ContraFect Corporation (Nasdaq:CFRX), a clinical-stage
biotechnology company focused on the discovery and development of
direct lytic agents (DLAs), including lysins and amurin peptides,
as new medical modalities for the treatment of life-threatening,
antibiotic-resistant infections, today announced financial results
for the fourth quarter and full year ended December 31, 2019.
“We had a remarkable year of ‘firsts’ in 2019,
from announcing the first superiority dataset since vancomycin in
patients with MRSA bacteremia, to hosting our first R&D day in
New York City, to completing our first End-of-Phase 2 meeting with
the FDA which led to the initiation of our first Phase 3 trial: the
pivotal DISRUPT superiority study, to advancing our first DLA
candidate targeting a gram-negative pathogen, CF-370 for
Pseudomonas aeruginosa infections, towards an IND” said Roger J.
Pomerantz, MD, President, Chief Executive Officer, and Chairman of
ContraFect. “We continue to demonstrate our commitment to the
development of new treatment modalities with the potential for
superior clinical outcomes, as recently recognized by the
Breakthrough Therapy designation for exebacase for the treatment of
MRSA bloodstream infections. These new modalities, now more than
ever, must be prioritized as new infectious disease outbreaks take
hold and others continue to develop resistance to conventional
antibiotics,” he continued.
2019 Highlights
Initiated the Phase 3 DISRUPT Trial of
Exebacase
- In December 2019, the Company
announced the initiation of the Phase 3 DISRUPT (Direct Lysis of
Staph aureus Resistant Pathogen Trial) superiority design study of
exebacase in patients with Staph aureus bacteremia, including
right-sided endocarditis and subsequently announced in January 2020
that it began actively dosing patients. The Phase 3 DISRUPT
study of exebacase is a randomized, double-blind,
placebo-controlled clinical study conducted in the U.S. to assess
the efficacy and safety of exebacase in approximately 350 patients
with complicated Staph aureus bacteremia, including right-sided
endocarditis. Patients enrolled in the Phase 3 study will be
randomized 2:1 to receive either exebacase or placebo, with all
patients receiving standard-of-care antibiotics. The primary
efficacy endpoint will be clinical response at Day 14 in patients
with MRSA bacteremia, including right-sided endocarditis. Secondary
endpoints will include clinical response at Day 14 in the All Staph
aureus patients (MRSA and methicillin-sensitive Staph aureus
(MSSA)), 30-day all-cause mortality in MRSA patients, and clinical
response at later timepoints. The company plans to conduct an
interim futility analysis following the enrollment of approximately
60% of the study
population.
- In September 2019, the Company
completed a successful End-of-Phase 2 meeting with the U.S. Food
and Drug Administration (FDA). ContraFect obtained concurrence with
the FDA on key design features of the Phase 3 protocol, including
the study population, efficacy endpoints and safety follow-up
parameters. Importantly, the advancement of exebacase under the
FDA’s guidance for “streamlined development” provides that with
positive results, a single Phase 3 study, together with the full
package of Phase 1 and Phase 2 clinical data, along with a robust
non-clinical and PK/PD data package, would be sufficient to
potentially support a Biologics License Application (BLA) for
approval of exebacase.
- In May 2019, the Company hosted its
first investor and analyst R&D day that highlighted new
data from the exebacase Phase 2 clinical trial, demonstrating that
patients with MRSA, who were treated with exebacase and alive at
the time of discharge, had a four day lower mean length of hospital
stay and meaningful reductions in hospital readmission rates, for
both all-cause and Staph aureus infection readmissions, compared to
patients treated with standard-of-care alone.
- In April 2019, Vance G. Fowler, MD,
Professor of Medicine in the Division of Infectious Diseases at
Duke University and the principal investigator for the Phase 2
study of exebacase, presented new data from the trial at the 29th
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID). The oral presentation was entitled “Exebacase (Lysin
CF-301) Improved Clinical Responder Rates In MRSA Bacteremia
Including Endocarditis Compared To Standard Of Care Antibiotics
Alone In A First-in-Patient Phase 2 Study.”
- In January 2019, the Company
reported topline data from its Phase 2 clinical trial of exebacase
for the treatment of Staph aureus bacteremia, including
endocarditis, demonstrating clinically meaningful increases in
clinical responder rates in the pre-specified MRSA subgroup treated
with exebacase, compared to MRSA patients treated with
standard-of-care antibiotics alone, at all timepoints tested,
including a 43-percentage point higher clinical responder rate at
the Day 14 primary efficacy timepoint (p=0.010). Based on final
data from this Phase 2 superiority trial, the FDA has granted
Breakthrough Therapy designation to exebacase for the treatment of
MRSA bloodstream infections (bacteremia), including right-sided
endocarditis, when used in addition to standard-of-care (SOC)
anti-staphylococcal antibiotics in adult patients.
Advanced Portfolio of Lysins and Amurins
Targeting Gram-negative Pathogens
- In December 2019, the Company
announced the nomination towards its second IND of its DLA
candidate CF-370, targeting Pseudomonas aeruginosa (P. aeruginosa)
based on its potent in vitro bactericidal and antibiofilm activity
and in vivo activity and tolerability in preclinical models. In
preclinical rabbit models, single doses of CF-370 alone and in
addition to the antibiotic, meropenem, were tested against
multi-drug resistant P. aeruginosa to evaluate survival and
bacterial burden in lung and secondary organs. Strong efficacy
signals were observed for a single dose of CF-370 as a monotherapy,
showing longer survival compared to vehicle control and reductions
in bacterial burden in lung, kidney and spleen as well as synergy
with meropenem.
- In September 2019, the Company
presented data from an ex vivo study of its amurin peptide
candidate, Aap2-M1, at the jointly sponsored American Society of
Microbiology and European Society of Clinical Microbiology and
Infectious Disease (ASM/ESCMID) Conference on Drug Development to
Meet the Challenge of Antimicrobial Resistance. Data demonstrated a
clinically relevant concentration of Aap2-M1 eradicated
Stenotrophomonas maltophilia biofilm formed inside hemodialysis
catheters removed from patients with suspected catheter-related
bloodstream infections in the clinical care setting. These new data
provided the first evidence of the activity of an amurin peptide
against biofilm formed by a deadly gram-negative pathogen in the
setting of human infection.
- The Company also presented an
overview of its early research pipeline directed at gram-negative
pathogens at the 29th European Congress of Clinical Microbiology
and Infectious Diseases (ECCMID) held in April 2019. The “Pipeline
Talk” included new data on the ability of lysins targeting gram
negative pathogens to re-sensitize carbapenem-resistant P.
aeruginosa to imipenem.
Announced Multiple
Publications
- In November 2019, the peer-reviewed
journal, Diagnostic Microbiology and Infectious Disease, published
an article titled “In vitro activity of Exebacase (CF-301) against
clinical Staphylococcus aureus surveillance isolates from the
United States, Europe, and Latin America, 2015–2017.” The Company’s
investigation demonstrated the potent in vitro activity of
exebacase against all MSSA and MRSA surveillance isolates collected
between 2015 and 2017 from the US, EU and South America. The MSSA
and MRSA groups were equivalently susceptible to exebacase, with
MIC50/90 values of 0.5/1 mg/L and/or a range of 0.25–1
mg/L.
- In October 2019, the peer-reviewed
Antimicrobial Agents and Chemotherapy Journal of the American
Society of Microbiology (AAC) published the manuscript titled
“Antimicrobial Activity of Exebacase (Lysin CF-301) Against the
Most Common Causes of Infective Endocarditis.” The findings
demonstrate that exebacase has potent activity against all Staph
species and virulent Strep species, including S. intermedius,
S. agalactiae and S. dysgalactiae, which are some of the most
common causes of infective endocarditis.
- In June 2019, AAC published the
Company’s manuscript entitled “Postantibiotic and Sub-MIC Effects
of Exebacase (Lysin CF-301) Enhance Antimicrobial Activity against
Staphylococcus aureus.” The data demonstrate that sub-MIC
concentrations of exebacase during therapeutic use in addition to
standard-of-care antibiotics may contribute to efficacy via
sustained reductions in bacterial fitness and virulence in a series
of in vitro studies.
- In April 2019, AAC published the
Company’s article titled “The Antistaphylococcal Lysin, CF-301,
Activates Key Host Factors in Human Blood to Potentiate
Methicillin-Resistant Staphylococcus aureus Bacteriolysis.” The
results demonstrate the unique properties of exebacase, which
activates dormant host defense factors in human blood, such as
human lysozyme, to potentiate bactericidal power against
MRSA.
2019 Financial Highlights
- In December 2019 the Company
strengthened its balance sheet with the pricing of two separate
registered offerings of its common stock for a total of $20 million
dollars in addition to a concurrent $3 million private equity
placement by Pfizer Inc. Pfizer now has a senior executive serving
as a board observer on the Science and Technology Committee of the
ContraFect board of directors.
- In June 2019, the Congressionally
Directed Medical Research Programs awarded the Company $7.2 million
in funding over the course of three years from the Military
Infectious Diseases Research Program, United States Army Medical
Research and Development Command, to advance its lysin candidate,
CF-296, through IND-enabling studies. CF-296 is an engineered
variant of exebacase that may be suitable for development as a
novel therapy for bone and joint infections caused by Staph aureus,
such as prosthetic joint infections, which are notoriously poorly
responsive to current antibiotics, typically require surgery, and
are associated with substantial morbidity including long-term
disability.
- In March 2019, the Company
announced that the Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator (CARB-X) awarded the Company up to
$6.94 million in non-dilutive funding to accelerate the development
of its newly discovered and proprietary class of amurin peptides as
potential therapeutics to treat serious and potentially
life-threatening infections, including those caused by
antibiotic-resistant gram-negative ESKAPE pathogens. The award
commits initial funding up to $1.75 million with the potential to
receive an additional $5.19 million from CARB-X contingent on
reaching certain project milestones.
- In January 2019, the Company
announced that CARB-X awarded the Company $2.3 million in
additional non-dilutive funding for the development of lysin
therapeutics to treat serious, potentially life-threatening
invasive infections caused by antibiotic-resistant P. aeruginosa, a
virulent gram-negative pathogen.
Fourth quarter and Full Year 2019
Financial Results
- Research and development (R&D)
expenses were $3.9 million for the fourth quarter of 2019 compared
to $6.7 million in the comparable period in 2018. This decrease was
primarily attributable to a reduction in clinical study
expenditures as there was no active clinical study during most of
the quarter compared to the continuation of the Company’s Phase 2
study of exebacase in the fourth quarter of 2018. R&D expenses
for the full year 2019 were $18.1 million compared to $22.4 million
for the full year 2018. This decrease was again primarily
attributable to the reduction in clinical study expenditures as
there was no active study during most of 2019 compared to the
completion of enrollment and continuing safety follow-up of the
Phase 2 study in 2018.
- General and administrative
(G&A) expenses were $2.6 million for the fourth quarter of 2019
compared to $2.1 million in the comparable period in 2018. This
increase was due primarily to an increase in legal fees for general
corporate matters and expansion of the Company’s intellectual
property portfolio. G&A expenses for the full year 2019 were
$9.8 million compared to $8.7 million for the full year 2018. This
increase was due primarily to increases in legal fees for general
corporate matters and expansion of the Company’s intellectual
property portfolio, consulting fees for investor and media
relations and personnel expenses.
- Net loss was $10.4 million, or a
loss of $1.11 per share, for the fourth quarter of 2019 compared to
net income of $5.9 million, or income of $0.75 per share, for the
comparable period in 2018. The change to a net loss per share
includes an $18.5 million, or $1.99 per share, increase in the
non-cash charge for the change in fair value of warrant
liabilities.
- Net loss for the full year 2019 was
$12.8 million, or a loss of $1.54 per share, compared to net loss
of $37.7 million, or a loss of $4.95 per share, for the full year
2018. The decrease in net loss per share includes an $21.9 million,
or $2.65 per share, decrease in the non-cash charge for the change
in fair value of warrant liabilities.
- As of December 31, 2019, ContraFect
had cash, cash equivalents and marketable securities of $24.2
million.
About ContraFect
ContraFect is a biotechnology company focused on
discovering and developing differentiated biologic therapies for
life-threatening, drug-resistant infectious diseases, particularly
those treated in hospital settings. An estimated 700,000 deaths
worldwide each year are attributed to antimicrobial-resistant
infections. We intend to address life threatening infections using
our therapeutic product candidates from our platform of DLAs, which
include lysins and amurin peptides. Lysins are a new class of DLAs
which are recombinantly produced antimicrobial proteins with a
novel mechanism of action associated with the rapid killing of
target bacteria, eradication of biofilms and synergy with
conventional antibiotics. Amurin peptides are a new class of DLAs,
which exhibit broad-spectrum activity against a wide range of
antibiotic-resistant Gram-negative pathogens, including Pseudomonas
aeruginosa (P. aeruginosa), Acinetobacter baumannii, and
Enterobacter species. We believe that the properties of our lysins
and amurin peptides will make them suitable for targeting
antibiotic-resistant organisms, such as methicillin-resistant Staph
aureus (MRSA) and P. aeruginosa, which can cause serious infections
such as bacteremia, pneumonia and osteomyelitis. We have completed
a Phase 2 clinical trial for the treatment of Staph aureus
bacteremia, including endocarditis, with our lead lysin candidate,
exebacase, which is the first lysin to enter clinical studies in
the U.S.
Follow ContraFect on Twitter @ContraFectCorp and
LinkedIn.
Forward-Looking Statements
This press release contains, and our officers
and representatives may make from time to time, “forward-looking
statements” within the meaning of the U.S. federal securities
laws. Forward-looking statements can be identified by words
such as “projects,” “may,” “will,” “could,” “would,” “should,”
“believes,” “expects,” “anticipates,” “estimates,” “intends,”
“plans,” “potential,” “promise” or similar references to future
periods. Examples of forward-looking statements in this release
include, without limitation, statements regarding ContraFect’s
ability to discover and develop DLAs as new medical modalities for
the treatment of life-threatening, antibiotic-resistant infections,
statements made by Dr. Pomerantz, including whether the Company’s
new treatment modalities have the potential for superior clinical
outcomes, statements regarding the Phase 3 trial design and FDA
concurrence, the End-of-Phase 2 meeting with the FDA, data that
would be sufficient to support a BLA, Phase 2 topline data, CF-370
data and Aap2-M1 data, statements made regarding the Company
balance sheet, financial results and funding sources,
ContraFect’s ability to address life threatening infections
using its DLA platform, whether lysins are a new class of
DLAs which are recombinantly produced, antimicrobial proteins with
a novel mechanism of action associated with the rapid killing of
target bacteria, eradication of biofilms and synergy with
conventional antibiotics, whether amurins exhibit broad-spectrum
activity against a wide range of antibiotic-resistant Gram-negative
pathogens and whether the properties of ContraFect’s lysins
and amurins will make them suitable for targeting
antibiotic-resistant organisms, such as MRSA and P. aeruginosa.
Forward-looking statements are statements that are not historical
facts, nor assurances of future performance. Instead, they are
based on ContraFect’s current beliefs, expectations and assumptions
regarding the future of its business, future plans, strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent risks, uncertainties and
changes in circumstances that are difficult to predict and many of
which are beyond ContraFect’s control, including those detailed
under the caption “Risk Factors” in ContraFect's filings with the
Securities and Exchange Commission. Actual results may differ
from those set forth in the forward-looking statements. Important
factors that could cause actual results to differ include, among
others, our ability to develop treatments for drug-resistant
infectious diseases. Any forward-looking statement made by
ContraFect in this press release is based only on information
currently available and speaks only as of the date on which it is
made. Except as required by applicable law, ContraFect expressly
disclaims any obligations to publicly update any forward-looking
statements, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
CONTRAFECT CORPORATION |
Condensed Balance Sheets |
|
|
|
|
December 31, 2019 |
|
|
December 31, 2018 |
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
24,184,140 |
|
$ |
8,320,317 |
Marketable securities |
― |
|
|
22,131,936 |
Prepaid expenses and other current assets |
|
6,575,375 |
|
|
988,779 |
Total current assets |
|
30,759,515 |
|
|
31,441,052 |
Property and equipment, net. |
|
1,099,948 |
|
|
1,079,099 |
Operating lease right-of-use
assets |
|
3,042,826 |
― |
Other assets |
|
105,420 |
|
|
355,420 |
Total assets |
$ |
35,008,709 |
|
$ |
32,872,571 |
|
|
|
Liabilities and
stockholders’ equity |
|
|
Current liabilities |
$ |
10,057,950 |
|
$ |
5,797,019 |
Other liabilities |
|
9,405,853 |
|
|
21,533,292 |
Total liabilities |
|
19,463,803 |
|
|
27,330,611 |
Total stockholders’ equity |
|
15,544,906 |
|
|
5,541,960 |
Total liabilities and
stockholders’ equity |
$ |
35,008,709 |
|
$ |
32,872,571 |
CONTRAFECT
CORPORATION |
Unaudited
Statements of Operations |
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2019 |
|
|
2018 |
|
2019 |
|
2018 |
|
(unaudited) |
(unaudited) |
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
3,895,482 |
|
|
$ |
6,718,522 |
|
|
$ |
18,057,025 |
|
$ |
22,416,651 |
|
General and administrative |
|
2,575,179 |
|
|
|
2,125,990 |
|
|
|
9,809,423 |
|
|
8,707,774 |
|
Total operating expenses |
|
6,470,661 |
|
|
|
8,844,512 |
|
|
|
27,866,448 |
|
|
31,124,425 |
|
Loss from operations |
|
(6,470,661 |
) |
|
|
(8,844,512 |
) |
|
|
(27,866,448 |
) |
|
(31,124,425 |
) |
Other (expense) income: |
|
(3,884,823 |
) |
|
|
14,780,208 |
|
|
|
15,071,955 |
|
|
(6,559,999 |
) |
Net (loss) income |
$ |
(10,355,484 |
) |
|
$ |
5,935,696 |
|
|
$ |
(12,794,493 |
) |
$ |
(37,684,424 |
) |
|
|
|
|
|
Net (loss) income per common
share: |
|
|
|
|
Basic |
$ |
(1.11 |
) |
|
$ |
0.75 |
|
|
$ |
(1.54 |
) |
$ |
(4.95 |
) |
Diluted |
$ |
(1.11 |
) |
|
$ |
0.75 |
|
|
$ |
(1.54 |
) |
$ |
(4.95 |
) |
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
Basic |
|
9,300,073 |
|
|
|
7,940,931 |
|
|
|
8,283,509 |
|
|
7,606,266 |
|
Diluted |
|
9,300,073 |
|
|
|
7,966,155 |
|
|
|
8,283,509 |
|
|
7,606,266 |
|
The comparability of basic and diluted net loss
per share and weighted average shares outstanding was impacted by
the Company’s follow-on offerings of securities in December 2019
and August 2018.
The Company's financial position as of December
31, 2019 and 2018 and results of operations for the years ended
December 31, 2019 and 2018 have been extracted from the Company's
audited financial statements included in its Annual Report on Form
10-K filed with the Securities and Exchange Commission. You should
refer to the Company's Annual Report on Form 10-K for a complete
discussion of financial information.
Investor Relations Contacts
Michael MessingerContraFect CorporationTel: 914-207-2300Email:
mmessinger@contrafect.com
Lauren StivalStern Investor RelationsTel: 212-362-1200Email:
lauren.stival@sternir.com
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