Full Press Release Details
HISTOGENICS CORPORATION ANNOUNCES FIRST QUARTER 2016
FINANCIAL AND OPERATING RESULTS
- NeoCart Phase 3 Clinical Trial Remains on Track for Enrollment
Completion by End of Second Quarter of 2017 -
- Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT -
WALTHAM, Mass., May 12, 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 March 31, 2016.
We made significant progress on a number of important business objectives in the first quarter of 2016. Most importantly, we continued the positive
enrollment trends we have seen over the last several months in the NeoCart Phase 3 clinical trial and remain confident that we are on track to complete patient enrollment by the end of the second quarter of 2017, stated Adam Gridley, President
and Chief Executive Officer of Histogenics. In addition, we completed an important operational milestone for the in-house transfer of critical raw materials for NeoCart and received approval from the FDA to begin using internally produced
collagen in the ongoing NeoCart Phase 3 clinical trial. Operationally, the Company is in its strongest position in many years and we believe the completion of enrollment is in sight. We now have expanded rights in Japan, and continued positive
feedback from our investigators and the regulatory agencies, continued Mr. Gridley.
First Quarter 2016 and Recent Highlights
In early 2016, we have continued to execute by maintaining our recent enrollment momentum in the Phase 3 clinical trial,
strengthening the NeoCart development program by working with our partners at Intrexon and Cornell University to generate valuable data, and acquiring the NeoCart product rights for the Japanese market. Our objectives remain focused on the
near-term milestones that we believe will create the most value for our shareholders including completing the patient enrollment of the Phase 3 clinical trial and the manufacturing transition of critical raw materials, and potentially exploring
commercial partnering alternatives for NeoCart, stated Mr. Gridley.
Financial Results for the First Quarter of 2016
For the first quarter of 2016, Histogenics reported a net loss attributable to common stockholders of $(7.9) million, or $(0.60) per share, compared to $(8.0)
million, or $(0.60) per share, in the first quarter of 2015.
Research and development expenses were $5.6 million in the first quarter of 2016, compared
to $5.8 million in the first quarter of 2015. The decrease in expense was primarily due to raw materials purchased in 2015 for the NeoCart Phase 3 clinical trial and a reduction in consulting expense in the first quarter of 2016, which were
partially offset by increased headcount and clinical trial related activities in the first quarter of 2016. General and administrative expenses were $2.2 million in the first quarter of 2016, compared to $2.1 million in the first quarter of
2015. The increase was due to increased recruiting fees and stock compensation expense, which were partially offset by decreased insurance premiums.
At March 31, 2016 Histogenics had cash, cash equivalents and marketable securities of $22.9 million, compared
to $30.9 million at December 31, 2015. Histogenics believes its current cash position will fund its operations into the first quarter of 2017.
Conference Call and Webcast Information
host a conference call on Thursday, May 12, 2016 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 88447041 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.
About Histogenics Corporation
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, including, but not limited to, the market in Japan for the sale of NeoCart and Histogenics ability to find a partner
for such market, financial guidance regarding how long Histogenics current cash position will fund operations and comments about the clinical development of NeoCart, the transition of Histogenics manufacturing capabilities and
Histogenics collaboration with Intrexon 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 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 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; the sufficiency of Histogenics cash resources and the availability of additional financing on commercially reasonable terms; Histogenics ability to attract or retain key
personnel; the technologies on which Histogenics channel partnering agreement with Intrexon is based are currently in preclinical and clinical stages of development; Histogenics will incur additional expenses 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, which is on file with the SEC and available on the SEC s website at www.sec.gov. Additional factors may also be set forth in those sections of Histogenics
Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, to be filed with the SEC in the second 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 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
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 5,586 | $ | 5,764 | ||||
| General and administrative | 2,212 | 2,109 | ||||||
| Total operating expenses | 7,798 | 7,873 | ||||||
| Loss from operations | $ | (7,798 | ) | $ | (7,873 | ) | ||
| Other expense: | ||||||||
| Interest expense, net | $ | (19 | ) | $ | (62 | ) | ||
| Other expense, net | (101 | ) | (29 | ) | ||||
| Total other expense, net | (120 | ) | (91 | ) | ||||
| Net Loss | $ | (7,918 | ) | $ | (7,964 | ) | ||
| Net loss attributable to common stockholders basic and diluted | $ | (7,918 | ) | $ | (7,964 | ) | ||
| Net loss per common share basic and diluted: | $ | (0.60 | ) | $ | (0.60 | ) | ||
| Weighted-average shares used to compute net loss per common share basic and diluted: | 13,269,021 | 13,201,186 |
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
| March 31, | December 31, | |||||||
| 2016 | 2015 | |||||||
| Cash and cash equivalents | $ 22,897 | $ | 30,915 | |||||
| Prepaid expenses and other current assets | 466 | 321 | ||||||
| Property and equipment, net | 4,815 | 5,213 | ||||||
| Other assets, net | 337 | 337 | ||||||
| Total assets | $ | 28,515 | $ | 36,786 | ||||
| Current liabilities | $ | 5,975 | $ | 6,359 | ||||
| Non-current liabilities | 1,948 | 2,229 | ||||||
| Total stockholder s equity | 20,592 | 28,198 | ||||||
| Total liabilities and stockholders equity | $ | 28,515 | $ | 36,786 |
Tel: +1 (781) 547-7909