Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) today announced a definitive agreement of its
partnership with Akeso Inc. (HKEX Code: 9926.HK, “Akeso”), to
in-license its breakthrough bispecific antibody, ivonescimab. Akeso
is a pioneer and source originator in developing innovative
antibodies. The agreement supports Summit’s mission of developing
and commercializing groundbreaking oncology pipeline products aimed
at improving the quality of life of patients with serious unmet
medical needs. For Akeso, the deal represents an opportunity to
introduce its highly innovative antibodies to markets, including
the United States, Canada, Europe, and Japan – an important step
towards Akeso’s strategic intention of becoming a global biopharma
organization.
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
combining the power of immunotherapy via a blockade of PD-1 with
the anti-angiogenesis benefits of an anti-VEGF into a single
molecule. Ivonescimab is believed to be the PD-1 / VEGF bispecific
antibody that is most advanced in the clinic: there are no known
PD-1-based bispecific antibodies approved by the US Food and Drug
Administration (“FDA”) or the European Medicines Agency (“EMA”).
Akeso has already demonstrated success by commercializing the only
PD-1 bispecific approved in China. Its product 开坦尼 (pronounced
“Kaitanni”) (cadonilimab), a PD-1 / CTLA-4 bispecific, was approved
by the Chinese National Medical Products Administration (“NMPA”)
earlier this year for the treatment of relapsed or metastatic
cervical cancer patients who progressed on or after platinum-based
chemotherapy.
Ivonescimab was engineered to bring two well
established oncology targeted mechanisms together. It is our belief
that the novel design has the potential to reduce side effects and
safety concerns.
"The partnership between Summit Therapeutics and
Akeso is a strategically compelling opportunity,” stated Robert W.
Duggan, Chairman and Chief Executive Officer of Summit. “It
represents bringing together Akeso’s extraordinary team, which has
built an innovation engine capable of creating novel bispecific
technologies, and the talented members of Team Summit with their
proven track record of success of global clinical development,
regulatory approvals, and commercialization, particularly in
oncology. We believe the potential exists for enormous creation
through this partnership. We are extremely encouraged by
ivonescimab and the potential for improving the quality and
duration of patients’ lives based on clinical data to support this
point. Team Summit is honored and enthusiastic to partner with
Akeso. Our shared mission and vision is to create a
significant difference for the betterment of patient healthcare
outcomes around the world."
“Ivonescimab has demonstrated the potential to
deliver superior clinical benefit for patients and tremendous value
for investors,” said Dr. Michelle Xia, Co-founder, Chairwoman, CEO,
and President of Akeso. “The Akeso team has been dedicated to the
development of ivonescimab for the past 8 years, and proudly
advanced the molecule to the clinical Phase III stage. The
global value of ivonescimab awaits great work from a great team to
realize. We are so pleased to partner with the world-class Summit
team, who has the track record of successfully bringing over a
dozen indications to market for the first-in-class blockbuster drug
IMBRUVICA® (ibrutinib). Following intense and in-depth strategic,
scientific, and operational discussion on ivonescimab between the
Akeso and Summit teams in recent months, we are more confident than
ever on a winning path for ivonescimab’s global development. With
this tremendous momentum, we look forward to the swift execution of
the clinical development and commercial plan in a global setting
for ivonescimab.”
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.
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).
Summit is initiating development activities for
SMT112 and will do so first in NSCLC indications. Summit plans to
start treating patients in clinical studies by the second quarter
of 2023.
The definitive partnership calls for Summit to
receive the rights to develop and commercialize ivonescimab
(SMT112) in the United States, Canada, Europe, and Japan. 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. The total
potential deal value is $5.0 billion, as Akeso will be eligible to
receive regulatory and commercial milestones of up to $4.5 billion.
In addition, Akeso will be eligible to receive low double-digit
royalties on net sales. In conjunction with the closing of the
deal, Dr. Michelle Xia will be appointed to the board of directors
of Summit. The deal is subject to customary closing practices,
including applicable waiting periods under the Hart-Scott-Rodino
(HSR) Act.
“After reviewing a substantial number of
opportunities, much of which was focused on potential treatments
for solid tumors, we have found the ideal partnership with the
potential to change the paradigm for treating patients facing
difficult odds with devastating diagnoses,” added Dr. Maky
Zanganeh, Co-Chief Executive Officer, President, and a member of
Summit’s Board of Directors. “Ten years ago, metastatic lung cancer
patients rarely survived for more than ten to twelve months from
diagnosis. Today, survival can be measured in years. Our goal is to
improve the quality of life of a patient facing immeasurable odds
while extending the duration of that patient’s life. Our focus is
always on how we can improve the lives of patients. We sought
patient-friendly medicinal therapies through our search to expand
our pipeline portfolio, and we are proud to take this meaningful
step towards accomplishing this goal. We have significant work to
do, but we are steadfastly committed to bringing ivonescimab into
the hands of patients who need it most. We are thrilled to reach
this agreement with Michelle and the team at Akeso, and we are
excited to make this vision a reality. I am proud of Team Summit
who have diligently worked these past few months to establish a
strong bond with the team at Akeso, and I would like to thank the
talented people of Team Akeso for spending so much quality time
creating this meaningful partnership.”Announcement of $500
Million Rights Offering
In conjunction with today’s announcement
regarding the definitive agreement related to SMT112, the Company
has also announced that the Company’s Board of Directors has
approved a rights offering available to all holders of record of
the Company’s common stock, par value $0.01 (the “Common Stock”) as
of the close of the market on the record date which will be no
earlier than January 23, 2023 (the “Record Date”). The Company
intends to distribute to all holders of Common Stock as of the
Record Date non-transferable subscription rights to purchase shares
of Common Stock at a price per share equal to the lesser of (i)
$1.05, or (ii) the volume weighted-average price of the Common
Stock for the five consecutive trading days through and including
the expiration date of the offering. Assuming that the rights
offering is fully subscribed, the Company will receive gross
proceeds of up to $500 million, less expenses related to the rights
offering.
The rights offering will include an
over-subscription right to permit each rights holder that exercises
its basic subscription rights in full to purchase additional shares
of Common Stock that remain unsubscribed at the expiration of the
offering. The availability of the over-subscription right will be
subject to certain terms and conditions to be set forth in the
offering documents.
Mr. Duggan, the beneficial owner of
approximately 81% of Summit’s Common Stock prior to this rights
offering, and Dr. Zanganeh, the beneficial owner of approximately
6.4% of the Company’s 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.
The Company intends to register the rights
offering with the Securities and Exchange Commission (the “SEC”) by
filing a prospectus on Form S-1. When available, a copy of the
prospectus supplement may be obtained at the website maintained by
the SEC at www.sec.gov.
This press release does not constitute an offer
to sell or the solicitation of an offer to buy these securities,
nor will 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 registration or qualification under the
securities laws of any such state or jurisdiction. The rights
offering will be made pursuant to a registration statement on Form
S-1 containing the detailed terms of the rights offering to be
filed with the SEC. Any offer will be made only by means of a
prospectus forming part of the registration statement.
Issuance of $520 Million Promissory
Note
In conjunction with this agreement, Mr. Duggan
and Dr. Zanganeh entered into a Note Purchase Agreement pursuant to
which the Company was loaned $520 million in exchange for the
issuance by the Company of unsecured promissory notes in the 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 a rate of 7.5%.
Interest will be prepaid on the Notes for the
period through February 15, 2023; such prepaid interest will be
paid in shares of the Company’s common stock. If the Company
exercises its right to extend the term of the Notes, interest will
accrue on the outstanding principal balance at the interest rate
equal to the then US prime interest rate plus 50 basis points as
adjusted monthly. After the three months immediately following the
applicable Maturity Dates, interest will accrue at the then US
prime interest rate plus 300 basis points, as adjusted monthly. At
the Company’s election, the Notes are extendable to no later than
September 6, 2024. If the Company consummates a public offering,
then the February Notes will be prepaid by an amount equal to the
lesser of the net amount raised by the Company in the public
offering or the outstanding principal of the February Notes. The
prepayment would not be required prior to May 15, 2023.
The Company may prepay any portion of the Notes
at its option without penalty. It is anticipated that the February
Notes will be repaid in connection with the consummation of the
anticipated rights offering.
The Notes issued has 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.
The Company expects to use the funds raised to
support the following activities:
- Payment of the upfront obligation associated with the
aforementioned partnership agreement;
- Activities to support clinical development and regulatory
approval for SMT112;
- Pursue business development opportunities to expand our
pipeline of drug candidates; and
- General corporate purposes.
41st Annual J.P. Morgan Annual
Healthcare ConferenceSummit will present alongside Akeso
at the 41st Annual J.P. Morgan Healthcare Conference, which will
include additional details related to this transaction. The
presentation will be available afterwards through Summit’s website
at https://www.summittxinc.com.
Summit Therapeutics’ Mission
StatementTo build a viable, long-lasting health care
organization that assumes full responsibility for designing,
developing, trial execution and enrollment, regulatory submission
and approval, and successful commercialization of patient,
physician, caregiver, and societal-friendly medicinal therapy
intended to: improve quality of life, increase potential duration
of life, and resolve serious medical healthcare needs. To identify
and control promising product candidates based on exceptional
scientific development and administrational expertise, develop our
products in a rapid, cost-efficient manner, and to engage
commercialization and/or development partners when appropriate.
We accomplish this by building a team of world
class professional scientists and business administrators that
apply their experience and knowledge to this mission. Team Summit
exists to pose, strategize, and execute a path forward in medicinal
therapeutic health care that places Summit in a well-deserved, top
market share, leadership position. Team Summit assumes full
responsibility for stimulating continuous expansion of knowledge,
ability, capability, and well-being for all involved stakeholders
and highly-valued shareholders.
About Summit TherapeuticsSummit
was founded in 2003 and our shares are listed on the Nasdaq Global
Market (symbol ‘SMMT’). We are headquartered in Menlo Park,
California, and we have additional offices in Oxford, UK and
Cambridge, UK.For more information, please visit
https://www.summittxinc.com and follow us on Twitter
@summitplc.
Contact Summit Investor
RelationsDave GancarzHead of Stakeholder Relations &
Corporate Strategydavid.gancarz@summitplc.com
General Inquiries:
investors@summitplc.com
About Akeso Inc.Akeso (HKEX:
09926) is a commercial-stage biopharmaceutical company committed to
the discovery, development, manufacturing and commercialization of
innovative medicines with high unmet medical needs worldwide.
Founded in 2012, the company has established a comprehensive
in-house drug development platform (ACE Platform) and know-how,
including R&D, clinical development, CMC (Chemistry,
Manufacturing, and Controls), and commercialization capabilities.
With fully integrated multi-functional platform, Akeso is
internally working on a robust pipeline of over 30 innovative
assets in the fields of cancer, autoimmune disease, inflammation,
metabolic disease, and other major therapeutic areas. 17 assets
have entered into clinical stage. Leveraging its in-house
developed bispecific platform technology (“Tetrabody technology”),
Akeso has advanced four potential first-in-class bispecific
antibody drugs into market or clinical development, including
cadonilimab (PD-1 / CTLA-4), ivonescimab (PD-1 / VEGF), PD-1 /
LAG-3, and TIGIT / TGF-Beta bispecific antibodies. In June 2022,
cadonilimab was approved by the NMPA and became the first
commercialized PD-1 based bispecific drug globally. Another Akeso
internally discovered and developed oncology product, penpulimab (a
PD-1 antibody), was granted marketing approval in China in August
2021. Akeso is listed on the Main Board of the Stock Exchange of
Hong Kong Limited.
Contact Akeso Investor
RelationsMichael XiChief Financial
Officermichael.xi@akesobio.com
General Inquiries: ir@akesobio.com
Summit Forward-looking
StatementsAny 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., 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, the impact of the COVID-19 pandemic on the
Company’s operations and clinical trials, potential acquisitions
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 results of our evaluation of the underlying
data in connection with the development and commercialization
activities for SMT112, 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, including the coronavirus COVID-19 outbreak,
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 SMT112. 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.
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