Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES THIRD QUARTER 2015
FINANCIAL AND OPERATING RESULTS
- Completion of Enrollment of NeoCart Phase 3 Trial Now Expected in Second Quarter of 2017 -
- Company to Host Conference Call and Webcast Today at 8:30 a.m. EST -
WALTHAM, Mass., November 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 September 30, 2015.
With our new team fully in-place, we are working aggressively to enroll our NeoCart Phase 3 clinical trial, complete the technical transfer activities
for our manufacturing operations, continue to support our collaboration with Intrexon, and explore opportunities to enhance and expand our pipeline, stated Adam Gridley, President and Chief Executive Officer of Histogenics. We are
disappointed that the trial will take longer to enroll than initially expected, but are encouraged by what we see and hear from our investigators regarding their patients that receive NeoCart in the trial and we will be carefully managing our
operations to achieve our enrollment goals.
Third Quarter 2015 and Recent Highlights
We have now identified and
consented almost half of the patients in the NeoCart Phase 3 clinical trial and believe that we are beginning to see the early results from the changes we made to our clinical strategy in the second and third quarters of 2015, stated
Dr. Gloria Matthews, Histogenics Chief Medical Officer. We believe the positive momentum that we have recently seen is a result of our new approach that focuses on replacing certain existing sites with higher-enrolling sites;
focused, local patient recruiting done in conjunction with the investigators; and a practice management mindset in close cooperation with study coordinators, concluded Dr. Matthews.
Financial Results for the Third Quarter of 2015
third quarter of 2015, Histogenics reported a net loss attributable to common stockholders of $(8.1) million, or $(0.61) per share, compared to $(12.0) million, or $(19.38) per share, in the third quarter of 2014. The third quarter of 2014 included
a $3.0 million gain 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 $5.8 million in the third quarter of 2015, compared to $13.2 million in the third quarter of 2014. The decrease in
expense was primarily due to the expensing of license rights valued at $10.0 million and acquired as part of Histogenics exclusive channel collaboration with Intrexon Corporation in 2014 and was partially offset by higher costs related to the
NeoCart Phase 3 clinical trial and related development and manufacturing activities. General and administrative expenses were $2.2 million in the third quarter of 2015, compared to $1.7 million in the third quarter of 2014. The increase was due
to various public company costs such as increased insurance premiums, board fees and stock compensation expense.
At September 30, 2015 Histogenics
had cash, cash equivalents and marketable securities of $37.7 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
host a conference call on Thursday, November 12, 2015 at 8:30 a.m. EST. 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 60793192 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.
About Histogenics Corporation
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 quarter ended June 30, 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 September 30, 2015, to be filed
with the SEC in the fourth 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,848 | $ | 13,237 | $ | 17,470 | $ | 21,280 | ||||||||
| General and administrative | 2,191 | 1,703 | 6,035 | 4,843 | ||||||||||||
| Total operating expenses | 8,039 | 14,940 | 23,505 | 26,123 | ||||||||||||
| Loss from operations | $ | (8,039 | ) | $ | (14,940 | ) | $ | (23,505 | ) | $ | (26,123 | ) | ||||
| Other income (expense): | ||||||||||||||||
| Interest expense, net | $ | (23 | ) | $ | (19 | ) | $ | (111 | ) | $ | (19 | ) | ||||
| Other income (expense), net | (16 | ) | (1 | ) | (59 | ) | (6 | ) | ||||||||
| Change in fair value of warrant liability, other liability and net sales distribution payment liability | 2,986 | 2,435 | ||||||||||||||
| Total other income (expense), net | (39 | ) | 2,966 | (170 | ) | 2,410 | ||||||||||
| Net loss | $ | (8,078 | ) | $ | (11,974 | ) | $ | (23,675 | ) | $ | (23,713 | ) | ||||
| Loss attributable to common stockholders - basic and diluted | $ | (8,078 | ) | $ | (11,974 | ) | $ | (23,675 | ) | $ | (27,233 | ) | ||||
| Loss per common share - basic and diluted: | $ | (0.61 | ) | $ | (19.38 | ) | $ | (1.79 | ) | $ | (45.49 | ) | ||||
| Weighted-average shares used to compute earnings per common share - basic and diluted: | 13,238,997 | 617,860 | 13,218,765 | 598,684 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| September 30, 2015 | December 31, 2014 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 37,723 | $ | 58,060 | ||||
| Prepaid expenses and other current assets | 365 | 796 | ||||||
| Property and equipment, net | 5,513 | 4,878 | ||||||
| Other assets, net | 1,700 | 1,765 | ||||||
| Total assets | $ | 45,301 | $ | 65,499 | ||||
| Current liabilities | 6,690 | 8,251 | ||||||
| Non-current liabilities | 2,435 | 3,042 | ||||||
| Total stockholder s equity | 36,176 | 54,206 | ||||||
| Total liabilities and stockholders equity | $ | 45,301 | $ | 65,499 |
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