As filed with the Securities and Exchange
Commission on November 29, 2016
Registration
No. 333-213199
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
FORTRESS
BIOTECH, INC.
(Exact name of registrant as specified in
its charter)
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Delaware
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20-5157386
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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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2 Gansevoort Street, 9
th
Floor
New York, New York 10014
Telephone: (781) 652-4500
Facsimile: (781) 459-7788
(Address, including zip code, and telephone
number, including area code, of registrant’s principal executive offices)
Lindsay A. Rosenwald, M.D., Chairman,
President and Chief Executive Officer
2 Gansevoort Street, 9
th
Floor
New York, New York 10014
Telephone: (781) 652-4500
Facsimile: (781) 459-7788
(Name, address, including
zip code, and telephone number, including area code, of agent for service)
Copies to:
W. David Mannheim, Esq.
S. Halle Vakani, Esq.
Andrew J. Gibbons, Esq.
Wyrick Robbins Yates & Ponton LLP
4101 Lake Boone Trail, Suite 300
Raleigh, North Carolina 27607
Telephone: (919) 781-4000
Facsimile:
(919) 781-4865
Approximate date of commencement
of proposed sale to the public:
As soon as practicable after 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.
x
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
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.
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Large accelerated filer
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Accelerated filer
x
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Non-accelerated filer
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(Do not check if smaller reporting company)
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Smaller reporting company
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EXPLANATORY
NOTE
This registration statement contains
two prospectuses:
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a base prospectus which covers the offering, issuance and sale by
us of up to $53,000,000 of our common stock, preferred stock, warrants and/or units; and
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a sales agreement prospectus covering the offering and sale of our
common stock that may be issued and sold under an Amended and Restated At Market Sales Agreement, dated August 17, 2016 between
us, MLV & Co. LLC and FBR Capital Markets & Co. for shares of common stock having an aggregate offering price of up to
$53,000,000.
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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 $53,000,000
of common stock that may be offered, issued and sold under the sales agreement prospectus is included in the $53,000,000 of securities
that may be offered, issued and sold by us under the base prospectus.
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 that specifically states that this registration statement shall thereafter become
effective in accordance with section 8(a) of the securities act or until this registration statement shall become effective on
such date as the commission, acting pursuant to said section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. We may not sell these securities or accept an offer to buy 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 an offer to buy these securities in any state where the offer
or sale is not permitted.
SUBJECT
TO COMPLETION, DATED N
ovember
29, 2016
PROSPECTUS
$53,000,000
of
Common Stock,
Preferred Stock,
Warrants and/or
Units
From time to time, we may offer up to $53,000,000
of any combination of the securities described in this prospectus, either individually or in units, in one or more offerings in
amounts, at prices and on the terms that we will determine at the time of offering. We may also offer common stock upon conversion
of preferred stock, or common stock or preferred stock upon the exercise of warrants.
Each time we sell securities, we will provide
specific terms of the securities offered in a supplement to this prospectus. The prospectus supplement may also add, update or
change information contained in this prospectus. We will specify in any accompanying prospectus supplement the terms of any offering.
You should read this prospectus and the applicable prospectus supplement, as well as any documents incorporated by reference in
this prospectus and any prospectus supplement, carefully before you invest in any securities.
This prospectus may not be used by us
to consummate a sale of securities unless accompanied by the applicable prospectus supplement.
We will sell these securities directly to
our stockholders or to other purchasers or through agents on our behalf or through underwriters or dealers as designated from time
to time. If any agents or underwriters are involved in the sale of any of these securities, the applicable prospectus supplement
will provide the names of the agents or underwriters and any applicable fees, commissions, or discounts.
Our common stock is traded on The NASDAQ
Capital Market (the “Exchange”) under the symbol “FBIO.” The last reported sale price of our common stock
on November 28, 2016 was $2.52 per share. We recommend that you obtain current market quotations for our common stock prior to
making an investment decision.
You should carefully read this prospectus,
any prospectus supplement relating to any specific offering of securities, and all information incorporated by reference herein
and therein.
Investing in these securities
involves a high degree of risk. Before buying shares of our common stock, you should carefully consider the risk factors
described in “Risk Factors” beginning on page 4 of this prospectus and in the documents incorporated by
reference into this prospectus and any free writing prospectus that we have authorized for use in connection with this
offering.
Neither the Securities and
Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved of these
securities, or determined if this prospectus is accurate or complete. Any representation to the contrary is a criminal
offense.
__________________________________________
The date of this prospectus is , 2016.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of a registration
statement that we filed with the SEC utilizing a “shelf” registration process.
Under this shelf registration process, we may offer shares of our common stock, shares of our preferred stock and/or warrants to
purchase any of such securities, either individually or in units, in one or more offerings, up to a total dollar amount of $53,000,000.
This prospectus provides you with a general description of the securities we may offer. Each time we offer a type or series of
securities under this prospectus, we will provide a prospectus supplement that will contain specific information about the terms
of that offering.
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. Prospectus supplements may also add, update or change information
contained or incorporated by reference in this prospectus. However, no prospectus supplement will fundamentally change the terms
that are set forth in this prospectus or offer a security that is not registered and described in this prospectus at the time of
its effectiveness. This prospectus, together with the applicable prospectus supplements and the documents incorporated by reference
into this prospectus, include all material information relating to this offering. You should carefully read this prospectus, the
applicable prospectus supplement, the information and documents incorporated herein by reference and the additional information
under the heading “Where You Can Find Additional Information About Us” before making an investment decision.
You should rely only on the information
we have provided or incorporated by reference in this prospectus or any prospectus supplement. We have not authorized anyone to
provide you with information different from that contained or incorporated by reference in this prospectus. No dealer, salesperson
or other person is authorized to give any information or to represent anything not contained or incorporated by reference in this
prospectus. You must not rely on any unauthorized information or representation. This prospectus is an offer to sell only the securities
offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. You should assume that the information
in this prospectus or any prospectus supplement is accurate only as of the date on the front of the document and that any information
we have incorporated herein by reference is accurate only as of the date of the document incorporated by reference, regardless
of the time of delivery of this prospectus or any sale of a security.
To the extent there are inconsistencies
between any prospectus supplement, this prospectus and any documents incorporated by reference, the document with the most recent
date will control.
This prospectus may not be used to consummate
sales of our securities, unless it is accompanied by a prospectus supplement.
Unless otherwise indicated in this prospectus
or the context otherwise requires, all references to “we,” “us,” “our,” “the Company,”
and “Fortress” refer to Fortress Biotech, Inc.
PROSPECTUS SUMMARY
This
summary highlights certain information about us and selected information contained elsewhere in or incorporated by reference
into this prospectus. Because it is a summary, it might not contain all of the information that is important to you. For a
more complete understanding of our Company, we encourage you to read and consider carefully the more detailed information in
this prospectus, including the information incorporated by reference into this prospectus, and the information referred to
under the heading “Risk Factors” in this prospectus beginning on page 4 and in the documents incorporated by
reference into this prospectus.
Our Company
Founded
in 2006, Fortress is a biopharmaceutical company focused on acquiring, developing and commercializing
novel pharmaceutical and biotechnology products. We develop and commercialize products both within Fortress and through certain
of our subsidiary companies, which are sometimes referred to herein as the “Fortress Companies.” Additionally, the
Company recently acquired a controlling interest in National Holdings Corporation, a diversified independent brokerage company.
In addition to our internal development programs, we leverage our biopharmaceutical business expertise and drug development capabilities
to provide funding and management services to help Fortress Companies achieve their goals. The Company and the Fortress Companies
may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide
additional funding to support their research and development programs.
Corporate Information
We were incorporated
in June 2006 under the laws of Delaware. Our principal executive offices are located at 2 Gansevoort Street, 9th Floor, New York,
New York 10014, and our telephone number is (781) 652-4500. Our website address is www.fortressbiotech.com. Information found on,
or accessible through, our website is not a part of, and is not incorporated into, this prospectus, and you should not consider
it part of this prospectus or part of any prospectus supplement.
The Offering
We may offer shares
of our common stock, shares of our preferred stock and/or warrants to purchase any of such securities, either individually or in
units, with a total value of up to $53,000,000 from time to time under this prospectus at prices and on terms to be determined
by market conditions at the time of any offering. This prospectus provides you with a general description of the securities we
may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that
will describe the specific amounts, prices and other important terms of the securities.
The prospectus
supplement also may add, update or change information contained in this prospectus or in documents we have incorporated by reference
into this prospectus. However, no prospectus supplement will fundamentally change the terms that are set forth in this prospectus
or offer a security that is not registered and described in this prospectus at the time of its effectiveness.
This prospectus
may not be used to consummate a sale of any securities unless it is accompanied by a prospectus supplement.
We may sell the
securities directly to investors or to or through agents, underwriters or dealers. We, and our agents or underwriters, reserve
the right to accept or reject all or part of any proposed purchase of securities. If we offer securities through agents or underwriters,
we will include in the applicable prospectus supplement:
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the names of those agents or underwriters;
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applicable fees, discounts and commissions to be paid to them;
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details regarding over-allotment options, if any; and
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the net proceeds to us.
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Common Stock
We may issue shares
of our common stock from time to time. The holders of common stock are entitled to one vote per share on all matters to be voted
upon by stockholders. Subject to preferences that may be applicable to any outstanding preferred stock, the holders of common stock
are entitled to receive ratably any dividends that may be declared from time to time by our board of directors out of funds legally
available for that purpose. In the event of our liquidation, dissolution or winding up, the holders of common stock are entitled
to share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights of any preferred stock
then outstanding.
Preferred Stock
We may issue shares
of our preferred stock from time to time, in one or more class and/or series. Our board of directors will determine the rights,
preferences, privileges and restrictions of the preferred stock, including dividend rights, conversion rights, voting rights, terms
of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation
of such class and/or series, without any further vote or action by stockholders. Convertible preferred stock will be convertible
into our common stock or exchangeable for our other securities. Conversion may be mandatory or at your option or both and would
be at prescribed conversion rates.
If we sell any
class and/or series of preferred stock under this prospectus and applicable prospectus supplements, we will fix the rights, preferences,
privileges and restrictions of the preferred stock of such class and/or series in the certificate of designation relating to that
class and/or series. We will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate
by reference from reports that we file with the SEC, the form of any certificate of designation that describes the terms of the
class and/or series of preferred stock we are offering before the issuance of the related class and/or series of preferred stock.
We urge you to read the applicable prospectus supplement related to the class and/or series of preferred stock being offered, as
well as the complete certificate of designation that contains the terms of the applicable class and/or series of preferred stock.
Warrants
We may issue warrants
for the purchase of common stock or preferred stock in one or more series. We may issue warrants independently or together with
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 will issue under a separate agreement. We may enter into warrant agreements with a
bank or trust company that we select to be our warrant agent. We will indicate the name and address of the warrant agent in the
applicable prospectus supplement relating to a particular series of warrants.
In this prospectus,
we have summarized certain general features of the warrants. We urge you, however, to read the applicable prospectus supplement
related to the particular series of warrants being offered, as well as the warrant agreements and warrant certificates that contain
the terms of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate
by reference from reports that we file with the SEC, the form of warrant agreement or warrant certificate containing the terms
of the warrants we are offering before the issuance of the warrants.
Units
We may issue units
consisting of common stock, preferred stock and/or warrants for the purchase of common stock or preferred stock in one or more
class and/or series. In this prospectus, we have summarized certain general features of the units. We urge you, however, to read
the applicable prospectus supplement related to the series of units being offered, as well as the unit agreements that contain
the terms of the units. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate
by reference reports that we file with the SEC, the form of unit agreement and any supplemental agreements that describe the terms
of the series of units we are offering before the issuance of the related series of units.
RISK FACTORS
Investing
in our securities involves a high degree of risk. You should consider carefully the risks and uncertainties described below together
with the other information included in this prospectus and incorporated by reference herein, before deciding to purchase our securities.
In addition, you should carefully consider, among other things, the section entitled “Risk Factors” beginning on page
12 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, page 55 of our Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, as well as any amendment or update to our risk factors in subsequent filings with
the SEC, and other information in our consolidated financial statements, all of which are incorporated by reference into this
prospectus. The risks described below and incorporated herein by reference are those which we believe are the material risks that
we face. The occurrence of any of the following risks may materially and adversely affect our business, financial condition, results
of operations, cash flows, reputation and future prospects. In this event, the market price of our common stock could decline,
and you could lose part or all of your investment.
Risks Associated with our Capital
Stock
Some of our executives, directors and
principal stockholders can control our direction and policies, and their interests may be adverse to the interests of our other
stockholders.
At September 30,
2016, Lindsay A. Rosenwald, M.D., our Chairman, President and Chief Executive Officer, beneficially owned 12.8% of our issued
and outstanding capital stock. At September 30, 2016, Michael S. Weiss, our Executive Vice Chairman, Strategic Development, beneficially
owned 15.3% of our issued and outstanding capital stock. By virtue of their holdings and membership on our Board of Directors,
Dr. Rosenwald and Mr. Weiss may individually influence our management and our affairs and may make it difficult for us to consummate
corporate transactions such as mergers, consolidations or the sale of all or substantially all of our assets that may be favorable
from our standpoint or that of our other stockholders.
The market price of our common stock
may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
Our stock price may
experience substantial volatility as a result of a number of factors, including:
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announcements we make regarding our or
our subsidiaries’ current product candidates, acquisition of potential new product candidates and companies and/or in-licensing
through multiple subsidiaries;
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sales or potential sales of substantial
amounts of our common stock;
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our or our subsidiaries’ delay or
failure in initiating or completing pre-clinical or clinical trials or unsatisfactory results of any of these trials;
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announcements about us, our subsidiaries
or about our competitors, including clinical trial results, regulatory approvals or new product introductions;
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developments concerning our or our subsidiaries’
licensors and/or product manufacturers;
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litigation and other developments relating
to our or our subsidiaries’ patents or other proprietary rights or those of our competitors;
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conditions in the pharmaceutical or biotechnology
industries;
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governmental regulation and legislation;
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variations in our anticipated or actual
operating results; and
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change in securities analysts’ estimates
of our performance, or our failure to meet analysts’ expectations.
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Many of these factors are beyond our
control. The stock markets in general, and the market for pharmaceutical and biotechnological companies in particular, have historically
experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating
performance of these companies. These broad market and industry factors could reduce the market price of our common stock, regardless
of our actual operating performance.
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 48.9 million outstanding shares of our common stock as of September 30, 2016 are available for sale in the public market,
either pursuant to Rule 144 under the Securities Act of 1933, as amended, or the Securities Act, or an effective registration
statement. Pursuant to our shelf registration statement on Form S-3 of which this prospectus is a part, we may sell up to $53
million of our equity securities over the next three 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.
We and certain of our subsidiaries
have never paid and do not intend to pay cash dividends. As a result, capital appreciation, if any, will be your sole source of
gain.
We and certain
of our subsidiaries have never paid cash dividends on any of our or their capital stock and we and many of our subsidiaries currently
intend to retain future earnings, if any, to fund the development and growth of our business. In addition, the terms of existing
and future debt agreements may preclude us and certain of our subsidiaries from paying dividends. As a result, capital appreciation,
if any, of our common stock will be your sole source of gain for the foreseeable future.
Provisions in our certificate of
incorporation, our bylaws and Delaware law might discourage, delay or prevent a change in control of our Company or changes in
our management and, therefore, depress the trading price of our common stock.
Provisions of our
certificate of incorporation, our bylaws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or
preventing a change in control of our Company or changes in our management, including transactions in which our stockholders might
otherwise receive a premium for their shares over then-current market prices. In addition, these provisions may limit the ability
of stockholders to approve transactions that they may deem to be in their best interests. These provisions include:
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the inability of stockholders to call special meetings; and
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the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder
approval, which could include the right to approve an acquisition or other change in our control or could be used to institute
a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely
preventing acquisitions that have not been approved by our Board of Directors.
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In addition,
the Delaware General Corporation Law, or DGCL, prohibits a publicly held Delaware corporation from engaging in a business
combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last
three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the
person became an interested stockholder, unless the business combination is approved in a prescribed manner.
The existence of
the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future
for shares of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood that
you could receive a premium for your shares of our common stock in an acquisition.
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents
that we incorporate by reference, may 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. Statements in this prospectus, and documents
we incorporate by reference, that are not descriptions of historical facts are forward-looking statements that are based on management’s
current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial
condition and stock price. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “can,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “might,” “plans,” “potential,” “predicts,”
“should,” or “will” or the negative of these terms or other comparable terminology. Factors that could
cause actual results to differ materially from those currently anticipated include those set forth under “Risk Factors”
including, in particular, risks relating to:
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our ability to continue to commercialize products;
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our ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis;
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financing and strategic agreements, acquisitions and relationships;
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our need for substantial additional funds and uncertainties relating
to financings;
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our ability to attract, integrate and retain key personnel;
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the early stage of products under development;
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the results of research and development activities;
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uncertainties relating to preclinical and clinical testing;
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our ability to secure and maintain third-party manufacturing, marketing
and distribution of our products;
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dependence on third-party suppliers;
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patent and intellectual property matters; and
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You should read this prospectus and the
documents that we reference herein completely and with the understanding that our actual future results may be materially different
from what we currently expect. You should assume that the information appearing in this prospectus and any document incorporated
by reference is accurate as of its date only. Because the risk factors referred to above could cause actual results or outcomes
to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue
reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which
the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not
possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or
the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in
any forward-looking statements. We qualify all of the information presented in this prospectus, any accompanying prospectus supplement
and any document incorporated herein by reference, and particularly our forward-looking statements, by these cautionary statements.
USE OF PROCEEDS
Except as otherwise provided in the applicable
prospectus supplement, we intend to use the net proceeds from the sale of the securities covered by this prospectus for general
corporate purposes and working capital. The precise amount, use and timing of the application of such proceeds will depend upon
our funding requirements and the availability and cost of other capital. Additional information on the use of net proceeds from
an offering of securities covered by this prospectus may be set forth in the prospectus supplement relating to the specific offering.
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 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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the purchase price of the securities and the proceeds we will receive from the sale;
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any underwriting discounts and other items constituting underwriters’ compensation;
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any discounts or concessions allowed or reallowed or paid to dealers; and
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any securities exchange or market on which the securities may be listed or traded.
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We may distribute the securities from time
to time in one or more transactions at:
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a fixed price or prices, which may be changed;
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market prices prevailing at the time of sale, directly by us or through a designated agent;
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prices related to such prevailing market prices; or
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Only underwriters named in the prospectus
supplement are underwriters of the securities offered by the prospectus supplement.
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.
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.
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.
We may provide agents, underwriters and
other purchasers with indemnification against particular civil liabilities, including liabilities under the Securities Act, 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.
To facilitate the 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 exercising the over-allotment option granted
to those persons. 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.
Unless otherwise specified in the
applicable prospectus supplement, any common stock sold pursuant to a prospectus supplement will be eligible for listing on
the Exchange, 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.
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.
DESCRIPTION OF CAPITAL STOCK
General
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 certificate
of incorporation, any certificates of designation for our preferred stock, and bylaws, as may be amended from time to time. 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.
As of September 30, 2016, our authorized
capital stock consists of 115 million shares, consisting of 100 million shares of common stock par value $0.001 per share, and
15 million shares of preferred stock, par value $0.001 per share. 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 will not seek stockholder approval for the issuance and sale of our
common stock or preferred stock.
Common Stock
Our certificate of
incorporation authorizes the issuance of up to 100 million shares of common stock, par value $0.001 per share. As of
September 30, 2016, there were 48.9 million shares of common stock outstanding, as well as 4.6 million unissued shares of
common stock subject to outstanding options, unvested restricted stock units, warrants and deferred stock grants. Each holder
of issued common stock is entitled to one vote for each share of common stock held on all matters submitted to a vote of the
stockholders, including the election of directors. Our certificate of incorporation and bylaws do not provide for cumulative
voting rights. Subject to preferences that may be applicable to any then outstanding preferred stock, the holders of our
outstanding shares of common stock are entitled to receive dividends, if any, as may be declared from time to time by our
board of directors out of legally available funds. In the event of our liquidation, dissolution or winding up, holders of
common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the
payment of all of our debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the
holders of any outstanding shares of preferred stock. Holders of our common stock have no preemptive, conversion or
subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. The rights,
preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the
holders of shares of any series of our preferred stock that we may designate and issue in the future. All of our outstanding
shares of common stock are fully paid and nonassessable.
The transfer agent and registrar for
our common stock is VStock Transfer, LLC. The transfer agent’s address is 18 Lafayette Place, Woodmere, New York 11598.
Our common stock is listed for quotation on the Exchange under the symbol “FBIO.” On November 28, 2016, the last
reported sale price of our common stock was $2.52 per share.
Preferred Stock
We are authorized to issue 15 million
shares of preferred stock, par value $0.001 per share. In November 2011, all of our then outstanding shares of preferred stock
were converted, on a one-for-one basis, into 11.5 million shares of our common stock. As of September 30, 2016, there were no
shares of preferred stock outstanding.
Our board of directors may divide
the authorized shares of preferred stock into series and fix and determine the relative rights and preferences of the
preferred stock, such as the designation of series and the number of shares constituting such series, dividend rights,
redemption and sinking fund provisions, liquidation and dissolution preferences, conversion or exchange rights and voting
rights, if any. Issuance of preferred stock by our board of directors will 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, the board of directors is required by the DGCL and our certificate of incorporation
to adopt resolutions and file a certificate of designation with the Secretary of State of the State of Delaware. 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 the 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 the 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 will 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 certificate of incorporation and any certificates
of designation that our board of directors may adopt.
All shares of preferred
stock offered hereby will, when issued, be fully paid and nonassessable, including shares of 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.
DESCRIPTION OF WARRANTS
As of September 30, 2016, we had outstanding
warrants to purchase a total of 2,183,453 shares of our common stock.
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 any related warrant agreement and warrant certificate. While the terms summarized below will apply
generally to any warrants that we may offer, we will describe the specific terms of any series of warrants in more detail in the
applicable prospectus supplement. If we indicate in the prospectus supplement, the terms of any warrants offered under that 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 an exhibit to the registration statement which includes this prospectus.
General
We may issue warrants for the purchase of
common stock or preferred stock in one or more series. We may issue warrants independently or together with 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 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 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 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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LEGAL MATTERS
The validity of the securities offered will
be passed upon by Wyrick Robbins Yates & Ponton LLP, Raleigh, North Carolina.
EXPERTS
The
consolidated balance sheets of Fortress Biotech, Inc. as of December 31, 2015 and 2014 and the related consolidated statements
of operations, stockholders’ equity, and cash flows for each of the years then ended have been audited by EisnerAmper LLP,
independent registered public accounting firm, as stated in their reports, which are incorporated herein by reference, which reports
(1) express an unqualified opinion on the financial statements, and (2) express an unqualified opinion on the effectiveness of
internal control over financial reporting. Such financial statements have been incorporated herein by reference in reliance on
the reports of such firm given upon their authority as experts in accounting and auditing.
The consolidated
financial statements of Fortress Biotech, Inc. for the year ended December 31, 2013 incorporated in this prospectus by reference
to the Annual Report on Form 10-K for the year ended December 31, 2015 have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in
auditing and accounting.
The consolidated financial statements
of National Holdings Corporation as of September 30, 2015 and 2014 and for the years then ended appearing in its Annual Report
on Form 10-K for the year ended September 30, 2015 filed with the SEC and incorporated herein by
reference from Fortress Biotech, Inc.’s Current Report on Form 8-K/A filed on November 22, 2016 have been audited by EisnerAmper
LLP, independent registered public accounting firm, as set forth in their report thereon included in such Annual Report and incorporated
herein by reference. Such financial statements are incorporated in reliance upon such report given on the authority of such firm
as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We are subject to the reporting requirements
of the Exchange Act, and file annual, quarterly and current reports, proxy statements and other information with the SEC. You may
read and copy these reports, proxy statements and other information at the SEC’s public reference facilities at 100 F Street,
N.E., Room 1580, Washington, D.C. 20549. You can request copies of these documents by writing to the SEC and paying a fee for the
copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public reference facilities.
SEC filings are also available at the SEC’s web site at http://www.sec.gov.
This prospectus is only part of a
registration statement on Form S-3 that we have filed with the SEC under the Securities Act, and therefore omits certain
information contained in the registration statement. We have also filed exhibits and schedules with the registration
statement that are excluded from this prospectus, and you should refer to the applicable exhibit or schedule for a complete
description of any statement referring to any contract or other document. You may inspect a copy of the registration
statement, including the exhibits and schedules, without charge, at the public reference facilities or obtain a copy
from the SEC upon payment of the fees prescribed by the SEC.
INCORPORATION OF CERTAIN DOCUMENTS BY
REFERENCE
The SEC allows us to “incorporate
by reference” information we file with it into our registration statement of which this prospectus is a part, which means
that we can disclose important information to you by referring you to other documents. The information incorporated by reference
is considered to be part of this prospectus, and information that we file later with the SEC and incorporate by reference will
automatically update and supersede this information. We incorporate by reference into this prospectus the documents listed below
and all future filings made by us with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act, except for information
“furnished” under Items 2.02, 7.01 or 9.01 on Form 8-K or other information “furnished” to the SEC which
is not deemed filed and not incorporated in this prospectus, until the termination of the offering of securities described in the
applicable prospectus supplement.
We hereby incorporate by reference the following
documents:
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our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 15, 2016 including the information
specifically incorporated by reference into the Annual Report on Form 10-K from our definitive proxy statement for the 2016 Annual
Meeting of Stockholders;
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the SEC on May 10, 2016;
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our Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016;
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our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2016, filed with the SEC on
November 9, 2016;
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our Current Reports on Form 8-K filed with the SEC on January 7, 2016, April 18, 2016,
April 21, 2016, April 28, 2016, May 4, 2016, May 6, 2016, May 26, 2016, June 1,
2016, June 21, 2016, August 12, 2016, August 17, 2016, September 20, 2016, September 26, 2016, October 3, 2016, October
12, 2016, October 20, 2016 and October 24, 2016, and on Form 8-K/A filed with the SEC on November 22, 2016; and
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the description of our common stock included in our registration
statement on Form 8-A, filed with the SEC on December 7, 2011.
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Any statement contained in this
prospectus or in a document incorporated or deemed to be incorporated by reference into this prospectus will be deemed to be
modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or any
other subsequently filed document that is deemed to be incorporated by reference into this prospectus modifies or supersedes
such statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to
constitute a part of this registration statement.
We will furnish without charge to you, on
written or oral request, a copy of any or all of the documents incorporated by reference, including exhibits to these documents.
You should direct any requests for documents in writing to: Fortress Biotech, Inc., 2 Gansevoort Street, 9th Floor, New York, New
York 10014, Attention: Corporate Secretary, tel: 781-652-4500. These documents are also available on the Investors section of our
website, which is located at www.fortressbiotech.com, or as described under “Where You Can Find Additional Information”
above. The reference to our website address does not constitute incorporation by reference of the information contained on our
website.
You should rely only on information contained
in, or incorporated by reference into, this prospectus and any prospectus supplement. We have not authorized anyone to provide
you with information different from that contained in this prospectus or incorporated by reference in this prospectus. We are not
making offers to sell the securities in any jurisdiction in which such an offer or solicitation is not authorized or in which the
person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make such offer or solicitation.
$53,000,000
of
Common Stock,
Preferred Stock,
Warrants and/or
Units
PROSPECTUS
The date of
this prospectus is , 2016
The
information in this prospectus is not complete and may be changed. We may not sell these securities or accept an offer to buy 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 an offer to buy these securities in any state where the offer
or sale is not permitted.
SUBJECT
TO COMPLETION, DATED
November 29
, 2016
PROSPECTUS
$53,000,000
Fortress Biotech, Inc.
Common
Stock
In accordance with the terms of the Amended
and Restated At Market Issuance Sales Agreement entered into with MLV & Co. LLC, or MLV, and FBR Capital Markets & Co.,
or FBR, and collectively with MLV, the Agents, dated August 17, 2016, which we refer to as the sales agreement, we may offer and
sell under this prospectus shares of our common stock, $0.001 par value per share, having an aggregate offering price of up to
$53,000,000 from time to time through MLV and FBR, acting as the Agents.
Our common stock is traded on The NASDAQ
Capital Market (the “Exchange”) under the symbol “FBIO.” The last reported sale price of our common stock
on November 28, 2016 was $2.52 per share.
Sales of our common stock, if any, under
this prospectus will be made by any method permitted that is deemed an “at the market offering” as defined in Rule
415 under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on the Exchange, any other
existing trading market for our common stock, sales made to or through a market maker, in negotiated transactions at market prices,
and/or any other method permitted by law. The Agents are not required to sell any specific amount of shares of our common stock,
but will act as our sales agents using commercially reasonable efforts consistent with their normal trading and sales practices.
There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
The Agents will be entitled to compensation
at a commission rate of up to 3.0% of the gross sales price per share of our common stock sold. In connection with the sale of
our common stock on our behalf, each of the Agents will be deemed to be an “underwriter” within the meaning of the
Securities Act and the compensation of the Agents will be deemed to be underwriting commissions or discounts. We have also agreed
to provide indemnification and contribution to the Agents with respect to certain liabilities, including liabilities under the
Securities Act.
Investing in our common stock involves
a high degree of risk. Before buying shares of our common stock, you should carefully consider the risk factors described in “Risk
Factors” beginning on page SA-4 of this prospectus and in the documents incorporated by reference therein and any free writing
prospectus that we have authorized for use in connection with this offering.
Neither the Securities and
Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved of these
securities, or determined if this prospectus is accurate or complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is ,
2016.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This 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,
together with the information incorporated by reference as described under the heading “Where You Can Find Additional Information”
and “Incorporation of Certain Documents by Reference.” These documents contain important information that you should
consider when making your investment decision.
This prospectus describes the specific terms
of the common stock we are offering and also adds to and updates information contained in the documents incorporated by reference
into this prospectus. To the extent there is a conflict between the information contained in this prospectus, on the one hand,
and the information contained in any document incorporated by reference in this prospectus, on the other hand, you should rely
on the information in this prospectus. If any statement in one of these documents is inconsistent with a statement in another document
having a later date—for example, a document incorporated by reference into this prospectus—the statement in the document
having the later date modifies or supersedes the earlier statement.
You should rely only on the information
contained in or incorporated by reference in this prospectus and any free writing prospectus that we may authorize for use in connection
with this offering. We have not, and the Agents have not, authorized anyone to provide you with different information. If anyone
provides you with different or inconsistent information, you should not rely on it. We are not, and the Agents are not, making
an offer to sell these securities in any jurisdiction where the offer or sale is not permitted or in which the person making that
offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make an offer or solicitation. You should
assume that the information appearing in this prospectus, the documents incorporated by reference in this prospectus and 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. Our business, financial condition, results of operations and prospects may have changed since those dates. You should
read this prospectus, the documents incorporated by reference in this prospectus and any free writing prospectus that we have authorized
for use in connection with this offering, in their entirety before making an investment decision.
Unless otherwise indicated in this prospectus
or the context otherwise requires, all references to “we,” “us,” “our,” “the Company,”
and “Fortress” refer to Fortress Biotech, Inc.
PROSPECTUS SUMMARY
This summary
highlights certain information about us, this offering and selected information contained elsewhere in or incorporated by reference
into this prospectus. This summary is not complete and does not contain all of the information that you should consider before
deciding whether to invest in our common stock. For a more complete understanding of our Company and this offering, we encourage
you to read and consider carefully the more detailed information in this prospectus, including the information incorporated by
reference into this prospectus, and the information referred to under the heading “Risk Factors” in this prospectus
beginning on page SA-4, and in the documents incorporated by reference into this prospectus.
Our Company
Founded
in 2006, Fortress is a biopharmaceutical company focused on acquiring, developing and
commercializing novel pharmaceutical and biotechnology products. We develop and commercialize products both within
Fortress and through certain of our subsidiary companies, which are sometimes referred to herein as the “Fortress
Companies.” Additionally, the Company recently acquired a controlling interest in National Holdings Corporation, a
diversified independent brokerage company. In addition to our internal development programs, we leverage our
biopharmaceutical business expertise and drug development capabilities to provide funding and management services to help
Fortress Companies achieve their goals. The Company and the Fortress Companies may seek licensings, acquisitions,
partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support
their research and development programs.
Corporate Information
We were incorporated
in June 2006 under the laws of Delaware. Our principal executive offices are located at 2 Gansevoort Street, 9th Floor, New York,
New York 10014, and our telephone number is (781) 652-4500. Our website address is www.fortressbiotech.com. Information found on,
or accessible through, our website is not a part of, and is not incorporated into, this prospectus, and you should not consider
it part of this prospectus or part of any prospectus supplement.
The Offering
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Common stock offered by us pursuant to
this prospectus
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Shares of our common stock having an aggregate offering price of up to $53,000,000.
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Manner of offering
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“At the market offering” that may
be made from time to time on the Exchange or other market for our common stock in the United States through our agents, MLV
and FBR. See the section entitled “Plan of Distribution” below.
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Use of proceeds
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We intend to use the net proceeds of this offering for our operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product and working capital. See the section entitled “Use of Proceeds” below.
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R
isk factors
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See “Risk Factors” beginning on page SA-4 and the other information included in, or incorporated by reference into, this prospectus for a discussion of certain factors you should carefully consider before deciding to invest in shares of our common stock.
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NASDAQ Capital Market symbol
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FBIO
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RISK FACTORS
Investing
in our securities involves a high degree of risk. You should consider carefully the risks and uncertainties described below together
with the other information included in this prospectus and incorporated by reference herein, before deciding to purchase our securities.
In addition, you should carefully consider, among other things, the section entitled “Risk Factors” beginning on page
12 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, page 55 of our Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, as well as any amendment or update to our risk factors in subsequent filings with the
SEC, and other information in our consolidated financial statements, all of which are incorporated by reference into this prospectus.
The risks described below and incorporated herein by reference are those which we believe are the material risks that we face.
The occurrence of any of the following risks may materially and adversely affect our business, financial condition, results of
operations, cash flows, reputation and future prospects. In this event, the market price of our common stock could decline, and
you could lose part or all of your investment.
Risks Associated with our Capital
Stock
Some of our executives, directors and
principal stockholders can control our direction and policies, and their interests may be adverse to the interests of our other
stockholders.
At September 30,
2016, Lindsay A. Rosenwald, M.D., our Chairman, President and Chief Executive Officer, beneficially owned 12.8% of our issued
and outstanding capital stock. At September 30, 2016, Michael S. Weiss, our Executive Vice Chairman, Strategic Development, beneficially
owned 15.3% of our issued and outstanding capital stock. By virtue of their holdings and membership on our Board of Directors,
Dr. Rosenwald and Mr. Weiss may individually influence our management and our affairs and may make it difficult for us to consummate
corporate transactions such as mergers, consolidations or the sale of all or substantially all of our assets that may be favorable
from our standpoint or that of our other stockholders.
The market price of our common stock
may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
Our stock price may
experience substantial volatility as a result of a number of factors, including:
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announcements we make regarding our or
our subsidiaries’ current product candidates, acquisition of potential new product candidates and companies and/or in-licensing
through multiple subsidiaries;
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sales or potential sales of substantial
amounts of our common stock;
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our or our subsidiaries’ delay or
failure in initiating or completing pre-clinical or clinical trials or unsatisfactory results of any of these trials;
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announcements about us, our subsidiaries
or about our competitors, including clinical trial results, regulatory approvals or new product introductions;
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developments concerning our or our subsidiaries’
licensors and/or product manufacturers;
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litigation and other developments relating
to our or our subsidiaries’ patents or other proprietary rights or those of our competitors;
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conditions in the pharmaceutical or biotechnology
industries;
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governmental regulation and legislation;
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variations in our anticipated or actual
operating results; and
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change in securities analysts’ estimates
of our performance, or our failure to meet analysts’ expectations.
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Many of these factors are beyond our
control. The stock markets in general, and the market for pharmaceutical and biotechnological companies in particular, have historically
experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating
performance of these companies. These broad market and industry factors could reduce the market price of our common stock, regardless
of our actual operating performance.
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 48.9 million outstanding shares of our common stock as of September 30, 2016 are available for sale in the public market,
either pursuant to Rule 144 under the Securities Act of 1933, as amended, or the Securities Act, or an effective registration
statement. Pursuant to our shelf registration statement on Form S-3 of which this prospectus is a part, we may sell up to $53
million of our equity securities over the next three 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.
We and certain of our subsidiaries
have never paid and do not intend to pay cash dividends. As a result, capital appreciation, if any, will be your sole source of
gain.
We have never
paid cash dividends on any of our or their capital stock and we and many of our subsidiaries currently intend to retain future
earnings, if any, to fund the development and growth of our business. In addition, the terms of existing and future debt agreements
may preclude us and certain of our subsidiaries from paying dividends. As a result, capital appreciation, if any, of our common
stock will be your sole source of gain for the foreseeable future.
Provisions in our certificate of
incorporation, our bylaws and Delaware law might discourage, delay or prevent a change in control of our Company or changes in
our management and, therefore, depress the trading price of our common stock.
Provisions of our
certificate of incorporation, our bylaws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or
preventing a change in control of our Company or changes in our management, including transactions in which our stockholders might
otherwise receive a premium for their shares over then-current market prices. In addition, these provisions may limit the ability
of stockholders to approve transactions that they may deem to be in their best interests. These provisions include:
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the inability of stockholders to call special meetings; and
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the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder
approval, which could include the right to approve an acquisition or other change in our control or could be used to institute
a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely
preventing acquisitions that have not been approved by our Board of Directors.
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In addition,
the Delaware General Corporation Law (“DGCL”) prohibits a publicly held Delaware corporation from engaging in a
business combination with an interested stockholder, generally a person which together with its affiliates owns, or within
the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in
which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
The existence of
the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future
for shares of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood that
you could receive a premium for your shares of our common stock in an acquisition.
Risks Associated with this Offering
We have broad discretion in the
use of the net proceeds of this offering and may not use them effectively.
We intend to
use the net proceeds from this offering for our operations, including, but not limited to, general corporate purposes, which may
include research and development expenditures, clinical trial expenditures, manufacture and supply of product and working capital.
However, 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 our growth strategy, including but not limited to, the development and commercialization
of our and our subsidiaries’ product candidates.
You may experience immediate and
substantial dilution in the book value per share of the common stock you purchase.
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 $53
million at an assumed offering price of $2.52 per share, the last reported sale price of our common stock on the Exchange on
November 28, 2016, and after deducting estimated offering commissions payable by us, our net tangible book value as of
September 30, 2016 would have been $103.6 million, or $1.48 per share of common stock. This represents an immediate increase
in the net tangible book value of $0.43 per share to our existing stockholders and an immediate and substantial dilution in
net tangible book value of $1.04 per share to new investors who purchase our common stock in the offering. See
“Dilution” for a more detailed discussion of the dilution you may incur in connection with this offering.
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents
that we incorporate by reference, may 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. Statements in this prospectus, and documents
we incorporate by reference, that are not descriptions of historical facts are forward-looking statements that are based on management’s
current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial
condition and stock price. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “can,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “might,” “plans,” “potential,” “predicts,”
“should,” or “will” or the negative of these terms or other comparable terminology. Factors that could
cause actual results to differ materially from those currently anticipated include those set forth under “Risk Factors”
including, in particular, risks relating to:
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our ability to continue to commercialize products;
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our ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis;
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financing and strategic agreements, acquisitions and relationships;
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our need for substantial additional funds and uncertainties relating
to financings;
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our ability to attract, integrate and retain key personnel;
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the early stage of products under development;
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the results of research and development activities;
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uncertainties relating to preclinical and clinical testing;
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our ability to secure and maintain third-party manufacturing, marketing
and distribution of our products;
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dependence on third-party suppliers;
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patent and intellectual property matters; and
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You should read this prospectus and the
documents that we reference herein completely and with the understanding that our actual future results may be materially different
from what we currently expect. You should assume that the information appearing in this prospectus and any document incorporated
by reference is accurate as of its date only. Because the risk factors referred to above could cause actual results or outcomes
to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue
reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which
the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not
possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or
the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in
any forward-looking statements. We qualify all of the information presented in this prospectus, any accompanying prospectus supplement
and any document incorporated herein by reference, and particularly our forward-looking statements, by these cautionary statements.
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 the Agents as a source of financing.
We intend to use the net proceeds of this
offering for our operations, including, but not limited to, general corporate purposes, which may include research and development
expenditures, clinical trial expenditures, manufacture and supply of product and working capital. The precise amount, use and timing
of the application of such proceeds will depend upon our funding requirements and the availability and cost of other capital. Pending
application of the net proceeds as described above, we intend to invest the net proceeds of the offering in short-term, investment-grade,
interest-bearing securities and/or savings accounts.
DILUTION
If you invest in our common stock,
your interest will be diluted to the extent of the difference between the price per share you pay in this offering and the
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 September 30, 2016 was approximately $51.6 million, or approximately $1.05 per share of common stock based
upon 48.9 million shares outstanding at that time. Net tangible book value per share is equal to our total tangible assets,
less our total liabilities, divided by the total number of shares outstanding as of September 30, 2016.
After giving effect to the sale of
our common stock in the aggregate amount of $53 million at an assumed offering price of $2.52 per share, the last reported
sale price of our common stock on the Exchange on November 28, 2016, and after deducting estimated offering commissions
payable by us, our net tangible book value as of September 30, 2016 would have been $103.6 million, or $1.48 per share of
common stock based on 69.9 million shares of common stock outstanding on a pro forma basis at that time. This represents an
immediate increase in net tangible book value of $0.43 per share to our existing stockholders and an immediate dilution in net
tangible book value of $1.04 per share to new investors in this offering.
The following
table illustrates this calculation on a per share basis as of September 30, 2016:
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Offering price per share
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$
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2.52
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Net tangible book value per share
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$
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1.05
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Increase in net tangible book value per share attributable
to the offering
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$
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0.43
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Pro forma net tangible book value per share after
giving effect to the offering
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$
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1.48
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Dilution in net tangible book value per share to new
investors
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$
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1.04
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The foregoing
table does not give effect to the exercise of any outstanding options or warrants, the vesting of restricted stock units, or
stock grants that have been deferred pursuant to the Company’s Deferred Compensation Plan for Directors dated March 12,
2015 (the “Deferred Compensation Plan”). To the extent options and warrants are exercised, restricted stock units vest,
and stock grants are no longer deferred, there may be further dilution to new investors.
The
number of shares of our common stock to be outstanding immediately after this offering on a pro forma basis is based on 48.9 million
shares of our
common stock outstanding as of September 30, 2016 and excludes:
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483,453 shares issuable
upon exercise of outstanding warrants as of September 30, 2016 with a weighted average
exercise price of $6.63;
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1,130,501 shares issuable upon the exercise of outstanding options as of
September 30, 2016 with a weighted average exercise price of $3.71;
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1,700,000 shares issuable upon the exercise of a warrant issuable on
September
1, 2017;
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1,038,125 shares issuable
upon the vesting of outstanding restricted stock units as of September 30, 2016; and
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420,000 shares issuable
upon stock grants no longer deferred under the Deferred Compensation Plan as of September
30, 2016.
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DIVIDEND POLICY
We have never paid cash dividends and currently
intend to retain all available funds and any future earnings to fund the development and expansion of our business. We do not anticipate
paying any cash dividends in the foreseeable future.
PLAN OF DISTRIBUTION
We have entered into the sales
agreement with the Agents under which we may offer and sell up to $53,000,000 of shares of our common stock from time to time
through the Agents. The sales agreement is filed with the SEC as an exhibit to our Current Report on Form 8-K dated August
17, 2016 and is incorporated herein by reference. The sales, if any, of shares of our common stock made under the sales
agreement may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule
415 of the Securities Act, including, without limitation, sales made directly on the Exchange, on any other existing trading
market for the common stock or through a market maker. In addition, with our prior consent, the Agents may also sell shares
of our common stock by any other method permitted by law, including, but not limited to, negotiated transactions. We may
instruct the Agents not to sell the shares of our common stock if the sales cannot be effected at or above the price
designated by us from time to time. We or the Agents may suspend the offering of shares of our common stock upon notice and
subject to other conditions. The Agents will not engage in any transactions that stabilizes the price of our common
stock.
Each time we wish to issue and sell shares
of our common stock under the sales agreement, we will notify either of the Agents of the number of shares to be issued, the dates
on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters
as we deem appropriate. Once we have so instructed the Agent, unless such Agent declines to accept the terms of the notice, the
Agent shall use commercially reasonable efforts consistent with its respective normal trading and sales practices to sell such
shares up to the amount specified on such terms. The obligations of the Agents under the sales agreement to sell shares of our
common stock are subject to a number of conditions that we must meet.
We will pay each Agent a commission
for its services in acting as agent in the sale of the shares of our common stock. The Agents will be entitled to compensation
at a commission rate of up to 3.0% of the gross proceeds from each sale 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, each of the Agents will
be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of the Agents will
be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution to the Agents
against certain civil liabilities, including liabilities under the Securities Act. We estimate that the total expenses for the
offering, excluding compensation payable to the Agents under the terms of the sales agreement, will be approximately $170,000.
Settlement for sales of shares of our common
stock will occur on the third business day following the date on which any sales are made, or on another date that is agreed upon
by us and the Agents in connection with a particular transaction, in return for payment of the net proceeds to us. There is no
arrangement for funds to be received in an escrow, trust or similar arrangement.
The offering pursuant to the sales agreement
will terminate upon the earlier of (i) the issuance and sale of all common shares subject to the agreement or (ii) termination
of the sales agreement as permitted therein.
MLV & Co. LLC is an affiliate of FBR
Capital Markets & Co.
The Agents and their respective affiliates
may in the future provide various investment 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, the Agents will not engage in any market
making activities involving our common stock while the offering is ongoing under this prospectus.
LEGAL MATTERS
Wyrick Robbins Yates & Ponton LLP,
Raleigh, North Carolina, has passed upon the validity of the shares of common stock offered under this prospectus. Duane Morris
LLP, Newark, New Jersey, is counsel for the Agents in connection with this offering.
EXPERTS
The
consolidated balance sheets of Fortress Biotech, Inc. as of December 31, 2015 and 2014 and the related consolidated statements
of operations, stockholders’ equity, and cash flows for each of the years then ended have been audited by EisnerAmper LLP,
independent registered public accounting firm, as stated in their reports, which are incorporated herein by reference, which reports
(1) express an unqualified opinion on the financial statements, and (2) express an unqualified opinion on the effectiveness of
internal control over financial reporting. Such financial statements have been incorporated herein by reference in reliance on
the reports of such firm given upon their authority as experts in accounting and auditing.
The consolidated financial statements of Fortress Biotech, Inc. for
the year ended December 31, 2013 incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended
December 31, 2015 have been so incorporated in reliance on the report of PricewaterhouseCoopers LLP, an independent registered
public accounting firm, given on the authority of said firm as experts in auditing and accounting.
The consolidated financial statements
of National Holdings Corporation as of September 30, 2015 and 2014 and for the years then ended appearing in its Annual Report
on Form 10-K for the year ended September 30, 2015 filed with the SEC and incorporated herein by
reference from Fortress Biotech, Inc.’s Current Report on Form 8-K/A filed on November 22, 2016 have been audited by EisnerAmper
LLP, independent registered public accounting firm, as set forth in their report thereon included in such Annual Report and incorporated
herein by reference. Such financial statements are incorporated in reliance upon such report given on the authority of such firm
as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We are subject to the reporting requirements
of the Exchange Act, and file annual, quarterly and current reports, proxy statements and other information with the SEC. You may
read and copy these reports, proxy statements and other information at the SEC’s public reference facilities at 100 F Street,
N.E., Room 1580, Washington, D.C. 20549. You can request copies of these documents by writing to the SEC and paying a fee for the
copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public reference facilities.
SEC filings are also available at the SEC’s web site at http://www.sec.gov.
This prospectus is only part of a
registration statement on Form S-3 that we have filed with the SEC under the Securities Act, and therefore omits certain
information contained in the registration statement. We have also filed exhibits and schedules with the registration
statement that are excluded from this prospectus, and you should refer to the applicable exhibit or schedule for a complete
description of any statement referring to any contract or other document. You may inspect a copy of the registration
statement, including the exhibits and schedules, without charge, at the public reference facilities or obtain a copy from the
SEC upon payment of the fees prescribed by the SEC.
INCORPORATION OF CERTAIN DOCUMENTS BY
REFERENCE
The SEC allows us to “incorporate
by reference” information we file with it into our registration statement of which this prospectus is a part, which means
that we can disclose important information to you by referring you to other documents. The information incorporated by reference
is considered to be part of this prospectus, and information that we file later with the SEC and incorporate by reference will
automatically update and supersede this information. We incorporate by reference into this prospectus the documents listed below
and all future filings made by us with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act, except for information
“furnished” under Items 2.02, 7.01 or 9.01 on Form 8-K or other information “furnished” to the SEC which
is not deemed filed and not incorporated in this prospectus, until the termination of the offering of securities described in the
applicable prospectus supplement.
We hereby incorporate by reference the following
documents:
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(a)
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our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 15, 2016 including the information
specifically incorporated by reference into the Annual Report on Form 10-K from our definitive proxy statement for the 2016 Annual
Meeting of Stockholders;
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(b)
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the SEC on May 10, 2016;
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(c)
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our Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016;
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(d)
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our Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, filed with the SEC on November 9, 2016;
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(e)
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our Current Reports on Form 8-K filed with the SEC on January 7, 2016, April 18, 2016,
April 21, 2016, April 28, 2016, May 4, 2016, May 6, 2016, May 26, 2016, June 1,
2016, June 21, 2016, August 12, 2016, August 17, 2016, September 20, 2016, September 26, 2016, October 3, 2016, October
12, 2016, October 20, 2016 and October 24, 2016, and on Form 8-K/A filed with the SEC on November 22, 2016; and
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(f)
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the description of our common stock included in our registration
statement on Form 8-A, filed with the SEC on December 7, 2011.
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Any statement contained in this prospectus
or in a document incorporated or deemed to be incorporated by reference into this prospectus will be deemed to be modified or superseded
for purposes of this prospectus to the extent that a statement contained in this prospectus or any other subsequently filed document
that is deemed to be incorporated by reference into this prospectus modifies or supersedes such statement. Any statement so modified
or superseded will not be deemed, except as so modified or superseded, to constitute a part of this registration statement.
We will furnish without charge to you, on
written or oral request, a copy of any or all of the documents incorporated by reference, including exhibits to these documents.
You should direct any requests for documents in writing to: Fortress Biotech, Inc., 2 Gansevoort Street, 9th Floor, New York, New
York 10014, Attention: Corporate Secretary, tel: 781-652-4500. These documents are also available on the Investors section of our
website, which is located at www.fortressbiotech.com, or as described under “Where You Can Find Additional Information”
above. The reference to our website address does not constitute incorporation by reference of the information contained on our
website.
You should rely only on information contained
in, or incorporated by reference into, this prospectus and any prospectus supplement. We have not authorized anyone to provide
you with information different from that contained in this prospectus or incorporated by reference in this prospectus. We are not
making offers to sell the securities in any jurisdiction in which such an offer or solicitation is not authorized or in which the
person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make such offer or solicitation.
$53,000,000
Common Stock
PROSPECTUS
The date of
this prospectus is , 2016
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. Other Expenses of Issuance and Distribution.
We estimate that expenses payable by us
in connection with the offering described in this registration statement will be as follows:
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SEC registration fee
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$
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0
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Legal fees and expenses
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$
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80,000
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*
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Accounting fees and expenses
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$
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75,000
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*
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Printing expenses
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$
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10,000
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*
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Miscellaneous
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$
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5,000
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*
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Total
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$
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170,000
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*
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* Estimated as permitted under Rule 511 of Regulation S-K.
ITEM 15. Indemnification of Directors and Officers.
Bylaws
Pursuant to our bylaws, our directors and
officers will be indemnified to the fullest extent allowed under the laws of the State of Delaware for their actions in their capacity
as our directors and officers.
We must indemnify any person made a party
to any threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative, or investigative
(“Proceeding”), by reason of the fact that he is or was a director, against judgments, penalties, fines, settlements
and reasonable expenses (including attorney’s fees) (“Expenses”) actually and reasonably incurred by him in connection
with such Proceeding if: (a) he conducted himself in good faith, and: (i) in the case of conduct in his own official capacity with
us, he reasonably believed his conduct to be in our best interests, or (ii) in all other cases, he reasonably believes his conduct
to be at least not opposed to our best interests; and (b) in the case of any criminal Proceeding, he had no reasonable cause to
believe his conduct was unlawful.
We must indemnify any person made a party
to any Proceeding by or in the right of us, by reason of the fact that he is or was a director, against reasonable Expenses actually
incurred by him in connection with such Proceeding if he conducted himself in good faith, and: (a) in the case of conduct in his
official capacity with us, he reasonably believed his conduct to be in our best interests; or (b) in all other cases, he reasonably
believed his conduct to be at least not opposed to our best interests; provided that no such indemnification may be made in respect
of any Proceeding in which such person shall have been adjudged to be liable to us.
No indemnification will be made unless authorized
in the specific case after a determination that indemnification of the director is permissible in the circumstances because he
has met the applicable standard of conduct.
Reasonable Expenses incurred by a director
who is party to a Proceeding may be paid or reimbursed by us in advance of the final disposition of such Proceeding in certain
cases.
We have the power to purchase and maintain
insurance on behalf of any person who is or was our director, officer, employee, or agent or is or was serving at our request as
an officer, employee or agent of another corporation, partnership, joint venture, trust, other enterprise, or employee benefit
plan against any liability asserted against him and incurred by him in any such capacity or arising out of his status as such,
whether or not we would have the power to indemnify him against such liability under the provisions of the amended and restated
bylaws.
Delaware Law
We are incorporated under the laws of the
State of Delaware. Section 145 of the DGCL provides that a Delaware corporation may indemnify any persons
who are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact
that such person was an officer, director, employee or agent of such corporation, or is or was serving at the request of such person
as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including
attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection
with such action, suit or proceeding, provided that such person acted in good faith and in a manner he or she reasonably believed
to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no
reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who are, or are
threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by
reason of the fact that such person was a director, officer, employee or agent of such corporation, or is or was serving at the
request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include
expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement
of such action or suit provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed
to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer
or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise
in the defense of any action referred to above, the corporation must indemnify him or her against the expenses which such officer
or director has actually and reasonably incurred. Our certificate of incorporation and bylaws provide for the indemnification of
our directors and officers to the fullest extent permitted under the DGCL.
Section 102(b)(7) of the DGCL permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not
be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director,
except for liability for any:
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transaction from which the director derives an improper personal benefit;
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act or omission not in good faith or that involves intentional misconduct
or a knowing violation of law;
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unlawful payment of dividends or redemption of shares; or
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breach of a director’s duty of loyalty to the corporation or
its stockholders.
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Our certificate of incorporation includes
such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding in advance of its
final disposition shall be paid by us upon delivery to us of an undertaking, by or on behalf of such director or officer, to repay
all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by
us.
Section 174 of the DGCL provides,
among other things, that a director who willfully or negligently approves of an unlawful payment of dividends or an unlawful
stock purchase or redemption may be held liable for such actions. A director who was either absent when the unlawful actions
were approved, or dissented at the time, may avoid liability by causing his or her dissent to such actions to be entered in
the books containing minutes of the meetings of the board of directors at the time such action occurred or immediately
after such absent director receives notice of the unlawful acts.
Indemnification Agreements
As permitted by the DGCL, we have
entered, and intend to continue to enter, into separate indemnification agreements with each of our directors and executive
officers, that require us to indemnify such persons against any and all expenses (including attorneys’ fees),
witness fees, damages, judgments, fines, settlements and other amounts incurred (including expenses of a derivative action)
in connection with any action, suit or proceeding, whether actual or threatened, to which any such person may be made a party
by reason of the fact that such person is or was a director, an officer or an employee of us or any of our affiliated
enterprises, provided that such person acted in good faith and in a manner such person reasonably believed to be in or not
opposed to our best interests and, with respect to any criminal proceeding, had no reasonable cause to believe his or her
conduct was unlawful. The indemnification agreements also set forth certain procedures that will apply in the event of a
claim for indemnification thereunder.
At present, there is no proceeding
or pending litigation involving any of our directors or executive officers as to which indemnification is required
or permitted, and we are not aware of any proceeding or threatened litigation that may result in a claim for
indemnification.
We have an insurance policy covering our
officers and directors with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to our directors, officers or controlling persons, we have been advised that
in the opinion of the SEC this indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
ITEM 16. Exhibits
See Exhibit Index.
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(b)
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Financial statement schedule.
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None.
ITEM 17. Undertakings
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(a)
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The undersigned registrant hereby undertakes:
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(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 Commission pursuant to Rule 424(b) if, in the aggregate,
the changes in volume and price represent no more than a 20% 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 (1)(i), (1)(ii)
and (1)(iii) 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 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 this 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 the purpose 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 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 such effective date.
(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 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 Securities and Exchange Commission such indemnification
is against public policy as expressed in the Securities Act 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 Act 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 shall be deemed to be part of this registration statement
as of the time it was declared effective; and
(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.
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 November
29
,
2016.
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Fortress Biotech, Inc.
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By:
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/s/ Lindsay A. Rosenwald,
M.D.
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Name:
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Lindsay A. Rosenwald, M.D.
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Title:
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Chairman, President and 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.
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Signature
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Title
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Date
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/s/
Lindsay A. Rosenwald, M.D.
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Chairman of
the Board of Directors, President and
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November 29, 2016
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Lindsay A. Rosenwald,
M.D.
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Chief Executive
Officer
(principal executive officer)
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/s/ Lucy Lu, M.D.
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Executive
Vice President and Chief Financial Officer
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November 29, 2016
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Lucy Lu, M.D.
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(principal
financial officer)
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*
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Executive
Vice Chairman, Strategic Development
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November 29, 2016
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Michael S. Weiss
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and Director
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Co-Vice Chairman
of the Board of Directors and
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November 29, 2016
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Eric K. Rowinsky,
M.D.
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Director
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*
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Director
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November 29, 2016
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Jimmie Harvey,
Jr., M.D.
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Director
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November 29, 2016
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Malcolm Hoenlein
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Director
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November 29, 2016
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Dov Klein
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Director
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November 29, 2016
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J. Jay Lobell
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* By:
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/s/
Lindsay A. Rosenwald, M.D.
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Lindsay A. Rosenwald,
M.D., Attorney-in-Fact
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EXHIBIT INDEX
Exhibit
Number
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Incorporated
by Reference (Unless Otherwise Indicated)
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Exhibit
Description
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Form
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File
No.
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Exhibit
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Filing
Date
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1.1*
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Form of underwriting agreement with respect to common stock, preferred stock and/or warrants.
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—
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—
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—
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—
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4.1
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Amended and Restated Certificate of Incorporation of the registrant.
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10-12G
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000-54463
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3.1
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July 15, 2011
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4.2
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First Certificate of Amendment of Amended and Restated Certificate of Incorporation of
the registrant.
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10-12G
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000-54463
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3.2
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July 15, 2011
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4.3
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Second Amended and Restated Bylaws of the registrant.
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8-K
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—
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3.7
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October 31, 2014
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4.4
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Second Certificate of Amendment of Amended and Restated Certificate of Incorporation,
as amended.
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10-K
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—
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3.8
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March 14, 2014
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4.5
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Form of Common Stock Certificate.
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10-12G
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000-54463
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4.1
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July 15, 2011
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4.6*
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Form of underwriter warrant, if any.
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—
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—
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—
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—
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4.7*
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Form of specimen preferred stock certificate, if any.
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—
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—
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4.8*
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Certificate of designation for preferred stock, if any.
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—
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4.9*
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Form of warrant agreement and warrant certificate, if any.
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—
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—
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—
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4.10*
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Form of unit agreement and unit certificate, if any.
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—
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5.1
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Opinion of Wyrick Robbins Yates & Ponton LLP.
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S-3
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333-213199
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5.1
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August 18, 2016
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10.32
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Amended and Restated At Market Issuance Sales Agreement, dated August 17, 2016, between
the registrant, MLV & Co. LLC and FBR Capital Markets & Co.
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8-K
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—
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10.32
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August 17, 2016
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23.1
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Consent of EisnerAmper LLP, Independent Registered Public Accounting Firm.
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—
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—
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—
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Filed Herewith
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23.2
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Consent of EisnerAmper LLP, Independent Registered Public Accounting Firm.
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—
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—
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—
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Filed Herewith
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23.3
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Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
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—
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—
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—
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Filed Herewith
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23.4
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Consent of Wyrick Robbins Yates & Ponton LLP (included in Exhibit 5.1)
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S-3
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333-213199
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23.3
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August 18, 2016
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24.1
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Power of Attorney (included on Signature Page)
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S-3
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333-213199
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24.1
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August 18, 2016
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To the extent applicable, to be filed by a post-effective amendment or as an exhibit to a document filed under the Exchange
Act and incorporated by reference herein.
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