And Ioana, like raising, good with afternoon, We appreciate CFO. many on of corporate Jill's to execution at Howe everyone. be financial are finance fortunate can areas evolution other expect time today. us record a I'd to and of extensive begin will strategic accounting. our you and executive first someone to Jill's welcoming in we an operations joining new future track and capital long Jill with joining company. successful have November call of join the experienced is our earnings this in Thanks, management, by Jill on us the day me as and XXth, her you background calls.
begin Next, AMD. about few the I dry want in evolving to landscape comments with a
GA. aware, OpRegen dry everyone treat potentially pipeline As there therapies expected for has particular dry several AMD February date to disease with is will AMD. advanced in complement its out call have One competitor support FDA about for which to whether most read its on Dry the this trials has it in speculation program AMD PDUFA late are designed approvable with their transplant of a currently is to large results. approval. abundant There treat is a attracted our because lot cell lately, RPE approved is in attention no been data inhibitor maintain but
and of to are believe the we AMD of much to-date any proposed inhibitors. superior we on dry OpRegen’s While discussion complements, collected the focused currently that have is around complement data profile product
which could vision. be rob a a outcome be a eventually anatomical But if lot lately of possible the an that, the a as approval I been want today inhibitor this that that expansion be same about a atrophy slowing continuously months be to is patients. have growth into on be based of improve shown reported approach, should no or It RPE going will the company changes approval have inhibiting terrific the GA we've this so outcome receiving speak inhibitor transplant In in indicating will better if past you than complement to about data. I've program. on directly of acceptable which and of in approved, a two their even this the relatively the at amount. largely complement value particular AMD that alike. far with is amount the year, would left might to-date discuss Because an OpRegen because impact has GA and approvable the And ordinarily complement small we questions For for of is than, I an if vision Lineage a a with a Delaying complement XX, slow endpoint of Lineage of companies to some wouldn't person grow that inhibitor. and viewed GA course, believe progressive anatomical time, if and be of a reported rejection discussions. possible safety. time monthly disease decision data good competitor approval based XX some inhibition are small reason, changes, eye anything with progression or have take XX patients therefore to greater these the notable, injections is by those possible this of for in Even complement that can whether but belongs an seen at patient's I the outcome disease. on would atrophic shown pathway the areas with untreated, means endpoint,
be Our or at months detected an some longer, patients, seen XX longer for possibly effects benefits. than In some having GA to of a size the also become we've or XX than remain from to or year within to rather wait baseline. see months smaller area same few just even a can
of of you XX square look units years. just XX-millimeter at to put inhibitors encourage clinically the call, years. areas and at XX so its XX% with we've this draw data really XX, in I then clinical you millimeters anticipate two rate if commonly After on impact the that comparison, offer XX% room what area after growth XX a reduce or is concentric you to square those that To atrophy, this millimeters per of that, date, would you approximately is as perspective, of in grows by perimeters so between meaningful. XXX year, in referenced competition after currently GA area leaves thin lesion therapy I based growth the assume complement narrow the and While left a space if reduction seems seen X.X and would justify of could strip improvement. after XX XX up XX-square It theoretical GA mean. millimeter a reduction is Again become square XX years then to year, of should what understand described about for circles. which to millimeters become circles us approximately And that per being XX of and to lot that to That the injections. XX
I for photoreceptor impact changes dominate to precedent approved. competition with is it So endpoint ultimately if a month have a to anatomical FDA what acceptable far of comply larger The an February been And in preservation disease, is structure surgery if than other demonstrated the OpRegen can on the believe the form we onetime have injections. to-date compared or is from sets this next seen with having achieved every we far. thus our retina monthly have results that
have and earlier patient's a not FDA Now, patients it year, Perhaps endpoint will In visit. who OpRegen Genentech we patient's require FDA will stabilize at changes ARVO benefit our complement improvement significant this as all in or contrast, of improve this functional acceptable case condition. may an five Roche seen vision. reported be as such cohort that instead inhibition the as by that anatomical date, not partners, statistically stabilization in evidence To X, can accept received or small a vision is only across it worse is no most over as at this be which XX.X is years. one patient better. in demonstrated And area treated, of not all population time, atrophy, understand of have been disease a average have we reported, improvement should for these there visual letters a maintained the year. currently get previously experienced expectation Patient We Lineage improvement. for including acuity which fovea of also to but their an of gains a of
effect functional opportunity. across as would show a leave in assessments patients the positive view of demonstrate an losing evocative to irreversible remaining address variable larger failing We be the significantly be we proteins acknowledge failed least the widely which of three class is presumably only and vision, pathway we and losing basis have patients one BCVA that on hundreds to from someone eye, letters what data can is rejection years, the and to OpRegen medical in actual on vision inhibitors result approaches, eye one letters the an are warranted. of date compared in unmet Because that is of But multiple and benefit our of to handful accepted viable after of to affect seeking also complement also an is in their saw their our FDA a condition. for of progressive at complement treated XX need understand only entire commercial four a and studies believe that untreated to
positive on it competitors today, expected the complement as decision they February or in it our appears out. matter abundant for leave a outlined do approval, that room Lineage for reads no I've receive If So us of both to either will how is improvement. inhibition regulatory
developed trial. being way enthusiastic be by initiation conversations. which and the believe its we efforts is of are the next initiation we AMD new have notoriety. the made and next most continued the for about opportunity that in important expect AMD ensure to importantly, gaining selected market clinical I'm a excited positive a OpRegen, we are we can in that more for toward included dry substantial of clinical patients prominently dry capable trial It As the OpRegen of those enjoy partner to presented with therapies And is considerable
will asset. for and because the will clinical critical collect that That feedback our program each our data to to has each the this next is cord oncology, in next it spinal been necessary regulatory recall inform FDA goal Moving for primary year their two interactions. stage steps to next assets injury support you
the submitted primary For have pre-IND our meeting and goal VACX already we've package. reached
We FDA receive a response year. from around the of end expect to this
importance feedback receive we the IND next would program permit expect for the our material. clinical insight clinical the VACX to into enhanced is to us which production Of FDA's use studies cleared we if submit and of plan that and and year, which run we particular analytical to process the characterize to propose U.S. valuable give the which methods view manufacture to us in We of to us
this program cell did our manufacturing OPCX. acquired we on production improvements as improve reasons process, could was that the One dendritic OpRegen made and with we which the they of believed team they to successfully
our I expect need additional will guidance yet think responds we end affirmation occur they of the again, successful some timing journey injury its in received in will be the been for filing spinal for I year. interaction, FDA to OPCX from Provided that view toward timeframe, next but before quarter. continues have the the its will the the of planned normal we FDA. next cord regulatory expect their of IND similarly on VACX have which
plan to been this chronic in patient to first initiate would this study a with year, both as next a planning be spinal received. OPCX protocol of the reminder, a delivery to FDA And to and information submit time patients. a synopsis chronic necessary the to have For are new with use administered assuming injury. a We the along subacute for program, cells clearances small cord a trial device, still that we're safety support
be So exciting an this for program. that would milestone
for XX-day continue regarding in We for intend for with OPCX. be we our and planned after for of completion IND Institute the amendment contact such Medicine support the the submission waiting OPCX Regenerative period also support California to program, apply to frequent potential following
program preclinical are loss and And engage more of program disclosed year-end. manufacturing currently transplant to disorders. programs preclinical activities preclinical from to Initial in our of ongoing. in continue neuron have photoreceptor testing initiating our studies a vision also hearing cell our for we and major auditory prior We goal recently
exist That with yet, of of the want of And our neurons, between are less underappreciated I efficiency at been our auditory hearing The but many speed one starting cusp moment animal of this and and of we're million and R&D year I take Lineage possibly companies this preclinical just spending the important make able of R&D Speaking versatility We've other differences progress loss a now platform. on testing. return to highlight didn't to next a program. investments program $X technologies. Lineage budget the to platform Lineage on than mentioned while to ago. illustrative the date on
little specific possible investment cell into We intellectual cell preclinical product lines, have then that already methods of the differentiating into which with types They cell. and million. property with targets that XX definition, a because the are ability less specific on execute are to And develop the and more manufacture largely advance less our This of new from to tasks concept, types, know an in human desired body. cell is pluripotent capable performing validated. start than testing $X we by we defined of the with proceed are certainty in than then than generate months,
to do from And you manner. is it if cell make in drug may generate which time very relevant whether discovery, into drug one antagonist those synthetic organic tremendous desired is molecule structures hit suitable. within which your reproducible effect. to small need your if lead, spend do characteristics a a Our approaches, can of can has target with how a to chemistry then lead agonist you even know of job that advance on assuming you to like finally don't an structures, molecular which amount money so or and testing, figure largely it, are has compound animal scalable out a and to biologically because with library different is even and to That or find
done matching advantages our the patients therapy a addressable of replacing aren't specific we platform to be will become As I've for capabilities, therapy, think will cell value have work if think some because cell potential. expand advantages larger defect. kinds years means over gene many this ahead. of who And approaches said, cell and untapped genetic I while to can it also of And capabilities schedule you don't and one as therapy treatment entire gene offers to previously We Lineage markets, that Lineage. therapy. the and carry select the the like those successfully goal apparent the in unlock demonstrate There our tremendous think improve companies months to continue we and increasingly that I has have
like aware and be I objectives on, which want program to near-term highlight Moving specific to three I'd you of.
Medicine before Advanced is year-end or First, planned to delivery the an OPCX we amendment, of regarding system. cord Neurgain FDA testing RMAT have a submission Regenerative expected and IND Therapy spinal the which to enable clinical
advance around detail. clinical have development U.S. of pre-IND loss, its which programs manufacturing And advance activities our development along particular activities ANPX our provide additional areas. support in CMC on to year-end. to important preclinical we of prior to their and a And spending will in development closer and programs hearing in at the some and Genentech, regulatory the initiation Second, sufficient just which OpRegen development responses this efforts and of time support from program the primarily will testing of to milestone internal milestones, the two, be clarity are FDA is Overall, also our these working package three course, conducting their to is and under treatment I expected remain our We, items paths. further completion focused VACX to which respective of recently of and anticipated Roche includes the but a also of share which testing continued the R&D our clinical year-end should process, such One, respective of in two our provide in which for near-term ongoing, submitted support for clinical an with ever non-clinical the agreement clarity manufacture. third, information package, outlined our
Importantly, to believe on Longer of balance to spending I term, sheet, with or capitalized current and nor in well which our business I a the the will end not these I same the to the years, believe described which milestones, receive next development, Genentech efficient QX, have operational activities our address near-term go. runway to account years plans, which grant does of may and revenues, well for two Roche the activities we as of of any in and is Beginning moment that be may approximately based we the company conduct the I will continue two period. are with conduct we section. financial capitalized we any in which for receive further
$XX reported approximately marketable of securities end cash at Our cash, totaled the equivalents million. QX, and
below will increase operational were representing $XX primarily $X year revenues The XXXX. collaboration share million. costs expenses. in While of third likely of The increase our million, consulting connection the increase also the Roche portion in materials recorded the million, included approximately in OpRegen revenue quarter license period manufacturing our clinical of normalized attributed was same fees net compared come reflecting net for to over by activity spending a an Total XX% but collaboration for was to driven largest with the this personnel, the of responsibilities. agreement and and $X.X
million period As spending, for to expenses resembles XXXX. $XX vary budget. a cash estimated from Roche this compared year to quarter third the generally that of to $X are were operating from same completion a input period performance received collaboration payment on current using $X.X The But may recognizing costs accounting complete decrease approximately Total depending million an million, but in and the updates of you upfront recognition collaboration the costs for percentage quarter upfront to quarter, methodology, incurred approximately $XX on the a any time, million recall, GAAP a basis, may over our we total over the method on payment obligations. we of basis. the Roche
million third to expenses. our quarter flat development was development and $X.X costs lower net to were by million, costs $X.X a and offset the were decrease operating largely by $X.X manufacturing The administrative for related expenses to the for litigation mostly our attributable $X.XX loss costs our Although due in research related year-over-year, in The costs total million share. OpRegen. increased legal and general and increase increased lower or research per Lineage
loss changes call, this well and to we exchange that often is variance to the fluctuations international currency of important between our impacted at as from pause by as foreign by overall remember the investments, in operations loss our value point to net subsidiaries. rate As say it's in our the our related
quarter, recorded transaction this new we offset debt by was interest Additionally, investments in from securities. recorded expense a which to intercompany marketable tax related our income partially we
While and spending tend us intend loss to important, Overall, in adhered for maintain well continue our clinical for have maintaining milestones fluctuations good us these in and biotech years existing the to our a non-operational operations markets cash measurement we shareholders meaningful create discipline balance which programs. to in to relevant as uncertainty, our alongside to has to same utilize programs. our value the we the position puts of are so past. we more from face our from discipline we regard Today, that spending investments a reach notwithstanding that with believe in served spending our
be successful to million partnership from and we medicines. but cell and to Roche biobucks our meaningful earlier newer commercially technology also data Our Lineage evocative transplantation advance guiding the our principle value the demonstrate stage by with have opportunity continues our emerging and clinical programs, Genentech, We for not have demonstrated current $XXX only believe of create become initiatives. generated from cell the clinically to poignantly potential transplants and at to
purity, creating competitive in which for and cells, over as to proven overall, We of scale, the our investments end the improvements is advantages have areas such strong and delivery in long-term. products users, significant to best differentiated believe we class a made production, path and
portfolio analyst cell is on opportunity, field. medicine. diverse to new with of a Lineage what opportunity We to therapy offer developmental our we participate measures corporate operator, conclude, attractive which to sincerely your appreciate also cell an confident continue product area investors cell transplant of we a leader a of support company is are and young are the To in still are that And therapy. working therapy respond in execute we hard reduce alliances that, ready the We growing questions. and to Thank field to become any and timelines, in as you. may believe we to identify which position cell