Kiadis Pharma raises €18.0 million in a private placement of 2.25 million new shares

Amsterdam-Duivendrecht, The Netherlands, October 10, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces that it has raised gross proceeds of €18 million through an undocumented private placement of 2.25 million new shares to institutional investors via an accelerated bookbuilding process as announced on October 9, 2017 (the “Placing”). The Placing was completed at a subscription price of €8.00 per share and represented 15.0% 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 Brussels on October 12, 2017. Following the Placing, the issued share capital of the Company will be 17,287,397.
The proceeds from the Placing, combined with €2.3 million received by Kiadis Pharma from the exercise of warrants placed pursuant to the Company’s private placement of June 13, 2017, will allow the company to draw down an additional €5 million of debt financing from Kreos Capital as announced on August 17, 2017. More… »

Kiadis Pharma launches a private placement of approximately 2.25 million new shares

Amsterdam-Duivendrecht, The Netherlands, October 9, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces the launch of an undocumented private placement of approximately 2.25 million new shares to institutional investors, representing approximately 15.0% of the Company’s current issued share capital (the “Placing”). The Company retains the option to increase the number of shares to be sold. Kiadis Pharma intends to use the net proceeds of the Placing to:
advance the Phase III international, randomized, controlled, multicentre clinical trial for ATIR101TM in the United States, Canada and Europe;
– secure additional manufacturing capacity at vendors and lease its own commercial manufacturing facility;
– prepare Kiadis Pharma for launch of ATIR101TM in the EU in 2019 by investing in medical affairs, market access preparation and re-imbursement discussions;
– pursue ATIR201 and a new study combining ATIR101TM with the Baltimore protocol and/or another T-cell depleted hematopoietic stem cell transplantation;
– expand the organization to accommodate the increased number of activities;
– apply funds for debt repayment, capital expenditure, general and administrative expenses, general corporate purposes in line with Kiadis Pharma’s strategy and other working capital needs. More… »

Kiadis Pharma appoints Dr. Andrew Sandler as Chief Medical Officer

Amsterdam-Duivendrecht, The Netherlands, September 29, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces the appointment of Dr. Andrew Sandler as Chief Medical Officer (CMO), effective October 1, 2017. Dr. Sandler will take over the role from Dr. Jeroen Rovers who will work closely with Dr. Sandler until the end of 2017, as part of a planned transition.
Dr. Sandler will be a member of the Executive Management Team and will oversee the overall medical function and strategy of the Company, including clinical development, regulatory affairs, pharmacovigilance and medical affairs.
Dr. Sandler has over 20 years of experience within the healthcare industry, dedicated to hematologic malignancies and solid tumors. He has served as the senior medical executive in multiple global NASDAQ listed oncology companies. Most recently, Dr. Sandler was Senior Vice President, Medical Affairs, at Medivation (now part of Pfizer). Prior to that he was CMO at Dendreon Pharmaceuticals and Spectrum Pharma. He has also held senior-level positions with several other leading biotechnology and pharmaceutical companies, including Bayer Healthcare, Berlex and Seattle Genetics. Dr. Sandler obtained his MD from Mount Sinai School of Medicine, New York and completed a fellowship in medical oncology at University of California San Francisco. A US citizen, Dr. Sandler is a board certified medical oncologist and has treated many patients with hematologic malignancies, including bone marrow transplant patients. More… »

Kiadis Pharma provides update on the Marketing Authorization Application process for ATIR101™ in Europe

Amsterdam-Duivendrecht, The Netherlands, September 27, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces that the Company has received and reviewed the Day 120 List of Questions (“LoQs”) for its lead product ATIR101™ from the European Medicines Agency’s (“EMA”) Committee for Advanced Therapies (“CAT”). Following review of the LoQs, Kiadis Pharma expects that it will be able to address all questions within the six months response time that has been agreed with EMA.
Kiadis submitted the marketing authorization application (“MAA”) for ATIR101™ to the EMA in April 2017 and CAT issued the Day 120 LoQs in September 2017. Under the EMA review process, the CAT review of the MAA will resume with Day 121 upon submission of Kiadis Pharma’s response.
Arthur Lahr, CEO of Kiadis Pharma, commented: “We expect to adequately address EMA’s questions within the coming six months. Kiadis Pharma is on track to potentially obtain (conditional) EMA approval for ATIR101™ in the second half of 2018, which would allow for a European launch in 2019.

Kiadis Pharma receives FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ATIR101™

Amsterdam-Duivendrecht, The Netherlands, September 20, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces that the US Food and Drug Administration (FDA) has granted ATIR101™, Kiadis Pharma’s lead investigational product for blood cancers, the Regenerative Medicine Advanced Therapy (RMAT) designation.
Arthur Lahr, CEO of Kiadis Pharma, commented: “To receive the RMAT designation from the FDA is an important milestone for Kiadis Pharma and a recognition by the FDA of the significant potential for ATIR101™ to help patients receive safer and more effective bone marrow transplantations. RMAT is analogous to the Breakthrough Therapy designation, and a clear validation of ATIR101™ towards doctors and investors. We are now going to work even closer with the FDA to agree a path to make this cell therapy treatment available for patients in the US as soon as possible. In Europe ATIR101™ was filed for registration in April 2017 and we continue to prepare the Company for the potential European launch in 2019.More… »