$200 Million in Net Proceeds Raised at Premium
to Previous Closing Price
In Separate Transaction, Summit Expanded
License Territories for Ivonescimab in Deal with Akeso to include
Latin America, Middle East, and Africa
Expansion Is in Addition to Existing License
Territories of US, Canada, Europe, and Japan
Conference Call to be Held at 8:00am ET on
Monday, June 3, 2024
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) today announced that the Company received and accepted
an unsolicited offer from an institutional investor to purchase
22,222,222 shares of the Company’s common stock at $9.00 per share,
a premium to the closing price on Friday, May, 31, 2024, for
aggregate gross proceeds to the Company of approximately $200.0
million.
Summit intends to use the net proceeds to advance the clinical
development of ivonescimab, and for working capital and general
corporate purposes.
The securities described above have not been registered under
the Securities Act of 1933, as amended. Accordingly, these
securities may not be offered or sold in the United States, except
pursuant to an effective registration statement or an applicable
exemption from the registration requirements of the Securities Act.
Summit has agreed to file a registration statement with the
Securities and Exchange Commission (SEC) registering the resale of
the shares of common stock and shares of common stock issuable
within 60 days of the closing of the securities purchase
agreement.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or other jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to the registration or qualification under the securities laws of
any such jurisdiction.
Expansion of Ivonescimab License Territories
In addition, Summit announced an expansion of its license
territories for ivonescimab via an amendment of the collaboration
and in-license agreement with Akeso, Inc. (Akeso, HKEX Code:
9926.HK). Under the terms of the expanded agreement, Summit’s
license territories for ivonescimab will include Latin America,
including Mexico and all countries in Central America and South
America, in addition to the Middle East and Africa. This expansion
adds to the territory licensed by Summit, which previously included
the United States, Canada, Japan, and Europe.
“Both parties are strengthening their bond with the intent to
bring ivonescimab to as many patients as possible around the world
who can potentially benefit from this novel anti-cancer therapy,”
stated Dr. Maky Zanganeh, Chief Executive Officer and President of
Summit. “Therefore, we are thrilled to be expanding our
collaboration agreement with Akeso; we are incredibly proud of our
growing partnership as our shared mission and vision can help
rapidly progress the development of ivonescimab.”
In exchange for these rights, the total deal value is worth up
to $70 million. Consistent with the original governing
collaboration agreement are the remaining provisions, including
royalty payments, manufacturing provisions, and other business
terms. The amendment also strengthens the partnership for both
parties by increasing the mutual data sharing benefits for all
trials involving ivonescimab worldwide, which may help facilitate
clinical development and regulatory approval processes in various
regions.
Conference Call
Summit Therapeutics Inc. will host a conference call to discuss
recent updates related to ivonescimab, including data released at
ASCO, on Monday June 3, 2024, before the market opens.
Summit will host a live webcast of the conference call at 8:00am
ET, which will be accessible through our website www.smmttx.com,
and can also be accessed via the following link:
https://events.q4inc.com/attendee/130822402.
The dial-in information for US attendees is toll-free at (800)
715-9871. Additionally, all attendees may access through the toll
number, (646) 307-1963. The Conference ID is 4259251.
An archived edition of the webcast will be available on our
website later in the day on Monday.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
the United States, Canada, Europe, Japan, Latin America, including
Mexico and all countries in Central America, South America, and the
Caribbean, the Middle East, and Africa, and as AK112 in China and
Australia, is a novel, potential first-in-class investigational
bispecific antibody combining the effects of immunotherapy via a
blockade of PD-1 with the anti-angiogenesis effects associated with
blocking VEGF into a single molecule. Ivonescimab displays unique
cooperative binding to each of its intended targets with higher
affinity when in the presence of both PD-1 and VEGF.
This could differentiate ivonescimab as there is potentially
higher expression (presence) of both PD-1 and VEGF in tumor tissue
and the tumor microenvironment (TME) as compared to normal tissue
in the body. Ivonescimab’s tetravalent structure (four binding
sites) enables higher avidity (accumulated strength of multiple
binding interactions) in the tumor microenvironment with over
18-fold increased binding affinity to PD-1 in the presence of VEGF
in vitro, and over 4-times increased binding affinity to VEGF in
the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This
tetravalent structure, the intentional novel design of the
molecule, and bringing these two targets into a single bispecific
antibody with cooperative binding qualities have the potential to
direct ivonescimab to the tumor tissue versus healthy tissue. The
intent of this design, together with a half-life of 6 to 7 days,1
is to improve upon previously established efficacy thresholds, in
addition to side effects and safety profiles associated with these
targets.
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK)
and is currently engaged in multiple Phase III clinical trials.
Over 1,600 patients have been treated with ivonescimab in clinical
studies globally. Summit has begun its clinical development of
ivonescimab in non-small cell lung cancer (NSCLC), commencing
enrollment in 2023 in two Phase III clinical trials, HARMONi and
HARMONi-3.
HARMONi is a Phase III clinical trial which intends to evaluate
ivonescimab combined with chemotherapy compared to placebo plus
chemotherapy in patients with EGFR-mutated, locally advanced or
metastatic non-squamous NSCLC who have progressed after treatment
with a 3rd generation EGFR TKI (e.g., osimertinib).
HARMONi-3 is a Phase III clinical trial which is designed to
evaluate ivonescimab combined with chemotherapy compared to
pembrolizumab combined with chemotherapy in patients with
first-line metastatic squamous NSCLC.
Ivonescimab is an investigational therapy that is not approved
by any regulatory authority in Summit’s license territories,
including the United States and Europe. Ivonescimab was approved
for marketing authorization in China in May 2024.
About Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology 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.
Summit was founded in 2003 and our shares are listed on the
Nasdaq Global Market (symbol "SMMT"). We are headquartered in
Miami, Florida, and we have additional offices in Menlo Park,
California, and Oxford, UK.
For more information, please visit https://www.smmttx.com and
follow us on X @summitplc.
Summit Forward-looking Statements
Any statements in this press release about the Company’s future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of the
Company’s product candidates, entry into and actions related to the
Company’s partnership with Akeso Inc., including the expected
benefits of the amendment to the collaboration and license
agreement, the expected timing of the closing of the private
placement of the Company’s shares of common stock, the intended use
of the net proceeds from the private placement, the Company's
anticipated spending and cash runway, the therapeutic potential of
the Company’s product candidates, the potential commercialization
of the Company’s product candidates, the timing of initiation,
completion and availability of data from clinical trials, the
potential submission of applications for marketing approvals,
potential acquisitions, statements about the previously disclosed
At-The-Market equity offering program (“ATM Program”), the expected
use proceeds and uses thereof, and other statements containing the
words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict,"
"project," "should," "target," "would," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including the
Company’s ability to sell shares of our common stock under the ATM
Program, the conditions affecting the capital markets, general
economic, industry, or political conditions, including the results
of our evaluation of the underlying data in connection with the
development and commercialization activities for ivonescimab, the
outcome of discussions with regulatory authorities, including the
Food and Drug Administration, the uncertainties inherent in the
initiation of future clinical trials, availability and timing of
data from ongoing and future clinical trials, the results of such
trials, and their success, and global public health crises, that
may affect timing and status of our clinical trials and operations,
whether preliminary results from a clinical trial will be
predictive of the final results of that trial or whether results of
early clinical trials or preclinical studies will be indicative of
the results of later clinical trials, whether business development
opportunities to expand the Company’s pipeline of drug candidates,
including without limitation, through potential acquisitions of,
and/or collaborations with, other entities occur, expectations for
regulatory approvals, laws and regulations affecting government
contracts and funding awards, availability of funding sufficient
for the Company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements and other factors discussed in
the "Risk Factors" section of filings that the Company makes with
the Securities and Exchange Commission. Any change to our ongoing
trials could cause delays, affect our future expenses, and add
uncertainty to our commercialization efforts, as well as to affect
the likelihood of the successful completion of clinical development
of ivonescimab. Accordingly, readers should not place undue
reliance on forward-looking statements or information. In addition,
any forward-looking statements included in this press release
represent the Company’s views only as of the date of this release
and should not be relied upon as representing the Company’s views
as of any subsequent date. The Company specifically disclaims any
obligation to update any forward-looking statements included in
this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240603240336/en/
Contact Summit Investor Relations: Dave Gancarz Chief
Business & Strategy Officer
Nathan LiaBraaten Senior Director, Investor Relations
investors@smmttx.com
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