ContraFect Corporation (Nasdaq: CFRX), a late 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
and business updates for the fourth quarter ended December 31,
2020.
“ContraFect has made important progress with the
Phase 3 DISRUPT superiority study of exebacase for patients with
Staph aureus bloodstream infections, a life-threatening condition
that has not seen meaningful innovation in over half a century.
Earlier this month, we were extremely pleased to receive a
substantial contract award from BARDA for $9.8 million in initial
funding, and up to an additional $77 million, to support the
continued development of exebacase. In addition to the financial
support provided, the BARDA contract adds another point of external
validation, as do the investments by Pfizer and the funding
received from numerous government agencies and the Cystic Fibrosis
Foundation. ContraFect also successfully raised $57.5 million in a
public equity offering, providing additional resources to support
the Company’s promising pipeline programs,” said Roger J.
Pomerantz, M.D., President, Chief Executive Officer, and Chairman
of ContraFect.
“With the BARDA contract and subsequent $57.5
million raised, ContraFect is well positioned to execute the
DISRUPT study towards the anticipated interim futility analysis in
the second half of 2021. In addition, we continue to advance, with
alacrity, our promising preclinical assets, including CF-370 for
the treatment of Pseudomonas aeruginosa infections, and our amurin
peptides targeting other Gram-negative pathogens. We look forward
to providing updates on these key programs later this year,”
concluded Dr. Pomerantz.
Fourth Quarter 2020 Highlights and
Recent Developments
-
In March 2021, ContraFect announced that it had entered into a
cost-share contract with BARDA, part of the Office of the Assistant
Secretary for Preparedness and Response (ASPR) at the U.S.
Department of Health and Human Services (HHS). Under the terms of
the contract, the Company will receive $9.8 million in initial
funding and is eligible for up to an additional $77.0 million. The
initial funding will be used to support ContraFect’s ongoing
pivotal Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant
Pathogen Trial) superiority study of exebacase in patients with
Staph aureus bacteremia, including right-sided endocarditis. Under
the terms of the agreement, and if supported by Phase 3 DISRUPT
study data, BARDA may provide the Company with additional funding
upon achievement of key milestones to continue the advancement of
exebacase through FDA product approval and completion of
post-approval commitments.
- In March 2021,
ContraFect closed an underwritten public offering of 11,500,000
shares of its common stock at a public offering price of $5.00 per
share, including 1,500,000 shares sold pursuant to the
underwriters’ exercise in full of their option to purchase
additional shares. The gross proceeds from the offering were $57.5
million, before deducting underwriting discounts and commissions
and offering expenses payable by ContraFect.
- In October 2020, ContraFect
initiated an expanded access program to provide exebacase for the
treatment of persistent bacteremia caused by methicillin-resistant
Staphylococcus aureus (MRSA) in COVID-19 patients. The Company is
providing expanded access to exebacase under a treatment protocol
available to clinical sites participating in the ongoing Phase 3
study, which enables physicians to use exebacase to treat severely
ill COVID-19 patients with persistent MRSA bacteremia, despite
treatment with standard of care antibiotics. Hospitalized patients
with COVID-19 may now have access to exebacase since they are not
eligible to participate in the ongoing Phase 3 study.
Fourth quarter and Full Year 2020 Financial
Results
- Research and
development (R&D) expenses were $7.3 million for the fourth
quarter of 2020 compared to $3.9 million in the comparable period
in 2019. This increase was primarily attributable to increases in
expenditures on personnel and contract research organizations
(CROs) to support the active enrollment of patients in the Phase 3
DISRUPT study of exebacase and on the completion of process
scale-up and the initiation of the validation of the exebacase
manufacturing process to support the chemistry, manufacturing and
controls (CMC) activities required for potential BLA
submission.
- R&D expenses
for the full year 2020 were $22.6 million compared to $18.1 million
for the full year 2019. This increase was again primarily
attributable to increases in expenditures on personnel, consultants
and contract research organizations (CROs) to support a full year
of patient enrollment in and the expansion to over 40 actively
recruiting investigator sites for the Phase 3 DISRUPT study of
exebacase and on the process scale-up and initiation of the
validation of the exebacase manufacturing process to support
potential BLA submission. Finally, process development and
small-scale batch manufacturing for both CF-370 and CF-296 programs
increased R&D expenses in 2020 compared to 2019.
- General and administrative
(G&A) expenses were $3.4 million for the fourth quarter of 2020
compared to $2.6 million in the comparable period in 2019. This
increase was due primarily to increases in compensation and legal
fees for general corporate matters and expansion of the Company’s
intellectual property portfolio.
- G&A expenses for the full year
2020 were $11.6 million compared to $9.8 million for the full year
2019. This increase was due primarily to increases in compensation
and insurance costs.
- Net loss was $6.4 million, or a
loss of $0.23 per share, for the fourth quarter of 2020 compared to
net loss of $10.4 million, or a loss of $1.11 per share, for the
comparable period in 2019. The decrease in net loss per share
includes an $8.2 million, or $0.29 per share, increase to the
non-cash gain for the change in fair value of warrant
liabilities.
- Net loss for the full year 2020 was
$28.2 million, or a loss of $1.24 per share, compared to net loss
of $12.8 million, or a loss of $1.54 per share, for the full year
2019. The decrease in net loss per share is primarily due to the
increase in the weighted average shares outstanding and also
includes a decrease of $6.7 million, or $0.26 per share, in the
non-cash gain for the change in fair value of warrant
liabilities.
- As of December 31, 2020, ContraFect
had cash, cash equivalents and marketable securities of $42.5
million. Subsequent to the end of the fourth quarter, the Company
further strengthened its balance sheet with $53.7 million in
estimated net proceeds from an underwritten public offering of
shares of its common stock.
About DISRUPT:
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 are randomized 2:1 to receive either
exebacase or placebo, with all patients receiving SOC antibiotics.
The primary efficacy endpoint of the study is clinical response at
day 14 in patients with MRSA bacteremia, including right-sided
endocarditis. Secondary endpoints 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. An independent Data
Safety Monitoring Board (DSMB) will conduct the interim futility
analysis after 60% of the study population completes the Day 14
primary endpoint study visit.
About Exebacase (CF-301):
Exebacase is a recombinantly-produced lysin
(cell wall hydrolase enzyme) with potent bactericidal activity
against Staph aureus, a major cause of bloodstream infections
(BSIs) also known as bacteremia. In the Company’s Phase 2 study of
exebacase, a pre-specified analysis of MRSA-infected patients
showed that the clinical responder rate at day 14 in patients
treated with exebacase was nearly 43-percentage points higher than
in patients treated with SOC antibiotics alone (74.1% for patients
treated with exebacase compared to 31.3% for patients treated with
SOC antibiotics alone (p=0.010)). In addition to the higher rate of
clinical response, MRSA-infected patients treated with exebacase
showed a 21-percentage point reduction in 30-day all-cause
mortality (p=0.056), a four-day lower mean length of hospital stay
and meaningful reductions in hospital readmission rates. Exebacase
is being studied in the Phase 3 DISRUPT superiority design study of
exebacase in patients with Staph aureus bacteremia, including
right-sided endocarditis.
Exebacase has the potential to be a
first-in-class treatment for Staph aureus bacteremia. Exebacase was
licensed from The Rockefeller University and is being developed at
ContraFect.
About CF-370:
CF-370 is an investigational first-in-class
therapeutic candidate targeting Pseudomonas aeruginosa (P.
aeruginosa), a Gram-negative pathogen. CF-370 has been engineered
to bypass the outer membrane of the bacteria and to enable potent
activity in human serum. The Company believes this is a significant
milestone for direct lytic agents as native lysins are typically
unable to penetrate the outer membrane of Gram-negative bacteria
and consequently unable to work in vitro in human blood or in
animal models. However, based on the proprietary methods the
Company has identified and utilizes to engineer lysins, CF-370 has
exhibited the hallmark in vitro features of the lysin class,
including rapid and potent bactericidal activity, synergy with a
broad range of standard of care agents and the eradication of
biofilms in preclinical studies. The promising data from animal
models support the potential therapeutic utility of CF-370 for the
treatment of serious infections caused by P. aeruginosa, including
hospital-acquired and ventilator-associated pneumonias and
pulmonary exacerbations of cystic fibrosis.
About ContraFect:
ContraFect is a biotechnology company focused on
the discovery and development of DLAs, including lysins and amurin
peptides, as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections. 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 novel class of DLAs which exhibit broad-spectrum
activity against a wide range of antibiotic-resistant Gram-negative
pathogens, including 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 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. Exebacase, currently being
studied in a pivotal Phase 3 clinical study, was granted
Breakthrough Therapy designation by the FDA for the treatment of
MRSA bloodstream infections, including right-sided endocarditis,
when used in addition to SOC anti-staphylococcal antibiotics in
adult patients.
Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.
Activities related to exebacase during the
period of performance under the contract will be funded in part
with federal funds from HHS; ASPR; BARDA, under contract number
75A501212C00021.
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: Phase 3 study enrollment
and timing of the interim futility analysis, expected receipt and
use of BARDA funding, use of public offering funds, the continued
advancement of pre-clinical assets, the Company’s financial
results, financial position, balance sheets and statements of
operations, ContraFect’s ability to discover and develop DLAs as
new medical modalities for the treatment of life-threatening,
antibiotic-resistant infections, whether exebacase has the
potential to be a first-in-class treatment for Staph aureus
bacteremia, the potential therapeutic utility of CF-370, whether
ContraFect will 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 are a novel class of DLAs which
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 the occurrence of any adverse events related to
the discovery, development and commercialization of ContraFect’s
product candidates such as unfavorable clinical trial results,
insufficient supplies of drug products, the lack of regulatory
approval, or the unsuccessful attainment or maintenance of patent
protection and other important risks 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
|
December 31,2020 |
|
December 31,2019 |
|
|
|
|
|
|
|
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
15,484,899 |
|
$ |
24,184,140 |
|
Marketable securities |
|
27,005,388 |
|
|
― |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
4,799,165 |
|
|
6,575,375 |
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
47,289,452 |
|
|
30,759,515 |
|
Property and equipment,
net |
|
910,075 |
|
|
1,099,948 |
|
Operating lease right-of-use
assets |
|
2,810,632 |
|
|
3,042,826 |
|
Other assets |
|
105,420 |
|
|
105,420 |
|
Total assets |
$ |
51,115,579 |
|
$ |
35,008,709 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
Current liabilities |
$ |
6,060,103 |
|
$ |
10,057,950 |
|
Other liabilities |
|
32,435,731 |
|
|
9,405,853 |
|
Total liabilities |
|
38,495,834 |
|
|
19,463,803 |
|
Total stockholders’
equity |
|
12,619,745 |
|
|
15,544,906 |
|
Total liabilities and
stockholders’ equity |
$ |
51,115,579 |
|
$ |
35,008,709 |
|
|
|
|
|
|
|
|
|
|
|
CONTRAFECT
CORPORATIONStatements of Operations
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
(unaudited) |
|
(unaudited) |
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and
development |
$ |
7,259,515 |
|
|
$ |
3,895,482 |
|
|
$ |
22,613,968 |
|
|
$ |
18,057,025 |
|
|
General and
administrative |
|
3,439,452 |
|
|
|
2,575,179 |
|
|
|
11,625,621 |
|
|
|
9,809,423 |
|
Total operating expenses |
|
10,698,697 |
|
|
|
6,470,661 |
|
|
|
34,239,589 |
|
|
|
27,866,448 |
|
Loss from operations |
|
(10,698,697 |
) |
|
|
(6,470,661 |
) |
|
|
(34,239,589 |
) |
|
|
(27,866,448 |
) |
Other income (expense): |
|
4,294,585 |
|
|
|
(3,884,823 |
) |
|
|
6,083,916 |
|
|
|
15,071,955 |
|
Net loss |
|
(6,404,382 |
) |
|
|
(10,355,484 |
) |
|
|
(28,155,673 |
) |
|
|
(12,794,493 |
) |
Per share information: |
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
|
(0.23 |
) |
|
|
(1.11 |
) |
|
|
(1.24 |
) |
|
|
(1.54 |
) |
|
Shares used
in computing net loss per share |
|
27,810,102 |
|
|
|
9,300,073 |
|
|
|
22,763,528 |
|
|
|
8,283,509 |
|
|
|
|
|
|
|
|
|
|
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 May 2020.
The Company's financial position as of December
31, 2020 and 2019 and results of operations for the years ended
December 31, 2020 and 2019 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
Corporationmmessinger@contrafect.com
Carlo Tanzi, Ph.D.Kendall Investor
Relationsctanzi@kendallinvestorrelations.com
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