Promising Updated Phase II Data Presented at
ASCO 2023 for Ivonescimab
First US Patient Treated in Ivonescimab Phase
III Clinical Trial with the First Patient in Ivonescimab's Second
Phase III Clinical Trial Planned for the Second Half of 2023
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the
"Company") today reports its financial results and provides an
update on operational progress for the second quarter and six
months ended June 30, 2023.
Operational & Corporate Updates
- Our operational progress with ivonescimab (SMT112), an
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:
- Summit is actively engaged in development activities for
SMT112. In just over six months since we closed our in-licensing
transaction for ivonescimab, Summit has:
- Held multiple meetings with the US Food & Drug
Administration (FDA) regarding its planned Phase III clinical
program and incorporated this feedback accordingly, and
- Begun 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 in Summit's license territories
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.
- In June 2023, promising Phase II data from AK112-201, a study
of Chinese subjects conducted and analyzed by our partners, Akeso,
was presented at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting. In addition to encouraging data in multiple
indications within NSCLC, a portion of the updated data presented
at ASCO supports Summit's HARMONi-3 clinical trial in first-line
metastatic squamous NSCLC: Phase II data in 63 treatment-naive,
squamous NSCLC patients treated with ivonescimab plus chemotherapy
with a median follow-up time of 13.3 months experienced:
- Median progression-free survival (PFS) of 11.0 months (95% CI:
9.5 to 16.8 months)
- Overall response rate (ORR) of 67% (95% CI: 53% to 78%) with a
median duration of response of 15 months
- Median overall survival (OS) was not reached; although
estimated 9-month OS was 93.2%
- Grade >3 treatment-related
adverse events (TRAEs) was 41%; the most frequent TRAEs were
anemia, decreased neutrophil counts, and alopecia
- Recapping our Collaboration and License Agreement with Akeso
Inc. (Akeso) for ivonescimab (SMT112):
- On December 5, 2022, Summit and Akeso entered into a
Collaboration and License Agreement for ivonescimab.
- 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.
- 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 a novel PD-1 / CTLA-4
bispecific antibody. Akeso has over 2,400 employees.
Financial Highlights
- Aggregate cash, cash-equivalents, short-term investments, and
receivables on June 30, 2023 totaled $220.1 million as compared to
$654.7 million on December 31, 2022.
- Our cash, cash-equivalents and short-term investments on June
30, 2023 was $215.0 million as compared to $648.6 million on
December 31, 2022. Accounts receivable and research and development
tax credits receivable on June 30, 2023 were $5.1 million as
compared to $6.1 million on December 31, 2022.
- Our short-term investments consist of U.S. treasury
securities.
- Our notes payable balance at June 30, 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, for at least twelve months following the
issuance of our Q2 financial statements filed on Form 10-Q.
- Net loss for the three and six months ended June 30, 2023 was
$14.7 million and $557.1 million, respectively. Net loss for the
three and six months ended June 30, 2022 was $16.8 million and
$38.2 million, respectively.
- The net loss for the six months ended June 30, 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 six months ended June 30, 2023
and 2022 was $42.4 million and $38.2 million, respectively.
Second Quarter 2023 Earnings Call
Summit will host an earnings call this morning, Wednesday,
August 9, 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 Ivonescimab
Ivonescimab, known as SMT112 in the United States, Canada,
Europe, and Japan (Summit’s license territories), 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 was discovered by Akeso Inc. (HKEX Code: 9926.HK) and
is currently engaged in multiple Phase III clinical trials in
China. Summit has begun its clinical development of ivonescimab in
NSCLC, enrolling the first patient in its license territory in
2023, with multiple Phase III clinical trials intended to be
initiated in 2023. Over 825 patients have been treated with
ivonescimab in clinical studies in China and Australia, with
enrollment beginning recently in the United States.
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 X (formerly 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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenue
$
—
$
235
$
—
$
485
Operating expenses:
Research and development
9,451
9,008
19,334
29,564
In-process research and development
—
—
520,915
—
General and administrative
6,316
6,933
13,256
13,592
Total operating expenses
15,767
15,941
553,505
43,156
Other operating (expense) income, net
(27
)
3,014
557
7,821
Operating loss
(15,794
)
(12,692
)
(552,948
)
(34,850
)
Other income (expense), net
1,077
(4,079
)
(4,145
)
(3,318
)
Net loss
$
(14,717
)
$
(16,771
)
$
(557,093
)
$
(38,168
)
Basic and diluted loss per share
$
(0.02
)
$
(0.12
)
$
(1.03
)
$
(0.27
)
Comprehensive loss:
Net loss
$
(14,717
)
$
(16,771
)
$
(557,093
)
$
(38,168
)
Other comprehensive (loss)
income:
Foreign currency translation
adjustments
(76
)
789
(128
)
(971
)
Reclassification of cumulative currency
translation gain to other (expense) income, net
—
—
(419
)
—
Net changes related to short-term
investments
(965
)
—
3
—
Comprehensive loss
$
(15,758
)
$
(15,982
)
$
(557,637
)
$
(39,139
)
CONDENSED CONSOLIDATED BALANCE
SHEET INFORMATION
(Unaudited)
In thousands
June 30, 2023
December 31, 2022
Cash, Restricted Cash, Short-term
Investments
$
215,014
$
648,607
Total assets
$
237,372
$
664,168
Total liabilities
$
117,773
$
537,514
Total stockholders' equity
$
119,599
$
126,654
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS INFORMATION
(Unaudited)
In thousands
Six Months Ended June
30,
2023
2022
Net cash used in operating
activities
$
(42,404
)
$
(38,218
)
Net cash used in investing
activities
(644,856
)
(654
)
Net cash provided by financing
activities
80,032
25,187
Effect of exchange rate changes on
cash
737
(771
)
(Decrease) increase in cash and cash
equivalents
$
(606,491
)
$
(14,456
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809529387/en/
Dave Gancarz SVP, Stakeholder Relations, Business Development,
& Corporate Strategy investors@smmttx.com
Summit Therapeutics (NASDAQ:SMMT)
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