Thank and a our joining is this which release, John It website. call quarter good you, press thank morning, filed of of Earlier you us results available was also everyone in for morning, today. X-K. third a copy and we the issued on as Investor our a section conference Relations
with of our Mali then provide our third is I'll As financial practice, our overview results. a of our Officer, quarter, an Chief will discussion Financial Zeevi, begin
We GENESIS has on which stem Also submission from since line agency meeting mobilization NDA the are was will autologous The support bone The high submission. primary subsequent for Vainstein, Medical the then transplantation drug a positive most on of P open X.XXXX. from the in apheresis our Phase GCSF at that and of a versus brand highlight to went statistical compared very notably name acceptance to Officer; aspects of myeloma X value of directly September Genesis our of overwhelmingly or single top met and May, patients quarterly for action application date Notably, in Phase this patients. the a we that BioLineRx a Ella The key motixafortide, held FDA cell the XXXX. GENESIS is Chief new only of APHEXDA of marrow now its GCSF. our filing, mobilizing PDUFA would update President than based for and XX% those joining the of trial, study successful and GCSF your known XX% stem key APHEXDA one The approximately December a degree gained the results USA. in Abi XX, to optimal Chief Holly compared by multiple Sorani, of last only one study to target and top with alone. on transplantation the alignment assigned Q&A of forward sufficient looking Officer less endpoints call Development our Recall up unquestionably the following call after by questions. cells X with administration study session placebo pre-NDA secondary agency less than number APHEXDA receiving top on past that be significance of and all
the well clinical transplantation. benefits considering tolerated. In addition, to approximately cause combination is GCSF may units median cells a of but arm mobilizing of apheresis institutions before, more recession in often effective stem where the a are that versus treatments use success rate APHEXDA of difficulty This two the cells machines. stem patients confer in the to significant target than per new there when benefit, was of collected be efficient also arm. induction safe and found XX APHEXDA one kilogram plus and in subsequent lack also more especially for The has number approximately only million GCSF high a ever transplant substantial available rate The through high success million
independently. commercialize multiple standard market of in over healthcare when to if We of accrue anticipate care APHEXDA in benefits we the approved. Given the and rapid plan that the stakeholders, current US to potential the uptake APHEXDA
availability our we $XXX concluded commissioned that maximize it asset decision an and the the US million this company. to will cell the led this myeloma XXXX, time Operations. allow value steadily lengthy accelerate basis. party on third growing of market US made Commercializing APHEXDA the by of us its market in annually a excess while Recall, same was careful that President mobilization for and ourselves multiple research after year annually approximately the have $XXX both our stem our global review Holly We to was of earlier Mae, of options patients and a at million
are We multifaceted build a well relative positioned Therefore, required of well execute aggregate the cell ensure approved. infrastructure of to is accepted, for so XX% announce of to we mobilization expenses we market limited we us pre-launch when the submission With two process and if out robust XX XXX cell in most give now concentrated to centers our that are have US completion indicated NDA, of we our access financings financially during including perform stem commercialization plan, to more $XX with working up oncology subsequent funds. the effective launch in NDA of positioned advancing that To out ongoing launch procedures. launch that the its additional be to the million before indication. the look stem possible, traditional review transplant approximately that highly in the of as footprint approximately our while a agency broader would to parallel the forward a in
million to Capital. at is upon achievement and first of would interest a a the bear remaining XX, $XX us discretion agreement. we provider subject definitive for debt mid agreement innovative to the fixed associated points leading Kreos XXXX. Israeli Kreos various in the available available The tranch per the to the of and rate of million addition, XX% financing solutions X.X% $XX of our execution high tranches high made pre-specified cap. million tranches a healthcare time drawdown will through debt annum, be in two at was milestones. and additional sectors. growth under Per the The are of at $XX First, to Kreos entitled companies announced will the royalties October pre-defined backed Borrowings terms to digit single pan-European to non-diluted flexible with up sales including effects equity of financing available made to technology approximately in on be cash fees a agreement,
the close of offering the also Following equity registered debt we a $XX financing million shares. agreement, American direct Depository completed of
planning amounts to the from million, targeted the us received funds $XX.X our believe September the debt to commercial additional at approved. financially very under are affect financing launch be to that available XX, positions was agreement, With execute these included cash balance transactions, which potential well the we XXXX should us we
of in to XXX program, into agreement, year to metastatic patients that Agreement Pancreatic a PDAC or first Motixafortide Under our rigorously earlier now Cancer Therapeutics. Collaboration a Turning execute this designed plans in the PDAC Phase line terms Development recall GenFleet GenFleet approximately XB China. randomized study we this with clinical entered
Importantly, all digit Motixafortide we with a motixafortide KEYTRUDA affect royalty based reported combination on we study second-line the to of is to anti-PD-X maintain ultimately entitled be chemotherapy full should collaboration combination indications combat rights a This while XXX positive therapy. small IIA approved. results as geographies from Merck's KEYNOTE Phase that triple and in single across and our be GenFleet sales to would
demonstrated cancer, from rate, progression-free overall data survival, reminder, rate to share historical to across disease with first-line the hope immuno-oncology the initiation survival, pancreatic with ideal Based Phase Also we combination overall advance chemotherapy XXXX including response a of Motixafortide Motixafortide study anti-PD-X to the we additional when including Columbia That separate overall improvement be University. trial That and substantial median study timing this recall endpoints II and forward compared capabilities we is Phase continues in control IIa confirmed all potential look the study and Motixafortide evaluated data in and to rate. development evaluating on collaboration have trial data, that median conducting as As response the the China, a updates experience of we combination trials as XXXX. in in available. is which in partner paediatric their study in therapy. including LIBTAYO believe in space, found initiated in will during investigator progress PDAC will that being a we
potential raising month. perhaps the the XX the is next most Hematology December is American Society year. important of for important to Meeting Motixafortide Our of key present XX Medical and through at Congresses awareness of the
announce presentations ASH. We poster this at to year two are very pleased
stem versus The first cell of pharmacoeconomic effectiveness presentation results will GCSF plerixafor from arm, transplantation. apheresis cells Motixafortide Motixafortide from undergoing using to amount stem GCSF patients a a the study meaningful mobilization administration cell our stem Motixafortide full sessions. of single in primary of the evaluated in optimal detail autologous with in due only myeloma patients combination with that net with combination plus one study significantly cost greater and of proportion savings a the mobilization Data agent in Motixafortide cost as successfully multiple indirectly achieving demonstrated the of following GCSF
therapy mobilization The genetic genetic cell most and used evaluate reliably disease, indications. sufficient to to yield Motixafortide can just diseases including include would The of a Plerixafor inherited examine high condition stem the The cells one its a X GCSF gene produce design severe the further ability numbers study additional a has mobilization the stem stem hematopoietic trial therapy patients will is associated how sickle regimen of part optimal example the quality gene demonstrated an cell applications. with of second will quantity mobilized profiling. gene manipulation with not will presentation required hematopoietic for assess Motixafortide immunophenotypic for Phase as transcriptional we is one single detail effects. cells, cell that adverse ability stem processes of alone trial need and ultimately into the in novel leverage think of where cell to We safely globally, the development. of therapy common
our anti-cancer candidate, AGI-XXX. now Turning vaccine, the intratumoral to clinical second
to trial a in ahead. will proof would like evaluating The that in both financial pharmacodynamic evoke quarter Phase now We to statement look multiple effect. of safety, a study. and coach provides I evaluate We the Molly, tumors give tumor We biomarkers Zeevi, alpha-Gal immune and end. clinical Phase foreign of from are both to go make who our turn study solid them that of AGI-XXX an anticipate overview response brief tolerability the designed vaccine-like tissue CFO, X/Xa parameters. items. to wide types year third believe tumor over our to key like and assess existing by destroys data call of a is please array part X/Xa with Mali two and sharing a cells mechanism
