Kiadis Pharma on track with European reg­u­la­to­ry review for ATIR101

Responses sub­mit­ted to EMA Day 120 list of ques­tions

Amsterdam, The Netherlands, March 28, 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) in hematopoi­et­ic stem cell trans­plan­ta­tions (HSCT), today con­firms it has sub­mit­ted its respons­es to the European Medicines Agency’s (EMA) Day 120 List of Questions for its lead prod­uct can­di­date ATIR101 with­in the time­line that had been agreed with EMA and announced in September 2017.

Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “We are pleased to have sub­mit­ted our respons­es to EMA’s Day 120 List of Questions in a time­ly man­ner. We believe we have ade­quate­ly addressed the ques­tions and remain on track to poten­tial­ly obtain a pos­i­tive CHMP opin­ion for ATIR101 in Q4 2018 and (con­di­tion­al) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019.

Kiadis Pharma rais­es €23.4 mil­lion in a pri­vate place­ment of 2.6 mil­lion new shares

Amsterdam, The Netherlands, March 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 designed to reduce Graft ver­sus Host Disease (GVHD) in hematopoi­et­ic stem cell trans­plan­ta­tions (HSCT), today announces that it has raised gross pro­ceeds of €23.4 mil­lion through a pri­vate place­ment of 2.6 mil­lion new shares to insti­tu­tion­al investors via an accel­er­at­ed book­build­ing process as announced on March 12, 2018 (the “Placing”). The Placing was com­plet­ed at a sub­scrip­tion price of €9.00 per share and rep­re­sent­ed 14.8% 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 March 15, 2018. Following the Placing, the issued share cap­i­tal of the Company will con­sist of 20,115,092 ordi­nary shares.
Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “This €23.4 mil­lion pri­vate place­ment will fund the Company into H2 2019 and thus well beyond poten­tial EU approval and into poten­tial European launch of ATIR101TM. The offer­ing was over­sub­scribed and allowed us to make full use of the remain­ing author­i­ty to issue new shares as grant­ed by the share­hold­ers. Strong inter­est from exist­ing and new spe­cial­ized biotech investors from Europe and the US fur­ther val­i­dates Kiadis Pharma’s great progress and poten­tial. With more than €60 mil­lion raised in the last 10 months, we have now suc­cess­ful­ly financed the Company towards major near-term mile­stones.More… »

Kiadis Pharma launch­es a pri­vate place­ment of approx­i­mate­ly 2.6 mil­lion new shares

Amsterdam, The Netherlands, March 12, 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 designed to reduce Graft ver­sus Host Disease (GVHD) in hematopoi­et­ic stem cell trans­plan­ta­tions (HSCT) today announces the launch of a pri­vate place­ment of approx­i­mate­ly 2.6 mil­lion new shares to insti­tu­tion­al investors, rep­re­sent­ing approx­i­mate­ly 14.8% of the Company’s cur­rent issued cap­i­tal (the “Placing”). Existing share­hold­ers of the Company will not have pre-emp­tive rights in rela­tion to the new shares to be issued. The new shares will rank pari pas­su in all respects with the cur­rent­ly out­stand­ing shares of the Company. With the cap­i­tal increase, the Company intends to make full use of the remain­ing author­i­ty that the share­hold­ers
meet­ing has grant­ed to the Company’s Management and Supervisory Boards to issue new shares.

Kiadis Pharma intends to use the net pro­ceeds of the Placing to:
– con­tin­ue the Phase 3 inter­na­tion­al, ran­dom­ized, con­trolled, mul­ti­cen­tre clin­i­cal tri­al for ATIR101 in the United States, Canada and Europe;
gen­er­ate addi­tion­al man­u­fac­tur­ing capac­i­ty at ven­dors and to refur­bish, equip and staff its leased man­u­fac­tur­ing facil­i­ty;
– fur­ther pre­pare the Company for com­mer­cial­iza­tion by invest­ing into a com­mer­cial orga­ni­za­tion, mar­ket access prepa­ra­tion and reim­burse­ment dis­cus­sions;
– sup­port fur­ther pro­duc­tion process opti­miza­tion of ATIR;
– expand the orga­ni­za­tion to accom­mo­date the increased num­ber of activ­i­ties;
– start a fur­ther clin­i­cal tri­al to assess the ben­e­fit of ATIR101 in con­junc­tion with
anoth­er T-cell deplet­ed hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) pro­to­col or with a cyclophos­phamide-based hap­lo trans­plan­ta­tion pro­to­col;
– apply funds for debt repay­ment, cap­i­tal expen­di­tures, gen­er­al and admin­is­tra­tive expens­es, gen­er­al cor­po­rate pur­pos­es in line with Kiadis Pharma’s strat­e­gy and oth­er work­ing cap­i­tal needs; and
– finance poten­tial oppor­tu­ni­ties to broad­en and diver­si­fy the research and devel­op­ment port­fo­lio (e.g. through in-licens­ing or acquir­ing pro­grams and com­pa­nies with syn­er­gis­tic or com­ple­men­tary tech­nolo­gies, prod­ucts and/or prod­uct can­di­dates).
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Last patient dosed with ATIR101™ in the Phase II ‘008’ clin­i­cal tri­al

– Results from the sin­gle dose 1-year fol­low up con­sis­tent with pri­or Phase II study
– Data sup­ports already sub­mit­ted mar­ket­ing autho­riza­tion appli­ca­tion

Amsterdam-Duivendrecht, The Netherlands, January 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell ther­a­py prod­ucts aim­ing to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that the last patient in the Phase II CR-AIR-008 (‘008’) tri­al has received a sin­gle dose of ATIR101™.
This explorato­ry Phase II tri­al (clinicaltrials.gov iden­ti­fi­er: NCT02500550) was designed to eval­u­ate the safe­ty and effi­ca­cy of two dos­es of ATIR101™ in patients with a hema­to­log­ic malig­nan­cy who received a hematopoi­et­ic stem cell trans­plan­ta­tion from a hap­loiden­ti­cal (half-matched) donor.
A total of 15 patients were recruit­ed into the tri­al. Six of these patients received two dos­es of ATIR101™ before the inde­pen­dent data mon­i­tor­ing com­mit­tee (IDMC) rec­om­mend­ed that the tri­al should con­tin­ue treat­ing patients with one dose of ATIR101™ (announced on December 21, 2016). The remain­ing nine patients on the tri­al have now been treat­ed with a sin­gle dose of ATIR101™. Of these nine patients, five patients are 1-year post treat­ment and results are con­sis­tent with the pre­vi­ous­ly con­duct­ed 23-patient CR-AIR-007 sin­gle dose Phase II tri­al. More… »

Kiadis Pharma pro­pos­es for­mer Cipla CEO Subhanu Saxena as new Supervisory Board mem­ber

Amsterdam-Duivendrecht, The Netherlands, January 16, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell ther­a­py prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that at its next General Meeting of Shareholders, the Kiadis Pharma Supervisory Board will nom­i­nate Subhanu Saxena to be appoint­ed as a new mem­ber of the Supervisory Board.
Subhanu Saxena is cur­rent­ly a Regional Director with The Bill & Melinda Gates Foundation as well as part­ner New Rhein Healthcare and Senior Advisor to Bain Capital. He was, until recent­ly, the Managing Director and Global Chief Executive Officer of Cipla, a pub­licly list­ed, lead­ing Indian phar­ma­ceu­ti­cal and biotech com­pa­ny with glob­al oper­a­tions and around 25,000 employ­ees. During Mr. Saxena’s lead­er­ship Cipla was trans­formed into a more inter­na­tion­al and agile com­pa­ny. Prior to join­ing Cipla, Mr. Saxena was Head of Global Product Strategy and Commercialization and mem­ber of the Executive Committee at Novartis. Before that, Mr. Saxena was CEO of Novartis UK and held var­i­ous lead­er­ship roles in busi­ness devel­op­ment. Prior to join­ing the phar­ma indus­try Mr. Saxena worked with lead­ing glob­al com­pa­nies includ­ing Citicorp, the Boston Consulting Group and PepsiCo across mar­kets in Europe, North America, Africa and Asia. Mr. Saxena holds a Graduate degree in Engineering from Oxford University and an MBA from INSEAD, France. More… »