Amsterdam, The Netherlands, October 19, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces that it has raised gross proceeds of €31.2 million through a private placement of 3.9 million new shares to institutional investors via an accelerated bookbuilding process as announced on October 18, 2018 (the “Placing”). The Placing was completed at a subscription price of €8.00 per share and represented approximately 19% of the issued share capital of the Company prior to the transaction. The new ordinary shares will rank pari passu in all respects with the currently outstanding shares of the Company and are expected to be listed and traded on Euronext Amsterdam and Euronext Brussels on October 23, 2018. Following the Placing, the issued share capital of the Company will consist of 24,341,410 ordinary shares. Continue reading “Kiadis Pharma raises €31.2 million in a private placement of 3.9 million new shares”
– Potential CHMP opinion moved from Q4 2018 into H1 2019
– Guidance for initial EU commercial launch in H2 2019 unchanged
– FDA meeting held under RMAT status
– Phase 3 study on track with over 20 open sites expected by end 2018, of which several in US
Amsterdam, The Netherlands, October 12, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces a regulatory and clinical update for ATIR101.
Following recent meetings of the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Kiadis Pharma received a Day 180 second List of Outstanding Issues relating to its marketing authorization application (MAA) for ATIR101. Kiadis Pharma has completed its evaluation of these remaining Day 180 questions. Addressing the questions will require additional analyses of existing clinical data. As expected, no new experimental or new clinical data needs to be generated. EMA has accepted the Company’s request for the time needed to respond to the remaining questions. As a result, the timing of the expected CHMP opinion has moved from the fourth quarter of 2018 into the first half of 2019. Following potential EU approval, which typically follows a positive CHMP Opinion within 67 days, Kiadis Pharma intends to commercially launch ATIR101 in a first EU member state in the second half of 2019, which is unchanged versus previous guidance.
In 2017, the US Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. Similar to a Breakthrough Therapy designation, RMAT status allows companies developing regenerative medicine therapies to interact with the FDA more frequently, and RMAT-designated products may be eligible for priority review and accelerated approval. As part of its RMAT status, Kiadis Pharma is benefitting from productive interactions with the US FDA, including a recent meeting.
Phase 3 clinical trial
The Company is on track with the ongoing Phase 3 clinical study to enroll 250 patients at leading transplant centers globally. The Company has now enrolled 22 patients and has 14 sites open in 7 countries. Kiadis Pharma expects to have over 20 sites open by the end of 2018, including several US sites. An interim analysis of the Phase 3 study is expected in the second half of 2020. Continue reading “KIADIS PHARMA PROVIDES REGULATORY AND CLINICAL UPDATE ON ATIR101”
Amsterdam, The Netherlands, August 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its unaudited interim Financial Results for the six months ended June 30, 2018, which have been prepared in accordance with IAS 34 as adopted by the European Union.
Arthur Lahr, CEO of Kiadis Pharma, commented: “We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018, we are on track with our Phase 3 trial, and obtained further confirmatory data from our Phase 2 trials. To allow us to ramp up our Phase 3 trial and prepare for commercialization in the EU we also raised substantial equity and debt facilities that extended our cash runway into the third quarter of 2019, and, upon positive CHMP opinion, potentially into the first quarter of 2020. We have also significantly strengthened our organization in medical, operations, commercial and finance functions. Kiadis is in great shape and well positioned to deliver on the promise of ATIR101.” Continue reading “Kiadis Pharma announces Financial Results for the six months ended June 30, 2018 and Company update”
Amsterdam, The Netherlands, August 30, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces that Robbert van Heekeren is stepping down as Chief Financial Officer, or CFO, and as member of the Management Board. Scott A. Holmes has been appointed as new CFO. Mr. Holmes, who currently serves as Senior Vice President and CFO at Keryx Biopharmaceuticals, will join the Company following the completion of Nasdaq-listed Keryx Biopharmaceuticals’ recently announced merger with Akebia Therapeutics, which is expected to close by the end of 2018. Continue reading “Kiadis Pharma announces resignation of Robbert van Heekeren and appoints Scott A. Holmes as new Chief Financial Officer”
Amsterdam, The Netherlands, August 1, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), today announces that it has received a new debt facility from Kreos Capital providing the Company with up to €20 million of additional financing. This is in addition to the Company’s €15 million debt financing from Kreos Capital in 2017.
The new loan consists of two tranches, with the first tranche of €5 million being immediately drawn down and a second tranche of up to an additional aggregate amount of €15 million, which Kiadis Pharma can at its option draw down until March 31, 2019, conditional on the Company having received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the Company’s T-cell product candidate ATIR101. Kiadis Pharma will use funds drawn down under the debt facility to advance the Phase 3 clinical development of ATIR101, to prepare for a possible commercial launch in Europe and for general corporate purposes. If drawn down in full, this new €20 million debt facility would extend the Company’s cash runway into the first quarter of 2020. Continue reading “Kiadis Pharma secures €20 million debt financing facility from Kreos Capital”