Summit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September ...
16 Novembre 2020 - 10:05PM
Summit Therapeutics
Inc.(‘Summit’, the ‘Company’ or the ‘Group’)
Summit Therapeutics Reports Financial
Results and Operational Progress for the Third Quarter and Nine
Months Ended September 30, 2020
Cambridge, MA, November 16,
2020 - Summit Therapeutics Inc. (NASDAQ: SMMT) today
reports its financial results and provides an update on its
operational progress for the third quarter and nine months ended
September 30, 2020.
Ridinilazole for C. difficile Infection
(‘CDI’)
- As of November 15, 2020, Summit had enrolled a total of
448 patients into its Phase 3 Ri-CoDIFy clinical trials of
ridinilazole. Below is a table outlining the enrollment statistics
by calendar quarter 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 |
Q3 2020 |
|
64 |
|
389 |
Q4 2020* |
|
59* |
|
448 |
*Q4 2020 includes quarter to date enrollment through November
15th
- Due to the uncertainties surrounding COVID-19, Summit has
withdrawn public commentary on the timing of completion of the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 and for reduction of recurrence of 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 September 30, 2020, an
aggregate of $47.0 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.
Corporate Highlights
- Dr. Camilla Graham was promoted to Chief Clinical Affairs
Officer in October 2020. An infectious disease specialist, she has
practiced since 2001 at Beth Israel Deaconess Medical Center and is
on faculty at Harvard Medical School in Boston, MA.
Additionally, she has fourteen years of experience straddling
academic medicine and the pharmaceutical industry, including
leading the launch of Incevik (hepatitis C) and Kalydeco (cystic
fibrosis) as the Global Head of Medical Affairs at Vertex
Pharmaceuticals, and advising numerous state and federal government
agencies on access to medications on the academic side. Dr. Graham
received her MD from Medical College of Pennsylvania, Philadelphia,
PA and MPH from Harvard School of Public Health, Boston, MA.
-
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 on September 30, 2020, of $21.3
million compared to $63.8 million at December 31, 2019.
-
In November 2020, the Company closed a private placement for a
fundraising of $50 million through the issuance and sale of shares
of common stock to the Company’s Chief Executive Officer and
Executive Chairman, Robert W. Duggan, Polar Capital and Dr. Mahkam
Zanganeh.
-
The Company's existing cash and cash equivalents, committed
external funding and $50.0 million private placement completed in
November 2020 are expected to be sufficient to enable the Company
to fund its operating expenses and capital expenditure requirements
into the fourth quarter of 2021.
-
Net loss for the nine months ended September 30, 2020, of $39.3
million compared to a net loss of $20.0 million for the nine months
ended September 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,
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 and the
reduction of recurrence 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 and reduction of
recurrence 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.summittxinc.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 per share data |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
Licensing
agreements |
$ 181 |
|
$ 148 |
|
$ 675 |
|
$795 |
Total revenue |
181 |
|
148 |
|
675 |
|
795 |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
14,387 |
|
9,951 |
|
40,979 |
|
32,586 |
General and
administrative |
7,460 |
|
2,683 |
|
13,430 |
|
7,917 |
Impairment |
859 |
|
- |
|
859 |
|
- |
Total operating
expenses |
22,706 |
|
12,634 |
|
55,268 |
|
40,503 |
|
|
|
|
|
|
|
|
Other operating
income |
4,309 |
|
|
6,296 |
|
|
14,949 |
|
|
19,881 |
|
Operating
loss |
(18,216) |
|
|
(6,190) |
|
|
(39,644) |
|
|
(19,827) |
|
Other (income)
expense, net |
416 |
|
(75) |
|
296 |
|
(231) |
|
Loss before income
tax |
(17,800) |
|
|
(6,265) |
|
|
(39,348) |
|
|
(20,058) |
|
|
|
|
|
|
|
|
|
Income tax benefit
(expense) |
99 |
|
(111) |
|
93 |
|
|
13 |
Net loss |
|
$(17,701) |
|
|
$(6,376) |
|
$(39,255) |
|
$(20,045) |
|
|
|
|
|
|
|
|
Basic loss per
share |
$ (0.26) |
|
$ (0.20) |
|
$ (0.58) |
|
$ (0.63) |
Diluted loss per
share |
$ (0.26) |
|
$ (0.20) |
|
$ (0.58) |
|
$ (0.63) |
|
|
|
|
|
|
|
|
Other
comprehensive income/(loss): |
|
|
|
|
|
|
|
Foreign currency
translation adjustment |
2,255 |
|
|
(1,255) |
|
|
(2,312) |
|
|
(1,299) |
Total
comprehensive loss |
|
$(15,446) |
|
|
|
$(7,631) |
|
|
|
$(41,567) |
|
|
$(21,344) |
CONDENSED CONSOLIDATED BALANCE
SHEET INFORMATION
(Unaudited)
In
thousands
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
|
$ |
21,270 |
|
|
$ |
63,842 |
|
Total
assets |
|
|
|
$ |
56,865 |
|
|
$ |
96,679 |
|
Total
liabilities |
|
|
|
$ |
20,004 |
|
|
$ |
19,442 |
|
Total
stockholders' equity |
|
|
|
$ |
36,861 |
|
|
$ |
77,237 |
|
CONDENSED
CONSOLIDATED STATEMENT OF CASH FLOWS
INFORMATION
(Unaudited)
In
thousands
|
|
Nine months ended |
|
|
September 30, |
|
|
2020 |
|
2019 |
|
|
|
|
|
Net cash used
in operating activities |
|
$ |
(40,140) |
|
|
$ |
(13,861) |
|
Net cash used
in investing activities |
|
(371) |
|
|
(358) |
|
Net cash
provided by financing activities |
|
3 |
|
|
24,504 |
|
Effect of
exchange rates in cash and cash equivalents |
|
(2,064) |
|
|
(787) |
|
|
|
|
|
|
Net (decrease)
/ increase in cash and cash equivalents |
|
$ |
(42,572) |
|
|
$ |
9,498 |
|
|
|
|
|
|
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