First US Patient Treated in Ivonescimab
Clinical Trial after Closing Agreement; $500M Raised in
Fully-Subscribed Rights Offering
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the
"Company") today reports its financial results and provides an
update on operational progress for the first quarter ended March
31, 2023.
Operational & Corporate Updates
- Our Collaboration and License Agreement with Akeso Inc. (Akeso)
for ivonescimab:
- On December 5, 2022, Summit and Akeso entered into a
Collaboration and License Agreement for ivonescimab, Akeso's
innovative, potentially first-in-class 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.
- The Collaboration and License Agreement with Akeso closed on
January 17, 2023 after going effective following customary waiting
periods.
- Summit received the rights to develop and commercialize
ivonescimab (SMT112) in the United States, Canada, Europe, and
Japan. Akeso retained development and commercialization rights for
the rest of the world, including China.
- In exchange for these rights, Summit committed to an upfront
payment of $500 million, which was paid in two installments.
- The first installment worth $300 million was paid in January in
conjunction with the closing of the transaction. Of the $300
million paid to Akeso by Summit, Akeso opted, in accordance with
the Collaboration and License Agreement, to receive 10 million
shares in lieu of a cash payment of $25.1 million; the remaining
$274.9 million was paid by Summit to Akeso in cash.
- The second installment of $200 million was paid on March 6,
2023 in cash.
- Going forward, Akeso will be eligible to receive regulatory and
commercial milestones of up to $4.5 billion. In addition, Akeso
will receive low double-digit royalties on net sales in the Summit
territories.
- Summit is actively engaged in development activities for
SMT112, including holding multiple meetings with the US Food &
Drug Administration (FDA) regarding its planned Phase III clinical
program and incorporated this feedback accordingly. Summit will
start its clinical development in non-small cell lung cancer
(NSCLC) in the following indications:
- Ivonescimab combined with chemotherapy in patients with
epidermal growth factor receptor (EGFR)-mutated, locally advanced
or metastatic non-squamous NSCLC who have progressed after
treatment with a third-generation EGFR tyrosine kinase inhibitor
(TKI) (“HARMONi” trial)
- Ivonescimab combined with chemotherapy in first-line metastatic
squamous NSCLC patients (“HARMONi-3” trial)
- In May 2023, the first patient was treated in the Phase III
HARMONi clinical trial.
- Summit intends to dose patients in the HARMONi-3 trial during
the second half of 2023.
- Akeso has a rich and diversified antibody drug pipeline with
over 30 internally discovered drug candidates in various stages of
development, including six bispecific antibodies. Akeso has taken
part in over 80 clinical trials for 17 drug candidates, including
14 pivotal trials. Akeso has two drugs approved for oncology
indications in China: a PD-1 inhibitor, and novel PD-1 / CTLA-4
bispecific antibody. Akeso has over 2,400 employees.
- In January 2023, upon the closing of the Collaboration and
License Agreement, Yu (Michelle) Xia, Ph.D., Co-Founder,
Chairwoman, and CEO of Akeso, was appointed to our Board of
Directors. Dr. Xia has over 27 years of experience in the
pharmaceutical industry and academic research. Prior to founding
Akeso, Dr. Xia held senior leadership roles at Crown Bioscience
Inc., where she played a decisive role in constructing Crown
Bioscience’s platform, building its team and forging its joint
venture with Pfizer (the Pfizer-Crown Asian Cancer Research
Centre). Dr. Xia also served as a senior scientist and group leader
at PDL BioPharma, Inc. (later acquired by AbbVie Inc.), a senior
process development scientist at Bayer Corporation, and held
scientific and managerial roles at Axys Pharmaceuticals, Inc.
(later acquired by Celera Genomics, Inc.). In addition, Dr. Xia has
also received numerous awards and recognitions for her
contributions to both the pharmaceutical industry and commercial
enterprises. Most recently, Dr. Xia was selected into Forbes’
Powerful Women in Technology in 2020 and in 2023 was named by
Forbes China as a Top 100 Women in Business in China.
Financial Highlights
- Aggregate cash, cash-equivalents, short-term investments, and
receivables on March 31, 2023 totaled $246.9 million as compared to
$654.7 million on December 31, 2022.
- Our cash, cash-equivalents and short-term investments on March
31, 2023 was $241.9 million as compared to $648.6 million on
December 31, 2022. Accounts receivable and research and development
tax credits receivable on March 31, 2023 were $5.0 million as
compared to $6.1 million on December 31, 2022.
- Our short-term investments consist of highly-liquid U.S.
treasury securities.
- Our notes payable balance at March 31, 2023 was $100.0 million,
which is due in September 2024.
- Based on our current cash and investments position, we believe
that we have sufficient capital resources to fund our operating
costs and working capital needs, including our planned clinical
trials for ivonescimab, going into the second half of 2024.
- Net loss for the three months ended March 31, 2023 and 2022 was
$542.4 million and $21.4 million, respectively.
- The net loss for the three months ended March 31, 2023 includes
one-time in-process research and development expenses associated
with the in-licensing of ivonescimab from Akeso of $520.9
million.
- Operating cash outflow for the three month ended March 31, 2023
and 2022 was $13.1 million and $19.0 million, respectively.
- On December 6, 2022, the Company entered into a Note Purchase
Agreement with the Company's Chairman and CEO, Robert W. Duggan,
and the Company's Co-Chief Executive Officer, President, and a
member of the Company's Board of Directors, Dr. Maky Zanganeh, in
the aggregate amount of $520.0 million. Interest due and payable
through February 15, 2023 was prepaid in shares of the Company's
common stock.
- On February 15, 2023, Dr. Zanganeh's $20.0 million note became
due and the Company repaid the outstanding principal balance.
- On December 6, 2022, the Company announced a Rights Offering
for its existing shareholders to participate in the purchase of
additional shares of its common stock. The Rights Offering
commenced on February 7, 2023, and the associated subscription
rights expired on March 1, 2023. Through the fully subscribed
Rights Offering, the Company raised $500.0 million in gross
proceeds through the issuance and sale of 476.2 million shares of
its common stock at a price per share of $1.05. Issuance costs
associated with the Rights Offering were $0.6 million, resulting in
net proceeds of approximately $499.4 million.
- In connection with the closing of the rights offering, a $400.0
million note payable with Mr. Duggan matured and became due, and
the Company satisfied all principal and accrued interest of $401.3
million using a combination of a portion of the cash proceeds from
the 2023 Rights Offering and the extinguishment of a portion of the
amount due equal to the subscription price for shares subscribed by
Mr. Duggan in the 2023 Rights Offering.
First Quarter 2023 Earnings Call
Summit will host an earnings call this morning, Thursday, May
11, 2023, at 9:00am ET. A live webcast and instructions for joining
the call are accessible through Summit’s website www.smmttx.com. An
archived edition of the webcast will be available on our website
after the call.
Summit Therapeutics’ Mission Statement
To 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 Therapeutics
Summit 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.
For more information, please visit https://www.smmttx.com and
follow us on Twitter @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., 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.
SUMMIT THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
In thousands, except per share
data
Three Months Ended March
31,
2023
2022
Revenue
$
—
$
250
Operating expenses:
Research and development
9,883
20,556
In-process research and development
520,915
—
General and administrative
6,940
6,659
Total operating expenses
537,738
27,215
Other operating income
584
4,807
Operating loss
(537,154
)
(22,158
)
Other expense, net
(5,222
)
761
Net loss
$
(542,376
)
$
(21,397
)
Basic and diluted loss per share
$
(1.43
)
$
(0.15
)
Comprehensive loss:
Net loss
$
(542,376
)
$
(21,397
)
Other comprehensive (loss)
income:
Foreign currency translation
adjustments
(51
)
(1,760
)
Reclassification of cumulative currency
translation gain to other (expense) income, net
(419
)
—
Unrealized gain on investments
968
—
Comprehensive loss
$
(541,878
)
$
(23,157
)
CONDENSED CONSOLIDATED BALANCE
SHEET INFORMATION
(Unaudited)
In thousands
March 31, 2023
December 31, 2022
Cash, Restricted Cash, Short-term
Investments
$
241,932
$
648,607
Total assets
$
254,897
$
664,168
Total liabilities
$
121,415
$
537,514
Total stockholders' equity
$
133,482
$
126,654
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS INFORMATION
(Unaudited)
In thousands
Three Months Ended March
31,
2023
2022
Net cash used in operating
activities
$
(13,131
)
$
(19,001
)
Net cash used in investing
activities
(645,063
)
(361
)
Net cash provided by financing
activities
80,112
25,187
Effect of exchange rate changes on
cash
444
(166
)
(Decrease) increase in cash and cash
equivalents
$
(577,638
)
$
5,659
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005349/en/
Contact Summit Investor Relations: Dave Gancarz SVP,
Stakeholder Relations, Business Development, & Corporate
Strategy investors@smmttx.com
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