As filed with the United States Securities
and Exchange Commission on December 13, 2017
Registration No. 333
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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)
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DELAWARE
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58-1959440
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(State or other jurisdiction of
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(IRS Employer
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incorporation or organization)
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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)
Copies to:
Richard E. Baltz
Arnold & Porter Kaye Scholer LLP
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.
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 class
of securities pursuant to Rule 413(b) under the Securities Act, check the following box.
¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2
of the Exchange Act.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
x
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(Do not check if a smaller reporting company)
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Emerging growth company
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If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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CALCULATION OF REGISTRATION FEE
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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
Share
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Proposed Maximum Aggregate
Offering Price
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Amount of
Registration Fee
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Common Stock
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(1
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)
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(2
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)
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(2
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)
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N/A
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Warrants to Purchase Common Stock
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(1
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)
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(2
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)
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(2
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)
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N/A
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Units
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(1
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)
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(2
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)
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(2
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)
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N/A
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Total for sale by Registrant
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(1
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)
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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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12,450
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(3)
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(1)
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There are being registered hereunder such indeterminate
number of shares of securities as may be sold by the Registrant from time to time, which shall have an aggregate initial offering
price not to exceed $100,000,000 (the “Shelf Securities”). Any Shelf Securities registered hereunder may be sold separately
or in combination with other Shelf Securities registered hereunder. The proposed maximum offering price of the Shelf Securities
will be determined, from time to time, by the Registrant in connection with the issuance by the Registrant of the Shelf Securities
registered hereunder. The securities registered hereunder also include such indeterminate number of shares of common stock as
may be issued upon exercise of warrants or pursuant to the anti-dilution provisions of any of such securities. In addition, pursuant
to Rule 416 under the Securities Act of 1933, as amended (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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(2)
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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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(3)
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Calculated pursuant to Rule
457(o) under the Securities Act.
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The registrant hereby amends this registration
statement (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 or until the 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 any of the securities described in this prospectus until the registration statement
that we have filed with the Securities and Exchange Commission to cover the securities is effective. This prospectus is not an
offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale
is not permitted.
SUBJECT TO COMPLETION, DATED
December 13, 2017
PROSPECTUS
CASI PHARMACEUTICALS, INC.
$100,000,000
Common Stock
Warrants to Purchase Common Stock
Units
We may offer and sell from time to time shares
of common stock or warrants to purchase shares of common stock either individually or in units. We may also offer common stock
upon exercise of warrants. We may sell any combination of the above described securities, either individually or in units, in one
or more offerings in amounts, at prices and on terms determined at the time of the offering. We refer to the shares of common stock,
warrants to purchase shares of common stock and units collectively as the “securities.”
This prospectus provides you with a general description
of the securities that we may offer. This prospectus may not be used to consummate sales of securities unless accompanied by a
prospectus supplement. Each time we sell securities, we will provide a prospectus supplement that will contain specific information
about the terms of that offering. The prospectus supplement may also add information or update information contained in this prospectus.
You should read both this prospectus and any prospectus supplement together with the documents incorporated by reference and described
under the heading “Where You Can Find More Information” before you make your investment decision.
An investment in the securities offered under
this prospectus involves a high degree of risk. You should carefully consider the risk factors described in the applicable prospectus
supplement and certain of our filings with the Securities and Exchange Commission, as described under “Risk Factors”
on page 4.
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
TABLE OF CONTENTS
About This Prospectus
This prospectus is part of a “shelf”
registration statement we filed with the Securities and Exchange Commission, or the SEC. By using a shelf registration statement,
we may offer to sell any one or more or a combination of the securities described in this prospectus from time to time for an aggregate
offering price of up to $100,000,000.
You should rely only on the information contained
in or specifically incorporated by reference into this prospectus or a prospectus supplement. No dealer, sales person, agent or
other individual has been authorized to give any information or to make any representations not contained in this prospectus. If
given or made, such information or representations must not be relied upon as having been authorized by us.
This prospectus does not constitute an offer
to sell, or a solicitation of an offer to buy, the securities offered hereby in any jurisdiction where, or to any person to whom,
it is unlawful to make such offer or solicitation.
We may sell securities to underwriters who will
sell the securities to the public on terms fixed at the time of sale. In addition, the securities may be sold by us directly or
through dealers or agents designated from time to time. If we, directly or through agents, solicit offers to purchase the securities,
we reserve the sole right to accept and, together with any agents, to reject, in whole or in part, any of those offers.
Any prospectus supplement will contain the names
of the underwriters, dealers or agents, if any, together with the terms of offering, the compensation of those underwriters and
the net proceeds to us. Any underwriters, dealers or agents participating in the offering may be deemed “underwriters”
within the meaning of the Securities Act of 1933, as amended, or the Securities Act.
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.
The information contained in this prospectus
is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of securities.
Neither the delivery of this prospectus nor any sale made hereunder shall, under any circumstances, create an implication that
there has not been any change in the facts set forth in this prospectus or in our affairs since the date of this prospectus.
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 and Section 21E of the Securities Exchange Act
of 1934, as amended, or 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 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: the risk that we may be unable to continue as a going concern as a result of our inability
to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital
Market; the volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ
from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances; the difficulty
of executing our business strategy in China; 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; 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; the 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; dependence on
third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory,
patent, product liability, supply, competition and other risks). 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 U.S. Securities and Exchange Commission, or
the SEC, which are available at www.sec.gov.
About CASI Pharmaceuticals, Inc.
We are a U.S. based, late-stage biopharmaceutical
company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet
medical needs for the global market, with a focus on commercialization in China. We intend to execute our plan to become a leading
fully-integrated pharmaceutical company with a substantial commercial business in China. We are headquartered in Rockville, Maryland
with established China operations that are growing as we continue to further in-license products for our pipeline.
Our product pipeline features (1) EVOMELA®,
MARQIBO® and ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals,
Inc. for China regional rights, and currently in various stages in the regulatory and clinical process for market approval in China,
(2) CASI-001 and CASI-002, proprietary preclinical candidates in immune-oncology, and (3) our proprietary drug candidate, ENMD-2076,
ongoing in one Phase 2 clinical study.
Our China rights to EVOMELA® (melphalan)
for Injection, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and ZEVALIN® (ibritumomab tiuxetan) were previously licensed
from its our partner Spectrum Pharmaceuticals, Inc. Based on the U.S. FDA’s approval of these three licensed products, we
are pursuing the Import Drug registration path for approval in China.
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 innovative drug
candidates that we will commercialize in China and collaborate with partners for the rest of the world. For in-licensed products,
the Company uses a market-oriented approach to identify pharmaceutical candidates that we believe 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 ENMD-2076, our current development is focused on niche and orphan indications.
Our primary research and development focus is
on oncology therapeutics. Our strategy is to develop innovative drugs that are potential first-in-class or market-leading compounds
for treatment of cancer. 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, the Company is conducting business in
China through its wholly-owned China-based subsidiary that will execute the China portion of the Company’s drug development
strategy, including conducting clinical trials in China, pursuing local funding opportunities and strategic collaborations, and
implementing the Company’s plan to build a leading commercial business in China.
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 SEC, which are available on our website at http://www.casipharmaceuticals.com
and on the SEC’s website at www.sec.gov. The information on our website is not deemed to be part of this prospectus.
Risk Factors
An investment in our securities involves a high
degree of risk. Before you decide whether to purchase any of our securities, in addition to the other information in this prospectus
and the accompanying prospectus supplement, you should carefully consider the risk factors set forth under the heading “Risk
Factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, which are incorporated
by reference into this prospectus, as the same may be updated from time to time by our future filings under the Securities Exchange
Act of 1934. For more information, see the section entitled “Incorporation of Certain Documents by Reference.” The
risks and uncertainties we have described are not the only ones facing our company. Additional risks and uncertainties not presently
known to us or that we currently consider immaterial may also affect our business operations. To the extent that a particular offering
implicates additional significant risks, we will include a discussion of those risks in the applicable prospectus supplement.
Use of Proceeds
Except as may be otherwise set forth in the prospectus
supplement accompanying this prospectus, we will use the net proceeds we receive from sales of the securities offered hereby for
general corporate purposes, including support for our continuing research and development, commercialization activities, business
development activities, and, if opportunities arise, acquisitions of businesses, products, technologies or licenses that are complementary
to our business, although we have no current definitive plans, commitments or agreements with respect to any acquisitions as of
the date of this prospectus.
Plan of Distribution
We may sell the securities offered through
this prospectus in any one or more of the following ways:
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directly to investors or purchasers;
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to investors through agents;
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to or through brokers or dealers;
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to the public through underwriting syndicates led by one or more managing underwriters;
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to one or more underwriters acting alone for resale to investors or to the public;
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through a block trade in which the broker or dealer engaged to handle the block trade will attempt to sell the securities as
agent, but may position and resell a portion of the block as principal to facilitate the transaction; and
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through a combination of any such methods of sale.
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Securities may also be issued upon exercise
of warrants. We reserve the right to sell securities directly to investors on our own behalf in those jurisdictions where we are
authorized to do so.
The securities may be distributed at a fixed
price or prices, which may be changed; market prices prevailing at the time of sale; prices related to the prevailing market prices;
or negotiated prices.
The prospectus supplement will, where applicable:
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describe the terms of the offering;
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identify any underwriters, dealers or agents;
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identify any managing underwriter or underwriters;
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provide purchase price of the securities;
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provide the net proceeds from the sale of the securities;
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describe any delayed delivery arrangements;
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describe any underwriting discounts, commissions and other items constituting underwriters’ compensation;
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describe any initial public offering price;
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describe any discounts or concessions allowed or reallowed or paid to dealers; and
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describe any commissions paid to agents.
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Sale Through Underwriters or Dealers
If underwriters are used in the sale, the underwriters
will acquire the securities for their own account, including through underwriting, purchase, security lending or repurchase agreements
with us. The underwriters may resell the securities from time to time in one or more transactions, including negotiated transactions.
Underwriters may sell the securities in order to facilitate transactions in any of our other securities (described in this prospectus
or otherwise), including other public or private transactions and short sales. Underwriters may offer securities to the public
either through underwriting syndicates represented by one or more managing underwriters or directly by one or more firms acting
as underwriters. Unless otherwise indicated in the prospectus supplement, the obligations of the underwriters to purchase the securities
will be subject to certain conditions, and the underwriters will be obligated to purchase all the offered securities if they purchase
any of them. The underwriters may change from time to time any initial public offering price and any discounts or concessions allowed
or reallowed or paid to dealers.
If dealers are used in the sale of securities
offered through this prospectus, we will sell the securities to them as principals. They may then resell those securities to the
public at varying prices determined by the dealers at the time of resale. The prospectus supplement will include the names of the
dealers and the terms of the transaction.
Direct Sales and Sales Through Agents
We may sell the securities offered through
this prospectus. In this case, no underwriters or agents would be involved. Such securities may also be sold through agents designated
from time to time. The prospectus supplement will name any agent involved in the offer or sale of the offered securities and will
describe any commissions payable to the agent. Unless otherwise indicated in the prospectus supplement, any agent will agree to
use its reasonable best efforts to solicit purchases for the period of its appointment.
We may sell the securities directly to institutional
investors or others who may be deemed to be underwriters within the meaning of the Securities Act with respect to any sale of those
securities. The terms of any such sales will be described in the prospectus supplement.
Delayed Delivery Contracts
If the prospectus supplement indicates, we
may authorize agents, underwriters or dealers to solicit offers from certain types of institutions to purchase securities at the
public offering price under delayed delivery contracts. These contracts would provide for payment and delivery on a specified date
in the future. Delayed delivery contracts will be subject only to those conditions set forth in each applicable prospectus supplement,
and each prospectus supplement will set forth any commissions we pay for solicitation of these contracts.
“At the Market” Offerings
We may from time to time engage a firm to act
as our agent for one or more offerings of our securities. We sometimes refer to this agent as our “offering agent.”
If we reach agreement with an offering agent with respect to a specific offering, including the number of securities and any minimum
price below which sales may not be made, then the offering agent will try to sell such securities on the agreed terms. The offering
agent could make sales in privately negotiated transactions or any other method permitted by law, including sales deemed to be
an “at the market” offering as defined in Rule 415 promulgated under the Securities Act, including sales made
directly on the The Nasdaq Capital Market, or sales made to or through a market maker other than on an exchange. The offering agent
will be deemed to be an “underwriter” within the meaning of the Securities Act with respect to any sales effected through
an “at the market” offering.
Market Making, Stabilization and Other Transactions
Unless the applicable prospectus supplement
states otherwise, each series of offered securities will be a new issue and will have no established trading market. We may elect
to list any series of offered securities on an exchange. Any underwriters that we use in the sale of offered securities may make
a market in such securities, but may discontinue such market making at any time without notice. Therefore, we cannot assure you
that the securities will have a liquid trading market.
To the extent permitted by and in accordance
with Regulation M under the Exchange Act in connection with an offering an underwriter may engage in over-allotments, stabilizing
transactions, short covering transactions and penalty bids. Over-allotments involve sales in excess of the offering size, which
creates a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids
do not exceed a specified maximum. Short covering transactions involve purchases of the securities in the open market after the
distribution is completed to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a
dealer when the securities originally sold by the dealer are purchased in a covering transaction to cover short positions. Those
activities may cause the price of the securities to be higher than it would be otherwise. If commenced, the underwriters may discontinue
any of the activities at any time.
To the extent permitted by and in accordance
with Regulation M under the Exchange Act, any underwriters who are qualified market makers on the Nasdaq Capital Market may
engage in passive market making transactions in the securities on the Nasdaq Capital Market during the business day prior to the
pricing of an offering, before the commencement of offers or sales of the securities. 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.
Derivative Transactions and Hedging
We, the underwriters or other agents may engage
in derivative transactions involving the securities. These derivatives may consist of short sale transactions and other hedging
activities. The underwriters or agents may acquire a long or short position in the securities, hold or resell securities acquired
and purchase options or futures on the securities and other derivative instruments with returns linked to or related to changes
in the price of the securities. In order to facilitate these derivative transactions, we may enter into security lending or repurchase
agreements with the underwriters or agents. The underwriters or agents may effect the derivative transactions through sales of
the securities to the public, including short sales, or by lending the securities in order to facilitate short sale transactions
by others. The underwriters or agents may also use the securities purchased or borrowed from us or others (or, in the case of derivatives,
securities received from us in settlement of those derivatives) to directly or indirectly settle sales of the securities or close
out any related open borrowings of the securities.
General Information; Offering Limitations
Agents, underwriters, and dealers may be entitled,
under agreements entered into with us, to indemnification by us against certain liabilities, including liabilities under the Securities
Act. Our agents, underwriters, and dealers, or their affiliates, may be customers of, engage in transactions with or perform services
for us, in the ordinary course of business. No securities may be sold under this prospectus without delivery, in paper format,
in electronic format on the Internet, or both, of the applicable prospectus supplement describing the method and terms of the offering.
Dilution
We will set forth in a prospectus supplement
the following information regarding any material dilution of the equity interests of investors purchasing securities in an offering
under this prospectus:
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the net tangible book value per share of our equity securities before and after the offering;
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the amount of the increase in such net tangible book value per share attributable to the cash payments made by purchasers in
the offering; and
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the amount of the immediate dilution from the public offering price which will be absorbed by such purchasers.
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The Securities We May Offer
The descriptions of the securities contained
in this prospectus, together with the applicable prospectus supplement, summarize the material terms and provisions of the various
types of securities that we may offer. We will describe in the applicable prospectus supplement relating to any securities the
particular terms of the securities offered by that prospectus supplement. If we so indicate in a prospectus supplement, the terms
of the securities may revise, amend, modify or supersede the terms we have summarized below. We will also include in the prospectus
supplement information, where applicable, about material United States federal income tax considerations relating to the securities,
and the securities exchange or market, if any, on which the securities will be listed or quoted.
We may sell from time to time, in one or more
offerings, one or more of the following securities:
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warrants to purchase common stock; and
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units, comprised of shares of common stock and/or warrants to purchase shares of common stock.
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These securities may be offered and sold from
time to time for an aggregate offering price not to exceed $100,000,000.
Description of Common Stock
The following summary of the terms of our common
stock is subject to and qualified in its entirety by reference to our certificate of incorporation and by-laws, each as amended
to date, copies of which are on file with the SEC as exhibits to previous SEC filings. Please see “Where You Can Find More
Information” below for directions on obtaining these documents.
As of September 30, 2017, we had 170,000,000
shares of common stock authorized, of which 60,196,574 shares were outstanding. All of our outstanding common shares are fully
paid and non-assessable. Any additional common shares that we issue will be fully paid and non-assessable.
General
Holders of our common stock are entitled to
one vote per share on matters on which our stockholders vote. There are no cumulative voting rights. Holders of our common stock
are entitled to receive proportionally any dividends declared by our board of directors, out of funds that we may legally use to
pay dividends. In the event of our liquidation or dissolution, holders of our common stock are entitled to share ratably in all
assets remaining after payment of all debts and other liabilities.
Since our initial public offering in 1996,
we have not paid cash dividends on our common stock. We currently anticipate that any earnings will be retained for the continued
development of our business and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Transfer Agent and Registrar
The transfer agent and registrar for our common
stock is American Stock Transfer & Trust Company.
Nasdaq Capital Market
Our common stock is listed for quotation on
the Nasdaq Capital Market under the symbol “CASI.”
Description of Warrants
We may issue warrants to purchase shares of common
stock. The warrants may be issued independently or together with any other securities and may be attached to or separate from the
other securities. Further terms of the warrants will be set forth in the applicable prospectus supplement.
The applicable prospectus supplement will describe
the terms of the warrants in respect of which this prospectus is being delivered, including, where applicable, the following:
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the title of the warrants;
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the aggregate number of the warrants;
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the price or prices at which the warrants will be issued and the currency in which the price for the warrants may be paid;
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the designation, terms and number of shares of common stock purchasable upon exercise of such warrants;
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the designation and terms of the shares of common stock with which such warrants are issued and the number of such warrants
issued with such shares;
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·
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the date on and after which such warrants and the related common stock will be separately transferable, including any limitations
on ownership and transfer of such warrants;
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·
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provisions for changes to or adjustments in the exercise price of the warrants;
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·
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the price at which each share of common stock purchasable upon exercise of such warrants may be purchased;
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·
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the date on which the right to exercise such warrants shall commence and the date on which such right shall expire;
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·
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the minimum or maximum amount of such warrants which may be exercised at any one time;
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·
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information with respect to book-entry procedures, if any;
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·
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a discussion of certain material U.S. federal income tax consequences; and
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·
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any other terms of such warrants, including terms, procedures and limitations relating to the exchange and exercise of such
warrants.
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Description of Units
The following description, together with the
additional information we may include in any applicable prospectus supplements, summarizes the material terms and provisions of
the units that we may offer under this prospectus and any related unit agreements and unit certificates. While the terms summarized
below will apply generally to any units that we may offer, we will describe the particular terms of any series of units in more
detail in the applicable prospectus supplement. If we indicate in the prospectus supplement, the terms of any units offered under
that prospectus supplement may differ from the terms described below.
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, any form
of unit agreement that describes the terms of the series of units we are offering, and any supplemental agreements, before the
issuance of the related series of units. The following summaries of material terms and provisions of the units are subject to,
and qualified in their entirety by reference to, all the provisions of such unit agreements and any supplemental agreements applicable
to a particular series of units. We urge you to read the applicable prospectus supplements related to the particular series of
units that we may offer under this prospectus and the complete unit agreement and any supplemental agreements that contain the
terms of the units.
We may issue units comprised of shares of our
common stock and warrants to purchase common stock or any combination thereof. Each unit will be issued so that the holder
of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations
of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included
in the unit may not be held or transferred separately, at any time or at any time before a specified date.
We may evidence units by unit certificates
that we issue under a separate agreement. We may issue the units under a unit agreement between us and one or more unit agents.
If we elect to enter into a unit agreement with a unit agent, the unit agent will act solely as our agent in connection with the
units and will not assume any obligation or relationship of agency or trust for or with any registered holders of units or beneficial
owners of units. We will indicate the name and address and other information regarding the unit agent in the applicable prospectus
supplement relating to a particular series of units if we elect to use a unit agent.
We will describe in the applicable prospectus
supplement the terms of the series of units being offered, including:
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·
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the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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·
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any provisions of the governing unit agreement that differ from those described below; and
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·
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any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the
units.
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The other provisions regarding our common stock
and warrants as described in this section will apply to each unit to the extent such unit consists of shares of our common stock
and warrants to purchase our common stock.
Certain Provisions of Our Certificate of
Incorporation, Our Bylaws and Delaware Law
The following paragraphs summarize certain
provisions of the Delaware General Corporation Law and our certificate of incorporation and bylaws. The summary does not purport
to be complete and is subject to and qualified in its entirety by reference to the Delaware General Corporation Law and to our
certificate of incorporation and bylaws, copies of which are on file with the SEC.
Section 203 of the Delaware General Corporation Law
We are subject to the provisions of Section 203
of the Delaware General Corporation Law, an anti-takeover law. In general, the statute prohibits a publicly held Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years
after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved
in a prescribed manner. For purposes of Section 203, a “business combination” includes a merger, asset sale or
other transaction resulting in a financial benefit to the interested stockholder, and an “interested stockholder” is
a person who, together with affiliates and employees, owns or, within three years prior, did own 15% or more of the corporation’s
voting stock.
Staggered Board of Directors
Our board of directors is divided into
three classes, the members of each of which will serve for a staggered three-year term. Our shareholders may elect only one-third
of the directors each year; therefore, it is more difficult for a third party to gain control of our board of directors than if
our board was not staggered.
Stockholder Meetings
Our bylaws provide that a special meeting of
stockholders may be called only by the chairman of the board after the receipt of a written request of a majority of our board
of directors.
Voting Rights
Each of our outstanding common shares as of
the applicable record date is entitled to one vote in each matter submitted to a vote at a meeting of stockholders and, in all
elections for directors, every stockholder has the right to vote the number of shares owned by it for as many persons as there
are directors to be elected, provided directors are elected according to our articles of incorporation and by-laws. Our stockholders
may vote either in person or by proxy.
Requirements for Advance Notification of Stockholder Nominations
and Proposals
Our bylaws establish advance notice procedures
with respect to stockholder proposals and the nomination of candidates for election as directors, other than nominations made by
or at the direction of the board of directors or a committee of the board of directors.
Amendment of Bylaws
Any amendment of our bylaws by our stockholders
requires approval at a meeting at which a quorum is present by vote of a majority of the number of shares of stock entitled to
vote present in person or by proxy at such meeting. Our bylaws may also be amended, changed, added to or repealed by our board
of directors without the assent or vote of our stockholders.
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, 2016, 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 December 31, 2016 are incorporated by reference in
reliance on CohnReznick’s report, given on their authority as experts in accounting and auditing.
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.
In addition, we file annual, quarterly and special
reports, proxy statements and other information with the SEC. You may read and copy this information and the registration statement
at the SEC public reference room located at 100 F Street, N.E., Washington D.C. 20549. Please call the SEC at 1-800-SEC-0330 for
more information about the operation of the public reference room.
In addition, any information we file with the
SEC, including the documents incorporated by reference into this prospectus, is also available on the SEC’s website at http://www.sec.gov.
We also maintain a web site at http://www.casipharmaceuticals.com, which provides additional information about our company and
through which you can also access our SEC filings. The information set forth on our web site is not part of this prospectus.
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. These documents contain important information about us.
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1.
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The Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 31, 2017.
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2.
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The Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017, June 30, 2017 and September 30, 3017,
filed with the SEC on May 15, 2017, August 14, 2017 and November 14, 2017, respectively.
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3.
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The Company’s Definitive Proxy Statement on Schedule 14A for its 2015 Annual Stockholder’s Meeting, filed with
the SEC on April 14, 2017.
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4.
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The Company’s Current Reports on Form 8-K, filed on March 31, 2017, May 15, 2017, June 9, 2017, August 14, 2017, September
7, 2017, October 19, 2017, November 14, 2017 and December 8, 2017.
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5.
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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.
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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 website at http://www.sec.gov. You also can obtain these documents from us
without charge by visiting our website at http://www.casipharmaceuticals.com or by requesting them in writing, by email or by telephone
at the following address:
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive, Suite 300
Rockville, Maryland 20850
(240) 864-2600
ir@casipharmaceuticals.com
PART II
Information Not Required in This Prospectus
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|
ITEM 14.
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Other Expenses of Issuance and Distribution.
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The following table sets forth the costs and
expenses in connection with the issuance and distribution of the common stock being registered. All amounts are estimated except
the SEC registration fee.
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SEC registration fee
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$
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12,450
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Accounting fees and expenses
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$
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4,000
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Legal fees and expenses
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$
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10,000
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Printing expenses
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$
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550
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Miscellaneous
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$
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1,000
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Total
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$
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28,000
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The expenses set forth above relate solely to
the preparation and filing of this Registration Statement. We may incur additional expenses in connection with any offering of
the securities registered hereunder.
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ITEM 15.
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Indemnification of Officers and Directors.
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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. We have adopted provisions in our Amended
and Restated Certificate of Incorporation that provide for indemnification of our officers and directors to the maximum extent
permitted under the DGCL. As authorized by the DGCL, our Amended and Restated Certificate of Incorporation limits the liability
of our directors for monetary damages. The effect of this provision is to eliminate the rights of our company and our 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 our rights or the rights of 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. We have purchased an insurance policy that purports to insure our officers
and directors 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 on August 9, 2006 as an Exhibit to our Quarterly Report on Form 10-Q, which we
incorporate with this filing by reference.
The exhibits listed on the Index to Exhibits
of this Registration Statement are filed herewith or are incorporated herein by reference to other filings.
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(a)
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The undersigned registrant hereby undertakes:
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(1)
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to file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
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(i)
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to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(ii)
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to reflect in the prospectus any facts or events arising after the effective date of this 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 20% change in the
maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration
statement; and
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(iii)
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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;
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provided, however,
that paragraphs (a)(1)(i),
(a)(1)(ii) and (a)(1)(iii) of this section do not apply if the registration statement is on Form S-3 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.
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(2)
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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.
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(3)
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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.
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(4)
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That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser, if the registrant is relying
on Rule 430B of the Securities Act of 1933,
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(i)
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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
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(ii)
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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)(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.
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(5)
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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, 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:
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(i)
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Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
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(ii)
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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;
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(iii)
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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
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(iv)
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Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
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(b)
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The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of
1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in this registration statement shall be deemed to be a new registration
statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the
initial
bona fide
offering thereof.
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|
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(c)
|
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 SEC such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant
of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,
the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities
Act of 1933 and will be governed by the final adjudication of such issue.
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(d)
|
The undersigned registrant hereby undertakes that:
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|
|
(1)
|
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus
filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant
pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act of 1933 will be deemed to be part of this registration
statement as of the time it was declared effective.
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|
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(2)
|
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains
a form of prospectus will be deemed to be a new registration statement relating to the securities offered therein, and the offering
of such securities at that time will be deemed to be the initial bona fide offering thereof.
|
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.
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CASI PHARMACEUTICALS, INC.
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Dated: December 13, 2017
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By:
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/s/ Cynthia W. Hu
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Cynthia W. Hu
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COO, General Counsel & Secretary
|
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that the
persons whose signatures appear below constitute and appoint Cynthia W. Hu and Sara B. Capitelli 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, as amended, this Registration Statement has been signed by the following persons in the capacities indicated on December
13, 2017.
|
Signature
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Title
|
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/s/ Ken. K Ren
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|
Chief Executive Officer and Director
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|
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Ken K. Ren
|
|
(Principal Executive Officer)
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/s/Sara B. Capitelli
|
|
Principal Accounting Officer
|
|
|
Sara B. Capitelli
|
|
(Principal Financial and Accounting Officer)
|
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/s/ Wei-Wu He
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|
Chairman
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Wei-Wu He
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/s/ James Z. Huang
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Director
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|
James Z. Huang
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/s/ Franklin C. Salisbury
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|
Director
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|
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Franklin C. Salisbury
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/s/ Rajesh C. Shrotriya
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Director
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Rajesh C. Shrotriya
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/s/ Y. Alexander Wu
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Director
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Y. Alexander Wu
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/s/ Quan Zhou
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Director
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Quan Zhou
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INDEX TO EXHIBITS
|
|
(1)
|
To be filed by amendment
or by a Current Report on Form 8-K, or where applicable, incorporated by reference from a subsequent filing, if the registrant
enters into any such agreement or issues any such instrument in connection with the offer of any securities registered hereunder.
|
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