XXXX. you us. to to you you my morning quarter for progress all. good pleasure Thank the for fourth and joining Thank review our It’s Julia
really of next fourth with highlighted Slide our during which to we’re X, XXXX, the two operational and quarter slides. progress Moving program is pleased the over
based FELIX II disease interim pivotal its verified relapsed on response by obe-cel as in analysis monitoring independent a clinical to patients overall data in December delighted morphological committee. point Phase were patients that refractory announce we in adult end with and study rate Firstly, met the XX ALL evaluating an of primary pre-planned
closer this I’ll another into in to more the an population, We’re later presentation. bringing innovative ALL potential to underserved treatment delve detail step in this and data
with partner, at the end This triggered Sciences, most earlier our by positive year, well are the million U.S. anticipated, planned on year. to treated ASCO, BLA this patients from than of update and to Blackstone follow-up data milestone XXXX planned end a FDA provide mid $XX longer a the planning data as the by we all at likely Life submission of as
December was busy a us. month for
a presenting follow-up number Hematology from anti-leukemia patients showing of American no adult term with of XX% obe-cel of of follow-up, ALL the in updates Society our clinical Conference, longer had in also therapy. of at at XX additional We including follow-up--median ongoing Phase remission Annual months the ALLCARXX data study patients I
lymphoblastic chronic high to refractory and well safety In with manageable levels addition, profile. in of activity non-Hodgkins patients leukemia continued relapsed show clinical lymphoma paired obe-cel a
CDXX no very also a CAR presented achieving observed. molecular ALL antigen we patients I XX% AUTOX/XX, our negative of Phase of with encouraged remission were We relapses therapy the dual program, the from CARPALL our T pediatric trial targeting complete over CDXX with data targeting with and
up including one I on remission. cell TX year patient in the follow-up of term T Phase patients one treatment experiencing in durable the trial metabolic LibrA longer mark provided continued obviously peripheral CRs, with we’ve to post some Additionally, lymphoma AUTOX and
in the MCARTY will also start expected data quarter. study CNS in neuroblastoma patients, AUTOXNG of in of Phase year these of and and over is of programs patients, I from the trial the AUTOX in course to this the lymphoma Phase obe-cel patients on next We will finally myeloma be providing presenting multiple peripheral I CAROUSEL be trial updates the
Turning made to progress Slide X, we’ve some quarter. great during operational the
transformative end offering, underwriting after discounts of of partial underwriters. net $XXX aggregate the proceeds public closed raising Towards expenses a the we million $XXX.X and the a gross we [indiscernible] believe exercise by and of of including year, proceeds offering are We at of million, be innovative the commercial financially launch obe-cel, year positioned underserved in an fully and the we a will working In focused bring adult application ALL an well on to XXXX, the potentially and end treatment population. patient submitting towards XXXX. to BLA
our analysis also of manufacturing earlier, partner, qualification supporting from a Blackstone process. Blackstone received from adult an same result million milestone obe-cel we the time, received million a activity of as obe-cel I the milestone as the Sciences, result additional of ALL. and in As planned Life of we a the $XX $XX mentioned interim positive performance At
lead equity our You the for recall obe-cel, program have at XXXX, and committed received million the part $XXX will we that collaboration with we of of financing signed million $XXX now capital. a agreement the and candidate, part total end Blackstone
to rituximab-induced end which in we Bristol what therapy believe RQRX developed selected underscores our We January one a into October is an in to an them switch Squibb have announce proprietary cell three incorporation We technology granting Myers Autolus. and with deals, we at safety cell XXXX, were two pleased signed platform industry-leading of for XXXX very programs. post programming period set agreement access
we the August against one undisclosed the messenger pioneering Moderna binders In stems an This being option option on license therapeutics. with of addition, RNA the exercised target proprietary Moderna XXXX. for immuno-oncology an delivery in of developed deal announced from
incorporate agreement $X.X of in revenue cell them for potential program these for has we and royalties. revenue allows RQRX therapy fees, the Bio which Cabaletta the in autoimmune near safety the term and option switch an additional each deals XXXX to total The XXXX milestone treatment payments, signed a million license into with of in Finally, exercise disease. January was
our progress CMC in steady make to manufacturing operations. continue at We
completed the first the handover of facility clean The of commercial build the rooms with phase last year. three of the of end first of at was manufacturing our
We have named this Nucleus. facility the
for Nucleus we of commencing remain and and on We second on practice XXXX. half of the now validation are track good in working the manufacturing the operations qualification
undertaking also FDA. generation submission the for to development We’re the and planned the package BLA to CMC support the report work
and cash restricted at and $XXX.X cash of total Finally, end the equivalents cash December were million.
With that, X. talk on obe-cel Slide about No. let’s more
has maximal the heart of of has from rapid patients. to the binding This cell, and Obe-cel differentiated toxicity with at fundamentally What’s lymphoblastic activity about paired target observing once target, cell target product different delivered. ability has chronic to clinical a which the lymphoma an is delivers been that unique rapidly off-rate disengagement leukemia physiologically mechanism it with action. for acute candidate engage is specificity fast a minimizing the non-Hodgkins the kill patients, while lymphoblastic we the leukemia, and are engagement profile unique drives in our
clinical ALL rate Slide shows response high experience high No. all--shows our across with overall onto activity X, obe-cel level a across clinical indications. of in Moving all
Our shows ALL now study. response patient level clinical all in very experience high across in ALLCARXX populations, the have over term high observed a a obe-cel with that of including rate the activity we overall longer clinical
of further patients XX therapy. anti-leukemia of PRIME have levels profile and XX The XX a now with safety XX% program ILAP months of receiving in the of with The long obe-cel median are remission and low remission see designations. We T and manageable is the patients slide the that study cells midsection RMAT, long-term and follow-up a of in presence high to receiving shows term this of grade no after developed we observation, observation months follow-up of under ICANS. over the is The CRS continued entire with CAR well and period.
we based to we patients, overall had at remaining followed adult study, as relapsed primary an sustained benefit Moving call refractory ALL rate least in the of and end and the in patients remission. be December announced three we I of the Slide on will analysis FELIX that we point the met study, the assessed XX complete on in based patients pivotal Clinical in completed response for follow-up. enrollment dosing first months ALL mentioned, a X, of in study interim
to regulations, we and in the part and of the trial significant XX due refractory It important the poses highly suppressed the pandemic are rules to various clinical this sites seven in ALL most three adult relapsed Spain that centers realize conducted not our U.S., in a risk centers Moreover, centers, pandemic. We to them. access U.K., access and added patients is immune could pandemic during of restrictions the study. peak XX study in other the for FELIX centers and the
ways, this difficult we difficult real As patients particularly is infection, ALL was and imagine, there world of you are to more patient did an to conducted where a patients end under can environment a of circumstances. indeed about many with, stage study work In lose COVID. high risk in as a study population
also priority from flights. U.S. this In reduced our addition every during our to product as the aspect the also of and an U.S. the asset turned to flights trial for manufacturing to out have haul pressure-tested be on domestic safety, patient Remarkably, for with the in between manufacturing were U.K. and all delivery pandemic of facility massively air and long impact EU patients teams. delivery traffic logistics U.K. over the U.S.
Next, in this readout for ASCO year. data a key is planned June
at The and all patients of overall used analysis No. Slide marrow XX in made fact pre-specified XX studies. dosed on in and a based CRI. primary recovery, respective in first December point patients the had end and in as incomplete their ORR remission announcement of of is reached regarding or programs in slide we rate, with primary remission The least three to follow-up. remission was XX% end months ALL interim summarizes XX, CR which Moving out have bone the in that complete ORR patients this the recent includes point complete
contrast grade patient Safety ICANS analysis were an a in therapies, or patients. less population. high T XX profile release patients neurotoxicity, larger profile and fully with than T this cytokine or unusual had of in and approved engaging XX% than and conducted of grade patients of of cell experienced data less neurotoxicity on X% set to cell grade safety in ICANS excellent very higher in was showed X% reversible less any a than
set milestone from As I mentioned a earlier, this $XX exciting data triggered Blackstone. million
this across obe-cel experience with XX, slide No. current Slide our to summarizes ALL. Moving
pandemic. Worth the CARFALL ALLCARXX noting both study conducted conducted U.K. data were can the CARFALL in the you during study that FELIX studies, was As the see, were of is the and various conducted study ALLCARXX the U.S. FELIX to and in pandemic, safety while efficacy. the while highly conducted Both parts the studies both were and are prior consistent the largely in the across
gain a essence the burden disease based so-called in presence the their anti-leukemia of of to more Patients marrow and in pick grow disease successfully poorly disease. respond and the patients therapy. up This allows is is tumor What we in other leukemia bone the type settle of extra-medullary is function in on to advanced increased that organs. did that leave of were study FELIX and with extra-medullary any
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ALL. quite has high cell Moving to XX, T B Slide very to medical lymphoma need a similar
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at to levels Slide to dose Moving targeting unique that approach, higher show with meaningful we its XX, AUTOX impact evaluated. clinical the starts have
to year those CRs reaching we metabolic one are post-treatment follow The continue patients. first and
and in streamlined additional on later exploring have activity in outcome that cohort XXXX. planning report addition, are In the an to we and the manufacturing we’re process
at is program. process highly is the the about Moving reliable, robust a to for autologous manufacturing, therapy. of of critical cell to core economical success Developing any manufacturing XX any and cell Slide talk
scale standing up is clinical Nucleus for already deliver of at site and fact to is validating to the of the used the our its our to commercial manufacture had many therapy. for study, able roll-out In staff trial the a have and process FELIX entire successful be on mile new matching well to and manufacturing clinical it to as robust This process be study. called able size that Building medical do and are to the we’re have important from be the away addition, cell facility, the in important will able manufacturing need move capacity of characterized product them to we indication, the your a of facility. proximity we to facility, used about the the in the to in Nucleus, we
quality capacity of The a two-thirds design in patient build to been terms of build. of size year realize to the with per initial offsite fantastic the Nucleus the set-up market innovative an XX% maximizing about of batches The the its X,XXX adult Nucleus ALL of project about or the has is while accelerate in capacity. building
would fiscal over With that, to like I Lucinda for financial Lucy? call pass to and year Slide the to XX turn XXXX update. our
