AS FILED WITH THE UNITED STATES SECURITIES
AND EXCHANGE COMMISSION ON NOVEMBER 14, 2018
File No. 333 -
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES
ACT OF 1933
CASI PHARMACEUTICALS,
INC.
(Exact name of registrant as specified in
its charter)
DELAWARE
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(State or other jurisdiction of
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58-1959440
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incorporation or organization)
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(IRS Employer Identification No.)
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9620 Medical Center Drive, Suite 300
Rockville, Maryland 20850
(240) 864-2600
(Address, including zip code, and telephone
number, including area
code, of registrant’s principal executive
offices)
Cynthia W. Hu
COO, General Counsel and Secretary
CASI PHARMACEUTICALS, INC.
9620 Medical Center Drive, Suite 300
Rockville, Maryland 20850
(240) 864-2600
(Name, address, including zip code, and
telephone number,
including area code, of agent for service)
Copy to:
Richard E. Baltz
Arnold & Porter
601 Massachusetts Avenue, N.W.
Washington, D.C. 20001
(202) 942-5000
Approximate date of
commencement of proposed sale to the public: From time to time after the effective date of this Registration Statement, as determined
by the selling stockholders.
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 of 1933, check the following box
and list the Securities Act registration statement number of the earlier effective registration statement for the same offering:
¨
If
this form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.
¨
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following
box.
¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
¨
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Accelerated
filer
¨
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Non-accelerated filer
x
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Smaller reporting company
x
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Emerging growth company
¨
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If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act.
¨
CALCULATION OF REGISTRATION FEE
Title of each class
of securities to be registered
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Amount to be
registered (1)
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Proposed
maximum
offering
price per
share (2)
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Proposed
maximum
aggregate
offering price (2)
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Amount of
registration
fee
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Common Stock, par value $0.01 per share
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9,095,143
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$
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3.27
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$
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29,741,117.61
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$
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3,604.62
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(1)
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Pursuant
to Rule 416 under the Securities Act of 1933, as amended, this registration statement shall be deemed to cover any additional
securities issuable pursuant to stock splits, stock dividends and similar transactions.
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(2)
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Estimated
solely for purposes of calculating the registration fee pursuant to Rule 457(c) of the Securities Act of 1933, as amended, based
upon the average of the high and low sale prices of the Registrant’s common stock as reported on the Nasdaq Capital Market
on November 12, 2018.
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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 which specifically states that this Registration Statement shall thereafter become effective in accordance
with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such
date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. The selling stockholders named in this prospectus may not sell
these securities until the Registration Statement filed with the Securities and Exchange Commission is effective. This prospectus
is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer
or sale is not permitted.
PROSPECTUS
Subject to Completion
Preliminary Prospectus Dated
November 14, 2018
Up to 9,095,143 shares of our Common Stock
This prospectus relates to up to 9,095,143
shares of our common stock that may be offered for sale by the selling stockholders named in this prospectus under “Selling
Stockholders.” The shares consist of 6,996,266 outstanding shares of common stock and 2,098,877 shares of common stock issuable
upon the exercise of outstanding warrants held by the selling stockholders. We will not receive any of the proceeds from the sale
of the shares.
The selling stockholders or their pledgees,
assignees or successors-in-interest may offer and sell or otherwise dispose of the shares of common stock described in this prospectus
from time to time through public or private transactions at prevailing market prices, at prices related to prevailing market prices
or at privately negotiated prices. The selling stockholders will bear all commissions and discounts, if any, attributable to the
sales of sales. We will bear all other costs, expenses and fees in connection with the registration of the shares. See “Plan
of Distribution” for more information about how the selling stockholders may sell or dispose of their shares of common stock.
Our common stock is
listed on the Nasdaq Capital Market and traded under the symbol “CASI.” On November 13, 2018, the last reported sale
price of our common stock on the NASDAQ Capital Market was $3.30 per share.
Investing in our common stock involves
a high degree of risk. You should review carefully the risk and uncertainties described under the heading “Risk Factors”
beginning on page 4 of this prospectus, any applicable prospectus supplement or free writing prospectus, and under similar headings
in the documents that are incorporated by references into this prospectus.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of
this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is _______________
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
You should rely only on the information
provided in this prospectus, including the information incorporated by reference. We have not authorized anyone to provide you
with different information. You should not assume that the information in this prospectus, or any supplement to this prospectus,
is accurate at any date other than the date indicated on the cover page of these documents.
Neither we nor the selling stockholders
are making an offer to sell these securities in any jurisdiction where such offer or sale is not permitted. Furthermore, you should
not consider this prospectus to be an offer or solicitation relating to our common stock if the person making the offer or solicitation
is not qualified to do so or it is unlawful for you to receive such an offer or solicitation.
We have not taken any action to permit a
public offering of the shares of common stock outside the United States or to permit the possession or distribution of this prospectus
outside the United States. Persons outside the United States who come into possession of this prospectus must inform themselves
about and observe any restrictions relating to the offering of the shares of common stock and the distribution of this prospectus
outside of the United States.
This prospectus is part of a registration
statement that we filed with the Securities and Exchange Commission, under which the selling stockholders may offer from time to
time up to an aggregate of 9,095,143 shares of our common stock in one or more offerings. If required, each time a selling stockholder
offers common stock, in addition to this prospectus, we will provide you with a prospectus supplement that will contain 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 that offering. We may also use a prospectus supplement and any related free writing
prospectus to add, update or change any of the information contained in this prospectus or in documents we have incorporated by
reference. This prospectus, together with any applicable prospectus supplements, any related free writing prospectuses and the
documents incorporated by reference into this prospectus, includes all material information relating to this offering. To the extent
that any statement that we make in a prospectus supplement is inconsistent with statements made in this prospectus, the statements
made in this prospectus will be deemed modified or superseded by those made in a prospectus supplement. Please carefully read both
this prospectus and any prospectus supplement together with the additional information described below under “Incorporated
of Certain Documents by Reference.”
SUMMARY
This summary highlights selected information
contained elsewhere in or incorporated by reference in this prospectus 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, any applicable prospectus supplement
and any related free writing prospectus, including the risks of investing in our common stock discussed under the heading “Risk
Factors” contained in this prospectus, any 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 the exhibits to the
registration statement of which this prospectus forms a part.
CASI Pharmaceuticals, Inc.
We are a U.S. based biopharmaceutical company
dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to
patients in the U.S., China and throughout the world. We intend to execute our plan to become a leading pharmaceutical company
with a substantial market share in China. We are headquartered in Rockville, Maryland and have a wholly owned subsidiary and R&D
operations in Beijing, China.
Our product pipeline features the following:
(1) EVOMELA®, MARQIBO®, and ZEVALIN®, all U.S. FDA approved drugs in-licensed from Spectrum Pharmaceuticals, Inc.
for China regional rights, and currently in various stages in the regulatory process for market approval in China, and (2) an
acquired portfolio of 25 FDA-approved abbreviated new drug applications (“ANDAs”) and four pipeline ANDAs that are
pending FDA approval, from which we will prioritize a select subset for product registration and commercialization in China. The
Company also recently announced entering into an agreement with Laurus Labs Limited to purchase an ANDA for tenofovir disoproxil
fumarate (TDF) indicated for hepatitis B virus. In addition to these advanced products, our pipeline includes a proprietary Phase
2 drug candidate, ENMD-2076, that the Company has determined not to pursue as a single agent and is exploring feasibility of combination
as a clinical strategy, and also CASI-001 and CASI-002, proprietary early-stage candidates in immuno-oncology in preclinical development.
We believe our pipeline reflects a risk-balanced approach between products in various stages of development, and between products
that we develop ourselves and those that we develop with our partners for the China regional market. We intend to continue building
a significant product pipeline of high quality, cost-effective pharmaceuticals, as well as innovative drug candidates that we
will commercialize alone in China and with partners for the rest of the world. For in-licensed products, the Company uses a market-oriented
approach to identify pharmaceutical candidates that it believes have the potential for gaining widespread market acceptance, either
globally or in China, and for which development can be accelerated under the Company’s drug development strategy. For our
FDA-approved ANDAs, we intend to select and commercialize certain products from the portfolio that offer unique market and cost-effective
manufacturing opportunities in China and/or in the U.S.
Our focus is to acquire high quality, cost-effective
medicines, as well as to in-license clinical-stage and late-stage drug candidates so that we can immediately employ our U.S. and
China drug development model to accelerate commercialization, and clinical and regulatory progress. In addition to our high quality,
cost-effective medicines, and our clinical-and late-stage approach for innovative products, we have other potential drug candidates
in preclinical development which we will continue to evaluate through 2018 and 2019. The implementation of our plans will include
leveraging our resources in both the United States and China. In order to capitalize on the drug development and capital resources
available in China, we are doing business in China through our wholly-owned China-based subsidiary that will execute the China
portion of our drug development strategy, including conducting clinical trials in China, pursuing local funding opportunities and
strategic collaborations, and implementing our transition to a commercial enterprise.
Our principal offices are located at 9620
Medical Center Drive, Suite 300, Rockville, Maryland 20850, and our telephone number is (240) 864-2600. Additional information
concerning us can be found in our periodic filings with the U.S. Securities and Exchange Commission, or the SEC, which are available
on our website at http://www.casipharmaceuticals.com and on the SEC’s website at https://www.sec.gov. The information on
our website is not deemed to be part of this prospectus.
EVOMELA
®
, MARQIBO
®
and ZEVALIN
®
are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates.
The Offering
Common stock offered by selling stockholders
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9,095,143 shares
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Common stock outstanding as of November 13, 2018
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95,287,268 shares
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Use of Proceeds
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We will not receive any of the proceeds from the sale of shares under this prospectus. All of the proceeds from the sale or other disposition of the shares of common stock offered by this prospectus will be received by the selling stockholders.
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Dividend Policy
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We do not expect to declare or pay dividends for the foreseeable future.
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Risk Factors
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See “Risk Factors” and other information included or incorporated by reference in this prospectus for a discussion of certain factors that you should carefully consider before investing in our common stock.
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RISK FACTORS
An investment in our securities involves
significant risk. Before deciding whether to invest in our common stock, you should consider carefully the risks and uncertainties
discussed under the heading “Risk Factors” contained in our most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q, which are incorporated by reference in this prospectus, as the same may be updated from time to time by our
future filings under the Securities Exchange Act of 1934, as amended, or the Exchange Act. For more information, see the section
entitled “Incorporation of Certain Documents by Reference.” Prospective investors should review all of these risk factors
before making an investment decision. If any of these risks or uncertainties actually occurs, our business, financial condition
or results of operations could be materially adversely affected. Additional risks and uncertainties of which we are unaware or
that we currently believe are immaterial could also materially adversely affect our business, financial condition or results of
operations. In any case, the trading price of our common stock could decline, and you could lose all or part of your investment.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus contains and incorporates
certain 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 Exchange Act. Forward-looking statements also may be included in other statements that we make. All
statements that are not descriptions of historical facts are forward-looking statements. These statements can generally be identified
by the use of forward-looking terminology such as “believes,” “expects,” “intends,” “may,”
“will,” “should,” or “anticipates” or similar terminology. These forward-looking statements
include, among others, statements regarding our strategy of manufacturing and commercializing drugs in China and elsewhere, the
timing of our clinical trials, our cash position and future expenses, and our future revenues.
Our forward-looking statements are based
on information available to us today, and we will not update these statements.
Actual results could differ materially from
those currently anticipated due to a number of factors, including: risks relating to interests of our largest stockholders that
differ from our other stockholders; the difficulty of executing our business strategy in China; the risk that we will not be able
to effectively select, register and commercialize products from our recently acquired portfolio of abbreviated new drug applications
(ANDAs); our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical
or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing,
safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product
candidates will be approved for marketing by the China Food and Drug Administration authorities; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future
candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty
of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage
products under development; risk that results in preclinical and early clinical models are not necessarily indicative of later
clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials;
the lack of success in the clinical development of any of our products; and our dependence on third parties. Such factors, among
others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers
not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about
the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings
with the SEC, which are available at www.sec.gov.
USE OF PROCEEDS
We will not receive any proceeds from the
sale of the shares of our common stock by the selling stockholders. We may, however, receive cash proceeds equal to up to the total
exercise price of the warrants to the extent that the warrants are exercised for cash. The exercise price of the warrants is $7.19
per share of common stock. The exercise price and the number of shares of common stock issuable upon exercise of the warrants may
be adjusted in certain circumstances, including stock splits, dividends or distributions, or other similar transactions. However,
the warrants contain a “cashless exercise” feature that allows the holders to exercise the warrants without making
a cash payment to us in the event that there is no registration statement registering the warrant shares for resale. There can
be no assurance that any of these warrants will be exercised by the selling stockholders at all or that the warrants will be exercised
for cash rather than pursuant to the “cashless exercise” feature. To the extent we receive proceeds from the cash exercise
of the warrants, we intend to use such proceeds to provide capital support or for general corporate purposes, which may include,
without limitation, supporting asset growth and engaging in acquisitions or other business combinations. We do not have any specific
plans for acquisitions or other business combinations at this time. Our management will retain broad discretion in the allocation
of the net proceeds from the exercise of the warrants for cash.
The selling stockholders will pay any underwriting
discounts and commissions and expenses incurred by the selling stockholders in disposing of the shares. We will bear all other
costs, fees and expenses incurred in effecting the issuance and registration of the shares covered by this prospectus, including,
without limitation, all registration and filing fees, NASDAQ Capital Market listing fees and fees and expenses of our counsel and
our accountants.
SELLING STOCKHOLDERS
This prospectus covers an aggregate of 9,095,143
shares of our common stock, consisting of (i) 6,996,266 outstanding shares of common stock and (ii) 2,098,877 shares of common
stock issuable upon the exercise of outstanding warrants held by certain of the selling stockholders.
We are registering the shares under the
Securities Act, to give the selling stockholders the opportunity, if they so desire, to publicly sell the shares for their own
accounts in such amounts and at such times and prices as each may choose. The selling stockholders may from time to time offer
and sell pursuant to this prospectus any or all of the below listed shares of common stock owned by them. The registration of these
shares does not require that any of the shares be offered or sold by the selling stockholders. The selling stockholders may from
time to time offer and sell all or a portion of their shares through ordinary brokerage transactions on the Nasdaq Capital Market,
the principal exchange on which our common stock is listed, in the over-the-counter market or other exchanges on which our shares
are traded, in negotiated transactions or otherwise, at market prices then prevailing or related to the then current market price
or at negotiated prices.
The following table sets forth information
with respect to the number of shares of common stock beneficially owned by the selling stockholders named below and as adjusted
to give effect to the sale of the shares offered hereby. The shares beneficially owned have been determined in accordance with
rules promulgated by the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose.
The information in the table below is current
as of November 13, 2018. All information contained in the table is based upon information provided to us by the selling stockholders
and we have not independently verified this information. The selling stockholders are not making any representation that any shares
covered by the prospectus will be offered for sale.
No affiliate of any of the selling stockholders
has held any position or office with us or any of our affiliates and no selling stockholder has had any other material relationship
with us or any of our affiliates within the past three years other than as a result of its ownership of shares of equity securities.
As explained below under “Plan of
Distribution,” we have agreed with the selling stockholders to bear certain expenses (other than broker discounts and commissions,
if any) in connection with the registration statement, which includes this prospectus.
We considered the following factors and
made the following assumptions regarding the table:
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unless otherwise indicated below, to our knowledge, the selling stockholders
named below have sole voting and investment power with respect to their shares of common stock;
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·
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the “Number of Shares Beneficially Owned After Offering”
column assumes the sale of all shares offered pursuant to this registration statement; and
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·
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the “Percentage Beneficial Ownership After Offering” column
is based upon 95,287,268 shares of our common stock outstanding as of November 13, 2018.
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Notwithstanding these assumptions, the selling
stockholders may sell less than all of the shares listed on the table. In addition, the shares listed below may be sold pursuant
to this prospectus or in privately negotiated transactions. Accordingly, we cannot estimate the number of shares of common stock
that the selling stockholders will sell under this prospectus.
Selling Stockholder
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Number of Shares
Beneficially
Owned
Prior to
Offering
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Number of
Shares
Offered
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Number of
Shares
Beneficially
Owned
After Offering
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Percentage
Beneficial
Ownership
After Offering
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Lim Kok Thay
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4,850,745
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4,850,745
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-
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-
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Wealth Strategy Holding Limited (1)
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10,684,625
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2,425,372
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8,259,253
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8.5
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%
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Dapeng Li (2)
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9,364,130
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727,611
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8,636,519
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8.9
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%
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Jiayuan Xu
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511,074
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485,074
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26,000
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*
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Keren Wang
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242,537
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242,537
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-
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-
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Sizhen Wang
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331,614
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242,537
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89,077
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*
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Kevin Hong
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121,267
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121,267
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-
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-
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* Less than 1%
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(1)
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Kung Hung Ka is a Director of Wealth Strategy Holding Limited and may be deemed to have voting and/or investment power over
the shares held by Wealth Strategy Holding Limited.
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(2)
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Dapeng Li is the Chairman of Zhejiang Kanglaite Group Co., Ltd. (“ZKG”) and may be deemed to have voting and/or
investment power over 823,044 warrant shares held by ZKG.
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PLAN OF DISTRIBUTION
Each of the selling stockholders and any
of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their shares of common stock
on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These sales may be
at fixed or negotiated prices. The selling stockholders may use any one or more of the following methods when selling shares:
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·
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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·
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block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
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·
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
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·
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an exchange distribution in accordance with the rules of the applicable exchange;
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·
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privately negotiated transactions;
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·
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in the over-the-counter market;
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·
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settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;
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·
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in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities at a stipulated price per security;
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·
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through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; or
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·
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a combination of any such methods or any other method permitted pursuant to applicable law.
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The selling stockholders may, from time
to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in
the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from
time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision
of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances,
in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this
prospectus.
The selling stockholders may also sell shares
under Rule 144 under the Securities Act, if available, rather than under this prospectus.
To the extent required, this prospectus
may be amended or supplemented from time to time to describe a specific plan of distribution. In connection with distributions
of the shares or otherwise, the selling stockholder may enter into hedging transactions with broker-dealers or other financial
institutions. In connection with such transactions, broker-dealers or other financial institutions may engage in short sales of
the common stock in the course of hedging the positions they assume with the selling stockholder. The selling stockholder may also
sell the common stock short and redeliver the shares to close out such short positions. The selling stockholders may also enter
into option or other transactions with broker-dealers or other financial institutions which require the delivery to such broker-dealer
or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution
may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). The selling stockholders may also
pledge shares to a broker-dealer or other financial institution, and, upon a default, such broker-dealer or other financial institution,
may effect sales of the pledged shares pursuant to this prospectus (as supplemented or amended to reflect such transaction).
In effecting sales,
broker-dealers or agents engaged by the selling stockholders may arrange for other broker-dealers to participate. Broker-dealers
or agents may receive commissions, discounts or concessions from the selling stockholders in amounts to be negotiated immediately
prior to the sale.
In offering the shares covered by this prospectus,
the selling stockholders and any broker-dealers who execute sales for the selling stockholder may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. Any profits realized by the selling stockholders and the
compensation of any broker-dealer may be deemed to be underwriting discounts and commissions.
In order to comply with the securities laws
of certain states, if applicable, the shares must be sold in such jurisdictions only through registered or licensed brokers or
dealers. In addition, in certain states the shares may not be sold unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or qualification requirement is available.
Under applicable rules and regulations under
the Exchange Act, any person engaged in the distribution of the common stock may not simultaneously engage in market making activities
with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of
the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Exchange Act and the rules
and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of securities of the common
stock by the selling stockholders or any other person. The selling stockholders may indemnify any broker-dealer that participates
in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities
Act.
At the time a particular offer of shares
is made, if required, a prospectus supplement will be distributed that will set forth the number of shares being offered and the
terms of the offering, including the name of any underwriter, dealer or agent, the purchase price paid by any underwriter, any
discount, commission and other item constituting compensation, any discount, commission or concession allowed or reallowed or paid
to any dealer, and the proposed selling price to the public.
We are required to pay certain fees and
expenses incurred by us incident to the registration of the securities. In addition, we have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective
until the earlier of (i) the date on which the securities may be resold by the selling stockholders without registration and without
regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance
with the current public information under Rule 144 under the Securities Act or any other rule of similar effect, and (ii) such
time as the selling stockholders own no securities that are required to be registered pursuant to their respective agreements.
LEGAL MATTERS
The validity of the shares of common stock
offered hereby has been passed upon for us by Arnold & Porter Kaye Scholer LLP, Washington, D.C.
EXPERTS
CohnReznick LLP (“CohnReznick”),
independent registered public accounting firm, has audited our consolidated financial statements included in our Annual Report
on Form 10-K for the year ended December 31, 2017, as set forth in their report which is incorporated by reference in this prospectus
and elsewhere in the registration statement. Our financial statements as of and for the years ended December 31, 2017 and 2016
are incorporated by reference in reliance on CohnReznick’s report, given upon their authority as experts in accounting and
auditing.
INCORPORATION OF CERTAIN DOCUMENTS
BY REFERENCE
The SEC allows us to incorporate by reference
the information that we file with the SEC, which means that we can disclose important information to you by referring you to those
documents. The information incorporated by reference is considered to be part of this prospectus. These documents may include periodic
reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as well as Proxy
Statements. Any documents that we subsequently file with the SEC will automatically update and replace the information previously
filed with the SEC. Thus, for example, in the case of a conflict or inconsistency between information set forth in this prospectus
and information incorporated by reference into this prospectus, you should rely on the information contained in the document that
was filed later.
This prospectus incorporates by reference
the documents listed below that we previously have filed with the SEC and any additional documents that we may file with the SEC
under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act (excluding portions thereof deemed to be “furnished” to
the SEC pursuant to Item 2.02, Item 7.01 or Item 9.01 of a Current Report on Form 8-K) between the date of this prospectus and
the termination of the offering of the securities. Additionally, all such filings from the date of the initial registration statement
and prior to effectiveness of the registration statement shall be deemed to be incorporated by reference into the prospectus. These
documents contain important information about us.
|
1.
|
The
Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 29, 2018.
|
|
2.
|
The
Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2018, June 30, 2018, and September 30, 2018 filed
with the SEC on May 15, 2018, August 14, 2018, and November 14, 2018, respectively.
|
|
3.
|
The
Company’s Definitive Proxy Statement on Schedule 14A for its 2018 Annual Stockholder’s Meeting, filed with the SEC
on April 17, 2018.
|
|
4.
|
The
Company’s Current Reports on Form 8-K, filed on January 26, 2018, February 9, 2018, February 23, 2018, March 16, 2018, March
23, 2018, June 11, 2018, September 14, 2018, September 28, 2018 (as amended on October 24, 2018), October 1, 2018, and October
24, 2018.
|
|
5.
|
The
description of the Company’s common stock contained in the Company’s Registration Statement on Form 8-A filed under
the Exchange Act on May 14, 1996, including any amendment or report filed for the purpose of updating such description.
|
You can obtain a copy of any or all of the
documents incorporated by reference in this prospectus (other than an exhibit to a document unless that exhibit is specifically
incorporated by reference into that document) from the SEC on its web site at http://www.sec.gov. You also can obtain these documents
from us without charge by visiting our web site at http://www.casipharmaceuticals.com or by requesting them in writing or by telephone
at the following address:
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive, Suite 300
Rockville, Maryland 20850
(240) 864-2600
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration
statement under the Securities Act that registers the distribution of the securities offered under this prospectus. The registration
statement, including the attached exhibits and schedules and the information incorporated by reference, contains additional relevant
information about us and the securities. The rules and regulations of the SEC allow us to omit from this prospectus certain information
included in the registration statement. You can obtain a copy of the registration statement from the SEC at the address listed
below or from the SEC’s Internet site.
We file reports, proxy statements and other
documents with the SEC. You may read and copy any document we file at the SEC’s public reference room at 100 F Street, N.E.,
Washington, D.C. 20549. You should call 1-800-SEC-0330 for more information on the public reference room. Our SEC filings are also
available to you on the SEC’s Internet site at http://www.sec.gov.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. Other Expenses of Issuance
and Distribution.
The following table sets forth the estimated
costs and expenses in connection with the sale and distribution of the securities being registered, all of which will be paid by
the Company. All amounts are estimates except with respect to the SEC registration fee.
|
|
Amount
|
|
SEC Registration Fee
|
|
$
|
3,604.62
|
|
Accounting fees and expenses
|
|
$
|
3,000
|
|
Printing fees and expenses
|
|
$
|
1,000
|
|
Legal fees and expenses
|
|
$
|
10,000
|
|
Miscellaneous expenses
|
|
$
|
1,000
|
|
Total
|
|
$
|
18,604.62
|
|
ITEM 15. Indemnification of Directors
and Officers.
Section 145 of the Delaware General Corporation
Law (“DGCL”), permits, under certain circumstances, the indemnification of any person who was or is a party or is threatened
to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative
or investigative (other than an action by or in the right of the corporation) by reason of the fact that he is or was a director,
officer, employee or agent of the corporation, or is or was serving in a similar capacity for another enterprise at the request
of the corporation. To the extent that a director, officer, employee or agent of the corporation has been successful in defending
any such proceeding, the DGCL provides that he shall be indemnified against expenses (including attorneys’ fees) actually
and reasonably incurred by him in connection therewith. With respect to a proceeding by or in the right of the corporation, such
person may be indemnified against expenses (including attorneys’ fees), actually and reasonably incurred, if he acted in
good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation. The DGCL provides,
however, that indemnification shall not be permitted in such a proceeding if such person is adjudged liable to the corporation
unless, and only to the extent that, the court, upon application, determines that he is entitled to indemnification under the circumstances.
With respect to proceedings other than those brought by or in the right of the corporation, notwithstanding the outcome of such
a proceeding, such person may be indemnified against judgments, fines and amounts paid in settlement, as well as expenses, if he
acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation and,
with respect to any criminal action, had no reason to believe his conduct was unlawful. Except with respect to mandatory indemnification
of expenses to successful defendants as described in the preceding paragraph or pursuant to a court order, the indemnification
described in this paragraph may be made only upon a determination in each specific case (1) by majority vote of the directors that
are not parties to the proceeding, even though less than a quorum, or (2) by a committee of the directors that are not a party
to the proceeding who have been appointed by a majority vote of directors who are not a party to the proceeding, even though less
than a quorum, or (3) if there are no such directors, or if such directors so direct, by independent legal counsel in a written
opinion, or (4) by the stockholders.
The DGCL permits a corporation to advance
expenses incurred by a proposed indemnitee in advance of final disposition of the proceeding, provided that the indemnitee undertakes
to repay such advanced expenses if it is ultimately determined that he is not entitled to indemnification. Also, a corporation
may purchase insurance on behalf of an indemnitee against any liability asserted against him in his designated capacity, whether
or not the corporation itself would be empowered to indemnify him against such liability. The Company has adopted provisions in
its Amended and Restated Certificate of Incorporation that provide for indemnification of its officers and directors to the maximum
extent permitted under the DGCL. As authorized by the DGCL, the Company’s Amended and Restated Certificate of Incorporation
limits the liability of directors of the Company for monetary damages. The effect of this provision is to eliminate the rights
of the Company and its stockholders to recover monetary damages against a director for breach of the fiduciary duty of care as
a director except in certain limited situations. This provision does not limit or eliminate the rights of the Company or any stockholder
to seek non-monetary relief such as an injunction or rescission in the event of a breach of a director’s duty of care. This
provision will not alter the liability of directors under federal securities laws. The Company has purchased an insurance policy
that purports to insure the officers and directors of the Company against certain liabilities incurred by them in the discharge
of their functions as such officers and directors. The foregoing descriptions are only general summaries. For additional information
we refer you to the full text of our Amended and Restated Certificate of Incorporation, filed as an exhibit to our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006, and our Certificates of Amendment to Amended and Restated Certificate of Incorporation,
filed as exhibits to our Current Reports on Form 8-K filed on July 7, 2010 and September 20, 2012, and our Amended and Restated
By-laws, filed as an exhibit to our Current Report on Form 8-K filed on December 12, 2007 with the SEC.
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons pursuant to the foregoing provisions,
or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in
the Securities Act and is, therefore, unenforceable.
ITEM 16. Exhibits.
The exhibits listed on the Index to Exhibits
of this Registration Statement are filed herewith or are incorporated herein by reference to other filings.
ITEM 17. Undertakings.
|
A.
|
The undersigned Registrant hereby undertakes:
|
|
(1)
|
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
|
(i)
|
To
include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set
forth in the registration statement;
|
|
(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:
|
(A)
|
Paragraphs
(a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the registration statement is on Form S-3 or Form F-3 and
the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or
furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that
are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b)
that is part of the registration statement.
|
|
(2)
|
That,
for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.
|
|
(3)
|
To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at
the termination of the offering.
|
|
(4)
|
That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
|
(i)
|
If
the registrant is relying on Rule 430B:
|
|
(A)
|
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
|
|
(B)
|
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
Provided, however
, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date; or
|
|
(ii)
|
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating
to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A,
shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness.
Provided, however
, that no statement made in a registration statement or prospectus that is part of the registration statement
or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part
of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify
any statement that was made in the registration statement or prospectus that was part of the registration statement or made in
any such document immediately prior to such date of first use.
|
|
(5)
|
That, for the purpose of determining liability of the
registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned Registrant
undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser
by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered
to offer or sell such securities to such purchaser: (i) Any preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule 424; (ii) any free writing prospectus relating to the offering
prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; (iii) the portion
of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and (iv) any other communication that is an offer in
the offering made by the undersigned registrant to the purchaser.
|
|
B.
|
The undersigned Registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act, 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.
|
|
C.
|
Insofar as indemnification for liabilities arising under
the Securities Act 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, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all
the requirements for filings on Form S-3 and has duly caused this Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized.
|
CASI PHARMACEUTICALS, INC.
|
|
|
|
Dated: November 14, 2018
|
|
|
|
By:
|
/s/ Cynthia W. Hu
|
|
|
Cynthia W. Hu
|
|
|
COO, General Counsel & Secretary
|
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that
the persons whose signatures appear below constitute and appoint Ken K. Ren, Cynthia W. Hu and George Chi as their true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution, for them and in their names, places and steads,
in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement,
and to sign any subsequent registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and
any and all amendments thereto, and to file the same, with all exhibits thereto, and the other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agent full power and authority to do and
perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes
as they might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or their substitutes,
may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities
Act of 1933, this Registration Statement has been signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Ken
K. Ren
Ken K. Ren
|
|
Chief Executive Officer and Director
(Principal Executive Officer)
|
|
November 14, 2018
|
|
|
Chief Financial Officer
(Principal
Financial Officer and Principal Accounting Officer)
|
|
November 14, 2018
|
/s/ George
Chi
George Chi
|
|
|
|
|
|
|
|
/s/ Wei
Wu He
Wei-Wu He
|
|
Executive Chairman
|
|
November 14, 2018
|
|
|
|
|
|
/s/ James
Z. Huang
James Z. Huang
|
|
Director
|
|
November 14, 2018
|
|
|
|
|
|
/s/ Quan
Zhou
Quan Zhou
|
|
Director
|
|
November 14, 2018
|
|
|
|
|
|
/s/ Franklin
C. Salisbury, Jr.
Franklin C. Salisbury, Jr.
|
|
Director
|
|
November 14, 2018
|
|
|
|
|
|
/s/ Rajesh
C. Shrotriya
|
|
Director
|
|
November 14, 2018
|
Rajesh C. Shrotriya
|
|
|
|
|
|
|
/s/ Y.
Alexander Wu
|
|
Director
|
|
November 14, 2018
|
Y. Alexander Wu
|
|
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