Enrollment Initiated in Second Phase III
Clinical Study for Ivonescimab, HARMONi-3
Continuing Enrollment of HARMONi Phase III
Study, with Enrollment Completion Expected in Second Half of
2024
Manmeet S. Soni Joined Summit as COO, Invested
$5 Million in the Company
Dave Gancarz, Dr. Urte Gayko, Dr. Fong Clow,
& Dr. Allen S. Yang Elevated to Leadership Positions
Dr. Jack West & Dr. Laura Chow Bolster
Summit's Clinical Development Team with Combined 45+ Years of Lung
Cancer, Immunotherapy, & Anti-Angiogenic Treatment
Experience
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the
"Company") today reports its financial results and provides an
update on operational progress for the third quarter and nine
months ended September 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:
- We are actively engaged in development activities for SMT112.
In just over nine months since we closed our in-licensing
transaction for ivonescimab, we have:
- Held multiple meetings with the US Food & Drug
Administration (FDA) regarding our planned Phase III clinical
program and incorporated this feedback accordingly,
- Begun our clinical development in non-small cell lung cancer
(NSCLC) in the following proposed 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),
- Launched the Phase III HARMONi clinical trial in less than 4
months of acquiring the rights to ivonescimab; enrollment is
expected to complete in the second half of 2024
- Commenced patient enrollment in the second Phase III clinical
study, HARMONi-3.
- 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.
- 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.
- Over 950 patients have been treated with ivonescimab in
clinical studies in China and Australia, with enrollment beginning
recently in Summit's license 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 2,700 employees.
- In the beginning of Q4, we announced that we have bolstered our
leadership and clinical experience at Team Summit:
- Manmeet S. Soni has joined the Company as our Chief Operating
Officer. Mr. Soni has over 20 years of financial and operational
leadership experience. He was President, Chief Operating Officer,
& Chief Financial Officer at Reata Pharmaceuticals, Inc., which
was sold to Biogen Inc. for $7.5 billion. Prior to Reata, Mr. Soni
was the CFO at Alnylam Pharmaceuticals, Inc. and Ariad
Pharmaceuticals, Inc., the latter of which was purchased by Takeda
Pharmaceutical Co. Ltd. for $5.4 billion in 2017. Mr. Soni was also
the CFO at Pharmacyclics, Inc., which, along with the leadership of
Robert W. Duggan and Dr. Maky Zanganeh, was sold to AbbVie Inc. for
$21 billion in 2015. In addition to his continuing board service to
Summit, he serves on the Board of Directors of Pulse Biosciences,
Inc. In conjunction with joining Summit as COO, Mr. Soni invested
$5.0 million in the Company via a private placement.
- Based on the accomplishments of the Company, including our deal
to in-license ivonescimab and the operational progress that has
been achieved since, the following elevated appointments have been
made from current leaders at Team Summit:
- Dave Gancarz as Chief Business & Strategy Officer
- Urte Gayko, PhD, as Chief Regulatory, Quality, &
Pharmacovigilance Officer
- Fong Clow, DSc, as Chief Biometrics Officer
- Allen S. Yang, MD, PhD, as Chief Medical Officer
- H. Jack West, MD, joined Summit as Vice President of Clinical
Development. Dr. West brings over 25 years of experience as a
practicing thoracic oncologist; he joined Summit from City of Hope,
one of the nation’s leading cancer treatment and research centers.
At City of Hope, he was the Vice President of Network Strategy at
AccessHope, as well as an Associate Professor and practicing
medical oncologist. Prior to joining City of Hope, Dr. West spent
over 15 years at Providence Health & Services, including time
as the Medical Director of the Thoracic Oncology Program. As a
practicing physician, Dr. West earned his medical degree from
Harvard Medical School, was the Howard Hughes Medical Student
Research Fellow at Massachusetts General Hospital, and did his
medical oncology fellowship training at the University of
Washington Fred Hutchinson Cancer Research Center.
- Laura Chow, MD, joined Summit as Senior Vice President of
Clinical Development. Dr. Chow brings nearly two decades of
experience as a practicing medical oncologist and clinical
researcher. She was previously a professor and Director of the Head
& Neck and Lung Cancer Program at Dell Medical School and
University of Texas at Austin. Prior to joining the University of
Texas, Dr. Chow was a professor at the University of Washington
Fred Hutchinson Cancer Research Center where she was a clinical
researcher in lung cancer, thyroid cancers, head and neck cancers,
and novel immunotherapies and anti-angiogenic agents. Dr. Chow has
participated in advisory boards for multiple novel immunotherapies,
including the early PD-1 therapies that now represent some of the
most significant cancer therapies in present time. Dr. Chow earned
her medical degree from the University of British Columbia and
performed her residency at the University of Alberta.
Financial Highlights
- Aggregate cash and cash equivalents, restricted cash,
short-term investments, and receivables on September 30, 2023
totaled $200.5 million as compared to $654.7 million on December
31, 2022.
- Our cash, cash equivalents, restricted cash, and short-term
investments on September 30, 2023 was $198.9 million as compared to
$648.6 million on December 31, 2022. Accounts receivable and
research and development tax credits receivable on September 30,
2023 were $1.6 million as compared to $6.1 million on December 31,
2022.
- Our short-term investments consist of U.S. treasury
securities.
- Our current notes payable balance at September 30, 2023 was
$100.0 million, which is due in September 2024.
- Based on our current cash and investments position, current
operating plans, and with the $100.0 million notes payable due in
September 2024, we have sufficient funds to operate into the second
half of 2024.
- Net loss for the three and nine months ended September 30, 2023
was $21.3 million and $578.4 million, respectively. Net loss for
the three and nine months ended September 30, 2022 was $21.4
million and $59.6 million, respectively.
- The net loss for the nine months ended September 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 nine months ended September 30,
2023 and 2022 was $57.3 million and $46.8 million,
respectively.
Third Quarter 2023 Earnings Call
Summit will host an earnings call this morning, Tuesday,
November 7, 2023, at 9:00am ET. The conference call will be
accessible by dialing (888) 210-3702 (toll-free domestic) or (646)
960-0191 (international) using conference code 5785899. 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. Summit
has begun its clinical development of ivonescimab in NSCLC,
commencing enrolling in its license territory in 2023 in two Phase
III clinical trials. Over 950 patients have been treated with
ivonescimab in clinical studies in China and Australia, with
enrollment beginning recently in Summit's license territories.
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 September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Revenue
$
—
$
220
$
—
$
705
Operating expenses:
Research and development
15,323
17,049
34,657
46,613
In-process research and development
—
—
520,915
—
General and administrative
5,434
5,573
18,690
19,165
Total operating expenses
20,757
22,622
574,262
65,778
Other operating income, net
265
5,462
822
13,283
Operating loss
(20,492
)
(16,940
)
(573,440
)
(51,790
)
Other (expense) income, net
(776
)
(4,445
)
(4,921
)
(7,763
)
Net loss
$
(21,268
)
$
(21,385
)
$
(578,361
)
$
(59,553
)
Basic and diluted loss per share
$
(0.03
)
$
(0.10
)
$
(0.98
)
$
(0.37
)
Comprehensive loss:
Net loss
$
(21,268
)
$
(21,385
)
$
(578,361
)
$
(59,553
)
Other comprehensive (loss)
income:
Foreign currency translation
adjustments
108
(49
)
(20
)
(1,020
)
Reclassification of cumulative currency
translation gain to other (expense) income, net
—
—
(419
)
—
Net changes related to short-term
investments
6
—
9
—
Comprehensive loss
$
(21,154
)
$
(21,434
)
$
(578,791
)
$
(60,573
)
CONDENSED CONSOLIDATED BALANCE
SHEET INFORMATION
(Unaudited)
In thousands
September 30, 2023
December 31, 2022
Cash, Restricted Cash, Short-term
Investments
$
198,945
$
648,607
Total assets
$
218,476
$
664,168
Total liabilities
$
119,097
$
537,514
Total stockholders' equity
$
99,379
$
126,654
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS INFORMATION
(Unaudited)
In thousands
Nine Months Ended September
30,
2023
2022
Net cash used in operating
activities
$
(57,301
)
$
(46,773
)
Net cash used in investing
activities
(648,342
)
(634
)
Net cash provided by financing
activities
80,261
100,184
Effect of exchange rate changes on
cash
567
(2,597
)
(Decrease) increase in cash and cash
equivalents
$
(624,815
)
$
50,180
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231107407341/en/
Contact Summit Investor Relations: Dave Gancarz Chief
Business & Strategy Officer investors@smmttx.com
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