Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES FINANCIAL AND OPERATING RESULTS
FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2017
NeoCart Top-line Phase 3 Clinical
Trial Data and Potential Biologics License Application Filing
Remain on Track for Third Quarter of 2018
NeoCart Licensing Agreement with MEDINET Co. Ltd. Provides Important Source of Funding and
Enables Development and Potential Commercialization in Japanese Market
Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT
WALTHAM, Mass., March 15, 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 and year ended December 31, 2017.
We achieved multiple, significant milestones in our global development strategy for NeoCart in 2017, providing a strong foundation for additional value
creation in 2018. With the completion of enrollment in the NeoCart Phase 3 clinical trial in the first half of 2017, we are on track to report top-line data from this trial and potentially submit a Biologics
License Application for this novel restorative cell therapy in the third quarter of 2018. In parallel we are initiating pre-commercialization activities for the U.S. market in advance of a potential launch of
NeoCart in fourth quarter of 2019, and we continue to hear positive anecdotal feedback from our investigators regarding NeoCart patients, stated Adam Gridley, President and Chief Executive Officer of Histogenics. We also made significant
progress on the international expansion of the NeoCart platform by completing formal discussions with the Japan Pharmaceuticals and Medical Devices Agency on the development and regulatory pathway for NeoCart in Japan. Our robust historical data
packages and the PMDA conclusions were instrumental in our ability to complete the licensing agreement with MEDINET for the rights to develop and commercialize NeoCart in Japan.
2017 and Recent Milestones
Regulatory and Commercialization
NeoCart Data Publications and Presentations
2018 Corporate Objectives
Financial Results for the Year Ended December 31, 2017
Histogenics loss from operations was $(25.0) million for the year ended December 31, 2017, compared to $(30.3) million for the year ended
December 31, 2016. The decrease in operating loss was driven by a reduction in research and development expenses and partially offset by an increase in general and administrative expenses.
Research and development expenses were $15.6 million for the year ended December 31, 2017, compared to $21.6 million for the year ended
December 31, 2016. The decrease was primarily due to decreases in collaboration, consulting and temporary labor expenses, clinical trial-related costs, personnel-related expenses and repairs and maintenance costs concurrent with the wind up of
enrollment in our NeoCart Phase 3 clinical trial. General and administrative expenses were $9.4 million for the year ended December 31, 2017, compared to $8.5 million for the year ended December 31, 2016. The increase was
primarily due to increased activities related to potential commercialization of NeoCart and was driven by increases in personnel-related costs, professional fees and facility-related and stock-based compensation expenses.
Basic net loss attributable to common stockholders was $(22.5) million for the year ended December 31, 2017, or $(0.99) per share, compared to $(13.9)
million, or $(0.97) per share, for the year ended December 31, 2016. The increase in basic net loss attributable to common stockholders is attributable to the conversion into common stock in 2017 of a significant portion of the convertible
preferred stock issued in connection with the 2016 private placement and changes in the fair value of the warrants issued in connection with the 2016 private placement, both of which were offset by a reduction in operating expenses in 2017 relative
to 2016. Diluted net loss attributable to common stockholders was $(22.5) million for the year ended December 31, 2017, or $(0.99) per share, compared to $(31.4) million, or $(2.18) per share, for the year ended December 31, 2016. The
difference in diluted net loss per share is primarily due to a reduction in operating expenses.
At December 31, 2017, Histogenics had cash, cash
equivalents and marketable securities of $8.0 million, compared to $31.9 million at December 31, 2016. Cash at December 31, 2017 excludes approximately $9.0 million net of expenses received in January 2018 in connection with
the licensing agreement entered into with MEDINET in December 2017 and $5.9 in net proceeds from the registered direct offering completed in January 2018.
Histogenics expects total operating expenses of between $29 million and $31 million for the year ending December 31, 2018 and believes its
current cash position will be sufficient to fund its operations into the fourth quarter of 2018.
Conference Call and Webcast Information
Histogenics management will host a conference call on Thursday, March 15, 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 7394538 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; 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, 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, 2017, to be filed with the SEC in the first quarter of 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
(in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,366 | 5,317 | 15,566 | 21,577 | ||||||||||||
| General and administrative | 2,667 | 2,389 | 9,384 | 8,530 | ||||||||||||
| Impairment of intangible asset | 200 | 200 | ||||||||||||||
| Total operating expenses | 6,033 | 7,906 | 24,950 | 30,307 | ||||||||||||
| Loss from operations | (6,033 | ) | (7,906 | ) | (24,950 | ) | (30,307 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | 20 | (5 | ) | 134 | (60 | ) | ||||||||||
| Other income (expense), net | 25 | 50 | (116 | ) | (248 | ) | ||||||||||
| Warrant expense | (44 | ) | (3,100 | ) | ||||||||||||
| Change in fair value of warrant liability | (808 | ) | 16,968 | (1,482 | ) | 17,507 | ||||||||||
| Total other income (expense), net | (763 | ) | 16,969 | (1,464 | ) | 14,099 | ||||||||||
| Net Income (loss) | $ | (6,796 | ) | $ | 9,063 | $ | (26,414 | ) | $ | (16,208 | ) | |||||
| Net Income (loss) attributable to common stockholders | ||||||||||||||||
| Basic: | $ | (6,129 | ) | $ | 5,844 | $ | (22,499 | ) | $ | (13,863 | ) | |||||
| Diluted: | $ | (6,129 | ) | $ | (11,125 | ) | $ | (22,499 | ) | $ | (31,370 | ) | ||||
| Net Income (loss) per common share: | ||||||||||||||||
| Basic: | $ | (0.26 | ) | $ | 0.34 | $ | (0.99 | ) | $ | (0.97 | ) | |||||
| Diluted: | $ | (0.26 | ) | $ | (0.63 | ) | $ | (0.99 | ) | $ | (2.18 | ) | ||||
| Weighted-average shares used to compute earnings (loss) per common share: | ||||||||||||||||
| Basic: | 24,005,598 | 17,143,121 | 22,669,819 | 14,256,954 | ||||||||||||
| Diluted: | 24,005,598 | 17,508,120 | 22,669,819 | 14,389,192 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
| December 31, 2017 | December 31, 2016 | |||||||
| Cash, cash equivalents and marketable securities | $ | 7,981 | $ | 31,908 | ||||
| Prepaid expenses and other current assets | 194 | 173 | ||||||
| Property and equipment, net | 2,723 | 3,860 | ||||||
| Other assets, net | 137 | 137 | ||||||
| Total assets | $ | 11,035 | $ | 36,078 | ||||
| Current liabilities | $ | 3,805 | $ | 5,171 | ||||
| Warrant and other non-current liabilities | 18,498 | 17,340 | ||||||
| Total stockholders equity (deficit) | (11,268 | ) | 13,567 | |||||
| Total liabilities and stockholders equity (deficit) | $ | 11,035 | $ | 36,078 |
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