Summit Therapeutics Inc.
(‘Summit’, the ‘Company’ or the ‘Group’)
Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2020
Cambridge, MA, September 29, 2020 - Summit Therapeutics Inc. (NASDAQ: SMMT) today reports its financial results and provides an update on its operational progress for the second quarter and six months ended June 30, 2020.
Ridinilazole for C. difficile Infection (‘CDI’)
|Quarter||Number of patients enrolled||Cumulative Patients Enrolled|
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.
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, led by Dr. Ventzislav Stefanov and 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 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 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 medical need.
For more information, visit www.summitplc.com and follow us on Twitter @summitplc. For more information on the Company’s Discuva Platform, visit https://www.summitplc.com/our-science/discuva-platform.
|Contacts Summit Press Officefirstname.lastname@example.org|
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|
|In thousands, except share and per share data|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Licensing agreements||$ 170||$ 156||$ 494||$ 647|
|Research and development||14,105||11,257||26,592||22,635|
|General and administrative||5,299||2,136||5,970||5,234|
|Total operating expenses||19,404||13,393||32,562||27,869|
|Loss from operations||(19,234)||(13,237)||(32,068)||(27,222)|
|Other operating income||3,867||6,494||10,640||13,585|
|Interest expense, net||(55)||(79)||(120)||(156)|
|Loss before income tax||(15,422)||(6,822)||(21,548)||(13,793)|
|Income tax benefit (expense)||191||139||(6)||124|
|Basic loss per share||$ (0.23)||$ (0.21)||$ (0.32)||$ (0.44)|
|Diluted loss per share||$ (0.23)||$ (0.21)||$ (0.32)||$ (0.44)|
|Other comprehensive income/(loss):|
|Foreign currency translation adjustment||(45)||(1,255)||(4,567)||(44)|
|Total comprehensive loss||$(15,276)||$(7,938)||$(26,121)||$(13,713)|
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
|June 30, 2020||December 31, 2019|
|Cash and cash equivalents||$||36,410||$||63,842|
|Total stockholders' equity||$||51,946||$||77,237|
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
|Six months ended|
|Net cash used in operating activities||$||(23,491)||$||(9,235)|
|Net cash used in investing activities||(327)||(225)|
|Net cash provided by financing activities||3||24,503|
|Effect of exchange rates in cash and cash equivalents||(3,617)||29|
|Net (decrease) / increase in cash and cash equivalents||$||(27,432)||$||15,072|