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Histogenics Corporation Announces Financial and Operating Results for the Fourth Quarter and Year Ended December 31, 2016
‒ NeoCart® Phase 3 Clinical Trial Enrollment on Track for Completion by End of Second Quarter of 2017 ‒
‒ Strong Performance in all Areas of the Business in 2016 ‒
‒ Financing Completed in the Third Quarter of 2016 Expected to
‒ Company to Host Conference Call and Webcast Today at
“We made significant progress in all areas of our business in 2016. We enrolled 82 patients in the NeoCart Phase 3 clinical trial to bring total enrollment to 196 patients at the end of 2016, consistent with the high end of our previously raised enrollment guidance. In addition, we made substantial progress on the transition of NeoCart raw materials from third party suppliers to our in-house manufacturing, completed a successful
2016 and Recent Highlights
- Continued Strength in NeoCart Phase 3 Clinical Trial Enrollment: As of
March 14, 2017, Histogenicshas enrolled 214 of the 245 patients required under the Special Protocol Assessment (SPA) with the United States Food and Drug Administration( FDA) in the NeoCart Phase 3 clinical trial. Total enrollment at the end of 2016 was approximately 70% higher than year-end 2015. In addition, enrollment has remained strong in the first quarter of 2017 with contributions from both existing and new clinical sites, including additional sites in Canada. Histogenicsreceived approval from Health Canadato expand the ongoing NeoCart Phase 3 clinical trial to investigative sites in Canadaand added four clinical sites that were selected based on their patient demographics and their potential ability to provide additional patients into the trial. Histogenicsconfirms its expectation that patient enrollment in the Phase 3 clinical trial will be complete by the end of the second quarter of 2017.
Progresson NeoCart Critical Raw Materials: Histogenicsreached agreement with the FDAon the transition plan for internally produced collagen in April 2016, and incorporated this material into the ongoing Phase 3 trial in June 2016. In August 2016, Histogenicsreached agreement with the FDAon the transition and qualification plan for the NeoCart collagen scaffold. Histogenicsis in the process of qualifying the scaffold for use upon commercialization of NeoCart, if approved.
- Completion of
$30 MillionFinancing: Histogenicscompleted a $30 millionprivate placement of common stock, Series A Convertible Preferred Stock and warrants in September 2016. The financing was led by new healthcare-focused, institutional investors and supported by existing Histogenicsinvestors. Histogenicscurrently anticipates that its existing cash will enable it to reach its objective of generating top-line data from the ongoing NeoCart Phase 3 clinical trial in the middle of 2018.
- Discussions with Japanese Regulatory Authorities:
Histogenicscontinues to maintain an active dialog with the Japan Pharmaceuticalsand Medical Devices Agency(PMDA) regarding the development of NeoCart for the Japanese market using the new Japanese Regenerative Medicine Laws passed in 2014. Histogenicshas had a series of productive meetings to discuss the NeoCart Phase 1 and Phase 2 data generated to date, the proposed confirmatory clinical development program in Japanand the required regulatory submission package for potential conditional approval.
- Development of NeoCart Clinical Data and
Related Publications: Long-term data from the combined Phase 1 and 2 NeoCart clinical trials was recently published in the American Journal of Sports Medicine. The magnetic resonance imaging data from the trials indicated NeoCart repair tissue is durable and evolves over time. In addition, patients receiving NeoCart implants in the two trials demonstrated statistically significant improvements when compared to baseline on virtually all of the pain and functional endpoints. These improvements were reported by patients as early as 3 to 6 months, with sustained outcomes through 5 years from the date of implant.
- Development of NeoCart Pre-Clinical Data and
Related Publications: Together with its partners, Cornell University(Cornell), Intrexon Corporation( Intrexon), and Brigham and Women’s Hospital, Histogenicsexpanded and strengthened the NeoCart platform technology to support the potential commercialization of NeoCart, if approved. Histogenicsand Cornellgenerated biomechanical and structural data under a Sponsored Research Agreement that was initially presented at the Orthopaedic Research Societyannual meeting in March 2016and at the Biomedical Engineering SocietyAnnual Meeting in October 2016. These data, which were also recently published in the Journal of Orthopaedic Research, demonstrate that Histogenics’ tissue engineered cartilage constructs exhibit mechanical properties approaching native human cartilage as early as three weeks in culture. In conjunction with Histogenicscollaboration with Cornell, Professor Lawrence Bonassar, a leading researcher in the field of cartilage biomechanics and tissue engineering, joined the Histogenics Scientific Advisory Boardin October 2016. Histogenicsand Intrexonadvanced their effort to develop a second generation NeoCart by producing compelling, proof-of-concept data showing NeoCart implants based on iPSC derived chondrocytes exhibited similar properties to current generation, autologous NeoCart tissue implants.
2017 Corporate Objectives
- Complete NeoCart Clinical Enrollment and Manufacturing Transition: In addition to completing enrollment in the Phase 3 clinical trial by the end of the second quarter 2017,
Histogenicsintends to complete the raw materials engineering runs in 2017, including generating the data for the collagen scaffold and proprietary adhesive. These materials contain Histogenicsproduced collagen, which is currently being used in the Phase 3 clinical trial.
- Generate and Publish Additional Data to Support NeoCart Commercialization:
Histogenicsintends to work with its investigators and collaborators to generate and publish additional, meaningful data to support the NeoCart technology platform including, five-year data from the completed Phase 2 clinical trial and additional mechanical data generated under the SPA with Cornell.
- Complete Meetings with
Japanese Regulatory Authorityto Define Requirements for Approval of NeoCart in Japan: Histogenicsintends to conduct and complete formal meetings with the PMDA to agree upon the development and regulatory pathway for the potential conditional approval of NeoCart in Japan. Histogenicsintends to leverage the results of these meetings to create value and advance discussions with potential partners for the Japan/Asiamarket with a goal of completing by the end of the year, a collaboration to manufacture and commercialize NeoCart, if approved.
Financial Results for the Year Ended
Histogenics’ loss from operations was
Research and development expenses were
Basic net loss attributable to common stockholders was
Conference Call and Webcast Information
A live audio webcast of the presentation will be available via the “Investor Relations” page of the
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
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||5,317||5,773||21,577||23,243|
|General and administrative||2,389||2,231||8,530||8,266|
|Impairment of intangible asset||200||310||200||310|
|Total operating expenses||7,906||8,314||30,307||31,819|
|Loss from operations||(7,906||)||(8,314||)||(30,307||)||(31,819||)|
|Other income (expense):|
|Interest expense, net||(5||)||(22||)||(60||)||(133||)|
|Other income (expense), net||50||(13||)||(248||)||(72||)|
|Change in fair value of warrant liability||16,968||‒||17,507||‒|
|Total other income (expense), net||16,969||(35||)||14,099||(205||)|
|Net Income (loss)||$||9,063||$||(8,349||)||$||(16,208||)||$||(32,024||)|
|Net Income (loss) attributable to common stockholders|
|Net Income (loss) per common share:|
|Weighted-average shares used to compute earnings (loss) per common share:|
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|December 31,||December 31,|
|Cash and cash equivalents||$||31,908||$||30,915|
|Prepaid expenses and other current assets||173||321|
|Property and equipment, net||3,860||5,213|
|Other assets, net||137||337|
|Warrant and other non-current liabilities||17,340||2,229|
|Total stockholder’s equity||13,567||28,198|
|Total liabilities and stockholders’ equity||$||36,078||$||36,786|
Contact: Investor Relations Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com