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
second quarter ended June 30, 2022.
“Despite the recent setback from the interim
futility analysis of our Phase 3 DISRUPT superiority study of
intravenous (IV) exebacase, we continue to advance our lead
programs toward new clinical studies. We expect to file with
regulatory authorities later this year to initiate a study of
intra-articular exebacase in patients with chronic or recurrent
prosthetic joint infections. We believe this patient population
provides the best opportunity now for exebacase to again
demonstrate proof of concept, as well as to differentiate this
molecule from the current, surgical standard of care treatment. We
are also completing the GLP toxicology studies required for the IND
application of CF-370, for resistant gram-negative infections. We
currently expect to advance CF-370 into clinical development with a
multiple day dose regimen aimed at maximizing its opportunity to
demonstrate clinical efficacy,” said Roger J. Pomerantz, M.D.,
President, Chief Executive Officer, and Chairman of ContraFect.
“The needs of patients with deadly and debilitating resistant
bacterial infections demand that we continue to move our product
candidates forward to establish a potential new treatment modality
for these patients, their families and their physicians,” added Dr.
Pomerantz.
Corporate Strategy
In order to be positioned to initiate the
potential clinical trials discussed above, the Company has taken
multiple actions to maximize its resources and focus its efforts on
the execution of its corporate strategy. Subsequent to the Data
Safety Monitoring Board (“DSMB”) recommendation, disclosed in the
Company’s press release issued and 8-K filed with the Securities
and Exchange Commission (“SEC”) on July 13, 2022, that the Phase 3
DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial)
trial be stopped for futility, the Company has implemented the
following actions:
- The Company
initiated and has completed a significant portion of its own
analyses of the accrued DISRUPT study data and expects to complete
the analysis toward the end of the third quarter of 2022. The
Company expects that conclusions drawn from the ongoing data review
will inform next steps for any potential further development of
exebacase.
- Investigators were
notified of the DSMB recommendation and that new patient enrollment
in the trials was being stopped. The Company expects the final
patients already enrolled in the study at the time of the DSMB
recommendation to complete their follow-up visits in September. The
Company also expects to complete all clinical study reports as
required by the FDA.
- All CMC
(chemistry, manufacturing and controls) activities related to the
potential commercialization of IV exebacase have been or are in the
process of being suspended.
- The Company has
reduced its workforce by 16 employees, or approximately 37% of the
Company’s headcount as of June 30, 2022. The Company expects to
recognize a restructuring charge in the third quarter of 2022 of
approximately $1.5 million consisting primarily of severance,
one-time termination and other related costs, all of which will
result in future cash expenditures. The Company expects this
headcount reduction to lower its annual operating costs by over
$4.0 million. This reduction includes the resignation of Cara
Cassino, M.D. as Chief Medical Officer and Executive Vice President
of Research and Development of the Company. Dr. Cassino’s
resignation as an officer of the Company was effective on August
14, 2022. The Company thanks Dr. Cassino for her years of
dedication and for remaining with the Company through August 31,
2022 to transition the role and for continuing to serve as a valued
consultant after the transition.
- Finally, the
Company has engaged Garrett Nichols, M.D., M.S., to be its Interim
Chief Medical Officer. With more than 20 years in the life sciences
industry, Dr. Nichols brings vast experience managing the global
development efforts of multiple infectious disease and cancer
therapeutics at both small and large, biopharmaceutical companies.
Dr. Nichols earned his M.D. from Duke University and his M.S. in
epidemiology from the University of Washington, where he also
completed a fellowship in infectious diseases. The Company welcomes
Dr. Nichols into the organization to assist with the potential
advancement of exebacase and CF-370 into new clinical trials.
Recent Corporate Highlights
- In June 2022, at
the 2022 ASM Microbe Conference, the Company provided the results
from a study evaluating the activity of exebacase or CF-296 in a
preclinical rabbit model of implant-associated
methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis
which demonstrated that the local administration of either lysin to
the affected bone, in addition to systemically administered
daptomycin, resulted in significant reduction in MRSA counts on
infected implants compared to daptomycin alone. Notably, the
administration of exebacase alone, without systemic antibiotics,
resulted in significant reductions in MRSA counts compared to
controls. Further information about this study can be found by
reading the manuscript published in the peer-reviewed Journal of
Bone and Joint Infection.
- 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.
Second Quarter 2022 Financial Results
- Research and
development (R&D) expense was $16.8 million for the second
quarter of 2022 compared to $7.8 million in the comparable period
in 2021. This increase was primarily attributable to an increase in
spending on CMC costs related to the analytical and process
validation and pre-commercial manufacturing of exebacase, an
increase in spending on non-clinical studies of exebacase and
IND-enabling studies of CF-370 to support a potential IND
application, and an increase in spending on clinical activities as
we continued to enroll patients and expand the number of clinical
sites ahead of the interim futility analysis of the Phase 3 DISRUPT
study of exebacase.
- General and administrative
(G&A) expense was $3.3 million for the second quarter of 2022
compared to $2.9 million in the comparable period in 2021. This was
due primarily to an increase in costs for personnel and related
expenses.
- Net loss was $18.1 million, or a
loss of $0.46 per share, for the second quarter of 2022 compared to
net loss of $5.4 million, or a loss of $0.14 per share, for the
comparable period in 2021. The net loss per share in the current
period includes a $1.9 million, or $0.05 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 per share
included a $5.3 million, or $0.13 per share, non-cash gain from the
change in the fair value of the Company’s warrant liabilities.
- As of June 30, 2022, ContraFect had
cash, cash equivalents and marketable securities of $27.3
million.
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 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 further details as to how
ContraFect intends to proceed with the development of exebacase and
the ongoing analysis of the data sets from the Phase 3 clinical
study of exebacase, timing and expectations surrounding regulatory
submissions and initiation of potential clinical trials, statements
made by Dr. Pomerantz, expectations surrounding the workforce
reduction, ContraFect’s corporate strategy, ContraFect’s ability to
discover and develop DLAs as new medical modalities for the
treatment of life-threatening, antibiotic-resistant infections, 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, without limitation, that ContraFect has and
expects to continue to incur significant losses, ContraFect’s need
for additional funding, which may not be available, 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, changes in
management may negatively affect ContraFect’s business and other
important risks detailed under the caption “Risk Factors” in
ContraFect's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022 and its other filings with the Securities and
Exchange Commission. Actual results may differ from those set forth
in the forward-looking statements. 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)
|
|
|
|
June 30,2022 |
|
December 31,2021 |
|
|
(unaudited) |
(audited) |
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
9,549 |
|
$ |
16,654 |
|
Marketable securities |
|
17,753 |
|
|
37,631 |
|
Prepaid expenses |
|
8,313 |
|
|
4,439 |
|
Other current assets |
|
2,097 |
|
|
4,140 |
|
|
|
|
Total current assets |
|
37,712 |
|
|
62,864 |
|
Property and equipment, net |
|
653 |
|
|
741 |
|
Operating lease right-of-use assets |
|
2,326 |
|
|
2,544 |
|
Other assets |
|
107 |
|
|
613 |
|
Total assets |
$ |
40,798 |
|
$ |
66,762 |
|
|
|
|
Liabilities and stockholders’ equity |
|
|
Current liabilities |
$ |
20,600 |
|
$ |
12,174 |
|
Warrant liabilities |
|
4,826 |
|
|
2,530 |
|
Long-term portion of lease liabilities |
|
2,414 |
|
|
2,609 |
|
Other liabilities |
|
73 |
|
|
73 |
|
Total liabilities |
|
27,913 |
|
|
17,386 |
|
Total stockholders’ equity |
|
12,885 |
|
|
49,376 |
|
Total liabilities and stockholders’ equity |
$ |
40,798 |
|
$ |
66,762 |
|
|
|
|
CONTRAFECT
CORPORATIONUnaudited Statements of Operations(in
thousands, except share and per-share
data)
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
16,760 |
|
|
$ |
7,777 |
|
|
$ |
29,485 |
|
|
$ |
15,798 |
|
|
General and administrative |
|
3,266 |
|
|
|
2,935 |
|
|
|
6,520 |
|
|
|
5,700 |
|
|
|
|
|
|
|
Total operating expenses |
|
20,026 |
|
|
|
10,712 |
|
|
|
36,005 |
|
|
|
21,498 |
|
|
|
|
|
|
|
Loss from operations |
|
(20,026 |
) |
|
|
(10,712 |
) |
|
|
(36,005 |
) |
|
|
(21,498 |
) |
|
Other (expense) income: |
|
|
|
|
Interest income |
|
21 |
|
|
|
30 |
|
|
|
55 |
|
|
|
55 |
|
|
Change in fair value of warrant liabilities |
|
1,916 |
|
|
|
5,286 |
|
|
|
(2,296 |
) |
|
|
10,852 |
|
|
|
|
|
|
|
Total other (expense) income, net |
|
1,937 |
|
|
|
5,316 |
|
|
|
(2,241 |
) |
|
|
10,907 |
|
|
|
|
|
|
|
Net loss |
$ |
(18,089 |
) |
|
$ |
(5,396 |
) |
|
$ |
(38,246 |
) |
|
$ |
(10,591 |
) |
|
|
|
|
|
|
Per share information: |
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.46 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.97 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
|
Shares used in computing net loss per share |
|
39,332,721 |
|
|
|
39,332,721 |
|
|
|
39,332,721 |
|
|
|
34,176,801 |
|
|
|
|
|
|
|
In this release, management has presented its
financial position as of June 30, 2022 and its operating results
for the three and six months ended June 30, 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
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