Summit Therapeutics
plc(‘Summit’, the ‘Company’ or the ‘Group’)
Summit Therapeutics Reports Financial
Results and Operational Progress for the First Quarter and Three
Months Ended March 31, 2020
Oxford, UK, and Cambridge, MA, US, June
2, 2020 - Summit Therapeutics plc (NASDAQ: SMMT) today
reports its financial results and provides an update on its
operational conditions for the first quarter and three months ended
March 31, 2020.
Ridinilazole for C. difficile Infection
(‘CDI’)
- As of May 31, 2020, the Company had enrolled a total of 291
patients into its Phase 3 Ri-CoDIFy clinical trials. Below is a
table outlining the enrollment statistics by calendar quarter and
for this past April and May since the opening of the trials in
February 2019.
Quarter |
Number of patients enrolled |
Cumulative Patients Enrolled |
Q1 2019 |
9 |
9 |
|
Q2 2019 |
21 |
30 |
|
Q3 2019 |
43 |
73 |
|
Q4 2019 |
78 |
151 |
|
Q1 2020 |
101 |
252 |
|
April 2020 |
16 |
|
268 |
|
May 2020 |
23 |
|
291 |
|
- Due to the uncertainties surrounding COVID-19, Summit
Therapeutics is withdrawing public commentary on the timing of
completion of the Phase 3 Ri-CoDIFy clinical trials. The Company
will be updating stakeholders quarterly as to enrollment
status.
- The Ri-CoDIFy clinical trials aim to support registration of
the precision antibiotic ridinilazole in the US and other
territories resulting in its intended adoption as a first-line
treatment for CDI by:
- testing for superiority over the current standard of care,
vancomycin, in the primary endpoint of sustained clinical response
at 30 days after treatment has ended;
- generating health economic data to support ridinilazole's
commercial launch, when as and if approved by regulatory
authorities; and
- undertaking microbiome analysis that aims to show
ridinilazole’s impact on the gut microbiome.
- BARDA is supporting the Phase 3 clinical and regulatory
development of ridinilazole with a financial award of potential
funding of up to $72.5 million. As of March 31, 2020, an aggregate
of $42.4 million had been received.
Discuva Platform
Enterobacteriaceae
- DDS-04 compound series is a new class of precision antibiotics
in lead optimisation that acts via the novel bacterial target
LolCDE with the potential to treat infections caused by the
Gram-negative bacteria, Enterobacteriaceae.
Gonorrhoea
- DDS-01 compound series is a new class of precision antibiotics
in lead optimization against Neisseria gonorrhoeae, and is
supported by an award of up to $5.7 million from CARB-X.
Corporate Highlights
- Mr. Robert W. Duggan was appointed as Chief Executive Officer,
Dr. Elaine Stracker was appointed Interim Chief Operating Officer
and Dr. Ventzislav Stefanov was appointed Executive Vice President
and President of Discuva, the Company's discovery engine employing
14 people, in April 2020. Mr. Glyn Edwards stepped down as Chief
Executive Officer in April 2020, and he remains on the board as a
Non-Executive Director.
- Dr. David Powell was promoted to Chief Scientific Officer and
Ms. Divya Chari was appointed as Head of Global Clinical Operations
in March 2020. Ms. Laura Trespidi was promoted to SVP, CMC and
Supply Chain in February 2020.
COVID-19
- In light of the ongoing COVID-19 pandemic, Summit's employees
continue to work remotely, enabling the majority of day to day
business operations to continue. Summit's own laboratory facilities
have begun to reopen to resume work on key projects; site access by
staff is being monitored closely and is limited to ensure the
safety of Summit researchers. There continues to be a negative
impact on patient enrollment into the Ri-CoDIFy clinical
trials.
Financial Highlights
- Cash and cash equivalents at March 31, 2020, of $55.3 million
(£44.4 million) compared to $60.3 million (£48.4 million) at
December 31, 2019.
- Loss for the three months ended March 31, 2020, of $6.1 million
(£4.9 million) compared to a loss of $6.9 million (£5.3 million)
for the three months ended March 31, 2019. Excluding the impact of
exchange rate changes, the loss for the three months ended March
31, 2020, would be $9.3 million (£7.5 million) compared to a loss
of $6.2 million (£4.7 million) for the three months ended March 31,
2019.
About C. difficile
InfectionClostridioides difficile, or C. difficile,
infection (CDI) is a bacterial infection of the colon that produces
toxins causing inflammation of the colon and severe diarrhea. CDI
can also result in more serious disease complications, including
pseudomembranous colitis, bowel perforation, toxic megacolon and
sepsis. CDI represents a serious healthcare issue in hospitals,
long-term care homes and in the wider community. Summit estimates
there are over one million cases of CDI each year in the United
States and Europe, based on an epidemiology report on CDI that was
published in 2015 by Decision Resources, a healthcare research and
consulting company. Recurrence rates of up to 25% have been
reported following treatment with the current standard of care,
vancomycin. The vicious cycle of recurrence continues further, with
patients who have one recurrence being at increased risk for
another. The Healthcare Cost and Utilization Project, a family of
databases developed through a federal-state-industry partnership,
sponsored by the Agency for Healthcare Research and Quality of the
US Department of Health and Human Services, reported an approximate
3.5-fold increase in hospital stays associated with CDI between
2000 and 2008. The economic impact of CDI is significant. A study
published in 2016 in BMC Infectious Diseases estimated that the
total costs attributable to the management of CDI were
approximately $6.3 billion per year.
About
EnterobacteriaceaeEnterobacteriaceae are a family of
bacteria responsible for severe and often deadly infections. They
accountfor a significant number of cases across a number of
conditions including bloodstream infections, urinary tract
infections and hospital-acquired pneumonias. Summit estimates that
there are more than one million infections in the United States
annually caused by Enterobacteriaceae across these three conditions
based on data published in 2018 in the Journal of Antimicrobial
Chemotherapy, 2016 in the Journal of Molecular Science, 2014 in the
National Healthcare Safety Network, 2014 and 2018 in the New
England Journal of Medicine, 2015 in Nature Reviews Microbiology,
2012 in World Journal of Urology and 2014 in PLOS One. Mechanisms
of antibiotic resistance to Enterobacteriaceae are listed as both
urgent and serious threats by the CDC.
About GonorrheaThere is an
urgent unmet need for the development of new antibiotics against
gonorrhea, which is a sexually transmitted infection caused by an
overgrowth of the bacteria Neisseria gonorrhoeae (N. gonorrhoeae).
N. gonorrhoeae can cause infection of the genitals, throat, and
eyes. Untreated infections may spread to the rest of the body,
especially the joints, and in women may cause pelvic inflammatory
disease and possible infertility. It is estimated by the WHO that
there are approximately 78 million new cases of gonorrhea globally
per year. N gonorrhoeae has consistently developed resistance to
each class of antibiotics recommended for the treatment of
gonorrhea infections, and there is now only one treatment that is
recommended by the CDC, a combination of the cephalosporin
antibiotic ceftriaxone and the macrolide antibiotic azithromycin.
The WHO ranks gonorrhea as a “high” priority for research and
development while the CDC states that additional treatment options
are urgently needed.
About Summit TherapeuticsSummit
Therapeutics, led by its Discuva Platform, the Company's discovery
engine, is a leader in antibiotic innovation. Our new mechanism
antibiotics are designed to become the patient-friendly new era
standard of care for those suffering from infectious disease,
subject to regulatory approvals, and create value for payors and
healthcare providers. In the present time, we are developing new
mechanism antibiotics to treat infections caused by C. difficile,
Enterobacteriaceae and N. gonorrhoeae and are using our proprietary
Discuva Platform to expand our pipeline. For more information,
visit www.summitplc.com and follow us on Twitter @summitplc. For
more information on the Company's Discuva Platform, visit
https://www.summitplc,com/our-science/discuva-platform.
For more information:
ContactsSummit Press Office |
investors@summitplc.com |
Forward Looking StatementsAny
statements in this press release about the Company’s future
expectations, plans and prospects, including but not limited to,
statements about the potential benefits and future operation of the
BARDA or CARB-X contract, including any potential future payments
thereunder, the clinical and preclinical development of the
Company’s product candidates, the therapeutic potential of the
Company’s product candidates, the potential of the Discuva
Platform, the potential commercialization of the Company’s product
candidates, the sufficiency of the Company’s cash resources, the
timing of initiation, completion and availability of data from
clinical trials, the potential submission of applications for
marketing approvals, the impact of the COVID-19 pandemic and other
statements containing the words "anticipate," "believe,"
"continue," "could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "should," "target," "would," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: the ability of BARDA or CARB-X to terminate the
contract for convenience at any time, the uncertainties inherent in
the initiation of future clinical trials, availability and timing
of data from ongoing and future preclinical studies and clinical
trials and the results of such preclinical studies and clinical
trials, whether preliminary results from a clinical trial will be
predictive of the final results of that trial or whether results of
early clinical trials or preclinical studies will be indicative of
the results of later clinical trials, expectations for regulatory
approvals, legal, regulatory, political and economic risks arising
from or relating to global public health crises that reduce
economic activity (including the recent coronavirus COVID-19
outbreak) and the enrollment in and completion of clinical trials,
laws and regulations affecting government contracts, availability
of funding sufficient for the Company’s foreseeable and
unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the "Risk Factors"
section of filings that the Company makes with the Securities and
Exchange Commission, including the Company’s Transition Report on
Form 20-F for the eleven months ended December 31, 2019.
Accordingly, readers should not place undue reliance on
forward-looking statements or information. In addition, any
forward-looking statements included in this press release represent
the Company’s views only as of the date of this release and should
not be relied upon as representing the Company’s views as of any
subsequent date. The Company specifically disclaims any obligation
to update any forward-looking statements included in this press
release.
The financial information in the Company’s
financial statements has been prepared assuming the Company will
continue on a going concern basis. Based on management's forecasts,
the Company's existing cash and cash equivalents, anticipated
payments from BARDA under its contract for the development of
ridinilazole, anticipated payments from CARB-X under its contract
for the development of its gonorrhea antibiotic program, and
anticipated milestone payments from its license and
commercialization agreement with Eurofarma are expected to be
sufficient to enable the Company to fund its operating expenses and
capital expenditure requirements through January 31, 2021. The
Company will need to raise additional funding in order to support,
beyond this date, its planned research and development efforts, its
preparatory commercialization related activities should
ridinilazole receive marketing approval, as well as to support
activities associated with operating as a public company in the
United States. The failure of the Company to obtain sufficient
funds on acceptable terms when needed could have a material adverse
effect on the Company’s business, results of operations and
financial condition, and may cast and raise significant doubt on
the Company’s ability to continue as a going concern.
FINANCIAL STATEMENTS
Condensed Consolidated Statement of Comprehensive
Income (unaudited) For the three months ended March 31,
2020
|
|
Three months ended March 31, 2020 |
Three months ended March 31, 2020 |
Three months ended March 31, 2019 |
|
|
|
|
|
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Revenue |
|
315 |
|
253 |
|
375 |
|
|
|
|
|
|
Other
operating income |
|
5,096 |
|
4,092 |
|
4,574 |
|
|
|
|
|
|
Operating expenses |
|
|
|
|
Research and development |
|
(12,143 |
) |
(9,750 |
) |
(8,693 |
) |
General and administration |
|
(651 |
) |
(523 |
) |
(2,367 |
) |
Total operating expenses |
|
(12,794 |
) |
(10,273 |
) |
(11,060 |
) |
Operating (loss) |
|
(7,383 |
) |
(5,928 |
) |
(6,111 |
) |
|
|
|
|
|
Finance
income |
|
1 |
|
1 |
|
2 |
|
Finance
costs |
|
(65 |
) |
(52 |
) |
(60 |
) |
(Loss) before income tax |
|
(7,447 |
) |
(5,979 |
) |
(6,169 |
) |
|
|
|
|
|
Income
tax |
|
1,298 |
|
1,042 |
|
831 |
|
(Loss) for the period |
|
(6,149 |
) |
(4,937 |
) |
(5,338 |
) |
|
|
|
|
|
Other
comprehensive (loss) / income |
|
|
|
|
Items that may be
reclassified subsequently to profit or loss |
|
|
|
|
Exchange
differences on translating foreign operations |
|
16 |
|
13 |
|
(6 |
) |
Total comprehensive (loss) for the period |
|
(6,133 |
) |
(4,924 |
) |
(5,344 |
) |
|
|
|
|
|
Basic and diluted (loss) per ordinary share from
operations |
|
(2) cents |
(1) pence |
(3) pence |
Condensed Consolidated Statement of Financial
Position (unaudited) As at March 31, 2020
|
|
March 31, 2020 |
March 31, 2020 |
December 31, 2019 |
|
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Goodwill |
|
2,259 |
|
1,814 |
|
1,814 |
|
Intangible
assets |
|
12,292 |
|
9,870 |
|
9,950 |
|
Property, plant
and equipment |
|
1,305 |
|
1,048 |
|
1,167 |
|
|
|
15,856 |
|
12,732 |
|
12,931 |
|
Current
assets |
|
|
|
|
Trade and other
receivables |
|
12,179 |
|
9,780 |
|
8,116 |
|
Current tax
receivable |
|
6,080 |
|
4,882 |
|
3,659 |
|
Cash and cash
equivalents |
|
55,296 |
|
44,400 |
|
48,417 |
|
|
|
73,555 |
|
59,062 |
|
60,192 |
|
Total assets |
|
89,411 |
|
71,794 |
|
73,123 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current liabilities |
|
|
|
|
Lease
liabilities |
|
(374 |
) |
(300 |
) |
(320 |
) |
Deferred
revenue |
|
(1,039 |
) |
(834 |
) |
(374 |
) |
Provisions for
other liabilities and charges |
|
(2,633 |
) |
(2,114 |
) |
(2,050 |
) |
Deferred tax
liability |
|
(2,127 |
) |
(1,708 |
) |
(1,560 |
) |
|
|
(6,173 |
) |
(4,956 |
) |
(4,304 |
) |
Current
liabilities |
|
|
|
|
Trade and other
payables |
|
(12,645 |
) |
(10,154 |
) |
(8,020 |
) |
Lease
liabilities |
|
(418 |
) |
(336 |
) |
(358 |
) |
Deferred
revenue |
|
(2,156 |
) |
(1,731 |
) |
(1,136 |
) |
Contingent consideration |
|
(100 |
) |
(80 |
) |
(80 |
) |
|
|
(15,319 |
) |
(12,301 |
) |
(9,594 |
) |
Total liabilities |
|
(21,492 |
) |
(17,257 |
) |
(13,898 |
) |
Net assets |
|
67,919 |
|
54,537 |
|
59,225 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
Share
capital |
|
4,187 |
|
3,362 |
|
3,359 |
|
Share premium
account |
|
160,794 |
|
129,110 |
|
129,110 |
|
Share-based
payment reserve |
|
1,825 |
|
1,465 |
|
1,299 |
|
Merger
reserve |
|
3,770 |
|
3,027 |
|
3,027 |
|
Special
reserve |
|
24,899 |
|
19,993 |
|
19,993 |
|
Currency
translation reserve |
|
85 |
|
69 |
|
56 |
|
Accumulated
losses reserve |
|
(127,641 |
) |
(102,489 |
) |
(97,619 |
) |
Total equity |
|
67,919 |
|
54,537 |
|
59,225 |
|
Condensed Consolidated Statement of Cash Flows
(unaudited)
For the three months ended March 31, 2020
|
|
Three months ended March 31, 2020 |
Three months ended March 31, 2020 |
Three months ended March 31, 2019 |
|
|
$000s |
£000s |
£000s |
Cash flows from operating activities |
|
|
|
|
Loss before
income tax |
|
(7,447 |
) |
(5,979 |
) |
(6,169 |
) |
|
|
(7,447 |
) |
(5,979 |
) |
(6,169 |
) |
Adjusted
for: |
|
|
|
|
Loss on recognition of contingent
consideration payable |
|
— |
|
— |
|
(2 |
) |
Finance
income |
|
(1 |
) |
(1 |
) |
(2 |
) |
Finance
costs |
|
65 |
|
52 |
|
60 |
|
Foreign
exchange (gain) / loss |
|
(3,429 |
) |
(2,753 |
) |
691 |
|
Depreciation |
|
178 |
|
143 |
|
150 |
|
Amortization
of intangible fixed assets |
|
259 |
|
208 |
|
207 |
|
Loss on
disposal of assets |
|
— |
|
— |
|
26 |
|
Share-based
payment |
|
290 |
|
233 |
|
260 |
|
Adjusted loss from operations before changes in working
capital |
|
(10,085 |
) |
(8,097 |
) |
(4,779 |
) |
|
|
|
|
|
Increase in
prepayments and other receivables |
|
(1,537 |
) |
(1,235 |
) |
(30 |
) |
Increase /
(decrease) in deferred revenue |
|
1,315 |
|
1,055 |
|
(1,025 |
) |
Increase /
(decrease) in trade and other payables |
|
1,967 |
|
1,579 |
|
(2,270 |
) |
Cash used in operations |
|
(8,340 |
) |
(6,698 |
) |
(8,104 |
) |
|
|
|
|
|
Contingent
consideration paid |
|
— |
|
— |
|
2 |
|
Taxation
(paid) / received |
|
(5 |
) |
(4 |
) |
1 |
|
Net cash used in operating activities |
|
(8,345 |
) |
(6,702 |
) |
(8,101 |
) |
|
|
|
|
|
Investing activities |
|
|
|
|
Purchase of property, plant and
equipment |
|
(30 |
) |
(24 |
) |
(64 |
) |
Purchase of intangible assets |
|
(159 |
) |
(128 |
) |
— |
|
Interest received |
|
1 |
|
1 |
|
2 |
|
Net cash used in investing activities |
|
(188 |
) |
(151 |
) |
(62 |
) |
|
|
|
|
|
Financing activities |
|
|
|
|
Proceeds from
issue of share capital |
|
— |
|
— |
|
19,648 |
|
Transaction
costs on share capital issued |
|
— |
|
— |
|
(455 |
) |
Proceeds from
exercise of share options |
|
4 |
|
3 |
|
— |
|
Repayment of
lease liabilities |
|
(51 |
) |
(42 |
) |
(80 |
) |
Repayment of lease interest |
|
(7 |
) |
(6 |
) |
(9 |
) |
Net cash (used in) / generated from financing
activities |
|
(54 |
) |
(45 |
) |
19,104 |
|
|
|
|
|
|
(Decrease) / increase in cash and cash
equivalents |
|
(8,587 |
) |
(6,898 |
) |
10,941 |
|
Effect
of exchange rates in cash and cash equivalents |
|
3,584 |
|
2,881 |
|
(617 |
) |
Cash
and cash equivalents at beginning of the period |
|
60,299 |
|
48,417 |
|
9,521 |
|
Cash and cash equivalents at end of the
period |
|
55,296 |
|
44,400 |
|
19,845 |
|
Condensed Consolidated Statement of
Changes in Equity (unaudited)
Three months ended March 31, 2020
Group |
Share capital£000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£000s |
Total £000s |
At January 1, 2020 |
3,359 |
|
129,110 |
|
1,299 |
|
3,027 |
|
19,993 |
|
56 |
|
(97,619 |
) |
59,225 |
|
Loss for the period |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(4,937 |
) |
(4,937 |
) |
Currency
translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
13 |
|
— |
|
13 |
|
Total comprehensive loss for the
period |
— |
|
— |
|
— |
|
— |
|
— |
|
13 |
|
(4,937 |
) |
(4,924 |
) |
Share options exercised |
3 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
3 |
|
Equity based compensation expense |
— |
|
— |
|
233 |
|
— |
|
— |
|
— |
|
— |
|
233 |
|
Share-based payment reserve transfer |
— |
|
— |
|
(67 |
) |
— |
|
— |
|
— |
|
67 |
|
— |
|
At March 31, 2020 |
3,362 |
|
129,110 |
|
1,465 |
|
3,027 |
|
19,993 |
|
69 |
|
(102,489 |
) |
54,537 |
|
Year ended December 31, 2019
Group |
Share capital£000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£000s |
Total £000s |
At January 1, 2019 |
823 |
|
74,394 |
|
1,119 |
|
3,027 |
|
19,993 |
|
65 |
|
(74,217 |
) |
25,204 |
|
Profit for the year |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(23,904 |
) |
(23,904 |
) |
Currency
translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
(9 |
) |
— |
|
(9 |
) |
Total comprehensive profit for the
period |
— |
|
— |
|
— |
|
— |
|
— |
|
(9 |
) |
(23,904 |
) |
(23,913 |
) |
New share capital issued |
2,535 |
|
55,872 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
58,407 |
|
Transaction costs on share capital
issued |
— |
|
(1,156 |
) |
— |
|
— |
|
— |
|
— |
|
— |
|
(1,156 |
) |
Share options exercised |
1 |
|
— |
|
|
— |
|
— |
|
— |
|
— |
|
1 |
|
Equity based compensation expense |
— |
|
— |
|
682 |
|
— |
|
— |
|
— |
|
— |
|
682 |
|
Share-based payment reserve transfer |
— |
|
— |
|
(502 |
) |
— |
|
— |
|
— |
|
502 |
|
— |
|
At December 31, 2019 |
3,359 |
|
129,110 |
|
1,299 |
|
3,027 |
|
19,993 |
|
56 |
|
(97,619 |
) |
59,225 |
|
Three months ended March 31, 2019
Group |
Share capital£000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£000s |
Total £000s |
At January 1, 2019 |
823 |
|
74,394 |
|
1,119 |
|
3,027 |
|
19,993 |
|
65 |
|
(74,217 |
) |
25,204 |
|
Loss for the period |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(5,338 |
) |
(5,338 |
) |
Currency
translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
(6 |
) |
— |
|
(6 |
) |
Total comprehensive profit for the
period |
— |
|
— |
|
— |
|
— |
|
— |
|
(6 |
) |
(5,338 |
) |
(5,344 |
) |
New share capital issued |
781 |
|
18,867 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
19,648 |
|
Transaction costs on share capital
issued |
— |
|
(456 |
) |
— |
|
— |
|
— |
|
— |
|
— |
|
(456 |
) |
Equity based compensation expense |
— |
|
— |
|
260 |
|
— |
|
— |
|
— |
|
— |
|
260 |
|
Share-based payment reserve transfer |
|
|
(418 |
) |
|
|
|
418 |
|
— |
|
At March 31, 2019 |
1,604 |
|
92,805 |
|
961 |
|
3,027 |
|
19,993 |
|
59 |
|
(79,137 |
) |
39,312 |
|
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