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
first quarter ended March 31, 2022.
“I am very pleased to announce that we have
eclipsed the enrollment threshold, meaning over 60% of the
methicillin-resistant Staph aureus (MRSA) patients, needed for the
interim futility analysis of our Phase 3 DISRUPT study to be
conducted and we currently have about two-thirds of the entire
study population enrolled as well. I want to thank our entire team
for their hard work and tremendous persistence to achieve these
milestones during the pandemic,” said Roger J. Pomerantz, M.D.,
ContraFect’s President, Chief Executive Officer, and Chairman. “Now
we turn our attention to the interim futility analysis, which,
unlike other analyses for non-inferiority endpoints, will enable
the Data Safety Monitoring Board, or DSMB, to assess the
probability for exebacase to achieve superiority on the primary
efficacy endpoint of the study. Once the data necessary for this
analysis is collected, processed and delivered to the DSMB, we will
be informed of their recommendation regarding study continuation.
We expect this to occur during the first week of July. We are
extremely eager to get the recommendation of the DSMB, and, if
positive, pivot with alacrity towards building our organization to
support potential BLA submission, approval and commercialization of
this new modality therapeutic.”
First Quarter 2022 Highlights and Recent
Developments
- ContraFect expanded
its senior team with the promotion of Matthew Salamone, SPHR, PHR
to Vice President of Human Resources who will support the
anticipated growth and development of the Company through the
upcoming key milestones.
- In April 2022, the
Company provided an oral presentation at the 32nd European Congress
of Clinical Microbiology & Infectious Diseases (ECCMID) Annual
Meeting of new data from an in vivo efficacy study of CF-370 in a
rabbit acute pneumonia model caused by an extensively
drug-resistant (XDR) Pseudomonas aeruginosa (P. aeruginosa).
Multiple dose regimens of CF-370 administered alone and in addition
to amikacin, demonstrated statistically significant reductions of
bacteria counts in the lungs as compared to amikacin alone and
vehicle controls. Statistically significant reductions of bacteria
counts in secondary organs of interest, the spleen and the kidney,
were also seen when CF-370 was administered in addition to amikacin
compared to the administration of amikacin alone.
- In April 2022,
ContraFect presented multiple posters at the 32nd ECCMID Annual
Meeting characterizing the susceptibility profile of CF-370.
Utilizing the standard 28-day serial passage method to induce in
vitro resistance, CF-370 demonstrated an extremely low propensity
for developing decreased susceptibility to the Gram-negative ESKAPE
pathogens (P. aeruginosa, Acinetobacter baumannii, Klebsiella
pneumoniae and Enterobacter cloacae) as well as other deadly
Gram-negative pathogens – Escherichia Coli, Stenotrophomonas
maltophilia, and Achromobacter xylosoxidans. Furthermore, CF-370
also demonstrated the ability to suppress in vitro resistance of P.
aeruginosa to current standard of care antibiotics – meropenem,
tobramycin and levofloxacin.
- In January 2022,
the Company received its second contract award from the Cystic
Fibrosis Foundation. This contract award will support in vitro and
in vivo investigations of the potential utility of exebacase for
treating cystic fibrosis (CF) lung infections caused by MRSA. The
program will expand and augment the positive data from the in vitro
characterization of the activity of CF-370 and selected amurin
peptides against bacterial specimens obtained from CF patients
under the first award.
First Quarter 2022 Financial Results
- Research and
development expense was $12.7 million for the first quarter of 2022
compared to $8.0 million in the comparable period in 2021. This
increase was primarily attributable to an increase in spending on
manufacturing costs related to the process transfer, analytical and
process validation, and manufacturing of exebacase that will
support a potential BLA submission and on clinical activities as we
continued to enroll patients and expand the number of clinical
sites in the Phase 3 DISRUPT study of exebacase. These increases
were partially offset by a decrease in spending on non-clinical
studies of CF-370 and our other preclinical programs.
- General and administrative expense
was $3.3 million for the first quarter of 2022 compared to $2.8
million in the comparable period in 2021. This was due primarily to
an increase in costs for personnel and related expenses.
- Net loss was $20.2 million, or a
loss of $(0.51) per share, for the first quarter of 2022 compared
to a net loss of $5.2 million, or a loss of of $(0.18) per share,
for the comparable period in 2021. The net loss per share in the
current period includes a $4.2 million, or $0.11 per share,
non-cash charge from the change in the fair value of the Company’s
warrant liabilities. In the prior year period, the net loss per
share included a $5.6 million, or $0.19 per share, non-cash gain
from the change in the fair value of the Company’s warrant
liabilities.
- As of March 31, 2022, ContraFect
had cash, cash equivalents and marketable securities of $42.3
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 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 median length of hospital
stay and meaningful reductions in hospital readmission rates.
Exebacase was well-tolerated and treatment emergent adverse events,
including serious treatment-emergent serious adverse events (SAEs)
were balanced between the treatment groups. There were no SAEs
determined to be related to exebacase, there were no reports of
hypersensitivity related to exebacase and no patients discontinued
treatment with study drug in either treatment group.
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. The
lysin 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 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
microbiologic attributes 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 highly resistant strains of 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 development as a
treatment of MRSA bloodstream infections, including right-sided
endocarditis, when used in addition to SOC anti-staphylococcal
antibiotics.
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 patient
enrollment, the interim futility analysis, the study data necessary
for the analysis, 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,
timing of the interim futility analysis and whether the DSMB will
conduct the same, the DSMB recommendation, whether the Company will
be able to pivot towards supporting a BLA submission, approval and
commercialization of exebacase, whether the Company will grow and
develop through key milestones, statements made regarding the
Cystic Fibrosis Foundation award, the Company’s financial results,
financial position, balance sheets and statements of operations,
exebacase and CF-370 attributes, the potential therapeutic utility
of CF-370, whether ContraFect will address life-threatening
infections using therapeutic candidates from its DLA platform,
whether exebacase has the potential to be a first-in-class
treatment for Staph aureus bacteremia, 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
(in thousands) |
|
|
|
|
March 31,2022 |
December 31,2021 |
|
(unaudited) |
(audited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
9,637 |
$ |
16,654 |
Marketable securities |
|
32,644 |
|
37,631 |
Prepaid expenses |
|
6,541 |
|
4,439 |
Other current assets |
|
3,450 |
|
4,140 |
|
|
|
Total current assets |
|
52,272 |
|
62,864 |
Property and equipment, net |
|
696 |
|
741 |
Operating lease right-of-use assets |
|
2,471 |
|
2,544 |
Other assets |
|
601 |
|
613 |
|
|
|
Total assets |
$ |
56,040 |
$ |
66,762 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
Current liabilities |
$ |
16,714 |
$ |
12,174 |
Warrant liabilities |
|
6,742 |
|
2,530 |
Long-term portion of lease liabilities |
|
2,513 |
|
2,609 |
Other liabilities |
|
73 |
|
73 |
|
|
|
Total liabilities |
|
26,042 |
|
17,386 |
|
|
|
Total stockholders’ equity |
|
29,998 |
|
49,376 |
|
|
|
Total liabilities and stockholders’ equity |
$ |
56,040 |
$ |
66,762 |
|
|
|
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
(in thousands, except share and per-share
data) |
|
Three Months Ended March 31, |
|
2022 |
|
2021 |
Operating expenses |
|
|
|
Research and development |
$ |
12,725 |
|
|
$ |
8,021 |
|
General and administrative |
|
3,254 |
|
|
|
2,765 |
|
|
|
|
|
Total operating expenses |
|
15,979 |
|
|
|
10,786 |
|
|
|
|
|
Loss from operations |
|
(15,979 |
) |
|
|
(10,786 |
) |
Other income: |
|
|
|
Interest income |
|
34 |
|
|
|
24 |
|
Change in fair value of warrant liabilities |
|
(4,212 |
) |
|
|
5,567 |
|
|
|
|
|
Total other income |
|
(4,178 |
) |
|
|
5,591 |
|
|
|
|
|
Net loss |
$ |
(20,157 |
) |
|
$ |
(5,195 |
) |
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.51 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
Basic and diluted weighted average shares outstanding |
|
39,332,721 |
|
|
|
28,963,594 |
|
|
|
|
|
In this release, management has presented its
financial position as of March 31, 2022 and its operating results
for the first quarters of 2022 and 2021 in accordance with U.S.
Generally Accepted Accounting Principles (GAAP). The Company's
financial position as of December 31, 2021 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 25, 2021. 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
Jules AbrahamCORE IRTel: 917-885-7378Julesa@coreir.com
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