ContraFect Corporation (NASDAQ:CFRX), a
biotechnology company focused on the discovery and development of
protein and antibody therapeutics for life-threatening,
drug-resistant infectious diseases, today announced results for the
third quarter ended September 30, 2017.
This quarter, ContraFect completed a public stock offering
raising net proceeds of $37.1 million. The Company ended the third
quarter with cash, cash equivalents, and marketable securities of
$52.6 million which the Company believes is sufficient to fund
operations to mid-2019.
“Enrollment in our Phase 2 trial of CF-301 in patients with
complicated bacteremia including endocarditis due to Staphylococcus
aureus (Staph aureus) advanced as expected in the quarter, and we
continue to anticipate the release of topline data in 4Q18,” said
Steven C. Gilman, Ph.D., ContraFect's Chairman and CEO. The Company
continues to actively evaluate lysins active against Gram-negative
pathogens, in part through funding from CARB-X, and develop the
data and infrastructure necessary to support future regulatory
filings and the commercial launch of CF-301.
ContraFect maintained an active schedule presenting at several
scientific, medical, and investor conferences since the Company’s
last quarterly report. This included the presentation of new
data at ID Week in October demonstrating synergy with our lead
lysin candidate CF-301 and a wide range of anti-staphylococcal
antibiotics, as well as activity of CF-301 against contemporary
strains of Staph aureus from clinical isolates in the United States
and Europe.
In October, ContraFect announced the appointment of Lisa
Ricciardi to the newly-created position of Chief Operating
Officer. Ms. Ricciardi brings to ContraFect significant
experience in both the operational and business development areas,
having worked previously at companies such as Pfizer, Medco Health
Solutions, and Foundation Medicine. Her appointment adds
depth to the management team as ContraFect advances its product
pipeline towards commercialization.
Third Quarter 2017 Financial Results:
- Research and development expenses were $4.9 million for the
third quarter of 2017 compared to $5.9 million in the third quarter
of 2016. The decrease was primarily due to decreased spending on
CF-404 as well as lower expenditure on research headcount and
related laboratory expenses. These decreases were partially
offset by an expected increase in our spending on CF-301 for the
ongoing Phase 2 clinical trial and manufacturing expenses related
to the advancement of the CF-301 program.
- General and administrative expenses were $1.8 million for the
third quarter of 2017 compared to $1.9 million in the third quarter
of 2016. The decrease in general and administrative expenses was
primarily attributable to a decrease in the administrative portion
of the expenditure on our office and laboratory facility.
- Net loss was $1.6 million, or $0.02 per share, for the third
quarter of 2017 compared to a net loss of $10.5 million, or $0.28
per share, for the third quarter of 2016. The decrease in net loss
per share was due to a $5.9 million, or $0.09 per share, non-cash
gain for the change in fair value of warrant liabilities as well as
the year-over-year decrease in operating expenses discussed
above.
- As of September 30, 2017, ContraFect had cash, cash equivalents
and marketable securities of $52.6 million compared to $35.2
million as of December 31, 2016.
About ContraFect:
ContraFect is a biotechnology company focused on discovering and
developing therapeutic protein and antibody products 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 and monoclonal
antibody platforms to target conserved regions of either bacteria
or viruses (regions that are not prone to mutation). ContraFect's
initial product candidates include new agents to treat
antibiotic-resistant infections such as MRSA (Methicillin-resistant
Staph aureus) and influenza. The Company’s lead lysin, CF-301, is
currently being studied in a Phase 2 multicenter, multinational,
randomized, controlled clinical trial in patients with Staph aureus
bacteremia including endocarditis. ContraFect is also conducting
research focused on the discovery of lysins to target Gram-negative
bacteria.
About CF-301:
CF-301 is a recombinant bacteriophage-derived lysin with potent
bactericidal activity against Staph aureus, a major cause of blood
stream infections, or bacteremia. CF-301 has the potential to be a
first-in-class treatment for Staph aureus bacteremia. It has
a novel, rapid, and specific mechanism of bactericidal action
against Staph aureus and does not impact the body's natural
bacterial flora. By targeting a conserved region of the cell wall
that is vital to bacteria, resistance is less likely to develop to
CF-301. Combinations of CF-301 with standard of care antibiotics
significantly increased bacterial killing and survival in animal
models of disease when compared to treatment with antibiotics or
CF-301 alone. In addition, in vitro and in vivo experiments have
shown that CF-301 is highly active against biofilm infections.
CF-301 was licensed from The Rockefeller University and is being
developed at ContraFect. It is the first lysin to enter clinical
studies in the U.S.
About Gram-negative Infections:
The 2013 CDC report on Antibiotic Resistance Threats identifies
several Gram-negative pathogens including Enterobacteriaceae (a
family that includes Escherichia coli and Klebsiella spp.),
Pseudomonas aeruginosa (P. aeruginosa), and Acinetobacter spp. as
among the most worrisome because of strains that are resistant to
all or nearly all available antibiotics. In particular, the CDC
classifies Carbapenem-resistant Enterobacteriaceae (CRE) as an
"Urgent" threat and multi-drug resistant P. aeruginosa and
Acinetobacter spp. as "Serious" threats. Bacteria are generally
classified as either Gram-positive or Gram-negative based on their
staining in the "Gram" strain test. In March, 2017, ContraFect was
selected to receive a funding award from the Combating Antibiotic
Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to help
accelerate ContraFect's development of lysin therapeutics to treat
invasive infections caused by drug resistant strains of P.
aeruginosa, a potentially life threatening Gram-negative
pathogen.
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 our ability to
discover and develop protein and antibody therapeutics for
life-threatening, drug-resistant infectious diseases, including
whether CF-301 has the potential to be a first-in-class treatment
for Staph aureus bacteremia, whether topline results from the study
will be available in Q4 2018, whether the company can successfully
fund operations to mid-2019, our ability to support future
regulatory filings and the commercial launch of CF-301, whether we
can continue to evaluate and discover lysins against Gram-negative
pathogens, partly with CARB-X funding, whether Ms. Ricciardi’s
appointment adds depth to the management team, our ability to
address life threatening infections using our therapeutic product
candidates from our lysin and monoclonal antibody platforms to
target conserved regions of either bacteria or viruses and whether
the company’s initial product candidates can treat antibiotic
resistant infections such as MRSA and influenza. 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.
Investor Relations Contact Paul Boni
ContraFect Corporation Tel: 914-207-2300
Email: pboni@contrafect.com
|
CONTRAFECT CORPORATION |
Balance Sheets |
|
|
September 30,
2017 |
|
December 31,
2016 |
|
|
(unaudited) |
|
(audited) |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
4,297,503 |
|
$ |
3,806,984 |
|
Marketable securities |
|
48,254,552 |
|
|
31,354,170 |
|
Prepaid
expenses and other current assets |
|
1,259,521 |
|
|
1,017,645 |
|
|
|
|
|
|
|
|
Total current
assets |
|
53,811,576 |
|
|
36,178,799 |
|
Property and equipment,
net |
|
1,148,138 |
|
|
1,281,152 |
|
Other assets |
|
164,519 |
|
|
164,519 |
|
|
|
|
|
|
|
|
Total assets |
$ |
55,124,233 |
|
$ |
37,624,470 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
$ |
1,235,480 |
|
$ |
1,549,845 |
|
Accrued
liabilities |
|
1,694,232 |
|
|
2,868,352 |
|
|
|
|
|
|
|
|
Total current
liabilities |
|
2,929,712 |
|
|
4,418,197 |
|
Deferred rent |
|
704,240 |
|
|
994,439 |
|
Warrant
liabilities |
|
16,024,207 |
|
|
12,698,980 |
|
|
|
|
|
|
|
|
Total liabilities |
|
19,658,159 |
|
|
18,111,616 |
|
Commitments and
contingencies |
|
— |
|
|
— |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
Preferred
stock, $0.0001 par value, 25,000,000 shares authorized and none
outstanding at September 30, 2017 and December 31, 2016 |
|
— |
|
|
— |
|
Common
stock, $0.0001 par value, 200,000,000 shares and 100,000,000
shares authorized at September 30, 2017 and December 31,
2016, respectively; 73,656,006 shares and 41,656,006
shares issued and outstanding at September 30, 2017 and
December 31, 2016, respectively |
|
7,366 |
|
|
4,166 |
|
Additional paid-in capital |
|
192,360,418 |
|
|
165,678,164 |
|
Accumulated other comprehensive loss |
|
(23,750) |
|
|
(51,666) |
|
Accumulated deficit |
|
(156,877,960) |
|
|
(146,117,810) |
|
|
|
|
|
|
|
|
Total stockholders’
equity |
|
35,466,074 |
|
|
19,512,854 |
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
$ |
55,124,233 |
|
$ |
37,624,470 |
|
|
|
|
|
|
|
|
CONTRAFECT CORPORATION |
Unaudited Statements of
Operations |
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
4,934,788 |
|
$ |
5,948,026 |
|
$ |
12,893,655 |
|
$ |
17,650,395 |
|
General
and administrative |
|
1,800,400 |
|
|
1,943,484 |
|
|
6,265,668 |
|
|
9,173,714 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
6,735,188 |
|
|
7,891,510 |
|
|
19,159,323 |
|
|
26,824,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(6,735,188) |
|
|
(7,891,510) |
|
|
(19,159,323) |
|
|
(26,824,109) |
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
123,960 |
|
|
54,620 |
|
|
245,979 |
|
|
126,370 |
|
Other
expense |
|
(905,014) |
|
|
(1,569,341) |
|
|
(905,014) |
|
|
(1,569,341) |
|
Change in
fair value of warrant liabilities |
|
5,941,144 |
|
|
(1,124,353) |
|
|
9,058,208 |
|
|
(865,688) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
5,160,090 |
|
|
(2,639,074) |
|
|
8,399,173 |
|
|
(2,308,659) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(1,575,098) |
|
$ |
(10,530,584) |
|
$ |
(10,760,150) |
|
$ |
(29,132,768) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock, basic and diluted |
$ |
(0.02) |
|
$ |
(0.28) |
|
$ |
(0.22) |
|
$ |
(0.94) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted weighted average shares outstanding |
|
64,960,354 |
|
|
37,446,087 |
|
|
49,509,486 |
|
|
30,833,362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The comparability of basic and diluted net loss per share and
weighted average shares outstanding was impacted by the Company’s
follow-on offering of securities on July 25, 2017.The Company’s
financial position as of September 30, 2017 and results of
operations for the three and nine months ended September 30, 2017
and 2016 have been extracted from the Company’s Quarterly Report on
Form 10-Q. The Company’s financial position as of December
31, 2016 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 15, 2017. 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.
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