Top-line, 1-year Superiority Data for
NeoCart® Phase 3 Clinical Trial and Potential Biologics License
Application Filing Remain on Track for Third Quarter of
2018
Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in
the development of restorative cell therapies that may offer
rapid-onset pain relief and restored function, announced financial
and operational results for the quarter ended September 30,
2017.
“With enrollment in the NeoCart Phase 3 clinical
trial complete, we are focused on preparing for the top- line,
superiority data and potential BLA filing for NeoCart in the third
quarter of 2018. In the third quarter of 2017, we enhanced
Histogenics’ operational capabilities and expanded our portfolio of
data supporting the unique mechanism of action of NeoCart,” stated
Adam Gridley, President and Chief Executive Officer of Histogenics.
“We believe that the data published in the Journal of Biomechanics
in October 2017 provide additional evidence that Histogenics’
proprietary cell therapy platform produces cartilage that may
accelerate recovery time and reduce pain. These data support
the potential of NeoCart to replace microfracture as the standard
of care for the treatment of knee cartilage defects, as well as the
future development of additional product candidates from the
NeoCart product platform. Histogenics’ priorities are now
focused on preparing for our upcoming Biologics License Application
(BLA) submission, further defining our commercial strategies for
our launch of NeoCart, and our ongoing partnering activities for
NeoCart in Japan and Asia.”
Recent Highlights
- Peer Reviewed Publication Further Strengthens NeoCart Data
Portfolio. In October 2017, Histogenics announced the
publication of a study, “In Vitro Culture Increases Mechanical
Stability of Human Tissue Engineered Cartilage Constructs by
Prevention of Microscale Scaffold Buckling” in the online version
of the peer-reviewed Journal of Biomechanics. The study
analyzes the compressive properties of engineered cartilage tissue
grown with chondrocytes seeded in a porous scaffold.
Histogenics intends to include the results of this study to
provide additional data to the U.S. Food and Drug Administration
(FDA) as part of a potential BLA for NeoCart, subject to a
successful outcome in the ongoing NeoCart Phase 3 clinical
trial.
- Enhancement of Executive Team in Advance of Potential Approval
and Commercialization of NeoCart. In October 2017,
Histogenics promoted Stephen Kennedy from Chief Technology Officer
to Executive Vice President & Chief Operating Officer.
The promotion is consistent with Mr. Kennedy’s focus on the
manufacturing scale-up of NeoCart to supply the U.S. market, if
approved. Mr. Kennedy has more than 30 years of executive
product development, manufacturing, technology assessment and
commercialization experience at leading biotechnology companies,
which includes extensive experience overseeing product technologies
from development through commercial launch.
Financial Results for the Third Quarter
of 2017
Loss from operations was $(5.7) million in the
third quarter of 2017, compared to $(6.6) million in the third
quarter of 2016. The decrease in operating expenses was
primarily driven by a reduction in research and development
expenses that was offset by an increase in general and
administrative expenses.
Research and development expenses were $3.5
million in the third quarter of 2017, compared to $4.9 million in
the third quarter of 2016. The decrease was primarily due to
reductions in collaboration, consulting and temporary labor
expenses and clinical trial-related costs. General and
administrative expenses were $2.2 million in the third quarter of
2017, compared to $1.8 million in the third quarter of 2016.
The increase was primarily due to activities related to a potential
BLA submission and commercialization of NeoCart, if
approved.
Net loss attributable to common stockholders was
$(5.1) million in the third quarter of 2017, or $(0.23) per share,
compared to $(9.2) million, or $(0.70) per share, in the third
quarter of 2016. The decrease in net loss attributable to
common stockholders is primarily due to lower operating expenses in
the third quarter of 2017, $3.1 million in expenses related to the
private placement completed in the third quarter of 2016 and an
increase in weighted average shares outstanding, also resulting
from the 2016 private placement.
As of September 30, 2017, Histogenics had cash,
cash equivalents and marketable securities of $12.6 million,
compared to $31.9 million at December 31, 2016. Histogenics
believes its current cash position will be sufficient to fund its
operations into the middle of 2018.
Conference Call and Webcast
Information
Histogenics’ management will host a conference
call on Thursday, November 9, 2017 at 8:30 a.m. ET. A
question-and-answer session will follow Histogenics’ remarks.
To participate on the live call, please dial 877-930-8064
(domestic) or 253-336-8040 (international) and provide the
conference ID: 89009539 five to ten minutes before the start of the
call.
A live audio webcast of the presentation will be
available via the “Investor Relations” page of the Histogenics
website, www.histogenics.com, or by clicking here. A replay
of the webcast will be archived on Histogenics’ website for
approximately 45 days following the presentation.
About Histogenics
Corporation
Histogenics (NASDAQ:HSGX) is a leader in the
development of restorative cell therapies that may offer
rapid-onset pain relief and restored function. Histogenics’
lead investigational product, NeoCart, is designed to rebuild a
patient’s own knee cartilage to treat pain at the source and
potentially prevent a patient’s progression to osteoarthritis.
NeoCart is one of the most rigorously studied restorative
cell therapies for orthopedic use. Histogenics recently
completed enrollment of its NeoCart Phase 3 clinical trial and
expects to report top-line, one-year superiority data in the third
quarter of 2018. NeoCart is designed to perform like
articular hyaline cartilage at the time of treatment, and as a
result, may provide patients with more rapid pain relief and
accelerated recovery as compared to the current standard of care.
Histogenics’ technology platform has the potential to be used for a
broad range of additional restorative cell therapy indications.
For more information on Histogenics and NeoCart, please visit
www.histogenics.com.
Forward-Looking Statements
Various statements in this release are
“forward-looking statements” under the securities laws. Words
such as, but not limited to, “anticipate,” “believe,” “can,”
“could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,”
“might,” “objective,” “plan,” “predict,” “project,” “target,”
“likely,” “should,” “will,” and “would,” or the negative of these
terms and similar expressions or words, identify forward-looking
statements. Forward-looking statements are based upon current
expectations that involve risks, changes in circumstances,
assumptions and uncertainties.
Important factors that could cause actual
results to differ materially from those reflected in Histogenics’
forward-looking statements include, among others: the timing
and success of Histogenics’ NeoCart Phase 3 clinical trial,
including, without limitation, possible delays in generating the
data from the trial; the ability to obtain and maintain regulatory
approval of NeoCart or any product candidates, and the labeling for
any approved products; the scope, progress, expansion, and costs of
developing and commercializing Histogenics’ product candidates; the
ability to obtain and maintain regulatory approval regarding the
comparability of critical NeoCart raw materials following our
technology transfer and manufacturing location transition; the size
and growth of the potential markets for Histogenics’ product
candidates and the ability to serve those markets; Histogenics’
expectations regarding its expenses and revenue; and other factors
that are described in the “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” sections of Histogenics’ Annual Report on Form 10-K for
the year ended December 31, 2016 and Quarterly Report on Form 10-Q
for the quarter ended June 30, 2017, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC’s
website at www.sec.gov. Additional factors may be set forth in
those sections of Histogenics quarterly report on Form 10-Q for the
quarter ended September 30, 2017, to be filed with the SEC in the
fourth quarter of 2017. In addition to the risks described
above and in Histogenics’ annual report on Form 10-K and quarterly
reports on Form 10-Q, current reports on Form 8-K and other filings
with the SEC, other unknown or unpredictable factors also could
affect Histogenics’ results.
There can be no assurance that the actual
results or developments anticipated by Histogenics will be realized
or, even if substantially realized, that they will have the
expected consequences to, or effects on, Histogenics.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking
statements attributable to Histogenics or any person acting on its
behalf are expressly qualified in their entirety by the cautionary
statements contained or referred to herein. Histogenics
cautions investors not to rely too heavily on the forward-looking
statements Histogenics makes or that are made on its behalf.
The information in this release is provided only as of the date of
this release, and Histogenics undertakes no obligation, and
specifically declines any obligation, to update or revise publicly
any forward-looking statements, whether as a result of new
information, future events or otherwise.
|
|
|
HISTOGENICS
CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Unaudited) |
|
(in thousands, except share and per share
data) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Revenue |
|
$ |
‒ |
|
|
$ |
‒ |
|
|
$ |
‒ |
|
|
$ |
‒ |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
3,488 |
|
|
|
4,880 |
|
|
|
12,200 |
|
|
|
16,260 |
|
|
General and
administrative |
|
|
2,225 |
|
|
|
1,768 |
|
|
|
6,717 |
|
|
|
6,141 |
|
Total
operating expenses |
|
|
5,713 |
|
|
|
6,648 |
|
|
|
18,917 |
|
|
|
22,401 |
|
Loss from
operations |
|
|
(5,713 |
) |
|
|
(6,648 |
) |
|
|
(18,917 |
) |
|
|
(22,401 |
) |
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
Interest income
(expense), net |
|
|
39 |
|
|
|
(20 |
) |
|
|
114 |
|
|
|
(55 |
) |
|
Other expense, net |
|
|
(52 |
) |
|
|
(130 |
) |
|
|
(142 |
) |
|
|
(298 |
) |
|
Warrant expense |
|
|
‒ |
|
|
|
(3,056 |
) |
|
|
‒ |
|
|
|
(3,056 |
) |
|
Change in fair value of
warrant liability |
|
|
(269 |
) |
|
|
539 |
|
|
|
(673 |
) |
|
|
539 |
|
Total other
(expense), net |
|
|
(282 |
) |
|
|
(2,667 |
) |
|
|
(701 |
) |
|
|
(2,870 |
) |
Net
loss |
|
$ |
(5,995 |
) |
|
$ |
(9,315 |
) |
|
$ |
(19,618 |
) |
|
$ |
(25,271 |
) |
|
|
|
|
|
|
|
|
|
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
Unrealized gain from
available for sale securities |
|
|
1 |
|
|
|
‒ |
|
|
|
‒ |
|
|
|
‒ |
|
Comprehensive Loss |
|
$ |
(5,994 |
) |
|
$ |
(9,315 |
) |
|
$ |
(19,618 |
) |
|
$ |
(25,271 |
) |
|
|
|
|
|
|
|
|
|
Net Loss
attributable to common stockholders - basic and diluted |
|
$ |
(5,080 |
) |
|
$ |
(9,234 |
) |
|
$ |
(16,380 |
) |
|
$ |
(25,197 |
) |
|
|
|
|
|
|
|
|
|
|
Net Loss
per common share - basic and diluted: |
|
$ |
(0.23 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.74 |
) |
|
$ |
(1.90 |
) |
Weighted-average shares used to compute loss per common share -
basic and diluted: |
|
|
22,552,341 |
|
|
|
13,297,546 |
|
|
|
22,219,666 |
|
|
|
13,279,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HISTOGENICS
CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(Unaudited) |
|
(in thousands, except share and per share
data) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents and marketable securities |
|
$ |
12,619 |
|
|
$ |
31,908 |
|
Prepaid expenses and
other current assets |
|
|
258 |
|
|
|
173 |
|
Property and equipment,
net |
|
|
2,814 |
|
|
|
3,860 |
|
Other assets, net |
|
|
137 |
|
|
|
137 |
|
Total
assets |
|
$ |
15,828 |
|
|
$ |
36,078 |
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
2,914 |
|
|
$ |
5,171 |
|
Warrant and other
non-current liabilities |
|
|
17,727 |
|
|
|
17,340 |
|
Total stockholders’
equity (deficit) |
|
|
(4,813 |
) |
|
|
13,567 |
|
Total
liabilities and stockholders’ equity (deficit) |
|
$ |
15,828 |
|
|
$ |
36,078 |
|
|
|
|
|
|
|
|
|
Contact:
Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com
Histogenics (NASDAQ:HSGX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Histogenics (NASDAQ:HSGX)
Historical Stock Chart
From Sep 2023 to Sep 2024