Full Press Release Details
Summit Therapeutics Reports Financial Results
and Operational Progress
for the Second Quarter and Six Months Ended
Cambridge, Massachusetts, August 11, 2021 -
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results
and provides an update on its operational progress for the second quarter and six months ended June 30, 2021.
Note: A glossary of terms is included at the
end of this document in order to allow for the ease of understanding of terms or concepts used throughout this release.
Financial Highlights
Ridinilazole for C. difficile Infection
In conjunction with this release, we have simultaneously
issued a press release today providing an update with respect to our Phase III Ri-CoDIFy clinical trials. Please refer to that release
for our current operational progress with respect to ridinilazole.
SMT-738 for Carbapenem-Resistant Enterobacteriaceae
The DDS-04 compound series is a novel class of
precision antibiotics generated from our Discuva Platform with a new mechanism of action that acts via the novel bacterial target, LolCDE.
SMT-738 is the first molecule of this novel class with the potential to treat multidrug resistant infections caused by a large family
of pathogenic Gram-negative bacteria, the Enterobacteriaceae, that include serious human pathogens such as Escherichia coli and
Klebsiella pneumoniae. Combining a novel antibiotic class (SMT-738) with a clinically unexploited target (LolCDE) mitigates the
risk of pre-existing resistance, potentially allowing for the effective treatment of Enterobacteriaceae-caused infections that currently
have very limited and failing treatment options due to resistance to existing antibiotic classes.
Corporate Highlights
About C. difficile Infection
Clostridioides difficile, or C. difficile,
infection (CDI) is a bacterial infection of the colon that produces toxins causing inflammation of the colon, severe watery diarrhea,
painful abdominal cramping, nausea, fever, and dehydration. CDI can also result in more serious disease complications, including bowel
perforation, sepsis, and death. CDI is a contagious infectious disease that represents a serious healthcare issue in hospitals, long-term
care facilities, and the wider community. Summit estimates that there are approximately 500,000 cases of CDI each year across the United
States with acute care costs exceeding $5.4 billion in the US based on a meta-analysis published in the Journal of Global Health,
About Enterobacteriaceae
Enterobacteriaceae are a family of bacteria
responsible for serious infections across a number of conditions including bloodstream infections, urinary tract infections, and
hospital-acquired pneumonias. Multidrug resistant Enterobacteriaceae are resistant to treatment by most or occasionally all existing
antibiotics. The most difficult to treat among them are the carbapenem-resistant Enterobacteriaceae (CRE), which are classified as
an Urgent Threat by the US Centers for Disease Control and Prevention (CDC).
About Summit Therapeutics
The overriding objective of Summit Therapeutics
is to create value for patients, hospital caregivers, and community-based healthcare providers, as well as healthcare payers around the
world. We seek to create value by developing drugs with high therapeutic efficacy - curing the cause of the patient's condition with minimal
or zero disease recurrence or antimicrobial resistance, for the longest extent possible - and minimizing the trauma caused to the patient
and healthcare ecosystem by minimizing serious side effects, disease recurrence, and inaccessibility to our treatments as a result of
financial or other barriers. Summit Therapeutics, empowered by its Discuva Platform, the Company's innovative antibiotic discovery
engine, and supported by BARDA and CARB-X funding, intends to be the leader in patient-friendly and paradigm-shifting treatments for infectious
diseases and other significant unmet medical needs while being an ally to physicians. Our new mechanism pipeline product candidates are
designed with the goal to become the patient-friendly, new-era standard of care, by working in harmony with the human microbiome to treat
prospective patients suffering from infectious diseases, initially focusing on Clostridioides difficile infection (CDI). Currently,
Summit's lead product candidate, ridinilazole, is a novel, first-in-class drug engaged in a global Phase III trial program versus
vancomycin, for use as first-line therapy for the treatment of initial and recurrent Clostridioides difficile infection, and to
show superiority in sustained clinical response. Commercialization of ridinilazole is subject to regulatory approvals. SMT-738, the second
candidate within Summit's portfolio, is currently in the IND-enabling phase for the treatment of multidrug resistant infections,
specifically those caused by carbapenem-resistant Enterobacteriaceae (CRE).
For more information, please visit https://www.summittxinc.com
Contact Summit Investor Relations:
Head of Investor Relations & Corporate Strategy
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, 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 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 uncertainties inherent
in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results
of such trials, 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, 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
SUMMIT THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
In thousands, except per share data
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Revenue: | |||||||||||||||
| Licensing agreements | $ | 57 | $ | 170 | $ | 249 | $ | 494 | |||||||
| Total revenue | 57 | 170 | 249 | 494 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 23,923 | 13,572 | 42,302 | 26,484 | |||||||||||
| General and administrative | 5,984 | 5,774 | 10,169 | 9,346 | |||||||||||
| Total operating expenses | 29,907 | 19,346 | 52,471 | 35,830 | |||||||||||
| Other operating income | 6,120 | 3,820 | 11,569 | 10,640 | |||||||||||
| Loss from operations | (23,730) | (15,356) | (40,653) | (24,696) | |||||||||||
| Other income (expense), net | (686) | (114) | (1,251) | 3,147 | |||||||||||
| Loss before income tax | (24,416) | (15,470) | (41,904) | (21,549) | |||||||||||
| Income tax benefit | - | 191 | - | 136 | |||||||||||
| Net loss | $ | (24,416) | $ | (15,279) | $ | (41,904) | $ | (21,413) | |||||||
| Basic and diluted loss per share | $ | (0.27) | $ | (0.23) | $ | (0.48) | $ | (0.32) | |||||||
| Other comprehensive income (loss): | |||||||||||||||
| Foreign currency translation adjustment | 540 | (52) | 1,215 | (4,676) | |||||||||||
| Total comprehensive loss | $ | (23,876) | $ | (15,331) | $ | (40,689) | $ | (26,089) |
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
| June 30, 2021 | December 31, 2020 | |||||||
| Cash and cash equivalents | $ | 103,386 | $ | 66,417 | ||||
| Total assets | 145,517 | 102,498 | ||||||
| Total liabilities | 26,090 | 23,045 | ||||||
| Total stockholders' equity | 119,427 | 79,453 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW INFORMATION
| Six Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Net cash used in operating activities | $ | (39,843) | $ | (23,492) | ||||
| Net cash used in investing activities | (190) | (327) | ||||||
| Net cash provided by financing activities | 75,979 | 3 | ||||||
| Effect of exchange rates in cash and cash equivalents | 1,023 | (3,616) | ||||||
| Net increase / (decrease) in cash and cash equivalents | $ | 36,969 | $ | (27,432) |
Appendix: Glossary of Critical Terms
Antibiotic resistance genes -
Genes known to be involved in bacterial resistance; such genes may include for example beta-lactamases which can inactivate various beta-lactam
Bile acids - a collection of
steroid-based gut metabolites, the balance of the amount of and types of bile acids in the gut microbiome are believed to play an important
role in the development of or prevention of an initial and potential recurrent infection of Clostridioides difficile.i
Bloodstream infections - an
infectious disease defined by the presence of viable bacterial or fungal microorganisms in the bloodstream
that elicit or have elicited an inflammatory response.ii
Carbapenem-Resistant Enterobacteriaceae
(CRE) - Enterobacteriaceae that are resistant to carbapenems, a type of antibiotic used
to treat some of the most resistant forms of gram-negative bacteria. This resistance means that there are fewer options available