CMRX - Earnings call transcript Q1 2024

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Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix First Quarter 2024 Earnings Conference Call. I would now like to introduce you to your host for today's call, Will O'Connor of Stern Investor Relations. Please proceed.

Will O'Connor

Thank you, operator. Good morning, everyone, and welcome to the Chimerix First Quarter 2024 Financial and Operating Results Conference Call. a related issued quarter our we update. operating morning, press to release first This

the in Tom Technology are press of access Operating and Chief can You release Chief Melemed; Allen Financial With Executive Mike Chief on Officer, Medical Chief LaSpaluto; Officer, the Commercial our Allen. me today's Chief and Officer, call Officer, Josh President and Officer, Andriole; Riga; website. section Investors Michelle

to include made I'd with Please Reform to turn begin, to you these I'll to statements Mike in and on the of cause today's meaning the SEC to the like risks time, other Chief over Executive will and Act are actual Litigation statements we complete Before results subject and forward-looking our that the and call refer These referred factors. differ factors to disclosure uncertainties remind filings now other a call risks those forward-looking materially XXXX Securities more and the within for this could risks of the Andriole. Private and President and uncertainties. At statements. uncertainties Chimerix Officer, of from

Michael Andriole

KXXM-mutant of first advanced our most is ACTION study, continued interim is several which of disease. quarter remains a for the by senior study approval pleased of readout level update Thanks, Chimerix and focus to morning, to joining which positive members accrual. The Phase ACTION is first success at trial to I'm study, thank HX this outcome medicine the everyone, the is to treat a reaching a across on the high leadership specific our represents other likely morning continued on be this key you state year Will, quarter. The execute first to central drive in steady III the productive us. in initiatives. of A team to joined importance next year an primary for and good and strategy the and the as this glioma, strategic enrollment team share the track, during

drives As have of KXXM-mutant are beyond this action aware a keenly treatment available in radiation that disease, clinical significant the need are patients therapy organization benefit glioma. unmet enrollment, with as options there proven no for we approved the HX

our where access As a possible. result, globally continuously as registration team known evaluating is ONCXXX, accelerate dordaviprone, pathways to also to commercial

Ministry As that about this the Australian a enables country. of an unmet underscore that to of Health maturation that action we contemplate is lethal we the share complementary see ongoing end, discussions. To received disease. every pivotal are a Late a the also and want in Phase global with conversations effort, within accelerated in I such dordaviprone study communication enrollment of our magnitude from well experiences consideration undertake I the aware for and having patients day regulatory that underway strategy this III important year, we approval need set have last inquiring need been of his to

the which dordaviprone to other as registration early features, recognize pivotal in the similar in evaluation program the with registration is Australia. the explore that the provisional pathway the That of the data the dordaviprone to in process, from application. the Australia I'll advance advance presubmission clear, to interaction, provisional in and raised, process. our details presubmission this recent in for more States. This Australia provide let United accelerated was set During step going of X-step status a Goods the TGA, provisional dordaviprone's of Administration, or pleased eligibility forward. To Therapeutic process, be determination pathway with with to Allen on in begins process remains well a second the this in recurrent was meeting the we topic intend to which as including current approval disease studies. We're is to catalyst interaction the provisional approval meeting outcome

meeting are the we This, that of meet for data provisional Phase process. date to set supports strategy criteria advancement in However, ACTION sharing partner with Australia dordaviprone, the in outcome are TGA to along this their accelerate encouraged of the global Phase now with registration. does the access status our of we're to III by we II and to potentially example conclusion as of the provisional their TGA's advance program the approval. the towards study, further emblematic eager to dordaviprone is registration provisional This overall potential and review

safety the ONCXXX, parent the profile, we confidence therapeutic compound have to and increasing potential second differentiated imipridone, and novel dordaviprone. Turning window in for generation our from indications

half I Phase for near are Josh of this we to program the before development nevertheless a complete, II year are we strategies studies frame the this expect we While end preparing the safety investment as into that second of not decision. we further XXXX. share let look yet as I'll Phase process

we and the remains and to discipline. cash discuss to the Allen Australia. runway. Finally, of Michelle path to footing, call full into provide in performance over insights now continue undertaking financial first in company the the with I'll strong quarter financially, financial will Allen? on process summary a and we're execute our turn

Allen Melemed

everyone. Thanks, and Mike, good morning,

possible dordaviprone around is as development to the our mentioned, accelerate world. Mike strategy as patients to for need quickly As in access

supportive glioma. countries approval from the supportive very Phase safety interest randomized of recurrent results a We our the diffuse we of regulatory and recent in efficacy said, to progress ACTION in step where a setting and study, options of ACTION HX find X registration of frontline definitive majority a in is to that glioma; the III being the is the validate attributes: the data; KXXM-mutant additional is will the and alone. The pathways TGA the program the nature will complementary Phase positive as on patients assessment Australia sooner meeting our a in problem trial need next as unmet in this early to of HX treat provide outcome and moving was the and the KXXM-mutant the encouraging this to current provision broader two, the high ACTION one, advances, study. We to to data in oncologist. The our in being and based strategy. enrollment unmet setting pediatric That process three, of designed the of vast are as me potential II exploring inspiring setting a require undeniable, expect recurrent this in for in

the advances application and provisional the for We be will to review to the TGA Once successful, X coming next collaboratively step provisional last submitted, in about that as process is will with an year. the process will submitted, dordaviprone expected work registration is approximately month. If the determination review a application process in months. the take

potential the filing commercial the in expect end XXXX, availability of by submitted We with XXXX. could be

submitted have specific the Josh Our ONCXXX. interim scenarios regulatory plans in lines early [indiscernible] later organization efficacy much to time to to hard opportunity analyses. those about NDA our [indiscernible] Josh? at and discuss of execution work complementary to in that, the the focus to Allen submission to come commercial to say call this activities as preparing I'll an stopping With parallel the the upcoming over ACTION already is and readiness turn for ensure TGA study year. progress.

Joshua Allen

everyone. and morning, Allen, good you, Thank

dordaviprone, about also to earlier we programs. stage excited our are addition In

report Regarding safety preliminary track this Phase evaluation ONCXXX, and of escalation summer. pharmacokinetic I dose remains to finding on

was being being with compound safety CNS per ranging dose adult of intensified basis, is the a to their on response an Dose duration dose completed that a evaluated of tumors. schedule for on milligrams now advanced evaluated the per schedule with days per from limiting observations in or twice this week exposure. X XXX based and milligrams, to at advanced escalation is majority As pediatric signals model doses has of selected consecutive on week. This XX ONCXXX patients cancer and once intensified reminder, day prior to without maximized

variable efficacy mechanism Phase aimed that step occur primary KXXM-mutation, investigations clinical identify nervous HX both of in of evaluation. therapeutic aim critical this with studies range. Ensuring preliminary adequate to dose at present safe in evaluation. These are and include potential the new efficacy continue on of data will tumors dose to therapeutic to for the and to in is do We but the be drivers therapeutic anticipated for clinical remain the I track Phase While a be system that concentration population. carefully central I of while Nonclinical prior outside being an safety report disease escalation in harbor not Establishing patient addressed parallel treatment within evaluations ONCXXX. humans the within that adequately summer by that time lines. inherently at selected this the on at amount next exposure are is development, levels and future adaptive which to directly prioritize time rely is opportunities do

of We of are include impact experience drivers, a epigenetic specific pathways. vast as compounds oncogenic our reversal leveraging degradation These pro of the disease as mechanism central biology. dordaviprone inactivation the the aspects survival of multidimensional critical well that and of clinical proteins of signaling tumor knowledge

providing financial of are now context concepts in the the a by in lab, in over With these will that, of on promise of the are and the some view showing an forward decision year details Michelle look program. investment to We totality that anticipated call more delighted update the turn of for Phase we end to the the of II I results.

Michelle Laspaluto

management of release we Chimerix' We disciplined our containing to results today, operations sheet the XXXX. XX, the company. remain included highly at press in Thank quarter balance fund XXXX, financial of outstanding you. $XXX.X Earlier financial issued no March first and a the available capital million debt. of for

at peer XXXX us III rate quarter most million of our among group. Our the company the rolling QX capital-efficient burn X end $XX Phase of benchmarks in

in to the and evaluate approach investment retain as we disciplined gate territories. Our commercial strong, is different models

to to be sufficient into We XXXX. cash to support continue operations XQ expect our balance

results expenses quarter General back or $X.X to $X.XX net per compared of call quarter million to will turn share for XXXX development of million loss the were share period compared company net diluted our for $XX.X expenses the $XX.X compared the a first in and same the closing over to XXXX. period to same of and first of for $XX.X Research to per and that, or million basic decreased million Mike now reported XXXX. in Turning for basic of of million loss first The XXXX. flat I a diluted the quarter and to remarks. $X.XX $X.X With the XXXX. in administrative

Michael Andriole

year focus In and the high to importance the which of Michelle. execute for continued our closing, team study for ACTION III the a enrollment primary Phase of level. Chimerix strategic Thanks, at this drive is continues

we broadly, is advocates significant that patient need, ONCXXX we're potentially in to open bringing to gaps neuro-oncology, dordaviprone dedicated Despite bringing we're in the closer this Chimerix focused ultrarare new the data preliminary pathways patients, commitment which on of to paradigm team call explore potential take thank disease. doctors, PK we in as as questions. with to to lethal medicines and profile as excited well the particularly the emerging move forward to like Chimerix, altering continue to that, and to this accelerate in at of tumors, in medicines opportunity patients we're I'd we a for the life patients and their later we'll the for these need. and our Additionally, may unmet serve. devoted More oncology. to access treatment filling With new defined field about safety caregivers genetically unwavering John, patients there reporting summer. At and remains this to advances look

Operator

line Your Instructions] Jefferies. [Operator the Raycroft of Thank first question Maury comes from you. from

Maurice Raycroft

you further in for enrollment? I you'll does and Phase in that include perspective you're Seeing can additional sites Congrats U.S. progress. geographies? on to event X more just that fourth provide the since added to on some seeing study? volume do your meaningful enrollment start the the enrollment of going quarter require off with you sites ex you III. rates was a higher update, Or And change the whether the think optimize sites

Michael Andriole

travel we the be than talked Maury, initial not were of to additional sites, tranche less question. And that the the sort the strategic so XX additional It's where we're added been really in about patients it's of markets probably going sites for last Mike. Yes, event. that's of distances. quarter. have including recently part seeing Appreciate great any that X sites

interim those projections, we necessary our first achieve to in continue expect So aren't XXXX. enrollment to OS and

Maurice Raycroft

it. Got

for for then the filing your a TGA, the what applications in there. contingent to status expect enrollment? and questions do to want that submission? guess, OS Or Australia to what the often TGA the you with the I've got will TGA will interim it as progress how and And helpful. be are And of you it That's do I XXXX? factors on couple the Phase gating relates III application the prior ACTION in you submitted the just plan meeting data to on filing? Okay. the Phase do Is getting see the approval anticipate of -- III study? When

Michael Andriole

Maury. great Yes, Yes. question,

ongoing the So that. the that in evaluate terms and summer, application and the the application. preliminary process We'll is interactions, of a in what's but here over our next needed initiate step determination they'll then for

move Assuming the step provisional the traditional application. that final to in the will process, drug resemble we new application

So for the as X earlier, submission of between overlap between creating doing alluded the in already the within overlap Allen lot those company work Australia, we're and that there's document things. to the a

the provisional is they'll terms making period. sure definitive key and that during efficacy safety In of their data registration in have progress consideration enrollment,

with that. they've I comfortable enough already feel think to seen

trajectory is, about. going parts additional of expect that which we've And be tailwinds that, think, the so to we're on I course, of talked I already And to your we assumed. missed? on continued trajectory there's question Other

Maurice Raycroft

Yes.

often on plan how public meetings? prior Just after meeting filing will to you could and take And updates those those place? when provide the to you meetings TGA with

Michael Andriole

this particularly that Yes, into to in certainly, there's application. third we move with interactions frequency with process, the heading the next the degree determination get collaborative some second the phase expect as of of far. assuming through we preliminary process, meet ongoing that we step then And TGA,

but would any think it. I interactions covers there's Allen, regulatory comment don't So there, that if know that additional you I

Allen Melemed

this make that trial well the Phase the of approval is on is the trial is ensure is to add, And It's a Allen, at to submission data. thing contingent I'll only not that the decision. III the for time them underway

Maurice Raycroft

Understood.

Operator

from comes Capital question next of from line Naureen The the One. Quibria

Naureen Quibria

Congrats potential well, just on up sort the -- of for accelerated the asked regarding that. approval Maury Australia, on the -- following what on the progress. I in for guess

more commercial that could considering talk territories you the what a be about Australia? in curious Just be lines? you might same might the bit opportunity if also, And other along

Michael Andriole

Yes.

Naureen, take potential on I'll So Riga for I'll X Tom the thanks, ask the the questions. comment for second commercial the in and then call, Australia. to first,

the ACTION I focused study our other as countries, the look, and terms of in priority. we're is on first key -- mentioned, So strategic foremost,

We are countries of have pathway. evaluating that handful a a other

around an from interim because that you variable As could you as potentially on the can imagine, study think the of line submit corner strategically, a first next there ACTION is we the when time about important potential we're just year.

we're evaluate we potential So time. we'll that market if on intend commercial Australia? Comments to or pursue a update in Tom? that evaluating, pathway at the

Thomas Riga

Riga. Tom Naureen, Yes.

in I think, and is parallel, process, the the the end by access first, it And of year. runs Australian and for we're regulators here with excited of about that process the the submission process. sequence in a and along pricing, with potentially HTA proposition reimbursement,

is much we studied could market, different commercial room there conducted some more is a we evaluations in evaluate of particular ONCXXX and So see prices as optimism very when how perspective. those lower. But potentially we are the that are have for market analogous interesting to and than attributes criteria from that be Europe this very Southern those U.S. for

think area issues one, medical first-in-class high an in I need. of those product are, unmet

I think importance second to treat an that's area think product that of disease. third, currently illness. an ultra-rare and of this And not is is there anchor approved I is significant

some commercial optimism see do standpoint. we but early, So from a

behalf a coupled our exists make that, along ACTION in unaided could we'll neuro-oncology think efficient the efficient country perspective network much in for have would in-country process. progress the with that of significant and about Australia investment exists with commercial I say in sites, more community the high a in within we be We that as Chimerix. and very the foresee human We model. collaborations, capital that lean awareness for to on looking today from do not

Naureen Quibria

at Got in trials. other instance, But in is more the not let's for dose report if it. incomplete, same For from still and escalation data commenting ONCXXX, That's pace? I say, complete data if both that. helpful. trial isn't trials, know will have me they the stage one the the time guess the of I frame? pediatric that are on what you you on one moving terms is you're adult

Michael Andriole

would you Josh, like answer Naureen. Thanks, to that?

Joshua Allen

the on the exact are provide and for at There safety just of But adults the the an day, Thanks Naureen. studies. the different next in in both of what the of nuances design quarter ways. end trials to see pharmacokinetic can and on update from information expect are think they pediatrics key mean and how as parallel. I you both I question, in proceeding some kind in out play

the across little about would that a have XX SKU. think expect of pediatric of different because in patients, enrolled dose cetera, population, around aggregate study. the experience setting be we et couple to a to that's has cohorts, I'd think an going contrast I and say adult to X/X just I levels the it's pediatric trial in

you PK to represented see and from permission both can trials. safety and So expect

Naureen Quibria

Terrific. Okay.

Operator

comes question Soumit the from Research. next of from line Jones The Roy

Soumit Roy

progress on of are expecting Or on question the change again ], there is enrollment A across and or XXX between front. pace Congratulations deyronfrotamib approval -- any quick both on alteration? with XXX? HX you any for KXXM [ BRAF in overlap every

Michael Andriole

I a on that comment one. Great just neuro-oncology. to ask contemporary to field and Josh and want the before specifically. Soumit, I'll for milestone day But on approval. congratulate a I meaningful pause question, that It's do, X of

with that's quarter girth field years. over really glioma. low-grade a genetically the in meaningful significant and the last account, a innovation defined And patients third our milestone the are the last that's in for by of century, several think approval I pediatric after quite

excited do KXXM between want So for the you field. and HX talk to about and overlap Josh, congratulations we're to the BRAF? that team,

Joshua Allen

X. first thing with and fusions the think BRAF think I KXXM includes I for congratulations other really VXXXE foremost, said, mutations, day co-occur and Mike. Thanks, out is and the And that HX Yes, to point Yes. well doesn't the that actionable population.

really the point So you for tovorafenib relapse accelerated is our or patients that in has these focused Soumit, overlap. that of And the would just do are don't in Phase in I The co-occurrence. I that approval recurrent that have patient frontline was setting. out, trial would is final just event highlight populations III unlikely that a the thing a setting. the

-- ACTION. available are evidence based following cooccurrence would the sequence there's be the on again, So therapy there for opportunity exceedingly actually that an rare

Soumit Roy

you And if can one Last any expanding it any results? the seeing you provide second you to changing is, Is as other versus U.S.? prior treatment how have in your I mentioned know KXXM XX%? difference are U.S. is seeing on depending survey don't time Or the HX you you The U.S. being is, temozolomide according that is anything market more expected color or percent U.S. to else to territories ACTION the thing affect patients are initial X% usage, of handled? X% are globally. still ex could ex in are ex patients mutation

Michael Andriole

terms have your question. reason different races. percent U.S. we're KXXM percentage in different just that on speaking, Soumit, broadly or within for geographically. of no with one, we any, terms if it's the seeing standards in one country care, the conclude different first On to of to the country Soumit, ex to incidents, Thanks, HX talk I'll Yes. I'll first Allen of what take the the mutation. ask about of And

uniform sites have In globally, fact, it's consistent of kind that relative where almost conclusion. our is with proportion to of enrollment we

of in the reason to care? the to you would geographic Allen, no of any differences mutation. like standards comment So on expect terms

Allen Melemed

may the is care the for radiation these that you standard have seen question, in a There's therapies patients. In difference slight U.S. the general, of for Thank you Soumit. worldwide still

do radiation. of proton the as receiving a There Some are it's some is prior This radiation temozolomide, as there are mainstay. are more pediatric the still even the little whole, beam a but globally in adult globally. patients in typically patients higher receiving setting. instance temozolomide. who patients But patients is Pediatric not,

Soumit Roy

congratulations Thank you, again. and

Operator

the comes question Baird. line Joel from of The from Beatty next

Unknown Analyst

This ] Beatty. Ben Peloton is [ Joe for

what's it be monotherapy? being path non-CNS combination On Or ONCXXX, Is a contemplated? therapy that give maybe treating tumor development potentially fields? that possible the us solid of Is would tumors? to sense future is a with of that a

Michael Andriole

for would Ben, the Josh, to like you comment? question. Thanks,

Joshua Allen

tumors. the is Sure. monotherapy restricted Thanks the is solid least prioritization focus the tumors HX I I of for on the think are the harbor KXXM is for given answer to mutation question opportunities but short not that development. question. opportunities to the CNS mean and At initially, inclusive to

those the identify considerations I opportunities of we're that mentioned we defined some potentials either neuroendocrine ONCXXX I and looking wouldn't or specific mechanistic paraganglioma. in in highlight specific drug remarks by this And just medulloblastoma, certain corporate are specific think activity published if opportunities prepared to biomarkers vivo with such further that -- in combination studies for of our as refine development. So defined enriched and of we of that that deck. how GBM, could clinical indications more and several really, in line to cancer you are specificity, my this, some with to monotherapy there. I'll for and monotherapy these meaningful positive examples there represent include There's mentioned ONCXXX hold tumors, summarized prioritize right? is you're is for the the guide cancer, histologically indications and in breast for goal Those kinds that uterine of them. that using pitch

Operator

comes last TD the The question line Troy Langford from Cowen. of from

Troy Langford

the progress. on Congrats

do So dordaviprone? with Or constitute Phase any believe in followed to patient the do respect likely program study, studies for II smaller selected these any you'll you the do did next by Phase -- more populations? just what first, controlled studies could similar single-arm think these you pivotal a to III larger believe to you you with future ONCXXX, of for do of steps the studies

Michael Andriole

that. let to Sure. for I'll question. the Thanks Josh speak

may well you the on But and would Josh, of depend the indication the in pursued. I think, program direction it like further? to short, comment

Joshua Allen

exactly That's right.

and we that can at is of update up and adequate totality the next about of opportunities achieve into of to tailored sufficient going going nature are be for the humans an specific disease this in program intend opportunity. of development. to on the activity. to design, most that something very decision think well of the exact to and endpoints the what opportunity. additional now time is thinking if But monotherapy year, on are able be possible and therapeutic the confirmation for and that of sure Mike that via that the to in be adequate -- tolerated. signals sort of goal the the but said, registration the the path a amount that And clear steps see and be are we approval term to lot exact drug if everyone further We going we're right to the that's we're middle for near Like exact concentrations open efficient trial focused to take that to obviously, that Our get identifying we make much

Operator

to Andriole. the at queue like this time, no turn the over Mike questions would I back to are further at call there As

Michael Andriole

months. Thanks, you, for we coming your everyone, John. in Thank this forward to morning, you the and look updating time

Operator

participation. This call. concludes Thank you for your today's conference

You may now disconnect.

Chimerix (CMRX) 1 May 242024 Q1 Earnings call transcript