Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES SECOND QUARTER 2015
FINANCIAL AND OPERATING RESULTS
- Continued Progress on NeoCart Phase 3 Trial and 2015 Business Objectives -
- Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT -
WALTHAM, Mass., August 12, 2015 /GLOBE NEWSWIRE/ Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a regenerative medicine company
focused on developing and commercializing products in the musculoskeletal space, announced its financial and operational results for the quarter ended June 30, 2015.
The second quarter was one of transition as we hired several new executives to drive the further development and commercialization of NeoCart,
stated Adam Gridley, President and Chief Executive Officer of Histogenics. We continued to make steady enrollment progress in our NeoCart trial, and in our collaboration with Intrexon, where our partnership has generated some exciting early
technical results. With our new management team and Scientific Advisory Board in place, we re also turning our efforts to new indications and applications for our regenerative medicine technology platform. Our primary focus for the rest of the
year will remain on the enrollment of the NeoCart Phase 3 trial, the technical transfer activities for our manufacturing operations, and on opportunities to advance and expand our pipeline.
Second Quarter 2015 and Recent Highlights
Financial Results for the Second Quarter 2015
For the second quarter of 2015, Histogenics reported a net loss attributable to common stockholders of $(7.6) million, or $(0.58) per share, compared to
$(11.8) million, or $(19.85) per share, in the second quarter of 2014. The second quarter of 2014 included a $2.3 million charge related to fair value adjustments to certain liabilities that were either settled or terminated upon the closing of
Histogenics initial public offering in the fourth quarter of 2014. Research and development expenses were $5.9 million in the second quarter of 2015, compared to $4.7 million in the second quarter of 2014 reflecting increased activity and
enrollment in the NeoCart Phase 3 clinical trial as well as increased investment in various NeoCart development and manufacturing programs. General and administrative expenses were $1.7 million in the second quarter of 2015, compared to $1.3 million
in the second quarter of 2014 with the increase due to various public company costs such as increased insurance premiums, board fees and stock compensation expense.
At June 30, 2015 Histogenics had cash, cash equivalents and marketable securities of $45.2 million, compared to $58.1 million at December 31, 2014.
Histogenics believes its current cash position will fund its operations into 2017.
Conference Call and Webcast Information
Management will host a conference call on Wednesday, August 12, 2015 at 8:30 a.m. EDT. A question-and-answer session will follow Histogenics
remarks. To participate on the live call, please dial (855) 890-8663 (domestic) or (720) 634-2936 (international) and provide the conference ID 85532537 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. A
replay of the webcast will be archived on Histogenics website for approximately 30 days following the presentation.
Histogenics is a regenerative medicine company focused on developing and commercializing products in the musculoskeletal segment of the
marketplace. Histogenics regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions that can be utilized individually or in concert to treat
musculoskeletal-related conditions. Histogenics first investigational product candidate, NeoCart, leverages its platform to provide an innovative treatment in the orthopedic space, specifically cartilage damage in the knee.
Forward-Looking Statements
Various statements in this
release, including, but not limited to, the guidance provided above, 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 the Company s forward-looking statements include, among others: the timing and success of Histogenics NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling
the NeoCart Phase 3 clinical 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; the sufficiency of Histogenics cash resources and
needs for additional financing; Histogenics ability to attract or retain key personnel; the technologies on which Histogenics channel partnering agreement with Intrexon Corporation is based are currently in preclinical and clinical
stages of development; Histogenics will incur additional expenses in connection with its exclusive channel collaboration agreement with Intrexon Corporation 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, 2014 and Quarterly Report on Form 10-Q for the three
months ended March 31, 2015 which are on file with the SEC and available on the SEC s website at www.sec.gov. Additional factors may also be set forth in those sections of Histogenics quarterly report on Form 10-Q for the quarter
ended June 30, 2015, to be filed with the SEC in the third quarter of 2015. 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,858 | $ | 4,669 | $ | 11,622 | $ | 8,043 | ||||||||
| General and administrative | 1,735 | 1,341 | 3,844 | 3,140 | ||||||||||||
| Total operating expenses | 7,593 | 6,010 | 15,466 | 11,183 | ||||||||||||
| Loss from operations | $ | (7,593 | ) | $ | (6,010 | ) | $ | (15,466 | ) | $ | (11,183 | ) | ||||
| Other income (expense): | ||||||||||||||||
| Interest expense, net | $ | (26 | ) | $ | $ | (88 | ) | $ | ||||||||
| Other income (expense), net | (14 | ) | (3 | ) | (43 | ) | (5 | ) | ||||||||
| Change in fair value of warrant liability, other liability and net sales distribution payment liability | (2,289 | ) | (551 | ) | ||||||||||||
| Total other income (expense), net | (40 | ) | (2,292 | ) | (131 | ) | (556 | ) | ||||||||
| Net loss | $ | (7,633 | ) | $ | (8,302 | ) | $ | (15,597 | ) | $ | (11,739 | ) | ||||
| Loss attributable to common stockholders - basic and diluted | $ | (7,633 | ) | $ | (11,822 | ) | $ | (15,597 | ) | $ | (15,259 | ) | ||||
| Loss per common share - basic and diluted: | $ | (0.58 | ) | $ | (19.85 | ) | $ | (1.18 | ) | $ | (25.91 | ) | ||||
| Weighted-average shares used to compute earnings per common share - basic and diluted: | 13,215,701 | 595,552 | 13,208,483 | 588,936 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| June 30, 2015 | December 31, 2014 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 45,222 | $ | 58,060 | ||||
| Prepaid expenses and other current assets | 897 | 796 | ||||||
| Property and equipment, net | 5,428 | 4,878 | ||||||
| Other assets, net | 1,691 | 1,765 | ||||||
| Total assets | $ | 53,238 | $ | 65,499 | ||||
| Current liabilities | 6,687 | 8,251 | ||||||
| Non-current liabilities | 2,686 | 3,042 | ||||||
| Total stockholder s equity | 43,865 | 54,206 | ||||||
| Total liabilities and stockholders equity | $ | 53,238 | $ | 65,499 |
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