ContraFect Reports Third Quarter 2019 Financial Results and Provides Business Update
November 12 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 new medical modalities for the treatment of life-threatening,
antibiotic-resistant infections, today announced financial results
for the third quarter ended September 30, 2019.
“The third quarter was marked by a successful
end-of-Phase 2 meeting with the FDA, and we are progressing towards
our goal of initiating the Phase 3 trial of exebacase in patients
with Staphylococcus aureus (Staph aureus) bacteremia, including
right-sided endocarditis, by the end of this year,” said Roger J.
Pomerantz, MD, President, Chief Executive Officer, and Chairman of
ContraFect. “This is a very exciting time for the company as we
continue to lead the way with the first direct lytic agent to
potentially demonstrate superiority over current standard of care
and usher in a new medical modality within the antibacterial
space,” he continued.
Recent Corporate Highlights
- In October 2019, the Company
announced it had completed an End-of-Phase 2 meeting with the U.S.
Food and Drug Administration (FDA) regarding the advancement of its
lead lysin candidate, exebacase. At this meeting the Company
obtained concurrence with the FDA on key design features of the
Phase 3 protocol and that positive results from a single Phase 3
study could support a Biologics License Application (BLA) for
approval of exebacase. Based on this feedback, the Company plans to
initiate its Phase 3 DISRUPT trial (Direct Lysis of Staph aureus
Resistant Pathogen Trial) by the end of 2019. DISRUPT is a
randomized, double-blind, placebo-controlled clinical study to
assess the efficacy and safety of exebacase in approximately 350
patients with Staph aureus bacteremia, including right-sided
endocarditis. Patients entering the Phase 3 study will be
randomized 2:1 to 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
methicillin-resistant Staph aureus (MRSA) bacteremia, including
right-sided endocarditis. Secondary endpoints will include clinical
response at Day 14 in the All Staph aureus bacteremia patient group
(MRSA and methicillin-sensitive Staph aureus (MSSA)), 30-day
all-cause mortality in MRSA patients, and clinical response at
later timepoints.
- In October 2019, the Company
presented a Late-Breaker oral presentation on the reduction in
health resource utilization among MRSA patients treated with
exebacase from its recently completed Phase 2 study at ID Week
2019. Data showed that the median number of hospital days from
study drug administration through discharge was 6 days in the
exebacase-treated group compared to 10 days for patients who
received standard of care (SOC) alone, while 30-day all cause
hospital readmission rates were 16% compared to 30.8% in the
exebacase vs SOC antibiotics alone groups and 8.0% compared to
15.4% for those with confirmed S. aureus.
- 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 biofilms 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.
Third Quarter 2019 Financial Results
- Research and development expenses
were $5.3 million for the third quarter of 2019 compared to $5.7
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 all related contract
research services were completed 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 manufacturing costs to support the advancement of
exebacase into Phase 3 clinical development compared to the prior
year period.
- General and administrative expenses
were $2.4 million for the third quarter of 2019 compared to $2.1
million in the comparable period in 2018. This increase was due
primarily to increases in costs incurred for legal and professional
fees and non-cash share-based compensation expense.
- Net loss was $5.4 million, or a
loss of $0.07 per share, for the third quarter of 2019 compared to
a net loss of $4.4 million, or a loss of $0.06 per share, for the
comparable period in 2018. The increase in net loss was primarily
due to a $0.01 share decrease in the non-cash gain associated with
the change in fair value of warrant liabilities.
- As of September 30, 2019,
ContraFect had cash, cash equivalents and marketable securities of
$10.5 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 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, ContraFect’s ability to discover and develop
DLAs as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections statements made
regarding ContraFect’s end-of-Phase 2 meeting with the FDA, Phase 3
planning, and presented data, ContraFect’s ability to address
life-threatening infections using its therapeutic product
candidates from 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, whether the properties of ContraFect’s lysins and
amurins will make them suitable for targeting antibiotic-resistant
organisms, such as Staph aureus and P. aeruginosa, the Company’s
balance sheets, statements of operations and financial results.
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
CORPORATIONCondensed Balance Sheets
|
September 30, 2019 |
|
December 31,
2018 |
|
(unaudited) |
|
|
(audited) |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
10,501,589 |
|
$ |
8,320,317 |
Marketable securities |
|
— |
|
|
22,131,936 |
Prepaid expenses and other current assets |
|
2,340,520 |
|
|
988,799 |
|
|
|
|
|
Total current assets |
|
12,842,109 |
|
|
31,441,052 |
Property and equipment, net |
|
1,147,727 |
|
|
1,076,099 |
Operating lease right-of-use
assets |
|
3,098,179 |
|
|
— |
Other assets |
|
355,420 |
|
|
355,420 |
|
|
|
|
|
Total assets |
$ |
17,443,435 |
|
$ |
32,872,571 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current liabilities |
|
7,659,673 |
|
|
5,797,019 |
Warrant liabilities |
|
2,159,192 |
|
|
20,781,663 |
Long-term portion of lease
liabilities |
|
3,332,866 |
|
|
— |
Other liabilities |
|
72,747 |
|
|
751,929 |
|
|
|
|
|
Total liabilities |
|
13,224,478 |
|
|
27,330,611 |
|
|
|
|
|
Total stockholders’ equity |
|
4,218,957 |
|
|
5,541,960 |
|
|
|
|
|
Total liabilities and
stockholders’ equity |
$ |
17,443,435 |
|
$ |
32,872,571 |
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
5,250,327 |
|
|
$ |
5,710,455 |
|
|
$ |
14,161,543 |
|
|
$ |
15,698,129 |
|
General and administrative |
|
2,376,248 |
|
|
|
2,088,835 |
|
|
|
7,234,244 |
|
|
|
6,581,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
7,626,575 |
|
|
|
7,799,290 |
|
|
|
21,395,787 |
|
|
|
22,279,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(7,626,575 |
) |
|
|
(7,799,290 |
) |
|
|
(21,395,787 |
) |
|
|
(22,279,913 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
80,747 |
|
|
|
174,778 |
|
|
|
334,307 |
|
|
|
490,170 |
|
Change in fair value of warrant liabilities |
|
2,186,710 |
|
|
|
3,246,765 |
|
|
|
18,622,471 |
|
|
|
(21,830,377 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
2,267,457 |
|
|
|
3,421,543 |
|
|
|
18,956,778 |
|
|
|
(21,340,207 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,359,118 |
) |
|
$ |
(4,377,747 |
) |
|
$ |
(2,439,009 |
) |
|
$ |
(43,620,120 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.58 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average shares outstanding |
|
79,409,556 |
|
|
|
77,447,599 |
|
|
|
79,409,556 |
|
|
|
74,934,774 |
|
The Company's financial position as of September
30, 2019 and results of operations for the three and nine months
ended September 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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