TIDMSUMM 
 
 
   THIS ANNOUNCEMENT (INCLUDING THE APPIX) AND THE INFORMATION CONTAINED 
HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, 
IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, OR INTO ANY 
JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE 
UNLAWFUL. THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES 
NOT CONSTITUTE AN OFFER OR AN INVITATION TO ACQUIRE OR DISPOSE OF ANY 
SECURITIES. YOUR ATTENTION IS ALSO DRAWN TO THE IMPORTANT NOTICES AT THE OF THIS ANNOUNCEMENT. 
 
   Summit Therapeutics plc 
 
   ("Summit", or the "Company") 
 
   Summit Announces a Proposed Subscription and Placing to Raise 
approximately $50.0 Million and Notice of General Meeting 
 
   Oxford, UK, and Cambridge, MA, US, 6 December 2019 - Summit Therapeutics 
plc (AIM: SUMM, NASDAQ: SMMT), a leader in antibiotic innovation, 
announces a proposed fundraising (the "Fundraising") of approximately 
$50 million through a subscription and placing of new ordinary shares 
and warrants to existing investors which is subject to certain 
shareholder approvals being obtained and certain customary closing 
conditions being satisfied. The transaction includes proposals to 
restructure the Company's board of directors (the "Board") and to cancel 
the trading on AIM of the Company's ordinary shares. The Company's 
American Depositary Shares ("ADSs") will remain listed on the Nasdaq 
Stock Market ("Nasdaq") where one ADS represent five ordinary shares. 
 
   Highlights 
 
   Fundraising 
 
 
   -- $50.0 million (before expenses) to be raised through a subscription 
      ("Subscription") of 166,157,050 new ordinary shares of one penny each in 
      the Company ("Subscription Shares") and the placing (the "Placing") of 
      9,221,400 new ordinary shares of one penny each in the Company ("Placing 
      Shares") at a subscription and placing price of 22.1 pence per new 
      ordinary share ("Offer Price"). 
 
   -- The Subscription Shares are being subscribed for by Mr Robert W. Duggan, 
      an existing shareholder of the Company. Upon completion of the proposed 
      Fundraising, Mr Duggan will control approximately 72.78 per cent of the 
      Company's enlarged share capital. 
 
   -- The Placing involves the subscription of the Placing Shares by two 
      placees, being an existing institutional shareholder and Mr Glyn Edwards, 
      the Company's Chief Executive Officer and a director. 
 
   -- In addition, a total of 26,306,765 warrants ("Investor Warrants") are 
      proposed to be granted to the participants in the Subscription and the 
      Placing, providing for the right to subscribe for an aggregate of 
      26,306,765 ordinary shares at a premium of 10 per cent. to the Offer 
      Price. 
 
 
   Board Restructuring 
 
 
   -- It is proposed that the Board will be restructured to support 
      preparations for the potential commercial launch of Summit's lead product 
      candidate, ridinilazole, for the treatment of C. difficile infection. 
 
   -- Conditional on the Fundraising being completed, Mr Robert W. Duggan, Mr 
      Manmeet Soni, Dr Elaine Stracker and Dr Ventzislav Stefanov have been 
      appointed as non-executive directors, and Dr Frank Armstrong, Mr Leopoldo 
      Zambeletti and Mr David Wurzer have agreed to step down from the Board. 
      Mr Glyn Edwards will take the role of Chairman in addition to his 
      existing role as Chief Executive Officer (the "Board Restructuring"). 
 
 
   AIM Delisting 
 
 
   -- As a condition of the Fundraising, it is proposed that the admission of 
      the Company's ordinary shares to trading on AIM will be cancelled (the 
      "AIM Delisting"). The Company's ADSs will remain listed on Nasdaq where 
      one ADS represents five ordinary shares. 
 
   -- The proposed AIM Delisting reflects the increasing focus of Summit's 
      business operations on the United States and, specifically, the Company's 
      plan to commercialise ridinilazole in the United States with its own 
      specialised sales force that it plans to establish. 
 
 
   Use of Proceeds 
 
 
   -- The Directors believe that if the Fundraising is completed, the net 
      proceeds of the Subscription and the Placing, together with the Company's 
      existing cash resources and funding agreements, will extend its cash 
      runway to 31 January 2021. The Company expects to use these funds to 
      support the following activities: 
 
          -- Ridinilazole: Continued patient enrolment into the Ri-CoDIFy Phase 
             3 clinical trial programme of ridinilazole for the treatment of 
             Clostridium difficile infection. 
 
          -- Ridinilazole: Preparatory activities to support the commercial 
             launch of ridinilazole, if approved. 
 
          -- Development of early-stage research projects using the Company's 
             Discuva Platform. 
 
          -- General corporate purposes. 
 
 
   Glyn Edwards, Chief Executive Officer of Summit, said: "Patients need 
new and better antibiotics. Innovation is required to develop 
distinctive new drugs that address the resistance crisis without 
damaging our healthy microbiomes. Summit sees a huge opportunity in the 
antibiotic space for precision drugs targeting specific bacteria. We 
have great technology and people at Summit to bring forward potent 
antibiotics with the potential to deliver better outcomes for patients 
and healthcare systems. 
 
   It is great that Bob Duggan is leading this much-needed investment into 
Summit that will support progression of our ambitious plans, including 
developing ridinilazole, our precision antibiotic for the treatment of 
C. difficile infection. We have the opportunity to show that 
ridinilazole is superior to vancomycin in sustained cures of C. 
difficile infection, is able to preserve the microbiome of patients and 
offers substantial benefits to payors by reducing costly recurrences." 
 
   Mr Robert W. Duggan added: "Microbiome friendly treatments I believe are 
the future. I am delighted to be investing in, and working with, the 
Summit team with the goal of developing ridinilazole as the new 
front-line treatment option for C. difficile infection that is also kind 
to the microbiome of patients. I see a bright future for Summit as a 
public company listed on Nasdaq, and I look forward to joining the board 
and working to deliver ridinilazole to patients." 
 
   Shareholder Approval and General Meeting Information 
 
   The Fundraising is not being underwritten and is conditional (amongst 
other things) upon the passing by the Company's shareholders 
("Shareholders") of a resolution to approve a waiver (the "Rule 9 
Waiver"), which has been granted by the Takeover Panel, of certain 
obligations that would otherwise arise on Mr Duggan in connection with 
the Subscription pursuant to rule 9 of the City Code on Takeovers and 
Mergers (the "City Code"). Shareholder approval of this resolution and 
other applicable resolutions relating to the issue of the Subscription 
Shares, the Placing Shares and the Investor Warrants, together with the 
proposed cancellation of the Company's ordinary shares to trading on AIM 
(collectively, the "Resolutions") will be sought at a general meeting of 
the Company to be held at the offices of CMS Cameron McKenna Nabarro 
Olswang LLP, at Cannon Place, 78 Cannon Street, London EC4N 6AF, at 
10.30 a.m. on 23 December 2019 (the "General Meeting"). 
 
   The Fundraising and the AIM Delisting are conditional (amongst other 
things) on the passing of all of the Resolutions by Shareholders at the 
General Meeting. 
 
   A circular, including notice of the General Meeting, setting out 
(amongst other things) further details on the Subscription, the Placing, 
the proposed restructuring of the Board and AIM Delisting, and the 
Resolutions to be proposed at the General Meeting (the "Circular"), is 
expected to be uploaded to the Company's website and posted to 
Shareholders later today. 
 
   Application will be made to the London Stock Exchange for the new 
ordinary shares to be issued pursuant to the Subscription and the 
Placing to be admitted to trading on AIM. Subject to the satisfaction of 
all applicable conditions, admission of the Subscription Shares and the 
Placing Shares to trading on AIM is expected to occur at 8.00 a.m. on 30 
December 2019. 
 
   Related Party Transaction 
 
   Robert W. Duggan is a substantial Shareholder and Glyn Edwards is a 
director of the Company. Both Mr Duggan and Mr Edwards are therefore 
related parties pursuant to the AIM Rules. Mr Duggan's participation in 
the Subscription and Mr Edwards' participation in the Placing, by way of 
subscription for 452,475 Placing Shares and receipt of 67,870 Investor 
Warrants, are deemed to be related party transactions (the "Related 
Party Transactions"). 
 
   The Directors (with the exception of Glyn Edwards), having consulted 
with Cairn Financial Advisers LLP, the Company's nominated adviser, 
consider that the terms of the Related Party Transactions are fair and 
reasonable insofar as the Shareholders are concerned. 
 
   Important Information on Rule 9 Waiver 
 
   Mr Duggan is currently the beneficial owner of approximately 48.78% of 
the Company's current issued share capital. Mr Duggan has agreed, 
subject, amongst other things, to the approval of the Resolutions, to 
subscribe for 166,157,050 Subscription Shares. This is an amount that 
would increase his interest in ordinary shares of the Company following 
completion of the Subscription and the Placing to over 50%, which, 
without a waiver of the obligations under Rule 9 of the City Code, would 
oblige Mr Duggan to make a general offer to Summit Shareholders under 
Rule 9 of the City Code (a "Rule 9 Offer"). 
 
   It is expected that Mr Duggan will be the beneficial owner of 
approximately 72.78% of the total voting rights of the Company 
immediately following completion of the Subscription and the Placing. 
 
   The Company has applied for a waiver of the requirements for Mr Duggan 

to make a Rule 9 Offer. The Takeover Panel has agreed to such a waiver, 
subject to the passing of a resolution in respect of the Rule 9 Waiver 
by a poll of independent shareholders at the General Meeting. 
 
   Accordingly, shareholders should be aware that, following completion of 
the Subscription and the Placing, Mr Duggan will be beneficially 
interested in more than 50 per cent. of the Company's voting share 
capital and will be able to increase his holdings in the Company without 
incurring an obligation under Rule 9 of the City Code to make a 
mandatory offer to the other Shareholders. 
 
   The Takeover Panel has confirmed that the Company will remain subject to 
the Code until such time as both (1) the proposed Board Restructuring 
has occurred, resulting in the Company's place of central management and 
control no longer being in the United Kingdom, Channel Islands and Isle 
of Man and (2) the Company's shares are no longer admitted to trading on 
AIM. Subject inter alia to the Cancellation Resolution being approved, 
it is expected that the Company will no longer be subject to the Code 
from 24 February 2020. 
 
   For so long as both the Company's place of central management and 
control is outside the United Kingdom, Channel Islands and Isle of Man 
and the Company's shares are not traded on a regulated market or 
multilateral trading facility in the UK, the Code will not apply to the 
Company. Therefore in those circumstances Shareholders would not receive 
the protections afforded by the Code in the event there is a subsequent 
offer to acquire their shares in the Company. 
 
   Information on the future application of the City Code will be available 
in the Circular. 
 
   Importance of the Vote 
 
   Unless all of the Resolutions are passed by Shareholders at the General 
Meeting, the Fundraising will not proceed. 
 
   The Company's existing cash and funding arrangements will be sufficient 
to fund the Company's operating expenses, including the ongoing Phase 3 
clinical trial of ridinilazole for the treatment of C. difficile 
infection, and capital expenditure requirements through to 31 January 
2020. If approved and completed, the Company expects that the 
Fundraising will extend this runway by approximately 12 months to 31 
January 2021. 
 
   If the Fundraising does not proceed, there is no certainty that the 
Company will have access to alternative sources of funding, and the 
Directors would need to consider alternative strategic options that may 
not be in the best interests of Shareholders, including the Company 
entering into liquidation or administration. Furthermore, if no 
alternative sources of funding are available, the Company will be 
required to reduce its expenditures and stop its ongoing research and 
development activities including, amongst other things, the Phase 3 
clinical trials of ridinilazole. 
 
   The directors therefore believe that the terms of the Fundraising, the 
proposed Board Restructuring and the AIM Delisting, are in the best 
interests of the Company and the Shareholders as a whole. 
 
   AIM Rule 17 Schedule 2(g) Disclosure 
 
   The following information is disclosed pursuant to AIM Rule 17 and 
Schedule 2(g) to the AIM Rules for Companies. 
 
   a) Mr Robert W. Duggan has held the following directorships and/or 
partnerships in the past five years: 
 
 
 
 
Current:                                                        Past: 
Pulse Biosciences,                Blazon Corporation            Genoscience Pharmaceuticals 
 Inc.                              Blaze-On Corporation          Pharmacyclics, Inc. 
 Genius, Inc.                      Oxstem Limited                Human Longevity, Inc. 
 Radial Medical, Inc.              Duggan Investments 
 Genuine First Aid International   Inc. 
 Medical Distribution              Robert W. Duggan Foundation 
 Industries 
 
 
   Mr Duggan's shareholding is disclosed in paragraph 1.1 of Part III of 
the Circular. 
 
   b) Dr Elaine Carla Stracker has held the following directorships and/or 
partnerships in the past five years: 
 
 
 
 
Current:  Past: 
none      Genoscience Pharmaceuticals 
 
 
   Dr Stracker does not hold any shares or options in the Company. 
 
   c) Mr Manmeet Singh Soni has held the following directorships and/or 
partnerships in the past five years: 
 
 
 
 
Current:                Past: 
Arena Pharmaceuticals,  Genoscience Pharmaceuticals 
 Inc. 
 Pulse Biosciences, 
 Inc. 
 
 
   Mr Soni does not hold any shares or options in the Company. 
 
   d) Dr Ventzislav Kirilov Stefanov has not held any directorships and/or 
partnerships in the past five years. Dr Stefanov's shareholding is 
disclosed in paragraph 2.1 of Part III of the Circular. 
 
   There is no further information to be disclosed in relation to Dr 
Stracker's, Mr Soni's, Dr Stefanov's nor Mr Duggan's appointments 
pursuant to AIM Rule 17 or Schedule Two, paragraph (g) (i)-(viii) of the 
AIM Rules for Companies. 
 
   About Summit Therapeutics 
 
   Summit Therapeutics is a leader in antibiotic innovation. Its 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. It is currently developing new mechanism antibiotics for 
infections caused by C. difficile, N. Gonorrhoeae and ESKAPE pathogens 
and is using its proprietary Discuva Platform to expand its pipeline. 
For more information, visit www.summitplc.com. 
 
   For more information, please contact: 
 
 
 
 
Summit 
Glyn Edwards / Richard Pye (UK office)     Tel:                  44 (0)1235 443 951 
Michelle Avery (US office)                                          +1 617 225 4455 
 
Cairn Financial Advisers LLP (Nominated 
 Adviser)                                  Tel:                 +44 (0)20 7213 0880 
Liam Murray / Tony Rawlinson 
 
N+1 Singer (Joint Broker)                  Tel:                 +44 (0)20 7496 3000 
Aubrey Powell / Jen Boorer, Corporate 
 Finance 
 Tom Salvesen, Corporate Broking 
 
Bryan Garnier & Co Limited (Joint Broker)  Tel:                 +44 (0)20 7332 2500 
Phil Walker / Dominic Wilson 
MSL Group (US)                             Tel:                     +1 781 684 6652 
                                                         mailto:summit@mslgroup.com 
Erin Anthoine                                                   summit@mslgroup.com 
                                                  --------------------------------- 
 
Consilium Strategic Communications (UK)    Tel:                 +44 (0)20 3709 5700 
Mary-Jane Elliott / Sue Stuart / Sukaina          mailto:summit@consilium-comms.com 
 Virji                                             summit@consilium-comms.com 
                                                  --------------------------------- 
Lindsey Neville 
 
 
   This Announcement should be read in its entirety. In particular, you 
should read and understand the information provided in the "Important 
Notices" section of this Announcement. Shareholders should also read in 
full the Circular and Form of Proxy being sent to them; the Circular is 
also being made available online at 
https://www.globenewswire.com/Tracker?data=98w6xPt2YM71Xpt2BnTIpVOlY6oT5Kb0b_loxYipH0DJ_w5KBjvLB5eCaa1aR9eJg8btjCau0XWKeEyPY428UzeORFd5ObMP6yfDChbk2Tw= 
www.summitplc.com. 
 
   Expected Timetable of Principal Events 
 
 
 
 
Event                                                                 Date 
------------------------------------------- 
Announcement of the Fundraising              6 December 2019 
Publication of this Document and             6 December 2019 
 the Form of Proxy 
Latest time and date for receipt             10.30 a.m. on 19 December 
 of the Form of Proxy                         2019 
General Meeting                              10.30 a.m. on 23 December 
                                              2019 
Result of General Meeting announced          23 December 2019 
 via RIS 
Expected date of Admission and commencement  8.00 a.m. on 30 December 2019 
 of dealings in the New Ordinary Shares 
 on AIM 
Expected date of the cancellation            7.00 a.m. on 24 February 2020 
 of admission of the Ordinary Shares 
 to trading on AIM 
------------------------------------------- 
 
 
 
 
 
 
 
   IMPORTANT NOTICES 
 
   Forward Looking Statements 
 
   Any statements in this Announcement about the Company's future 
expectations, plans and prospects, including but not limited to, whether 
or not the Company will consummate the Subscription and the Placing and 
the anticipated use of proceeds from the Subscription and the Placing, 
the Board Restructuring, the AIM Delisting, the trading markets for the 
Company's ordinary shares and ADSs, 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 risk that the Company's shareholders do not approve the 
Subscription, the Placing and the AIM Delisting, the risk that the other 
closing conditions to the Subscription and the Placing are not satisfied, 
the ability of BARDA or CARB-X to terminate the Company's 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 Announcement 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 Announcement. 
 
   Inside Information 
 
   This Announcement contains inside information for the purposes of 
Article 7 of EU Regulation 596/2014 ("MAR"). In addition, market 
soundings (as defined in MAR) were taken in respect of the Subscription 
and the Placing with the result that certain persons became aware of 
inside information (as defined in MAR), as permitted by MAR. This inside 
information is set out in this Announcement. Therefore, those persons 
that have received inside information in a market sounding are no longer 
in possession of such inside information relating to the Company and its 
securities. The person responsible for arranging for the release of this 
Announcement on behalf of the Company is Richard Pye, Vice President, 
Investor Relations and Corporate Affairs. 
 
   US Securities Act 
 
   The securities to be sold in the Placing are being offered and sold 
pursuant to an exemption from registration under Section 4(a)(2) of the 
US Securities Act of 1933, as amended (the "Securities Act") and 
Regulation S under the Securities Act, and the securities to be sold in 
the Subscription are being offered and sold pursuant to an exemption 
from registration under Section 4(a)(2) of the Securities Act and 
Regulation D under the Securities Act, and in each case have not been 
registered under the Securities Act, or applicable US state securities 
laws, and accordingly may not be offered or sold in the United States 
except pursuant to an effective registration statement or an applicable 
exemption from the registration requirements of the Securities Act and 
such applicable state securities laws. 
 
   This Announcement does not constitute an offer to sell or the 
solicitation of an offer to buy the securities, nor shall there be any 
sale of the securities in any jurisdiction in which such offer, 
solicitation or sale would be unlawful prior to the registration or 
qualification under the securities laws of such jurisdiction. 
 
   APPIX I 
 
   BACKGROUND TO THE FUNDRAISING 
 
   1. Introduction 
 
   The Company today announced that it proposes to raise approximately $50 
million (before expenses) from certain investors (the "Investors") by 
means of a fundraising which comprises the subscription for and the 
placing of (collectively referred to as the "Fundraising"), in aggregate, 
175,378,450 new ordinary shares of one penny in the share capital of the 
Company ("New Ordinary Shares") at a price of 22.1 pence per New 
Ordinary Share (the "Offer Price"). In addition, a total of 26,306,765 
warrants are proposed to be granted to the Investors with each such 
Investor being granted the right to subscribe for approximately 0.15 
ordinary shares in respect of each New Ordinary Share issued pursuant to 
the Fundraising (the "Investor Warrants"). 
 
   As part of the Fundraising, it is also proposed to restructure the Board 
and to cancel the trading on AIM of the Company's ordinary shares. 
 
   The investor participating in the Fundraising pursuant to the 
subscription is Mr Robert W. Duggan, who is currently beneficially 
interested in approximately 48.78 per cent of the Company's issued share 
capital. Mr Duggan has agreed, subject, amongst other things, to the 
approval of the Resolutions, to subscribe for 166,157,050 New Ordinary 
Shares raising gross proceeds of approximately $47.4 million. Following 
completion of the Fundraising, Mr Duggan will be beneficially interested, 
in aggregate, in 244,445,255 ordinary shares representing approximately 
72.78 per cent. of the Company's enlarged share capital. Mr Duggan will 
also receive 24,923,555 of the Investor Warrants. 
 
   The participants in the placing comprise an institutional shareholder 
and a director and Chief Executive Officer of the Company, Mr Glyn 
Edwards (the "Placees"). The Placees have agreed to subscribe for, in 
aggregate, 9,221,400 New Ordinary Shares raising gross proceeds of 
approximately $2.6 million. Mr Edwards, who currently holds 383,333 
ordinary shares, representing approximately 0.23 per cent. of the 
Company's issued share capital has agreed to subscribe for 452,475 New 
Ordinary Shares raising gross proceeds of approximately GBP100,000. 
Following completion of the Fundraising, Mr Edwards will hold, in 
aggregate, 835,808 ordinary shares representing approximately 0.25 per 
cent. of the Company's enlarged share capital. Mr Edwards will also 
receive 67,870 of the Investor Warrants and the other Placee will 
receive the remaining balance of the Investor Warrants. 
 
   The Offer Price is equal to the trailing ten-day volume weighted average 
price of the ordinary shares up to and including 25 November 2019. The 
exercise price of each Investor Warrant is 24.3 pence, which represents 
a premium of 10 per cent. to the Offer Price. 
 
   Completion of the Fundraising is subject, amongst other things, to the 
granting of the Rule 9 Waiver in respect of Mr Duggan. Further details 
relating to the Rule 9 Waiver and the City Code will be contained in the 
Circular, to be posted to shareholders and made available via the 
Company's website later today. 
 
   The Fundraising, proposed board restructuring, and cancellation of 
trading on AIM, are conditional, inter alia, on the passing by 
shareholders of all of the Resolutions to be proposed at the General 
Meeting to be held at 10.30 a.m. on 23 December 2019 at the offices of 
CMS Cameron McKenna Nabarro Olswang LLP at Cannon Place, 78 Cannon 
Street, London, EC4N 6AF. Notice of the General Meeting will be 
contained in the Circular. 
 
   2. Information on Summit 
 
   Overuse and misuse of antibiotics contribute to two serious public 
health issues: antimicrobial resistance, or AMR, and Clostridium 
difficile infection. AMR is a natural process that has allowed microbes 
(bacteria, viruses, fungi and parasites) to survive in their 
environments for millions of years. As microbes are challenged with 
antimicrobial substances, some microbes will be able to survive and can 
pass their AMR genes to other bacteria. The overuse and inappropriate 
use of antimicrobial medicines has increased the rate at which microbes 
are developing AMR. 
 
   Approximately 700,000 people die every year from antimicrobial resistant 
infections. According to the 2016 report, Tackling Drug-Resistant 
Infections Globally, chaired by Jim O'Neill, the number of deaths due to 
antimicrobial resistant infections is projected to rise to 10 million by 
2050, a number that surpasses deaths due to cancer. The rise of AMR 
could render once easily treated infections untreatable and undermine 
physicians' abilities to perform surgeries and other medical procedures. 
 
   The Microbiome 
 
   The human microbiome is the vast collection of microbes, including 
bacteria, viruses, archaea and fungi, which live on and inside human 
beings. Microbiomes can be found colonising different parts of the human 
body including the gut, skin and respiratory system. The important role 
that these microbiomes play in the natural protection against infection 
and maintenance of general well-being in human health is becoming 
increasingly evident, along with the consequences of what happens when a 
microbiome is perturbed, for example through use of antibiotics. 
 
   Summit, a Leader in Antibiotic Innovation 
 
   Summit's goal is to become a fully integrated biopharmaceutical company 
focussed on the discovery, development and commercialisation of new 
mechanism antibiotics that are designed to target specific infections 
and preserve the microbiome. These targeted antibiotics are being 
developed with the aim of showing significant advantages over current 
standards of care in clinical trials and offering a compelling value 
proposition to payors. Through these collective efforts, Summit believes 
it can position its new mechanism antibiotics for commercial success and 
help combat the threat from antibiotic resistance by the appropriate 
stewardship of antibiotics in clinical use. 
 
   Ridinilazole for the Treatment of C. difficile Infection 
 
   Summit's strategy in antibiotic development is primarily focussed on the 
development of ridinilazole, the Company's novel-class, precision 
antibiotic for the potential front-line treatment of Clostridium 
difficile infection ("CDI"). 
 
   CDI is a bacterial infection of the colon that produces toxins causing 
inflammation of the colon and severe diarrhoea. CDI can also result in 
more serious disease complications, including pseudomembranous colitis, 
bowel perforation, toxic megacolon, sepsis and death. It is estimated 
that there are over one million cases of CDI annually in the United 
States and Europe, with CDI associated with approximately 29,000 deaths 
per year in the United States alone. The community of microorganisms 
that make up the natural gut flora microbiome is known to play an 
important role in protecting against CDI. Its perturbation by the use of 

broad-spectrum antibiotics for other infections causes CDI. The US 
Centers for Disease Control and Prevention (the "CDC") classifies C. 
difficile as one of four bacteria that pose an urgent healthcare threat, 
the highest warning level. 
 
   Based on clinical trial results to date, ridinilazole selectively 
targets C. difficile bacteria without causing collateral damage to the 
gut microbiome, and therefore has the potential to be a front-line 
therapy that treats not only the initial CDI infection, but importantly 
reduces the rate of CDI recurrence. 
 
   In a Phase 2 proof of concept clinical trial called CoDIFy, ridinilazole 
demonstrated clinical and statistical superiority in sustained clinical 
response ("SCR") over vancomycin, the current standard of care for CDI. 
In this trial, SCR was a combined clinical trial endpoint that measured 
cure of the initial infection and whether patients had not experienced 
disease recurrence 30 days after completing treatment. In the CoDIFy 
trial, ridinilazole treated patients achieved a SCR rate of 66.7% 
compared to 42.4% for vancomycin treated patients. Ridinilazole was also 
shown to be highly preserving of the microbiome compared to patients who 
were treated with vancomycin and experienced substantial damage to their 
gut microbiome. For many of the vancomycin-treated patients, this damage 
persisted after treatment had ended. 
 
   Ri-CoDIFy Phase 3 Clinical Trials & Enrolment Status 
 
   Ridinilazole is currently being evaluated in the Phase 3 clinical trial 
programme called Ri-CoDIFy that was initiated in February 2019. The 
Ri-CoDIFy trials have been designed to be similar to the Phase 2 CoDIFy 
trial and seek to support adoption of ridinilazole as the new standard 
of care treatment for CDI. 
 
   These landmark design clinical trials aim to: i) show superiority over 
vancomycin using a composite endpoint measuring SCR; ii) generate health 
economic data to help support ridinilazole's commercial launch, if 
approved; and iii) undertake deep microbiome analysis that aims to show 
ridinilazole's preservation of the gut microbiome. 
 
   The programme comprises two Phase 3 clinical trials that will enrol up 
to a total of approximately 1,360 patients with CDI. The trials are 
randomised and double blind with half of the patients receiving 
ridinilazole, and the other half receiving vancomycin. Based on progress 
to date on enrolment, the Phase 3 clinical trial programme remains on 
track to report top-line data in the second half of 2021. Initiation of 
enrolment and dosing commenced in February 2019. By the end of September 
2019, the trial initiation phase was progressing well with trial sites 
in 17 countries open for enrolment, including trial sites in nine new 
countries opening in August and September 2019. More than half of the 
300 planned clinical trial sites had been opened and patient enrolment 
was at 73 as of 30 September 2019. As of 30 November 2019, over two 
thirds of planned clinical trial sites had been opened and patient 
enrolment was at 128 meaning a further 1,232 patients remain to be 
enrolled. Further updates on the status of enrolment into the Ri-CoDIFy 
clinical trials are expected to be provided in future quarterly 
financial results. 
 
   Commercialisation Plans 
 
   Summit holds exclusive commercialisation rights for ridinilazole for all 
indications in the United States. If ridinilazole receives marketing 
approval, Summit intends to commercialise it in the United States with 
its own focussed, specialised sales force that it plans to establish. As 
of the date of this Announcement, initial commercial and medical affairs 
hires have been made in the US. Work to prepare for a potential launch 
and secure future market access for ridinilazole has begun. During the 
coming months, Summit plans to hire additional staff with specialist 
skills to support this activity. 
 
   The Company will also evaluate its options to maximise the commercial 
opportunity for ridinilazole in other key territories, including the 
potential for out-licensing to third parties, where it retains exclusive 
commercialisation rights, including Europe and Asia. 
 
   BARDA Contract 
 
   The ongoing clinical and regulatory development of ridinilazole is being 
supported by a contract with the Biomedical Advanced Research and 
Development Authority ("BARDA"), an agency of the United States 
government, which potentially provides up to $63.7 million in aggregate 
in non-dilutive funding. To date, total committed BARDA funding under 
this contract is $53.6 million, including a $9.6 million option that was 
exercised by BARDA in June 2019. These committed funds from BARDA are 
expected to be drawn down during the course of the Phase 3 clinical 
trials and the drug manufacturing activities required for the submission 
of marketing approval applications and other regulatory activities. As 
of 31 July 2019, a total of $30.1 million under the BARDA contract had 
been recognised as income by Summit. 
 
   Discuva Platform 
 
   The development of Summit's pipeline of new classes of antibiotics is 
underpinned by its proprietary Discuva Platform. The platform is being 
used to support the development of ridinilazole by seeking to gain a 
greater insight into its ability to preserve the patient's healthy 
microbiome. In addition, the Discuva Platform is utilised from discovery 
through the selection of optimised clinical candidates, to deliver 
potential antibiotics with new mechanisms of action and a low likelihood 
of drug resistance developing from their use, combined with a targeted 
spectrum of activity. This further supports Summit's strategy of 
developing treatments that preserve the healthy functioning microbiome 
of patients. Current early stage research projects focus on developing 
new mechanism antibiotics for gonorrhoea and Enterobacteriaceae. 
 
   3. Board Restructuring 
 
   In the event that the Fundraising is completed, the Board will be 
restructured to support preparations for the potential launch of 
Summit's lead product candidate, ridinilazole, for the treatment of CDI, 
should it gain marketing approval. 
 
   Mr Robert W. Duggan, Dr Ventzislav Stefanov, Mr Manmeet Soni and Dr 
Elaine Stracker (the "Proposed Directors") have each been appointed as 
non-executive directors of the Company with effect from and conditional 
on Admission. Mr Glyn Edwards, currently Chief Executive Officer, has 
been appointed as Chairman with effect from and conditional on Admission 
and will remain as Chief Executive Officer. The three current 
non-executive directors, Dr Frank Armstrong, Mr David Wurzer and Mr 
Leopoldo Zambeletti have agreed to resign from the Board with effect 
from and conditional on Admission. 
 
   Biographies for each of the Proposed Directors are set out below: 
 
   Mr Robert W. Duggan (age 75) is a serial US based entrepreneur who has 
built several successful companies across different industries, 
including biotechnology. Mr Duggan is currently the Chief Executive 
Officer of Duggan Investment Inc., a private US investment firm. Mr 
Duggan has served on the boards of a number of US public and private 
companies and he is currently chairman of the board of the Nasdaq listed 
company, Pulse Biosciences, Inc. He was previously a substantial 
shareholder in and the Chairman of the Board and Chief Executive Officer 
of Pharmacyclics, Inc., which was sold to AbbVie Inc., in 2015. 
Previously, he was the Chairman of the Board and Chief Executive Officer 
of Computer Motion, Inc., which later merged with Intuitive Surgical, 
Inc. 
 
   Dr Ventzislav Stefanov (age 52) is an experienced pharmaceutical 
executive who has been involved in the commercial launch and marketing 
of drug products, including a number of antibiotics, across Europe 
having held positions with Bayer, Merck Sharp & Dohme, AstraZeneca and 
Eli Lilly. Dr Stefanov is currently a healthcare investor and 
independent consultant who provides advice, including to Duggan 
Investments Inc, on the therapeutic and commercial prospects of marketed 
and investigational antibiotics. Dr Stefanov received his MD degree from 
the Medical University in Sofia, Bulgaria. 
 
   Dr Elaine Stracker (age 59) has over 20 years of legal experience for 
Fortune 500 and start-up life science companies. She currently serves as 
General Counsel and Senior Vice President for Corporate Development at 
Maky Zanganeh & Associates Inc., where she assists with due diligence, 
intellectual property, financings, transactional matters, HR, compliance, 
litigation, operations and overall strategy development. Previously, Dr 
Stracker served as General Counsel at Indigo Ag. and at Pharmacyclics, 
and has held various senior legal counsel positions at Medtronic Inc., 
Gilead Sciences Inc. Merck & Co., Inc. and Molecular Probes, Inc. 
(acquired by Invitrogen, Inc.). Dr Stracker earned both a Bachelor's 
degree in chemistry and a Doctor of Philosophy degree in organic 
chemistry from the University of California, Davis.  In addition, she 
earned a Juris Doctorate degree from the Boalt School of Law at the 
University of California. 
 
   Mr Manmeet Soni (age 42) has extensive experience in transitioning 
biotechnology companies from development stage through commercialisation 
and globalisation. He is currently the Chief Financial Officer and 
Executive Vice President of Reata Pharmaceuticals, Inc. where he is 
responsible for overall global functions of finance, tax, treasury, 
internal audit, information technology, investor relations, corporate 
communication and strategy functions. He has served as the Chief 
Financial Officer of several publicly-listed life science companies, 
including Pharmacyclics, Inc. (acquired by Abbvie, Inc. in 2015), Ariad 
Pharmaceuticals Inc. (acquired by Takeda Inc. in 2017), Alnylam 
Pharmaceuticals, Inc. Mr Soni currently serves on the board of Arena 
Pharmaceuticals, Inc. and Pulse Biosciences, Inc. He is a certified 
public accountant and chartered accountant from India and received his 
Bachelor of Commerce from Hansraj College, Delhi University, India. 
 

   4. Maky Zanganeh & Associates Consultancy Agreement 
 
   On 6 December 2019, in connection with the Subscription, the Company 
entered into a consulting agreement (the "Consulting Agreement") with 
Maky Zanganeh & Associates, Inc. ("MZA"), an executive management and 
consulting firm that specializes in the life sciences industry. The 
Consulting Agreement with MZA is expected to provide support for 
clinical operation activities related to the Company's ongoing global 
Phase 3 clinical trials of ridinilazole for the treatment of CDI, 
regulatory activities pertaining to a potential new drug application 
should the Phase 3 clinical trials be successful and strategic planning 
support more generally for the ridinilazole program. 
 
   Under the terms of the Consulting Agreement, a monthly consultancy fee 
of $75,000 will be payable by the Company to MZA, and the Company will 
grant MZA a warrant to acquire up to 16,793,660 Ordinary Shares of the 
Company (the "Consultant Warrant"). The exercise price of the Consultant 
Warrant will be 22.1 pence per ordinary share. The Consultant Warrant 
will vest on a quarterly basis over three years from Admission and have 
a term of ten years. 
 
   5. AIM Delisting 
 
   It is proposed as part of the Fundraising to seek to cancel admission of 
the ordinary shares to trading on AIM (the "AIM Delisting"). This 
proposal reflects the increasing focus of the Company's business 
operations to the United States, and specifically Summit's strategy to 
commercialise ridinilazole in the United States with its own focussed, 
specialised sales force it plans to establish. 
 
   It is the belief of the Directors that the AIM Delisting has the 
following potential benefits for the Company and the shareholders by: 
 
 
   -- enhancing the liquidity of trading in the ordinary shares by 
      consolidating all transactions onto a single exchange, Nasdaq; 
 
   -- simplifying the Company's regulatory and corporate governance compliance 
      by not having to adhere to two differing sets of market regulations and 
      corporate governance rules; and 
 
   -- reducing the administrative costs of maintaining a dual-listing. 
 
 
   The AIM Delisting requires the approval of a resolution by shareholders 
at the General Meeting. The Fundraising will only proceed if this AIM 
Delisting resolution, as well as the other resolutions are approved by 
shareholders. 
 
   Should shareholders approve the AIM Delisting, the final day of trading 
on AIM of the ordinary shares is expected to be 21 February 2020. On 
that basis, the AIM Delisting would take effect at 7.00 a.m. on 24 
February 2020. Thereafter, ordinary shares will continue to be capable 
of being held and transferred in certificated form, but there will be no 
public market in the UK on which shareholders will be able to trade 
ordinary shares. 
 
   6. Action to be Taken 
 
   A notice convening the General Meeting, to be held at the offices of CMS 
Cameron McKenna Nabarro Olswang LLP at Cannon Place, 78 Cannon Street, 
London EC4N 6AF at 10.30 a.m. on 23 December 2019, will be included in 
the Circular which is expected to be posted to shareholders and uploaded 
to the Company's website later today. 
 
   -END- 
 
 
 
 

(END) Dow Jones Newswires

December 06, 2019 07:00 ET (12:00 GMT)