Summit Therapeutics
Inc.(‘Summit’ or the ‘Company’)
Cambridge, MA, March 17, 2021 - Summit
Therapeutics Inc. (NASDAQ: SMMT) today reports its financial
results and provides an update on its operational progress for the
fourth quarter and full-year ended December 31, 2020.
Note: A glossary of terms has been added
to the end of this document in order to allow for the ease of
understanding of terms or concepts in advance of reviewing this
release.
Ridinilazole for C. difficile Infection
(‘CDI’)
- As of March 12, 2021, Summit had enrolled a total of 581
patients into its two ridinilazole Phase 3 Ri-CoDIFy clinical
trials; together, both trials have a projected enrollment goal of
1,360 patients. 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 |
105 |
494 |
Q1 2021* |
87* |
581* |
*Q1 2021 includes quarter-to-date enrollment
through March 12, 2021
- As previously disclosed, Summit is not providing 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, with the goal of use as
first-line therapy to treat initial infection and reduce recurrence
of CDI.
-
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 December 31, 2020, an
aggregate of $53.3 million had been received.
-
As presented within the American Journal of Physiology -
Gastrointestinal and Liver Physiology (August 2020), dysbiosis of
the gut microbiota with altered bile acid composition within the
microbiome is believed to play a critical role in C. difficile
infection, including recurrence of disease. Ridinilazole is
believed to spare the microbiome of further harm while killing C.
difficile.
Discuva Platform
Enterobacteriaceae
The DDS-04 compound series is a new class of
precision antibiotics with a new mechanism of action that acts via
the novel bacterial target, LolCDE. Our lead compound is in
late lead optimization with the potential to treat multidrug
resistant infections caused by a large group of pathogenic
gram-negative bacteria, the Enterobacteriaceae. Because
LolCDE has never been a target of existing antibiotics and
antimicrobials, bacterial resistance is not believed to exist to
this approach, potentially allowing for the treatment of
Enterobacteriaceae-caused infections that do not have effective
current treatments due to high levels of resistance to existing
classes of antibiotics.
Corporate Highlights
- Dr. Mahkam “Maky” Zanganeh was appointed to the Company’s
Board of Directors and subsequently named the Company’s Chief
Operating Officer in November 2020. She joined Summit from Maky
Zanganeh and Associates (“MZA”), a consulting firm in the biotech
space, where she is currently President and CEO. Prior to
MZA, Dr. Zanganeh was the Chief Operating Officer at Pharmacyclics,
Inc., overseeing all clinical, research, commercial, and
business-related matters, including playing a critical role in
Pharmacyclics’ sale to AbbVie, Inc., in 2015. Dr. Zanganeh
also serves as a board member for Pulse BioSciences, Inc., and
RenovoRx, Inc. Dr. Zanganeh received her DDS from the Louis
Pasteur University (France) and her MBA from Schiller International
University (France).
-
During the fourth quarter of 2020 and into the first quarter of
2021, the Company appointed several individuals to positions of
senior leadership, bolstering a strong existing core leadership
team and positioning the Company well for the completion of the
Ri-CoDIFy clinical trials, the potential commercialization of
ridinilazole, and the further development of the Company’s pipeline
over the coming years. These positions are Heads of
departments including, but not limited to, Medical Science,
Regulatory, Clinical Operations, and Patient Safety &
Pharmacovigilance.
Financial Highlights
- Cash and cash equivalents on December 31, 2020, of $66.4
million compared to $63.8 million on 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 Executive Chairman and Chief
Executive Officer, Robert W. Duggan, Polar Capital, and the
Company’s Director and Chief Operating Officer, Dr. Mahkam
Zanganeh.
-
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 into the fourth quarter of 2021. The Company's
principal shareholder, Robert W. Duggan, has given his intention to
the Board of Directors to participate in future fundraising, as
required, to support the Company with its operating expenses and
capital expenditure requirements.
-
Net loss for the year ended December 31, 2020, of $52.7 million
compared to a net loss of $29.1 million for the eleven months ended
December 31, 2019.
About C. difficile
Infection
Clostridioides 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 is a contagious infectious disease that represents
a serious healthcare issue in hospitals, long-term care homes, and
the wider community. Summit estimates that there are
approximately 500,000 cases of CDI each year across the United
States based on a meta-analysis published in the Journal of Global
Health, June 2019.
About Enterobacteriaceae
Enterobacteriaceae 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 existent antibiotics. The most difficult to
treat among them are the Carbapenem-resistant Enterobacteriaceae,
which are classified as Urgent Threats by the CDC.
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-friendly and paradigm-shifting antibiotic innovation while
being an ally to physicians. 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
focusing on Clostridioides difficile infections (CDI). The
overriding objective of Summit Therapeutics is to create value for
patients, hospital infectious disease caregivers, and
community-based infectious disease healthcare providers, as well as
healthcare payers around the world. We seek to create value
by developing drugs with high therapeutic efficacy - curing the
cause of the patient's condition with minimal or zero disease
recurrence or antimicrobial resistance, for the longest extent
possible - and minimizing the trauma caused to the patient and
healthcare ecosystem by minimizing serious side effects, disease
recurrence, and inaccessibility to our treatments as a result of
financial or other barriers. Currently, Summit’s lead product
candidate, ridinilazole, is engaged in two global Phase 3 trials,
Ri-CoDIFy 1 & 2, each enrolling approximately 680 patients vs.
the standard of care (vancomycin) for the treatment and reduction
of recurrence of C. difficile infections. Commercialization
of ridinilazole for the treatment and the reduction of recurrence
of CDI is subject to regulatory approvals.
For more information, please visit
www.summittxinc.com and follow us on Twitter @summitplc. For more
information on the Company’s Discuva Platform, please visit
https://www.summittxinc.com/our-science/discuva-platform.
Contact Summit Investor
Relations:
Dave GancarzVice President, Investor Relations
& Corporate Strategydavid.gancarz@summitplc.com
General Inquiries:
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 COMPREHENSIVE
LOSS(Unaudited)In thousands,
except share and per share data
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
Eleven Months Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
Licensing
agreements |
$ |
185 |
|
|
$ |
161 |
|
|
$ |
860 |
|
|
$ |
743 |
|
Total
revenue |
185 |
|
|
161 |
|
|
860 |
|
|
743 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
12,264 |
|
|
10,714 |
|
|
53,274 |
|
|
39,809 |
|
General
and administrative |
3,840 |
|
|
4,146 |
|
|
19,232 |
|
|
11,279 |
|
Impairment |
— |
|
|
— |
|
|
859 |
|
|
— |
|
Total
operating expenses |
16,104 |
|
|
14,860 |
|
|
73,365 |
|
|
51,088 |
|
Other
operating income |
4,363 |
|
|
5,644 |
|
|
19,312 |
|
|
22,872 |
|
Loss from
operations |
(11,556) |
|
|
(9,055) |
|
|
(53,193) |
|
|
(27,473) |
|
Other
income (expense), net |
(2,006) |
|
|
(2,703) |
|
|
283 |
|
|
(1,618) |
|
Loss
before income tax |
(13,562) |
|
|
(11,758) |
|
|
(52,910) |
|
|
(29,091) |
|
|
|
|
|
|
|
|
|
Income tax (expense)
benefit |
21 |
|
|
(64) |
|
|
213 |
|
|
(36) |
|
Net
loss |
$ |
(13,541) |
|
|
$ |
(11,822) |
|
|
$ |
(52,697) |
|
|
$ |
(29,127) |
|
|
|
|
|
|
|
|
|
Basic
loss per share |
$ |
(0.18) |
|
|
$ |
(0.34) |
|
|
$ |
(0.76) |
|
|
$ |
(0.89) |
|
Diluted
loss per share |
$ |
(0.18) |
|
|
$ |
(0.34) |
|
|
$ |
(0.76) |
|
|
$ |
(0.89) |
|
|
|
|
|
|
|
|
|
Other
comprehensive income: |
|
|
|
|
|
|
|
Foreign
currency translation adjustment |
3,320 |
|
|
3,150 |
|
|
970 |
|
|
51 |
|
Total
comprehensive loss |
$ |
(10,221) |
|
|
$ |
(8,672) |
|
|
$ |
(51,727) |
|
|
$ |
(29,076) |
|
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In thousands
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
|
|
$ |
66,417 |
|
|
$ |
63,842 |
|
Total
assets |
|
|
|
$ |
102,498 |
|
|
$ |
96,248 |
|
Total
liabilities |
|
|
|
$ |
23,045 |
|
|
$ |
17,385 |
|
Total
stockholders' equity |
|
|
|
$ |
79,453 |
|
|
$ |
78,863 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOW INFORMATION(Unaudited)In
thousands
|
|
Twelve Months Ended |
|
Eleven Months Ended |
|
|
December 31, 2020 |
|
December 31, 2019 |
|
|
|
|
|
Net cash
used in operating activities |
|
$ |
(48,111) |
|
|
$ |
(20,757) |
|
Net cash
used in investing activities |
|
(421) |
|
|
(341) |
|
Net cash
provided by financing activities |
|
50,551 |
|
|
49,505 |
|
Effect of
exchange rates in cash and cash equivalents |
|
556 |
|
|
190 |
|
|
|
|
|
|
Net
increase in cash and cash equivalents |
|
$ |
2,575 |
|
|
$ |
28,597 |
|
|
|
|
|
|
Appendix: Glossary of Critical
Terms Contained Herein
Bile acids – a collection of
steroid-based gut metabolites, the balance of the amount of and
types of bile acids in the gut microbiome are believed to play an
important role in the development of or prevention of an initial
and potential recurrent infection of Clostridioides difficile.i
Bloodstream infections – an
infectious disease defined by the presence of viable bacterial or
fungal microorganisms in the bloodstream that elicit or have
elicited an inflammatory response.ii
Carbapenem-Resistant Enterobacteriaceae
(“CRE”) – Enterobacteriaceae that are resistant to
carbapenems, a type of antibiotic used to treat some of the most
resistant forms of gram-negative bacteria. This resistance
means that there are fewer options available to treat infections
caused by these bacteria, as CRE do not respond to commonly used
antibiotics. In many cases, including infections such as
urinary tract infections caused by CRE germs, more complex
treatments are required. Instead of taking oral antibiotics at
home, patients with these infections might require hospitalization
and intravenous (IV) antibiotics. Occasionally CRE are
resistant to all available antibiotics. CRE are a threat to
public health.iii
Clostridioides difficile
(C. difficile or C. diff.) – a germ (bacterium)
that can cause severe diarrhea and colitis (an inflammation of the
colon). C. difficile can live naturally in the intestines
(gut) of humans and not cause any problem. Sometimes changes in the
gut microbiome lead the bacteria to grow and produce toxins from
which illness can develop.iv
C. diff. Infection
(CDI) – a bacterial infection of the colon that produces
toxins causing inflammation of the colon and severe watery
diarrhea, very painful and persistent abdominal cramping, nausea,
fever, and dehydration. CDI can also result in more serious disease
complications, including bowel perforation (a tear in the
gastrointestinal tract), sepsis, and death. Most cases of C.
diff. infection occur while a person is taking antibiotics or not
long after a person has finished taking antibiotics. CDI is
an insidious and debilitating disease that necessitates patient
isolation because of its contagious nature, making it able to be
passed from one person to another either in a hospital or long-term
care facility setting or in the community.v
DDS-04 – a series of new
mechanism antibiotics targeting Enterobacteriaceae. DDS-04
acts via LolCDE, an essential bacterial complex responsible for the
transport of lipoproteins from the inner to outer membrane in
gram-negative bacteria. Because this complex has not been a
previous target of existing antimicrobials, bacterial resistance
does not yet exist to this targeted approach, potentially allowing
for the treatment of highly-resistant Enterobacteriaceae-caused
infections. Some of these infections, particularly in a
subset of CRE-caused infections, do not have effective treatments
through currently available antibiotics.vi
Discuva Platform – Summit
Therapeutics’ proprietary platform that enables the identification
of novel antimicrobials to expand Summit’s pipeline of
investigational drugs. The Discuva Platform focuses on
identifying new antibiotics against bacteria where increasing
resistance has limited treatment via existing antibiotics currently
on the market.vii
Enterobacteriaceae – a large
family of different types of bacteria (germs) that commonly cause
infections both in healthcare settings, such as hospitals and
long-term care facilities, and in communities. Examples of germs in
the Enterobacteriaceae family include Escherichia coli (commonly
known as E. coli) and Klebsiella pneumoniae.
Enterobacteriaceae are frequent carriers of resistance genes to
many of the currently available antibiotics used to treat bacterial
infections. Because they are bacteria, Enterobacteriaceae can
be passed from person to person.viii
Escherichia coli (E. coli) – a
type of Enterobacteriaceae found in the environment, foods, and
intestines of people and animals. E. coli are a large and diverse
group of bacteria. Although most strains of E. coli are harmless,
others can make a person sick. Some kinds of E. coli can cause
diarrhea, while others cause urinary tract infections, bloodstream
infections, respiratory illness and pneumonia, and other
illnesses.ix
Gastrointestinal tract – a
series of hollow organs joined in a long, twisting tube from the
mouth to the anus. These organs also include the esophagus,
stomach, small intestine, and large intestine.x
Gut microbiome – within the
human gastrointestinal tract, the gut microbiome is a collection of
microbiota, consisting of trillions of microorganisms that inhabit
the gut. The gut microbiota is considered an important
partner to human cell systems, interacting extensively with other
organs in the body to influence a wide range of functions from
digestion to immunity. The balance of the different types of
cells and microorganisms within the microbiome is considered to be
important in the microbiome's ability to properly play its role
within the human body. Disruption in the balance of
microorganisms within the gut microbiome (known as dysbiosis) is
believed to impact its role in keeping a person healthy and free of
certain conditions or diseases.xi xii
Hospital-acquired pneumonia
(HAP) – pneumonia that occurs 48 hours or more
after a patient has been admitted to a hospital and was not present
and incubating at the time of admission.
Ventilator-associated pneumonia (VAP) is a significant sub-set of
HAP, often occurring in intensive care units (ICUs) with a patient
on a ventilator. Common pathogens of HAP and VAP include
Enterobacteriaceae and Pseudomonas species. Due to the
presence of the bacteria in a hospital, these bacteria may be
resistant to different antibiotics, potentially causing the
resulting infection to be more difficult to treat.xiii
Klebsiella pneumoniae – a type
of Enterobacteriaceae that can cause different types of
healthcare-associated infections, including pneumonia, bloodstream
infections, wound or surgical site infections, and meningitis.
Increasingly, Klebsiella bacteria have developed resistance to
antibiotics, most recently to the class of antibiotics known as
carbapenems. Klebsiella bacteria are normally found in the human
intestines (where they do not cause disease). In healthcare
settings, Klebsiella infections commonly occur among sick patients
who are receiving treatment for other conditions. Patients
whose care requires devices like ventilators (breathing machines)
or intravenous (vein) catheters, and patients who are receiving
long courses of certain antibiotics are most at risk for Klebsiella
infections. Healthy people typically do not develop Klebsiella
infections.xiv
Ri-CoDIFy Clinical Trials – Two
clinical trials in the Phase 3 stage of drug development for
ridinilazole, a novel antibiotic being tested by Summit
Therapeutics for the treatment of CDI. The goal of the
clinical trials is to achieve comparable cure rates of CDI to the
current standard of care (vancomycin) and reduce rates of recurrent
CDI.xv
Sepsis – the body’s extreme
response to an infection and a life-threatening medical
emergency. Sepsis occurs when an existing infection triggers
a chain reaction throughout a person’s body via the
bloodstream. Without timely treatment, sepsis can rapidly
lead to tissue damage, multi-organ failure, and death. Almost
any type of infection can lead to sepsis. Infections that lead to
sepsis most often start in the lung, urinary tract, skin, or
gastrointestinal tract. Sepsis is a condition and is not
contagious; however, the underlying cause of the infection (e.g.,
bacteria) can be spread from person to person. Bacterial
infections cause most cases of sepsis.xvi
Urinary tract infections (UTI)
– common infections that happen when bacteria, often from the skin
or rectum, enter the urethra, and infect the urinary tract. The
infections can affect several parts of the urinary tract, but the
most common type is a bladder infection. Kidney infections
are another type of UTI and can be more serious than bladder
infections. UTIs are usually caused by bacteria and are
treated with antibiotics. People who have had multiple UTIs
requiring multiple courses of antibiotics are at increased risk of
developing antibiotic-resistant infections that can become
increasing complex to treat.xvii
Vancomycin – an antibiotic that
is used to treat CDI when taken by mouth.
_____________________________
i Qian, X, et. al. Ridinilazole, a narrow spectrum antibiotic
for treatment of Clostridioides difficile infection, enhances
preservation of microbiota-dependent bile acids. Am J Physiol
Gasterintest Liver Physiol 319: G227-G237, 2020.
ii Viscoli C. Bloodstream Infections: The peak of the iceberg.
Virulence. 7(3):248-251, 2016.
iii United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/hai/organisms/cre/index.html. Accessed
February 2021.
iv Virginia Department of Health.
https://www.vdh.virginia.gov/epidemiology/epidemiology-fact-sheets/clostridiodes-difficile/.
Accessed February 2021.
v United States Centers for Disease Control and
Prevention. https://www.cdc.gov/cdiff/what-is.html.
Accessed February 2021.
vi Summit Therapeutics, Inc.
https://www.summittxinc.com/our-programmes/enterobacteriaceae/.
Accessed February 2021.
vii Summit Therapeutics, Inc.
https://www.summittxinc.com/our-science/discuva-platform/.
Accessed February 2021.
viii United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/hai/organisms/ESBL.html. Accessed
February 2021.
ix United States Centers for Disease Control and
Prevention. https://www.cdc.gov/ecoli/index.html.
Accessed February 2021.
x US National Institute of Health, National Institute of
Diabetes and Digestive and Kidney Diseases.
https://www.niddk.nih.gov/health-information/digestive-diseases/digestive-system-how-it-works.
Accessed February 2021.
xi Cani PD. Human gut microbiome: hopes, threats and
promises. British Medical Journal (BMJ) Gut
67:1716-1725, 2018.
xii Qian, X, et. al. Ridinilazole, a narrow spectrum antibiotic
for treatment of Clostridioides difficile infection, enhances
preservation of microbiota-dependent bile acids. Am J Physiol
Gasterintest Liver Physiol 319: G227-G237, 2020.
xiii Shebl E, Gulick PG. Nosocomial Pneumonia. StatPearls.
Updated 2020 Jul 21.
xiv United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/hai/organisms/klebsiella/klebsiella.html.
Accessed February 2021.
xv Ri-CoDIFy 1 and Ri-CoDIFy 2 as per ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT03595553 and
https://clinicaltrials.gov/ct2/show/NCT03595566. Accessed
February 2021.
xvi United States Centers for Disease Control and
Prevention. https://www.cdc.gov/sepsis/index.html.
Accessed February 2021.
xvii United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/antibiotic-use/community/for-patients/common-illnesses/uti.html.
Accessed February 2021.
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