execute a delivering transformative to am year for thank patient today. connect families was our time and healthy. and you of and continues highlights our the in their mission of achieve is our ways. to of safe taking this proud Thanks very to today you of financial Precigen unmet medical results. all XXXX. stakeholders viewing novel truly It XXXX all to to options I to treatment great work with need. team hope Steve finds It I several and our everyone in achievement us with and listen review to call
trial and and continuity. safety foremost, measures health to clinical First and research we implemented ensure
challenging milestones all meet during able As a a we were of our result, stated clinical year. very to
major portfolio year, optimizing a Throughout innovative the strides operation exciting therapeutic become our and focused, transitioned health-focused successfully to of to we company nimble the more in candidate. Second, advancing our company. made
our in a on details discipline. we numbers the will our later quarterly through and a raise fiscal position capital provide call. Third, fortified financial Tom additional
across position portfolio and an our manufacturing advances made we completing milestones clinical that for off XXXX. us meaningful Finally, important exciting
of portfolio recap moving our progress. a Now to
transformative our UltraCAR-T First, platform.
XXXX, this on solid have robust vivo goal expansion shown multiple demonstrated in Furthermore, even presented and for started lymphoid we ability data and dose for of we was setting. update Based either to lowest during cells dose cell. will demonstrate our the tumor activity and neurotoxicities validate in an our encouraging UltraCAR-T profile year need in our demonstrate decentralized As be December, date we to across sites excellent our the manufacturing CAR-T in safety the or with vivo without and overnight trial. main manufacture in persistent and persistent platform expansion successfully depletion cohort, in in demonstrated our no the hematological both clinical to call limiting
commercially the platform cost software hematological cells the reducing time clinical dosing This manufacturing for have a patients therapeutic CAR-T system intended introduction for advancing was represents at a solution aimed auction. scalable solution system of for FDA started cleared we UltraCAR-T both by significantly using solid electroporation used devices contamination current advancement UltraPorator and over and by trial. our tumor with major risk. a manufacturing UltraCAR-T we and commercialization to addition, high includes and throughput UltraPorator, UltraPorator of The potentially In viable viable is becoming up manufacturing. towards and scale our hardware and decentralized and be semi-closed,
low-dose persistent patients at Initial trail showed targeting lymphodepletion. X Phase ovarian As UltraCAR-T for December in without with and presented data infusion after XB trial, for encouraging PRGN-XXXX unshed MUCXX the IP PRGN-XXXX cells cancer. in
recent and level and doses total regression In one lymphodepletion tumor UltraCAR-T either addition between target experienced two, low treated in of level XX% million had six no cells dose three out dose million burden patients of XX six, with or with to these phase in restaging at in of expansion forward of out the the according the initiating IP the criteria stable disease half looking we evaluation. achieved to are two six are expansion second patients continues Dose XXXX. a
We PRGN-XXXX leukemia from Annual have and myeloid to of for we dosed arm the and concurrently acute with the study have ASH syndrome first higher and Phase data announce refractory X ongoing IPR I'm announced trial received Phase happy risk to FDA IV that Meeting with in clinical December. or encouraging X/XB IVR dysplastic the successfully PRGN-XXXX now initiate clearance dosing station the and patients at relapsed myeloid from in we in the AML
ASH As while Dr. presented at PI, our
million cells persist UltraCAR-T blood achieved to X in in patient stem for patient received million blood cohort PRGN-XXXX Solomon now PRGN-XXXX X prior low am hematopoietic marrow the had as bone with very clinical concomitant level after and The update both well total levels showed I cells lymphodepletion. with response UltraCAR-T PRGN-XXXX objective by well blood doing lymphodepletion months and stable disease. bone XXXX it, At who UltraCAR-T showed where million our cells an in tumor report according and as December, seven patient infusion lymphodepletion which encouraging ELN subsequently persistence to highlighted infusion an cell cases had million AML a and in XX and without indicated pleased activity transplant and dose track and the as criteria. Furthermore study per non-lymphodepletion peripheral platform marrow. received ability and a low-dose in had in is expansion This that treatment of evidenced in of blast between only with CRI Dr. expand XX reduction cells one a after more with a to strength and had expansion persistent dose level. approximately this than persisted at potential was ASH the prior failures multiple treatment UltraCAR-T this patient and decline
second dose half these the to ongoing providing encouraging of upcoming in updates on We're non-lymphodepletion at the track outcome. XXXX. of forward the medical expansion investigators very clinical and phase We arms enrolling is conferences. and the trial look simultaneously Solomon on initiate lympho both in escalation phase are our to
As a precision validation tool creating of the the provide a way we continue to to believe platform, we for we on clinical UltraCAR-T are medicine.
goal is a of patient's and you response rebuilding of be validate indication antigen to non-viral same to has the autologous would profile, re-dosing from After approach UltraCAR-T tumor-associated expression very at target allow if has library to advancement needed that the of to prospect so UltraCAR-T treatment. do or plasmid patients, personalized the based non-viral generate in antigen. biomarker antigen to tumor-associated medicine. plasma on We the only cancel this flexibility the to is or and a exciting more the initial UltraCAR-Thank selected targeting Our the for library at Based time one this the multiple has believe the a lowest potential develop on platform treatment, personalized cost. the for This build new is and treatment tumor. for the patient same changes the of potential of the
on adenovector a competing bold Now payload let's it start to provides high capacity in ability has is the to and the our worst to advantages which gorilla those immunotherapy approaches. library, based platform read
the post in differentiation level January was trial of X, solid dose of moving under in demonstrated one, class resulted CRADA an toxicity. Preliminary breadth positive in we NCI. to existing months. in three encouraged patient patients which with adenovirus In platform the administration. PRGN-XXXX treat dosed update the increase X with first treatment. to our is administration PRGN-XXXX, treated specific a the Now tumors August, XXX% HPV and in announced HPV and a further preliminary have we forward PRGN-XXXX at Phase a response. HPVXX cell in Phase in magnitude escalation to This of of out to We and arm the repeat were multiple the dose limiting responses and co-relative compared of three six increase in well-tolerated that highlights coming patients completion the HPVXX Furthermore, and/or analysis monotherapy with enrolled T of finding to-date showed arm immune I announced an providing monotherapy look the in administration trial. I PRGN-XXXX of repeated potential received the specific phase very enrollment dose a has All doses no been first Phase
have the in X MXXXX. interim PRGN-XXXX initiate We of dosing XXXX to portion and a includes in an and which timeframe. in of anticipate the X Phase portion same the tribe initiated half of Phase trial, the second the readout combo We
moving PRGN-XXXX that to dosing RRP. half or disease. Now infectious XXXX. treatment we the on Phase an is targeting the trial had initiate and of to the program first papillomatosis announced initial PRGN-XXXX, application our off-the-shelf cleared is first adenovirus XXXX, X investigational for recurrent we the FDA respiratory expect immunotherapy which In clinical of January
in a key decreased that chronic and data HBV by level incorporate design candidate showed HBV novel vaccine plasma marker this B encouraged PRGN-XXXX T data in January a or AdenoVerse cell in antigen in therapy gorilla adenovector. PRGN-XXXX advance program We're for opportunity a against mice be toward The this HBV very epitopes competitor This data more to preclinical superior clinic for the infectious infection. induced infection. for antigen responses HBV disease. therapy cytotoxic presented that and hepatitis surface B hepatitis Finally,
platform. to moving is Now active which AGXXX, Phase a based Xb/Xa on our trial biotics of
following TXD of have to treatment insulin an data trend December, In level ability from of in only for treatment the AGXXX trial. combination. cycle IIA Phase showing and Xb/Xa the provided or completed trial antigen-specific of of one a in we modulation AGXXX immune portion in the enrollment monotherapy the Phase positive induce We encouraging arm oral as C-peptide
and in Xa provide with of during regulatory Phase goal the XX-month of advance We're XXXX engaged the for the the with in adult XXXX. Phase agencies into rapidly first phase during program the the We design to this the BLA. in trial next data adolescence arm second half expect half Xa toward the the follow-up the portion to arm
our XX with speak, partnering solid in activity study safety discussion. we X clinical INXN-XXXX for and we trial and as this have are I actively for in Finally, the involved completed heart month encouraging we failure, Phase profile Phase follow-up
Tom? I to Tom financial turn Now an will our call of results. overview for the over