02 May 18
Kuros Biosciences receives European clearance for MagnetOs Putty and prepares for commercial roll-out in the U.S. and Europe
Kuros Biosciences announced today that it has received the CE Mark for MagnetOs Putty indicated for use as an osteoconductive and osteoinductive bone void filler in the skeletal system (i.e. spine, extremities, pelvis, cranium, mandible and maxilla). This market clearance allows commercialization of MagnetOs Putty in Europe, and complements the existing clearance for MagnetOs Granules, and the 510K clearance for both formulations from the U.S. Food and Drug Administration as an autograft extender in the posterolateral spine. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to autograft (patient’s own bone), the current gold standard.
30 Apr 18
Kuros Biosciences Reports Full-Year 2017 Results
Kuros Biosciences reported today its Full-Year 2017 Results, and the publication of its annual report. Financial highlights CHF 17.0 million cash at year-end . CHF 16.9 million equity raise in June 2017 . Standby equity facility established in November 2017 to increase financial flexibility . Operational highlights Successful completion of merger with Xpand Biotechnology creating a leader in orthobiologics. FDA approvals for MagnetOs Granules & Putty. Prepared for U.S. launch of MagnetOs by end of June 2018. Clinical development of Fibrin-PTH for spinal fusion on track.
12 Mar 18
Kuros Biosciences obtains European patent covering osteoinductive materials
Kuros announced today that its Dutch subsidiary, Kuros Biosciences BV, has been granted the European patent, EP3021878, entitled “Method for producing an osteoinductive calcium phosphate and products thus obtained” by the European Patent Office (EPO).
08 Jan 18
Kuros Biosciences Expands License Agreement with Checkmate
Kuros (SIX: KURN) announced today that it has amended its exclusive license agreement, which was originally signed in 2015, that grants Checkmate Pharmaceuticals Inc., Cambridge, MA, USA (“Checkmate”) access to Kuros’ clinically validated product candidate CYT003 as well as its VLP platform and to technology related to oligonucleotide synthesis.
14 Dec 17
Kuros Biosciences Announces Management Succession
Kuros announced today the appointment of Michael Grau as Chief Financial Officer (CFO) effective February 1, 2018. Michael Grau succeeds Harry Welten, who will step down as CFO on February 1, 2018 to focus on his board roles and part-time CFO functions in privately held companies. Harry Welten will remain on the Board of Directors of Kuros.
28 Nov 17
Kuros Biosciences’ Chief Medical Officer to Retire
Kuros announced today that its Chief Medical Officer, Dr. Virginia Jamieson, has reached retirement age and will retire from full-time employment with effect as of May 31, 2018. Her succession will be announced in due course.
22 Nov 17
Kuros Biosciences May Secure Equity Financing of up to CHF 30 million
Kuros (SIX: KURN) announced today it has entered into a Standby Equity Distribution Agreement (“SEDA”) with a fund managed by Yorkville Advisors Global, LLC (“Yorkville”). Under the terms of the agreement, Yorkville has committed to provide up to CHF 30 million in equity financing over a 36-month period in individual tranches of up to CHF 1,000,000 each. In exchange for the funds to be provided, Yorkville will receive Kuros shares at a price, which will be determined anew each time a SEDA tranche is called. The shares will be placed at a 5% discount to the market price – which is in line with Swiss market practice for private placements.
16 Nov 17
Kuros announces management changes
Kuros Biosciences AG announced today the promotion of Dr. Joost de Bruijn to Chief Executive Officer (CEO), effective December 4, 2017. Dr. de Bruijn is co-founder and current managing director of Kuros Biosciences BV (formerly known as Xpand Biotechnology BV), a wholly owned subsidiary of Kuros. Dr. Ivan Cohen-Tanugi has decided to step down as CEO and member of the Board of Directors. Further, Kuros’ founding CEO and current President, Didier Cowling, will retire from the Executive Management team to serve as a senior advisor to the CEO and continue to serve as a Director on the company’s Board.
26 Sep 17
Kuros Biosciences Reports Financial Results for First Half-Year of 2017
Kuros, an orthobiologic company with several commercial-stage products, today announced the financial figures for the first six months of 2017. The Company reported significantly lower net operating costs of CHF 7.5 million and a substantial reduction of net loss of CHF 7.0 million (first half-year 2016: CHF 13.3 million) mainly due to the absence of non-recurring, non-cash charges. Cash reserves by mid-year 2017 amounted to CHF 21.4 million. Summary of progress since the beginning of the year: • All-share strategic acquisition of Xpand accelerates Kuros’ transition to commercial stage and provides an EU hub for future distribution, pre-clinical and manufacturing operations. • Newly appointed CEO Dr. Ivan Cohen-Tanugi prepares Kuros for late-stage clinical development of Fibrin-PTH candidates and for product launches and commercialization in the United States of America and the European Economic Area. • MagnetOs received clearance for commercialization in the Unites States as well as in Europe, while Neuroseal received clearance in Europe. • Portfolio extension into new formulations and indications is well underway with MagnetOs Putty receiving market clearance in the United States and filing the product for CE marking in Europe. • Successful placement of new shares strengthens Kuros’ equity base to fund future commercial activities and Fibrin-PTH development programs.
28 Aug 17
Kuros receives clearance for MagnetOs Putty for commercialization in the United States and files the product for CE marking in Europe
Kuros Biosciences announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for MagnetOs Putty indicated for use as an autograft extender in posterolateral spine. This market clearance allows commercialization of MagnetOs Putty in the United States and complements the existing clearance for MagnetOs Granules, which was granted by the FDA in February 2017. In addition, Kuros has filed MagnetOs Putty for CE mark certification in Europe. MagnetOs is a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to current gold standard autograft.
31 Jul 17
Kuros Biosciences announces full exercise of over-allotment option
Kuros Biosciences today announced that the over-allotment option granted to Zürcher Kantonalbank in connection with the capital increase has been exercised in full on July 28, 2017. Including the 200,000 shares placed in connection with the over-allotment option, Kuros has sold a total of 1,351,606 registered shares in the rights and share offering.
29 Jun 17
Kuros Biosciences strengthens equity base with placement of new shares
Kuros Biosciences (SIX:KURN) today announced that it sold 1,151,606 new shares (excluding an over-allotment option of up to 200,000 shares) to existing and new investors at a price of CHF 12.50 per share. In total, Kuros raised gross proceeds of CHF 14.4 million (or CHF 16.9 million if the over-allotment option will be exercised in full). The new funds will fund Kuros’ commercial activities, in particular the market launch of novel products MagnetOS and Neuroseal as well as certain important activities for the ongoing Fibrin-PTH development programs.
21 Jun 17
Kuros receives CE certification for Neuroseal ® , a novel dural sealant
Kuros Biosciences (SIX:KURN) announced today that it has received CE certification for its novel dural sealant, Neuroseal ®. The CE certification allows for the commercialization of the product anywhere in the European Economic Area. As part of the supporting evidence, Neuroseal ® has been tested clinically and demonstrated effective sealing. Furthermore, Neuroseal ® is specifically designed for ease of preparation, use and handling thereby reducing the risk of adverse effects which may result in longer hospitalizations and an increase in healthcare costs. With this approval and together with MagnetOs TM , Kuros has now two products ready to be commercialized in Europe.
19 Jun 17
Kuros Biosciences launches rights and share offering
Kuros Biosciences (SIX:KURN) today announced that the Board of Directors determined the final structure and terms of its share placement. The Board decided to offer up to 1,612,330 shares within a price range of CHF 12.50 to CHF 15.50 per share. The gross proceeds, net of certain costs and expenses associated with the placement, will be used to prepare the commercialization of Kuros’ lead products MagnetOS and Neuroseal.
06 Jun 17
Kuros Biosciences submits MagnetOs Putty for US FDA Clearance
Kuros (SIX:KURN) today announced it has filed the submission package for MagnetOs Putty seeking 510(k) clearance from the US Food and Drug Administration (FDA) for use as an autograft extender in posterolateral spine. MagnetOs is a novel synthetic bone graft substitute designed to support bone healing in the implanted site in the body. MagnetOs Putty is a moldable putty formulation of MagnetOs Granules, which is already cleared for commercialization in the United States of America and the European Union.
23 May 17
General Meeting of Kuros Biosciences approves all resolutions
Kuros Biosciences announced that yesterday's General Meeting approved all resolutions proposed by the Board of Directors with a vast majority. In particular, shareholders resolved on an increase of the conditional and authorized capital. Prof. Dr. Clemens van Blitterswijk, Frank-Jan van der Velden, Giacomo Di Nepi and Dr. Ivan Cohen-Tanugi were elected as new members of the Board of Directors. A total of 36.1 % of shares were represented at the General Meeting.
16 May 17
Kuros prepares for commercialization of its lead products and considers share placement
Kuros Biosciences, a late-stage life sciences company focusing primarily on innovative orthobiologics, today announced that it is preparing the commercialization of its first two products: MagnetOs, an innovative synthetic bone graft substitute recently approved in the US and Europe, and Neuroseal, a novel dural sealant expected to be approved in Europe in 2017. In order to maximize the commercial opportunity of these products, Kuros is evaluating options to raise additional funds including a potential placement of new shares.
28 Apr 17
Kuros Biosciences Proposes Election of Four New Board Members
Kuros Biosciences Ltd (“Kuros”) today announced that the Board of Directors (“Board”) proposes to the upcoming General Meeting the election of Professor Clemens van Blitterswijk, Frank-Jan van der Velden, Giacomo Di Nepi and Dr. Ivan Cohen-Tanugi as new members of the Board. The General Meeting will take place in Schlieren on May 22, 2017.
26 Apr 17
Kuros Biosciences Reports Financial Results for 2016
• Merger successfully completed: Cytos Biotechnology and Kuros Biosurgery Holding combined their businesses to create Kuros Biosciences, a future leader in tissue repair and regeneration • Transition to commercial-stage accelerated: Acquisition of Xpand in January 2017 results in orthobiologics company with commercial-ready products in the European Union (EU) and in the United States of America (US) • Shift towards commercialization realized: Kuros names commercialization veteran Dr. Ivan Cohen-Tanugi new CEO; MagnetOs TM Granules is approved in the EU and the US and Neuroseal (KUR-023) is awaiting CE mark certification. • Financials influenced by IFRS3 accounting: For accounting purposes, the financial figures for 2016 of the combined company are not comparable to the published figures of former Cytos for 2015. Kuros Biosciences ("Kuros" announced today the full-year financial results after the merger of Cytos Biotechnology and Kuros Biosurgery. Two one-time non-cash-relevant expense items totaling CHF 12.4 million and the significant expansion of development activities with an associated higher staff number resulted in a net loss of CHF 19.7 Mio. Cash reserves at year-end amounted to CHF 12.4 million and the gross cash burn for operating activities was a monthly average of CHF 0.7 million in 2016. Further, headcount increased to 17 people as per year-end 2016. For accounting purposes in accordance to IFRS 3, the legal acquiree was identified as the acquiring entity. As a consequence, the financial figures for 2016 of the merged company are a continuation of those of Kuros Biosurgery Holding and not comparable to the published figures of former Cytos for 2015.
13 Apr 17
Kuros announces CEO succession
- Commercialization veteran and life science executive Dr. Ivan Cohen-Tanugi named Chief Executive Officer of Kuros - Didier Cowling will serve as President on the Executive Committee and remain on the Board of Directors Kuros Biosciences Ltd announced today that Dr. Ivan Cohen-Tanugi has been appointed Chief Executive Officer with effect as of April 13, 2017. Dr. Cohen-Tanugi will be proposed for election to the Board of Directors at the next General Meeting. He succeeds Didier Cowling, who continues to serve the Company as President and remains a member of the Executive Committee and the Board.
27 Feb 17
Kuros receives clearance from the US FDA for MagnetOs allowing marketing in the United States
Kuros Biosciences (SIX: KURN) announces today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for MagnetOs Granules. FDA’s approval clearance allows marketing in the United States indicated for use as an autograft extender in posterolateral spine. MagnetOs is a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body. Numerous studies have shown that MagnetOs leads to progressive bone formation comparable to current gold standard autograft. The FDA 510(k) clearance follows CE mark certification in Europe in 2016 allowing MagnetOs to be marketed now both in the US and the EU.
08 Feb 17
Kuros achieves ISO certification for surgical sealants
Kuros Biosciences (SIX:KURN) announced today that the Company has been certified as European Normative (EN) ISO 13485:2012 compliant for the design, development, manufacturing and distribution of implantable polymeric sealants for surgical application. Receiving ISO certification is an important achievement towards obtaining a CE mark approval, for which Kuros submitted Neuroseal, a novel dural sealant device, in December 2016.
25 Jan 17
Kuros closes acquisition of Xpand creating a leading commercial-stage orthobiologics company
Kuros Biosciences (SIX:KURN) today announced the closing of the all-share strategic acquisition of Xpand Biotechnology B.V. of Bilthoven, the Netherlands. The takeover accelerates Kuros’ transition to commercial stage with two products expected to be ready for commercialization in the European Union this year, one of which may also obtain US approval. In addition, the acquisition provides Kuros with a EU operation with certified and GMP-controlled manufacturing capabilities.
21 Dec 16
Kuros submits regulatory filing seeking CE certification for Neuroseal, a novel dural sealant
Kuros Biosciences AG, announced today that it has submitted its application for CE conformity assessment for Neuroseal (also known as KUR-023). This regulatory filing seeks CE certification for Neuroseal as a Class III medical device. Obtaining CE certification will enable the dural sealant to be marketed and sold within the European Union.
19 Dec 16
Kuros to acquire Xpand in an all-share strategic transaction to create a leading commercial stage orthobiologics company
Xpand’s first product MagnetOs , a novel orthobiologic, is approved for sale in the EU and has been filed for approval in the US. Xpand has operations in the Netherlands including manufacturing and an experienced management team and staff with extensive knowledge of the orthobiologics sector. Kuros’ modular submission to obtain CE mark for Neuroseal (KUR-023) is on-going with commercial launch in the European Union planned for 2017. Kuros’ existing orthobiologics product development, with two late-stage candidates, continues as planned. Kuros is now preparing for commercialization activities in 2017. Schlieren (Zurich), Switzerland, December 19, 2016 – Kuros Biosciences Ltd. (SIX:KURN) (“Kuros”) today announced the signing of a combination agreement with Xpand Biotechnology B.V. (“Xpand”) with the intention to acquire Xpand by way of an exchange of all Xpand shares for up to 2.105 million new Kuros shares, subject to customary conditions. Xpand is a privately-held company based in Bilthoven in the Netherlands. Its novel orthobiologic MagnetOs was approved for sale in the European Union in July 2016 and is under regulatory review in the US.
20 Oct 16
Kuros Biosciences’ KUR-112 Receives Rare Pediatric Disease Designation
Kuros Biosciences announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to KUR-112, an investigational product candidate for the treatment of Solitary Bone Cysts (SBC).
29 Sep 16
Kuros Biosciences Reports Financial Results for First Half-Year of 2016
• Merger successfully completed: Cytos Biotechnology and Kuros Biosurgery Holding have combined their businesses to create Kuros Biosciences, a future leader in tissue repair and regeneration. • Lead products progressing: KUR-023 is being readied for CE mark submission while development of orthobiologics assets continues apace. • Key positions filled and staff significantly expanded: Industry expert elected as new Board member, Chief Medical Officer and Chief Development Officer appointed and employees increased substantially. Kuros Biosciences today announced for the first time financial figures after the merger of Cytos Biotechnology and Kuros Biosurgery on January 18, 2016. For the first six months of 2016, the Company reported revenues of CHF 1.1 million primarily from a milestone payment. Net operating costs increased to CHF 15.1 million as a result of an i mpairment and modifications of share-based payments in connection with the merger. Net loss for the first half-year 2016 rose to CHF 13.3 million. Cash reserves at the end of the reporting period amounted to CHF 17.5 million.
30 Aug 16
Arbutus terminates license agreement for VLP platform for the treatment of hepatitis B infections
Kuros Biosciences announced today that it was informed by Arbutus Biopharma Inc. about the decision to terminate an exclusive license agreement with former Cytos Biotechnology Ltd., a predecessor company of Kuros. As a result, all licensed rights will revert back to Kuros. Under the agreement signed in early 2015, Oncore Biopharma, Inc., a predecessor of Arbutus, was granted access to Cytos’ clinically validated virus like particle (VLP) platform for the use in the treatment and prevention of hepatitis B viral infections as well as an option to use the VLP technology for additional viral diseases. No investments into the program have been made by Cytos or its successor Kuros since 2014.
10 Aug 16
Kuros appoints Philippe Saudan as Chief Development Officer
Kuros Biosciences announced today that Dr. Philippe Saudan has been appointed Chief Development Officer and member of the Executive Board with immediate effect.
28 Jun 16
valuationLAB Initiates Research Coverage on Kuros
Kuros Biosciences Ltd (“Kuros”) today announced that independent life science research boutique valuationLAB has issued its first report on Kuros. The research analyst estimates a current risk-adjusted net present value (NPV) for the Company’s late-stage development pipeline of CHF 55 per share. The valuation is based on the three most advanced programs in surgical sealants and orthobiologics. valuationLAB sees significant upside should Kuros successfully execute on its strategy to advance its other pipeline opportunities.
23 Jun 16
First Trading Day of New Kuros Share after Reverse Split
Kuros Biosciences Ltd (“Kuros”) today announced the first trading day of the new shares after a reverse split at the ratio of 100 to 1 approved by the recent Annual Shareholders’ Meeting.
16 Jun 16
Kuros Bioscience’s Shareholders Approve All Resolutions
Kuros Biosciences Ltd (“Kuros”) today announced that its shareholders approved all resolutions at the Annual Shareholders’ Meeting 2016. In particular, they vot- ed with a large majority for the proposed reverse stock split at the ratio of 100 to 1 and therefore the necessary changes of the articles of association. The reverse stock split is expected to simplify the trading and increase the shares’ attractiveness for investors. The first trading day of the new shares is expected to be June 23, 2016. The shareholders' meeting further resolved on an authorized capital increase which the Board intends to partially use for a quick and flexible raising of capital (including private placements), Shareholders also elected Leanna Caron as new member of the Board of Directors.
26 May 16
Kuros Invites to the Annual Shareholders’ Meeting 2016
Kuros Biosciences Ltd (“Kuros”) today announced that the Annual Shareholders’ Meeting 2016 will take place on Thursday, June 16, 2016 at 1 p.m. at the Company’s offices in Schlieren/Zurich (Switzerland). The Board of Directors proposes to carry out a reverse stock split at the ratio of 100 to 1 and to amend the Articles of Association accordingly.
26 Apr 16
Kuros Biosciences Reports Financial Results for 2015
Three extraordinary one-time factors lead to positive result for 2015. Debt-free balance sheet after mandatory conversion of bonds and settlement with convertible loan note holders. Two partnering agreements signed for CYT003 and the VLP technology with Checkmate for the treatment of cancer and with Arbutus for the treatment of hepatitis B infections. Business combination with Kuros Biosurgery closed in January 2016 creating future leader in tissue repair and regeneration.
20 Apr 16
Kuros receives milestone payment from Checkmate
Kuros Biosciences Ltd. (“Kuros” or the “Company”), has been informed by Checkmate Pharmaceuticals Inc., Cambridge, MA, USA (“Checkmate”) that the first melanoma patient has been dosed in a Phase 1b clinical trial with CMP-001, formerly known as CYT003. The trial is designed as a multi-center, open-label study of CMP-001 in combination with pembrolizumab for patients with advanced melanoma who have either progressed on anti-PD1 therapy or have failed to respond to at least 12 weeks of therapy.
08 Mar 16
Kuros Biosciences Ltd. appoints Chief Medical Officer
Kuros Biosciences Ltd. (“Kuros” or the “Company”), announced today that Dr. Virginia Jamieson has been appointed Chief Medical Officer and member of the Executive Board with immediate effect.
20 Jan 16
Kuros Biosurgery Holding Ltd. closes merger with Cytos Biotechnology Ltd. which is renamed Kuros Biosciences Ltd.
Kuros Biosciences Ltd. (SIX:KURN formerly CYTN) (“Kuros”) today announced the closing of the acquisition of Kuros Biosurgery Holding Ltd. and the change of name of the combined company to Kuros Biosciences Ltd. Starting 20 January 2016 all 508'432'244 Kuros Biosciences Ltd. shares are listed and freely tradable under the ticker symbol KURN on the SIX Swiss Exchange under the International Reporting Standard and include all former 108’015’276 Cytos Biotechnology AG shares, which remain listed and freely tradable under the unchanged ISIN number (CH0011025217).
08 Jan 16
Cytos Biotechnology Ltd. will be renamed Kuros Biosciences Ltd., constitutes its Board of Directors and appoints Executive Officers
Cytos Biotechnology Ltd (“Cytos” or the “Company” - to be renamed Kuros Biosciences Ltd.), announced today that the Board of Directors has constituted itself with Dr. Christian Itin stepping down as CEO but remaining as Chairman of the Board and Mr. Dominik Ellenrieder being appointed as the Vice Chairman of the Board. Further, the newly constituted Board elected Didier Cowling as Chief Executive Officer, Dr. Alistair Irvine as Chief Business Officer, Dr. Jason Schense as Chief Technology Officer and confirmed Harry Welten as the Chief Financial Officer. All appointments are effective upon closing of the acquisition of Kuros Biosurgery Holding AG which is expected to take place within the next few weeks.
06 Jan 16
Extraordinary Shareholders’ Meeting of Cytos Biotechnology Ltd. approves all resolutions
Cytos Biotechnology Ltd (“Cytos” or the “Company”), announced today that its shareholders have approved all resolutions at today’s Extraordinary Shareholders’ Meeting with overwhelming majority. These resolutions, among other things, consist of an ordinary capital increase of around 392 million shares which will be used to acquire Kuros Biosurgery Ltd. After the capital increase, a total of around 500 million Cytos shares with a nominal value of CHF 0.01 each will be issued and outstanding.