- Completion of Enrollment of NeoCart® Phase 3 Trial Now Expected in Second Quarter of 2017 -
- Company to Host Conference Call and Webcast Today at 8:30 a.m. EST -
WALTHAM, Mass., Nov. 12, 2015 (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, 2015.
“With our new team fully in-place, we are working aggressively to enroll our NeoCart Phase 3 clinical trial, complete the technical transfer activities for our manufacturing operations, continue to support our collaboration with Intrexon, and explore opportunities to enhance and expand our pipeline,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “We are disappointed that the trial will take longer to enroll than initially expected, but are encouraged by what we see and hear from our investigators regarding their patients that receive NeoCart in the trial and we will be carefully managing our operations to achieve our enrollment goals.”
Third Quarter 2015 and Recent Highlights
• Histogenics has enrolled a total of 103 patients in its NeoCart Phase 3 trial and now expects to complete enrollment by the end of the second quarter of 2017. Histogenics completed in the second and third quarters several enrollment optimization initiatives, which included a change in patient recruiting efforts as well as changes to the site initiation process. These efforts are beginning to positively impact enrollment. In addition, Histogenics continues to change the mix of sites with a goal of increasing the rate of enrollment. In the third quarter, Histogenics closed several more low-performing clinical sites than originally anticipated and now has 32 sites in this trial. Histogenics’ new clinical leadership has already identified additional investigative sites to bring the total to the 40 permitted sites in the first quarter of 2016.
• Histogenics recently completed the last performance qualification manufacturing run for collagen, which is a key raw material needed for the manufacture of NeoCart. In the coming months, Histogenics intends to complete the manufacturing transition of the remaining raw materials, including the scaffold component and surgical adhesive for NeoCart, pending approval by the United States Food and Drug Administration.
• Histogenics and Intrexon Corporation (Intrexon), Histogenics’ collaboration partner for potential next generation products, are pursuing an induced pluripotent stem cells (iPSC) approach, and continue to make excellent progress on a multi-step process development plan for an iPSC chondrocyte program. The partners have multiple scientific pathways ongoing with plans for a pilot manufacturing run in the first quarter of 2016 using Intrexon’s cell line in the NeoCart cell and tissue engineering manufacturing process.
• In October 2015, Histogenics received a United States Patent regarding a method of preparing an implant for cartilage repair. Histogenics believes this patent further enhances the protection around Histogenics’ NeoCart proprietary collagen scaffolds.
• In September and October 2015, Histogenics hosted its first Scientific Advisory Board meetings focused on its tissue engineering and biomaterials capabilities, and on its future stem cell and regenerative medicine platform opportunities. Feedback from the members of the Scientific Advisory Board was universally positive regarding the quality of the data generated to date from the laboratory work as well as the clinical trials, and Histogenics looks forward to exploring further opportunities to expand its future pipeline.
• Histogenics has initiated discussions around various business development opportunities including collaborations around the commercial rights to NeoCart outside of the United States, including recent discussions with our licensing partner in Japan with regards to an accelerated regulatory process in that market.
“We have now identified and consented almost half of the patients in the NeoCart Phase 3 clinical trial and believe that we are beginning to see the early results from the changes we made to our clinical strategy in the second and third quarters of 2015,” stated Dr. Gloria Matthews, Histogenics’ Chief Medical Officer. “We believe the positive momentum that we have recently seen is a result of our new approach that focuses on replacing certain existing sites with higher-enrolling sites; focused, local patient recruiting done in conjunction with the investigators; and a practice management mindset in close cooperation with study coordinators,” concluded Dr. Matthews.
Financial Results for the Third Quarter of 2015
For the third quarter of 2015, Histogenics reported a net loss attributable to common stockholders of $(8.1) million, or $(0.61) per share, compared to $(12.0) million, or $(19.38) per share, in the third quarter of 2014. The third quarter of 2014 included a $3.0 million gain related to fair value adjustments to certain liabilities that were either settled or terminated upon the closing of Histogenics’ initial public offering in the fourth quarter of 2014.
Research and development expenses were $5.8 million in the third quarter of 2015, compared to $13.2 million in the third quarter of 2014. The decrease in expense was primarily due to the expensing of license rights valued at $10.0 million and acquired as part of Histogenics’ exclusive channel collaboration with Intrexon Corporation in 2014 and was partially offset by higher costs related to the NeoCart Phase 3 clinical trial and related development and manufacturing activities.
General and administrative expenses were $2.2 million in the third quarter of 2015, compared to $1.7 million in the third quarter of 2014. The increase was due to various public company costs such as increased insurance premiums, board fees and stock compensation expense.
At September 30, 2015 Histogenics had cash, cash equivalents and marketable securities of $37.7 million, compared to $58.1 million at December 31, 2014. Histogenics believes its current cash position will fund its operations into 2017.
Conference Call and Webcast Information
Management will host a conference call on Thursday, November 12, 2015 at 8:30 a.m. EST. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial (855) 890-8663 (domestic) or (720) 634-2936 (international) and provide the conference ID “60793192” 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 30 days following the presentation.
About Histogenics Corporation
Histogenics is a regenerative medicine company focused on 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 that can be utilized individually or in concert to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart, leverages its platform to provide an innovative treatment in the orthopedic space, specifically cartilage damage in the knee.
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