During Friday’s Morning trade, Shares of Histogenics Corp (NASDAQ:HSGX), lost -7.42% to $3.88.
Histogenics Corporation, declared 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 partnership with Intrexon, and explore opportunities to enhance and expand our pipeline,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “We are disdesignated that the trial will take longer to enroll than initially predictable, 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 aims.”
Third Quarter 2015 and Recent Highlights
- Histogenics has enrolled a total of 103 patients in its NeoCart Phase 3 trial and now anticipates to complete enrollment by the end of the second quarter of 2017. Histogenics accomplished in the second and third quarters several enrollment optimization initiatives, which comprised a change in patient recruiting efforts in addition to changes to the site initiation process. These efforts are startning to positively impact enrollment. In addition, Histogenics continues to change the mix of sites with a aim 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 accomplished 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, counting the scaffold component and surgical adhesive for NeoCart, pending approval by the United States Food and Drug Administration.
- Histogenics and Intrexon Corporation (Intrexon), Histogenics’ partnershippartner 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 in addition to the clinical trials, and Histogenics looks forward to exploring further opportunities to expand its future pipeline.
- Histogenics has initiated negotiations around various business development opportunities counting collaborations around the commercial rights to NeoCart outside of the United States, counting recent negotiations 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 startning 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 administration mindset in close cooperation with study coordinators,” concluded Dr. Matthews.
Histogenics Corporation develops and commercializes regenerative medicine products in the musculoskeletal segment of the marketplace. Its product candidate comprises NeoCart, which is in Phase III clinical trials, a first-line therapy for full thickness knee chondral lesions in skeletally mature adults age 18 to 55.
Shares of Ardelyx Inc (NASDAQ:ARDX), inclined 5.80% to $19.15, during its current trading session.
Ardelyx, declared financial results for the third quarter ended September 30, 2015. The Company also recently declared that two clinical trials were initiated in October 2015: a Phase 3 clinical trial evaluating tenapanor for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and a clinical study evaluating the pharmacodynamic activity of RDX022, a potassium binder for the treatment of hyperkalemia. Additionally, the Company indicated that it plans to initiate a Phase 2b study to evaluate tenapanor in CKD patients with hyperphosphatemia on dialysis in December 2015. Results from this study are presently predictable in the second half of 2016.
“We have made a tremendous amount of progress in our key clinical programs over the last few months and are on pace to surpass our formerly declared timelines for tenapanor and RDX022,” Mike Raab, President and CEO of Ardelyx remarked. “We are happy to declare that we commenced the first Phase 3 clinical study of tenapanor in IBS-C in October and we now expect to commence the second Phase 3 clinical study in December, rather than in the first quarter of 2016. A pharmacodynamic study is also now underway to evaluate our novel potassium binder, RDX022. While we formerly anticipated that we would obtain results in the first half of 2016, due to the rapid progress of the study we can now confirm that we expect results in January 2016. We are happy with the team’s productivity and look forward to ending the year with several mid to late-stage programs advancing in the clinic.”
Ardelyx, Inc. discovers, develops, and commercializes minimally-systemic small molecule therapeutics for the gastrointestinal (GI) tract to treat cardio-renal, GI, and metabolic diseases. Its lead product candidate is tenapanor, a small molecule NHE3 inhibitor, which has accomplished Phase 2b clinical trial for the treatment of patients with constipation-predominant irritable bowel syndrome and hyperphosphatemic patients with chronic kidney disease on dialysis, in addition to Phase 2a clinical trial in patients with late-stage chronic kidney disease.
Finally, Shares of SMART Technologies Inc (NASDAQ:SMT), lost -2.53%, and is now trading at $0.390.
Sierra Metals Inc., stated revenue of $28.4 million and an adjusted EBITDA of $2.0 million on throughput of 452,082 tonnes and 2.4 million silver equivalent ounces or 16.2 million copper equivalent pounds for Q3 2015. The Company continues to be a low cost producer, maintaining its low operating costs again this quarter.
The company is presently undergoing operational improvements to improvement safety, development and productivity at its Yauricocha Mine in an effort to improvement production in the coming years. The Mine is undergoing various training programs using modern drifting techniques such as blast-control, ground support practices in addition to the use of remote control Load Haul Dump equipment. These improvements, while causing some reduced production in the near-term, will enable the Company to benefit from improved safety practices and future production improvements.
“The company has been working to implement best practices and transition to modern technologies, equipment and methodologies which shall serve to improvement production in the coming years”, commented Mark Brennan , President and CEO of Sierra Metals. “Despite lower production in the short-term at Yauricocha we are happy the company has still maintained a solid quarter of production overall.” He continued, “Sierra continues to be a low cost producer with a strong balance sheet and we remain on track to fall within our 2015 production guidance. The quality of our assets, being run by our practiced teams, will enable Sierra to continue on its growth path going forward.”
SMART Technologies Inc. designs, develops, and sells interactive technology products and integrated solutions worldwide. Its SMART solutions comprise interactive large-format displays, partnershipsoftware, and services that enable interactive, engaging, and productive teaching, learning, and work experiences in schools and workplaces.