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 announces business updates and financial results for the
fourth quarter and full year ended December 31, 2021.
“Most importantly, we are on track and continue
to expect to conduct the planned interim futility analysis based on
approximately 60% of the MRSA study population by the end of the
first half of 2022. Unlike other analyses for non-inferiority, this
analysis will assess the probability for exebacase to achieve
superiority on the primary efficacy endpoint over standard-of-care
antibiotics alone,” said Roger J. Pomerantz, M.D., ContraFect’s
President, Chief Executive Officer, and Chairman. “In addition, we
look forward to the continued execution of our ongoing early and
late stage preclinical pipeline programs for some of the most
resistant bacterial pathogens, and to providing updates as they
become available.”
Fourth Quarter 2021 Highlights and
Recent Developments
- In January 2022,
the Company received its second contract award from the Cystic
Fibrosis Foundation. This contract award will support investigation
of the potential utility of exebacase for treating serious lung
infections caused by methicillin-resistant Staphylococcus
aureus (MRSA) in people with cystic fibrosis (CF). The
program, titled Nonclinical Assessment of Lysin Exebacase for
Treating MRSA Infections in CF will, over the course of
approximately 12 months, evaluate the in vitro activity of
exebacase against bacterial specimens obtained from CF
patients.
- In December 2021, a case study
report was published in Clinical Infectious Diseases, a journal of
the Infectious Disease Society of America (IDSA), highlighting the
potential of exebacase to treat MRSA bacteremia in a pediatric
population. The patient, a previously healthy 5-month-old male
infant, presented to Duke University Hospital for evaluation of
jerking movements and inability to sit independently. Following a
full evaluation, it was determined that he had blood culture
confirmed MRSA infection with life-threatening multi-organ
involvement, affecting the brain (left temporal subdural empyema),
upper airway (a retropharyngeal abscess), and heart (right-sided
endocarditis). Despite targeted antibiotic therapy, optimized
dosing, and attempts at source control, clearance of bacteremia and
clinical improvement was not achieved with standard of care (SOC)
antibiotics alone. The treating physician obtained authorization
from the U.S. Food and Drug Administration (FDA) to use exebacase
under an emergency individual patient investigational new drug
application and the patient subsequently received one 3 mg dose of
exebacase on hospital day 7. The patient continued to receive SOC
anti-staphylococcal antibiotics throughout the hospital stay. Blood
cultures became sterile on hospital day 12. The patient had ongoing
clinical improvement and serial echocardiograms noted no evidence
of heart valve vegetation on hospital day 40. The patient was
discharged, without the need for additional surgery.
- In October 2021, the Company
presented important new data at IDWeek 2021, in a late breaker,
oral presentation, from the Phase 2 study of exebacase. These data
demonstrated that exebacase, used in addition to standard-of-care
antibiotics (SOCA), more rapidly resolved clinical symptoms of
Staph aureus bacteremia versus SOCA alone. The median time to
resolution was 3 days for exebacase-treated patients, as compared
to 6 days for SOCA-alone patients. Notably, among the
exebacase-treated patients with MRSA bacteremia, the median time to
symptom resolution was 3 days, as compared to 7 days in patients
who received SOCA alone. Additionally, 94.1% of exebacase-treated
patients with MRSA bacteremia showed symptom resolution, compared
with only 81.8% MRSA bacteremia patients treated with SOCA
alone.
- In October 2021, new microbiologic
surveillance data was presented at IDWeek 2021 on the in vitro
activity of exebacase against Staph aureus clinical isolates
causing bacteremia in the United States, including
multidrug-resistant (MDR) strains. The data showed that Staph
aureus accounted for approximately 25% of all pathogens recovered
from blood specimens and nearly 40% of Staph aureus infected
samples were of a methicillin-resistant phenotype. These data
demonstrated the potent activity of exebacase and that its activity
was consistent, regardless of resistance phenotype (MSSA, MRSA,
including MDR isolates).
- In October 2021, the Company
presented new data on the activity of DLAs against the most
prevalent MDR pathogenic Gram-negative strains responsible for
pulmonary infections in CF patients at the North American Cystic
Fibrosis Conference. The data further support the in vitro activity
profile of CF-370 and amurin AM1 against specific Gram-negative
pathogens, including Pseudomonas aeruginosa (P. aeruginosa),
Stenotrophomonas maltophilia, and Achromobacter spp.
Fourth Quarter 2021 Financial Results
- Research and
development (R&D) expenses were $11.0 million for the fourth
quarter of 2021 compared to $7.3 million in the comparable period
in 2020. This increase was primarily attributable to increases in
expenditures on contract research organizations (CROs) to support
the active enrollment of patients in the Phase 3 DISRUPT study of
exebacase, and on contract manufacturers to complete the process
transfer of, and progress the validation of, the exebacase
manufacturing process to support the chemistry, manufacturing and
controls (CMC) activities required for potential BLA submission for
exebacase. The manufacturing process for CF-370 has also moved
forward towards enabling an Investigational New Drug (IND)
application later this year. Finally, the Company increased its
clinical development and CMC headcount and related personnel costs
to support the continued advancement of its programs across the
pipeline. These increases were partially offset by an increase in
the reimbursement of expenses under the Company’s BARDA contract
and grants compared to the prior year period.
- R&D expenses were
$35.5 million for the year ended December 31, 2021, compared
to $22.6 million for the year ended December 31, 2020. This
increase was primarily attributable to increases in expenditures
for the Phase 3 DISRUPT study of exebacase as we increased patient
enrollment and expanded the number of clinical sites, for the
manufacturing costs related to the process transfer, ongoing
process validation and manufacturing of exebacase and for the
expansion of the Company’s internal research, clinical development
and CMC teams. These increases were partially offset by an increase
in the reimbursement of expenses under the Company’s contract with
BARDA and various grants compared to the prior year period.
- General and administrative
(G&A) expenses were $3.0. million for the fourth quarter of
2021 compared to $3.4 million in the comparable period in 2020.
This decrease was primarily attributable to decreases in legal
expenses and recruiting costs.
- G&A expenses were
$11.8 million for the year ended December 31, 2021, compared
with $11.6 million for the year ended December 31, 2020. This
increase was primarily attributable to the increase in insurance
costs.
- Net loss was $4.4 million, or a
loss of $(0.11) per share, for the fourth quarter of 2021 compared
to net loss of $6.4 million, or a loss of $(0.23) per share, for
the comparable period in 2020. The net loss in the current period
includes a $9.7 million, or $0.25 per share, non-cash gain from the
change in the fair value of the Company’s warrant liabilities. In
the prior year period, the net loss included a $4.3 million, or
$0.15 per share, non-cash gain from the change in the fair value of
the Company’s warrant liabilities.
- Net loss was $20.3 million, or a
loss of $(0.55) per share, for the year ended December 31, 2021
compared to net loss of $28.2 million, or a loss of $(1.24) per
share, for the year ended December 31, 2020. The net loss for the
current year period includes a $26.9 million, or $0.73 per share,
non-cash gain from the change in the fair value of the Company’s
warrant liabilities. In the prior year period, the net loss
included an $8.1 million, or $0.35 per share, non-cash gain from
the change in the fair value of the Company’s warrant liabilities.
The net loss per share was also impacted by the year-over-year
increase in the weighted average shares outstanding.
- As of December 31, 2021, ContraFect
had cash, cash equivalents and marketable securities of $54.3
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 SOCA alone (74.1% for patients treated
with exebacase compared to 31.3% for patients treated with SOCA
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 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 SOCA. 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 MRSA population (the primary endpoint study population)
completes the Day 14 primary endpoint study visit.
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. However, based on the
proprietary methods the Company has identified and utilizes to
engineer lysins, CF-370 has exhibited the microbiologic attributes
of the lysin class, including rapid and potent bactericidal
activity, synergy with a broad range of SOCA 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.
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.
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,
timing of the interim futility analysis and whether it will be
conducted in H1 2022, 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, the Company’s ability to provide updates on
pipeline programs, the Company’s financial results, financial
position, balance sheets and statements of operations, ContraFect’s
ability to 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, the potential therapeutic utility of CF-370, 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) |
|
December 31,2021 |
|
December 31,2020 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
16,654 |
|
$ |
15,485 |
Marketable securities |
|
37,631 |
|
|
27,005 |
Prepaid expenses |
|
4,439 |
|
|
3,084 |
Other current assets |
|
4,140 |
|
|
1,081 |
Total current assets |
|
62,864 |
|
|
46,655 |
Property and equipment, net |
|
741 |
|
|
910 |
Operating lease right-of-use assets |
|
2,544 |
|
|
2,811 |
Other assets |
|
613 |
|
|
740 |
Total assets |
$ |
66,762 |
|
$ |
51,116 |
|
|
|
Liabilities and stockholders’ equity |
|
|
Current liabilities |
$ |
12,174 |
|
$ |
6,060 |
Warrant liabilities |
|
2,530 |
|
|
29,404 |
Long-term portion of lease liabilities |
|
2,609 |
|
|
2,959 |
Other liabilities |
|
73 |
|
|
73 |
Total liabilities |
|
17,386 |
|
|
38,496 |
Total stockholders’ equity |
|
49,376 |
|
|
12,620 |
Total liabilities and stockholders’ equity |
$ |
66,762 |
|
$ |
51,116 |
|
|
|
CONTRAFECT
CORPORATIONStatements of Operations
(in thousands, except share and per-share
data) |
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
(unaudited) |
(unaudited) |
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
11,048 |
|
|
$ |
7,260 |
|
|
$ |
35,508 |
|
|
$ |
22,614 |
|
General and administrative |
|
3,033 |
|
|
|
3,439 |
|
|
|
11,757 |
|
|
|
11,625 |
|
Total operating expenses |
|
14,081 |
|
|
|
10,699 |
|
|
|
47,265 |
|
|
|
34,239 |
|
Loss from operations |
|
(14,081 |
) |
|
|
(10,699 |
) |
|
|
(47,265 |
) |
|
|
(34,239 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
18 |
|
|
|
39 |
|
|
|
109 |
|
|
|
192 |
|
Other income (expense) |
|
— |
|
|
|
─ |
|
|
|
— |
|
|
|
(2,165 |
) |
Change in fair value of warrant liabilities |
|
9,664 |
|
|
|
4,256 |
|
|
|
26,874 |
|
|
|
8,056 |
|
Total other income |
|
9,682 |
|
|
|
4,295 |
|
|
|
26,983 |
|
|
|
6,083 |
|
Net loss |
$ |
(4,339 |
) |
|
$ |
(6,404 |
) |
|
$ |
(20,282 |
) |
|
$ |
(28,156 |
) |
Per share information: |
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.11 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.24 |
) |
Basic and diluted weighted average shares outstanding |
|
39,332,721 |
|
|
|
27,810,102 |
|
|
|
36,775,950 |
|
|
|
22,763,528 |
|
|
|
|
|
|
In this release, management has presented its
financial position as of December 31, 2021 and its operating
results for the three months and years ended December 31, 2021 and
2020 in accordance with U.S. Generally Accepted Accounting
Principles (GAAP). The Company's financial position as of December
31, 2020 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 30, 2021. You
should refer to both the Company's 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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