Full Press Release Details
Summit Therapeutics Inc.
( Summit', the Company'
Summit Therapeutics Reports Financial
Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2020
Cambridge, MA, November 16, 2020 -
Summit Therapeutics Inc. (NASDAQ: SMMT) today reports its financial results and provides an update on its operational progress
for the third quarter and nine months ended September 30, 2020.
Ridinilazole for C. difficile Infection
| Quarter | Number of Patients Enrolled | Cumulative Patients Enrolled | ||
| Q1 2019 | 9 | 9 | ||
| Q2 2019 | 21 | 30 | ||
| Q3 2019 | 43 | 73 | ||
| Q4 2019 | 78 | 151 | ||
| Q1 2020 | 101 | 252 | ||
| Q2 2020 | 73 | 325 | ||
| Q3 2020 | 64 | 389 | ||
| Q4 2020* | 59* | 448 |
quarter to date enrollment through November 15th
Corporate Highlights
Financial 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 and 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 represents a serious healthcare issue in hospitals, long-term care homes and
in the wider community. Summit estimates that there are over 3 million cases of CDI each year worldwide, based on a meta-analysis
of 229 publications with data from 41 countries, published in the Journal of Global Health, June 2019.
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 of
existent antibiotics. The most difficult to treat among them are the ESBL-producing and the Carbapenem-resistant Enterobacteriaceae
which according to the CDC, have collectively caused an estimated 210,500 infections and 10,200 deaths in hospitalized patients
in the United States in 2017.
About Summit Therapeutics
Summit Therapeutics, empowered by its
Discuva Platform, the Company's innovative antibiotic discovery engine, supported by BARDA
and Carb-X funding, intends to be the leader in patient and physician friendly paradigm shifting antibiotic innovation. Our new
mechanism antibiotics are designed 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 disease, initially focussing on Clostridioides difficile infections
("CDI") which is estimated to impact over 3 million patients worldwide annually. Commercialization of ridinilazole
for the treatment and the reduction of recurrence of CDI is subject to regulatory approvals. The overriding objective of Summit
Therapeutics is to create value for patients, hospital infectious disease care givers, community based infectious disease healthcare
providers, as well as healthcare payors around the world. Currently, Summit's lead product candidate ridinilazole is engaged
in two global phase III trials, Ri-CoDIFy 1 & 2, each enrolling 680 patients vs standard of care (Vancomycin) for the treatment
and reduction of recurrence of C. difficile infections.
Summit's vision and mission is
to extend our pipeline through the development of new mechanism, narrow spectrum, microbiome sparing antibiotics targeting C. difficile,
Gram-negative Enterobacteriaceae such as Escherichia coli and Klebsiella pneumoniae and other bacterial infections with high unmet
For more information, visit www.summitplc.com
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. 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.
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS | |||||||||||||
| (Unaudited) | |||||||||||||
| In thousands, except per share data | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||
| Revenue: | |||||||||||||
| Licensing agreements | $ 181 | $ 148 | $ 675 | $795 | |||||||||
| Total revenue | 181 | 148 | 675 | 795 | |||||||||
| Operating expenses: | |||||||||||||
| Research and development | 14,387 | 9,951 | 40,979 | 32,586 | |||||||||
| General and administrative | 7,460 | 2,683 | 13,430 | 7,917 | |||||||||
| Impairment | 859 | - | 859 | - | |||||||||
| Total operating expenses | 22,706 | 12,634 | 55,268 | 40,503 | |||||||||
| Other operating income | 4,309 | 6,296 | 14,949 | 19,881 | |||||||||
| Operating loss | (18,216) | (6,190) | (39,644) | (19,827) | |||||||||
| Other (income) expense, net | 416 | (75) | 296 | (231) | |||||||||
| Loss before income tax | (17,800) | (6,265) | (39,348) | (20,058) | |||||||||
| Income tax benefit (expense) | 99 | (111) | 93 | 13 | |||||||||
| Net loss | $(17,701) | $(6,376) | $(39,255) | $(20,045) | |||||||||
| Basic loss per share | $ (0.26) | $ (0.20) | $ (0.58) | $ (0.63) | |||||||||
| Diluted loss per share | $ (0.26) | $ (0.20) | $ (0.58) | $ (0.63) | |||||||||
| Other comprehensive income/(loss): | |||||||||||||
| Foreign currency translation adjustment | 2,255 | (1,255) | (2,312) | (1,299) | |||||||||
| Total comprehensive loss | $(15,446) | $(7,631) | $(41,567) | $(21,344) |
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
| September 30, 2020 | December 31, 2019 | |||||||||
| Cash and cash equivalents | $ | 21,270 | $ | 63,842 | ||||||
| Total assets | $ | 56,865 | $ | 96,679 | ||||||
| Total liabilities | $ | 20,004 | $ | 19,442 | ||||||
| Total stockholders' equity | $ | 36,861 | $ | 77,237 |
CONDENSED CONSOLIDATED STATEMENT OF CASH
| Nine months ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| Net cash used in operating activities | $ | (40,140) | $ | (13,861) | ||||
| Net cash used in investing activities | (371) | (358) | ||||||
| Net cash provided by financing activities | 3 | 24,504 | ||||||
| Effect of exchange rates in cash and cash equivalents | (2,064) | (787) | ||||||
| Net (decrease) / increase in cash and cash equivalents | $ | (42,572) | $ | 9,498 |