As
filed with the U.S. Securities and Exchange Commission on January
20, 2023.
Registration
Statement No. 333-268932
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
S-3/A
(AMENDMENT
NO. 1)
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
Summit Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
37-1979717
|
(State
or other jurisdiction of incorporation
or organization) |
|
(I.R.S.
Employer Identification Number) |
2882
Sand Hill Road, Suite 106
Menlo
Park, CA 94025
(617)
514-7149
(Address,
including zip code, and telephone number,
including area code, of registrant’s principal executive
offices)
| Robert
Duggan |
Mahkam
Zanganeh |
| Chairman
and Chief Executive Officer |
Co-Chief
Executive Officer and President |
| Summit
Therapeutics Inc. |
Summit
Therapeutics Inc. |
| 2882
Sand Hill Road, Suite 106 |
2882
Sand Hill Road, Suite 106 |
| Menlo
Park, CA 94025 |
Menlo
Park, CA 94025 |
| (617)
514-7149 |
(617)
514-7149 |
(Name,
address, including zip code, and telephone number, including area
code, of agent for service)
With copies to:
Adam
Finerman, Esq.
Baker
& Hostetler LLP
45
Rockefeller Plaza
New
York, NY 10111
Tel:
(212) 589-4233
Approximate
date of commencement of proposed sale to the public: As soon as
practicable after this registration statement becomes
effective.
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 check the following box: ☐
If
this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same offering.
☐
If
this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box.
☐
If
this Form is a post-effective amendment to a registration statement
filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant
to Rule 413(b) under the Securities Act, check the following box.
☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, 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 |
☐ |
Accelerated
filer |
☐ |
| Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
| |
|
Emerging
growth company |
☐ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
The
Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states
that this Registration Statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933
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 these securities until the registration statement
filed with the Securities and Exchange Commission is effective.
This prospectus is not an offer to sell these securities and we are
not soliciting offers to buy these securities in any jurisdiction
where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS SUBJECT TO COMPLETION, DATED JANUARY 20,
2023
PROSPECTUS
SUMMIT
THERAPEUTICS INC.
Subscription
Rights to Purchase Up to 476,190,476 Shares of Common Stock at the
Initial Price
Summit
Therapeutics Inc. is distributing at no charge to the holders of
our common stock, par value $0.01 per share, non-transferable
subscription rights (each, a “Subscription Right”) to purchase up
to 476,190,476 shares of common stock (the “Rights Offering”) at
the Initial Price (as defined below) with an aggregate offering
value of up to $500,000,000. The subscription price per share of
common stock shall be equal to the lesser of (i) $1.05 (the
“Initial Price”) and (ii) the volume weighted-average price of our
common stock for the preceding five-day trading period through and
including the Expiration Date (as defined below) (the “Alternate
Price”), as provided herein. Each stockholder will receive one
Subscription Right entitling the holder to purchase 2.152353 shares
of common stock at the Initial Price (the “Basic Subscription
Right”), for each share of our common stock owned at 4:00 p.m.,
Eastern Time, on [●] (the “Record Date”). To the extent that
the Alternate Price is lower than the Initial Price, we will sell
additional shares of common stock in the Rights Offering, provided
that we will not issue any fractional shares of common stock. For a
more detailed discussion, see “Rights Offering —Subscription
Rights — Basic Subscription Rights” beginning on page 40. The
Initial Price or Alternate Price, as applicable, is sometimes
referred to herein as the “Subscription Price”. The Subscription
Price may present a significant discount to the recent closing
trading price of $4.23 on January 19, 2023. Following the closing
of the Rights Offering, there is no assurance that the price will
remain at the current trading price, and the price may decline to
the Subscription Price, or to a price lower than the Subscription
Price. For a more detailed discussion, see “Dilution”
beginning on page 37. If the Rights Offering is not fully
subscribed and you fully exercise your Basic Subscription Right,
you may also exercise your Subscription Rights to purchase
additional shares of common stock at the Subscription Price that
were not subscribed for by other Subscription Rights holders under
the Rights Offering (the “Over-Subscription Right”), subject to the
availability and pro rata allocation of shares among persons
exercising this Over-Subscription Right. However, we will not issue
shares in excess of the total amount authorized by our Board of
Directors. For a more detailed discussion, see “Rights
Offering” beginning on page 40.
The
purpose of this Rights Offering is to raise equity capital in a
cost-effective manner that provides all of our existing
stockholders the opportunity to participate. The net proceeds will
be used for one or more of the following purposes: (i) the
repayment to Robert W.
Duggan, the Company’s Chief Executive Officer, Chairman of the
Board, and beneficial owner of approximately 78.1% of the Company’s
common stock and Dr. Mahkam Zanganeh, the Company’s co-Chief
Executive Officer, President, member of the Board and beneficial
owner of approximately 6.0% of the Company’s common stock,
of certain unsecured promissory notes totaling $420 million issued
pursuant to the Note Purchase Agreement and (ii) general corporate
purposes, which includes funding the Company’s activities to support clinical
development and regulatory approval for ivonescimab (also referred
to herein as SMT112) and pursue business development opportunities
to expand or enhance our pipeline of drug candidates. For a
more detailed discussion, see “Use of Proceeds” beginning on
page 35.
On
December 5, 2022, we entered into a Collaboration and License
Agreement (the “License Agreement”) with Akeso, Inc. and its
affiliates (“Akeso”) and
certain ancillary transaction documents as set forth in the License
Agreement. The License Agreement was subject to customary
closing conditions, including applicable waiting periods under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR
Act”). Pursuant to the terms of the License Agreement, we are
obligated to make an upfront payment of $500 million, $300 million of which is
payable within the later of 15 days after execution of the License
Agreement or upon the earliest date on which the parties
have actual knowledge that all applicable waiting periods under the
HSR Act and any comparable extension periods with respect to the
transactions contemplated by the License Agreement have expired or
been terminated (the “Antitrust Clearance Date”) and $200 million of which is payable upon
the later of (i) 90 days after the execution of the License
Agreement or (ii) the Antitrust Clearance Date. In connection with
the first payment, Akeso may elect to receive up to 16 million
shares of Company common stock in lieu of cash. Following
the Antitrust Clearance Date, on January 17, 2023 the License
Agreement closed and Akeso was issued 10 million shares of Company
common stock and was paid $274.9 million dollars in cash. The $200
million remaining amount of the $500 million upfront payment is
payable March 5, 2023. For a more detailed discussion, see
“Prospectus Summary” beginning on page 18.
On
December 6, 2022, we entered into a Note Purchase Agreement
(the “Note Purchase
Agreement”) and promissory notes with Robert W. Duggan, the
Company’s Chief Executive Officer, Chairman of the Board, and
beneficial owner of approximately 78.1% of the Company’s common
stock and Dr. Mahkam Zanganeh, the Company’s co-Chief Executive
Officer, President, member of the Board and beneficial owner of
approximately 6.0% of the Company’s common stock. Pursuant to the
Note Purchase Agreement, the Company agreed to sell to Mr. Duggan
and Dr. Zanganeh unsecured promissory notes in the aggregate amount
of $520 million for the principal purpose of funding the
Company’s initial payment obligations under the License Agreement.
These unsecured promissory notes will be repaid, in part, with the
proceeds of this Rights Offering. For a more detailed discussion,
see “Prospectus Summary — Other Material Agreements”
beginning on page 21.
The
Subscription Rights will be distributed and exercisable beginning
on the date of this prospectus. The Subscription Rights will expire
and will have no value if they are not exercised prior to the
expiration date of this Rights Offering, which is currently
expected to be 5:00 p.m. Eastern Time, on [●] (the
“Expiration Date”), unless we, in our sole discretion, extend the
period for exercising the Subscription Rights. We will extend the
duration of the Rights Offering as required by applicable law and
may choose to extend the Rights Offering if we decide that changes
in the market price of our common stock warrant an extension or if
we decide that the degree of participation in this Rights Offering
by holders of our common stock is less than the level we desire.
You should carefully consider whether or not to exercise your
Subscription Rights before the Expiration Date. We reserve the
right to cancel the Rights Offering at any time before the
expiration of the Rights Offering, for any reason.
Robert
W. Duggan, our Executive Chairman, Chief Executive Officer, and the
beneficial owner of approximately 78.1% of our common stock prior
to this Rights Offering, and Dr. Mahkam Zanganeh, our co-Chief
Executive Officer, President, a member of our Board of Directors,
and the beneficial owner of approximately 6.0% of our common stock
prior to this Rights Offering, have each indicated that they intend
to participate in the Rights Offering and subscribe for at least
the full amount of their Basic Subscription Rights, but have not
made any formal binding commitment to participate.
There
is no minimum number of shares of common stock that we must sell in
order to complete the Rights Offering. If the Rights Offering is
not fully subscribed and you fully exercise your Basic Subscription
Right, you may also exercise your Over-Subscription Right, subject
to the availability and pro rata allocation of shares among persons
exercising this Over-Subscription Right. Stockholders who do not
participate in the Rights Offering will continue to own the same
number of shares, but will own a smaller percentage of the total
shares outstanding after the Rights Offering to the extent that
other stockholders participate in the Rights Offering. Rights that
are not exercised by the Expiration Date will expire and have no
value.
We
are distributing the rights and offering the underlying securities
directly to you. We have not employed any brokers, dealers or
underwriters in connection with the solicitation or exercise of
rights in the Rights Offering and no commissions, fees or discounts
will be paid in connection with the Rights Offering. Broadridge
Corporate Issuer Solutions, LLC is acting as the subscription agent
and information agent for the Rights Offering. While certain of our
directors, officers and other employees may solicit responses from
you, those directors, officers and other employees will not receive
any commissions or compensation for their services other than their
normal compensation.
If
you want to participate in this Rights Offering and you are the
record holder of your shares, we recommend that you submit your
subscription documents to the Subscription Agent well before the
deadline. If you want to participate in this Rights Offering and
you hold shares through your broker, dealer, bank, or other
nominee, you should promptly contact your broker, dealer, bank, or
other nominee and submit your subscription documents in accordance
with the instructions and within the time period provided by your
broker, dealer, bank, or other nominee.
The
Subscription Rights may not be sold or transferred except as
required by operation of law and will not be listed for trading on
NASDAQ or any other stock exchange or market. You are urged to
obtain a current price quote for our common stock before exercising
your Subscription Rights.
Our
common stock is listed on the Nasdaq Global Market under the symbol
“SMMT”. On January 19, 2023, the last reported sales price of our
common stock was $4.23.
There
is no minimum amount of proceeds necessary in order for us to close
the Rights Offering.
Investing
in our securities involves a high degree of risk. See “Risk
Factors” beginning on page 23 of this prospectus and page 41 of
our Annual Report on Form 10-K for the year ended December 31,
2021, incorporated by reference herein as well as the other information
contained in this prospectus and the documents incorporated
by reference in this prospectus or in any accompanying prospectus
supplement for a discussion of the factors you should carefully
consider before making a
decision to invest in our securities.
Our
board of directors, or the Board, reserves the right to terminate
the Rights Offering for any reason at any time before the
completion of the Rights Offering. If we terminate the Rights
Offering, all subscription payments received will be returned as
soon as practicable, without interest or penalty.
The
Board is making no recommendations regarding your exercise of the
Subscription Rights. You should carefully consider whether to
exercise your Subscription Rights before the Expiration Date. You
may not revoke or revise any exercises of Subscription Rights once
made, unless we terminate the Rights Offering.
You
should rely only on the information contained in this prospectus or
any prospectus supplement or amendment hereto. We have not
authorized anyone to provide you with different
information.
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
Page
ABOUT THIS
PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we
filed with the United States Securities and Exchange Commission
(the “SEC”). Under this registration statement, we may distribute
non-transferable subscription rights (the “Subscription Rights”) to
purchase up to 476,190,476 of shares of our common stock (the
“Rights Offering”).
You
should read this prospectus, the documents incorporated by
reference into this prospectus, and any prospectus supplement or
free writing prospectus that we may authorize for use in connection
with this Rights Offering in their entirety before making an
investment decision. You should also read and consider the
information in the documents to which we have referred you in the
sections of this prospectus entitled “Incorporation of Certain
Information by Reference” beginning on page 53 and “Where
You Can Find More Information” beginning on page 54. These
documents contain important information that you should consider
when making your investment decision.
You
should only rely on the information contained in, or incorporated
by reference into, this prospectus, in any prospectus supplement or
in any free writing prospectus prepared by or on behalf of us or to
which we have referred you. We have not authorized anyone to
provide any information other than that contained in this
prospectus, in any prospectus supplement or in any free writing
prospectus prepared by or on behalf of us or to which we have
referred you. We are offering to sell, and seeking offers to buy,
securities only in jurisdictions where such offers and sales are
permitted. The information in this prospectus, in any prospectus
supplement or any free writing prospectus is accurate only as of
its date, regardless of its time of delivery or of any sale of
securities. Our business, financial condition, results of
operations and prospects may have changed since that
date.
Unless
otherwise indicated, information contained in, or incorporated by
reference into, this prospectus concerning our industry and the
markets in which we operate, including our general expectations and
market position, market opportunity and market share, is based on
information from our own management estimates and research, as well
as from industry and general publications and research, surveys and
studies conducted by third parties. Management estimates are
derived from publicly available information, our knowledge of our
industry and assumptions based on such information and knowledge,
which we believe to be reasonable. In addition, assumptions and
estimates of our and our industry’s future performance are
necessarily subject to a high degree of uncertainty and risk due to
a variety of factors, see “Risk Factors” beginning on page
23. These and other factors could cause our future performance to
differ materially from our assumptions and estimates. See
“Cautionary Note Regarding Forward-Looking Statements”
beginning on page 1.
Except
as otherwise indicated herein or as the context otherwise requires,
references in this prospectus to “Summit,” the “Company,” “we,”
“us,” “our” and similar references refer to Summit Therapeutics
Inc., a Delaware corporation, and its consolidated
subsidiaries.
CAUTIONARY NOTE
REGARDING FORWARD-LOOKING STATEMENTS
Some
of the statements made under “Prospectus Summary,” “Risk
Factors,” “Use of Proceeds,” and elsewhere in this
prospectus and the documents incorporated by reference herein,
including in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2021 and other documents incorporated by
reference into this prospectus, constitute forward-looking
statements. In some cases, you can identify forward-looking
statements by terminology such as “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential” “intends” or “continue,” or the negative of
these terms or other comparable terminology.
These
forward-looking statements may include, but are not limited to,
statements relating to our objectives, plans and strategies,
statements that contain projections of results of operations or of
financial condition, expected capital needs and expenses,
statements relating to the research, development, completion and
use of our products, and all statements (other than statements of
historical facts) that address activities, events or developments
that we intend, expect, project, believe or anticipate will or may
occur in the future.
Forward-looking
statements are not guarantees of future performance and are subject
to risks and uncertainties. We have based these forward-looking
statements on assumptions and assessments made by our management in
light of their experience and their perception of historical
trends, current conditions, expected future developments and other
factors they believe to be appropriate.
Important
factors that could cause actual results, developments and business
decisions to differ materially from those anticipated in these
forward-looking statements include, among others, those factors
referred to in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2021, and Quarterly Reports on Form 10-Q filed
thereafter, which are incorporated by reference herein.
These
statements are only current predictions and are subject to known
and unknown risks, uncertainties, and other factors that may cause
our or our industry’s actual results, levels of activity,
performance or achievements to be materially different from those
anticipated by the forward-looking statements. We discuss many of
these risks in this prospectus in greater detail under the heading
“Risk Factors” and other risk factors contained in the
documents incorporated by reference herein. You should not rely
upon forward-looking statements as predictions of future
events.
Although
we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, performance, or achievements. Except as
required by law, we are under no duty to update or revise any of
the forward-looking statements, whether as a result of new
information, future events or otherwise, after the date of this
prospectus.
SUMMARY OF THE
RIGHTS OFFERING
| Securities
to be Offered: |
We
are distributing to you, at no charge, one non-transferable
Subscription Right (each, a “Right”) to purchase 2.152353 shares of
our common stock at the Initial Price for every one share of our
common stock that you owned as of 4:00 p.m., Eastern Time, on [●],
either as a holder of record or, in the case of shares held of
record by custodian banks, brokers, dealers or other nominees on
your behalf, as a beneficial owner of such shares. Subscription
Rights will be rounded down to the nearest whole number and,
accordingly, no fractional Subscription Rights will be issued. To
the extent that the Alternate Price (as defined below) is lower
than the Initial Price, we will sell additional shares of common
stock.
The
shares of common stock sold in this Rights Offering will be issued
only in book-entry form. The Subscription Rights will not be
transferable and will not trade as a separate security on any
trading market.
|
| Subscription
Price: |
The
subscription price per share of common stock will be the lesser of
(i) $1.05 (the “Initial Price”) and (ii) the volume
weighted-average price of the common stock for the preceding five
consecutive trading days through and including the Expiration Date
(as defined below) (the “Alternate Price”). The Initial Price or
Alternate Price, as applicable, is sometimes referred to herein as
the “Subscription Price”. The Subscription Price may present a
significant discount to the recent closing trading price of $4.23
on January 19, 2023. Following the closing of the Rights Offering,
there is no assurance that the price will remain at the current
trading price, and the price may decline to the Subscription Price,
or to a price lower than the Subscription Price. For a more
detailed discussion, see “Dilution” beginning on page 37.
Prior to the Expiration Date, subscribers must fund their
subscriptions pursuant to both the Basic Subscription Right and
Over-Subscription Right at the Initial Price. To be effective, any
payment related to the exercise of a right must clear prior to the
expiration of the Rights Offering.
|
| Record
Date: |
[●]
(the “Record Date”)
|
| Basic
Subscription Rights: |
Each
Subscription Right will entitle the holder to purchase 2.152353
shares of common stock at the Initial Price (the “Basic
Subscription Right”) which shall be paid in cash. To the extent
that the Alternate Price is lower than the Initial Price, we will
sell additional shares of common stock.
|
| Over-Subscription
Rights: |
We do
not expect that all of our stockholders will exercise all of their
Basic Subscription Rights. If you fully exercise your Basic
Subscription Right and other stockholders do not fully exercise
their Basic Subscription Rights, you may also exercise your
Subscription Rights to purchase at the Subscription Price common
stock that were not subscribed for by other Subscription Rights
holders under the Rights Offering (the “Over-Subscription Right”),
subject to the availability and pro rata allocation of shares among
persons exercising this Over-Subscription Right. If an insufficient
number of shares of common stock are available to fully satisfy all
proper Over-Subscription Right requests, the available shares of
common stock issuable in this Rights Offering will be distributed
proportionately among Subscription Rights holders who properly
exercise their Over-Subscription Right based on the number of
shares of common stock each Subscription Rights holder timely
subscribed and paid for under the Basic Subscription Right. The
proration process will be repeated until all shares of common stock
have been allocated or all properly made Over-Subscription Right
exercises have been fulfilled, whichever occurs
earlier.
|
| Expiration
Date: |
The
Subscription Rights will expire at 5:00 PM Eastern Time, on [●]
(the “Expiration Date”). We reserve the right to extend the
Expiration Date in our sole discretion.
|
| Excess
Subscription Amount |
If,
on the Expiration Date, the Alternate Price is lower than the
Initial Price, any excess subscription amounts paid by a subscriber
(the “Excess Subscription Amount”) will be allocated towards the
purchase of additional shares of common stock. For more
information, see “Questions and Answers About the Rights
Offering”.
|
| Purchase
Commitments |
Robert
W. Duggan, our Executive Chairman, Chief Executive Officer, and the
beneficial owner of approximately 78.1% of our common stock prior
to this Rights Offering, and Dr. Mahkam Zanganeh, our co-Chief
Executive Officer, President, a member of our Board of Directors,
and the beneficial owner of approximately 6.0% of our common stock
prior to this Rights Offering, have each indicated that they intend
to participate in the Rights Offering and subscribe for at least
the full amount of their Basic Subscription Rights, but have not
made any formal binding commitment to participate.
|
| Procedure
for Exercising Subscription Rights: |
You
may exercise your Subscription Rights by properly completing and
executing your rights certificate and delivering it, together with
the Subscription Price for each share of common stock for which you
subscribe under the Basic Subscription Right and Over-Subscription
Right, to the subscription agent, Broadridge Corporate Issuer
Solutions, LLC, on or prior to the Expiration Date. If you use
mail, we recommend that you use insured, registered mail, with
return receipt requested.
|
| How
Subscription Rights Holders Can Exercise Rights Through
Others |
If
you hold our common stock through a custodian bank, broker, dealer,
or other nominee, we will ask your custodian bank, broker, dealer
or other nominee to notify you of the Rights Offering. If you wish
to exercise your Subscription Rights, you will need to have your
custodian bank, broker, dealer or other nominee act for you. To
indicate your decision, you should complete and return to your
custodian bank, broker, dealer or other nominee the form entitled
“Beneficial Owners Election Form.” You should receive this form
from your custodian bank, broker, dealer or other nominee with the
other Rights Offering materials. You should contact your custodian
bank, broker, dealer or other nominee if you believe you are
entitled to participate in the Rights Offering but you have not
received this form.
|
| How
Foreign Stockholders and Other Stockholders Can Exercise
Rights |
The
subscription agent will not mail rights certificates to you if you
are a registered stockholder whose address is outside the United
States or if you have an Army Post Office or a Fleet Post Office
address. Instead, we will have the subscription agent hold the
Subscription Rights certificates for your account. To exercise your
Subscription Rights, you must notify the subscription agent prior
to 11:00 a.m., Eastern Time, at least three (3) business days prior
to the Expiration Date, and establish to the satisfaction of the
subscription agent that it is permitted to exercise your
Subscription Rights under applicable law. If you do not follow
these procedures by such time, your Subscription Rights will expire
and will have no value. If you hold your shares in the name of a
custodian bank, broker, dealer or other nominee, you should follow
the instructions you receive from it, as described
above.
|
| No
Fractional Shares |
We
will not sell fractional shares of common stock but rather will
round down the aggregate number of shares of common stock you are
entitled to receive to the nearest whole number. For more
information about how the number of shares of common stock is
computed, see “Questions and Answers About the Rights Offering —
What happens if the final Subscription Price is less than the
Initial Price?”
Any
Excess Subscription Amount resulting from the reduction of the
Subscription Price from the Initial Price to the Alternate Price
will be allocated towards the purchase of additional shares of
common stock (either towards your Basic Subscription Right, if
available, or towards the Over-Subscription Right if you have
already exercised your Basic Subscription Right in full). The
excess amount for any fractional shares will be returned to you as
soon as practicable, in the form in which made. You will not
receive interest or a deduction on any payments refunded to you
under the Rights Offering.
|
| Payment
Adjustments |
If
you send a payment that is insufficient to purchase the number of
shares of common stock requested, or if the number of shares of
common stock requested is not specified in the rights certificate,
the payment received will be applied to exercise your Subscription
Rights to the extent of the payment. If the payment exceeds the
amount necessary for the full exercise of your Subscription Rights,
including any Over-Subscription Rights exercised and permitted and,
on the Expiration Date, the Alternate Price is lower than the
Initial Price, any Excess Subscription Amount will be allocated
towards the purchase of additional shares of common stock (either
towards your Basic Subscription Right, if available, or towards the
Over-Subscription Right if you have already exercised your Basic
Subscription Right in full). Otherwise, the excess will be returned
to you as soon as practicable, in the form in which made. You will
not receive interest or a deduction on any payments refunded to you
under the Rights Offering.
|
| Conditions |
See
“The Rights Offering — Conditions to the Rights Offering”
beginning on page 40.
|
| Delivery
of Shares: |
As
soon as practicable after the expiration of the Rights Offering,
the subscription agent will arrange for the issuance of the shares
of common stock received pursuant to the Rights Offering. All
shares that are purchased in the Rights Offering will be issued in
book-entry, or uncertificated, form meaning that you will receive a
direct registration (DRS) account statement from our transfer agent
reflecting ownership of these securities if you are a holder of
record of shares. If you hold your shares in the name of a
custodian bank, broker, dealer, or other nominee, the Depository
Trust Company (DTC) will credit your account with your nominee with
the securities you purchased in the Rights Offering.
|
| Non-transferability
of Subscription Rights: |
The
Subscription Rights may not be sold, transferred or assigned and
will not be listed for trading on the Nasdaq Global Market or any
other stock exchange or trading market.
|
| No
Recommendation to Subscription
Rights Holders: |
Although
certain of our directors may be investing their own money in the
Rights Offering, our board of directors is making no recommendation
regarding your exercise of the Subscription Rights. You are urged
to make your decision based on your own assessment of our business
and the Rights Offering. An investment in shares of common stock
must be made according to your evaluation of your own best
interests and after considering all of the information herein,
including the section titled “Risk Factors” beginning on
page 23 of this prospectus. Neither we nor our board of directors
are making any recommendation regarding whether you should exercise
your Subscription Rights.
|
| No
Revocation: |
Once
you submit the form of rights certificate to exercise any
Subscription Rights, you may not revoke or change your exercise or
request a refund of monies paid. All exercises of rights are
irrevocable, even if you subsequently learn information about us
that you consider to be unfavorable. You should not exercise your
Subscription Rights unless you are certain that you wish to
purchase shares of common stock in the Rights Offering.
|
| Use
of Proceeds: |
Although
we cannot determine what the actual net proceeds from the sale of
common stock in the Rights Offering will be until the Rights
Offering is completed, assuming all Subscription Rights are
exercised, we estimate that the aggregate net proceeds from the
Rights Offering, after deducting estimated offering expenses, will
be approximately $499.5 million. We currently intend to use
the net proceeds for one or more of the following purposes: (i) the
repayment of certain unsecured promissory notes totaling $420
million issued pursuant to the Note Purchase Agreement (as defined
in “Prospectus
Summary — Other
Material Agreements” beginning on page 21) and (ii)
general corporate purposes, which includes funding the Company’s
activities to support
clinical development and regulatory approval for ivonescimab (also
referred to herein as SMT112) and pursue business development
opportunities to expand or enhance our pipeline of drug
candidates. The
Company expects to use the proceeds of the Note Purchase Agreement
to support (1) payment of the upfront obligation totaling $500
million associated with the License Agreement (as defined in
“Prospectus Summary — Collaboration and License
Agreement”
beginning on page 19) as described herein; (2) activities to
support clinical development and regulatory approval for SMT112;
(3) pursue business development opportunities to expand or enhance
our pipeline of drug candidates; and (4) general corporate
purposes. For a more detailed discussion, see “Use of
Proceeds” beginning on page 35. |
| Material
U.S. Federal Income Tax Consequences: |
Although
the authorities governing transactions such as this Rights Offering
are complex and unclear in certain respects, we believe and intend
to take the position that the distribution of Subscription Rights
to you with respect to your shares of common stock generally should
be treated, for U.S. federal income tax purposes, as a non-taxable
distribution if you are a U.S. taxpayer. For a more detailed
discussion, see “Material U.S. Federal Income Tax
Consequences” beginning on page 48. You should consult your tax
advisor as to the particular consequences to you of the Rights
Offering.
|
| Extension
and Termination: |
We
have the option, exercisable in our sole discretion, to extend the
Rights Offering and the period for exercising your Subscription
Rights, although we do not presently intend to do so. The board of
directors, in its sole discretion, reserves the right to amend or
modify the terms of the Rights Offering. We also reserve the right
to terminate the Rights Offering at any time prior to the
Expiration Date for any reason, in which event all funds received
in connection with the Rights Offering will be returned without
interest or deduction to those persons who exercised their
Subscription Rights.
|
| Subscription
Agent: |
Broadridge
Corporate Issuer Solutions, LLC |
| Questions: |
You
should direct any questions or requests for assistance concerning
the method of subscribing for shares of common stock or for
additional copies of this prospectus the information agent,
Broadridge Corporate Issuer Solutions, LLC, toll free at
1-855-793-5068, by e-mail at shareholder@broadridge.com, or by mail
at:
Broadridge
Corporate Issuer Solutions, LLC
P.O.
Box 1317
Attn:
BCIS Re-Organization Dept.
Brentwood,
NY 11717-0718
|
| Market
for Common Stock: |
Our
common stock is listed on the Nasdaq Global Market under the symbol
“SMMT.” The shares of common stock to be issued in connection with
the Rights Offering will also be listed on the Nasdaq Global Market
under the same symbol. The Subscription Rights will not be listed
for trading on the Nasdaq Global Market or any other stock exchange
or market.
|
| Fees
and Expenses |
We
are not charging any fee or sales commission to issue Subscription
Rights to you or to sell common stock to you if you exercise your
Subscription Rights (other than the Subscription Price). If you
exercise your Subscription Rights through a custodian bank, broker,
dealer or other nominee, you are responsible for paying any fees
your nominee may charge you.
|
| Risk
Factors: |
Before
you exercise your Subscription Rights to purchase shares, you
should be aware that there are risks associated with your
investment, and you should carefully read and consider risks
described herein, see “Risk Factors” beginning on page 23,
together with all of the other information included and
incorporated by reference in this prospectus.
|
| No
“Going Private” Transaction |
The
Rights Offering is not a transaction or series of transactions
which has either a reasonable likelihood or a purpose of producing
a “going private effect” as specified in Rule 13e-3 of the Exchange
Act.
|
| Important
Dates to Remember: |
Set
forth below are certain important dates for this Rights Offering,
which are generally subject to extension:
Record
Date: [●]
Expiration
Date: [●]
Deadline
for Delivery of Subscription Rights Statements and Payment for
Shares: [●]
Anticipated
Delivery of Shares Purchased in Rights Offering:
[●]
|
QUESTIONS AND
ANSWERS RELATING TO THE RIGHTS OFFERING
The
following are examples of what we anticipate will be common
questions about the Rights Offering. The answers are based on
selected information included elsewhere in this prospectus. The
following questions and answers do not contain all of the
information that may be important to you and may not address all of
the questions that you may have about the Rights Offering. This
prospectus and the documents incorporated by reference into this
prospectus contain more detailed descriptions of the terms and
conditions of the Rights Offering and provide additional
information about us and our business, including potential risks
related to the Rights Offering, the shares offered hereby, and our
business. We urge you to read this entire prospectus and the
documents incorporated by reference into this
prospectus.
|
Q: |
What is the Rights Offering? |
| A: |
We
are distributing to you, at no charge, one Right to purchase
2.152353 shares of common stock at the Initial Price for every
share of our common stock that you owned as of 4:00 p.m., Eastern
Time, on [●], either as a holder of record or, in the case of
shares held of record by custodian banks, brokers, dealers or other
nominees on your behalf, as a beneficial owner of such
shares. |
|
Q: |
Why are we conducting the Rights Offering? |
| A: |
The
purpose of this Rights Offering is to raise equity capital in a
cost-effective manner that provides all of our existing
stockholders the opportunity to participate. We currently intend to
use the net proceeds for one or more of the following purposes: (i)
the repayment of certain unsecured promissory notes totaling $420
million issued pursuant to the Note Purchase Agreement and (ii)
general corporate purposes, which includes funding the Company’s
activities to support
clinical development and regulatory approval for SMT112 and pursue
business development opportunities to expand or enhance our
pipeline of drug candidates. For a more detailed discussion,
see “Use of Proceeds” beginning on page 35. |
|
Q: |
Will fractional Subscription Rights be issued? |
| A: |
No.
As we will not sell fractional shares of common stock, and each
Subscription Right represents the right to purchase 2.152353 shares
of common stock. Subscription Rights holders will only be entitled
to purchase a whole number of shares of common stock, rounded down
to the nearest whole number of shares of common stock a holder
would otherwise be entitled to purchase. For example, if you owned
1,000 shares of our common stock on the Record Date, you would be
granted Subscription Rights to purchase an aggregate of 2,152
shares of common stock (rounded down to the nearest whole share as
described herein) at the Initial Price. If you are entitled to
receive a fraction of a share, we will round down the number of
shares to which you are entitled to purchase to the nearest whole
number.
Any
Excess Subscription Amount resulting from the reduction of the
Subscription Price from the Initial Price to the Alternate Price
will be allocated towards the purchase of additional shares of
common stock (either towards your Basic Subscription Right, if
available, or towards the Over-Subscription Right if you have
already exercised your Basic Subscription Right in full). The
excess amount for any fractional shares of common stock will be
returned to you as soon as practicable, in the form in which made.
You will not receive interest or a deduction on any payments
refunded to you under the Rights Offering.
|
|
Q: |
How was the Subscription Price determined? |
| A: |
In
determining the Subscription Price, a special committee of
independent directors consisting of Manmeet Soni, Ujwala Mahatme
and Dr. Robert Booth (the “Special Committee”) considered a number
of factors, including: the likely cost of capital from other
sources and general conditions of the securities markets, the price
at which our stockholders might be willing to participate in the
Rights Offering, our need for liquidity and capital, the average
price for the 30-day period prior to the filing of the preliminary
Proxy Statement (as defined below) on November 29, 2022, and the
desire to provide an opportunity to our stockholders to participate
in the Rights Offering on a pro rata basis. The Special Committee
determined that it was in the best interests of the Company’s
stockholders to publicly announce the Initial Price and the
Alternate Price so that all stockholders had the opportunity to
determine whether to buy or sell the Company’s shares of common
stock prior to the Record Date. The Company did not consider
revising the Initial Price. The Company believes this disclosure
has provided its stockholders and the public with sufficient
information about the Company’s expectation to sell a significant
number of shares in the Rights Offering, as described herein. The
Subscription Price is not necessarily related to our book value,
net worth or any other established criteria of value and may or may
not be considered the fair value of the common stock to be offered
in the Rights Offering. You should not consider the Subscription
Price as an indication of value of us or our common stock. The
market price of our common stock may decline during or after the
Rights Offering, including below the Subscription Price for the
common stock. You should obtain a current quote for our common
stock before exercising your Subscription Rights and make your own
assessment of our business and financial condition, our prospects
for the future, and the terms of the Rights Offering. |
|
Q: |
Why did our board of directors elect to price the Rights Offering
at the lesser of the Initial Price and the Alternate
Price? |
| A: |
The
Special Committee elected to price the Rights Offering at the
lesser of the Initial Price and the Alternate Price to attempt to
protect stockholders from any decline in the price of the Company’s
common stock, which may occur after the commencement of the Rights
Offering and prior to the Expiration Date. While there is no
guarantee that this mechanism will sufficiently protect
stockholders that exercise their rights (see “Risk Factors”
below), our board of directors and management wanted to encourage
participation in the Rights Offering and strike what they believe
to be a fair balance between the capital needs of the Company and
the fair value of the common stock to be sold to the stockholders
in this Rights Offering. |
|
Q: |
Because the final Subscription Price may not be determined until
the Expiration Date, how much money should I send to the
subscription agent if I want to exercise my Subscription
Rights? |
| A: |
For
purposes of initially exercising your Subscription Rights, you
should assume that the Subscription Price will equal the Initial
Price of $1.05 per share. Accordingly, for each right that you
would like to exercise, including any rights that you would like
the opportunity to exercise pursuant to the Over-Subscription
Right, you should send $1.05 per share, noting that each
Subscription Right corresponds to 2.152353 shares of common stock
at the Initial Price. For assistance you may contact the
information agent, Broadridge Corporate Issuer Solutions, LLC, toll
free at 1-855-793-5068 or by e-mail at
shareholder@broadridge.com. |
|
Q: |
What happens if the final Subscription Price is less than the
Initial Price? |
| A: |
If,
on the Expiration Date, the Alternate Price is lower than the
Initial Price, any Excess Subscription Amounts will be allocated
towards the purchase of additional shares of common stock. When
submitting your subscription, you should assume that the
Subscription Price will equal the Initial Price of $1.05 per share.
However, if the Alternate Price is lower than the Initial Price,
the final Subscription Price will be the Alternate Price. For
example, if you want to exercise your Subscription Rights to
purchase 100 shares of common stock, you will promptly send payment
to the subscription agent in the amount of $105. If the final
Subscription Price per share remains at the Initial Price, you will
receive 100 shares of common stock. If the Alternate Price was
equal to $0.99 per share, the final Subscription Price will be the
Alternate Price of $0.99 per share. In such case, you will receive
106 shares of common stock rather than 100, and, because we will
not issue fractional shares of common stock, you will also receive
a refund of $0.06. The excess amount of cash for any fractional
shares of common stock will be returned to you as soon as
practicable, in the form in which made. You will not receive
interest or a deduction on any payments refunded to you under the
Rights Offering. Detailed instructions to exercise your
Subscription Rights, including regarding payment of the
Subscription Price, are also included on your rights certificate.
For assistance you may contact the information agent, Broadridge
Corporate Issuer Solutions, LLC, toll free at 1-855-793-5068 or by
e-mail at shareholder@broadridge.com. |
|
Q: |
What is the Basic Subscription Right? |
| A: |
Each
Right gives our stockholders the right to purchase 2.152353 shares
of common stock at the Initial Price, which shall be payable in
cash and subject to the limits described below. To the extent that
the Alternate Price is lower than the Initial Price, we will sell
additional shares of common stock. We have granted to you, as a
stockholder of record as of 4:00 p.m., Eastern Time on the Record
Date, one Subscription Right for every one share of our common
stock you owned at that time. For example, if you owned 100 shares
of our common stock as of 4:00 p.m., Eastern Time on the Record
Date, you would have received Subscription Rights to purchase 215
shares of common stock at the Initial Price, subject to certain
limitations. You may exercise all or a portion of your Basic
Subscription Rights or you may choose not to exercise any Rights at
all. However, if you exercise fewer than all of your Basic
Subscription Rights, you will not be entitled to purchase any
additional shares of common stock pursuant to the Over-Subscription
Right. |
|
Q: |
What is the Over-Subscription Right? |
| A: |
We do
not expect all of our stockholders to exercise all of their Basic
Subscription Rights. The Over-Subscription Right provides
stockholders that exercise all of their Basic Subscription Rights
the opportunity to purchase shares of common stock that are not
purchased by other stockholders. If you fully exercise your Basic
Subscription Right, the Over-Subscription Right entitles you to
subscribe for additional shares of common stock unclaimed by other
holders of rights in this Rights Offering at the same Subscription
Price per share. If an insufficient number of shares is available
to fully satisfy all proper Over-Subscription Right requests, the
available shares will be distributed proportionately among
Subscription Rights holders who properly exercise their
Over-Subscription Right based on the number of shares each
Subscription Rights holder timely subscribed and paid for under the
Basic Subscription Right. The proration process will be repeated
until all shares of common stock have been allocated or all
properly made Over-Subscription Right exercises have been
fulfilled, whichever occurs earlier. |
In
order to properly exercise your Over-Subscription Right, you must
deliver the subscription payment for exercise of your
Over-Subscription Right before the expiration of the Rights
Offering. Because we will not know the total number of unsubscribed
shares of common stock before the expiration of the Rights
Offering, if you wish to maximize the number of shares you purchase
pursuant to your Over-Subscription Right, you will need to deliver
payment in an amount equal to the aggregate Subscription Price for
the maximum number of shares of common stock available, assuming
that no stockholder other than you has purchased any shares of
common stock pursuant to such stockholder’s Basic Subscription
Right and Over-Subscription Right. Any excess subscription payments
received by the subscription agent caused by proration will be
returned by the subscription agent to you by mail, without interest
or penalty, as soon as practicable after the Expiration Date of the
Rights Offering. The subscription agent will return any excess
payments in the form in which it was made. Any Excess Subscription
Amount resulting from the reduction of the Subscription Price from
the Initial Price to the Alternate Price will be allocated towards
the purchase of additional shares of common stock (either towards
your Basic Subscription Right, if available, or towards the
Over-Subscription Right if you have already exercised your Basic
Subscription Right in full). See “The Rights Offering —
Subscription Rights — Over-Subscription Rights” beginning on
page 40.
|
Q: |
Who will receive Subscription Rights? |
| A: |
Holders
of our common stock will receive one Right for every one share of
common stock owned as of 4:00 p.m., Eastern Time on the Record
Date. |
|
Q: |
How many shares of common stock may I purchase if I exercise my
Subscription Rights? |
| A: |
Each
Right evidences a right to purchase 2.152353 shares of common stock
at the Initial Price, which shall be paid in cash. To the extent
that the Alternate Price is lower than the Initial Price, we will
sell additional shares of common stock. You may exercise any number
of your Subscription Rights. You are urged to obtain a current
price quote for our common stock before exercising your
Subscription Rights. |
|
Q: |
Am I required to subscribe in the Rights
Offering? |
| A: |
No. |
|
Q: |
What happens if I choose not to exercise my Subscription
Rights? |
| A: |
If
you choose not to exercise your Subscription Rights, you will
retain your current number of shares of common stock of the
Company. If other stockholders fully exercise their Subscription
Rights or exercise a greater proportion of their Subscription
Rights than you exercise, the percentage of our common stock owned
by these other stockholders will increase relative to your
ownership percentage, and your voting and other rights in the
Company will likewise be diluted. |
|
Q: |
Am I required to exercise all of the Subscription Rights I receive
in the Rights Offering? |
| A: |
No.
You may exercise any number of your Subscription Rights, or you may
choose not to exercise any Subscription Rights. If you do not
exercise any Subscription Rights, the number of shares of our
common stock you own will not change; however, you will own a
smaller proportional interest in us than if you had timely
exercised all or a portion of your Subscription Rights. If you
choose not to exercise your Subscription Rights or you exercise
fewer than all of your Subscription Rights and other stockholders
fully exercise their Subscription Rights or exercise a greater
proportion of their Subscription Rights than you exercise, the
percentage of our common stock owned by these other stockholders
will increase relative to your ownership percentage, and your
voting and other rights in us will likewise be diluted. In
addition, if you do not exercise your Basic Subscription Right in
full, you will not be entitled to participate in the
Over-Subscription Right. |
|
Q: |
If I am a holder of stock options or warrants, may I participate in
the Rights Offering? |
| A: |
No.
Holders of outstanding stock options or warrants on the Record Date
will not be entitled to participate in the Rights Offering, except
to the extent they hold shares of our common stock on the Record
Date. |
|
Q: |
Will the equity awards of our employees, officers and directors
automatically convert into common stock in connection with the
Rights Offering? |
|
A: |
No,
equity awards will not automatically convert into common stock.
Holders of our equity awards, including outstanding stock options,
will not receive rights in the Rights Offering in connection with
such equity awards, but will receive Subscription Rights in
connection with any shares of our common stock held as of the
Record Date. |
|
Q: |
How soon must I act to exercise my Subscription
Rights? |
| A: |
If
you received a rights certificate and elect to exercise any or all
of your Subscription Rights, the subscription agent must receive
your completed and signed rights certificate and payment (and your
payment must clear) prior to the expiration of the Rights Offering,
which is [●], at 4:00 p.m., Eastern Time. If you hold your shares
in the name of a custodian bank, broker, dealer or other nominee,
your nominee may establish a deadline prior to 5:00 p.m., Eastern
Time, on [●] by which you must provide it with your instructions to
exercise your Subscription Rights and payment for your common
stock. Our board of directors may, in its discretion, extend the
Rights Offering one or more times. Our board of directors may
cancel or amend the Rights Offering at any time before its
expiration. In the event that the Rights Offering is cancelled, all
subscription payments received will be returned promptly, without
interest or penalty. |
|
Q: |
Does Summit need to achieve a minimum participation level in order
to complete the Rights Offering? |
| A: |
No.
We may choose to consummate, amend, extend or terminate the Rights
Offering regardless of the number of shares of common stock
actually subscribed for by stockholders. |
|
Q: |
Can Summit terminate the Rights Offering? |
| A: |
Yes.
Our board of directors may decide to terminate the Rights Offering
at any time prior to the expiration of the Rights Offering, for any
reason. If we cancel the Rights Offering, any money received from
subscribing stockholders will be refunded as soon as practicable,
without interest or a deduction on any payments refunded to you
under the Rights Offering. See “The Rights Offering — Expiration
of the Rights Offering and Extensions, Amendments and
Termination” beginning on page 41. |
|
Q: |
May I transfer my Subscription Rights if I do not want to purchase
any shares of common stock? |
| A: |
No.
Should you choose not to exercise your Subscription Rights, you may
not sell, give away or otherwise transfer your Subscription Rights.
However, rights will be transferable as required by operation of
law, for example, upon the death of the recipient. |
|
Q: |
When will the Rights Offering expire? |
| A: |
The
Subscription Rights will expire and will have no value, if not
exercised prior thereto, at 5:00 p.m., Eastern Time, on [●], unless
we decide to extend the Expiration Date until some later time or
terminate it earlier. See “The Rights Offering — Expiration of
the Rights Offering and Extensions, Amendments and Termination”
beginning on page 41. The subscription agent must actually receive
all required documents and payments in cash, as provide herein,
before the Expiration Date. There is no maximum duration for the
Rights Offering. |
|
Q: |
Is there a guaranteed delivery period? |
| A: |
No.
There is no guaranteed delivery period in connection with this
Rights Offering, so you must ensure that you properly complete all
required steps prior to 5:00 p.m., Eastern Time, on [●], unless we
decide to extend the Expiration Date until some later time or
terminate it earlier. |
|
Q: |
How do I exercise my Subscription Rights if I own shares in
certificate form? |
| A: |
You
may exercise your Subscription Rights by properly completing and
executing your rights certificate and delivering it, together in
full with the Subscription Price for each share of common stock you
subscribe for, to the subscription agent on or prior to the
Expiration Date. If you use mail, we recommend that you use
insured, registered mail, return receipt requested. |
If
you send a payment that is insufficient to purchase the number of
shares of common stock you requested, or if the number of shares of
common stock you requested is not specified in the forms, the
payment received will be applied to exercise your Subscription
Rights to the fullest extent possible based on the amount of the
payment received, subject to the availability of shares of common
stock in the Rights Offering and the elimination of fractional
shares. Any excess subscription payments received by the
subscription agent will be returned promptly, without interest,
following the expiration of the Rights Offering.
| |
Q: |
What form of payment is required to purchase shares of common
stock? |
| |
A: |
As
described in the instructions accompanying the rights certificate,
you must timely pay the full Subscription Price for the full number
of shares of common stock you wish to acquire under your
Subscription Rights at the Initial Price by delivering to
Broadridge Corporate Issuer Solutions, LLC, the subscription agent
for this Rights Offering, a certified check, money order, or wire
transfer of funds, or as otherwise acceptable to the
Company. |
Please
note that we will not accept payment by means of uncertified
personal check, bank draft or cashier’s check.
|
Q: |
What should I do if I want to participate in the Rights Offering
but my shares are held in the name of my custodian bank, broker,
dealer or other nominee? |
| A: |
If
you hold our common stock through a custodian bank, broker, dealer
or other nominee, we will ask your custodian bank, broker, dealer
or other nominee to notify you of the Rights Offering. If you wish
to exercise your Subscription Rights, you will need to have your
custodian bank, broker, dealer or other nominee act for you. To
indicate your decision, you should complete and return to your
custodian bank, broker, dealer or other nominee the form entitled
“Beneficial Owner Election Form” substantially in the form
accompanying this prospectus. You should receive this form from
your custodian bank, broker, dealer or other nominee with the other
Rights Offering materials. You should contact your custodian bank,
broker, dealer or other nominee if you believe you are entitled to
participate in the Rights Offering but you have not received this
form. |
|
Q: |
What should I do if I want to participate in the Rights Offering,
but I am a stockholder with a foreign address or a stockholder with
an Army Post Office or Fleet Post Office
address? |
| A: |
The
subscription agent will not mail rights certificates to you if you
are a registered stockholder whose address is outside the United
States or if you have an Army Post Office or a Fleet Post Office
address. To exercise your Subscription Rights, you must notify the
subscription agent prior to 11:00 a.m., Eastern Time, at least
three (3) business days prior to the Expiration Date, and establish
to the satisfaction of the subscription agent that it is permitted
to exercise your Subscription Rights under applicable law. If you
do not follow these procedures by such time, your Subscription
Rights will expire and will have no value. If you hold your shares
in the name of a custodian bank, broker, dealer or other nominee,
you should follow the instructions you receive from it, as
described above. |
|
Q: |
Will I be charged a sales commission or a fee if I exercise my
Subscription Rights? |
|
A: |
We
will not charge a brokerage commission or a fee to Subscription
Rights holders for exercising their Subscription Rights. However,
if you exercise your Subscription Rights through a custodian bank,
broker, dealer or nominee, you will be responsible for any fees
charged by your custodian bank, broker, dealer or
nominee. |
|
Q: |
Are there any conditions to my right to exercise my Subscription
Rights? |
|
A: |
Yes.
We may terminate the Rights Offering, in whole or in part, if at
any time before completion of the Rights Offering there is any
judgment, order, decree, injunction, statute, law or regulation
entered, enacted, amended or held to be applicable to the Rights
Offering that in the sole judgment of our board of directors would
or might make the Rights Offering or its completion, whether in
whole or in part, illegal or otherwise restrict or prohibit
completion of the Rights Offering. See “The Rights Offering —
Conditions to the Rights Offering” beginning on page
43. |
|
Q: |
Has the board of directors made a recommendation regarding the
Rights Offering? |
|
A: |
Neither
the Company, nor our board of directors is making any
recommendation as to whether or not you should exercise your
Subscription Rights. You are urged to make your decision based on
your own assessment of the Rights Offering, after considering all
of the information herein, including the “Risk Factors”
beginning on page 23 of this prospectus, and of your best
interests.
|
|
Q: |
Have any directors, officers, and/or stockholders agreed to
exercise their rights? |
| A: |
All
holders of our common stock as of the Record Date for the Rights
Offering will receive, at no charge, the non-transferable
Subscription Rights to purchase shares of common stock as described
in this prospectus. To the extent that our directors and officers
held shares of our common stock (including shares of restricted
common stock) as of the Record Date, they will receive the
Subscription Rights and, while they are under no obligation to do
so, will be entitled to participate in the Rights
Offering. |
| |
|
Robert
W. Duggan, our Executive Chairman, Chief Executive Officer, and the
beneficial owner of approximately 78.1% of our outstanding common
stock prior to this Rights Offering, and Dr. Mahkam Zanganeh, our
co-Chief Executive Officer, President, a member of our Board of
Directors, and the beneficial owner of approximately 6.0% of our
issued and outstanding common stock prior to this Rights Offering,
have each indicated that they intend to participate in the Rights
Offering and subscribe for at least the full amount of their Basic
Subscription Rights, but have not made any formal binding
commitment to participate.
|
Q: |
May stockholders in all states participate in the Rights
Offering? |
|
A: |
Although
we intend to distribute the rights to all stockholders, we reserve
the right in some states to require stockholders, if they wish to
participate, to state and agree upon exercise of their respective
rights that they are acquiring the securities for investment
purposes only, and that they have no present intention to resell or
transfer any securities acquired. Our securities are not being
offered in any jurisdiction where the offer is not permitted under
applicable local laws. |
|
Q: |
Are there risks in exercising my Subscription
Rights? |
| A: |
The
exercise of your Subscription Rights involves significant risks.
Exercising your Subscription Rights means buying our common stock,
and should be considered as carefully as you would consider any
other equity investment. Among other things, you should carefully
consider the risks described under the heading “Risk
Factors,” beginning on page 23. |
|
Q: |
How many shares of our common stock will be outstanding after the
Rights Offering? |
| A: |
The
number of shares of our common stock that will be outstanding after
the Rights Offering will depend on the number of shares of common
stock that are purchased in the Rights Offering. Assuming no
additional shares of common stock are issued by us prior to
consummation of the Rights Offering and assuming all offered shares
of common stock are sold in the Rights Offering at the Initial
Price, we will issue approximately 476,190,476 shares of common
stock. In that case, we will have approximately 697,432,201 shares
of common stock outstanding after the Rights Offering. This would
represent an increase of approximately 215% in the number of
outstanding shares of common stock. To the extent that the
Alternate Price is lower than the Initial Price, we will sell
additional shares of common stock and the number of shares of
common stock outstanding after the Rights Offering will accordingly
be higher. However, we will not issue shares in excess of the total
amount authorized by our Board of Directors. |
The
issuance of shares of our common stock in the Rights Offering will
dilute, and thereby reduce, your proportionate ownership in our
shares of common stock, unless you fully exercise your Basic
Subscription Rights. In addition, the issuance of our common stock
at a Subscription Price that is less than the market price as of
the Record Date for the Rights Offering will likely reduce the
price per share of our common stock held by you prior to the Rights
Offering.
|
Q: |
What will be the proceeds of the Rights
Offering? |
| A: |
If
all rights are exercised, we will receive gross proceeds of
approximately $500 million before expenses, as provided herein. We
are offering shares of common stock in the Rights Offering with no
minimum purchase requirement. As a result, there is no assurance we
will be able to sell all or any of the shares of common stock being
offered, and it is not likely that all of our stockholders will
participate in the Rights Offering. |
|
Q: |
After I exercise my Subscription Rights, can I change my mind and
cancel my purchase? |
| A: |
No.
Once you exercise and send in your Subscription Rights certificate
and subscription payment, as provided herein, you cannot revoke the
exercise of your Subscription Rights, even if you later learn
information about the Company that you consider to be unfavorable.
You should not exercise your Subscription Rights unless you are
certain that you wish to purchase shares of common stock at the
Initial Price. See “The Rights Offering — No Revocation or
Change” beginning on page 46. |
|
Q: |
What are the material U.S. Federal income tax consequences of
exercising my Subscription Rights? |
| A: |
Although
the authorities governing transactions such as this Rights Offering
are complex and unclear in certain respects, we believe and
intend to take the position that the distribution of Subscription
Rights to a holder with respect to such holder’s shares of
common stock generally should be treated, for U.S.
federal income tax purposes, as a non-taxable distribution.
For a more detailed discussion, see “Material U.S.
Federal Income Tax Consequences” beginning on page 48. You
should consult your tax advisor as to the
particular consequences to you of the Rights
Offering. |
|
Q: |
If the Rights Offering is not completed, for any reason, will my
subscription payment be refunded to me? |
| A: |
Yes.
The subscription agent will hold all funds it receives in a
segregated bank account until the Rights Offering is completed. If
the Rights Offering is not completed, for any reason, any money
received from subscribing stockholders will be refunded in the form
which paid as soon as practicable, without interest or deduction.
If your shares are held in the name of a custodian bank, broker,
dealer or other nominee, it may take longer for you to receive the
refund of your subscription payment than if you were a record
holder of your shares because the subscription agent will return
payments through the record holder of your shares. |
|
Q: |
Will I receive interest on any funds I deposit with the
subscription agent? |
| A: |
No.
You will not be entitled to any interest on any funds that are
deposited with the subscription agent pending completion or
cancellation of the Rights Offering. If the Rights Offering is
cancelled for any reason, the subscription agent will return this
money to subscribers, without interest or penalty, as soon as
practicable. |
|
Q: |
If I exercise my Subscription Rights, when will I receive my shares
of common stock that I purchased in the Rights
Offering? |
| A: |
We
will issue the shares of common stock purchased in the Rights
Offering to you in book-entry, or uncertificated, form of our
common stock purchased in the Rights Offering as soon as
practicable after the expiration of the Rights Offering and after
all pro rata allocations and adjustments have been completed. We
will not be able to calculate the number of shares to be issued to
each exercising holder until after the Expiration Date of the
Rights Offering. |
|
Q: |
When can I sell the shares of common stock I receive in the Rights
Offering? |
| A: |
If
you exercise your Subscription Rights and receive common stock, you
will be able to resell the shares of common stock once your account
has been credited with those shares, provided you are not otherwise
restricted from selling the shares (for example, because you are an
insider or affiliate of the Company or because you possess material
nonpublic information about the Company). Although we will endeavor
to issue the shares as soon as practicable after completion of the
Rights Offering, there may be a delay between the Expiration Date
of the Rights Offering and the time that the shares are issued due
to factors such as the time required to complete all necessary
calculations. In addition, following the exercise of your
Subscription Rights, you may not be able to sell the shares
purchased in the Rights Offering at a price equal to or greater
than the Subscription Price. |
|
Q: |
To whom should I send my forms and payment? |
| A: |
If
your shares are held in the name of a custodian bank, broker,
dealer or other nominee, the nominee will notify you of the Rights
Offering and provide you with the Rights Offering materials,
including a form entitled “Beneficial Owners Election Form.” You
should send the Beneficial Owner Election Form and payment, as
provided therein, to the nominee, at the deadline that your nominee
sets which may be earlier than the expiration of the Rights
Offering. You should contact your custodian bank, broker, dealer or
other nominee if you believe you are entitled to participate in the
Rights Offering but you have not received this form. |
| |
|
If
your shares are held in your name such that you are the record
holder, then you should send your subscription documents, rights
certificate and subscription payment, as provided herein, by first
class mail or courier service to Broadridge Corporate Issuer
Solutions, LLC, the subscription agent. The address for delivery to
the subscription agent is as follows:
|
By Mail:
Broadridge
Corporate Issuer Solutions, LLC
Attn:
BCIS Re-Organization Dept.
P.O.
Box 1317
Brentwood,
NY 11717-0718
|
By Overnight Delivery:
Broadridge
Corporate Issuer Solutions, LLC
Attn:
BCIS IWS
51
Mercedes Way
Edgewood,
NY 11717
|
Your
delivery to a different address or other than by the methods set
forth above will not constitute valid delivery. You, or, if
applicable, your nominee, are solely responsible for ensuring the
subscription agent receives your subscription documents, rights
certificate, and subscription payment. You should allow sufficient
time for delivery of your subscription materials to the
subscription agent and clearance of payment before the expiration
of the Rights Offering period.
|
Q: |
Will this Rights Offering result in the Company “going private” for
purposes of Rule 13e-3 of the Exchange Act? |
| A: |
No.
The Rights Offering is not a transaction or series of transactions
which has either a reasonable likelihood or a purpose or producing
a “going private effect” as specified in Rule 13e-3 of the Exchange
Act. Given the structure of the Rights Offering, as described in
this prospectus, the Company will continue to be registered
pursuant to Section 12 of the Exchange Act and intends to remain
listed on the Nasdaq Global Market following completion of the
Rights Offering. |
|
Q: |
What if I have other questions? |
| A: |
If
you have other questions about the Rights Offering, please contact
our information agent, Broadridge Corporate Issuer Solutions, LLC,
toll free at 1-855-793-5068, by e-mail at
shareholder@broadridge.com, or by mail at: |
| |
|
Broadridge
Corporate Issuer Solutions, LLC
Attn: BCIS Re-Organization Dept.
P.O. Box 1317
Brentwood, NY 11717-0718
PROSPECTUS
SUMMARY
This
summary highlights certain information about us, this Rights
Offering and selected information contained in the prospectus. This
summary is not complete and does not contain all of the information
that you should consider before deciding whether to invest in our
common stock. For a more complete understanding of the Company and
this Rights Offering, we encourage you to read and consider the
more detailed information included or incorporated by reference in
this prospectus, including risk factors, see “Risk Factors”
beginning on page 23, and our most recent consolidated financial
statements and related notes. As described below, on December 5,
2022, we entered into the License Agreement (as defined below),
pursuant to which we will partner with Akeso (as defined below) to
in-license its breakthrough bispecific antibody, ivonescimab, known
as AK112 in China and Australia, and also as SMT112 in the United
States, Canada, Europe, and Japan. The License Agreement and
transactions contemplated thereby closed on January 17,
2023.
Overview
We
are a biopharmaceutical company focused on the discovery,
development, and commercialization of patient-, physician-,
caregiver- and societal-friendly medicinal therapies intended to
improve quality of life, increase potential duration of life, and
resolve serious unmet medical needs. Our pipeline of product
candidates is designed with the goal to become the
patient-friendly, new-era standard-of-care medicines.
On
September 28, 2022, we determined that we would seek partners or a
divestiture of ridinilazole, our lead product candidate for
treating patients suffering from Clostridioides difficile
infection, also known as C. difficile infection, or CDI, as
the path forward for the clinical development of the asset. As a
result of this determination, we discontinued our only active study
for ridinilazole, a pediatric clinical trial evaluating
ridinilazole for treating adolescent patients with CDI. We are
currently involved in activities related to closeout of
ridinilazole clinical trials.
Our
second product candidate, SMT-738, is being developed for combating
multidrug resistant infections, specifically carbapenem-resistant
Enterobacteriaceae (“CRE”) infections. SMT-738 is the first of a
novel class of precision antibiotics that has entered into
preclinical development. SMT-738 is currently undergoing
IND-enabling activities. We have been and will continue to pursue
partnership discussions to continue the development of
SMT-738.
We
have two additional discovery-phase targets in our pipeline with
undisclosed targets in the therapeutic area of oncology.
On
December 5, 2022, we entered into a Collaboration and License
Agreement (the “License Agreement”) with Akeso, Inc. and its
affiliates (“Akeso”) pursuant to which we are partnering with Akeso
to in-license its breakthrough bispecific antibody, ivonescimab.
Ivonescimab, known as AK112 in China and Australia, and also as
SMT112 in the United States, Canada, Europe, and Japan, is a novel,
potential first-in-class bispecific antibody intending to combine
the power of immunotherapy via a blockade of PD-1 with the
anti-angiogenesis benefits of an anti-VEGF into a single molecule.
Ivonescimab was engineered to bring two well established oncology
targeted mechanisms together. Through the License Agreement, we
obtained the rights to develop and commercialize SMT112 in the
United States, Canada, Europe, and Japan. The License Agreement and
transactions contemplated thereby closed on January 17,
2023.
The entry into the License Agreement and potential partnership or
divestiture of ridinilazole represents a material shift in the
Company’s strategy. All prior development and marketing activities
relating to ridinilazole are being terminated and our future
operations will be heavily dependent on the License Agreement and
other future activities as the Company determines. The success of
this transaction will depend, in part, on the clinical success of
ivonescimab as well as the success of our collaboration with Akeso.
This transaction may not result in the realization of the full
benefit of any anticipated growth opportunities or these benefits
may not be realized within the expected time frames. We will also
require significant additional financing to fund the clinical
development plan and certain payments contemplated by the License
Agreement that could result in an increase in the number of our
outstanding shares or the aggregate amount of our debt. If we are
unable to raise capital to fund these additional payments, it may
cause a material adverse effect on our business.
We
have devoted substantially all of our efforts to research and
development, including clinical trials. We have not completed the
development of any drugs. We expect to continue to incur
significant expenses and increasing operating losses for at least
the next few years. The net losses we incur may fluctuate
significantly from quarter to quarter and year to year, due to the
nature and timing of our research and development activities. We
expect that our research and development and general and
administrative expenses will continue to be significant in
connection with our ongoing research and development
efforts.
Collaboration
and License Agreement
Our
License Agreement with Akeso, as referred to above, calls for
Summit to receive the rights to develop and commercialize
ivonescimab in the United States, Canada, Europe, and Japan (the
“Licensed Territory”). Akeso will retain development and
commercialization rights for the rest of the regions including
China. In exchange for these rights, Summit will make an upfront
payment of $500 million, $300 million of which is payable within
the later of 15 days after execution of the License Agreement or
upon the earliest date on which the parties have actual knowledge
that all applicable waiting periods under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 and any comparable extension
periods with respect to the transactions contemplated by the
License Agreement have expired or been terminated (the “Antitrust
Clearance Date”) and $200 million of which is payable within the
later of (i) 90 days after execution of the License Agreement or
(ii) the Antitrust Clearance Date. In connection with the first
payment, up to 16 million shares of Company common stock may be
issued in lieu of cash at Akeso’s election (the “Share Transfer”),
with the value of such shares based on the ten (10) day
volume-weighted average price for the five-trading day period prior
to and the five-trading day period after the execution of the
License Agreement. The total of the upfront payment and potential
milestone payments is $5.0 billion, as Akeso will be eligible to
receive regulatory milestones of up to $1.05 billion and commercial
milestones of up to $3.45 billion. In addition, Akeso will be
eligible to receive low double-digit royalties on net sales.
Following the Antitrust Clearance Date, on January 17, 2023, the
License Agreement closed and, as initial upfront payment, Akeso was
issued 10 million shares of Company common stock pursuant to the
Share Transfer and was paid $274.9 million dollars in cash. The
$200 million remaining amount of the $500 million upfront payment
is payable on March 5, 2023. In connection with the License
Agreement, the Company has also agreed to enter into a Supply
Agreement with Akeso, pursuant to which Summit agreed to purchase a
certain portion of drug substance for clinical and commercial
supply (the “Supply Agreement”).
Pursuant to the terms of the License Agreement, Summit will have
final decision-making authority with respect to commercial
strategy, pricing and reimbursement and other commercialization
matters in the Licensed Territory. Summit is not assuming any
liabilities (including contingent liabilities), acquiring any
physical assets or trade names, or hiring or acquiring any
employees from Akeso in connection with the License Agreement.
Akeso has incurred research and development expenses relating to
ivonescimab, including expenses for pre-clinical studies, as well
as safety and efficacy clinical trials in non-licensed
territories.
Our
Strategy
Our
goal is to become a fully integrated biopharmaceutical company
focused on the discovery, development, and commercialization of our
pipeline product portfolio in the therapeutic area of oncology
and/or new era products that work in harmony with the human gut
microbiome, including innovative therapeutics for the treatment of
certain cancers and infectious diseases.
Product
Pipeline
Ivonescimab
Ivonescimab is believed to be the PD-1 / VEGF bispecific antibody
that is most advanced in the clinic. Ivonescimab has received
Breakthrough Therapy Designation status in China from the NMPA for
three indications: combination therapy with chemotherapy for NSCLC
patients who have failed a previous EGFR-TKI, combination therapy
with chemotherapy for NSCLC patients who have failed to respond to
a prior PD-(L)1 therapy, and monotherapy as first-line treatment
for locally advanced or metastatic NSCLC patients with positive
PD-L1 expression. Ivonescimab is currently being developed in China
and Australia in multiple solid tumors, including a Phase III
clinical trial in patients with NSCLC that is positive for an
epidermal growth factor receptor (EGFR) mutation whose disease has
progressed after treatment with an EGFR tyrosine-kinase inhibitor
(TKI). As
presented at ASCO 2022, ivonescimab treatment was associated with
an overall response rate (ORR) in a Phase II study in patients with
non-small cell lung cancer (NSCLC) who have failed EGFR-TKI’s of
68.4% and a median Progression-Free Survival (mPFS) time period of
8.2 months when combined with combination chemotherapy (pemetrexed
and carboplatin) as compared to historical mPFS of 4.3 months in
patients treated with combination chemotherapy (pemetrexed and
platinum-based chemotherapy) alone, the current standard of care.
In a separate cohort, ivonescimab combined with docetaxel in
patients who have failed PD-(L)1 and chemotherapies demonstrated a
mPFS of 6.6 months as compared to a historical mPFS of 4.5 months
with docetaxel alone, a current standard of care regimen for these
patients. The study, which similarly had patients receiving
ivonescimab plus chemotherapy as their first line therapy for
metastatic disease, was considered to have demonstrated a tolerable
safety profile and a low discontinuation rate for adverse
events.
Summit has clinical development and commercialization rights for
SMT112 in its Licensed Territory (United States, Canada, Europe,
and Japan). Summit plans to design and conduct the clinical trial
activities for SMT112 in its Licensed Territory, to support and
submit relevant regulatory filings. Summit is initiating
development activities for ivonescimab and will do so first in
NSCLC indications. Summit plans to start treating patients in
clinical studies by the second quarter of 2023.
Discuva Platform
In December 2017, we expanded our activities in the field of
infectious diseases with the acquisition of Discuva Limited, a
privately held United Kingdom-based company. Through this
acquisition, we obtained a bacterial genetics platform and a suite
of software-based technologies (collectively termed our “Discuva
Platform”), which facilitate the discovery and development of new
mechanism antibiotics. Our Discuva Platform can be used to identify
new bacterial targets for drug discovery, understand the mechanism
of action of small molecules targeting varying types of bacteria
and select the most optimal preclinical candidates, including those
with the least propensity to develop bacterial resistance. On
January 20, 2023, we announced that given the License Agreement and
the Company’s shift in focus to oncology, we will cease further
investment in theDiscuva platform and evaluate further options for
the use of the Discuva Platform. Based on the evaluation of further
options for the use of the Discuva Platform, we willassess the
carrying value of the acquired Discuva Platform intangible
asset.
Enterobacteriaceae
Program
We
continue to advance our highly innovative program targeting
infections caused by Enterobacteriaceae. We have used our Discuva
Platform to identify our DDS-04 series, a novel chemotype active
against a clinically unexploited bacterial target that has the
potential to treat Enterobacteriaceae infections.
Enterobacteriaceae are a family of bacteria responsible for serious
infections across a number of conditions including bloodstream
infections, urinary tract infections (“UTI”) and hospital-acquired
pneumonias. Multi-drug resistant (“MDR”) Enterobacteriaceae are
resistant to treatment by most or occasionally all existing
antibiotics. The most difficult to treat among them are the
Extended Spectrum Beta-Lactamase (“ESBL”)-producing and the
Carbapenem-resistant CRE. According to the Center for Disease
Control and Prevention (“CDC”), ESBL-producing and CRE
Enterobacteriaceae have collectively caused an estimated 197,400
infections and 9,100 deaths in hospitalized patients in the United
States in 2019. Our DDS-04 series continues to build on highly
promising preclinical in vivo efficacy data with an
immediate focus on a new antibiotic agent for the treatment of
complicated urinary tract infections, pneumonia and the associated
bacteremia.
Our
lead preclinical candidate for the Enterobacteriaceae program from
the DDS-04 series is SMT026738 (formerly “DIS-0104145” and referred
to as “SMT-738”). SMT-738 is a novel small molecule inhibitor of
the essential bacterial lipoprotein transport system (LolCDE) in
Gram-negative bacteria, which displays a narrow spectrum of
activity towards Enterobacteriaceae. SMT-738 has demonstrated
potent in vitro activity against global MDR isolates of
E. coli and K. pneumoniae, including the clinically
challenging NDM-carrying CRE isolates where many currently
available treatment options have succumbed to clinical resistance
including colistin, an antibiotic of last resort. Most importantly,
SMT-738 has also shown robust in vivo efficacy in relevant
murine models of UTI, pneumonia and sepsis. A preliminary rodent
toxicity study has been concluded and the data supports the
continued clinical development of SMT-738. SMT-738 has the
potential to become a first in class antibiotic to treat
life-threatening infections. We retain worldwide clinical
development and commercial rights to SMT-738 and plan to continue
to perform IND-enabling activities. We have been and will continue
to pursue partnership discussions to continue the development of
SMT-738.
Other
Material Agreements
On
December 6, 2022, we entered into a Note Purchase Agreement (the
“Note Purchase Agreement”) and promissory notes with Robert W.
Duggan, the Company’s Chief Executive Officer, Chairman of the
Board, and beneficial owner of approximately 78.1% of the Company’s
common stock and Dr. Mahkam Zanganeh, the Company’s co-Chief
Executive Officer, President, member of the Board and beneficial
owner of approximately 6.0% of the Company’s common stock. Pursuant
to the Note Purchase Agreement, the Company agreed to sell to Mr.
Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate
amount of $520 million.
Pursuant
to the Note Purchase Agreement, the Company has issued to Mr.
Duggan and Dr. Zanganeh unsecured promissory notes in the amount of
$400 million and $20 million, respectively (the “February Notes”),
which will mature and become due on February 15, 2023 (the
“February Maturity Date”) and an unsecured promissory note to Mr.
Duggan in the amount of $100 million (the “September Note” and
together with the February Notes, the “Notes”), which will mature
and become due on September 15, 2023 (the “September Maturity Date”
and together with the February Maturity Date, the “Maturity
Dates”). The Maturity Dates may be extended one or more times at
the Company’s election, but in no event to a date later than
September 6, 2024. The Notes accrue interest at an initial rate of
7.5%. All interest on the Notes shall be paid on the date of
signing for the period through the February Maturity Date. Such
prepaid interest shall be paid in a number of shares of the
Company’s common stock, par value $0.01 equal to the dollar amount
of such prepaid interest, divided by $0.7913 (the consolidated
closing bid price immediately preceding the time the Company
entered into the Note Purchase Agreement, plus $0.01), which is
9,720,291 shares. If the Company exercises its right to extend the
term of the February Notes for all periods following the February
Maturity Date and, with respect to the September Note following the
February Maturity Date, interest shall accrue on the outstanding
balance of such extended Notes at the US prime interest rate plus
50 basis points, as adjusted monthly, for three months immediately
following the Maturity Date, and thereafter at the US prime rate
plus 300 basis points, as adjusted monthly, in each case payable in
cash quarterly in arrears. In addition, if the Company shall
consummate a public offering, then upon the later to occur of (i)
five business days after the Company receives the net cash proceeds
therefrom or (ii) May 15, 2023, the February Notes shall be prepaid
by an amount equal to the lesser of (a) 100% of the amount of the
net proceeds of such offering and (b) the outstanding principal
amount on such Notes. In January 2023, the Company provided notice
to Mr. Duggan that it has elected to extend the Maturity Dates of
the $400 million February Note and the September Note to September
6, 2024. The Company and Mr. Duggan have rectified the $400 million
February Note and the September Note in order to correctly reflect
the parties’ intent in such notes that the Company may only prepay
(i) the $400 Million February Note following the completion of the
Rights Offering, or a similar capital raise, in an amount equal to
the lesser of (x) the net proceeds of the Rights Offering or such
capital raise or (y) the full amount outstanding of the such note,
and (ii) the September Note following the completion of a capital
raising transaction subsequent to the Rights Offering in an amount
equal to the lesser of (i) the net proceeds of such capital raise
or (ii) the full amount outstanding of the September
Note.
The
Company intends to repay the February Notes within five business
days following the consummation of this Rights Offering in an
amount equal to the lesser of (a) 100% of the amount of the net
proceeds of the Rights Offering and (b) the outstanding principal
amount on such Notes. The Notes were issued to Mr. Duggan and Dr.
Zanganeh, as applicable, in a private placement in reliance on
Regulation D promulgated under the Securities Act of 1933, as
amended. The Notes have not been registered under the Securities
and Exchange Act of 1933, as amended, and may not be offered or
sold absent registration or an applicable exemption from
registration requirements.
Liquidity
As of
the date of this filing, the Company has received $520 million from
the Note Purchase Agreement as discussed above. On January 17,
2023, Akeso was issued 10 million shares of Company common stock
pursuant to the Share Transfer and was paid $274.9 million dollars
in cash. The Company expects to use the proceeds of the Note
Purchase Agreement to support (i) payment of the upfront obligation
totaling $500 million associated with the License Agreement as
described above (which includes the payment of $274.9 million in
cash referenced in the preceding sentence); (ii) activities to
support clinical development and regulatory approval for SMT112;
(iii) its pursuit of business development opportunities to expand
or enhance our pipeline of drug candidates; and (iv) general
corporate purposes. In January 2023, the Company provided notice to
Mr. Duggan that it has elected to extend the Maturity Dates of the
$400 million February Note and the September Note to September 6,
2024.
The
purpose of this Rights Offering is to raise equity capital in a
cost-effective manner that provides all of our existing
stockholders the opportunity to participate. The net proceeds will
be used for one or more of the following purposes: (i) the
repayment of certain unsecured promissory notes totaling $420
million issued pursuant to the Note Purchase Agreement and (ii)
general corporate purposes, which includes funding the Company’s
activities to support
clinical development and regulatory approval for SMT112 and pursue
business development opportunities to expand or enhance our
pipeline of drug candidates.
We
believe that our existing cash, cash equivalents and U.K. research
and development tax credits, together with the net proceeds from
this Rights Offering after the repayment of certain unsecured
promissory notes totaling $420 million issued pursuant to the
Note Purchase
Agreement, will be sufficient to fund our operations and
initially planned clinical trials for ivonescimab into the second
half of 2024. If the Company
is unable to successfully complete this Rights Offering, or if the
net proceeds are significantly less than expected, the
Company would seek other funding alternatives. However, if
additional funding is not available, or is not available on terms
acceptable to the Company, the Company will focus its available
capital on certain initially planned clinical trials for
ivonescimab. This would allow the Company to be able to operate
into the third quarter of 2024. These actions could adversely
affect the Company’s business prospects.
The
Company expects to continue generating operating losses for the
foreseeable future. Until the Company can generate substantial
revenue and achieve profitability, the Company will need to raise
additional capital to fund its ongoing operations and capital
needs. The Company continues to evaluate options to further finance
its operating cash needs for its product candidates through a
combination of some, or all, of the following: equity and debt
offerings, collaborations, strategic alliances, grants and clinical
trial support from government entities, philanthropic,
non-government and not-for-profit organizations and patient advocacy groups, and
marketing, distribution or licensing arrangements.
While the Company believes
that funds would be available in this manner before 2024,
there is no assurance,
however, that additional financing will be available when needed or
that management of the Company will be able to obtain financing on
terms acceptable to the Company. If the Company is unable to obtain
funding when required in the future, the Company could be
required to delay, reduce, or eliminate research and development
programs, product portfolio expansion, or future commercialization
efforts, which could adversely affect its business
prospects.
Corporate
Information
Summit Therapeutics Inc. was incorporated in Delaware on July 17,
2020. Our principal executive office is located at 2882 Sand Hill
Road, Suite 106, Menlo Park, California and our phone number is
(617) 514-7149. Our website is https://www.smmttx.com.
Information contained on or accessible through our website is not
incorporated by reference into this prospectus and should not be
considered a part of this prospectus.
Recent Developments
In
addition to the recent developments included in this Prospectus
Summary, on January 6, 2023 the Company held a Special Meeting of
Stockholders in which the stockholders approved: (i) an amendment
to our restated certificate of incorporation to increase the number
of authorized shares of our common stock by 650,000,000 (from
350,000,000 to 1,000,000,000); and (ii) an amendment to our
restated certificate of incorporation to effect a reverse stock
split of all of the outstanding shares of our common stock at a
ratio in the range of 1-for-5 to 1-to-10, such that every holder of
common stock of the Company shall receive ten to twenty shares of
common stock for every 100 shares of common stock held. On January
19, 2023, the Board approved, and the Company subsequently filed,
an amendment to the amended and restated certificate of
incorporation to increase the Company’s capitalization as described
in clause (i). The Board reserves the right to adopt the proposal
described in clause (ii) at any time prior to January 6, 2024 but
has no intention to effect the reverse stock split prior to the
closing of the Rights Offering and issuance of shares thereunder.
For a more detailed discussion, see “Risk Factors” on page
23.
RISK
FACTORS
Investing
in our common stock involves risks. Please carefully consider the
risk factors described in our periodic reports filed with the SEC,
including those set forth under the caption “Item 1A. Risk Factors”
in our annual report on Form 10-K for the fiscal year ended
December 31, 2021 and quarterly reports on Form 10-Q filed
thereafter, which are incorporated by reference in this prospectus
and in any other documents we may file in the future and that will
be incorporated by reference into this prospectus. Before making an
investment decision, you should carefully consider these risks as
well as other information we include or incorporate by reference in
this prospectus. You should be able to bear a complete loss of your
investment.
Risks
Related to the License Agreement and the Development and
Commercialization of Ivonescimab
The License Agreement and the transactions contemplated thereby
represent a material shift in the Company’s strategic focus, may
not achieve intended results and could increase the number of our
outstanding shares or amount of outstanding
debt.
As
the Company previously announced, on September
28, 2022, we determined that we would seek partners or a
divestiture of ridinilazole, our lead product candidate for
treating patients suffering from CDI, as the path forward for the
clinical development of the asset. As a result of this
determination, we discontinued our only active study for
ridinilazole, a pediatric clinical trial evaluating ridinilazole
for treating adolescent patients with CDI. We are currently
involved in activities related to closeout of ridinilazole clinical
trials.
On
December 5, 2022 we entered into the License Agreement with
Akeso pursuant
to which Akeso granted the Company an in-license to its
breakthrough bispecific antibody, ivonescimab, in the Licensed
Territory. The entry into the
License Agreement and potential partnership or divestiture of
ridinilazole represents a material shift in the Company’s strategy.
All prior development and marketing activities relating to
ridinilazole are being terminated and our future operations will be
heavily dependent on the License Agreement and other future
activities as the Company determines.
Given
the License Agreement and shift in focus to oncology, the Company
decided it will cease further investment in the Discuva platform
and evaluate further options for the use of the Discuva Platform.
Based on the evaluation of further options for the use of the
Discuva Platform, the Company will assess the carrying value of the
acquired Discuva Platform intangible asset.
The
success of this transaction will depend, in part, on the clinical
success of ivonescimab as well as the success of our collaboration
with Akeso. This transaction may not result in the realization of
the full benefit of any anticipated growth opportunities or these
benefits may not be realized within the expected time frames. Our
Company has no prior history of a successful product candidate and,
as discussed above, we determined that we would seek partners or a
divestiture for our prior lead product candidate, ridinilazole, on
September 28, 2022, and will pursue partnership discussions to
continue the development of SMT-738. We will also require
significant additional financing to fund the clinical development
plan and certain payments contemplated by the License Agreement
that could result in an increase in the number of our outstanding
shares or the aggregate amount of our debt. If we are unable to
raise capital to fund these additional payments, it may cause a
material adverse effect on our business.
We will depend heavily on the success of ivonescimab. If we are
unable to commercialize ivonescimab, or experience significant
delays in doing so, our business will be materially
harmed.
We
plan to invest a significant portion of our efforts and financial
resources in the development of ivonescimab, which is still in
clinical development. Our ability to generate product revenues,
which may not occur for several years, if ever, will depend heavily
on the successful development and commercialization of ivonescimab.
The success of this product candidate will depend on a number of
factors, including the following:
|
● |
Ability
to use data of patients from Akeso’s clinical trials in China in
seeking regulatory approval; |
|
● |
successful
completion of clinical development; |
|
● |
receipt
of marketing approvals from applicable regulatory
authorities; |
|
● |
establishing
supply chain and commercial manufacturing arrangements with
third-party manufacturers; |
|
● |
obtaining
and maintaining patent and trade secret protection and regulatory
exclusivity; |
|
● |
protecting
our rights in our intellectual property portfolio; |
|
● |
establishing
sales, marketing and distribution capabilities; |
|
● |
launching
commercial sales of ivonescimab if and when approved, whether alone
or in collaboration with others; |
|
● |
acceptance
of ivonescimab, if and when approved, by patients, the medical
community and third-party payors; |
|
● |
obtaining
adequate pricing and a reimbursement profile; |
|
● |
ensuring
no disruption in supply or lack of sufficient quantities of
ivonescimab; |
|
● |
effectively
competing with other therapies; and |
|
● |
maintaining
a continued acceptable safety profile of ivonescimab, following
approval. |
If we
do not achieve one or more of these factors in a timely manner or
at all, we could experience significant delays or an inability to
successfully commercialize ivonescimab,
which would materially harm our business.
We depend on our relationship with, and the intellectual property
licensed from, Akeso, and termination of the License Agreement or
any of the licenses under the License Agreement could have a
material adverse effect on our business.
We
depend on the know-how and other intellectual property licensed
from Akeso through the License Agreement for the development and,
if approved, commercialization of product candidates with the use
of Akeso’s bispecific antibody, ivonescimab. If the License
Agreement is terminated, or found to be unenforceable, it could
result in the loss of significant rights and could harm our ability
to commercialize ivonescimab.
The
License Agreement imposes certain obligations on us, including
obligations to use diligent efforts to meet development thresholds,
funding requirements, payment obligations, patent prosecution and
commercialization. Accordingly, disputes may arise between us and
Akeso regarding these obligations and various contract terms, as
they relate to the intellectual property subject to the License
Agreement or other issues with intellectual property, including
those relating to:
|
● |
the
scope of rights, if any, granted under the License Agreement and
other interpretation-related issues; |
|
● |
whether
and to what extent our technology and processes infringe on
intellectual property rights of Akeso or other third parties that
are not subject to the License Agreement; |
|
● |
whether
Akeso had the right to grant the licenses under the License
Agreement; |
|
● |
whether
third parties are entitled to compensation or equitable relief,
such as an injunction, for our use of intellectual property without
their authorization; |
|
● |
our
right to sublicense patent and other rights to third parties under
collaborative development relationships; |
|
● |
whether
we are complying with our obligations with respect to the use of
the licensed technology in relation to our development and
commercialization of product candidates; |
|
● |
ownership
of specific intellectual property; |
|
● |
our
involvement in and ability to align on the prosecution and
enforcement of the licensed patents and patent applications and
Akeso’s overall patent prosecution, intellectual property
protection and enforcement strategies; and |
|
● |
the
impact on payments and costs associated with commercialization if
there is blocking intellectual property in or costs associated with
prosecution, maintenance and enforcement under the License
Agreement. |
The
resolution of any such disputes, disagreements, or issues that may
arise could narrow what we believe to be the scope of our rights to
the relevant intellectual property or technology, or increase what
we believe to be our financial or other obligations under the
relevant agreement.
Our primary product candidate, ivonescimab, is subject to a license
from Akeso, which is revocable in certain circumstances, including
in the event we do not achieve certain payment deadlines. Without
the license, we will not be able to continue to develop
ivonescimab.
The
License Agreement may be terminated by Akeso in the event of a
material breach by us or if we default in the performance of any of
our material obligations under the License Agreement, and such
default continues for 90 days, or with respect to any breach of any
undisputed payment obligations, for 60 days, or with respect to any
breach of a supply requirement, for 30 days after written notice
thereof. Akeso may also terminate the agreement upon written notice
upon the Company’s bankruptcy.
We
may not continue to be able to make the various payment obligations
under the License Agreement, including certain significant payments
due upon satisfaction of pre-commercialization milestones. If the
License Agreement were to be terminated by Akeso for any reason, we
would lose our most significant asset and primary product
candidate, and would likely not be able to develop ivonescimab,
which would have a material adverse effect on our
operations.
We will be reliant on Akeso for knowledge transfer relating to
manufacturing of our product candidate. The loss of any of the
knowledge transferred relating to ivonescimab from Akeso may cause
us to incur additional transition costs or result in delays in the
manufacturing and delivery of our product
candidate.
We
have entered into the License Agreement and the Supply Agreement
with Akeso for information and drug substance that we will rely on
to be used in our product candidate, and the termination or Akeso’s
breach of these agreements could have a material adverse effect on
our business.
If we
lost our relationship with Akeso we could experience an increase in
our costs, result in delays in the manufacturing and delivery of
our product candidate or cause us to carry excess or obsolete
inventory. Additionally, poor quality in any of the drug substances
could result in lost sales or lost sales opportunities. Further,
failure of Akeso to adequately transfer knowledge to the Company to
continue to produce ivonescimab could have a material adverse
effect on our business. Manufacturing of biological compounds is
inherently complex and establishing new manufacturing relationships
with a third party manufacturer may take longer, resulting in
higher costs and potential inventory issues. Manufacturing
processes may use materials which Summit may not be able to secure,
requiring Summit to have to develop alternative processes and delay
manufacturing. The product may not comply with the FDA quality
requirements and/or have sufficient stability for
commercialization, which may require additional manufacturing
development and delays. As Summit is relying initially on supply
from Akeso, any delays in obtaining import or export licenses may
delay start of clinical trials.
If clinical trials of our product candidates fail to demonstrate
safety and efficacy to the satisfaction of the U.S. Food and Drug
Administration, or the FDA, or the European Medicines Agency, or
the EMA, or do not otherwise produce favorable results, we may
incur additional costs or experience delays in completing, or
ultimately be unable to complete, the development and
commercialization of ivonescimab or any other product
candidate.
In
connection with obtaining marketing approval from regulatory
authorities for the sale of any product candidate, we must complete
preclinical development and then conduct extensive clinical trials
to demonstrate the safety and efficacy of our product candidates in
humans. Clinical testing is expensive, difficult to design and
implement, can take many years to complete and is inherently
uncertain as to outcome. A failure of one or more clinical trials
can occur at any stage of testing. The outcome of preclinical
testing and early clinical trials may not be predictive of the
success of later clinical trials, and interim results of a clinical
trial do not necessarily predict final results. In particular, due
to the small number of patients in our early clinical trials,
results from such trials may not be predictive of the outcome of
later clinical trials. The design of a clinical trial can determine
whether its results will support approval of a product, and flaws
in the design of a clinical trial may not become apparent until the
clinical trial is well advanced or completed. We have limited
experience in designing clinical trials and may be unable to design
and execute a clinical trial to support marketing approval.
Moreover, preclinical and clinical data are often susceptible to
varying interpretations and analyses, and many companies that have
believed their product candidates performed satisfactorily in
preclinical studies and clinical trials have nonetheless failed to
obtain marketing approval of their products.
To
date, we have not conducted a clinical trial for ivonescimab and
cannot predict the results of such trials.
If we experience delays or difficulties in the enrollment of
patients in our clinical trials, our receipt of necessary marketing
approvals could be delayed or prevented.
We
may not be able to initiate or continue clinical trials for our
product candidates, if we are unable to locate and enroll a
sufficient number of eligible patients to participate in these
clinical trials.
Patient
enrollment is affected by other factors, including:
|
● |
severity
of the disease under investigation; |
|
● |
eligibility
criteria for the clinical trial in question; |
|
● |
perceived
risks and benefits of the product candidate under
study; |
|
● |
competition
for patients, time and resources at clinical trials sites from
other investigational therapies in clinical trials that target the
same patient population; |
|
● |
approval
of other therapies to treat the indication that is being
investigated in the clinical trial; |
|
● |
efforts
to facilitate timely enrollment in clinical trials; |
|
● |
patient
referral practices of physicians; |
|
● |
the
ability to monitor patients adequately during and after treatment;
and |
|
● |
proximity
and availability of clinical trial sites for prospective
patients. |
Enrollment
delays in our clinical trials may result in increased development
costs for our product candidates, which would cause the value of
our company to decline and limit our ability to obtain additional
financing. Our inability to enroll a sufficient number of patients
in a clinical trial for ivonescimab or any other planned clinical
trials would result in significant delays, may generate a limited
data set from which no meaningful conclusions could be made, or may
require us to abandon one or more clinical trials
altogether.
If serious adverse or inappropriate side effects are identified
during the development of ivonescimab or any other product
candidate, we may need to abandon or limit our development of that
product candidate.
All
of our product candidates are in clinical or early-stage
development and their risk of failure is high. It is impossible to
predict when or if any of our product candidates will prove
effective or safe in humans or will receive marketing approval. If
our product candidates are associated with undesirable side effects
or have characteristics that are unexpected, we may need to abandon
their development or limit development to certain uses or
subpopulations in which the undesirable side effects or other
characteristics are less prevalent, less severe or more acceptable
from a risk-benefit perspective.
Many
compounds that initially showed promise in clinical or earlier
stage testing have later been found to cause side effects or other
safety issues that prevented further development of the compound.
If we elect or are forced to suspend or terminate any clinical
trial of our product candidates, the commercial prospects of such
product candidate will be harmed and our ability to generate
product revenues from such product candidate will be delayed or
eliminated. Any of these occurrences could materially harm our
business.
The Committee on Foreign Investment in the United States (“CFIUS”)
or other regulatory agencies may modify, delay or prevent the
transactions contemplated by the License
Agreement.
The
Committee on Foreign Investment in the United States (“CFIUS”) has
authority to review direct or indirect foreign investments in U.S.
companies. Among other things, CFIUS is empowered to require
certain foreign investors to make mandatory filings, to charge
filing fees related to such filings and to self-initiate national
security reviews of foreign direct and indirect investments in U.S.
companies if the parties to that investment choose not to file
voluntarily. In the case that CFIUS determines an investment to be
a threat to national security, CFIUS has the power to unwind or
place restrictions on the investment. Whether CFIUS has
jurisdiction to review an acquisition or investment transaction
depends on, among other factors, the nature and structure of the
transaction, including the level of beneficial ownership interest
and the nature of any information or governance rights involved.
For example, investments that result in “control” of a U.S.
business by a foreign person always are subject to CFIUS
jurisdiction. CFIUS’s expanded jurisdiction under the Foreign
Investment Risk Review Modernization Act of 2018 and implementing
regulations that became effective on February 13, 2020 further
includes investments that do not result in control of a U.S.
business by a foreign person but afford certain foreign investors
certain information or governance rights in a U.S. business that
has a nexus to “critical technologies,” “critical infrastructure”
and/or “sensitive personal data.”
We
believe that no mandatory filing was required in connection with
the License Agreement but we have not yet determined whether we
will make a voluntary filing. CFIUS may decide to modify or delay
our proposed business combination, impose conditions with respect
to such business combination, request the President of the United
States to order us to divest all or a portion of the assets we
acquired without first obtaining CFIUS approval or prohibit the
License Agreement entirely. If it is determined that a mandatory
filing was required to be made, it is possible that a material
penalty could be assessed against the Company.
We may complete a future acquisition that may not achieve intended
results or could increase the number of our outstanding shares or
amount of outstanding debt or result in a change of
control.
In
addition to the License Agreement and the transactions contemplated
thereby, we may pursue business development opportunities to expand
or enhance our pipeline of drug candidates, including without
limitation, through potential acquisitions of and/or collaborations
with other entities. Any such transaction could happen at any time,
could be material to our business and could take any number of
forms, including, for example, an acquisition, merger or a
collaboration with other entities.
Evaluating
potential transactions and integrating completed ones may divert
the attention of our management from ordinary operating matters.
The success of these potential transactions will depend, in part,
on our ability to realize the anticipated growth opportunities
through the successful integration of the businesses we acquire
with our existing business, as well as the success of the
underlying business or intellectual property that we acquire or
otherwise obtain rights to. Even if we are successful in
integrating the acquired businesses, these integrations may not
result in the realization of the full benefit of any anticipated
growth opportunities or these benefits may not be realized within
the expected time frames. In addition, acquired businesses may have
unanticipated liabilities or contingencies.
If we
complete an acquisition, investment or other strategic transaction,
we may require additional financing that could result in an
increase in the number of our outstanding shares or the aggregate
amount of our debt.
We will need substantial additional capital to fund our operations
and to make payments under the License Agreement and the Note
Purchase Agreement and if we fail to obtain necessary financing, we
could be forced to delay, reduce or eliminate the development and
commercialization of our product candidates.
Conducting
preclinical testing and clinical trials is a time-consuming,
expensive and uncertain process that takes years to complete, and
we may never generate the necessary data or results required to
obtain marketing approval and achieve product sales. In addition,
our product candidates, if approved, may not achieve commercial
success. Our commercial revenues, if any, will be derived from
sales of products that we are not planning to have commercially
available for several years, if at all. Accordingly, we will need
to continue to rely on additional financing to achieve our business
objectives. In addition, we may seek additional capital due to
favorable market conditions or strategic considerations, even if we
believe that we have sufficient funds for our current or future
operating plans. Additional financing may not be available to us on
acceptable terms, or at all.
We
expect our research and development expenses to increase
substantially in connection with our ongoing activities,
particularly in connection with the License Agreement. In addition,
if we obtain marketing approval these potential future product
candidates where we retain commercial rights or any other product
candidates we develop, we expect to incur significant
commercialization expenses related to product sales, marketing,
distribution and manufacturing. Accordingly, we will need to obtain
substantial additional funding in connection with our continuing
operations. If we are unable to raise capital when needed or on
attractive terms, we could be forced to delay, reduce or eliminate
our research and development programs or any future
commercialization efforts.
Our
primary future capital requirements will be related to our
obligations under the License Agreement.
We
expect to continue to generate operating losses for the foreseeable
future. The License Agreement calls for initial consideration
payments of $500 million, as well as total contingent payments by
the Company of up to $5.0 billion, as Akeso will be eligible to
receive regulatory milestones of up to $1.05 billion and commercial
milestones of up to $3.45 billion, many of which will be due before
the Company anticipates generating any revenue from the License
Agreement. We entered into the Note Purchase Agreement to fund the
initial consideration payments and we will need additional capital
to fund our operations and payments under the License Agreement and
the Note Purchase Agreement. $420 million of the proceeds of the
Rights Offering are anticipated to be used to repay borrowings
under the Note Purchase Agreement. We also anticipate further
capital raises to repay the remaining borrowings under the Note
Purchase Agreement. We do not have any committed external sources
of funds and do not anticipate receiving any additional funds from
BARDA with respect to SMT112. Under this Rights Offering, Mr.
Robert W. Duggan and Dr. Mahkam Zanganeh have each indicated that
they intend to participate in the Rights Offering and subscribe for
at least the full amount of their Basic Subscription Rights, but
they have not made any formal binding commitment to participate. We
will need to seek additional funding in the future to fund
operations. Additional capital, when needed, may not be available
to us on acceptable terms, or at all. To the extent that we raise
additional capital through the sale of equity or convertible debt
securities, the ownership interest of our existing stockholders may
be diluted, and the terms of these securities may include
liquidation or other preferences that adversely affect the rights
of our existing stockholders. Debt financing, if available, may
involve agreements that include covenants limiting or restricting
our ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends or other
distributions. If we raise additional funds through collaborations,
strategic alliances or marketing, distribution, or licensing
arrangements with third parties, we may have to relinquish valuable
rights to our technologies, future revenue streams, research
programs or product candidates or to grant licenses on terms that
may not be favorable to us. If we are unable to raise sufficient
funds through this Rights Offering or other equity, debt
financings, or other arrangements when needed based on our
liquidity needs, we may implement an alternative operating plan
that materially scales back our operations, reduces cash
expenditures, and focuses our available capital on a reduced number
of activities and programs.
In January 2023, the Company provided notice to Mr. Duggan that it
has elected to extend the Maturity Dates of the $400 million
February Note and the September Note to September 6, 2024.
By
extending the Notes to the final maturing date, the Company’s cash,
cash equivalents and U.K. research and development tax credits
would be sufficient to fund our operations into the second half of
2024.
We have substantial indebtedness and will likely require additional
indebtedness in the future, which may require us to use a
substantial portion of our cash flow to service debt and limit our
financial and operating flexibility.
We
have substantial indebtedness and will likely require additional
indebtedness in the future. As of [●], we had a total of $520
million of indebtedness outstanding under the Note Purchase
Agreement. Upon the completion of this Rights Offering, after
giving effect to the use of proceeds described in this prospectus,
we expect to have repaid $420 million of indebtedness outstanding
under the Note Purchase Agreement. Further, the License Agreement
calls for certain additional future payment obligations and we may
require additional indebtedness to fund those obligations. Our
existing and future indebtedness will require interest payments and
need to be repaid or refinanced and could require us to divert
funds identified for other purposes to service our debt, could
result in cash demands and impair our liquidity position and could
result in financial risk for us. Diverting funds identified for
other purposes for debt service may adversely affect our growth
prospects. If we cannot generate sufficient cash flow from
operations to service our debt, we may need to refinance our debt,
dispose of assets, or issue equity to obtain necessary funds. We do
not know whether we would be able to take any of these actions on a
timely basis, on terms satisfactory to us, or at all.
The Company’s failure to comply with the terms and obligations of
the Note Purchase Agreement, including as a result of events beyond
our control, may result in an event of default.
The
Note Purchase Agreement requires us to comply with certain
repayment obligations, representations and covenants. For a more
detailed discussion, see “Prospectus Summary — Other Material
Agreements” beginning on page 21. A breach of any of these
obligations, representations or covenants or the occurrence of
certain other specified events could result in an event of default
under the Note Purchase Agreement. Upon the occurrence of any event
of default under the Note Purchase Agreement, the outstanding
balance on the corresponding Note will, at the option of such
lender, become immediately and automatically due and payable in
cash and a default interest rate of an additional 2% per annum will
apply on all outstanding obligations during the occurrence and
continuance of an event of default.
We
may not be able to maintain compliance with these repayment
obligations and covenants in the future and, if we fail to do so,
that we may not able to obtain waivers from the lenders and/or
amend the covenants. Our failure to comply with the repayment
obligations and covenants described above could result in an event
of default, which, if not cured or waived, and if lender
accelerates, would result in us being required to repay these
borrowings before their due date. If we are forced to refinance
these borrowings on less favorable terms or if we are unable to
refinance these borrowings, our business, financial condition, and
results of operations could be materially adversely
affected.
We are a development-stage company and have incurred significant
losses since our inception. We expect to incur losses for at least
the next several years and may never generate profits from
operations or maintain profitability.
We
are a development-stage company and we cannot assure profitability.
We expect to continue to generate operating losses for the
foreseeable future. Until we can generate substantial revenue and
achieve profitability, we will need to raise additional capital to
fund ongoing operations and capital needs. Since inception, we have
incurred significant operating losses. In the year ended December
31, 2021, we incurred a net loss of $88,602. In the three months
ended September 30, 2022, we incurred net losses of $21,385. These
losses could continue for the next several years as we invest in
clinical development of ivonescimab. We believe that our existing
cash, cash equivalents and U.K. research and development tax
credits, together with the net proceeds from this Rights Offering,
will fund our operations and initially planned clinical trials for
ivonescimab into the second half of 2024.
To
become and remain profitable, we must succeed in developing and
eventually either commercializing or partnering with other
organizations to commercialize products that generate significant
revenue. This will require us to be successful in a range of
challenging activities, including completing preclinical testing
and clinical trials of our product candidates, discovering
additional product candidates, obtaining regulatory approval for
these product candidates and manufacturing, marketing, and selling
any products for which we may obtain regulatory approval. We are in
the preliminary stages of many of these activities. We may never
succeed in these activities and, even if we do, may never generate
revenue that is significant enough to achieve
profitability.
Because
of the numerous risks and uncertainties associated with
pharmaceutical products and biological development, we are unable
to accurately predict the timing or amount of increased expenses or
when, or if, we will be able to achieve profitability.
Even
if we do achieve profitability, we may not be able to sustain or
increase profitability on a quarterly or annual basis. Our failure
to become and remain profitable would depress our value and could
impair our ability to raise capital, expand our business, maintain
our research and development efforts, diversify our product
offerings or even continue our operations.
Our business is subject to the risks associated with doing business
in China.
As a
result of our reliance on Akeso, located in China, our results of
operations, financial condition, and prospects are subject to a
significant degree to economic, political, and legal developments
in China including government control over capital investments or
changes in tax regulations that are applicable to us. China’s
economy differs from the economies of most developed countries in
many respects, including with respect to the amount of government
involvement, level of development, growth rate and control of
foreign exchange, and allocation of resources. Since we rely on an
entity located in China, our business is subject to the risks
associated with doing business in China, including:
|
● |
adverse
political and economic conditions, particularly those potentially
negatively affecting the trade relationship between the United
States and China; |
|
● |
trade
protection measures, such as tariff increases, and import and
export licensing and control requirements; |
|
● |
potentially
negative consequences from changes in tax laws; |
|
● |
difficulties
associated with the Chinese legal system, including increased costs
and uncertainties associated with enforcing contractual obligations
in China; |
|
● |
historically
lower protection of intellectual property rights; |
|
● |
requirements
relating to China’s data security rules and
regulations; |
|
● |
changes
and volatility in currency exchange rates; |
|
● |
unexpected
or unfavorable changes in regulatory requirements; and |
|
● |
difficulties
in managing foreign relationships and operations
generally. |
U.S.-China trade relations may adversely impact our supply
chain operations and business.
The
U.S. and Chinese governments have taken certain actions that change
trade policies, including tariffs that affect certain products
which are manufactured in China and mutual exchange of certain
types of data. Due to our collaboration with Akeso, we are reliant
on collaborating with a company with significant operations in
China. It is unknown whether and to what extent new tariffs, laws
or regulations will be adopted that increase the cost or
feasibility of importing and/or exporting products, components and
information from China to the United States and vice versa.
Further, the effect of any such new tariffs or actions on our
industry and customers is unknown and difficult to predict. As
additional new tariffs, legislation and/or regulations are
implemented, or if existing trade agreements are renegotiated or if
China or other affected countries take retaliatory trade
actions, such changes could have a material adverse effect on our
clinical development plans, business, financial condition, results
of operations or cash flows.
Risks
Related to this Rights Offering and the Ownership of the Common
Stock
The Subscription Price determined for this Rights Offering is not
an indication of our value.
In
determining the Subscription Price for the Rights Offering, the
Special Committee considered a number of factors, including: the
likely cost of capital from other sources and general conditions of
the securities markets, the price at which our stockholders might
be willing to participate in the Rights Offering, our need for
liquidity and capital, the average price for the 30-day period
prior to the filing of the preliminary Proxy Statement on November
29, 2022, and the desire to provide an opportunity to our
stockholders to participate in the Rights Offering on a pro rata
basis. The Special Committee determined that it was in the best
interests of the Company’s stockholders to publicly announce the
Initial Price and the Alternate Price so that all stockholders had
the opportunity to determine whether to buy or sell the Company’s
shares of common stock prior to the Record Date. The Company did
not consider revising the Initial Price. The Company believes this
disclosure has provided its stockholders and the public with
sufficient information about the Company’s expectation to sell a
significant number of shares in the Rights Offering, as described
herein. The Subscription Price is not necessarily related to our
book value, net worth or any other established criteria of value
and may or may not be considered the fair value of the common stock
to be offered in the Rights Offering. The market price of our
common stock may decline during or after the Rights Offering,
including below the applicable Subscription Price. After the date
of this prospectus, our common stock may trade at prices above or
below the Subscription Price.
This Rights Offering may cause the trading price of our common
stock to decrease.
The
Subscription Price, together with the number of the common stock we
propose to issue and ultimately will issue if this Rights Offering
is completed, may result in an immediate decrease in the market
price of our common stock. This decrease may continue after the
completion of this Rights Offering. If that occurs, you may have
committed to buy common stock in the Rights Offering at a price
greater than the prevailing market price. The Alternate Price
provides certain protection in the event that the market price
declines after subscription but immediately prior to the expiration
of the Rights Offering. However, it is possible that the Alternate
Price may be higher than the market price at the time you receive
your shares. Your subscription is not revocable. Once you submit
your subscription, even if the market price declines, you will not
be able to revoke your subscription. Given that the Board reserves
the right to terminate the Rights Offering at any time, the Special
Committee and Board determined that a floor price was not in the
best interests of the Company. Following the closing of the Rights
Offering, if a substantial number of Subscription Rights are
exercised and the holders of the shares received upon exercise of
those Subscription Rights choose to sell some or all of the shares
underlying the Subscription Rights, the resulting sales could
depress the market price of our common stock. Following the
exercise of your Subscription Rights you may not be able to sell
your common stock at a price equal to or greater than the
Subscription Price.
The price of our common stock may be volatile.
The
trading price of our common stock may fluctuate significantly. The
price of our common stock that will prevail in the market after
this Rights Offering may be higher or lower than the Subscription
Price depending on many factors, some of which are beyond our
control and may not be directly related to our operating
performance. These factors include, but are not limited to, the
following:
|
● |
The
terms of any potential future transaction(s) related to debt
financing, debt restructuring or capital raising; |
|
● |
developments
in our relationships with employees, suppliers, distributors, sales
representatives and customers; |
|
● |
acquisitions
or divestitures; |
|
● |
litigation
and government proceedings; |
|
● |
adverse
legislation, including changes in governmental
regulation; |
|
● |
additions
or departures of key personnel; |
|
● |
sales
of our equity securities by our significant stockholders or
management or sales of additional equity securities by our
company; |
|
● |
changes
in securities analysts’ recommendations; |
|
● |
economic
and other external factors; and |
|
● |
general
market conditions. |
Additionally,
the stock market historically has experienced significant price and
volume fluctuations. These fluctuations are often unrelated to the
operating performance of particular companies. These broad market
fluctuations, such as those caused by the COVID-19 pandemic, may
cause declines in the trading price and market value of our common
stock.
We have received the requisite approvals and if the Board decides
to proceed with the reverse stock split after the closing
of the Rights Offering and issuance of shares thereunder, it may
decrease the liquidity of the shares of our common stock and could
lead to a decrease in our overall market
capitalization.
While
the Board reserves the right to effect the reverse stock split
prior to January 6, 2024, we do not intend to effect the reverse
stock split prior to the closing of the Rights Offering and
issuance of shares thereunder. The liquidity of the shares of our
common stock may be affected adversely by
such reverse stock split given the reduced number of
shares of our common stock that will be outstanding following
such reverse stock split, especially if the market
price of our common stock does not increase as a result of
such reverse stock split. In addition,
such reverse stock split may increase the
number of stockholders who own odd lots (less than 100 shares) of
our common stock, creating the potential for such stockholders to
experience an increase in the cost of selling their shares of
common stock and greater difficulty effecting such
sales.
We
expect that the proposed reverse stock split, if effected, will
increase the per share trading price of our common stock. However,
the market price per share of our common stock after the reverse
stock split may not rise (or remain constant) in proportion to the
reduction in the number of shares of common stock outstanding
before the reverse stock split. We cannot predict the effect of the
reverse stock split on the per share trading price of our common
stock, and the history of reverse stock splits for other companies
is varied, particularly since some investors may view a reverse
stock split negatively. Our total market capitalization after the
reverse stock split, if approved and effective, may be lower than
our total market capitalization before the reverse stock
split.
There is no guarantee that by the time the shares are
delivered to you, the market price of our common stock will be
above the Subscription Price for such shares. Further, because the
exercise of your Subscription Rights is not revocable and because
the rights are not transferable, you will not be able to revoke
your subscription if the market price decreases prior to the
delivery of the shares or transfer of the shares until after they
are delivered.
There
is no guarantee that the Subscription Price, whether it is set at
the Initial Price or the Alternate Price, will be lower than the
market price of our common stock at the time that the shares that
you receive in the Rights Offering are delivered. Further, because
the exercise of your Subscription Rights is not revocable and
because the rights are not transferable, you will not be able to
revoke your subscription if the market price decreases prior to the
delivery of the shares or transfer of the shares until after they
are delivered to you. Accordingly, the Subscription Price at which
you are purchasing shares of common stock may be above the
prevailing market price by the time that the shares of common stock
are purchased and delivered.
If
you exercise your Subscription Rights and the market price of the
common stock falls below the Subscription Price, then you will have
committed to subscribe in the Rights Offering at a price that is
higher than the market price. Moreover, we may never be able to
sell shares of common stock that you received in the Rights
Offering at a price equal to or greater than the Subscription Price
or exercise price. Until shares are issued to you in book-entry, or
uncertificated, form upon expiration of the Rights Offering, you
may not be able to sell the shares of our common stock that you
receive in the Rights Offering. We will issue shares of our common
stock that you received in the Rights Offering in book-entry, or
uncertificated, form as soon as practicable after expiration of the
Rights Offering. We will not pay you interest on funds delivered to
the subscription agent pursuant to the exercise of
rights.
If you do not exercise your Subscription Rights in full, your
percentage ownership and voting rights in Summit will experience
dilution.
If
you choose not to exercise your Subscription Rights, you will
retain your current number of shares of our common stock. If other
stockholders fully exercise their Subscription Rights or exercise a
greater proportion of their Subscription Rights than you exercise,
the percentage of our common stock owned by these other
stockholders will increase relative to your ownership percentage,
and your voting and other rights in the Company will likewise be
diluted.
The Subscription Rights are non-transferable and thus there will be
no market for them.
You
may not sell, transfer or assign your Subscription Rights to anyone
else, unless as required by operation of law. We do not intend to
list the Subscription Rights on the Nasdaq or any securities
exchange or trading market. Because the Subscription Rights are
non-transferable, there is no market or other means for you to
directly realize any value associated with the Subscription
Rights.
You may not be able to resell any shares of our common stock that
you receive pursuant to the exercise of Subscription Rights
immediately upon expiration of the Subscription Rights Offering
period or be able to sell your shares at a price equal to or
greater than the Subscription Price.
If
you exercise Subscription Rights, you may not be able to resell the
common stock that you receive in the Rights Offering until you, or
your custodian bank, broker, dealer or other nominee, if
applicable, have received those shares. Moreover, you will have no
rights as a stockholder of the shares you received in the Rights
Offering until we issue the shares to you. Although we will
endeavor to issue the shares as soon as practicable after
completion of the Rights Offering, and after all necessary
calculations have been completed, there may be a delay between the
Expiration Date of the Rights Offering and the time that the shares
are issued. In addition, following the exercise of your
Subscription Rights, you may not be able to sell your common stock
at a price equal to or greater than the Subscription
Price.
Because no minimum subscription is required and because we do not
have formal commitments from our stockholders for the entire amount
we seek to raise pursuant to the Rights Offering, we cannot assure
you of the amount of proceeds that we will receive from the Rights
Offering.
No
minimum subscription is required for consummation of the Rights
Offering. Although Robert W. Duggan, our Executive Chairman, Chief
Executive Officer, and the beneficial owner of approximately 78.1%
of our common stock prior to this Rights Offering, and Dr. Mahkam
Zanganeh, our co-Chief Executive Officer, President, a member of
our Board of Directors, and the beneficial owner of approximately
6.0% of our common stock prior to this Rights Offering, have each
indicated that they intend to participate in the Rights Offering
and subscribe for at least the full amount of their Basic
Subscription Rights, but have not made any formal binding
commitment to participate. It is also possible that no
Over-Subscription Rights will be exercised in connection with the
Rights Offering. As a result, we cannot assure you of the amount of
proceeds that we will receive in the Rights Offering. Therefore, if
you exercise all or any portion of your Subscription Rights, but
other stockholders do not, we may not raise the desired amount of
capital in the Rights Offering, the market price of our common
stock could be adversely impacted and we may find it necessary to
pursue alternative means of financing, which may be dilutive to
your investment.
Because we may terminate the Rights Offering at any time prior to
the Expiration Date, your participation in the Rights Offering is
not assured.
We do
not intend, but have the right, to terminate the Rights Offering at
any time prior to the Expiration Date. If we determine to terminate
the Rights Offering, we will not have any obligation with respect
to the Subscription Rights except to return any money received from
subscribing stockholders as soon as practicable, without interest
or deduction.
You will need to act promptly and carefully follow the subscription
instructions, or your exercise of rights may be
rejected.
Stockholders
who desire to subscribe for shares of common stock in the Rights
Offering must act promptly to ensure that all required forms and
payments are actually received by the subscription agent prior to
the Expiration Date, which is currently set to be 5:00 p.m. on [●].
If you are a beneficial owner of shares, you must act promptly to
ensure that your custodian bank, broker, dealer or other nominee
acts for you and that all required forms and payments are actually
received by the subscription agent prior to the Expiration Date.
Your nominee may establish a deadline prior to the Expiration Date
by which you must provide it with your instructions to exercise
your Subscription Rights and payment for your shares of common
stock. We will not be responsible if your custodian bank, broker,
dealer or nominee fails to ensure that all required forms and
payments are actually received by the subscription agent prior to
the Expiration Date. If you fail to complete and sign the required
subscription forms, send an incorrect payment amount, or otherwise
fail to follow the subscription procedures that apply to your
desired transaction the subscription agent may, depending on the
circumstances, reject your subscription or accept it to the extent
of the payment received. Neither we nor our subscription agent will
undertake to contact you concerning, or attempt to correct, an
incomplete or incorrect subscription form or payment. We have the
sole discretion to determine whether a subscription exercise
properly follows the subscription procedures.
By participating in the Rights Offering and executing a rights
certificate, you are making binding and enforceable representations
to the Company.
By
signing the rights certificate and exercising their rights, each
stockholder agrees, solely with respect to such stockholder’s
exercise of rights in the Rights Offering, that we have the right
to void and cancel (and treat as if never exercised) any exercise
of rights, and securities issued pursuant to an exercise of rights,
if any of the agreements, representations or warranties of a
subscriber in the subscription documents are false.
If you exercise the Over-Subscription Right, you may not receive
all of the shares of common stock for which you
subscribe.
Exercise
of the Over-Subscription Right will only be honored if and to the
extent that the Basic Subscription Rights have not been exercised
in full. If a sufficient number of shares of common stock are
available, we will seek to honor your over-subscription request in
full. If, however, over-subscription requests exceed the number of
shares available to be purchased pursuant to the Over-Subscription
Right, we will allocate the available share proportionately among
stockholders who exercised their Over-Subscription Rights based on
the number of shares each stockholder subscribed for under such
stockholder’s Basic Subscription Rights. As a result, you may not
receive any or all of the shares of common stock for which you
exercise your Over-Subscription Right.
As
soon as practicable after the Expiration Date, the subscription
agent will determine the number of shares of common stock that you
may purchase pursuant to the Over-Subscription Right. If you have
properly exercised your Over-Subscription Right, we will issue the
shares of common stock purchased in the Rights Offering to you in
book-entry, or uncertificated, form as soon as practicable after
the Expiration Date and after all allocations and adjustments have
been effected. If you request and pay for more shares than are
allocated to you, we will refund the overpayment, without interest
or deduction. In connection with the exercise of the
Over-Subscription Right, custodian banks, brokers, dealers and
other nominee holders of Subscription Rights who act on behalf of
beneficial owners will be required to certify to us and to the
subscription agent as to the aggregate number of Subscription
Rights exercised, and the number of shares requested through the
Over-Subscription Right, by each beneficial owner on whose behalf
the nominee holder is acting.
The tax treatment of the Rights Offering may be treated as a
taxable event to you.
We
believe and intend to take the position that the distribution of
the Subscription Rights in connection with the Rights Offering
generally should not be a taxable event to U.S. holders of our
common stock for U.S. federal income tax purposes. However, if the
distribution of rights (or a series of distributions of which this
distribution is one) were deemed to be a “disproportionate
distribution” under Section 305(b)(2) of the Internal Revenue Code
of 1986, as amended (the “Code”), holders of our common stock may
recognize taxable income for U.S. federal income tax purposes in
connection with the receipt of Subscription Rights in the Rights
Offering. Holders of our common stock are urged to consult their
own tax advisors with respect to the tax consequences of the Rights
Offering. Please see the section titled “Material U.S. Federal
Income Tax Consequences” beginning on page 48 for further
information.
We have broad discretion in the use of the net proceeds from this
Rights Offering and may use them in a manner that does not improve
our financial performance or operating results.
We
currently intend to use the net proceeds from this Rights Offering,
after deducting our offering expenses, for one or more of the
following purposes: (i) the repayment of certain unsecured
promissory notes totaling $420 million issued pursuant to the Note
Purchase Agreement and (ii) general corporate purposes, which
includes funding the Company’s activities to support clinical
development and regulatory approval for SMT112 and pursue business
development opportunities to expand or enhance our pipeline of drug
candidates. For a more detailed discussion, see “Use of
Proceeds” beginning on page 35. Although we plan to use the net
proceeds from this Rights Offering as described, we have not
designated the amount of net proceeds from this Rights Offering to
be used for any specific purpose. We will have broad discretion in
the use of the net proceeds. You will be relying on the judgment of
our management regarding the application of the proceeds of this
Rights Offering. The results and effectiveness of the use of
proceeds are uncertain, and we could spend the proceeds in ways
that you do not agree with or that do not improve our results of
operations or enhance the value of our common
stock.
If our common stock trades below $1.00, we may fail to meet the
continued listing requirements of the Nasdaq Global Market and our
common stock may be delisted.
Our
common stock is subject to certain continued listing standards set
by the Nasdaq Global Market, including a requirement to maintain a
minimum bid price of at least $1.00 per share. If our common stock
fails to meet such standards, it could be delisted from the Nasdaq
Global Market. This would have a negative impact on the liquidity
of our common stock, including shares subscribed for in this Rights
Offering.
USE OF
PROCEEDS
Although
we cannot determine what the actual net proceeds from the sale of
common stock in the Rights Offering will be until the Rights
Offering is completed, assuming all Subscription Rights are
exercised, we estimate that the aggregate net proceeds from the
sale of the common stock, after deducting estimated offering
expenses, will be approximately $499.5 million.
We
currently intend to use the net proceeds from this Rights Offering,
after deducting our offering expenses, for one or more of the
following purposes: (i) the repayment of certain unsecured
promissory notes totaling $420 million issued pursuant to the Note
Purchase Agreement and (ii) general corporate purposes, which
includes funding the Company’s activities to support clinical
development and regulatory approval for SMT112 and pursue business
development opportunities to expand or enhance our pipeline of drug
candidates. We have not determined the amount of net
proceeds to be used for any specific purpose, and management will
retain broad discretion over the allocation of net proceeds. While
we have no current agreements, commitments or understandings for
any specific acquisitions at this time other than the License
Agreement, we may use a portion of the net proceeds for these
purposes. We believe that our existing cash, cash equivalents and
U.K. research and development tax credits, together with the net
proceeds from this Rights Offering, will fund our operations and
initially planned clinical trials for ivonescimab into the second
half of 2024.
As
previously disclosed, on December 6, 2022, we entered into the Note
Purchase Agreement and
promissory notes with Robert W. Duggan, the Company’s Chief
Executive Officer, Chairman of the Board, and beneficial owner of
approximately 78.1% of the Company’s common stock and Dr. Mahkam
Zanganeh, the Company’s co-Chief Executive Officer, President,
member of the Board and beneficial owner of approximately 6.0% of
the Company’s common stock. Pursuant to the Note Purchase
Agreement, the Company agreed to sell to Mr. Duggan and Dr.
Zanganeh unsecured promissory notes in the aggregate amount of $520
million for the principal purpose of funding the Company’s
initial payment obligations under the License Agreement.
The Company expects to use
the proceeds of the Note Purchase Agreement to support (i) payment
of the upfront obligation totaling $500 million associated with the
License Agreement as described herein; (ii) activities to support
clinical development and regulatory approval for SMT112; (iii)
pursue business development opportunities to expand or enhance our
pipeline of drug candidates; and (iv) general corporate
purposes.
This
expected use of the net proceeds from this Rights Offering
represents our intentions based upon our current plans and business
conditions and numerous factors, including the factors described
under “Risk Factors.” As of the date of this prospectus, we
cannot predict with certainty all of the particular uses for the
net proceeds to be received upon the completion of this Rights
Offering or the amounts that we will actually spend on the uses set
forth above. The amounts and timing of our actual expenditures and
the use of these proceeds may vary significantly depending on
numerous factors, including the progress of our expansion efforts
and acquisition activities, as well as any unforeseen cash needs.
As a result, our management will retain broad discretion over the
allocation of the net proceeds from this Rights
Offering.
CAPITALIZATION
The
following table sets forth our capitalization as of September 30,
2022 to reflect the following:
|
● |
on an
actual basis per our Form 10-Q for the quarter ended September 30,
2022, which is incorporated into this prospectus by
reference; |
|
● |
on an
adjusted basis to give effect to the following events, as if each
event had occurred on September 30, 2022: (i) $520 million in
proceeds of the Note Purchase Agreement, offset by $7.7 million of
prepaid interest which represents the value of the shares issued in
connection with the Note Purchase Agreement, (ii) the issuance of
9,346,434 and 373,857 shares for the prepaid interest to Robert W.
Duggan and Dr. Mahkam Zanganeh, respectively, in connection with
the Note Purchase Agreement and (iii) the first installment payment
to Akeso for the upfront payment pursuant to the License Agreement,
of which Akeso opted to receive 10 million shares of Summit common
stock with a fair value on the Antitrust Clearance Date and $274.9
million was paid to Akeso in cash; and |
|
● |
on a
pro forma as adjusted basis giving further effect to the following
events (i) the first installment payment of $300 million in cash to
Akeso for the upfront payment pursuant to the License Agreement,
(i) the issuance of 476,190,476 common stock in the Rights
Offering, assuming the exercise of all of the Subscription Rights
at a Subscription Price of $1.05 per common stock with aggregate
net proceeds of approximately $499.5 million, after deducting our
payment of estimated offering expenses and (ii) repayment of
certain unsecured promissory notes totaling $420 million issued
pursuant to the Note Purchase Agreement with proceeds of the Rights
Offering and recognition of the $7.7 million of prepaid
interest. |
The
following table does not consider the second upfront payment due to
Akeso of $200 million pursuant to the License Agreement, as this is
expected to be paid after the consummation of the Rights
Offering.
The
information presented in the table below should be read in
conjunction with “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and the historical
consolidated financial statements and notes thereto included in our
Form 10-Q for the quarter ended September 30, 2022, which is
incorporated into this prospectus by reference.
| |
|
As of September 30, 2022 |
| |
|
As
reported |
|
As
adjusted |
|
Pro Forma
As Adjusted |
| |
|
(U.S.
dollars in thousands)
Unaudited
|
| Cash
and cash equivalents |
|
|
121,971 |
|
|
|
367,071 |
|
|
|
446,571 |
|
| Total current
assets |
|
|
137,119 |
|
|
|
382,219 |
|
|
|
461,719 |
|
| Debt |
|
|
— |
|
|
|
512,308 |
|
|
|
100,000 |
|
| Shareholders'
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
| Preferred stock,
$0.01 par value, 20,000,000 shares authorized; no shares issued or
outstanding actual or as adjusted |
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Common stock, $0.01
par value, 350,000,000 shares authorized; 201,321,175 issued and
outstanding actual; 1,000,000,000 shares authorized as adjusted;
221,041,466 issued and outstanding as adjusted; 1,000,000,000
shares authorized as pro forma adjusted; 697,231,942 issued and
outstanding as pro forma adjusted |
|
|
2,013 |
|
|
|
2,210 |
|
|
|
6,972 |
|
| Additional paid-in
capital |
|
|
493,553 |
|
|
|
546,947 |
|
|
|
1,041,686 |
|
| Accumulated other
comprehensive income (loss) |
|
|
(3,217 |
) |
|
|
(3,217 |
) |
|
|
(3,217 |
) |
| Accumulated
deficit |
|
|
(359,101 |
) |
|
|
(679,101 |
) |
|
|
(687,593 |
) |
| Total shareholders'
equity |
|
|
133,248 |
|
|
|
133,960 |
|
|
|
357,848 |
|
DILUTION
Our
net tangible book value as of September 30, 2022 was approximately
$123.6 million, or $0.61 per share of our common stock. Net
tangible book value per share is equal to our total net tangible
book value, which is our total tangible assets less our total
liabilities, divided by the number of shares of our outstanding
common stock. Dilution per share equals the difference between the
amount per share paid by purchasers of shares of common stock that
are sold in the Rights Offering and the net tangible book value per
share of our common stock immediately after the Rights
Offering.
After
giving effect to the assumed sale of 476,190,476 shares of our
common stock in the Rights Offering, based on the assumed
Subscription Price of $1.05 per shares of common stock, and after
deducting estimated offering expenses payable by us, our pro forma
net tangible book value as of September 30, 2022 would have been
approximately $623.1 million, or $0.92 per share. This represents
an immediate increase in pro forma net tangible book value to
existing stockholders of $0.31 per share and an immediate dilution
to purchasers in the Rights Offering of $0.13 per share.
The
following table illustrates this per-share dilution, assuming the
Rights Offering is fully subscribed at the assumed Subscription
Price of $1.05 per share of common stock. To the extent that the
Alternate Price is lower than the Initial Price, purchasers of our
common stock in the Rights Offering will experience further
dilution.
| Assumed Subscription Price per share |
|
|
|
|
$ |
1.05 |
|
| Net tangible book value per share as of September 30, 2022 |
|
$ |
0.61 |
|
|
|
|
| Increase in net tangible book value
per share attributable to this Rights Offering |
|
$ |
0.31 |
|
|
|
|
| Net tangible book value per share as
of September 30, 2022, after giving effect to this Rights
Offering |
|
|
|
|
$ |
0.92 |
|
| Dilution per share to investors
purchasing shares in this Rights Offering |
|
|
|
|
$ |
0.13 |
|
The
information above is illustrative only and will adjust based on the
actual Subscription Price and the actual number of shares of common
stock sold in the Rights Offering. The number of shares to be
outstanding after this Rights Offering is based on 201,321,175
shares of common stock outstanding at September 30, 2022 and does
not give effect to:
|
● |
the
exercise of outstanding warrants to purchase 5,821,137 shares of
common stock at a weighted-average exercise price of
$1.56; |
|
● |
the
exercise of outstanding options to purchase 19,660,009 shares of
common stock at a weighted-average exercise price of
$3.59; |
|
● |
the
issuance of 9,346,434 shares of common stock issued to Mr. Duggan
in connection with the Note Purchase Agreement, dated December 6,
2022, between the Company, Mr. Duggan and Dr. Zanganeh; |
|
● |
the
issuance of 373,857 shares of common stock issued to Dr. Zanganeh
in connection with the Note Purchase Agreement, dated December 6,
2022, between the Company, Mr. Duggan and Dr. Zanganeh; |
| |
● |
the issuance of 10,000,000 shares
of common stock issued to Akeso, Inc in connection with the Common
Stock Issuance Agreement, dated January 17, 2023, between the
Company and Akeso, Inc. |
|
● |
the
issuance of up to 5,545,818 shares of common stock reserved for
future issuance under our 2020 Stock Incentive Plan;
and |
|
● |
the
issuance of up to 2,628,893 shares of common stock reserved for
future issuances under our 2020 Employee Share Purchase
Plan. |
Furthermore,
we may choose to raise additional capital through the sale of
equity or equity-linked securities due to market conditions or
strategic considerations, even if we believe we have sufficient
funds for our current or future operating plans. To the extent that
any of our outstanding warrants or options are exercised or we
issue additional shares of common stock or other equity or
equity-linked securities in the future, there may be further
dilution to investors participating in this Rights Offering. This
information does not reflect the annual increases provided under
the 2020 Stock Incentive Plan and 2020 Employee Stock Purchase
Plan, which have not yet been determined by the Board.
DESCRIPTION OF CAPITAL
STOCK
The
following description of our capital stock is intended as a summary
only and therefore is not a complete description of our capital
stock. This description is based upon, and is qualified by
reference to, our restated certificate of incorporation, our
amended and restated bylaws and applicable provisions of Delaware
corporate law. You should read our restated certificate of
incorporation and amended and restated bylaws, which are filed as
exhibits to the registration statement of which this prospectus
forms a part, for the provisions that are important to
you.
Our
authorized capital stock consists of 1,000,000,000 shares of common
stock, $0.01 par value per share and 20,000,000 shares of preferred
stock, $0.01 par value per share. As of the Record Date, the
Company had 221,241,725 shares of common stock issued and
outstanding and an aggregate of 25,481,146 shares reserved for
potential future issuance upon exercise of outstanding awards under
its 2020 Stock Incentive Plan, 2016 Long Term Incentive Plan, and
its outstanding warrants. The Company may also issue up to an
additional 8,174,711 authorized shares reserved for potential
issuance of future awards under its 2020 Stock Incentive Plan and
2020 Employee Stock Purchase Plan.
On
January 6, 2023, the Company held a Special Meeting of Stockholders
in which the stockholders approved: (i) an amendment to the
Company’s restated certificate of incorporation to increase the
number of authorized shares of our common stock by 650,000,000
(from 350,000,000 to 1,000,000,000), and (ii) an amendment to
authorize the Board to amend our restated certificate of
incorporation to effect a reverse stock split of all of the
outstanding shares of our common stock, at a ratio in the range of
1-for-5 to 1-for-10. On January 19, 2023, the Board approved, and
the Company filed, an amendment to the amended and restated
certificate of incorporation to increase the Company’s
capitalization as described in clause (i). The Board reserves the
right to adopt the proposal described in clause (ii) at any time
prior to January 6, 2024 but has no intention to effect the reverse
stock split prior to the closing of the Rights Offering and
issuance of shares thereunder.
Common
Stock
Annual
Meeting. Annual meetings of our stockholders are held on the
date designated in accordance with our by-laws. Written notice must
be mailed to each stockholder entitled to vote not less than ten
nor more than 60 days before the date of the meeting. The presence
in person or by proxy of the holders of record of a majority of our
issued and outstanding shares entitled to vote at such meeting
constitutes a quorum for the transaction of business at meetings of
the stockholders. Special meetings of the stockholders may be
called for any purpose by the board of directors and shall be
called by the secretary upon the written request, stating the
purpose of such meeting, of the holders of at least twenty-five
percent (25%) of the shares of capital stock entitled to vote in an
election of directors. Except as may be otherwise provided by
applicable law, our certificate of incorporation or our by-laws,
all elections shall be decided by a plurality, and all other
questions shall be decided by a majority, of the votes cast by
stockholders entitled to vote thereon at a duly held meeting of
stockholders at which a quorum is present.
Voting
Rights. Each holder of common stock is entitled to one vote for
each share held of record on all matters to be voted upon by
stockholders.
Dividends.
Subject to the rights, powers and preferences of any outstanding
preferred stock, and except as provided by law or in our
certificate of incorporation, dividends may be declared and paid or
set aside for payment on the common stock out of legally available
assets or funds when and as declared by the board of
directors.
Liquidation,
Dissolution and Winding Up. Subject to the rights, powers and
preferences of any outstanding preferred stock, in the event of our
liquidation, dissolution or winding up, our net assets will be
distributed pro rata to the holders of our common stock.
Other
Rights. Holders of the common stock have no right
to:
|
● |
convert
the stock into any other security; |
|
● |
have
the stock redeemed; |
|
● |
purchase
additional stock; or |
|
● |
maintain
their proportionate ownership interest. |
The
common stock does not have cumulative voting rights. Holders of
shares of the common stock are not required to make additional
capital contributions.
Transfer
Agent and Registrar. Computershare Trust Company, N.A. is
transfer agent and registrar for the common stock.
Preferred
Stock
We
are authorized to issue “blank check” preferred stock, which may be
issued in one or more series upon authorization of our board of
directors. Our board of directors is authorized to fix the
designations, powers, preferences and the relative, participating,
optional or other special rights and any qualifications,
limitations and restrictions of the shares of each series of
preferred stock. The authorized shares of our preferred stock are
available for issuance without further action by our stockholders,
unless such action is required by applicable law or the rules of
any stock exchange on which our securities may be listed. If the
approval of our stockholders is not required for the issuance of
shares of our preferred stock, our board may determine not to seek
stockholder approval.
Certain
Provisions of Our Certificate of Incorporation and By-laws and
Delaware Law
Board
of Directors. All of our directors are elected annually. The
number of directors comprising our board of directors is fixed from
time to time by the board of directors.
Stockholder
Nomination of Directors. Our Bylaws provide that a stockholder
must notify us in writing of any stockholder nomination of a
director not earlier than the 120th day and not
later than the 90th day prior to the first
anniversary of the preceding year’s annual meeting; provided, that
if the date of the annual meeting is advanced or delayed by more
than 30 days from such anniversary date, notice by the stockholder
to be timely must be so delivered (x) not earlier than the
120th day prior to the date of such annual meeting
and not later than the 90th day prior to the date
of such meeting and (y) the 10th day following the
day on which public announcement of the date of such annual meeting
is first made by us.
Exclusive
forum provision. Our Certificate of Incorporation provides
that, unless we consent in writing to the selection of an
alternative forum, the Court of Chancery of the State of Delaware
(or, if the Court of Chancery of the State of Delaware does not
have jurisdiction, the federal district court for the District of
Delaware) shall be the sole and exclusive forum for the following
types of proceedings: (1) any derivative action or proceeding
brought on behalf of our company, (2) any action asserting a claim
of breach of a fiduciary duty owed by any of our directors,
officers, employees or stockholders to our company or our
stockholders, (3) any action asserting a claim arising pursuant to
any provision of the General Corporation Law of the State of
Delaware or as to which the General Corporation Law of the State of
Delaware confers jurisdiction on the Court of Chancery of the State
of Delaware, or (4) any action asserting a claim arising pursuant
to any provision of our Certificate of Incorporation or Bylaws (in
each case, as they may be amended from time to time) or governed by
the internal affairs doctrine. These choice of forum provisions
will not apply to suits brought to enforce a duty or liability
created by the Exchange Act. Furthermore, Section 22 of the
Securities Act creates concurrent jurisdiction for federal and
state courts over all such Securities Act actions. Accordingly,
both state and federal courts have jurisdiction to entertain such
claims. To prevent having to litigate claims in multiple
jurisdictions and the threat of inconsistent or contrary rulings by
different courts, among other considerations, our Certificate of
Incorporation provides that, unless we consent in writing to the
selection of an alternative forum, the federal district courts of
the United States of America shall, to the fullest extent permitted
by law, be the sole and exclusive forum for the resolution of any
claims arising under the Securities Act. While the Delaware courts
have determined that such choice of forum provisions are facially
valid, a stockholder may nevertheless seek to bring a claim in a
venue other than those designated in the exclusive forum
provisions. In such instance, we would expect to vigorously assert
the validity and enforceability of the exclusive forum provisions
of our Certificate of Incorporation. This may require significant
additional costs associated with resolving such action in other
jurisdictions and there can be no assurance that the provisions
will be enforced by a court in those other
jurisdictions.
THE RIGHTS
OFFERING
Subscription
Rights
Basic
Subscription Rights
We
will distribute to each holder of our common stock who is a record
holder of our common stock on the Record Date, which is [●], at no
charge, one Subscription Right for every one share of common stock
owned. The Subscription Rights will be evidenced by
non-transferable Subscription Rights certificates. Each
Subscription Right will entitle the Subscription Rights holder to
purchase 2.152353 shares of common stock at the Initial Price,
which shall be paid in cash, upon timely delivery of the required
documents and payment of the Subscription Price. To the extent that
the Alternate Price is lower than the Initial Price, we will sell
additional shares of common stock, but we will not sell fractional
shares, instead rounding down to the nearest whole number of shares
a holder would otherwise be entitled to purchase. While at this
time the Company has no reason to believe the Alternate Price will
decline such that the number of shares of common stock to be
offered would cause the Company to exceed the number of authorized
shares of common stock set forth in the Company’s amended
certificate of incorporation, the Company has reserved the right to
terminate the Rights Offering at any time before the completion of
the Rights Offering, as further disclosed herein, and may do so
under those circumstances. If Subscription Rights holders wish to
exercise their Subscription Rights, they must do so prior to 5:00
p.m., Eastern Time, on [●], the Expiration Date for the Rights
Offering, subject to extension. After the Expiration Date, the
Subscription Rights will expire and will have no value. See below
“—Expiration of the Rights Offering and Extensions, Amendments
and Termination.” You are not required to exercise all of your
Subscription Rights. We will issue to the record holders who
purchase shares of common stock in the Rights Offering the shares
in book-entry, or uncertificated, form as soon as practicable after
the Rights Offering has expired.
Over-Subscription
Rights
Subject
to the allocation described below, each Subscription Right also
grants the holder an Over-Subscription Right to purchase additional
shares of common stock that are not purchased by other Subscription
Rights holders pursuant to their Basic Subscription Rights. You are
entitled to exercise your Over-Subscription Right only if you
exercise your Basic Subscription Right in full.
If
you wish to exercise your Over-Subscription Right, you should
indicate the number of additional shares of common stock that you
would like to purchase in the space provided on your rights
certificate, as well as the number of shares that you beneficially
own without giving effect to any shares to be purchased in this
Rights Offering. When you send in your rights certificate, you must
also send the full purchase price, as provided herein, for the
number of additional shares of common stock that you have requested
to purchase (in addition to the payment, as provided herein, due
for shares of common stock purchased through your Basic
Subscription Right). If the number of shares of common stock
remaining after the exercise of all Basic Subscription Rights is
not sufficient to satisfy all requests for shares pursuant to
Over-Subscription Rights, you will be allocated additional shares
in the proportion which the number of shares you purchased through
the Basic Subscription Right bears to the total number of shares
that all oversubscribing stockholders purchased through the Basic
Subscription Right. The subscription agent will return any excess
payments in the form in which made.
As
soon as practicable after the Expiration Date, the subscription
agent will determine the number of shares of common stock that you
may purchase pursuant to the Over-Subscription Right. If you
request and pay for more shares than are allocated to you, we will
refund the overpayment in the form in which made. In connection
with the exercise of the Over-Subscription Right, custodian banks,
brokers, dealers and other nominee holders of Subscription Rights
who act on behalf of beneficial owners will be required to certify
to us and to the subscription agent as to the aggregate number of
Subscription Rights exercised, and the number of shares of common
stock requested through the Over-Subscription Right, by each
beneficial owner on whose behalf the nominee holder is
acting.
Subscription
Price
The
subscription price per share of common stock will be the lesser of
(i) $1.05 (the “Initial Price”) and (ii) the volume
weighted-average price of our common stock for the preceding five
(5) consecutive trading days through and including the Expiration
Date (the “Alternate Price”). The Initial Price or Alternate Price,
as applicable, is sometimes referred to herein as the “Subscription
Price”. The Subscription Price may present a significant discount
to the recent closing trading price of $4.23 on January 19, 2023.
Following the closing of the Rights Offering, there is no assurance
that the price will remain at the current trading price, and the
price may decline to the Subscription Price, or to a price lower
than the Subscription Price. For a more detailed discussion, see
“Dilution” beginning on page 37. Subscribers must fund their
subscriptions pursuant to both the Basic Subscription Right and
Over-Subscription Right at the Initial Price.
The
Board determined that it was in the best interests of the Company
to have the Special Committee consider the Rights Offering and its
terms in light of the significant common stock ownership by the
Company’s Chairman of the Board and Chief Executive Officer and the
Company’s co-Chief Executive Officer, President, and member of the
Board. In determining the Subscription Price, the Special Committee
considered a number of factors, including: the likely cost of
capital from other sources and general conditions of the securities
markets, the price at which our stockholders might be willing to
participate in the Rights Offering, our need for liquidity and
capital, the average price for the 30-day period prior to the
filing of the preliminary Proxy Statement on November 29, 2022, and
the desire to provide an opportunity to our stockholders to
participate in the Rights Offering on a pro rata basis. The Special
Committee determined that it was in the best interests of the
Company’s stockholders to publicly announce the Initial Price and
the Alternate Price so that all stockholders had the opportunity to
determine whether to buy or sell the Company’s shares of common
stock prior to the Record Date. The Company did not consider
revising the Initial Price. The Company believes this disclosure
has provided its stockholders and the public with sufficient
information about the Company’s expectation to sell a significant
number of shares in the Rights Offering, as described herein. The
Subscription Price is not necessarily related to our book value,
net worth or any other established criteria of value and may or may
not be considered the fair value of our common stock to be offered
in the Rights Offering. You should not consider the Subscription
Price as an indication of value of us or our common stock. The
market price of our common stock may decline during or after the
Rights Offering, including below the Subscription Price for the
common stock in the Rights Offering. You should obtain a current
quote for our common stock before exercising your Subscription
Rights and make your own assessment of our business and financial
condition, our prospects for the future, and the terms of the
Rights Offering.
Expiration
of the Rights Offering and Extensions, Amendments and
Termination
You
may exercise your Subscription Rights at any time prior to 5:00
p.m., Eastern Time, on [●], the Expiration Date for the Rights
Offering. If you do not exercise your Subscription Rights before
the Expiration Date of the Rights Offering, your Subscription
Rights will expire and will have no value. We will not be required
to sell shares of common stock to you if the subscription agent
receives your rights certificate or payment, after the Expiration
Date, regardless of when you sent the rights certificate and
payment.
We
may, in our sole discretion, extend the time for exercising the
Subscription Rights. We may extend the Expiration Date at any time
after the Record Date. If the commencement of the Rights Offering
is delayed for a period of time, the Expiration Date of the Rights
Offering may be similarly extended. We will extend the duration of
the Rights Offering as required by applicable law, and may choose
to extend the duration of the Rights Offering for any reason. We
may extend the Expiration Date of the Rights Offering by giving
oral or written notice to the subscription agent on or before the
scheduled Expiration Date. If we elect to extend the Expiration
Date of the Rights Offering, we will issue a press release
announcing such extension no later than 9:00 a.m., Eastern Time, on
the next business day after the most recently announced Expiration
Date.
We
reserve the right, in our sole discretion, to amend or modify the
terms of the Rights Offering. We also reserve the right to
terminate the Rights Offering at any time prior to the Expiration
Date for any reason, in which event all funds received in
connection with the Rights Offering will be returned without
interest or deduction to those persons who exercised their
Subscription Rights as soon as practicable.
Calculation
of Subscription Rights Exercised; Missing or Incomplete
Subscription Information
If
you do not indicate the number of Subscription Rights being
exercised, or do not forward full payment of the total Subscription
Price payment for the number of Subscription Rights that you
indicate are being exercised, then you will be deemed to have
exercised your Subscription Rights with respect to the maximum
number of whole shares of common stock that may be exercised with
the aggregate Subscription Price payment you delivered to the
subscription agent. If your aggregate Subscription Price payment is
greater than the amount you owe for exercise of your Basic
Subscription Right in full, you will be deemed to have exercised
your Over-Subscription Right to purchase the maximum number of
shares with your over-payment.
If an
insufficient number of shares of common stock is available to fully
satisfy all proper Over-Subscription Right requests, the available
shares will be distributed proportionately among Subscription
Rights holders who properly exercise their Over-Subscription Right
based on the number of shares each Subscription Rights holder
timely subscribed and paid for under the Basic Subscription Right.
The proration process will be repeated until all shares of common
stock have been allocated or all properly made Over-Subscription
Right exercises have been fulfilled, whichever occurs earlier. Any
excess subscription payments received by the subscription agent
caused by proration will be returned by the subscription agent to
you by mail, without interest or penalty, as soon as practicable
after the Expiration Date of the Rights Offering. The subscription
agent will return any excess payments in the form in which it was
made. Any Excess Subscription Amount resulting from the reduction
of the Subscription Price from the Initial Price to the Alternate
Price will be allocated towards the purchase of additional shares
of common stock (either towards your Basic Subscription Right, if
available, or towards the Over-Subscription Right if you have
already exercised your Basic Subscription Right in
full).
No
Fractional Shares
We
will not issue fractional shares of common stock in the Rights
Offering. Subscription Rights holders will only be entitled to
purchase a whole number of shares of common stock, rounded down to
the nearest whole number of shares a holder would otherwise be
entitled to purchase. Any Excess Subscription Amount resulting from
the reduction of the Subscription Price from the Initial Price to
the Alternate Price will be allocated towards the purchase of
additional shares of common stock (either towards your Basic
Subscription Right, if available, or towards the Over-Subscription
Right if you have already exercised your Basic Subscription Right
in full). The excess amount for any fractional shares of common
stock will be returned to you as soon as practicable, in the form
in which made. You will not receive interest or a deduction on any
payments refunded to you under the Rights Offering.
Conditions
to the Rights Offering
We
may terminate the Rights Offering, in whole or in part, if at any
time before completion of the Rights Offering there is any
judgment, order, decree, injunction, statute, law or regulation
entered, enacted, amended or held to be applicable to the Rights
Offering that in the sole judgment of our board of directors would
or might make the Rights Offering or its completion, whether in
whole or in part, illegal or otherwise restrict or prohibit
completion of the Rights Offering. We may waive this condition and
choose to proceed with the Rights Offering even if this occurs. If
we terminate the Rights Offering, in whole or in part, all affected
Subscription Rights will expire without value and all subscription
payments in the form in which received by the subscription agent
will be returned in the form in which paid, without interest or
deduction, as soon as practicable. See also “—Expiration of the
Rights Offering and Extensions, Amendments and
Termination.”
Method
of Exercising Subscription Rights
The
exercise of Subscription Rights is irrevocable and may not be
cancelled or modified. Your Subscription Rights will not be
considered exercised unless the subscription agent receives from
you, your custodian bank, broker, dealer or nominee, as the case
may be, all of the required documents properly completed and
executed and your full Subscription Price payment in cash, as
provided herein, prior to the Expiration Date of the Rights
Offering, which is currently set to be 5:00 p.m., Eastern Time, on
[●]. Subscription Rights holders may exercise their rights as
follows:
Subscription
by Registered Holders
Subscription
Rights holders who are registered holders of our common stock as of
the Record Date may exercise their Subscription Right by properly
completing and executing the rights certificate together with any
required signature guarantees and forwarding it, together with
payment in full, as provided herein, of the Subscription Price for
each share of common stock for which they subscribe, to the
subscription agent at the address set forth under the subsection
titled “—Delivery of Subscription Materials and Payment,” on
or prior to the Expiration Date.
Subscription
by DTC Participants
Banks,
trust companies, securities dealers and brokers (each, a “Nominee”)
that hold shares of our common stock on the Record Date as nominee
for more than one beneficial owner may, upon proper showing to the
subscription agent, exercise such beneficial owner’s Subscription
Right through DTC on the same basis as if the beneficial owners
were stockholders on the Record Date. Such Nominee may exercise the
Subscription Right on behalf of the exercising beneficial owner
through DTC’s PSOP Function on the “agents subscription over PTS”
procedure by (1) providing a certification as to the aggregate
number of Subscription Rights exercised by the beneficial owner on
whose behalf such Nominee is acting, and (2) instructing DTC to
charge the Nominee’s applicable DTC account for the subscription
payment for the new shares of common stock to facilitate the
delivery of the full subscription payment to the subscription
agent. DTC must receive the subscription instructions and payment
for the new shares of common stock no later than the Expiration
Date.
Subscription
by Beneficial Owners
Subscription
Rights holders who are beneficial owners of shares of our common
stock as of the Record Date and whose shares are registered in the
name of a custodian bank, broker, dealer or other nominee, or would
prefer to have an institution conduct the transaction relating to
the rights on their behalf, should instruct their custodian bank,
broker, dealer or other nominee or institution to exercise their
rights and deliver all documents and payment, on their behalf,
prior to the Expiration Date. A Subscription Rights holder’s
Subscription Rights will not be considered exercised unless the
subscription agent receives from such Subscription Rights holder or
the Subscription Rights holder’s custodian bank, broker, dealer, or
other nominee or institution, as the case may be, all of the
required documents and such holder’s full Subscription Price
payment.
Method
of Payment
You
must timely pay the full Subscription Price, in U.S. currency, for
the full number of shares of common stock at the Initial Price you
wish to acquire pursuant to the exercise of rights (including any
exercise of the Over-Subscription Rights, if available) by
delivering:
|
● |
a
wire transfer of immediately available funds to accounts maintained
by the subscription agent; |
|
● |
a
certified check drawn against a U.S. bank payable to “Broadridge
Corporate Issuer Solutions, LLC (acting as Subscription Agent for
Summit Therapeutics)”; |
|
● |
a
U.S. Postal money order payable to “Broadridge Corporate Issuer
Solutions, LLC (acting as Subscription Agent for Summit
Therapeutics)”; |
|
● |
some
combination thereof; or |
|
● |
other
method otherwise acceptable to the Company. |
Rights
certificates received after the Expiration Date of the Rights
Offering will not be honored, and we will return your payment to
you in the form received as soon as practicable, without interest
or deduction. The subscription agent will not accept uncertified
personal checks, bank drafts or cashier’s checks as a means of
payment.
The
subscription agent will be deemed to receive payment
upon:
|
● |
receipt
of collected funds wired in the subscription agent’s
account; |
|
● |
receipt
by the subscription agent of any certified check drawn upon a U.S.
bank; |
|
● |
receipt
by the subscription agent of any U.S. Postal money order;
or |
|
● |
other
method otherwise acceptable to the Company. |
If,
on the Expiration Date, the Alternate Price is lower than the
Initial Price, any Excess Subscription Amounts paid by a subscriber
will be allocated towards the purchase of additional shares of
common stock.
Instructions
for Completing Your Subscription Rights Certificate
You
should read the instruction letter accompanying the rights
certificate carefully and strictly follow it. DO NOT SEND
RIGHTS CERTIFICATES OR PAYMENTS TO THE COMPANY. We will not
consider your subscription received until the subscription agent
has received delivery of a properly completed and duly executed
rights certificate and payment of the full subscription amount as
set forth herein. The risk of delivery of all documents and
payments is on you or your nominee, not us or the subscription
agent.
The
method of delivery of rights certificates and payment of the
subscription amount to the subscription agent will be at the risk
of the holders of rights, but, if sent by mail, we recommend that
you send those certificates and payments by overnight courier or by
registered mail, properly insured, with return receipt requested,
and that a sufficient number of days be allowed to ensure delivery
to the subscription agent and clearance of payment before the
expiration of the subscription period.
Unless
a rights certificate provides that the shares of common stock are
to be delivered to the record holder of such rights or such
certificate is submitted for the account of a bank or a broker,
signatures on such rights certificate must be guaranteed by an
“Eligible Guarantor Institution,” as such term is defined in Rule
17Ad-15 of the Securities Exchange Act of 1934 (an “Eligible
Institution”), subject to any standards and procedures adopted by
the subscription agent. See “—Medallion Guarantee May Be
Required.”
Medallion
Guarantee May Be Required
If
you completed any part of the Subscription Rights certificate to
provide that the common stock purchased pursuant to your exercise
of Subscription Rights were to be (x) issued in a name other than
that of the registered holder, or (y) issued to an address other
than that shown on the front of the Subscription Rights
certificate, your signature on each Subscription Rights certificate
must be guaranteed by an Eligible Institution, such as a member
firm of a registered national securities exchange or a member of
the Financial Industry Regulatory Authority, Inc., or a commercial
bank or trust company having an office or correspondent in the
United States, or by a member of a Stock Transfer Association
approved medallion program such as STAMP, SEMP or MSP subject to
standards and procedures adopted by the subscription
agent.
Subscription
and Information Agent
The
subscription agent and information agent for this Rights Offering
is Broadridge Corporate Issuer Solutions, LLC. We will pay all fees
and expenses of Broadridge related to the Rights Offering and have
also agreed to indemnify Broadridge from certain liabilities that
it may incur in connection with the Rights Offering. Broadridge can
be contacted at the following address and telephone
number:
Broadridge
Corporate Issuer Solutions, LLC
Attn: BCIS Re-Organization Dept.
P.O. Box 1317
Brentwood, NY 11717-0718
Toll Free: 1-855-793-5068
Delivery
of Subscription Materials and Payment
You
should deliver your Subscription Rights certificate and payment of
the Subscription Price, as provided herein, or, if applicable,
nominee holder certifications, to the subscription agent by one of
the methods described below:
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By Mail:
Broadridge
Corporate Issuer Solutions, LLC
Attn:
BCIS Re-Organization Dept.
P.O.
Box 1317
Brentwood,
NY 11717-0718
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By Overnight Delivery:
Broadridge
Corporate Issuer Solutions, LLC
Attn:
BCIS IWS
51
Mercedes Way
Edgewood,
NY 11717
|
Your
delivery to an address or by any method other than as set forth
above will not constitute valid delivery and we may not honor the
exercise of your Subscription Rights.
You
should direct any questions or requests for assistance concerning
the method of subscribing for shares of common stock or for
additional copies of this prospectus to the information
agent.
Funding
Arrangements; Return of Funds
Broadridge
Corporate Issuer Solutions, LLC, the subscription agent, will hold
funds received in payment for shares of common stock in a
segregated account pending completion of the Rights Offering. The
subscription agent will hold this money until the Rights Offering
is completed or is withdrawn or terminated. If the Rights Offering
is canceled for any reason, all subscription payments received by
the subscription agent will be returned to subscribers, without
interest or penalty, as soon as practicable.
Guaranteed
Delivery
There
is no guaranteed delivery period in connection with this Rights
Offering, so you must ensure that you properly complete all
required steps prior to 5:00 p.m., Eastern Time, on [●], unless we
decide to extend the Expiration Date until some later time or
terminate it earlier.
Notice
to Beneficial Holders
If
you are a broker, a trustee or a depositary for securities who
holds shares of our common stock for the account of others as of
the Record Date, you should notify the respective beneficial owners
of such shares of the Rights Offering as soon as possible to find
out their intentions with respect to exercising their Subscription
Rights. You should obtain instructions from the beneficial owners
with respect to their Subscription Rights, as set forth in the
instructions we have provided to you for your distribution to
beneficial owners. If a beneficial owner so instructs, you should
complete the appropriate Subscription Rights certificates and
submit them to the subscription agent with the proper payment. If
you hold shares of our common stock for the account(s) of more than
one beneficial owner, you may exercise the number of Subscription
Rights to which all such beneficial owners in the aggregate
otherwise would have been entitled had they been direct record
holders of our common stock on the Record Date, provided that you,
as a nominee record holder, make a proper showing to the
subscription agent by submitting the form entitled “Nominee Holder
Certification” substantially in the form accompanying this
prospectus. If you did not receive this form, you should contact
the subscription agent to request a copy.
Beneficial
Owners
If
you are a beneficial owner of shares of our common stock or will
receive Subscription Rights through a custodian bank, broker,
dealer or other nominee, we will ask your custodian bank, broker,
dealer or other nominee to notify you of the Rights Offering. If
you wish to exercise your Subscription Rights, you will need to
have your custodian bank, broker, dealer or other nominee act for
you. If you hold shares of our common stock directly under your
name in stock certificate(s) or in book-entry, or uncertificated,
form, but would prefer to have your custodian bank, broker, dealer
or other nominee act for you, you should contact your nominee and
request it to effect the transactions for you. Your nominee may
establish a deadline prior to the Expiration Date by which you must
provide it with your instructions to exercise your Subscription
Rights and payment for your shares.
To
indicate your decision with respect to your Subscription Rights,
you should complete and return to your custodian bank, broker,
dealer or other nominee the form entitled “Beneficial Owners
Election Form” substantially in the form accompanying this
prospectus. You should receive the “Beneficial Owners Election
Form” from your custodian bank, broker, dealer or other nominee
with the other Rights Offering materials. If you wish to obtain a
separate Subscription Rights certificate, you should contact the
nominee as soon as possible and request that a separate
Subscription Rights certificate be issued to you. You should
contact your custodian bank, broker, dealer or other nominee if you
do not receive this form but you believe you are entitled to
participate in the Rights Offering. We are not responsible if you
do not receive this form from your custodian bank, broker, dealer
or nominee or if you receive it without sufficient time to
respond.
No
Revocation or Change
Once
you submit the form of rights certificate to exercise any
Subscription Rights, you may not revoke or change your exercise or
request a refund of monies paid. All exercises of rights are
irrevocable, even if you subsequently learn information about us
that you consider to be unfavorable. You should not exercise your
Subscription Rights unless you are certain that you wish to
purchase additional shares of common stock at the Initial
Price.
Non-Transferability
of the Rights
The
Subscription Rights granted to you are non-transferable and,
therefore, may not be assigned, gifted, purchased, sold or
otherwise transferred to anyone else. Notwithstanding the
foregoing, you may transfer your Subscription Rights as required by
operation of law; for example, a transfer of rights to the estate
of the recipient upon the death of the recipient would be
permitted. If the rights are transferred as permitted, evidence
satisfactory to us that the transfer was proper must be received by
us prior to the Expiration Date.
Issuance
of Common Stock
All
shares of our common stock that you purchase in the Rights Offering
will be issued in book-entry, or uncertificated, form, meaning that
you will receive a direct registration (DRS) account statement from
our transfer agent reflecting ownership of these securities if you
are a holder of record of shares or warrants. If you hold your
shares of common stock in the name of a custodian bank, broker,
dealer, or other nominee, DTC will credit your account with your
nominee with the securities you purchased in the Rights Offering.
Subject to state securities laws and regulations, we have the
discretion to delay distribution of any securities you may have
elected to purchase by exercise of your Subscription Rights in
order to comply with state securities laws.
Validity
of Subscriptions
We
will resolve all questions regarding the validity and form of the
exercise of your Subscription Rights, including time of receipt and
eligibility to participate in the Rights Offering. Our
determination will be final and binding. Once made, subscriptions
and directions are irrevocable, and we will not accept any
alternative, conditional or contingent subscriptions or directions.
We reserve the absolute right to reject any subscriptions or
directions not properly submitted or the acceptance of which would
be unlawful. You must resolve any irregularities in connection with
your subscriptions before the subscription period expires, unless
waived by us in our sole discretion. Neither the subscription agent
nor we shall be under any duty to notify you or your representative
of defects in your subscriptions. A subscription will be considered
accepted, subject to our right to cancel the Rights Offering, only
when a properly completed and duly executed Subscription Rights
certificate and any other required documents and payment of the
full subscription amount have been received by the subscription
agent and any defects or irregularities therein waived by us. Our
interpretations of the terms and conditions of the Rights Offering
will be final and binding.
Rights
of Subscribers
You
will have no rights as a holder of the shares of our common stock
you purchase in the Rights Offering until shares are issued in
book-entry form or your account at your broker, dealer, bank or
other nominee is credited with the shares of our common stock
purchased in the Rights Offering. You will have no right to revoke
your subscriptions after you deliver your completed rights
certificate, subscription payment, as provided herein, and any
other required documents to the subscription agent.
Foreign
Stockholders and Stockholders with Army Post Office or Fleet Post
Office Addresses
The
subscription agent will not mail rights certificates to you if you
are a registered stockholder whose address is outside the United
States or if you have an Army Post Office or a Fleet Post Office
address. Instead, we will have the subscription agent hold the
Subscription Rights certificates for your account. To exercise your
Subscription Rights, you must notify the subscription agent prior
to 11:00 a.m., Eastern Time, at least three (3) business days prior
to the Expiration Date and establish to the satisfaction of the
subscription agent that it is permitted to exercise your
Subscription Rights under applicable law. If you do not follow
these procedures by such time, your Subscription Rights will expire
and will have no value. If you hold your shares in the name of a
custodian bank, broker, dealer or other nominee, you should follow
the instructions you receive from it, as described
above.
No
Board of Directors Recommendation
An
investment in the Company’s common stock must be made according to
your evaluation of your own best interests and after considering
all of the information herein, including the section titled
“Risk Factors” beginning on page 23 of this prospectus.
Neither we nor our board of directors are making any recommendation
regarding whether you should exercise your Subscription
Rights.
Purchase
Commitments
Robert
W. Duggan, our Executive Chairman, Chief Executive Officer, and the
beneficial owner of approximately 78.1% of our outstanding common
stock prior to this Rights Offering, and Dr. Mahkam Zanganeh, our
co-Chief Executive officer, President, a member of our Board of
Directors, and the beneficial owner of approximately 6.0% of our
issued and outstanding common stock prior to this Rights Offering,
have each indicated that they
intend to participate in the Rights Offering and subscribe for at
least the full amount of their Basic Subscription Rights, but have
not made any formal binding commitment to
participate.
Shares
of Common Stock Outstanding After the Rights
Offering
The
number of shares of our common stock that will be outstanding after
the Rights Offering will depend on the number of shares of common
stock that are purchased in the Rights Offering. Assuming no
additional shares of common stock are issued by us prior to
consummation of the Rights Offering and assuming all offered shares
of common stock are sold in the Rights Offering at the Initial
Price, we will issue approximately 476,190,476 shares of common
stock. In that case, we will have approximately 697,432,201 shares
of common stock outstanding after the Rights Offering. This would
represent an increase of approximately 215% in the number of
outstanding shares of common stock. To the extent that the
Alternate Price is lower than the Initial Price, we will sell
additional shares of common stock in the Rights Offering, and the
number of shares of common stock outstanding after the Rights
Offering will accordingly be higher.
Fees
and Expenses
Neither
we, nor the subscription agent, will charge a brokerage commission
or a fee to Subscription Rights holders for exercising their
rights. However, if you exercise your Subscription Rights through a
custodian bank, broker, dealer or nominee, you will be responsible
for any fees charged by your custodian bank, broker, dealer or
nominee.
Questions
About Exercising Subscription Rights
If
you have any questions or require assistance regarding the method
of exercising your Subscription Rights or requests for additional
copies of this document or any document mentioned herein, you
should contact the subscription agent at the address and telephone
number set forth above under “— Delivery of Subscription
Materials and Payment.”
No
“Going Private” Transaction
The
Rights Offering is not a transaction or series of transactions
which has either a reasonable likelihood or a purpose of producing
a “going private effect” as specified in Rule 13e-3 of the Exchange
Act. Given the structure of the Rights Offering, as described in
this prospectus, the Company will continue to be registered
pursuant to Section 12 of the Exchange Act and intends to remain
listed on the Nasdaq Global Market following completion of the
Rights Offering.
Other
Matters
The
Company is not making the Rights Offering in any state or other
jurisdiction in which it is unlawful to do so, nor is the Company
distributing or accepting any offers to purchase any of our
securities from Subscription Rights holders who are residents of
those states or of other jurisdictions or who are otherwise
prohibited by federal or state laws or regulations to accept or
exercise the Subscription Rights. The Company may delay the
commencement of the Rights Offering in those states or other
jurisdictions, or change the terms of the Rights Offering, in whole
or in part, in order to comply with the securities law or other
legal requirements of those states or other jurisdictions. Subject
to state securities laws and regulations, the Company also has the
discretion to delay allocation and distribution of any securities
you may elect to purchase by exercise of your Subscription Rights
in order to comply with state securities laws. The Company may
decline to make modifications to the terms of the Rights Offering
requested by those states or other jurisdictions, in which case, if
you are a resident in one of those states or jurisdictions or if
you are otherwise prohibited by federal or state laws or
regulations from accepting or exercising the Subscription Rights
you will not be eligible to participate in the Rights
Offering.
MATERIAL U.S.
FEDERAL INCOME TAX CONSEQUENCES
The
following summary does not purport to be a complete analysis of all
of the potential U.S. federal income tax considerations, and does
not address any tax consequences arising under any state, local or
non-U.S. tax laws or any other U.S. federal tax laws, including the
U.S. federal estate or gift tax laws. This discussion applies only
to holders who are U.S. persons (as defined below) and does not
address all aspects of U.S. federal income taxation that may be
relevant to holders in light of their particular circumstances or
to holders who may be subject to special tax treatment under the
Code, including, without limitation, holders who are dealers in
securities or non-U.S. currency, non-U.S. persons, certain former
citizens or long-term residents of the United States, insurance
companies, tax-exempt organizations, banks, financial institutions
or broker-dealers, holders who hold our common stock as part of a
hedge, straddle, conversion or other risk reduction transaction, or
holders who acquired our common stock pursuant to the exercise of
compensatory stock options or otherwise as compensation.
This
summary is of a general nature only and is not intended to
constitute a complete analysis of all tax consequences relating to
the receipt, exercise and expiration of the Subscription Rights,
and the ownership and disposition of our common stock. It is not
intended to constitute, and should not be construed to constitute,
legal or tax advice to any particular holder. This discussion
neither binds nor precludes the Internal Revenue Service (“IRS”)
from adopting a position contrary to, or otherwise challenging, the
positions addressed in this prospectus, and we cannot assure you
that such a contrary position will not be asserted successfully by
the IRS or adopted by a court if the position or matter was
litigated. We have not sought, and will not seek, either (i) a
ruling from the IRS or (ii) an opinion from legal counsel, in
either instance regarding the tax considerations discussed
herein. Holders should consult their own tax
advisors as to the tax consequences in their particular
circumstances.
For
purposes of this discussion, a “U.S. person” means a beneficial
owner of Subscription Rights that is:
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An
individual who is a citizen or resident of the United
States; |
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A
corporation (or entity treated as a corporation for U.S. federal
income tax purposes) created or organized, or treated as created or
organized, in or under the laws of the United States, any state
thereof or the District of Columbia; |
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An
estate whose income is subject to U.S. federal income tax
regardless of its source; or |
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A
trust (i) if a U.S. court can exercise primary supervision
over the trust’s administration and one or more U.S. persons are
authorized to control all substantial decisions of the trust, or
(ii) that has a valid election in effect under applicable
Treasury Regulations promulgated under the Code (“Treasury
Regulations”) to be treated as a U.S. person.
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If a
partnership (including any entity treated as a partnership for U.S.
federal income tax purposes) receives the Subscription Rights or
holds the stock received upon exercise of the Subscription Right,
the tax treatment of a partner in such partnership generally will
depend upon the status of the partner and the activities of the
partnership. Such a partner and the partnership are urged to
consult their own tax advisors as to the U.S. federal income tax
consequences of receiving the Subscription Rights and exercising
(or allowing to expire) the Subscription Rights.
This
discussion does not describe all of the tax considerations which
may be relevant to a particular holder’s ownership of the shares of
common stock received upon exercise of the Basic Subscription
Rights or the Over-Subscription Rights.
EACH
HOLDER OF SHARES OF OUR COMMON STOCK IS STRONGLY URGED TO CONSULT
SUCH HOLDER’S OWN TAX ADVISORS REGARDING THE SPECIFIC FEDERAL,
STATE, LOCAL AND NON-U.S. INCOME AND OTHER TAX CONSIDERATIONS OF
THE RECEIPT AND EXERCISE OF THE SUBSCRIPTION RIGHTS, AND THE
OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK.
U.S.
Federal Income Tax Considerations Applicable to the Receipt of
Subscription Rights
Receipt of Subscription Rights
Under
section 61(a)(3) of the Code, gross income includes “gains derived
from dealings in property.” Under section 301 of the Code, “a
distribution of property… made by a corporation to its stockholder
with respect to its stock” is taxable as gross income to the extent
that the distribution is made out of the corporation’s current or
accumulated earnings and profits. If at the time of the
distribution the corporation does not have current or accumulated
earnings and profits, then the amount of the distribution is
applied first as a reduction in the stockholder’s basis in its
stock; the amount of any distribution in excess of the
stockholder’s basis is treated as a capital gain from the sale or
exchange of property.
Code
section 305(a), however, provides that gross income does not
include “the amount of any distribution of the stock of a
corporation made by such corporation to its stockholders with
respect to its stock.” For purposes of Code section 305, “stock” is
defined in Code section 305(d)(1) to include rights to acquire such
stock.
The
general rule set forth in Code section 305(a) regarding
nonrecognition is subject to certain exceptions, including if
receipt by a holder of Subscription Rights is part of a
“disproportionate distribution” as set forth in Code section
305(b)(2). A “disproportionate distribution” is a distribution or a
series of distributions, including deemed distributions, that has
the effect of the receipt of cash or other property by some holders
and an increase in the proportionate interest of other holders in
our assets or earnings and profits. During the last 36 months, we
have made a distribution of Subscription Rights to holders of our
common stock. Our common stock was then and is now our sole
outstanding class of stock, and we have no current intention of
issuing another class of stock or convertible debt. The fact that
we have made a prior distribution of Subscription Rights within the
last 36 months means that the 36-month safe harbor rule set forth
in the Treasury Regulations will not apply and, therefore, the
distribution of Subscription Rights will not be presumed to not
result in the receipt of cash or property by some stockholders and
an increase in the proportionate interest of other stockholders. We
also have outstanding options (issued as equity awards) which could
cause, under certain circumstances that cannot be predicted
currently, the receipt of Subscription Rights pursuant to this
Rights Offering to be part of a disproportionate distribution. The
Company believes that the distribution of Subscription Rights in
this Rights Offering is not likely to constitute an increase in the
proportionate interest of some stockholders in the assets or
earnings and profits of the Company for purposes of Code section
305(b)(2) based on the fact that all of our stockholders will
receive rights in the Rights Offering based upon their respective
ownership of our common stock. The Company also intends to take the
position that the outstanding options (issued as equity awards) and
their potential exercise do not cause the Subscription Rights
issued pursuant to this Rights Offering to be part of a
disproportionate distribution, but there can be no assurances in
this regard.
Our
position regarding the tax-free treatment of the receipt of
Subscription Rights in this Rights Offering is not binding on the
IRS or the courts, and there can be no assurance that the IRS or
any applicable court would agree. If this position were finally
determined to be incorrect, whether on the basis that the issuance
of the subscriptions rights is a “disproportionate distribution” or
otherwise, the fair market value of the Subscription Rights would
be taxable to holders of our common stock as a dividend on the date
of the distribution to the extent of the holder’s pro rata share of
our current and accumulated earnings and profits, if any, with any
excess being treated as a return of capital to the extent of the
holder’s basis in shares of our common stock and thereafter as
capital gain. Although no assurance can be given, it is anticipated
that we will not have current and accumulated earnings and profits
through the end of 2022.
The
following discussion assumes that the receipt by a holder of
Subscription Rights with respect to such holder’s common stock
pursuant to this Rights Offering is non-taxable for U.S. federal
income tax purposes.
Tax Basis in the Subscription Rights
A
holder’s tax basis in its Subscription Rights will depend on the
relative fair market value of the Subscription Rights received by
such holder and the common stock owned by such holder at the time
the Subscription Rights are distributed. If either (i) the
fair market value of the Subscription Rights on the date such
Subscription Rights are distributed is equal to at least 15% of the
fair market value on such date of the common stock with respect to
which the Subscription Rights are received or (ii) the holder
elects, in its U.S. federal income tax return for the taxable year
in which the Subscription Rights are received, to allocate part of
its tax basis in such common stock to the Subscription Rights, then
upon exercise of the Subscription Rights (and upon exercise,
between the old stock and the stock received upon the exercise of
the rights), the holder’s tax basis in the common stock will be
allocated between the common stock and the Subscription Rights in
proportion to their respective fair market values on the date the
Subscription Rights are distributed. If the Subscription Rights
received by a holder have a fair market value that is less than 15%
of the fair market value of the common stock owned by such holder
at the time the Subscription Rights are distributed, the holder’s
tax basis in its Subscription Rights will be zero unless the holder
elects to allocate its adjusted tax basis in the common stock owned
by such holder in the manner described in the previous sentence.
The fair market value of the Subscription Rights on the date the
Subscription Rights are received is uncertain, and we have not
obtained, and do not intend to obtain, an appraisal of the fair
market value of the Subscription Rights as of that date. Therefore,
you should consult with your tax advisor to determine the proper
allocation of basis between the Subscription Rights and the shares
of common stock with respect to which the Subscription Rights are
received.
Expiration of Subscription Rights
A
holder that allows the Subscription Rights received in the Rights
Offering to expire will not recognize any gain or loss, and the tax
basis in the common stock owned by such holder with respect to
which such Subscription Rights were distributed will be equal to
the tax basis in such common stock immediately before the receipt
of the Subscription Rights in the Rights Offering.
Exercise of Subscription Rights and Holding
Period
A
holder will not recognize any gain or loss upon the exercise of the
Subscription Rights received in the Rights Offering. The tax basis
in the common stock acquired through exercise of the Subscription
Rights will equal the sum of the Subscription Price for the common
stock and the holder’s tax basis, if any, allocated to the rights
as described above. The holding period for the common stock
acquired through exercise of the Subscription Rights will begin on
the date the Subscription Rights are exercised. Holders who
exercise Subscription Rights after disposing of all of the shares
of the common stock owned by such holder should consult with their
own tax advisor regarding the allocation of tax basis.
U.S.
Federal Income Tax Considerations Applicable to Our Common
Shares
Distributions
Distributions
with respect to shares of our common stock acquired upon exercise
of Subscription Rights will be taxable as dividend income when
actually or constructively received to the extent of our current or
accumulated earnings and profits as determined for U.S. federal
income tax purposes. The excess will generally be treated first as
a return of capital to the extent of a holder’s adjusted tax basis
in its shares of our common stock, and, thereafter, as capital
gain.
Dividend
income received by certain non-corporate holders with respect to
shares of our common stock generally will be “qualified dividends”
subject to preferential rates for U.S. federal income tax purposes,
provided that the holder meets applicable holding period and other
requirements. Subject to similar exceptions for short-term and
hedged positions, dividend income on our shares of common stock
paid to holders that are domestic corporations generally will
potentially qualify for the dividends-received
deduction.
Dispositions
A
holder which sells or otherwise disposes of shares of common stock
acquired upon exercise of Subscription Rights in a taxable
transaction generally will recognize capital gain or loss equal to
the difference between the amount realized and such holder’s
adjusted tax basis in the shares. Such capital gain or loss will be
long-term capital gain or loss if a holder’s holding period for
such shares is more than one year at the time of disposition.
Long-term capital gain of a non-corporate holder is generally taxed
at preferential U.S. income tax rates. The deductibility of capital
losses is subject to limitations.
Information
Reporting and Backup Withholding
U.S.
backup withholding (currently at a rate of 24%) is imposed upon
certain distributions (or deemed distributions) to persons who fail
(or are unable) to furnish the information required pursuant to
U.S. information reporting requirements. Distributions (or deemed
distributions or similar transactions) to a holder will generally
be exempt from backup withholding, provided the holder meets
applicable certification requirements, including (i) providing
us with such holder’s U.S. taxpayer identification number
(e.g., an individual’s social security number or
individual taxpayer identification number, or an entity’s employer
identification number, each a “TIN”) or (ii) otherwise
establishing an exemption (e.g., an exemption from
backup withholding as a corporate payee), in each instance on a
properly completed IRS Form W-9, certifying under penalties of
perjury that, among others, such TIN or exemption is correct,
together with such other certifications as may be required by
law.
Backup
withholding does not represent an additional tax. Any amounts
withheld from a payment to a holder under the backup withholding
rules will generally be allowed as a credit against such holder’s
U.S. federal income tax liability, and may entitle such holder to a
refund, provided the required information and returns are timely
furnished by such holder to the IRS.
AS
INDICATED ABOVE, THE FOREGOING DISCUSSION IS FOR GENERAL
INFORMATION PURPOSES ONLY AND SHOULD NOT BE VIEWED AS COMPLETE OR
COMPREHENSIVE TAX ADVICE. HOLDERS RECEIVING A DISTRIBUTION OF STOCK
RIGHTS CONTEMPLATED IN THIS RIGHTS OFFERING AND HOLDERS CONSIDERING
THE PURCHASE OF OUR COMMON STOCK BY EXERCISING SUCH STOCK RIGHTS
ARE URGED TO CONSULT THEIR OWN TAX ADVISORS REGARDING THE
APPLICATION OF THE U.S. FEDERAL TAX LAWS TO THEIR PARTICULAR
SITUATIONS AND THE APPLICABILITY AND EFFECT OF STATE, LOCAL AND
NON-U.S. LAWS TO THEM.
PLAN OF
DISTRIBUTION
We
are distributing rights certificates and copies of this prospectus
to those persons who were holders of our common stock on [●], the
Record Date for the Rights Offering, following the effective date
of the registration statement of which this prospectus forms a
part. We have not employed any brokers, dealers or underwriters in
connection with the solicitation or exercise of rights in the
Rights Offering and no commissions, fees or discounts will be paid
in connection with the Rights Offering. While certain of our
directors, officers and other employees may solicit responses from
you, those directors, officers and other employees will not receive
any commissions or compensation for their services other than their
normal compensation, and will not register with the SEC as brokers
in reliance on certain safe harbor provisions contained in Rule
3a4-1 under the Exchange Act.
Delivery
of Subscription Rights
As
soon as practicable after the Record Date for the Rights Offering,
we will distribute the rights, rights certificates and copies of
this prospectus to individuals who owned shares of common stock on
4:00 p.m., Eastern Time, on [●]. If your shares are held in the
name of a custodian bank, broker, dealer or other nominee, then you
should send your subscription documents and subscription payment to
that record holder. If you are the record holder, then you should
send your subscription documents, rights certificate, and
subscription payment to the subscription agent, Broadridge
Corporate Issuer Solutions, LLC, at the following address. If sent
by mail, we recommend that you send documents and payments by
registered mail, properly insured, with return receipt requested,
and that a sufficient number of days be allowed to ensure delivery
to the subscription agent. Do not send or deliver these materials
to the Company.
|
By Mail:
Broadridge
Corporate Issuer Solutions, LLC
Attn:
BCIS Re-Organization Dept.
P.O.
Box 1317
Brentwood,
NY 11717-0718
|
By Overnight Delivery:
Broadridge
Corporate Issuer Solutions, LLC.
Attn:
BCIS IWS
51
Mercedes Way
Edgewood,
NY 11717
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In
the event that the Rights Offering is not fully subscribed, holders
of rights who exercise all of their rights pursuant to their Basic
Subscription Right will have the opportunity to subscribe for
additional shares of common stock pursuant to the Over-Subscription
Right. See further the section titled “The Rights Offering”
beginning on page 40.
We
have not agreed to enter into any standby or other arrangement to
purchase or sell any rights or any of our securities. Robert W.
Duggan, our Executive Chairman, Chief Executive Officer, and the
beneficial owner of approximately 78.1% of our outstanding common
stock prior to this Rights Offering, and Dr. Mahkam Zanganeh, our
co-Chief Executive Officer, President, a member of our Board of
Directors, and the beneficial owner of approximately 6.0% of our
issued and outstanding common stock prior to this Rights Offering,
have each indicated that they
intend to participate in the Rights Offering and subscribe for at
least the full amount of their Basic Subscription Rights, but have
not made any formal binding commitment to
participate.
We
have not entered into any agreements regarding stabilization
activities with respect to our securities. If you have any
questions, you should contact the information agent at Broadridge
Corporate Issuer Solutions, LLC, Attn: BCIS Re-Reorganization
Dept., P.O. Box 1317, Brentwood, NY 11717-0718, by telephone at
1-855-793-5068 or by email at shareholder@broadridge.com. We have
agreed to pay Broadridge Corporate Issuer Solutions, LLC a fee plus
certain expenses, which we estimate will total approximately
$50,000. We estimate that our total expenses in connection with the
Rights Offering will be approximately $500,000.
Other
than as described herein, we do not know of any existing agreements
between any stockholder, broker, dealer, underwriter or agent
relating to the sale or distribution of the shares of common
stock.
LEGAL
MATTERS
Baker &
Hostetler, LLP will pass upon the validity of any securities we
offer by this prospectus.
EXPERTS
The
financial statements as of and for the year ended December 31, 2021
incorporated by reference in this prospectus by reference to the
Annual Report on Form 10-K/A for the year ended December 31, 2021
have been so incorporated in reliance on the report (which
contains an emphasis of matter paragraph related to the Company’s
requirement for additional financing to fund future operations and
management’s plans as described in Note 3 to the consolidated
financial statements) of PricewaterhouseCoopers LLP (a Delaware
limited liability partnership), an independent registered public
accounting firm, given on the authority of said firm as experts in
auditing and accounting.
The
financial statements as of and for the year ended December 31, 2020
incorporated by reference in this prospectus by reference to the
Annual Report on Form 10-K/A for the year ended December 31, 2021
have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP (a United Kingdom entity), an
independent registered public accounting firm, given on the
authority of said firm as experts in auditing and
accounting.
INCORPORATION OF
CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” information into this
prospectus. This means that we can disclose important information
about us and our financial condition to you by referring you to
other documents filed separately with the SEC. The information
incorporated by reference is considered to be a part of this
prospectus, except any information that is superseded by
information that is included in a document subsequently filed with
the SEC.
This
prospectus incorporates by reference the documents listed below
that we have previously filed with the SEC and any future filings
we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of
the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), from the date of this prospectus until the termination of an
offering of securities, except that we are not incorporating by
reference any information furnished (and not filed) with the SEC,
including any information furnished pursuant to Items 2.02 or 7.01
of Form 8-K or related exhibits furnished pursuant to
Item 9.01 of Form 8-K:
|
● |
Our Annual Report on Form 10-K for
the fiscal year ended
December 31, 2021, as filed on March 17, 2022 (except for the
consolidated financial statements on pages 91 to 127); |
|
● |
The
Annual Report on Form 10-K/A for the fiscal year ended
December 31, 2021, as filed on December 22, 2022; |
|
● |
Our Current Reports on Form 8-K
filed on
January 12, 2022,
January 25, 2022,
February 9, 2022,
March 11, 2022,
June 1, 2022,
June 22, 2022,
June 22, 2022,
July 14, 2022;
July 18, 2022,
July 26, 2022,
July 29, 2022,
August 9, 2022,
August 16, 2022,
October 3, 2022,
October 4, 2022,
November 17, 2022,
December 6, 2022,
December 21, 2022,
December 27, 2022, and
January 9, 2023 (except for information contained therein which
is furnished rather than filed) and January 20, 2023; |
|
● |
Our Definitive Proxy Statements on
Schedule 14A filed on
April 29, 2022 (only the information specifically incorporated
by reference into our Annual Report on Form 10-K for the fiscal
year ended December 31, 2021) and
December 13, 2022 (the “Proxy Statement”); |
|
● |
The description of the securities
contained in our Current Report on Form 8-K dated
September 18, 2020, including any amendment or report filed for
the purpose of updating such description. |
Any
statement contained in a document all or a portion of which is
incorporated or deemed to be incorporated by reference herein will
be deemed to be modified or superseded to the extent that a
statement contained herein or in any other subsequently filed
document which also is or is deemed to be incorporated by
reference
herein modifies or supersedes such statement. Any statement so
modified will not be deemed to constitute a part hereof, except as
so modified, and any statement so superseded will not be deemed to
constitute a part hereof.
A
copy of any document incorporated by reference in this prospectus
may be obtained at no cost by writing or telephoning us at the
following address and telephone number:
Summit
Therapeutics Inc.
2882
Sand Hill Road, Suite 106
Menlo
Park, CA 94025
Attention:
Investor Relations
(617)-514-7149
We
maintain a website at www.smmttx.com. Information about us,
including our reports filed with the SEC, is available through that
site. Such reports are accessible at no charge through our website
and are made available as soon as reasonably practicable after such
material is filed with or furnished to the SEC. Our website and the
information contained on that website, or connected to that
website, are not incorporated by reference in this
prospectus.
You
may read and copy any materials we file with the SEC at the SEC’s
website mentioned under the heading “Where You Can Find More
Information.” The information on the SEC’s website is not
incorporated by reference in this prospectus.
WHERE YOU CAN FIND
MORE INFORMATION
We
file annual, quarterly and current reports, proxy statements and
other information with the SEC. Our SEC filings are available to
the public over the Internet at the SEC's website at www.sec.gov.
Copies of certain information filed by us with the SEC are also
available on our website at www.smmttx.com. The information
contained in, or accessible through, our website, however, should
not be considered a part of this prospectus.
This
prospectus is part of a registration statement we filed with the
SEC. This prospectus does not contain all of the information
included in the registration statement and the amendments, exhibits
and schedules thereto, in accordance with SEC rules and
regulations. You should review the information and exhibits in the
registration statement for further information on us and our
consolidated subsidiaries and the securities we are offering.
Statements in this prospectus concerning any document we filed as
an exhibit to the registration statement or that we otherwise filed
with the SEC are not intended to be comprehensive and are qualified
by reference to these filings. You should review the complete
document to evaluate these statements. You can obtain a copy of the
registration statement from the SEC at the address listed above or
from the SEC’s website.
PART
II — INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution.
The
following table sets forth all expenses, payable by the registrant
in connection with the sale of its common stock being registered.
All the amounts shown are estimates except the SEC registration
fee.
| |
|
Amount to be Paid |
|
| SEC
Registration Fee |
|
$ |
55,100 |
|
| Subscription and
Information Agent Expenses |
|
$ |
16,000 |
|
| Printing
Expenses |
|
$ |
8,250 |
|
| Accounting Fees and
Expenses |
|
$ |
125,000 |
|
| Legal Fees and
Expenses |
|
$ |
200,000 |
|
|
Miscellaneous |
|
$ |
95,650 |
|
| Total |
|
$ |
500,000 |
|
We are
paying all expenses of the Rights Offering listed above. No portion
of these expenses will be borne by our stockholders.
Item
14. Indemnification of Directors and Officers.
Section
145(a) of the DGCL provides, in general, that a corporation may
indemnify any person who was or is a party to 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), because he or she is or was a director, officer,
employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or
agent of another corporation, partnership, joint venture, trust or
other enterprise, against expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlement actually and
reasonably incurred by the person in connection with such action,
suit or proceeding, if he or she acted in good faith and in a
manner he or she reasonably believed to be in or not opposed to the
best interests of the corporation and, with respect to any criminal
action or proceeding, had no reasonable cause to believe his or her
conduct was unlawful.
Section
145(b) of the DGCL provides, in general, that a corporation may
indemnify any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action or suit
by or in the right of the corporation to procure a judgment in its
favor because the person is or was a director, officer, employee or
agent of the corporation, or is or was serving at the request of
the corporation as a director, officer, employee or agent of
another corporation, partnership, joint venture, trust or other
enterprise, against expenses (including attorneys’ fees) actually
and reasonably incurred by the person in connection with the
defense or settlement of such action or suit if he or she acted in
good faith and in a manner he or she reasonably believed to be in
or not opposed to the best interests of the corporation, except
that no indemnification shall be made with respect to any claim,
issue or matter as to which he or she shall have been adjudged to
be liable to the corporation unless and only to the extent that the
Court of Chancery or other adjudicating court determines that,
despite the adjudication of liability but in view of all of the
circumstances of the case, he or she is fairly and reasonably
entitled to indemnity for such expenses that the Court of Chancery
or other adjudicating court shall deem proper.
Section
145(g) of the DGCL provides, in general, that a corporation may
purchase and maintain insurance on behalf of any person who is or
was a director, officer, employee or agent of the corporation, or
is or was serving at the request of the corporation as a director,
officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, against any liability
asserted against such person and incurred by such person in any
such capacity, or arising out of his or her status as such, whether
or not the corporation would have the power to indemnify the person
against such liability under Section 145 of the DGCL.
The
registrant’s Certificate of Incorporation provides that the
registrant will indemnify each person who was or is a party or
threatened to be made a party to or is involved in 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 registrant) by reason of the fact that he or
she is or was a director or officer of the registrant, or is or was
serving at the registrant’s request as a director or officer of
another corporation, partnership, joint venture, trust or other
enterprise to the fullest extent permitted by the DGCL. The
registrant’s Certificate of Incorporation provides that any
reasonable, documented, out-pocket expenses must be advanced to
these indemnitees under certain circumstances.
The
indemnification provisions contained in the registrant’s
Certificate of Incorporation are not exclusive. In addition, the
registrant has entered into indemnification agreements with each of
its directors and executive officers. Each indemnification
agreement provides that the registrant will indemnify the director
or executive officer to the fullest extent permitted by law for
claims arising in his or her capacity as a director or executive
officer, provided that he or she acted in good faith and in a
manner that he or she reasonably believed to be in, or not opposed
to, the registrant’s best interests and, with respect to any
criminal proceeding, had no reasonable cause to believe that his or
her conduct was unlawful. In the event that the registrant does not
assume the defense of a claim against a director or executive
officer, the registrant is required to advance his or her expenses
in connection with his defense, provided that he or she undertakes
to repay all amounts advanced if it is ultimately determined that
he or she is not entitled to be indemnified by the
registrant.
In
addition, the registrant maintains standard policies of insurance
under which coverage is provided to the registrant’s directors and
officers against losses arising from claims made by reason of
breach of duty or other wrongful act, and to the registrant with
respect to payments which may be made by the registrant to such
directors and officers pursuant to the above indemnification
provisions or otherwise as a matter of law.
Item
15. Recent Sales of Unregistered Securities.
None.
Item
16. Exhibits.
| Exhibit |
|
|
|
No. |
|
Description |
| 3.1 |
|
Restated Certificate of Incorporation of the Registrant
(incorporated by reference to Exhibit 3.1 to the Registrant’s
Current Report on Form 8-K (File No. 001-36866), filed with the
Securities and Exchange Commission on September 18, 2020) |
| 3.2 |
|
Amendment to Restated Certificate of Incorporation of the
Registrant (incorporated by reference to Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-36866), filed
with the Securities and Exchange Commission on July 29,
2022) |
| 3.3 |
|
Amended and Restated Bylaws (incorporated by reference to Exhibit
3.2 to the Registrant’s Current Report on Form 8-K (File No.
001-36866), filed with the Securities and Exchange Commission on
September 18, 2020) |
| 3.4 |
|
Amendment No. 2 to Restated Certificate of Incorporation of the
Registrant (incorporated by reference to Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-36866), filed
with the Securities and Exchange Commission on January 20,
2023) |
| 4.1* |
|
Form of Subscription Rights Certificate |
| 5.1* |
|
Opinion of Baker & Hostetler LLP |
| 10.1*† |
|
Collaboration and License Agreement dated December 5, 2022 by and
between Akeso, Inc. and its affiliates and Summit Therapeutics Sub,
Inc. |
| 23.1** |
|
Consent of
PricewaterhouseCoopers LLP, a Delaware limited liability
partnership, and independent registered public accounting firm for
the Registrant. |
| 23.2** |
|
Consent of
PricewaterhouseCoopers LLP, a United Kingdom entity, and
independent registered public accounting firm for the
Registrant. |
| 23.3* |
|
Consent of Baker & Hostetler LLP (included in Exhibit 5.1
hereto) |
| 24.1* |
|
Powers of Attorney (included on
signature page hereto) |
| 99.1* |
|
Form of Instructions As To Use of Non-Transferable Subscription
Rights Certificates |
| 99.2* |
|
Form of Letter to Stockholders who are Record Holders |
| 99.3* |
|
Form of Letter to Brokers and other Nominee Holders |
| 99.4* |
|
Form of Letter to Clients of Brokers and other Nominee
Holders |
| 99.5* |
|
Form of Nominee Holder Certification |
| 99.6* |
|
Form of Beneficial Owner Election Form |
| 107* |
|
Filing fee table |
|
* |
Previously filed. |
| ** |
Filed herewith. |
|
† |
Portions
of this exhibit have been omitted in compliance
with Regulation S-K Item 601(b)(10)(iv) because
the Registrant has determined that the information is not material
and is the type that the Registrant treats as private or
confidential. |
Item
17. Undertakings.
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;
(ii) to
reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the SEC pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than
20 percent change in the maximum aggregate offering price set forth
in the “Calculation of Registration Fee” table in the effective
registration statement; and
(iii) to
include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement; provided, however, that: Paragraphs (a)(1)(i),
(a)(1)(ii) and (a)(1)(iii) of this section do not apply if the
information required to be included in a post-effective amendment
by those paragraphs is contained in reports filed with or furnished
to the SEC by the registrant pursuant to Section 13 or Section
15(d) of the Exchange Act, 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, 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
to any purchaser:
(i) Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall
be deemed to be part of the registration statement as of the date
the filed prospectus was deemed part of and included in the
registration statement; and
(ii) Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5)
or (b)(7) as part of a registration statement in reliance on Rule
430B relating to an offering made pursuant to Rule 415(a)(1)(i),
(vii) or (x) for the purpose of providing the information required
by Section 10(a) of the Securities Act 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.
(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.
(6) That,
for purposes of determining any liability under the Securities Act
of 1933, each filing of the registrant’s annual report pursuant to
Section 13(a) or Section 15(d) of the Securities Exchange Act of
1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to Section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(7) Insofar
as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, or
otherwise, the registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act 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.
(8) That,
for the purposes of determining any liability under the Securities
Act of 1933:
(i) The
information omitted from the form of prospectus filed as part of
this registration statement in reliance upon Rule 430A and
contained in a form of prospectus filed by the registrant pursuant
to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall
be deemed to be part of this registration statement as of the time
it was declared effective.
(ii) Each
post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the
Registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has
duly caused this Registration Statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of Menlo
Park, State of California, on January 20, 2023.
| |
SUMMIT
THERAPEUTICS INC. |
|
| |
|
|
|
| |
By: |
/s/
Robert W. Duggan
|
|
| |
|
Name:
Robert W. Duggan |
|
| |
|
Title: Chief Executive
Officer; Executive Chairman |
|
Pursuant
to the requirements of the Securities Act of 1933, as amended, the
following persons in the capacities indicated have signed this
Registration Statement below on the 20th day of January,
2023.
| |
|
|
|
|
Signature
|
|
Title
|
|
| |
|
|
|
|
/s/
Robert W. Duggan
Robert
W. Duggan
|
|
Chief Executive
Officer; Executive Chairman
(Principal Executive Officer) |
|
| |
|
|
|
|
/s/
Ankur Dhingra
Ankur
Dhingra
|
|
Chief
Financial Officer (Principal Financial and Accounting
Officer) |
|
| |
|
|
|
|
/s/
Dr. Mahkam Zanganeh
Dr.
Mahkam Zanganeh
|
|
Co-Chief
Executive Officer and President, Director |
|
| |
|
|
|
|
*
Kenneth
A. Clark
|
|
Director |
|
| |
|
|
|
|
*
Dr.
Robert Booth
|
|
Director |
|
| |
|
|
|
|
*
Ujwala
Mahatme
|
|
Director |
|
| |
|
|
|
|
*
Manmeet
S. Soni
|
|
Director |
|
| |
|
|
|
|
*
|
|
Director
|
|
| Dr. Alessandra
Cesano |
|
|
|
|
|
|
Director |
| Dr. Yu Xia |
|
|
|
| * By: /s/ Ankur
Dhingra |
|
| Ankur
Dhingra |
|
| As
Attorney-in-Fact |
|
| |
|