Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter and Three Months Ended March 31, 2020

Summit Therapeutics plc
(‘Summit’, the ‘Company’ or the ‘Group’)

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter and Three Months Ended March 31, 2020

Oxford, UK, and Cambridge, MA, US, June 2, 2020 - Summit Therapeutics plc (NASDAQ: SMMT) today reports its financial results and provides an update on its operational conditions for the first quarter and three months ended March 31, 2020.

Ridinilazole for C. difficile Infection (‘CDI’)

QuarterNumber of patients enrolledCumulative Patients Enrolled
Q1 201999 
Q2 20192130 
Q3 20194373 
Q4 201978151 
Q1 2020101252 
April 202016 268 
May 202023 291 

Discuva Platform



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 diarrhea. CDI can also result in more serious disease complications, including pseudomembranous colitis, bowel perforation, toxic megacolon and sepsis. CDI represents a serious healthcare issue in hospitals, long-term care homes and in the wider community. Summit estimates there are over one million cases of CDI each year in the United States and Europe, based on an epidemiology report on CDI that was published in 2015 by Decision Resources, a healthcare research and consulting company. Recurrence rates of up to 25% have been reported following treatment with the current standard of care, vancomycin. The vicious cycle of recurrence continues further, with patients who have one recurrence being at increased risk for another. The Healthcare Cost and Utilization Project, a family of databases developed through a federal-state-industry partnership, sponsored by the Agency for Healthcare Research and Quality of the US Department of Health and Human Services, reported an approximate 3.5-fold increase in hospital stays associated with CDI between 2000 and 2008. The economic impact of CDI is significant. A study published in 2016 in BMC Infectious Diseases estimated that the total costs attributable to the management of CDI were approximately $6.3 billion per year.

About Enterobacteriaceae
Enterobacteriaceae are a family of bacteria responsible for severe and often deadly infections. They account
for a significant number of cases across a number of conditions including bloodstream infections, urinary tract infections and hospital-acquired pneumonias. Summit estimates that there are more than one million infections in the United States annually caused by Enterobacteriaceae across these three conditions based on data published in 2018 in the Journal of Antimicrobial Chemotherapy, 2016 in the Journal of Molecular Science, 2014 in the National Healthcare Safety Network, 2014 and 2018 in the New England Journal of Medicine, 2015 in Nature Reviews Microbiology, 2012 in World Journal of Urology and 2014 in PLOS One. Mechanisms of antibiotic resistance to Enterobacteriaceae are listed as both urgent and serious threats by the CDC.

About Gonorrhea
There is an urgent unmet need for the development of new antibiotics against gonorrhea, which is a sexually transmitted infection caused by an overgrowth of the bacteria Neisseria gonorrhoeae (N. gonorrhoeae). N. gonorrhoeae can cause infection of the genitals, throat, and eyes. Untreated infections may spread to the rest of the body, especially the joints, and in women may cause pelvic inflammatory disease and possible infertility. It is estimated by the WHO that there are approximately 78 million new cases of gonorrhea globally per year. N gonorrhoeae has consistently developed resistance to each class of antibiotics recommended for the treatment of gonorrhea infections, and there is now only one treatment that is recommended by the CDC, a combination of the cephalosporin antibiotic ceftriaxone and the macrolide antibiotic azithromycin. The WHO ranks gonorrhea as a “high” priority for research and development while the CDC states that additional treatment options are urgently needed.

About Summit Therapeutics
Summit Therapeutics, led by its Discuva Platform, the Company's discovery engine, is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the patient-friendly new era standard of care for those suffering from infectious disease, subject to regulatory approvals, and create value for payors and healthcare providers. In the present time, we are developing new mechanism antibiotics to treat infections caused by C. difficile, Enterobacteriaceae and N. gonorrhoeae and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit and follow us on Twitter @summitplc. For more information on the Company's Discuva Platform, visit https://www.summitplc,com/our-science/discuva-platform.

For more information:

Summit Press Office

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 potential benefits and future operation of the BARDA or CARB-X contract, including any potential future payments thereunder, the clinical and preclinical development of the Company’s product candidates, the therapeutic potential of the Company’s product candidates, the potential of the Discuva Platform, the potential commercialization of the Company’s product candidates, the sufficiency of the Company’s cash resources, 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 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 ability of BARDA or CARB-X to terminate the contract for convenience at any time, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future preclinical studies and clinical trials and the results of such preclinical studies and clinical trials, 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, legal, regulatory, political and economic risks arising from or relating to global public health crises that reduce economic activity (including the recent coronavirus COVID-19 outbreak) and the enrollment in and completion of clinical trials, laws and regulations affecting government contracts, 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, including the Company’s Transition Report on Form 20-F for the eleven months ended December 31, 2019. 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.

The financial information in the Company’s financial statements has been prepared assuming the Company will continue on a going concern basis. Based on management's forecasts, the Company's existing cash and cash equivalents, anticipated payments from BARDA under its contract for the development of ridinilazole, anticipated payments from CARB-X under its contract for the development of its gonorrhea antibiotic program, and anticipated milestone payments from its license and commercialization agreement with Eurofarma are expected to be sufficient to enable the Company to fund its operating expenses and capital expenditure requirements through January 31, 2021. The Company will need to raise additional funding in order to support, beyond this date, its planned research and development efforts, its preparatory commercialization related activities should ridinilazole receive marketing approval, as well as to support activities associated with operating as a public company in the United States. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition, and may cast and raise significant doubt on the Company’s ability to continue as a going concern.


Condensed Consolidated Statement of Comprehensive Income (unaudited)
For the three months ended March 31, 2020

  Three months ended March 31, 2020Three months ended March 31, 2020Three months ended March 31, 2019
Revenue 315 253 375 
Other operating income 5,096 4,092 4,574 
Operating expenses    
Research and development (12,143)(9,750)(8,693)
General and administration (651)(523)(2,367)
Total operating expenses (12,794)(10,273)(11,060)
Operating (loss) (7,383)(5,928)(6,111)
Finance income 1 1 2 
Finance costs (65)(52)(60)
(Loss) before income tax (7,447)(5,979)(6,169)
Income tax 1,298 1,042 831 
(Loss) for the period (6,149)(4,937)(5,338)
Other comprehensive (loss) / income    
Items that may be reclassified subsequently to profit or loss    
Exchange differences on translating foreign operations 16 13 (6)
Total comprehensive (loss) for the period (6,133)(4,924)(5,344)
Basic and diluted (loss) per ordinary share from operations (2) cents(1) pence(3) pence

Condensed Consolidated Statement of Financial Position (unaudited)
As at March 31, 2020

  March 31, 2020March 31, 2020December 31, 2019
Non-current assets    
Goodwill 2,259 1,814 1,814 
Intangible assets 12,292 9,870 9,950 
Property, plant and equipment 1,305 1,048 1,167 
  15,856 12,732 12,931 
Current assets    
Trade and other receivables 12,179 9,780 8,116 
Current tax receivable 6,080 4,882 3,659 
Cash and cash equivalents 55,296 44,400 48,417 
  73,555 59,062 60,192 
Total assets 89,411 71,794 73,123 
Non-current liabilities    
Lease liabilities (374)(300)(320)
Deferred revenue (1,039)(834)(374)
Provisions for other liabilities and charges (2,633)(2,114)(2,050)
Deferred tax liability (2,127)(1,708)(1,560)
Current liabilities    
Trade and other payables (12,645)(10,154)(8,020)
Lease liabilities (418)(336)(358)
Deferred revenue (2,156)(1,731)(1,136)
Contingent consideration (100)(80)(80)
Total liabilities (21,492)(17,257)(13,898)
Net assets 67,919 54,537 59,225 
Share capital 4,187 3,362 3,359 
Share premium account 160,794 129,110 129,110 
Share-based payment reserve 1,825 1,465 1,299 
Merger reserve 3,770 3,027 3,027 
Special reserve 24,899 19,993 19,993 
Currency translation reserve 85 69 56 
Accumulated losses reserve (127,641)(102,489)(97,619)
Total equity 67,919 54,537 59,225 

Condensed Consolidated Statement of Cash Flows (unaudited)

For the three months ended March 31, 2020

  Three months ended March 31, 2020Three months ended March 31, 2020Three months ended March 31, 2019
Cash flows from operating activities    
Loss before income tax (7,447)(5,979)(6,169)
Adjusted for:    
Loss on recognition of contingent consideration payable   (2)
Finance income (1)(1)(2)
Finance costs 65 52 60 
Foreign exchange (gain) / loss (3,429)(2,753)691 
Depreciation 178 143 150 
Amortization of intangible fixed assets 259 208 207 
Loss on disposal of assets   26 
Share-based payment 290 233 260 
Adjusted loss from operations before changes in working capital (10,085)(8,097)(4,779)
Increase in prepayments and other receivables (1,537)(1,235)(30)
Increase / (decrease) in deferred revenue 1,315 1,055 (1,025)
Increase / (decrease) in trade and other payables 1,967 1,579 (2,270)
Cash used in operations (8,340)(6,698)(8,104)
Contingent consideration paid   2 
Taxation (paid) / received (5)(4)1 
Net cash used in operating activities (8,345)(6,702)(8,101)
Investing activities    
Purchase of property, plant and equipment (30)(24)(64)
Purchase of intangible assets (159)(128) 
Interest received 1 1 2 
Net cash used in investing activities (188)(151)(62)
Financing activities    
Proceeds from issue of share capital   19,648 
Transaction costs on share capital issued   (455)
Proceeds from exercise of share options 4 3  
Repayment of lease liabilities (51)(42)(80)
Repayment of lease interest (7)(6)(9)
Net cash (used in) / generated from financing activities (54)(45)19,104 
(Decrease) / increase in cash and cash equivalents (8,587)(6,898)10,941 
Effect of exchange rates in cash and cash equivalents 3,584 2,881 (617)
Cash and cash equivalents at beginning of the period 60,299 48,417 9,521 
Cash and cash equivalents at end of the period 55,296 44,400 19,845 

Condensed Consolidated Statement of Changes in Equity (unaudited)

Three months ended March 31, 2020

GroupShare capital
Share premium account
Share-based payment reserve
Merger reserve
Special reserve
Accumulated losses  reserve
At January 1, 20203,359 129,110 1,299 3,027 19,993 56 (97,619)59,225 
Loss for the period      (4,937)(4,937)
Currency translation adjustment     13  13 
Total comprehensive loss for the period     13 (4,937)(4,924)
Share options exercised3       3 
Equity based compensation expense  233     233 
Share-based payment reserve transfer  (67)   67  
 At March 31, 20203,362 129,110 1,465 3,027 19,993 69 (102,489)54,537 

Year ended December 31, 2019

GroupShare capital
Share premium account
Share-based payment reserve
Merger reserve
Special reserve
Accumulated losses  reserve
At January 1, 2019823 74,394 1,119 3,027 19,993 65 (74,217)25,204 
Profit for the year      (23,904)(23,904)
Currency translation adjustment     (9) (9)
Total comprehensive profit for the period     (9)(23,904)(23,913)
New share capital issued2,535 55,872      58,407 
Transaction costs on share capital issued (1,156)     (1,156)
Share options exercised1       1 
Equity based compensation expense  682     682 
Share-based payment reserve transfer  (502)   502  
At December 31, 20193,359 129,110 1,299 3,027 19,993 56 (97,619)59,225 

Three months ended March 31, 2019

GroupShare capital
Share premium account
Share-based payment reserve
Merger reserve
Special reserve
Accumulated losses reserve
At January 1, 2019823 74,394 1,119 3,027 19,993 65 (74,217)25,204 
Loss for the period      (5,338)(5,338)
Currency translation adjustment     (6) (6)
Total comprehensive profit for the period     (6)(5,338)(5,344)
New share capital issued781 18,867      19,648 
Transaction costs on share capital issued (456)     (456)
Equity based compensation expense  260     260 
Share-based payment reserve transfer  (418)   418  
At March 31, 20191,604 92,805 961 3,027 19,993 59 (79,137)39,312 

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