• Continuing filgotinib 200mg among induction non-responders at week 10 resulted in clinical benefits for ulcerative colitis (UC) patients in the long-term extension study (LTE)

    • Treatment with filgotinib 200mg resulted in clinically meaningful improvements in health-related quality of life (HRQoL) measures by week 58 among patients with UC

    Mechelen, Belgium; 4 October 2021, 22.01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced results of two post-hoc analyses from the SELECTION and SELECTION LTE studies, which are part of the investigational clinical program for filgotinib, for the treatment of patients with moderately to severely active UC. These analyses showed clinical benefits of continued dosing with filgotinib 200mg,

    • Continuing filgotinib 200mg among induction non-responders at week 10 resulted in clinical benefits for ulcerative colitis (UC) patients in the long-term extension study (LTE)



    • Treatment with filgotinib 200mg resulted in clinically meaningful improvements in health-related quality of life (HRQoL) measures by week 58 among patients with UC



    Mechelen, Belgium; 4 October 2021, 22.01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced results of two post-hoc analyses from the SELECTION and SELECTION LTE studies, which are part of the investigational clinical program for filgotinib, for the treatment of patients with moderately to severely active UC. These analyses showed clinical benefits of continued dosing with filgotinib 200mg, an oral once-daily JAK1 preferential inhibitor, in patients who did not respond at week 10. Separately, HRQoL benefits of filgotinib 200mg treatment versus placebo, in patients with UC were shown. These data will be presented at the UEGW virtual 2021 congress (3 – 5 October).

    In SELECTION, patients who did not respond to induction therapy at week 10 could receive open-label filgotinib in the LTE. In a post-hoc analysis, it was shown that continuing filgotinib 200mg among those non-responders resulted in 65.7% biologic-naïve and 62.2% biologic-experienced patients achieving partial Mayo Clinic Score (pMCS) response by Week 12, with 17.1% biologic-naïve and 16.7% biologic-experienced patients in pMCS remission (Presentation MP082).1

    A post-hoc analysis of HRQoL data from the SELECTION study shows that patients treated with filgotinib 200mg achieved clinically meaningful improvements in their quality of life, versus placebo. These included Inflammatory Bowel Disease Questionnaire remission and measurements of productivity, physical, and mental components, assessed by 36-item Short Form Survey (SF-36), EuroQol 5-dimension (EQ-5D) visual analogue scale and Work Productivity and Activity Impairment questionnaire (Poster PO457).2

    Dr Walid Abi-Saab, Chief Medical officer, at Galapagos said, "The SELECTION study has provided us with a wealth of data on the efficacy and safety profile of filgotinib that, if approved can potentially inform clinical treatment approaches. This includes findings on the benefits of prolonged dosing with filgotinib 200mg among induction non-responders and the achievement of treatment goals beyond clinical symptoms of UC. We know that patients with UC are impacted by this disease physically, socially and psychologically, which is why inclusion of health-related quality of life measures in our clinical trials is so important to build a holistic understanding of the management of the disease."

    These data were in two of thirteen abstracts from the company relating to filgotinib in the treatment of patients with UC. The use of filgotinib for the treatment of UC is investigational and is not approved anywhere globally.

      

    Key Filgotinib Abstracts:

    Abstract Title Lead Author Poster number and time and date
    Benefit of prolonged filgotinib dosing in patients with ulcerative colitis who did not respond to induction therapy: data from the SELECTION long-term extension study Séverine Vermeire Moderated poster presentation
    • Presentation number: MP082
    • Session: IBD: Clinical trials poster II
    • Date: Monday 4 October 2021, 13:30–14:30 CET
    Clinically meaningful improvements in health-related quality of life among patients with ulcerative colitis treated with filgotinib – a post hoc analysis of SELECTION William J Sandborn Poster presentation
    • Presentation number: P0457
    • Poster Session: IBD
    • Date: Sunday 3 – Tuesday 5 October
    A Matching-Adjusted Indirect Comparison of Maintenance Oral Filgotinib versus Intravenous Vedolizumab for Moderately to Severely Active Ulcerative Colitis Xiaoyan Lu Poster presentation
    • Presentation number: P0489
    • Poster Session: IBD
    • Date: Sunday 3 – Tuesday 5 October
    Efficacy of filgotinib in patients with ulcerative colitis by line of therapy in the phase 2b/3 SELECTION trial Laurent Peyrin-Biroulet Oral presentation
    • Presentation number: OP191
    • Session: IBD clinical trials IV
    • Session Type: Live Abstract-based Session
    • Date: Tuesday 5 October 2021 13:30–14:30 CEST
    Relationship between histo-endoscopic mucosal healing and baseline characteristics in patients with moderately to severely active ulcerative colitis receiving filgotinib in the phase 2b/3 SELECTION study Laurent Peyrin-Biroulet Poster presentation
    • Presentation number: P0427
    • Poster session: IBD
    • Date: Sunday 3 – Tuesday 5 October

    About Ulcerative Colitis  

    Ulcerative colitis (UC) is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2.5 - 3 million people3 are affected by IBD, which includes UC and Crohn's Disease (CD). UC is a chronic inflammatory condition of the gastrointestinal (GI) tract. The disease course of UC is often a state of flare ups and ensuing periods of remission. In addition to the physical impact from flare ups, there is also a psychological impact associated with UC. It causes significant impairments on quality of life and a poor prognosis is often seen in patients with symptoms of moderate to severe UC at diagnosis.

    About the SELECTION Phase 3 Trial

    The SELECTION Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC. The SELECTION trial comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.

    The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION trial were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with UC. A majority of patients included in the SELECTION trial had a MCS score of 9 or higher at baseline, and 43% of biologic experienced patients had insufficient response to a TNF antagonist and vedoluzimab as well.

    About HRQoL and IBDQ

    Health-related quality of life (HRQoL) is a concept that measures physical, emotional, mental, and social impact of the disease on patients' lives. The instruments used to measure HRQoL were a 36-item Short Form Survey (SF-36), EuroQol 5-dimension visual analogue scale (EQ-5D-VAS) and Work, Productivity and Activity Impairment (WPAI) questionnaire, and Inflammatory Bowel Disease Questionnaire (IBDQ).

    The IBDQ is a questionnaire for health-related quality of life assessment in patients with inflammatory bowel diseases: ulcerative colitis and Crohn's disease. It consists of 32 questions divided into four groups: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 to 7, and thus the total score can range from 32 to 224 with higher scores representing better health-related quality of life. IBDQ remission was defined by an IBQ total score ≥170 points. The IBDQ is a validated assessment tool that reflects important changes in the quality of life of patients with IBD (adapted from Pallis et al, Inflamm Bowel Dis, Volume 10, Number 3, May 2004).

    SF-36 is a generic health-assessment questionnaire that is utilized in clinical trials to study the impact of chronic disease on health-related quality of life.

    EQ-5D is a general, non–disease-specific health-related quality-of-life questionnaire.

    WPAI is a tool used to measure the impact of a disease on work and on daily activities.

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca® (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The individual Great Britain and Northern Ireland Summary of Product Characteristics can be found at www.medicines.org.uk/emc and www.emcmedicines.com/en-GB/northernireland respectively. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. A positive opinion was recommended for this UC indication by the EMA's Committee for Medicinal Products for Human Use (CHMP) on 17th September. Filgotinib is not approved in any other countries.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in the European Union, Great-Britain and Japan, and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    1. Vermeire, S, et al. Benefit of prolonged filgotinib dosing in patients with ulcerative colitis who did not respond to induction therapy: data from the SELECTION long-term extension study: post hoc analysis of the phase 2b/3 SELECTION study MP082, UEGW Congress 2021
    2. Sandborn. W, et al. Clinically meaningful improvements in health-related quality of life among patients with ulcerative colitis treated with filgotinib: post hoc analysis of the phase 2b/3 SELECTION study. P0457, UEGW Congress 2021
    3. Burisch J. et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337



    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    Evelyn Fox

    Director Executive Communications 

    +31 65 3591 999 

    communications@glpg.com

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development in UC or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, the risk that Galapagos will not be able to continue to execute on its currently contemplated business plan and/or will need to revise its business plan, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the risk that the transition will not be completed on the currently contemplated timeline or at all, and the risk that the transition will not have the currently expected results for our business and results of operations; and, the uncertainties relating to the impact of the COVID-19 pandemic on our strategy, business plans and focus as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

     

    Attachment



    View Full Article Hide Full Article
    • 1,374 patients enrolled into the phase 3 study across 369 global sites
    • Topline data anticipated in H1 2023
    • Galapagos will assume responsibility for the DIVERSITY study

    Mechelen, Belgium; 4 October 2021, 07.01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced randomization of the last patient into the multi-center, global DIVERSITY Phase 3 study. The study is designed to evaluate the efficacy and safety of filgotinib, a JAK1 preferential inhibitor, in the induction and maintenance of remission in patients with Crohn's Disease (CD).

    The DIVERSITY study enrolled 1,374 participants with moderately to severely active CD, including biologic-naïve and biologic-experienced patients. The study evaluates the safety and efficacy of 100mg…

    • 1,374 patients enrolled into the phase 3 study across 369 global sites
    • Topline data anticipated in H1 2023
    • Galapagos will assume responsibility for the DIVERSITY study

    Mechelen, Belgium; 4 October 2021, 07.01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced randomization of the last patient into the multi-center, global DIVERSITY Phase 3 study. The study is designed to evaluate the efficacy and safety of filgotinib, a JAK1 preferential inhibitor, in the induction and maintenance of remission in patients with Crohn's Disease (CD).

    The DIVERSITY study enrolled 1,374 participants with moderately to severely active CD, including biologic-naïve and biologic-experienced patients. The study evaluates the safety and efficacy of 100mg and 200mg filgotinib versus placebo on clinical remission and endoscopic response, in a 10-week induction phase, followed by a 47-week maintenance phase. Topline results of the DIVERSITY study are anticipated in H1 2023.

    Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos NV said: "This is an important milestone in the DIVERSITY program, as it brings us closer to delivering robust evidence to assess the use of our JAK1 preferential inhibitor as a potentially new class of medicine in the treatment of patients with Crohn's Disease. I would like to thank the patients and the clinical trial centers for participating in this important program, especially during the recent COVID-19 pandemic, which has been a particularly challenging time for the health services and society as a whole."

    The DIVERSITY clinical program design was informed by results from the Phase 2 FITZROY study, with filgotinib, which provided positive results for the use of this JAK1 inhibitor in patients with active CD. Full results were reported in The Lancet.1  

    The use of filgotinib for CD is investigational and is not approved anywhere globally.

    Galapagos will assume operational and financial responsibility for DIVERSITY

    In agreement with Gilead, Galapagos will assume sponsorship of and operational and financial responsibility for the ongoing DIVERSITY clinical study, evaluating filgotinib in CD, and its long-term extension study. The parties intend to complete the transfer no later than June 30, 2022. Under the terms of the agreement and upon completion of the transfer, Gilead will make a one-time payment of $15 million to Galapagos in consideration for Galapagos assuming responsibility for the DIVERSITY clinical study. From April 1, 2022, Galapagos will also be solely responsible for all development costs for the DIVERSITY clinical study. In addition, if the European Medicines Agency grants regulatory approval of filgotinib for the treatment of CD based on data from the DIVERSITY trial, then royalties payable by Galapagos to Gilead will be reduced by 30% across all filgotinib indications and will become 5.6 to 10.5% of net sales in Europe. These royalties are payable as of 2024. Gilead remains responsible for commercial activities outside of Europe.

    About Crohn's Disease

    Crohn's disease is a type of inflammatory bowel disease in which the well-controlled balance of the intestinal immune system is disturbed. CD causes ulcerations that may affect any part of the digestive system from mouth to anus. The cause of the disease is unknown, with onset usually between the ages of 15 and 35. Patients suffer from abdominal pain, diarrhea (often blood), vomiting, fever and weight loss. Estimates suggest there could be up to 1.6 million people living with CD across Europe and up to 78,000 new cases every year.2

    About the DIVERSITY Phase 3 Study

    DIVERSITY consists of a combined, double-blind, placebo-controlled Phase 3 study, enrolling 1,374 patients from 369 centers worldwide. The study compares the efficacy of filgotinib 100mg or 200mg once-daily oral treatment versus placebo in the induction and maintenance of clinical remission measured by Crohn's Disease Activity Index (CDAI) score and endoscopic response measured as simple endoscopic score for Crohn's Disease (SES-CD) at week 10 and week 58, in biologically-naive and biologically-experienced patients with moderately to severely active CD. There are EU-specific co-primary objectives that evaluate clinical remission measured by Patient Reported Outcome (PR02) and endoscopic response (SES-CD) at Week-10 and Week-58. In addition to clinical endpoints the study will also evaluate the effects on Health-Related Quality of Life (HRQoL) scores and Health Care Resource Utilization (HCRU) at Week-10 and Week-58. Safety will be evaluated by assessment of clinical laboratory tests, physical examination, vital signs measurements at various timepoints during the study, and by the documentation of Adverse Events.

    For DIVERSITY study information visit: ClinicalTrials.gov Identifier NCT02048618

    About the filgotinib collaboration

    Gilead and Galapagos NV are partners in a global collaboration to develop and commercialize filgotinib, which is approved and marketed as Jyseleca® in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Galapagos will be responsible for the commercialization of filgotinib in Europe (transition from Gilead to Galapagos anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Applications to extend the approved indication of filgotinib to include ulcerative colitis have been filed in the European Union, Great Britain, and Japan, and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.

    The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The individual Great Britain and Northern Ireland Summary of Product Characteristics can be found at www.medicines.org.uk/emc and www.emcmedicines.com/en-GB/northernireland respectively.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    Evelyn Fox

    Director Executive Communications 

    +31 65 3591 999 

    communications@glpg.com

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the DIVERSITY study and filgotinib clinical program, the timeline of topline results from clinical trials, competitive developments, and regulatory approval requirements, including the risk that the results of the DIVERSITY study may not support continued approval of filgotinib or may not support registration or further development in CD or other indications due to safety or efficacy concerns or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, the risk that Galapagos will not be able to continue to execute on its currently contemplated business plan and/or will need to revise its business plan, the risk that the parties would not be able to complete the contemplated transfer of the DIVERSITY STUDY in a timely manner or at all, the risk that parties may not be able to successfully implement transfer of rights and activities in a timely or efficient manner or at all, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the risk that Galapagos' estimations regarding its filgotinib development program may be incorrect and the uncertainty regarding estimates of the commercial potential of filgotinib, the risks and costs involved in selling and marketing filgotinib, the timing of and risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the risk that the transition will not be completed on the currently contemplated timeline or at all, and the risk that the transition will not have the currently expected results for our business and results of operations; and the uncertainties relating to the impact of the COVID-19 pandemic on our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. 


    1 The Lancet Vol. 389 No. 10066 p266–275 Published: December 14, 2016

    2 Journal of Crohn's and Colitis, Volume 7, Issue 4, May 2013, Pages 322 337, https://doi.org/10.1016/j.crohns.2013.01.010

    3  https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf (last accessed 01.09.21)

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
  1. Mechelen, Belgium; 20 September 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 7,600 new ordinary shares on 20 September 2021, for a total capital increase (including issuance premium) of €151,787.50.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one management board member exercised 5,000 subscription rights.

    In accordance with Belgian transparency legislation1, Galapagos notes…

    Mechelen, Belgium; 20 September 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 7,600 new ordinary shares on 20 September 2021, for a total capital increase (including issuance premium) of €151,787.50.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one management board member exercised 5,000 subscription rights.

    In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €354,459,739.11, the total number of securities conferring voting rights amounts to 65,530,121, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 8,931,342 subscription rights under several outstanding employee subscription right plans, which equals 8,931,342 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    Evelyn Fox

    Director Executive Communications

    +31 65 3591 999

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements. Such forward-looking statements are not guarantees of future results. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any forward-looking statements in this document, unless specifically required by law or regulation.


    1         Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market

     

    Attachment



    View Full Article Hide Full Article
  2. Mechelen, Belgium; 17 September 2021; 13.15 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year.

    The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated…

    Mechelen, Belgium; 17 September 2021; 13.15 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year.

    The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately to severely active UC who have failed conventional therapy or biologics. SELECTION comprised two placebo-controlled induction studies, one in biologic-naive patients and the other in biologic-experienced patients, followed by a 47-week maintenance study for those who responded to filgotinib after 10 weeks. Responders to placebo continued on blinded placebo during the maintenance phase. The trial was recently published in The Lancet1.

    Dr Walid Abi-Saab, Chief Medical Officer at Galapagos, said: "Ulcerative colitis can have significant and profound effects on the people who suffer with the condition. Persistent inflammation and uncontrolled disease mean patients may experience debilitating relapses, may need increasing doses of steroids and in some instances may require surgery, which impacts them not only physically, but also psychologically. Today's decision brings us one step closer to providing a new treatment option for people living with this chronic disease."   

    The CHMP positive opinion will now be reviewed by the European Commission and a decision is expected before year end 2021. This positive opinion follows the previous approval of filgotinib for the treatment of patients with moderate to severe active rheumatoid arthritis. The use of filgotinib for UC is investigational and is not approved anywhere globally.

    About Ulcerative Colitis  

    Ulcerative colitis (UC) is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2 million people2 are affected by IBD, which includes UC and Crohn's Disease (CD). UC is a chronic inflammatory condition of the gastrointestinal (GI) tract. The disease course of UC is often a state of flare ups and ensuing periods of remission. In addition to the physical impact from flare ups, there is also a significant psychological impact associated with UC. It causes significant impairments on quality of life and a poor prognosis is often seen in patients with symptoms of moderate to severe UC at diagnosis.

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The individual Great Britain and Northern Ireland Summary of Product Characteristics can be found at www.medicines.org.uk/emc and www.emcmedicines.com/en-GB/northernireland, respectively. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe, Great-Britain and Japan, and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    1. Feagan. B., et al: Filgotinib as induction and maintenance therapy for ulcerative colitis: the SELECTION trial. The Lancet https://doi.org/10.1016/S0140-6736(21)00666-8.
    2. Burisch J. et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    Evelyn Fox

    Director Executive Communications 

    +31 65 3591 999 

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These forward-looking statements include statements concerning the timing and outcome of a final decision by the European Commission and statements concerning the safety, efficacy and commercial potential of filgotinib. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development in UC or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Attachment



    Primary Logo

    View Full Article Hide Full Article

  3. Mechelen, Belgium; 30 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces the planned retirement of CEO Onno van de Stolpe.

    Onno van de Stolpe co-founded Galapagos in 1999 and built and led the company as CEO from its early R&D days through to the commercial launch of Jyseleca® (filgotinib) in Europe. Onno will retire and make way for a new CEO to lead the company going forward; he plans to stay on as CEO until a successor is appointed. The Supervisory Board has initiated an external search for his replacement.

    "Over the last 20 years, Onno has built one of the most important biotechnology companies in Europe, guiding it from a new start-up to a public company that recently launched…



    Mechelen, Belgium; 30 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces the planned retirement of CEO Onno van de Stolpe.

    Onno van de Stolpe co-founded Galapagos in 1999 and built and led the company as CEO from its early R&D days through to the commercial launch of Jyseleca® (filgotinib) in Europe. Onno will retire and make way for a new CEO to lead the company going forward; he plans to stay on as CEO until a successor is appointed. The Supervisory Board has initiated an external search for his replacement.

    "Over the last 20 years, Onno has built one of the most important biotechnology companies in Europe, guiding it from a new start-up to a public company that recently launched its first approved medicine. The Supervisory Board is deeply grateful to Onno for his years of dedication and leadership, and for creating an enduring organization," said Dr. Raj Parekh, Chairman of the Supervisory Board of Galapagos.

    "My time at the helm of Galapagos will come to an end. We have built a great company that bridges novel target discovery all the way to new medicines in the clinic and to the patient. Despite recent setbacks, we continue to progress a deep pipeline of novel target-based compounds, while the commercial roll-out of our first approved product is underway. With our strong balance sheet and long-term R&D collaboration with Gilead, I am confident that the company is well positioned to grow again from here," said Onno van de Stolpe, CEO.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Except for filgotinib's approval for the treatment of rheumatoid arthritis by the European Commission, Great Britain's Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Carmen Vroonen 

    Global Head of Communications and Public Affairs 

    +32 473 82 48 74  

    Evelyn Fox

    Director Executive Communications

    +31 6 53 59 19 99

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for RA, UC or any other indication, such regulatory authorities requiring additional studies, changes in our management board and key personnel, our ability to effectively transfer knowledge during this period of transition, the search and recruitment of a suitable successor to lead our organization, the risk that Galapagos will be unable to successfully achieve the anticipated benefits from its leadership transition plan, the possibility that Galapagos will encounter challenges retaining or attracting talent, the risk that Galapagos will not be able to continue to execute on its business plan, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio, and potential changes of such ambitions, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), the uncertainties relating to the impact of the COVID-19 pandemic and our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.



    Attachment



    View Full Article Hide Full Article
    • First half-year 2021 financial results:
      • Group revenues and other income of €277.2 million
      • Operating loss of €97.6 million
      • Net loss of €55.0 million
      • Cash and current financial investments of €5.0 billion on 30 June 2021
    • Advancing refocused pipeline; encouraging clinical read-outs reported in earlier-stage inflammatory programs
    • Commercial launch of filgotinib in Europe on track
    • Executing on operational restructuring and savings program

    Webcast presentation tomorrow, 6 August 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 8245817

    Mechelen, Belgium; 5 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) is pleased to report progress on earlier-stage programs as well as its commercial launch

    • First half-year 2021 financial results:
      • Group revenues and other income of €277.2 million
      • Operating loss of €97.6 million
      • Net loss of €55.0 million
      • Cash and current financial investments of €5.0 billion on 30 June 2021
    • Advancing refocused pipeline; encouraging clinical read-outs reported in earlier-stage inflammatory programs
    • Commercial launch of filgotinib in Europe on track
    • Executing on operational restructuring and savings program

    Webcast presentation tomorrow, 6 August 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 8245817

    Mechelen, Belgium; 5 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) is pleased to report progress on earlier-stage programs as well as its commercial launch of filgotinib in Europe. Following recent setbacks, the company is moving forward with its revised strategy and operational restructuring announced in May. The unaudited H1 financial and operational results are further detailed in the H1 2021 report available on the website, www.glpg.com.

    "Multiple assets are moving through clinical development, and we recently reported positive topline data on our TYK2 compound GLPG3667. In a Phase 1b trial in psoriasis (Pso), clinical activity was observed at 4 weeks, combined with an encouraging safety and tolerability profile. We currently are running an extended dose escalation study in healthy volunteers, and plan to progress GLPG3667 to a Phase 2b dose finding study in Pso as well as a Phase 2 study in ulcerative colitis (UC) in 2022.

    We continue to develop our SIK portfolio of molecules, and recently reported encouraging early data from the first patient studies with SIK2/3 inhibitor GLPG3970. In a Phase 1b trial in Pso (CALOSOMA), clinical activity was observed at 6 weeks, and in a Phase 2a trial in UC (SEA TURTLE), biologically important effects were observed on a number of objective endpoints, both of which point to the potential of SIK inhibition as a novel mode of action in inflammation. No activity was observed in the LADYBUG study in rheumatoid arthritis (RA). GLPG3970 was generally safe and well tolerated. Based on these encouraging data, we work on optimizing the pharmacology of follow-up compounds from our SIK portfolio, and plan to bring an improved SIK2/3 molecule into the clinic in 2022.

    On the commercial side, we report rapid progress in establishing our commercial operations for Jyseleca across Europe, with 11 countries launched to date. Reimbursement procedures are on track, and we are on target to achieve our commercial objectives.

    We remain excited about the potential of our target discovery platform, our drug development capabilities, and the strength of our teams. We want to thank our shareholders for their continued support and patience as we are working hard to build our pipeline and establish Galapagos as a fully integrated European biopharma," said Onno van de Stolpe, CEO of Galapagos.

    Bart Filius, President and COO, added, "Following the strategic exercise announced at Q1, we are focused on advancing our pipeline, implementing our savings program, and diligently evaluating business development opportunities. At the same time, we have been delivering on the launch of Jyseleca, building out our organization in new European markets. In line with our review, we reiterate our 2021 operational cash burni guidance of between €580 million and €620 million. We believe that the decisions and actions taken put us on the strongest footing for the future. We look forward to a busy second half of the year, not the least of which is the expected outcome of the regulatory review in Europe of Jyseleca in UC."

    Key figures first half-year report 2021 (unaudited)

    (€ millions, except basic & diluted loss per share)

      30 June 2021 group total 30 June 2020 group total (*)
    Revenues and other income 277.2 217.2
    R&D expenditure (268.8) (262.9)
    G&Aii and S&Miii expenses (106.0) (88.7)
    Operating loss (97.6) (134.4)
    Fair value re-measurement of financial instruments 2.8 (21.1)
    Net other financial result 17.1 (13.0)
    Income taxes



     
    0.5 (0.7)
    Net loss from continuing operations (77.2) (169.2)
    Net profit from discontinued operations 22.2 3.6
    Net loss of the period (55.0) (165.6)
    Basic and diluted loss per share (€) (0.84) (2.55)
         
    Current financial investments and cash and cash equivalents 5,006.6 5,566.5

    (*) The 2020 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.

    Details of the financial results

    Due to the sale of our fee-for-service business (Fidelta) to Selvita on 4 January 2021 for a total consideration of €37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as "Net profit from discontinued operations" in our unaudited condensed consolidated income statements for the six months ended 30 June 2021 and 30 June 2020.

    Revenues and other income from continuing operations

    Our revenues and other income from continuing operations for the first six months of 2021 increased to €277.2 million compared to €217.2 million in the first six months of 2020. Our revenues from the Gilead collaboration in the first six months of 2021 (€253.2 million) related to (i) the exclusive access to our drug discovery platform (€115.7 million), (ii) the filgotinib revenue recognition (€136.1 million) and (iii) royalties (€1.4 million).

    Our deferred income balance on 30 June 2021 includes €1.9 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and €0.7 billion allocated for the filgotinib development (including considerations for the previous and the renegotiated collaboration combined) that is recognized over time until the end of the development period.

    Results from continuing operations

    We realized a net loss from continuing operations of €77.2 million for the first six months of 2021, compared to a net loss of €169.2 million for the first six months of 2020.

    We reported an operating loss amounting to €97.6 million for the first six months of 2021, compared to an operating loss of €134.4 million for the same period last year.

    Our R&D expenditure in the first six months of 2021 amounted to €268.8 million, compared to €262.9 million for the first six months of 2020. This increase, primarily related to our filgotinib program and our Toledo program, was compensated by a decrease for ziritaxestat, the osteoarthritis (OA) program with GLPG1972, and the program in atopic dermatitis (AtD) with MOR106. Personnel costs increased due to an increase in headcount compared to the same period last year and increased costs of our subscription right plans. This factor, and the increased cost of the commercial launch of filgotinib in Europe, contributed to the increase in our S&M and G&A expenses, which were respectively €29.1 million and €76.9 million in the first six months of 2021, compared to respectively €26.9 million and €61.8 million in the first six months of 2020. 

    We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.8 million, mainly due to the decreased implied volatility of the Galapagos share price and its evolution between 31 December 2020 and 30 June 2021.

    Net other financial income in the first six months of 2021 amounted to €17.1 million, compared to net other financial loss of €13.0 million for the first six months of 2020, which was primarily attributable to €33.4 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, to €8.7 million of negative changes in (fair) value of current financial investments and financial assets and to €4.4 million of interest expenses. The other financial expenses also contained the effect of discounting our long term deferred income of €4.8 million.

    Results from discontinued operations

    The net profit from discontinued operations for the six months ended 30 June 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.

    Group net results

    We reported a group net loss for the first six months of 2021 of €55.0 million, compared to a group net loss of €165.6 million for the first six months of 2020.

    Cash position

    Current financial investments and cash and cash equivalents totaled €5,006.6 million on 30 June 2021, as compared to €5,169.3 million on 31 December 2020.

    Total net decrease in cash and cash equivalents and current financial investments amounted to €162.7 million during the first six months of 2021, compared to a net decrease of €214.3 million during the first six months of 2020. This net decrease was composed of (i) €223.2 million of operational cash burn, (ii) offset by €2.6 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first six months of 2021, (iii) €5.8 million negative changes in (fair) value of current financial investments and €35.0 million of mainly positive exchange rate differences, (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed.

    Finally, our balance sheet on 30 June 2021 held a receivable from the French government (Crédit d'Impôt Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €142.7 million.

    Outlook 2021

    In 2021, we expect the European regulatory assessment of filgotinib for the treatment of UC and anticipate both an opinion from the Committee for Medicinal Products for Human Use (CHMP) and a decision from the European Commission later this year. We also expect additional reimbursement decisions for filgotinib in RA across a number of European countries. We are on track to complete the transition from our collaboration partner Gilead to us of the full European commercial operations for filgotinib by year-end, and we anticipate reporting on our own European sales of filgotinib starting in the second half of the year.

    Completion of the recruitment in the global DIVERSITY Phase 3 trial with filgotinib in Crohn's disease by our collaboration partner Gilead is also expected later this year.

    With regard to our SIK portfolio, we are advancing our SIK3 inhibitor GLPG4399 in healthy volunteers this year, and we aim to advance a follow-up SIK2/3 preclinical candidate into the clinic in 2022.

    Following the positive topline data from our TYK2 inhibitor, GLPG3667, we currently are running an extended dose escalation study in healthy volunteers, and we are preparing for a Phase 2b trial in Pso and a Phase 2 trial in UC next year.

    In our other programs, by year-end we intend to finalize recruitment into the GLPG2737 Phase 2a trial in polycystic kidney disease.

    Following the previously announced review of our plans for 2021, we reiterate our guidance for full year 2021 operational cash burn of €580 to €620 million.

    First half-year report 2021

    Galapagos' financial report for the first half-year ended 30 June 2021, including details of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.

    Conference call and webcast presentation

    Galapagos will conduct a conference call open to the public tomorrow, 6 August 2021, at 14:00 CET / 8 AM ET, which will also be webcasted. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

    CODE: 8245817

    Standard International: +44 (0) 2071 928338
    USA: +1 646 741 3167
    UK: +44 844 481 9752
    Netherlands: +31 207 95 66 14
    France: +33 1 70 70 0781
    Belgium: +32 2 793 38 47

    A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

    Financial calendar

    4 November 2021 Third quarter 2021 results (webcast 5 November 2021)
    24 February 2022 Full year 2021 results (webcast 25 February 2022)

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in clinical development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    Except for filgotinib's approval for the treatment of rheumatoid arthritis by the European Commission, Great Britain's Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead, the amount and timing of potential future milestones, opt-in and/or royalty payments by Gilead, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio and Toledo platform, and potential changes of such ambitions, the guidance from management (including guidance regarding the expected operational use of cash during financial year 2021), financial results, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including recruitment for trials and topline results for our trials and studies in our inflammation portfolio, statements regarding the strategic re-evaluation, statements relating to interactions with regulatory authorities, the timing or likelihood of additional regulatory authorities' approval of marketing authorization for filgotinib for RA, UC or any other indication, including UC and IBD indication for filgotinib in Europe, Great-Britain, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization, statements and expectations regarding commercial sales for filgotinib, the expected impact of COVID-19, and our strategy, business plans and focus. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that our expectations regarding our 2021 revenues and financial results and our 2021 operating expenses may be incorrect (including because one or more of its assumptions underlying its expense expectations may not be realized), Galapagos' expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including the risk that data from Galapagos' ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, other inflammatory indications and kidney disease may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including our collaboration partner Gilead), the timing of and the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, estimating the commercial potential of our product candidates and Galapagos' expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, and the uncertainties relating to the impact of the COVID-19 pandemic. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.


    i The operational cash burn (or operational cash flow if this performance measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:

    1. the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities
    2. the net proceeds or cash used, if any, in acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, included in the net cash flows generated from/used in (-) investing activities.

    This alternative performance measure is in our view an important metric for a biotech company in the development stage.

    The operational cash burn for the six months ended 30 June 2021 amounted to €223.2 million and can be reconciled to our cash flow statement by considering the increase in cash and cash equivalents of €477.4 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €2.6 million, (ii) the net sale of current financial investments amounting to €669.4 million, and (iii) the cash in from sale of subsidiaries, net of cash disposed, of €28.7 million.   

    ii General and administrative

    iii Sales and marketing

    iv Crédit d'Impôt Recherche refers to an innovation incentive system underwritten by the French government



     

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
    • Biologic effect of salt inducible kinase (SIK) mechanism in first patient studies supports further progression of Toledo portfolio
    • SIK2/3 inhibitor GLPG3970 generally safe and well-tolerated
    • Study in psoriasis patients shows improvement in PASI score at Week 6
    • Study in ulcerative colitis (UC) patients shows signs of biologically important effects; does not translate to signal on Mayo score at Week 6
    • No signal observed in rheumatoid arthritis (RA) study at Week 6

    Mechelen, Belgium; 14 July 2021; 22.01 CET; regulated informationGalapagos NV (Euronext & Nasdaq: GLPG) reports topline results with GLPG3970 in three patient studies. GLPG3970, the first product candidate from a broad portfolio of SIK inhibitor compounds, provides clinical data

    • Biologic effect of salt inducible kinase (SIK) mechanism in first patient studies supports further progression of Toledo portfolio
    • SIK2/3 inhibitor GLPG3970 generally safe and well-tolerated
    • Study in psoriasis patients shows improvement in PASI score at Week 6
    • Study in ulcerative colitis (UC) patients shows signs of biologically important effects; does not translate to signal on Mayo score at Week 6
    • No signal observed in rheumatoid arthritis (RA) study at Week 6



    Mechelen, Belgium; 14 July 2021; 22.01 CET; regulated informationGalapagos NV (Euronext & Nasdaq: GLPG) reports topline results with GLPG3970 in three patient studies. GLPG3970, the first product candidate from a broad portfolio of SIK inhibitor compounds, provides clinical data supporting the role of SIK inhibition in inflammation. SIK is a novel target class discovered by Galapagos.

    Galapagos evaluated GLPG3970, a proprietary salt inducible kinase (SIK) 2/3 inhibitor, in three randomized, placebo-controlled, double-blind studies: a Phase 1b study in patients with moderate to severe psoriasis and two Phase 2a studies in patients with moderate to severely active UC and RA. GLPG3970 or placebo were administered orally once-daily for 6 weeks. Main objectives were to evaluate the safety and tolerability of GLPG3970 as well as early signs of biologic and clinical effect.

    Across the three studies, GLPG3970 was generally safe and well tolerated. There were no deaths nor serious adverse events, and the majority of treatment emergent adverse events (TEAEs) were mild or moderate in nature.

    CALOSOMA study: Phase 1b trial in psoriasis

    This study randomized 26 patients with moderate to severe psoriasis in a 3:2 ratio, GLPG3970 to placebo. Two out of 15 patients discontinued in the treatment arm (COVID-19 and pruritus) versus 1 out of 11 on placebo (psoriatic arthropathy). 

    At Week 6, four out of 13 patients on GLPG3970 had a PASI1 50 response, defined as at least a 50% improvement of baseline PASI, compared to none on placebo. Specifically, the four responders achieved 50%, 50%, 56%, and 77% improvement in their PASI scores from baseline, reaching statistical significance compared to placebo (p=0.002) at Week 6. Positive signals of clinical effect were also consistently observed for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at Week 6.

    SEA TURTLE study: Phase 2a trial in UC

    This study randomized 31 biologic-naïve patients with moderate to severely active UC in a 2:1 ratio, GLPG3970 to placebo. One out of 21 patients discontinued in the active treatment arm (COVID-19) versus one out of 10 on placebo (QT abnormality at baseline). 

    At Week 6, positive signals were observed in patients on GLPG3970 on objective parameters such as endoscopy, histology, and fecal calprotectin. These findings did not translate in a differentiation from placebo on change from baseline total Mayo Clinic Score in this 6-week study (GLPG3970 -2.7, placebo -2.6). Seven out of 18 patients on GLPG3970 who underwent endoscopy at Week 6 met the criteria for Endoscopic Improvement, defined as a score of 0 or 1 on the endoscopic response score, compared to one out of 9 patients on placebo. The robustness of these signals will be further examined when additional efficacy and biomarker data become available later this year.

    LADYBUG study: Phase 2a trial in RA

    This study randomized 28 patients with moderate to severely active RA and an inadequate response to methotrexate in a 3:2 ratio, GLPG3970 to placebo. Three out of 16 patients discontinued in the treatment arm (COVID-19, ALT increase and physician decision) versus 2 out of 12 on placebo (COVID-19).

    At Week 6, patients on GLPG3970 showed no differentiation from placebo on change from baseline DAS28 (CRP)2 response (GLPG3970 -1.29, placebo -1.24), nor on the majority of other efficacy endpoints.

    Further development of Toledo product portfolio

    GLPG3970 is the first compound from Galapagos' broad portfolio of novel molecules to provide clinical evidence for the potential role of SIK inhibition in inflammation. Biomarker data from these signal-finding studies with GLPG3970 will be further analyzed for signature profiles. Our aim with the Toledo program is to  explore this novel mode of action fully and bring forward improved molecules directed toward SIK2/3 as well as other SIK selectivity profiles. Galapagos currently has two compounds exhibiting SIK2/3 inhibition in preclinical development.

    "We are excited to demonstrate, for the first time, important biologic and clinical effects with a SIK inhibitor in patients with inflammatory conditions. This is a major achievement when working on a novel mode of action target class. The CALOSOMA trial in psoriasis patients indicates clear proof of activity and the SEA TURTLE trial in ulcerative colitis patients provides encouraging results that support further development with Toledo compounds with improved pharmacology. In addition, these studies in patients confirm the safety and tolerability profile previously observed in healthy volunteers," said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. "The GLPG3970 broad dataset is an important step forward, and we aim to apply key learnings from these studies to the further development of our Toledo portfolio of SIK inhibitors."

    Galapagos intends to submit study outcomes with GLPG3970 for publication at scientific conferences and in peer-reviewed medical journals.

    About Toledo

    "Toledo" is an extensive program with a novel target class, SIK, whose potential role in inflammation was discovered by Galapagos. The Toledo program aims to treat a broad range of autoimmune conditions with important unmet medical needs. The Toledo platform delivers small molecule inhibitors of SIK targets with different selectivity profiles. The most advanced compound, SIK2/3 inhibitor GLPG3970, has shown immunomodulatory activity in vitro preclinically and ex vivo clinically with what Galapagos believes is a dual mode of action characterized by enhanced transcription of anti-inflammatory cytokines and inhibited transcription of pro-inflammatory cytokines. SIK inhibition has previously shown encouraging preclinical activity in a range of inflammatory disease models.

    GLPG3970 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.

    About Galapagos

    Galapagos NV ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in clinical development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Contacts



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    ir@glpg.com

    Media:

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    Evelyn Fox

    Director Executive Communications

    +31 65 3591 999

    communications@glpg.com

    Galapagos Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with GLPG3970 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG3970 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties and that Galapagos' estimations regarding its GLPG3970 development program and regarding the commercial potential of GLPG3970 as well as regarding its Toledo platform, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.


    1 Psoriasis Area and Severity Index; an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area

    2 DAS28 is a RA Disease Activity Score based on a calculation that uses tender and swollen joint counts of 28 defined joints, the physician's global health assessment and a serum marker for inflammation, such as C-reactive protein. DAS28 (CRP) includes the C-reactive protein score calculation

     

    Attachment



    View Full Article Hide Full Article
  4. New post-hoc analyses of data from SELECTION Phase 3 program presented at European Crohn's and Colitis Organisation (ECCO) virtual congress

    Mechelen, Belgium; 10 July 2021, 11.10 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced new post-hoc analyses from the Phase 3 SELECTION program, supporting the activity and tolerability of filgotinib, a once-daily, oral JAK1 preferential inhibitor, under investigation for the treatment of patients with moderately to severely active ulcerative colitis (UC). These data were presented at the European Crohn's and Colitis Organisation (ECCO) 16th annual congress.

    A post-hoc analysis of the induction study data from SELECTION showed significant improvements in patient-reported outcomes…

    New post-hoc analyses of data from SELECTION Phase 3 program presented at European Crohn's and Colitis Organisation (ECCO) virtual congress

    Mechelen, Belgium; 10 July 2021, 11.10 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced new post-hoc analyses from the Phase 3 SELECTION program, supporting the activity and tolerability of filgotinib, a once-daily, oral JAK1 preferential inhibitor, under investigation for the treatment of patients with moderately to severely active ulcerative colitis (UC). These data were presented at the European Crohn's and Colitis Organisation (ECCO) 16th annual congress.

    A post-hoc analysis of the induction study data from SELECTION showed significant improvements in patient-reported outcomes (PROs) of stool frequency (SF) and of rectal bleeding (RB), that were observed as early as the first week of therapy in patients on 200mg of filgotinib daily versus placebo in patients with moderately to severely active UC. These findings were observed in both biologic-naïve and biologic-experienced patients. More patients receiving filgotinib 200mg versus placebo achieved a composite score of RB=0 and SF≤1 as early as day 9 in Induction study A (biologic-naïve; filgotinib 200mg 18.8%, placebo 9.5%, p<0.05) and as early as day 7 in Induction study B (biologic-experienced; filgotinib 200mg 10.7%; placebo 4.2%, p<0.05).1

    A further post-hoc analysis of the SELECTION maintenance study reported the proportion of patients who were steroid-free at different timepoints, before achieving remission at Week 58. These data indicated that filgotinib 200mg reduced and eliminated corticosteroid (CS) use versus placebo at Week 58 in patients with moderately to severely active UC. Compared with placebo, a significantly higher proportion of patients who demonstrated CS-free remission at Week 58 with filgotinib 200mg had been CS-free in the previous six months (27% filgotinib 200mg vs 6% placebo, 95% CI 21 (8, 34), with a difference seen from as early as the previous eight months (22% filgotinib 200mg vs 6% placebo, 95% CI 15 (3, 28)).2

    Additional safety analysis from SELECTION, combining induction, maintenance and the long-term extension study data, with a cumulative treatment exposure of 1,207 patient years for filgotinib 200mg versus 318 patient years for placebo, showed results consistent with the original induction and maintenance trials, where filgotinib was well tolerated in patients with moderately to severely active UC.3

    Walid Abi-Saab, Chief Medical Officer at Galapagos stated, "Listening to the needs of patients living with moderately and severely active UC, and the healthcare professionals treating them, helps us understand the importance of finding treatments that address both clinical symptoms and patient reported outcomes. These new data from SELECTION and the long-term extension study suggest that patients with moderately to severely active UC have experienced rapid response, sustained steroid-free remission and long-term tolerability when taking filgotinib 200mg versus those on a placebo".

    About Ulcerative Colitis

    Ulcerative colitis (UC) is a chronic type of inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2 million people4 are affected by IBD, which includes UC and Crohn's Disease (CD). It is a chronic inflammatory condition of the gastrointestinal (GI) tract. The disease course of UC is often a state of flare ups and ensuing periods of remission. In addition to the physical impact from flare ups, there is also a significant psychological impact associated with UC, which is further compounded by the perceived stigma of the condition.

    About the SELECTION Phase 3 Trial

    The SELECTION Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC. The SELECTION trial comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.

    Across both induction studies, 1348 patients with moderately to severely active UC were randomized to receive either filgotinib 200mg, filgotinib 100mg or placebo in a 2:2:1 ratio. Moderately to severely active UC was defined as a centrally read endoscopy score ≥ 2, a rectal bleeding score ≥ 1, a stool frequency score ≥ 1 and Physician Global Assessment (PGA) of ≥ 2 based on the Mayo Clinic Score (MCS). 644 patients with clinical remission or response at Week 10 of induction were subsequently re-randomized to the induction dose of filgotinib or placebo in a 2:1 ratio and treated through Week 58.

    The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION trial were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with moderately to severely active UC. A majority of patients included in the trials had a MCS of 9 or higher at baseline, and 43% of biologic experienced patients had insufficient response to a TNF antagonist and vedolizumab as well.

    For SELECTION study information visit: https://clinicaltrials.gov/ct2/show/NCT02914522

      

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain and Northern Ireland Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe, the UK and Japan, and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov

      

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    1. Danese. S, et al. Rapidity of symptom improvements during filgotinib induction therapy in patients with Ulcerative Colitis: post hoc analysis of the phase 2b/3 SELECTION study. OP37, ECCO Congress 2021
    2. Loftus, E, et al. Corticosteroid-free remission of Ulcerative Colitis with filgotinib maintenance therapy: post hoc analysis of the phase 2b/3 SELECTION study DOP82, ECCO Congress 2021
    3. Schreiber. S, et al. Safety analysis of filgotinib for Ulcerative Colitis: results from the phase 2b/3 SELECTION study and phase 3 SELECTIONLTE long-term extension study. OP04, ECCO Congress 2021
    4. Burisch J. et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337

      

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the SELECTION study, competitive developments, and regulatory approval requirements, including the risk that the results of the SELECTION study may not support continued approval of Jyseleca for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent due to safety, efficacy or other reasons , the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, Galapagos' estimations regarding its filgotinib development program and regarding the commercial potential of filgotinib, risks related to the implementation of the transition of the European commercialization responsibility to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. 

     

    Attachment



    View Full Article Hide Full Article
  5. Mechelen, Belgium; 22 June 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces the departure of Dr. Piet Wigerinck later this year.

    Dr. Piet Wigerinck joined Galapagos as Senior Vice President Development in 2008 and became Chief Scientific Officer in 2012, overseeing the discovery of novel drug targets through to clinical Proof-of-Concept studies. He led his teams through the very first clinical research done in healthy volunteers at Galapagos and was responsible for the Phase 2 FITZROY and DARWIN programs for filgotinib, which later became Galapagos' first commercial product Jyseleca®. Under his leadership, Galapagos achieved a significant portfolio of over 100 patent families.

    Effective immediately…

    Mechelen, Belgium; 22 June 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces the departure of Dr. Piet Wigerinck later this year.

    Dr. Piet Wigerinck joined Galapagos as Senior Vice President Development in 2008 and became Chief Scientific Officer in 2012, overseeing the discovery of novel drug targets through to clinical Proof-of-Concept studies. He led his teams through the very first clinical research done in healthy volunteers at Galapagos and was responsible for the Phase 2 FITZROY and DARWIN programs for filgotinib, which later became Galapagos' first commercial product Jyseleca®. Under his leadership, Galapagos achieved a significant portfolio of over 100 patent families.

    Effective immediately, all early-stage development activities will be added to late-stage clinical development under the responsibility of Chief Medical Officer Dr. Walid Abi-Saab. Piet will remain with the company the coming five months to steer progression of early research while a new leader is sought.

    "We are grateful to Piet for his strong scientific leadership over the years. Piet's vision to identify novel druggable targets has resulted in a large, data-rich pipeline of promising molecules in multiple disease areas which ultimately was partnered with Gilead in a landmark deal. The results with TYK2 inhibitor GLPG3667 and the patient studies with Toledo molecule GLPG3970 expected this summer form part of his considerable legacy," said Onno van de Stolpe, CEO of Galapagos.

    Galapagos retains all guidance for full year 2021 newsflow, including the report of topline results this summer from a Phase 1b trial with TYK2 inhibitor GLPG3667 in psoriasis, and three patient studies with lead Toledo candidate SIK2/3 inhibitor GLPG3970 in psoriasis, ulcerative colitis, and rheumatoid arthritis.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Except for filgotinib's approval for the treatment of rheumatoid arthritis by the European Commission and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Evelyn Fox

    Director Executive Communications

    +31 6 53 59 19 99

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for RA, UC or any other indication, such regulatory authorities requiring additional studies, changes in our management board and key personnel, our ability to effectively transfer knowledge during this period of transition, the search and recruitment of a suitable successor to lead our research organization, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio, and potential changes of such ambitions, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), the uncertainties relating to the impact of the COVID-19 pandemic and our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Attachment



    View Full Article Hide Full Article
  6. Mechelen, Belgium; 7 June 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 10,940 new ordinary shares on 7 June 2021, for a total capital increase (including issuance premium) of €325,279.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one management board member exercised 5,000 subscription rights.

    In accordance with Belgian transparency legislation1, Galapagos notes that its total…

    Mechelen, Belgium; 7 June 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 10,940 new ordinary shares on 7 June 2021, for a total capital increase (including issuance premium) of €325,279.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one management board member exercised 5,000 subscription rights.

    In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €354,418,623.11, the total number of securities conferring voting rights amounts to 65,522,521, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 6,709,662 subscription rights under several outstanding employee subscription right plans, which equals 6,709,662 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 2,736,250 subscription rights of Subscription Right Plan 2021 BE, Subscription Right Plan 2021 RMV and Subscription Right Plan 2021 ROW, which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

    About Galapagos

    Galapagos ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements. Such forward-looking statements are not guarantees of future results. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any forward-looking statements in this document, unless specifically required by law or regulation.


    1         Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market.

     

    Attachment



    View Full Article Hide Full Article
  7. Mechelen, Belgium; 4 June 2021; 07.01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced that primary and secondary endpoint results from the phase 3 SELECTION induction and maintenance study (NCT02914522) were published in The Lancet (doi.org/10.1016/S0140-6736(21)00666-8). The study, sponsored by Gilead Sciences, Inc., was designed to assess the efficacy and safety of the once-daily, oral preferential JAK1 inhibitor, filgotinib, under investigation in patients with moderately to severely active ulcerative colitis (UC).

    In addition to the primary and secondary endpoints, which have been reported at the United European Gastroenterology congress in October 2020   and can be found on the Galapagos website, www.glpg.com/press-releases

    Mechelen, Belgium; 4 June 2021; 07.01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that primary and secondary endpoint results from the phase 3 SELECTION induction and maintenance study (NCT02914522) were published in The Lancet (doi.org/10.1016/S0140-6736(21)00666-8). The study, sponsored by Gilead Sciences, Inc., was designed to assess the efficacy and safety of the once-daily, oral preferential JAK1 inhibitor, filgotinib, under investigation in patients with moderately to severely active ulcerative colitis (UC).

    In addition to the primary and secondary endpoints, which have been reported at the United European Gastroenterology congress in October 2020   and can be found on the Galapagos website, www.glpg.com/press-releases, the publication also reports data from a post-hoc analysis by induction cohort of filgotinib 200mg versus placebo during the maintenance study on multiple efficacy endpoints. These include sustained clinical remission, 6-month corticosteroid free remission, Mayo Clinic Score (MCS), endoscopic and histologic remission, MCS response and endoscopic improvement. Across all these endpoints, numerically greater differences in favor of filgotinib 200mg compared to placebo were shown. This is reported independent of previous biologic treatment status (biologic-naïve and biologic-experienced) with an overall larger numerical effect among biologic-naïve patients1.

    A further post-hoc analysis in the publication reports mucosal healing, a composite endpoint defined as endoscopic improvement (Mayo endoscopy score 0-1) and histological remission in the same patient. The proportion of patients achieving mucosal healing after 10 weeks of induction treatment with filgotinib 200mg was numerically greater compared with placebo (23.3% vs 10.9% in biologic-naïve and 9.9% vs 4.2% in biologic-experienced) and at week 58 in the overall study population (32.7% vs 10.2%)2.

    Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos said, "Achieving early and sustained remission from symptoms, combined with mucosal healing are key goals of therapy in ulcerative colitis. These analyses suggest a positive treatment effect on a range of measures, including mucosal healing, across a broad patient population, which includes those who have failed conventional therapy as well as those who have failed previous biologics."

    The incidence of adverse events (AEs), serious adverse events (SAEs) and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study. In the induction studies, SAEs occurred in 4.7%, 5.0% and 4.3% of patients who received placebo, filgotinib 100mg and 200mg respectively. In the maintenance study, SAEs were experienced by 4.5% of patients in the filgotinib 100mg group and 7.7% in the respective placebo group and by 4.5% of patients in the filgotinib 200mg group and no patients in the respective placebo group. Exposure adjusted incidence rates of SAEs were similar across treatment groups in the induction and maintenance studies. Two deaths were observed in the filgotinib 200mg treatment group in the maintenance trial; both adverse events leading to deaths were considered by the study investigators as unrelated to study drug.

    UC is a long-term condition characterized by inflammation of the mucosal lining of the colon and rectum. As an increasingly prevalent disease, UC has a significant impact on the quality of life of more than 2 million people across Europe. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea, and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep, and fatigue.

    The use of filgotinib for UC is investigational and not approved anywhere globally. Its efficacy and safety have not been established.

    About the SELECTION Phase 3 Trial

    The SELECTION Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC. The SELECTION trial comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.

    The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION trial were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with moderately to severely active UC. A majority of patients included in the trials had a MCS score of 9 or higher at baseline, and 43% of biologic experienced patients had insufficient response to a TNF antagonist and vedolizumab as well.

    Data on the primary endpoint showed that a greater proportion of biologic-naïve and biologic-experienced patients receiving filgotinib 200mg achieved clinical remission at Week 10 than those on placebo (26.1% versus 15.3% p=0.0157 and 11.5% versus 4.2% p=0.013 respectively). This clinical remission was maintained up to 58 weeks for those receiving filgotinib 200mg versus those receiving placebo (37.2% versus 11.2% p<0.001). The difference for filgotinib 100mg was not statistically significant in the induction study, however in the maintenance study at Week 58 a statistically significant difference was seen versus placebo (23.8% versus 13.5%, p=0.0420).

    Overall, the incidence of adverse events (AEs), serious AEs and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study, as reported above.

    For SELECTION study information visit: https://clinicaltrials.gov/ct2/show/NCT02914522

    For access to SELECTION in The Lancet publication visit; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00666-8/fulltext

    1 Feagan. B., et al: Filgotinib as induction and maintenance therapy for ulcerative colitis: the SELECTION trial. The Lancet https://doi.org/10.1016/S0140-6736(21)00666-8. Appendix page 29, Table S4

    2 Feagan. B., et al: Filgotinib as induction and maintenance therapy for ulcerative colitis: the SELECTION trial. The Lancet https://doi.org/10.1016/S0140-6736(21)00666-8. Appendix page 15, Figure S5

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe and Japan a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development in UC or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to completing and implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

     

    Attachment



    View Full Article Hide Full Article
  8. Mechelen, Belgium, 27 May 2021, 22:01 CET, – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced that 15 abstracts, including scientific updates, and data providing further understanding on the profile of filgotinib as a treatment for people with Rheumatoid Arthritis (RA), will be presented at the European League Against Rheumatism (EULAR) virtual congress 2021, 2-5 June.

    New data analyses on the safety profile of filgotinib, an oral, once-daily, JAK1 preferential inhibitor for the treatment of moderately to severely active RA, are presented from seven trials from the development program for filgotinib (DARWIN 1 and 2 and FINCH 1, 2 and 3 and two long term extension studies DARWIN 3 and FINCH 4). Data will be shared on the incidence…

    Mechelen, Belgium, 27 May 2021, 22:01 CET, – Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that 15 abstracts, including scientific updates, and data providing further understanding on the profile of filgotinib as a treatment for people with Rheumatoid Arthritis (RA), will be presented at the European League Against Rheumatism (EULAR) virtual congress 2021, 2-5 June.

    New data analyses on the safety profile of filgotinib, an oral, once-daily, JAK1 preferential inhibitor for the treatment of moderately to severely active RA, are presented from seven trials from the development program for filgotinib (DARWIN 1 and 2 and FINCH 1, 2 and 3 and two long term extension studies DARWIN 3 and FINCH 4). Data will be shared on the incidence of infections and serious infections (OP0126) and herpes zoster virus (POS0092), as well as the effects of concomitant use of statins in filgotinib-treated patients with rheumatoid arthritis (POS0660) and the effect of filgotinib on the pharmacokinetics of rosuvastatin, atorvastatin, and pravastatin (AB0259).

    Galapagos is also presenting scientific research investigating the hypothesis that differences in the selectivity of molecules in the JAK inhibitor class could result in a differential functional modulation of natural killer (NK) cells, which could be a component of the differences in clinical safety profiles of JAK inhibitors (POS0224).

    In addition to the clinical data, Galapagos will present initial results from a European real-world survey investigating patient and physician attitudes to setting treatment target goals in RA, as a strategy for managing the disease (POS0305).

    "At Galapagos, we are working to understand the different dimensions of treatment needs that people living with RA say are important, reflecting a deeper understanding of their complex lives and needs," said Walid Abi-Saab, MD, Chief Medical Officer at Galapagos. "In our drive to deliver innovation and make a real difference where the patient need is greatest, we are excited to be sharing a range of data and insights that represent our ongoing work to understand what matters most to people living with RA and to deliver on the health outcomes most important to patients."

    The presentations at EULAR capture a broad range of research and commitment to the RA community, demonstrating the importance of patient and clinical insight and highlighting Galapagos' position as a science-driven company led by research into patient unmet needs.

    Galapagos Key Abstracts

    Title Authors Oral | Poster Number Time and Date
    Herpes Zoster in the Filgotinib Rheumatoid Arthritis Program



     
    Kevin Winthrop, et al



     
    POS0092



     
    Poster tour: 03 June 2021, 11:50:00-13:30:00 CEST



     
    Infections and Serious Infections in the Filgotinib Rheumatoid Arthritis Program James Galloway, et al OP0126



     
    Session: 03 June 2021, 10:15:00-11:45:00 CEST



     
    Concomitant Use of Statins in Filgotinib-Treated Patients with Rheumatoid Arthritis Peter C Taylor, et al



     
    POS0660



     
    Display: Wednesday, 02 June 2021, 08:00 CEST – Saturday 05 June 2021, 23:59 CEST
    Evaluation of the effect of filgotinib on the pharmacokinetics of rosuvastatin, atorvastatin, and pravastatin Kacey Anderson, et al AB0259 Publish: Abstract Book official supplement to the Annals of Rheumatic Diseases ARD
    Selectivity of clinical JAK inhibitors and the impact on Natural Killer (NK) cell functional responses Paqui G. Traves, et al POS0224



     
    Poster tour: 04 June 2021, 11:50:00-13:30:00 CEST



     
    Physician and Patient Attitudes towards Treat-to-Target, its Implementation and Stated Treatment Goals in Patients with Rheumatoid Arthritis in a Real-World Setting across Europe Bruno Fautrel, et al



     
    POS0305



     
    Poster tour: 05 June 2021, 10:30:00-12:00:00 CEST



     

    For further information on the EULAR congress visit: www.congress.eular.org  

    For further details about the filgotinib rheumatoid arthritis clinical trial program, visit www.clinicatrials.gov: FINCH 1 NCT02889796; FINCH 2 NCT02873936; FINCH 3 NCT02886728; FINCH 4 NCT03025308; DARWIN 1 NCT01888874; DARWIN 2 NCT01894516; DARWIN 3 NCT02065700; FITZROY NCT02048618

    About rheumatoid arthritis

    RA is a chronic inflammatory disease. In RA a person's immune system attacks healthy cells, causing painful swelling in affected parts of the body, primarily in the joints.1 RA can cause tissue damage resulting in chronic pain, unsteadiness and physical disability.1 More than 2.3 million individuals are living with RA in Europe2 and women are 2 – 3 times more likely to develop RA.3 The onset of disease is typically between 30 and 50 years of age.4

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    1. Centers for Disease Control and Prevention. Rheumatoid Arthritis (RA). Available at: https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html. Accessed September 2020.
    2. National Rheumatoid Arthritis Society. The Burden of Rheumatoid Arthritis across Europe a Socioeconomic Survey (BRASS). Summary Report. Available at: https://www.nras.org.uk/data/files/Publications/Surveys%20Reports/UoC_HCD_BRASS%20Summary%20Report%20FINAL.pdf. Accessed September 2020
    3. Arthritis Foundation. Arthritis by the Numbers. Available at: https://www.arthritis.org/getmedia/e1256607-fa87-4593-aa8a-8db4f291072a/2019-abtn-final-march-2019.pdf. Accessed September 2020.
    4. Wasserman, A. Diagnosis and Management of Rheumatoid Arthritis. American Family Physician. Available at: https://www.aafp.org/afp/2011/1201/p1245.html. Accessed September 2020

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program, competitive developments, and regulatory approval requirements, the risk that the results of ongoing clinical studies with filgotinib will not support continued approval of filgotinib for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs) due to safety, efficacy or other reasons or would not support approval of filgotinib for any other indication, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, risks related to the implementation of the transition of European commercialization responsibility for filotinib from Gilead to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. 

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
  9. Study uses mobile device technology to support capture of patient-reported outcomes during early and ongoing use of study treatment amongst patients with rheumatoid arthritis

    Mechelen, Belgium; 18 May 2021; 22.01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced that the first patient has been enrolled in the FILOSOPHY Phase 4 European real-world outcomes study. The goal of the FILOSOPHY study is to advance understanding of the effectiveness and safety of filgotinib as it is used with patients with rheumatoid arthritis (RA) in clinical practice.

    The study, with target enrollment of 1500 patients across Europe, will evaluate the effectiveness, safety, and patient-reported outcomes (PROs) in patients with moderate to severe…

    Study uses mobile device technology to support capture of patient-reported outcomes during early and ongoing use of study treatment amongst patients with rheumatoid arthritis

    Mechelen, Belgium; 18 May 2021; 22.01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that the first patient has been enrolled in the FILOSOPHY Phase 4 European real-world outcomes study. The goal of the FILOSOPHY study is to advance understanding of the effectiveness and safety of filgotinib as it is used with patients with rheumatoid arthritis (RA) in clinical practice.

    The study, with target enrollment of 1500 patients across Europe, will evaluate the effectiveness, safety, and patient-reported outcomes (PROs) in patients with moderate to severe active RA while receiving filgotinib in a real-world setting for up to two years. Mobile device technology will play a central role in collection of PROs, allowing data collection to begin within the first weeks of treatment. This may also prove to be an effective tool during the pandemic, while in-person clinic visits are harder to achieve.

    FILOSOPHY will enable the gathering of comprehensive real-world data in a population that may not be fully represented in clinical trials, as randomized, placebo-controlled trials require strict patient inclusion criteria. These data will expand the evidence base to support the appropriate use of filgotinib in clinical practice.

    Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos said, "This study can enhance our understanding about the effectiveness and safety of filgotinib from the experiences of RA patients who are prescribed the treatment in a real-world healthcare setting. We aim to improve disease management and outcomes for people living with this debilitating condition."

    Professor Gerd Burmester, Director Department of Rheumatology and Clinical Immunology, Charité, Universitätsmedizin, Berlin and FILOSOPHY Steering Committee Member, added, "We expect that use of remote devices to collect treatment outcomes data will give us more comprehensive insights into early treatment effects in relation to patient reported outcomes, including pain and fatigue. In addition, we are interested to understand how long patients stay on treatment and how this could be affected by patient characteristics or treatment effects."

    About Rheumatoid Arthritis

    RA is a chronic inflammatory disease. In RA a person's immune system attacks healthy cells, causing painful swelling in affected parts of the body, primarily in the joints.1 RA can cause tissue damage resulting in chronic pain, unsteadiness and physical disability.1 More than 2.3 million individuals are living with RA in Europe2 and women are 2 – 3 times more likely to develop RA3. The onset of disease is typically between 30 and 50 years of age4.

    About the FILOSOPHY Phase 4 study

    FILOSOPHY (FILgotinib Observational Study Of Patient Health related outcomes over 2 Years), is a prospective, non-interventional cohort study enrolling approximately 1500 patients across Europe. Data will be collected by the clinical sites and patients using an electronic case report form (eCRF) and mobile devices. Each enrolled patient will be followed for 24 months or until discontinuation of study, whichever occurs first. Baseline assessments may be collected within 30 days prior to the first dose of filgotinib.

    The primary objective of the study is to evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation. Secondary and exploratory objectives include effectiveness, evaluation of the effect of filgotinib on patient reported outcomes (PROs) including on pain, fatigue and work productivity, rate of adverse events (AEs) and serious adverse events (SAEs) as well as adverse events of interest, including serious and opportunistic infections (including herpes zoster), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), hyperlipidemia, malignancies, non-melanoma skin cancer (NMSC), and gastrointestinal (GI) perforation.

    For more information go to ClinicalTrials.gov Identifier: NCT04871919

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the Europe Union, Great Britain and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other jurisdictions.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe and Japan and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    1. Centers for Disease Control and Prevention. Rheumatoid Arthritis (RA). Available at: https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html. Accessed September 2020.
    2. National Rheumatoid Arthritis Society. The Burden of Rheumatoid Arthritis across Europe a Socioeconomic Survey (BRASS). Summary Report. Available at: https://www.nras.org.uk/data/files/Publications/Surveys%20Reports/UoC_HCD_BRASS%20Summary%20Report%20FINAL.pdf. Accessed September 2020
    3. Arthritis Foundation. Arthritis by the Numbers. Available at: https://www.arthritis.org/getmedia/e1256607-fa87-4593-aa8a-8db4f291072a/2019-abtn-final-march-2019.pdf. Accessed September 2020.
    4. Wasserman, A. Diagnosis and Management of Rheumatoid Arthritis. American Family Physician. 2011;84(11):1245-1252.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the FILOSOPHY study, competitive developments, and regulatory approval requirements, the risk that the results of the FILOSOPHY study will not support continued approval of Jyseleca for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs) due to safety, efficacy or other reasons, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, risks related to the implementation of the transition of European commercialization responsibility to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
    • First three months 2021 financial results:
      • Group revenues and other income of €124.2 million
      • Operating loss of €50.8 million
      • Net profit of €9.4 million
      • Cash and current financial investments of €5.1 billion on 31 March 2021
    • Refocused clinical pipeline by critically examining risk profile and breadth
    • Filgotinib launch in Europe on track
    • Initiated €150 million savings program

    Webcast presentation tomorrow, 07 May 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 5042688

    Mechelen, Belgium; 06 May 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces its unaudited Q1 results and operational highlights, which are further detailed in the Q1 2021 report available on the Galapagos

    • First three months 2021 financial results:
      • Group revenues and other income of €124.2 million
      • Operating loss of €50.8 million
      • Net profit of €9.4 million
      • Cash and current financial investments of €5.1 billion on 31 March 2021
    • Refocused clinical pipeline by critically examining risk profile and breadth
    • Filgotinib launch in Europe on track
    • Initiated €150 million savings program

    Webcast presentation tomorrow, 07 May 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 5042688

    Mechelen, Belgium; 06 May 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces its unaudited Q1 results and operational highlights, which are further detailed in the Q1 2021 report available on the Galapagos website, www.glpg.com.

    "These last months, we completed a review of our portfolio and development plans with the goal to select a more risk-balanced pipeline. We decided to retain our focus on novel targets to address unmet medical needs in inflammation, fibrosis, and kidney diseases. We also remain fully committed to the launch of Jyseleca in Europe. Moving forward with confidence, we decided to:

    • Refocus our clinical pipeline by critically examining its risk profile and breadth;
    • Cut significant cost in the organization to support this re-sized pipeline development;
    • Task our business development team to identify and execute on a transformative opportunity.

    We believe that our strong cash position, expert teams, and solid scientific foundation position us well for future growth," said Onno van de Stolpe, CEO of Galapagos.

    Refocused pipeline

    In the revision exercise, Galapagos set goals to focus and adjust the overall risk profile of its clinical pipeline. Consequently, we prioritized those assets with what we believe have enhanced chances of clinical success in our core therapeutic areas. As such, we announce:

    • We are testing our lead Toledo program ‘3970, a SIK2/3 inhibitor, in five Proof of Concept studies in different indications, and pending the outcome of the studies, we plan to roll out our further development plans in the second half of the year;
    • We selected an additional molecule from our Toledo program, SIK2/3 inhibitor '4876, as a candidate to accelerate from preclinical phase into clinical development;
    • We aim to progress our TYK2 inhibitor ‘3667 into Phase 2b;
    • We selected chitinase inhibitor '4617 to progress to Phase 2 in IPF and decided to stop development of our other IPF molecule '1205;
    • We stopped further work on ‘4059 for metabolic disease, given that this is not a core therapeutic area;
    • We discontinued our early research efforts in metabolic diseases and osteoarthritis; and
    • We challenged and fine-tuned our stage-gating process to advance compounds.



    Commercial progress

    We remain well on track in launching filgotinib in Europe. In the first quarter, we successfully completed the transitions of commercial and medical teams from Gilead in Germany, the UK, Spain, and Italy. We believe everything is in place to complete the final transitions from Gilead to us by year-end. Q1 also saw progress on access and reimbursement for filgotinib in rheumatoid arthritis (RA). Gilead submitted the new drug application in Japan for the treatment of ulcerative colitis (UC). We are encouraged by the primary endpoint outcome with the MANTA/RAy semen parameter studies as we await the Committee for Medicinal Products for Human Use (CHMP) opinion in UC.

    Bart Filius, President and COO, added, "In line with our review, we decided to discontinue or cancel certain studies and consequently identified opportunities to reduce operational costs, for a total potential savings of €150M on a full-year basis. Roughly half of these savings will be realized in 2021, resulting in a 2021 cash burni guidance of between €580 million and €620 million. We are working towards a right-sized, refocused version of Galapagos, setting us on a path towards success with our first commercial product, new R&D opportunities, substantial clinical news flow, and a lengthened cash runway for validation of our early pipeline assets."

    Key figures first quarter report 2021 (unaudited)

    (€ millions, except basic & diluted gain/loss (-) per share)

      31 March 2021 group total 31 March 2020 group total (*)
    Revenues and other income 124.2 103.6
    R&D expenditure (130.0) (115.5)
    G&Aii and S&Miii expenses (45.0) (34.3)
    Operating loss (50.8) (46.2)
    Fair value re-measurement of financial instruments 2.0 (20.5)
    Net other financial result 36.2 14.8
    Income taxes



     
    (0.2) (0.3)
    Net loss from continuing operations (12.8) (52.3)
    Net profit from discontinued operations 22.2 1.7
    Net profit/loss (-) of the period 9.4 (50.6)
    Basic gain/loss (-) per share (€) 0.14 (0.78)
    Diluted gain/loss (-) per share (€) 0.14 (0.78)
    Current financial investments and cash and cash equivalents 5,114.7 5,722.4

    (*) The 2020 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.

    Details of the financial results

    Due to the sale of our fee-for-service business (Fidelta) to Selvita on 4 January 2021 for a total consideration of €37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as "Net profit from discontinued operations" in our consolidated income statements for the three months ended 31 March 2021 and 31 March 2020.

    Revenues and other income from continuing operations

    Our revenues and other income from continuing operations for the first three months of 2021 increased to €124.2 million compared to €103.6 million in the first three months of 2020. Our revenues from the Gilead collaboration in the first three months of 2021 (€113.7 million) related to (i) the exclusive access to our drug discovery platform (€57.8 million), (ii) the filgotinib revenue recognition (€55.3 million) and (iii) royalties (€0.7 million).

    Our deferred income balance on 31 March 2021 includes €1.9 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and €0.8 billion allocated for the filgotinib development (including considerations for the previous and the renegotiated collaboration combined) that is recognized over time until the end of the development period.

    Results from continuing operations

    We realized a net loss from continuing operations of €12.8 million for the first three months of 2021, compared to a net loss of €52.3 million for the first three months of 2020.

    We reported an operating loss amounting to €50.8 million for the first three months of 2021, compared to an operating loss of €46.2 million for the same period last year.

    Our R&D expenditure in the first three months of 2021 amounted to €130.0 million, compared to €115.5 million for the first three months of 2020. This increase was due to an increase in subcontracting costs primarily related to our filgotinib program, our Toledo program and other clinical programs, compensated by a decrease for ziritaxestat, the OA program with GLPG1972 and the program in atopic dermatitis (AtD) with MOR106. Furthermore, the increase in personnel costs is explained by a planned headcount increase following the growth in our activities, and increased cost of the subscription right plans. This factor, and the increased cost of the commercial launch of filgotinib in Europe, contributed to the increase in our S&M and G&A expenses, which were respectively €14.6 million and €30.4 million in the first three months of 2021, compared to respectively €9.8 million and €24.5 million in the first three months of 2020.

    We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.0 million, mainly due to the decreased implied volatility of the Galapagos share price and its evolution between 31 December 2020 and 31 March 2021.

    Net other financial income in the first three months of 2021 amounted to €36.2 million, compared to net other financial income of €14.8 million for the first three months of 2020, which was primarily attributable to €45.5 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, and to €6.5 million of negative changes in (fair) value of current financial investments and financial assets.

    Results from discontinued operations

    The net profit from discontinued operations for the three months ended 31March 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.

    Group net results

    We reported a group net profit for the first three months of 2021 of €9.4 million, compared to a group net loss of €50.6 million for the first three months of 2020.

    Cash position

    Current financial investments and cash and cash equivalents totaled €5,114.7 million on 31 March 2021, as compared to €5,169.3 million on 31 December 2020.

    Total net decrease in cash and cash equivalents and current financial investments amounted to €54.6 million during the first three months of 2021, compared to a net decrease of €58.4 million during the first three months of 2020. This net decrease was composed of (i) €127.7 million of operational cash burn, (ii) offset by €2.3 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first three months of 2021, (iii) €3.6 million negative changes in (fair) value of current financial investments and €45.7 million of mainly positive exchange rate differences, (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed.

    Finally, our balance sheet on 31 March 2021 held a receivable from the French government (Crédit d'Impôt Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €142.3 million.

    Outlook 2021

    We anticipate several regulatory announcements on filgotinib as well as progress in our differentiated pipeline of novel target-based candidates.

    We expect reimbursement decisions in most key European markets for filgotinib in RA this year, as we complete the transition to a full European commercial operation by year end. We anticipate a CHMP opinion and a European Commission decision for filgotinib in UC. We expect that our collaboration partner Gilead will complete recruitment for the global DIVERSITY Phase 3 trial in Crohn's disease this year.

    Within our broader inflammation portfolio, we expect to report topline results from several trials this year, including a Phase 1b trial with TYK2 inhibitor ‘3667 in psoriasis, and three Proof of Concept studies with lead Toledo candidate SIK2/3 inhibitor ‘3970 in psoriasis, UC, and RA.

    Within our fibrosis portfolio, we expect to progress early clinical compounds with novel mechanisms of action, with the aim to develop novel treatments to help patients suffering from this debilitating condition.

    Following the review of our plans for 2021, we give guidance for full year 2021 operational cash burn of €580 to €620 million.

    First quarter report 2021

    Galapagos' financial report for the first three months ended 31 March 2021, including details of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.

    Results of annual ordinary shareholders' meeting

    On 28 April 2021, Galapagos held its annual ordinary shareholders' meeting. All agenda items were approved, including the re-appointments of Ms. Katrine Bosley and Dr. Raj Parekh as members of the supervisory board, and approval of the remuneration report. All documents relating to the shareholders' meeting are posted on our website at https://www.glpg.com/shareholders-meetings.

    Conference call and webcast presentation

    Galapagos will conduct a conference call open to the public tomorrow, 07 May 2021, at 14:00 CET / 8 AM ET, which will also be webcasted. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

    CODE: 5042688

    Standard International: +44 (0) 2071 928338
    USA: +1 646 741 3167
    UK: +44 844 481 9752
    Netherlands: +31 207 95 66 14
    France: +33 1 70 70 0781
    Belgium: +32 2 793 38 47

    A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

    Financial calendar

    05 August 2021         Half year 2021 results (webcast 06 August 2021)
    04 November 2021 Third quarter 2021 results (webcast 05 November 2021)
    24 February 2022 Full year 2021 results (webcast 25 February 2022)

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    Except for filgotinib's approval for the treatment of rheumatoid arthritis by the European Commission and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead, the amount and timing of potential future milestones, opt-in and/or royalty payments by Gilead, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio, and potential changes of such ambitions, the guidance from management (including guidance regarding the expected operational use of cash during financial year 2021), financial results, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including recruitment for trials and topline results for our trials and studies in our inflammation portfolio, statements regarding the strategic re-evaluation, statements relating to interactions with regulatory authorities, the timing or likelihood of additional regulatory authorities' approval of marketing authorization for filgotinib for RA, UC or any other indication, including UC and IBD indication for filgotinib in Europe, the UK, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization and commercial sales for filgotinib, including in Europe, the expected impact of COVID-19, and our strategy, business plans and focus. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that our expectations regarding our 2021 revenues and financial results and our 2021 operating expenses may be incorrect (including because one or more of its assumptions underlying its expense expectations may not be realized), Galapagos' expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including the risk that data from Galapagos' ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including our collaboration partner Gilead), the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, estimating the commercial potential of our product candidates and Galapagos' expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, and the uncertainties relating to the impact of the COVID-19 pandemic. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.


    i The operational cash burn (or operational cash flow if this performance measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:

    1. the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities
    2. the net proceeds or cash used, if any, in acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, included in the net cash flows generated from/used in (-) investing activities.

    This alternative performance measure is in our view an important metric for a biotech company in the development stage.

    The operational cash burn for the three months ended 31 March 2021 amounted to €127.7 million and can be reconciled to our cash flow statement by considering the increase in cash and cash equivalents of €379.1 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €2.3 million, (ii) the net sale of current financial investments amounting to €475.8 million, and (iii) the cash in from sale of subsidiaries, net of cash disposed of, of €28.7 million.   

    ii General and administrative

    iii Sales and marketing

    iv Crédit d'Impôt Recherche refers to an innovation incentive system underwritten by the French government

     

    Attachment



    View Full Article Hide Full Article
  10. Mechelen, Belgium; 4 May 2021; 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) received a new transparency notification from The Capital Group Companies, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 30 April 2021 from The Capital Group Companies, Inc., who notified that it holds 4.65% of the current 65,511,581 outstanding Galapagos shares. The Capital Group Companies, Inc. thus crossed below the 5% threshold of Galapagos' voting rights by disposing of voting securities on 29 April 2021. The full transparency notice is available on the Galapagos website.

    About Capital Group
    Capital Group controls Capital Bank & Trust Company and Capital Research & Management…

    Mechelen, Belgium; 4 May 2021; 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a new transparency notification from The Capital Group Companies, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 30 April 2021 from The Capital Group Companies, Inc., who notified that it holds 4.65% of the current 65,511,581 outstanding Galapagos shares. The Capital Group Companies, Inc. thus crossed below the 5% threshold of Galapagos' voting rights by disposing of voting securities on 29 April 2021. The full transparency notice is available on the Galapagos website.

    About Capital Group

    Capital Group controls Capital Bank & Trust Company and Capital Research & Management Company through its direct subsidiary Capital Group International, Inc. ("CGII"), controls four CGII investment management companies (Capital International, Inc.; Capital International Limited, Capital International Sàrl; and Capital International K.K.), which all together hold 3,049,333 of Galapagos' voting rights, consisting of ordinary shares, which represents 4.65%.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    communications@glpg.com


    1  Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market

    Attachment



    View Full Article Hide Full Article
  11. Mechelen, Belgium; 30 April 2021, 22.01 CET; regulated information –– Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its supervisory board created 2,736,250 subscription rights under new subscription right plans for the benefit of the personnel of the company and its subsidiaries.

    On 30 April 2021, the supervisory board of Galapagos approved "Subscription Right Plan 2021 BE", intended for members of personnel of the company and its Belgian subsidiaries, "Subscription Right Plan 2021 RMV", intended for the employees of its French subsidiary, Galapagos SASU, and "Subscription Right Plan 2021 ROW", intended for the employees of its other non-Belgian subsidiaries, within the framework of the authorized capital. Under these subscription…

    Mechelen, Belgium; 30 April 2021, 22.01 CET; regulated information –– Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its supervisory board created 2,736,250 subscription rights under new subscription right plans for the benefit of the personnel of the company and its subsidiaries.

    On 30 April 2021, the supervisory board of Galapagos approved "Subscription Right Plan 2021 BE", intended for members of personnel of the company and its Belgian subsidiaries, "Subscription Right Plan 2021 RMV", intended for the employees of its French subsidiary, Galapagos SASU, and "Subscription Right Plan 2021 ROW", intended for the employees of its other non-Belgian subsidiaries, within the framework of the authorized capital. Under these subscription right plans, 2,736,250 subscription rights were created, subject to acceptances, and offered to the beneficiaries of the plans.

    The subscription rights have an exercise term of eight years as of the date of the offer and have an exercise price of €64.76 (the closing price of the share on Euronext Amsterdam and Brussels on the day preceding the date of the offer). The subscription rights are not transferable. The subscription rights under Subscription Right Plan 2021 BE can in principle not be exercised prior to 1 January 2025. The subscription rights under Subscription Right Plan 2021 RMV and Subscription Right Plan 2021 ROW vest and become exercisable in instalments: with 25% of each grant being exercisable as of 1 January 2023, 25% as of 1 January 2024 and 50% as of 1 January 2025. Each subscription right gives the right to subscribe to one new Galapagos share. Should the subscription rights be exercised, Galapagos will apply for the listing of the resulting new shares on a regulated stock market. The subscription rights as such will not be listed on any stock market.

    Galapagos' total share capital currently amounts to €354,359,437.71; the total number of securities conferring voting rights is 65,511,581, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights to subscribe to not yet issued securities conferring voting rights is (i) 6,776,730 subscription rights under several outstanding employee subscription right plans, which equals 6,776,730 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 2,736,250 subscription rights of Subscription Right Plan 2021 BE, Subscription Right Plan 2021 RMV and Subscription Right Plan 2021 ROW, which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

    About Galapagos

    Galapagos NV ((Euronext &, NASDAQ:GLPG) discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director IR

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs+32 473 82 48 74

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements. Such forward-looking statements are not guarantees of future results. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any forward-looking statements in this document, unless specifically required by law or regulation.

     

    Attachment



    View Full Article Hide Full Article
  12. Application is based on Phase 2b/3 SELECTION study data with patients with moderately to severely active ulcerative colitis

    Mechelen, Belgium; 23 April 2021; 06.01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today report that their collaboration partner Gilead Sciences K.K. ("Gilead") and Eisai Co., Ltd. ("Eisai") today announced that Gilead submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for approval of filgotinib for an additional indication to treat patients with moderately to severely active ulcerative colitis (UC). Filgotinib is a new oral Janus kinase (JAK) inhibitor approved in Japan in September 2020 for the treatment of rheumatoid arthritis.

    This latest regulatory submission is based…

    Application is based on Phase 2b/3 SELECTION study data with patients with moderately to severely active ulcerative colitis

    Mechelen, Belgium; 23 April 2021; 06.01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today report that their collaboration partner Gilead Sciences K.K. ("Gilead") and Eisai Co., Ltd. ("Eisai") today announced that Gilead submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for approval of filgotinib for an additional indication to treat patients with moderately to severely active ulcerative colitis (UC). Filgotinib is a new oral Janus kinase (JAK) inhibitor approved in Japan in September 2020 for the treatment of rheumatoid arthritis.

    This latest regulatory submission is based on data from the randomized, double-blind, placebo-controlled Phase 2b/3 SELECTION study evaluating the efficacy and safety of filgotinib for the induction and maintenance of remission in patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. This study showed a statistically significant higher proportion of patients treated with filgotinib 200mg once daily achieved clinical remission at week 10 and maintained remission at week 58 compared with placebo. No new safety risks were identified.

    Ulcerative colitis is a chronic disease characterized by inflammation of the lining of the mucosa of the colon and rectum. The prevalence of ulcerative colitis has been increasing in recent years, and it has a significant impact on the quality of life of more than 2 million people around the world. Even with treatment, defecation urgency, incontinence, recurrent bloody diarrhea, frequent bowel movements, abdominal pain, insomnia and fatigue are common. Ulcerative colitis is one of the intractable diseases1 designated by the Ministry of Health, Labour and Welfare in Japan. According to a nationwide survey, the estimated number of patients with ulcerative colitis in Japan in 2014 was 219,685. The annual prevalence rate per 100,000 was 172.9 (192.3 men, 154.5 women).2

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the Europe Union, Great Britain and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). This definition from the European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the EMA, the MHRA and the PMDA for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review.  Filgotinib is not approved in any other countries.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe and Japan and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development in UC or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, statements relating to interactions with the regulatory authorities, Galapagos' strategic R&D ambitions and potential changes of such ambitions, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), the uncertainties relating to the impact of the COVID-19 pandemic, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    1Japan promotes research related to intractable diseases and financially supports patients with these diseases. Intractable diseases are designated as those that fulfill the following criteria: (1) rarity (affecting less than 0.1% of the population in Japan), (2) unknown etiology, (3) lack of effective treatment, (4) necessity of long-term treatment, and (5) existence of objective diagnostic criteria and not necessarily equal to rare diseases in other countries. Neurol Med Chir (Tokyo). 2017 Jan; 57(1): 1–7. Published online 2016 Sep 21. doi: 10.2176/nmc.st.2016-0135

    2Murakami Y, Nishiwaki Y, Oba MS, Asakura K, Ohfuji S, Fukushima W, et al. Estimated prevalence of ulcerative colitis and Crohn's disease in Japan in 2014: an analysis of a nationwide survey. J Gastroenterol 2019;54 (12):1070-7

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
  13. Leuven, BE, Boston, MA, US – April 13th, 2021 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in retinal vascular disorders, today announces that Grace Chang, M.D., Ph.D., Chief Medical Officer (CMO) of Oxurion, will be presenting at the Wet AMD and DME Drug Development Summit, taking place from April 13 to 15, 2021.

    Dr. Chang will be joining the Summit as a presenter and a panelist:

    •   Presentation on New Therapeutics Target RGD Integrins and The Plasma Kallikrein System: Overview of First Clinical Findings
    Date & Time: April 15, 2021 at 9:55 am EDT
           
    •   Participation in Q&A session entitled Targeting

    Leuven, BE, Boston, MA, US – April 13th, 2021 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in retinal vascular disorders, today announces that Grace Chang, M.D., Ph.D., Chief Medical Officer (CMO) of Oxurion, will be presenting at the Wet AMD and DME Drug Development Summit, taking place from April 13 to 15, 2021.

    Dr. Chang will be joining the Summit as a presenter and a panelist:

    •   Presentation on New Therapeutics Target RGD Integrins and The Plasma Kallikrein System: Overview of First Clinical Findings

    Date & Time: April 15, 2021 at 9:55 am EDT

           

    •   Participation in Q&A session entitled Targeting New Therapeutic Pathways & Looking Beyond Anti-VEGF

    Date & Time: April 15, 2021 at 10:35 am EDT

    •   Participation in Panel Discussion on the Topic Searching for Novel Therapeutic Targets – Addressing Developmental Challenges for New Drug Candidates in Wet AMD & DME

    Date & Time: April 15, 2021 at 11:10 am EDT

    For more information and registration details:  https://wet-amd-drugdevelopment.com

    Under the leadership of Dr. Chang, Oxurion is advancing a pipeline of innovative clinical drug candidates with distinct and complementary modes of action, for treatment of retinal vascular disorders, including DME but also wet AMD.

    THR-149 is a potential first in class plasma kallikrein inhibitor with the possibility to become the treatment of choice for the 40% DME patients who respond sub-optimally to anti-VEGF therapy. Oxurion is currently recruiting patients in a Phase 2 and is on track to readout Part A data later this year. 

    THR-687 is a potential best in class small molecule pan-RGD integrin antagonist initially being developed to treat DME with the possibility to become the standard of care for most DME patients. The Company is currently preparing an IND to start a Phase 2 study evaluating THR-687 as a new therapy for most DME patients. This Phase 2 is expected to start in mid-year.

    Beyond DME, THR-687 also has development possibilities in additional retinal vascular disorders including for wet age-related macular degeneration (Wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12 billion.

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32

    wouter.piepers@oxurion.com





     
    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com



     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    chris.brinzey@westwicke.com

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with retinal vascular disorders including diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

    Oxurion is aiming to build the leading global franchise in the treatment of retinal vascular disorders based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for the 40% of DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 in DME patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

       
    • THR-687 is a pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO. THR-487 is an optimized compound derived from a broader library of integrin antagonists in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG).

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

     



    Primary Logo

    View Full Article Hide Full Article
  14. Oxurion is a leader in the development of pan-RGD integrin antagonists for retinal vascular disorders - THR-687 on track to enter Phase 2 development by mid-year

    Leuven, BE, Boston, MA, US – April 7, 2021 – 05.45 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care therapies for retinal vascular disorders, announces the publication of a review article describing the cutting-edge science and rationale for the design and development of THR-687. The article entitled: Targeting RGD-binding integrins as an integrative therapy for diabetic retinopathy and neovascular age-related macular degeneration' (I Van Hove et al, reference below) was published in Progress in Retinal Eye Research

    Oxurion is a leader in the development of pan-RGD integrin antagonists for retinal vascular disorders - THR-687 on track to enter Phase 2 development by mid-year

    Leuven, BE, Boston, MA, US – April 7, 2021 – 05.45 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care therapies for retinal vascular disorders, announces the publication of a review article describing the cutting-edge science and rationale for the design and development of THR-687. The article entitled: Targeting RGD-binding integrins as an integrative therapy for diabetic retinopathy and neovascular age-related macular degeneration' (I Van Hove et al, reference below) was published in Progress in Retinal Eye Research.

    Integrins are a class of transmembrane receptors that are involved in a wide range of biological functions. The authors describe how RGD integrins affect a multitude of disease-related proteins and molecular pathways in relation to retinal vascular disorders. RGD integrins have been demonstrated to play an important role in diabetic retinopathy (DR), age-related macular degeneration (AMD), glaucoma, dry eye disease and retinal vein occlusion (RVO).

    Based on these findings, the authors conclude that therapies that engage integrin-linked pathways, including THR-687, have the potential to block all of these pathways and to deliver important clinical benefits to patients with these vision threatening conditions. 

    Oxurion is a leader in the development of pan-RGD integrin antagonists for retinal vascular disorders, with THR-687, a potential best-in-class molecule on track to enter a Phase 2 study in patients with diabetic macular edema (DME) in mid-2021. Oxurion is initially developing THR-687 as a first line therapy for DME. THR-687 also holds potential for development in wet AMD and RVO.

    Prof Alan Stitt, Ph.D., Chief Scientific Officer (CSO) of Oxurion, said, "We are pleased to have made this important scientific contribution to retinal eye research. Selective integrin antagonists are becoming an ever-more attractive option to block key processes such as vasopermeability, neovascularisation and inflammation to prevent sight-loss, a therapeutic area in which Oxurion is well placed. The review highlights the potential of our pioneering pan-RGD integrin antagonist THR-687 to deliver important clinical benefits to patients with retinal vascular disorders. We are on track to start a Phase 2 study in patients with DME in mid-year, and we are excited by the significant potential of THR-687 to provide a broad therapeutic alternative for retinal vascular diseases including DME, wet AMD and RVO."  

    References

    I Van Hove, et al. Targeting RGD-binding integrins as an integrative therapy for diabetic retinopathy and neovascular age-related macular degeneration in Progress in Retinal Eye research

    Article abstract can be accessed at: https://www.sciencedirect.com/science/article/abs/pii/S1350946221000276

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32

    wouter.piepers@oxurion.com





    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com



     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    chris.brinzey@westwicke.com

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

    Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 in DME patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

       
    • THR-687 is a pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, which is an optimized compound derived from a broader library of integrin antagonists in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG), also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.



    Primary Logo

    View Full Article Hide Full Article
  15. Leuven, BE, Boston, MA, US – April 6, 2021 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care back of the eye therapies, today announces that is has agreed to a capital commitment of up to €30 Million with Negma Group.

    Negma Group is a Paris-based leading financial institution focused on supporting growth and capturing value through a multi-strategy approach.

    Negma Group has committed to subscribe to up to €30 million in equity in tranches over a 12-month period through mandatory convertible bonds at Oxurion's sole discretion.

    Oxurion anticipates initial clinical data from its lead drug candidate THR-149 later this year. THR-149 is a plasma kallikrein…

    Leuven, BE, Boston, MA, US – April 6, 2021 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care back of the eye therapies, today announces that is has agreed to a capital commitment of up to €30 Million with Negma Group.

    Negma Group is a Paris-based leading financial institution focused on supporting growth and capturing value through a multi-strategy approach.

    Negma Group has committed to subscribe to up to €30 million in equity in tranches over a 12-month period through mandatory convertible bonds at Oxurion's sole discretion.

    Oxurion anticipates initial clinical data from its lead drug candidate THR-149 later this year. THR-149 is a plasma kallikrein inhibitor being developed as a potential new standard of care for diabetic macular edema (DME) patients, who respond sub-optimally to anti-VEGF therapy.  

    Oxurion also expects to initiate a Phase 2 clinical trial with THR-687 in DME by mid-year. THR-687 is a pan-RGD integrin inhibitor that is being developed as a potential first line therapy for all DME patients. THR-687 also holds potential to deliver improved treatment outcomes for patients with wet Age-related Macular Degeneration (wet AMD) and Retinal Vein Occlusion (RVO).

    Patrik De Haes, M.D., CEO of Oxurion, says: "I am happy that we have been able to agree on this flexible financing agreement, which is under our control and can be exercised at our discretion. Access to these funds will allow us to focus on progressing our two exciting novel and differentiated back of the eye drug candidates that are targeting potential market opportunities of over $12 billion, beyond key value inflection points in 2021 and 2022."

    "We are excited to collaborate with Oxurion. At Negma Group, we invest in people and have been very impressed by both the scientific rigor and clinical experience of the Oxurion team. We are proud to partner with this team while they advance two very distinct and innovative programs that have great potential to deliver much improved clinical outcomes to patients suffering from debilitating retinal vascular disorders such as DME, wet AMD and RVO", says Sophie Villedieu, Equity Capital Market Associate of Negma Group.

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32

    wouter.piepers@oxurion.com





     



    Negma Group

    Anthony de Rauville, CIO

    Tel : +33 (0)6 48 10 16 41

    anthony@negmagroup.com



     



    Sophie Villedieu, ECM Associate

    Tel: +33 (0)6 24 48 07 94

    sophie@negmagroup.com



     
    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com



     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    chris.brinzey@westwicke.com



     

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with Diabetic Macular Edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet Age-related Macular Degeneration (AMD) and Retinal Vein Occlusion (RVO).

    Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 in DME-patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

       
    • THR-687 is a pan-RGD integrin inhibitor that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, which is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG), also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.  More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

     



    Primary Logo

    View Full Article Hide Full Article
  16. Leuven, BE, Boston, MA, US – March 31st, 2021 – 07.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, today announces its management will participate and meet one on one with investors at the following upcoming virtual meetings:

          •        European Biotech Investor Days 2021- April 7-8, 2021
                Company Presentation, featuring Tom Graney, CFA, CFO available on demand for all registered users to view on the event's portal.

          •        19th Annual Needham Healthcare Conference- April 14-15, 2021
                Company Presentation, featuring Tom Graney, CFA, CFO available on demand for all registered users to view on event's portal.

    Leuven, BE, Boston, MA, US – March 31st, 2021 – 07.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, today announces its management will participate and meet one on one with investors at the following upcoming virtual meetings:

          •        European Biotech Investor Days 2021- April 7-8, 2021

                Company Presentation, featuring Tom Graney, CFA, CFO available on demand for all registered users to view on the event's portal.

          •        19th Annual Needham Healthcare Conference- April 14-15, 2021

                Company Presentation, featuring Tom Graney, CFA, CFO available on demand for all registered users to view on event's portal.

          •        Bio€quity Europe- May 17-19, 2021

                Company Presentation, featuring Patrik De Haes, MD, CEO available on demand for all registered users to view on event's portal.

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32

    wouter.piepers@oxurion.com



     
    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com



     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    chris.brinzey@westwicke.com

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with Diabetic Macular Edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet Age-related Macular Degeneration (AMD) and Retinal Vein Occlusion (RVO).

    Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

       
    • THR-687 is a pan-RGD integrin inhibitor that is initially being developed as a potential first line therapy for all DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021. THR-687, which is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG), has potential to deliver improved treatment outcomes for patients with wet AMD and RVO.

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.  More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.



    Primary Logo

    View Full Article Hide Full Article
  17. Mechelen, Belgium; 25 March 2021; 21.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) published its annual report for the financial year 2020.

    The annual report for the financial year 2020, including a review of figures and performance, is available online at
    https://www.glpg.com/financial-reports and can also be downloaded as PDF. Our annual 2020 Form 20-F filing with the SEC is also available at www.sec.gov/edgar.

    Furthermore, Galapagos has the honor to invite its shareholders, holders of subscription rights, board members, and statutory auditor to its annual (ordinary) shareholders' meeting that will be held on Wednesday 28 April 2021 at 2:00 p.m. (CET) at the Company's registered office.

    The items on the agenda…

    Mechelen, Belgium; 25 March 2021; 21.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) published its annual report for the financial year 2020.

    The annual report for the financial year 2020, including a review of figures and performance, is available online at

    https://www.glpg.com/financial-reports and can also be downloaded as PDF. Our annual 2020 Form 20-F filing with the SEC is also available at www.sec.gov/edgar.

    Furthermore, Galapagos has the honor to invite its shareholders, holders of subscription rights, board members, and statutory auditor to its annual (ordinary) shareholders' meeting that will be held on Wednesday 28 April 2021 at 2:00 p.m. (CET) at the Company's registered office.

    The items on the agenda of the ordinary shareholders' meeting include, amongst other items, the reappointments of Dr. Raj Parekh as a non-executive member of the supervisory board for four years and Katrine Bosley as an independent non-executive member of the supervisory board for one year.

    In order to be admitted to the shareholders' meeting, the holders of securities issued by the Company must comply with article 7:134 of the Belgian Code of Companies and Associations and article 24 of the Company's articles of association, and fulfill the formalities described in the convening notice. The convening notice and other documents pertaining to the shareholders' meeting can be consulted on our website, www.glpg.com/shareholders-meetings.

    In light of the COVID-19 pandemic, it is currently envisaged that the measures imposed by the Belgian government to deal with this pandemic, such as the obligation to guarantee a distance of 1.5 meters between each person, may still be in effect as of Wednesday 28 April 2021, date of the Company's annual shareholders' meeting. These measures are in the interest of the health of individual securities holders, as well as of the employees of the Company and others who are responsible for organizing the shareholders' meeting. It can also not be excluded that the Belgian government will again impose additional measures. We are monitoring the situation closely and will, if necessary, disclose additional relevant information and measures affecting the ordinary general meeting on the Galapagos website (https://www.glpg.com/shareholders-meetings). In light of this, the Company recommends that shareholders who wish to participate in the annual shareholders' meeting exercise as much as practically possible the right to vote by letter or by proxy to the general counsel. Moreover, holders of securities of the Company are encouraged to exercise their right to ask questions related to the items on the agenda of the general shareholders' meeting in writing.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements. Such forward-looking statements are not guarantees of future results. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any forward-looking statements in this document, unless specifically required by law or regulation.

    Disclaimer

    The contents of our website, including the annual report for the financial year 2020, and any other website that may be accessed from our website, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Attachment



    View Full Article Hide Full Article
  18. Mechelen, Belgium; 19 March 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 99,814 new ordinary shares on 19 March 2021, for a total capital increase (including issuance premium) of €2,258,042.82.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 subscription rights and in total he exercised 41,874 subscription rights. These 41,874 subscription…

    Mechelen, Belgium; 19 March 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 99,814 new ordinary shares on 19 March 2021, for a total capital increase (including issuance premium) of €2,258,042.82.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 subscription rights and in total he exercised 41,874 subscription rights. These 41,874 subscription rights were due to expire in May 2021 and this exercise window was his last possibility to exercise. Two other management board members exercised an aggregate number of 10,000 subscription rights.

    In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €354,359,437.71, the total number of securities conferring voting rights amounts to 65,511,581, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 6,792,843 subscription rights under several outstanding employee subscription right plans, which equals 6,792,843 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9%  of the actually issued and outstanding shares after the exercise of the subscription right. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

    About Galapagos

    Galapagos ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapy Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements. Such forward-looking statements are not guarantees of future results. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any forward-looking statements in this document, unless specifically required by law or regulation.








     

    1     Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market





     

     

    Attachment



    View Full Article Hide Full Article
  19. Advancing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies – with Novel MoAs Beyond anti-VEGF

    Recruiting Phase 2 study (‘KALAHARI') evaluating THR-149, a potent plasma kallikrein inhibitor in DME – On track for Part A data by mid-year

    Positive data from Phase 1 study evaluating THR-687, potential best in class pan-RGD integrin antagonist in DME – On track to start Phase 2 by mid-year

    Highlights
                  

    • Industry-leading pipeline targeting a total potential market opportunity of $12 billion in retinal vascular disorders
       
    • First patients dosed in Phase 2 study (‘KALAHARI') evaluating multiple injections of THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME. Part A data…

    Advancing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies – with Novel MoAs Beyond anti-VEGF

    Recruiting Phase 2 study (‘KALAHARI') evaluating THR-149, a potent plasma kallikrein inhibitor in DME – On track for Part A data by mid-year

    Positive data from Phase 1 study evaluating THR-687, potential best in class pan-RGD integrin antagonist in DME – On track to start Phase 2 by mid-year

    Highlights

                  

    • Industry-leading pipeline targeting a total potential market opportunity of $12 billion in retinal vascular disorders

       
    • First patients dosed in Phase 2 study (‘KALAHARI') evaluating multiple injections of THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME. Part A data expected by mid-year

       
    • THR-687, a pan-RGD integrin antagonist, Phase 2 DME study planned to start by mid-year, following positive Phase 1 data released in 2020

       
    • The Company has strengthened the management team with the appointments of Tom Graney, CFA, based in Boston as CFO, Grace Chang M.D., PhD, based in LA as CMO, and Professor Alan Stitt, PhD as CSO.

       
    • At the end of December 2020, Oxurion had cash, cash equivalents & investments of €24.8 million, allowing the Company to execute on its business plans through the end of Q3 2021.  The Company is in advanced discussions with potential investors in order to increase its cash position.

    Leuven, Belgium, Boston, MA, US – March 17, 2021 – 08.00 PM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with an initial focus on diabetic macular edema (DME), today issues its business and financial update for the twelve-month period ending December 31, 2020.

    Oxurion is focused on developing an industry leading DME franchise based on novel therapies. These new drug candidates, which have novel modes of action, largely independent of anti-VEGF pathways, have been designed to improve visual outcomes for all DME patients and to deliver other important clinical benefits.

    DME is a significant and growing global healthcare problem and the major cause of vision loss in persons with diabetes worldwide. Global prevalence of DME is estimated to be 28 million people in 2019.1 The current market value for DME treatments globally is estimated to be approximately $4.5 billion.

    The Company is advancing its pipeline of innovative clinical drug candidates for treating DME. Oxurion's clinical development pipeline consists of two novel product candidates with different and complementary modes of action:   

    • THR-149 is a potential first in class plasma kallikrein inhibitor with the possibility to become the treatment of choice for DME patients who respond sub-optimally to anti-VEGF therapy. 

       
    • THR-687 is a potential best in class small molecule pan-RGD integrin antagonist being developed to treat DME with the possibility to become the standard of care for most DME patients.

    By advancing both of these exciting new drug candidates, with differentiated modes of action, Oxurion expects to bring much needed innovation and improved clinical outcomes to patients with DME.

    Beyond DME, THR-687 also has development possibilities in additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12 billion.

    Patrik De Haes, M.D., CEO of Oxurion, commented:

    "The last 12 months have seen further important progress towards Oxurion's goal of building the industry leading DME franchise based on bringing much needed innovation to this significant market opportunity. Over this period, we have advanced the clinical development of our lead assets and been successful in making a number of significant senior management appointments.

    In September 2020, we dosed the first patients in the Phase 2 KALAHARI study of our potential first in class plasma kallikrein inhibitor THR-149. These patients with DME have sub-optimally responded to previous anti-VEGF. This two-part study is an important step in bringing THR-149 to patients and is designed to support our goal of positioning THR-149 as the treatment of choice for the large number of DME patients who have a sub-optimal response to anti-VEGF therapy. The KALAHARI study is progressing as planned, despite the widespread COVID-19 pandemic, and we anticipate announcing Part A dose selection data in mid-2021.

    In 2020 we announced positive and highly promising Phase 1 results with THR-687. The data confirmed that this potential best in class pan-RGD integrin antagonist has the profile to become the standard of care for the majority of DME patients by replacing anti-VEGFs as the mainstay of DME therapy. We have carried out additional multiple dose preclinical studies to support the next phase of clinical development and remain on track to start a Phase 2 study in mid 2021. We are very excited by the potential for THR-687 given it has the possibility to be developed for other significant vascular retinal disorders including wet AMD and RVO.

    We have also taken important steps to strengthen our management team. I am pleased to welcome Grace Chang, M.D. as our Chief Medical Officer, Tom Graney, C.F.A. as Chief Financial Officer, and more recently Professor Alan Stitt, Ph.D., as Chief Scientific Officer. We are delighted to be able to attract individuals with such great industry standing to Oxurion as we seek to advance our lead assets through the clinic towards commercialization and in parallel expand our pipeline of differentiated drug candidates. I am confident that we have a team that can deliver results, and with both Tom and Grace being based in the US, we are starting to build the transatlantic organization we need to deliver on our global ambition.

    Oxurion remains focused on its strategy to deliver significant benefits to DME patients and other retinal vascular disorders globally as well as value to our shareholders. These goals are based on successfully advancing THR-149 and THR-687 which together have the potential to provide innovative tailored therapeutic solutions that deliver much improved clinical outcomes to all DME patients, and in the case of THR-687, also the broader market for retinal vascular disorders."

    Diabetes, Diabetic Retinopathy, Diabetic Macular Edema – a global and growing health concern

    Diabetic macular edema (DME) is a result of diabetes caused by fluid accumulation in the macula (central part of the retina), due to leaking blood vessels, leading to swelling of the macular area due to the increased permeability of the vessels resulting in the loss of vision.

    DME is caused by another complication of diabetes, called diabetic retinopathy (DR), in which blood vessels in the eye are damaged, allowing fluid to escape. DR is the presence and characteristic evolution of typical retinal microvascular lesions in an individual with diabetes. DR is a chronic, progressive, sight-threatening, and life-altering disease, and is the leading cause of vision loss in working-age adults (20-65 years). DME can occur at any stage in the development of DR.

    DR and DME are a growing public health concerns due to the rapid growth in the number of people with diabetes globally. More than one in three people living with diabetes will develop some form of DR in their lifetime, and twenty percent of those will have some vision-threatening form of the disease such as DME.

    The current market value for DME treatments has been estimated to be approximately $4.5 billion. Along with the development of diabetes as a global health issue, prevalence numbers of DME are expected to raise for the foreseeable future.  

    Oxurion DME franchise addressing unmet medical need

    The market for DME therapies is currently dominated by anti-VEGFs, which are the standard of care.

    However, anti-VEGFs have been shown to deliver sub-optimal results in a significant portion of the patient population.  Approximately forty percent of DME patients have an unsatisfactory visual response with anti-VEGF therapy, and in many cases anti-VEGFs fail to achieve a clinically meaningful visual improvement. 

    Moreover, despite the significant success of anti-VEGFs, there will always be a need from both physicians and patients for improved therapies, not only to expand treatment capabilities for the forty percent of DME patients who respond sub-optimally to anti-VGEFs, but equally to deliver:

    • Faster onset of action
    • Better therapeutic effect in terms of visual function, best corrected visual acuity (BCVA), and response rate (proportion of patients)
    • Longer duration of response allowing extended treatment intervals
    • Improved convenience of treatment through a simpler dosing regimen

    The above requirements are driving the development of THR-149 and THR-687 to meet specific unmet needs in this market so that these novel compounds could become the new standard of care for patients with DME.

    Oxurion's emerging DME franchise will be based on the successful development of THR-149 and THR-687, two novel therapeutics with different validated modes of action designed for specific complementary target patient groups. 

    Oxurion is confident that with both THR-149 and THR-687 it has the potential to be able to provide new tailored therapeutic solutions that deliver improved clinical outcomes to all DME patients.

    THR-149 – a plasma kallikrein inhibitor for treatment of DME: currently recruiting patients in Phase 2 Part A

    In September 2020, Oxurion announced that the first patient had been treated in the Phase 2 KALAHARI study evaluating THR-149 for treatment of DME.

    THR-149 is a novel plasma kallikrein inhibitor being developed as a potential new standard of care for the forty of DME patients who respond sub-optimally to anti-VEGF therapy.

    THR-149 acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin) system, a validated target for DME.

    The first part (Part A) of our Phase 2 study will evaluate 3 dose levels of multiple injections of THR-149 in patients with DME to select the optimal dosing regimen based on safety and efficacy. Initial data (from Part A) is expected in mid-2021.

    In Part B of the study, planned to start in H2 2021, the dosing regimen selected in Part A will be compared to the current anti-VEGF standard of care in the form of aflibercept (Eylea) in terms of its ability to improve BCVA. Topline data from Part B is planned to become available in the first half of 2023.

    A positive Phase 1 study with THR-149 showed that it:

    • Is well-tolerated and safe. No dose-limiting toxicities nor drug-related serious adverse events were reported at any of the dosages evaluated in the study.

       
    • Delivered promising efficacy results, particularly improvements in the patient's BCVA. There was a rapid onset of action observed from Day 1, with an increasing average improvement in BCVA of up to 7.5 letters at Day 14.

       
    • Importantly, this activity was maintained with an average improvement in BCVA of 6.5 letters at Day 90 following a single injection of THR-149.

    This novel drug candidate was generated using Bicycle Therapeutics' Bicycles® technology platform. 

    THR-687 - a small molecule pan-RGD integrin antagonist for the treatment of DME:

    Positive Phase 1 Results with THR-687 for the treatment of DME – Phase 2 program planned to start in mid-2021

    Oxurion is developing THR-687, a potential best in class pan-RGD integrin antagonist, to preserve vision in a broad range of patients with DME as first line therapy. Inhibition of integrins is a validated target in DME.

    Topline data in 2020 from the Phase 1 trial showed that THR-687:

    • Is well-tolerated and safe with no dose-limiting toxicities. No serious adverse events were reported at any of the doses evaluated in the study.

       
    • The study also looked at efficacy including changes to the patient's BCVA. Across all doses, a rapid onset of action as measured by mean BCVA change was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Day 30.

       
    • This activity was maintained with a mean BCVA improvement of 8.3 letters at Day 90 following a single injection of THR-687.

       
    • A clear dose response was seen in terms of BCVA with the highest dose of THR-687 delivering a mean BCVA Improvement of 11 letters at Day 14, with a peak improvement of 12.5 letters at Day 90. 

       
    • In addition, a peak mean central subfield thickness (CST) decrease of 106 µm was observed at Day 14 with the highest dose of THR-687.

    Data from this positive Phase 1 study with THR-687 were presented by a leading retina expert at the Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2020 Meeting in Miami (US).

    Oxurion is preparing a Phase 2 study with THR-687. The team has carried out additional multiple dose pre-clinical studies and is in the process of completing the IND (Investigational New Drug) submission ahead of the planned start of the Phase 2 study in mid-2021.

    The planned Phase 2 study will be a multiple dose study in two parts, the first Part A to select the optimal dose of THR-687 and the second Part B to compare this selected dose to aflibercept. Dose selection following Part A is anticipated in the first half of 2022 with topline data from Part B planned for the second half of 2023.

    Oxurion preclinical data presentation on THR-687 and dry AMD

    Oxurion presented new preclinical data on THR-687 and dry AMD at the EURETINA 2020 Virtual Meeting in October 2020. The European Society of Retina Specialists (EURETINA) was established over 20 years ago and hosts the leading annual European retinal congress which now attracts over 5,000 global vitreoretinal and macular specialists.

    • The first presentation (title: THR-687, a potent pan-RGD integrin antagonist, holds promise as next-generation therapy for diabetic macular edema) confirmed THR-687 as a promising drug candidate for the treatment of vision-threatening retinal pathologies such as diabetic retinopathy (DR) and DME.

       
    • The second presentation (title: Characterization of the acute rat model of sodium iodate-induced dry age-related macular degeneration) reported data from a new preclinical model for testing and validation of drug candidates for different stages of dry AMD using complementary read-outs.

    Details of the abstracts can be found on the EURETINA 2020 Virtual website: https://www.euretina.org/congress/amsterdam-2020/virtual-2020-freepapers/

    Oxurion Virtual R&D Day

    On October 15, 2020 Oxurion held a virtual R&D day for analysts and investors, highlighting its innovative drug candidates for next generation DME therapy. This included presentations from leading KOLs on THR-149 and THR-687 clinical data and our ongoing and future clinical development strategies for these assets. The presenting KOLs were:

    • For THR-149: Ramin Tadayoni, M.D., Ph.D., Professor of ophthalmology at University of Paris, Head of the Ophthalmology Departments at Lariboisière, St Louis and Rothschild Foundation Hospitals in Paris, France

       
    • For THR-687: Arshad Khanani, M.D., M.A., Managing Partner, Director of Clinical Research, Director of Fellowship at Sierra Eye Associates, and Clinical Associate Professor at the University of Nevada, Reno, US.

    The virtual R&D day was highly successful, attended by approximately 100 participants, mainly analysts and investors.  

    Key Management Appointments

    Tom Graney, CFA, appointed Chief Financial Officer

    In October, Oxurion announced the appointment of Tom Graney, CFA as its Chief Financial Officer (effective October 14, 2020) to succeed Dominique Vanfleteren.

    He is based in Boston, MA, US.

    Tom has over 25 years' experience in senior finance, strategy and operational roles including capital raising, corporate development, and audit. Before joining Oxurion he served as CFO at Generation Bio (NASDAQ:GBIO), a non-viral gene therapy company based in Cambridge, MA, where he led all of the company's financial operations.

    Prior to joining Generation Bio, Tom was Senior Vice President (SVP) and CFO at Vertex Pharmaceuticals (NASDAQ:VRTX), one of the world's most highly valued commercial stage biotech companies, with a multi-billion-dollar turnover. At Vertex Tom was responsible for financial strategy and operations including finance, accounting, and internal audit functions.

    Prior to Vertex, he was the CFO and senior vice president, finance, and corporate strategy at Ironwood Pharmaceuticals (NASDAQ:IRWD), a commercial stage GI-focused biotech company. Before joining Ironwood, Tom spent 20 years with Johnson & Johnson, serving in various roles in the US and abroad, including being Worldwide VP of Finance and CFO of Ethicon, a major medical device company and VP and CFO of Janssen Pharmaceuticals NA, a major pharmaceutical company in North America.

    Grace Chang, M.D., Ph.D. appointed Chief Medical Officer

    In August, Oxurion appointed Grace Chang, M.D., Ph.D. as its Chief Medical Officer (effective August 1, 2020).  She is responsible for leading the Company's clinical programs for both THR-687 and THR-149 as Oxurion looks to build a world-leading DME franchise that could provide much improved therapeutic solutions for all DME patients.

    Dr Chang is a board-certified ophthalmologist and practicing vitreoretinal surgeon with deep expertise in ophthalmic drug research and development.

    Dr Chang is also currently an adjunct Clinical Associate Professor in the Department of Ophthalmology, Vitreoretinal Service at the University of Southern California in Los Angeles.

    Professor Alan Stitt, Ph.D. appointed Chief Scientific Officer

    Effective January 19, 2021, Professor Alan Stitt, Ph.D. was appointed Chief Scientific Officer (CSO) of Oxurion NV. This appointment follows the retirement of the former CSO Jean Feyen, PhD, who has served in this position since joining the Company in 2013. Dr. Feyen will remain available to the Company during a transition period to support Professor Stitt and the rest of the preclinical development team. 

    Professor Stitt is the Chair of Experimental Ophthalmology at Queen's University of Belfast and is internationally known for his research in ophthalmology, particularly in basic science relating to the pathogenesis of retinal diseases, especially diabetic retinopathy, and age-related macular degeneration. He has also been awarded many accolades for his research including a Royal Society Merit Award, election to membership of the Royal Irish Academy (RIA) and Fellowship of the Association for Research in Vision & Ophthalmology (ARVO).

    Beyond his research programs, Alan contributes significantly to the international academic community by serving on advisory boards and grant panels and has a range of editor and editorial board memberships in the ophthalmology are­­na. Going forward, Alan will continue to perform his University duties and affiliations on a part-time basis.

    Other appointments

    Following the tragic passing of Oxurion's Chief Legal Officer and Corporate Secretary/Global Head of Corporate Development, Claude Sander, in December 2019, Oxurion appointed Kathleen Paisley as Chief Legal Officer and Michaël Dillen as Chief Corporate Development Officer and Corporate Secretary.

    Kathleen Paisley is an accomplished lawyer with more than 25 years' experience in major law firms practicing in Brussels, London and The Hague, including as a partner engaged in life sciences at US-based international law firms and Ambos Lawyers in Brussels. She is a US national who is qualified in New York and Washington DC, and earned her JD from the Yale Law School, as well as an MBA in Finance, Bachelor of Sciences and has passed the Certified Public Accountancy exam.

    Michaël Dillen joined the Company from Mithra Pharmaceuticals SA where he was Company Secretary and Vice President of Corporate Development. Prior to Mithra, he was Senior Legal Counsel at Terumo Corporation. His experience includes corporate development, legal, regulatory, and company secretary activities, for pharmaceutical companies as well as at leading law firms. He holds law degrees from the University of Antwerp and Queen Mary University of London, and a business degree from Solvay Brussels School.

    ONCURIOUS - Exciting Progress with Solid Tumor Pipeline Announced

    Oncurious is developing next-generation immuno-oncology drugs targeting a broad spectrum of cancers. Oncurious is a majority owned subsidiary of Oxurion. The remainder of the shares in the company are owned by VIB, a leading life sciences research institute based in Flanders, Belgium.

    Oncurious scientists, in collaboration with world-class immuno-oncology experts in T cell and endothelial cell biology – Prof. Dr. Gabriele Bergers (VIB-KU Leuven), Prof. Dr. Massimiliano Mazzone (VIB-KU Leuven) and Prof. Dr. Jo Van Ginderachter (VIB-VUB), and the drug discovery unit at VIB, are building a pipeline of proprietary investigational I-O therapies with distinct modes of action.

    The team has discovered a potent and diverse panel of leads targeting human CCR8, has reached preclinical proof of concept and is entering the final lead optimization stages nearing preclinical candidate selection. Oncurious is accelerating its efforts towards initiation of preclinical development of the therapeutic antibody program in early 2021.

    Oncurious' CCR8 leads have been generated using an antibody technology platform that has been validated and used for more than a decade to generate high quality binders against G-protein coupled receptors. Molecules discovered using this technology were tested in several preclinical tumor models, and showed that targeting CCR8, depleted Tregs specifically in the tumor microenvironment and resulted in strong anti-tumor responses in monotherapy as well as in combination with anti-PD1. The treatments led to the establishment of immunological memory.

    In addition to the anti-CCR8 program, Oncurious is focusing on two other programs aimed at boosting anti-tumor T cell influx and activity in immune excluded tumors. Exclusion of T cells is an immunosuppressive mechanism commonly used by cancers to evade the immune system and as such is an attractive target for new therapeutic modalities.

    ONCURIOUS – Update TB-403 study in Pediatric Subjects with Medulloblastoma

    Data from the Phase 1, Open-Label, Multicenter, Dose Escalation Study of TB-403 in Pediatric Subjects with Relapsed or Refractory Medulloblastoma are scheduled for presentation at the AACR (American Association for Cancer Research) Annual Meeting on Saturday April 10, 2021.

    Financial Results (unaudited)

    Total revenue amounted to €2.1 million in 2020 compared to €3.9 million in 2019.

    The Company reported a gross profit of €1.5 million in 2020. This compares to a gross profit of €1.7 million in 2019.

    R&D expenses in 2020 were €22.1 million compared to €25.7 million in 2019. R&D expenses were mainly related to preclinical activities as well as clinical activities in THR-687 and THR-149. The 2020 figure included a milestone payment of €2.0 million related to the development of THR-149. Government grants and income from recharge of costs are deducted from the research and development expenses.

    Selling and marketing expenses were €3.3 million in 2020. This compares to €7.0 million in 2019.

    General and administrative expenses decreased from €6.3 million in 2019 to €5.5 million in 2020.

    In 2020, Oxurion made a loss for the year of €28.6 million, compared to a loss for the year in 2019 of €52.1 million resulting in negative diluted earnings per share of €0.75 euro in 2020 versus €1.36 euro in 2019.

    The Oxurion cash position (including investments) at the end of 2020 amounted to €24.8 million. This compares to €52.9 million (including investments) at the end of 2019.

    Oxurion believes that its cash position will allow it to execute on its business plans through the end of Q3 2021 given the cost reductions it has made.  The Company is therefore in advanced discussions with potential investors and other sources of capital to secure the necessary funding to deliver on its further plans, as well as continuing to manage its cash position carefully.

    The financial results included in this press release remain unaudited. Audited financial results and the Annual Report 2020 for the period ending December 31, 2020, will be published by April 5, 2021, on the Company's website.

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 16 75 13 10 / +32 478 33 56 32

    wouter.piepers@oxurion.com



     
    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com



     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    chris.brinzey@westwicke.com

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients. Our initial focus is in diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.

    Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 in DME patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

       
    • THR-687 is a pan-RGD integrin inhibitor, that is initially being developed as a potential new standard of care for the majority of first line DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021 after receiving regulatory approval. THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG).

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.



     

    Unaudited Consolidated statement of profit and loss

    In '000 euro (for the year ended 31 December) 2020 2019
         
    Income 2,078 3,946
    Sales 2,000 3,820
    Income from royalties 78 126
    Cost of sales -550 -2,259
    Gross profit 1,528 1,687
    Research and development expenses -22,053 -25,709
    General and administrative expenses -5,489 -6,324
    Selling expenses -3,252 -6,955
    Other operating income 777 2,022
    Other operating expense -6 -4
    Impairment losses -125 -16,891
    Operating result -28,620 -52,174
    Finance income 468 495
    Finance expense -408 -407
    Result before income tax -28,560 -52,086
    Taxes 0 -17
    Result of the year -28,560 -52,103
         
    Attributable to:    
    Equity holders of the company -28,012 -51,827
    Non-controlling interest -548 -276
         
    Result per share    
    Basic earnings / loss (-) per share (euro) -0.75 -1.36
    Diluted earnings / loss (-) per share (euro) -0.75 -1.36



    In '000 euro (as at 31 December) 2020 2019
    Result of the year -28,560 -52,103
    Exchange differences on translation of foreign operations and remeasurement DBP -424 -342
    Other comprehensive income, net of income tax -424 -342
    Other comprehensive income that will not be reclassified to profit or loss -424 -342
    Total comprehensive loss (-) / income for the year -28,984 -52,445
    Attributable to:    
    Equity holders of the company -28,436 -52,169
    Non-controlling interest -548 -276



     

    Unaudited Consolidated statement of financial position

    In '000 euro (as at 31 December) 2020 2019
         
    ASSETS    
    Property, plant and equipment 230 340
    Right-of-use assets 1,069 2,212
    Intangible assets 2,127 1,982
    Other non-current assets 96 96
    Non-current tax credit 3,708 3,385
    Non-current assets 7,230 8,015
    Inventories 85 20
    Trade and other receivables 1,451 3,592
    Current tax receivables 719 467
    Investments 288 10,444
    Cash and cash equivalents 24,511 42,492
    Current assets 27,054 57,015
    Total assets 34,284 65,030
         
    EQUITY AND LIABILITIES    
    Share capital 44,913 100,644
    Share premium 0 0
    Cumulative translation differences -1,039 -615
    Other reserves -6,133 -12,122
    Retained earnings -12,561 -34,747
    Equity attributable to equity holders of the company 25,180 53,160
    Non-controlling interest -132 146
    Total equity 25,048 53,306
    Lease liabilities 447 1,335
    Employee benefit liabilities 1,096 801
    Non-current liabilities 1,543 2,136
    Trade payables 4,377 4,725
    Lease liabilities 649 898
    Other short-term liabilities 2,667 3,965
    Current liabilities 7,693 9,588
    Total equity and liabilities 34,284 65,030



     

    Unaudited Consolidated statement of cash flows

    In '000 euro (for the year ended 31 December) 2020 2019
         
    Cash flows from operating activities    
    Loss for the period -28,560 -52,103
    Finance expense 408 407
    Finance income -468 -495
    Depreciation of property, plant and equipment 194 330
    Amortization and impairment of intangible assets 125 18,468
    Amortization of right-of-use assets 916 864
    Gain on sale of property, plant and equipment -7 0
    Equity settled share-based payment transactions 458 440
    Decrease in trade and other receivables including tax receivables and inventories 1,501 1,082
    Increase / Decrease (-) in short-term liabilities -1,646 -432
    Net cash flows generated / used (-) in operating activities -27,079 -31,439
         
    Cash flows from investing activities    
    Disposal of property, plant and equipment (following a sale) 35 77
    Decrease / Increase (-) in investments 10,154 10,033
    Interest received and similar income -6 4
    Purchase of property, plant and equipment -119 -133
    Purchase / divestment (-) of other non-current assets 0 31
    Net cash flows generated / used (-) in investing activities 10,064 10,012
         
    Cash flows from financing activities    
    Principal paid on lease liabilities -903 -843
    Interest paid on lease liabilities -16 -24
    Paid interests -12 -10
    Net cash flows used (-) / generated in financing activities -931 -877
         
    Net change in cash and cash equivalents -17,946 -22,304
    Net cash and cash equivalents at the beginning of the period 42,492 64,652
    Effect of exchange rate fluctuations -35 144
    Net cash and cash equivalents at the end of the period 24,511 42,492



     

    Unaudited Consolidated statement of changes in equity

      Share capital Share premium Cumulative translation differences and revaluation reserve Other reserves Retained earnings Attributable to equity holders of the company Non-controlling interest Total
    Balance as at 1 January 2019 137,564 13 -273 -12,563 -19,853 104,888 422 105,310
    Result of the year 2019 0 0 0 0 -51,827 -51,827 -276 -52,103
    Change to foreign currency translation difference and revaluation reserve 0 0 -342 0 0 -342 0 -342
    Net change in fair value of investments 0 0 0 1 0 1 0 1
    Capital decrease -36,920 -13 0 0 36,933 0 0 0
    Share-based payment transactions 0 0 0 440 0 440 0 440
    Balance as at 31 December 2019 100,644 0 -615 -12,122 -34,747 53,160 146 53,306
                     
    Balance as at 1 January 2020 100,644 0 -615 -12,122 -34,747 53,160 146 53,306
    Result of the year 2020 0 0 0 0 -28,012 -28,012 -548 -28,560
    Change to foreign currency translation difference and revaluation reserve 0 0 -424 0 0 -424 0 -424
    Net change in fair value of investments 0 0 0 -2 0 -2 0 -2
    Issue of ordinary shares 0 0 0 0 0 0 270 270
    Capital decrease -55,731 0 0 5,533 50,198 0 0 0
    Share-based payment transactions 0 0 0 458 0 458 0 458
    Balance as at 31 December 2020 44,913 0 -1,039 -6,133 -12,561 25,180 -132 25,048










     

    1 Estimated and based on International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. http://www.diabetesatlas.org; Yau JW et al. Diabetes Care 2012;35(3):556-564; Thomas RL et al. Diabetes Res Clin Pract 2019;157:107840





     

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
  20. KRAKOW, Poland, March 16, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported today its financial results for 2020 highlighting the increase in revenues to PLN 37.3 million, including PLN 15.4 million from partnering agreements and recapped on the most significant clinical and corporate milestones of the past year.

    "The year 2020 was very eventful for us. We announced an updated development strategy, made significant progress in clinical projects and, with the move to our new headquarters, we have completed the largest investment in Ryvu 13-year history. We are working at full speed to bring new…

    KRAKOW, Poland, March 16, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported today its financial results for 2020 highlighting the increase in revenues to PLN 37.3 million, including PLN 15.4 million from partnering agreements and recapped on the most significant clinical and corporate milestones of the past year.

    "The year 2020 was very eventful for us. We announced an updated development strategy, made significant progress in clinical projects and, with the move to our new headquarters, we have completed the largest investment in Ryvu 13-year history. We are working at full speed to bring new treatments to oncology patients and 2021 is shaping up to be an important year for the company" – said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics.

    Przewiezlikowski also draws attention to the most important achievements of the Company in the passing year:

    Strengthening our resources

    "We raised over USD 36 million from the share issue in July 2020, which combined with the grant financing received, gives us financial resources required to fulfill all the goals set until 2023. We have also completed an investment into our fully-owned R&D Center for Innovative Drugs in Krakow. We moved to our new laboratories, finalizing the corporate division between Ryvu and Selvita, now in distinct locations. What's more, additional research space allows us to scale up our discovery and development activities."

    We are bringing oncology treatments closer to patients

    "SEL24/MEN1703 has successfully completed Phase I Clinical Study in Acute Myeloid Leukemia (AML). A couple of months later, the first patient was dosed with SEL24/MEN1703 in Europe within the Expansion Cohort of Phase I/II Study also in AML.

    RVU120 (formerly SEL120), our flagship, fully-owned first in class CDK8/CDK9 inhibitor, has progressed through its first Phase I study in AML and myeloid dysplastic syndrome. The Phase Ib study is on-going in six clinical sites in the U.S. In order to de-risk the study and provide a platform for future development, we decided to activate additional sites in Europe, including Poland. We have already received appropriate official approvals to start research in our country and one of the European countries.

    We are also investigating the development potential of RVU120 in multiple solid tumors, which can potentially significantly increase the market potential for our molecule. We submitted appropriate applications to start clinical trials in 2021. In March this year, we signed a contract with Covance Inc. for the execution of Phase I studies for RVU120 in solid tumors.

    In 2020, We have initiated and are developing a promising research collaboration with Galapagos NV in the area of inflammatory diseases.

    Throughout the year, we actively presented our projects at several scientific and investor conferences.

    We assured business continuity and safety of our employees during COVID-19 pandemic introducing the highest sanitary standards and preventive measures."

    Major Achievements

    February 2020: Ryvu signed a grant agreement for the development of targeted oncology therapies based on the synthetic lethality concept. This grant provides Ryvu with almost USD 8.3 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. The total net value of the project amounts to USD 14 million, and the anticipated project duration is until December 2023.

    March 2020:

    • On March 5, Menarini Group announced the successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a USD 1.96 million milestone payment. The full data from the study was presented as a poster "Results of the dose escalation part of DIAMOND trial (CLI24-001): First-in-human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia", during the Virtual 25th EHA Congress taking place June 11-21.
    • On March 27, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to Ryvu's SEL120 for the treatment of patients with acute myeloid leukemia (AML). The FDA's orphan drug designation allows the drug for the designated indication to be eligible for requesting a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as potential of other development assistance and financial incentives.

    April 2020: Galapagos NV ((Euronext &, NASDAQ:GLPG) and Ryvu Therapeutics announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation. Ryvu will contribute its biology and chemistry platform, as well as related intellectual property, to the program. During the joint research collaboration, Ryvu is responsible for early drug discovery, and Galapagos will be responsible for the further development of this program.

    June 2020:

    • On June 2, Ryvu obtained the occupancy permits for its newly built R&D Center for Innovative Drugs, meaning it has completed the construction of the facility. Subsequently, Ryvu has initiated its move to the new headquarters. The laboratory-office complex is made up of 6 floors with a total area of ca. 108,000 sq. ft. At the heart of the new Ryvu facility is an array of laboratories incl. medicinal chemistry, biochemistry, cell & molecular biology and analytical chemistry, capable of accommodating up to 300 employees. The newly built facilities are located at Sternbach St., named after Dr. Leo Sternbach, a graduate of Jagiellonian University who went on to discover Vallium, the most prescribed drug in the history of the pharmaceutical industry. New building offers Ryvu additional research space and comfort, which turned out to be a great advantage for Ryvu during COVID-19 spatial restrictions. Cost of the investment, including the purchase of a plot of land and laboratory equipment, incurred until February, 2021, amounted to approximately USD 21.2 million, of which ca. USD 6.7 million was covered by the grant financing.
    • On June 3, NodThera, Ryvu spin-off company, secured GBP 44.5 million (USD 54.5 million) Series B financing. NodThera was founded by Epidarex Capital and Ryvu in 2016, based on world class research on NLRP3 inflammasome conducted at Ryvu (at that time Selvita) in 2012-2016. The Company focused on the development of inflammasome inhibitors has already raised over GBP 80.8 million (over USD 100 million) in three funding series. After the full completion of Series B capital increase, Ryvu owns 4.8% share in NodThera.
    • On June 4, Ryvu signed a grant agreement for the development of targeted immuno-oncology therapy, which provides Ryvu with almost USD 5.6 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches.
    • On June 15, Ryvu announced its updated development strategy for 2020-2022, which assumes, i.a.: completing Phase I clinical development of SEL120 in AML/MDS by the end of 2022, expanding therapeutic potential for SEL120 in solid tumors and launching a new Phase I study in selected indications in parallel to the ongoing hemato-oncology studies, advancing at least one program into the Phase I of clinical trials from preclinical pipeline.
    • On June 22-24, Ryvu presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II the most recent data from its oncology projects, including results from the small-molecule STING agonists, dual A2A/A2B adenosine receptors antagonist program, HPK1 inhibitors and SMARCA2 (BRM) degraders program.



    July 2020: Ryvu successfully closed its series I follow-on share offering, with 2,384,245 shares offered at a price of PLN 60 per share. The Company raised over USD 36 million (PLN 143 million) of new capital. Proceeds from the share issue will be allocated primarily to Company's R&D programs.

    September 2020: The first patient has been treated in Europe for the cohort expansion part of Phase II DIAMOND-01 clinical trial (CLI24-001; NCT03008187) investigating SEL24/MEN1703, a first-in-class, oral dual PIM/FLT3 inhibitor, as a single agent in Acute Myeloid Leukemia (AML).

    October 2020: The Management Board of the Company made a strategic decision to revise its preclinical projects' pipeline. As a consequence, the Company stopped the development of two projects: a dual adenosine receptor antagonist (A2A/A2B) and the project in the area of synthetic lethality (SMARCA2). The above decision was made after consultation with the Supervisory Board of the Company. Ryvu now intends to concentrate its resources on the SEL120 project, currently in Phase I clinical trials, as well as the remaining preclinical projects, and assign financing to newly initiated discovery and development projects in the area of synthetic lethality.

    November 2020: Ryvu presented its poster regarding the STING agonists program – "Development of improved small molecule STING agonists suitable for systemic administration", at the Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (SITC 2020).

    December 2020: Announcement of the positive results of the pharmacodynamic assay demonstrating target engagement in the dose escalation part of the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187), a study investigating SEL24/MEN1703 – first-in-class, orally available, dual PIM/FLT3 inhibitor as single agent in acute myeloid leukemia (AML). The poster entitled "SEL24/MEN1703 provides PIM/FLT3 Downstream Pathway Inhibition in Acute Myeloid Leukemia (AML) Blast Cells: Results of the Pharmacodynamic (PD) Assay in the Dose Escalation Part of First-in-Human DIAMOND Trial" was presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.

    Throughout 2020, Ryvu Therapeutics participated and presented at several scientific and investor conferences, including:

    • AACR 2020 Virtual Annual Meeting,
    • Virtual 25th Annual European Hematology Association (EHA) Congress,
    • Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (SITC 2020),
    • Jefferies 2020 Virtual Healthcare Conference,
    • BIO Digital 2020,
    • Solebury Trout Investor Access during JP Morgan 2020,
    • Solebury Trout Virtual Investor Conference,
    • BIO-Europe Spring 2020,
    • 32nd Annual ROTH Conference,
    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference,
    • Erste Group Innovation Conference 2020,
    • Trigon Investor Week,
    • The Finest CEElection Investor Conference by Erste Group,
    • BIO-Europe 2020 - one of the global biotechnology flagship events.

    Important events in Q1 2021, until the report publication date

    January 2021:

    • Ryvu has submitted a new Clinical Trial Application (CTA), seeking approval to commence a Phase I/II trial, investigating the safety and efficacy of RVU120 in patients with relapsed / refractory metastatic or advanced solid tumors. The study will start in selected investigational sites in Europe, and later on at start of phase II, will expand also to other regions.
    • Ryvu Therapeutics' CTA to commence the First In Human (FIH), Phase I trial investigating RVU120, a selective CDK8/CDK19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HRMDS), who have failed the prior standard treatment, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee. Following these approvals, Ryvu Therapeutics can expand the clinical trial already ongoing in the United States also in Poland, aiming to assess the safety and tolerability of RVU120, as well as to determine the Recommended Phase II Dose (RP2D) of the study drug, in participants with AML or HRMDS.

    March 2020: Ryvu Therapeutics has concluded a service agreement with Covance Inc. to conduct a Phase I (dose escalation) part of a Phase I/II clinical study – aimed at determining the safety and efficacy profile of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors.

    Ryvu Financial Results 2020 acc. to IFRS

    In 2020 Ryvu Therapeutics recognized total operating revenue of USD 9.6 million, which constitutes the increase of 9%* compared to the corresponding period in 2019. Revenues from partnering contracts have increased to USD 4.0 million from USD 1.0 million comparing to the corresponding period in 2019. Revenue from subsidies decreased to USD 5.5 million from USD 7.8 million in the previous period year.

    Operational costs related in majority to the research and development expenditures amounted in 2020 to USD 18.7 million, as compared to USD 20.7 million in the same period last year. Operational loss has decreased and amounted to USD 9.2 million, compared to USD 11.8 million in 2019. Net loss amounted to USD 8.1 million compared to USD 11.5 million from the previous year. The realized financial result is in line with Ryvu's strategy, since the company focuses on the increase of projects value, taking into account the plan of commercialization on later stages of development.

    As of December 31, 2020, the value of the Company's liquid financial resources amounted to USD 42.9 million. On March 10, 2021, all liquid financial resources amounted to USD 40.3 million – decrease is caused mainly by operating costs and capital expenditure.

    *Percentage changes in the press release are calculated based on the functional currency [PLN].

    About Ryvu Therapeutics

    Ryvu Therapeutics is a clinical stage drug discovery and development company developing novel small molecule therapies that address emerging targets in oncology. Pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality and immuno-oncology targets. RVU120 (SEL120) is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. The second clinical program of Ryvu is SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia. Other Ryvu programs developed through internal discovery platform are focused on new oncology targets.

    The Company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs more than 150 associates, including more than 80 PhDs. Ryvu is headquartered in Krakow, Poland. Ryvu Therapeutics is listed on the main market of the Warsaw Stock Exchange, and has been a component of sWIG80 index since March 2017. For more information, please see www.ryvu.com.

    Cision View original content:http://www.prnewswire.com/news-releases/ryvu-therapeutics-reports-financial-results-for-2020-301248595.html

    SOURCE Ryvu Therapeutics

    View Full Article Hide Full Article
  21. Leuven, BE, Boston, MA, US – March 8, 2021 – 08.00 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in diabetic eye disease, today announces its management will participate and meet with investors at the following upcoming virtual meetings in March: 
           
        · H.C. Wainwright Global Life Sciences Conference - March 9-10, 2021
     Pre-Recorded Company Presentation, featuring Tom Graney, CFA, CFO to be made live on March 9 at 7:00 am EST.
    The presentation will be available in the events section of Oxurion's website at www.oxurion.com.
    A replay will be available for approximately 90 days following the conference.

        ·14th Annual

    Leuven, BE, Boston, MA, US – March 8, 2021 – 08.00 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in diabetic eye disease, today announces its management will participate and meet with investors at the following upcoming virtual meetings in March: 

           

        · H.C. Wainwright Global Life Sciences Conference - March 9-10, 2021

     Pre-Recorded Company Presentation, featuring Tom Graney, CFA, CFO to be made live on March 9 at 7:00 am EST.

    The presentation will be available in the events section of Oxurion's website at www.oxurion.com.

    A replay will be available for approximately 90 days following the conference.

        ·14th Annual European Life Sciences CEO Forum - March 10-11, 2021

    Pre-Recorded Company Presentation, featuring Patrik De Haes, MD, CEO available on demand for all registered users to view on events portal.

        ·33rd Annual Roth Conference - March 15-17, 2021

    Oxurion to join panel discussion entitled ‘Disruptive Back of the Eye Therapies' which will take place on March 16 at 9:00 am EST.

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 16 75 13 10 / +32 478 33 56 32

    wouter.piepers@oxurion.com





    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com



     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    chris.brinzey@westwicke.com

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.

    Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME.  The Company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy.  THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC)

       
    • THR-687 is a pan-RGD integrin inhibitor, that is initially being developed as a potential new standard of care for all DME patients.  Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021 after receiving regulatory approval.   THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG).

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.  More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.



    Primary Logo

    View Full Article Hide Full Article

  22.  

    • 8.3% patients on placebo and 6.7% patients on filgotinib had a 50% or more decline in sperm concentration at week 13
    • No new safety findings were identified
    • Data will be submitted to the relevant regulatory authorities

    Mechelen, Belgium, 4 March 2021, 07.40 CET, regulated information –Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced interim results from MANTA and MANTA-RAy, two ongoing safety studies investigating the effect of Jyseleca® (filgotinib) on sperm parameters in males with inflammatory bowel disease (MANTA) or rheumatic conditions (MANTA-RAy).

    In total, 248 patients were randomized 1:1 to receive filgotinib 200 mg once daily or placebo for an initial 13-week, double-blind treatment period. The primary endpoint…



     

    • 8.3% patients on placebo and 6.7% patients on filgotinib had a 50% or more decline in sperm concentration at week 13
    • No new safety findings were identified
    • Data will be submitted to the relevant regulatory authorities

    Mechelen, Belgium, 4 March 2021, 07.40 CET, regulated information –Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced interim results from MANTA and MANTA-RAy, two ongoing safety studies investigating the effect of Jyseleca® (filgotinib) on sperm parameters in males with inflammatory bowel disease (MANTA) or rheumatic conditions (MANTA-RAy).

    In total, 248 patients were randomized 1:1 to receive filgotinib 200 mg once daily or placebo for an initial 13-week, double-blind treatment period. The primary endpoint in both trials was the proportion of patients who had a reduction of 50% or more in sperm concentration at Week 13. Patients who met this endpoint discontinued study treatment at Week 13, were switched to standard of care treatment and were monitored for reversibility every 13 weeks for up to 52 weeks.

    Out of the 248 randomized patients, 240 reached Week 13 with two evaluable semen samples at baseline and Week 13. Of those, 18 patients showed a ≥50% decline in sperm concentration, with 10/120 (8.3%) patients on placebo and 8/120 (6.7%) patients on filgotinib. These studies, which were designed with the input of the relevant health authorities, are not powered for statistical comparison between groups. These data will now be submitted to relevant regulatory authorities.

    Beyond the double-blind, placebo-controlled, 13-week period, for which MANTA and MANTA-RAy results are pooled, patients who did not meet the primary endpoint of 50% or more decline in sperm motility or morphology could continue under their respective trial protocol on blinded treatment, receive open-label filgotinib or receive standard of care therapy based on disease response, for another 13 weeks before entering a long-term extension period. At any point, patients exhibiting a predetermined sperm decline enter a monitoring phase in which they are assessed every 13 weeks for reversibility for up to 52 weeks.

    As the MANTA and MANTA-RAy trials are ongoing, and to maintain data integrity, Galapagos and Gilead intend to report additional results only after all patients in the monitoring phase have completed the protocol-defined observation period.

    "We are pleased the interim results reported today will be submitted to the relevant regulatory authorities," said said Dr. Walid Abi-Saab, CMO of Galapagos.

    When the MANTA and MANTA-RAy trials are completed, Galapagos and Gilead intend to submit the full results for publication in a peer-reviewed medical journal.

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200 mg and 100 mg tablets) in Europe, Great Britain and Japan for the treatment of adults with moderately to severely active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. Filgotinib was submitted to the European Commission for an extended indication for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

    With the exception of filgotinib's approval for the treatment of RA by the European Commission and Japanese Ministry of Health, Labour and Welfare, all of our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority and they are not yet approved for any use outside of clinical trials.

    About the MANTA and MANTA-RAy Studies

    MANTA is a Phase 2 safety study being conducted by Gilead in men with moderate/severe active ulcerative colitis (UC) or Crohn's disease (CD) to assess semen parameters while taking filgotinib. MANTA-RAy is a similar study being conducted by Galapagos outside the US, in men with rheumatic diseases. The results of both studies have been pooled in the interim results of the primary endpoint.

    About Galapagos

    Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs (including but not limited to the data from the up to 52 weeks monitoring phase of the MANTA and MANTA-RAy trials) with filgotinib may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of additional regulatory authorities approval of marketing authorization for filgotinib, such additional regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to completing and implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Evelyn Fox

    Communications & Public Affairs

    +31 653 591 999

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com



     

    Attachment



    View Full Article Hide Full Article
  23. Mechelen, Belgium; 3 March 2021; 22.15 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) received a new transparency notification from The Capital Group Companies, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 26 February 2021 from The Capital Group Companies, Inc., who notified that it holds 9.91% of the current 65,411,767 outstanding Galapagos shares. The Capital Group Companies, Inc. thus crossed below the 10% threshold of Galapagos' voting rights by disposing of voting securities on 22 February 2021. The full transparency notice is available on the Galapagos website.

    About Capital Group
    Capital Group controls Capital Bank & Trust Company and Capital Research…

    Mechelen, Belgium; 3 March 2021; 22.15 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a new transparency notification from The Capital Group Companies, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 26 February 2021 from The Capital Group Companies, Inc., who notified that it holds 9.91% of the current 65,411,767 outstanding Galapagos shares. The Capital Group Companies, Inc. thus crossed below the 10% threshold of Galapagos' voting rights by disposing of voting securities on 22 February 2021. The full transparency notice is available on the Galapagos website.

    About Capital Group

    Capital Group controls Capital Bank & Trust Company and Capital Research & Management Company through its direct subsidiary Capital Group International, Inc. ("CGII"), controls four CGII investment management companies (Capital International, Inc.; Capital International Limited, Capital International Sàrl; and Capital International K.K.), which all together hold 6,483,973 of Galapagos' voting rights, consisting of ordinary shares, which represents 9.91%.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com








    1  Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market





    Attachment



    View Full Article Hide Full Article
  24. Key 2020 events:

    • Jyseleca approved for rheumatoid arthritis (RA) in Europe & Japan
    • Gilead decided not to pursue the RA indication in the U.S. as a result of Complete Response Letter (CRL) from the Food and Drug Administration (FDA)
    • Galapagos to assume commercialization of Jyseleca in Europe by the end of 2021, first sales achieved
    • Primary endpoint achieved in SELECTION Phase 3 trial in ulcerative colitis (UC) with Jyseleca, submitted for approval in UC in Europe
    • Positive topline results in PINTA Phase 2 trial with ‘1205 in idiopathic pulmonary fibrosis (IPF); no signal with ‘1972 in ROCCELLA Phase 2b trial in osteoarthritis (OA)
    • Initiation of five Proof-of-Concept studies with Toledo program lead candidate ‘3970, a SIK2/3 inhibitor
    • Sale…

    Key 2020 events:

    • Jyseleca approved for rheumatoid arthritis (RA) in Europe & Japan
    • Gilead decided not to pursue the RA indication in the U.S. as a result of Complete Response Letter (CRL) from the Food and Drug Administration (FDA)
    • Galapagos to assume commercialization of Jyseleca in Europe by the end of 2021, first sales achieved
    • Primary endpoint achieved in SELECTION Phase 3 trial in ulcerative colitis (UC) with Jyseleca, submitted for approval in UC in Europe
    • Positive topline results in PINTA Phase 2 trial with ‘1205 in idiopathic pulmonary fibrosis (IPF); no signal with ‘1972 in ROCCELLA Phase 2b trial in osteoarthritis (OA)
    • Initiation of five Proof-of-Concept studies with Toledo program lead candidate ‘3970, a SIK2/3 inhibitor
    • Sale of fee-for-service business Fidelta to Selvita
    • Business development deals to complement the inflammation & fibrosis pipelines

    Financial results:

    • Group revenues & other income from continuing operations of €530 million, compared to €886 million in 2019
    • Net loss of €305 million, compared to a net profit of €150 million in 2019
    • Operational cash burn¡ of €517 million, within the guided range
    • Strong balance sheet with cash and current financial investments of €5.2 billion and €2.8 billion in deferred revenues

           

    Audio webcast presentation tomorrow, 19 February 2021 at 14.00 CET/8 AM ET, +32 (0)2 793 3847, code 8873918, https://www.glpg.com/webcasts

    Mechelen, Belgium; 18 February 2021, 22.01 CET, regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) presents financial results 2020 and reviews the key events for the full year 2020.

    "We are turning the page on an eventful 2020," said Onno van de Stolpe, CEO of Galapagos. "We received the very disappointing CRL from the FDA for Jyseleca for RA, and as a result, our partner Gilead will not commercialize Jyseleca in the U.S. in this indication. That being said, 2020 is also marked by our first ever approval in both Europe and Japan, and with the renegotiated agreement with Gilead, we are excited to bring Jyseleca to patients throughout Europe. Moreover, following the positive Phase 3 results in UC, we are looking forward to potentially adding a second indication in Europe in 2021.

    Our earlier inflammation pipeline continues to advance, including our Toledo program, where we currently are conducting 5 patient trials with our SIK2/3 inhibitor ‘3970, with read-outs of three Proof-of-Concept trials (PoCs) expected mid this year.

    In our fibrosis portfolio we made progress last year, with the positive topline results in our PINTA trial in IPF, preclinical candidate nomination of a new Toledo compound directed toward IPF, and the inlicensing of exciting new molecules. We recently discontinued all development with ziritaxestat due to an insufficient risk-benefit profile observed in the ISABELA Phase 3 program.

    Given the recent setbacks in our late stage portfolio, we aim to assess lessons learned and will continue to reassess the R&D portfolio in light of this learning."

    Bart Filius, COO and CFO of Galapagos, added: "We ended 2020 with again a very strong balance sheet, providing us with the capital to leverage our R&D engine to execute on our novel target based programs. We remain focused on investing in our maturing clinical pipeline of candidates. We landed our operational cash burni in 2020 in line with our guidance at €517 million, including the milestones received for the approval of Jyseleca in Europe and Japan. Following the very recent discontinuation of the ziritaxestat trials, we aim to review our plans for 2021, after which we expect to give cash burn guidance for 2021."

    Key figures (consolidated)

    (€ millions, except basic & diluted income/loss (-) per share)

      31 Dec 2020 Group total 31 Dec 2019 Group total (*)
    Revenues and other income 530.3 885.8
    R&D expenditure -523.7 -420.1
    G&Aii and S&M expensesiii -185.2 -97.0
    Operating profit / loss (-) -178.6 368.7
     



    Fair value re-measurement of financial instruments
    3.0 -181.6
    Other financial result -134.2 -38.6
    Income taxes -1.2 0.2
    Net profit / loss (-) from continuing operations



     



    Net profit from discontinued operations



     



    Net profit / loss (-) of the year



     



     
    -311.0



     



     



    5.6



     



     



    -305.4
    148.7



     



     



    1.1



     



     



    149.8
    Basic income / loss (-) per share (€)

    Diluted income / loss (-) per share (€)



     
    -4.69



     



    -4.69
    2.60



     



    2.49
    Current financial investments and cash and cash equivalents at year-end 5,169.3 5,780.8

    (*) The 2019 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.

    Details of the financial results

    We previously held two operating segments. Due to the completion of the sale of our fee-for-service business (Fidelta) to Selvita on the 4th January 2021 for an enterprise value of €31.2 million (plus the customary adjustments for net cash and working capital), the results of Fidelta are presented as "Net results from discontinued operations" in our consolidated income statements for the year 2020 and 2019.

    Revenues and other income from continuing operations

    Our revenues and other income from continuing operations for 2020 amounted to €530.3 million, compared to €885.8 million in 2019. Revenues (€478.1 million in 2020 compared to €834.9 million in 2019) were lower due to the one-time revenue recognition in 2019 of the upfront payment received from Gilead in August 2019 related to ziritaxestat for €667.0 million. In 2020, our revenues from the Gilead collaboration (€473.9 million) related to (i) the exclusive access to our drug discovery platform (€229.6 million) and (ii) the filgotinib revenue recognition (€228.1 million). Additionally we have recognized royalty income from Gilead for Jyseleca for €16.2 million.

    Due to the approval of Jyseleca by both the Japanese and European authorities on 25 September 2020, we received a total milestone of $105.0 million (€90.2 million) from Gilead. As a consequence of the recently renegotiated collaboration for filgotinib, we also have accrued for a €160 million payment expected from Gilead in our 2020 financial statements. Both amounts are recognized in revenue over time until the end of the development period.

    Our deferred income balance on 31 December 2020 includes €2.0 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and €0.8 billion for the filgotinib development (including considerations for the previous and the renegotiated collaboration combined) that is recognized over time until the end of the development period.

    Other income (€52.2 million vs €50.9 million for the same period last year) mainly consists of incentives income from the government for our R&D activities.

    Results from continuing operations

    We realized a net loss from continuing operations in 2020 of €311.0 million, compared to a net profit of €148.7 million in 2019.

    We reported a net operating loss in 2020 of €178.6 million, compared to a net operating profit of €368.7 million in 2019.

    Our R&D expenditure increased by 25% in 2020 to €523.7 million compared to €420.1 million in 2019. This planned increase was mainly due to an increase in subcontracting costs primarily related to our filgotinib program, our Toledo program and other clinical programs. Furthermore, personnel costs increased, explained by a planned headcount increase following the growth in our R&D investments, and increased cost of the subscription right plans. This factor, and the increased cost of the commercial launch of Jyseleca in Europe, contributed to the increase in our S&M and G&A expenses which were respectively €66.5 million and €118.8 million in 2020, compared to €24.6 million and €72.4 million in 2019.

    We reported a non-cash fair value gain amounting to €3.0 million resulting from the re-measurement of initial warrant B issued to Gilead, primarily due to the evolution of the Galapagos share price and its implied volatility.

    Net other financial loss in 2020 amounted to €134.2 million, compared to net other financial loss of €38.6 million in 2019, and was primarily attributable to €106.4 million of unrealized exchange loss on our cash and cash equivalents and current financial investments in U.S. dollars (€10.6 million of unrealized exchange loss in 2019), and to €15.9 million of negative changes in (fair) value of current financial investments (€3.1 million of net negative changes in (fair) value in 2019).

    Group net results

    We reported a group net loss in 2020 of €305.4 million, compared to a group net profit of €149.8 million in 2019.

    Cash position

    Current financial investments and cash and cash equivalents totaled €5,169.3 million on 31 December 2020, as compared to €5,780.8 million on 31 December 2019.

    The net decrease comprises (i) €517.4 million of operational cash burn, within the guided range, (ii) offset by €28.3 million of cash proceeds from capital and share premium increase from the exercise of subscription rights in 2020, and (iii) €106.4 million of unrealized negative exchange rate differences and €15.9 million of negative changes in (fair) value of current financial investments.

    Furthermore, our balance sheet on 31 December 2020 held a receivable from the French government (Crédit d'Impôt Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €135.7 million.

    Outlook 2021

    We anticipate a year filled with announcements on regulatory developments with Jyseleca as well as progress in our deep pipeline of novel target-based candidates.

    In early 2021, Jyseleca received a recommendation by NICE in the UK for use in moderate to severe active RA patients. This is a landmark decision, as Jyseleca is the first JAK inhibitor and first advanced therapy recommended by NICE in the moderate disease population. Going forward, we anticipate reimbursement decisions in most key European markets for Jyseleca in RA this year, as we complete the transition to a full European commercial operation by year end. We anticipate a Committee for Medicinal Products for Human Use (CHMP) opinion and a European Commission  (EC) approval decision for Jyseleca in UC, as well as Gilead's submission for approval of Jyseleca in UC in Japan. We expect to update the markets on the MANTA/RAy semen parameter studies, which determines the path forward for inflammatory bowel disease (IBD) indications with Jyseleca in the U.S. We expect that our collaboration partner Gilead will complete recruitment for the global DIVERSITY Phase 3 trial in Crohn's disease this year.

    Within our broader inflammation portfolio, we expect to report topline results from several trials this year, including a Phase 1b trial with TYK2 inhibitor ‘3667 in psoriasis, a Phase 1b trial with JAK1 inhibitor ‘555 via intra-articular injection in OA, and three proof-of-concept studies with lead Toledo candidate SIK2/3 inhibitor ‘3970 in psoriasis, UC and RA.

    Within our fibrosis portfolio, we expect to progress early clinical compounds with novel mechanisms of action, casting a wide net with the aim to develop novel treatments to help patients suffering from this debilitating disease.

    Following the very recent discontinuation of the ziritaxestat trials, we aim to review our plans for 2021, after which we expect to give cash burn guidance for 2021.

    Annual report 2020

    Galapagos is currently finalizing its financial statements for the year ended 31 December 2020. The auditor has confirmed that his audit procedures, which are substantially completed, have not revealed any material corrections required to be made to the financial information included in this press release. Should any material changes arise during the audit finalization, an additional press release will be issued. Galapagos expects to be able to publish its fully audited annual report for the full year 2020 on or around 25 March 2021.

    Conference call and webcast presentation

    Galapagos will conduct a conference call open to the public tomorrow, 19 February 2021, at 14:00 CET/8 AM ET, which will also be webcasted. To participate in the conference call, please call one of the following numbers, ten minutes prior to scheduled start of the call:

    Confirmation Code:        8873918

    Belgium: +32 2 793 3847
    France: +33 1 70 700 781
    Netherlands:      +31 20 795 6614
    United Kingdom: +44 2071 928338
    United States:    +1 646 741 3167



     

    A question and answer session will follow the presentation of the results. Go to https://www.glpg.com/webcasts to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

    Financial calendar

    25 March 2021               Publication Annual Report and 20-F 2020

    28 April 2021                 Annual Shareholders' meeting in Mechelen, Belgium

    6 May 2021                   First quarter 2021 results (webcast 7 May)

    5 August 2021                Half year 2021 results (webcast 6 August)

    4 November 2021          Third quarter 2021 results (webcast 5 November)

    24 February 2022           Full year 2021 results (webcast 25 February)

    About Galapagos

    Galapagos ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which showed promising patient results and are currently in late-stage development in multiple diseases. Galapagos' pipeline comprises discovery programs through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. The Company's ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines.

    With the exception of filgotinib's approval for the treatment of RA by the European Commission and Japanese Ministry of Health, Labour and Welfare, all of our drug candidates  are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority and they are not yet approved for any use outside of clinical trials.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead and regarding the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), including Gilead's recruitment in the Phase 3 trial in Crohn's disease, the amount and timing of potential future milestones, opt-in and/or royalty payments by Gilead, Galapagos' strategic R&D ambitions and potential changes of such ambitons, the guidance from management (including the timing and/or outcome of the review of our plans for 2021, and of the guidance regarding the expected operational cash burn during financial year 2021), commercialization of Jyseleca, including in Europe, financial results, timing and/or results of clinical trials, including trials with our SIK2/3 inhibitor ‘3970 (Toledo), TYK2 inhibitor ‘3667, JAK1 inhibitor ‘555, and ziritaxestat and the MANTA/MANTA-RAy trials with filgotinib, mechanisms of action and potential commercialization of our product candidates, interaction with regulators, the timing or likelihood of additional regulatory authorities' approval of marketing authorization for filgotinib for RA, UC or any other indication, including UC and IBD indication for Jyseleca in Europe, Japan, and the US, such additional regulatory authorities requiring additional studies, the timing or likelihood of reimbursement decisions for filgotinib, including in key European markets, statements relating to the build-up of our commercial organization for filgotinib, the expected impact of COVID-19, and our strategy, business plans and focus.Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that Galapagos' expectations regarding its 2021 operating expenses may be incorrect (including because one or more of its assumptions underlying its expense expectations may not be realized), Galapagos' expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from Galapagos' ongoing clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons, including ziritaxestat for IPF, systemic sclerosis or any other indication), Galapagos' reliance on collaborations with third parties (including our collaboration partner for filgotinib and ziritaxestat, Gilead), that Galapagos' expectations regarding the timing of and the risks related to completing and implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib) and Galapagos' expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, and the inherent uncertainty associated with estimating the commercial potential of our product candidates, including Galapagos' estimates regarding the commercial potential of ziritaxestat, and the possibility that Galapagos and Gilead may make a strategic decision to discontinue development of ziritaxestat and that ziritaxestat may as a result never be successfully commercialized, including unanticipated expenses in connection with such decision and the potential effects on Galapagos' revenues and earnings, and the uncertainties relating to the impact of the COVID-19 pandemic. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.


    i The operational cash burn (or operational cash flow if this performance measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:

    i.the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated / used (–) in financing activities

    ii.the net proceeds or cash used, if any, in acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, included in the net cash flows generated / used (–) in investing activities. This alternative performance measure is in our view an important metric for a biotech company in the development stage.

    The operational cash burn for 2020 amounted to €517.4 million and can be reconciled to our cash flow statement by considering the increase in cash and cash equivalents of €352.0 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €28.3 million and (ii) the net sale of current financial investments amounting to €841.1 million.

    ii General and administrative

    iii Sales and marketing

    iv Crédit d'Impôt Recherche refers to an innovation incentive system underwritten by the French government.





     

     

    Attachments



    View Full Article Hide Full Article
  25. Galapagos NV ((Euronext &amp, NASDAQ:GLPG) and Gilead Sciences (NASDAQ:GILD) today announced the decision to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat's benefit-risk profile no longer supported continuing these studies. Detailed data of the ISABELA studies will be presented at future medical meetings.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210210005578/en/

    Investigators are being informed of the…

    Galapagos NV ((Euronext &, NASDAQ:GLPG) and Gilead Sciences (NASDAQ:GILD) today announced the decision to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat's benefit-risk profile no longer supported continuing these studies. Detailed data of the ISABELA studies will be presented at future medical meetings.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210210005578/en/

    Investigators are being informed of the decision and they will be contacting their study participants to discontinue the investigational treatment.

    The ISABELA Phase 3 program consists of two identically designed trials, ISABELA 1 & 2, aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized on to either 200 mg or 600 mg ziritaxestat once daily or placebo. The primary endpoint was the rate of decline of forced vital capacity until week 52.

    "We are very disappointed not to be able to bring a novel medication to patients suffering from such a devastating disease with high unmet need. We would like to thank the patients and the medical professionals who participated in the ISABELA studies and contributed to the advancement of IPF research. We intend to learn from this data in our continued commitment to develop therapies in IPF and fibrosis," said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.

    "We are extremely disappointed by this news. Despite this setback, we remain committed to leveraging our novel target research engine and strong cash balance to discover potential therapies for IPF and fibrosis," said Onno van de Stolpe, CEO of Galapagos.

    Ziritaxestat (GLPG1690) is an investigational autotaxin inhibitor discovered by Galapagos. Gilead in-licensed ex-European rights to ziritaxestat in July 2019 and commenced sharing the Phase 3 development costs.

    All clinical trials with ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued.

    About Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Gilead Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead may not realize any anticipated benefits from the collaborations with Galapagos; difficulties or unanticipated expenses in connection with the collaborations; the potential effects on Gilead's revenues and earnings; the ability of the companies to discover, develop and commercialize any products under the collaborations; the ability of the companies to initiate and complete clinical trials involving any product candidates under the collaborations in the currently anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving any product candidates under the collaborations; uncertainties relating to regulatory applications and related filing and approval timelines, the risk that any marketing approvals, if granted, may have significant limitations on its use; the possibility that the companies may make a strategic decision to discontinue development of involving any product candidates under the collaborations, and as a result, such products may never be successfully commercialized; and the accuracy of any assumptions underlying any of the foregoing. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    Galapagos Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with ziritaxestat may not support registration or further development due to safety, efficacy or other reasons for IPF, systemic sclerosis or any other indication, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for ziritaxestat, the uncertainty regarding estimates of the commercial potential of ziritaxestat, and the possibility that Galapagos and Gilead may make a strategic decision to discontinue development of ziritaxestat and that ziritaxestat may as a result never be successfully commercialized, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Ziritaxestat is investigational; its efficacy and safety have not been fully evaluated by any regulatory authority and it is not yet approved for any use outside of clinical trials.

    View Full Article Hide Full Article
  26. Foster City, CA and Mechelen, Belgium, 10 February 2021, 15.00 CET; regulated information –  Galapagos NV ((Euronext &amp, NASDAQ:GLPG) and Gilead Sciences (NASDAQ:GILD) today announced the decision to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat's benefit-risk profile no longer supported continuing these studies. Detailed data of the ISABELA studies will be presented at future medical meetings.

    Investigators are being informed of the decision and they will…

    Foster City, CA and Mechelen, Belgium, 10 February 2021, 15.00 CET; regulated information –  Galapagos NV ((Euronext &, NASDAQ:GLPG) and Gilead Sciences (NASDAQ:GILD) today announced the decision to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat's benefit-risk profile no longer supported continuing these studies. Detailed data of the ISABELA studies will be presented at future medical meetings.

    Investigators are being informed of the decision and they will be contacting their study participants to discontinue the investigational treatment.

    The ISABELA Phase 3 program consists of two identically designed trials, ISABELA 1 & 2, aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized on to either 200mg or 600mg ziritaxestat once daily or placebo. The primary endpoint was the rate of decline of forced vital capacity until week 52.

    "We are very disappointed not to be able to bring a novel medication to patients suffering from such a devastating disease with high unmet need. We would like to thank the patients and the medical professionals who participated in the ISABELA studies and contributed to the advancement of IPF research. We intend to learn from this data in our continued commitment to develop therapies in IPF and fibrosis," said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.

    "We are extremely disappointed by this news. Despite this setback, we remain committed to leveraging our novel target research engine and strong cash balance to discover potential therapies for IPF and fibrosis," said Onno van de Stolpe, CEO of Galapagos.

    Ziritaxestat (GLPG1690) is an investigational autotaxin inhibitor discovered by Galapagos. Gilead in-licensed ex-European rights to ziritaxestat in July 2019 and commenced sharing the Phase 3 development costs.

    All clinical trials with ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued.

    About Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Contacts Galapagos  
    Investors: Media:
    Elizabeth Goodwin   Carmen Vroonen
    VP IR  Global Head of Communications & Public Affairs
    +1 781 460 1784  +32 473 824 874
       
    Sofie Van Gijsel   Anna Gibbins
    Senior Director IR     Senior Communications Director – Therapeutic Areas
    +32 485 19 14 15    +44 (0) 7717 801900
    ir@glpg.com communications@glpg.com
       
    Contacts Gilead  
    Investors: Media:
    Jacquie Ross Arran Attridge
    +1 (408) 656-8793 +1 (650) 425-8975

    Gilead Forward-Looking Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead may not realize any anticipated benefits from the collaborations with Galapagos; difficulties or unanticipated expenses in connection with the collaborations; the potential effects on Gilead's revenues and earnings; the ability of the companies to discover, develop and commercialize any products under the collaborations; the ability of the companies to initiate and complete clinical trials involving any product candidates under the collaborations in the currently anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving any product candidates under the collaborations; uncertainties relating to regulatory applications and related filing and approval timelines, the risk that any marketing approvals, if granted, may have significant limitations on its use; the possibility that the companies may make a strategic decision to discontinue development of involving any product candidates under the collaborations, and as a result, such products may never be successfully commercialized; and the accuracy of any assumptions underlying any of the foregoing. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's periodic reports filed with the U.S.  Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    Galapagos Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with ziritaxestat may not support registration or further development due to safety, efficacy or other reasons for IPF, systemic sclerosis or any other indication, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for ziritaxestat, the uncertainty regarding estimates of the commercial potential of ziritaxestat, and the possibility that Galapagos and Gilead may make a strategic decision to discontinue development of ziritaxestat and that ziritaxestat may as a result never be successfully commercialized, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Ziritaxestat is investigational; its efficacy and safety have not been fully evaluated by any regulatory authority and it is not yet approved for any use outside of clinical trials.

    Attachment



    View Full Article Hide Full Article
  27. Mechelen, Belgium; 9 February 2021; 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) received a new transparency notification from The Capital Group Companies, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 5 February 2021 from The Capital Group Companies, Inc., that it holds 10.03% of the current 65,411,767 outstanding Galapagos shares. The Capital Group Companies, Inc. thus crossed above the 10% threshold of Galapagos' voting rights by purchase of voting securities on 22 January 2021. The full transparency notice is available on the Galapagos website.

    About Capital Group
    Capital Group controls Capital Bank & Trust Company and Capital Research & Management…

    Mechelen, Belgium; 9 February 2021; 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a new transparency notification from The Capital Group Companies, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 5 February 2021 from The Capital Group Companies, Inc., that it holds 10.03% of the current 65,411,767 outstanding Galapagos shares. The Capital Group Companies, Inc. thus crossed above the 10% threshold of Galapagos' voting rights by purchase of voting securities on 22 January 2021. The full transparency notice is available on the Galapagos website.

    About Capital Group

    Capital Group controls Capital Bank & Trust Company and Capital Research & Management Company through its direct subsidiary Capital Group International, Inc. ("CGII"), controls four CGII investment management companies (Capital International, Inc.; Capital International Limited, Capital International Sàrl; and Capital International K.K.), which all together hold 6,563,320 of Galapagos' voting rights, consisting of ordinary shares (6,559,874) and equivalent financial instruments (right to recall lent American Depository Shares) (3,446), which represents 10.03%.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com




    1  Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market





     

     

    Attachment



    View Full Article Hide Full Article
  28.   NOT FOR DISTRIBUTION IN THE UNITED KINGDOM

     

    • NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1
    • More than 400,000 people across the UK live with RA2 and around 70% have moderate or severe disease3

    Mechelen, Belgium, 21 January 2021, 08:05 CET –  Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA® (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible…

      NOT FOR DISTRIBUTION IN THE UNITED KINGDOM

     

    • NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1
    • More than 400,000 people across the UK live with RA2 and around 70% have moderate or severe disease3

    Mechelen, Belgium, 21 January 2021, 08:05 CET –  Galapagos NV ((Euronext &, NASDAQ:GLPG) today welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA® (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).1 It is the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the potential to achieve remission earlier - potentially slowing the irreversible damage and life-limiting symptoms RA can cause.2 RA is a degenerative auto-immune disease that can cause life-threatening complications.4 The sooner treatment begins, the better the chance of slowing disease progression.2 With thousands of people potentially eligible, the recommendation could help improve many lives as well as lessen the significant societal burden RA has in England.5,6

     "We are delighted with the NICE recommendation for Jyseleca today. For patients with moderate to severe RA in England this decision represents a significant new opportunity and especially for those with moderate symptoms who can now receive an advanced treatment earlier," said Onno van de Stolpe, Galapagos CEO.

    Filgotinib is a once daily oral pill that can be given on its own (as a monotherapy) or used alongside another common RA medicine, called methotrexate.7 Eligible patients with moderate or severe RA will have responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs).1 Eligible patients with severe disease will also have wider access to filgotinib in line with criteria defined by NICE. Filgotinib is an advanced therapy which, in RA, is a term used to describe biologic DMARDs and targeted synthetic DMARDs.1

    More than 400,000 people in the UK live with RA (around 380,000 in England), and it is recognised as a condition that can cause debilitating physical pain, affect mental health and require chronic care.2 Studies have shown that RA shortens life expectancy, with some estimates putting this at around 10 years.8 Nearly 50% of patients diagnosed with RA suffer from mental health issues with 1 in 6 people having a major depressive disorder.6,9 RA is also a significant burden on the UK economy. Around a third of people diagnosed with RA stop work within two years of diagnosis10 and the combined cost of workdays lost due to osteoarthritis and RA in the UK was estimated at £2.58 billion in 2017 – estimated to rise to £3.43 billion by 2030.5

    NICE guidance covers England. Wales and Northern Ireland are expected to follow the guidance with timelines for implementation currently under consideration. Filgotinib will be reviewed separately by the Scottish Medicines Consortium for use on the NHS in Scotland.

    Under a new arrangement between Gilead and Galapagos, announced in December 2020, Galapagos will assume sole responsibility for filgotinib in Europe, including the UK. Through a phased transition the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021.

    About filgotinib7

    Filgotinib is a Janus-kinase (JAK) inhibitor and works by preferentially targeting JAK1, part of a specific pathway involved in inflammation – an immune response of the body that causes symptoms of RA. In clinical studies, filgotinib has been shown to significantly improve the chance of disease remission (a DAS28-CRP score of <2.6, indicating few or no symptoms).7 In the FINCH 1 study of 1,755 patients with RA who had an inadequate response to methotrexate, 34% of patients given filgotinib 200mg + methotrexate (n=475) achieved disease remission after just 12 weeks, compared to 9% of a group given placebo (n=475). After 24 weeks, 48% of patients in this group had achieved remission vs. 16% of those on placebo and these response levels were sustained through 52 weeks. In many cases, responses were seen within two weeks (measured using an ACR20 score).

    Data supporting filgotinib include more than 3,800 patients treated across the Phase 3 FINCH and Phase 2 DARWIN programmes. In the FINCH studies, filgotinib consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or methotrexate.

    Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness. Rates of herpes zoster and pneumonia were uncommon. The frequency of serious infections in the filgotinib 200mg group was 1.0 percent compared with 0.6 percent in the placebo group. In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) with filgotinib were comparable to placebo. The rates of serious infections remained stable with long-term exposure.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Except for filgotinib's approval for the treatment of RA by the European Commission and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority and they are not yet approved for any use outside of clinical trials.

    Galapagos Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of additional regulatory authorities approval of marketing authorization for filgotinib, such additional regulatory authorities requiring additional studies, the timing or likelihood of additional guidance or final appraisal determinations for filgotinib, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to completing and implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

    CONTACTS:

    Investors:                                                                                                      

    Elizabeth Goodwin                                                                                    

    VP Investor Relations

     +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Communications Director

    +44 (0) 7717 801900

    mailto:communications@glpg.com

                                                                                                                      

    ▼ The black triangle next to JYSELECA® means that it is subject to additional monitoring. This is to allow quick identification of new safety information. Patients can help with this by reporting any side effects that they experience. More information can be found online at https://www.mhra.gov.uk/yellowcard


    References

    1 National Institute for Health and Care Excellence. Filgotinib for treating moderate to severe rheumatoid arthritis ID1632. Available at: https://www.nice.org.uk/guidance/proposed/gid-ta10541. Accessed: January 2021

    2 National Rheumatoid Arthritis Society. What is RA? Available at https://www.nras.org.uk/what-is-ra-article Accessed: January 2021

    3 Data on file. Gilead Science Ltd. UK-INF-2020-09-0025

    4 NHS. (2019). Rheumatoid Arthritis. Available: https://www.nhs.uk/conditions/rheumatoid-arthritis/ Accessed January 2021.

    5 Versus Arthritis, 2019. The State of Musculoskeletal Health 2019. Available at:

    https://www.versusarthritis.org/media/14594/state-of-musculoskeletal-health-2019.pdf Accessed: January 2021

    6 Versus Arthritis. Versus Arthritis representation to the Budget 2018. September 2018. Key fact available at

    https://www.versusarthritis.org/media/1996/versus-arthritis-response-budget-2018pdf.pdf Accessed: January 2021

    7 Filgotinib summary of product characteristics. Available at Jyseleca, INN-filgotinib (europa.eu) Accessed January 2021.

    8 NRAS – How Is life expectancy affected by RA? Available at NRAS - National Rheumatoid Arthritis Society Accessed: January 2021

    9 KCL. (2018). Mental health linked to disease flare of patients with rheumatoid arthritis. Available: https://www.kcl.ac.uk/news/mental-health-linked-to-disease-flare-of-patients-with-rheumatoid-arthritis-3 Accessed January 2021.

    10 NICE. (2018). Rheumatoid arthritis in adults: management. Available: https://www.nice.org.uk/guidance/ng100/resources/rheumatoid-arthritis-in-adults-management-pdf-66141531233989 Accessed January 2021.

     

     

    Attachment



    View Full Article Hide Full Article
  29. Leuven, BE and Boston, MA, US - January 20, 2021 – 08.00 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a focus on diabetic macular edema (DME), is pleased to announce the appointment of Professor Alan Stitt, Ph.D. as the company's Chief Scientific Officer (CSO), effective January 19, 2021. This appointment follows the retirement of current CSO Jean Feyen, PhD, who has served in this position since joining the company in 2013. Dr. Feyen will remain available to the company during a transition period to support Professor Stitt and the rest of the pre-clinical development team. 

    Professor Stitt is the Chair of Experimental Ophthalmology…

    Leuven, BE and Boston, MA, US - January 20, 2021 – 08.00 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a focus on diabetic macular edema (DME), is pleased to announce the appointment of Professor Alan Stitt, Ph.D. as the company's Chief Scientific Officer (CSO), effective January 19, 2021. This appointment follows the retirement of current CSO Jean Feyen, PhD, who has served in this position since joining the company in 2013. Dr. Feyen will remain available to the company during a transition period to support Professor Stitt and the rest of the pre-clinical development team. 

    Professor Stitt is the Chair of Experimental Ophthalmology at Queen's University of Belfast and is internationally known for his research in ophthalmology, particularly in basic science relating to the pathogenesis of retinal diseases, especially diabetic retinopathy and age-related macular degeneration. He has also been awarded many accolades for his research including a Royal Society Merit Award, election to membership of the Royal Irish Academy (RIA) and Fellowship of the Association for Research in Vision & Ophthalmology (ARVO).

    Beyond his research programme, Alan contributes significantly to the international academic community by serving on advisory boards and grant panels and has a range of editor and editorial board memberships in the ophthalmology are­­na.  Going forward, Alan will continue to perform his University duties and affiliations on a part time basis.

    "I am excited to be joining Oxurion, a highly innovative company that I know well from my academic collaborations that have contributed to the selection and early development of THR-149 and THR-687," said Professor Alan Stitt. "I look forward to working with their great team of scientists to help advance and broaden Oxurion's highly promising pipeline. This comprises of novel drug candidates with differentiated modes of action targeting retinal disorders such as DME, but also dry AMD, for which there are currently no treatment options."

    Patrik De Haes, M.D., CEO of Oxurion, said: "We are delighted to welcome Alan, with whom we have collaborated successfully for many years, to Oxurion to lead and direct our scientific research efforts. His successful research career in eye disease, extensive international network, and experience in translating science into clinical leads provide an ideal skill set to enhance our discovery and pre-clinical efforts. I look forward to working with Alan as our CSO as we pursue our mission to prevent vision loss and fight blindness worldwide by developing and delivering next generation treatments for key retinal disorders such as DME and dry AMD.

    "I would like to thank Jean for his leadership of the company's pre-clinical development activities over the last several years which has been instrumental in building Oxurion's success to date. We are grateful for his support during the transition and wish him well in his retirement." 

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 16 75 13 10 / +32 478 33 56 32

    wouter.piepers@oxurion.com
    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571

    oxurion@citigatedewerogerson.com

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.

    Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

    • THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME.  The company is currently conducting a Phase 2 clinical trial evaluating multiple injections of THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy.  THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC)

       
    • THR-687 is a pan-RGD integrin inhibitor, that is initially being developed as a potential new standard of care for all DME patients.  Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021 after receiving regulatory approval.   THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG).

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.  More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

     



    Primary Logo

    View Full Article Hide Full Article
  30. Mechelen, Belgium; 11 January 2021; 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a transparency notification from Gilead Sciences, Inc.

    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 6 January 2021 from Gilead Sciences, Inc., who notified a change in the chain of intermediary companies through which Gilead holds its shares in Galapagos. The change in the chain of intermediary companies is the result of an internal reorganization as a result of which Gilead holds its shares in Galapagos as of 31 December 2020 through its direct subsidiary Gilead Biopharmaceutics US, LLC, which through Gilead Sciences Ireland UC controls Gilead Therapeutics A1 Unlimited Company, which in turn holds 16,707,477 of Galapagos' voting rights, consisting of 16,707,477 shares (unchanged). Those 16,707,477 shares represent 25.54% of Galapagos' currently outstanding 65,411,767 shares.

    The full transparency notification is available on the Galapagos website.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

                                                                 


    1 Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market and regarding miscellaneous provisions, as amended from time to time.





     

     

    Attachment



    View Full Article Hide Full Article
  31. Mechelen, Belgium; 6 January 2021, 15.30 CET – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) will participate in the 39th Annual J.P. Morgan Healthcare Conference on January 11-14, 2021.

    Onno van de Stolpe, CEO, will present on Thursday, January 14 at 15.10 CET (09:10 am EST). The presentation will be a live audio webcast and can be accessed via the following link. A replay of the webcast will be available on the Galapagos' website at www.glpg.com.

    About Galapagos
    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis…

    Mechelen, Belgium; 6 January 2021, 15.30 CET – Galapagos NV ((Euronext &, NASDAQ:GLPG) will participate in the 39th Annual J.P. Morgan Healthcare Conference on January 11-14, 2021.

    Onno van de Stolpe, CEO, will present on Thursday, January 14 at 15.10 CET (09:10 am EST). The presentation will be a live audio webcast and can be accessed via the following link. A replay of the webcast will be available on the Galapagos' website at www.glpg.com.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com  

    Media:

    Carmen Vroonen

    Global Head Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with Galapagos' compounds may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of Galapagos' compounds due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties and that Galapagos' estimations regarding its compounds development program and regarding the commercial potential of Galapagos' compounds, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Attachment



    View Full Article Hide Full Article
  32. Mechelen, Belgium and Krakow, Poland – 04 January 2021, 22.01 TIME CET – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) and Selvita S.A. (WSE: SLV) announced today that the strategic transaction in which Selvita has acquired Fidelta from Galapagos has been completed.

    The closing of the transaction comes shortly after its first announcement on November 23, 2020. Selvita has acquired 100% of the outstanding shares in Fidelta for an enterprise value of €31.2M plus the customary adjustments for net cash and working capital.

    Acquisition of Fidelta substantially expands Selvita's integrated drug discovery services offering and strengthens its position as one of the largest preclinical contract research organizations in Europe. The transaction will almost…

    Mechelen, Belgium and Krakow, Poland – 04 January 2021, 22.01 TIME CET – Galapagos NV ((Euronext &, NASDAQ:GLPG) and Selvita S.A. (WSE: SLV) announced today that the strategic transaction in which Selvita has acquired Fidelta from Galapagos has been completed.

    The closing of the transaction comes shortly after its first announcement on November 23, 2020. Selvita has acquired 100% of the outstanding shares in Fidelta for an enterprise value of €31.2M plus the customary adjustments for net cash and working capital.

    Acquisition of Fidelta substantially expands Selvita's integrated drug discovery services offering and strengthens its position as one of the largest preclinical contract research organizations in Europe. The transaction will almost double Selvita's revenues. Fidelta will now be fully consolidated under the Selvita Group, it will however continue to operate under the Fidelta name.

    Fidelta is a contract research organization with core scientific competences in inflammation, fibrosis, and anti-infectives. The scope of services provided by Fidelta is complementary to Selvita's offerings and will enable Selvita to build a competitive advantage in business areas such as DMPK, in vivo pharmacology, and toxicology, as well as increase its scale of operations within medicinal chemistry and in vitro pharmacology.

    Fidelta currently employs 181 employees, including over 150 highly experienced scientists, providing integrated drug discovery services in the biotech and pharmaceutical industry, with a proven track record of accomplished laboratory projects over many years. The Company is located in state-of-the art R&D facilities in Zagreb, Croatia which offer almost 6,000 m2 of research space. Fidelta will continue performing drug discovery services for Galapagos for the next five years.

    About Selvita

    Selvita is a preclinical Contract Research Organization providing multidisciplinary support in resolving the unique challenges of research within area of drug discovery, regulatory studies, as well as research and development.

    The Company was established in 2007 and currently employs over 550 professionals, of which over 1/3 hold a PhD title. Selvita is headquartered in Krakow, Poland, with a second research site in Poznan, Poland and international offices located in Cambridge, MA and South San Francisco, in the U.S., as well as in Cambridge, UK. Selvita is a major shareholder in Ardigen – bioinformatics company harnessing advanced Artificial Intelligence methods for novel precision medicine.

    Selvita has a proven track record of successfully completed projects and customers in 40 countries. The majority of Company revenues come from pharma, biotech, chemical and agrochemical companies from the U.S. and Europe. Selvita is listed on the Warsaw Stock Exchange (WSE:SLV). More information at www.selvita.com.

    About Galapagos

    Galapagos ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. The company's pipeline comprises early discovery through to Phase 3 programs in inflammation, fibrosis, and other indications. Galapagos' ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts Selvita



    Media & Investors:

    Natalia Baranowska

    +48 784 069 418

    natalia.baranowska@selvita.com



     
    Contacts Galapagos



     



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784



     



    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com



     



    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874



     



    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com



     

    Forward-looking statements Selvita

    Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Selvita as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements.

    We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

    Forward-looking statements Galapagos

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that Galapagos' expectations regarding Fidelta's future service performance for Galapagos would be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Attachment



    View Full Article Hide Full Article
  33. Mechelen, Belgium; 23 December 2020, 18.00 CET – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announces that Onno van de Stolpe, CEO of Galapagos, has committed to make a personal €10 million donation to African Parks, a non-profit organization that serves at the front lines of wildlife conservation, ecosystem restoration, and community development. The €10 million donation will be in the form of ordinary shares of Galapagos, donated by Mr. van de Stolpe to African Parks and spread over the coming five years. The first €2 million (25,150 ordinary shares held by Mr. van de Stolpe) have been transferred on 22 December 2020.

    "I strongly believe that we all have a responsibility to make this world a better place." said Onno van de Stolpe: "For…

    Mechelen, Belgium; 23 December 2020, 18.00 CET – Galapagos NV ((Euronext &, NASDAQ:GLPG) today announces that Onno van de Stolpe, CEO of Galapagos, has committed to make a personal €10 million donation to African Parks, a non-profit organization that serves at the front lines of wildlife conservation, ecosystem restoration, and community development. The €10 million donation will be in the form of ordinary shares of Galapagos, donated by Mr. van de Stolpe to African Parks and spread over the coming five years. The first €2 million (25,150 ordinary shares held by Mr. van de Stolpe) have been transferred on 22 December 2020.

    "I strongly believe that we all have a responsibility to make this world a better place." said Onno van de Stolpe: "For me, African Parks is a very worthy cause to contribute to in order to make this happen. Saving the African nature reserves for future generations, with their animals, flora and in harmony with the local populations, is providing hope in a world that urgently needs it."

    "We are extremely grateful to Onno in making this very generous commitment to African Parks, where our vision is to make the parks under our management ecologically, socially and financially sustainable," said Peter Fearnhead, CEO of African Parks. "A gift like this one is just so important for building the longterm financial base necessary to sustain the portfolio of 19 parks spanning 14.5m hectares. And the timing is essential in that protecting nature now is more important than ever, and inextricably linked to the health of our planet and our very own survival."

    About African Parks

    African Parks is a non-profit conservation organisation that takes on the complete responsibility for the rehabilitation and long-term management of national parks in partnership with governments and local communities. We currently manage 19 national parks and protected areas in 11 countries covering 14.5 million hectares in: Angola, Benin, Central African Republic, Chad, the Democratic Republic of Congo, Malawi, Mozambique, the Republic of Congo, Rwanda, Zambia and Zimbabwe. For more information visit www.africanparks.orgTwitterInstagram and Facebook.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Attachment



    Primary Logo

    View Full Article Hide Full Article
  34. -- Gilead will Not Advance Jyseleca for the Treatment of Rheumatoid Arthritis (RA) in the U.S. Following FDA Type A Meeting --

    -- Galapagos to Assume Sole Responsibility in Europe for Jyseleca in RA and Ulcerative Colitis (UC) Plus Future Indications; Gilead to Receive Royalties on European Sales Starting in 2024 --

    -- Galapagos to Assume Responsibility for Majority of Ongoing Clinical Trials --

    -- Gilead will Pay Galapagos €160 million to Support Ongoing Development and Accelerated Commercial Buildout in EU --

    Galapagos webcast presentation tomorrow, 16 December 2020, at 14:00 CET / 8 AM ET,
    www.glpg.com +32 2 793 38 47, code 7689939

    Foster City, Calif., and Mechelen, Belgium, December 15, 2020, 22.15 CET; regulated information

    -- Gilead will Not Advance Jyseleca for the Treatment of Rheumatoid Arthritis (RA) in the U.S. Following FDA Type A Meeting --

    -- Galapagos to Assume Sole Responsibility in Europe for Jyseleca in RA and Ulcerative Colitis (UC) Plus Future Indications; Gilead to Receive Royalties on European Sales Starting in 2024 --

    -- Galapagos to Assume Responsibility for Majority of Ongoing Clinical Trials --

    -- Gilead will Pay Galapagos €160 million to Support Ongoing Development and Accelerated Commercial Buildout in EU --

    Galapagos webcast presentation tomorrow, 16 December 2020, at 14:00 CET / 8 AM ET,

    www.glpg.com +32 2 793 38 47, code 7689939

    Foster City, Calif., and Mechelen, Belgium, December 15, 2020, 22.15 CET; regulated information – Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that the companies have agreed to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib). This announcement follows a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of RA.

    Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for RA. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in RA in the United States and that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without conducting substantial additional clinical studies.

    Under the new arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications. Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib. This is an acceleration of the commercial strategy in place for products under the separate ten-year research and development collaboration between the companies, where Galapagos is also responsible for European commercialization.

    Through a phased transition including the transfer of filgotinib's marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead will retain commercial rights and remain marketing authorization holder for filgotinib outside of Europe, including in Japan where filgotinib has recently been approved, and is co-marketed with Eisai.

    "While we believe that the clinical profile of Jyseleca could help many patients living with RA, we no longer see a viable path to U.S. approval in this indication," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "In this new context, Gilead and Galapagos believe it makes sense for Galapagos to drive commercialization in Europe. We are confident that through our strategic alliance with Galapagos, we will deliver many important new therapies for inflammatory diseases in the future."

    "Jyseleca is already providing an important new treatment option, making a difference to the lives of patients living with RA, where it is available in Europe," said Onno van de Stolpe, Chief Executive Officer of Galapagos. "While we are very disappointed by the outcome of the FDA meeting, we are excited that we can now accelerate the plan for Galapagos to lead on commercial activities in Europe in our ongoing collaboration with Gilead, and fully leverage the commercial organization Galapagos has built for the Jyseleca launch. This is an important new chapter in Galapagos' ongoing journey to be a leading European biotech company in inflammation and fibrosis."

    Filgotinib Development

    Under the terms of the amended agreement, Galapagos will assume operational responsibility for ongoing clinical trials evaluating filgotinib in RA. Gilead and Galapagos recently paused clinical trials of filgotinib in psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-infectious uveitis following receipt of the CRL and, without a viable path forward in the United States, the companies no longer believe it is feasible to continue the current global development program for filgotinib in these indications. As a result, these trials will be stopped over the coming months.

    Week 26 data from the MANTA and MANTA-RAy studies, including primary and key secondary endpoints, will be available by mid-2021 and the parties expect to submit the data to regulatory authorities shortly thereafter. In order to complete their review of filgotinib in RA or other future indications, the FDA has requested up to Week 52 follow-up data for patients who show >50% decrease in semen parameters by Week 26 and do not recover in the ongoing MANTA and MANTA-RAy studies.

    Gilead and Galapagos will continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease (IBD). Gilead will retain operational responsibility for the current trials in Crohn's disease while Galapagos will assume operational responsibility for ongoing trials in UC. Filgotinib is currently under review by the European Medicines Agency (EMA) for the treatment of UC and is expected to be submitted to the Japanese Ministry of Health, Labour and Welfare in the first half of 2021. Gilead and Galapagos expect to have further clarity on the potential U.S. filing of filgotinib in IBD, after consultation with FDA, including on the results of the MANTA and MANTA-RAy studies as described above.

    Financial Terms of the Agreement

    Under the terms of the new arrangement, Galapagos will assume all development, manufacturing, commercialization and certain other rights for filgotinib in Europe. The transfer will be subject to applicable local legal, regulatory and consultation requirements. The parties intend to transfer most activities by December 31, 2021 and complete the transition by December 31, 2022. Beginning on January 1, 2021, Galapagos will bear the future development costs for certain studies, in lieu of the equal cost split contemplated by the previous agreement. These studies include the DARWIN3, FINCH4, FILOSOPHY, and Phase 4 studies and registries in RA, MANTA and MANTA-RAy, the PENGUIN1 and 2 and EQUATOR2 studies in PsA, the SEALION1 and 2 studies in AS, the HUMBOLDT study in uveitis in addition to other clinical and non-clinical expenses supporting these studies and support for any investigator sponsored trials in non-IBD conditions and non-clinical costs on all current trials. The existing 50/50 global development cost sharing arrangement will continue for the following studies: SELECTION and its long-term extension study (LTE) in UC, DIVERSITY and its LTE, DIVERGENCE 1 and 2 and their LTEs and support for Phase 4 studies and registries in Crohn's disease, pediatric studies and their LTEs in RA, UC and Crohn's disease, and support for investigator sponsored trials in IBD.

    All commercial economics on filgotinib in Europe will transfer to Galapagos as of January 1, 2022, subject to payment of tiered royalties of 8 to 15 percent of net sales in Europe to Gilead, starting in 2024. In connection with the amendments to the existing arrangement for the commercialization and development of filgotinib, Gilead has agreed to irrevocably pay Galapagos €160 million, which will be split between a €110 million payment in 2021 and a €50 million payment in 2022 and is subject to certain adjustments for higher than budgeted development costs. In addition, Galapagos will no longer be eligible to receive any future milestone payments relating to filgotinib in Europe. Gilead expects to recognize the full amount of these payments in its R&D expenses in the fourth quarter of 2020.

    Information on Related Party Transaction

    The following information is provided by Galapagos pursuant to article 7:116, paragraph 4 of the Belgian Companies and Association Code in connection with the term sheet that has been entered into between Gilead Sciences, Inc. and Galapagos NV on 15 December 2020. For a summary of the main terms of the term sheet and the amended terms of the parties' existing agreement for the commercialization and future development of filgotinib, see above in this press release. These terms and amendments will be reflected in new agreements that will be entered into by Gilead and Galapagos on the basis of the term sheet.

    Gilead has two representatives on the supervisory board of Galapagos (Daniel O'Day and Linda Higgins). In addition, Gilead holds (indirectly, through one of its subsidiaries) more than 25% of the shares in Galapagos. Hence, Gilead is considered a "related party" of Galapagos in accordance with the International Financial Reporting Standards as adopted by the European Union. In view hereof, the supervisory board of Galapagos applied the procedure of article 7:116 of the Belgian Companies and Association Code in connection with the approval of term sheet with Gilead. The two representatives of Gilead on the supervisory board of Galapagos did not participate in the deliberation and voting by the supervisory board in relation to the term sheet.

    Within the context of the aforementioned procedure, a committee of three independent members of the supervisory board of Galapagos (the Committee) issued an advice to the supervisory board in which the Committee assessed the term sheet. In its advice to the supervisory board, the Committee concluded the following: "The Committee believes that under the circumstances the proposed amendments to Filgotinib Agreements are in the interest of Galapagos and all of its shareholders, and fully aligned with the long-term strategy of Galapagos. The proposed amendments offer an important opportunity to accelerate the plan for Galapagos to lead on commercial activities in Europe for future compounds in its ongoing R&D collaboration with Gilead, and to bolster and further leverage the commercial organization Galapagos has built for the launch of filgotinib. The return of the rights and responsibilities for filgotinib to Galapagos also comes with a number of challenges and risks in terms execution and operation, but these are not unreasonable and can be managed going forward. The Committee therefore believes that the proposed amendments to the collaboration with Gilead, are in the interest of Galapagos, and in any event not manifestly abusive. In view hereof, the Committee issues a favorable and unqualified opinion to the supervisory board of Galapagos." The supervisory board did not deviate from the Committee's advice.

    The assessment by the statutory auditor of Galapagos of the advice of the committee and the minutes of the supervisory board is as follows: "Based on our review, we have noted no material inconsistency between the accounting and financial information included in the minutes of the supervisory board and in the advice of the ad hoc committee of the independent members of the supervisory board compared to the information that we, as the Company's statutory auditor, have within the framework of our mandate."

    About Jyseleca (filgotinib)

    Filgotinib is approved and marketed as Jyseleca (200 mg and 100 mg tablets) in Europe and Japan for the treatment of adults with moderately to severely active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. Filgotinib was submitted to the European Commission for an extended indication for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

    About Galapagos

    Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Conference call and Webcast presentation



    Galapagos will conduct a conference call open to the public tomorrow, 16 December 2020, at 14:00 CET / 8 AM ET, which will also be webcasted. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

    CODE: 7689939

    Standard International:      +44 (0) 2071 928338
    USA:  +1 646 741 3167
    UK:  +44 844 481 9752
    Netherlands:+31 207 95 66 14
    France:   +33 1 70 70 0781
    Belgium:  +32 2 793 38 47

                

    A question and answer session will follow the presentation. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

    Gilead Forward-Looking Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Galapagos, the filgotinib collaboration and the ten-year research and development collaboration that are subject to risks, uncertainties and other factors, including the ability of the companies to complete the transaction in a timely manner or at all, including the ability to successfully transition the commercialization of filgotinib in Europe from Gilead to Galapagos in the anticipated timelines; difficulties or unanticipated expenses in connection with implementing the transaction; the risk that Gilead may not realize any anticipated benefits from the collaborations; the potential effects on Gilead's revenues and earnings; the ability of the companies to discover, develop and commercialize any products under the collaborations, including the ability of the companies to commercialize filgotinib or develop and commercialize filgotinib for additional indications; the ability of the companies to initiate and complete clinical trials involving any product candidates under the collaborations, including filgotinib, in the currently anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving any product candidates under the collaborations, including filgotinib; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that EMA may not approve filgotinib for the treatment of UC in the anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; the possibility that the companies may make a strategic decision to discontinue development of involving any product candidates under the collaborations, including filgotinib for the treatment of RA, UC, PsA, AS, non-infectious uveitis, IBD, Crohn's disease or other indications, and as a result, such products may never be successfully commercialized; and the accuracy of any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead's periodic reports filed with the U.S.  Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies and members of their senior management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    Galapagos Forward-Looking Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that the parties would not be able to complete the contemplated transaction in a timely manner or at all, the risk that parties may not be able to successfully implement the transaction and transfer of rights and activities in a timely or efficient manner or at all, taking into account the need to fulfil applicable local legal, regulatory and consultation requirements and other integration risks and expenses, that Galapagos' expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development for UC, IBD, RA, or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities' approval of marketing authorization for filgotinib for UC, IBD, RA, or other indications, including the risk of such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead, the uncertainty regarding estimates of the commercial potential of filgotinib, the risks and costs involved in selling and marketing filgotinib, the possibility that the companies may make a strategic decision to discontinue development of any product candidates under the collaborations, including filgotinib for the treatment of RA, UC, PsA, AS, non-infectious uveitis, IBD, Crohn's disease or other indications, and as a result, such products may never be successfully commercialized, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    # # #

    Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

    Contacts Galapagos  
    Investors: Media:
    Elizabeth Goodwin   Carmen Vroonen
    VP IR  Global Head of Communications & Public Affairs
    +1 781 460 1784  +32 473 824 874
       
    Sofie Van Gijsel   Anna Gibbins
    Senior Director IR     Senior Communications Director – Therapeutic Areas
    +32 485 19 14 15    +44 (0) 7717 801900
    ir@glpg.com communications@glpg.com
       
    Contacts Gilead  
    Investors: Media:
    Monica Tellado Arran Attridge
    +1 (650) 219-3882 +1 (650) 425-8975

     

    Attachment



    View Full Article Hide Full Article
  35. -- Gilead will Not Advance Jyseleca for the Treatment of Rheumatoid Arthritis (RA) in the U.S. Following FDA Type A Meeting --

    -- Galapagos to Assume Sole Responsibility in Europe for Jyseleca in RA and Ulcerative Colitis (UC) Plus Future Indications; Gilead to Receive Royalties on European Sales Starting in 2024 --

    -- Galapagos to Assume Responsibility for Majority of Ongoing Clinical Trials; Gilead will Pay Galapagos €160 million to Support Ongoing Development and Accelerated Commercial Buildout in EU --

    Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced that the companies have agreed to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib…

    -- Gilead will Not Advance Jyseleca for the Treatment of Rheumatoid Arthritis (RA) in the U.S. Following FDA Type A Meeting --

    -- Galapagos to Assume Sole Responsibility in Europe for Jyseleca in RA and Ulcerative Colitis (UC) Plus Future Indications; Gilead to Receive Royalties on European Sales Starting in 2024 --

    -- Galapagos to Assume Responsibility for Majority of Ongoing Clinical Trials; Gilead will Pay Galapagos €160 million to Support Ongoing Development and Accelerated Commercial Buildout in EU --

    Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that the companies have agreed to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib). This announcement follows a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of RA.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201215006105/en/

    Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for RA. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in RA in the United States and that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without conducting substantial additional clinical studies.

    Under the new arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications. Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib. This is an acceleration of the commercial strategy in place for products under the separate ten-year research and development collaboration between the companies, where Galapagos is also responsible for European commercialization.

    Through a phased transition including the transfer of filgotinib's marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead will retain commercial rights and remain marketing authorization holder for filgotinib outside of Europe, including in Japan where filgotinib has recently been approved, and is co-marketed with Eisai.

    "While we believe that the clinical profile of Jyseleca could help many patients living with RA, we no longer see a viable path to U.S. approval in this indication," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "In this new context, Gilead and Galapagos believe it makes sense for Galapagos to drive commercialization in Europe. We are confident that through our strategic alliance with Galapagos, we will deliver many important new therapies for inflammatory diseases in the future."

    "Jyseleca is already providing an important new treatment option, making a difference to the lives of patients living with RA, where it is available in Europe," said Onno van de Stolpe, Chief Executive Officer of Galapagos. "While we are very disappointed by the outcome of the FDA meeting, we are excited that we can now accelerate the plan for Galapagos to lead on commercial activities in Europe in our ongoing collaboration with Gilead, and fully leverage the commercial organization Galapagos has built for the Jyseleca launch. This is an important new chapter in Galapagos' ongoing journey to be a leading European biotech company in inflammation and fibrosis."

    Filgotinib Development

    Under the terms of the amended agreement, Galapagos will assume operational responsibility for ongoing clinical trials evaluating filgotinib in RA. Gilead and Galapagos recently paused clinical trials of filgotinib in psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-infectious uveitis following receipt of the CRL and, without a viable path forward in the United States, the companies no longer believe it is feasible to continue the current global development program for filgotinib in these indications. As a result, these trials will be stopped over the coming months.

    Week 26 data from the MANTA and MANTA-RAy studies, including primary and key secondary endpoints, will be available by mid-2021 and the parties expect to submit the data to regulatory authorities shortly thereafter. In order to complete their review of filgotinib in RA or other future indications, the FDA has requested up to Week 52 follow-up data for patients who show >50% decrease in semen parameters by Week 26 and do not recover in the ongoing MANTA and MANTA-RAy studies.

    Gilead and Galapagos will continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease (IBD). Gilead will retain operational responsibility for the current trials in Crohn's disease while Galapagos will assume operational responsibility for ongoing trials in UC. Filgotinib is currently under review by the European Medicines Agency (EMA) for the treatment of UC and is expected to be submitted to the Japanese Ministry of Health, Labour and Welfare in the first half of 2021. Gilead and Galapagos expect to have further clarity on the potential U.S. filing of filgotinib in IBD, after consultation with FDA, including on the results of the MANTA and MANTA-RAy studies as described above.

    Financial Terms of the Agreement

    Under the terms of the new arrangement, Galapagos will assume all development, manufacturing, commercialization and certain other rights for filgotinib in Europe. The transfer will be subject to applicable local legal, regulatory and consultation requirements. The parties intend to transfer most activities by December 31, 2021 and complete the transition by December 31, 2022. Beginning on January 1, 2021, Galapagos will bear the future development costs for certain studies, in lieu of the equal cost split contemplated by the previous agreement. These studies include the DARWIN3, FINCH4, FILOSOPHY, and Phase 4 studies and registries in RA, MANTA and MANTA-RAy, the PENGUIN1 and 2 and EQUATOR2 studies in PsA, the SEALION1 and 2 studies in AS, the HUMBOLDT study in uveitis in addition to other clinical and non-clinical expenses supporting these studies and support for any investigator sponsored trials in non-IBD conditions and non-clinical costs on all current trials. The existing 50/50 global development cost sharing arrangement will continue for the following studies: SELECTION and its long-term extension study (LTE) in UC, DIVERSITY and its LTE, DIVERGENCE 1 and 2 and their LTEs and support for Phase 4 studies and registries in Crohn's disease, pediatric studies and their LTEs in RA, UC and Crohn's disease, and support for investigator sponsored trials in IBD.

    All commercial economics on filgotinib in Europe will transfer to Galapagos as of January 1, 2022, subject to payment of tiered royalties of 8 to 15 percent of net sales in Europe to Gilead, starting in 2024. In connection with the amendments to the existing arrangement for the commercialization and development of filgotinib, Gilead has agreed to irrevocably pay Galapagos €160 million, which will be split between a €110 million payment in 2021 and a €50 million payment in 2022 and is subject to certain adjustments for higher than budgeted development costs. In addition, Galapagos will no longer be eligible to receive any future milestone payments relating to filgotinib in Europe. Gilead expects to recognize the full amount of these payments in its R&D expenses in the fourth quarter of 2020.

    Information on Related Party Transaction

    The following information is provided by Galapagos pursuant to article 7:116, paragraph 4 of the Belgian Companies and Association Code in connection with the term sheet that has been entered into between Gilead Sciences, Inc. and Galapagos NV on 15 December 2020. For a summary of the main terms of the term sheet and the amended terms of the parties' existing agreement for the commercialization and future development of filgotinib, see above in this press release. These terms and amendments will be reflected in new agreements that will be entered into by Gilead and Galapagos on the basis of the term sheet.

    Gilead has two representatives on the supervisory board of Galapagos (Daniel O'Day and Linda Higgins). In addition, Gilead holds (indirectly, through one of its subsidiaries) more than 25% of the shares in Galapagos. Hence, Gilead is considered a "related party" of Galapagos in accordance with the International Financial Reporting Standards as adopted by the European Union. In view hereof, the supervisory board of Galapagos applied the procedure of article 7:116 of the Belgian Companies and Association Code in connection with the approval of term sheet with Gilead. The two representatives of Gilead on the supervisory board of Galapagos did not participate in the deliberation and voting by the supervisory board in relation to the term sheet.

    Within the context of the aforementioned procedure, a committee of three independent members of the supervisory board of Galapagos (the Committee) issued an advice to the supervisory board in which the Committee assessed the term sheet. In its advice to the supervisory board, the Committee concluded the following: "The Committee believes that under the circumstances the proposed amendments to Filgotinib Agreements are in the interest of Galapagos and all of its shareholders, and fully aligned with the long-term strategy of Galapagos. The proposed amendments offer an important opportunity to accelerate the plan for Galapagos to lead on commercial activities in Europe for future compounds in its ongoing R&D collaboration with Gilead, and to bolster and further leverage the commercial organization Galapagos has built for the launch of filgotinib. The return of the rights and responsibilities for filgotinib to Galapagos also comes with a number of challenges and risks in terms execution and operation, but these are not unreasonable and can be managed going forward. The Committee therefore believes that the proposed amendments to the collaboration with Gilead, are in the interest of Galapagos, and in any event not manifestly abusive. In view hereof, the Committee issues a favorable and unqualified opinion to the supervisory board of Galapagos." The supervisory board did not deviate from the Committee's advice.

    The assessment by the statutory auditor of Galapagos of the advice of the committee and the minutes of the supervisory board is as follows: "Based on our review, we have noted no material inconsistency between the accounting and financial information included in the minutes of the supervisory board and in the advice of the ad hoc committee of the independent members of the supervisory board compared to the information that we, as the Company's statutory auditor, have within the framework of our mandate."

    About Jyseleca (filgotinib)

    Filgotinib is approved and marketed as Jyseleca (200 mg and 100 mg tablets) in Europe and Japan for the treatment of adults with moderately to severely active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. Filgotinib was submitted to the European Commission for an extended indication for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

    About Galapagos

    Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Gilead Forward-Looking Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Galapagos, the filgotinib collaboration and the ten-year research and development collaboration that are subject to risks, uncertainties and other factors, including the ability of the companies to complete the transaction in a timely manner or at all, including the ability to successfully transition the commercialization of filgotinib in Europe from Gilead to Galapagos in the anticipated timelines; difficulties or unanticipated expenses in connection with implementing the transaction; the risk that Gilead may not realize any anticipated benefits from the collaborations; the potential effects on Gilead's revenues and earnings; the ability of the companies to discover, develop and commercialize any products under the collaborations, including the ability of the companies to commercialize filgotinib or develop and commercialize filgotinib for additional indications; the ability of the companies to initiate and complete clinical trials involving any product candidates under the collaborations, including filgotinib, in the currently anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving any product candidates under the collaborations, including filgotinib; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that EMA may not approve filgotinib for the treatment of UC in the anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; the possibility that the companies may make a strategic decision to discontinue development of involving any product candidates under the collaborations, including filgotinib for the treatment of RA, UC, PsA, AS, non-infectious uveitis, IBD, Crohn's disease or other indications, and as a result, such products may never be successfully commercialized; and the accuracy of any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead's periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies and members of their senior management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    Galapagos Forward-Looking Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that the parties would not be able to complete the contemplated transaction in a timely manner or at all, the risk that parties may not be able to successfully implement the transaction and transfer of rights and activities in a timely or efficient manner or at all, taking into account the need to fulfil applicable local legal, regulatory and consultation requirements and other integration risks and expenses, that Galapagos' expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development for UC, IBD, RA, or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities' approval of marketing authorization for filgotinib for UC, IBD, RA, or other indications, including the risk of such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead, the uncertainty regarding estimates of the commercial potential of filgotinib, the risks and costs involved in selling and marketing filgotinib, the possibility that the companies may make a strategic decision to discontinue development of any product candidates under the collaborations, including filgotinib for the treatment of RA, UC, PsA, AS, non-infectious uveitis, IBD, Crohn's disease or other indications, and as a result, such products may never be successfully commercialized, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

    Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

    View Full Article Hide Full Article
  36. Mechelen, Belgium; 4 December 2020, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 70,925 new ordinary shares on 4 December 2020, for a total capital increase (including issuance premium) of €2,615,857.50.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 subscription rights. Three other management board members exercised an aggregate number…

    Mechelen, Belgium; 4 December 2020, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces a share capital increase arising from subscription right exercises.

    Galapagos issued 70,925 new ordinary shares on 4 December 2020, for a total capital increase (including issuance premium) of €2,615,857.50.

    Pursuant to the subscription right exercise program of Galapagos' management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 subscription rights. Three other management board members exercised an aggregate number of 15,000 subscription rights.

    In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €353,819,443.97, the total number of securities conferring voting rights amounts to 65,411,767, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 6,928,337 subscription rights under several outstanding employee subscription right plans, which equals 6,928,337 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

    About Galapagos

    Galapagos ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +32 485 19 14 15

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapy Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward-looking statements