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 announces business updates and financial results for the
fourth quarter and full year ended December 31, 2022.
“With the important support from our recent
financings, we remain on track to both begin dosing patients in our
Phase 1b/2 clinical study of intra-articular exebacase for the
treatment of chronic prosthetic joint infections of the knee, and
to file an IND for our second program, CF-370, for the treatment of
Gram-negative infections, including resistant Pseudomonas,
Acinetobacter and Klebsiella species,” said Roger J. Pomerantz,
M.D., ContraFect’s President, Chief Executive Officer, and
Chairman. “We are excited to get in the clinic with both of our
lead programs, as we continue to execute on our mission to develop
new therapies with the potential to significantly improve clinical
outcomes for patients suffering from deadly and debilitating
resistant bacterial infections.”
Fourth Quarter 2022 Highlights and
Recent Developments
- In January 2023,
the Company received ethics approval for the clinical study of
intra-articularly administered exebacase in patients with chronic
prosthetic joint infection (PJI) of the knee due to Staphylococcus
aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS) from
the Hôspices Civils de Lyon in Lyon, France, the clinical site
where the study is being conducted. This approval followed the
authorization of the Company’s Clinical Trial Application from
ANSM, the French National Agency for the Safety of Medicines and
Health Products in November 2022. This is a valuable opportunity
for exebacase to demonstrate its potential to change standard of
care and recapitulate the positive and durable clinical results we
have observed in the compassionate use setting.The Phase 1b/2 study
of exebacase is a randomized, double-blind, placebo-controlled
clinical study conducted in France to assess the safety,
pharmacokinetics (PK), and efficacy of intra-articularly
administered exebacase in patients with chronic PJI of the knee due
to S. aureus or CoNS. The study will be conducted in two parts.
Part I will assess efficacy at an early, six-week timepoint in
addition to safety and PK. Part II will be a long-term clinical
safety and efficacy follow-up for a period of up to two years.
Patients entering the study will be randomized 3:1 to either
exebacase or placebo, with patients receiving study drug in the
setting of a of a minimally-invasive arthroscopic debridement,
antibiotics, irrigation, and retention (DAIR) Procedure.
- In December 2022, the Company
closed on a $7.0 million registered direct offering and concurrent
private placement of warrants to purchase common stock. In March
2023, the Company closed on another $10.0 million registered direct
offering and concurrent private placement of warrants to purchase
common stock, bringing the total estimated net proceeds of both
capital raises to $15.3 million.
Fourth Quarter 2022 and Full Year 2022 Financial
Results
- Research and
development (R&D) expenses were $4.4 million for the fourth
quarter of 2022 compared to $11.0 million in the comparable period
in 2021. This decrease was primarily attributable to significantly
reduced expenditures on the chemistry, manufacturing and controls
(CMC) activities for exebacase, the contract research organizations
(CROs) to support the continued closure of the Phase 3 DISRUPT
study of exebacase and headcount and related personnel costs after
the restructuring of the Company’s workforce in the third quarter
of 2022.
- R&D expenses were
$44.7 million for the year ended December 31, 2022, compared
to $35.5 million for the year ended December 31, 2021. This
increase was primarily attributable to the increase in spending on
clinical activities related to the Phase 3 DISRUPT study of
exebacase and on manufacturing costs for both exebacase and CF-370.
These costs decreased significantly after we stopped enrollment in
the Phase 3 DISRUPT study and implemented our restructuring
plan.
- General and administrative
(G&A) expenses were $2.3 million for the fourth quarter of 2022
compared to $3.0 million in the comparable period in 2021. This
decrease was primarily attributable to decreases in headcount and
related personnel costs after the restructuring of the Company’s
workforce in the third quarter of 2022, legal expenses and
professional fees.
- G&A expenses were
$12.2 million for the year ended December 31, 2022, compared
with $11.8 million for the year ended December 31, 2021. This
increase was primarily attributable to an increase in legal
expenses.
- Net loss was $9.8 million, or a
loss of $16.14 per share, for the fourth quarter of 2022 compared
to net loss of $4.4 million, or a loss of $8.95 per share, for the
comparable period in 2021. The net loss in the current period
includes $4.8 million, or $7.90 per share, of non-cash charges
related to the value of the warrants issued in the Company’s
December 2022 offering of securities and the allocation of the
offering costs from the offering to the warrants. These charges
were partially offset by a $1.7 million, or $2.72 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 $9.7 million, or $19.66 per share, non-cash gain from
the change in the fair value of the Company’s warrant
liabilities.
- Net loss was $65.2 million, or a
loss of $124.97 per share, for the year ended December 31, 2022
compared to net loss of $20.3 million, or a loss of $44.12 per
share, for the year ended December 31, 2021. The net loss for the
current year period includes $4.8 million, or $9.23 per share, of
non-cash charges related to the value of the warrants issued in the
Company’s December 2022 offering of securities and the allocation
of the offering costs from the offering to the warrants. These
charges were partially offset by a $4.2 million, or $8.03 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 $26.9 million, or $58.46 per share, non-cash gain
from the change in the fair value of the Company’s warrant
liabilities.
- As of December 31, 2022, ContraFect
had cash, cash equivalents and marketable securities of $13.7
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 the timing of patient
dosing in the Phase 1b/2 study and the filing of the CF-370 IND,
statements made by Dr. Pomerantz, whether the company can continue
to execute on its mission to develop new therapies with the
potential to significantly improve clinical outcomes for patients
suffering from deadly and debilitating resistant bacterial
infections, ContraFect’s ability to discover and develop DLAs as
new medical modalities for the treatment of life-threatening,
antibiotic-resistant infections, whether exebacase will demonstrate
its potential to change standard of care and recapitulate the
positive and durable clinical compassionate use results, the
Company’s financial results, financial position, balance sheets and
statements of operations, whether ContraFect will address
life-threatening infections using therapeutic candidates from 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, 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 Annual Report on Form 10-K for the year ended December
31, 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)
|
|
|
|
December 31,2022 |
|
December 31,2021 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
8,907 |
|
$ |
16,654 |
Marketable securities |
|
4,775 |
|
|
37,631 |
Prepaid expenses |
|
1,382 |
|
|
4,439 |
Other current assets |
|
2,642 |
|
|
4,140 |
|
|
|
Total current assets |
|
17,706 |
|
|
62,864 |
Property and equipment,
net |
|
627 |
|
|
741 |
Operating lease right-of-use
assets |
|
2,241 |
|
|
2,544 |
Other assets |
|
105 |
|
|
613 |
|
|
|
Total assets |
$ |
20,679 |
|
$ |
66,762 |
|
|
|
|
|
|
Liabilities and
stockholders’ (deficit) equity |
|
|
Current liabilities |
$ |
20,840 |
|
$ |
12,174 |
Warrant liabilities |
|
9,299 |
|
|
2,530 |
Long-term portion of lease
liabilities |
|
2,210 |
|
|
2,609 |
Other liabilities |
|
182 |
|
|
73 |
|
|
|
Total liabilities |
|
32,531 |
|
|
17,386 |
|
|
|
Total stockholders’ (deficit)
equity |
|
(11,852 |
) |
|
49,376 |
|
|
|
Total liabilities and
stockholders’ (deficit) equity |
$ |
20,679 |
|
$ |
66,762 |
|
|
|
|
|
|
CONTRAFECT
CORPORATIONStatements of Operations(in thousands,
except share and per-share data)
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
(unaudited) |
(unaudited) |
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
4,438 |
|
|
$ |
11,048 |
|
|
$ |
44,738 |
|
|
$ |
35,508 |
|
General and administrative |
|
2,265 |
|
|
|
3,033 |
|
|
|
12,151 |
|
|
|
11,757 |
|
Restructuring |
|
— |
|
|
|
— |
|
|
|
7,719 |
|
|
|
— |
|
|
|
|
|
|
Total
operating expenses |
|
6,703 |
|
|
|
14,081 |
|
|
|
64,608 |
|
|
|
47,265 |
|
|
|
|
|
|
Loss
from operations |
|
(6,703 |
) |
|
|
(14,081 |
) |
|
|
(64,608 |
) |
|
|
(47,265 |
) |
Other
(expense) income: |
|
|
|
|
Interest income |
|
17 |
|
|
|
18 |
|
|
|
81 |
|
|
|
109 |
|
Other expense |
|
(4,813 |
) |
|
|
— |
|
|
|
(4,813 |
) |
|
|
— |
|
Change in fair value of warrant liabilities |
|
1,660 |
|
|
|
9,664 |
|
|
|
4,187 |
|
|
|
26,874 |
|
|
|
|
|
|
Total
other (expense) income, net |
|
(3,136 |
) |
|
|
9,682 |
|
|
|
(545 |
) |
|
|
26,983 |
|
|
|
|
|
|
Net loss |
$ |
(9,839 |
) |
|
$ |
(4,399 |
) |
|
$ |
(65,153 |
) |
|
$ |
(20,282 |
) |
|
|
|
|
|
Per
share information: |
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(16.14 |
) |
|
$ |
(8.95 |
) |
|
$ |
(124.97 |
) |
|
$ |
(44.12 |
) |
|
|
|
|
|
Basic and diluted weighted average shares outstanding |
|
609,590 |
|
|
|
491,626 |
|
|
|
521,359 |
|
|
|
459,699 |
|
|
|
|
|
|
In this release, management has presented its
financial position as of December 31, 2022 and its operating
results for the three months and years ended December 31, 2022 and
2021 in accordance with U.S. Generally Accepted Accounting
Principles (GAAP). All share and per share amounts have been
adjusted for all periods presented to reflect a one-for-eighty
reverse stock split effected on February 14, 2023. 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, 2022. 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 CorporationEmail:
mmessinger@contrafect.com
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