Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the
"Company") today reports its financial results and provides an
update on its operational progress for the third quarter and nine
months ended September 30, 2021.
Note: A glossary of terms is included at the end
of this document in order to allow for the ease of understanding of
terms or concepts used throughout this release.
Financial Highlights
-
Aggregate cash, accounts receivable, and tax credits receivable on
September 30, 2021 totaled $103.9 million as compared to $76.6
million on December 31, 2020. Our cash balance on September 30,
2021 was $80.2 million as compared to $66.4 million on December 31,
2020. Accounts receivable and research and development tax credits
receivable on September 30, 2021 were $23.7 million as compared to
$10.2 million on December 31, 2020.
-
Net loss for the three months ended September 30, 2021 and 2020,
was $19.6 million and $17.7 million, respectively. Net
loss for the nine months ended September 30, 2021 and 2020, was
$61.5 million and $39.2 million, respectively.
-
In September 2021, the Company reached the second enrollment
milestone under its exclusive license and commercialization
agreement with Eurofarma Laboratórios S.A. and billed $1.25 million
associated with achieving this milestone, the balance of which was
received in November.
-
During the three months ended September 30, 2021, the Company
received non-dilutive funding of $1.1 million from the
Biomedical Advanced Research and Development Authority ("BARDA"),
part of the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services, in
support of the Company's Ri-CoDIFy clinical trials and clinical
development of ridinilazole. As of September 30, 2021, an aggregate
of $55.8 million out of a potential award of $72.5 million has
been received from BARDA under contract number HHSO100201700014C.
(Remaining potential funding from BARDA has not been included in
our previously disclosed aggregate cash and receivables balances,
above.)
-
During the three months ended September 30, 2021, the Company
received non-dilutive funding of $0.2 million from the
Trustees of Boston University under the Combating Antibiotic
Resistant Bacteria Biopharmaceutical Accelerator ("CARB-X")
program, in support of IND-enabling activities for SMT-738. As of
September 30, 2021, an aggregate of $0.2 million out of a
potential of up to $7.8 million of funding has been received from
CARB-X.
Ridinilazole for C. difficile Infection
(CDI)Summit’s global Phase III clinical trial program for
ridinilazole aims to support application for marketing approval of
the precision antibiotic in the United States and other
territories, with the goal of use of ridinilazole as first-line
therapy to treat initial infection and reduce recurrence of
Clostridioides difficile Infection (CDI). 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 the disease. Using data from our Phase II clinical
trial, ridinilazole has shown a relative sparing of the microbiome
compared to the broad-spectrum antibiotics that are the current
standard of care for C. diff. Infection treatment today, as
presented at ECCMID 2021. In addition, the use of broad-spectrum
antibiotics and a perturbed gut microbiome may be associated with
certain other infectious diseases, including COVID-19 (Giovanni,
Schneider, Calder, and Fauci, Journal of Infectious Diseases, Aug
2021).
As announced in August 2021, the Company
combined its Ri-CoDIFy 1 and 2 studies into a single,
fully-enrolled clinical trial. Top-line results for this combined
trial are expected in Q1 2022. The Ri-CoDIFy 3 clinical trial is
currently enrolling adolescent subjects ages 12 to 17 years to
evaluate the safety of the investigational drug and how it is
metabolized in such patients.
Discuva PlatformSMT-738 for
Carbapenem-Resistant Enterobacteriaceae Infections
The DDS-04 compound series is a novel class of
precision antibiotics generated from our Discuva Platform with a
new mechanism of action that acts via the clinically unexploited
bacterial target, LolCDE. SMT-738 is the first molecule of this
novel class with the potential to treat multidrug resistant
infections caused by a large family of pathogenic Gram-negative
bacteria, the Enterobacteriaceae, that include serious human
pathogens such as Escherichia coli and Klebsiella pneumoniae.
Combining a novel antibiotic class (SMT-738) with a clinically
unexploited target (LolCDE) mitigates the risk of pre-existing
resistance, potentially allowing for the effective treatment of
Enterobacteriaceae-caused infections that currently have very
limited and failing treatment options due to resistance to existing
antibiotic classes.
Corporate Highlights
-
In July, the Company presented breakthrough research data from its
Phase II clinical trials for ridinilazole. Topics included evidence
from Phase II trial sample data evidencing ridinilazole's
preservation of the gut microbiome, potential benefits for the
control of antimicrobial resistance related to the minimal impact
of ridinilazole on the gut resistome, and a novel mechanism of
action for ridinilazole. These topics were displayed in the form of
three ePosters at the prestigious ECCMID 2021 conference, one of
which was an ECCMID-designated Top Rated ePoster. These posters can
be found on our corporate website,
www.summittxinc.com/publications.
-
On August 11, the Company announced that, based on a thorough
review of the design and enrollment status of two ongoing blinded
Phase III Ri-CoDIFy trials, it will combine its two blinded pivotal
Phase III clinical trials evaluating ridinilazole versus vancomycin
into a single study.
-
On October 7, Kenneth A. Clark, a prominent advisor to
biotechnology and biopharmaceutical companies, was appointed to the
Company’s Board of Directors. Mr. Clark is a partner at Wilson
Sonsini Goodrich & Rosati (WSGR). He has previously served as a
board member for privately-held and publicly-traded companies,
including Pharmacyclics, Inc., where Mr. Clark advised on two
significant transactions, highlighted by Pharmacyclics’ $21 billion
acquisition by AbbVie, one of the largest bio/pharma acquisitions
of its kind. He received his undergraduate degree from Vanderbilt
University and earned his juris doctorate from the University of
Texas School of Law.
-
On November 3, Dr. Urte Gayko, a seasoned regulatory and clinical
development executive, was appointed to the Company’s Board of
Directors. Dr. Gayko is the Senior Vice President of Drug
Development & Regulator Affairs at Nektar Therapeutics; she was
previously the Global Head of Regulatory Affairs and
Pharmacovigilance at Pharmacyclics, Inc. Dr. Gayko has over 20
years of experience in regulatory affairs and clinical development
ranging from pre-commercial entities to large biopharmaceutical
companies, including Amgen and AbbVie. Dr. Gayko performed her PhD
research in molecular and cellular biology at Harvard
University.
-
Throughout the first three quarters of 2021, we have continued to
build supporting layers to our team to fit the expansive vision of
our company going forward. In doing so, we have appointed several
individuals to positions of senior leadership, continuing to
enhance the strong existing core leadership team and positioning
the Company well for our strategic goals in the coming years.
Leaders who have joined in Q3 and the beginning of Q4 comprise
Heads of departments including, but not limited to, Marketing,
Clinical Pharmacology & DMPK, Clinical Development, Information
Technology, Market Access, and our General Counsel. Each of these
leaders brings substantial experience and are respected leaders
within their fields.
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, 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 facilities, and the wider community. Summit
estimates that there are approximately 500,000 cases of CDI each
year across the United States with acute care costs exceeding $5.4
billion in the US based on a meta-analysis 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 existent antibiotics. The most difficult to treat
among them are the carbapenem-resistant Enterobacteriaceae (CRE),
which are classified as an Urgent Threat by the US Centers for
Disease Control and Prevention (CDC).
About Summit Therapeutics The overriding
objective of Summit Therapeutics is to create value for patients,
hospital caregivers, and community-based 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 or effect 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. Summit Therapeutics,
empowered by its Discuva Platform, the Company’s innovative
antibiotic discovery engine, and supported by BARDA and CARB-X
funding, intends to be the leader in patient-friendly and
paradigm-shifting treatments for infectious diseases and other
significant unmet medical needs while being an ally to
physicians. Our new mechanism pipeline product candidates are
designed with the goal 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 diseases,
initially focusing on Clostridioides difficile infection
(CDI). Currently, Summit’s lead product candidate,
ridinilazole, is a novel, first-in-class drug engaged in a global
Phase III trial program versus vancomycin, for use as first-line
therapy for the treatment of initial and recurrent Clostridioides
difficile infection, and to show superiority in sustained clinical
response. Commercialization of ridinilazole is subject to
regulatory approvals. SMT-738, the second candidate within
Summit’s portfolio, is currently in the IND-enabling phase for the
treatment of multidrug resistant infections, specifically those
caused by carbapenem-resistant Enterobacteriaceae (CRE).
For more information, please visit
https://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 GancarzHead of Stakeholder 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.
Any change to our ongoing trials could cause delays, affect our
future expenses, and add uncertainty to our commercialization
efforts, as well as to affect the likelihood of the successful
completion of clinical development of ridinilazole.
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.
SUMMIT THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)In thousands, except per share
data
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue |
$ |
1,309 |
|
|
$ |
181 |
|
|
$ |
1,558 |
|
|
$ |
675 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
19,943 |
|
|
13,726 |
|
|
62,245 |
|
|
40,210 |
|
General and administrative |
5,662 |
|
|
6,846 |
|
|
15,831 |
|
|
16,192 |
|
Impairment of intangible assets |
— |
|
|
859 |
|
|
— |
|
|
859 |
|
Total
operating expenses |
25,605 |
|
|
21,431 |
|
|
78,076 |
|
|
57,261 |
|
Other
operating income |
4,810 |
|
|
4,309 |
|
|
16,379 |
|
|
14,949 |
|
Operating
loss |
(19,486) |
|
|
(16,941) |
|
|
(60,139) |
|
|
(41,637) |
|
Other
(expense) income, net |
(113) |
|
|
(858) |
|
|
(1,364) |
|
|
2,289 |
|
Loss
before income tax |
(19,599) |
|
|
(17,799) |
|
|
(61,503) |
|
|
(39,348) |
|
Income tax
benefit |
— |
|
|
56 |
|
|
— |
|
|
192 |
|
Net
loss |
$ |
(19,599) |
|
|
$ |
(17,743) |
|
|
$ |
(61,503) |
|
|
$ |
(39,156) |
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
$ |
(0.20) |
|
|
$ |
(0.26) |
|
|
$ |
(0.68) |
|
|
$ |
(0.58) |
|
|
|
|
|
|
|
|
|
Other
comprehensive (loss) income: |
|
|
|
|
|
|
|
Foreign
currency translation adjustments |
(863) |
|
|
2,326 |
|
|
352 |
|
|
(2,350) |
|
Comprehensive loss |
$ |
(20,462) |
|
|
$ |
(15,417) |
|
|
$ |
(61,151) |
|
|
$ |
(41,506) |
|
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In thousands
|
|
September 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
Cash |
|
$ |
80,248 |
|
|
$ |
66,417 |
|
Total
assets |
|
128,673 |
|
|
102,498 |
|
Total
liabilities |
|
26,375 |
|
|
23,045 |
|
Total
stockholders' equity |
|
102,298 |
|
|
79,453 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS INFORMATION(Unaudited)In thousands
|
|
Nine Months EndedSeptember
30, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Net cash
used in operating activities |
|
$ |
(63,408) |
|
|
$ |
(40,140) |
|
Net cash
used in investing activities |
|
(186) |
|
|
(371) |
|
Net cash
provided by financing activities |
|
76,655 |
|
|
3 |
|
Effect of
exchange rate changes on cash |
|
770 |
|
|
(2,064) |
|
|
|
|
|
|
Increase
(decrease) in cash |
|
$ |
13,831 |
|
|
$ |
(42,572) |
|
Appendix: Glossary of Critical Terms
Contained Herein
Antibiotic resistance genes – Genes known
to be involved in bacterial resistance; such genes may include for
example beta-lactamases which can inactivate various beta-lactam
antibiotics.
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 instance of C. difficile Infection.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
Clostridia – a class of bacteria that
exist within a healthy gut microbiome that likely plays a largely
crucial role in microbiome homeostasis by interacting with the
other resident microbe populations and providing specific and
essential functions to the overall microbiome. While most groups of
Clostridia have a commensal, or co-existing, relationship with the
rest of the gut microbiome, some Clostridia can be pathogenic, when
larger concentrations of the bacteria exist, such as Clostridioides
difficile bacteria.iv
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.v
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.vi
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.vii
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.viii
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.ix
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.x
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.xi
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 the gut microbiome's role in keeping a person
healthy and free of certain conditions or diseases.xii xiii
Gut microbiota – the trillions of
microorganisms, including symbiotic and pathogenic microorganisms,
that inhabit the gut. Examples of these microorganisms
include bacteria, fungi, viruses, protists, and archaea.
Gut resistome – within the human
gastrointestinal tract, the diversity and dynamics of the
antibiotic resistance genes that are harbored by the gut
microbiota. Examples of the gut resistome include genes
associated with resistance to carbapenem antibiotics.xiv
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.xv
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.xvi
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.xvii
Shotgun metagenomic analysis – shotgun metagenomic
sequencing sequences all genomic DNA present in a sample. This
allows a more accurate taxonomic annotation of the microbiota
compared to other techniques such as 16S rRNA amplicon sequencing
as well as antibiotic resistance gene profiling and metabolic
function profiling.
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.xviii
Vancomycin – an antibiotic that is used
to treat CDI
_____________________________
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 Lopetuso, L.R., et al. Commensal Clostridia: leading players
in the maintenance of gut homeostasis. Gut Pathog 5, 23, 2013.
v Virginia Department of Health.
https://www.vdh.virginia.gov/epidemiology/epidemiology-fact-sheets/clostridiodes-difficile/.
Accessed February 2021.
vi United States Centers for Disease Control and
Prevention. https://www.cdc.gov/cdiff/what-is.html.
Accessed February 2021.
vii Summit Therapeutics, Inc.
https://www.summittxinc.com/our-programmes/enterobacteriaceae/.
Accessed February 2021.
viii Summit Therapeutics, Inc.
https://www.summittxinc.com/our-science/discuva-platform/.
Accessed February 2021.
ix United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/hai/organisms/ESBL.html. Accessed
February 2021.
x United States Centers for Disease Control and
Prevention. https://www.cdc.gov/ecoli/index.html.
Accessed February 2021.
xi 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.
xii Cani PD. Human gut microbiome: hopes, threats and
promises. British Medical Journal (BMJ) Gut
67:1716-1725, 2018.
xiii 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.
xiv van Schaik, W. The human gut resistome. Philos Trans R Soc
Lond B Biol Sci. 370(1670):20140087, 2015.
xv Shebl E, Gulick PG. Nosocomial Pneumonia. StatPearls.
Updated 2020 Jul 21.
xvi United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/hai/organisms/klebsiella/klebsiella.html.
Accessed February 2021.
xvii United States Centers for Disease Control and
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