Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES
FINANCIAL AND OPERATING RESULTS
Top-line Superiority Data from
NeoCart Phase 3 Clinical Trial on Track for Third Quarter of 2018
Initiation of Phase 3 Clinical Trial in Japan Expected in Second Half of 2018
Expansion of Management Team in Preparation for Potential Commercialization of NeoCart in 2020
Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT
WALTHAM, Mass., August 9, 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 operating results for the quarter ended June 30, 2018.
Our focus in the second quarter of 2018 was on the NeoCart Biologics License Application submission and we remain on track to announce top-line data in the third quarter of 2018. In preparation for this exciting milestone, we enhanced our management team with the addition of Lynne Kelley as Chief Medical Officer. Lynne s experience and
capabilities in medical and regulatory affairs and product development will be instrumental as we advance the preparation of the upcoming BLA for NeoCart, said Adam Gridley, President and Chief Executive Officer of Histogenics. We also
made important progress on the international expansion of the NeoCart platform alongside MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the Phase 3 trial in Japan in the second half of
Second Quarter 2018 and Recent Highlights
Financial Results for the Second Quarter of 2018
Loss from operations was $(7.3) million in the second quarter of 2018, compared to $(6.4) million in the second quarter of 2017. The increase in
operating expenses was due to an increase in both research and development expenses and general and administrative expenses.
Research and development
expenses were $4.5 million in the second quarter of 2018, compared to $4.2 million in the second quarter of 2017. The increase was primarily due to increases in consulting, salaries and materials in connection with the potential submission
of a BLA for NeoCart with the FDA and was partially offset by a reduction in patient costs related to the NeoCart Phase 3 clinical trial, for which enrollment was completed in June 2017. General and administrative expenses were $2.8 million in
the second quarter of 2018, compared to $2.2 million in the second quarter of 2017. The increase was primarily due to higher salaries and consulting expenses related to increased activities to support the potential commercialization of NeoCart.
Net loss attributable to common stockholders was $(3.7) million in the second quarter of 2018, or $(0.13) per share, compared to $(5.5) million, or
$(0.25) per share, in the second quarter of 2017. The decrease in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock issued in connection with the 2016 private placement into common stock
and a change in the fair value of the warrant liability which generated a gain in the second quarter of 2018, both of which were partially offset by an increase in operating expenses.
As of June 30, 2018, Histogenics had cash, cash equivalents and marketable securities of $8.8 million, compared to $8.0 million at
December 31, 2017. Histogenics believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.
Conference Call and Webcast Information
management will host a conference call on Thursday, August 9, 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 6679509 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 completed enrollment of its NeoCart Phase 3 clinical trial in June 2017 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 in Japan; 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, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31,
2018, 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 Quarterly Report on Form 10-Q for the quarter
ended June 30, 2018, to be filed with the SEC in the third 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
thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,458 | 4,208 | 7,744 | 8,712 | ||||||||||||
| General and administrative | 2,826 | 2,166 | 5,633 | 4,492 | ||||||||||||
| Total operating expenses | 7,284 | 6,374 | 13,377 | 13,204 | ||||||||||||
| Loss from operations | (7,284 | ) | (6,374 | ) | (13,377 | ) | (13,204 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | 32 | 40 | 69 | 75 | ||||||||||||
| Other expense, net | (26 | ) | (73 | ) | (50 | ) | (90 | ) | ||||||||
| Change in fair value of warrant liability | 3,501 | (135 | ) | (5,252 | ) | (404 | ) | |||||||||
| Total other income (expense), net | 3,507 | (168 | ) | (5,233 | ) | (419 | ) | |||||||||
| Net loss | $ | (3,777 | ) | $ | (6,542 | ) | $ | (18,610 | ) | $ | (13,623 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) from available for sale securities | 4 | (2 | ) | |||||||||||||
| Comprehensive loss | $ | (3,777 | ) | $ | (6,538 | ) | $ | (18,610 | ) | $ | (13,625 | ) | ||||
| Net loss attributable to common stockholders basic and diluted | $ | (3,697 | ) | $ | (5,454 | ) | $ | (18,124 | ) | $ | (11,285 | ) | ||||
| Net loss per common share basic and diluted: | $ | (0.13 | ) | $ | (0.25 | ) | $ | (0.64 | ) | $ | (0.51 | ) | ||||
| Weighted-average shares used to compute loss per common share basic and diluted: | 28,740,030 | 22,183,804 | 28,208,030 | 22,050,572 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2018 | December 31, 2017 | |||||||
| Cash and cash equivalents and marketable securities | $ | 8,772 | $ | 7,981 | ||||
| Prepaid expenses and other current assets | 881 | 194 | ||||||
| Property and equipment, net | 5,173 | 2,723 | ||||||
| Other assets, net | 325 | 137 | ||||||
| Total assets | $ | 15,151 | $ | 11,035 | ||||
| Current liabilities | $ | 11,657 | $ | 3,805 | ||||
| Warrant and other non-current liabilities | 26,932 | 18,498 | ||||||
| Total stockholders equity (deficit) | (23,438 | ) | (11,268 | ) | ||||
| Total liabilities and stockholders equity (deficit) | $ | 15,151 | $ | 11,035 |
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