Kiadis Pharma announces Financial Results for the six months end­ed June 30, 2018 and Company update

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.

Operating high­lights – ATIR101 (includ­ing post report­ing peri­od)

European mar­ket­ing autho­riza­tion appli­ca­tion for ATIR101:
– Responses to the Day 120 List of Questions sub­mit­ted in March 2018;
– Day 180 List of Issues received in May 2018 and respons­es sub­mit­ted in August 2018;
– On track to obtain CHMP opin­ion from the European Medicines Agency in the fourth quar­ter of 2018.

Phase 3 tri­al CR-AIR-009, com­par­ing ATIR101 against the post-trans­plant cyclophos­phamide (PTCy) or ‘Baltimore’ pro­to­col:
– Progress in line with inter­nal plans: 14 clin­i­cal sites are cur­rent­ly open for recruit­ment, 16 patients have been enrolled;
– Protocol amend­ment sub­mit­ted to reg­u­la­to­ry author­i­ties: num­ber of patients increased to 250 to fur­ther increase pow­er [80% pow­er to detect 16% Graft-ver­sus-host-dis­ease-free and Relapse-Free Survival (GRFS) dif­fer­ence]; inter­im analy­sis to occur after 2/3 of GRFS events to increase chance of pos­i­tive read out, now expect­ed in the sec­ond half of 2020; con­di­tion­ing reg­i­mens har­mo­nized between the two treat­ment arms to reduce het­ero­gene­ity.

Phase 2 tri­al CR-AIR-008 (‘008’): The last patient received a sin­gle dose of ATIR101 in January 2018.
Pooled analy­sis: Further analy­sis of 1-year Phase 2 pooled data [Intention-To-Treat (ITT), 37 patients] from stud­ies CR-AIR-007 and sin­gle dose CR-AIR-008 shows GRFS 53% [95% con­fi­dence inter­val (CI), 39%-72%]; Overall Survival (OS) 58% (95% CI, 44%-77%), in line with Phase 2 CR-AIR-007 tri­al. For the PTCy/Baltimore pro­to­col, sin­gle site data from Johns Hopkins (McCurdy et al. 2017) and Atlanta (Solh et al, 2016) show a dis­ease-risk index (DRI) nor­mal­ized 1-year GRFS val­ue of 40% and 30%, respec­tive­ly.

Operating high­lights – Organization (includ­ing post report­ing peri­od)

– Robbert van Heekeren resigned as Chief Financial Officer and as mem­ber of the Management Board.
– Scott A. Holmes appoint­ed as new Chief Financial Officer.
– Organization strength­ened across all func­tions, com­pris­es 73 employ­ees, up from 51 a year ago. Key new appoint­ments include head of Medical US (for­mer Iovance/ Dendreon), head of Medical EU (for­mer Genzyme/ AstraZeneca), head of mar­ket access EU (for­mer Genzyme/ Novo Nordisk), head of phar­ma­covig­i­lance (for­mer Astellas), head of facil­i­ties (for­mer Merck/ Douwe Egberts).
– Otto Schwarz, for­mer Chief Operating Officer of Actelion and Mr. Subhanu Saxena, for­mer Chief Executive Officer of Cipla and for­mer mem­ber of the senior exec­u­tive team of Novartis, were appoint­ed as Supervisory Board mem­bers of the Company at the Annual General Meeting of share­hold­ers in June 2018. Mr. Stuart Chapman resigned from the Supervisory Board fol­low­ing the share­hold­ers’ meet­ing.

Financial high­lights (includ­ing post report­ing peri­od)

– In the first six months of 2018, the Company did not gen­er­ate any rev­enues. Total oper­at­ing expens­es increased by EUR2.9 mil­lion from EUR8.2 mil­lion in the first six months of 2017 to EUR11.1 mil­lion in the same peri­od of 2018. This increase was pri­mar­i­ly caused by a fur­ther expan­sion of the work­force in all areas of the orga­ni­za­tion, the move to a larg­er build­ing which includes a com­mer­cial man­u­fac­tur­ing facil­i­ty, lab­o­ra­to­ries and office space, and con­sul­tan­cy expens­es for busi­ness devel­op­ment and mar­ket access.
– In the first six months of 2018, net finan­cial result came in at EUR3.0 mil­lion com­pared to EUR0.4 mil­lion for the same peri­od of 2017. Higher finance costs were main­ly the result of high­er inter­est expens­es on loans and bor­row­ings, and a net for­eign exchange loss in the first six months of 2018 com­pared to a net for­eign exchange gain in 2017.
– The net loss for the six months end­ed June 30, 2018 came at a lev­el of EUR14.1 mil­lion com­pared to a loss of EUR8.5 mil­lion for the six months end­ed June 30, 2017. Operating expens­es and net result for the first six months of 2018 were in line with man­age­ment expec­ta­tions.
– The Company end­ed the first six months of 2018 with EUR41.7 mil­lion in cash and cash equiv­a­lents. In March 2018, the Company issued 2.6 mil­lion shares and raised EUR23.4 mil­lion in gross pro­ceeds.
– On July 31, 2018, the Company received a new debt facil­i­ty from Kreos Capital V (UK) Ltd pro­vid­ing the Company with up to EUR20 mil­lion of addi­tion­al financ­ing.