Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the
"Company") today reports its financial results and provides an
update on operational progress for the first quarter ended March
31, 2022.
Note: A glossary of terms is included at the end
of this document 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 March 31, 2022 totaled
$95.3 million as compared to $89.0 million on December 31,
2021. Our cash balance on March 31, 2022 was $77.5 million as
compared to $71.8 million on December 31, 2021. Accounts
receivable and research and development tax credits receivable on
March 31, 2022 were $17.8 million as compared to $17.2 million on
December 31, 2021.
- On March 10, 2022, Robert W.
Duggan, the Company’s Chairman and Chief Executive Officer,
provided an unsecured loan to the Company in the amount of $25.0
million. The loan accrues interest at annual rate equal to the
prime rate as reported in the Wall Street Journal, which was 3.50%
as of March 31, 2022. The loan becomes due upon the earlier of (i)
the consummation of a registered public offering with net proceeds
of no less than $25.0 million or (ii) 18 months from the date of
issuance of the loan.
- Net loss for the three months ended
March 31, 2022 and three months ended March 31, 2021, was
$21.4 million and $17.5 million, respectively.
- Operating cash outflow for the
three months ended March 31, 2022 and three months ended March 31,
2021, was $19.0 million and $20.7 million,
respectively.
- During the three months ended March
31, 2022, the Company received non-dilutive funding of $1.5 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 March 31,
2022, an aggregate of $57.9 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 aggregate cash and receivables balances, above.)
- Our contract with BARDA was set to expire on April 30, 2022.
The contract was extended through December 2022 as a no cost
contract, solely to close out open activities.
- During the three months ended March
31, 2022, the Company received non-dilutive funding of $0.5 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 March 31, 2022, an aggregate of $0.9 million out of
a potential of up to $7.8 million of funding has been received from
CARB-X. (Remaining potential funding from CARB-X has not been
included in aggregate cash and receivables balances, above.)
Operational & Corporate
Updates
Our intention is to expand our pipeline product
portfolio in the therapeutic areas of oncology and infectious
diseases and/or product offerings that are designed to work in
harmony with the human gut microbiome.
Throughout the process of our clinical
development of ridinilazole, we learned a substantial amount
regarding the function of the microbiome as we sought to reduce C.
difficile infection recurrence to the lowest practical levels. Our
leadership team brings substantial experience in the therapeutic
treatment areas of oncology and anti-infectives, in addition to our
recent work surrounding the gut microbiome. We plan to move forward
in one or more of these fields. We intend to enact this through
business development activities, including possible acquisitions
and/or collaborations.
We intend to communicate the data associated
with our Ri-CoDIFy Phase III trial for ridinilazole to the FDA
later this year.
We are continuing to perform IND-enabling
activities for our second drug candidate, SMT-738.
Summit Therapeutics’ Mission
StatementTo build a viable, long-lasting health care
organization that assumes full responsibility for designing,
developing, trial execution and enrollment, regulatory submission
and approval, and successful commercialization of patient,
physician, caregiver, and societal-friendly medicinal therapy
intended to: improve quality of life, increase potential
duration of life, and resolve serious medical healthcare needs. To
identify and control promising product candidates based on
exceptional scientific development and administrational expertise,
develop our products in a rapid, cost-efficient manner, and to
engage commercialization and/or development partners when
appropriate.
We accomplish this by building a team of world
class professional scientists and business administrators that
apply their experience and knowledge to this mission. Team Summit
exists to pose, strategize, and execute a path forward in medicinal
therapeutic health care that places Summit in a well-deserved, top
market share, leadership position. Team Summit assumes full
responsibility for stimulating continuous expansion of knowledge,
ability, capability, and well-being for all involved stakeholders
and highly-valued shareholders.
About Summit TherapeuticsSummit
was founded in 2003 and our shares are listed on the Nasdaq Global
Market (symbol ‘SMMT’). We are headquartered in Cambridge,
Massachusetts, and we have additional offices in Oxford, UK,
Cambridge, UK, and Menlo Park, California
For more information, please visit
https://www.summittxinc.com and follow us on Twitter
@summitplc.
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, potential acquisitions 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 results of our evaluation of the underlying
data in connection with the topline results of our Phase III
Ri-CoDIFy study evaluating ridinilazole, the outcome of discussions
with regulatory authorities, including the Food and Drug
Administration, the uncertainties inherent in the initiation of
future clinical trials, availability and timing of data from
ongoing and future clinical trials, the results of such trials, and
their success, and 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, whether business development opportunities to
expand the Company’s pipeline of drug candidates, including without
limitation, through potential acquisitions of, and/or
collaborations with, other entities occur, 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 Ended March 31, |
|
2022 |
|
2021 |
Revenue |
$250 |
|
$192 |
|
|
|
|
Operating
expenses: |
|
|
|
Research and development |
20,556 |
|
18,379 |
General and administrative |
6,659 |
|
4,185 |
Total
operating expenses |
27,215 |
|
22,564 |
Other
operating income |
4,807 |
|
5,449 |
Operating
loss |
(22,158) |
|
(16,923) |
Other income
(expense), net |
761 |
|
(565) |
Net
loss |
$(21,397) |
|
$(17,488) |
|
|
|
|
Basic and
diluted loss per share |
$(0.22) |
|
$(0.21) |
|
|
|
|
Comprehensive loss: |
|
|
|
Net
loss |
$(21,397) |
|
$(17,488) |
Other
comprehensive (loss) income: |
|
|
|
Foreign
currency translation adjustments |
(1,760) |
|
675 |
Comprehensive loss |
$(23,157) |
|
$(16,813) |
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)In
thousands
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
Cash |
|
$77,450 |
|
$71,791 |
Total
assets |
|
$116,472 |
|
$113,374 |
Total
liabilities |
|
$52,065 |
|
$30,090 |
Total
stockholders' equity |
|
$64,407 |
|
$83,284 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS INFORMATION(Unaudited)In
thousands
|
|
Three Months Ended March 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
Net cash
used in operating activities |
|
$(19,001) |
|
$(20,669) |
Net cash
used in investing activities |
|
(361) |
|
(39) |
Net cash
provided by financing activities |
|
25,187 |
|
55,897 |
Effect of
exchange rate changes on cash |
|
(166) |
|
588 |
|
|
|
|
|
Increase
in cash |
|
$5,659 |
|
$35,777 |
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
Microbiome - a community
of microorganisms (such as bacteria, fungi, and viruses)
that live in or on humans; the collection of microbial genomes that
contribute to the broader genetic portrait, or metagenome, of a
human.xvii
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.xviii
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.xix
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 Britannica Medical Dictionary.
https://www.britannica.com/science/microbiome. Accessed March
2022.
xviii United States Centers for Disease Control and
Prevention. https://www.cdc.gov/sepsis/index.html.
Accessed February 2021.
xix United States Centers for Disease Control and
Prevention.
https://www.cdc.gov/antibiotic-use/community/for-patients/common-illnesses/uti.html.
Accessed February 2021.
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Jul 2023 to Jul 2024