As filed with the Securities and Exchange
Commission on June 3, 2019
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Outlook Therapeutics, Inc.
(Exact name of registrant as specified
in its charter)
Delaware
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38-3982704
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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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7 Clarke Drive
Cranbury, New Jersey 08512
(609) 619-3990
(Address, including zip code, and telephone
number, including area code, of registrant’s principal executive offices)
Lawrence A. Kenyon
President, Chief Executive Officer and
Chief Financial Officer
Outlook Therapeutics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
(609) 619-3990
(Name, address, including zip code, and
telephone number, including area code, of agent for service)
Copies to:
Yvan-Claude Pierre
Marianne C. Sarrazin
Pia Kaur
Cooley LLP
55 Hudson Yards
New York, New York 10001
From time to time after the effective
date of this Registration Statement
(Approximate date of commencement of
proposed sale to the public)
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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 to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following
box.
¨
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions
of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging
growth company” in Rule 12b–2 of the Exchange Act:
Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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x
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Smaller reporting company
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x
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Emerging growth company
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x
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If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
x
CALCULATION OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered
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Amount
to be
Registered
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Proposed
Maximum
Offering Price
Per Unit
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Proposed
Maximum
Aggregate
Offering
Price
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Amount of
Registration
Fee (1)
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Common Stock, par value $0.01 per share
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(2
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)
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(3
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)
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(3
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)
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—
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Preferred Stock, par value $0.01 per share
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(2
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)
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(3
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)
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(3
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)
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—
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Debt Securities
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(2
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)
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(3
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)
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(3
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)
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—
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Warrants
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(2
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)
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(3
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)
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(3
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)
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—
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Total
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(2
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)
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$
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100,000,000
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$
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12,120
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(1)
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Calculated pursuant to Rule 457(o) under the Securities Act of 1933, as amended, or the Securities Act.
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(2)
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There are being registered hereunder such indeterminate number of shares of common stock and preferred stock, such indeterminate principal amount of debt securities and such indeterminate number of warrants to purchase common stock, preferred stock or debt securities as shall have an aggregate initial offering price not to exceed $100,000,000. If any debt securities are issued at an original issue discount, then the principal amount of such debt securities shall be in such greater amount as shall result in an aggregate initial offering price not to exceed $100,000,000, less the aggregate dollar amount of all securities previously issued hereunder. Any securities registered hereunder may be sold separately or in combination with other securities registered hereunder. The securities registered also include such indeterminate number of shares of common stock and preferred stock and amount of debt securities as may be issued upon conversion of or exchange for preferred stock or debt securities that provide for conversion or exchange, upon exercise of warrants or pursuant to the anti-dilution provisions of any such securities. In addition, pursuant to Rule 416 under the Securities Act, the shares being registered hereunder include such indeterminate number of shares of common stock and preferred stock as may be issuable with respect to the shares being registered hereunder as a result of stock splits, stock dividends or similar transactions.
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(3)
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The proposed maximum aggregate offering price per class of security will be determined from time to time by the Registrant in connection with the issuance by the Registrant of the securities registered hereunder and is not specified as to each class of security pursuant to General Instruction II.D. of Form S-3 under the Securities Act.
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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 of 1933, 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 is
not soliciting offers to buy these securities in any jurisdiction where such offer or sale is not permitted.
Subject to Completion, Dated
June 3, 2019
PROSPECTUS
$100,000,000
Common
Stock
Preferred
Stock
Debt Securities
Warrants
From time to time, we may offer and sell up to $100,000,000
of any combination of the securities described in this prospectus, either individually or in combination. We may also offer common
stock or preferred stock upon conversion of debt securities, common stock upon conversion of preferred stock, or common stock,
preferred stock or debt securities upon the exercise of warrants.
This prospectus provides a general description of the securities
we may offer. We will provide the specific terms of these offerings and securities in one or more supplements to this prospectus.
We may also authorize one or more free writing prospectuses to be provided to you in connection with these offerings. The prospectus
supplement and any related free writing prospectus may also add, update or change information contained in this prospectus. You
should carefully read this prospectus, the applicable prospectus supplement and any related free writing prospectus, as well as
any documents incorporated by reference, before buying any of the securities being offered.
This prospectus may not be used to consummate a sale of securities
unless accompanied by a prospectus supplement.
We may sell these securities directly to investors, through
agents designated from time to time or to or through underwriters or dealers, on a continuous or delayed basis. For additional
information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus
and in the applicable prospectus supplement. If any agents or underwriters are involved in the sale of any securities with respect
to which this prospectus is being delivered, the names of such agents or underwriters and any applicable fees, discounts or commissions
and over-allotment options will be set forth in a prospectus supplement. The price to the public of such securities and the net
proceeds we expect to receive from such sale will also be set forth in a prospectus supplement.
Our common stock is listed on The Nasdaq Capital Market under
the trading symbol “OTLK.” On May 31, 2019, the last reported sale price of our common stock on The Nasdaq Capital
Market was $2.40 per share. The applicable prospectus supplement will contain information, where applicable, as to other listings,
if any, on The Nasdaq Capital Market or other securities exchange of the securities covered by the applicable prospectus supplement.
Investing
in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the
heading “Risk Factors” on page 4 of this prospectus and any similar section contained in the applicable prospectus
supplement and in any related free writing prospectuses we have authorized for use in connection with a specific offering, and
under similar headings in the documents that are incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete.
Any representation to the contrary is a criminal offense.
The date of this prospectus is ,
2019.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement on Form
S-3 that we filed with the Securities and Exchange Commission, or SEC, using a “shelf” registration process. Under
this shelf registration statement, we may sell from time to time in one or more offerings up to a total dollar amount of $100,000,000
of common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either
individually or in combination with other securities as described in this prospectus.
This prospectus provides you with a general description of the
securities we may offer. Each time we sell any type or series of securities under this prospectus, we will provide a prospectus
supplement that will contain more specific information about the terms of that offering. We may also authorize one or more free
writing prospectuses to be provided to you that may contain material information relating to these offerings. We may also add,
update or change in a prospectus supplement or free writing prospectus any of the information contained in this prospectus or in
the documents we have incorporated by reference into this prospectus. This prospectus, together with the applicable prospectus
supplement, any related free writing prospectus and the documents incorporated by reference into this prospectus and the applicable
prospectus supplement, will include all material information relating to the applicable offering. You should carefully read both
this prospectus and the applicable prospectus supplement, any related free writing prospectus, together with the information and
documents incorporated by reference herein as described under the heading “Incorporation of Certain Information by Reference.”
This prospectus may not be used to consummate a sale of securities
unless accompanied by a prospectus supplement.
You should rely only on the information contained in, or incorporated
by reference into, this prospectus and any applicable prospectus supplement, along with the information contained in any free writing
prospectuses we have authorized for use in connection with a specific offering. We have not authorized anyone to provide you with
different or additional information. You must not rely upon any information or representation not contained or incorporated by
reference in this prospectus, any applicable prospectus supplement or any related free writing prospectus. This prospectus, any
applicable supplement to this prospectus or any related free writing prospectus do not constitute an offer to sell or the solicitation
of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus, any applicable
supplement to this prospectus or any related free writing prospectus constitute an offer to sell or the solicitation of an offer
to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.
The information appearing in this prospectus, any applicable
prospectus supplement or any related free writing prospectus is accurate only as of the date on the front of the document and any
information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless
of the time of delivery of this prospectus, any applicable prospectus supplement or any related free writing prospectus, or any
sale of a security. Our business, financial condition, results of operations and prospects may have changed since those dates.
This prospectus contains and incorporates by reference market
data and industry statistics and forecasts that are based on independent industry publications and other publicly available information.
Although we believe that these sources are reliable, we do not guarantee the accuracy or completeness of this information and we
have not independently verified this information. Although we are not aware of any misstatements regarding the market and industry
data presented in this prospectus and the documents incorporated herein by reference, these estimates involve risks and uncertainties
and are subject to change based on various factors, including those discussed under the heading “Risk Factors” contained
in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents
that are incorporated by reference into this prospectus. Accordingly, investors should not place undue reliance on this information.
This prospectus contains summaries of certain provisions contained
in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries
are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will
be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and
you may obtain copies of those documents as described below under the heading “Where You Can Find More Information.”
Except as otherwise indicated or unless the context otherwise
requires, references to “company,” “we,” “us,” “our” or “Outlook Therapeutics,”
refer to Outlook Therapeutics, Inc. and its consolidated subsidiaries.
Our name “Outlook Therapeutics,” the Outlook Therapeutics
logo and other trademarks or service marks of Outlook Therapeutics, Inc. appearing in this prospectus and in any prospectus supplement
or free writing prospectus and the information incorporated by reference herein or therein are the property of Outlook Therapeutics,
Inc. Other trademarks, service marks or trade names appearing in this prospectus in any prospectus supplement or free writing prospectus
and the information incorporated by reference herein or therein are the property of their respective owners. We do not intend our
use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement
or sponsorship of us by, these other companies.
PROSPECTUS SUMMARY
This summary highlights selected information contained
elsewhere in this prospectus or incorporated by reference herein and does not contain all of the information that you need to consider
in making your investment decision. You should carefully read the entire prospectus, the applicable prospectus supplement and any
related free writing prospectus, including the risks of investing in our securities discussed under the heading “Risk Factors”
contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other
documents that are incorporated by reference into this prospectus. You should also carefully read the information incorporated
by reference into this prospectus, including our financial statements and related notes, and the exhibits to the registration statement
of which this prospectus is a part, before making your investment decision.
Overview
We are a late clinical-stage biopharmaceutical
company focused on developing and commercializing ONS-5010, a complex, technically challenging and commercially attractive monoclonal
antibody, or mAb, for various ophthalmic indications. Our goal is to launch ONS-5010 as the first, and only, approved bevacizumab
in the United States, Europe, Japan and other markets for the treatment of wet age related macular degeneration, or wet AMD, diabetic
macular edema, or DME, and branch retinal vein occlusion, or BRVO.
ONS-5010 is an innovative mAb therapeutic
product candidate that was reviewed at a successful end of Phase 2 meeting with the FDA conducted in 2018. Our investigational
new drug, or IND, application was filed with, and accepted by, the U.S. Food and Drug Administration, or FDA, in the first quarter
of calendar 2019. We are currently enrolling patients in a Phase 3 clinical trial in Australia (ONS-5010-001) designed to serve
as the first of two adequate and well controlled studies evaluating ONS-5010 against ranibizumab (Lucentis) for wet AMD. Enrollment
in ONS-5010-001 is nearly complete with 51 of the planned 60 patients enrolled as of May 15, 2019. The second of the two Phase
3 studies (ONS-5010-002) has been initiated and is expected to begin enrolling wet AMD patients in the United States, Australia
and New Zealand by the end of June 2019. The ONS-5010-002 study is now expected to enroll a total of at least 220 patients. The
endpoint for both studies is a mean increase in baseline visual acuity of at least five letters at 11 months for ONS-5010 dosed
on a monthly basis compared to Lucentis dosed using the approved alternative dosing regimen of three monthly doses followed by
quarterly dosing.
Currently, the cancer drug Avastin (bevacizumab)
is used off-label for the treatment of wet AMD and other retina diseases such as DME and BRVO even though Avastin has not been
approved by regulatory authorities for use in these diseases. If the ONS-5010 clinical program is successful, it will support our
plans to submit for regulatory approval in multiple markets in 2020 including the United States, Europe and Japan. Because there
are no approved bevacizumab products for the treatment of retinal diseases in such major markets, we are developing ONS-5010 as
an innovative therapy and not using the biosimilar drug development pathway that would be normally be required if Avastin were
an approved drug for the targeted diseases. If approved, we believe ONS-5010 has potential to mitigate risks associated with off-label
use of Avastin or other drugs. Off label use of Avastin is currently estimated to account for at least 50% of all wet AMD prescriptions
in the United States.
Risks Associated with our Business
Our
business is subject to numerous risks, as described under the heading “Risk Factors” contained in the applicable prospectus
supplement and in any free writing prospectuses we have authorized for use in connection with a specific offering, and under similar
headings in the documents that are incorporated by reference into this prospectus.
Additional Information
For additional information related to our business and operations,
please refer to the reports incorporated herein by reference, including our Annual Report on Form 10-K for the year ended September 30,
2018 as filed with the SEC on December 18, 2018, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019
as filed with the SEC on May 15, 2019 and our other Quarterly Reports and our Current Reports on Form 8-K as filed with the
SEC, as described in the section titled “Incorporation of Certain Information by Reference.”
Implications of Being an Emerging Growth
Company
We are an “emerging
growth company,” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012, and
we may remain an emerging company for up to five years from the closing of our IPO in May 2016. For so long as we remain
an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements,
including not being required to have our internal control over financial reporting audited by our independent registered public
accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive
compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory
vote on executive compensation and any golden parachute payments not previously approved.
Company Information
We initially incorporated in January 2010
in New Jersey as Oncobiologics, Inc., and in October 2015, we reincorporated in Delaware by merging with and into a Delaware corporation.
In November 2018, we changed our name to Outlook Therapeutics, Inc. Our headquarters are located at 7 Clarke Drive, Cranbury, New
Jersey, 08512, and our telephone number at that location is (609) 619-3990. Our website address is www.outlooktherapeutics.com.
The information contained on, or that can be accessed through, our website is not part of, and is not incorporated by reference
into this prospectus.
THE SECURITIES WE MAY OFFER
We may offer shares of our common stock and preferred stock,
various series of debt securities and/or warrants to purchase any of such securities, either individually or in combination, up
to a total dollar amount of $100,000,000 from time to time under this prospectus, together with the applicable prospectus supplement
and any related free writing prospectus, at prices and on terms to be determined by market conditions at the time of any offering.
We may also offer common stock, preferred stock and/or debt securities upon the exercise of warrants. 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,
including, to the extent applicable:
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designation or classification;
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aggregate principal amount or aggregate offering price;
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original issue discount;
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rates and times of payment of interest or dividends;
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redemption, conversion, exercise, exchange or sinking fund terms;
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voting or other rights;
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conversion or exchange prices or rates and, if applicable, any provisions for changes to or adjustments in the conversion or
exchange prices or rates and in the securities or other property receivable upon conversion or exchange;
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voting or other rights; and
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a discussion of material or special U.S. federal income tax considerations.
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The applicable prospectus supplement and any related free writing
prospectus that we may authorize to be provided to you may also add, update or change any of the information contained in this
prospectus or in the documents we have incorporated by reference. However, no prospectus supplement or free writing prospectus
will offer a security that is not registered and described in this prospectus at the time of the effectiveness of the registration
statement of which this prospectus is a part.
This prospectus may not be used to consummate a sale of
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, underwriters or dealers reserve the right to accept or reject all or part
of any proposed purchase of securities. If we do offer securities to or through agents, underwriters or dealers, we will include
in the applicable prospectus supplement:
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the names of those agents, underwriters or dealers;
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applicable fees, discounts and commissions to be paid to them;
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details regarding over-allotment or other 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. Each
holder of our common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including
the election of directors. Subject to preferences that may be applicable to any then-outstanding preferred stock, holders of common
stock are entitled to receive ratably those 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 are 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 and the satisfaction of any liquidation preference granted to the holders of any then-outstanding shares of preferred
stock. Holders of 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 preferred stock that we may designate in
the future. In this prospectus, we have summarized certain general features of the common stock under “Description of Capital
Stock — Common Stock.” We urge you, however, to read the applicable prospectus supplement (and any related free writing
prospectus that we may authorize to be provided to you) related to any common stock being offered.
Preferred Stock
We may issue shares of our preferred stock from time to time,
in one or more series. Our board of directors will determine the designations, voting powers, preferences and rights of the preferred
stock, as well as the qualifications, limitations or restrictions thereof, including dividend rights, conversion rights, preemptive
rights, terms of redemption or repurchase, liquidation preferences, sinking fund terms and the number of shares constituting any
series or the designation of any series. Convertible preferred stock will be convertible into our common stock or exchangeable
for other securities. Conversion may be mandatory or at your option and would be at prescribed conversion rates.
If we sell any series of preferred stock under this prospectus,
we will fix the designations, voting powers, preferences and rights of such series of preferred stock, as well as the qualifications,
limitations or restrictions thereof, in the certificate of designation relating to that 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 contains the terms of the series of preferred stock we are offering. In this
prospectus, we have summarized certain general features of the preferred stock under “Description of Capital Stock –
Preferred Stock.” We urge you, however, to read the applicable prospectus supplement (and any related free writing prospectus
that we may authorize to be provided to you) related to the series of preferred stock being offered, as well as the complete certificate
of designation that contains the terms of the applicable series of preferred stock.
Debt Securities
We may issue debt securities from time to time, in one or more
series, as either senior or subordinated debt or as senior or subordinated convertible debt. The senior debt securities will rank
equally with any other unsecured and unsubordinated debt. The subordinated debt securities will be subordinate and junior in right
of payment, to the extent and in the manner described in the instrument governing the debt, to all of our senior indebtedness.
Convertible debt securities will be convertible into or exchangeable for our common stock or other securities. Conversion may be
mandatory or at your option and would be at prescribed conversion rates.
Any debt securities issued under this prospectus will be issued
under one or more documents called indentures, which are contracts between us and a national banking association or other eligible
party, as trustee. In this prospectus, we have summarized certain general features of the debt securities under “Description
of Debt Securities.” We urge you, however, to read the applicable prospectus supplement (and any free writing prospectus
that we may authorize to be provided to you) related to the series of debt securities being offered, as well as the complete indentures
that contain the terms of the debt securities. We have filed the form of indenture as an exhibit to the registration statement
of which this prospectus is a part, and supplemental indentures and forms of debt securities containing the terms of the debt securities
being offered will be filed as exhibits to the registration statement of which this prospectus is a part or will be incorporated
by reference from reports that we file with the SEC.
Warrants
We may issue warrants for the purchase of common stock, preferred
stock and/or debt securities in one or more series. We may issue warrants independently or in combination with common stock, preferred
stock and/or debt securities. In this prospectus, we have summarized certain general features of the warrants under “Description
of Warrants.” We urge you, however, to read the applicable prospectus supplement (and any free writing prospectus that we
may authorize to be provided to you) related to the particular series of warrants being offered, as well as the complete warrant
agreements and warrant certificates that contain the terms of the warrants. We have filed forms of the warrant agreements and forms
of warrant certificates containing the terms of the warrants that may be offered as exhibits to the registration statement of which
this prospectus is a part. 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 and/or the warrant agreement and warrant certificate,
as applicable, that contain the terms of the particular series of warrants we are offering, and any supplemental agreements, before
the issuance of such warrants.
Any warrants issued under this prospectus may be evidenced by
warrant certificates. Warrants may be issued under an applicable warrant agreement that we enter into with a warrant agent. We
will indicate the name and address of the warrant agent, if applicable, in the prospectus supplement relating to the particular
series of warrants being offered.
RISK FACTORS
Investing in our securities involves a
high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties
described under the heading “Risk Factors” contained in the applicable prospectus supplement and any related free writing
prospectus, and discussed under the heading “Risk Factors” contained in our most recent Annual Report on Form 10-K,
as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus
in their entirety, together with other information in this prospectus, the documents incorporated by reference and any free writing
prospectus that we may authorize for use in connection with this offering. The risks described in these documents are not the only
ones we face, but those that we consider to be material. There may be other unknown or unpredictable economic, business, competitive,
regulatory or other factors that could have material adverse effects on our future results. Past financial performance may not
be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future
periods. If any of these risks actually occurs, our business, financial condition, results of operations or cash flow could be
seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your
investment. Please also read carefully the section below titled “Special Note Regarding Forward-Looking Statements.”
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus, including the documents that
we incorporate by reference herein, contains, and any applicable prospectus supplement or free writing prospectus including the
documents we incorporate by reference therein may contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended,
or the Exchange Act, about us and our industry that involve substantial risks and uncertainties. All statements, other than statements
of historical facts contained in this prospectus, including statements regarding our future financial condition, business strategy
and plans, and objectives of management for future operations, are forward-looking statements. In some cases you can identify these
statements by forward-looking words such as “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “could,” “would,” “project,”
“plan,” “expect” or the negative or plural of these words or similar expressions. These forward-looking
statements include, but are not limited to, statements concerning the following:
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the timing and the success of the design of the clinical trials and planned clinical trials of our lead product candidate,
ONS-5010;
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whether the results of our clinical trials will be sufficient to support domestic or global regulatory approvals;
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our ability to obtain and maintain regulatory approval for ONS-5010 in the United States and other markets if we successfully
complete clinical trials;
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our expectations regarding the potential market size and the size of the patient populations for our product candidates, if
approved, for commercial use;
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our ability to fund our working capital requirements;
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the rate and degree of market acceptance of our current and future product candidates;
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the implementation of our business model and strategic plans for our business and product candidates;
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developments or disputes concerning our intellectual property or other proprietary rights;
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our ability to maintain and establish collaborations or obtain additional funding;
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our expectations regarding government and third-party payor coverage and reimbursement;
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our ability to compete in the markets we serve; and
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the factors that may impact our financial results.
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These statements reflect our current views
with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking statements. We discuss in greater detail many of these risks under
the heading “Risk Factors” contained in the applicable prospectus supplement, in any free writing prospectuses we may
authorize for use in connection with a specific offering, and in our most recent annual report on Form 10-K and in our most recent
quarterly report on Form 10-Q, which are incorporated by reference into this prospectus in their entirety, as well as any amendments
thereto reflected in subsequent filings with the SEC. Also, these forward-looking statements represent our estimates and assumptions
only as of the date of the document containing the applicable statement. Unless required by law, we undertake no obligation to
update or revise any forward-looking statements to reflect new information or future events or developments. Thus, you should not
assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.
You should read this prospectus, any applicable prospectus supplement, together with the documents we have filed with the SEC that
are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely
and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the
forward-looking statements in the foregoing documents by these cautionary statements.
USE OF PROCEEDS
Except as described in any applicable prospectus supplement
or in any free writing prospectuses we have authorized for use in connection with a specific offering, we currently intend to use
the net proceeds from the sale of the securities offered by us hereunder, if any, for working capital, capital expenditures and
general corporate purposes, which may include, among other things, funding research and development, clinical trials, vendor payable,
potential regulatory submissions, hiring additional personnel and capital expenditures. We may also use a portion of the net proceeds
to in-license, acquire, or invest in additional businesses, technologies, products, or assets, though we currently have no specific
agreements, commitments, or understandings with respect to any in-licensing or acquisitions.
The amounts and timing of our use of the net proceeds from this
offering will depend on a number of factors, such as the timing and progress of our research and development efforts, the timing
and progress of any partnering and commercialization efforts, technological advances and the competitive environment for our products.
As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from
the sale of the securities offered by us hereunder. Accordingly, our management will have broad discretion in the timing and application
of these proceeds. Pending application of the net proceeds as described above, we intend to temporarily invest the proceeds in
short-term, interest-bearing instruments.
DESCRIPTION OF CAPITAL STOCK
As
of the date of this prospectus, our authorized capital stock consists of 200,000,000 shares of common stock, par value $0.01 per
share, and 10,000,000 shares of preferred stock, par value $0.01 per share.
The
following summary description of our capital stock is based on the provisions of our amended and restated certificate of incorporation,
our amended and restated bylaws and the applicable provisions of the Delaware General Corporation Law. This information may not
be complete in all respects and is qualified entirely by reference to the provisions of our amended and restated certificate of
incorporation, our amended and restated bylaws and the Delaware General Corporation Law. For information on how to obtain copies
of our amended and restated certificate of incorporation and our amended and restated bylaws, see “Where You Can Find More
Information.”
Common Stock
As
of May 31, 2019, we had 26,050,811 shares of common stock outstanding.
Voting Rights
Each
holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders. The affirmative
vote of holders of 66⅔% of the voting power of all of the then-outstanding shares of capital stock, voting as a single class,
will be required to amend certain provisions of our amended and restated certificate of incorporation, including provisions relating
to amending our amended and restated bylaws, the classified board, the size of our board, removal of directors, director liability,
vacancies on our board, special meetings, stockholder notices, actions by written consent and exclusive jurisdiction.
Dividends
Subject
to preferences that may apply to any outstanding preferred stock, holders of our common stock are entitled to receive ratably any
dividends that our board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. Our
outstanding senior secured notes first issued beginning December 2016 restrict our ability to pay dividends.
Liquidation
In
the event of our liquidation, dissolution or winding up, holders of our common stock are entitled to share ratably in all assets
remaining after payment of liabilities and the liquidation preference of any outstanding preferred stock.
Rights and Preferences
Holders
of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions
applicable to our common stock. The rights, preferences and privileges of the holders of our 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 in the
future.
Preferred Stock
Our
board of directors has the authority, without further action by our stockholders, to issue up to 10,000,000 shares of preferred
stock in one or more series and to fix the number, rights, preferences, privileges and restrictions thereof. These rights, preferences
and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences and
sinking fund terms, and the number of shares constituting any series or the designation of such series, any or all of which may
be greater than the rights of common stock. The issuance of our preferred stock could adversely affect the voting power of holders
of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition,
the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in control or other corporate
action. In June 2018, our Board designated 200,000 shares as “Series A-1 Convertible preferred stock.” As
of March 31, 2019, there were 63,250 shares of our Series A-1 Convertible preferred stock issued and outstanding.
Series A-1
Convertible Preferred Stock
As
of March 31, 2019, 200,000 shares of Series A-1 Convertible preferred stock have been authorized for issuance, 63,250 of which
were issued and outstanding at such date. The shares of Series A-1 Convertible preferred stock have a stated value of
$100.00 per share and the 63,250 outstanding shares are convertible into approximately 1,195,295 shares of our common stock as
of March 31, 2019.
Dividends
The
Series A-1 Convertible preferred stock accrue dividends at a rate of 10% per annum, compounded quarterly, payable quarterly
at our option in cash or in kind in additional shares of Series A-1 Convertible preferred stock. The Series A-1 Convertible
preferred stock are also entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares
of our common stock or other securities. The initial conversion rate is subject to appropriate adjustment in the event of a stock
split, stock dividend, combination, reclassification or other recapitalization affecting our common stock.
Voting
The
holders of the Series A-1 Convertible preferred stock have the right to vote on matters submitted to a vote of our stockholders
on an as-converted basis. In addition, without the prior written consent of a majority of the outstanding shares of Series A-1
Convertible preferred stock, we may not take certain actions.
The
terms of the Series A-1 Convertible preferred stock distinguish between certain liquidation events (such as a voluntary or
involuntary liquidation, dissolution or winding up of our company) and “deemed” liquidation events (such as a sale
of all or substantially all of our assets, various merger and reorganization transactions, being delisted from the Nasdaq and the
occurrence of an event of default under the terms of the senior secured notes), in each case as defined in the Certificate of Designation.
In the event of a liquidation (as defined in the Certificate of Designation) the liquidation preference payable equals the sum
of (A) 550% of the stated value per share plus (B) (x) 550% of any accrued but unpaid preferred dividends
(as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate
of Designation). In the case of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased
to 600%.
Conversion
The
Series A-1 Convertible preferred stock is convertible at any time at the option of the holder based on the then applicable
conversion rate. If conversion is in connection with a liquidation (as defined in the Certificate of Designation), the holder is
entitled to receive 550% of the number of shares of common stock issuable based upon the then applicable conversion rate. In the
event of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased to 600%.
Redemption
Additionally,
the holder may require the Company to redeem the Series A-1 Convertible preferred stock in the event of deemed liquidation
event for the sum of (A) 600% of the stated value per share plus (B) an amount equal to (x) 600% of any accrued,
but unpaid, preferred dividends plus (y) any unpaid participating dividends, although such redemption may not be made without
the consent of the senior secured noteholders if such notes are outstanding at the time of any such redemption.
Common Stock Equivalents
As
of March 31, 2019, we had issued and outstanding 16,131 performance stock unit awards, 7,156 restricted stock unit awards and
541,746 stock option awards under our equity incentive plans. At such date, we also had outstanding warrants to acquire an
aggregate of 5,660,949 shares of our common stock. Subsequent to March 31, 2019 we issued warrants to acquire an aggregate of
20,680,000 shares of our common stock. In addition, as March 31, 2019, we had 63,250 shares of our Series A-1
Convertible preferred stock issued and outstanding. We also had outstanding at March 31, 2019 an aggregate $8.5 million
principal amount of senior secured notes, which are convertible (along with accrued but unpaid interest thereon) into shares
of our common stock at an initial conversion price of $8.9539 per share and an aggregate $1.0 million of
unsecured notes, which are exchangeable (along with accrued and unpaid interest thereon) into shares of our common stock at
an initial exchange rate of $13.44 per share. As of March 31, 2019, the outstanding senior secured notes were
convertible into an aggregate of 957,482 shares of our common stock, and the outstanding unsecured notes were convertible into an aggregate of 147,347 shares of our common
stock.
Stockholder Registration
Rights
Certain
holders of our securities, including certain holders of 5% of our capital stock, certain of our directors, and the holder of the
Series A-1 Convertible preferred stock are entitled to certain rights with respect to registration of such securities under
the Securities Act. These securities are referred to as registrable securities. The holders of these registrable securities possess
registration rights pursuant to the terms of registration rights agreements.
In
general, the registration of shares of our common stock pursuant to the exercise of registration rights enables the holders to
trade such shares without restriction under the Securities Act when the applicable registration statement is declared effective.
We generally have agreed to pay the registration expenses for such registration statements, other than underwriting discounts,
selling commissions and stock transfer taxes, of the shares registered.
Generally,
in an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions, to limit the number
of shares the holders may include. We must use commercially reasonable efforts to keep the registration statement effective until
the earlier of the date on which all registrable securities covered by such registration statement have been sold, or at such time
that the holders of the registrable securities can sell their shares under Rule 144 of the Securities Act during any three-month
period.
Anti-Takeover Provisions
of Delaware Law and Our Charter Documents
Section 203
of the Delaware General Corporation Law
We
are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in
any business combination with any interested stockholder for a period of three years after the date that such stockholder
became an interested stockholder, with the following exceptions:
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before such date, the board of directors of the corporation approved
either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
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upon completion of the transaction that resulted in the stockholder
becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding
at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding
voting stock owned by the interested stockholder) those shares owned (1) by persons who are directors and also officers
and (2) employee stock plans in which employee participants do
not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange
offer; and
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on or after such date, the business combination is approved by the
board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative
vote of at least 66⅔% of the outstanding voting stock that is not owned by the interested stockholder.
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In
general, Section 203 defines a “business combination” to include the following:
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any merger or consolidation involving the corporation and the interested
stockholder;
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any sale, transfer, pledge or other disposition of 10% or more of
the assets of the corporation involving the interested stockholder;
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subject to certain exceptions, any transaction that results in the
issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
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any transaction involving the corporation that has the effect of
increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested
stockholder;
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the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits by or through the corporation; and
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in general, Section 203 defines an “interested stockholder”
as an entity or person who, together with the person’s affiliates and associates, beneficially owns, or within three years
prior to the time of determination of interested stockholder status did own, 15% or more of the outstanding voting stock of the
corporation.
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The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly,
may discourage attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock
at a price above the prevailing market price.
Amended and Restated
Certificate of Incorporation and Amended and Restated Bylaws, as Amended
Among
other things, our amended and restated certificate of incorporation and amended and restated bylaws, as amended:
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permit our board of directors to issue up to 10,000,000 shares of
preferred stock, with any rights, preferences and privileges as they may designate, including the right to approve an acquisition
or other change in control;
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provide that the authorized number of directors may be changed only
by resolution of our board of directors;
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provide that our board of directors is classified into three classes
of directors;
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provide that, subject to the rights of any series of preferred stock
to elect directors, directors may only be removed for cause, which removal may be effected, subject to any limitation imposed by
law, by the holders of at least a majority
of the voting power of all of our then-outstanding shares of the capital
stock entitled to vote generally at an election of directors;
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provide that all vacancies, including newly created directorships,
may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if
less than a quorum;
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require that any action to be taken by our stockholders must be
effected at a duly called annual or special meeting of stockholders and not be taken by written consent or electronic transmission;
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provide that stockholders seeking to present proposals before a
meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice
in writing, and also specify requirements as to the form and content of a stockholder’s notice;
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provide that special meetings of our stockholders may be called
only by the chairman of our board of directors, our chief executive officer or president or by our board of directors pursuant
to a resolution adopted by a majority of the total number of authorized directors; and
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not provide for cumulative voting rights, therefore allowing the
holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors
standing for election, if they should so choose.
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amendment of any of these provisions requires approval by the holders of at least 66⅔% of the voting power of all of our
then-outstanding common stock entitled to vote generally in the election of directors, voting together as a single class.
The
combination of these provisions may make it more difficult for our existing stockholders to replace our board of directors as well
as for another party to obtain control of us by replacing our board of directors. Because our board of directors has the power
to retain and discharge our officers, these provisions could also make it more difficult for existing stockholders or another party
to effect a change in management. In addition, the authorization of undesignated preferred stock makes it possible for our board
of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to
change our control.
These
provisions are intended to enhance the likelihood of continued stability in the composition of our board of directors and its policies
and to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to reduce our vulnerability
to hostile takeovers and to discourage certain tactics that may be used in proxy fights. However, such provisions could have the
effect of discouraging others from making tender offers for our shares and may have the effect of delaying changes in our control
or management. As a consequence, these provisions may also inhibit fluctuations in the market price of our stock that could result
from actual or rumored takeover attempts. We believe that the benefits of these provisions, including increased protection of our
potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company,
outweigh the disadvantages of discouraging takeover proposals, because negotiation of takeover proposals could result in an improvement
of their terms.
Choice of Forum
Our
amended and restated certificate of incorporation, as amended, and our amended and restated bylaws, as amended, provides that the
Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf;
any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General
Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that is governed by
the internal affairs doctrine. The enforceability of similar choice of forum provisions in other companies’ certificates
of incorporation has been challenged in legal proceedings, and it is possible that, in connection with one or more actions or proceedings
described above, a court could find the choice of forum provisions contained in our amended and restated certificate of incorporation
to be inapplicable or unenforceable.
Listing
Our
common stock and Series A warrants are listed on The Nasdaq Capital Market under the trading symbols “OTLK” and “OTLKW,”
respectively. The applicable prospectus supplement will contain information, where applicable, as to any other listing, if any,
on The Nasdaq Capital Market or any securities market or other exchange of the preferred stock or other securities covered by such
prospectus supplement.
Transfer
Agent and Registrar
The transfer agent and registrar for our common
stock is American Stock Transfer & Trust Company, LLC. Its address is 6201 15th Avenue, Brooklyn, New York 11219.
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities from time to time, in one or more
series, as either senior or subordinated debt or as senior or subordinated convertible debt. While the terms we have summarized
below will apply generally to any debt securities that we may offer under this prospectus, we will describe the particular terms
of any debt securities that we may offer in more detail in the applicable prospectus supplement. The terms of any debt securities
offered under a prospectus supplement may differ from the terms described below. Unless the context requires otherwise, whenever
we refer to the indenture, we also are referring to any supplemental indentures that specify the terms of a particular series of
debt securities.
We will issue the debt securities under the indenture that we
will enter into with the trustee named in the indenture. The indenture will be qualified under the Trust Indenture Act of 1939,
as amended, or the Trust Indenture Act. We have filed the form of indenture as an exhibit to the registration statement of which
this prospectus is a part, and supplemental indentures and forms of debt securities containing the terms of the debt securities
being offered will be filed as exhibits to the registration statement of which this prospectus is a part or will be incorporated
by reference from reports that we file with the SEC.
The following summary of material provisions of the debt securities
and the indenture is subject to, and qualified in its entirety by reference to, all of the provisions of the indenture applicable
to a particular series of debt securities. We urge you to read the applicable prospectus supplements and any related free writing
prospectuses related to the debt securities that we may offer under this prospectus, as well as the complete indenture that contains
the terms of the debt securities.
General
The indenture does not limit the amount of debt securities that
we may issue. It provides that we may issue debt securities up to the principal amount that we may authorize and may be in any
currency or currency unit that we may designate. Except for the limitations on consolidation, merger and sale of all or substantially
all of our assets contained in the indenture, the terms of the indenture do not contain any covenants or other provisions designed
to give holders of any debt securities protection against changes in our operations, financial condition or transactions involving
us.
We may issue the debt securities issued under the indenture
as “discount securities,” which means they may be sold at a discount below their stated principal amount. These debt
securities, as well as other debt securities that are not issued at a discount, may be issued with “original issue discount,”
or OID, for U.S. federal income tax purposes because of interest payment and other characteristics or terms of the debt securities.
Material U.S. federal income tax considerations applicable to debt securities issued with OID will be described in more detail
in any applicable prospectus supplement.
We will describe in the applicable prospectus supplement the
terms of the series of debt securities being offered, including:
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the title of the series of debt securities;
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any limit upon the aggregate principal amount that may be issued;
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the maturity date or dates;
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the form of the debt securities of the series;
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the applicability of any guarantees;
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whether or not the debt securities will be secured or unsecured, and
the terms of any secured debt;
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whether the debt securities rank as senior debt, senior subordinated
debt, subordinated debt or any combination thereof, and the terms of any subordination;
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if the price (expressed as a percentage of the aggregate principal
amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of
the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or if applicable, the portion of
the principal amount of such debt securities that is convertible into another security or the method by which any such portion
shall be determined;
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the interest rate or rates, which may be fixed or variable, or the
method for determining the rate or rates and the date interest will begin to accrue, the dates interest will be payable and the
regular record dates for interest payment dates or the method for determining such dates;
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our right, if any, to defer payment of interest and the maximum length
of any such deferral period;
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if applicable, the date or dates after which, or the period or periods
during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional
or provisional redemption provisions and the terms of those redemption provisions;
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the date or dates, if any, on which, and the price or prices at which
we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s
option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;
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the denominations in which we will issue the series of debt securities,
if other than denominations of $1,000 and any integral multiple thereof;
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any and all terms, if applicable, relating to any auction or remarketing
of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms
which may be advisable in connection with the marketing of debt securities of that series;
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whether the debt securities of the series shall be issued in whole
or in part in the form of a global security or securities, the terms and conditions, if any, upon which such global security or
securities may be exchanged in whole or in part for other individual securities, and the depositary for such global security or
securities;
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if applicable, the provisions relating to conversion or exchange of
any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable,
including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional
(at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and
the manner of settlement for any conversion or exchange;
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if other than the full principal amount thereof, the portion of the
principal amount of debt securities of the series which shall be payable upon declaration of acceleration of the maturity thereof;
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additions to or changes in the covenants applicable to the particular
debt securities being issued, including, among others, the consolidation, merger or sale covenant;
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additions to or changes in the events of default with respect to the
securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if
any, with respect to such securities to be due and payable;
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additions to or changes in or deletions of the provisions relating
to covenant defeasance and legal defeasance;
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additions to or changes in the provisions relating to satisfaction
and discharge of the indenture;
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additions to or changes in the provisions relating to the modification
of the indenture both with and without the consent of holders of debt securities issued under the indenture;
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the currency of payment of debt securities if other than U.S. dollars
and the manner of determining the equivalent amount in U.S. dollars;
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whether interest will be payable in cash or additional debt securities
at our or the holders’ option and the terms and conditions upon which the election may be made;
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the terms and conditions, if any, upon which we will pay amounts in
addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that
is not a “United States person” for federal tax purposes;
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any restrictions on transfer, sale or assignment of the debt securities
of the series; and
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any other specific terms, preferences, rights or limitations of, or
restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may
be required by us or advisable under applicable laws or regulations.
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Conversion or Exchange Rights
We will set forth in the applicable prospectus supplement the
terms on which a series of debt securities may be convertible into or exchangeable for our common stock or our other securities.
We will include provisions as to settlement upon conversion or exchange and whether conversion or exchange is mandatory, at the
option of the holder or at our option. We may include provisions pursuant to which the number of shares of our common stock or
our other securities that the holders of the series of debt securities receive would be subject to adjustment.
Consolidation, Merger or Sale
Unless we provide otherwise in the prospectus supplement applicable
to a particular series of debt securities, the indenture will not contain any covenant that restricts our ability to merge or consolidate,
or sell, convey, transfer or otherwise dispose of our assets as an entirety or substantially as an entirety. However, any successor
to or acquirer of such assets (other than a subsidiary of ours) must assume all of our obligations under the indenture or the debt
securities, as appropriate.
Events of Default under the Indenture
Unless we provide otherwise in the prospectus supplement applicable
to a particular series of debt securities, the following are events of default under the indenture with respect to any series of
debt securities that we may issue:
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if we fail to pay any installment of interest on any series of debt
securities, as and when the same shall become due and payable, and such default continues for a period of 90 days; provided, however,
that a valid extension of an interest payment period by us in accordance with the terms of any indenture supplemental thereto shall
not constitute a default in the payment of interest for this purpose;
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if we fail to pay the principal of, or premium, if any, on any series
of debt securities as and when the same shall become due and payable whether at maturity, upon redemption, by declaration or otherwise,
or in any payment required by any sinking or analogous fund established with respect to such series; provided, however, that a
valid extension of the maturity of such debt securities in accordance with the terms of any indenture supplemental thereto shall
not constitute a default in the payment of principal or premium, if any;
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if we fail to observe or perform any other covenant or agreement contained
in the debt securities or the indenture, other than a covenant specifically relating to another series of debt securities, and
our failure continues for 90 days after we receive written notice of such failure, requiring the same to be remedied and stating
that such is a notice of default thereunder, from the trustee or holders of at least 25% in aggregate principal amount of the outstanding
debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency or reorganization occur.
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If an event of default with respect to debt securities of any
series occurs and is continuing, other than an event of default specified in the last bullet point above, the trustee or the holders
of at least 25% in aggregate principal amount of the outstanding debt securities of that series, by notice to us in writing, and
to the trustee if notice is given by such holders, may declare the unpaid principal of, premium, if any, and accrued interest,
if any, due and payable immediately. If an event of default specified in the last bullet point above occurs with respect to us,
the principal amount of and accrued interest, if any, of each issue of debt securities then outstanding shall be due and payable
without any notice or other action on the part of the trustee or any holder.
The holders of a majority in principal amount of the outstanding
debt securities of an affected series may waive any default or event of default with respect to the series and its consequences,
except defaults or events of default regarding payment of principal, premium, if any, or interest, unless we have cured the default
or event of default in accordance with the indenture. Any waiver shall cure the default or event of default.
Subject to the terms of the indenture, if an event of default
under an indenture shall occur and be continuing, the trustee will be under no obligation to exercise any of its rights or powers
under such indenture at the request or direction of any of the holders of the applicable series of debt securities, unless such
holders have offered the trustee reasonable indemnity. The holders of a majority in principal amount of the outstanding debt securities
of any series will have the right to direct the time, method and place of conducting any proceeding for any remedy available to
the trustee, or exercising any trust or power conferred on the trustee, with respect to the debt securities of that series, provided
that:
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the direction so given by the holder is not in conflict with any law
or the applicable indenture; and
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subject to its duties under the Trust Indenture Act, the trustee need
not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the
proceeding.
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A holder of the debt securities of any series will have the
right to institute a proceeding under the indenture or to appoint a receiver or trustee, or to seek other remedies only if:
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the holder has given written notice to the trustee of a continuing
event of default with respect to that series;
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the holders of at least 25% in aggregate principal amount of the outstanding
debt securities of that series have made written request;
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such holders have offered to the trustee indemnity satisfactory to
it against the costs, expenses and liabilities to be incurred by the trustee in compliance with the request; and
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the trustee does not institute the proceeding, and does not receive
from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting
directions within 90 days after the notice, request and offer.
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These limitations do not apply to a suit instituted by a holder
of debt securities if we default in the payment of the principal, premium, if any, or interest on, the debt securities.
We will periodically file statements with the trustee regarding
our compliance with specified covenants in the indenture.
Modification of Indenture; Waiver
We and the trustee may change an indenture
without the consent of any holders with respect to specific matters:
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to cure any ambiguity, defect or inconsistency in the indenture or
in the debt securities of any series;
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to comply with the provisions described above under “Description
of Debt Securities—Consolidation, Merger or Sale;”
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to provide for uncertificated debt securities in addition to or in
place of certificated debt securities;
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to add to our covenants, restrictions, conditions or provisions such
new covenants, restrictions, conditions or provisions for the benefit of the holders of all or any series of debt securities, to
make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions
or provisions an event of default or to surrender any right or power conferred upon us in the indenture;
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to add to, delete from or revise the conditions, limitations, and
restrictions on the authorized amount, terms, or purposes of issue, authentication and delivery of debt securities, as set forth
in the indenture;
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to make any change that does not adversely affect the interests of
any holder of debt securities of any series in any material respect;
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to provide for the issuance of and establish the form and terms and
conditions of the debt securities of any series as provided above under “Description of Debt Securities—General”
to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt
securities, or to add to the rights of the holders of any series of debt securities;
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to evidence and provide for the acceptance of appointment under any
indenture by a successor trustee; or
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to comply with any requirements of the SEC in connection with the
qualification of any indenture under the Trust Indenture Act.
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In addition, under the indenture, the rights of holders of a
series of debt securities may be changed by us and the trustee with the written consent of the holders of at least a majority in
aggregate principal amount of the outstanding debt securities of each series that is affected. However, unless we provide otherwise
in the prospectus supplement applicable to a particular series of debt securities, we and the trustee may make the following changes
only with the consent of each holder of any outstanding debt securities affected:
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extending the fixed maturity of any debt securities of any series;
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reducing the principal amount, reducing the rate of or extending the
time of payment of interest, or reducing any premium payable upon the redemption of any series of any debt securities; or
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reducing the percentage of debt securities, the holders of which are
required to consent to any amendment, supplement, modification or waiver.
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Discharge
Each indenture provides that we can elect to be discharged from
our obligations with respect to one or more series of debt securities, except for specified obligations, including obligations
to:
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register the transfer or exchange of debt securities of the series;
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replace stolen, lost or mutilated debt securities of the series;
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pay principal of and premium and interest on any debt securities of
the series;
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maintain paying agencies;
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hold monies for payment in trust;
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recover excess money held by the trustee;
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compensate and indemnify the trustee; and
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appoint any successor trustee.
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In order to exercise our rights to be discharged, we must deposit
with the trustee money or government obligations sufficient to pay all the principal of, any premium, if any, and interest on,
the debt securities of the series on the dates payments are due.
Form, Exchange and Transfer
We will issue the debt securities of each series only in fully
registered form without coupons and, unless we provide otherwise in the applicable prospectus supplement, in denominations of $1,000
and any integral multiple thereof. The indenture provides that we may issue debt securities of a series in temporary or permanent
global form and as book-entry securities that will be deposited with, or on behalf of, The Depository Trust Company, or DTC, or
another depositary named by us and identified in the applicable prospectus supplement with respect to that series. To the extent
the debt securities of a series are issued in global form and as book-entry, a description of terms relating to any book-entry
securities will be set forth in the applicable prospectus supplement.
At the option of the holder, subject to the terms of the indenture
and the limitations applicable to global securities described in the applicable prospectus supplement, the holder of the debt securities
of any series can exchange the debt securities for other debt securities of the same series, in any authorized denomination and
of like tenor and aggregate principal amount.
Subject to the terms of the indenture and the limitations applicable
to global securities set forth in the applicable prospectus supplement, holders of the debt securities may present the debt securities
for exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed thereon duly executed if so required
by us or the security registrar, at the office of the security registrar or at the office of any transfer agent designated by us
for this purpose. Unless otherwise provided in the debt securities that the holder presents for transfer or exchange, we will impose
no service charge for any registration of transfer or exchange, but we may require payment of any taxes or other governmental charges.
We will name in the applicable prospectus supplement the security
registrar, and any transfer agent in addition to the security registrar, that we initially designate for any debt securities. We
may at any time designate additional security registrars or transfer agents or rescind the designation of any security registrars
or transfer agent or approve a change in the office through which any security registrars or transfer agent acts, except that we
will be required to maintain a security registrar and a transfer agent in each place of payment for the debt securities of each
series.
If we elect to redeem the debt securities of any series, we
will not be required to:
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issue, register the transfer of, or exchange any debt securities of
that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption
of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or
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register the transfer of or exchange any debt securities so selected
for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part.
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Information Concerning the Trustee
The trustee, other than during the occurrence and continuance
of an event of default under an indenture, undertakes to perform only those duties as are specifically set forth in the applicable
indenture. Upon an event of default under an indenture, the trustee must use the same degree of care as a prudent person would
exercise or use in the conduct of his or her own affairs. Subject to this provision, the trustee is under no obligation to exercise
any of the powers given it by the indenture at the request of any holder of debt securities unless it is offered reasonable security
and indemnity against the costs, expenses and liabilities that it might incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement,
we will make payment of the interest on any debt securities on any interest payment date to the person in whose name the debt securities,
or one or more predecessor securities, are registered at the close of business on the regular record date for the interest.
We will pay principal of and any premium and interest on the
debt securities of a particular series at the office of the paying agents designated by us, except that unless we otherwise indicate
in the applicable prospectus supplement, we will make interest payments by check that we will mail to the holder or by wire transfer
to certain holders. Unless we otherwise indicate in the applicable prospectus supplement, we will designate the corporate trust
office of the trustee as our sole paying agent for payments with respect to debt securities of each series. We will name in the
applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular series.
We may at any time rescind the designation or any paying agent or approve a change in the office through which any paying agent
acts, except that we will be required to maintain a paying agent in each place of payment for the debt securities of a particular
series.
All money we pay to a paying agent or the trustee for the payment
of the principal of or any premium or interest on any debt securities that remains unclaimed at the end of two years after such
principal, premium or interest has become due and payable will be repaid to us, and the holder of the debt security thereafter
may look only to us for payment thereof.
Governing Law
The indenture and the debt securities will be governed by and
construed in accordance with the internal laws of the State of New York, except to the extent that the Trust Indenture Act of 1939
is applicable.
DESCRIPTION OF WARRANTS
The following description, together with the additional information
we may include in any applicable prospectus supplement and in any related free writing prospectus that we may authorize to be distributed
to you, summarizes the material terms and provisions of the warrants that we may offer under this prospectus, which may consist
of warrants to purchase common stock, preferred stock or debt securities and may be issued in one or more series. Warrants may
be offered independently or in combination with common stock, preferred stock or debt securities offered by any prospectus supplement.
While the terms we have summarized below will apply generally to any warrants that we may offer under this prospectus, we will
describe the particular terms of any series of warrants in more detail in the applicable prospectus supplement. The following description
of warrants will apply to the warrants offered by this prospectus unless we provide otherwise in the applicable prospectus supplement.
The applicable prospectus supplement for a particular series of warrants may specify different or additional terms.
We have filed forms of the warrant agreements and forms of warrant
certificates containing the terms of the warrants that may be offered as exhibits to the registration statement of which this prospectus
is a part. 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 and/or the warrant agreement and warrant certificate, as applicable,
that contain the terms of the particular series of warrants we are offering, and any supplemental agreements, before the issuance
of such warrants. The following summaries of material terms and provisions of the warrants are subject to, and qualified in their
entirety by reference to, all the provisions of the form of warrant and/or the warrant agreement and warrant certificate, as applicable,
and any supplemental agreements applicable to a particular series of warrants that we may offer under this prospectus. We urge
you to read the applicable prospectus supplement related to the particular series of warrants that we may offer under this prospectus,
as well as any related free writing prospectus, and the complete form of warrant and/or the warrant agreement and warrant certificate,
as applicable, and any supplemental agreements, that contain the terms of the warrants.
General
We will describe in the applicable prospectus supplement the
terms of the series of warrants being offered, including, to the extent applicable:
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the offering price and aggregate number of warrants offered;
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the currency for which the warrants may be purchased;
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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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in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one
warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise;
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in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock,
as the case may be, purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such
exercise;
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the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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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;
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the manner in which the warrant agreements and warrants may be modified;
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a discussion of material or special U.S. federal income tax considerations of holding or exercising the warrants;
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the terms of the securities issuable upon exercise of the warrants; 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:
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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; or
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in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or
interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture.
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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.
The warrants may be exercised as set forth in the prospectus supplement relating to the warrants offered. Unless we otherwise specify
in the applicable prospectus supplement, warrants may be exercised at any time up to the specified time on the expiration date
that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants
will become void.
Upon receipt of payment and the warrant or warrant certificate,
as applicable, properly completed and duly executed at the corporate trust office of the warrant agent, if any, or any other office,
including ours, indicated in the prospectus supplement, we will, as soon as practicable, issue and deliver the securities purchasable
upon such exercise. If less than all of the warrants (or the warrants represented by such warrant certificate) are exercised, a
new warrant or a new warrant certificate, as applicable, will be issued for the remaining warrants.
Governing Law
Unless we provide otherwise in the applicable prospectus supplement,
the warrants and warrant agreements will be governed by and construed in accordance with the laws of the State of New York.
Enforceability of Rights by Holders of Warrants
Each warrant agent, if any, will act solely as our agent under
the applicable warrant agreement and will not assume any obligation or relationship of agency or trust with any holder of any warrant.
A single bank or trust company may act as warrant agent for more than one issue of warrants. A warrant agent will have no duty
or responsibility in case of any default by us under the applicable warrant agreement or warrant, including any duty or responsibility
to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent
of the related warrant agent or the holder of any other warrant, enforce by appropriate legal action its right to exercise, and
receive the securities purchasable upon exercise of, its warrants.
LEGAL OWNERSHIP OF SECURITIES
We can issue securities in registered form or in the form of
one or more global securities. We describe global securities in greater detail below. We refer to those persons who have securities
registered in their own names on the books that we or any applicable trustee, depositary or warrant agent maintain for this purpose
as the “holders” of those securities. These persons are the legal holders of the securities. We refer to those persons
who, indirectly through others, own beneficial interests in securities that are not registered in their own names, as “indirect
holders” of those securities. As we discuss below, indirect holders are not legal holders, and investors in securities issued
in book-entry form or in street name will be indirect holders.
Book-Entry Holders
We may issue securities in book-entry form only, as we will
specify in the applicable prospectus supplement. This means securities may be represented by one or more global securities registered
in the name of a financial institution that holds them as depositary on behalf of other financial institutions that participate
in the depositary’s book-entry system. These participating institutions, which are referred to as participants, in turn,
hold beneficial interests in the securities on behalf of themselves or their customers.
Only the person in whose name a security is registered is recognized
as the holder of that security. Securities issued in global form will be registered in the name of the depositary or its participants.
Consequently, for securities issued in global form, we will recognize only the depositary as the holder of the securities, and
we will make all payments on the securities to the depositary. The depositary passes along the payments it receives to its participants,
which in turn pass the payments along to their customers who are the beneficial owners. The depositary and its participants do
so under agreements they have made with one another or with their customers; they are not obligated to do so under the terms of
the securities.
As a result, investors in a global security will not own securities
directly. Instead, they will own beneficial interests in a global security, through a bank, broker or other financial institution
that participates in the depositary’s book-entry system or holds an interest through a participant. As long as the securities
are issued in global form, investors will be indirect holders, and not legal holders, of the securities.
Street Name Holders
We may terminate a global security or issue securities in non-global
form. In these cases, investors may choose to hold their securities in their own names or in “street name.” Securities
held by an investor in street name would be registered in the name of a bank, broker or other financial institution that the investor
chooses, and the investor would hold only a beneficial interest in those securities through an account he or she maintains at that
institution.
For securities held in street name, we or any applicable trustee
or depositary will recognize only the intermediary banks, brokers and other financial institutions in whose names the securities
are registered as the holders of those securities, and we or any such trustee or depositary will make all payments on those securities
to them. These institutions pass along the payments they receive to their customers who are the beneficial owners, but only because
they agree to do so in their customer agreements or because they are legally required to do so. Investors who hold securities in
street name will be indirect holders, not legal holders, of those securities.
Legal Holders
Our obligations, as well as the obligations of any applicable
trustee or any third party employed by us or a trustee, run only to the legal holders of the securities. We do not have obligations
to investors who hold beneficial interests in global securities, in street name or by any other indirect means. This will be the
case whether an investor chooses to be an indirect holder of a security or has no choice because we are issuing the securities
only in global form.
For example, once we make a payment or give a notice to the
holder, we have no further responsibility for the payment or notice even if that holder is required, under agreements with its
participants or customers or by law, to pass it along to the indirect holders but does not do so. Similarly, we may want to obtain
the approval of the holders to amend an indenture, to relieve us of the consequences of a default or of our obligation to comply
with a particular provision of the indenture or for other purposes. In such an event, we would seek approval only from the holders,
and not the indirect holders, of the securities. Whether and how the holders contact the indirect holders is up to the holders.
Special Considerations for Indirect Holders
If you hold securities through a bank, broker or other financial
institution, either in book-entry form or in street name, you should check with your own institution to find out:
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how it handles securities payments and notices;
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whether it imposes fees or charges;
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how it would handle a request for the holders’ consent, if ever required;
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whether and how you can instruct it to send you securities registered in your own name so you can be a holder, if that is permitted
in the future;
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how it would exercise rights under the securities if there were a default or other event triggering the need for holders to
act to protect their interests; and
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if the securities are in book-entry form, how the depositary’s rules and procedures will affect these matters.
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Global Securities
A global security is a security that represents one or any other
number of individual securities held by a depositary. Generally, all securities represented by the same global securities will
have the same terms.
Each security issued in book-entry form will be represented
by a global security that we issue to, deposit with and register in the name of a financial institution or its nominee that we
select. The financial institution that we select for this purpose is called the depositary. Unless we specify otherwise in the
applicable prospectus supplement, DTC will be the depositary for all securities issued in book-entry form.
A global security may not be transferred to or registered in
the name of anyone other than the depositary, its nominee or a successor depositary, unless special termination situations arise.
We describe those situations below under the section titled “Special Situations When a Global Security Will Be Terminated.”
As a result of these arrangements, the depositary, or its nominee, will be the sole registered owner and holder of all securities
represented by a global security, and investors will be permitted to own only beneficial interests in a global security. Beneficial
interests must be held by means of an account with a broker, bank or other financial institution that in turn has an account with
the depositary or with another institution that does. Thus, an investor whose security is represented by a global security will
not be a legal holder of the security, but only an indirect holder of a beneficial interest in the global security.
If the prospectus supplement for a particular security indicates
that the security will be issued in global form only, then the security will be represented by a global security at all times unless
and until the global security is terminated. If termination occurs, we may issue the securities through another book-entry clearing
system or decide that the securities may no longer be held through any book-entry clearing system.
Special Considerations for Global Securities
The rights of an indirect holder relating to a global security
will be governed by the account rules of the investor’s financial institution and of the depositary, as well as general laws
relating to securities transfers. We do not recognize an indirect holder as a holder of securities and instead deal only with the
depositary that holds the global security.
If securities are issued only in the form of a global security,
an investor should be aware of the following:
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an investor cannot cause the securities to be registered in his or her name, and cannot obtain non-global certificates for
his or her interest in the securities, except in the special situations we describe below;
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an investor will be an indirect holder and must look to his or her own bank or broker for payments on the securities and protection
of his or her legal rights relating to the securities, as we describe above;
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an investor may not be able to sell interests in the securities to some insurance companies and to other institutions that
are required by law to own their securities in non-book-entry form;
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an investor may not be able to pledge his or her interest in a global security in circumstances where certificates representing
the securities must be delivered to the lender or other beneficiary of the pledge in order for the pledge to be effective;
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the depositary’s policies, which may change from time to time, will govern payments, transfers, exchanges and other matters
relating to an investor’s interest in a global security;
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we and any applicable trustee have no responsibility for any aspect of the depositary’s actions or for its records of
ownership interests in a global security, nor do we or any applicable trustee supervise the depositary in any way;
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the depositary may, and we understand that DTC will, require that those who purchase and sell interests in a global security
within its book-entry system use immediately available funds, and your bank or broker may require you to do so as well; and
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financial institutions that participate in the depositary’s book-entry system, and through which an investor holds its
interest in a global security, may also have their own policies affecting payments, transfers, exchanges, notices and other matters
relating to the securities.
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There may be more than one financial intermediary in the chain
of ownership for an investor. We do not monitor and are not responsible for the actions of any of those intermediaries.
Special Situations When a Global Security Will Be Terminated
In a few special situations described below, the global security
will terminate and interests in it will be exchanged for physical certificates representing those interests. After that exchange,
the choice of whether to hold securities directly or in street name will be up to the investor. Investors must consult their own
banks or brokers to find out how to have their interests in securities transferred to their own name, so that they will be direct
holders. We have described the rights of holders and street name investors above.
Unless we provide otherwise in the applicable prospectus supplement,
the global security will terminate when the following special situations occur:
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if the depositary notifies us that it is unwilling, unable or no longer qualified to continue as depositary for that global
security and we do not appoint another institution to act as depositary within 90 days;
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if we notify any applicable trustee that we wish to terminate that global security; or
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if an event of default has occurred with regard to securities represented by that global security and has not been cured or
waived.
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The applicable prospectus supplement may also list additional
situations for terminating a global security that would apply only to the particular series of securities covered by the prospectus
supplement. When a global security terminates, the depositary, and not we or any applicable trustee, is responsible for deciding
the names of the institutions that will be the initial direct holders.
PLAN OF DISTRIBUTION
We may sell the securities from time to time pursuant to underwritten
public offerings, direct sales to the public, “at the market” offerings, negotiated transactions, block trades or a
combination of these methods. We may sell the securities to or through underwriters or dealers, through agents, or directly to
one or more purchasers. We may distribute securities from time to time in one or more transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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A prospectus supplement or supplements (and any related free
writing prospectus that we may authorize to be provided to you) will describe the terms of the offering of the securities, including,
to the extent applicable:
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the name or names of the underwriters or agents, if any;
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the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale;
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any over-allotment or other options under which underwriters may purchase additional securities from us;
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any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation;
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any public offering price;
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any discounts or concessions allowed or reallowed or paid to dealers; and
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any securities exchange or market on which the securities may be listed.
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Only underwriters named in the prospectus supplement will be
underwriters of the securities offered by the prospectus supplement.
If underwriters are used in the sale, they will acquire the
securities for their own account and may resell the securities from time to time in one or more transactions at a fixed public
offering price or at varying prices determined at the time of sale. The obligations of the underwriters to purchase the securities
will be subject to the conditions set forth in the applicable underwriting agreement. We may offer the securities to the public
through underwriting syndicates represented by managing underwriters or by underwriters without a syndicate. Subject to certain
conditions, the underwriters will be obligated to purchase all of the securities offered by the prospectus supplement, other than
securities covered by any over-allotment or other option. Any public offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may use underwriters with whom we have a material relationship. We
will describe in the prospectus supplement, naming the underwriter, the nature of any such relationship.
We may sell securities directly or through agents we designate
from time to time. We will name any agent involved in the offering and sale of securities and we will describe any commissions
we will pay the agent in the prospectus supplement. Unless the prospectus supplement states otherwise, our agent will act on a
best-efforts basis for the period of its appointment.
We may authorize agents or underwriters to solicit offers by
certain types of institutional investors to purchase securities from us at the public offering price set forth in the prospectus
supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future. We will
describe the conditions to these contracts and the commissions we must pay for solicitation of these contracts in the prospectus
supplement.
We may provide agents and underwriters with indemnification
against civil liabilities, including liabilities under the Securities Act, or contribution with respect to payments that the agents
or underwriters may make with respect to these liabilities. Agents and underwriters may engage in transactions with, or perform
services for, us in the ordinary course of business.
All securities we may offer, other than common stock, will be
new issues of securities with no established trading market. Any underwriters may make a market in these securities, but will not
be obligated to do so and may discontinue any market making at any time without notice. We cannot guarantee the liquidity of the
trading markets for any securities.
Any underwriter may engage in over-allotment, stabilizing transactions,
short-covering transactions and penalty bids in accordance with Regulation M under the Exchange Act. Over-allotment involves sales
in excess of the offering size, which create a short position. Stabilizing transactions permit bids to purchase the underlying
security so long as the stabilizing bids do not exceed a specified maximum price. Syndicate-covering or other short-covering transactions
involve purchases of the securities, either through exercise of the over-allotment option or in the open market after the distribution
is completed, to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when
the securities originally sold by the dealer are purchased in a stabilizing or covering transaction to cover short positions. Those
activities may cause the price of the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue
any of the activities at any time.
Any underwriters or agents that are qualified market makers
on The Nasdaq Capital Market may engage in passive market making transactions in the common stock on The Nasdaq Capital Market
in accordance with Regulation M under the Exchange Act, during the business day prior to the pricing of the offering, before the
commencement of offers or sales of the common stock. Passive market makers must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market maker must display its bid at a price not in excess
of the highest independent bid for such security; if all independent bids are lowered below the passive market maker’s bid,
however, the passive market maker’s bid must then be lowered when certain purchase limits are exceeded. Passive market making
may stabilize the market price of the securities at a level above that which might otherwise prevail in the open market and, if
commenced, may be discontinued at any time.
In compliance with guidelines of the Financial Industry Regulatory
Authority, or FINRA, the maximum consideration or discount to be received by any FINRA member or independent broker dealer may
not exceed 8% of the aggregate amount of the securities offered pursuant to this prospectus and any applicable prospectus supplement.
LEGAL MATTERS
Unless otherwise indicated in the applicable prospectus supplement,
the validity of the securities offered by this prospectus and any supplement thereto, will be passed upon for us by Cooley LLP.
Additional legal matters may be passed upon for us or any underwriters, dealers or agents, by counsel that we will name in the
applicable prospectus supplement.
EXPERTS
The consolidated
financial statements of Outlook Therapeutics, Inc. as of September 30, 2018 and 2017, and for the years then ended, have been incorporated
by reference in this prospectus in reliance upon the report of KPMG LLP, independent registered public accounting firm, incorporated
by reference herein, and upon the authority of said firm as experts in accounting and auditing. The audit report covering the September
30, 2018 consolidated financial statements contains an explanatory paragraph that states that the Company has incurred recurring
losses and negative cash flows from operations and has an accumulated deficit at September 30, 2018 of $216.3 million,
$13.5 million of senior secured notes that may become due in fiscal 2019 and $4.6 million of unsecured indebtedness, $1.0 million
of which is due on demand, and $3.6 million of which matures December 22, 2018, that raise substantial doubt about the Company’s
ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result
from the outcome of that uncertainty.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement we filed
with the SEC. This prospectus does not contain all of the information set forth in the registration statement and the exhibits
to the registration statement. For further information with respect to us and the securities we are offering under this prospectus,
we refer you to the registration statement and the exhibits and schedules filed as a part of the registration statement. You should
rely only on information contained in this prospectus or incorporated by reference into this prospectus. We have not authorized
any person to provide you with different information. We are not making an offer of these securities in any state where the offer
is not permitted. You should not assume that the information in this prospectus is accurate as of any date other than the date
on the front page of this prospectus, regardless of the time of delivery of this prospectus or any sale of the securities offered
by this prospectus.
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. Our SEC filings are available to the public at the SEC’s website at
http://www.sec.gov
.
We maintain a website at
http://www.outlooktherapeutics.com
.
Information contained in or accessible through our website does not constitute a part of this prospectus.
INCORPORATION OF CERTAIN INFORMATION
BY REFERENCE
The SEC allows us to incorporate by reference the information
we file with it, which means that we can disclose important information to you by referring you to another document that we have
filed separately with the SEC. You should read the information incorporated by reference because it is an important part of this
prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the SEC prior to
the date of this prospectus, while information that we file later with the SEC will automatically update and supersede the information
in this prospectus. We incorporate by reference into this prospectus and the registration statement of which this prospectus is
a part the information and documents listed below that we have filed with the SEC (Commission File No. 001-37759):
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·
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our Annual Report on
Form 10-K
for the fiscal year ended September 30,
2018, filed with the SEC on December 18, 2018;
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·
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our Quarterly Reports on Form 10-Q for the quarters ended
December 31, 2018
and
March 31, 2019
, filed with the SEC on February 14, 2019 and May 15, 2019, respectively;
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·
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our Current Reports on Form 8-K, filed with the SEC on
October 26, 2018
,
October 30, 2018
,
November 9, 2018
,
December 6, 2018
,
December 18, 2018
,
January 22, 2019
,
March 5, 2019
,
March 18, 2019
,
April 5, 2019
and
April 26, 2019
, to the extent the information in such reports is filed and
not furnished; and
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·
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the description of our common stock set forth in our registration
statement on Form 8-A, filed with the SEC on
April 29, 2016
, as amended on
May 11, 2016
, including any further amendments
thereto or reports filed for the purposes of updating this description.
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We also incorporate by reference any future filings (other than
Current Reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to
such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act, including those made after the date of the initial filing of the registration statement of which
this prospectus is a part and prior to effectiveness of such registration statement, until we file a post-effective amendment that
indicates the termination of the offering of the common stock made by this prospectus and will become a part of this prospectus
from the date that such documents are filed with the SEC. Information in such future filings updates and supplements the information
provided in this prospectus. Any statements in any such future filings will automatically be deemed to modify and supersede any
information in any document we previously filed with the SEC that is incorporated or deemed to be incorporated herein by reference
to the extent that statements in the later filed document modify or replace such earlier statements.
We will furnish without charge to each person, including any
beneficial owner, to whom a prospectus is delivered, upon written or oral request, a copy of any or all of the documents incorporated
by reference into this prospectus but not delivered with the prospectus, including exhibits that are specifically incorporated
by reference into such documents. You should direct any requests for documents to Outlook Therapeutics, Inc., Attention: Corporate
Secretary, 7 Clarke Drive, Cranbury, New Jersey 08512. Our phone number is (609) 619-3990. You may also view the documents that
we file with the SEC and incorporate by reference in this prospectus on our corporate website at www.outlooktherapeutics.com. The
information on our website is not incorporated by reference and is not a part of this prospectus.
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth an estimate of the fees and expenses,
other than the underwriting discounts and commissions, payable by the registrant in connection with the issuance and distribution
of the securities being registered. All amounts are estimated except for the SEC registration filing fee.
SEC Registration Fee
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$
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12,120
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FINRA Filing Fee (if applicable)
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*
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Legal Fees and Expenses
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*
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Nasdaq Capital Market Listing Fees
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*
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Accounting Fees
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*
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Printing and Miscellaneous Fees
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*
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Total
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$
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*
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*
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These fees are calculated based on the securities offered
and the number of issuances and, accordingly, cannot be estimated at this time.
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Item 15. Indemnification of Directors and Officers.
Section 145 of the Delaware General Corporation Law authorizes
a court to award, or a corporation’s board of directors to grant, indemnity to directors and officers in terms sufficiently
broad to permit such indemnification under certain circumstances for liabilities, including reimbursement for expenses incurred,
arising under the Securities Act of 1933, as amended. Our amended and restated certificate of incorporation provides for indemnification
of our directors, officers, employees and other agents to the maximum extent permitted by the Delaware General Corporation Law,
and our amended and restated bylaws provide for indemnification of our directors, officers, employees and other agents to the maximum
extent permitted by the Delaware General Corporation Law.
We have entered into indemnification agreements with our directors
and executive officers, whereby we have agreed to indemnify our directors and executive officers to the fullest extent permitted
by law, including indemnification against expenses and liabilities incurred in legal proceedings to which the director or executive
officer was, or is threatened to be made, a party by reason of the fact that such director or executive officer is or was our director,
officer, employee or agent, provided that such director or executive officer acted in good faith and in a manner that the director
or executive officer reasonably believed to be in, or not opposed to, the our best interest. At present, there is no pending litigation
or proceeding involving any of our directors or executive officers regarding which indemnification is sought, nor are we aware
of any threatened litigation that may result in claims for indemnification.
We maintain insurance policies that indemnify our directors
and officers against various liabilities arising under the Securities Act of 1933, as amended, or the Securities Act, and the Securities
Exchange Act of 1934, as amended, that might be incurred by any director or officer in his or her capacity as such.
Item 16. Exhibits.
* To be filed by amendment
or as an exhibit to a Current Report on Form 8-K and incorporated herein by reference, if applicable.
** To be filed separately
under electronic form type 305B2, if applicable.
+ Filed herewith.
Item 17. Undertakings
The undersigned registrant hereby undertakes:
(a) 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(a)(i), (ii) and (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 the registration statement, or is contained in a form of prospectus filed pursuant
to Rule 424(b) that is part of the registration statement.
(b) 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.
(c) 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.
(d) That, for the purpose of determining liability under the
Securities Act of 1933 to any purchaser:
(i) 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
(ii) 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.
(e) 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.
(f) That, for the purpose of determining liability of the registrant
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.
(g) To file an application for the purpose of determining the
eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and
regulations prescribed by the Commission under Section 305(b)(2) of the Trust Indenture Act.
(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 Securities Act and will be governed by the final adjudication of such issue.
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 Cranbury, New Jersey, on June 3, 2019.
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OUTLOOK THERAPEUTICS, INC.
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By:
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/s/ Lawrence A. Kenyon
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Lawrence A. Kenyon
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President, Chief Executive Officer and Chief Financial Officer
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POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Lawrence A. Kenyon and Ralph H. Thurman, his true and lawful agent, proxy and attorney-in-fact,
each acting alone, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all
capacities, to (i) act on, sign, and file with the SEC any and all amendments (including post-effective amendments) to this registration
statement together with all schedules and exhibits thereto, (ii) act on, sign and file such certificates, instruments, agreements
and other documents as may be necessary or appropriate in connection therewith, (iii) act on and file any supplement to any prospectus
included in this registration statement or any such amendment or any subsequent registration statement filed pursuant to Rule 462(b)
under the Securities Act, and (iv) take any and all actions that may be necessary or appropriate to be done, as fully for all intents
and purposes as he might or could do in person, hereby approving, ratifying and confirming all that such agent, proxy and attorney-in-fact
or any of his substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Act, this Registration
Statement has been signed by the following persons in the capacities and on the dates indicated:
Signature
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Title
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Date
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/s/ Ralph H. Thurman
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Ralph H. Thurman
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Executive Chairman
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June 3, 2019
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/s/ Lawrence A. Kenyon
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Lawrence A. Kenyon
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President, Chief Executive Officer, Chief Financial Officer, Treasurer, Secretary and Director (
Principal Executive, Financial and Accounting Officer)
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June 3, 2019
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/s/ Yezan Haddadin
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Yezan Haddadin
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Director
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June 3, 2019
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/s/ Kurt J. Hilzinger
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Kurt J. Hilzinger
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Director
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June 3, 2019
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/s/ Pankaj Mohan
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Pankaj Mohan, Ph.D.
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Director
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June 3, 2019
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/s/ Faisal G. Sukhtian
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Faisal G. Sukhtian
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Director
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June 3, 2019
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/s/ Joe Thomas
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Joe Thomas
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Director
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June 3, 2019
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/s/ Joerg Windisch
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Joerg Windisch, Ph.D.
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Director
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June 3, 2019
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