Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES THIRD QUARTER 2016
FINANCIAL AND OPERATING RESULTS
- NeoCart Phase 3 Clinical Trial More than 75% Enrolled -
- Enrollment On-Track to Complete by End of Second Quarter of 2017 -
- Third Quarter Financing Expected to Fund Company to Phase 3 Data -
- Company to Host Conference Call and Webcast Today at 8:30 a.m. EST -
WALTHAM, Mass., November 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 quarter ended September 30, 2016.
We continue to execute on our strategy and operating initiatives in the third quarter of 2016. We have now enrolled more than three-quarters of the
245 patients required to complete our NeoCart Phase 3 clinical trial, and made continued progress on the manufacturing elements of the NeoCart development program. Enrollment is expected to be completed prior to the end of the second quarter of
2017, and we are preparing for the top-line data in the middle of 2018 and a BLA submission shortly thereafter, stated Adam Gridley, President and Chief Executive Officer of Histogenics. Furthermore, we believe that the financing
completed in the third quarter of 2016 was in large part due to our execution over the last year and the recognition of the market opportunity for this important therapy. We believe we are now funded to our expected top-line Phase 3 data
read-out in mid-2018, continued Mr. Gridley.
Third Quarter 2016 and Recent Highlights
Financial Results for the Third Quarter of 2016
For the third quarter of 2016, Histogenics reported a loss from operations of $(6.6) million compared to $(8.0) million in the third quarter of 2015. The
decrease in operating expenses was driven by reductions in both research and development and general and administrative expenses.
Research and development
expenses were $4.9 million in the third quarter of 2016, compared to $5.8 million in the third quarter of 2015. The decrease in expense was primarily due to a reduction in consulting and temporary labor costs, hiring fees, and raw materials and
patient recruiting expenses related to the NeoCart Phase 3 clinical trial. This decrease was partially offset by an increase in clinical trial related expenses and facility-related and other expenses in the third quarter of 2016. General
and administrative expenses were $1.8 million in the third quarter of 2016, compared to $2.2 million in the third quarter of 2015. The decrease was primarily due to a reduction in hiring fees, facility-related costs and legal and consulting
costs which were partially offset by an increase in stock-based compensation expense.
For the third quarter of 2016, Histogenics reported a net loss
attributable to common stockholders of $(9.2) million, or $(0.70) per share, compared to $(8.1) million, or $(0.61) per share, in the third quarter of 2015. The increase in net loss attributable to common stockholders is primarily due to
accounting charges related to the warrants issued as part of the financing that was completed in September 2016 and was partially offset by the aforementioned reductions in operating expenses.
At September 30, 2016, Histogenics had cash, cash equivalents and marketable securities of $38.0 million, compared to $30.9 million at December 31,
2015. Histogenics believes its current cash position will fund its operations into the middle of 2018.
Conference Call and Webcast Information
Management will host a conference call on Thursday, November 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 73416804 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 June 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 Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, to be filed with the SEC in the fourth 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 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
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, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,880 | 5,848 | 16,260 | 17,470 | ||||||||||||
| General and administrative | 1,768 | 2,191 | 6,141 | 6,035 | ||||||||||||
| Total operating expenses | 6,648 | 8,039 | 22,401 | 23,505 | ||||||||||||
| Loss from operations | (6,648 | ) | (8,039 | ) | (22,401 | ) | (23,505 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest expense, net | (20 | ) | (23 | ) | (55 | ) | (111 | ) | ||||||||
| Other expense, net | (130 | ) | (16 | ) | (298 | ) | (59 | ) | ||||||||
| Warrant expense | (3,056 | ) | (3,056 | ) | ||||||||||||
| Change in fair value of warrant liability | 539 | 539 | ||||||||||||||
| Total other expense, net | (2,667 | ) | (39 | ) | (2,870 | ) | (170 | ) | ||||||||
| Net loss | $ | (9,315 | ) | $ | (8,078 | ) | $ | (25,271 | ) | $ | (23,675 | ) | ||||
| Loss attributable to common stockholders - basic and diluted | $ | (9,234 | ) | $ | (8,078 | ) | $ | (25,197 | ) | $ | (23,675 | ) | ||||
| Loss per common share - basic and diluted: | $ | (0.70 | ) | $ | (0.61 | ) | $ | (1.90 | ) | $ | (1.79 | ) | ||||
| Weighted-average shares used to compute loss per common share - basic and diluted: | 13,297,546 | 13,238,997 | 13,279,833 | 13,218,765 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
| September 30, | December 31, | |||||||
| 2016 | 2015 | |||||||
| Cash and cash equivalents | $ | 37,994 | $ | 30,915 | ||||
| Prepaid expenses and other current assets | 201 | 321 | ||||||
| Property and equipment, net | 4,263 | 5,213 | ||||||
| Other assets, net | 337 | 337 | ||||||
| Total assets | $ | 42,795 | $ | 36,786 | ||||
| Current liabilities | $ | 7,209 | $ | 6,359 | ||||
| Warrant and other non-current liabilities | 31,550 | 2,229 | ||||||
| Total stockholder s equity | 4,036 | 28,198 | ||||||
| Total liabilities and stockholders equity | $ | 42,795 | $ | 36,786 |
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