Summit Therapeutics Inc. Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2022
November 09 2022 - 08:30AM
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, 2022.
Financial Highlights
- Aggregate cash, accounts
receivable, and tax credits receivable on September 30, 2022
totaled $138.4 million as compared to $89.0 million on
December 31, 2021. Our cash balance on September 30, 2022 was
$122.0 million as compared to $71.8 million on December
31, 2021. Accounts receivable and research and development tax
credits receivable on September 30, 2022 were $16.4 million as
compared to $17.2 million on December 31, 2021.
- Net loss for the three months ended
September 30, 2022 and 2021 was $21.4 million and
$19.6 million, respectively. Net loss for the nine months
ended September 30, 2022 and 2021 was $59.6 million and
$61.5 million, respectively.
- Operating cash outflow for the nine
months ended September 30, 2022 and 2021 was $46.8 million and
$63.4 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
103,092,783 shares of its common stock at a price per share of
$0.97. Issuance costs associated with the Rights Offering were $0.1
million, resulting in net proceeds of $99.9 million.
- In connection with the closing of the rights offering, a $25.0
million note payable with the Company's Chairman and CEO, Robert W.
Duggan, matured and became due, and the Company repaid all
principal and accrued interest of $0.4 million via a portion
of the proceeds from this Rights Offering.
- During the three months ended
September 30, 2022, the Company received non-dilutive funding of
$0.8 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 September 30, 2022, an aggregate of
$58.8 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 and 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
September 30, 2022, the Company received non-dilutive funding of
$1.6 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 September 30, 2022, an aggregate of
$2.9 million of funding has been received from CARB-X. CARB-X
previously announced changes to its funding arrangements, including
its terms and conditions going forward. As a result, the current
arrangement concluded as of June 30, 2022; funds previously spent
in accordance with the original agreement were able to be submitted
for reimbursement in the third quarter of 2022. The Company is in
current discussions with CARB-X to negotiate a new agreement; the
original agreement was for an aggregate potential of up to $7.8
million of funding. 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 elevated Dr. Mazy
Zanganeh, DDS, MBA, as Co-Chief Executive Officer & President
of Summit. Dr. Zanganeh was formerly our Chief Operating Officer
having served in that capacity since she joined the Company as an
employee in November 2020, in addition to her responsibilities as a
member of the our Board of Directors. Dr. Zanganeh is also the
founder of Maky Zanganeh and Associates and was previously the
Chief Operating Officer at Pharmacyclics until Pharmacyclics was
purchased by AbbVie in 2015 for $21 billion.
- In September 2022, we determined
that we would seek partners for ridinilazole. As a result of this
determination, the Company discontinued its pediatric clinical
trial evaluating ridinilazole for treating adolescent patients with
CDI.
- In October 2022, we appointed
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.
- We are continuing to perform
IND-enabling activities for our second drug candidate,
SMT-738.
Summit Therapeutics’ Mission
StatementTo 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 TherapeuticsSummit
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 September
30, |
|
Nine Months Ended September
30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue |
$220 |
|
$1,309 |
|
$705 |
|
$1,558 |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
17,049 |
|
19,943 |
|
46,613 |
|
62,245 |
General and administrative |
5,573 |
|
5,662 |
|
19,165 |
|
15,831 |
Total
operating expenses |
22,622 |
|
25,605 |
|
65,778 |
|
78,076 |
Other
operating income |
5,462 |
|
4,810 |
|
13,283 |
|
16,379 |
Operating
loss |
(16,940) |
|
(19,486) |
|
(51,790) |
|
(60,139) |
Other
expense, net |
(4,445) |
|
(113) |
|
(7,763) |
|
(1,364) |
Net
loss |
$(21,385) |
|
$(19,599) |
|
$(59,553) |
|
$(61,503) |
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
$(0.14) |
|
$(0.20) |
|
$(0.52) |
|
$(0.67) |
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
Net
loss |
$(21,385) |
|
$(19,599) |
|
$(59,553) |
|
$(61,503) |
Other
comprehensive (loss) income: |
|
|
|
|
|
|
|
Foreign
currency translation adjustments |
(49) |
|
(863) |
|
(1,020) |
|
352 |
Comprehensive loss |
$(21,434) |
|
$(20,462) |
|
$(60,573) |
|
$(61,151) |
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In
thousands
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
Cash |
|
$121,971 |
|
$71,791 |
Total
assets |
|
$155,327 |
|
$113,374 |
Total
liabilities |
|
$22,079 |
|
$30,090 |
Total
stockholders' equity |
|
$133,248 |
|
$83,284 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS INFORMATION(Unaudited)In
thousands
|
|
Nine Months Ended September
30, |
|
|
2022 |
|
2021 |
|
|
|
|
|
Net cash
used in operating activities |
|
$(46,773) |
|
$(63,408) |
Net cash
used in investing activities |
|
(634) |
|
(186) |
Net cash
provided by financing activities |
|
100,184 |
|
76,655 |
Effect of
exchange rate changes on cash |
|
(2,597) |
|
770 |
|
|
|
|
|
Increase
in cash |
|
$50,180 |
|
$13,831 |
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Feb 2024 to Mar 2024
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Mar 2023 to Mar 2024