ZURICH, Switzerland, Aug. 12, 2020 (GLOBE NEWSWIRE) — Kuros Biosciences, a leader in next generation bone graft technologies, today reported its results for the first half year 2020. Despite the adverse impact of COVID-19 on elective surgery, Kuros accelerated sales of its lead product MagnetOs, which increased by 42% compared to the same period last year. In addition, the clinical development of Fibrin-PTH (KUR-113) continued apace, with several sites initiated in the STRUCTURE Phase II clinical study and ready to begin enrolling patients.
Joost de Bruijn, Chief Executive Officer, said: “In the first half of 2020, we achieved impressive growth in product sales, despite COVID-19 related disruptions to elective surgery in this period. This is an important step towards establishing our MagnetOs bone grafts as standard of care. Based on feedback from leading spine surgeons, we are confident that MagnetOs is best-in-class and has the potential to capture substantial revenue in the $2.2 billion bone grafting market.”
De Bruijn added: “We continue to advance the Fibrin-PTH program in spinal fusion. Three sites are already activated for the Phase II trial for single level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease and the first patient is expected imminently. This program is particularly exciting as it represents a substantial commercial opportunity. Growing global awareness and interest in Fibrin-PTH is evident as the lead investigator of our STRUCTURE clinical trial, Dr. J Chi, recently opened the Korean American Spine Society meeting with a presentation on Fibrin-PTH.”
Developments in H1
In the first half of 2020, Kuros has added to the body of data supporting the use of MagnetOs as an alternative to gold standard treatment autograft. These included data from a clinically relevant model comparing MagnetOs with autologous bone, Vitoss® BA2X (Stryker Corp.) and Novabone Putty® (Novabone Products, LLC) in instrumented posterolateral spinal fusion in sheep. The study concluded that MagnetOs is an appropriate alternative to autograft when used as a standalone graft and was significantly better at achieving uniform, solid and stable fusions than the comparator products.
Kuros has also received powerful results of a U.S. investigator-led retrospective chart review of 25 cervical and 52 lumbar reconstruction patients, who underwent circumferential- or anterior column only interbody reconstruction surgery with MagnetOs to achieve solid spinal arthrodesis. Lumbar fusion rates were 94/97 levels (96.9%) while cervical fusion was confirmed in 75/80 (93.8%) levels. Modified Prolo scores showed Meaningful Clinically Important Differences (MCID) in 74/77 patients.
Kornelis Poelstra, MD, PhD, of The Robotic Spine Institute of Silicon Valley and principal investigator of the study, said: “Our work clearly demonstrates that for patients in need of complex cervical or lumbar reconstruction surgery, MagnetOs is a viable substitute to autograft for reliable augmentation of interbody arthrodesis formation with excellent clinical outcomes.”
In 2020 H1, Kuros also strengthened its patent portfolio with a U.S. patent covering the use of PTH containing matrices for spinal fusion, further extending the remaining patent life.
Cash and cash equivalents (including trade and other receivables) amounted to CHF 16.0 million as per June 30, 2020, compared with CHF 21.9 million as per December 31, 2019.
- Net operating costs amounted to CHF 7.5 million (first half 2019: CHF 6.1 million).
- Costs for research and development which includes costs for the preparation of the Phase II study (spine indication) of Fibrin PTH decreased to CHF 3.1 million (first half 2019: CHF 3.4 million).
- General and administrative costs increased to CHF 2.4 million (first half 2019: CHF 2.0 million) as 2019 was impacted by a non-cash settlement gain from the pension fund due to personnel reduction.
- Sales and marketing expenses increased to CHF 2.1 million (first half 2019: CHF 0.9 million). These were previously included in General and Administrative costs and are now reported separately. The increase is mainly due to an increase in headcount of sales personnel in the US and expanded marketing efforts for MagnetOs.
- Revenues amounted to CHF 1.3 million (first half 2019: CHF 0.9 million) and originated from product sales. Other income amounted to CHF 0.1 million (first half 2019 CHF 0.2 million).
- The net loss for the six months ended June 30, 2020 amounted to CHF 5.8 million (first half 2019: CHF 5.2 million).