Summit Therapeutics : Reports Financial Results and Operational Progress for the First Quarter Ended 30 April 2019

Summit Therapeutics plc

('Summit', the 'Company' or the 'Group')

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended 30 April 2019

Oxford, UK, and Cambridge, MA, US, 12 June 2019 - Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today reports its financial results and provides an update on its operational progress for the first quarter ended 30 April 2019.

"As global leaders are sounding the alarm for new antibiotics, we are proud to be taking a leadership role in discovering and developing new classes of antibiotics with the potential to help combat the rising threat posed by antibiotic resistance," said Mr Glyn Edwards, Chief Executive Officer of Summit. "We believe these new class antibiotics have the potential to transform patient lives and that it is possible to show clear advantages over standard of care treatments and cost effectiveness during development. With this differentiated approach, we believe we will have the opportunity to be commercially successful.

"Ridinilazole is the exemplar of this strategy. It is a precision, microbiome preserving antibiotic that aims to sustain cures of C. difficile infection to improve outcomes for patients. We were excited to initiate our landmark Ri-CoDIFy Phase 3 clinical programme in February 2019. If successful, we believe our two Phase 3 clinical trials of ridinilazole will deliver clinical and economic data to support ridinilazole as the new standard of care for patients with C. difficile infection.

"Our Discuva Platform is enabling us to expand our leadership role as innovators in infectious disease. In April 2019, we announced the addition to our pipeline of another new class antibiotic programme targeting Enterobacteriaceae infections. With this new discovery-stage programme, our preclinical programme for N. gonorrhoeae and ridinilazole for C. difficile, our pipeline now targets the three most urgent bacterial threats as defined by the US Centers for Disease Control and Prevention with new classes of antibiotics."

Programme Highlights

Strategy

• Through its scientific focus, Summit is discovering new classes of antibiotics to treat serious infectious diseases. Through creative development programmes, Summit aims to show its new classes of antibiotics offer significant advantages over current standards of care. Through demonstrating economic advantages, Summit aims to provide compelling value for payors and healthcare systems and achieve commercial success.

Ridinilazole for C. difficile Infection ('CDI')

• RiCoDIFy Phase 3 clinical trial programme initiated in February 2019, which aims to support adoption of ridinilazole as the new standard of care treatment for C. difficile infection.
• These landmark design clinical trials aim to: i) show superiority over the current standard of care, vancomycin, using a composite endpoint measuring sustained clinical response; ii) generate health economic data to help support the commercial launch, if approved; and iii) undertake deep microbiome analysis that aims to show ridinilazole's preservation of the gut microbiome.

• Recruitment of patients into the two Phase 3 clinical trials is ongoing, and the programme remains on-track for expected reporting of top-line data in H2 2021.
• Clinical and regulatory development of ridinilazole is supported by a BARDA contract worth up to $62 million.

SMT-571 for Gonorrhoea

• SMT-571is a new class antibiotic that is designed to treat infections caused by Neisseria gonorrhoeae.
• In February 2019, preclinical data was published in the Journal of Antimicrobial Chemotherapy that showed SMT-571 had consistently high potency across over 200 clinically relevant strains of N. gonorrhoeae, including numerous multi-drug resistant and extensively-drug resistant strains.
• IND-enabling studies are ongoing and expected to continue through the second half of the year. The Phase 1 clinical trial is no longer expected to initiate in H2 2019. Summit is evaluating the design of a clinical trial programme with the potential to shorten the overall clinical development timeline of SMT- 571, subject to regulatory approvals. Further updates on the design and timelines for the start of the clinical programme to be provided when available.
• SMT-571development is being supported by an award of up to $4.5 million from CARB-X.

DDS-04 for Enterobacteriaceae

• Identification of DDS-04 compound series, a new class of antibiotics that acts via the novel bacterial target LolCDE with the potential to treat infections caused by the gram-negative bacteria, Enterobacteriaceae.
• In vivo proof of concept demonstrated with a DDS-04 series compound cured infection in a translationally-relevant animal model of urinary tract infection, while therapeutic concentrations were also achieved in the lungs and bloodstream showing potential to treat other major Enterobacteriaceae infection sites. These data were presented at the 20th European Congress of Clinical Microbiology & Infectious Diseases.

Financial Highlights

Cash and cash equivalents at 30 April 2019 of £28.3 million compared to £26.9 million at 31 January 2019. Loss for the three months ended 30 April 2019 of £4.0 million compared to a loss of £5.8 million for the three months ended 30 April 2018.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).

About Summit Therapeutics

Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics to treat infections caused by C. difficile, N. gonorrhoeae and Enterobacteriaceae and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit www.summitplc.com and follow us on Twitter @summitplc.

For more information:
Summit	Tel: [phone]
Glyn Edwards / Richard Pye (UK office)
Michelle Avery (US office)	[phone]
Cairn Financial Advisers LLP (Nominated Adviser)	Tel: [phone]
Liam Murray / Tony Rawlinson
N+1 Singer (Joint Broker)	Tel: [phone]
Aubrey Powell / Jen Boorer, Corporate Finance
Tom Salvesen, Corporate Broking
Bryan Garnier & Co Limited (Joint Broker)	Tel: [phone]
Phil Walker / Dominic Wilson
MSL Group (US)	Tel: [phone]
Jon Siegal	[e-mail]
Consilium Strategic Communications (UK)	Tel: [phone]
Mary-Jane Elliott / Sue Stuart /	[e-mail]
Jessica Hodgson / Lindsey Neville

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 commercialisation 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 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 our 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 clinical trials and the results of such 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, 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 Annual Report on Form 20-F for the fiscal year ended 31 January 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.

FINANCIAL REVIEW

Revenue

Revenue was £0.2 million for the three months ended 30 April 2019 compared to £3.9 million for the three months ended 30 April 2018. This decrease was principally due to the reduction in revenue related to the Sarepta licence and collaboration agreement following the Group's decision to discontinue development of ezutromid in June 2018. Revenue recognised during the three months ended 30 April 2019 relating to the cost- share arrangement under the Sarepta agreement amounted to £0.1 million.

The Group also recognised £0.1 million of revenue during the three months ended 30 April 2019 relating to the receipt of a $2.5 million (£1.9 million) upfront payment in respect of the licence and commercialisation agreement signed with Eurofarma Laboratórios SA ('Eurofarma') in December 2017.

Other Operating Income

Other operating income was £4.9 million for the three months ended 30 April 2019, as compared to £3.5 million for the three months ended 30 April 2018. This increase resulted primarily from the recognition of operating income from Summit's funding contract with BARDA for the development of ridinilazole, which was £4.6 million for the three months ended 30 April 2019 as compared to £3.3 million for the three months ended 30 April 2018.

The Group also recognised operating income of £0.2 million during the three months ended 30 April 2019 related to the Group's CARB-X award supporting the development of SMT-571 for the treatment of gonorrhoea.

Operating Expenses

Research and Development Expenses

Research and development expenses decreased by £3.3 million to £8.3 million for the three months ended 30 April 2019 from £11.6 million for the three months ended 30 April 2018.

Expenses related to the CDI programme increased by £0.8 million to £5.8 million for the three months ended 30 April 2019 from £5.0 million for the three months ended 30 April 2018. This increase primarily related to clinical and manufacturing activities related to the Ri-CoDIFy Phase 3 clinical trials of ridinilazole that commenced in February 2019.

Investment in the Group's antibiotic pipeline development activities was £0.7 million for the three months ended 30 April 2019 compared to £0.2 million for the three months ended 30 April 2018. This increase primarily related to preclinical development activities for SMT-571 for the treatment of gonorrhoea and the DDS-04 series for the treatment of Enterobacteriaceae infections.

Expenses related to the Duchenne muscular dystrophy ('DMD') programme decreased by £4.1 million to £0.1 million for the three months ended 30 April 2019 from £4.2 million for the three months ended 30 April 2018, as a result of the discontinuation of the development of ezutromid in June 2018. The Group does not expect to incur further significant cost for this programme.

Other research and development expenses decreased by £0.5 million to £1.7 million during the three months ended 30 April 2019 as compared to £2.2 million during the three months ended 30 April 2018, which was

driven by a decrease in staffing and facilities costs reflecting implementation of cost-cutting measures following the decision to discontinue development of ezutromid in June 2018.

General and Administration Expenses

General and administration expenses decreased by £0.6 million to £1.7 million for the three months ended 30 April 2019 from £2.3 million for the three months ended 30 April 2018. This decrease was driven by a reduction in staff related costs and legal and professional fees, offset by a net negative movement in exchange rate variances.

Finance Costs

Finance costs recognised during the three months ended 30 April 2019 relate to lease liability interest payable and the unwinding of the discount associated with provisions. Finance costs were £0.1 million for the three months ended 30 April 2019 compared to £0.2 million for the three months ended 30 April 2018. This decrease relates to the cessation of the unwinding of the discount following the remeasurement of the financial liabilities on funding arrangements relating to DMD-related US not for profit organisations to £nil in June 2018.

Taxation

The income tax credit for the three months ended 30 April 2019 was £0.8 million as compared to £0.9 million for the three months ended 30 April 2018. This net decrease was driven by a decrease in the Group's accrued UK research and development tax credit, reflecting lower research and development expenditure, offset by a net positive movement in taxes relating to the US operations and the release of deferred tax liabilities associated with the amortisation of intangible assets.

Losses

Loss before income tax was £4.9 million for the three months ended 30 April 2019 compared to a loss before income tax of £6.8 million for the three months ended 30 April 2018. Net loss for the three months ended 30 April 2019 was £4.0 million with a basic loss per share of 3 pence compared to a net loss of £5.8 million for the three months ended 30 April 2018 with a basic loss per share of 8 pence.

Cash Flows

The Group had a net cash inflow of £1.3 million for the three months ended 30 April 2019 as compared to £7.2 million for the three months ended 30 April 2018.

Operating Activities

For the three months ended 30 April 2019, net cash generated from operating activities was £1.4 million compared to net cash used in operating activities of £7.0 million for the three months ended 30 April 2018. This net positive movement of £8.4 million was driven by an increase in cash received from licensing agreements and funding arrangements of £3.8 million and an increase in taxation cash inflows of £4.9 million due to the timing of receipt of the Group's research and development tax credits receivable on qualifying expenditure in respect of financial years ended 31 January 2017 and 2018, offset by an increase in operating costs of £0.3 million.

Investing Activities