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, 2022.
“I am quite proud of our team at ContraFect, as
we worked through significant, unexpected adversity while
continuing to successfully execute on our near-term objectives. We
submitted a CTA to ANSM, the French regulatory agency, to begin a
Phase 1b/2 clinical study of intra-articular exebacase in patients
with chronic prosthetic joint infections of the knee. In addition,
we completed the GLP toxicology studies of CF-370, our lysin for
the potential treatment of important Gram-negative infections,
including resistant Pseudomonas, Acinetobacter and Klebsiella, and
expect to submit an IND for CF-370 by the end of the first quarter
of 2023. We also completed the patient monitoring and follow-up of
the final patients of the DISRUPT study and look to achieve
database lock in December. We expect to communicate the results
from the full study population in the first half of 2023 and from
our own analysis of the futility analysis dataset shortly after
database lock, or earlier if possible,” said Roger J. Pomerantz,
M.D., President, Chief Executive Officer, and Chairman of
ContraFect. “We are excited about 2023 and the prospect of having
two different programs in the clinic, with the potential to
demonstrate that we can significantly improve clinical outcomes for
patients suffering from deadly and debilitating resistant bacterial
infections,” added Dr. Pomerantz.
Third Quarter 2022 Highlights and Recent
Developments
- In October 2022,
the Company’s Clinical Trial Authorization (CTA) submission to
Agence nationale de sécurité du médicament et des produits de santé
(ANSM), the French National Agency for the Safety of Medicines and
Health Products, for the study of intra-articular exebacase in
patients with chronic prosthetic joint infections of the knee due
to S. aureus or coagulase-negative Staphylococci (CoNS) was
accepted for review. Assuming approval of the submission by ANSM,
the Company expects to begin dosing patients in the first quarter
of 2023.
- In October 2022,
at IDWeek 2022, the Company provided a poster presentation of new
clinical data from a single center, exploratory, open-label
prospective study using the minimally invasive LysinDAIR procedure
(lysin administration during an arthroscopic DAIR procedure) in
patients with suspected relapsing chronic CoNS prosthetic hip
infection (PHI). At two years follow up, all patients had
resolution of fistula and no clinical signs of infection. The
LysinDAIR procedure was easy-to-perform, safe and demonstrated the
therapeutic potential of exebacase to facilitate the success of
salvage therapy for chronic relapsing CoNS PJIs and to cure initial
chronic PJIs. The poster can be found on the Company’s
website.
- In September 2022,
at the 40th Annual Meeting of the European Bone and Joint Infection
Society, Dr. Tristan Ferry of the Infectious and Tropical Diseases
Unit, Croix-Rousse Hospital, Hôspices Civils de Lyon in Lyon,
France provided an oral presentation of new clinical data from a
single center, exploratory, open-label prospective study using a
minimally invasive LysinDAIR procedure in patients with chronic
knee PJI, due to CoNS, with two different clinical presentations
and treatment paradigms. The first cohort included patients
suffering their first episode of CoNS knee PJI. The LysinDAIR
procedure was followed by three months of clindamycin and
levofloxacin. Through follow up periods of up to 36 months, the
patients have experienced no relapse of infection, no recurrence of
the joint effusion and no loosening of the prostheses. The second
cohort included patients suffering from a complex episode of
multi-drug resistant CoNS knee PJI. The LysinDAIR procedure was
followed by three months of antibiotics plus additional suppressive
antimicrobial therapy. Two patients, through follow up periods of
up to 12 months, have experienced no relapse of infection, no
recurrence of the joint effusion and no loosening of the
prostheses. One patient experienced a relapse of infection of
Staphylococcus caprae after six months. One patient died from an
unrelated COVID-19 infection. Exebacase was well tolerated by all
patients. No local or systemic serious adverse events (SAEs)
related to exebacase were reported.
- In September 2022,
the Company announced two publications. The first, an editorial in
the Journal of Bone and Joint Infection, discussed the potential
for lysins to become advantageous agents in the treatment
armamentarium against bone and joint infections (BJIs) compared
with current antibiotic treatments alone based on the in vitro
activity of lysins seen against CoNS, the bacteria most frequently
involved in implant-associated BJIs, and the potential for both
local and systemic anti-biofilm activity. The second article,
published in Antimicrobial Agents and Chemotherapy, a leading peer
reviewed journal dedicated to the study of treatments for
infectious diseases, presented the results demonstrating such in
vitro activity of exebacase against biofilms isolated from patients
with PJIs formed by clinical strains of Staphylococcus epidermidis
(S. epidermidis), a CoNS species. Exebacase displayed significant
anti-biomass and bactericidal activity against S. epidermidis
biofilms, as well as synergistic effects in addition to rifampicin,
vancomycin, and daptomycin.
- In August 2022,
ContraFect announced the publication of a manuscript in the Journal
of Bone and Joint Infection presenting the results from a study
evaluating the activity of exebacase or the CF-296 lysin in a
preclinical rabbit model of implant-associated
methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
The results demonstrated that the local administration of either
lysin to the affected bone, in addition to systemic antibiotics,
reduced MRSA counts in the bone and on implants compared with
control animals. Notably, the administration of exebacase alone,
without systemic antibiotics, resulted in significant reductions in
MRSA counts compared to controls. Furthermore, when used in
addition to systemically administered daptomycin, either lysin also
resulted in significant reduction in MRSA counts on infected
implants compared to daptomycin alone.
Third Quarter 2022 Financial Results
- Research and
development (R&D) expense was $10.8 million for the third
quarter of 2022 compared to $8.7 million in the comparable period
in 2021. This increase was primarily attributable to an increase in
spending on clinical activities as the Company stopped enrollment
of patients in the Phase 3 DISRUPT study of exebacase and continued
patient follow-up procedures and monitoring and an increase in
spending on non-clinical studies of CF-370 to support a potential
IND application and the completion of ongoing non-clinical studies
of exebacase. A decrease in the reimbursable expenditures under the
Company’s grants and BARDA contract also contributed to the
increase. These increases were partially offset by a decrease in
manufacturing expenses due to the suspension of CMC activities
related to the potential commercialization of exebacase, a decrease
in spending on development personnel as a result of the Company’s
restructuring plan and decrease in external research expenditures
on other discovery programs.
- General and administrative
(G&A) expense was $3.4 million for the third quarter of 2022
compared to $3.0 million in the comparable period in 2021. This was
due primarily to an increase in legal fees and stock-based
compensation expense.
- Restructuring expense was $7.7
million for the third quarter of 2022 compared to no expense in the
comparable period in 2021. The restructuring plan announced during
the quarter was designed to reduce costs and align resources with
the Company’s anticipated product development milestones for
exebacase and CF-370 and to help preserve the value of the
Company’s drug discovery operations. This expense was comprised of
employee termination costs, including severance, health benefits
and other related expenses from a workforce reduction and a
write-off of prepaid manufacturing costs.
- Net loss was $17.1 million, or a
loss of $0.43 per share, for the third quarter of 2022 compared to
net loss of $5.3 million, or a loss of $0.13 per share, for the
comparable period in 2021. The net loss per share in the current
period includes a $4.8 million, or $0.12 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 $6.4 million, or $0.16 per share, non-cash gain from the
change in the fair value of the Company’s warrant liabilities.
- As of September 30, 2022,
ContraFect had cash, cash equivalents and marketable securities of
$17.6 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 continued advancement
of exebacase and CF-370, whether the company will execute near-term
objectives, the ongoing analysis of the data sets from the Phase 3
clinical study of exebacase, timing and expectations surrounding:
the ANSM CTA submission, initiation of patient dosing in the Phase
1b/2 clinical study, CF-370 tox studies, the CF-370 IND submission,
and DISRUPT study activities including: database lock, patient
monitoring and follow-up, analysis of results and communication of
those results, statements made by Dr. Pomerantz, whether the
company can 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, 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 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 September 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)
|
September 30,2022 |
|
December 31,2021 |
|
(unaudited) |
(audited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
4,664 |
|
$ |
16,654 |
Marketable securities |
|
12,984 |
|
|
37,631 |
Prepaid expenses |
|
1,815 |
|
|
4,439 |
Other current assets |
|
586 |
|
|
4,140 |
|
|
|
Total current assets |
|
20,049 |
|
|
62,864 |
Property and equipment, net |
|
628 |
|
|
741 |
Operating lease right-of-use assets |
|
2,249 |
|
|
2,544 |
Other assets |
|
108 |
|
|
613 |
|
|
|
Total assets |
$ |
23,034 |
|
$ |
66,762 |
|
|
|
|
|
|
Liabilities and stockholders’ (deficit)
equity |
|
|
Current liabilities |
$ |
23,783 |
|
$ |
12,174 |
Warrant liabilities |
|
3 |
|
|
2,530 |
Long-term portion of lease liabilities |
|
2,313 |
|
|
2,609 |
Other liabilities |
|
38 |
|
|
73 |
|
|
|
Total liabilities |
|
26,137 |
|
|
17,386 |
|
|
|
Total stockholders’ (deficit) equity |
|
(3,013 |
) |
|
49,376 |
|
|
|
Total liabilities and stockholders’ (deficit) equity |
$ |
23,034 |
|
$ |
66,762 |
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
(in thousands, except share and per-share
data) |
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
10,814 |
|
$ |
8,664 |
|
$ |
40,299 |
|
$ |
24,462 |
|
General and administrative |
|
3,366 |
|
|
3,022 |
|
|
9,886 |
|
|
8,722 |
|
Restructuring |
|
7,719 |
|
― |
|
|
7,719 |
|
― |
|
|
|
|
|
|
Total operating expenses |
|
21,899 |
|
|
11,686 |
|
|
57,904 |
|
|
33,184 |
|
|
|
|
|
|
Loss from operations |
|
(21,899 |
) |
|
(11,686 |
) |
|
(57,904 |
) |
|
(33,184 |
) |
Other income: |
|
|
|
|
Interest income, net |
|
9 |
|
|
36 |
|
|
64 |
|
|
91 |
|
Change in fair value of warrant liabilities |
|
4,823 |
|
|
6,358 |
|
|
2,527 |
|
|
17,210 |
|
|
|
|
|
|
Total other income, net |
|
4,832 |
|
|
6,394 |
|
|
2,591 |
|
|
17,301 |
|
|
|
|
|
|
Net loss |
$ |
(17,067 |
) |
$ |
(5,292 |
) |
$ |
(55,313 |
) |
$ |
(15,883 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.43 |
) |
$ |
(0.13 |
) |
$ |
(1.41 |
) |
$ |
(0.44 |
) |
|
|
|
|
|
Shares used in computing net loss per share |
|
39,332,721 |
|
|
39,332,721 |
|
|
39,332,721 |
|
|
35,914,327 |
|
|
|
|
|
|
In this release, management has presented its
financial position as of September 30, 2022 and its operating
results for the three and nine months ended September 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
ContraFect (NASDAQ:CFRX)
Historical Stock Chart
From Apr 2024 to May 2024
ContraFect (NASDAQ:CFRX)
Historical Stock Chart
From May 2023 to May 2024