MedSciences Capital

– 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.

Europe EMA
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.

US FDA
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. More… »

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.” More… »

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. More… »

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. More… »

• Significantly strength­ened cash posi­tion; raised over EUR 60 mil­lion in equi­ty and debt (gross, includ­ing raise in March 2018)
• Filed Marketing Authorization Application with the European Medicines Agency for ATIR101 in blood can­cers
• Received Regenerative Medicine Advanced Therapy des­ig­na­tion from the US FDA
• First patient enrolled in Phase 3 tri­al for ATIR101 in adult patients with blood can­cer
• Leased exist­ing com­mer­cial man­u­fac­tur­ing facil­i­ty in The Netherlands
• Strengthened Organization and Supervisory Board

Amsterdam, The Netherlands, April 13, 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 its audit­ed 2017 Annual Results for the year end­ed December 31, 2017, which have been pre­pared in accor­dance with International Financial Reporting Standards (IFRS) as adopt­ed by the European Union. More… »