Earnings Call with Management Team Scheduled
for Today at 9:00am EST
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the
"Company") today reports its financial results and provides an
update on operational progress for the fourth quarter and year
ended December 31, 2022.
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
breakthrough, 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 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 to be 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 of Summit common stock valued at $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 initiating development activities for SMT112 and will
do so first in non-small cell lung cancer (NSCLC) indications.
Summit intends to start treating patients in clinical studies
during the second quarter of 2023.
- Summit is in communication with and has planned multiple
meetings with health authorities, including the US Food & Drug
Administration ("FDA") in order to align on our approach for
multiple potential late-stage trials for SMT112.
- The deal closed on January 17, 2023 following customary waiting
periods. At this time, Michelle Xia, Ph.D., Co-Founder, Chairwoman,
and CEO of Akeso, was appointed to our Board of Directors.
- Dr. Xia has exceptional experience in leadership across
scientific discovery, R&D, building and scaling manufacturing,
and overall leadership through her experience at companies in the
US. Prior to founding Akeso, Dr. Xia held roles of increasing
leadership at Celera Genomics, Bayer, and Crown Biosciences. Dr.
Xia has approximately 20 years of experience in the pharmaceutical
industry and academic research in the US and the UK alone, in
addition to her deep experience in China leading Akeso.
- 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 2,300 employees.
- In October 2022, we announced the appointment of renowned
biotech executive and scientific leader, Dr. Robert Booth, PhD, to
our Board of Directors. Dr. Booth initiated the BTK inhibitor
program at Celera Genomics, Inc. that ultimately became
Pharmacyclics, Inc.’s IMBRUVICA® (ibrutinib), the blockbuster drug
that changed the paradigm of treatment for many hematological
cancers. In addition to his scientific breakthrough discoveries,
Dr. Booth was an adjunct professor at Stanford University School of
Medicine. He is the co-founder of CuraSen Therapeutics and its
former Executive Chairman, and was the co-founder and CEO of
Virobay Inc. in addition to his previous role as a Senior Vice
President at Roche. Dr. Booth previously served on the boards of
Pharmacyclics and CymaBay Inc.
- In November 2022, we appointed experienced clinical leader, Dr.
Alessandra Cesano, MD, to our Board of Directors. Dr. Cesano is the
Chief Medical Officer (CMO) at Essa Pharma Inc. (NASDAQ: EPIX), a
clinical-stage pharmaceutical company focused on developing novel
therapies for the treatment of prostate cancer. Previously, she was
the CMO at NanoString Inc. and Cleave Biosciences. She has 25 years
of experience in the biopharmaceutical industry focused in
oncology, including extensive experience at Biogen, Amgen, and GSK.
She was instrumental in the development and approval of two
marketed drugs including Vectibix® (panitumumab), an anti-EGFR
antibody for the treatment of certain colorectal cancers. Dr.
Cesano currently serves on the board of Puma Biotechnology Inc.
(NASDAQ: PBYI), a clinical stage oncology company focused on solid
tumors.
Financial Highlights
- Aggregate cash and cash equivalents, restricted cash, accounts
receivable, and tax credits receivable on December 31, 2022 totaled
$654.7 million as compared to $89.0 million on December 31, 2021.
Our cash and cash equivalents and restricted cash balance on
December 31, 2022 was $648.6 million as compared to $71.8 million
on December 31, 2021. Accounts receivable and research and
development tax credits receivable on December 31, 2022 were $6.1
million as compared to $17.2 million on December 31, 2021.
- Net loss for the three months ended December 31, 2022 and 2021
was $19.2 million and $27.1 million, respectively. Net loss for the
year ended December 31, 2022 and 2021 was $78.8 million and $88.6
million, respectively.
- Operating cash outflow for the year ended December 31, 2022 and
2021 was $41.6 million and $72.6 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 approximately $0.5
million, resulting in net proceeds of approximately $499.5 million.
- In connection with the closing of the rights offering, a $400
million note payable with Mr. Duggan, matured and became due, and
the Company repaid all principal and accrued interest of $401.3
million using a portion of the proceeds from this Rights
Offering.
- Based on our current cash balance, including the net proceeds
received from our Rights Offering, repayments of certain notes, and
payments to Akeso in accordance with our Collaboration and License
Agreement during the first quarter of 2023, we believe that we have
sufficient capital resources to fund our operating costs and
working capital needs, including our planned clinical trials for
ivonescimab, into the second half of 2024.
- After accounting for the information described above, as of
February 28, 2023, we have a current aggregate cash and cash
equivalents, accounts receivable, and tax credits receivable
balance of approximately $240 million, inclusive of approximately
$100 million in notes payables due in September 2024.
Q4 and Year-end 2022 Earnings Call
Summit’s management team will host an earnings call to discuss
its fourth quarter 2022 financial results and provide an
operational update for the Company today, March 9, 2023, at 9:00am
ET. It will be accessible through Summit’s website www.smmttx.com
or through the following link:
https://events.q4inc.com/attendee/646367239. An archived version of
the webcast will be available on our website.
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 and
Cambridge, 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 December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
Revenue
$
—
$
251
$
705
$
1,809
Operating expenses:
Research and development
5,386
23,107
51,999
85,352
General and administrative
7,578
7,780
26,743
23,611
Impairment of intangible assets
8,468
—
8,468
—
Total operating expenses
21,432
30,887
87,210
108,963
Other operating income
1,133
4,589
14,416
20,968
Operating loss
(20,299
)
(26,047
)
(72,089
)
(86,186
)
Other expense, net
1,070
(1,052
)
(6,693
)
(2,416
)
Net loss
$
(19,229
)
$
(27,099
)
$
(78,782
)
$
(88,602
)
Basic and diluted loss per
share
$
(0.07
)
$
(0.19
)
$
(0.41
)
$
(0.67
)
Comprehensive loss:
Net loss
$
(19,229
)
$
(27,099
)
$
(78,782
)
$
(88,602
)
Other comprehensive (loss)
income:
Foreign currency translation
adjustments
1,324
1,245
304
1,597
Comprehensive loss
$
(17,905
)
$
(25,854
)
$
(78,478
)
$
(87,005
)
CONDENSED CONSOLIDATED BALANCE
SHEET INFORMATION
(Unaudited)
In thousands
December 31, 2022
December 31, 2021
Cash and cash equivalents and
restricted cash
$
648,607
$
71,791
Total assets
$
664,168
$
113,374
Total liabilities
$
537,514
$
30,090
Total stockholders' equity
$
126,654
$
83,284
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS INFORMATION
(Unaudited)
In thousands
Year Ended
December 31,
2022
2021
Net cash used in operating
activities
$
(41,582
)
$
(72,587
)
Net cash used in investing
activities
(624
)
(306
)
Net cash provided by financing
activities
620,244
77,916
Effect of exchange rate changes on
cash
(1,222
)
351
Increase in cash
$
576,816
$
5,374
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230309005355/en/
Contact Summit Investor Relations: Dave Gancarz SVP of
Corporate Strategy & Stakeholder Relations
investors@smmttx.com
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Jul 2023 to Jul 2024