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Name | Symbol | Market | Type |
---|---|---|---|
Summit Therapeutics Inc | NASDAQ:SMMT | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 9.47 | 9.35 | 9.90 | 13 | 09:00:00 |
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¨
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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SHELL COMPANY PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Title of each class
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Name of each exchange on which registered
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American Depositary Shares, each representing
5 Ordinary Shares, par value £0.01 per share
|
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The Nasdaq Stock Market LLC
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U.S. GAAP
¨
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International Financial Reporting Standards as issued by the International Accounting Standards Board
x
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Other
¨
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Page
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Item 1:
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Item 2:
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Item 3:
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Item 4:
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Item 4A:
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Item 5:
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Item 6:
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Item 7:
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Item 8:
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Item 9:
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Item 10:
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Item 11:
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Item 12:
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Item 13:
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Item 14:
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Item 15:
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Item 16A:
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Item 16B:
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Item 16C:
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Item 16D:
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Item 16E:
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Item 16F:
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Item 16G:
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Item 16H:
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Item 17:
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Item 18:
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Item 19:
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•
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the timing and conduct of our clinical trials of ezutromid (formerly SMT C1100) for the treatment of patients with Duchenne muscular dystrophy and ridinilazole (formerly SMT19969) for the treatment of patients with
Clostridium difficile
infection, including statements regarding the timing of initiation and completion of the clinical trials and the period during which the results of the clinical trials will become available;
|
•
|
the timing of and our ability to obtain marketing approval of ezutromid and ridinilazole, and the ability of ezutromid and ridinilazole to meet existing or future regulatory standards;
|
•
|
our plans to continue the research and development of the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation utrophin modulators that we are developing in collaboration with the University of Oxford and Sarepta Therapeutics, Inc., or Sarepta;
|
•
|
our plans to conduct research and development and advance potential new mechanism antibiotic compounds identified and developed under our bacterial genetics-based discovery and development platform;
|
•
|
the potential benefits and future operation of our collaboration with Sarepta;
|
•
|
the potential benefits and future operation of our collaboration with the Biomedical Advanced Research and Development Authority, or BARDA;
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•
|
the potential benefits and future operation of our license and commercialization agreement with Eurofarma Laboratórios SA;
|
•
|
the potential benefits of our acquisition of Discuva Limited, or Discuva, including the future operations of the acquired bacterial genetics-based discovery and development platform;
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•
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our plans with respect to possible future collaborations and partnering arrangements;
|
•
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our plans to pursue research and development of other future product candidates;
|
•
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the potential advantages of ezutromid and ridinilazole;
|
•
|
the rate and degree of market acceptance and clinical utility of ezutromid and ridinilazole;
|
•
|
our estimates regarding the potential market opportunity for ezutromid and ridinilazole;
|
•
|
our sales, marketing and distribution capabilities and strategy;
|
•
|
our ability to establish and maintain arrangements for manufacture of ezutromid and ridinilazole;
|
•
|
our intellectual property position;
|
•
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our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
|
•
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the impact of government laws and regulations; and
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•
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our competitive position.
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|
Year Ended January 31,
|
||||||||||||||||||||||
|
2018
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||||
|
(in thousands, except per share data)
|
||||||||||||||||||||||
Revenue
|
$
|
36,070
|
|
|
£
|
25,419
|
|
|
£
|
2,304
|
|
|
£
|
—
|
|
|
£
|
—
|
|
|
£
|
—
|
|
Other operating income
|
3,867
|
|
|
2,725
|
|
|
72
|
|
|
1,281
|
|
|
1,888
|
|
|
1,526
|
|
||||||
Operating loss
|
(18,198
|
)
|
|
(12,825
|
)
|
|
(24,853
|
)
|
|
(20,346
|
)
|
|
(12,233
|
)
|
|
(7,027
|
)
|
||||||
Finance income
|
4,393
|
|
|
3,096
|
|
|
8
|
|
|
30
|
|
|
51
|
|
|
9
|
|
||||||
Finance cost
|
(1,652
|
)
|
|
(1,164
|
)
|
|
(862
|
)
|
|
(2,879
|
)
|
|
(499
|
)
|
|
(385
|
)
|
||||||
Income tax credit
|
5,338
|
|
|
3,762
|
|
|
4,336
|
|
|
3,058
|
|
|
1,297
|
|
|
607
|
|
||||||
Loss for the period
|
(10,119
|
)
|
|
(7,131
|
)
|
|
(21,371
|
)
|
|
(20,137
|
)
|
|
(11,384
|
)
|
|
(6,796
|
)
|
||||||
Basic and diluted loss per ordinary share from continuing operations
|
$
|
(0.15
|
)
|
|
£
|
(0.11
|
)
|
|
(0.35
|
)
|
|
(0.34
|
)
|
|
(0.29
|
)
|
|
(0.33
|
)
|
||||
Weighted average number of shares outstanding (in thousands)
|
65,434
|
|
|
65,434
|
|
|
61,549
|
|
|
59,102
|
|
|
39,599
|
|
|
20,510
|
|
|
As of January 31,
|
||||||||||||||||||||||
|
2018
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||||
|
(in thousands)
|
||||||||||||||||||||||
Cash and cash equivalents
|
$
|
28,525
|
|
|
£
|
20,102
|
|
|
£
|
28,062
|
|
|
£
|
16,304
|
|
|
£
|
11,265
|
|
|
£
|
2,030
|
|
Working capital
(1)
|
(4,478
|
)
|
|
(3,156
|
)
|
|
(5,621
|
)
|
|
1,327
|
|
|
359
|
|
|
(816
|
)
|
||||||
Total assets
|
76,573
|
|
|
53,962
|
|
|
37,587
|
|
|
25,057
|
|
|
19,396
|
|
|
7,295
|
|
||||||
Accumulated losses reserve
|
(114,794
|
)
|
|
(80,898
|
)
|
|
(73,767
|
)
|
|
(52,396
|
)
|
|
(32,259
|
)
|
|
(47,166
|
)
|
||||||
Total equity/(deficit)
|
$
|
14,012
|
|
|
£
|
9,875
|
|
|
£
|
(3,493
|
)
|
|
£
|
16,080
|
|
|
£
|
12,962
|
|
|
£
|
2,779
|
|
(1)
|
We define working capital as prepayments and other receivables (including current tax receivables) less current liabilities.
|
|
Period End
(1)
|
|
Average
(2)
|
|
Low
|
|
High
|
||||
|
($ per pound sterling)
|
||||||||||
Fiscal Year Ended January 31:
|
|
|
|
|
|
|
|
||||
2014
|
1.645
|
|
|
1.572
|
|
|
1.484
|
|
|
1.661
|
|
2015
|
1.503
|
|
|
1.634
|
|
|
1.502
|
|
|
1.717
|
|
2016
|
1.418
|
|
|
1.518
|
|
|
1.417
|
|
|
1.588
|
|
2017
|
1.259
|
|
|
1.331
|
|
|
1.212
|
|
|
1.469
|
|
2018
|
1.419
|
|
|
1.301
|
|
|
1.215
|
|
|
1.426
|
|
Month Ended:
|
|
|
|
|
|
|
|
||||
October 2017
|
1.328
|
|
|
1.320
|
|
|
1.306
|
|
|
1.133
|
|
November 2017
|
1.351
|
|
|
1.322
|
|
|
1.307
|
|
|
1.351
|
|
December 2017
|
1.353
|
|
|
1.340
|
|
|
1.332
|
|
|
1.353
|
|
January 2018
|
1.419
|
|
|
1.382
|
|
|
1.351
|
|
|
1.426
|
|
February 2018
|
1.379
|
|
|
1.396
|
|
|
1.379
|
|
|
1.413
|
|
March 2018
|
1.403
|
|
|
1.398
|
|
|
1.376
|
|
|
1.424
|
|
April 2018 (through April 6, 2018)
|
1.409
|
|
|
1.405
|
|
|
1.399
|
|
|
1.409
|
|
(1)
|
In the event that the period end fell on a day for which data are not available, the exchange rate on the prior most recent business day is given.
|
(2)
|
The average of the noon buying rate for pounds sterling on the last day of each full month during the relevant year or each business day during the relevant month indicated.
|
•
|
continue the research and development of the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
continue the research and development of ridinilazole;
|
•
|
seek to identify and develop additional product candidates, including through our bacterial genetics-based platform for the discovery and development of new mechanism antibiotics;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical development;
|
•
|
ultimately establish a sales, marketing and distribution infrastructure in jurisdictions where we have retained commercialization rights and scale up external manufacturing capabilities to commercialize any product candidates for which we receive marketing approval;
|
•
|
acquire or in-license other product candidates and technology;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire additional clinical, regulatory and scientific personnel;
|
•
|
expand our physical presence; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
|
•
|
successfully initiating and completing clinical trials of ezutromid for the treatment of DMD and ridinilazole for the treatment of CDI;
|
•
|
obtaining approval to market ezutromid for the treatment of DMD and ridinilazole for the treatment of CDI;
|
•
|
protecting our rights to our intellectual property portfolio related to ezutromid and ridinilazole;
|
•
|
contracting for the manufacture of clinical and commercial quantities of ezutromid and ridinilazole;
|
•
|
negotiating and securing adequate reimbursement from third-party payors for ezutromid and ridinilazole; and
|
•
|
establishing sales, marketing and distribution capabilities to effectively market and sell ezutromid in the United States and ridinilazole in the United States and the European Union, as well as other geographies.
|
•
|
the progress, costs and results of clinical trials of ezutromid for DMD and ridinilazole for CDI;
|
•
|
the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
the number and development requirements of other future product candidates that we pursue;
|
•
|
the costs, timing and outcome of regulatory review of ezutromid, ridinilazole and our other future product candidates;
|
•
|
the costs and timing of commercialization activities, including product sales, marketing, distribution and manufacturing, for any of our product candidates that receive marketing approval;
|
•
|
subject to receipt of marketing approval, revenue received from commercial sales of ezutromid, ridinilazole or any of our other future product candidates;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims;
|
•
|
the amounts we receive from Sarepta under our license and collaboration agreement, including for the achievement of development, regulatory and sales milestones and royalty payments;
|
•
|
our contract with BARDA and whether BARDA elects to pursue its designated options beyond the base period;
|
•
|
the amounts we receive from Eurofarma under our license and commercialization agreement, including for the achievement of development, commercialization and sales milestones and for product supply transfers;
|
•
|
our ability to establish and maintain collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
•
|
the extent to which we acquire or invest in other businesses, products and technologies;
|
•
|
the rate of the expansion of our physical presence; and
|
•
|
the costs of operating as a public company in the United States and in the United Kingdom.
|
•
|
successful completion of clinical development;
|
•
|
receipt of marketing approvals from applicable regulatory authorities;
|
•
|
establishing commercial manufacturing arrangements with third-party manufacturers;
|
•
|
obtaining and maintaining patent and trade secret protection and regulatory exclusivity;
|
•
|
protecting our rights in our intellectual property portfolio;
|
•
|
establishing sales, marketing and distribution capabilities;
|
•
|
launching commercial sales of ezutromid or ridinilazole, as applicable, if and when approved, whether alone or in collaboration with others;
|
•
|
acceptance of ezutromid or ridinilazole, as applicable, if and when approved, by patients, the medical community and third-party payors;
|
•
|
effectively competing with other therapies; and
|
•
|
maintaining a continued acceptable safety profile of ezutromid or ridinilazole, as applicable, following approval.
|
•
|
be delayed in obtaining marketing approval for our product candidates;
|
•
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not obtain marketing approval at all;
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•
|
obtain approval for indications or patient populations that are not as broad as we intended or desired;
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•
|
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;
|
•
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be subject to additional post-marketing testing requirements or restrictions; or
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•
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have the product removed from the market after obtaining marketing approval.
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•
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clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
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•
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the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;
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•
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we may be unable to enroll a sufficient number of patients in our clinical trials to ensure adequate statistical power to detect any statistically significant treatment effects;
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•
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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
regulators, institutional review boards or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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•
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we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
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•
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we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;
|
•
|
regulators, institutional review boards or independent ethics committees may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
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•
|
the cost of clinical trials of our product candidates may be greater than we anticipate;
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and
|
•
|
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators, institutional review boards or independent ethics committees to suspend or terminate the clinical trials.
|
•
|
severity of the disease under investigation;
|
•
|
eligibility criteria for the clinical trial in question;
|
•
|
perceived risks and benefits of the product candidate under study;
|
•
|
competition for patients, time and resources at clinical trials sites from other investigational therapies in clinical trials that target the same patient population;
|
•
|
approval of other therapies to treat the indication that is being investigated in the clinical trial;
|
•
|
efforts to facilitate timely enrollment in clinical trials;
|
•
|
patient referral practices of physicians;
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
•
|
proximity and availability of clinical trial sites for prospective patients.
|
•
|
the efficacy and potential advantages compared to alternative treatments or competitive products;
|
•
|
the prevalence and severity of any side effects;
|
•
|
the ability to offer our product candidates for sale at competitive prices, including in the case of ridinilazole, which we expect, if approved, will compete with vancomycin and metronidazole, both of which are available in generic form at low prices, and the antibiotic, fidaxomicin, and potentially other approaches to be used as an adjunctive therapy to antibiotics, such as the monoclonal antibody bezlotoxumab, vaccines or fecal therapy;
|
•
|
convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
•
|
the strength of marketing and distribution support;
|
•
|
the availability of third-party coverage and adequate reimbursement;
|
•
|
the timing of any such marketing approval in relation to other product approvals;
|
•
|
support from patient advocacy groups; and
|
•
|
any restrictions on concomitant use of other medications.
|
•
|
our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
|
•
|
the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any future products;
|
•
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
reduced resources of our management to pursue our business strategy;
|
•
|
decreased demand for any product candidates or products that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants;
|
•
|
significant costs to defend the related litigation;
|
•
|
substantial monetary awards to clinical trial participants or patients;
|
•
|
loss of revenue;
|
•
|
increased insurance costs; and
|
•
|
the inability to commercialize any products that we may develop.
|
•
|
terminate agreements, in whole or in part, at any time, for any reason or no reason;
|
•
|
unilaterally modify the parties’ obligations under such contracts, subject to government-determined equitable price adjustments;
|
•
|
decline to exercise any option for work beyond the initial base period under multi-year contracts;
|
•
|
suspend contract performance if Congressionally appropriated funding becomes unavailable;
|
•
|
obtain rights to inventions and technical data made or first produced in the performance of such contracts;
|
•
|
audit contract-related costs and fees, including allocated indirect costs;
|
•
|
suspend or debar the contractor from receiving new contracts pending resolution of alleged violations of procurement laws or regulations in the event of wrongdoing by us;
|
•
|
take actions that result in a longer development timeline than expected;
|
•
|
direct the course of a development program in a manner not chosen by the government contractor;
|
•
|
impose U.S. manufacturing requirements for products that embody or that are produced through the use of inventions conceived or first reduced to practice under such contracts;
|
•
|
assert qualified march-in rights to grant licenses to third parties to practice contractor-owned inventions that are conceived or first reduced to practice under such contracts;
|
•
|
pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and
|
•
|
limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.
|
•
|
specialized accounting systems unique to government contracts;
|
•
|
potential liability for price adjustments or recoupment of government funds after such funds have been spent;
|
•
|
mandatory disclosure of credible evidence of certain contractual or statutory violations occurring in connection with the contract;
|
•
|
public disclosures of certain contract information, which may enable competitors to gain insights into our research program; and
|
•
|
mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affirmative action programs and environmental compliance requirements.
|
•
|
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts;
|
•
|
extensive U.S. government regulation of government-funded clinical research activities, including, for example, compliance requirements relating to protection of human and animal research subjects, restrictions on uses of human research materials, and conditions on dissemination of research results.
|
•
|
business ethics and public integrity obligations, which govern areas such as conflicts of interest, the recruitment and hiring of former government employees, bribes and gratuities, and limitations on and mandatory disclosure of lobbying activities, pursuant to laws such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act; and
|
•
|
export control and import laws and regulations.
|
•
|
termination of any government contracts, including our BARDA contract;
|
•
|
suspension of payments;
|
•
|
administrative sanctions, such as long-term monitoring arrangements;
|
•
|
fines; and
|
•
|
suspension, debarment, or exclusion from eligibility for U.S. government contracts, funding programs and regulatory approvals.
|
•
|
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;
|
•
|
collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;
|
•
|
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
|
•
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
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a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products;
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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
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collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
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disputes may arise between the collaborator and us as to the ownership of intellectual property arising during the collaboration;
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we may grant exclusive rights to our collaborators, which would prevent us from collaborating with others;
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disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources; and
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collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
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reliance on the third party for regulatory compliance and quality assurance;
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the possible breach of the manufacturing agreement by the third party;
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the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
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the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
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litigation involving patients taking our products;
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restrictions on such products, manufacturers or manufacturing processes;
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restrictions on the labeling or marketing of a product;
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restrictions on product distribution or use;
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requirements to conduct post-marketing studies or clinical trials;
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warning or untitled letters;
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withdrawal of the products from the market;
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refusal to approve pending applications or supplements to approved applications that we submit;
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recall of products;
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fines, restitution or disgorgement of profits or revenues;
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suspension or withdrawal of marketing approvals;
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damage to relationships with any potential collaborators;
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unfavorable press coverage and damage to our reputation;
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refusal to permit the import or export of our products;
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product seizure; or
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injunctions or the imposition of civil or criminal penalties.
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The federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federally funded healthcare programs such as Medicare and Medicaid. This statute has been broadly interpreted to apply to manufacturer arrangements with prescribers, purchasers and formulary managers, among others. Several other countries, including the United Kingdom, have enacted similar anti-kickback, fraud and abuse, and healthcare laws and regulations.
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The federal False Claims Act imposes civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. The government and qui tam relators have brought False Claims Act actions against pharmaceutical companies on the theory that their practices have caused false claims to be submitted to the government. There is also a separate false claims provision imposing criminal penalties.
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The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.
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HIPAA also imposes criminal liability for knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.
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The federal Physician Sunshine Act requirements under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to together as the Affordable Care Act, require manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value made to or at the request of covered recipients, such as physicians and teaching hospitals, and physician ownership and investment interests in such manufacturers. Payments made to physicians and research institutions for clinical trials are included within the ambit of this law.
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Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures. Additionally, some state and local laws require the registration of pharmaceutical sales representatives in the jurisdiction.
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an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
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expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70% starting January 1, 2019) point-of-sale discounts off negotiated prices;
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extension of manufacturers’ Medicaid rebate liability;
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expansion of eligibility criteria for Medicaid programs;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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new requirements to report certain financial arrangements with physicians and teaching hospitals;
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
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the success of competitive products or technologies;
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results of clinical trials of ezutromid, ridinilazole and any other future product candidate that we develop;
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results of clinical trials of product candidates of our competitors;
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changes or developments in laws or regulations applicable to ezutromid and ridinilazole and any other future product candidates that we develop;
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our entry into, and the success of, any collaboration agreements with third parties;
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the operation of our contract with BARDA, and whether BARDA elects to pursue its option work segments beyond the base period;
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developments or disputes concerning patent applications, issued patents or other proprietary rights;
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the recruitment or departure of key personnel;
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the level of expenses related to any of our product candidates or clinical development programs;
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the results of our efforts to discover, develop, acquire or in-license additional product candidates, products or technologies;
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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
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variations in our financial results or those of companies that are perceived to be similar to us;
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changes in the structure of healthcare payment systems;
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market conditions in the biotechnology and pharmaceutical sectors;
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general economic, industry and market conditions;
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the trading volume of ADSs on the Nasdaq Global Market and of our ordinary shares on AIM; and
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the other factors described in this “Risk Factors” section.
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have a majority of the board of directors consist of independent directors;
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require non-management directors to meet on a regular basis without management present;
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adopt a code of conduct and promptly disclose any waivers of the code for directors or executive officers that should address certain specified items;
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have an independent compensation committee;
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have an independent nominating committee;
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solicit proxies and provide proxy statements for all shareholder meetings;
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review related party transactions; and
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seek shareholder approval for the implementation of certain equity compensation plans and issuances of ordinary shares.
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not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
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reduced disclosure obligations regarding executive compensation; and
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
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*
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We have granted Eurofarma an exclusive license to the commercial rights for ridinilazole in specified countries in South America, Central America and the Caribbean. We retain commercialization rights in the rest of the world.
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†
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We have granted Sarepta an exclusive license to the commercial rights for our utrophin modulator pipeline, including ezutromid, in the European Union, Iceland, Norway, Switzerland, Turkey and the Commonwealth of Independent States, with an option to expand its commercial rights to include specified countries in Central and South America. We retain commercialization rights in the rest of the world.
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Trial
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Description
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Duration of
Treatment
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Total No.
of Patients
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No. of Patients
Treated with
Ezutromid
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Phase 1 healthy volunteer trial (Trial 01)
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Double blind, placebo controlled, ascending single and multiple oral dose trial
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10 days
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49
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36
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Phase 1b DMD patient trial (Trial 02)
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Open label, ascending single and multiple oral dose trial
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10 days
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12
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12
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Phase 1b modified diet trial (Trial 03)
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Double blind, randomized, placebo controlled multiple oral dose trial with dietary guidance
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14 days
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12
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12
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Phase 1 healthy volunteer and DMD patient trial (Trial 04)
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Open label, ascending multiple oral dose trial with dietary guidance evaluating new F6 formulation of ezutromid
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5 days (healthy volunteers) and 7 days (DMD patients)
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24
(16 healthy
volunteers,
8 DMD
patients)
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24
(16 healthy
volunteers,
8 DMD
patients)
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Ezutromid was Well Tolerated
. In both Part 1 and Part 2 of the clinical trial, ezutromid was well tolerated at all doses tested. The only observed treatment related adverse event was pale stools, which only occurred at the 200 mg/kg and 400 mg/kg dose levels. The pale stools were attributed to unabsorbed ezutromid passing through the gastrointestinal tract at these higher dose levels. All other adverse events were mild in severity and resolved without treatment.
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Higher Plasma Concentrations When Ezutromid Dosed with Food
. The dietary state of subjects in the clinical trial had a meaningful effect on systemic exposure. As illustrated in the figure below, after we administered a single dose of 200 mg/kg of ezutromid to subjects in the 200 mg/kg cohort of Part 1 of the clinical trial, the mean plasma concentration of drug in the blood over time, as determined by quantification of the area under the curve, in the subjects when they were in a fed state (n = 6) was approximately five times higher than the same subjects when they were in a fasted state (n = 5).
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Targeted Plasma Levels Achieved in All Subjects after Multiple Dosing
. When we administered 100 mg/kg doses of ezutromid twice a day for ten days, the steady state plasma concentration achieved in all subjects was greater than 0.2 µM (67 ng/mL), which was the concentration that corresponded to a 50% increase in utrophin protein levels in our preclinical studies described in more detail below. The mean blood plasma concentration of ezutromid in the 12 hours following administration of the final dose is illustrated in the figure below. However, there were differences among subjects, with the amount of time that each subject had plasma concentrations of utrophin protein greater than 0.2 µM ranging from seven to 12 hours following dosing. Utrophin protein has a half-life of three to four weeks, and we believe that a few hours of exposure to ezutromid following regular dosing may lead to an accumulation of utrophin protein in muscle tissue over time. Subjects receiving 200 mg/kg doses of ezutromid twice a day for ten days did not achieve higher plasma concentrations of ezutromid than subjects receiving 100 mg/kg doses of ezutromid on this dosing schedule. As a result, we expect that the maximum dose of ezutromid in our future clinical trials will be 100 mg/kg.
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Stable Plasma Levels of Ezutromid When Administered Through Multiple Dosing
. When we administered 100 mg/kg doses of ezutromid twice a day for ten days with meals, all subjects achieved stable, or steady state, blood plasma concentrations of drug within three to five days after the beginning of dosing. However, we observed differences in plasma concentrations across subjects, which we believe resulted from varying levels of activity of CYP1A, a liver enzyme that metabolizes ezutromid, in different subjects.
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a single 50 mg/kg dose on day one;
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50 mg/kg doses administered twice per day on days two to ten; and
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a single 50 mg/kg dose on day 11.
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a single 100 mg/kg dose on day one;
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100 mg/kg doses administered twice per day on days two to ten; and
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a single 100 mg/kg dose on day 11.
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a single 100 mg/kg dose on day one;
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100 mg/kg doses administered three times per day on days two to ten; and
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a single 100 mg/kg dose on day 11.
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Ezutromid was Well Tolerated
. Ezutromid was well tolerated at all doses tested in this clinical trial with no serious adverse events reported. All reported adverse events were mild in severity and gastrointestinal in nature. In the opinion of the trial investigator, there were no clinically meaningful changes in physical examination, vital signs and hematology or biochemistry parameters in any of the patients. We also did not observe any issues with patient compliance.
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Patients had Variable Plasma Levels of Ezutromid; Possible Impact from Diet on Absorption of Ezutromid
. We observed variability among patients in all three cohorts in plasma concentrations of ezutromid after administering multiple daily doses for eleven days. As illustrated in the figure below, the mean blood plasma concentrations of two of the 12 DMD patients, who we refer to as high absorbers, exceeded the target level of 0.2 µM (67 ng/mL) for several hours following dosing. We determined this target level prior to conducting this clinical trial based on the composite results of our preclinical studies in tissue culture, or
in vitro
preclinical studies, and our preclinical studies in live animals, or
in vivo
preclinical studies, which indicated that this plasma concentration leads to an increase of approximately 50% in levels of utrophin protein. The mean plasma concentrations of the remaining ten patients, who we refer to as low absorbers, were less than this target level and similar to the levels achieved by fasted healthy volunteers in our completed Phase 1 clinical trial who had received a single 200 mg/kg dose of ezutromid. Nonetheless, we believe that the patients who did not achieve the target plasma level in the clinical trial may still have achieved a plasma level of ezutromid sufficient to modulate the production of utrophin and possibly result in a clinical benefit. This belief is based in part on the work of Professor Davies’ research group, in which the continued expression of utrophin protein in transgenic lines of an mdx mouse, even at levels just above those in a normal mdx mouse, had a meaningful, positive effect on muscle performance.
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Patients Experienced a Reduction in CK and Other Enzyme Markers of Muscle Damage
. We observed a reduction compared to baseline in the enzymes CK, aspartate aminotransferase, or AST, and alanine aminotransferase, or ALT, in over 90% of the patients in the clinical trial during dosing with ezutromid. Other liver associated enzymes, gamma glutamyl transferase, alkaline phosphatase and albumin, showed no meaningful change from baseline over the same dosing period. The levels of CK, ALT and AST are typically low in healthy people. In DMD patients, however, damage to muscle fibers leads to the release of these enzymes from the muscle and accumulation in the blood. The mean reductions in CK, ALT and AST were statistically significant as compared to the baseline pre-dose levels (p <0.05). We determine statistical significance based on a widely used, conventional statistical method that establishes the p-value of clinical results. Typically, a p-value of 0.05 or less represents statistical significance. Following the end of dosing, the levels of these enzymes increased toward pre-
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a single dose on day one; and
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twice daily doses on days two to fourteen.
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Modified Diet had a Positive Impact on Plasma Absorption
. In this trial, plasma absorption of ezutromid was increased in patients with DMD who followed specific dietary guidance that provided a balanced diet of fats, carbohydrates and proteins. Ten of the 12 patients achieved plasma exposure levels above 30 ng/mL for a mean of 14.0 hours in a 22-hour period on day 14 of the trial, with six of these patients achieving levels above 67 ng/mL for a mean of 8.2 hours in the same 22-hour period on day 14. Plasma levels of 30 ng/mL and 67 ng/mL correlate to an increase in utrophin levels of approximately 30% and 50%, respectively, based on our
in vitro
studies that were undertaken in myoblast cells from patients with DMD and myotubes from healthy individuals. The remaining two patients achieved maximum plasma exposure levels that exceeded 20 ng/mL. We believe that these two patients also achieved plasma exposure that may be sufficient to modulate the production of utrophin protein and possibly result in clinical benefit. The plasma exposure levels described above for all 12 patients were achieved after each received twice daily doses of 2,500 mg of ezutromid.
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Higher Plasma Levels of Ezutromid were Observed on Day 14 Compared to Day 1 in the Majority of Patients
. In this trial, seven of the 12 patients had higher plasma levels when measuring plasma levels over time and calculating the area under the curve, or AUC, on day 14 compared to day 1. This accumulation of drug had not been observed in our previous Phase 1 clinical trial conducted in healthy volunteers or our initial Phase 1b clinical trial conducted in patients with DMD. We expect to evaluate the impact of longer-term dosing of ezutromid on plasma exposure in future clinical trials, including in our Phase 2 PhaseOut DMD clinical trial.
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Treatment with Ezutromid did not Alter CK Levels, an Enzyme Biomarker of Muscle Damage, Compared to Placebo
. We did not observe a change in the levels of the enzyme CK compared to baseline when patients were treated with 1,250 mg or 2,500 mg of ezutromid twice a day for 14 days compared to placebo. In our initial Phase 1b clinical trial, in which there was no placebo control, we observed a statistically significant reduction in CK levels compared to baseline when dosing patients with ezutromid. We believe that the results from our Phase 1b modified diet trial indicate that the reduction in CK levels we observed previously is likely not related to treatment with ezutromid. We plan to evaluate CK levels, as well as additional biomarkers, over a longer duration of exposure to ezutromid in future clinical trials.
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Ezutromid was Well Tolerated.
Ezutromid was well tolerated at all doses tested in this clinical trial, with no serious adverse events reported. All reported adverse events were mild in severity and resolved prior to completion of the study. The most common adverse event was pale stools and this was reported by patients in the placebo group and each of the ezutromid treatment groups. In the opinion of the trial investigator, there were no clinically meaningful changes in physical examination, vital signs and hematology or biochemistry parameters in any of the patients. We also did not observe any issues with patient compliance.
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A twice daily dose of 3,000 mg on days one to three in a fed state;
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A twice daily dose of 6,000 mg on day four in a fed state;
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A single dose of 6,000 mg in the morning on day five in a fasted state; and
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A single dose of 6,000 mg in the evening on day five in a fed state.
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A twice daily dose of 2,000 mg on days one to three in a fed state;
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A twice daily dose of 4,000 mg on day four in a fed state;
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A single dose of 4,000 mg in the morning on day five in a fasted state; and
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A single dose of 4,000 mg in the evening on day five in a fed state.
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250 mg twice a day for seven days;
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500 mg twice a day for seven days; and
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1,000 mg twice a day for seven days.
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Healthy Volunteers Demonstrated Increased Plasma Levels With the F6 Formulation of Ezutromid.
In healthy volunteers, the F6 formulation of ezutromid achieved an over ten-fold increase in plasma levels compared to the F3 formulation of ezutromid. This formulation was selected to progress into Part B of the trial and undergo evaluation in patients with DMD.
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DMD Patients Demonstrated Increased Plasma Levels of Ezutromid with F6 Formulation.
At the 1,000 mg twice a day dose of the F6 formulation of ezutromid, the five evaluable patients achieved an average maximum plasma concentration of 390 ng/mL on day 7, the final day of dosing. By comparison, in our Phase 1b modified diet trial, a twice daily dose of 2,500 mg of the F3 formulation of ezutromid achieved an average maximum plasma concentration of 63 ng/mL on day 14, the final day of dosing. We believe both the F6 and F3 formulations of ezutromid will be able to modulate utrophin. However, we anticipate that only one of these formulations will be chosen to move forward in clinical development, based on the safety and efficacy data from PhaseOut DMD.
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Ezutromid was Generally Well Tolerated.
Ezutromid was generally well tolerated at all doses tested in both the healthy volunteers and DMD patients, except for one DMD patient who exhibited changes in liver parameters and withdrew from the trial, despite showing no clinical symptoms. The finding was classified as a serious adverse event.
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Screening and Baseline Stage
: A screening and baseline phase lasts up to 28 days for each patient. During this time, we take a number of baseline measurements. These include magnetic resonance spectroscopy / magnetic resonance imaging, or MR, analysis of upper leg muscle, a baseline muscle biopsy from the bicep, blood samples for pharmacokinetic and enzyme biomarker measurements, and baseline measurements for functional tests, including the six minute walk test and the North Star Ambulatory Assessment.
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Treatment Stage
: The treatment phase for each patient lasts a total of 48 weeks. During the treatment stage, an MR analysis will be conducted at 12, 24, 36 and 48 weeks of treatment. Blood samples for pharmacokinetic and enzyme biomarker analysis will be taken at 4, 8, 12, 24, 36 and 48 weeks of treatment. In addition, 24 of the patients are scheduled to have a second muscle biopsy taken at week 24, with the remaining 16 patients are scheduled to have their second biopsy at week 48; As of January 2018, one patient from each of these groups has withdrawn from the trial prior to their second biopsy due to reasons unrelated to ezutromid. Functional tests will be performed at 12, 24, 36 and 48 weeks of treatment.
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Safety and Tolerability Follow-up Stage
: Each patient in the trial will have a 30-day safety and tolerability follow up. For trial patients who do not enroll in the extension phase, the safety and tolerability follow-up will occur after the 48 week treatment phase. Patients enrolling in the extension phase are expected to have a 30-day safety and tolerability follow-up following completion of the extension phase.
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Trial Extension Phase
: At the end of the 48 weeks of dosing, all patients have the option of enrolling into an extension phase and continue to receive ezutromid. We expect that the extension phase will last until ezutromid either receives marketing approval in the relevant country or its development is discontinued. This extension phase will allow us to monitor safety and efficacy data related to longer-term dosing of the F3 and F6 formulations of ezutromid. The decision to include the extension phase followed a review of the safety and tolerability data from PhaseOut DMD by an independent data monitoring committee. A protocol amendment was submitted to the MHRA, U.K. Ethics Committee and the FDA in March 2017 and was subsequently approved, which enables enrollment of patients into the extension phase once they have completed 48 weeks of dosing without a cessation in dosing.
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Additional Cohort:
The amended protocol we submitted to the regulatory authorities and ethics committee to extend the trial also provides for the enrollment into PhaseOut DMD of patients who participated in prior clinical trials of ezutromid but who did not meet the inclusion criteria for PhaseOut DMD. All safety, tolerability and functional data from this arm of the trial will be distinct from analyses of the efficacy portion of PhaseOut DMD.
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Mean Increase in Utrophin Protein Intensity.
We observed an increase in mean utrophin protein intensity levels of 7% in biopsies at 24 weeks compared to baseline (0.370 to 0.396, 95% C.I., -0.005, 0.058). Background levels of utrophin are high in patients with DMD as their muscle fibers undergo a continuous cycle of damage and repair. Utrophin protein is produced during the initial stage of muscle repair, but its production is naturally switched off as muscle fibers mature.
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Reduction in Muscle Damage as Measured by Developmental Myosin.
We observed a statistically significant and meaningful reduction in muscle damage as measured by a 23% decrease in mean developmental myosin in muscle biopsies at 24 weeks compared to baseline (11.37% to 8.76%, 95% C.I., -4.33, -0.90). Developmental myosin is a biomarker of muscle damage and is present in muscle fibers that are repairing. Studies show that there is a correlation between disease severity and levels of developmental myosin present in muscle fibers with higher levels typically found in DMD patients with lower levels found in patients with the milder disease, BMD.
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Reduction in Muscle Inflammation as Measured by Magnetic Resonance Spectroscopy.
We observed a decrease in muscle inflammation as measured by magnetic resonance spectroscopy transverse relaxation time T2, or MRS-T2. We observed a mean decrease from baseline to 24 weeks in the soleus (calf muscle) in patients (n=38) of -0.861 milliseconds that achieved statistical significance (31.850 milliseconds to 30.989 milliseconds, 95% C.I., -1.440, -0.281). We also observed a mean decrease of -0.470 milliseconds in MRS-T2 in the vastus lateralis (thigh muscle) of patients (n=37) from baseline to 24 weeks (32.265 milliseconds to 31.795 milliseconds, 95% C.I., -1.158, 0.218). We believe the decrease in MRS-T2 is independent of any anti-inflammatory effect provided by corticosteroids due to the patients being on stable regimens of such treatments.
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DMD Patients Achieved Plasma Levels of Ezutromid Expected to Modulation Utrophin Protein with F3 and F6 Formulation.
We observed that all patients achieved plasma levels of ezutromid that we believe will be sufficient to modulate the expression of utrophin protein. The responses in utrophin protein intensity, developmental myosin and MRS-T2 were observed in patients treated with either the F3 or the F6 formulations of ezutromid. We did not observe a relationship between drug exposure levels and responses to these pharmacology measures or the safety measures after 24-weeks of treatment with ezutromid.
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A decrease in the mean muscle fiber diameter from 42.1µm at baseline to 40.3µm at 24 weeks as measured by muscle biopsy.
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The mean fat fraction in the vastus lateralis muscle increased from 14.7% at baseline to 18.5% at 24 weeks (n=37) as measured by magnetic resonance spectroscopy. We believe that the potential for change in this magnetic resonance parameter is expected to be observable after longer-term dosing of patients.
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A change in mean six-minute walk distance from 404m at baseline to 395m at 24 weeks (n=39) and a change in mean North Star Ambulatory Assessment score from 25.0 at baseline to 24.4 at 24 weeks (n=39). The North Star Ambulatory Assessment has a maximum score of 40.
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All patients retained ambulation after 24-weeks of treatment (n=39).
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Increased Utrophin Levels in DMD Patient Derived Myoblast Cells
. We dosed
in vitro
muscle derived cells called myoblasts from DMD patients with ezutromid. After three days of dosing, we observed a two-fold mean increase in utrophin protein levels in these myoblast cells as compared to baseline levels.
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Increased Utrophin Protein Expression in Heart, Diaphragm and Other Skeletal Muscles in mdx Mouse
. We dosed
mdx
mice with ezutromid daily for 28 days. Following the 28 days of dosing, we observed increased mean utrophin protein levels in the diaphragm (p<0.05) and the heart (p<0.01) as compared to untreated
mdx
mice. We also observed an increase in utrophin protein levels in the tibialis anterior, or TA, and extensor digitorum longus, or EDL, skeletal muscles. We also observed a mean increase in utrophin messenger ribonucleic acid, or mRNA, which is the precursor to utrophin protein. We believe that the good systemic distribution of drug observed in this experiment is important for DMD therapies that aim to maintain ambulation and prolong life for DMD patients.
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Localized Utrophin Production at the Sarcolemma in mdx Mouse
. In the
mdx
mouse experiment described in the prior bullet, we observed an increase in utrophin protein in the TA and EDL skeletal muscles of
mdx
mice treated with ezutromid compared to untreated
mdx
mice as evidenced by an observable increase in the number of utrophin positive muscle fibers in these muscles. The increase in utrophin protein was localized at the sarcolemma, which is the required site of action for utrophin production in muscle. In a separate study in which we forced
mdx
mice to exercise, we observed a similar increase in utrophin positive muscle fibers in the diaphragm and the TA and EDL muscles, and an increase of utrophin levels within these muscle fibers, of
mdx
mice treated with ezutromid compared to untreated
mdx
mice. We believe that these results are noteworthy because DMD disease pathology is even more pronounced in the diaphragm and hind-limb muscles of the forced exercise
mdx
mice as compared to sedentary
mdx
mice.
|
•
|
Reduction in Secondary Markers of DMD in mdx Mouse
. We dosed
mdx
mice with ezutromid daily for 28 days. In this study, we observed a mean 75% reduction in CK levels as compared to untreated
mdx
mice after 15 days, which is the time at which muscle degeneration is at a maximum in this model. We continued to observe lower mean CK levels in the treated
mdx
mice group after 28 days, at which point muscle degeneration stabilized. Plasma levels of CK, muscle regeneration, inflammation and fibrosis are secondary markers of DMD. We also observed a reduction in the mean level of muscle fiber regeneration in
mdx
mice treated with ezutromid compared to untreated
mdx
mice as evidenced by a reduction in the number of muscle fibers with centrally localized nuclei, which are biomarkers of regeneration. We believe this resulted from the continual expression of utrophin, which protected the dystrophin deficient muscle fibers, and therefore reduced the amount of muscle regeneration. In addition, following treatment with ezutromid, we observed a mean reduction in overall skeletal muscle inflammation and fibrosis in the
mdx
mice treated with ezutromid compared to untreated
mdx
mice, which indicates a reduction in muscle fiber damage.
|
•
|
Protection of Muscle Function in Forced Exercise mdx Mouse
. We dosed
mdx
mice with ezutromid daily for 28 days and forced the mice to exercise during this treatment period. As illustrated in the figure below, at the end of dosing the forced exercise
mdx
mice treated with ezutromid demonstrated a statistically significant mean increase in protection against exercise-induced forelimb weakness (p<0.05) compared to untreated forced exercise
mdx
mice. We measured forelimb weakness by the force increment required for the
mdx
mice to lose the strength to grip. The
mdx
mice treated with ezutromid exhibited forelimb strength comparable to that observed in the wild type control mice, which unlike
mdx
mice are not dystrophin deficient. The untreated
mdx
mice experienced a mean decrease in forelimb strength by the end of the 28 day study. Forcing the
mdx
mouse to exercise worsens the impact of DMD and we believe more closely approximates the pathology of human DMD patients.
|
•
|
Target Plasma Concentration to Achieve a 50% Increase in Utrophin Levels
. The composite results from our
in vitro
and
in vivo
preclinical studies indicated that a plasma concentration of approximately 0.2 µM (67 ng/mL) leads to an increase of approximately 50% in levels of utrophin protein. These plasma concentration findings formed the basis of the target pharmacokinetic level that we have used in our clinical trials of ezutromid. As noted above, in the experiments performed by Professor Kay Davies, the continued expression of utrophin, even at levels just above those in a normal
mdx
mouse, had a meaningful, positive effect on muscle performance.
|
•
|
quantifying numbers of utrophin positive fibers and distribution of utrophin protein in each fiber from muscle biopsies using immunohistochemistry;
|
•
|
evaluating muscle biopsies to quantify numbers of regenerating fibers; and
|
•
|
developing other serum biomarkers that will quantify muscle damage.
|
•
|
four fasted subjects, randomized for three subjects to receive a single 2 mg dose of ridinilazole and one subject to receive placebo;
|
•
|
four fasted subjects, randomized for three subjects to receive a single 20 mg dose of ridinilazole and one subject to receive placebo;
|
•
|
eight fasted subjects, randomized for six subjects to receive a single 100 mg dose of ridinilazole and two subjects to receive placebo;
|
•
|
eight fasted subjects, randomized for six subjects to receive a single 400 mg dose of ridinilazole and two subjects to receive placebo;
|
•
|
eight fasted subjects, randomized for six subjects to receive a single 2,000 mg dose of ridinilazole and two subjects to receive placebo; and
|
•
|
eight subjects, randomized for six subjects to receive a single 1,000 mg dose of ridinilazole under fasted conditions and a single 1,000 mg dose under fed conditions, and two subjects to receive two single doses of placebo on the same dosing schedule. The doses under fed and fasted conditions were separated by a minimum of six days.
|
•
|
eight subjects randomized for six subjects to receive 200 mg doses of ridinilazole twice per day for nine days with a single final dose on day ten and two subjects to receive placebo on the same dosing schedule; and
|
•
|
eight subjects randomized for six subjects to receive 500 mg doses of ridinilazole twice per day for nine days with a single final dose on day ten and two subjects to receive placebo on the same dosing schedule.
|
•
|
Ridinilazole was Well Tolerated.
Ridinilazole was well tolerated at all doses tested in the clinical trial. The incidence of adverse events in the clinical trial was low for patients treated with ridinilazole and comparable to the incidence of adverse events for patients receiving placebo. The majority of the adverse events that were considered to be possibly related to ridinilazole were classified as gastrointestinal disorders and were mild in severity and resolved without intervention. One patient withdrew from the clinical trial after suffering from appendicitis on day one. The trial investigator determined this serious adverse event was unlikely to be related to treatment with ridinilazole.
|
•
|
Ridinilazole was Retained in the Gastrointestinal Tract.
Ridinilazole was targeted to the gastrointestinal tract, which is the site where CDI occurs in the body. Systemic exposure was close to or below the level of detection in both fed and fasted subjects.
|
•
|
Ridinilazole was Highly Selective for Total Clostridia Bacteria with Minimal Impact on Other Natural Gut Flora.
We measured levels of bacteria in fecal samples from Part 2 of the clinical trial for gut flora composition on the day prior to commencement of dosing and on days four and nine of drug administration during the clinical trial. As illustrated in the figure below, in both the 200 mg and 500 mg dose cohorts, median levels of key bacteria groups that comprise the natural gut flora remained relatively constant during this period and did not fluctuate substantially from baseline. The one exception was the total clostridia bacterial group. The counts of total clostridia decreased from the
|
•
|
Ridinilazole Demonstrated Statistical Superiority Over Vancomycin.
Our Phase 2 proof of concept trial met its primary endpoint with ridinilazole achieving a SCR rate of 66.7% compared to 42.4% for vancomycin (non-inferiority margin of 15%, p=0.0004). This represented statistical superiority of ridinilazole over vancomycin using the pre-specified 90% confidence interval. The primary analysis was conducted on the modified intent-to-treat, or mITT, population (36 patients dosed with ridinilazole, 33 patients dosed with vancomycin) that comprised patients with CDI confirmed by the presence of free toxin in feces. The results of the mITT population were consistent with the intent-to-treat, or ITT, population (50 patients dosed with ridinilazole, 50 patients dosed with vancomycin) and the per protocol, or PP, population (31 patients dosed with ridinilazole, 25 patients dosed with vancomycin). We also observed a generally consistent trend to improved SCR with ridinilazole across subgroups at higher risk of recurrence, including the elderly, patients who were on concomitant antibiotics at the start of treatment and patients with a prior history of CDI.
|
•
|
Ridinilazole Demonstrated a Large Reduction in Rates of Recurrence Compared to Vancomycin.
We observed that the statistical superiority in SCR with ridinilazole compared to vancomycin was driven by a large numerical reduction in rates of disease recurrence. Clinical cure rates at the end of ten days of treatment were similar, with ridinilazole achieving a rate of 77.8% compared to 69.7% for vancomycin, but ridinilazole achieved a recurrence rate of 14.3% compared to 34.8% for vancomycin during the 30-day post-treatment period.
|
•
|
Ridinialzole Preserved the Gut Microbiome.
Stool samples were obtained from 82 patients enrolled in the Phase 2 clinical trial to evaluate the efficacy of ridinilazole compared to vancomycin. These samples were analyzed on study entry, day five and day ten of treatment, day 25 and day 40 post-entry and at the time of any recurrence for five specific bacterial groups associated with a healthy gut microbiome (
Bacteroides
,
Prevotella
,
Enterbactericeae
,
C. coccoides
and
C. leptum
) and also for total bacteria present. We observed that patients treated with vancomycin had a significant decrease (p<0.001) in four of the five bacterial groups (
Bacteroides
,
Prevotella
,
C. coccoides
and
C. leptum
) at day five and day ten, and a significant decrease in total bacteria. Patients treated with ridinilazole did not have a significant decrease in these specific bacterial groups nor the total bacteria. Moreover, we observed the initial evidence of recovery of these key bacterial groups in some patients treated with ridinilazole. We believe that these data provide evidence that ridinilazole is able to preserve a healthy gut microbiome during treatment for CDI and that the recovery of the key bacterial groups contributed to the large numerical reduction in disease recurrence we observed in the trial results.
|
•
|
Ridinilazole was Retained in the Gastrointestinal Tract.
Ridinilazole was targeted to the gastrointestinal tract, which is the site where CDI occurs in the body. Systemic exposure was close to or below the level of detection in patients with CDI, with plasma concentrations very similar to those observed in our Phase 1 clinical trial in healthy volunteers.
|
•
|
Ridinilazole Reduced Biomarkers of Inflammation.
We measured levels of two key markers of inflammation, calprotectin and lactoferrin, in feces collected from the 69 patients who comprised the mITT group. The samples analyzed were collected at the time of randomization (prior to initiation of treatment), at day five and at day ten. We observed that ridinilazole and vancomycin reduced concentrations of calprotectin and lactoferrin by similar levels when analyzing the results for all patients. We also observed that a subset of patients with severe CDI had a greater reduction in levels of calprotectin and lactoferrin when treated with ridinilazole compared to vancomycin. We believe these data indicate that ridinilazole is associated with a greater reduction in inflammatory markers compared to vancomycin in patients with severe CDI.
|
•
|
Ridinilazole was Well Tolerated.
Ridinilazole was generally well tolerated. The overall rate of adverse events and serious adverse events reported in the ridinilazole and vancomycin treatment arms were comparable.
|
•
|
the plasma pharmacokinetics of ridinilazole in patients with CDI;
|
•
|
the qualitative and quantitative effect of ridinilazole and fidaxomicin on gut flora;
|
•
|
the plasma, urine and fecal concentrations of ridinilazole and its metabolites; and
|
•
|
the efficacy of ten days of dosing with ridinilazole compared to fidaxomicin for the treatment of CDI.
|
•
|
Ridinilazole Preserved the Microbiome to a Greater Extent than Fidaxomicin.
We observed that following 10 days of treatment, ridinilazole had markedly less of an impact on the gut microbiome of trial patients by measures of overall diversity and changes in key bacterial families when compared to those trial patients dosed with fidaxomicin. We observed that while ridinilazole and fidaxomicin both reduced the abundance of
C. difficile
, fidaxomicin treated patients had reduced abundance of other bacterial families, including Firmicutes phylum that are thought to have direct functional roles in protecting against CDI. We observed that for a number of these bacterial families, the difference between the two treatments reach statistical significance. We also reported alpha diversity, as measured by the Simpson's Diversity Index, as another measure of microbiome health, We observed a greater reduction in alpha-diversity during fidaxomicin treatment compared with ridinilazole treatment. These measures were a key secondary endpoint of the trial. We believe that these measures provide further evidence of ridinilazole's precision in killing
C. difficile
while preserving the gut microbiome.
|
•
|
Ridinilazole was Well Tolerated.
The primary endpoint of the trial was safety, as measured by the number of treatment emergent adverse events and serious adverse events. During the trial, no new or unexpected safety signals were identified and ridinilazole was well-tolerated.
|
•
|
Comparable Rates of Sustained Clinical Response.
We observed that seven of the 14 ridinilazole treated patients and six of the 13 fidaxomicin treatment patients were cured at the end of treatment and did not have a recurrence of CDI within the following 30 days to achieve a sustained clinical response. The trial was however not designed for efficacy comparisons due to the small number of patients enrolled and so we believe no conclusions on efficacy should be made based solely on this data.
|
•
|
Potency Against C. difficile
. We screened ridinilazole
in vitro
against panels of
C. Difficile
clinical isolates from the United States and the United Kingdom. In these studies, ridinilazole displayed a potent bactericidal effect against all clinical isolates of
C. difficile
, including hypervirulent strains, such as ribotype 027. Ridinilazole was more potent than both vancomycin and metronidazole, and was either equally potent to, or more potent than, fidaxomicin. We have also tested ridinilazole against a panel of
C. difficile
clinical isolates that maximize the diversity of resistance to key classes of commonly used antibiotics. Ridinilazole did not display evidence of cross resistance with other classes of key antibiotics in common use.
|
•
|
Targeted Spectrum of Activity
. We conducted
in vitro
testing of ridinilazole, vancomycin, metronidazole and fidaxomicin against a wide panel of bacteria that are commonly found in the gut flora and are necessary for normal function of the gastrointestinal tract and also have wide implications on human health, such as the proper function of the immune system. As illustrated in the figure below, in this study ridinilazole had a minimal antibiotic effect against these beneficial bacterial groups. Ridinilazole also displayed higher selectivity for
C. difficile
in this study as compared to vancomycin, metronidazole and fidaxomicin and published data for cadazolid, an antibiotic that was reported recently by another company to have missed its primary endpoint of non-inferiority to vancomycin on clinical cure in one Phase 3 clinical trial, but achieved the same primary endpoint in a second Phase 3 clinical trial.
In vitro
potency is measured by determining the concentration of a drug (in micrograms per liter) needed to inhibit the growth of 90% of the bacterial strains being tested, referred to as a MIC
90
measurement. A high number, typically higher than 256, indicates a weak antimicrobial effect, and a low number, typically less than eight, indicates a potent antimicrobial effect. We believe that the targeted spectrum of activity for ridinilazole seen in this study compared to the relatively broad spectrum of activity of other antibiotics indicates the potential for ridinilazole to selectively target
C. difficile
bacteria without causing collateral damage to the gut flora and thereby reduce CDI recurrence rates.
|
•
|
Protection Against CDI Recurrence
. In a hamster model, we infected one group of hamsters with the hypervirulent CDI strain ribotype 027 and a second group of hamsters with a second CDI strain ribotype 012. In the United States, the hypervirulent CDI strain ribotype 027 accounts for approximately one third of all CDI cases. We then treated hamsters from each of the two infected groups with different doses of ridinilazole, vancomycin and fidaxomicin for five days. We evaluated disease recurrence over the 21 days following treatment. In this hamster model, a hamster fatality within the first five days is a result of initial
C.
difficile
infection, while a fatality from day six to day 25 is a result of recurrent disease. As illustrated in the figure below, the hamsters from both infected groups that were treated with two different doses of ridinilazole had survival rates of 90% to 100% against strain ribotype 027 and 80% to 100% against strain ribotype 012. These survival rates were higher than hamsters treated with vancomycin (0% to 10% survival rates) for both CDI strains, comparable to hamsters treated with two different doses of fidaxomicin against strain ribotype 027 (90% to 100% survival rates) and higher than hamsters treated with two different doses of fidaxomicin against strain ribotype 012 (0% to 40% survival rates). All infection control hamsters received placebo and died by the second day following infection.
|
•
|
Inhibition of Sporulation
. In the
in vitro
testing of ridinilazole described above, we treated
C. difficile
cells with different concentrations of ridinilazole and measured the percentage of spores formed 96 hours after treatment. Untreated cells had a 100% conversion rate into
C. difficile
spores, which are the dormant protected form of the bacteria, after 96 hours. In this study, treatment with ridinilazole resulted in a meaningful reduction in spore count compared with untreated cells against all strains of
C. difficile
tested. We believe the reduction in sporulation may benefit rates of recurrent disease as the spores are highly resistant to standard cleaning practices and lead to increased risks of environmental persistence and disease transmission.
|
•
|
Reduction in Toxin and Inflammation Levels
. In an
in vitro
study, Caco-2 cells, a type of cell found in the colon of humans commonly used in studies of intestinal function, were exposed to
C. difficile
and then treated with ridinilazole, metronidazole and vancomycin or were untreated to act as a control. Following treatment with ridinilazole, toxin A levels were reduced by 91%, toxin B was not detected and IL-8 levels were reduced by 74%. Metronidazole and vancomycin had minimal effect on toxin A or B concentrations, and IL-8 concentrations were similar to control. Toxins A and B are produced by
C. difficile
to elicit an inflammatory response, including IL-8 release, which results in the symptoms of the disease including severe diarrhea. We believe that these data indicate that ridinilazole has the potential to reduce the severity of disease symptoms and that it has the potential to be more effective than current treatment options.
|
•
|
Concomitant Antibiotic Use
. In an
in vitro
bacterial culture study, we administered ridinilazole in combination with selected other antibiotics. In this study, concomitant use of antibiotics had neither a synergistic nor an antagonistic effect on the MIC
90
values of ridinilazole against the
C. difficile
strains tested. We believe these results indicate that concomitant use of other antibiotics will not diminish the potency of ridinilazole. We believe this is an important finding because a significant portion of CDI patients receive antibiotic treatment for persistent or new infections.
|
•
|
Low Propensity for Resistance
. In an
in vitro
study, we treated
C. difficile
bacteria with ridinilazole and assessed the number of resistant bacteria at the end of treatment. We repeated this process multiple times, with each cycle referred to as a serial passage. We observed that use of ridinilazole resulted in a low frequency of spontaneous mutation and no resistance after 14 serial passages of treatment. We have also evaluated ridinilazole mutant prevention concentration, or MPC, a measure evaluating the ability of an antibiotic to minimize the development of resistant organisms, against
C. difficile
clinical isolates.
In vitro
results show that ridinilazole has low MPC values against these isolates, providing further evidence supporting ridinilazole’s profile for low resistance development.
|
•
|
Ridinilazole Arrests Cell Division
. In an
in vitro
study, we treated
C. difficile
bacteria with ridinilazole and assessed its effects on killing the bacteria. The study revealed that ridinilazole halts
C. difficile
cell division, characterized by a significant increase in the length of
C. difficile
cells and an absence of division septum formation.
|
•
|
two granted U.S. patents covering the composition of matter of ezutromid and combinations of ezutromid with ancillary therapeutic agents, which are scheduled to expire in 2029 and 2030, respectively;
|
•
|
a granted U.S. patent covering methods of manufacture of ezutromid, which is scheduled to expire in 2029;
|
•
|
a granted U.S. patent covering formulations of ezutromid, which is scheduled to expire in 2033;
|
•
|
a granted European patent covering the composition of matter of ezutromid that cleared the opposition period in April 2015 with no opposition filed against it at the European Patent Office, and which is scheduled to expire in 2027;
|
•
|
a granted European patent covering formulations of ezutromid, which is scheduled to expire in 2033;
|
•
|
a granted European patent covering combinations of ezutromid with ancillary therapeutic agents, which is scheduled to expire in 2028; and
|
•
|
a number of pending patent applications covering formulations of ezutromid, further methods of use of ezutromid and the composition of matter of second generation utrophin modulator candidates.
|
•
|
a granted U.S. patent covering the use of ridinilazole in the treatment of CDI, which is scheduled to expire in 2029;
|
•
|
a corresponding granted European patent covering the use of ridinilazole in the treatment of CDI, which is scheduled to expire in 2029;
|
•
|
a granted U.S. patent covering hydrates of ridinilazole, which is scheduled to expire in 2029;
|
•
|
a granted European divisional patent covering hydrates of ridinilazole and pharmaceutical compositions comprising ridinilazole;
|
•
|
a further granted U.S. patent covering the use of ridinilazole in the treatment of CDI, which is scheduled to expire in 2029; and
|
•
|
two granted U.S. patents, a granted European patent and a pending European divisional application covering second generation agents for the treatment of CDI, which are scheduled to expire in 2031.
|
•
|
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
|
•
|
submission to the FDA of an IND, which must take effect before human clinical trials may begin;
|
•
|
approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;
|
•
|
performance of adequate and well-controlled human clinical trials in accordance with current good clinical practices, or GCP, to establish the safety and efficacy of the proposed drug product for each indication;
|
•
|
preparation and submission to the FDA of a new drug application, or NDA;
|
•
|
review of the product candidate by an FDA advisory committee, where appropriate or if applicable;
|
•
|
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
|
•
|
satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;
|
•
|
payment of user fees and securing FDA approval of the NDA; and
|
•
|
compliance with any post-approval requirements, including Risk Evaluation and Mitigation Strategies, or REMS, where applicable, and any post-approval studies required by the FDA.
|
•
|
restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls;
|
•
|
fines, warning letters or holds on post-approval clinical trials;
|
•
|
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the required patent information has not been filed;
|
•
|
the listed patent has expired;
|
•
|
the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
|
•
|
the listed patent is invalid, unenforceable or will not be infringed by the new product.
|
•
|
the applicant must complete an identified program of studies within a time period specified by the competent authority, the results of which form the basis of a reassessment of the benefit/risk profile;
|
•
|
the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radiopharmaceutical, by an authorized person; and
|
•
|
the package leaflet and any medical information must draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.
|
•
|
Compliance with the EU’s stringent pharmacovigilance or safety reporting rules must be ensured. These rules can impose post-authorization studies and additional monitoring obligations.
|
•
|
The manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice. These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU.
|
•
|
The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the EU notably under Directive 2001/83EC, as amended, and EU Member State laws. Direct-to-consumer advertising of prescription medicines is prohibited across the EU.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
|
•
|
the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government.
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to health care matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing ·or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services;
|
•
|
the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the Affordable Care Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-government third-party payors, including private insurers.
|
•
|
an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
|
•
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
|
•
|
expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices;
|
•
|
addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
|
•
|
expanded the types of entities eligible for the 340B drug discount program;
|
•
|
established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% (and 70% starting January 1, 2019) point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; and
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
Name of subsidiary
|
Country of
registration
|
Activity
|
%
holding
|
Summit Therapeutics Inc.
|
USA
|
Research and Development Services
|
100%
|
Summit Corporation Limited
|
England and Wales
|
Dormant
|
100%
|
Summit (Oxford) Limited
|
England and Wales
|
Research and Development
|
100%
|
Summit (Wales) Limited
|
England and Wales
|
Research and Development
|
100%
|
Summit (Cambridge) Limited
|
England and Wales
|
Dormant
|
100%
|
Summit Discovery 1 Limited
|
England and Wales
|
Dormant
|
100%
|
Summit Corporation Employee Benefit Trust Company Limited
|
England and Wales
|
Dormant
|
100%
|
MuOx Limited
|
England and Wales
|
Dormant
|
100%
|
Discuva Limited
|
England and Wales
|
Research and Development
|
100%
|
Summit Infectious Diseases Limited
|
England and Wales
|
Dormant
|
100%
|
Type/Uses
|
|
Location
|
|
Size
|
|
Lease Expiry
|
Executive office
|
|
Oxfordshire, United Kingdom
|
|
6,781 square feet
|
|
February 2027
|
Executive office
|
|
Cambridge, Massachusetts
|
|
1,168 square feet
|
|
Rolling
|
Laboratory and office
|
|
Cambridge, United Kingdom
|
|
8,834 square feet
|
|
December 2021
|
•
|
costs incurred in conducting our preclinical studies and clinical trials through contract research organizations, including preclinical toxicology, pharmacology, formulation and manufacturing work;
|
•
|
employee related expenses, which include salary and benefits, for our research and development staff;
|
•
|
costs associated with our strategic alliance with the University of Oxford; and
|
•
|
facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies.
|
|
Year ended January 31,
|
||||||||||||||
|
2018
|
|
2018
|
|
2017
|
|
2016
|
||||||||
|
(in thousands)
|
||||||||||||||
DMD program
|
$
|
22,646
|
|
|
£
|
15,959
|
|
|
£
|
9,480
|
|
|
£
|
7,526
|
|
CDI program
|
7,996
|
|
|
5,635
|
|
|
4,088
|
|
|
5,567
|
|
||||
Other research and development costs
|
10,467
|
|
|
7,376
|
|
|
5,384
|
|
|
3,763
|
|
||||
Total
|
$
|
41,109
|
|
|
£
|
28,970
|
|
|
£
|
18,952
|
|
|
£
|
16,856
|
|
•
|
the progress, costs and results of clinical trials of ezutromid for DMD and ridinilazole for CDI;
|
•
|
the scope, rate of progress, costs and results of preclinical development, laboratory testing and clinical trials for our future product candidates;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the efficacy and potential advantages of our product candidates compared to alternative treatments, including any standard of care, and our ability to achieve market acceptance for any of our product candidates that receive marketing approval;
|
•
|
the costs and timing of commercialization activities, including product sales, marketing, distribution and manufacturing, for any of our product candidates that receive marketing approval and the rate we expand our physical presence; and
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining, enforcing and protecting our intellectual property rights and defending against any intellectual property-related claims.
|
|
|
Year ended January 31,
|
|
Change 2018 vs. 2017
|
|||||||||||
|
|
2018
|
|
2017
|
|
Increase/(Decrease)
|
|||||||||
|
|
(in thousands, except percentages)
|
|||||||||||||
Revenue
|
|
£
|
25,419
|
|
|
£
|
2,304
|
|
|
£
|
23,115
|
|
|
1,003.3
|
%
|
Other operating income
|
|
2,725
|
|
|
72
|
|
|
2,653
|
|
|
3,684.7
|
|
|||
Operating expenses
|
|
|
|
|
|
|
|
|
|||||||
Research and development
|
|
(28,970
|
)
|
|
(18,952
|
)
|
|
10,018
|
|
|
52.9
|
|
|||
General and administration
|
|
(11,999
|
)
|
|
(8,277
|
)
|
|
3,722
|
|
|
45.0
|
|
|||
Operating loss
|
|
(12,825
|
)
|
|
(24,853
|
)
|
|
(12,028
|
)
|
|
(48.4
|
)
|
|||
Finance income
|
|
3,096
|
|
|
8
|
|
|
3,088
|
|
|
38,600.0
|
|
|||
Finance cost
|
|
(1,164
|
)
|
|
(862
|
)
|
|
302
|
|
|
35.0
|
|
|||
Loss before income tax
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(14,814
|
)
|
|
(57.6
|
)
|
|||
Income tax credit
|
|
3,762
|
|
|
4,336
|
|
|
(574
|
)
|
|
(13.2
|
)
|
|||
Loss for the year
|
|
£
|
(7,131
|
)
|
|
£
|
(21,371
|
)
|
|
£
|
(14,240
|
)
|
|
(66.6
|
)%
|
|
|
Year ended January 31,
|
|
Change 2017 vs. 2016
|
|||||||||||
|
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
|||||||||
|
|
(in thousands, except percentages)
|
|||||||||||||
Revenue
|
|
£
|
2,304
|
|
|
£
|
—
|
|
|
£
|
2,304
|
|
|
—
|
|
Other operating income
|
|
72
|
|
|
1,281
|
|
|
(1,209
|
)
|
|
(94.4
|
)%
|
|||
Operating expenses
|
|
|
|
|
|
|
|
|
|||||||
Research and development
|
|
(18,952
|
)
|
|
(16,856
|
)
|
|
2,096
|
|
|
12.4
|
|
|||
General and administration
|
|
(8,277
|
)
|
|
(4,771
|
)
|
|
3,506
|
|
|
73.5
|
|
|||
Operating loss
|
|
(24,853
|
)
|
|
(20,346
|
)
|
|
4,507
|
|
|
22.2
|
|
|||
Finance income
|
|
8
|
|
|
30
|
|
|
(22
|
)
|
|
(73.3
|
)
|
|||
Finance cost
|
|
(862
|
)
|
|
(2,879
|
)
|
|
(2,017
|
)
|
|
(70.1
|
)
|
|||
Loss before income tax
|
|
(25,707
|
)
|
|
(23,195
|
)
|
|
2,512
|
|
|
(10.8
|
)
|
|||
Income tax credit
|
|
4,336
|
|
|
3,058
|
|
|
1,278
|
|
|
41.8
|
|
|||
Loss for the year
|
|
£
|
(21,371
|
)
|
|
£
|
(20,137
|
)
|
|
£
|
1,234
|
|
|
(6.1
|
)%
|
|
|
Year ended January 31,
|
||||||||||||||
|
|
2018
|
|
2018
|
|
2017
|
|
2016
|
||||||||
|
|
(in thousands)
|
||||||||||||||
Net cash (outflow) / inflow from operating activities
|
|
$
|
(20,843
|
)
|
|
£
|
(14,689
|
)
|
|
£
|
12,141
|
|
|
£
|
(17,182
|
)
|
Net cash outflow from investing activities
|
|
(7,439
|
)
|
|
(5,242
|
)
|
|
(80
|
)
|
|
(36
|
)
|
||||
Net cash inflow from financing activities
|
|
19,731
|
|
|
13,905
|
|
|
413
|
|
|
22,136
|
|
||||
Net (decrease) / increase in cash and cash equivalents
|
|
$
|
(8,551
|
)
|
|
£
|
(6,026
|
)
|
|
£
|
12,474
|
|
|
£
|
4,918
|
|
•
|
continue the research and development of the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation utrophin modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
continue the research and development of ridinilazole;
|
•
|
seek to identify and develop additional future product candidates, including through our bacterial genetics-based platform for the discovery and development of new mechanism antibiotics;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical development;
|
•
|
ultimately establish a sales, marketing and distribution infrastructure in jurisdictions where we have retained commercialization rights and scale up external manufacturing capabilities to commercialize any product candidates for which we receive marketing approval;
|
•
|
acquire or in-license other product candidates and technology;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire additional clinical, regulatory and scientific personnel;
|
•
|
expand our physical presence; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
|
•
|
the progress, costs and results of clinical trials of ezutromid for DMD and ridinilazole for CDI;
|
•
|
the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for our F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation utrophin modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
the number and development requirements of other future product candidates that we pursue;
|
•
|
the costs, timing and outcome of regulatory review of ezutromid, ridinilazole and our other future product candidates;
|
•
|
the costs and timing of commercialization activities, including product sales, marketing, distribution and
|
•
|
subject to receipt of marketing approval, revenue received from commercial sales of ezutromid, ridinilazole or any of our other future product candidates;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims;
|
•
|
the amounts we receive from Sarepta under our license and collaboration agreement, including for the achievement of development, regulatory and sales milestones and royalty payments;
|
•
|
our contract with BARDA and whether BARDA elects to pursue its designated options beyond the base period;
|
•
|
the amounts we receive from Eurofarma under our license and commercialization agreement, including for the achievement of development, commercialization and sales milestones and for product supply transfers;
|
•
|
our ability to establish and maintain collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
•
|
the extent to which we acquire or invest in other businesses, products and technologies;
|
•
|
the rate of the expansion of our physical presence; and
|
•
|
the costs of operating as a public company in the United States in addition to in the United Kingdom.
|
|
|
Payments due by period
|
|||||||||||||||||
|
|
Total
|
|
Less than 1
Year
|
|
Between 1 and 3
Years
|
|
Between 3 and 5
Years
|
|
More than 5
Years
|
|||||||||
|
|
(in thousands)
|
|||||||||||||||||
Operating lease obligations
|
|
£
|
1,480
|
|
|
£
|
337
|
|
|
£
|
740
|
|
|
£
|
403
|
|
|
—
|
|
Contractual obligations
|
|
1,673
|
|
|
981
|
|
|
692
|
|
|
—
|
|
|
—
|
|
||||
Total contractual cash obligations
|
|
£
|
3,153
|
|
|
£
|
1,318
|
|
|
£
|
1,432
|
|
|
£
|
403
|
|
|
—
|
|
•
|
an exemption from compliance with the auditor attestation requirement on the effectiveness of our internal controls over financial reporting;
|
•
|
an exemption from compliance with any requirement that the Public Company Accounting Oversight Board may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
|
•
|
reduced disclosure about the company’s executive compensation arrangements; and
|
•
|
exemptions from the requirements to obtain a non-binding advisory vote on executive compensation or a shareholder approval of any golden parachute arrangements.
|
Name
|
|
Age
|
|
Position
|
Executive Officers
|
|
|
|
|
Glyn Edwards
|
|
62
|
|
Chief Executive Officer, Executive Director
|
Erik Ostrowski
|
|
45
|
|
Chief Financial Officer
|
David Roblin
|
|
51
|
|
Chief Operating Officer, Chief Medical Officer and President of Research and Development
|
Key Employees
|
|
|
|
|
Jonathon Tinsley
|
|
59
|
|
Chief Scientific Officer, DMD
|
Richard Vickers
|
|
42
|
|
Senior Vice President, Anti-Infectives
|
Non-Employee Directors
|
|
|
|
|
Frank Armstrong
(2)(3)(4)
|
|
61
|
|
Non-Executive Chairman
|
Barry Price
(3)(4)
|
|
74
|
|
Non-Executive Director
|
Stephen Davies
(2)(3)(4)
|
|
68
|
|
Non-Executive Director
|
Leopoldo Zambeletti
(1)(3)(4)
|
|
49
|
|
Non-Executive Director
|
Valerie Andrews
(1)(2)(3)(4)
|
|
58
|
|
Non-Executive Director
|
David Wurzer
(1)(3)(4)
|
|
59
|
|
Non-Executive Director
|
|
(1)
|
Member of the Audit Committee.
|
(2)
|
Member of the Remuneration Committee.
|
(3)
|
Member of the Nominating and Corporate Governance Committee.
|
(4)
|
An “independent director” as such term is defined in Rule 10A-3 under the Exchange Act.
|
|
|
Name
|
|
Salary and
Bonus /
Fees
|
|
Taxable
Benefits
(1)
|
|
Pension
Benefit
|
|
Total
|
||||||||||||
Glyn Edwards
|
|
£
|
|
609,000
|
|
|
£
|
|
1,359
|
|
|
£
|
|
18,270
|
|
|
£
|
|
628,629
|
|
Chief Executive Officer and Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Erik Ostrowski
|
|
$
|
|
640,000
|
|
|
|
|
—
|
|
|
$
|
|
17,741
|
|
|
$
|
|
657,741
|
|
Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
David Roblin
|
|
£
|
|
436,442
|
|
|
£
|
|
|
|
£
|
|
14,100
|
|
|
£
|
|
450,542
|
|
|
Chief Operating Officer, Chief Medical Officer and President of Research & Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Frank Armstrong
|
|
£
|
|
75,000
|
|
|
£
|
|
2,804
|
|
|
|
|
—
|
|
|
£
|
|
77,804
|
|
Non-Executive Chairman
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Barry Price
|
|
£
|
|
38,195
|
|
|
£
|
|
2,793
|
|
|
|
|
—
|
|
|
£
|
|
40,988
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stephen Davies
|
|
£
|
|
40,000
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
£
|
|
40,000
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Leopoldo Zambeletti
|
|
£
|
|
36,805
|
|
|
£
|
|
587
|
|
|
|
|
—
|
|
|
£
|
|
37,392
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Valerie Andrews
|
|
£
|
|
58,587
|
|
|
£
|
|
2,108
|
|
|
|
|
—
|
|
|
£
|
|
60,695
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
David Wurzer
|
|
£
|
|
50,978
|
|
|
£
|
|
2,484
|
|
|
|
|
—
|
|
|
£
|
|
53,462
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Taxable benefits represent the value of the personal benefits granted, which include private medical insurance and life assurance for executive officers and travel costs (and associated income tax and national insurance contributions which were settled on behalf of the Non-Executive Directors) for attendance at board meetings for the Non-Executive Directors. Amounts included are based on the taxable benefits reported in the year ended
January 31, 2018
to HM Revenue & Customs.
|
Name
|
|
Date of grant
|
|
At February 1, 2017
|
|
Granted
during
the
period
|
|
Lapsed
during
the
period
|
|
At January 31, 2018
|
|
Price
per
share
(£)
|
|
Date from
which
exercisable
|
|
Expiration
date
|
|||||
Glyn Edwards
|
|
May 10, 2012
|
|
150,046
|
|
|
—
|
|
|
—
|
|
|
150,046
|
|
|
0.60
|
|
|
Note 1
|
|
May 10, 2022
|
Chief Executive Officer and Executive Director
|
|
May 10, 2012
|
|
657,500
|
|
|
—
|
|
|
(657,500
|
)
|
|
—
|
|
|
0.60
|
|
|
Note 2
|
|
May 10, 2022
|
January 31, 2013
|
|
72,973
|
|
|
—
|
|
|
—
|
|
|
72,973
|
|
|
0.20
|
|
|
Note 3
|
|
January 31, 2023
|
||
|
December 18, 2013
|
|
76,364
|
|
|
—
|
|
|
—
|
|
|
76,364
|
|
|
0.20
|
|
|
Note 4
|
|
December 18, 2023
|
|
|
|
July 15, 2014
|
|
600,000
|
|
|
—
|
|
|
—
|
|
|
600,000
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
|
|
June 16, 2015
|
|
887,333
|
|
|
—
|
|
|
—
|
|
|
887,333
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
June 23, 2016
|
|
110,576
|
|
|
—
|
|
|
—
|
|
|
110,576
|
|
|
0.01
|
|
|
Note 7
|
|
June 23, 2026
|
|
|
April 11, 2017
|
|
—
|
|
|
762,764
|
|
|
—
|
|
|
762,764
|
|
|
1.85
|
|
|
Note 8
|
|
April 11, 2027
|
|
|
July 18, 2017
|
|
—
|
|
|
135,478
|
|
|
—
|
|
|
135,478
|
|
|
1.83
|
|
|
Note 9
|
|
July 18, 2027
|
|
|
October 24, 2017
|
|
—
|
|
|
198,776
|
|
|
—
|
|
|
198,776
|
|
|
1.80
|
|
|
Note 10
|
|
October 24, 2027
|
|
|
|
|
2,554,792
|
|
|
1,097,018
|
|
|
(657,500
|
)
|
|
2,994,310
|
|
|
|
|
|
|
|
|
Erik Ostrowski
|
|
June 23, 2014
|
|
400,000
|
|
|
—
|
|
|
—
|
|
|
400,000
|
|
|
1.48
|
|
|
Note 11
|
|
June 23, 2024
|
Chief Financial Officer
|
|
June 16, 2015
|
|
400,000
|
|
|
—
|
|
|
—
|
|
|
400,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
June 23, 2016
|
|
250,000
|
|
|
—
|
|
|
—
|
|
|
250,000
|
|
|
1.05
|
|
|
Note 12
|
|
June 23, 2026
|
|
|
|
July 18, 2017
|
|
—
|
|
|
68,062
|
|
|
—
|
|
|
68,062
|
|
|
1.83
|
|
|
Note 9
|
|
July 18, 2027
|
|
|
October 24, 2017
|
|
—
|
|
|
98,495
|
|
|
—
|
|
|
98,495
|
|
|
1.80
|
|
|
Note 10
|
|
October 24, 2027
|
|
|
|
|
1,050,000
|
|
|
166,557
|
|
|
—
|
|
|
1,216,557
|
|
|
|
|
|
|
|
|
David Roblin
|
|
July 15, 2014
|
|
100,000
|
|
|
—
|
|
|
—
|
|
|
100,000
|
|
|
0.80
|
|
|
Note 5
|
|
July 15, 2024
|
Chief Operating Officer, Chief Medical Officer and President of R&D
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
June 23, 2016
|
|
17,500
|
|
|
—
|
|
|
—
|
|
|
17,500
|
|
|
1.05
|
|
|
Note 7
|
|
June 23, 2026
|
|
|
April 11, 2017
|
|
—
|
|
|
324,324
|
|
|
—
|
|
|
324,324
|
|
|
1.85
|
|
|
Note 8
|
|
April 11, 2027
|
|
|
July 18, 2017
|
|
—
|
|
|
164,384
|
|
|
—
|
|
|
164,384
|
|
|
1.83
|
|
|
Note 9
|
|
July 18, 2027
|
|
|
|
|
|
142,500
|
|
|
488,708
|
|
|
—
|
|
|
631,208
|
|
|
|
|
|
|
|
|
Barry Price
|
|
April 7, 2011
|
|
13,981
|
|
|
|
|
|
|
13,981
|
|
|
0.65
|
|
|
Note 13
|
|
April 7, 2021
|
||
Non-Executive Director
|
|
July 15, 2014
|
|
17,500
|
|
|
—
|
|
|
—
|
|
|
17,500
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
|
|
56,481
|
|
|
—
|
|
|
—
|
|
|
56,481
|
|
|
|
|
|
|
|
|
Frank Armstrong
|
|
July 15, 2014
|
|
37,500
|
|
|
—
|
|
|
—
|
|
|
37,500
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
Non-Executive Director
|
|
June 16, 2015
|
|
50,000
|
|
|
—
|
|
|
—
|
|
|
50,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
87,500
|
|
|
—
|
|
|
—
|
|
|
87,500
|
|
|
|
|
|
|
|
||
Stephen Davies
|
|
July 15, 2014
|
|
17,500
|
|
|
—
|
|
|
—
|
|
|
17,500
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
Non-Executive Director
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
42,500
|
|
|
—
|
|
|
—
|
|
|
42,500
|
|
|
|
|
|
|
|
||
Leopoldo Zambeletti
|
|
June 23, 2014
|
|
25,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
—
|
|
|
1.48
|
|
|
Note 14
|
|
June 23, 2024
|
Non-Executive Director
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
50,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
25,000
|
|
|
|
|
|
|
|
||
Valerie Andrews
Non-Executive Director
|
|
December 23, 2014
|
|
25,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
—
|
|
|
1.37
|
|
|
Note 15
|
|
December 23, 2024
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
|
50,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
25,000
|
|
|
|
|
|
|
|
||
David Wurzer
Non-Executive Director
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
|
|
|
|
|
Name
|
|
Date of grant
|
|
At February 1, 2017
|
|
Granted
during
the
period
|
|
Lapsed
during
the
period
|
|
At January 31, 2018
|
|
Price
per
share
(£)
|
|
Date from
which
exercisable
|
|
Expiration
date
|
|||||
Barry Price
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
Frank Armstrong
|
|
June 18, 2017
|
|
—
|
|
|
41,096
|
|
|
—
|
|
|
41,096
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
41,666
|
|
|
—
|
|
|
41,666
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
82,762
|
|
|
—
|
|
|
82,762
|
|
|
|
|
|
|
|
||
Stephen Davies
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
Leopoldo Zambeletti
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
Valerie Andrews
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
David Wurzer
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
1.
|
These options became exercisable on May 10, 2015 due to the satisfaction of the performance conditions relating to the share price. In order to vest in full, the average closing share price needed to be equal to or greater than £2.20 for the two months preceding the third anniversary of the date of the grant, 25% would vest where the average closing share price was £1.40 and pro-rated where the average closing share price was between £1.41 and £2.19. The options lapsed if the performance condition relating to our average closing share price was not met by the third anniversary of the date of grant. On measurement, 150,046 options have vested and 77,454 options have lapsed. No options were exercised in the year
.
|
2.
|
These options were split into four tranches with varying performance conditions and would only vest if the average closing share price had been equal to or greater than the specified condition in any period of 60 consecutive calendar days, ending on or before the fifth anniversary of the date of grant. Details of the tranches are as follows: 207,500 with a performance condition based on an average closing share price of £4.00; 200,000 with a performance condition based on an average closing share price of £6.00; 150,000 with a performance condition based on an average closing share price of £8.00; and 100,000 with a performance condition based on an average closing share price of £10.00. The options lapsed as the performance conditions were not met by the fifth anniversary of the date of grant
.
|
3.
|
These deferred bonus options vested and became exercisable on July 31, 2013. These options were awarded as a bonus for the financial year ended January 31, 2013
.
|
4.
|
These deferred bonus options vested and became exercisable on June 18, 2014. These options were awarded as a bonus for the financial year ended January 31, 2014 representing 70% of Mr. Glyn Edwards’ gross basic salary for that financial year
.
|
5.
|
These options vested on March 13, 2017 as the average closing share price was equal to or greater than £1.89 in a period of 30 consecutive days during the period from the date of the grant to the third anniversary of the date of the grant. One third of the options became exercisable on March 13, 2017, following the second anniversary of the date of grant and the remaining options became exercisable on July 15, 2017, the third anniversary of the date of grant
.
|
6.
|
These options vest if the average closing share price is equal to or greater than £2.145 in any period of 30 consecutive days during the period from the date of the grant to June 16, 2018. Once vested, a third of the options can be exercised on or after June 16, 2017 and all of the options, if vested, can be exercised on or after June 16, 2018. These options will lapse if the performance condition is not met by June 16, 2018
.
In April 2018, all Non-Executive Directors surrendered these awards.
|
7.
|
T
hese deferred bonus options vested and became exercisable on July 21, 2016. These options were awarded in part settlement of the bonus for the financial year ended January 31, 2016 representing 50% of Mr. Glyn Edwards’ gross basic salary for that financial year
.
|
8.
|
These options achieved the performance conditions during the financial year pertaining to corporate and program development milestones. Accordingly, these options will vest in full on June 23, 2019
.
|
9.
|
These options are subject to achievement of performance conditions pertaining to corporate and program development milestones. These options will vest in full on the third anniversary of the date of grant
.
|
10.
|
These options are subject to achievement of performance conditions pertaining to corporate and program development milestones. These options will vest in full on the third anniversary of the date of grant
.
|
11.
|
These options vest and become exercisable in the following proportions, assuming the average closing share price of our ordinary shares on AIM during the two months prior to each relevant vesting date is £2.213 or higher: 25% on the second anniversary of the date of grant, 75% on the third anniversary of the date of grant and 100% on the fourth anniversary of the date of grant. These options will lapse if the performance condition is not met by the fourth anniversary of the date of grant.
|
12.
|
These options will vest in full on June 23, 2019 subject to achievement of performance conditions pertaining to certain corporate and program development milestones. These options will lapse in full if the performance conditions are not met by June 23, 2019.
|
•
|
appointing, approving the compensation of, and assessing the independence, objectivity and effectiveness of our registered public accounting firm;
|
•
|
overseeing the work of our independent registered public accounting firm, including through the receipt and consideration of reports from that firm;
|
•
|
monitoring the integrity of our financial statements by reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial statements and related disclosures;
|
•
|
reviewing and monitoring our internal control over financial reporting, disclosure controls and procedures and code of business conduct;
|
•
|
reviewing and monitoring the effectiveness of our internal audit function;
|
•
|
overseeing our risk assessment and risk management policies;
|
•
|
establishing policies regarding procedures for the receipt and retention of accounting related complaints and concerns;
|
•
|
meeting independently with our internal auditing staff, if any, our independent registered public accounting firm and management; and
|
•
|
reviewing and approving or ratifying any related person transactions.
|
•
|
reviewing and approving, or making recommendations to our board of directors with respect to, the compensation of our directors and executive management;
|
•
|
overseeing an evaluation of our executive management; and
|
•
|
overseeing and administering our employee share option scheme or equity incentive plans in operation from time to time.
|
•
|
identifying individuals qualified to become members of our board;
|
•
|
recommending to our board the persons to be nominated for election as directors and to each of our board’s committees;
|
•
|
overseeing a periodic evaluation of our board;
|
•
|
reviewing and making recommendations to our board with respect to our board leadership structure;
|
•
|
reviewing and making recommendations to our board with respect to management succession planning; and
|
•
|
developing and recommending to our board corporate governance principles.
|
|
|
2018
|
|
2017
|
|
2016
|
|||
By Geography
|
|
|
|
|
|
|
|||
United Kingdom
|
|
54
|
|
|
28
|
|
|
25
|
|
North America
|
|
22
|
|
|
12
|
|
|
12
|
|
Total
|
|
76
|
|
|
40
|
|
|
37
|
|
|
|
2018
|
|
2017
|
|
2016
|
|||
By Function
|
|
|
|
|
|
|
|||
Research & Development
|
|
52
|
|
|
24
|
|
|
22
|
|
General & Administrative
|
|
24
|
|
|
16
|
|
|
15
|
|
Total
|
|
76
|
|
|
40
|
|
|
37
|
|
•
|
each of the members of our board of directors;
|
•
|
each of our other executive officers; and
|
•
|
each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our ordinary shares.
|
|
|
Ordinary shares
beneficially owned
|
||||
Name of beneficial owner
|
|
Shares
|
|
%
|
||
Executive officers and directors
|
|
|
|
|
||
Glyn Edwards
(1)
|
|
1,243,292
|
|
|
1.50
|
%
|
Erik Ostrowski
|
|
—
|
|
|
—
|
|
David Roblin
(2)
|
|
107,770
|
|
|
*
|
|
Frank Armstrong
(3)
|
|
51,942
|
|
|
*
|
|
Barry Price
(4)
|
|
107,211
|
|
|
*
|
|
Stephen Davies
(5)
|
|
602,481
|
|
|
*
|
|
Leopoldo Zambeletti
|
|
—
|
|
|
—
|
|
Valerie Andrews
|
|
10,500
|
|
|
*
|
|
David Wurzer
|
|
7,500
|
|
|
*
|
|
All executive officers and directors as a group (9 persons)
(6)
|
|
2,130,696
|
|
|
2.56
|
%
|
5% shareholders
|
|
|
|
|
||
Lansdowne Partners (UK) LLP
(7)
|
|
21,143,500
|
|
|
25.82
|
%
|
Robert Keith
(8)
|
|
4,294,816
|
|
|
5.24
|
%
|
*
|
Less than one percent.
|
(1)
|
Consists of (a) 1,009,959 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 233,333 ordinary shares.
|
(2)
|
Consists of 107,770 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date.
|
(3)
|
Consists of (a) 37,500 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 14,442 ordinary shares.
|
(4)
|
Consists of (a) 31,481 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 75,730 ordinary shares.
|
(5)
|
Consists of (a) 17,500 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 584,981 ordinary shares.
|
(6)
|
Consists of (a) 1,204,210 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 926,486 ordinary shares.
|
(7)
|
These shares are registered in the name of HSBC Client Holdings Nominee (UK) Limited. Lansdowne Partners (UK) LLP may be deemed to have voting and dispositive power over the ordinary shares. Investment decisions with respect to the ordinary shares held by Lansdowne Partners (UK) LLP can be made by Stuart Roden, Peter Davies and Jonathan Regis. The address of Lansdowne Partners (UK) LLP is 15 Davies Street, London, W1K 3AG.
|
(8)
|
This information is based on information contained in a TR-1 Notification sent to us on January 25, 2017 by Robert Keith.
|
|
|
Price Per Ordinary Share
|
|
Price Per Ordinary Share
|
||||||||
|
|
£
|
|
$
|
||||||||
|
|
High
|
|
Low
|
|
High
|
|
Low
|
||||
Annual (Fiscal Year Ended January 31):
|
|
|
|
|
|
|
|
|
||||
2014
|
|
3.90
|
|
|
0.78
|
|
|
5.53
|
|
|
1.11
|
|
2015
|
|
2.20
|
|
|
1.04
|
|
|
3.12
|
|
|
1.48
|
|
2016
|
|
1.84
|
|
|
1.17
|
|
|
2.61
|
|
|
1.66
|
|
2017
|
|
2.53
|
|
|
0.91
|
|
|
3.59
|
|
|
1.29
|
|
2018
|
|
2.43
|
|
|
1.43
|
|
|
3.45
|
|
|
2.03
|
|
Quarterly:
|
|
|
|
|
|
|
|
|
||||
First Quarter 2017
|
|
1.33
|
|
|
0.94
|
|
|
1.89
|
|
|
1.33
|
|
Second Quarter 2017
|
|
1.26
|
|
|
1.00
|
|
|
1.88
|
|
|
1.42
|
|
Third Quarter 2017
|
|
2.53
|
|
|
0.91
|
|
|
2.59
|
|
|
1.29
|
|
Fourth Quarter 2017
|
|
1.95
|
|
|
1.43
|
|
|
2.77
|
|
|
2.03
|
|
First Quarter 2018
|
|
2.20
|
|
|
1.75
|
|
|
3.12
|
|
|
2.48
|
|
Second Quarter 2018
|
|
2.03
|
|
|
1.73
|
|
|
2.88
|
|
|
2.45
|
|
Third Quarter 2018
|
|
2.43
|
|
|
1.53
|
|
|
3.45
|
|
|
2.17
|
|
Fourth Quarter 2018
|
|
2.15
|
|
|
1.43
|
|
|
3.05
|
|
|
2.03
|
|
Monthly:
|
|
|
|
|
|
|
|
|
||||
October 2017
|
|
1.98
|
|
|
1.53
|
|
|
2.81
|
|
|
2.17
|
|
November 2017
|
|
1.80
|
|
|
1.43
|
|
|
2.55
|
|
|
2.03
|
|
December 2017
|
|
1.80
|
|
|
1.63
|
|
|
2.55
|
|
|
2.41
|
|
January 2018
|
|
2.15
|
|
|
1.65
|
|
|
3.05
|
|
|
2.34
|
|
February 2018
|
|
1.98
|
|
|
1.63
|
|
|
2.81
|
|
|
2.31
|
|
March 2018
|
|
1.95
|
|
|
1.70
|
|
|
2.77
|
|
|
2.41
|
|
April 2018 (through April 6, 2018)
|
|
1.90
|
|
|
1.75
|
|
|
2.70
|
|
|
2.48
|
|
|
|
Price Per ADS
|
||||
|
|
$
|
||||
|
|
High
|
|
Low
|
||
Annual (Fiscal Year Ended January 31):
|
|
|
|
|
||
2016
|
|
13.68
|
|
|
8.25
|
|
2017
|
|
14.35
|
|
|
5.50
|
|
2018
|
|
16.00
|
|
|
9.05
|
|
Quarterly:
|
|
|
|
|
||
First Quarter 2017
|
|
10.97
|
|
|
6.35
|
|
Second Quarter 2017
|
|
9.84
|
|
|
7.00
|
|
Third Quarter 2017
|
|
14.35
|
|
|
5.50
|
|
Fourth Quarter 2017
|
|
12.08
|
|
|
8.12
|
|
First Quarter 2018
|
|
13.28
|
|
|
10.36
|
|
Second Quarter 2018
|
|
13.98
|
|
|
10.53
|
|
Third Quarter 2018
|
|
16.00
|
|
|
9.73
|
|
Fourth Quarter 2018
|
|
14.77
|
|
|
9.05
|
|
Monthly:
|
|
|
|
|
||
|
|
|
|
|
||
October 2017
|
|
12.79
|
|
|
9.73
|
|
November 2017
|
|
11.96
|
|
|
9.05
|
|
December 2017
|
|
12.02
|
|
|
9.89
|
|
January 2018
|
|
14.77
|
|
|
11.08
|
|
February 2018
|
|
13.64
|
|
|
10.60
|
|
March 2018
|
|
13.90
|
|
|
11.36
|
|
April 2018 (through April 6, 2018)
|
|
13.11
|
|
|
11.84
|
|
•
|
this summary only applies to an absolute beneficial owner of ordinary share or ADS and any dividend paid in respect of the ordinary share where the dividend is regarded for U.K. tax purposes as that person’s own income (and not the income of some other person); and
|
•
|
this summary: (a) only addresses the principal U.K. tax consequences for an investor who holds ordinary share or ADS as a capital asset, (b) does not address the tax consequences that may be relevant to certain special classes of investor such as a dealer, broker or trader in shares or securities and any other person who holds ordinary share or ADS otherwise than as an investment, (c) does not address the tax consequences for a holder that is a financial institution, insurance company, collective investment scheme, pension scheme, charity or tax-exempt organization, (d) assumes that a holder is not an officer or employee of the company (nor of any related company) and has not (and is not deemed to have) acquired the ordinary share or ADS by virtue of an office or employment, and (e) assumes that a holder does not control or hold (and is not deemed to control or hold), either alone or together with one or more associated or connected persons, directly or indirectly (including through the holding of an ADS), an interest of 10% or more in the issued share capital (or in any class thereof), voting power, rights to profits or capital of the company, and is not otherwise connected with the company.
|
•
|
banks or other financial institutions;
|
•
|
insurance companies;
|
•
|
brokers, dealers or traders in securities, currencies, or notional principal contracts;
|
•
|
grantor trusts;
|
•
|
tax-exempt entities, including an “individual retirement account” or “Roth IRA” retirement plan;
|
•
|
regulated investment companies or real estate investment trusts;
|
•
|
persons that hold the ordinary shares as part of a hedge, straddle, conversion, constructive sale or similar transaction involving more than one position;
|
•
|
persons required to accelerate the recognition of any item of gross income with respect to the ADSs as a result of such income being recognized on an applicable financial statement
|
•
|
an entity classified as a partnership and persons that hold the ordinary shares through partnerships or certain other pass-through entities;
|
•
|
holders (whether individuals, corporations or partnerships) that are treated as expatriates for some or all U.S. federal income tax purposes;
|
•
|
persons who acquired the ADSs as compensation for the performance of services;
|
•
|
persons who are resident, or ordinarily resident, in a foreign country;
|
•
|
persons holding the ADSs in connection with a trade or business conducted outside of the United States;
|
•
|
a U.S. holder who holds the ADSs through a financial account at a foreign financial institution that does not meet the requirements for avoiding withholding with respect to certain payments under Sections 1471 through 1474 of the Internal Revenue Code of 1986, as amended, or the Code;
|
•
|
holders that own (or are deemed to own) 10% or more of our voting shares; and
|
•
|
holders that have a “functional currency” other than the U.S. dollar.
|
•
|
an individual who is either a citizen or a tax resident of the United States;
|
•
|
a corporation, or other entity that is treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States or any state of the United States or the District of Columbia;
|
•
|
an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
|
•
|
a trust, if a court within the United States is able to exercise primary supervision over its administration and one or more U.S. persons have the authority to control all of the substantial decisions of such trust or has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a United States person.
|
Persons depositing or withdrawing shares or ADS
holders must pay:
|
|
For:
|
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
|
|
Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
|
|
|
|
$.05 (or less) per ADS
|
|
Any cash distribution to ADS holders
|
|
|
|
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs
|
|
Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders
|
|
|
|
$.05 (or less) per ADS per calendar year
|
|
Depositary services
|
|
|
|
Registration or transfer fees
|
|
Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares
|
|
|
|
Expenses of the depositary
|
|
Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
Converting foreign currency to U.S. dollars
|
|
|
|
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes
|
|
As necessary
|
|
|
|
Any charges incurred by the depositary or its agents for servicing the deposited securities
|
|
As necessary
|
|
|
Year Ended January 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(in thousands)
|
||||||
Audit Fees
|
|
£
|
341
|
|
|
£
|
230
|
|
Audit-Related Fees
(1)
|
|
118
|
|
|
166
|
|
||
Tax Fees
(2)
|
|
23
|
|
|
62
|
|
||
All Other Fees
(3)
|
|
—
|
|
|
—
|
|
||
Total
|
|
£
|
482
|
|
|
£
|
458
|
|
(1)
|
For the year ended January 31, 2018, audit-related fees includes assurance reporting in connection with our underwritten public offering in September 2017. These amounts were recognized directly in share premium. For the year ended January 31, 2017, audit-related fees includes assurance reporting in connection with our registration statement on Form F-3 that was originally filed with the U.S. Securities and Exchange Commission on May 12, 2016.
|
(2)
|
Fees relate to the aggregated fees for services rendered on tax compliance, tax advice and tax planning.
|
(3)
|
No fees incurred in this category.
|
•
|
We do not follow Nasdaq’s quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under U.K. law. In accordance with generally accepted business practice, our articles of association provide alternative quorum requirements that are generally applicable to meetings of shareholders.
|
•
|
We do not follow Nasdaq’s requirements that non-management directors meet on a regular basis without management present. Our board of directors may choose to meet in executive session at their discretion.
|
•
|
We do not follow Nasdaq’s requirements to seek shareholder approval for the implementation of certain equity compensation plans, the issuances of ordinary shares under such plans, or in connection with certain private placements of equity securities. In accordance with U.K. law, we are not required to seek shareholder approval to allot ordinary shares in connection with applicable employee equity compensation plans. We will follow U.K. law with respect to any requirement to obtain shareholder approval prior to any private placements of equity securities.
|
Exhibit No.
|
|
Description
|
|
|
|
|
Articles of Association of Summit Therapeutics plc (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Specimen certificate evidencing ordinary shares of Summit Therapeutics plc (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Form of Deposit Agreement among Summit Therapeutics plc, The Bank of New York Mellon, as depositary, and all Owners and Holders of ADSs issued thereunder (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Form of American Depositary Receipt (included in Exhibit 2.2) (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Warrant Instrument, dated April 4, 2012, creating warrant to subscribe for shares in Summit Therapeutics plc issued to Singer Capital Markets Limited (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Warrant Instrument, dated November 22, 2013, relating to Warrants in Registered Form to Subscribe for Ordinary Shares in Summit Therapeutics plc (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
4.1
†
|
|
Grant Agreement, entered into as of December 15, 2011, by and between Duchenne Partners Fund and Summit Therapeutics plc (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.2
†
|
|
MDA Venture Philanthropy Grant Contract, entered into as of December 15, 2011, by and between Muscular Dystrophy Association, Inc. and Summit Therapeutics plc (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.3
†
|
|
Translation Award Funding Agreement, entered into as of October 19, 2012, by and between the Wellcome Trust Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 27, 2015)
|
|
|
|
4.4
†
|
|
Agreement for the Sponsorship of a Research Programme, dated November 22, 2013, by and between The Chancellor Masters and Scholars of the University of Oxford; Isis Innovation Limited; and Summit Therapeutics plc (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.5
†
|
|
Deed of License of Know-How, dated November 22, 2013, by and between Isis Innovation Limited and MuOx Limited (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.6
†
|
|
Supplemental Variation Deed, dated July 24, 2014, by and between Isis Innovation Limited and MuOx Limited (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.7
†
|
|
Option Agreement, dated November 22, 2013, by and between The Chancellor Masters and Scholars of the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.8
†
|
|
Variation Agreement, dated July 16, 2014, by and between The Chancellor Masters and Scholars of the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
Lease, dated June 21, 2013, by and between MEPC Milton Park No. 1 Limited and MEPC Milton Park No. 2 Limited on behalf of MEPC Milton LP and Summit Therapeutics plc (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
Service Agreement, effective as of January 14, 2015, by and between Cambridge Innovation Center and Summit Therapeutics Inc. (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
2005 Enterprise Management Incentive Scheme (incorporated by reference to Exhibit 10.11 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated November 20, 2014, by and between Summit Therapeutics Inc. and Valerie Andrews (incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated November 21, 2012, by and between Summit Therapeutics plc and Frank Armstrong (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated December 19, 2013, by and between Summit Therapeutics plc and Stephen Davies (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated August 8, 2013, by and between Summit Therapeutics plc and Barry Price (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated April 16, 2014, by and between Summit Therapeutics plc and Leopoldo Zambeletti (incorporated by reference to Exhibit 10.16 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated February 18, 2015, by and between Summit Therapeutics plc and David Wurzer (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Form of Deed of Indemnity (incorporated by reference to Exhibit 10.18 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Deed of Variation, dated November 16, 2015, relating to the Warrant Instrument, dated November 22, 2013 (incorporated by reference to Exhibit 4.19 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
|
4.20
†
|
|
Variation Agreement, dated November 16, 2015, relating to the Option Agreement, dated November 22, 2013, by and between the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.20 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
4.21
†
|
|
Second Variation Agreement, dated November 16, 2015, relating to the Agreement for the Sponsorship of a Research Programme, dated November 22, 2013, by and between the Chancellor Masters and Scholars of the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.21 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
|
2016 Long Term Incentive Plan (incorporated by reference to Exhibit 4.22 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
|
4.23
†
|
|
License and Collaboration Agreement, dated October 3, 2016, by and between Summit (Oxford) Ltd. and Sarepta Therapeutics, Inc. (incorporated by reference to Exhibit 4.23 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
|
|
|
|
4.24
†
|
|
Deed of Novation and Variation, dated March 3, 2017, among MuOx Limited, Oxford University Innovation Limited (formerly Isis Innovation Limited) and Summit (Oxford) Limited (incorporated by reference to Exhibit 4.24 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
|
|
|
|
|
Lease, dated February 17, 2017, by and among MEPC Milton Park No. 1 Limited, MEPC Milton Park No. 2 Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.25 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
|
|
|
|
|
4.26
*+
|
|
Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA)
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
4.27
*+
|
|
License and Commercialization Agreement, dated December 18, 2017, by and between Summit (Oxford) Ltd. and Eurofarma Laboratórios S.A.
|
|
|
|
4.28
*+
|
|
Share Purchase Agreement, dated December 23, 2017, by and among Summit Therapeutics plc and the shareholders of Discuva Limited (1)
|
|
|
|
4.29
*+
|
|
Transfer Incentive Agreement, dated December 23, 2017, by and among Discuva Limited and certain of its managers.
|
|
|
|
4.30
*+
|
|
Third Variation Agreement, dated September 20, 2017, by and among the Chancellor Masters and Scholars of the University of Oxford, Oxford University Innovation Limited and Summit Therapeutics plc
|
|
|
|
4.31
*
|
|
Lease, dated December 22, 2017, by and between Merrifield Centre Ltd and Discuva Limited
|
|
|
|
4.32
*+
|
|
Equity and Revenue Sharing Agreement, dated October 16, 2017, by and between Summit (Oxford) Limited and the Wellcome Trust Limited
|
|
|
|
4.33
*
|
|
Form of Non-Executive Director Restricted Stock Unit (RSU) Agreement
|
|
|
|
8.1
*
|
|
Subsidiaries of Summit Therapeutics plc
|
|
|
|
12.1
*
|
|
Certification of Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
12.2
*
|
|
Certification of Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
13.1
*
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
15.1
*
|
|
Consent of PricewaterhouseCoopers LLP
|
|
|
|
101.INS
*
|
|
XBRL Instance Document
|
|
|
|
101.SCH
*
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
*
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
*
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
101.PRE
*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
*
|
|
Filed herewith.
|
†
|
|
Confidential treatment has been granted as to certain portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
+
|
|
Confidential treatment has been requested as to certain portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
(1)
|
|
The schedules and exhibits to the Share Purchase Agreement have been omitted. A copy of any omitted schedule or exhibit will be furnished to the Securities and Exchange Commission upon request.
|
SUMMIT THERAPEUTICS PLC
|
||
|
|
|
By:
|
|
/s/ Glyn Edwards
|
Name:
Title:
|
|
Glyn Edwards
Chief Executive Officer
|
|
|
Note
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
|
|
|
£000
|
|
£000
|
||
ASSETS
|
|
|
|
|
|
|
||
Non-current assets
|
|
|
|
|
|
|
||
Goodwill
|
|
12
|
|
2,478
|
|
|
664
|
|
Intangible assets
|
|
13
|
|
14,785
|
|
|
3,470
|
|
Property, plant and equipment
|
|
14
|
|
809
|
|
|
116
|
|
|
|
|
|
18,072
|
|
|
4,250
|
|
Current assets
|
|
|
|
|
|
|
||
Prepayments and other receivables
|
|
15
|
|
11,134
|
|
|
1,027
|
|
Current tax receivable
|
|
|
|
4,654
|
|
|
4,248
|
|
Cash and cash equivalents
|
|
|
|
20,102
|
|
|
28,062
|
|
|
|
|
|
35,890
|
|
|
33,337
|
|
Total assets
|
|
|
|
53,962
|
|
|
37,587
|
|
LIABILITIES
|
|
|
|
|
|
|
||
Non-current liabilities
|
|
|
|
|
|
|
||
Deferred revenue
|
|
17
|
|
(18,033
|
)
|
|
(23,615
|
)
|
Financial liabilities on funding arrangements
|
|
18
|
|
(3,090
|
)
|
|
(5,919
|
)
|
Provisions for other liabilities and charges
|
|
20
|
|
(1,641
|
)
|
|
(85
|
)
|
Deferred tax liability
|
|
21
|
|
(2,379
|
)
|
|
(565
|
)
|
|
|
|
|
(25,143
|
)
|
|
(30,184
|
)
|
Current liabilities
|
|
|
|
|
|
|
||
Trade and other payables
|
|
16
|
|
(8,932
|
)
|
|
(3,984
|
)
|
Deferred revenue
|
|
17
|
|
(10,012
|
)
|
|
(6,912
|
)
|
|
|
|
|
(18,944
|
)
|
|
(10,896
|
)
|
Total liabilities
|
|
|
|
(44,087
|
)
|
|
(41,080
|
)
|
Net assets / (liabilities)
|
|
|
|
9,875
|
|
|
(3,493
|
)
|
EQUITY
|
|
|
|
|
|
|
||
Share capital
|
|
22
|
|
736
|
|
|
618
|
|
Share premium account
|
|
|
|
60,237
|
|
|
46,420
|
|
Share-based payment reserve
|
|
|
|
6,743
|
|
|
5,136
|
|
Merger reserve
|
|
|
|
3,027
|
|
|
(1,943
|
)
|
Special reserve
|
|
|
|
19,993
|
|
|
19,993
|
|
Currency translation reserve
|
|
|
|
37
|
|
|
50
|
|
Accumulated losses reserve
|
|
|
|
(80,898
|
)
|
|
(73,767
|
)
|
Total equity / (deficit)
|
|
|
|
9,875
|
|
|
(3,493
|
)
|
|
|
Note
|
|
Year ended January 31, 2018
|
|
|
Year ended January 31, 2017
|
|
|
Year ended January 31, 2016
|
|
|||
|
|
|
|
£000
|
|
|
£000
|
|
|
£000
|
|
|||
Revenue
|
|
5
|
|
25,419
|
|
|
|
2,304
|
|
|
|
—
|
|
|
Other operating income
|
|
7
|
|
2,725
|
|
|
|
72
|
|
|
|
1,281
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
|
7
|
|
(28,970
|
)
|
|
|
(18,952
|
)
|
|
|
(16,856
|
)
|
|
General and administration
|
|
7
|
|
(11,999
|
)
|
|
|
(8,277
|
)
|
|
|
(4,771
|
)
|
|
Total operating expenses
|
|
|
|
(40,969
|
)
|
|
|
(27,229
|
)
|
|
|
(21,627
|
)
|
|
Operating loss
|
|
|
|
(12,825
|
)
|
|
|
(24,853
|
)
|
|
|
(20,346
|
)
|
|
Finance income
|
|
9
|
|
3,096
|
|
|
|
8
|
|
|
|
30
|
|
|
Finance cost
|
|
9
|
|
(1,164
|
)
|
|
|
(862
|
)
|
|
|
(2,879
|
)
|
|
Loss before income tax
|
|
|
|
(10,893
|
)
|
|
|
(25,707
|
)
|
|
|
(23,195
|
)
|
|
Income tax
|
|
10
|
|
3,762
|
|
|
|
4,336
|
|
|
|
3,058
|
|
|
Loss for the year
|
|
|
|
(7,131
|
)
|
|
|
(21,371
|
)
|
|
|
(20,137
|
)
|
|
Other comprehensive (loss) / income
|
|
|
|
|
|
|
|
|
|
|
|
|||
Items that may be reclassified subsequently to profit or loss
|
|
|
|
|
|
|
|
|
|
|
|
|||
Exchange differences on translating foreign operations
|
|
|
|
(13
|
)
|
|
|
29
|
|
|
|
(41
|
)
|
|
Total comprehensive loss
|
|
|
|
(7,144
|
)
|
|
|
(21,342
|
)
|
|
|
(20,178
|
)
|
|
Basic and diluted earnings per Ordinary Share from operations
|
|
11
|
|
(11
|
)
|
p
|
|
(35
|
)
|
p
|
|
(34
|
)
|
p
|
|
|
Note
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
|
|
£000s
|
|
£000s
|
|
£000s
|
|||
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|||
Loss before income tax
|
|
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(23,195
|
)
|
|
|
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(23,195
|
)
|
Adjusted for:
|
|
|
|
|
|
|
|
|
|||
Other operating income on derecognition of financial liabilities on funding
arrangements
|
|
18
|
|
(908
|
)
|
|
—
|
|
|
—
|
|
Finance income
|
|
9
|
|
(3,096
|
)
|
|
(8
|
)
|
|
(30
|
)
|
Finance cost
|
|
9
|
|
1,164
|
|
|
862
|
|
|
2,879
|
|
Foreign exchange loss / (gain)
|
|
|
|
1,960
|
|
|
711
|
|
|
(169
|
)
|
Depreciation
|
|
14
|
|
140
|
|
|
48
|
|
|
38
|
|
Amortization of intangible fixed assets
|
|
13
|
|
106
|
|
|
10
|
|
|
10
|
|
Loss on disposal of assets
|
|
13,14
|
|
40
|
|
|
—
|
|
|
—
|
|
Movement in provisions
|
|
20
|
|
(60
|
)
|
|
12
|
|
|
28
|
|
Research and development expenditure credit
|
|
7
|
|
(23
|
)
|
|
(3
|
)
|
|
(44
|
)
|
Share-based payment
|
|
6
|
|
1,607
|
|
|
1,379
|
|
|
1,160
|
|
Adjusted loss from operations before changes in working capital
|
|
|
|
(9,963
|
)
|
|
(22,696
|
)
|
|
(19,323
|
)
|
(Increase) / decrease in prepayments and other receivables
|
|
|
|
(8,993
|
)
|
|
492
|
|
|
1,106
|
|
(Decrease) / increase in deferred
revenue
|
|
|
|
(2,482
|
)
|
|
30,527
|
|
|
—
|
|
Increase / (decrease) in trade and other payables
|
|
|
|
3,375
|
|
|
813
|
|
|
(366
|
)
|
Cash (used by) / generated from operations
|
|
|
|
(18,063
|
)
|
|
9,136
|
|
|
(18,583
|
)
|
Taxation received
|
|
|
|
3,374
|
|
|
3,005
|
|
|
1,401
|
|
Net cash (used by) / generated from operating activities
|
|
|
|
(14,689
|
)
|
|
12,141
|
|
|
(17,182
|
)
|
Investing activities
|
|
|
|
|
|
|
|
|
|||
Acquisition of subsidiaries net of cash acquired
|
|
27
|
|
(4,775
|
)
|
|
—
|
|
|
—
|
|
Purchase of property, plant and equipment
|
|
|
|
(360
|
)
|
|
(81
|
)
|
|
(66
|
)
|
Purchase of intangible assets
|
|
|
|
(119
|
)
|
|
(7
|
)
|
|
—
|
|
Interest received
|
|
|
|
12
|
|
|
8
|
|
|
30
|
|
Net cash used in investing activities
|
|
|
|
(5,242
|
)
|
|
(80
|
)
|
|
(36
|
)
|
Financing activities
|
|
|
|
|
|
|
|
|
|||
Proceeds from issue of share capital
|
|
|
|
14,931
|
|
|
—
|
|
|
26,101
|
|
Transaction costs on share capital issued
|
|
|
|
(1,428
|
)
|
|
—
|
|
|
(4,187
|
)
|
Proceeds from exercise of warrants
|
|
|
|
10
|
|
|
107
|
|
|
—
|
|
Proceeds from exercise of share options
|
|
|
|
392
|
|
|
283
|
|
|
222
|
|
Cash received from funding arrangements accounted for as financial liabilities
|
|
18
|
|
—
|
|
|
23
|
|
|
—
|
|
Net cash generated from financing activities
|
|
|
|
13,905
|
|
|
413
|
|
|
22,136
|
|
(Decrease) / increase in cash and cash equivalents
|
|
|
|
(6,026
|
)
|
|
12,474
|
|
|
4,918
|
|
Effect of exchange rates on cash and cash equivalents
|
|
|
|
(1,934
|
)
|
|
(716
|
)
|
|
121
|
|
Cash and cash equivalents at beginning of the year
|
|
|
|
28,062
|
|
|
16,304
|
|
|
11,265
|
|
Cash and cash equivalents at end of the year
|
|
|
|
20,102
|
|
|
28,062
|
|
|
16,304
|
|
|
|
Share
capital
|
|
Share
premium
account
|
|
Share-
based
payment
reserve
|
|
Merger
reserve
|
|
Special
reserve
|
|
Currency
translation
reserve
|
|
Accumulated
losses
reserve
|
|
Total
Equity
|
||||||||
Group
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
||||||||
At February 1, 2017
|
|
618
|
|
|
46,420
|
|
|
5,136
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
50
|
|
|
(73,767
|
)
|
|
(3,493
|
)
|
Loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,131
|
)
|
|
(7,131
|
)
|
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
|
|
|
(13
|
)
|
Total comprehensive loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
(7,131
|
)
|
|
(7,144
|
)
|
New share capital issued
|
|
84
|
|
|
14,847
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,931
|
|
Transaction costs on share capital issued
|
|
—
|
|
|
(1,428
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,428
|
)
|
Issue of ordinary shares as consideration for a business combination
|
|
30
|
|
|
—
|
|
|
—
|
|
|
4,970
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,000
|
|
New share capital issued from exercise of warrants
|
|
1
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10
|
|
Share options exercised
|
|
3
|
|
|
389
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
392
|
|
Share-based payment
|
|
—
|
|
|
—
|
|
|
1,607
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,607
|
|
At January 31, 2018
|
|
736
|
|
|
60,237
|
|
|
6,743
|
|
|
3,027
|
|
|
19,993
|
|
|
37
|
|
|
(80,898
|
)
|
|
9,875
|
|
|
|
Share
capital
|
|
Share
premium
account
|
|
Share-
based
payment
reserve
|
|
Merger
reserve
|
|
Special
reserve
|
|
Currency
translation
reserve
|
|
Accumulated
losses
reserve
|
|
Total
Equity
|
||||||||
Group
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
||||||||
At February 1, 2016
|
|
613
|
|
|
46,035
|
|
|
3,757
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
21
|
|
|
(52,396
|
)
|
|
16,080
|
|
Loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(21,371
|
)
|
|
(21,371
|
)
|
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29
|
|
|
—
|
|
|
29
|
|
Total comprehensive loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29
|
|
|
(21,371
|
)
|
|
(21,342
|
)
|
New share capital issued from exercise of warrants
|
|
2
|
|
|
105
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
107
|
|
Share options exercised
|
|
3
|
|
|
280
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
283
|
|
Share-based payment
|
|
—
|
|
|
—
|
|
|
1,379
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,379
|
|
At January 31, 2017
|
|
618
|
|
|
46,420
|
|
|
5,136
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
50
|
|
|
(73,767
|
)
|
|
(3,493
|
)
|
|
|
Share
capital
|
|
Share
premium
account
|
|
Share-
based
payment
reserve
|
|
Merger
reserve
|
|
Special
reserve
|
|
Currency
translation
reserve
|
|
Accumulated
losses
reserve
|
|
Total
Equity
|
||||||||
Group
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
||||||||
At February 1, 2015
|
|
411
|
|
|
24,101
|
|
|
2,597
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
62
|
|
|
(32,259
|
)
|
|
12,962
|
|
Loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20,137
|
)
|
|
(20,137
|
)
|
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41
|
)
|
|
|
|
|
(41
|
)
|
Total comprehensive loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41
|
)
|
|
(20,137
|
)
|
|
(20,178
|
)
|
New share capital issued
|
|
198
|
|
|
25,903
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,101
|
|
Transaction costs on share capital issued
|
|
—
|
|
|
(4,187
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,187
|
)
|
Share options exercised
|
|
4
|
|
|
218
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
222
|
|
Share-based payment
|
|
—
|
|
|
—
|
|
|
1,160
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,160
|
|
At January 31, 2016
|
|
613
|
|
|
46,035
|
|
|
3,757
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
21
|
|
|
(52,396
|
)
|
|
16,080
|
|
1.
|
Basis of accounting (continued)
|
All patents (once filed)
|
Over the period of the relevant patents (assumed to be 20 years)
|
Option over non-financial assets
|
Over the period of the relevant agreement
|
1.
|
Basis of accounting (continued)
|
Leasehold improvements
|
Over the period of the remaining lease
|
Laboratory equipment
|
3-10 years
|
Office and IT equipment
|
3-5 years
|
1.
|
Basis of accounting (continued)
|
•
|
the initial recognition of goodwill;
|
•
|
the initial recognition of an asset or liability in a transaction which is not a business combination and at the time of the transaction affects neither accounting or taxable profit; and
|
•
|
investments in subsidiaries and jointly controlled entities where the Group is able to control the timing of the reversal of the difference, and it is probable that the difference will not reverse in the foreseeable future.
|
International Accounting Standards (IAS/IFRS)
|
|
Effective Date
|
Amendments resulting from Annual Improvements 2014–2016 Cycle (clarifying scope)
|
|
January 1, 2017
|
Amendment to IAS 7, Disclosure Initiative
|
|
January 1, 2017
|
Amendment to IAS 12, Recognition of Deferred Tax Assets for Unrealised Losses
|
|
January 1, 2017
|
International Accounting Standards (IAS/IFRS)
|
|
Effective Date
|
IFRS 9, Financial Instruments (as revised in 2014)
|
|
January 1, 2018
|
IFRS 15, Revenue from Contracts with Customers
|
|
January 1, 2018
|
Amendment to IFRS 2 Share Based Payments, Classification and Measurement of Share-based Payment Transactions
|
|
January 1, 2018
|
Amendments resulting from Annual Improvements 2014–2016 Cycle
|
|
January 1, 2018
|
IFRIC 22 Foreign Currency Transactions and Advance Consideration
|
|
January 1, 2018
|
IFRS 16, Leases
|
|
January 1, 2019
|
Amendments to IFRS 3 Business Combinations, Remeasurement of previously held interest
|
|
January 1, 2019
|
Amendments to IAS 12 Income Taxes, Income tax consequences of dividends
|
|
January 1, 2019
|
Amendments to IAS 19 Employee Benefits, Plan amendments, curtailments or settlements
|
|
January 1, 2019
|
Amendments to IAS 23 Borrowing Costs, Borrowing costs eligible for capitalisation
|
|
January 1, 2019
|
Amendments resulting from Annual Improvements 2015–2017 Cycle
|
|
January 1, 2019
|
IFRIC 23 Uncertainty over Income Tax Treatments
|
|
January 1, 2019
|
Amendment to IFRS 10 and IAS 28, Sale or Contribution of Assets between an Investor and its Associate or Joint Venture
|
|
To be determined
|
|
Year ended January 31, 2018
|
|
|
£000
|
|
Estimated decrease in revenue by category:
|
|
|
Licensing agreements
|
13,059
|
|
Research collaboration agreement
|
—
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Analysis of revenue by category:
|
|
|
|
|
|
|
|||
Licensing agreements
|
|
25,109
|
|
|
2,304
|
|
|
—
|
|
Research collaboration agreement
|
|
310
|
|
|
—
|
|
|
—
|
|
|
|
25,419
|
|
|
2,304
|
|
|
—
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Analysis of revenue by geography:
|
|
|
|
|
|
|
|||
United States
|
|
25,067
|
|
|
2,304
|
|
|
—
|
|
Latin America
|
|
42
|
|
|
—
|
|
|
—
|
|
Europe
|
|
310
|
|
|
—
|
|
|
—
|
|
|
|
25,419
|
|
|
2,304
|
|
|
—
|
|
|
|
January 31, 2018
|
|
January 31, 2017
|
|
January 31, 2016
|
|||
Technical, research and development
|
|
34
|
|
|
23
|
|
|
19
|
|
Corporate and administration
|
|
26
|
|
|
21
|
|
|
18
|
|
|
|
60
|
|
|
44
|
|
|
37
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Wages and salaries
|
|
7,493
|
|
|
5,932
|
|
|
3,876
|
|
Social security costs
|
|
643
|
|
|
434
|
|
|
247
|
|
Other pension costs
|
|
350
|
|
|
332
|
|
|
90
|
|
Share-based payment
|
|
1,607
|
|
|
1,379
|
|
|
1,160
|
|
|
|
10,093
|
|
|
8,077
|
|
|
5,373
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Short-term employee benefits
|
|
|
|
|
|
|
|||
Wages and salaries
|
|
1,520
|
|
|
1,252
|
|
|
934
|
|
Social security costs
|
|
162
|
|
|
98
|
|
|
58
|
|
|
|
1,682
|
|
|
1,350
|
|
|
992
|
|
Post-employment benefits
|
|
|
|
|
|
|
|||
Amounts paid in lieu of employer pension contributions
|
|
32
|
|
|
17
|
|
|
17
|
|
Other pension costs
|
|
14
|
|
|
11
|
|
|
—
|
|
|
|
46
|
|
|
28
|
|
|
17
|
|
Share-based payment
|
|
705
|
|
|
327
|
|
|
626
|
|
Total remuneration
|
|
2,433
|
|
|
1,705
|
|
|
1,635
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Other operating income
|
|
|
|
|
|
|
|||
Income recognized in respect of BARDA
|
|
1,772
|
|
|
—
|
|
|
—
|
|
Income on derecognition of the Wellcome Trust financial liability
|
|
908
|
|
|
—
|
|
|
—
|
|
Income recognized in respect of the Wellcome Trust
|
|
—
|
|
|
13
|
|
|
592
|
|
Grant income
|
|
13
|
|
|
56
|
|
|
645
|
|
Research and development credit
|
|
23
|
|
|
3
|
|
|
44
|
|
Other income
|
|
9
|
|
|
—
|
|
|
—
|
|
|
|
2,725
|
|
|
72
|
|
|
1,281
|
|
Research and development
|
|
|
|
|
|
|
|||
Employee benefit expense
|
|
5,616
|
|
|
4,218
|
|
|
2,848
|
|
Share-based payment expense
|
|
327
|
|
|
374
|
|
|
356
|
|
Program related costs
|
|
21,810
|
|
|
13,605
|
|
|
13,093
|
|
Amortization of intangible assets
|
|
105
|
|
|
10
|
|
|
10
|
|
Other research and development costs
|
|
1,112
|
|
|
745
|
|
|
549
|
|
|
|
28,970
|
|
|
18,952
|
|
|
16,856
|
|
General and administration
|
|
|
|
|
|
|
|||
Employee benefit expense
|
|
2,870
|
|
|
2,480
|
|
|
1,365
|
|
Share-based payment expense
|
|
1,280
|
|
|
1,005
|
|
|
804
|
|
Foreign exchange loss
|
|
1,986
|
|
|
533
|
|
|
(501
|
)
|
Depreciation of property, plant and equipment
|
|
141
|
|
|
48
|
|
|
38
|
|
Loss on disposal of assets
|
|
42
|
|
|
—
|
|
|
—
|
|
Operating lease rentals
|
|
289
|
|
|
213
|
|
|
131
|
|
Other general and administration costs
|
|
5,322
|
|
|
3,998
|
|
|
2,934
|
|
Royalty expense
|
|
69
|
|
|
—
|
|
|
—
|
|
|
|
11,999
|
|
|
8,277
|
|
|
4,771
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Fees payable to the auditors and its associates for the audit of the Company and Consolidated Financial Statements
|
|
132
|
|
|
110
|
|
|
44
|
|
Fees payable to the auditors and its associates for other services:
|
|
|
|
|
|
|
|||
- Audit of the Company’s subsidiaries
(2)
|
|
209
|
|
|
120
|
|
|
71
|
|
- Audit-related assurance services
|
|
—
|
|
|
3
|
|
|
6
|
|
- Other assurance services
(1)
|
|
118
|
|
|
163
|
|
|
158
|
|
- Tax advisory services
|
|
2
|
|
|
15
|
|
|
9
|
|
- Tax compliance services
|
|
21
|
|
|
47
|
|
|
11
|
|
Total fees payable
|
|
482
|
|
|
458
|
|
|
299
|
|
(1)
|
For the year ended January 31, 2018, other assurance services includes assurance reporting on information included in information used for the Company's underwritten public offering completed on 18 September 2017. These amounts were recognized directly in share premium. For the year ended January 31, 2017, other assurance services includes assurance reporting on information included in the Company’s registration statement on Form F-3 that was originally filed with the U.S. Securities and Exchange Commission on May 12, 2016.
|
(2)
|
For the year ended January 31, 2018,
fees payable for the Consolidated Financial Statements and fees payable for the Company's subsidiaries includes audit services relating to the initial audit and business combination accounting for Discuva Limited. These amounts will be non recurring fees.
|
|
Note
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
|
£000
|
|
£000
|
|
£000
|
|||
Finance income
|
|
|
|
|
|
|
|
|||
Derecognition of financial liabilities
|
18
|
|
3,085
|
|
|
—
|
|
|
—
|
|
Interest income on deposits
|
|
|
11
|
|
|
8
|
|
|
30
|
|
Finance income
|
|
|
3,096
|
|
|
8
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|||
Finance costs
|
|
|
|
|
|
|
|
|||
Unwinding of discount factor
|
18
|
|
(754
|
)
|
|
(862
|
)
|
|
(268
|
)
|
Re-measurement of financial liabilities on funding arrangements
|
18
|
|
(410
|
)
|
|
—
|
|
|
(2,611
|
)
|
Finance costs
|
|
|
(1,164
|
)
|
|
(862
|
)
|
|
(2,879
|
)
|
|
|
|
|
|
|
|
|
|||
Net finance income / (costs)
|
|
|
1,932
|
|
|
(854
|
)
|
|
(2,849
|
)
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Analysis of credit in the period
|
|
|
|
|
|
|
|||
Current tax
:
|
|
|
|
|
|
|
|||
Current tax income
|
|
3,767
|
|
|
4,245
|
|
|
2,971
|
|
Adjustments in respect of prior years
|
|
(5
|
)
|
|
(9
|
)
|
|
87
|
|
Total current tax
|
|
3,762
|
|
|
4,236
|
|
|
3,058
|
|
Total deferred tax
|
|
—
|
|
|
100
|
|
|
—
|
|
Total tax
|
|
3,762
|
|
|
4,336
|
|
|
3,058
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Loss before tax
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(23,195
|
)
|
Loss multiplied by the standard rate of corporation tax in the United Kingdom (Current tax) 19.17% (2017: 20%)
|
|
(2,088
|
)
|
|
(5,141
|
)
|
|
(4,678
|
)
|
Change in unrecognized tax losses
|
|
751
|
|
|
2,169
|
|
|
2,691
|
|
Non-deductible expenses
|
|
402
|
|
|
331
|
|
|
184
|
|
Tax relief for qualifying research and development expenditure
|
|
(3,043
|
)
|
|
(1,699
|
)
|
|
(1,170
|
)
|
Prior year adjustments
|
|
5
|
|
|
9
|
|
|
(87
|
)
|
Share options exercised
|
|
(40
|
)
|
|
(84
|
)
|
|
(45
|
)
|
Overseas profits taxed at different rates
|
|
251
|
|
|
179
|
|
|
47
|
|
Change in rate of deferred tax
|
|
—
|
|
|
(100
|
)
|
|
—
|
|
Total tax
|
|
(3,762
|
)
|
|
(4,336
|
)
|
|
(3,058
|
)
|
|
Discuva Limited £000
|
|
MuOx Limited
£000
|
|
Total
£000
|
|||
Cost
|
|
|
|
|
|
|||
At February 1, 2017
|
—
|
|
|
664
|
|
|
664
|
|
Additions
|
1,814
|
|
|
—
|
|
|
1,814
|
|
At January 31, 2018
|
1,814
|
|
|
664
|
|
|
2,478
|
|
Accumulated impairment
|
|
|
|
|
|
|||
At February 1, 2017
|
—
|
|
|
—
|
|
|
—
|
|
At January 31, 2018
|
—
|
|
|
—
|
|
|
—
|
|
Net book amount
|
|
|
|
|
|
|||
At February 1, 2017
|
—
|
|
|
664
|
|
|
664
|
|
At January 31, 2018
|
1,814
|
|
|
664
|
|
|
2,478
|
|
|
Discuva Limited £000
|
|
MuOx Limited
£000
|
|
Total
£000
|
|||
Cost
|
|
|
|
|
|
|||
At February 1, 2016
|
—
|
|
|
664
|
|
|
664
|
|
At January 31, 2017
|
—
|
|
|
664
|
|
|
664
|
|
Accumulated impairment
|
|
|
|
|
|
|||
At February 1, 2016
|
—
|
|
|
—
|
|
|
—
|
|
At January 31, 2017
|
—
|
|
|
—
|
|
|
—
|
|
Net book amount
|
|
|
|
|
|
|||
At February 1, 2016
|
—
|
|
|
664
|
|
|
664
|
|
At January 31, 2017
|
—
|
|
|
664
|
|
|
664
|
|
|
Iminosugar
related programs acquired £000 |
|
Utrophin
program acquired £000 |
|
Bacterial genetics-based platform acquired
£000 |
|
Option over non-financial assets
£000 |
|
Other
patents and licenses £000 |
|
Total
£000 |
|||||||
Cost
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2017
|
1,380
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
204
|
|
|
4,905
|
|
|
Acquisition of subsidiary (Note 27)
|
—
|
|
|
—
|
|
|
10,670
|
|
|
668
|
|
|
—
|
|
|
11,338
|
|
|
Additions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
119
|
|
|
119
|
|
|
Disposals
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(58
|
)
|
|
(1,438
|
)
|
|
At January 31, 2018
|
—
|
|
|
3,321
|
|
|
10,670
|
|
|
668
|
|
|
265
|
|
—
|
|
14,924
|
|
Accumulated amortization
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2017
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(55
|
)
|
—
|
|
(1,435
|
)
|
Charge for the year
|
—
|
|
|
—
|
|
|
(79
|
)
|
|
(4
|
)
|
|
(23
|
)
|
|
(106
|
)
|
|
Disposals
|
1,380
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
1,402
|
|
|
At January 31, 2018
|
—
|
|
|
—
|
|
|
(79
|
)
|
|
(4
|
)
|
|
(56
|
)
|
—
|
|
(139
|
)
|
Net book amount
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2017
|
—
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
149
|
|
|
3,470
|
|
|
At January 31, 2018
|
—
|
|
|
3,321
|
|
|
10,591
|
|
|
664
|
|
|
209
|
|
|
14,785
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
Iminosugar
related programs acquired £000 |
|
Utrophin
program acquired £000 |
|
Bacterial genetics-based platform acquired
£000 |
|
Option over non-financial assets
£000 |
|
Other
patents and licenses £000 |
|
Total
£000 |
|||||||
Cost
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2016
|
1,380
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
197
|
|
|
4,898
|
|
|
Additions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7
|
|
|
7
|
|
|
At January 31, 2017
|
1,380
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
204
|
|
|
4,905
|
|
|
Accumulated amortization
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2016
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(45
|
)
|
|
(1,425
|
)
|
|
Charge for the year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
(10
|
)
|
|
At January 31, 2017
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(55
|
)
|
|
(1,435
|
)
|
|
Net book amount
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2016
|
—
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
3,473
|
|
|
At January 31, 2017
|
—
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
149
|
|
|
3,470
|
|
•
|
expected research and development costs based on management’s past experience and knowledge;
|
•
|
probabilities of achieving development milestones based on industry standards;
|
•
|
reported disease prevalence;
|
•
|
expected discovery pipeline;
|
•
|
expected market share based on management’s estimates;
|
•
|
drug reimbursement, costs of goods and marketing estimates; and
|
•
|
expected patent life.
|
Cost
|
Leasehold
improvements
£000
|
|
Laboratory
equipment
£000
|
|
Office and IT
equipment
£000
|
|
Total
£000
|
||||
At February 1, 2017
|
9
|
|
|
19
|
|
|
284
|
|
|
312
|
|
Acquisition of subsidiary (Note 27)
|
—
|
|
|
280
|
|
|
49
|
|
|
329
|
|
Additions
|
340
|
|
|
—
|
|
|
173
|
|
|
513
|
|
Disposals
|
(9
|
)
|
|
|
|
|
(14
|
)
|
|
(23
|
)
|
Revaluation
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
(6
|
)
|
At January 31, 2018
|
340
|
|
|
299
|
|
|
486
|
|
|
1,125
|
|
Accumulated depreciation
|
|
|
|
|
|
|
|
||||
At February 1, 2017
|
(9
|
)
|
|
(17
|
)
|
|
(170
|
)
|
|
(196
|
)
|
Charge for the year
|
(31
|
)
|
|
(19
|
)
|
|
(90
|
)
|
|
(140
|
)
|
Disposals
|
9
|
|
|
—
|
|
|
10
|
|
|
19
|
|
Revaluation
|
—
|
|
|
—
|
|
|
1
|
|
|
1
|
|
At January 31, 2018
|
(31
|
)
|
|
(36
|
)
|
|
(249
|
)
|
|
(316
|
)
|
Net book value
|
|
|
|
|
|
|
|
||||
At February 1, 2017
|
—
|
|
|
2
|
|
|
114
|
|
|
116
|
|
At January 31, 2018
|
309
|
|
|
263
|
|
|
237
|
|
|
809
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
||||
Cost
|
Leasehold
improvements
£000
|
|
Laboratory
equipment
£000
|
|
Office and IT
equipment
£000
|
|
Total
£000
|
||||
At February 1, 2016
|
9
|
|
|
137
|
|
|
228
|
|
|
374
|
|
Additions
|
—
|
|
|
—
|
|
|
81
|
|
|
81
|
|
Disposals
|
—
|
|
|
(118
|
)
|
|
(25
|
)
|
|
(143
|
)
|
At January 31, 2017
|
9
|
|
|
19
|
|
|
284
|
|
|
312
|
|
Accumulated depreciation
|
|
|
|
|
|
|
|
||||
At February 1, 2016
|
(7
|
)
|
|
(135
|
)
|
|
(149
|
)
|
|
(291
|
)
|
Charge for the year
|
(2
|
)
|
|
—
|
|
|
(46
|
)
|
|
(48
|
)
|
Disposals
|
—
|
|
|
118
|
|
|
25
|
|
|
143
|
|
At January 31, 2017
|
(9
|
)
|
|
(17
|
)
|
|
(170
|
)
|
|
(196
|
)
|
Net book value
|
|
|
|
|
|
|
|
||||
At February 1, 2016
|
2
|
|
|
2
|
|
|
79
|
|
|
83
|
|
At January 31, 2017
|
—
|
|
|
2
|
|
|
114
|
|
|
116
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Other receivables
|
3,600
|
|
|
342
|
|
Prepayments
|
6,498
|
|
|
685
|
|
Accrued income
|
1,036
|
|
|
—
|
|
|
11,134
|
|
|
1,027
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Trade payables
|
4,414
|
|
|
906
|
|
Other taxes and social security
|
164
|
|
|
94
|
|
Accruals
|
4,078
|
|
|
2,884
|
|
Other creditors
|
276
|
|
|
100
|
|
|
8,932
|
|
|
3,984
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Due within one year
|
10,012
|
|
|
6,912
|
|
Due more than one year
|
18,033
|
|
|
23,615
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
At February 1
|
5,919
|
|
|
5,034
|
|
Unwinding of discount factor
|
754
|
|
|
862
|
|
Derecognition of financial liabilities – Finance income
|
(3,085
|
)
|
|
—
|
|
Re-measurement of financial liabilities on funding arrangements
|
410
|
|
|
—
|
|
Net finance income / (costs) on funding arrangements accounting for as financial liabilities
|
(1,921
|
)
|
|
862
|
|
Derecognition of financial liabilities – Other operating income
|
(908
|
)
|
|
—
|
|
Cash received from funding arrangements accounted for as financial liabilities
|
—
|
|
|
23
|
|
At January 31
|
3,090
|
|
|
5,919
|
|
|
January 31, 2018
|
|
|
£000
|
|
Estimated financial liabilities on funding arrangements
|
3,090
|
|
1% lower discount rate
|
3,354
|
|
1% higher discount rate
|
2,850
|
|
10% lower revenue assumptions
|
2,818
|
|
10% higher revenue assumptions
|
3,362
|
|
10% lower probability of success
|
1,005
|
|
10% higher probability of success
|
5,123
|
|
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
Note
|
|
£000
|
|
£000
|
||
Loans and receivables
|
|
|
|
|
|
||
Other receivables
(1)
|
15
|
|
3,600
|
|
|
342
|
|
Cash and cash equivalents
|
|
|
20,102
|
|
|
28,062
|
|
|
|
|
23,702
|
|
|
28,404
|
|
Financial liabilities measured at amortized cost
|
|
|
|
|
|
||
Trade and other payables
|
16
|
|
8,932
|
|
|
3,984
|
|
Financial liabilities on funding arrangements
|
18
|
|
3,090
|
|
|
5,919
|
|
|
|
|
12,022
|
|
|
9,903
|
|
(1)
|
Prepayments and accrued income have been excluded as they are not considered to be a financial instrument.
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Cash at bank and in hand
|
|
|
|
||
Pounds Sterling
|
5,535
|
|
|
8,969
|
|
US Dollar
|
14,567
|
|
|
19,093
|
|
|
20,102
|
|
|
28,062
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
On current account
|
20,102
|
|
|
28,062
|
|
|
20,102
|
|
|
28,062
|
|
Year ended January 31, 2018
|
(1)%
|
|
Actual
|
|
1%
|
|||
Interest rate
|
—
|
|
|
0.02
|
|
|
1.02
|
|
Interest received (£000)
|
—
|
|
|
5
|
|
|
246
|
|
Year ended January 31, 2017
|
(1)%
|
|
Actual
|
|
1%
|
|||
Interest rate
|
—
|
|
|
0.04
|
|
|
1.04
|
|
Interest received (£000)
|
—
|
|
|
8
|
|
|
230
|
|
|
Assumed contingent liabilities £000s
|
|
Dilapidations £000s
|
|
Royalties £000s
|
|
Total
£000s |
||||
At February 1, 2017
|
—
|
|
|
85
|
|
|
—
|
|
|
85
|
|
Additions
|
1,466
|
|
|
150
|
|
|
25
|
|
|
1,641
|
|
Used during the year
|
—
|
|
|
(85
|
)
|
|
—
|
|
|
(85
|
)
|
At January 31, 2018
|
1,466
|
|
|
150
|
|
|
25
|
|
|
1,641
|
|
|
Assumed contingent liabilities £000s
|
|
Dilapidations £000s
|
|
Royalties £000s
|
|
Total
£000s |
||||
At February 1, 2016
|
—
|
|
|
73
|
|
|
—
|
|
|
73
|
|
Additions
|
—
|
|
|
12
|
|
|
—
|
|
|
12
|
|
Used during the year
|
—
|
|
|
|
|
|
—
|
|
|
—
|
|
At January 31, 2017
|
—
|
|
|
85
|
|
|
—
|
|
|
85
|
|
|
January 31, 2018
|
|
|
£000
|
|
Estimated assumed contingent liabilities
|
1,466
|
|
1% lower discount rate
|
1,579
|
|
1% higher discount rate
|
1,368
|
|
10% lower probability of success
|
1,208
|
|
10% higher probability of success
|
1,705
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Amounts falling due after more than one year
|
|
|
|
||
At February 1
|
565
|
|
|
664
|
|
Acquisition of subsidiary (Note 27)
|
1,814
|
|
|
—
|
|
Credited to the income statement
|
—
|
|
|
(99
|
)
|
At January 31
|
2,379
|
|
|
565
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Allotted, called up and fully paid
|
|
|
|
||
73,563,624 (2017: 61,841,566) Ordinary shares of 1p each
|
736
|
|
|
618
|
|
|
736
|
|
|
618
|
|
|
Number of Shares
|
|
Total Nominal Value £000
|
|
Total Share Premium £000
|
|
Total Consideration £000
|
|||
At February 1, 2016
|
61,290,740
|
|
613
|
|
|
46,035
|
|
|
46,648
|
|
New share capital issued from exercise of warrants
|
177,045
|
|
2
|
|
|
105
|
|
|
107
|
|
Share options exercised
|
373,781
|
|
3
|
|
|
280
|
|
|
283
|
|
At January 31, 2017
|
61,841,566
|
|
618
|
|
|
46,420
|
|
|
47,038
|
|
|
|
|
|
|
|
|
|
|||
At February 1, 2017
|
61,841,566
|
|
618
|
|
|
46,420
|
|
|
47,038
|
|
New share capital issued (net of transaction costs)
|
8,389,250
|
|
84
|
|
|
13,419
|
|
|
13,503
|
|
Issue of Ordinary Shares as consideration for a business combination
(1)
|
2,934,272
|
|
30
|
|
|
—
|
|
|
30
|
|
New share capital issued from exercise of warrants
|
50,000
|
|
1
|
|
|
9
|
|
|
10
|
|
Share options exercised
|
348,536
|
|
3
|
|
|
389
|
|
|
392
|
|
At January 31, 2018
|
73,563,624
|
|
736
|
|
|
60,237
|
|
|
60,973
|
|
(1)
|
The difference between the nominal value of the share capital acquired in Discuva Limited and fair value of shares issued in the business combination using the acquisition method of accounting was
recognized as part of the Group's merger reserve arising as a result of certain requirements in the United Kingdom.
|
Date
|
Number of
options exercised
|
|
April 10, 2017
|
16,667
|
|
June 27, 2017
|
19,425
|
|
September 28, 2017
|
32,500
|
|
September 29, 2017
|
94,425
|
|
October 2, 2017
|
97,199
|
|
October 4, 2017
|
88,320
|
|
|
348,536
|
|
Date of grant
|
|
Exercise
price (£)
|
|
Number of
shares
|
|
Date from which
exercisable
|
|
Expiry date
|
||
Approved EMI scheme
|
|
|
|
|
|
|
|
|
||
April 7, 2011
|
|
0.65
|
|
|
5,873
|
|
|
April 8, 2014
|
|
April 7, 2021
|
May 10, 2012
|
|
0.60
|
|
|
150,046
|
|
|
May 10, 2014
|
|
May 10, 2022
|
December 24, 2012
|
|
0.85
|
|
|
21,500
|
|
|
December 24, 2015
|
|
December 24, 2022
|
January 31, 2013
|
|
0.20
|
|
|
72,973
|
|
|
July 31, 2013
|
|
January 31, 2023
|
July 15, 2014
|
|
1.26
|
|
|
249,621
|
|
|
July 15, 2016
|
|
July 15, 2024
|
January 21, 2015
|
|
1.23
|
|
|
25,000
|
|
|
January 21, 2017
|
|
January 21, 2025
|
June 23, 2016
|
|
1.05
|
|
|
560,343
|
|
|
June 23, 2017
|
|
June 23, 2026
|
|
|
|
|
1,085,356
|
|
|
|
|
|
Date of grant
|
|
Exercise
price (£)
|
|
Number of
shares
|
|
Date from which
exercisable
|
|
Expiry date
|
||
Unapproved scheme
|
|
|
|
|
|
|
|
|
||
April 7, 2011
|
|
0.65
|
|
|
13,981
|
|
|
April 8, 2014
|
|
April 8, 2021
|
December 18, 2013
|
|
0.20
|
|
|
76,364
|
|
|
June 19, 2013
|
|
June 19, 2023
|
June 23, 2014
|
|
1.48
|
|
|
400,000
|
|
|
June 23, 2015
|
|
June 23, 2024
|
July 15, 2014
|
|
1.26
|
|
|
847,500
|
|
|
July 15, 2016
|
|
July 15, 2024
|
July 15, 2014
|
|
0.80
|
|
|
100,000
|
|
|
May 30, 2015
|
|
May 30, 2023
|
January 21, 2015
|
|
1.23
|
|
|
75,000
|
|
|
January 21, 2017
|
|
January 21, 2025
|
June 16, 2015
|
|
1.43
|
|
|
2,252,333
|
|
|
June 16, 2017
|
|
June 16, 2025
|
October 15, 2015
|
|
1.31
|
|
|
50,000
|
|
|
October 15, 2017
|
|
October 15, 2025
|
June 23, 2016
|
|
0.01
|
|
|
110,576
|
|
|
July 21, 2016
|
|
June 23, 2026
|
June 23, 2016
|
|
1.05
|
|
|
250,000
|
|
|
June 23, 2019
|
|
June 23, 2026
|
June 23, 2016
|
|
1.05
|
|
|
363,092
|
|
|
June 23, 2017
|
|
June 23, 2026
|
April 11, 2017
|
|
1.85
|
|
|
150,436
|
|
|
April 11, 2018
|
|
April 11, 2027
|
April 11, 2017
|
|
1.85
|
|
|
324,324
|
|
|
April 11, 2020
|
|
April 11, 2027
|
April 11, 2017
|
|
1.85
|
|
|
762,764
|
|
|
June 23, 2019
|
|
April 11, 2027
|
June 27, 2017
|
|
1.80
|
|
|
34,711
|
|
|
June 27, 2017
|
|
June 27, 2027
|
July 18, 2017
|
|
1.83
|
|
|
533,629
|
|
|
June 18, 2018
|
|
June 18, 2027
|
July 18, 2017
|
|
1.83
|
|
|
367,924
|
|
|
July 18, 2020
|
|
July 18, 2027
|
October 24, 2017
|
|
1.80
|
|
|
481,975
|
|
|
October 24, 2018
|
|
October 24, 2027
|
October 24, 2017
|
|
1.80
|
|
|
297,271
|
|
|
October 24, 2020
|
|
October 24, 2027
|
|
|
|
|
7,491,880
|
|
|
|
|
|
|
|
|
|
|
8,577,236
|
|
|
|
|
|
|
Weighted
average
exercise price
£
|
|
Year ended January 31, 2018
|
|
Weighted
average
exercise price
£
|
|
Year ended January 31, 2017
|
||||
Outstanding at February 1,
|
1.17
|
|
|
7,383,401
|
|
|
1.29
|
|
|
7,006,306
|
|
Granted during the year
|
1.83
|
|
|
2,972,903
|
|
|
0.98
|
|
|
1,667,576
|
|
Lapsed during the year
|
0.99
|
|
|
(1,430,532
|
)
|
|
1.90
|
|
|
(916,700
|
)
|
Exercised during the year
|
1.13
|
|
|
(348,536
|
)
|
|
0.76
|
|
|
(373,781
|
)
|
Number of outstanding options at January 31,
|
1.43
|
|
|
8,577,236
|
|
|
1.17
|
|
|
7,383,401
|
|
Date of grant
|
|
Type of
award
|
|
Number of
shares
|
|
Exercise
price (£)
|
|
Share price
at grant
date (£)
|
|
Fair value
per option
(£)
|
|
Award
life
(years)
|
|
Risk free
rate
|
|||||
April 07, 2011
|
|
EMI
|
|
5,873
|
|
|
0.65
|
|
|
0.65
|
|
|
0.47
|
|
|
5.00
|
|
2.70
|
%
|
April 07, 2011
|
|
Unapproved
|
|
13,981
|
|
|
0.65
|
|
|
0.65
|
|
|
0.47
|
|
|
5.00
|
|
2.70
|
%
|
May 10, 2012
|
|
EMI
|
|
150,046
|
|
|
0.60
|
|
|
0.52
|
|
|
0.24
|
|
|
5.00
|
|
1.00
|
%
|
December 24, 2012
|
|
EMI
|
|
21,500
|
|
|
0.85
|
|
|
0.85
|
|
|
0.59
|
|
|
5.00
|
|
0.90
|
%
|
January 31, 2013
|
|
EMI
|
|
72,973
|
|
|
0.20
|
|
|
0.94
|
|
|
0.74
|
|
|
5.00
|
|
1.00
|
%
|
December 18, 2013
|
|
Unapproved
|
|
76,364
|
|
|
0.20
|
|
|
1.85
|
|
|
1.65
|
|
|
5.00
|
|
1.00
|
%
|
June 23, 2014
|
|
Unapproved
|
|
400,000
|
|
|
1.48
|
|
|
1.50
|
|
|
0.92
|
|
|
3.80
|
|
1.30
|
%
|
July 15, 2014
|
|
EMI
|
|
249,621
|
|
|
1.26
|
|
|
1.26
|
|
|
0.65
|
|
|
3.00
|
|
1.30
|
%
|
July 15, 2014
|
|
Unapproved
|
|
847,500
|
|
|
1.26
|
|
|
1.26
|
|
|
0.65
|
|
|
3.00
|
|
1.30
|
%
|
July 15, 2014
|
|
Unapproved
|
|
100,000
|
|
|
0.80
|
|
|
0.81
|
|
|
0.65
|
|
|
1.90
|
|
0.50
|
%
|
January 21, 2015
|
|
EMI
|
|
25,000
|
|
|
1.23
|
|
|
1.22
|
|
|
0.64
|
|
|
3.00
|
|
0.60
|
%
|
January 21, 2015
|
|
Unapproved
|
|
75,000
|
|
|
1.23
|
|
|
1.22
|
|
|
0.64
|
|
|
3.00
|
|
0.60
|
%
|
June 15, 2015
|
|
Unapproved
|
|
2,252,333
|
|
|
1.43
|
|
|
1.44
|
|
|
0.65
|
|
|
3.00
|
|
0.91
|
%
|
October 15, 2015
|
|
Unapproved
|
|
50,000
|
|
|
1.31
|
|
|
1.36
|
|
|
0.57
|
|
|
3.00
|
|
0.70
|
%
|
June 23, 2016
|
|
EMI
|
|
560,343
|
|
|
1.05
|
|
|
1.05
|
|
|
0.25
|
|
|
3.00
|
|
0.30
|
%
|
June 23, 2016
|
|
Unapproved
|
|
110,576
|
|
|
0.01
|
|
|
1.05
|
|
|
1.04
|
|
|
0.50
|
|
0.30
|
%
|
June 23, 2016
|
|
Unapproved
|
|
250,000
|
|
|
1.05
|
|
|
1.05
|
|
|
0.24
|
|
|
3.00
|
|
0.30
|
%
|
June 23, 2016
|
|
Unapproved
|
|
363,092
|
|
|
1.05
|
|
|
1.05
|
|
|
0.25
|
|
|
3.00
|
|
0.30
|
%
|
April 11, 2017
|
|
Unapproved
|
|
150,436
|
|
|
1.85
|
|
|
1.85
|
|
|
0.68
|
|
|
3.00
|
|
0.07
|
%
|
April 11, 2017
|
|
Unapproved
|
|
324,324
|
|
|
1.85
|
|
|
1.85
|
|
|
0.72
|
|
|
3.00
|
|
0.13
|
%
|
April 11, 2017
|
|
Unapproved
|
|
762,764
|
|
|
1.85
|
|
|
1.85
|
|
|
0.76
|
|
|
2.20
|
|
0.07
|
%
|
June 27, 2017
|
|
Unapproved
|
|
34,711
|
|
|
1.80
|
|
|
1.78
|
|
|
0.64
|
|
|
3.00
|
|
0.23
|
%
|
July 18, 2017
|
|
Unapproved
|
|
533,629
|
|
|
1.83
|
|
|
1.83
|
|
|
0.66
|
|
|
3.00
|
|
0.26
|
%
|
July 18, 2017
|
|
Unapproved
|
|
367,924
|
|
|
1.83
|
|
|
1.83
|
|
|
0.74
|
|
|
3.00
|
|
0.31
|
%
|
October 24, 2017
|
|
Unapproved
|
|
481,975
|
|
|
1.80
|
|
|
1.70
|
|
|
0.57
|
|
|
3.00
|
|
0.46
|
%
|
October 24, 2017
|
|
Unapproved
|
|
297,271
|
|
|
1.80
|
|
|
1.70
|
|
|
0.66
|
|
|
3.00
|
|
0.55
|
%
|
|
|
|
|
8,577,236
|
|
|
|
|
|
|
|
|
|
|
|
a.
|
Black-Scholes valuation methodology was used for all share options issued since 2016.
|
b.
|
The majority of share option awards made before 2016 are performance related and have been modeled using the Monte-Carlo methodology. The options granted on
January 31, 2013 and December 18, 2013 at an exercise price of
20
pence respectively, and
16,667
of the unapproved options granted on June 23, 2014 are not performance related.
|
c.
|
Figures in the range of
39%
-
134%
have been used for expected volatility. This has been derived from historic share price performance, weighted to exclude periods of unusually high volatility.
|
d.
|
Expected dividend yield is nil, consistent with the Directors’ view that the Group’s business model is to generate value through capital growth rather than the payment of dividends.
|
e.
|
The risk free rate is equal to the prevailing UK Gilts rate at grant date that most closely matches the expected term of the grant.
|
f.
|
Share options are assumed to be exercised immediately on vesting.
|
g.
|
The fair value of share options awarded where there are different vesting installments is the average of the fair values calculated per installment.
|
Date of grant
|
Exercise
price (£)
|
|
Number of
shares
|
|
Date from which
exercisable
|
|
Expiry date
|
||
July 18, 2017
|
0.01
|
|
|
136,991
|
|
|
July 18, 2018
|
|
December 31, 2018
|
October 24, 2017
|
0.01
|
|
|
138,886
|
|
|
October 24, 2018
|
|
December 31, 2018
|
|
|
|
275,877
|
|
|
|
|
|
|
Weighted
average exercise price £ |
|
Year ended January 31, 2018
|
|
Weighted
average exercise price £ |
|
Year ended January 31, 2017
|
||||
Outstanding at February 1,
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Granted during the year
|
0.01
|
|
|
275,877
|
|
|
—
|
|
|
—
|
|
Number of outstanding RSUs at January 31,
|
0.01
|
|
|
275,877
|
|
|
—
|
|
|
—
|
|
Date of grant
|
|
Number of
shares
|
|
Exercise
price (£)
|
|
Share price
at grant
date (£)
|
|
Fair value
per option
(£)
|
|
Award
life
(years)
|
|
Risk free
rate
|
|||||
July 18, 2017
|
|
136,991
|
|
|
0.01
|
|
|
1.83
|
|
|
1.82
|
|
|
1.00
|
|
0.24
|
%
|
October 24, 2017
|
|
138,886
|
|
|
0.01
|
|
|
1.70
|
|
|
1.69
|
|
|
1.00
|
|
0.40
|
%
|
|
|
275,877
|
|
|
|
|
|
|
|
|
|
|
|
a.
|
Black-Scholes valuation methodology was used for all RSUs.
|
b.
|
Figures in the range of
47%
-
84%
have been used for expected volatility. This has been derived from historic share price performance, weighted to exclude periods of unusually high volatility.
|
c.
|
Expected dividend yield is nil, consistent with the Directors’ view that the Group’s business model is to generate value through capital growth rather than the payment of dividends.
|
d.
|
The risk free rate is equal to the prevailing UK Gilts rate at grant date that most closely matches the expected term of the grant.
|
e.
|
RSUs are assumed to be exercised immediately on vesting.
|
|
Land & Buildings
|
||||
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Leases which expire
|
|
|
|
||
Not later than one year
|
337
|
|
|
88
|
|
Later than one year and not later than five years
|
1,143
|
|
|
122
|
|
|
1,480
|
|
|
210
|
|
|
|
£000
|
|
Consideration
|
|
|
|
Cash
|
|
6,091
|
|
2,934,272 new Summit Therapeutics plc Ordinary Shares issued
|
|
5,000
|
|
Total consideration
|
|
11,091
|
|
|
Book value £000
|
|
Fair value adjustment £000
|
|
Fair value £000
|
|||
Recognized amounts of identifiable assets acquired and liabilities assumed
|
|
|
|
|
|
|||
Cash and cash equivalents
|
1,316
|
|
|
—
|
|
|
1,316
|
|
Property, plant and equipment
|
329
|
|
|
—
|
|
|
329
|
|
Intangible assets - option over non-financial assets
|
668
|
|
|
—
|
|
|
668
|
|
Intangible assets - bacterial genetics-based platform
|
—
|
|
|
10,670
|
|
|
10,670
|
|
Trade and other receivables
|
1,129
|
|
|
—
|
|
|
1,129
|
|
Trade and other payables
|
(1,555
|
)
|
|
—
|
|
|
(1,555
|
)
|
Assumed contingent liabilities
|
—
|
|
|
(1,466
|
)
|
|
(1,466
|
)
|
Deferred tax liabilities
|
—
|
|
|
(1,814
|
)
|
|
(1,814
|
)
|
Book and fair value of identifiable net assets
|
1,887
|
|
|
7,390
|
|
|
9,277
|
|
Goodwill
|
—
|
|
|
1,814
|
|
|
1,814
|
|
Total consideration
|
1,887
|
|
|
9,204
|
|
|
11,091
|
|
1 Year Summit Therapeutics Chart |
1 Month Summit Therapeutics Chart |
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