Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES FIRST QUARTER 2017
FINANCIAL AND OPERATING RESULTS
NeoCart Phase 3 Clinical Trial Enrollment Near Completion
NeoCart Approval Pathway in Japan Defined After Successful Conclusion of Discussions with the Japan
Pharmaceuticals and Medical Devices Agency
Publication of Additional Data to Support Potential Approval and Commercialization of NeoCart
Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT
WALTHAM, Mass., May 11, 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 March 31, 2017.
In the first quarter of 2017, we continued to execute on our important near- and long-term business objectives. Importantly, we enrolled an additional
23 patients in the NeoCart Phase 3 clinical trial, and completed a series of productive formal meetings with the PMDA in Japan where we determined a near-term regulatory pathway for NeoCart to gain full Marketing Authorization in the Japanese
market, stated Adam Gridley, President and Chief Executive Officer of Histogenics. We are pleased to report continued strength in our enrollment of the clinical trial, which is expected to conclude this quarter. We also continue to build
on our strong portfolio of bench and clinical data with several new publications on the clinical and biomechanical performance of NeoCart. This contributes to our goal of a rapid BLA filing in the second half of 2018, and helps prepare us for the
potential commercialization of NeoCart in 2019, pending positive results from the NeoCart Phase 3 clinical trial and FDA approval, continued Mr. Gridley.
First Quarter 2017 and Recent Highlights
Financial Results for the First Quarter of 2017
from operations was $(6.8) million in the first quarter of 2017, compared to $(7.8) million in the first quarter of 2016. 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 $4.5 million in the first quarter of 2017, compared to $5.6
million in the first quarter of 2016. The decrease was primarily due to a reduction in consulting and temporary labor costs and patient recruiting expenses related to the NeoCart Phase 3 clinical trial. This decrease was partially offset by an
increase in hiring fees in the first quarter of 2017. General and administrative expenses were $2.3 million in the first quarter of 2017, compared to $2.2 million in the first quarter of 2016. The increase was primarily due to increases in
stock-based compensation and repairs and maintenance expense that were partially offset by a reduction in hiring fees and consulting costs.
attributable to common stockholders was $(5.8) million in first quarter of 2017, or $(0.27) per share, compared to $(7.9) million, or $(0.60) per share, in the first 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 March 31, 2017,
Histogenics had cash, cash equivalents and marketable securities of $24.4 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.
Conference Call and Webcast Information
Histogenics management will host a conference call on Thursday, May 11, 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 97247103 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 and is currently in Phase 3 clinical development.
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 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, 2016 which is 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 March 31, 2017, to be filed with the SEC in
the second 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 or otherwise.
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| Revenue | $ | $ | ||||||
| Operating expenses: | ||||||||
| Research and development | 4,504 | 5,586 | ||||||
| General and administrative | 2,326 | 2,212 | ||||||
| Total operating expenses | 6,830 | 7,798 | ||||||
| Loss from operations | (6,830 | ) | (7,798 | ) | ||||
| Other income (expense): | ||||||||
| Interest income (expense), net | 35 | (19 | ) | |||||
| Other expense, net | (17 | ) | (101 | ) | ||||
| Change in fair value of warrant liability | (269 | ) | ||||||
| Total other (expense), net | (251 | ) | (120 | ) | ||||
| Net Loss | $ | (7,081 | ) | $ | (7,918 | ) | ||
| Other comprehensive loss: | ||||||||
| Unrealized loss from available for sale securities | (6 | ) | ||||||
| Comprehensive Loss | $ | (7,087 | ) | $ | (7,918 | ) | ||
| Loss attributable to common stockholders basic and diluted | $ | (5,832 | ) | $ | (7,918 | ) | ||
| Loss per common share basic and diluted | $ | (0.27 | ) | $ | (0.60 | ) | ||
| Weighted-average shares used to compute loss per common share basic and diluted: | 21,914,001 | 13,269,021 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
| March 31, 2017 | December 31, 2016 | |||||||
| Cash and cash equivalents and marketable securities | $ | 24,374 | $ | 31,908 | ||||
| Prepaid expenses and other current assets | 296 | 173 | ||||||
| Property and equipment, net | 3,503 | 3,860 | ||||||
| Other assets, net | 137 | 137 | ||||||
| Total assets | $ | 28,310 | $ | 36,078 | ||||
| Current liabilities | $ | 3,895 | $ | 5,171 | ||||
| Warrant and other non-current liabilities | 17,443 | 17,340 | ||||||
| Total stockholder s equity | 6,972 | 13,567 | ||||||
| Total liabilities and stockholders equity | $ | 28,310 | $ | 36,078 |
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