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 and business updates for the
third quarter ended September 30, 2020.
“We are pleased with the progress of the Phase 3
DISRUPT superiority study of exebacase, which received Breakthrough
Therapy designation from the FDA earlier this year, in patients
suffering from life-threatening Staph aureus bloodstream
infections,” said Roger J. Pomerantz, M.D., President, Chief
Executive Officer, and Chairman of ContraFect. “We also continue to
advance our pipeline programs towards the clinic and appreciate the
tremendous financial support from CARB-X and the Cystic Fibrosis
Foundation for our second product candidate, CF-370, an engineered
lysin targeting Pseudomonas aeruginosa.”
Q3
2020 Highlights and Recent Developments
- In
October, 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.
- In
August, the Company entered into an agreement with the Cystic
Fibrosis Foundation to investigate the potential utility of DLAs
against resistant Gram-negative pathogens which afflict Cystic
Fibrosis (CF) patients. The first stage of the agreement will
provide funding for the in vitro characterization of the activity
of CF-370, an engineered lysin targeting Pseudomonas aeruginosa,
and selected amurin peptides, against bacterial specimens obtained
from CF patients at different stages of disease. With supportive
data, ContraFect plans to evaluate future clinical development of
CF-370 and/or amurin peptides as potential therapeutics for the
treatment of pulmonary exacerbations in CF patients.
- In July,
the Company announced that CARB-X (Combating Antibiotic Resistant
Bacteria Biopharmaceutical Accelerator), a global non-profit
partnership dedicated to accelerating antibacterial research and
development, awarded the Company up to $18.9 million in additional
non-dilutive capital to progress CF-370 through IND-enabling
activities toward Phase 1 clinical trials. The award provides
initial funding of $4.9 million, and ContraFect could receive
additional funding at the discretion of CARB-X if certain project
milestones are met.
Ongoing COVID-19 Response
- The Phase
3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial)
study of exebacase is ongoing. The Company continues to enroll
patients and open new clinical trial sites across the United
States. The study continues to experience some delays in patient
enrollment due to the diversion of healthcare resources resulting
from the COVID-19 pandemic in certain high impact areas.
Third Quarter 2020
Financial Results
- Research
and development (R&D) expenses were $4.7 million for the third
quarter of 2020 compared to $5.3 million in the comparable period
in 2019. This decrease was primarily attributable to a decrease in
internal and external research costs and a decrease in chemistry,
manufacturing and controls (CMC) activities in the current quarter.
These decreases were partially offset by increases in CRO expenses,
clinical headcount and related personnel costs and professional
fees to support the ongoing Phase 3 clinical study of
exebacase.
- General
and administrative (G&A) expenses were $2.6 million for the
third quarter of 2020 compared to $2.4 million in the comparable
period in 2019. This increase was primarily attributable to
increases in professional fees and insurance costs.
- GAAP net
income was $3.4 million, or $0.12 per share, for the third quarter
of 2020 compared to a GAAP net loss of $5.4 million, or $0.67 per
share, for the comparable period in 2019. After adjustment for the
dilutive impact of the change in fair value of certain warrant
liabilities, the Company reported a net loss of $5.4 million, or
$0.19 per diluted share, for the third quarter of 2020.
- As of
September 30, 2020, ContraFect had cash, cash equivalents and
marketable securities of $50.2 million.
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 on top of standard-of-care (SOC) antibiotics
was nearly 43-percentage points higher than in patients treated
with SOC antibiotics alone (74.1% for patients treated with
exebacase and SOC antibiotics, 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 30-day hospital
readmission rates. Exebacase is currently 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 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. The company plans to
conduct an interim futility analysis following the enrollment of
approximately 60% of the study population.
About ContraFect:
ContraFect is a 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.
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 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 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.
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 significance of the
CARB-X and Cystic Fibrosis Foundation (CFF) grants and whether they
will advance CF-370, whether the expanded access program was
initiated, ContraFect’s ability to discover and develop DLAs as new
medical modalities for the treatment of life-threatening,
antibiotic-resistant infections, statements made by Dr. Pomerantz,
whether physicians will use exebacase to treat severely ill
COVID-19 patients, whether hospitalized COVID-19 patients will have
access to exebacase, whether the Company will obtain supportive
data using CFF funding and be able to evaluate future clinical
development of CF-370 or amurin peptides as potential therapeutics
for the treatment of pulmonary exacerbations in CF patients,
whether the Company receives all initial and additional CARB-X
funding, statements made regarding how COVID-19 has effected the
Phase 3 DISRUPT study, statements made regarding the Phase 2 study
results, the Company’s financial results, financial position,
balance sheets and statements of operations, statements made
regarding the Phase 3 study and whether the Company will conduct an
interim futility analysis, whether exebacase has the potential to
be a first-in-class treatment for exebacase, 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 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
30,2020 |
|
December 31,2019 |
|
(unaudited) |
(audited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash
equivalents |
$ |
18,152,046 |
|
$ |
24,184,140 |
Marketable
securities |
|
32,082,709 |
|
|
— |
Prepaid expenses and other current
assets |
|
5,828,086 |
|
|
6,575,375 |
|
|
|
Total current
assets |
|
56,062,841 |
|
|
30,759,515 |
Property and equipment,
net |
|
957,587 |
|
|
1,099,948 |
Operating lease right-of-use
assets |
|
2,870,431 |
|
|
3,043,826 |
Other assets |
|
105,420 |
|
|
105,420 |
|
|
|
Total assets |
$ |
59,996,279 |
|
$ |
35,008,709 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
Current
liabilities |
|
4,828,382 |
|
|
10,057,950 |
Warrant
liabilities |
|
33,659,991 |
|
|
6,068,978 |
Long-term portion of lease
liabilities |
|
3,038,056 |
|
|
3,264,128 |
Other
liabilities |
|
72,747 |
|
|
72,747 |
|
|
|
Total
liabilities |
|
41,599,176 |
|
|
19,463,803 |
|
|
|
Total stockholders’
equity |
|
18,397,103 |
|
|
15,544,906 |
|
|
|
Total liabilities and stockholders’
equity |
$ |
59,996,279 |
|
$ |
35,008,709 |
|
|
|
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
Research and
development |
$ |
4,706,012 |
|
|
$ |
5,250,327 |
|
|
$ |
15,354,453 |
|
|
$ |
14,161,543 |
|
General and
administrative |
|
2,607,472 |
|
|
|
2,376,248 |
|
|
|
8,186,169 |
|
|
|
7,234,244 |
|
|
|
|
|
|
Total operating
expenses |
|
7,313,484 |
|
|
|
7,626,575 |
|
|
|
23,540,622 |
|
|
|
21,395,787 |
|
|
|
|
|
|
Loss from
operations |
|
(7,313,484 |
) |
|
|
(7,626,575 |
) |
|
|
(23,540,622 |
) |
|
|
(21,395,787 |
) |
Other income (expense): |
|
|
|
|
Interest
income |
|
58,451 |
|
|
|
80,747 |
|
|
|
154,019 |
|
|
|
334,307 |
|
Other income
(expense) |
|
9,609 |
|
|
|
― |
|
|
|
(2,165,044 |
) |
|
|
― |
|
Change in fair value of warrant
liabilities |
|
10,689,855 |
|
|
|
2,186,710 |
|
|
|
3,800,356 |
|
|
|
18,622,471 |
|
|
|
|
|
|
Total other income
(expense) |
|
10,757,915 |
|
|
|
2,267,457 |
|
|
|
1,789,331 |
|
|
|
18,956,778 |
|
|
|
|
|
|
Net income
(loss) |
$ |
3,444,431 |
|
|
$ |
(5,359,118 |
) |
|
$ |
(21,751,291 |
) |
|
$ |
(2,439,009 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Basic net income (loss) per share
|
$ |
0.12 |
|
|
$ |
(0.67 |
) |
|
$ |
(1.03 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
Shares used in computing basic net income (loss) per
share |
|
27,809,169 |
|
|
|
7,940,931 |
|
|
|
21,069,057 |
|
|
|
7,940,931 |
|
Diluted net loss per
share |
$ |
(0.19 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.03 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
Shares used in computing diluted net loss per
share |
|
29,079,107 |
|
|
|
7,940,931 |
|
|
|
21,069,057 |
|
|
|
7,940,931 |
|
|
|
|
|
|
The Company's financial position as of September
30, 2020 and results of operations for the three and nine months
ended September 30, 2020 and 2019 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, 2019 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 18,
2020. 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
Corporationmmessinger@contrafect.com
Carlo Tanzi, Ph.D.Kendall Investor
Relationsctanzi@kendallinvestorrelations.com
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