Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES FIRST QUARTER 2018
FINANCIAL AND OPERATING RESULTS
Top-line Superiority Data from
NeoCart Phase 3 Clinical Trial and Potential Biologics License
Submission on Track for Third Quarter of 2018
Initiation of Phase 3 Clinical Trial in Japan Expected in Second Half of
Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT
WALTHAM, Mass., May 10, 2018 /GLOBE NEWSWIRE/ Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the
development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, announced its financial and operational results for the quarter ended March 31, 2018.
The preparation for top-line data and the NeoCart Biologics License Application for the U.S. Food and Drug
Administration remained a key focus for Histogenics in the first quarter of 2018, and we are on track to achieve these important milestones in the third quarter, said Adam Gridley, President and Chief Executive Officer of Histogenics. We
are also actively supporting MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the planned confirmatory trial in Japan in the second half of 2018. We also continue to work with our surgeon
investigators on our commercialization plans in both the U.S. and Japanese markets, and are pursuing additional NeoCart licensing and partnership opportunities in other major international markets. Our objective is to make NeoCart available to as
many patients as possible with a goal of maximizing the clinical and commercial value of this innovative, restorative cell therapy that treats pain at the source, continued Mr. Gridley.
First Quarter 2018 and Recent Highlights
Financial Results for the First Quarter of 2018
from operations was $(6.1) million in the first quarter of 2018, compared to $(6.8) million in the first quarter of 2017. The decrease in operating expenses was driven by a reduction in research and development expenses which was partially offset by
an increase in general and administrative expenses.
Research and development expenses were $3.3 million in the first quarter of 2018, compared to
$4.5 million in the first quarter of 2017. The decrease was primarily due to a reduction in costs related to the NeoCart Phase 3 clinical trial, for which enrollment was completed in June 2017. General and administrative expenses were
$2.8 million in the first quarter of 2018, compared to $2.3 million in the first quarter of 2017. The increase was primarily due to increases in salaries and consulting expenses related to increased activities to support the potential
commercialization of NeoCart.
Net loss attributable to common stockholders was $(14.4) million in the first quarter of 2018, or $(0.52) per share,
compared to $(5.8) million, or $(0.27) per share, in the first quarter of 2017. The increase in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock into common stock and an increase in
expense related to the fair value of the warrant liability which was partially offset by lower operating expenses.
As of March 31, 2018, Histogenics
had cash, cash equivalents and marketable securities of $15.5 million, compared to $8.0 million at December 31, 2017. Histogenics believes its current cash position will be sufficient to fund its operations into the fourth quarter of
Conference Call and Webcast Information
Histogenics management will host a conference call on Thursday, May 10, 2018 at 8:30 a.m. EDT. 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 8376199 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 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 clinical trial; the
ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart s
regulation as a Regenerative Medical Product in Japan; the market size and potential patient population in Japan; 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 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, 2017, which is 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 March 31, 2018, to be filed with the SEC
in the second quarter 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.
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 CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenue | $ | $ | ||||||
| Operating expenses: | ||||||||
| Research and development | 3,286 | 4,504 | ||||||
| General and administrative | 2,807 | 2,326 | ||||||
| Total operating expenses | 6,093 | 6,830 | ||||||
| Loss from operations | (6,093 | ) | (6,830 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 37 | 35 | ||||||
| Other (expense), net | (24 | ) | (17 | ) | ||||
| Change in fair value of warrant liability | (8,753 | ) | (269 | ) | ||||
| Total other (expense), net | (8,740 | ) | (251 | ) | ||||
| Net Loss | $ | (14,833 | ) | $ | (7,081 | ) | ||
| Other comprehensive loss: | ||||||||
| Unrealized loss from available for sale securities | (6 | ) | ||||||
| Comprehensive Loss | $ | (14,833 | ) | $ | (7,087 | ) | ||
| Net loss attributable to common stockholders basic and diluted | $ | (14,370 | ) | $ | (5,832 | ) | ||
| Net loss per common share basic and diluted | $ | (0.52 | ) | $ | (0.27 | ) | ||
| Weighted-average shares used to compute loss per common share basic and diluted: | 27,670,118 | 21,914,001 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Cash and cash equivalents and marketable securities | $ | 15,507 | $ | 7,981 | ||||
| Prepaid expenses and other current assets | 858 | 194 | ||||||
| Property and equipment, net | 4,448 | 2,723 | ||||||
| Other assets, net | 512 | 137 | ||||||
| Total assets | $ | 21,325 | $ | 11,035 | ||||
| Current liabilities | $ | 8,420 | $ | 3,805 | ||||
| Warrant and other non-current liabilities | 32,975 | 18,498 | ||||||
| Total stockholders equity | (20,070 | ) | (11,268 | ) | ||||
| Total liabilities and stockholders equity | $ | 21,325 | $ | 11,035 |
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