Kuros Biosciences Announces Results from Two Prospective Randomized Clinical
Trials: STRUCTURE and MAXA

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   Kuros Biosciences AG / Key word(s): Study/Study results
   Kuros Biosciences Announces Results from Two Prospective
   Randomized Clinical Trials: STRUCTURE and MAXA
   27-Dec-2023 / 07:00 CET/CEST
   Release of an ad hoc announcement pursuant to Art. 53 LR
   The issuer is solely responsible for the content of this
   announcement.
     ____________________________________________________________

   
     * In the MAXA trial, standalone MagnetOs outperformed the gold
       standard autograft by 73% in posterior spinal fusion in a
       difficult-to-treat real life patient population (20%
       smokers). In the STRUCTURE trial, MagnetOs mixed with
       autograft showed posterolateral fusion rates comparable to
       autograft fusion rates in the less challenging interbody
       space
     * In the STRUCTURE trial, according to an interim analysis,
       Fibrin-PTH did not outperform autograft for interbody fusion,
       although patients showed excellent clinical outcomes
     * Considering the outstanding clinical results of MagnetOs in
       the MAXA and STRUCTURE trials, and the recent FDA interbody
       clearance, Kuros has decided not to proceed to Phase 3 with
       Fibrin-PTH and focus its resources on MagnetOs
     * Focusing on the MagnetOs program will result in lower
       development costs and lower expenses in the near-term,
       extending Kuros' cash runway, while still addressing a $2.4Bn
       annual bone graft market similar to that originally
       anticipated for both MagnetOs and Fibrin-PTH together

   Schlieren (Zurich), Switzerland, December 27, 2023 - Kuros
   Biosciences, a leader in next generation bone graft technologies,
   today announced results from two prospective, randomized clinical
   studies - the STRUCTURE and MAXA trials. In the MAXA trial,
   MagnetOs showed a 73% higher fusion rate relative to autograft in
   the challenging posterolateral space.  In the STRUCTURE trial,
   Fibrin-PTH, while demonstrating excellent clinical outcomes,
   showed fusion rates comparable to autograft in the less
   challenging interbody space.  As a result, Kuros will focus its
   resources to amplify the continued commercialization of its
   MagnetOs bone graft family of products.

   The MAXA trial is an observer-blinded, randomized, intra-patient
   controlled, multi-center clinical trial which compared MagnetOs
   standalone to autograft for posterolateral fusion. The STRUCTURE
   trial is investigating the safety and efficacy of Fibrin-PTH
   (KUR-113) in single-level transforaminal lumbar interbody fusion
   (TLIF) procedures, compared to local autograft in the interbody
   space. Both treatment groups underwent concomitant posterolateral
   fusion with MagnetOs mixed with local autograft.

MAXA Study Results

   The MAXA study is designed as a 100-patient, multi-center,
   observer-blinded, randomized, controlled, non-inferiority trial
   with intrapatient comparisons. This study compared MagnetOs
   standalone to autograft for posterolateral fusion. Patients
   requiring up to four-level instrumented posterolateral fusion
   (T10 - S2) were included, and lumbar/thoracolumbar fusion was
   assessed by CT-scan 12 months after surgery. Patients were
   randomized to have either MagnetOs or the gold standard autograft
   (at least 50% bone harvested from the iliac crest of the greater
   pelvis) implanted on one side of the spine.

   In the study, MagnetOs showed a 73% higher fusion rate relative
   to autograft in the challenging posterolateral space. MagnetOs
   outperformed autograft in a difficult-to-treat, real-life patient
   population, containing 20% smokers.

   Considering the very strong MagnetOs data and in order to most
   effectively allocate the Company's capital, Kuros Biosciences has
   decided not to proceed to Phase 3 with Fibrin-PTH and focus on
   continuing investment in its MagnetOs program and related
   initiatives for commercial advancement, while still addressing a
   USD 2.4 billion bone graft market similar to that originally
   anticipated for both MagnetOs and PTH together. This decision
   will result in lower development costs and lower expenses,
   extending the Company's cash runway in the near term. The Company
   expects to provide further financial guidance when presenting its
   financial statements for 2023.

   Chris Fair, Chief Executive Officer of Kuros, said: "We are
   encouraged by the excellent results obtained with MagnetOs in
   both trials, and this, coupled with a recent interbody FDA
   clearance of MagnetOs, means that we now have level one clinical
   evidence of a best-in-class product to treat even
   difficult-to-heal patients. As a result, we have made the
   decision not proceed to Phase 3 with Fibrin-PTH and focus our
   investment and resources on the MagnetOs bone graft family of
   products. We are fortunate to have growing robust sales from
   MagnetOs to readily support our ongoing commercial and clinical
   operations."

Interim STRUCTURE Study Results

   Interim analysis of the randomized part of the STRUCTURE study
   showed a good safety profile in both experimental groups, one
   treated with Fibrin-PTH (KUR-113) in single-level transforaminal
   lumbar interbody fusion (TLIF), and one treated with local
   autograft in the interbody space. Observed adverse events were
   those typical for spinal fusion surgeries. There were no
   Fibrin-PTH-related serious adverse events. Both study groups did
   well in terms of clinical parameters. The Oswestry disability
   score (ODI) was improved by 44 points in the Fibrin-PTH group and
   by 40 points in the autograft control group. Likewise, visual
   analog scale (VAS) scores improved by 50 points for the
   Fibrin-PTH group and by 36 points for the autograft control
   group. In this limited population of patients, the interbody
   fusion outcome with Fibrin-PTH did not outperform the autograft
   control group. MagnetOs mixed with autograft, which was used in
   both study groups for the more challenging to fuse posterior
   fusion, showed fusion outcomes that were comparable to the
   autograft group in the interbody space.

About the MAXA Trial

   The MAXA study is a 100-patient multicenter, observer blinded,
   randomized, intra-patient controlled, non-inferiority trial with
   intra-patient comparisons. Adult patients qualifying for
   instrumented posterolateral spinal fusion of one to six levels in
   the thoracolumbar and lumbosacral region (T10-S2) with the use of
   autograft were included and posterolateral lumbar/thoracolumbar
   fusion was assessed by CT-scan 12 months after surgery. According
   to a randomization scheme, MagnetOs was implanted on one side of
   the spine and the gold standard autograft (at least 50% bone
   harvested from the iliac crest mixed with local bone) was
   implanted on the other side of the spine. Thereby, each patient
   serves as its own control. More details can be found at
   www.clinicaltrials.gov (NCT03625544).

About the STRUCTURE Phase 2 Clinical Trial

   The STRUCTURE trial is investigating the safety and efficacy of
   Fibrin-PTH (KUR-113) in single-level transforaminal lumbar
   interbody fusion (TLIF) procedures with concomitant
   posterolateral fusion (PLF) in patients with degenerative disc
   disease (DDD). It is a dose-finding, multi-center, two-part
   trial, divided into a single-blind (randomized) first stage and
   an open-label (non-randomized) second stage. In the single-blind
   stage, 20 patients were randomized to Fibrin-PTH (0.4 mg
   TGplPTH1-34/mL Fibrin) and 10 patients to the gold standard local
   autograft which serves as a control. In the open-label stage, 20
   patients received Fibrin-PTH at a higher concentration of
   TGplPTH1-34 (0.7 mg TGplPTH1-34/mL Fibrin). For the
   posterolateral fusion both experimental groups were treated with
   MagnetOs mixed with autograft. The primary endpoint of the trial
   is radiographic interbody fusion (defined by evidence of bridging
   trabeculae or continuous bony connection between superior and
   inferior vertebrae) using CT scans at 12 months, as determined by
   an independent radiology expert panel. In addition, clinical and
   safety parameters are being assessed. This study intends to
   demonstrate the safety and efficacy of Fibrin-PTH (KUR-113)
   www.clinicaltrials.gov (NCT04294004). The STRUCTURE clinical
   trial is not statistically powered to detect non-inferiority.

   For further information, please contact:
   Kuros Biosciences AG
   Daniel Geiger
   Chief Financial Officer
   t: +41 44 733 47 47
   e: daniel.geiger@kurosbio.com LifeSci Advisors
   Sandya von der Weid
   Investor Relations
   t: +41 78 680 0538
   e: svonderweid@lifesciadvisors.com

   About MagnetOs
   MagnetOs is a bone graft like no other: thanks to its
   NeedleGripTM surface technology, it grows bone even in soft
   tissues.* This surface technology 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.^§3-6  The growing body of science behind NeedleGripTM
   is called osteoimmunology. But for surgeons and their patients we
   seek a more predictable fusion. ^¶5,6

   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 Netherlands, Switzerland and the United States,
   the company is listed on the SIX Swiss Exchange. The company's
   main commercial product, MagnetOs, is a unique synthetic bone
   graft that has already been used successfully across three
   continents and in over 15,000 fusion surgeries. 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. Duan, et al. eCM. 2019;37:60-73
   2. Van Dijk, et al. eCM. 2021;41:756-73
   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
   6. Data on file

*In large animal models

   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

§For a 510(k)-cleared synthetic bone graft.

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

____________________________________________________________

   End of Inside Information
     ____________________________________________________________

   Language:    English
   Company:     Kuros Biosciences AG
                Wagistrasse 25
                8952 Schlieren
                Switzerland
   Phone:       +41 44 733 4747
   Fax:         +41 44 733 4740
   E-mail:      info@kurosbio.com
   Internet:    www.kurosbio.com
   ISIN:        CH0325814116
   Valor:       32581411
   Listed:      SIX Swiss Exchange
   EQS News ID: 1803939

   End of Announcement EQS News Service
     ____________________________________________________________

1803939 27-Dec-2023 CET/CEST