Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft

Kuros Biosciences AG / Key word(s): Quarter Results

27-Apr-2022 / 08:07 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

• Medical devices  Q1 2022 sales accelerate, rising 102% over Q1 2021
• FDA cleared MagnetOs Granules for expanded indications in spine and MagnetOs Flex Matrix as bone void filler in posterolateral spine
• Promising first-in-human data from Phase II trial of Fibrin-PTH (KUR-113) in tibial fractures
• Milestone payment of $5 million to be received from Checkmate Pharmaceuticals

Schlieren (Zurich), Switzerland, April 27, 2022 - Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. 

Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared MagnetOs Granules for expanded indications in the spine, making it only the second-ever bone graft to achieve clearance for standalone use in the spine based on human clinical data, and MagnetOs Flex Matrix as a bone void filler for use in the posterolateral spine.

Kuros also published first-in-human data from a Phase II trial of Fibrin-PTH (KUR-113) in open tibial shaft fractures in The Journal of Bone and Joint Surgery, suggesting it has the potential to significantly improve treatment options.

Furthermore Kuros stands to receive a milestone payment of $5 million from Checkmate Pharmaceuticals related to one of Kuros' assets outside of the bone graft field upon closing of Checkmate's acquisition by Regeneron. Kuros will pay $2.5 million of the milestone payment to XOMA Corporation under a royalty purchase agreement.

Joost de Bruijn, Chief Executive Officer of Kuros, said: 'Kuros made strong progress in the first quarter of 2022 with an impressive increase in U.S. sales of our MagnetOs bone graft and clearences by the FDA for one new product and one new indication in the MagnetOs family. We also reported promising clinical data on Fibrin-PTH, which represents a significant commercial opportunity. We look forward to continuing to deliver on our plans through the rest of 2022, as we seek to ease the burden of spine-related pain through superior biologics.'

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About MagnetOs

MagnetOs isn't like other bone grafts. It grows bone even in soft tissue thanks to its unique NeedleGrip surface technology which provides traction for our body's vitally important 'pro-healing' immune cells (M2 macrophages). This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more efficient and predictable fusion. *†‡1-3

About Fibrin-PTH (KUR-113)

The latest candidate in our pipeline is based on proprietary controlled-release technology that combines the well-established mechanism of the bone growth factor parathyroid hormone (PTH) with the natural healing matrix, fibrin. Once implanted, the released PTH promotes spinal fusion by increasing the number and lifespan of bone-forming (osteogenic) cells in the fusion space. Fibrin-PTH is the first ever investigational drug-biologic candidate to be evaluated for spinal fusion; and the first to be compatible with narrow gauge cannulas for truly non-invasive surgical procedures. Fibrin-PTH is undergoing a Phase 2 clinical trial in the US as part of a de-risked pre-market clinical program. §

Investigational Product Candidates

Fibrin PTH (KUR-113) is an investigational drug/biologic combination product candidate and is not approved by FDA for the indications mentioned in this release. The safety & efficacy of Fibrin PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.

About Kuros Biosciences

Kuros Biosciences is a fast-growing leader in the development of spinal fusion biologics that ease the burden of back pain. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange.  The company's first commercial product, MagnetOs, is a unique synthetic bone graft that has already been used successfully across three continents and in over 5,000 spinal fusion surgeries. The next candidate in the Kuros pipeline is Fibrin-PTH - the first drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the US. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words 'will' or 'expect' or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

1. Van Dijk, et al. eCM. 2021;41:756-73

2. Duan, et al. eCM. 2019;37:60-73.

3. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276-E287.

*Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com.

†MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.

‡MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.

§Fibrin-PTH (KUR-113) is an investigational drug-biologic combination product candidate. Fibrin-PTH (KUR-113) has been evaluated in animals for use in lumbar interbody fusion. The safety & efficacy of Fibrin-PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.