Cambridge, MA, May 17, 2021 - Summit Therapeutics Inc.
(NASDAQ: SMMT) today reports its financial results and provides an
update on its operational progress for the first quarter ended
March 31, 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 in advance of reviewing this
release.
Ridinilazole for C. difficile Infection
(‘CDI’)
- As of May 14, 2021, Summit had enrolled a total of 652
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 |
109 |
603 |
Q2 2021* |
49* |
652* |
*Q2 2021 includes quarter-to-date enrollment
through May 14, 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 March 31, 2021, an
aggregate of $53.9 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 has,
thus far, shown a significant relative sparing of the microbiome
compared to the broad-spectrum antibiotics that are the current
standard of care for C. diff infection treatment today.
Discuva Platform
EnterobacteriaceaeThe DDS-04 compound series is
a novel 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 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
carbapenem-resistant Enterobacteriaceae (CRE)-caused infections,
have limited or failing treatment options through currently
available antibiotics.
Corporate HighlightsIn March 2021, Summit
launched its Ri-CoDIFy 3 study, an additional Phase 3 clinical
trial for the study of the use of ridinilazole in adolescents 12 to
17 years of age. The study, which is expected to enroll
approximately 40 patients, has an aim to determine the safety of
ridinilazole in adolescents as a part of the overall support for
our Phase 3 program.
Financial Highlights
- Cash and cash equivalents on March 31, 2021, of $102.2
million compared to $66.4 million on December 31, 2020. The
balance as of March 31, 2021, includes $55 million in proceeds
received in connection with a Note Purchase Agreement with Robert
W. Duggan, the Company’s Chairman, Chief Executive Officer, and
majority shareholder.
-
In March 2021, the Company announced a Rights Offering for our
existing shareholders to participate in the purchase of additional
shares our common stock, which commenced in April 2021 and the
associated subscription rights expired on May 10, 2021.
Through this Rights Offering, the Company raised $75 million
through the issuance and sale of 14,312,976 shares of common
stock. Of the $75 million raised through the Rights Offering,
$55 million was used to repay an outstanding note
payable.
-
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 2022.
-
Net loss for the three months ended March 31, 2021, of $17.5
million compared to a net loss of $6.1 million for the three months
ended March 31, 2020.
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 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
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 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 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 pivotal 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 in addition
to an adolescent trial, Ri-CoDIFy 3. 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.
SUMMIT THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)In thousands, except share and per
share data
|
|
Three Months EndedMarch 31, |
|
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
Licensing
agreements |
|
$ |
192 |
|
|
$ |
324 |
|
Total
revenue |
|
192 |
|
|
324 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Research
and development |
|
18,379 |
|
|
12,912 |
|
General
and administrative |
|
4,185 |
|
|
3,572 |
|
Total
operating expenses |
|
22,564 |
|
|
16,484 |
|
Other
operating income |
|
5,449 |
|
|
6,820 |
|
Loss from
operations |
|
(16,923) |
|
|
(9,340) |
|
Other
income (expense), net |
|
(565) |
|
|
3,261 |
|
Loss
before income tax |
|
(17,488) |
|
|
(6,079) |
|
|
|
|
|
|
Income tax
expense |
|
— |
|
|
(55) |
|
Net
loss |
|
$ |
(17,488) |
|
|
$ |
(6,134) |
|
|
|
|
|
|
Basic and
diluted loss per share |
|
$ |
(0.21) |
|
|
$ |
(0.09) |
|
|
|
|
|
|
Other
comprehensive income / (loss): |
|
|
|
|
Foreign
currency translation adjustment |
|
675 |
|
|
(4,624) |
|
Total
comprehensive loss |
|
$ |
(16,813) |
|
|
$ |
(10,758) |
|
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In thousands
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
102,194 |
|
|
$ |
66,417 |
|
Total
assets |
|
140,794 |
|
|
102,498 |
|
Total
liabilities |
|
76,389 |
|
|
23,045 |
|
Total
stockholders' equity |
|
64,405 |
|
|
79,453 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
INFORMATION(Unaudited)In thousands
|
|
Three Months EndedMarch 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Net
cash used in operating activities |
|
$ |
(20,669) |
|
|
$ |
(4,959) |
|
Net
cash used in investing activities |
|
(39) |
|
|
(194) |
|
Net
cash provided by financing activities |
|
55,897 |
|
|
3 |
|
Effect
of exchange rates in cash and cash equivalents |
|
588 |
|
|
(3,749) |
|
|
|
|
|
|
Net
increase / (decrease) in cash and cash equivalents |
|
$ |
35,777 |
|
|
$ |
(8,899) |
|
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
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.xv
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.xvi
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 United States Centers for Disease Control and
Prevention. https://www.cdc.gov/sepsis/index.html.
Accessed February 2021.
xvi 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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