Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2...
September 29 2020 - 7:00AM
Summit Therapeutics
Inc.(‘Summit’, the ‘Company’ or the ‘Group’)
Summit Therapeutics Reports Financial
Results and Operational Progress for the Second Quarter and Six
Months Ended June 30, 2020
Cambridge, MA, September 29,
2020 - Summit Therapeutics Inc. (NASDAQ: SMMT) today
reports its financial results and provides an update on its
operational progress for the second quarter and six months ended
June 30, 2020.
Ridinilazole for C. difficile Infection
(‘CDI’)
- Summit published data from its Phase 2 clinical trial of
ridinilazole evaluating the effects of a narrow-spectrum
(ridinilazole) or broad-spectrum antibiotic (vancomycin) on
intestinal bile acid profiles. This was the first study to
demonstrate in humans the relationships between Clostridioides
difficile antibiotic treatment choice and bile acid metabolism both
during therapy and after treatment cessation. The results indicated
that ridinilazole maintained an intestinal bile acid profile
associated with a lowered risk of recurrence. The data were
published in the American Journal of Physiology – Gastrointestinal
and Liver Physiology.
-
As of August 31, 2020, Summit had enrolled a total of 369 patients
into its Phase 3 Ri-CoDIFy clinical trials of ridinilazole. Below
is a table outlining the enrollment statistics by calendar quarter
and for this past July and August 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 |
Q2 2020 |
|
73 |
|
325 |
July 2020 |
|
22 |
|
347 |
August 2020 |
|
22 |
|
369 |
- Due to the uncertainties surrounding COVID-19, Summit is
withdrawing public commentary on the timing of completion of the
Phase 3 Ri-CoDIFy clinical trials. The Company plans to publicly
update stakeholders quarterly as to enrollment status.
-
The Ri-CoDIFy clinical trials aim to support application for
marketing approval of the precision antibiotic ridinilazole in the
United States and other territories and the goal of it being used
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 and metabolome analysis that aims to show ridinilazole’s
impact on the gut microbiome and bile acids composition
-
BARDA is supporting the Phase 3 clinical trials and regulatory
development of ridinilazole with a financial award of potential
funding of up to $72.5 million. As of June 30, 2020, an aggregate
of $46.6 million had been received.
Discuva Platform
Enterobacteriaceae
- DDS-04
compound series is a new class of precision antibiotics, with new
mechanism of action, which is in lead optimization that acts via
the novel bacterial target LolCDE with the potential to treat
multidrug resistant infections caused by the Gram-negative bacteria
Enterobacteriaceae.
Gonorrhoea
- Based on
results from recent preclinical studies, the DDS-01 series of
antibiotics against Neisseria gonorrhoeae was determined not to
have suitable qualities for further development as it had shown
toxicity in animal studies and therefore, Summit is ceasing work on
the gonorrhea program. The Company expects CARB-X will cover its
remaining share of the work that has been funded under the
award.
Corporate Highlights
- Mr. Michael Donaldson was appointed as Chief Financial
Officer in June 2020. Previously, Mr. Donaldson served as Vice
President, Finance, and Corporate Controller for Goldfinch Bio,
Inc. from 2018 to 2020 and Vice President, Finance, Corporate
Controller and Assistant Treasurer at ARIAD Pharmaceuticals, Inc.,
which was acquired by Takeda, Inc. in 2017, from 2016 to 2017.
Prior to that, he was the Corporate Controller for Hittite
Microwave Corporation, which was acquired by Analog Devices in
2014. Mr. Donaldson spent the first 11 years of his career at
PricewaterhouseCoopers
-
Dr. Jos Houbiers was promoted to Chief Medical Officer in July
2020. Dr Houbiers brings to Summit over 20 years of experience in
pharmaceutical clinical development, where he’s implemented
clinical development strategies, creative trial design and
comprehensive medical safety monitoring across therapeutic areas,
including functional urology, immunology and transplantation. He
was most recently at Astellas, where he served in roles of
increasing responsibility in clinical development from the Global
Development hub, where he ended as Executive Medical Director and
Group Head for the Medical Science Urology department. Dr. Houbiers
received his MD from Leiden University Medical Center and PhD
(immunology) and MSc in medicine from Leiden University.
-
Ms. Ujjwala Mahatme was appointed as a Director in July 2020.
-
Mr. Robert W. Duggan was appointed as Chief Executive 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 from the Board of Directors in
June 2020.
-
Summit has redomiciled to the United States, effective September
18, 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. We are working to implement a number of initiatives
and considering alternative courses of action to mitigate the
impact of the COVID-19 pandemic on our clinical trials, although
there can be no assurance that such actions will be
successful.
Financial Highlights
- Cash and cash equivalents at June 30, 2020, of $36.4
million compared to $63.8 million at December 31, 2019.
-
The Company's existing cash and cash equivalents and committed
external funding are expected to be sufficient to enable the
Company to fund its operating expenses and capital expenditure
requirements through January 31, 2021. The Principal shareholder of
the Company, Mr. Robert W. Duggan, has given his intention to the
Board of Directors to participate in a future fundraise as required
in order to support the Company with its clinical operations and
planned research and development efforts.
-
Loss for the six months ended June 30, 2020, of $21.6 million
compared to a loss of $13.7 million for the six months ended June
30, 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 watery
diarrhea, painful abdominal cramping, nausea, fever and
dehydration. CDI can also result in more serious disease
complications, including bowel perforation, sepsis and death. CDI
represents a serious healthcare issue in hospitals, long-term care
homes and in the wider community. Summit estimates that there are
over 3 million cases of CDI each year worldwide, based on a
meta-analysis of 229 publications with data from 41 countries,
published in the Journal of Global Health, June 2019.
About
EnterobacteriaceaeEnterobacteriaceae are a family of
bacteria responsible for serious infections across a number of
conditions including bloodstream infections, urinary tract
infections and hospital-acquired pneumonias. Multidrug resistant
Enterobacteriaceae are resistant to treatment by most or
occasionally all of existent antibiotics. The most difficult to
treat among them are the ESBL-producing and the
Carbapenem-resistant Enterobacteriaceae which according to the CDC,
have collectively caused an estimated 210,500 infections and 10,200
deaths in hospitalized patients in the United States in 2017.
About Summit Therapeutics
Summit Therapeutics, empowered by its Discuva
Platform, the Company’s innovative antibiotic discovery engine, led
by Dr. Ventzislav Stefanov and supported by BARDA and Carb-X
funding, intends to be the leader in patient and physician friendly
paradigm shifting antibiotic innovation. Our new mechanism
antibiotics are designed to become the patient-friendly, new era
standard-of-care, by working in harmony with the human microbiome
to treat prospective patients suffering from infectious disease,
initially focussing on Clostridioides difficile infections (“CDI”)
which is estimated to impact over 3 million patients worldwide
annually. Commercialization of ridinilazole for the treatment of
CDI is subject to regulatory approvals. The overriding objective of
Summit Therapeutics is to create value for patients, hospital
infectious disease care givers, community based infectious disease
healthcare providers, as well as healthcare payors around the
world. Currently, Summit’s lead product candidate
ridinilazole is engaged in two global phase III trials, Ri-CoDIFy 1
& 2, each enrolling 680 patients vs standard of care
(Vancomycin) for the treatment of C. difficile infections.
Summit’s vision and mission is to extend our
pipeline through the development of new mechanism, narrow spectrum,
microbiome sparing antibiotics targeting C. difficile,
Gram-negative Enterobacteriaceae such as Escherichia coli and
Klebsiella pneumoniae and other bacterial infections with high
unmet medical need.
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.
Contacts Summit Press Office |
investors@summitplc.com |
Summit Forward-looking
Statements
Any statements in this press release about the
Company’s future expectations, plans and prospects, including but
not limited to, statements about the clinical and preclinical
development of the Company’s product candidates, the therapeutic
potential of the Company’s product candidates, the potential
commercialization of the Company’s product candidates, 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 on the Company’s
operations and clinical trials 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
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials and the results of such trials, global public health crises,
including the coronavirus COVID-19 outbreak, that may affect timing
and status of our clinical trials and operations, whether
preliminary results from a clinical trial will be predictive of the
final results of that trial or whether results of early clinical
trials or preclinical studies will be indicative of the results of
later clinical trials, expectations for regulatory approvals, laws
and regulations affecting government contracts and funding awards,
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. 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER
COMPREHENSIVE LOSS |
(Unaudited) |
In thousands, except share and per share data |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
Licensing
agreements |
$ 170 |
|
$ 156 |
|
$ 494 |
|
$ 647 |
Total
revenue |
170 |
|
156 |
|
494 |
|
647 |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
14,105 |
|
11,257 |
|
26,592 |
|
22,635 |
General and
administrative |
5,299 |
|
2,136 |
|
5,970 |
|
5,234 |
Total operating
expenses |
19,404 |
|
13,393 |
|
32,562 |
|
27,869 |
Loss from
operations |
(19,234) |
|
(13,237) |
|
(32,068) |
|
(27,222) |
|
|
|
|
|
|
|
|
Other operating
income |
3,867 |
|
|
6,494 |
|
|
10,640 |
|
|
13,585 |
|
Operating
loss |
(15,367) |
|
|
(6,743) |
|
|
(21,428) |
|
|
(13,637) |
|
Interest expense,
net |
(55) |
|
(79) |
|
(120) |
|
(156) |
|
Loss before
income tax |
(15,422) |
|
|
(6,822) |
|
|
(21,548) |
|
|
(13,793) |
|
|
|
|
|
|
|
|
|
Income tax
benefit (expense) |
191 |
|
139 |
|
(6) |
|
|
124 |
Net loss |
|
$(15,231) |
|
|
$(6,683) |
|
$(21,554) |
|
$(13,669) |
|
|
|
|
|
|
|
|
Basic loss per
share |
$ (0.23) |
|
$ (0.21) |
|
$ (0.32) |
|
$ (0.44) |
Diluted loss per
share |
$ (0.23) |
|
$ (0.21) |
|
$ (0.32) |
|
$ (0.44) |
|
|
|
|
|
|
|
|
Other
comprehensive income/(loss): |
|
|
|
|
|
|
|
Foreign currency
translation adjustment |
(45) |
|
|
(1,255) |
|
|
(4,567) |
|
|
(44) |
Total
comprehensive loss |
|
$(15,276) |
|
|
|
$(7,938) |
|
|
|
$(26,121) |
|
|
$(13,713) |
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In
thousands
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
|
$ |
36,410 |
|
|
$ |
63,842 |
|
Total
assets |
|
|
|
$ |
70,949 |
|
|
$ |
96,679 |
|
Total
liabilities |
|
|
|
$ |
19,003 |
|
|
$ |
19,442 |
|
Total
stockholders' equity |
|
|
|
$ |
51,946 |
|
|
$ |
77,237 |
|
CONDENSED CONSOLIDATED STATEMENT OF CASH
FLOWS INFORMATION(Unaudited)In
thousands
|
|
Six months ended |
|
|
June 30, |
|
|
2020 |
|
2019 |
|
|
|
|
|
Net cash used in
operating activities |
|
$ |
(23,491) |
|
|
$ |
(9,235) |
|
Net cash used in
investing activities |
|
(327) |
|
|
(225) |
|
Net cash provided
by financing activities |
|
3 |
|
|
24,503 |
|
Effect of
exchange rates in cash and cash equivalents |
|
(3,617) |
|
|
29 |
|
|
|
|
|
|
Net (decrease) /
increase in cash and cash equivalents |
|
$ |
(27,432) |
|
|
$ |
15,072 |
|
|
|
|
|
|
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