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

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR TO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.

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.”