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, 2020.
“We continued to advance the Phase 3 DISRUPT
superiority study of our FDA designated Breakthrough Therapy new
modality drug candidate, exebacase, while taking steps to
meaningfully strengthen the Company’s financial position. We were
very pleased to have received a significant CARB-X award, an
important acknowledgment of our novel approach to developing
medicines for infectious disease. ContraFect also completed a
successful public offering and private placement which have
provided valuable resources that will support our efforts to
develop potentially transformative, first-in-class, first-in-field
treatments for life-threatening infections,” said Roger J.
Pomerantz, M.D., President, Chief Executive Officer, and Chairman
of ContraFect.
Q2 2020 Highlights and Recent
Developments
- In July, the Company announced that
CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator), a global non-profit partnership dedicated to
accelerating antibacterial research and development, is awarding
the Company up to $18.9 million in additional non-dilutive capital
to progress its second product candidate, CF-370, an engineered
lysin targeting Pseudomonas aeruginosa (P. aeruginosa),
in IND-enabling activities toward future Phase 1 clinical trials.
The award provides initial funding of $4.9 million, and ContraFect
could receive additional funding at the discretion of CARB-X if
certain project milestones are met.
- In June, the Company announced the
publication of the exebacase Phase 2 study results in the July 1,
2020 issue of the Journal of Clinical Investigation. The study
results established clinical proof-of-concept for exebacase and
informed the design of the ongoing Phase 3 DISRUPT (Direct Lysis
of Staph aureus Resistant Pathogen Trial) study of
exebacase for the treatment of patients with Staph
aureus bloodstream infections (BSIs), including right-sided
endocarditis.
- In June, the Company announced the
appointment of Lishan Aklog, M.D. to the Company’s board of
directors. Dr. Aklog is Co-Founder, Chairman and Chief Executive
Officer of PAVmed Inc. (Nasdaq: PAVM). Dr. Aklog has also served as
Executive Chairman of Lucid Diagnostics Inc. since its inception in
2018, as a co-founding Partner of both Pavilion Holdings Group LLC,
a medical device holding company, since its inception in 2007, and
Pavilion Medical Innovations LLC, a venture-backed medical device
incubator, since its inception in 2009.
- In May, the Company announced that
Pfizer Inc. (NYSE: PFE) entered into a stock purchase agreement to
purchase ContraFect securities for approximately $3.0 million in a
private placement transaction. This was the second investment by
Pfizer in ContraFect. The recent private placement was concurrent
with an underwritten public equity offering. The gross proceeds
from the public offering were approximately $52.5 million. Both
transactions closed on May 27, 2020.
Ongoing COVID-19 Response
- ContraFect continues to actively
monitor the evolving impact of COVID-19 on its business and
operations, with a primary focus on the health and safety of
employees. After initial shutdown restrictions were put in place in
March, operations were immediately adjusted, enabling the majority
of employees to work remotely. Once the Company re-opened its
laboratories in the second quarter, health and safety measures were
implemented to address risks posed by the COVID-19 pandemic. These
included strict cleaning and sanitizing plans, daily screening for
COVID-19 symptoms, mandatory use of personal protective equipment
and social distancing measures for on-site employees.
- The Phase 3 DISRUPT study of
exebacase is ongoing. The Company continues to enroll patients and
open new clinical trial sites across the United States. The study
continues to experience some delays in patient enrollment due to
the diversion of healthcare resources resulting from the COVID-19
pandemic in certain high impact areas.
Second Quarter 2020 Financial Results
- Research and development (R&D)
expenses were $5.5 million for the second quarter of 2020 compared
to $4.8 million in the comparable period in 2019. This increase was
primarily attributable to increases in spending for the ongoing
Phase 3 clinical study of exebacase and the chemistry,
manufacturing and controls activities that will ultimately support
a biologics license application for exebacase. The Company also
increased both clinical headcount and external professional support
for the Phase 3 clinical study.
- General and administrative
(G&A) expenses were $2.6 million for both the second quarter of
2020 and 2019. Although there was no overall change, there was an
increase in administrative headcount and related personnel costs
which was offset by a decrease in costs incurred for intellectual
property and general corporate legal fees.
- Net loss was $17.6 million, or a
loss of $0.88 per share, for the second quarter of 2020 compared to
a net loss of $8.7 million, or a loss of $1.09 per share, for the
comparable period in 2019. The net loss per share in the current
period includes a $5.9 million, or $0.30 per share, increase in the
non-cash charge for the change in the fair value of warrant
liabilities and a $2.2 million, or $0.11 per share, non-cash charge
for the allocation of offering expenses.
- As of June 30, 2020, ContraFect had
cash, cash equivalents and marketable securities of $58.3
million.
About DISRUPT:
DISRUPT is an ongoing, randomized, double-blind,
placebo-controlled, multi-center Phase 3 clinical study of
exebacase for the treatment of Staph aureus bacteremia,
including right-sided endocarditis. This study compares the
efficacy, safety and tolerability of exebacase used in addition to
SOC antibiotics to SOC antibiotics alone. DISRUPT is designed to
enroll approximately 350 patients randomized 2:1 to receive either
a single dose of exebacase administered as a 2-hour IV infusion in
addition to SOC antibiotics or placebo plus SOC antibiotics. The
primary efficacy endpoint is clinical response at day 14. Secondary
endpoints include clinical response at Day 14 in all Staph aureus
patients (MRSA and MSSA), 30-day all-cause mortality in MRSA
patients, and clinical response at day 30 and day 60 in both MRSA
and all Staph aureus patients. The principal investigator is Dr.
Vance Fowler, Professor of Medicine in the Division of Infectious
Diseases at Duke University.
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. Exebacase has the potential to be
a first-in-class treatment for Staph aureus bacteremia.
It has a novel, rapid, and specific mechanism of action that
targets the peptidoglycan cell wall that is vital to Staph
aureus bacteria. In addition, in vitro and in vivo experiments
have shown that exebacase is highly active against biofilms which
complicate Staph aureus infections. Exebacase was
licensed from The Rockefeller University and is being developed at
ContraFect.
About ContraFect:
ContraFect is a biotechnology company focused on
discovering and developing differentiated biologic therapies for
life-threatening, drug-resistant infectious diseases, particularly
those treated in hospital settings. 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 new class of DLAs,
which exhibit broad-spectrum activity against a wide range of
antibiotic-resistant Gram-negative pathogens,
including Pseudomonas aeruginosa (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. Our lead lysin candidate, exebacase,
was granted Breakthrough Therapy designation by the FDA for the
treatment of MRSA bloodstream infections (bacteremia), including
right-sided endocarditis, when used in addition to standard-of-care
(SOC) anti-staphylococcal antibiotics in adult patients.
Follow ContraFect on
Twitter @ContraFectCorp and LinkedIn.
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: whether the public equity
offering, Pfizer private placement and CARB-X grant will advance
the Company’s lead product candidates, statements made by Dr.
Pomerantz, ContraFect’s ability to discover and develop DLAs as new
medical modalities for the treatment of life-threatening,
antibiotic-resistant infections, whether CARB-X will award the
Company up to $18.9 million, whether the Company receives the $4.9
million, the Company’s ability to meet project milestones and
receive additional funding, the availability of funding, whether
the Company will continue to monitor the impact of COVID-19 on its
business, whether the Company will primarily focus on the health
and safety of its employees, statements made regarding how COVID-19
has affected the Company’s Phase 3 DISRUPT study, clinical trial
site opening and patient enrollment, whether exebacase has the
potential to be a first-in-class treatment for Staph aureus
bacteremia, the Company’s financial results, financial position,
balance sheets and statements of operations, ContraFect’s ability
to discover and develop differentiated biologic therapies for
life-threatening, drug-resistant infectious diseases, 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
new 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 those 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
|
June 30,
2020 |
|
December 31,
2019 |
|
|
(unaudited) |
|
|
(audited) |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents................................................................................................................................................................................. |
$ |
30,819,397 |
|
$ |
24,184,140 |
Short-term marketable
securities........................................................................................................................................................................ |
|
8,831,981 |
|
|
— |
Prepaid expenses and other current
assets........................................................................................................................................................ |
|
5,327,699 |
|
|
6,575,375 |
|
|
|
|
|
|
Total current
assets....................................................................................................................................................................................................... |
|
44,979,077 |
|
|
30,759,515 |
Long-term marketable
securities................................................................................................................................................................................... |
|
18,686,836 |
|
|
— |
Property and equipment,
net......................................................................................................................................................................................... |
|
1,004,389 |
|
|
1,099,948 |
Operating lease right-of-use
assets.............................................................................................................................................................................. |
|
2,930,022 |
|
|
3,043,826 |
Other
assets.................................................................................................................................................................................................................. |
|
105,420 |
|
|
105,420 |
|
|
|
|
|
|
Total
assets................................................................................................................................................................................................................... |
$ |
67,705,744 |
|
$ |
35,008,709 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current
liabilities............................................................................................................................................................................................................ |
|
5,894,333 |
|
|
10,057,950 |
Warrant
liabilities........................................................................................................................................................................................................... |
|
44,349,846 |
|
|
6,068,978 |
Long-term portion of lease
liabilities.............................................................................................................................................................................. |
|
3,115,284 |
|
|
3,264,128 |
Other
liabilities............................................................................................................................................................................................................... |
|
72,747 |
|
|
72,747 |
|
|
|
|
|
|
Total
liabilities................................................................................................................................................................................................................ |
|
53,432,210 |
|
|
19,463,803 |
|
|
|
|
|
|
Total stockholders’
equity............................................................................................................................................................................................... |
|
14,273,534 |
|
|
15,544,906 |
|
|
|
|
|
|
Total liabilities and
stockholders’
equity.......................................................................................................................................................................... |
$ |
67,705,744 |
|
$ |
35,008,709 |
CONTRAFECT
CORPORATIONUnaudited Statements of
Operations
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development...................................................... |
$ |
5,544,000 |
|
|
$ |
4,804,076 |
|
|
$ |
10,648,441 |
|
|
$ |
8,911,216 |
|
General and
administrative....................................................... |
|
2,618,797 |
|
|
|
2,603,403 |
|
|
|
5,578,697 |
|
|
|
4,857,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses............................................................... |
|
8,162,797 |
|
|
|
7,407,479 |
|
|
|
16,227,138 |
|
|
|
13,769,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations...................................................................... |
|
(8,162,797 |
) |
|
|
(7,407,479 |
) |
|
|
(16,227,138 |
) |
|
|
(13,769,212 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income........................................................................... |
|
25,546 |
|
|
|
104,441 |
|
|
|
95,568 |
|
|
|
253,560 |
|
Other
expense............................................................................ |
|
(2,174,653 |
) |
|
|
― |
|
|
|
(2,174,653 |
) |
|
|
― |
|
Change in fair value of warrant
liabilities.................................... |
|
(7,305,332 |
) |
|
|
(1,363,868 |
) |
|
|
(6,889,499 |
) |
|
|
16,435,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (expense)
income........................................................... |
|
(9,454,439 |
) |
|
|
(1,259,427 |
) |
|
|
(8,968,584 |
) |
|
|
16,689,321 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income......................................................................... |
$ |
(17,617,236 |
) |
|
$ |
(8,666,906 |
) |
|
$ |
(25,195,722 |
) |
|
$ |
2,920,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss) income per share
................................................ |
$ |
(0.88 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.43 |
) |
|
$ |
0.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic net income (loss) per
share...... |
|
19,991,894 |
|
|
|
7,940,931 |
|
|
|
17,661,968 |
|
|
|
7,940,931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per
share............................................... |
$ |
(0.88 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.43 |
) |
|
$ |
0.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing diluted net (loss) income per
share..... |
|
19,991,894 |
|
|
|
7,940,931 |
|
|
|
17,661,968 |
|
|
|
7,945,768 |
|
The Company's financial position as of June 30,
2020 and results of operations for the three and six months ended
June 30, 2020 and 2019 have been extracted from the Company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. The Company's financial position as of
December 31, 2019 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 18,
2020. 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 Messinger ContraFect Corporation Tel: 914-207-2300
Email: mmessinger@contrafect.com
Carlo Tanzi, PhD Kendall Investor Relations Tel: 617-914-0008
Email: ctanzi@kendallir.com
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