Cellectar Biosciences (CLRB) 18 Nov 242024 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome at this time -- [Operator Instructions] Please be advised that today's conference call may be recorded.

I would now like to hand the conference call over to Anne Marie Fields, Managing Director at Precision AQ. Please go ahead.

Thank you, Joel. Good morning, and welcome to Cellectar Biosciences Third Quarter 2024 Financial Results and Business Update Conference Call.

Chad Cellectar an Caruso, progress; quarter. overview the over from who and before today a call provide for will of to us are of President Jim CEO, turning financial Joining review CFO, the Kolean, the company's

this, Officer, President, will launch. will along market in update Senior review provide and Shane with Vice development WM, plans commercial the the CLOVER-WaM program; Shustov, for the Lea, Andrei an Following Medical, on Chief expected company's Commercial opportunity

Chief clinical Finally, give update of Longcor, will Jarrod Operating plans an on Officer, and progress for radiopharmaceuticals. the development company's its promising pipeline

issued today's earlier call. Cellectar on this of can copy the website. be found content of release press A page the morning a Investor detailing corporate Cellectar's

that today differ the the be management harbor callers or on making forward-looking Reform their Securities entirety safe the that materially the contained statements our in statements. remind is qualified those could under of SEC I Actual uncertainties discussed call the and statements are release provisions business. Private will forward-looking Act. Litigation the These filings. information to by cautionary want listeners covered caution I with press and risks stated in by statements associated from in to forward-looking due implied today's our results

conference webcast. forward-looking November circumstances conference call any XXXX. update this XX, We The reflect that is obligation time-sensitive live broadcast, revise the date to this contains or after content accurate of of the events information undertake call this and only as date of of statements to or no

recorded being webcast this a conference reminder, As and archived. are call and

With over let line prepared Caruso. with to me for remarks, turn the your begin open will call We the and Jim? Jim the call that, questions. then

all Anne for you, joining morning. us thank you this and Thank Marie,

represents outcome for second NDA remain product the characterize XXX can half of iopofosine exceptionally the game-changing in positive Waldenstrom's Cellectar our on transformational in event an planned the we submission and as focused XXXX. reported of the company. a for We accurately and that our CLOVER-WaM study for data from The future I launch

made and date, constituents role readiness commercial have patients, and providers. of analyzed we WM To and meaningful the towards the all payers associated such market progress as have

technology targeted research efficiently the Phase high-value have I and advanced investment to potential II opportunities business through and initiate yielding option cash collaborations, based our conditions we platform and position. creating clinical study on Importantly, near-term

that in outcomes rate clinical overall The an XX% XX.X% patient impressive major the XX.X% rate, study. and compelling response CLOVER-WaM evaluated demonstrating [ are heavily ] benefit response a pretreated ever most conducted clinically CLOVER-WaM rate, was a you consider WM particularly study when clinical relevant in population

As care was been an prestigious surprising our such, selected provides oral most upcoming presentation have of platform the exceptional Society health for industry's at Hematology's not WM to and ASH share pivotal the ASH. is it Annual an from to congress hematology data or Meeting, American new study.

for the of Biology be hand, outcomes focused the These have our will the on remain constructing a the Mayo principal and at in CLOVER-WaM podium Professor in data are Departments study. Oncology, and the Clinic, submitting These investigator we Medicine of by Sikander Division Medicine, application. Ailawadhi, of Dr. Cancer FDA, presentation NDA, Hematology, and compelling showcased engaged

our filing, we designation likely QX. X maintain have the XXXX, quarter months December our into timeline approval within the That from review very market of accelerated NDA given provides that, first approval determination and half potential for the XXXX. this the of pushed backend discussions on of Based and second launch said, approximately in which of potentially ongoing with we the submission our be and FDA, to will recently unfortunately, of determined year

We as statements requested session. the in and prepared in today's Q&A will regulatory additional provide pathway clarity

will and continue to teams commercial plan the U.S. prepared be and sales, Our launch. operation and our for marketing market construct execute

We production "fit additional supply XXX and which and have finish" provides redundancy manufacturing product progress, securing substantial source, I most recently capacity iopofosine second at our made launch.

cost-effective Long to term, to the we top view meaningfully expansion with smart, lymphomas and as other line increase potential the investments low-risk I iopofosine of overall XXX revenue indolent opportunity.

with the fungoides Our City Hope evaluating collaboration and of of example I this iopofosine an is approach. mycosis

demand believe radiotherapeutics. will infrastructure provider strongly cancer also networks pharmaceutical We invest in to importance growth continue that both to and necessary treatment in support increase anticipated the oncology-focused continuing the with aggressively of for radiotherapeutics in novel for to industry

value phase to XXX. includes company conjugates the pipeline alpha radiotherapeutic beyond solid phospholipid offer the and validated treatment preclinically for catalyze potential growth and next of isotope Our OG and significant I and drive of tumors iopofosine

me let of Chad over our financials. turn for the to Chad? review Kolean call Now a

classified morning, and financial warrants an and we Recently, statements a Jim, years to stock XXXX, prior XXXX for was amended preferred and third-party the precipitated expert filed the based assessment fiscal supported good our were you, time were by issued preferred issued, as and of Thank everyone. equity that permanent action the evaluations. XXXX. we stock accounting reevaluation they these on and warrants by for At

the August, for to mezzanine equity or and changed stock, classification In in the temporary revision the necessitating for that be historical reporting. warrants determined equity should the company the our preferred classification to liability

or the that noncash, of the R&D reclassification of note all were with did and restatement to to It exception is not earnings minor burn, a changes cash important cash to historical expenses and nonoperating the impact G&A.

results ended cash million financial as with the equivalents ended We million, XX, our December to $X.X the of compared for cash XX, XXXX. to Turning and quarter period $XX.X XXXX. of September

have July to XXXX an and funds warrants of exercise per closing Our common to additional exercise. major XXXX at B new hand investors warrants purchase was raise All up on share, cash Tranche from the exercises on investor at B $X.XX a from September the September of the the the warrants price financing million. which stock $XX.X their as-converted potential date price that of reduced the in of end includes Tranche of raised

$XX.X after customary of proceeds proceeds net expenses million and million. new the part fees investors also as of Those received $XX.X generating and warrants transaction, gross of

expect warrant based July is after tranches X adequate PDUFA tranche the to of we receive We upon with additional first million in from a [ the their of XXXX. funding on cash that The expiration dates respective into budgeted $XX.X approximately operations issued the occur date quarter hand fund which ], second FDA. provide

we second the XXX. and in A after iopofosine from of we $XX $XX.X approximately revenue quarter FDA, of tranche third of $XX.X from in million receive iopofosine after the tranche million approval approximately I million XXX which I generate first a

earlier Research XXXX X $X.X by this decreased was conclusion increase $X.X increased enrollment to of partially clinical approximately WM having September million, XXXX. and our patient and personnel the study approximately compared the in costs costs. activity XX, ongoing The study by in ended overall R&D months September trial a offset ended result pivotal XX, development year, for of and were the pediatric primarily in expenses for increase driven months our an X million occurred

General support and anticipated administrative market XXXX G&A period by the compared expenses necessary approval, ended development for the in personnel the infrastructure driven $X.X commercialization $X.X of related was primarily XX, with months XXXX. for the NDA including million upon development and costs costs. same September were to the The to associated X million, increase in

and valuation last quarter in of same almost ended, approximately financing and year. previously. category of for million timing $X.X cash exclusively while is quarter expenses of approximately warrants noncash $X.X issued. to a the approximately interest from component expenses which the improved the only to the million million the are are in were they just These The $X.X the million other result were period income, Net other the the $X.X

September XX, share XXXX. ended and during with fully $X.XX or was for the per period Net fully XXXX million per million basic $X.XX or share, compared same period diluted loss $X.XX basic per the share and in $XX.X diluted $XX.X

I will call the now Dr. over to Shustov. turn

Thank morning, you, Chad, and good everyone.

PRC, and asset, radio lead from small for cells, and CLOVER-WaM. exposure XXX Iodine-XXX that to targeted iopofosine by phospholipid of pivotal cancer designation believe both delivery or orphan a profile from a treatments has directly as We Our to from received fast-track limiting designed provide to molecule iopofosine many differentiates traditional I demonstrated healthy while WM FDA. on-market the is cells. drug Iopofosine I study in-development the results has it conjugate,

the single-arm therapy, CLOVER-WaM long-term patients study CLOVER-WaM and for Waldenstrom's iopofosine an line completed most pivotal refractory a evaluating who The follow-up. I refractory with had FDA-approved in of study this all WM lines cancer. WM provided we and clinical pretreated on BTKi, patients patients the Phase or in who macroglobulinemia. reported IIb is our in of class in top who least global at most relapsed examining the patient remaining were in I study prior July, In treatment heavily population results is study from treatment XXX Patients XXX received failed living including enrolled the ever CLOVER-WaM update iopofosine studies. X have enrolled those response optimal some fully to only

Based on compelling review globe a to iopofosine the In in radiotherapeutic IWWM. the International for to and prestigious we assuming at and on on EMA XXth October, were results, the address best-in-class clinical study agent the WM to results we first-in-class delighted has this the high relapsed/refractory potential CLOVER-WaM patients. to demonstrated believe need share initial become an discuss CLOVER-WaM presentation the from provide utilization insights and or approvals. around opportunity future experts the iopofosine and oral had data FDA WM the of Workshop macroglobulinemia, Waldenstrom's

gait, rare, syndrome, patient Harvard presented nervous case into School, central the treated as clearance with is Jorge by Cancer outcomes. CNS. in WM X MD, iopofosine His Clinical a relapsed/refractory Medical paralysis, Center visual that Professor system, nervous Waldenstrom's system Director, was changes in In headaches, or Medicine, and partial Institute. XXX. I and for Bing-Neel neurologic of the the addition, translates in typically It Macroglobulinemia an sequelae neuropathy, such Castillo study highlighted disturbances, Bing with associated life-threatening of complication review report Farber Dana various iopofosine at BNS is complete manifests BNS, Associate central

which died diagnosis. study, I an confidence evaluate outcomes potential blood-brain and for this patients while result single diagnosed in first years ability supports similar X encouraging an this to a the response Moreover, as case patient BNS the iopofosine us to glioma of was greater So up our of cross patients. XXX's in pediatric with the XX% the interesting within to barrier, high-grade gives case

Conference, be promising have Hematology ] Dr. earlier, Seconda to with provides highlighted to honored the CLOVER-WaM WM ASH for this where presenting will we Society who The [ presentation latest form. American presentation physicians Alawani at discussion peer-to-peer a in ASH year's care of a or tremendous patients an very share our opportunity noted the data oral are As study data. results these in

with in XX% to XX% set range compiled multiple in with myeloma the the Beyond variety we have rates WM, the relapsed/refractory iopofosine clinical a in rich of data success and response the European drug and has also for populations. Iopofosine XXX of iopofosine WM. I treatment received and granted to Track patient orphan Orphan Commission relapsed/refractory designation, I Fast refractory FDA Drug designation

in on legacy lymphoma these exciting well sensitivity results, as study established IIa lymphoid radioisotopes, radio development I-XXX, indolent Phase completed in clinical the clinical strategy. in be of iopofosine and franchise will provide beta-emitting lymphomas, our further known of aggressive analysis Iodine cancers Building particular, further iopofosine's related malignancies, warranted. cohort refine of lymphoma from Cellectar's Mature to of may the guidance as

and our research affects non-Hodgkin recently mycosis the with of need. To the the known XXX and focus and the be iopofosine T-cell world-renowned for Hope Cancer collaboration radio lymphomas, which internal on center cancer of treatment announced cutaneous are largest form clinical is will most of City [indiscernible] systemic T-cell the cutaneous The lymphoma, collaboration common I in skin their the this institutions oncologic targeted MF of subtype first and, acute in a Iopofosine the patients, high Center, U.S. of and or organs assessed end, in one to therapeutic the development in for blood. NHL. clinical sensitivity some radio lymphomas we

in clinical is support initiate institution oncology investigator-sponsored and this trial to XXXX. great interest more a is encouraging. indication opportunity This than early prestigious iopofosine, and patients in another showcase high evaluate iopofosine's and yet degree of will This XX is benefits planned of hematology for clinical a to

and activity ongoing our in study high in brain for in in of X Finally, sites pediatric to ability pediatric further high-grade tumors, therapeutic multitude This [indiscernible] maintains gliomas. and feature patient enrollment iopofosine particularly of barrier malignancies. as a mention payloads evidence primary applicable with clinical CNS. secondary such Ib to provides to cancers The be sites, now to potential cancers the deliver Phase the solid Absorbing development brief iopofosine brain ongoing. has need blood the CNS the a of this sanctuary of

Shane With will that, update. call the the commercial over I turn to for

morning, good and Thanks, Andre, everyone.

have XXX series to KOLs a we visibility Andre with Jim to presence both are session strong highlighting a As CLOVER-WaM I at community iopofosine the and doctors ASH, Cellectar. and the including and of outreach mentioned, year's key with outcomes and beginning the initiatives excited this for enhance oral

presence exhibit oral the to addition, on an novel CLOVER-WaM floor at an participants presentation I platform XXX, is learn In novel can where booth the we Selecting will data optimize with at outcomes, iopofosine important XXX science. conference conference our an profile. iopofosine's iopofosine our of I efficient an more as opportunity and ASH interactive visibility such pivotal enhance about

requiring X,XXX because patients total greater exhausted by the Turning third opportunity a Of and line now treatment eligibility is in of to progression for addressable annually. have X,XXX require setting, review of third or with prevalence those for XXX X,XXX approximately market WM, current approximately the who patients to the let's XX,XXX diagnosed patients. those, existing the in patients, therapies. being with which greater XX,XXX approximately treatment and there estimated X,XXX are the are in therapy to market patients line therapy. I line third iopofosine patients intolerance or is relapsed/refractory approximately of Therefore, begin WM, There U.S. X,XXX options an or

is patients treated complete patients demonstrate WM an therapies. to established for need require no that of of line provide as third broad are treatment. there rates lines FDA-approved not could of for greater or iopofosine treatments are response continuous failed options I FDA-approved note and are similar of or is unmet noncontinuous Clearly, and therapies heavily approved treatment, same especially on treatments the prior therapy. there a BTKI pretreated important therapy. from BTKI action, XX% such It Greater XX% patients. new with XXX that treatments novel utilized non-FDA treatment Furthermore, do mechanism responses than in progressing

in FDA or standard We market data, I approval, for research care XXX, based and significant share an the assuming of new can believe of therapy the resulting iopofosine and revenue. be greater capture third-line claims on

community to of continue large go-to-market which advancing patients. with radiotherapy-capable We practices is make progress and strategy, volume high hospitals our WM focused on a

This XXX the a claims nature to WM with Our visibility the data team. market be WM field opportunity. market representing of focused the small, of accounts, XX% concentrated provide can with integrated penetrated

be benefit treating their patients. Importantly, we radio strong commercializing off-the-shelf therapeutic noncontinuous therapy as a for believe first welcome with iopofosine mechanism, and therapeutic option WM clinical the a physicians will novel relapsed/refractory

Our FDA-approved provider completion clinical and a third-line patient plus capture best-in-class to a the being profile journey and opportunity from to rapidly for to provide treatment across vision radiotherapy establish share. is production patient experience patient no third-line plus of the therapies treatment strong treatment. Iopofosine's clear there

to including distribution, Commercial brand support, launch all and areas team positioning is to activation. continuing success, patient reimbursement, on key advance site pricing,

radiotherapy community favorability our from other interest our Importantly, that we're high product of product this space confirm success. physicians interactions for leveraging and findings rating profile. from launches market have with to a Direct learned in academic providers research iopofosine's lessons level enhance and

Jarrod? operations Let call turn the over an for me update. Jarrod to now

and to Thank morning you, good everyone. Shane,

about with is pathway put data important think I we the in approved programs. our to it other XXX, As we iopofosine for context regulatory believe

earlier an where were line Our in treatment who had post any major submission refractory rates of CLOVER-WaM's later XX.X% highly was had rate prior considered [ BTKI-naive. response lines, treatment, X XX% a patients the lines, over the prior X and and a of of patients NDA ] XX.X% response refractory study were having in for WM and to a with BTKI. major Ibrutinib's treatment, median line not

to primary observed population. iopofosine's endpoints The on the discussions our recent engaged this rates with significant a our with to a data included on of was confirmatory supporting and regarding the considering to potential a the submission. FDA of comprehensive and study. in strength endpoint shared required full tasks response which secondary acknowledged we steps, durability results the study, patient Based of the our has post goal agency on discussion FDA FDA data. a and the next The complete the and provide We remain focused overview cut, data enrollment facilitate

time the the internal Cellectar requests. evaluate was the from to submission agency maintained pushed we To remain however, flexible to FDA, FDA review allow sufficient November. time data, has with and timing October lines; the must meeting

revising time this submission subsequent first As December and anticipated of of on second a line result for delay requirements, our submission impact late our from late we to are NDA or quarter XXXX. XXXX quarter

a study. As confirmatory mentioned FDA recommending is the earlier, now

trial single-arm line designation study including EMA, We or from our like are earlier utilization. potential in a CLOVER-WaM, would the exploring strength a request FDA and which iopofosine's designs, based upon the desire prime therapy with KOL data active randomized align discussions the may broaden in discussions the with the to of study of recommendations an

stockholders, time We to understand we to program all steps important are lines. possible is taking partners and how patients, our this our and accelerate

We FDA have with and on rapidly will FDA. confirmatory believe the the come design with resolution we closely the a a dedicated team study expedite and process to working EMA

delay we success committed of and of rapid approximately Cellectar are and iopofosine the we this X to the submission subsequent launch unchanged, quarter, of Despite long-term believe remains and iopofosine.

timing. are steps with the the conduct reach potential FDA confirmatory on November Next and and agreement to any study submission meeting

Now our partnering transitioning activities. corporate development to and

acquisitions companies has radiopharmaceutical large the on from and pharmaceutical have market. been focused infrastructure. significant last months, XX midsized in date, radiopharmaceutical Over interest acquiring there the these To

product, now to are or platform We shift acquisitions. asset observing a

few stage with a with late-stage the of or -- large therapy radio X a delivery validated remains Cellectar platform. companies targeted

of believe active we the remain in result, a potential we evaluation As partnership structures.

well with early-stage unique involve is on that business potential based our the our fact the partners. and designed integrate evaluating collaborations our are programs also attributes platform of We model to that

activities. update on and now research I early provide development our will an

XXX initial as is our our phases. well provides phospholipid additional on which product, X focused conjugates. expansion validation The is underway. targeted to supporting investment This I drug first brings approach data iopofosine As market discussed, approved and phase development phase we've the and strategy our in and

second Auger with is emitter programs. expand advancement and phase line as to of and the The emitter our of such isotopes other radiotherapies both our targeted of extensions pipeline iopofosine alpha

three ]. peptide Phase payloads such as advances [ and molecule new small verticals, cytotoxins, oligonucleotides

Beyond franchise our radioconjugate we've and the emitting of are with alpha progress with PRC iopofosine, excited programs. made Auger we

cancer [ these therapy pancreatic product which Our promising novel demonstrated XXX tumors development in cancer, indications. targeted ] as ovarian triple-negative include breast has CLR-XXXXXX justifying actinium solid clinical cancer, for compounds candidates therapeutic potential alpha several known in and

deliver tested capacity has selection another Our Said based we can radioisotope PRC the any biology. way, alpha isotope platform and to for delivery we emitter, the the right and have specific right already optimized on tumor tumor. target

Phase and study We our standard with and X multi-dose then planned study will dose component The single an planned regimens. CLR-XXXXXX of X+X I plan XXXX. cohorts cohorts of initial in initiate with escalation dosimetry I trial to Phase include X via dose

approximately XX overall and that safety program well We data of survival. subjects and in exciting interest humans as create will as We rates strong safety will endpoints the primary data enrolled as be believe as distribution drug endpoint, are secondary positive be estimating response with advances. progression-free the and it

pay Beyond with therapeutics range and CLR-XXXXXX, alpha of first cancers market Auger to beta-emitting levels. solid our and a tumor radio to best-in-class treat strategy to broader bring is and and blood

excellent preclinical models Our activity Auger also program tumors. of solid has in demonstrated

nucleus. drug use the greater within as It delivery -- allows isotopes Auger and as provides the to to with this well allows regardless like enhanced distribution phospholipid emitters. of enhances that This targeting throughout is understand consistent the tumor cell targeting precision, our payload, important the platform, the of for targeting uptake ether payload

technically operationally to is targeted supply both now radiotherapies our chain. Turning Manufacturing and complex.

supply of and and the significant for ensure proud carrier to X of across essential The are targeting a manufacture combined We the products. multi-source progress ligand all supply the chain the radiotherapeutics. the made and manufacturing and finished isotope, components innovations our

of drug with we have strategy in development these to a directly adopted Starting relationships our isotopes, and our process. with suppliers isotope to contract establish early the

which suppliers separate validated iopofosine XXX, for assess suppliers. X Iodine-XXX, with continue discussed relationships additional utilizes As to we I previously, and have and

multiple production of Our supply isotope XXX times to in both current scalable iopofosine partners I a either week. provide allow weekly redundancy or the

strategy, sourcing volumes or capacity I produce other to X Currently, and sourcing to Similar we iopofosine XXX isotope our ligand support PLE the maximum contractors. at to greater targeting validated forecasted needed. increase years. enough produces the with PLE sales X secured from to than at additional multiple We batch supply a capacity program least as maintain PLE, for single

also we nearly production Importantly, are a supply weekly finished ready-to-use product. XXX sites to doses. can the fully X iopofosine multi-sourcing patient X,XXX America North in We scale approximately doses capacity as with XXX week have per that to I currently

announce Last of SpectronRx facility to manufacture SpectronRx week we This U.S. and our planned iopofosine the relationship delighted of Spectron's business the in XXX. a long-term with expands were collaboration supply commercial agreement anticipates I for Europe. utilization with

production As our assets achieved CLR-XXXXXX. with like iopofosine, the of development

recently signed non-carrier-added emitting. Actinium procurement We Star employed with North of Medical beta commercialization. which alpha, are and both or North whether sufficient guarantee will are our integration end, future into the delivery suppliers of development drug PLE for is Star's that we strategic existing they a platform. partnering proprietary the for throughout To of Radioisotopes into variety This Actinium, master of agreement approach supply Actinium supply with a process XXX and being OJ and radioisotopes,

Actinium sourcing already are we Iodine-XXX, with from suppliers. several other As

provides additional of to Actinium-XXX. Actinium-XXX as is It North Star the successfully reliable contract a with agreement source advances. this However, our and of program reproducible producers plan

capital finished future and we In the requirements, outsourcing expenditure our significantly associated costs addition benefits. to sourcing with have our manufacturing an One, capacity. reduced additional product maintenance internal model provides

demonstrated process Second, iopofosine a the technology multiple I to as rapid which organizations we manufacturing for other allows efficient such facilities transition complete XXX the have into and ability timely needed. transfer in to

Jim to closing back call the remarks. turn for I'll overview, that With

Jarrod. Thank you,

remain disease a opportunity. support drugs approved to I Cellectar. need, in a with iopofosine and and solid revenue driving and value treatment data XXX transformational focused value series for of great building on options with As significant growth with accelerated on limited long-term maintain product clinical its proposition approval we differentiated cusp a the unmet We a potential WM, see, compelling a near achieving you can sharply profile of and

provides with We for competitive expected unique successful we And product presenting scalable are of of share preparing clinic treatment for a market, assets currently into launch voice, maintain a delivery development of the solid an the iopofosine market end [ advance platform company of highly possess drug for for which PLE-based dynamics large market the radiotherapeutic a option the and optionality unique WM to launch tumors as and minimum dictate. X ] existing XXXX.

made the take a believe advancing beyond in talented team achievements We support to hard of the way XXXX marketing the are forward moment who of we've iopofosine's projected are and our pipeline here promising approval paving to progress. thank while and to dedicated look radiopharmaceuticals. and drive I growth and you working at in Cellectar smart keeping apprised and XXXX to our launch to want

for any, you, want patients also journey few, cancer and changing for with course treatment treatment to our the on of if together encouragement thank and we are this your stockholders viable partners, I support as continued options.

for call that, operator, the With open let's questions.

question from Jeff first Your Instructions] Jones [Operator comes with Oppenheimer.

on quarter. Congrats the

think some in studies do approval. uptake that addition, you commenced confirmatory on and during going required confirmatory launch, think is Just FDA's you here? in product as commentary up following that about cases, And have, interest that risk on impacts studies. how we They adoption? a confirmatory potential studies in think Do prior the the on to

our it from provide to That's correspondence application, on case written to Jarrod fair the based believe agency. that the study portion an your more to very over we a confirmatory capacity Jeff. submit regards direct the relative question. to to Sure, And that's In don't I'll prior to of specifics turn question. ongoing

what is that submission study, basically a NDA requirement not we that it to from not would agency is we agreement Yes. for correspondence great What Jim be as referring is yet our around to that seeking have they're to ongoing. confirmatory prior the says of is have the but

relative and would the in EU, N some of for study of X, in impact to would commercially. pretty would, study. the align participated top a of significant. confirmatory then regardless EMA of not actively protocol part other of portion study your what in N size, iopofosine course, XXX we the terms adoption and and anticipate anticipate we the the of would CLOVER-WaM evaluated Obviously, would top Andrei ex terms of with we potential be the Jarrod, the And second on And of look use and trial being the the X patients I to Jeff, U.S. sites like team question, that significant the

Great. I And X Okay. just for you guess question financial guys.

cash gave guidance. You runway

the $XX million that launch? exercise for worth as you of you full warrants, Assuming where take outstanding does the prepare roughly of

cash will have need at So first need say. as that to raise add additional time look be given timing you the to you an believe, we the I expect not would would if warrants the a fact step, coffers, think the we tranche a line, really until there just fall to as funds interim we of that the the into exercise for

get interim the current that required. that's expectation on into So of funding least once provide pathway. based additional process, be the will there exercise we warrants, those that the that, at should But the it us through raise will get beyond is an budgeted you believe

take that if X we the April tranche submission, so Jeff, a warrants. at and a for with if anticipate, of hits activation [indiscernible] -- And look that's an of you the first sake June X-day of the PDUFA, XX,

to continue evaluation of evaluate and the evaluating number financing corporate in form statements. the spoke and during prepared some of quarter have traditional a evaluate options a we to that and his development the Jarrod have would So or that funds, that would that's we of whether we're to raising currently we activities different relative a ongoing bridge, of are

and strike us we establish to options So number a to view bridge. of available different that

Waldenstrom's past, million the piece will I And here our think a that's of needs satisfy OpEx in as talked perspective nature from we've the to commercial significant launch because overall the scalable well. as the $XX drive we other adoption. is market, sufficient targeted with in a $XX year than being an trial to million, view use of this sales more as and organization around the a range and of million $XX kind

you're to $XX that, note. commercialization. typically I a effective the $XX at And more in spaces, year is lines think, the oncology of along Because million a million to important looking for expenditure

you leadership As us. this trial, more commercial high-value of pharmaceutical competitive to only typically medical investment in terms limited and of spend, multinational see competitive increase some a use there's that scalable, share these not a mind lot space "detailing" yields marketing from in is in of available share in a perspective and without really And in no highly the for you of limited of recall, as spaces, machinery There's the not yielding is thought space. mind adoption. highly

Great. hop Really into clarity, queue. the guys. the I'll back appreciate

are no call for turn to further now Jim this at the [Operator There time. over remarks. questions I Instructions] will closing

operator. of us you. to our we forward joining Again, Enjoy you you of day. you, all Thank Thank today. the keeping Okay. progress. look And apprised for you thank

lines. gentlemen, thank We Ladies and participating and please this your you for today. concludes ask conference your for that disconnect call you