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HISTOGENICS CORPORATION ANNOUNCES FINANCIAL AND OPERATING RESULTS FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2016 NeoCart Phase 3 Clinical Trial Enrollment on Track for Completion by End of Second Quarter of 2017

Key Takeaway: HISTOGENICS CORPORATION ANNOUNCES FINANCIAL AND OPERATING RESULTS FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2016 NeoCart Phase 3 Clinical Trial Enrollment on Track for Completion by End of Second Quarter of 2017 Strong Performance in all Areas of the Business in 2016

Full Press Release Details

HISTOGENICS CORPORATION ANNOUNCES FINANCIAL AND OPERATING RESULTS
FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2016
NeoCart Phase 3 Clinical Trial Enrollment on Track for Completion by End of
Second Quarter of 2017
Strong Performance in all Areas of the Business in 2016
Financing Completed in the Third Quarter of 2016 Expected to Fund Company to Phase 3 Data
Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT
WALTHAM, Mass., March 16, 2017 /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, 2016.
We made significant progress in all areas of our business in 2016. We enrolled 82 patients in the NeoCart Phase 3 clinical trial to bring total
enrollment to 196 patients at the end of 2016, consistent with the high end of our previously raised enrollment guidance. In addition, we made substantial progress on the transition of NeoCart raw materials from third party suppliers to our in-house
manufacturing, completed a successful $30 million capital raise, published compelling, long-term NeoCart data from our completed Phase 1 and 2 clinical trials and generated encouraging data as part of our collaborations with Cornell University and
Intrexon Corporation, stated Adam Gridley, President and Chief Executive Officer of Histogenics. We remain focused on our priority activities with the anticipated completion of enrollment in the NeoCart Phase 3 trial by end of the second
quarter of 2017, which leads to expected top-line data in the middle of 2018 and are rapidly turning our attention to the BLA submission based on those anticipated results, continued Mr. Gridley.
2016 and Recent Highlights
2017 Corporate Objectives
Financial Results for the Year Ended
Histogenics loss from operations was $(30.3) million for the year ended December 31, 2016, compared to $(31.8)
million for the year ended December 31, 2015. The decrease in operating expenses was driven by a reduction in research and development expense and partially offset by a small increase in general and administrative expenses.
Research and development expenses were $21.6 million for the year ended December 31, 2016, compared to $23.2 million for the year ended December 31,
2015. The decrease in expense was primarily due to a reduction in consulting, raw materials and patient recruiting expenses and was partially offset by an increase in clinical trial related expenses due to higher patient enrollment in the NeoCart
Phase 3 clinical trial in 2016. General and administrative expenses were $8.5 million for the year ended December 31, 2016, compared to $8.3 million for the year ended December 31, 2015. The increase was primarily due to higher personnel
and related costs as well as an increase in facility-related costs and was partially offset by a decrease in professional fees and consulting expense.
Basic net loss attributable to common stockholders was $(13.9) million for the year ended December 31, 2016, or $(0.97) per share, compared to $(32.0)
million, or $(2.42) per share, for the year ended December 31, 2015. The decrease in basic net loss attributable to common stockholders is primarily due to the change in fair value of the warrants issued as part of the financing that was
completed in September 2016 and reductions in operating expenses offset by increased expenses related to the financing. Diluted net loss attributable to common stockholders was $(31.4) million for the year ended December 31, 2016, or $(2.18)
per share, compared to $(32.0) million, or $(2.42) per share, for the year ended December 31, 2015. Diluted net loss attributable to common stockholders excludes the gain on fair value of warrant liability. The remaining difference between 2016
and 2015 is primarily due to increased expenses related to the financing, offset by a reduction in operating expense.
At December 31, 2016,
Histogenics had cash, cash equivalents and marketable securities of $31.9 million, compared to $30.9 million at December 31, 2015. Histogenics expects total operating expenses of between $25 and $27 million for the year ended December 31,
2017 and believes its current cash position will be sufficient to fund its operations into the middle of 2018.
Conference Call and Webcast Information
Histogenics management will host a conference call on Thursday, March 16, 2017 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 56826793 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 45 days following the presentation.
Histogenics is a 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.
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; 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; 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; the early stage of development of the technologies on which Histogenics
channel partnering agreement with Intrexon Corporation is based; the additional expenses that Histogenics will incur 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, 2015 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2016, 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 Annual Report on
Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017. 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.
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,
2016 2015 2016 2015
Revenue $ $ $ $
Operating expenses:
Research and development 5,317 5,773 21,577 23,243
General and administrative 2,389 2,231 8,530 8,266
Impairment of intangible asset 200 310 200 310
Total operating expenses 7,906 8,314 30,307 31,819
Loss from operations (7,906 ) (8,314 ) (30,307 ) (31,819 )
Other income (expense):
Interest expense, net (5 ) (22 ) (60 ) (133 )
Other income (expense), net 50 (13 ) (248 ) (72 )
Warrant expense (44 ) (3,100 )
Change in fair value of warrant liability 16,968 17,507
Total other income (expense), net 16,969 (35 ) 14,099 (205 )
Net Income (loss) $ 9,063 $ (8,349 ) $ (16,208 ) $ (32,024 )
Net Income (loss) attributable to common stockholders
Basic: $ 5,844 $ (8,349 ) $ (13,863 ) $ (32,024 )
Diluted: $ (11,125 ) $ (8,349 ) $ (31,370 ) $ (32,024 )
Net Income (loss) per common share:
Basic: $ 0.34 $ (0.63 ) $ (0.97 ) $ (2.42 )
Diluted: $ (0.63 ) $ (0.63 ) $ (2.18 ) $ (2.42 )
Weighted-average shares used to compute earnings (loss) per common share:
Basic: 17,143,121 13,266,866 14,256,954 13,231,126
Diluted: 17,508,120 13,266,866 14,389,192 13,231,126
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
December 31, December 31,
2016 2015
Cash and cash equivalents $ 31,908 $ 30,915
Prepaid expenses and other current assets 173 321
Property and equipment, net 3,860 5,213
Other assets, net 137 337
Total assets $ 36,078 $ 36,786
Current liabilities $ 5,171 $ 6,359
Warrant and other non-current liabilities 17,340 2,229
Total stockholder s equity 13,567 28,198
Total liabilities and stockholders equity $ 36,078 $ 36,786
Tel: +1 (781) 547-7909
Last updated: Mar 16, 2017