Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES FINANCIAL AND OPERATING RESULTS
FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2015
- NeoCart Phase 3 Clinical Trial More Than 50% Enrolled and on Track for Full
by End of Second Quarter of 2017 -
- Company to Host Conference Call and Webcast Today at 8:30 a.m. EST -
WALTHAM, Mass., March 10, 2016 /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 year ended December 31, 2015.
2015 was a year of transition for Histogenics. We made significant progress toward our long-term business objectives by strengthening our management
team with several key hires, changing and augmenting our approach to recruiting the NeoCart Phase 3 clinical trial and continuing to advance both the technical transfer activities for our manufacturing operations and our collaboration with
Intrexon, stated Adam Gridley, President and Chief Executive Officer of Histogenics. We believe that the recruiting and investigator changes we put in place for the NeoCart Phase 3 clinical trial are having a positive impact on our
enrollment rates and remain confident that we will complete enrollment by the end of the second quarter of 2017.
2015 and Recent Highlights
2016 Corporate Objectives
The changes we made in 2015 to our clinical trial strategy and management team provide a solid foundation for us to complete our NeoCart Phase 3
clinical trial, and we are now focused on execution of our objectives for 2016, stated Mr. Gridley. We are pleased with the enrollment rates we have seen over the last few months in the NeoCart Phase 3 clinical trial as well as with
the progress we have made on the other aspects of the NeoCart development program. We look forward to a successful year in 2016, concluded Mr. Gridley.
Financial Results for the Year Ended December 31, 2015
For the year ended December 31, 2015, Histogenics reported a net loss attributable to common stockholders of $(32.0) million, or $(2.42) per share,
compared to $(10.5) million, or $(6.85) per share, for the year ended December 31, 2014. The year ended December 31, 2014 included a $10.0 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 $23.2
million for the year ended December 31, 2015, compared to $26.0 million for the year ended December 31, 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 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 $8.3 million for the year ended December 31, 2015, compared to $6.6 million for the year ended December 31, 2014. The increase was due to various public company costs such as increased insurance premiums, board fees and stock
compensation expense.
At December 31, 2015 Histogenics had cash, cash equivalents and marketable securities of $30.9 million, compared to $58.5
million at December 31, 2014. Histogenics believes its current cash position will fund its operations through the first quarter of 2017.
Conference Call and Webcast Information
host a conference call on Thursday, March 10, 2016 at 8:30 a.m. EST. 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 60614260 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
leading regenerative medicine company 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 to treat musculoskeletal-related conditions. Histogenics first investigational product candidate, NeoCart , is currently in Phase 3
clinical development. NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient s own cells. Knee cartilage defects represent a significant opportunity in the United States, with an estimated
500,000 or more applicable procedures each year. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage,
characteristics not exhibited in other current treatment options. For more information, please visit www.histogenics.com.
Various statements in this release, including, but not limited to, the 2016 corporate objectives, the financial guidance regarding how long
the current cash position will fund operations and comments about the clinical development of NeoCart, the transition of Histogenics manufacturing capabilities and Histogenics collaboration with Intrexon 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 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 the availability of additional financing on commercially reasonable terms; Histogenics ability to attract or
retain key personnel; the technologies on which Histogenics channel partnering agreement with Intrexon 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 September 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 Annual Report on Form 10-K for the year ended December 31, 2015, to be filed with the SEC in the first quarter of 2016. 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
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 December 31, | Year Ended December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,773 | $ | 4,654 | $ | 23,243 | $ | 26,037 | ||||||||
| General and administrative | 2,231 | 1,825 | 8,266 | 6,565 | ||||||||||||
| Impairment of intangible asset | 310 | 60 | 310 | 60 | ||||||||||||
| Total operating expenses | 8,314 | 6,539 | 31,819 | 32,662 | ||||||||||||
| Loss from operations | $ | (8,314 | ) | $ | (6,539 | ) | $ | (31,819 | ) | $ | (32,662 | ) | ||||
| Other income (expense): | ||||||||||||||||
| Interest expense, net | $ | (22 | ) | $ | (132 | ) | $ | (133 | ) | $ | (151 | ) | ||||
| Other income (expense), net | (13 | ) | 19 | (72 | ) | 13 | ||||||||||
| Change in fair value of warrant liability, other liability and net sales distribution payment liability | 7,572 | 10,007 | ||||||||||||||
| Total other income (expense), net | (35 | ) | 7,459 | (205 | ) | 9,869 | ||||||||||
| Net Earnings (Loss) | $ | (8,349 | ) | $ | 920 | $ | (32,024 | ) | $ | (22,793 | ) | |||||
| Earnings (Loss) attributable to common stockholders basic | $ | (8,349 | ) | $ | 9,629 | $ | (32,024 | ) | $ | (10,510 | ) | |||||
| Earnings (Loss) attributable to common stockholders diluted | $ | (8,349 | ) | $ | 9,676 | $ | (32,024 | ) | $ | (10,510 | ) | |||||
| Earnings (Loss) per common share basic: | $ | (0.63 | ) | $ | 2.23 | $ | (2.42 | ) | $ | (6.85 | ) | |||||
| Earnings (Loss) per common share diluted: | $ | (0.63 | ) | $ | 1.70 | $ | (2.42 | ) | $ | (6.85 | ) | |||||
| Weighted-average shares used to compute earnings per common share basic: | 13,266,866 | 4,309,880 | 13,231,126 | 1,534,108 | ||||||||||||
| Weighted-average shares used to compute earnings per common share diluted | 13,266,866 | 5,691,162 | 13,231,126 | 1,534,108 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| December 31, | December 31, | |||||||
| 2015 | 2014 | |||||||
| Cash and cash equivalents | $ | 30,915 | $ | 58,527 | ||||
| Prepaid expenses and other current assets | 321 | 796 | ||||||
| Property and equipment, net | 5,213 | 4,878 | ||||||
| Other assets, net | 337 | 1,298 | ||||||
| Total assets | $ | 36,786 | $ | 65,499 | ||||
| Current liabilities | $ | 6,359 | $ | 7,600 | ||||
| Non-current liabilities | 2,229 | 3,693 | ||||||
| Total stockholder s equity | 28,198 | 54,206 | ||||||
| Total liabilities and stockholders equity | $ | 36,786 | $ | 65,499 |
Tel: +1 (781) 547-7909