Enrollment to cease im­medi­ately; top­line data antic­i­pated in H1 2021

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced pos­i­tive re­sults from a planned interim analysis of the on­go­ing GENESIS Phase 3 trial of motix­a­fortide for stem cell mo­bi­li­za­tion (SCM) in mul­ti­ple myeloma patients.

At a meeting of the study's in­de­pen­dent Data Monitoring Com­mit­tee (DMC), a planned interim analysis of the study's pri­mary end­point was con­ducted in­de­pen­dent­ly by the DMC. Based on the statistically sig­nif­i­cant evi­dence favoring treat­ment with motix­a­fortide, the DMC issued a recom­men­da­tion to the Com­pany that patient en­roll­ment may be ceased im­medi­ately, without the need to recruit all 177 patients originally planned for the study.

In accordance with the DMC's recom­men­da­tion, study en­roll­ment is now com­plete at 122 patients. Full re­sults for the study, in­clud­ing sec­ond­ary and exploratory ef­fi­cacy end­points, as well as ex­tended safety data, will be an­nounced after the last patient en­rolled reaches 100 days of follow-up post-transplantation, which is ex­pected to oc­cur in the first half of 2021.

"The compelling re­sults of this planned interim analysis are a very sig­nif­i­cant mile­stone for our Com­pany, as our SCM pro­gram is the Com­pany's most ef­fi­cient path to reg­is­tra­tion for motix­a­fortide," stated Philip Serlin, Chief Exec­u­tive Of­fi­cer of Bio­LineRx. "Stem cell mo­bi­li­za­tion rep­re­sents a sig­nif­i­cant unmet med­i­cal need in mul­ti­ple myeloma, as be­tween 50% and 70% of patients are poor mo­bi­lizers. We eagerly await the final re­sults of the study, ex­pected in the first half of next year, which we hope will sup­port our goal of changing the treat­ment par­a­digm in au­tol­o­gous stem-cell mo­bi­li­za­tion, thus positioning motix­a­fortide in com­bi­na­tion with G-CSF as the new stan­dard of care in this in­di­ca­tion."

The GENESIS trial was ini­ti­ated in De­cem­ber 2017. GENESIS is a ran­dom­ized, placebo-controlled, multi­center study, eval­u­ating the safety, tol­er­a­bil­ity and ef­fi­cacy of motix­a­fortide and G-CSF, com­pared to placebo and G-CSF, for the mo­bi­li­za­tion of HSCs for au­tol­o­gous trans­plan­ta­tion in mul­ti­ple myeloma patients. The pri­mary objective of the study is to dem­onstrate that only one dose of motix­a­fortide on top of G-CSF is superior to G-CSF alone in the ability to mo­bi­lize ≥ 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives in­clude time to engraftment of neu­tro­phils and plate­lets and durability of engraftment, as well as other ef­fi­cacy and safety parameters.

About Bio­LineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy. The Com­pany's busi­ness model is to in-license novel com­pounds, de­vel­op them through clin­i­cal stages, and then part­ner with pharma­ceu­tical com­pa­nies for fur­ther clin­i­cal de­vel­op­ment and/or com­mer­cial­i­za­tion.

The Com­pany's lead pro­gram, motix­a­fortide (BL-8040), is a can­cer ther­apy plat­form cur­rently being eval­u­ated in a Phase 2a study for the treat­ment of pancreatic can­cer in com­bi­na­tion with KEY­TRUDA® and chemo­ther­apy under a col­lab­o­ration agree­ment with MSD. Motixafortide is also being eval­u­ated in a Phase 2b study in con­sol­i­da­tion AML and a Phase 3 study in stem cell mo­bi­li­za­tion for au­tol­o­gous bone-marrow trans­plan­ta­tion.

BioLineRx is devel­op­ing a sec­ond on­col­ogy pro­gram, AGI-134, an im­mu­no­ther­apy treat­ment for mul­ti­ple solid tumors that is cur­rently being in­ves­ti­gated in a Phase 1/2a study.

For addi­tional in­for­ma­tion on Bio­LineRx, please visit the Com­pany's website at www.biolinerx.com, where you can re­view the Com­pany's SEC filings, press re­leases, an­nouncements and events. Bio­LineRx in­dus­try up­dates are also reg­u­larly up­dated on Face­book, Twitter, and LinkedIn.

Cautions Concerning Forward-Looking State­ments

Various state­ments in this re­lease con­cern­ing Bio­LineRx's future ex­pec­ta­tions con­sti­tute "forward-looking state­ments" within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995. These state­ments in­clude words such as "may," "expects," "antic­i­pates," "be­lieves," and "intends," and de­scribe opinions about future events. These for­ward-looking state­ments in­volve known and un­known risks and un­cer­tainties that may cause the actual re­sults, per­for­mance or achieve­ments of Bio­LineRx to be ma­teri­ally dif­fer­en­t from any future re­sults, per­for­mance or achieve­ments ex­pressed or im­plied by such for­ward-looking state­ments. Factors that could cause Bio­LineRx's actual re­sults to differ ma­teri­ally from those ex­pressed or im­plied in such for­ward-looking state­ments in­clude, but are not lim­ited to: the initiation, timing, progress and re­sults of Bio­LineRx's pre­clin­i­cal stud­ies, clin­i­cal trials and other thera­peutic can­di­date de­vel­op­ment efforts; Bio­LineRx's ability to ad­vance its thera­peutic can­di­dates into clin­i­cal trials or to suc­cess­fully com­plete its pre­clin­i­cal stud­ies or clin­i­cal trials; Bio­LineRx's receipt of regu­la­tory ap­prov­als for its thera­peutic can­di­dates, and the timing of other regu­la­tory filings and ap­prov­als; the clin­i­cal de­vel­op­ment, com­mer­cial­i­za­tion and mar­ket ac­ceptance of Bio­LineRx's thera­peutic can­di­dates; Bio­LineRx's ability to estab­lish and main­tain corporate col­lab­o­rations; Bio­LineRx's ability to integrate new thera­peutic can­di­dates and new per­son­nel; the interpretation of the properties and char­ac­ter­istics of Bio­LineRx's thera­peutic can­di­dates and of the re­sults ob­tained with its thera­peutic can­di­dates in pre­clin­i­cal stud­ies or clin­i­cal trials; the implementation of Bio­LineRx's busi­ness model and stra­te­gic plans for its busi­ness and thera­peutic can­di­dates; the scope of pro­tec­tion Bio­LineRx is able to estab­lish and main­tain for in­tel­lec­tual prop­er­ty rights cover­ing its thera­peutic can­di­dates and its ability to op­er­ate its busi­ness without infringing the in­tel­lec­tual prop­er­ty rights of others; esti­mates of Bio­LineRx's ex­penses, future revenues, capital re­quire­ments and its needs for addi­tional financing; risks re­lated to changes in health­care laws, rules and reg­u­la­tions in the United States or elsewhere; competitive com­pa­nies, tech­nolo­gies and Bio­LineRx's in­dus­try; risks re­lated to the coro­na­virus out­break; and state­ments as to the im­pact of the political and se­cu­ri­ty situation in Israel on Bio­LineRx's busi­ness. These and other factors are more fully discussed in the "Risk Factors" section of Bio­LineRx's most recent annual re­port on Form 20-F filed with the Se­cu­ri­ties and Ex­change Com­mis­sion on March 12, 2020. In addi­tion, any for­ward-looking state­ments rep­re­sent Bio­LineRx's views only as of the date of this re­lease and should not be relied upon as rep­re­senting its views as of any sub­se­quent date. Bio­LineRx does not assume any obli­ga­tion to up­date any for­ward-looking state­ments un­less re­quired by law.

Source: Bio­LineRx.