you. Thank
thanks, XXXX us financial and Therapeutics' the for quarter fourth results everyone, afternoon for joining Fate Good call.
found results Shortly today, after website can under these of we Time Investors be which issued a Press Media X:XX press release our PM section on the Eastern and Releases. with
Media for Financial year and on found can December our section our XXXX, under XX, and website of addition, In the was Form Information. be the XX-K ended filed thereafter Investors shortly
like would of the I call Before remind statements everyone by Private statements begin, we statements responses Safe conference for except to of XXXX. the on Securities historical made under that, Provisions are forward-looking this the Litigation facts, Harbor of to Reform management and questions Act
uncertainties in results well statement ended forward-looking issued press close SEC risks cause December in of after can year those from the involve with earnings as that in to today materially on XX, the filings forward-looking the market statements statements. see Risk XXXX, actual as was such release the Form the for today. Company's These included filed Company's our XX-K and Please differ disclaimer SEC Factors the the that
update forward-looking statements, by law, the Fate Undue reliance not the forward-looking change. this or required speak underlying to may these Except circumstances. to be statements information, placed events, they these only Therapeutics as circumstances should any of are and which on reflect date facts as made forward-looking future obligation statements disclaims
Vice President and Dr. Joining Development. me Senior Wayne our Dr. today's Chu, Dan Chief Shoemaker, Clinical our Officer; are call on of Scientific
investigation I in discuss quarter iPS-derived we Fate cell-based immunotherapy. iPS-derived milestones immunotherapies bringing our has to the of key cancer outlook on XXXX, during achieved comment clinical XXXX pioneered will the successfully I Therapeutics cellular of patients. off-the-shelf for fourth will and Today,
highly manner, can millions patient required be can master and believe donor-derived therapy mass for to cell a off-the-shelf is composition, approaches of lines scale significant are differentiated uniform from products source be of well-defined accessibility. which approach at unique It therapeutic and as iPSC which in cells. We primary cost-effective for a and in our engineering engineered therapy, using and delivered batch-to-batch sourcing renewable broad patient manufacturing produced cell
monoclonal to we iPS-derived a be that highly therapy antibody to therapy cancer forefront we XXXXs, Similar are of can cell excited and believe of therapeutic in the the disruptive treatment at is emerging transform field. this the paradigm
off-the-shelf dose by the in stage encouraged FTXXX, We the from the study of of reported company's December iPS-derived are first data initial product escalation NK-cell candidate. Phase I clinical our
is Our in product. an FTXXX the cell the of United Phase I study trial first-ever iPS-derived clinical States
over Additionally, FTXXX clinical course it treatment of of of to by consisting evaluate a three two up novel XX-day treatment followed once-weekly one to trials first-ever cycles. doses a of the multi-dose lympho-conditioning therapy outpatient cell is
of cytokine In the toxicities, events there or of patients as FTXXX no disease. November the release limiting XX, FTXXX X XX dose cutoff, events, advanced or for incidents tumors, data neurotoxicity, and greater adverse no graft-versus-host first reported administered solid Grade were serious adverse treatment XXXX or related syndrome, no of
the treatment multi-dose Additionally, repertoire, course. responses antibody evident patients’ based on of against over FTXXX assessments anti-product T-cell were the no immune and
doses data delivered patients in matching. FTXXX off-the-shelf can and manner. provides XX of these clinical patient total, In NK-cells administered doses were without to These evidence be tolerated iPS-derived strong of XX initial well a multiple safe that
first of for clinically believe this cell-based field We iPS-derived is cancer a immunotherapy. step significant the
and NK-cells advancement of engineered our rapid be to solid programs hematologic treatment for of continue clinical tumors. and excited our of iPS-derived the development malignancies into pipeline NK-cell of iPS-derived the therapeutic about We potential engineered the
from augment a company's modified has CDXX cellular on reported the the express to off-the-shelf clinical the iPSC Fc immunotherapy trial which non-cleavable engineered master open-label, in treated multi-dose we Phase been clonal of I derived line receptor, antibody-dependent FTXXX, high-affinity, first December, In a cytotoxicity. patients NK-cell to two novel cancer
in the FTXXX iPS-derived engineered FTXXX treatment AML and lympho-conditioning, rituximab one combination therapy a patient, B-cell of of FTXXX second platform is once-weekly to NK-cell cell clinical of a relapsed refractory received the in as and treatment administered for outpatient IL-X the treatment better product had world Each FTXXX undergo promote candidate the for is three and our with investigation. consisting iPSC from first of large the one doses lymphoma activity. first diffuse emerging to cycle product administered monotherapy it
well again, and tolerated. multi-dose was treatment initial indicated course clinical the that safe Once data
in AML, may first of at product confer bone relapsed the obtained bone activity. clinical iPS-derived marrow biopsy day-XX marrow leukemia, showed chimerism anti-tumor the in that evidence evidence engineered FTXXX morphologic of administered recovery, a for Additionally, treatment refractory of of NK-cells no evidence patient hematopoietic with initial evidence providing the there was and
clinical In December, monoclonal combination with are for antibody the tumors FDA solid expanding IND now its investigation we to our allowed second FTXXX application in therapy. and
CAR-T next-generation Hematology American the of with potential to the limitations at of press preclinical programs for of cancer At FTXXX CAR meeting immunotherapy the December, our Beyond presentation generation program, in and key organization's selected highlighted which IND-enabling was data Society overcome T-cell current four therapies. the promising
from three the CAR engineered cleared engineered for be anti-tumor multi-antigen first-ever the with derived master off-the-shelf investigation line company's active product FDA. the is to clonal components iPSC is targeted a NK-cell and clinical immunotherapy cellular FTXXX candidate by
receptor and complex receptor, our addition trans-activation proliferation In dual FTXXX support. survival, potent T-cells and non-cleavable expresses expresses of and a such the Fc also high-affinity, promotes CDXX, for CDXX systemic a proprietary as cytokine NK-cells enabling targeting of novel without CDXX. CDXX FTXXX tumor-associated that to need antigens novel cytokine targeting additional CAR IL-XX fusion, a
presented promoting at showed of and primary FTXXX ASH, CAR was models T-cells monotherapy vivo comparable a in survival. and preclinical clearance a in in data mouse as administered New humanized that tumor leukemia, extending lymphoma to
and to of potential B-cell rituximab vivo effectively to potential These alone. validate off-the-shelf functionality multiantigen antigen CDXX FTXXX provide compared treatment overcome combined FTXXX that support the lymphoma as escape of malignancies. Additionally, with cells rituximab, when has best-in-class enhanced unique of for killing showed data and its FTXXX the in targeted
announce We FTXXX of patient that open the enrollment. are to Phase I to open-label study is now pleased
We also products. is our Diego, GMP custom in-house our with are in master launch renewable iPSC to at CAR pleased facility and of San for the designed and as manufacture clonal use scaled NK-cell California off-the-shelf cell manufacturing headquarters that source of the lines a T-cell consistent
studies. of of FTXXX, infusion-ready released facilities cryopreserved, per been launched inventory stored FTXXX, programs, hundreds three for dose. of completed we each the of With clinical cryopreserved, and time, low this are have the stage immediately available product, of our qualified, cost in September, our at clinical for doses production clinical doses infusion-ready in successfully hundreds in FTXXX and At use and
of have to supply and production proven engineer to to industry of established full iPSCs cGMP capabilities ability our use, genetically the combined we and creating the off-the-shelf operational qualified clinical believe With our patients. manufacturing for with redundancies clonal we cell lines control products for master unique clinical cost-effective consistent
programs. we strong iPS-derived milestones and clinical immunotherapy we expect achieve our exited during XXXX cancer cell-based clinical As momentum, generate data to with across decisive XXXX significant clinical
I IL-X protocol We have study the clinical to cytokine of now include advanced multidose and tumors Phase FTXXX our solid amended support.
who refractory dose million and are or checkpoint per We patients have dose to expansion initiating cells are at following inhibitor relapsed XXX therapy.
trafficking with XX% non-small killing. Class NK-cell amenable highly complete to to these to and with enrollment lung We exhibit MHC recognition therapy targeting will partial tumor of cancer or checkpoint patients cancer, of and type cell loss susceptible expression, a making NK-cell up focus patients or to inhibitor resistance X cells on
dose is study I Phase to second report three sites currently and half FTXXX The U.S. in the clinical enrolling of data XXXX. expansion in the we plan at
We of to are rituximab AML of monotherapy as for and multidose the treatment treatment B-cell continuing of study for FTXXX the in combination escalation Phase dose the enroll of a our malignancies. stage I with
are these exists There donor-derived assess of we therapy established initially for NK-cell we proof-of-concept and clinical safety against can for the efficacy indications which FTXXX. there benchmarks clinical and believe
activity ranging XX% complete In response been the has of XX% setting studies. therapy donor-derived investigator from AML, refractory anti-leukemia and in shown rates reported to initiated have relapsed NK-cell
We lymphoma, second B-cell XXXX. activity monoclonal the approximately escalation agent data single complete been of of antibody dose reported. of rates plan report the In therapy relapsed response XX% currently having modest, is of setting half with in refractory to
with a FDA. broad across rituximab the B-cell PDLX, clinical and of our solid with malignancies, antibody application of in monoclonal combination for FTXXX IND has to therapies combination by HERX-targeting range investigation now the addition PDX, allowed In tumors EGFR and been
solid initially We and patients line targeting least to refractory of of to, are therapy. the following, monoclonal FTXXX who monoclonal intend tumors avelumab at prioritize PDLX or antibody relapsed antibody advanced have with one anti-PDLX the in combination
carcinoma complete only having having response for rate is an the treatment of XX%, of for advanced single and XX%. ADCC urothelial single inhibitor checkpoint overall Merkel a agent approved of approximately rate agent response competent a cell carcinoma Avelumab
enrollment initiate avelumab FTXXX of in combination mid-XXXX. We in with to expect
We which active modalities are am announce multiple enrollment. antigens incorporates B-cells tumor FTXXX, our pleased which and best-in-class it is three particularly on believe associated patient potential. expressed excited now uniquely open cancers I is We has for to anti-tumor target trial, clinical about designed FTXXX to
Our and no MD results the initial initial confidence CARXX in response investigation data leukemia Anderson, patients of toxicities. clinical lymphoma NK-cell FTXXX is Medicine where major England a refractory bolstered in Journal with from by showed with lymphocytic recently undergoing overall New in clinical non-Hodgkin's at the relapsed rate published clinical XX% program, a donor-derived chronic
demonstrate results CAR NK-cells CAR efficacy While potentially with toxicities these commonly without generation these current are therapies. clinical a associated can of that significant high-level are that data early, confer the T-cell
that the risk We to Annual currently of believe potential and have at address has and to escape initial patient-specific XXXX one report relapse CARXX only to supplant data to We FTXXX toxicities. significant fail T-cell antigen, ASH immunotherapies due Meeting. escalation dose plan the allogeneic antigen the recognized
monoclonal complete receptor, to We non-cleavable a CDXX off-the-shelf also of to knockout from fusion synergize XX iPS-derived master derived IL-XX for next enhanced functional our and CRISPR-edited, iPSC product IND promote a FTXXX elements; antibody-dependent candidate. application with three FTXXX our therapy cellular novel in cytotoxicity. expect the FTXXX, line designed anti-CDXX our file receptor is CDXX. and with clonal engineered is novel Fc antibody days NK-cell an high-affinity,
clinical of We in investigation FTXXX treatment daratumumab intend of to the half multiple myeloma combination in with for XXXX. second of initiate the
may applicability multiple beyond myeloma. Importantly, functionality broad FTXXX engineered therapeutic very of we have believe the
persistence As ASH, CDXX at preclinical we NK-cell in and studies. of presented potency expression elimination enhances
explores activated to lympho-conditioning, chemotherapy-based affecting non-toxic cell adversely of hematopoietic immune field is monoclonal anti-CDXX strategies the stem depletes therapy a reduce system as that therapy it significantly replace or well the antibody compartment. patient's adoptive documented without cell Additionally, patient's
including been Since without toxic engineered anti-CDXX conditioning the beyond of mediated we antibody and has use indications FTXXX to with agents, believe combined monoclonal depletion, FTXXX multiple maybe CDXX an effectively resist administered myeloma.
foundational iPSC the engineered for of product as we FTXXX building master NK-cell line Consequently, our the using clonal iPS-derived are for a candidates. future backbone
to world be novel mitigate clonal the strive any we is of the first iPSC complete XXXX, inserted from off-the-shelf T-cell to constant engineered CAR FTXXX the receptor patients. line disease. Finally, off-the-shelf therapy iPS-derived group engineered bring expression candidate CAR and elimination T-cell first with receptor iPSC-derived of in CAR to a XXX T-cell into a locus, T-cell targeting in to the master is derived product and for edited alpha risk graft-versus-host CDXX company's
a ASH, model clearance from to leukemia, Dr. with enhanced T-cells. in a we primary CARXX in data At survival and xenograft comparable that led manner of presented a by Center Sloan-Kettering Sadelain, tumor preclinical Memorial Michel Cancer new extended vivo demonstrating in lymphoblastic FTXXX collaboration
application intend and investigation we to of iPSC we At FTXXX generated quarter the the characterized engineered FDA to master this the for IND clinical in of and second XXXX. have for line submit an time, FTXXX
the our XXXX, $X.X was the same for derived collaboration for $X.X million to CAR the pharmaceutical. Ono from compared to company's year. quarter the period of in quarter current iPS-derived Revenue last Revenue million was financial Turning T-cell with results. the fourth
the for quarter product last of $XX.X in an activities, support period expenses company's Research million, The our development R&D in associated increase year. the compensation, product conduct including and our including million third-party pipeline, research internal expenses associated candidates, collaboration to the $XX.X expenses was increase of attributed the clinical company's development with and XXXX employee manufacturer for headcount of with fourth Pharmaceutical. compensation the to with compared the and of primarily same were the associated and under advancement with expenses Ono to the in growth share-based
compensation, million to G&A increase increase same for our in XXXX for compensation. were fourth million, employee primarily $X.X including of the was compared attributable to year. expenses last G&A $X.X the expenses The share-based an in period quarter
its loan, the quarter debt ended all of were obligations. and equivalents of million. operating retiring its $XXX Total XXXX net investments. expense cash, of XXXX November, the of cash full of in million of stock-based fourth million the with repayment, expenses term $XX.X non-cash million fourth $XX company approximately compensation Including company for repaid In quarter the $X.X such
and million five XX.X was common is outstanding under which convertible stock preferred Common each million into conditions. X.X outstanding was of convertible shares, shares certain of stock stock shares
with to like up And I'd questions. call any open to that, the
