Annual Results for the year end­ed December 31, 2017

  • 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.

Operating high­lights (includ­ing post report­ing peri­od)

  • In April 2017, based on the pos­i­tive results from the Phase 2 ‘007’ tri­al, filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of lead pro­gram ATIR101 as an adjunc­tive treat­ment in hap­loiden­ti­cal (genet­i­cal­ly half-matched) hema­to­log­i­cal stem-cell trans­plan­ta­tions for adult patients with malig­nant dis­ease.
  • In September 2017, received the Regenerative Medicine Advanced Therapy (RMAT) des­ig­na­tion from the US FDA for ATIR101. The RMAT path­way is equiv­a­lent to the Breakthrough Therapy des­ig­na­tion that allows com­pa­nies, such as Kiadis Pharma, that are devel­op­ing regen­er­a­tive med­i­cine ther­a­pies to inter­act with the US FDA more fre­quent­ly. During 2017 only 12 com­pa­nies obtained an RMAT des­ig­na­tion.
  • In December 2017, enrolled first patient in a Phase 3 tri­al of ATIR101 with par­tic­i­pat­ing sites in the US, Canada and Europe.
  • In December 2017, secured access to build in-house man­u­fac­tur­ing capa­bil­i­ties with an agree­ment to lease an exist­ing state of the art com­mer­cial man­u­fac­tur­ing facil­i­ty. This includes process devel­op­ment and qual­i­ty con­trol lab­o­ra­to­ries, as well as office space.
  • Strengthened Kiadis orga­ni­za­tion and Supervisory Board with key peo­ple who have a suc­cess­ful track record in devel­op­ing and com­mer­cial­iz­ing inno­v­a­tive prod­ucts, includ­ing Mr. Arthur Lahr as CEO, Mr. Jan Feijen as COO, Dr. Andrew Sandler as CMO and Dr. Karl Hård as Head of Investor Relations. Dr. Otto Schwarz, for­mer COO of Actelion and Mr. Subhanu Saxena, for­mer Head of Global Product Strategy at Novartis and CEO of Cipla, are pro­posed as new Supervisory Board mem­bers.
  • In March 2018, sub­mit­ted respons­es to the EMA’s list of ques­tions, poten­tial­ly allow­ing to obtain an opin­ion from the EMA as ear­ly as the fourth quar­ter of 2018. If pos­i­tive, this would enable a con­di­tion­al mar­ket­ing approval from the European Commission in the first quar­ter of 2019, with poten­tial launch in select­ed coun­tries in Europe start­ing in the sec­ond half of 2019.

Financial high­lights (includ­ing post report­ing peri­od)

  • Significantly strength­ened cash posi­tion, raised more than EUR 60 mil­lion in equi­ty and debt since June 2017.
  • The cash posi­tion increased to EUR 29.6 mil­lion at year-end 2017 com­pared to EUR 14.6 mil­lion at the end of 2016. This is main­ly due to cash received from share offer­ings less the cash used in oper­at­ing activ­i­ties in 2017. Cash posi­tion was EUR 47.7 mil­lion at end of March 2018.
  • Operating loss increased to EUR 16.1 mil­lion in 2017 from a loss of EUR 11.4 mil­lion in 2016.
  • Operating expens­es increased by EUR 4.7 mil­lion com­pared to last year as the num­ber of employ­ees increased from 39 at year-end 2016 to 61 at the end of 2017.
  • Net loss for the year increased to EUR 17.0 mil­lion in 2017 from EUR 14.8 mil­lion in 2016.

Commenting on the finan­cial results, Arthur Lahr, CEO of Kiadis Pharma, said: “We can look back at 2017 as a tru­ly trans­for­ma­tion­al year and are well on our way turn­ing Kiadis Pharma into a Phase 3 clin­i­cal and com­mer­cial stage com­pa­ny. I am very proud of what the entire Kiadis Pharma team achieved. We are on track to obtain a CHMP opin­ion in the fourth quar­ter of 2018 for our lead pro­gram ATIR101. If pos­i­tive, this would enable an approval from the European Commission in the first quar­ter of 2019, with poten­tial launch in select­ed coun­tries in Europe start­ing in the sec­ond half of 2019.

“I wish to thank our employ­ees, part­ners and share­hold­ers for their sup­port and con­fi­dence. ATIR101 has the poten­tial to address a very sig­nif­i­cant unmet need in trans­plan­ta­tion, reduc­ing relapse and Graft ver­sus Host Disease. We look for­ward to con­tin­ue this jour­ney togeth­er to achieve our vision to become a ful­ly inte­grat­ed bio­phar­ma­ceu­ti­cal com­pa­ny and improve the lives of patients suffer­ing from
seri­ous dis­eases.”