ContraFect Reports Second Quarter 2019 Financial Results and Provides Business Update
August 09 2019 - 7:00AM
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 a new modality for the treatment of life-threatening,
antibiotic-resistant infections, today announced financial results
for the second quarter ended June 30, 2019.
“Our organization has been working on many
fronts to advance our product candidates and raise awareness of the
profound importance of developing totally new treatment modalities
with the potential for superior outcomes compared to current
antibiotics alone for patients with antibiotic-resistant,
life-threatening infections. And we have made significant progress
already – from exebacase, our lead lysin candidate, reporting
demonstrably higher clinical responder rates in MRSA patients in a
Phase 2 study, to being awarded over $16 million of new,
non-dilutive grant funding since the beginning of the year. DLAs
are now the first non-antibiotic anti-infectives to reach late
stage clinical development,” said Roger J. Pomerantz, MD, Chairman,
Chief Executive Officer and President of ContraFect. “We have fully
prepared and submitted all necessary materials and documents in
anticipation of our upcoming meeting with the FDA to discuss our
proposed Phase 3 clinical trial for exebacase. We look forward to
sharing greater detail around our plans in the coming months.”
Second Quarter Highlights
- 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, titled “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,” reported data demonstrating
clinically meaningful increases in clinical responder rates in the
pre-specified MRSA subgroup treated with exebacase, compared to
MRSA patients treated with SOC alone, at all timepoints tested,
including a 43% higher clinical responder rate at the day 14
primary efficacy timepoint (p=0.010).
- The Company also presented data at
ECCMID in April from its early research pipeline directed at
Gram-negative pathogens in an invited “Pipeline Talk” on the
Company’s DLAs and an oral presentation on the ability of lysins
targeting Gram negative pathogens to re-sensitize
carbapenem-resistant P. aeruginosa to imipenem.
- In May 2019, the Company hosted an
investor and analyst day in New York that highlighted new data from
the exebacase Phase 2 clinical trial, demonstrating that U.S.
patients with MRSA, who were treated with exebacase and alive at
the time of discharge, had a reduced length of hospital stay (6
days versus 10 days) and 30-day all-cause readmission rates (16.0%
versus 30.8%) compared to patients treated with standard-of-care
alone.
- 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 June 2019, the Company presented
five posters at ASM Microbe 2019, including “PK-PD Relationship and
PK Driver of Efficacy of the Novel Antibacterial Lysin Exebacase
(CF-301) in Pre-Clinical Models”, which was selected for an
Outstanding Abstract Award sponsored by the American Society for
Microbiology (ASM) and determined by the ASM Microbe Program
Committee. In addition, the Company presented new data on its lead
Gram-negative lysins against resistant P. aeruginosa to
highlight the therapeutic potential of direct lytic agents against
a range of dangerous Gram-negative pathogens.
Recent Publications
- In May 2019, the Company announced
the publication of a manuscript entitled “Postantibiotic and
Sub-MIC Effects of Exebacase (Lysin CF-301) Enhance Antimicrobial
Activity against Staphylococcus aureus” in the June edition of the
peer-reviewed Antimicrobial Agents and Chemotherapy Journal of the
American Society of Microbiology. Ultimately, the article concluded
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, the Company
announced the publication of an article titled “The
Antistaphylococcal Lysin, CF-301, Activates Key Host Factors in
Human Blood to Potentiate Methicillin-Resistant Staphylococcus
aureus Bacteriolysis” in the April edition of the peer-reviewed
Antimicrobial Agents and Chemotherapy Journal of the American
Society of Microbiology. 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.
Second Quarter 2019 Financial Results
- Research and development expenses
were $4.8 million for the second quarter of 2019 compared to $5.3
million in the comparable period in 2018. This decrease was
primarily attributable to a decrease in spending related to our
Phase 2 clinical study of exebacase, as we completed the trial in
the current year period compared to the higher cost of active
patient enrollment in the prior year period. This decrease was
partially offset by an increase in external research and licensing
costs from a milestone payment recognized on completion of the
Phase 2 study and increased expenditures on our preclinical
programs.
- General and administrative expenses
were $2.6 million for the second quarter of 2019 compared to $2.2
million in the comparable period in 2018. This increase was due
primarily to an increase in costs incurred for intellectual
property and general corporate legal fees, which was partially
offset by a decrease in administrative headcount and related
personnel costs.
- Net loss was $8.7 million, or $0.11
per share, for the second quarter of 2019 compared to a net loss of
$20.1 million, or $0.27 per share, for the comparable period in
2018. This decrease in net loss was primarily due to a $0.14 share
decrease in the non-cash expense associated with the change in fair
value of warrant liabilities.
- As of June 30, 2019, ContraFect had
cash, cash equivalents and marketable securities of $14.2 million
compared to $30.5 million at December 31, 2018.
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 direct
lytic agents (DLAs), which include lysins and amurin peptides.
Lysins are a new therapeutic 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. We believe
that the properties of our lysins will make them suitable for
targeting antibiotic-resistant organisms, such as Staph aureus 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
(CF-301), 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 the
Company’s ability to discover and develop DLAs comprised of
lysins and amurins for life-threatening, antibiotic resistant
infections, whether those DLAs are a new treatment modality
and whether they have the potential for superior outcomes
compared to current antibiotics alone, whether the Company is
making significant progress, whether exebacase demonstrated higher
clinical responder rates in MRSA patients in a Phase 2 study,
statements made regarding grant funding, whether DLAs are the first
non-antibiotic anti-infective to reach late stage clinical
development, whether the Company has fully prepared and
submitted all necessary materials and documents to the FDA,
whether the Company will share greater detail about its plans in
the coming months, whether the Company can advance CF-296 through
IND-enabling studies, whether CF-296 may be suitable for
development as a novel therapy for bone and joint infections caused
by Staph aureus, statements made regarding data presented,
publications, the Company’s balance sheets, statements of
operations and financial results, the Company’s ability to address
life threatening infections using its therapeutic product
candidates from its DLA platform , whether lysins are a new
therapeutic 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, and whether the
properties of the Company’s lysins will make them suitable for
targeting antibiotic-resistant organisms, such as Staph aureus 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 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
CORPORATIONCondensed Balance Sheets
|
June 30, 2019 |
|
December 31, 2018
|
|
(unaudited) |
|
(audited) |
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
7,377,139 |
|
|
$ |
8,320,317 |
|
Marketable securities |
|
6,851,515 |
|
|
|
22,131,936 |
|
Prepaid expenses and other current assets |
|
1,986,484 |
|
|
|
988,799 |
|
|
|
|
Total
current assets. |
|
16,215,138 |
|
|
|
31,441,052 |
|
Property
and equipment, net |
|
1,195,506 |
|
|
|
1,076,099 |
|
Operating lease right-of-use assets |
|
3,150,932 |
|
|
|
— |
|
Other
assets |
|
355,420 |
|
|
|
355,420 |
|
|
|
|
Total
assets |
$ |
20,916,996 |
|
|
$ |
32,872,571 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
Current
liabilities |
|
3,910,355 |
|
|
|
5,797,019 |
|
Warrant
liabilities |
|
4,345,902 |
|
|
|
20,781,663 |
|
Long-term portion of lease liabilities |
|
3,399,926 |
|
|
|
— |
|
Other
liabilities |
|
72,747 |
|
|
|
751,929 |
|
|
|
|
Total
liabilities |
|
11,728,930 |
|
|
|
27,330,611 |
|
|
|
|
Total
stockholders’ equity |
|
9,188,066 |
|
|
|
5,541,960 |
|
|
|
|
Total
liabilities and stockholders’ equity |
$ |
20,916,996 |
|
|
$ |
32,872,571 |
|
|
|
|
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Operating expenses: |
|
|
|
|
Research and development. |
$ |
4,804,076 |
|
|
$ |
5,252,334 |
|
|
$ |
8,911,216 |
|
|
$ |
9,987,674 |
|
General and administrative |
|
2,603,403 |
|
|
|
2,244,120 |
|
|
|
4,857,996 |
|
|
|
4,492,949 |
|
|
|
|
|
|
Total operating expenses |
|
7,407,479 |
|
|
|
7,496,454 |
|
|
|
13,769,212 |
|
|
|
14,480,623 |
|
|
|
|
|
|
Loss from operations |
|
(7,407,479 |
) |
|
|
(7,496,454 |
) |
|
|
(13,769,212 |
) |
|
|
(14,480,623 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
104,441 |
|
|
|
163,145 |
|
|
|
253,560 |
|
|
|
315,392 |
|
Change in fair value of warrant liabilities |
|
(1,363,868 |
) |
|
|
(12,802,583 |
) |
|
|
16,435,761 |
|
|
|
(25,077,142 |
) |
|
|
|
|
|
Total other income
(expense) |
|
(1,259,427 |
) |
|
|
(12,639,438 |
) |
|
|
16,689,321 |
|
|
|
(24,761,750 |
) |
|
|
|
|
|
Net income (loss) |
$ |
(8,666,906 |
) |
|
$ |
(20,135,892 |
) |
|
$ |
2,920,109 |
|
|
$ |
(39,242,373 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Basic net income (loss) per share |
$ |
(0.11 |
) |
|
$ |
(0.27 |
) |
|
$ |
0.04 |
|
|
$ |
(0.53 |
) |
|
|
|
|
|
Shares used in computing basic net income (loss) per share |
|
79,406,556 |
|
|
|
73,658,529 |
|
|
|
79,409,556 |
|
|
|
73,657,537 |
|
|
|
|
|
|
Diluted net income (loss) per share |
|
(0.11 |
) |
|
|
(0.27 |
) |
|
|
0.04 |
|
|
|
(0.53 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing diluted net income (loss) per share |
|
79,406,556 |
|
|
|
73,658,529 |
|
|
|
79,457,926 |
|
|
|
73,657,537 |
|
The Company's financial position as of June 30,
2019 and results of operations for the three and six months ended
June 30, 2019 and 2018 have been extracted from the Company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. The Company's financial position as of
December 31, 2018 has 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 on March 14,
2019. You should refer to both the Company's Quarterly Report
on Form 10-Q and its 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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