Summit Therapeutics Inc Reports Financial Results and Operational Progress for the Second Quarter Ended June 30, 2022
August 11 2022 - 08:00AM
GlobeNewswire Inc.
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 ended June
30, 2022.
Financial Highlights
- Aggregate cash, accounts
receivable, and tax credits receivable on June 30, 2022 totaled
$74.0 million as compared to $89.0 million on December
31, 2021. Our cash balance on June 30, 2022 was $57.3 million
as compared to $71.8 million on December 31, 2021. Accounts
receivable and research and development tax credits receivable on
June 30, 2022 were $16.7 million as compared to
$17.2 million on December 31, 2021.
- Net loss for the three months ended
June 30, 2022 and 2021 was $16.8 million and
$24.4 million, respectively. Net loss for the six months ended
June 30, 2022 and 2021 was $38.2 million and $41.9 million,
respectively.
- Operating cash outflow for the six
months ended June 30, 2022 and 2021 was $38.2 million and
$39.8 million, respectively.
- On June 22, 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 July 18, 2022, and the
associated subscription rights expired on August 8, 2022. Through
the fully subscribed Rights Offering, the Company raised $100.0
million in gross proceeds through the issuance and sale of
approximately 103 million shares of its common stock at a price per
share of $0.97. Issuance costs associated with the Rights Offering
were approximately $0.1 million, resulting in net proceeds of
approximately $99.9 million.
- In connection with the closing of the rights offering, a $25.0
million note payable with our Chairman and CEO, Robert W. Duggan,
matured and became due, and the Company repaid all principal and
accrued interest via a portion of the proceeds from this Rights
Offering.
- During the three months ended June
30, 2022, the Company received non-dilutive funding of
$0.1 million from the Biomedical Advanced Research and
Development Authority ("BARDA"), part of the Office of the
Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services, in support of the
Company's Ri-CoDIFy clinical trials and clinical development of
ridinilazole. As of June 30, 2022, an aggregate of
$58.0 million out of a potential award of $72.5 million has
been received from BARDA under contract number HHSO100201700014C.
The contract with BARDA was set to expire on April 30, 2022. The
contract was extended through December 2022 as a no cost contract,
solely to close out open activities. Remaining potential funding
from BARDA has not been included in aggregate cash and receivables
balances, above.
- During the three months ended June
30, 2022, the Company received non-dilutive funding of
$0.3 million from the Trustees of Boston University under the
Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator ("CARB-X") program, in support of IND-enabling
activities for SMT-738. As of June 30, 2022, an aggregate of
$1.2 million out of a potential of up to $7.8 million of
funding has been received from CARB-X. Remaining potential funding
from CARB-X has not been included in aggregate cash and receivables
balances, above.
Operational & Corporate Updates
- Our intention is to expand our
pipeline product portfolio in the therapeutic area of oncology
and/or product offerings that are designed to work in harmony with
the human gut microbiome. We intend to enact this through business
development activities, including possible acquisitions and/or
collaborations in addition to internal research and discovery
efforts.
- In July 2022, we held a Type C
meeting with the US Food & Drug Administration (the “FDA”)
during which we discussed certain data from the Ri-CoDIFy Phase III
clinical trial with the agency. The FDA and Summit discussed a
possible pathway in which to advance ridinilazole forward with the
goal of achieving marketing authorization. This pathway would
involve at least one additional clinical trial. We plan to explore
this possibility.
- During the second quarter of 2022,
we continued to expand and bolster our leadership team to fit the
expansive vision of our Company going forward. In doing so, we have
appointed two individuals to positions of senior leadership,
continuing to enhance the strong existing core leadership team and
positioning the Company well for our strategic goals in the coming
years.
- In May, Ankur Dhingra joined Summit as our Chief Financial
Officer. Mr. Dhingra was most recently the CFO of CareDx;
previously, he spent over 15 years at Agilent Technologies, holding
positions of increasing responsibility across its finance
organization, including serving in multiple business unit CFO
roles. Mr. Dhingra has over 20 years of progressive financial
leadership experience in the fields of healthcare, medical devices,
and technology and has assumed responsibility for Summit's human
resources and information technology functions in addition to his
finance responsibilities.
- In April, Urte Gayko, PhD, was appointed as our Head of
Regulatory, Safety, and Quality. Dr. Gayko, who is also a member of
our Board of Directors, was most recently the Senior Vice President
of Drug Development & Regulatory Affairs at Nektar
Therapeutics; she was previously the Global Head of Regulatory
Affairs and Pharmacovigilance at Pharmacyclics, Inc. Dr. Gayko has
over 20 years of experience in regulatory affairs and clinical
development ranging from pre-commercial entities to large
biopharmaceutical companies, including Amgen and AbbVie.
- We are continuing to perform
IND-enabling activities for our second drug candidate,
SMT-738.
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.summittxinc.com and follow us on Twitter
@summitplc.
Contact Summit Investor Relations:
Dave GancarzHead of Stakeholder Relations &
Corporate Strategydavid.gancarz@summitplc.com
General Inquiries:
investors@summitplc.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, 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 topline results of our Phase III
Ri-CoDIFy study evaluating ridinilazole, 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 ridinilazole. 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, |
|
2022 |
|
2021 |
2022 |
|
2021 |
Revenue |
$235 |
|
$57 |
$485 |
|
$249 |
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
9,008 |
|
23,923 |
29,564 |
|
42,302 |
General and administrative |
6,933 |
|
5,984 |
13,592 |
|
10,169 |
Total
operating expenses |
15,941 |
|
29,907 |
43,156 |
|
52,471 |
Other
operating income |
3,014 |
|
6,120 |
7,821 |
|
11,569 |
Operating
loss |
(12,692) |
|
(23,730) |
(34,850) |
|
(40,653) |
Other
expense, net |
(4,079) |
|
(686) |
(3,318) |
|
(1,251) |
Net
loss |
$(16,771) |
|
$(24,416) |
$(38,168) |
|
$(41,904) |
|
|
|
|
|
|
|
Basic and
diluted loss per share |
$(0.17) |
|
$(0.27) |
$(0.38) |
|
$(0.48) |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Net
loss |
$(16,771) |
|
$(24,416) |
$(38,168) |
|
$(41,904) |
Other
comprehensive (loss) income: |
|
|
|
|
|
|
Foreign
currency translation adjustments |
789 |
|
540 |
(971) |
|
1,215 |
Comprehensive loss |
$(15,982) |
|
$(23,876) |
$(39,139) |
|
$(40,689) |
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In thousands
|
|
June 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
Cash |
|
$57,335 |
|
$71,791 |
Total
assets |
|
$95,718 |
|
$113,374 |
Total
liabilities |
|
$44,401 |
|
$30,090 |
Total
stockholders' equity |
|
$51,317 |
|
$83,284 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS INFORMATION(Unaudited)In
thousands
|
|
Six Months Ended June 30, |
|
|
2022 |
|
2021 |
|
|
|
|
|
Net cash
used in operating activities |
|
$(38,218) |
|
$(39,843) |
Net cash
used in investing activities |
|
(654) |
|
(190) |
Net cash
provided by financing activities |
|
25,187 |
|
75,979 |
Effect of
exchange rate changes on cash |
|
(771) |
|
1,023 |
|
|
|
|
|
(Decrease) Increase in cash |
|
$(14,456) |
|
$36,969 |
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