year and our Good recent voice results. we again provide hoarseness financial overview you of for XXXX us taking front, you, Victor. the back thank join as Thank the highlights as from today discuss and business full afternoon, everyone, up for right once time to come And flu. I an the apologies my in
begin for on LaFrance today recent progress, Financial me Dr. Chief Norman call the financials. the to call Sims, I'll then afternoon Andrew regulatory our a Officer; call and reviewing by will are with then the fourth Joining be And clinical this quarter, and review our turn the and us Chief Andrew our LaFrance, Q&A. for Officer. our Dr. Mr. to over focus joining Medical
CNS begin lead on with updates programs. our the X me Let cancer
we X think made effectively for an enviable position progress obisbemeda drug, GBM. LM. in in I LM promising have in lead that recurrent we're clinical means the and recent development we of This with the in rhenium have programs
good is very LM obisbemeda ReSPECT-LM show Our making single a positive signals Phase I/II dose continues to for and and of of rhenium escalation administration trial safety efficacy progress.
single of through Ommaya SNO, obisbemeda presented ReSPECT-LM We patients up ]. an November escalating received with XX XXXX Society [ millicuries intraventricular the reservoir. XX rhenium In results showed from Meeting, dose the indwelling X.X Neuro-Oncology a we at between to for that or LM
dose overall mild, the Grade was X XX% moderate were maximum feasible were majority And The or -- DLTs dose No Grade XX% of adverse events and maximum observed reached. X. not CSF in administration doses obisbemeda by radiation for critical circulated were following persisted CSF single hour the with administration. days, X organ and again, up X the a space Rhenium tolerated to low. throughout
up dose mean and rhenium to at is by that by median max patients single administration X the XXXX II assumes for X.
Enrollment along is the of was to XX%. CSF cohort fastest recommended anticipate year-end reporting, date enrollment X, Phase trial. way the escalation administration remained XX% to complete on trial just Phase XX [indiscernible] cohort X cohorts X also all treatment, cohorts. the currently, is for and of we the of determine That's X obisbemeda in and likely survival time months now was a following single I the with the decreased first cohorts X, dose patients overall X completed, of XX cohort and to through a alive II/III Cohort treated track This the reduction a enrolling. finish Phase enrollment dose. X
award. on size be meet with elements can breast trial tell both the and and recently This plan have on later will this Phase single II/III is community new potential pivotal the sites. have I but designation. continue other metastatic our this the very obisbemeda. FDA year, and tolerated Later for rhenium year, positive remains and orphan design, trial cancer financial substantial for in to endpoints this The X trial be remains focusing trial onboarded which CPRIT we we enthusiasm of development assuming for neuro-oncology anticipate the discussed high for at sites, the approach would through you administration support clinical trial, our dataset for trial we a discuss that key
for of safety we ReSPECT-LM CNS trial the updating Conference the at I the in full anticipate data, and August that Phase of the XXXX. terms Cancer November SNO feasibility Annual in SNO/ASCO Meeting and from In presenting LM interim data at likely XXXX
maximize doses currently multiple working in expand to disease trial term. also are LM accommodate the to We the impact long to
As our current increasingly protocol, safety patients under both so an more are obisbemeda treating anecdotally from aside, clinical patients which both the going trial, are are being in doses first following to administration treatments with additional we which of and requesting followed. well be compassionate of additional rhenium use perspective seems a their impact, closely
approach enrollment with We anticipate XXXX, the proposed dose have a a and of dosing meeting with in not the before. early expansion FDA XXXX, beginning multiple developed in expansion for for if goal
that fluid gears you highly company of let's a prior exceptionally rights a cell we We test. financial still sensitive switch XXXX. may Now recall, technology significant but to bit, recall had as very this testing September remain and cerebrospinal encouraged discussion. tumor operating specific, acquired But the Please LM by the issues. within in
but in assessment rationale disease a, LM for standard because our otherwise also very sensitivity for allows acquiring the was Our care difficult the to testing. this diagnostic for because therapeutic it its standard care, do that that current or improvement over could, longitudinal size it market double significant of impossible is of of with
partner, this that back February only adenocarcinomas a towards trial, our The work monoclonal antibodies, ReSPECT-LM and as successfully few various is The X losing is melanoma. in proprietary panel and being have in conducted our XX uses test broad conjunction Houston. a KXbio XXXX. we technology assay update in of patients into of on test geared largely diagnostic implemented with cohort the The
the test trials with for for funding cost-effective KX, a grant and our perform in manner support. can we existing leverage Working
in process indeed exciting with think upside this for of opportunity is trials to potential overall, the But the company. We our whether continue current we beyond new is partnership great assessing are our viable. the test broadening commercially KX and
and I through September, That million payment million continues of a a an revenue very receiving Phase CPRIT, million contract. well. be in in continues a And will the through of Andrew additional award. to on detail the think go grant million approximately a ReSPECT-LM part received To December part we date, in the state from Texas, anticipate received by as finally, $X.X to And have past product I moment. program throughout funded, planned the Now research we this grant payment $XX.X more CPRIT development we followed million CPRIT, provide XXXX. $X.X $X X-year, $X.X
an in grant rhenium this of the update continues of sites. have convection-enhanced patients, enroll ReSPECT-GBM trial adding the obisbemeda given our Now award, principal and NCI-NIH sites Until a with dose to based Texas. ReSPECT-GBM the investigator, supported we on of limited trial recently, single University we terms Andrew has to funding which via actively substantially Brenner, Dr. been glioblastoma trial through are on GBM. of patients delivery new clinical trial recurrent or and
in sites, sites efficiently direct trial corporate forward, expand the we interface more broader XXXX, will and Going trial. for with more and provide support
or and Phase enrollment XXXX, the XXXX. currently strong and XXXX. basis the a from a support X-year the PI, new pivotal ongoing, We we are adding to year, Phase Texas we grateful up of complete The We II to trial the to and felt NCI, latter anticipate trial this commencing University move which to this II provide total be point, the incredibly ball those going think to sites XXXX in and part early in sites the of for that's of will of pivotal is in starting take trial X as impact late from hope a enrollment we X a for trial. of
we presented from meeting Phase November, initial November. feasibility at the ReSPECT-GBM II the trial data and Last safety last SNO positive
that As the standard the GBM XX in care. a data the single overall patients of recurrent Phase II at patients assess to And endpoint study of Phase approximately X of in a median that survival the from versus XX time the months to remained reminder, obisbemeda was survival months, is compare survival, and dose alive primary of rhenium In treated at XX overall that following II that XX care. for the of summary, standard overall median analysis. of months X the time, showed
progression-free to obisbemeda to to for months XX or to profile the and far of is gray. patients, in by derived XX% of therapy patients continues that's thus radiation absorbed despite preclinical very now and coverage. giving XXX in typically studies up XX XX% was compared Median around dosing and met the target to mean of demonstrate up dose Phase XXX XXX greater is gray. XXX rhenium we've Rhenium than that dose a I that established threshold beam average we're dose of In empirically XX favorable to external which have in greater gone delivering than the X.X tumor XXx And the about bevacizumab, we've GBM, safety gray is tumor gray obisbemeda delivered survival months. radiation typically XX
trials who that using in has in with real-world convection-enhanced in with median The conducted in real-world of conjunction GBM a successfully data survival our Phase sizable bevacizumab other care Phase was overall months. standard in to median current data. survival I In meta-analysis another of in were GBM, partner trials with of In metadata trial trials Phase terms Phase in using overall in versus terms X one is survival, we performance the recurrent database in monotherapy II in those generated X our approximately metadata, the delivery history versus data II GBM will aligned be of a showing GBM controlled of and the FDA. I, our propensity terms recent matched overall that that with median trials X the
will, view in as pivotal. clinical Phase effective that we And you a so II and an a if hurdle rate, in currently,
survival, Phase year approximately is standard last median bevacizumab than example, our carries reported XX% overall data, XX November an comparing for to -- last months, as -- data, that's overall monotherapy, stands as II has which versus of care, time is that survival So which reminder, we of months. real-world of X data was the of a a as it better current
dose been recently Also, at has Imaging It I'd an noted receiving commonly data because such PI. important in trial to imaging trial, to same was namely like presented meeting the XX has patients signal. XXx our in the another presentation survival radiation, over overall that EBRT. November also secondary by are high been of assess that in pseudoprogression a is supporting endpoint difficult until of the to highlight the
progression TX/TX-weighted maps that from as think of increasingly, books, develop technical and volume, and rapidly adapted in therapy as adults. we as It that to for presentation can relative the our such going cerebral assessment if GBM, other this to MRI upon was able bottom improve primary pseudoprogression things more help and new blood we and are children a but GBM is can and recurrence, but also understand imaging line delineate cancers novel better and reliably is found we using be brain images, response well this on patterns website, beyond for ensure fit and not advanced treatment techniques standard very using
learned to me this we've a a think for about overcome it's to is view, And a minutes of delivery more developed just a point pure-play therapy, little take development drug unique thought program therapy. which sort working it we not that mainstay ecosystem beam in sort targeted as GBM about as not accurate might rather, a useful my this bit related what at on think external been In per that -- of can we've I last is the of forward-looking But a of and do the to -- way over radiotherapeutic couple the based this radiation ideal years we've above, novel on X of se. what limitations to that reframe development. over of therapeutic think be not and I GBM of that look it of it's GBM
we've limitations specific overcome available, barrier XX imaging, also state-of-the-art with surgical the that of aggressive well makes a dose optimized, by and local very the software resection the over GBM can to you with convection-enhanced known almost But are brain invasiveness makes the also absorbed challenging the of treatment amount which of that that we delivery GBM, now drugging radiation the matter couple blood that complete In XXx increased planning is limitations the impossible. when overcome neuronavigational and other technology custom that's with words, EBRT. catheters
far, radiation administration modality, convection-delivery thus in the we GBM, both of So using that the a improving the more types GBM improve the which upon and in potential we then in margins chemotherapeutics but seen care tremendous in radiotherapeutic and given general, parenchyma. opportunity only with drug brain surgery for delivery single see other recurrent is into standard have session. safety happy current and tumor to as standard CNS and And Q&A for this EBRT also approaches I'm the expanding such of the discuss upon of
XXXX. Now in SNO we anticipate update terms of an at in data, November
with and design ependymoma. XXXX, of children brain trial in cancer pivotal We FDA the glioma to on trial and also intend the enrollment ReSPECT GBM obtain FDA for with begin to to approval both high-grade meet the pediatric IND
in XXXX our our drug have pivotal To can of being rhenium fully and in relationships, supply, XXXX that drug, forecast. clinical commercial with goal all obisbemeda to backup that in are we meet expand validated manufacturing supply, manufacturers trials such focused drug activities support demand scale-up X foreseeable we our primary GMP
So all exciting chain radiation to supply target relatedly, intermediaries, radioisotope in is new very we think that working We and redundancy clinically interest in and is an radioisotope, services. are relevant in build rhenium including high.
these currently objectives. track important on are supply of drug We production meet to both
nondilutive our new term, is organizational funding. nanoliposome of areas: terms but we are focusing on success grant alginate call in RNL-BAM; building out expertise obtaining radiotherapeutic, microsphere our we it which discrete on In and long the pipeline, X and building rhenium biodegradable
reminder, First, the of variety as FDA as is now designated radioembolic next-generation treat is which device RNL-BAM, this a last it tumors. organ as designed a a of as by solid relates it's to year, to
the now updates As has and and device path more develops other provide the resolved that attributes attractive liver as FDA ensure over that this an both year. think cancers, is we for cancer design product will key we'll analyzing
increase Second, over In active in filed for XXXX, lead $XX as least me, for currently issue $X programs LM GBM. of approximately million grant -- XXXX, excuse plan million filed XXXX. funding in have the and we at to million X to and grants. We funding for our $XX in in awarded we that to in
practice, report only on awarded. our funding grant per when As we specific
over Now call with the our review CFO, to that who will Andrew? I'll turn Andrew the update, Sims, financials.