the holder or at our option;
●
events of
default;
●
whether we and/or
the debenture trustee may change an indenture without the consent
of any holders;
●
the form of debt
security and how it may be exchanged and transferred;
●
descriptions of the
debenture trustee and paying agent, and the method of payments;
and
●
any other specific
terms, preferences, rights or limitations of, or restrictions on,
the debt securities, including any additional events of default or
covenants provided with respect to the debt securities, and any
terms which may be required by us or advisable under applicable
laws or regulations.
Specific indentures
will contain additional important terms and provisions and will be
incorporated by reference as an exhibit to the registration
statement that includes this prospectus, or as an exhibit to a
report filed under the Exchange Act, incorporated by reference in
this prospectus.
17
Warrants
As of
January 31, 2019, warrants for the purchase of 23,404,046 shares of
our common stock were outstanding, exercisable at a weighted
average exercise price of $0.77. The outstanding warrants expire on
various dates from December 23, 2019 through December 6,
2021.
The
following description, together with the additional information we
may include in any applicable prospectus supplement, summarizes the
material terms and provisions of the warrants that we may offer
under this prospectus and the related warrant agreements and
warrant certificates. While the terms summarized below will apply
generally to any warrants that we may offer, we will describe the
particular terms of any series of warrants in more detail in the
applicable prospectus supplement. The terms of any warrants offered
under a prospectus supplement may differ from the terms described
below. Specific warrant agreements will contain additional
important terms and provisions and will be incorporated by
reference as exhibits to the registration statement that includes
this prospectus, or as exhibits to a report filed under the
Exchange Act, incorporated by reference in this
prospectus.
General. We will describe in the
applicable prospectus supplement the terms of the series of
warrants, including:
●
the title of
warrants;
●
the offering price
and aggregate number of warrants offered;
●
the currency for
which the warrants may be purchased;
●
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;
●
if applicable, the
date on and after which the warrants and the related securities
will be separately transferable;
●
in the case of
warrants to purchase common stock or preferred stock, the number 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
these shares may be purchased upon exercise;
18
●
in the case of
warrants to purchase debt securities, the principal amount of debt
securities purchasable upon exercise of one warrant and the price
at which, and currency in which, this principal amount of debt
securities may be purchased upon exercise;
●
the effect of any
merger, consolidation, sale or other disposition of our business on
the warrant agreement and the warrants;
●
the terms of any
rights to redeem or call the warrants;
●
any provisions for
changes to or adjustments in the exercise price or number of
securities issuable upon exercise of the warrants;
●
the dates on which
the right to exercise the warrants will commence and
expire;
●
the manner in which
the warrant agreement and warrants may be modified;
●
federal income tax
consequences of holding or exercising the warrants;
●
information
relating to book-entry procedures, if any;
●
the terms of the
securities issuable upon exercise of the warrants; and
●
any other specific
terms, preferences, rights or limitations of or restrictions on the
warrants.
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 debt securities, the right to receive payments
of principal of, or premium, if any, or interest on, the debt
securities purchasable upon exercise or to enforce covenants in the
applicable indenture; or
●
in the case of
warrants to purchase 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.
19
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. New York time 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 amount to the
warrant agent in immediately available funds, as provided in the
applicable prospectus supplement. We will set forth on the reverse
side of the warrant certificate and/or 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. If we so indicate in the applicable prospectus
supplement, holders of the warrants may surrender securities as all
or part of the exercise price for the warrants (cashless
exercise).
We will
describe in the applicable prospectus supplement exercise
procedures for warrants in a book-entry form, if any.
Enforceability of Rights by Holders of
Warrants. Each 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 its right to exercise,
and receive the securities purchasable upon exercise of, its
warrants.
ANTI-TAKEOVER
EFFECTS OF PROVISIONS OF DELAWARE LAW
AND OUR CHARTER DOCUMENTS
Amended and Restated Certificate of Incorporation
Our
amended and restated certificate of incorporation authorizes the
issuance of up to 10,000,000 shares of preferred stock, par value
$.01 per share, of which 264,000 shares are currently designated as
Series A Convertible Preferred Stock. The board of directors has
the authority, without further approval of the stockholders, to
issue and determine the rights and preferences of other series of
preferred stock, except as limited by the certificate of
designation for the Series A. The board could issue one or more
series of preferred stock with voting, conversion, dividend,
liquidation, or other rights which would adversely affect the
voting power and ownership interest of holders of common stock.
This authority may have the effect of deterring hostile takeovers,
delaying or preventing a change in control, and discouraging bids
for our common stock at a premium over the market
price.
Section 203 of the Delaware General Corporation Law
We are
subject to Section 203 of the Delaware General Corporation Law,
which, subject to certain exceptions, prohibits a Delaware
corporation from engaging in any business combination with any
interested stockholder for a period of three years following the
time that such stockholder became an interested stockholder,
unless:
●
prior to such time,
the board of directors approved either the business combination or
the transaction that resulted in the stockholder becoming an
interested holder;
●
upon consummation
of the transaction that resulted in the stockholder becoming an
interested stockholder, the interested stockholder owned at least
85% of the voting stock of the corporation outstanding at the time
the transaction commenced, excluding for purposes of determining
the number of shares outstanding those shares owned (a) by persons
who are directors and also officers and (b) by employee stock plans
in which employee participants do not have the right to determine
confidentially whether shares held subject to the plan will be
tendered in a tender or exchange offer; or
●
at or subsequent to
such time, the business combination is approved by the board of
directors and authorized at an annual or special meeting of
stockholders, and not by written consent, by the affirmative vote
of at least two thirds of the outstanding voting stock which is not
owned by the interested stockholder.
20
In
general, Section 203 defines “business combination” to
include the following:
●
any merger or
consolidation involving the corporation and the interested
stockholder;
●
any sale, transfer,
pledge or other disposition of 10% or more of the assets of the
corporation involving the interested stockholder;
●
subject to certain
exceptions, any transaction that results in the issuance or
transfer by the corporation of any stock of the corporation to the
interested stockholder;
●
any transaction
involving the corporation that has the effect of increasing the
proportionate share of the stock or any class or series of the
corporation beneficially owned by the interested stockholder;
or
●
the receipt by the
interested stockholder of the benefit of any loans, advances,
guarantees, pledges or other financial benefits provided by or
through the corporation.
In
general, Section 203 defines “interested stockholder”
as an entity or person beneficially owning 15% or more of the
outstanding voting stock of the corporation and any entity or
person affiliated with or controlling or controlled by such entity
or person.
Indemnification and Limitation of Liability
Our
amended and restated certificate of incorporation and bylaws
require us to indemnify our directors, officers, employees and
agents against the costs (including fines, judgments and attorney
fees) from involvement in legal proceedings arising from their
position or service, provided that the person seeking
indemnification acted:
●
in good
faith;
●
in a manner he or
she reasonably believed to be in, or not opposed to, the best
interests of the corporation; and,
●
with respect to any
criminal action or proceeding, had no reasonable cause to believe
his or her conduct was unlawful.
The
amended and restated certificate of incorporation and bylaws allow
us to buy indemnification insurance for this purpose.
Our
certificate of incorporation provides that, to the fullest extent
permissible under Delaware law, no director shall be personally
liable to the corporation or its stockholders for monetary damages
for breach of a fiduciary duty as a director. However, this
provision does not eliminate the duty of care, and in appropriate
circumstances, equitable remedies such as injunctive or other forms
of non-monetary relief that will remain available under Delaware
law. In addition, each director will continue to be subject to
liability for (a) breach of the director’s duty of loyalty to
us or our stockholders, (b) acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law,
(c) violating Section 174 of the Delaware General Corporation Law,
or (d) any transaction from which the director derived an improper
personal benefit. The provision also does not affect a
director’s responsibilities under any other law, such as the
federal securities laws or state or federal environmental
laws.
PLAN
OF DISTRIBUTION
We may
sell securities under this prospectus in public
offerings:
● through one or more
underwriters or dealers;
● through other
agents;
● directly to
investors; or
● through a
combination of any of these methods.
We may
price the securities we sell under this prospectus:
● at a fixed public
offering price or prices, which we may change from time to
time;
● at market prices
prevailing at the times of sale;
● at prices
calculated by a formula based on prevailing market
prices;
● at negotiated
prices; or
● in a combination of
any of the above pricing methods.
21
If we use
underwriters for an offering, they will acquire securities for
their own account and may resell them from time to time in one or
more transactions at a fixed public offering price or at varying
prices determined at the time of sale. The obligations of the
underwriters to purchase the securities will be subject to the
conditions set forth in the applicable underwriting agreement. We
may offer the securities to the public through underwriting
syndicates represented by managing underwriters or by underwriters
without a syndicate. Subject to certain conditions, the
underwriters will be obligated to purchase all the securities of
the series offered by the prospectus supplement. The public
offering price and any discounts or concessions allowed or
re-allowed or paid to dealers may change from time to time. Only
underwriters named in a prospectus supplement are underwriters of
the securities offered by that prospectus supplement.
We may
offer our securities in “at the market” offerings, with
the meaning of Rule 415(a)(4) of the Securities Act, into an
existing trading market on terms described in the applicable
prospectus supplement. Underwriters and dealers may participate in
any “at the market” offering.
We may
also sell securities directly or through agents. We will name any
agent involved in an offering and we will describe any commissions
we will pay the agent in the prospectus supplement. Unless the
prospectus supplement states otherwise, our agents will act on a
best-efforts basis.
We may
authorize agents or underwriters to solicit offers by certain types
of institutional investors to purchase securities from us at the
public offering price set forth in the prospectus supplement
pursuant to delayed delivery contracts providing for payment and
delivery on a specified date in the future. We will describe the
conditions of these contracts and the commissions we must pay for
solicitation of these contracts in the prospectus
supplement.
We may
provide agents and underwriters with indemnification against
certain civil liabilities, including liabilities under the
Securities Act, or contribution with respect to payments that the
agents or underwriters may make with respect to such liabilities.
Underwriters or agents may engage in transactions with us, or
perform services for us, in the ordinary course of business. We may
also use underwriters or agents with whom we have a material
relationship. We will describe the nature of any such relationship
in the prospectus supplement.
An
underwriter may engage in overallotment, stabilizing transactions,
short covering transactions and penalty bids in accordance with
Regulation M under the Exchange Act . Overallotment involves sales
in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying
security so long as the stabilizing bids do not exceed a specified
maximum. Short covering transactions involve purchases of the
securities in the open market after the distribution is completed
to cover short positions. Penalty bids permit the underwriter to
reclaim a selling concession from a dealer when the securities
originally sold by the dealer are purchased in a covering
transaction to cover short positions. These activities may cause
the price of our securities to be higher than it would otherwise be
on the open market. The underwriter may discontinue any of these
activities at any time.
All
securities we offer, other than common stock, will be new issues of
securities, with no established trading market. Underwriters may
make a market in these securities, but will not be obligated to do
so and may discontinue market making at any time without notice. We
cannot guarantee the liquidity of the trading markets for any
securities.
LEGAL
MATTERS
Unless
otherwise specified in the applicable prospectus supplement, the
validity of the securities covered by this prospectus will be
passed upon for us by Thompson Hine LLP, New York, New York. In
addition, counsel that will be named in the applicable prospectus
supplement will pass upon the validity of any securities offered
under the applicable prospectus supplement for any underwriters or
agents.
EXPERTS
The
consolidated financial statements of Palatin Technologies, Inc. and
subsidiary as of June 30, 2018 and 2017, and for each of the years
in the three-year period ended June 30, 2018, and
management’s assessment of the effectiveness of internal
control over financial reporting as of June 30, 2018, have been
incorporated by reference herein and in the registration statement
in reliance upon the reports of KPMG LLP, independent registered
public accounting firm, incorporated by reference herein, and upon
the authority of said firm as experts in accounting and
auditing.
22
This
prospectus is part of a registration statement we filed with the
SEC. You should rely only on the information or representations
contained in (or incorporated by reference in) this prospectus and
any accompanying prospectus supplement. We have not authorized
anyone to provide information other than that provided in this
prospectus and any accompanying prospectus supplement. We are not
making an offer of these securities in any jurisdiction where the
offer is not permitted. You should assume that the information in
this prospectus or any accompanying prospectus supplement, as well
as information we have previously filed with the SEC and
incorporated by reference herein, is accurate as of the date on the
front of those documents only. Our business, financial condition,
results of operations, and prospects may have changed since those
dates, and is not accurate as of any date other than the date on
the front of the document.
$100,000,000
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Units
PALATIN TECHNOLOGIES, INC.
PROSPECTUS
,
2019
23
PART II. INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND
DISTRIBUTION
The
following table sets forth expenses (estimated except for the SEC
registration fees) in connection with the offering described in the
registration statement. These estimates do not include expenses for
the preparation and filing of supplemental prospectuses relating to
the issuance of particular securities under this registration
statement.
|
SEC registration
fees
|
$6,320
|
|
Exchange
fees
|
0
|
|
Legal fees and
expenses
|
10,000
|
|
Accountants fees
and expenses
|
9,000
|
|
Miscellaneous
|
3,000
|
|
TOTAL
|
$28,320
|
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section
102(b)(7) of the Delaware General Corporation Law (DGCL) allows a
corporation to provide in its certificate of incorporation for the
elimination or limitation of personal liability of a director to
the corporation or its stockholders for monetary damages for breach
of fiduciary duty as a director, with some exceptions. Article V,
Section 3 of our amended and restated certificate of incorporation
provides that to the fullest extent permitted by the DGCL, no
director shall be personally liable to us or our stockholders for
monetary damages for breach of a fiduciary duty as a
director.
Section
145 of the DGCL provides that a corporation may indemnify any
person who was or is a party or is threatened to be made a party to
any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative by reason
of the fact that he is or was a director, officer, employee or
agent of the corporation, or serving at the request of the
corporation in similar capacities, against expenses (including
attorneys’ fees), judgments, fines, and amounts paid in
settlement actually and reasonably incurred by him in connection
with such action, suit or proceeding if he acted in good faith and
in a manner he reasonably believed to be in or not opposed to the
best interests of the corporation, and, with respect to any
criminal action or proceeding, had no reasonable cause to believe
his conduct was unlawful. In the case of an action or suit by or in
the right of the corporation, no indemnification shall be made with
respect to any claim, issue or matter as to which such person shall
have been adjudged to be liable to the corporation unless and only
to the extent that the court having jurisdiction shall determine
that such person is fairly and reasonably entitled to
indemnity.
Article
VI of our amended and restated certificate of incorporation and
Article IX of our bylaws provide that we shall make the
indemnification permitted under the DGCL, as summarized above, but
only (unless ordered by a court) upon a determination by a majority
of a quorum of disinterested directors, by independent legal
counsel in a written opinion, or by the stockholders, that the
indemnified person has met the applicable standard of
conduct.
Article
VI of our amended and restated certificate of incorporation and
Article IX of our bylaws further provide that we may advance
expenses for defending actions, suits or proceedings upon such
terms and conditions as our board of directors deems appropriate,
and that we may purchase insurance on behalf of indemnified persons
whether or not we would have the power to indemnify such persons
under Section 145 of the DGCL. We have obtained a directors’
and officers’ liability insurance policy which covers, among
other things, certain liabilities arising under the Securities Act
of 1933.
II-1
ITEM 16. EXHIBITS
EXHIBIT INDEX
|
Exhibit Number
|
Description
|
Filed Herewith
|
Form
|
Filing Date
|
SEC File No.
|
|
1.01
|
Underwriting
Agreement.†
|
|
|
|
|
|
Restated
Certificate of Incorporation of Palatin Technologies, Inc., as
amended.
|
|
10-K
|
September
27, 2013
|
001-15543
|
|
|
Bylaws
of Palatin Technologies, Inc.
|
|
10-Q
|
February
8, 2008
|
001-15543
|
|
|
Specimen
Certificate for shares of Common Stock, $.01 par value, of Palatin
Technologies, Inc.
|
|
S-1
|
September
29, 2014
|
333-198992
|
|
|
4.04
|
Form of
securities purchase agreement.†
|
|
|
|
|
|
4.05
|
Certificate
of designation of preferred stock and specimen preferred stock
certificate.†
|
|
|
|
|
|
Form of
debt indenture.
|
|
S-3
|
August
17, 2018
|
333-226905
|
|
|
4.07
|
Form of
note.†
|
|
|
|
|
|
4.08
|
Form of
warrant agreement and warrant certificate.†
|
|
|
|
|
|
Opinion
of Thompson Hine LLP.
|
|
S-3
|
August
17, 2018
|
333-226905
|
|
|
Consent
of Thompson Hine LLP.††
|
|
S-3
|
August
17, 2018
|
333-226905
|
|
|
Consent
of Independent Registered Public Accounting Firm.
|
X
|
|
|
|
|
|
Power
of Attorney.†††
|
|
S-3
|
August
17, 2018
|
333-226905
|
_______________
†
To be filed by
amendment, or as an exhibit to a report filed under the Securities
Exchange Act of 1934 and incorporated herein by
reference.
††
Included in Exhibit
5.01.
†††
Included in the
signature page of the registration statement filed on August 17,
2018.
II-2
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 Securities and Exchange Commission
(the “Commission”) pursuant to
Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than 20 percent change in the maximum
aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration
statement; and
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), (a)(1)(ii) and (a)(1)(iii) of this section do not apply
if the registration statement is on Form S-3 and the information
required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the
Commission 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.
(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 purposes of determining liability under the Securities Act of
1933 to any purchaser:
(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 and 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 such effective date; or
II-3
(C)
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 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 or 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 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.
(i)
The undersigned registrant hereby undertakes that:
(1) For
purposes of determining any liability under the Securities Act of
1933, the information omitted from the form of prospectus filed as
part of this registration statement in reliance upon Rule 430A and
contained in a form of prospectus filed by the registrant pursuant
to Rule 424(b)(1) or (4) or 497(h) under the Securities Act of 1933
shall be deemed to be part of this registration statement as of the
time it was declared effective.
(2)
For the purpose of determining any liability under the Securities
Act of 1933, each post-effective amendment that contains a form of
prospectus 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.
(j) 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 Commission under Section 305(b)(2) of the
Trust Indenture Act.
II-4
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 Amendment No. 1 to the Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the
Township of Cranbury, State of New Jersey, on February 5,
2019.
|
|
PALATIN TECHNOLOGIES, INC. |
|
|
|
|
|
|
|
|
|
By:
|
/s/ Carl
Spana
|
|
|
|
|
Carl Spana,
Ph.D.
|
|
|
|
|
President and Chief
Executive Officer
|
|
POWER
OF ATTORNEY
Pursuant to the
requirements of the Securities Act of 1933, this Amendment No. 1 to
the Registration Statement has been signed by the following persons
in the capacities on February 5, 2019.
|
Signature
|
|
Title
|
|
|
|
|
|
/s/
Carl Spana
|
|
President,
Chief Executive Officer and Director
|
|
Carl
Spana
|
|
(principal
executive officer)
|
|
|
|
|
|
/s/
Stephen T. Wills
|
|
Executive
Vice President, Chief Financial Officer
|
|
Stephen
T. Wills
|
|
and
Chief Operating Officer (principal financial and accounting
officer)
|
|
|
|
|
|
*
|
|
Chairman
and Director
|
|
John
K.A. Prendergast
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
Robert
K. deVeer, Jr.
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
J.
Stanley Hull
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
Alan W.
Dunton
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
Angela
Rossetti
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
Arlene
M. Morris
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
Anthony
M. Manning
|
|
|
|
*
By: /s/ Stephen T.
Wills
Stephen
T. Wills
Attorney-in-Fact
|
|
|
II-4