ContraFect Reports First Quarter 2019 Financial Results and Provides Business Update
May 10 2019 - 7:00AM
ContraFect Corporation (Nasdaq:CFRX), a clinical-stage
biotechnology company focused on the discovery and development of
direct lytic agents, comprised of lysins and amurins, a new
modality in therapeutics for life-threatening, drug-resistant
infectious diseases, today announced financial results for the
first quarter ended March 31, 2019.
“The first quarter of 2019 was rich in important milestones and
forward progress. In addition to announcing positive topline data
for our Phase 2 trial of exebacase in January, we received almost
$10 million in non-dilutive grant funding from the Combating
Antibiotic Resistant Bacteria Biopharmaceutical Accelerator
(CARB-X) during the quarter to further develop our novel amurin
peptides and lysins as direct lytic agents (DLAs) against
antibiotic-resistant Pseudomonas aeruginosa (P. aeruginosa) and
other resistant Gram-negative pathogens, which are considered
global threats to human health,” said Roger J. Pomerantz, MD,
Chairman and Chief Executive Officer of ContraFect. “We
recently announced additional positive data from further analysis
of our Phase 2 trial of exebacase that supports the strong clinical
response seen within the pre-specified methicillin-resistant
Staphylococcus aureus (MRSA) patient population treated with
exebacase. This is the first time that we, as an industry, have
seen such a striking increase in clinical responder rates
demonstrated in MRSA bloodstream infections, with a 42.8%
improvement for exebacase-treated patients, as compared to
standard-of-care (SOC) antibiotics alone. We look forward to
announcing further exebacase data this year, as we plan for the
Phase 3 trial.”
Recent Highlights
- In April 2019, the Company presented new data from its Phase 2
clinical trial of exebacase for the treatment of Staphylococcus
aureus (Staph aureus) bacteremia including endocarditis 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 new data demonstrating
clinically meaningful increases in clinical responder rates in the
pre-specified MRSA subgroup treated with exebacase, including a
22.9% higher responder rate at Day 7 and a 16.9% higher responder
rate at Test of Cure, compared to MRSA patients treated with SOC
alone.
- The Company also presented new data at ECCMID from its early
research pipeline directed at Gram-negative pathogens in an invited
a “Pipeline Talk” on the Company’s direct lytic agents and an oral
presentation on the ability of lysins targeting gram negative
pathogens to re-sensitize carbapenem-resistant P. aeruginosa to
imipenem.
- In April 2019, the Company’s manuscript titled “The
Antistaphylococcal Lysin, CF-301, Activates Key Host Factors in
Human Blood to Potentiate Methicillin-Resistant Staphylococcus
aureus Bacteriolysis” was published in the April edition of the
peer-reviewed Antimicrobial Agents and Chemotherapy Journal of the
American Society of Microbiology. The results demonstrated that the
unique properties of exebacase enabled bactericidal potentiation of
antimicrobial activity against MRSA. 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.
- In April 2019, the Company appointed Roger J. Pomerantz, MD,
FACP as President, Chief Executive Officer and Chairman of the
Board of ContraFect. Dr. Pomerantz had previously served as Vice
Chairman of the Board. Dr. Pomerantz’s experience in leading the
development of multiple anti-infective drugs to FDA approval will
be invaluable as the Company moves exebacase toward its first Phase
3 clinical trial.
- In March 2019, the Company participated in the inaugural
Bacteriophage Therapy Summit in Boston, MA, where it presented a
case study titled “The Pathway from Bench to Bedside: Lysin CF-301
(exebacase) – A Case Study” about its clinical path to positive
results in a Phase 2 clinical study of exebacase, which is the
first non-traditional antibacterial to progress to this stage of
development.
- In March 2019, the Company announced that the 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 February 2019, the Company gave an oral presentation, titled
“Bacteriophage-Derived Lysins Engineered to Exert a Rapid and
Potent Bactericidal Effect Against Pseudomonas aeruginosa,” at the
2019 Gordon Research Conference on Mechanisms and Application:
Realizing the Potential of Antimicrobial Host Defense Peptides for
Human and Veterinary Medicine in Lucca, Italy.
- In January 2019, the Company announced that the CARB-X awarded
the Company $2.3 million in additional non-dilutive funding over
the course of the next two years. Funds will be used 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.
First Quarter 2019 Financial Results
- Research and development expenses were $4.1 million for the
first quarter of 2019 compared to $4.7 million in the comparable
period in 2018. This decrease was primarily due to decreased
spending on our Phase 2 clinical study of exebacase, as we
completed long-term follow up 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
expenditures on manufacturing in preparation for a Phase 3 study of
exebacase.
- General and administrative expenses were $2.3 million for the
first quarter of 2019 compared to $2.2 million in the comparable
period in 2018. This increase was primarily due to costs incurred
for intellectual property and general corporate legal fees, which
was partially offset by lower administrative headcount and related
personnel costs.
- Net income was $11.6 million, or $0.15 per share, for the first
quarter of 2019 compared to a net loss of $19.1 million, or $0.26
per share, for the comparable period in 2018. Net income was due to
a $30.0 million, or $0.38 per share, increase in other income in
the current year period compared to the prior year period, directly
relating to the non-cash gain from the change in fair value of our
warrant liabilities.
- As of March 31, 2019, ContraFect had cash, cash equivalents and
marketable securities of $23.1 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 lysin platform and through the use of other
novel agents. Lysins are a new therapeutic class of
bacteriophage-derived, 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
Pseudomonas aeruginosa (P. aeruginosa), which can cause serious
infections such as bacteremia, pneumonia and osteomyelitis. Our
lead lysin candidate, exebacase is completing a Phase 2 clinical
trial for the treatment of Staph aureus bacteremia, including
endocarditis and 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 direct lytic agents comprised of
lysins and amurins for life-threatening, drug-resistant infectious
diseases, whether those direct lytic agents are a new modality in
therapeutics, whether the first quarter of 2019 was rich in
important milestones and forward progress, statements made
regarding CARB-X funding and the Company’s ability to further
develop amurins and lysins against antibiotic resistant P.
aeruginosa and other Gram-negative pathogens, whether the
additional data from the Phase 2 study was positive and whether it
supports the strong clinical response seen within the pre-specified
MRSA patient population treated with exebacase, whether this is
first time that the industry has seen such a striking increase in
clinical responder rates demonstrated in MRSA bloodstream
infections, whether the Company will announce further exebacase
data this year as it plans for its Phase 3 trial, statements made
regarding the presentation of new data, publications, the Company’s
CEO, presentations and CARB-X, 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 lysin platform and through
the use of other novel agents, whether lysins are a new therapeutic
class of bacteriophage-derived, 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
|
March 31, 2019 |
|
December 31, 2018
|
|
(unaudited) |
|
(audited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
6,825,592 |
|
$ |
8,320,317 |
Marketable securities |
|
16,267,629 |
|
|
22,131,936 |
Prepaid expenses and other current assets |
|
2,053,500 |
|
|
988,799 |
Total current assets |
|
25,146,721 |
|
|
31,441,052 |
Property and equipment, net |
|
1,243,285 |
|
|
1,076,099 |
Operating lease right-of-use
assets |
|
3,202,124 |
|
|
— |
Other assets |
|
355,420 |
|
|
355,420 |
Total assets |
$ |
29,947,550 |
|
$ |
32,872,571 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
Current liabilities |
|
5,943,336 |
|
|
5,797,019 |
Warrant liabilities |
|
2,982,034 |
|
|
20,781,663 |
Long-term portion of lease
liabilities |
|
3,465,348 |
|
|
— |
Other liabilities |
|
72,747 |
|
|
751,929 |
Total liabilities |
|
12,463,465 |
|
|
27,330,611 |
|
|
|
|
|
|
Total stockholders’ equity |
|
17,484,085 |
|
|
5,541,960 |
Total liabilities and
stockholders’ equity |
$ |
29,947,550 |
|
$ |
32,872,571 |
|
|
|
|
|
|
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
|
Three Months Ended March 31, |
|
|
2019 |
|
|
2018 |
|
Operating expenses |
|
|
Research and development |
$ |
4,107,140 |
|
$ |
4,735,340 |
|
General and administrative |
|
2,254,593 |
|
|
2,248,829 |
|
Total operating expenses |
|
6,361,733 |
|
|
6,984,169 |
|
Loss from operations |
|
(6,361,733 |
) |
|
(6,984,169 |
) |
Other income (expense): |
|
|
Interest income |
|
149,119 |
|
|
152,247 |
|
Change in fair value of warrant liabilities |
|
17,799,629 |
|
|
(12,274,559 |
) |
Total other income (expense) |
|
17,948,748 |
|
|
(12,122,312 |
) |
Net income (loss) |
$ |
11,587,015 |
|
$ |
(19,106,481 |
) |
|
|
|
Per share information: |
|
|
Net income (loss) per share of common stock, basic and diluted |
$ |
0.15 |
|
$ |
(0.26 |
) |
Basic and diluted weighted average shares outstanding |
|
79,409,556 |
|
|
73,656,534 |
|
|
|
|
The Company's financial position as of March 31, 2019 and
results of operations for the three months ended March 31, 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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