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)
Copyright (c) 2019 Dow Jones & Company, Inc.
Summit Therapeutics (LSE:SUMM)
Historical Stock Chart
From Apr 2024 to May 2024
Summit Therapeutics (LSE:SUMM)
Historical Stock Chart
From May 2023 to May 2024