Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES SECOND QUARTER 2017
FINANCIAL AND OPERATING RESULTS
Completed Enrollment in NeoCart Phase 3 Clinical Trial
Top-line Data and Potential BLA Filing Expected in Third Quarter of 2018
Defined Regulatory Pathway with Japan Pharmaceuticals and Medical Devices Agency
Market Research in U.S. and Japan Points to Potential Large Markets with Significant Unmet Need
WALTHAM, Mass., August 10, 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 quarter ended June 30, 2017.
We achieved a significant milestone in the second quarter of 2017 when we completed enrollment of the NeoCart Phase 3 clinical trial with a record 17
patients in the month of June and 30 patients for the quarter. Furthermore, we continue to receive positive feedback from our surgeons regarding the ease of the NeoCart procedure and the potential early pain and functional relief, stated Adam
Gridley, President and Chief Executive Officer of Histogenics. The small lesion microfracture market continues to be underserved and our recent market research in Japan and the United States indicates a product like NeoCart, if approved, could
have a meaningful impact in the market as both physicians and patients are seeking novel alternatives to treat cartilage defects. We look forward to the results from our Phase 3 study in the third quarter of 2018, and believe our robust dual
threshold responder protocol, along with our one-year endpoint, may provide clear evidence of the potential for NeoCart to replace microfracture as the standard of care for these small lesions.
Second Quarter 2017 and Recent Highlights
Financial Results for the Second Quarter of 2017
Loss from operations was $(6.4) million in the second quarter of 2017, compared to $(8.0) million in the second quarter of 2016. The decrease in operating
expenses was primarily driven by a reduction in research and development expenses.
Research and development expenses were $4.2 million in the second
quarter of 2017, compared to $5.8 million in the second quarter of 2016. The decrease was primarily due to reductions in collaboration, consulting and temporary labor costs as well as salary and patient recruitment costs and was partially
offset by a small increase in sponsored research expenses with institutions, including Cornell University and
Brigham and Women s Hospital. General and administrative expenses were $2.2 million in the second quarter of
2017, compared to $2.2 million in the second quarter of 2016. An increase in facility related costs was offset by a decrease in stock-based compensation expense.
Net loss attributable to common stockholders was $(5.5) million in the second quarter of 2017, or $(0.25) per share, compared to $(8.0) million, or $(0.61)
per share, in the second quarter of 2016. The decrease in net loss attributable to common stockholders is primarily due to lower operating expenses and the allocation of a portion of the net loss to the Series A Preferred Stock.
As of June 30, 2017, Histogenics had cash, cash equivalents and marketable securities of $18.5 million, compared to $31.9 million at
December 31, 2016. Histogenics believes its current cash position will be sufficient to fund its operations into the middle of 2018.
Call and Webcast Information
Histogenics management will host a conference call on Thursday, August 10, 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 37210066 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 novel tissue therapies that may offer more rapid and
durable recoveries for patients with pain and loss of function due to musculoskeletal conditions. Histogenics regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering and bioadhesives to create
tissue ex-vivo. Histogenics first investigational product candidate, NeoCart is designed to treat cartilage defects in the knee. The Company recently completed enrollment of its NeoCart Phase 3
clinical trial and expects to report top-line data in the third quarter of 2018. 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. As a result, NeoCart is the only product in development or on the market with a one-year primary superiority endpoint as compared to the standard of
care. There are more than 500,000 or more knee cartilage procedures in the United States each year, with many healthy active adults avoiding treatment as they seek other alternatives. Left untreated, even a small cartilage defect can expand in size
and progress to debilitating osteoarthritis, ultimately necessitating a joint replacement procedure. Osteoarthritis is more common in adults over the age of 50, but the condition and precursors of the condition can be observed much earlier, and
cartilage damage is believed to be one of the leading contributors of this disease. 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 releasing the top-line data for the NeoCart Phase 3 clinical trial and timing of filing a BLA; the ability
to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; Histogenics ability to secure a development and commercialization partner for NeoCart in Japan; 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 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 March 31, 2017, which are on file with
the Securities and Exchange Commission (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, 2017, to be filed with the SEC in the third 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.
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
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,208 | 5,794 | 8,712 | 11,380 | ||||||||||||
| General and administrative | 2,166 | 2,161 | 4,492 | 4,373 | ||||||||||||
| Total operating expenses | 6,374 | 7,955 | 13,204 | 15,753 | ||||||||||||
| Loss from operations | (6,374 | ) | (7,955 | ) | (13,204 | ) | (15,753 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | 40 | (17 | ) | 75 | (36 | ) | ||||||||||
| Other expense, net | (73 | ) | (66 | ) | (90 | ) | (167 | ) | ||||||||
| Change in fair value of warrant liability | (135 | ) | (404 | ) | ||||||||||||
| Total other (expense), net | (168 | ) | (83 | ) | (419 | ) | (203 | ) | ||||||||
| Net loss | $ | (6,542 | ) | $ | (8,038 | ) | $ | (13,623 | ) | $ | (15,956 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) from available for sale securities | 4 | (2 | ) | |||||||||||||
| Comprehensive Loss | $ | (6,538 | ) | $ | (8,038 | ) | $ | (13,625 | ) | $ | (15,956 | ) | ||||
| Net Loss attributable to common stockholders - basic and diluted | $ | (5,454 | ) | $ | (8,038 | ) | $ | (11,285 | ) | $ | (15,956 | ) | ||||
| Net Loss per common share - basic and diluted: | $ | (0.25 | ) | $ | (0.61 | ) | $ | (0.51 | ) | $ | (1.20 | ) | ||||
| Weighted-average shares used to compute loss per common share - basic and diluted: | 22,183,804 | 13,270,433 | 22,050,572 | 13,270,531 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
| June 30, 2017 | December 31, 2016 | |||||||
| Cash and cash equivalents and marketable securities | $ | 18,540 | $ | 31,908 | ||||
| Prepaid expenses and other current assets | 304 | 173 | ||||||
| Property and equipment, net | 3,146 | 3,860 | ||||||
| Other assets, net | 137 | 137 | ||||||
| Total assets | $ | 22,127 | $ | 36,078 | ||||
| Current liabilities | $ | 3,827 | $ | 5,171 | ||||
| Warrant and other non-current liabilities | 17,494 | 17,340 | ||||||
| Total stockholder s equity | 806 | 13,567 | ||||||
| Total liabilities and stockholders equity | $ | 22,127 | $ | 36,078 |
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