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 second quarter and six
months ended June 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
- Cash and cash equivalents on June 30, 2021, was $103.4
million, as compared to $66.4 million on December 31, 2020.
-
In April, the Company commenced a Rights Offering for our existing
shareholders to participate in the purchase of additional shares of
our common stock, in which the associated subscription rights
expired on May 10, 2021. Through this Rights Offering, the
Company raised $75 million through the issuance and sale of 14.3
million shares of common stock. Of the $75 million raised
through the Rights Offering, $55 million was used to repay an
outstanding note payable, which was issued in the previous quarter
to initiate our fund raising for the current year.
-
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 for at least the next twelve months.
-
Net loss for the three months ended June 30, 2021, was
$24.4 million, as compared to a net loss of $15.3 million
for the three months ended June 30, 2020. Net loss for the six
months ended June 30, 2021, was $41.9 million, as compared to
a net loss of $21.4 million for the six months ended June 30,
2020.
- BARDA, in its support of our Ri-CoDIFy clinical
trials and regulatory development of ridinilazole, has provided
Summit with a financial award, potentially funding of up to
$72.5 million. As of June 30, 2021, an aggregate of
$54.7 million had been received by Summit from BARDA.
Ridinilazole for C.
difficile Infection (‘CDI’)In conjunction
with this release, we have simultaneously issued a press release
today providing an update with respect to our Phase III Ri-CoDIFy
clinical trials. Please refer to that release for our current
operational progress with respect to ridinilazole.
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 novel 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 May, the Company announced its selection of a new
pre-clinical candidate, SMT-738, for development in the fight
against multidrug resistant infections, specifically CRE
infections. Simultaneously, Summit has received an award from
CARB-X to progress this candidate through preclinical development
and Phase Ia clinical trials. The award commits initial funding of
up to $4.1 million, with the possibility of up to another $3.7
million based on the achievement of future milestones.
-
In June, during our Annual Shareholders' Meeting, we announced our
intention to expand our pipeline beyond infectious diseases, and we
have begun and will continue to evaluate products and companies
with a focus on oncology and the health of the microbiome, in
addition to anti-infectives.
-
In June, the Company's NASDAQ-listed shares joined the broad-market
Russell 2000® Index at the conclusion of the 2021 Russell indexes
annual reconstitution.
-
In July, the Company presented breakthrough research data from our
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.
-
Throughout the first half 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 Q2 and the beginning of Q3 comprise
Heads of departments including, but not limited to, Research
(Oncology & Inflammation), Biometrics, Marketing, Clinical
Pharmacology & DMPK, Clinical Development, Information
Technology, 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 existing 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 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 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. 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 EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
Licensing
agreements |
$ |
57 |
|
|
$ |
170 |
|
|
$ |
249 |
|
|
$ |
494 |
|
Total
revenue |
57 |
|
|
170 |
|
|
249 |
|
|
494 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
23,923 |
|
|
13,572 |
|
|
42,302 |
|
|
26,484 |
|
General and administrative |
5,984 |
|
|
5,774 |
|
|
10,169 |
|
|
9,346 |
|
Total
operating expenses |
29,907 |
|
|
19,346 |
|
|
52,471 |
|
|
35,830 |
|
Other
operating income |
6,120 |
|
|
3,820 |
|
|
11,569 |
|
|
10,640 |
|
Loss from
operations |
(23,730) |
|
|
(15,356) |
|
|
(40,653) |
|
|
(24,696) |
|
Other income
(expense), net |
(686) |
|
|
(114) |
|
|
(1,251) |
|
|
3,147 |
|
Loss before
income tax |
(24,416) |
|
|
(15,470) |
|
|
(41,904) |
|
|
(21,549) |
|
|
|
|
|
|
|
|
|
Income tax benefit |
— |
|
|
191 |
|
|
— |
|
|
136 |
|
Net
loss |
$ |
(24,416) |
|
|
$ |
(15,279) |
|
|
$ |
(41,904) |
|
|
$ |
(21,413) |
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
$ |
(0.27) |
|
|
$ |
(0.23) |
|
|
$ |
(0.48) |
|
|
$ |
(0.32) |
|
|
|
|
|
|
|
|
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
Foreign
currency translation adjustment |
540 |
|
|
(52) |
|
|
1,215 |
|
|
(4,676) |
|
Total
comprehensive loss |
$ |
(23,876) |
|
|
$ |
(15,331) |
|
|
$ |
(40,689) |
|
|
$ |
(26,089) |
|
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In
thousands
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
103,386 |
|
|
$ |
66,417 |
|
Total
assets |
|
145,517 |
|
|
102,498 |
|
Total
liabilities |
|
26,090 |
|
|
23,045 |
|
Total
stockholders' equity |
|
119,427 |
|
|
79,453 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOW INFORMATION(Unaudited)In
thousands
|
|
Six Months EndedJune 30, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Net cash
used in operating activities |
|
$ |
(39,843) |
|
|
$ |
(23,492) |
|
Net cash
used in investing activities |
|
(190) |
|
|
(327) |
|
Net cash
provided by financing activities |
|
75,979 |
|
|
3 |
|
Effect of
exchange rates in cash and cash equivalents |
|
1,023 |
|
|
(3,616) |
|
|
|
|
|
|
Net
increase / (decrease) in cash and cash equivalents |
|
$ |
36,969 |
|
|
$ |
(27,432) |
|
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 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 the gut microbiome's role in keeping a person
healthy and free of certain conditions or diseases.xi xii
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.xiii
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.xiv
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.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
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.xvii
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 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 van Schaik, W. The human gut resistome. Philos Trans R Soc
Lond B Biol Sci. 370(1670):20140087, 2015.
xiv Shebl E, Gulick PG. Nosocomial Pneumonia. StatPearls.
Updated 2020 Jul 21.
xv United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/hai/organisms/klebsiella/klebsiella.html.
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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