‒ Histogenics and FDA Continue Discussions
on NeoCart® Phase 3 Data and Potential BLA Submission
‒‒ October 2018 Financing Expected to Provide
Funding Into Middle of 2019 ‒‒ Histogenics to Host
Conference Call and Webcast Today at 8:30 a.m. ET ‒
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 its financial and operating results for the quarter ended
September 30, 2018.
“We continue to focus on advancing NeoCart
towards the potential submission of a Biologics License Application
by the end of the first quarter of 2019 and have an extensive
dialogue with the FDA covering all aspects of the NeoCart
development program, including the clinical data and related
statistics from the NeoCart Phase 3 clinical trial,” said Adam
Gridley, President and Chief Executive Officer of
Histogenics. “We believe, based on our continued analysis of
the totality of the data, that NeoCart, if approved, may offer
patients a treatment alternative that provides a more rapid
recovery from pain and return to daily activity than other options
to treat damaged knee cartilage. We are also working closely
with MEDINET, our development and commercialization partner in
Japan, toward the goal of initiating the Japanese Phase 3 clinical
trial of NeoCart in 2019.”
Third Quarter 2018 and Recent
Highlights
- Meeting Held with FDA to Discuss Potential NeoCart Regulatory
Submission: Histogenics recently met with the United States
Food and Drug Administration (FDA) to discuss the NeoCart Phase 3
clinical trial data and the potential for the submission of a
Biologics License Application (BLA) for NeoCart. The FDA and
Histogenics continue to discuss the clinical data generated to
date, the potential need for any additional supplemental clinical
data, including longer-term data from the ongoing Phase 3 trial or
additional studies, and possible alternative regulatory pathways
for acceptance of the BLA. The FDA has not made a final
decision regarding a potential BLA submission and based on expected
feedback from the FDA, Histogenics intends to provide a further
update on these negotiations by the end of November 2018.
- NeoCart Top-Line Phase 3 Data Announced in Third Quarter of
2018: Histogenics reported top-line data from the NeoCart
Phase 3 clinical trial in September 2018. This trial is
believed to be the largest and first prospectively designed,
randomized clinical trial in North America evaluating the safety
and efficacy of a restorative cell therapy to treat knee cartilage
damage. It is also believed to be the only trial with a dual
threshold responder analysis endpoint. While the Phase 3
clinical trial did not meet its primary endpoint of a statistically
significant improvement in pain and function in the dual threshold
responder analysis one year after treatment as compared to
microfracture, patients treated with NeoCart saw statistically
significant and clinically meaningful improvements in their pain
and function levels using a variety of clinically validated scales.
In addition, NeoCart demonstrated superiority on the
responder analysis endpoint at six months, and in different
subgroups at one year such as patients with lesions greater than 2
cm or with higher body mass index. Both NeoCart and
microfracture were well tolerated and exhibited strong safety
profiles.
- Completion of $17.0 Million Financing: In October 2018,
Histogenics completed an underwritten public offering of common
stock and warrants that generated $17.0 million in gross proceeds
and approximately $15.4 million in net proceeds after deducting
underwriting discounts and commissions, and estimated offering
expenses payable by Histogenics. These amounts do not include
the proceeds, if any, that Histogenics may receive in connection
with any exercise of the warrants issued in the offering. The
financing was led by healthcare-focused, institutional investors
and supported by existing Histogenics investors. Histogenics
believes the financing will be sufficient to fund its projected
cash needs into the middle of 2019.
- Development and Presentation of Additional NeoCart
Biomechanical Data to Support Potential Commercialization: As
part of their Sponsored Research Agreement, Histogenics and Cornell
University continue to generate additional biomechanical data to
support the potential commercialization of NeoCart, if
approved. The most recent data were presented at the
Biomedical Engineering Society Annual Meeting in October
2018. These data build upon earlier studies and further
demonstrate the importance of the presence of extracellular matrix,
or tissue, in making biomechanically competent cartilage.
Histogenics believe the data may be important to both regulatory
agencies and clinicians regarding the potential performance
advantages of NeoCart when compared to other treatment
alternatives.
Financial Results for the Third Quarter
of 2018
Histogenics’ loss from operations was $(7.0)
million in the third quarter of 2018, compared to $(5.7) million in
the third quarter of 2017. The increase in loss from
operations was due to higher operating expenses in the third
quarter of 2018 relative to the third quarter of 2017.
Research and development expenses were $4.6
million in the third quarter of 2018, compared to $3.5 million in
the third quarter of 2017. The increase was primarily due to
increases in consulting and compensation related expenses in
connection with the preparation and evaluation of the data from the
NeoCart Phase 3 clinical trial and the potential submission of a
BLA for NeoCart with the FDA. General and administrative
expenses were $2.4 million in the third quarter of 2018, compared
to $2.2 million in the third quarter of 2017. The increase
was primarily due to higher salaries and consulting expenses
related to increased activities to support the potential
commercialization of NeoCart.
As of September 30, 2018, Histogenics had cash,
cash equivalents and marketable securities of $5.2 million,
compared to $8.0 million at December 31, 2017. In October
2018, Histogenics received net proceeds of approximately $15.9
million through an underwritten public offering of common stock and
warrants and sales through its at-the-market offering
facility. Histogenics believes its current cash position will
be sufficient to fund its operations into the middle of 2019.
Conference Call and Webcast
Information
Histogenics management will host a conference
call on Thursday, November 8, 2018 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 “5491168” five to ten minutes before the start of the
call.
To access a live audio webcast of the
presentation on the “Investor Relations” page of the Histogenics
website, please click 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 may
prevent a patient’s progression to osteoarthritis. NeoCart is
one of the most rigorously studied restorative cell therapies for
orthopedic use. 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:
expectations regarding the timing and success of ongoing
discussions with the FDA regarding the potential submission of a
BLA for NeoCart; NeoCart’s potential as a treatment for knee
cartilage damage; the timing, associated expenses and ability to
obtain and maintain regulatory approval of NeoCart or any product
candidates, and the labeling for any approved products; the market
size and potential patient population in markets where Histogenics’
and its partners expect to compete; updated or refined data based
on Histogenics’ continuing review and quality control analysis of
clinical data; the scope, progress, timing, 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 its
technology transfer and manufacturing location transition;
Histogenics’ expectations regarding its expenses and revenue;
Histogenics’ ability to obtain additional debt or equity capital;
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, 2017 and Quarterly Report
on Form 10-Q for the quarter ended June 30, 2018, which are on file
with the 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, 2018, expected to be filed with the SEC
in the fourth quarter of 2018. 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. Histogenics has not
yet received the official FDA meeting minutes from the Type C
meeting held on October 30, 2018 and the information in this
release may be altered or supplemented by the information contained
in the official meeting minutes or any subsequent meetings that may
be held with the FDA.
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, |
| |
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
| Revenue |
|
$ |
‒ |
|
|
$ |
‒ |
|
|
$ |
‒ |
|
|
$ |
‒ |
|
| |
|
|
|
|
|
|
|
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
| Research
and development |
|
|
4,563 |
|
|
|
3,488 |
|
|
|
12,307 |
|
|
|
12,200 |
|
| General
and administrative |
|
|
2,426 |
|
|
|
2,225 |
|
|
|
8,059 |
|
|
|
6,717 |
|
| Total operating
expenses |
|
|
6,989 |
|
|
|
5,713 |
|
|
|
20,366 |
|
|
|
18,917 |
|
| Loss from
operations |
|
|
(6,989 |
) |
|
|
(5,713 |
) |
|
|
(20,366 |
) |
|
|
(18,917 |
) |
| |
|
|
|
|
|
|
|
|
| Other income
(expense): |
|
|
|
|
|
|
|
|
| Interest
income, net |
|
|
19 |
|
|
|
39 |
|
|
|
88 |
|
|
|
114 |
|
| Other
expense, net |
|
|
(21 |
) |
|
|
(52 |
) |
|
|
(71 |
) |
|
|
(142 |
) |
| Change in
fair value of warrant liability |
|
|
17,776 |
|
|
|
(269 |
) |
|
|
12,524 |
|
|
|
(673 |
) |
| Total other income
(expense), net |
|
|
17,774 |
|
|
|
(282 |
) |
|
|
12,541 |
|
|
|
(701 |
) |
| Net income (loss) |
|
$ |
10,785 |
|
|
$ |
(5,995 |
) |
|
$ |
(7,825 |
) |
|
$ |
(19,618 |
) |
| |
|
|
|
|
|
|
|
|
| Other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
|
Unrealized gain from available for sale securities |
|
|
‒ |
|
|
|
1 |
|
|
|
‒ |
|
|
|
‒ |
|
| Comprehensive income
(loss) |
|
$ |
10,785 |
|
|
$ |
(5,994 |
) |
|
$ |
(7,825 |
) |
|
$ |
(19,618 |
) |
| |
|
|
|
|
|
|
|
|
| Net income (loss)
attributable to common stockholders |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
10,650 |
|
|
$ |
(5,080 |
) |
|
$ |
(7,657 |
) |
|
$ |
(16,380 |
) |
|
Diluted |
|
$ |
(7,126 |
) |
|
$ |
(5,080 |
) |
|
$ |
(20,181 |
) |
|
$ |
(16,380 |
) |
| |
|
|
|
|
|
|
|
|
| Net income (loss) per
common share |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.36 |
|
|
$ |
(0.23 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.74 |
) |
|
Diluted |
|
$ |
(0.24 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.74 |
) |
| Weighted-average shares
used to compute income (loss) per common share |
|
|
|
|
|
|
|
|
|
Basic |
|
|
29,737,632 |
|
|
|
22,552,341 |
|
|
|
28,723,500 |
|
|
|
22,219,666 |
|
|
Diluted |
|
|
29,737,632 |
|
|
|
22,552,341 |
|
|
|
29,515,700 |
|
|
|
22,219,666 |
|
| |
|
|
|
|
|
|
|
|
HISTOGENICS
CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS (Unaudited)(in
thousands)
| |
|
September 30, |
|
December 31, |
| |
|
|
2018 |
|
|
|
2017 |
|
| |
|
|
|
|
| |
|
|
|
|
| Cash and cash
equivalents and marketable securities |
|
$ |
5,192 |
|
|
$ |
7,981 |
|
| Prepaid expenses and
other current assets |
|
|
825 |
|
|
|
194 |
|
| Property and equipment,
net |
|
|
4,352 |
|
|
|
2,723 |
|
| Other assets, net |
|
|
512 |
|
|
|
137 |
|
| Total
assets |
|
$ |
10,881 |
|
|
$ |
11,035 |
|
| |
|
|
|
|
| Current
liabilities |
|
$ |
8,943 |
|
|
$ |
3,805 |
|
| Warrant and other
non-current liabilities |
|
|
11,614 |
|
|
|
18,498 |
|
| Total stockholders’
(deficit) |
|
|
(9,676 |
) |
|
|
(11,268 |
) |
| Total
liabilities and stockholders’ (deficit) |
|
$ |
10,881 |
|
|
$ |
11,035 |
|
SOURCE: Histogenics Corporation
Contact:
Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com
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