Press Release, 9 August 2022

Financial highlights

• CHF 29.4 million cash & cash equivalents, trade and other receivables as of June 30, 2022
• Product sales increased by 58% to CHF 5.7 million
   

Operational highlights

• FDA cleared MagnetOs Granules for use in expanded spinal indications
• FDA cleared MagnetOs Flex Matrix for spinal indications
• MagnetOs Easypack Putty launched in the US in May 2022
• Favorable preliminary results of MagnetOs as standalone alternative to autograft in first randomized controlled trial
• USD 5 million milestone recognized by Kuros, trigged by acquisition of Checkmate Pharmaceuticals by Regeneron Pharmaceuticals

Schlieren (Zurich), Switzerland, August 9, 2022 – Kuros Biosciences AG (“Kuros” or the “Company”), a leader in next generation bone graft technologies, reported a 58% increase in sales in the first six months of 2022 and continued to enroll patients in the Phase II spine study for Fibrin-PTH, confirming its successful transition into a fully-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration.

Joost de Bruijn, Chief Executive Officer, said: “The Kuros team has again delivered an outstanding performance, making significant progress at all fronts in the first half of 2022. The impressive sales growth of MagnetOs confirms our transformation into a commercial company and our clinical programs are progressing well. Our cash position has also been bolstered by a USD 5 million milestone as a result of Checkmate Pharmaceuticals’ acquisition by Regeneron Pharmaceuticals, with a further potential additional income of USD 164 million.”

Financial position

Cash and cash equivalents (including trade and other receivables) as of June 30, 2022, amounted to CHF 29.4 million, compared to CHF 30.7 million as of December 31, 2021.

The company’s revenues amounted to CHF 10.4 million (2021: CHF 9.1 million), originating from product sales and collaborations.

Operating costs increased to CHF 10.9 million (2021: CHF 8.6 million) primarily due to increased marketing and sales costs of CHF 5.4 million (2021: CHF 3.5 million), including personnel and other marketing costs. Research and development costs amounted to CHF 2.5 million (2020: CHF 2.5 million), and primarily included costs for the ongoing clinical Phase II trial of Fibrin-PTH and personnel. Other income amounted to CHF 0.1 million (2021: CHF 0.1 million) and mainly consisted of patent recharges to Checkmate.

The net loss for the first half of 2022 amounted to CHF 3.7 million, compared to CHF 0.1 million for the first half of 2021.

Events after the reporting period

None

Outlook

Kuros’ products are advancing according to plan, with MagnetOs generating sales in the US and in Europe and expected to become cashflow positive early 2023. Kuros is financed to accelerate the commercial roll-out of MagnetOs in the US  and to complete the Phase II clinical study of Fibrin-PTH in spine, with the first data expected to be available by mid-2023.

The interim report 2022 is available on our corporate website under the following link:

https://kurosbio.com/resources/kuros-interim-results-2022/

About MagnetOs

MagnetOs isn’t like other bone grafts. It grows bone even in soft tissue thanks to our unique NeedleGrip surface technology which provides traction for our body’s vitally important ‘pro-healing’ immune cells (M2 macrophages).*†1,2 This in turn, unlocks previously untapped potential to stimulate stem cells – and form new bone throughout the graft.*3-5 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.*‡5

Indications statement

Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.

About  Fibrin-PTH

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 known as 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.

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 10,000 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.

References: 1. Van Dijk, et al. eCM. 2021;41:756-73. 2. Duan, et al. eCM. 2019;37:60-73. 3. Van Dijk, et al. JOR Spine. 2018;e1039. 4. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater. 2019;107(6):2080-2090. 5. 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.