Kiadis announces the place­ment of €5 mil­lion con­vert­ible bonds with Kreos

  • 9% secured con­vert­ible bonds replace €5 mil­lion in Kreos debt
  • Conversion price €2 per share 
  • Remaining Kreos debt facil­i­ties reduced to €1.6 mil­lion  

Amsterdam, The Netherlands, October 1, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive NK-cell-based med­i­cines for the treat­ment of life-threat­en­ing dis­eases, announces the place­ment of €5 mil­lion of secured con­vert­ible bonds to Kreos Capital V (UK) Limited (“Kreos”) in con­sid­er­a­tion for Kreos waiv­ing the equiv­a­lent amount of €5 mil­lion in cash repay­ments under the Kreos debt facil­i­ties that the Company entered into with Kreos in 2017 and 2018. As a result of the place­ment of the bonds, the out­stand­ing amount under the Kreos debt facil­i­ties has decreased to €1.6 mil­lion.

Arthur Lahr, chief exec­u­tive offi­cer of Kiadis, com­ment­ed, “The restruc­tur­ing of our debt with Kreos reduces our cash burn. We have been pay­ing €1.9 mil­lion per quar­ter in cash instal­ments of prin­ci­pal and inter­est to Kreos and the exe­cu­tion of these con­vert­ible bonds elim­i­nates those pay­ments well into 2021 and reduces our remain­ing Kreos debt bur­den to €1.6 mil­lion.”

Maurizio PetitBon, gen­er­al part­ner of Kreos Capital, com­ment­ed, “We have been an investor in Kiadis for many years and are very pleased with Kiadis’ devel­op­ments espe­cial­ly with its recent refo­cus on its pro­pri­etary K-NK plat­form. The con­ver­sion of a size­able por­tion of our loan into a con­vert­ible struc­ture is a con­fir­ma­tion of our belief in the long-term poten­tial of both the Company and its K-NK plat­form.”

The bonds are unlist­ed, will be issued at par and will car­ry a coupon of 9.00% per annum, with inter­est on the bonds paid at matu­ri­ty. The bonds can be con­vert­ed into ordi­nary shares of the Company with the con­ver­sion price being €2.00, sub­ject to adjust­ment in the case of share split or con­sol­i­da­tion. The bonds are due September 30, 2021 but this due date may be extend­ed by Kreos to September 30, 2022.

Kiadis and Gulf Coast Regional Blood Center announce col­lab­o­ra­tion to pro­vide uni­ver­sal donor mate­r­i­al for K-NK cell ther­a­py pro­grams

Collaboration marks first con­trac­tu­al part­ner­ship with sup­pli­er of uni­ver­sal donor mate­r­i­al 

Amsterdam, The Netherlands, September 28, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive NK-cell-based med­i­cines for the treat­ment of life-threat­en­ing dis­eases and Gulf Coast Regional Blood Center (GCRBC), a pri­ma­ry sup­pli­er of blood com­po­nents to more than 170 hos­pi­tals and health care facil­i­ties, today announce a col­lab­o­ra­tion under which GCRBC will sup­ply uni­ver­sal donor start­ing mate­r­i­al for the man­u­fac­ture of Kiadis’ off-the-shelf K-NK Natural Killer (NK) cell ther­a­pies in the United States.

Kiadis’ pro­pri­etary off-the-shelf K-NK cell plat­form is based on NK cells from unique uni­ver­sal donors. This col­lab­o­ra­tion will pro­vide Kiadis with an ongo­ing sup­ply of start­ing mate­r­i­al need­ed for clin­i­cal sup­ply and research and devel­op­ment. The Company is devel­op­ing mul­ti­ple K-NK pro­grams uti­liz­ing uni­ver­sal donor start­ing mate­r­i­al.

Arthur Lahr, chief exec­u­tive offi­cer of Kiadis, com­ment­ed, “Our col­lab­o­ra­tion with Gulf Coast Regional Blood Center gives us access to their broad donor net­work to iden­ti­fy uni­ver­sal donors using our pro­pri­etary algo­rithm and selec­tion ana­lyt­ics. We then take the donor immune cells as source mate­r­i­al to pro­duce off-the-shelf K-NK cells. This col­lab­o­ra­tion fur­ther helps us ensure a con­tin­ued sup­ply of uni­ver­sal donor mate­r­i­al for our K-NK cell ther­a­py pro­grams.”

Hope Guidry-Groves, Cellular Life Solutions Director at Gulf Coast Regional Blood Center, stat­ed, “Our mis­sion is to part­ner with the com­mu­ni­ty to help save and sus­tain lives by pro­vid­ing a safe sup­ply of blood, bio­ther­a­pies and relat­ed ser­vices.  With our his­to­ry of excel­lence and proven exper­tise, we can help dri­ve more treat­ment options to patients through advanced blood ther­a­pies. By help­ing researchers locate will­ing and eli­gi­ble par­tic­i­pants for these spe­cial­ized col­lec­tions, we are doing our part in bring­ing new hope to patients.”

XVIVO Perfusion to acquire the Dutch medtech com­pa­ny Organ Assist and finances the acqui­si­tion through a pri­vate place­ment of new shares


XVIVO Perfusion AB (publ) (“XVIVO” or the “Company) has today signed an agree­ment to acquire 100 per­cent of the shares in the Dutch medtech com­pa­ny Organ Assist B.V. (“Organ Assist”) for a cash pur­chase price of up to EUR 24 mil­lion, with an upfront pay­ment of EUR 20 mil­lion and poten­tial earn-out pay­ments of up to EUR 4 mil­lion. Organ Assist focus­es pri­mar­i­ly on devel­op­ing machines and con­sum­ables for liv­er and kid­ney per­fu­sion. Through the acqui­si­tion XVIVO becomes the first organ preser­va­tion and eval­u­a­tion com­pa­ny in the world to be active­ly involved in all major organs, which accel­er­ates the Company’s strat­e­gy of becom­ing a glob­al all organ provider. The acqui­si­tion is to be financed by way of a new share issue of shares of approx­i­mate­ly SEK 500 mil­lion direct­ed to Swedish and inter­na­tion­al insti­tu­tion­al investors through an accel­er­at­ed book-build­ing pro­ce­dure, which is expect­ed to com­mence today.

Background and the trans­ac­tion
Organ Assist is a medtech com­pa­ny pri­mar­i­ly focus­ing on devel­op­ing per­fu­sion machines for liv­er and kid­ney. Organ Assist was found­ed in 2005 and its research and prod­ucts have since result­ed in a num­ber of patents and intel­lec­tu­al prop­er­ty rights, and its prod­ucts with­in the area of liv­er and kid­ney trans­plan­ta­tions are CE-marked.
The total pur­chase price for 100 per­cent of Organ Assist’s shares amounts to up to EUR 24 mil­lion, where­of EUR 20 mil­lion will be paid in cash on com­ple­tion of the trans­ac­tion, and two addi­tion­al cash mile­stone pay­ments, each up to EUR 2 mil­lion, become payable based on sales tar­get in 2021 and reg­u­la­to­ry approval in the US for Organ Assist’s kid­ney device, respec­tive­ly.
XVIVO secures that organs are kept in opti­mal con­di­tion dur­ing trans­porta­tion and perfusion/evaluation with focus on lungs and hearts. Organ Assist has, since the com­pa­ny was found­ed in 2005, focused pri­mar­i­ly on devel­op­ing per­fu­sion machines for liv­er and kid­ney. The com­pa­nies’ syn­er­gies enable greater mar­ket oppor­tu­ni­ties for XVIVO’s and Organ Assist’s prod­uct port­fo­lio through the inte­gra­tion of XVIVO’s unique and patent­ed STEEN Solution tech­nol­o­gy with the Organ Assist kid­ney and liv­er machines, and by lever­ag­ing XVIVO’s inter­na­tion­al mar­ket pres­ence.
The acqui­si­tion is in line with XVIVO’s com­mer­cial strat­e­gy to strength­en the Company’s prod­uct offer­ing and accel­er­ate the strat­e­gy of becom­ing a glob­al all organ provider. The com­ple­men­tary prod­uct port­fo­lio will cre­ate a unique posi­tion with pres­ence in all major organs (lung, heart, kid­ney and liv­er). The com­bined offer­ing expands XVIVO’s address­able mar­ket to approx­i­mate­ly 98 per­cent of the organ trans­plan­ta­tion mar­ket and aim to posi­tion the Company as the “first choice” for all mul­ti-organ clin­ics.
XVIVO has a strong pres­ence in the US and was the first com­pa­ny in the world to receive an U.S. Food and Drug Administration (FDA) approval (HDE approval) for a med­ical device for warm per­fu­sion of an organ. Organ Assist’s prod­ucts are CE marked and pro­tect­ed under patents and oth­er intel­lec­tu­al prop­er­ty rights. The plan is to com­mer­cial­ize the Organ Assist machines in the US by uti­liz­ing XVIVO’s strong mar­ket pres­ence and com­mer­cial­iza­tion- and reg­u­la­to­ry expe­ri­ence, once FDA approval has been grant­ed.
“This acqui­si­tion will enable the exe­cu­tion of an accel­er­at­ed growth plan, both in terms of sales as well as R&D activ­i­ties, while build­ing on a sol­id installed base and a lead­ing posi­tion in liv­er per­fu­sion. It is a token of appre­ci­a­tion of the inno­v­a­tive work done by our employ­ees in Groningen. We are look­ing for­ward to work­ing with the XVIVO team build­ing a world lead­ing medtech com­pa­ny, sup­port­ing our cus­tomers to save and improve patients’ lives” says Organ Assist CEO Wilfred den Hartog
“We are hap­py that Organ Assist becomes part of XVIVO Perfusion; it is the per­fect part­ner to bring the Organ Assist’s inno­v­a­tive sys­tems to the organ trans­plan­ta­tion com­mu­ni­ty” Willem van Lawick, Organ Assist’s Chairman added.
“XVIVO becomes the first organ preser­va­tion and eval­u­a­tion com­pa­ny in the world to be active­ly involved with all major organs after this strate­gi­cal­ly impor­tant acqui­si­tion” says XVIVO Perfusion CEO Dag Andersson.
Financials and syn­er­gies
Organ Assist had a turnover of EUR 3.5 mil­lion and an EBITDA of EUR 0.1 mil­lion in 2019 and a turnover of EUR 1.3 mil­lion and an EBITDA of EUR 0.1 mil­lion in January – June 2020. Organ Assist has its head office and R&D cen­ter in Groningen, The Netherlands, where its 18 employ­ees are based, and Groningen will remain as a com­pe­tence cen­ter for the devel­op­ment and com­mer­cial­iza­tion of machines and solu­tions for liv­er and kid­ney. Both prod­uct- and clin­i­cal devel­op­ment will be inten­si­fied after the acqui­si­tion.
XVIVO and Organ Assist have lim­it­ed over­lap­ping busi­ness­es with­in the field of tho­rax trans­plan­ta­tions – lungs and hearts – and XVIVO there­fore sees lim­it­ed cost syn­er­gies since the com­pa­nies as of today have few dou­ble costs and resources with­in this field. Within the field of abdom­i­nal trans­plan­ta­tions – kid­neys and liv­ers – the busi­ness­es com­ple­ment each oth­er.
Financing and con­di­tions
Completion of the acqui­si­tion is expect­ed to take place dur­ing October 2020 and is con­di­tion­al upon XVIVO rais­ing pro­ceeds to finance the pur­chase price through a pri­vate place­ment of shares on Nasdaq Stockholm. XVIVO has engaged Carnegie Investment Bank AB (“Carnegie”) to explore the con­di­tions to car­ry out a direct­ed share issue of up approx­i­mate­ly SEK 500 mil­lion based on the autho­riza­tion grant­ed by the annu­al gen­er­al meet­ing on 31 March 2020. The price of any new shares issued in the direct­ed share issue will be deter­mined through an accel­er­at­ed book­build­ing pro­ce­dure admin­is­tered by Carnegie. Further infor­ma­tion about the direct­ed share issue and the accel­er­at­ed book­build­ing pro­ce­dure, which is expect­ed to com­mence today, will be dis­closed through a sep­a­rate press release.

Kiadis announces U.S. FDA approval of the Abigail Wexner Research Institute at Nationwide Children’s Hospital’s IND for a COVID-19 clin­i­cal tri­al with off-the-shelf K-NK cells using Kiadis’ pro­pri­etary plat­forms

Amsterdam, The Netherlands, September 14, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell-based med­i­cines for the treat­ment of life-threat­en­ing dis­eases, today announces a col­lab­o­ra­tion with the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital to devel­op Kiadis-NK cells (K-NK cells) as a post-expo­sure pre-emp­tive ther­a­py for COVID-19. The U.S. Food and Drug Administration (FDA) approved AWRI’s inves­ti­ga­tion­al new drug appli­ca­tion (IND) for a study in an adult pop­u­la­tion with off-the-shelf nat­ur­al killer (NK) cells pro­duced with Kiadis’ pro­pri­etary Universal Donor and PM21 tech­nolo­gies. Kiadis and AWRI are devel­op­ing the plan for ini­ti­a­tion of the clin­i­cal study.

Kiadis has exclu­sive­ly licensed from AWRI intel­lec­tu­al prop­er­ty relat­ed to NK cells for treat­ment of micro­bial infec­tions, includ­ing SARS-CoV-2. The Company has recent­ly ini­ti­at­ed the pre­clin­i­cal and clin­i­cal devel­op­ment of its K-NK-ID101 COVID-19 pro­gram and is expect­ing to receive US gov­ern­ment fund­ing for this pro­gram.

Arthur Lahr, CEO of Kiadis com­ment­ed, “This is the sec­ond IND approved by the U.S. FDA for K-NK cells pro­duced with our PM21 plat­form, and the sec­ond IND approved for K-NK cells based on our Universal Donor off-the-shelf plat­form. We are excit­ed to study whether K-NK cells have the anti-viral prop­er­ties, safe­ty pro­file and man­u­fac­tur­ing scal­a­bil­i­ty to be wide­ly deployed as an off-the-shelf glob­al coun­ter­mea­sure against COVID-19 and future pan­dem­ic threats. This FDA approval marks rapid progress with our K-NK-ID101 COVID-19 pro­gram and demon­strates the poten­tial expan­sion with our K-NK cells into infec­tious dis­ease.”

“The coro­n­avirus pan­dem­ic has had a sig­nif­i­cant impact on our world, but has also cre­at­ed oppor­tu­ni­ties for inno­va­tion and for­ward think­ing,” says Dean Lee, MD, PhD, Director of the Cellular Therapy and Cancer Immunotherapy pro­gram at Nationwide Children’s Hospital. “Data from patients with COVID-19 have demon­strat­ed an impor­tant role for NK cells in this dis­ease. Our pre­vi­ous col­lab­o­ra­tions with Kiadis in devel­op­ing NK cells for can­cer enabled us to design a nov­el Phase I/II clin­i­cal tri­al that meets FDA rig­or in test­ing whether adop­tive trans­fer of NK cells is safe and effec­tive in mit­i­gat­ing pro­gres­sion of this virus in high-risk patients.”

Kiadis announces pub­li­ca­tion in Blood high­light­ing proof-of-con­cept to enhance poten­cy of anti-CD38 anti­bod­ies with Kiadis’ K-NK004, recent­ly licensed by Sanofi

CD38KO NK cell ther­a­py has the poten­tial to max­i­mize the effi­ca­cy of anti-CD38 against mul­ti­ple myelo­ma

Amsterdam, The Netherlands, July 22, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell ther­a­peu­tics for life-threat­en­ing dis­eases, today announces pub­li­ca­tion of an arti­cle in Blood, Journal of the American Society of Hematology. The arti­cle describes the syn­er­gy of mbIL21 expand­ed NK cells (FC21-NK) mod­i­fied with a CD38 gene knock­out togeth­er with an anti-CD38 mon­o­clon­al anti­body (mAb) for enhanced killing of mul­ti­ple myelo­ma cells.

The pub­li­ca­tion describes the use of the CRISPR/Cas9 sys­tem to delete CD38 (CD38KO) in ex vivo expand­ed periph­er­al blood K-NK cells, with 82% knock out effi­cien­cy. These CD38KO K-NK cells were com­plete­ly resis­tant to anti-CD38 anti­body-induced frat­ri­cide. In addi­tion, as com­pared to wild type NK cells, the CD38KO K-NK cells showed supe­ri­or per­sis­tence in immune defi­cient mice pre-treat­ed with anti-CD38 anti­body, and enhanced ADCC activ­i­ty against CD38-express­ing mul­ti­ple myelo­ma cell lines and pri­ma­ry mul­ti­ple myelo­ma cells. Additionally, analy­sis demon­strat­ed that CD38KO K-NK cells have unique meta­bol­ic repro­gram­ming with high­er mito­chon­dr­i­al res­pi­ra­to­ry capac­i­ty, impor­tant in a hypox­ic tumor micro-envi­ron­ment. Taken togeth­er, these find­ings pro­vide proof-of-con­cept that adop­tive immunother­a­py using ex vivo expand­ed CD38KO K-NK cells has the poten­tial to boost anti-CD38 anti­body activ­i­ty in mul­ti­ple myelo­ma.

Dean Lee, MD, PhD, co-author of the arti­cle, Director of the Cellular Therapy and Cancer Immunology Program at Nationwide Children’s Hospital and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard Solove Research Institute com­ment­ed, “This work was a great oppor­tu­ni­ty to col­lab­o­rate with Gabriel Ghiaur, MD, PhD, co-author of the arti­cle and Assistant Professor of Oncology at The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University. By com­bin­ing the CRISPR/Cas9 tech­nol­o­gy with the FC21-NK cell plat­form we were able to pro­duce and test an engi­neered NK cell ther­a­peu­tic to address a rec­og­nized hur­dle in immunother­a­py of mul­ti­ple myelo­ma. The ease and effi­cien­cy of this approach increas­es its poten­tial to be trans­lat­ed to the clin­ic.”

Robert Friesen, chief sci­en­tif­ic offi­cer of Kiadis com­ment­ed, “We are excit­ed to see the pub­lished results of this sci­en­tif­ic study, the proof-of-con­cept that tar­get­ed knock­out of CD38 in high­ly stim­u­lat­ed NK cells can be syn­er­gis­ti­cal­ly applied to anti­body treat­ments for the poten­tial ben­e­fit of patients with mul­ti­ple myelo­ma.”

Arthur Lahr, chief exec­u­tive offi­cer of Kiadis, added “This pub­li­ca­tion demon­strates that CD38KO K-NK cells are resis­tant to killing by anti-CD38 anti­bod­ies, and demon­strates how CD38KO K-NK cells improve poten­cy of anti-CD38 anti­bod­ies. This data drove Sanofi’s excite­ment to license KNK004 for com­bi­na­tion with Sarclisa®, to pro­vide bet­ter treat­ment options for mul­ti­ple myelo­ma patients. This data show­cas­es the sci­en­tif­ic ratio­nale under­pin­ning the col­lab­o­ra­tion with Sanofi, and should enhance the under­stand­ing of the poten­tial of this com­bi­na­tion.”