Earnings call transcript Q4 2022

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Operator

Good afternoon, and welcome to Capricor Fourth Quarter and Full Year 2022 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Financial Chief Capricor's Bergmann, Officer. AJ Mr. begin. Bergmann, you may

AJ Bergmann

Thank you good afternoon, and everyone.

possible These I start, looking state call. and manufacturing to These capabilities, potential statements of intended would efficacy, that uses the on our from expectations things, milestone in of we among are actual quarterly statements may other regarding, we today's change including contained utilization statements forward other to subject uncertainties safety cash certain like Before payments those current resources. the include making will potential number the during product These of research and and or plans, with statements preclinical investment cause are filings, including and future studies, our described assumptions developments and report clinical regarding risks and a reports. forward-looking and data, are our regulatory that plans made that anticipated plans SEC, may differ conduct risks our filings product candidates, and based information, materially present statements. and our our annual existing our and development to periodic additional our of results candidates, forward-looking and involving to involve timing regulatory our be in

not we cautioned place disclaim are such to these and on You any undue update forward-looking statements, reliance statements. obligation to

to Chief Officer. Executive over Marban, the Linda that, call turn With I'll

Linda Marban

quarter and XXXX Thank you, year fourth AJ. Good you full our afternoon and call joining today. thank conference for

Dystrophy platform, as updates on the We will important Today, few Duchenne XXXX. are updates. the Muscular months I made over past year pleased the first corporate program, and as into have with progress exosome we provide well our our of

DMD seen and which and are months follows. our program Duchenne continue execute three as for key many XX for to our CAP-XXXX past our on These program, highlights priorities we Capricor have

advancing X HOPE-X Phase First, our trial.

world. of to third the the to securing commercial continuing is with And outside the patients partnerships patients engage to CAP-XXXX with ensure is as that expeditiously to around possible. bring reaches FDA United the CAP-XXXX States Second, as DMD

update clinical I Phase continues with HOPE-X our very well. to will an X, begin which on trial, enroll

we to and have the up active today, treated XX of currently of over of patients. sample planned have size As XX% sites XX

to interim and reestimation plan analysis sample conduct these conditional in and quarter that or remain of analysis will unchanged this anticipate Our an be we size year. the power of results fourth available

are second in of In to majority activated bring with additional goal sites this our addition, continuing on quarter sites the the to have targeted of we year. a

dose in clinical OLE patients open HOPE-X follow-up portion patients In year on Phase of based or the the potential the positive year into of are this their the results parallel, treat and patients continue label in extension fifth are we and therapy. to of the X third continuing safety, these at OLE time, durability we to to study. further date, demonstrate These to term long going of a

in of the continuing of to in DMD quarter second study month support of disease, saw average report fundamentally HOPE-X. randomized in important data the safety of HOPE-X, term CAP-XXXX, data see long month the portion continue at an second to in XX year. to XX% and both presented year. this slowing and CAP-XXXX both XX the placebo. presented This we plan to in XX months data OLE we and of with significant the of show to were HOPE-X the XX% slowing plan who continue data at XX XX We slowing efficacy months data of on initially disease of patients patients. for to including XX treated these for is The similar this We of quarter the The the patients months report a the

accepted us at families last benefits World by Muscle on for hosted PPMD to Both you, term October Dallas, the Dr. potential for OLE can We March profile also patients of that at To thankful data and Parent continuation the MDA presented approved, results XX the note XX Society working the our supporting to and CAP-XXXX. to therapy effect their breaking believe impacted Muscular the as we to data with month the long and videos clinical and XX, safety XX young Association being or demonstrating were the was month XXXX. Muscular month or continuous the efficacy, from to are and the their presented last for these by remind with presentation men in webinar. XX a anchor serve at the Project lead late pleased continue were if scientific McDonald. this that Dystrophy therapy, mechanistic months recently Texas recently Dystrophy of were with investigator, Craig from for year's boys on this I'm a CAP-XXXX, conference disease. presented Together a commitment held

are know, expectations believe frequent from FDA a met CAP-XXXX priority, and meeting or Therapy you manufacturing granted we clinical meeting minutes, our and activities. since a productive Chemistry the more to awaiting designation, FDA's of guidance RMAT Advanced have HOPE-X scale was with we adjustments the CMC and regard as for RMAT meet meeting of constructive. to position plans intensive Under trial Controls discuss in with or that planned a And we or in in been Medicines BLA Type-B to while With our BLA second to will and production the some to potential we access the Manufacturing The our anticipation manufacturing FDA. we application. commercial Regenerative be designation, have recently we

facility product potential initial need with potency we great scale BLA meeting, GMP assessment to we application. that a a about Based this We anticipation release in criteria to this This able In the in with commercialization. year. HOPE-X support our we CAP-XXXX on requirement, potential the and potential BLA. FDA is Diego our new commercial to products plans of support of facility to assay this our treat San our believe from our of and to Diego produce outline San third will doses to functional we quarter manufactured and expect accomplishment facilitates to were patients our of other be facility path designed

provide becomes as results the registration. discuss HOPE-X our more label to study available. Furthermore, any color will towards review extension FDA, HOPE-X pathway their We from interim to of it potential have at impact the on we the request as our potential continue we submitted open for

the of commercial entered Now, Dystrophy. Muscular a our XXXX, few strategy. field the early agreement the agreement a additional a there provided payment in milestone upfront This one of DMD $XXX and approved In up $XX Duchenne million in leader distribution United turning into of significant million to Shinyaku, or and commercialization into with of agreement. Nippon payments partnership States. to built we therapeutics are the With potentially

these we may As that to XXXX I according have trigger to is milestones noted in should we start to possible execute our plan. continue before, it

meaningful additional to million Also, agreement in in announced Nippon a as approximately rights we to the to will $XX and double of to with a upfront digit Shinyaku February, receive Japan, revenue. that potentially which entered and we product I Duchenne distribution a payments up pleased share very net second highlight milestone payment pursuant to for have into $XX of Dystrophy Muscular for am receive million CAP-XXXX expect

similar and In based sales the responsible the on that clinical, product with achievements. these based of the manufacturing CAP-XXXX and is is U.S. regulatory milestones Nippon clinical approved. of the Capricor will the for for in from As Japan suffer U.S. agreement, to agreement has be with the that Nippon that This are Shinyaku if X,XXX reach in agreement Shinyaku. distribution And patients CAP-XXXX. region. cap will potential DMD to be estimated responsible This the development

if product is Nippon is marketing Shinyaku and in already established is [Viltexo], approved will authorization be in their exon already In hold drug in to will territory. the leverage skipping for addition, approved infrastructure which the Japan Capricorn Japan. the able that expertise that

to DMD plan Japan, for to as otherwise an PMDA Pharmaceuticals understanding for Device of of Our in the and CAP-XXXX regulatory in is known Japan. the approval gain process engage Medical Agency

as program available. We become they will on provide updates this

committed remain additional Lastly, being world Europe focus at securing for in us the partners around other the this main we to markets with time.

Phase results selected XX its clinical one Clinical our to Research recently studies Lancet as top publication in by in the The Forum. are the was trial In HOPE-X, announce addition, XXXX very and of we the proud of X world

look we the the new skeletal recall, paper slowing updates and and and additional further interaction highlights program, with you the cardiac and DMD. the efficacy Overall, sharing DMD As of our HOPE-X forward the in and of progress CAP-XXXX very both with our safety territory. to in progression partnerships with potential pleased of FDA, from myopathy development of progress we are our muscle the

the leverages which body. Now turn communication let platform of signaling technology, to system the exosome our cell me natural

delivery as exosomes We system applications. with broad drug are serve therapeutic harnessing to novel a

with of core for ensuring make We these action continue via from developed is progress exosomes and expertise quality extensive CAP-XXXX, and an production our we to how know manufacturing mediated emphasis evidence body exosomes, fronts. on on which scalability, have learnings for the an Building mechanism program of and three on control. the on reproducibility and of

methods downstream and efforts payload loading targeting. therapeutic innovative has foundation for tissue strong further specific Our supported

based January all core two are T-cell protein Our responses achieve we adjuvant. proprietary of vaccinology published and any data exosome competitive broader StealthX broad on is of StealthX that the we of show and year, protein is reactivity expression that modalities: immunity this the the more our In the lasting with development added longer Results to therapeutics. The from at nanograms potential deliver platform and mRNA vaccine focused which StealthX, program this combination broader two with on with to nucleocapsid. to platform. immunization, two online has server, cycle proteins, candidates that generated improve in necessary multivalent the vaccine and and spike the a an that that advanced of SARS-CoV-X vaccine without only application is potent immune efficient induce candidate our on potent, data strong of independently currently response against suggests a available, BioRxiv, study development most precision

is is reason The so data twofold. important this

vaccine. an case protein suggesting use the second, To response, most vaccines, strategy. to technology team any ease and with us also go strength pierce of recombinant antigen candidate. allows the vaccine that it be of takes it opens weeks end, an nanograms approximately development to to combination importantly, mRNA as in candidate. highlights a the immune This with could our protein characterization First, that for vaccine the to it to multivalent tiny the from And use a amounts vaccine XX of of for ability drive door

Our who capital securing to will and program is resources to do we on into should bring the partners provide this decide current clinic focused strategy additional so.

thus decreasing here to our targeted The precision higher The cells deliver is platform effectively payload, concentrations overall therapeutics. other targeted tissues, the develop exposure the a potential more of to StealthX at enhancing application to objective while systemic or payload the to is site.

patients. are specific and three a of which of deliver using platform a exosome the clinical for for on the clarify, therapeutics. is these we believe tissues for potentially planning are technology exosome approaches, developing vaccines improve primarily interest we technology, but currently platform, outcomes We To and StealthX, targeting our internally both can differentiated indications targeted

We with from also payloads therapeutic discussions for a have in potential therapeutic external clinical for of deliver established potential and initiated entities. fact benefits the characterized partners' open with us clinical This compounds to already their approach remain optimize allows portfolio preference programs. partners to

invest continue future the diligently of Capricorn. We to in

efficient. world meet We capital and continue have class a team assembled is to profile lean a that

organization, XX for employees the hiring complete we plan across the With today is have XXXX. our nearly

$XX provides prior a runway in expect our Our to from this receive us we announced $XX addition upfront cash, strategy. not this over including of execute our and call to on quarter the which million payment, with Nippon Shinyaku report financials to million

clinical continuing and to with look and with pleased are We this and towards We stage body late of development of our milestone. platform our momentum exosome accelerating the growing to the executing technology. advancements work pipeline upcoming our forward

through fourth Now financial the over quarter XXXX. turn I full AJ with Chief results for our call AJ? and will Bergmann, to our that, run year the to Financial Officer,

AJ Bergmann

full basis. of summary our GAAP This a year Thank quarter release on and afternoon's you, fourth press a XXXX Linda. financials provided

as to also Form the on website, refer website. our SEC annual our as may be of to well at become available company You shortly section XX-K, which we report financial and expect accessible the

cash on to equivalents, $XX.X sufficient million XXXX. totaled cash, plan, XX, of current compared cash, approximately million support As of into securities $XX.X XXXX, Based cash expected marketable our company’s is to operations company's approximately the to operating on December XX, the quarter fourth December XXXX. position be

activities our Turning now In in to quarter cash $X.X fourth operating million. used financials. of the was the XXXX, approximately net

excluding XXXX, in was excluding approximately based $X.X and XXXX. general of million XXXX. in $X.X compensation, to our QX expense approximately based stock administrative in stock fourth compared million the approximately $X development our million was compensation, Again, For quarter QX and research approximately and $X.X million QX XXXX expense

for Net to the loss loss for briefly $XX Valley recent would the fourth $X.X quarter of note approximately at the of full and million compared million Net time. $X.X quarter approximately holds to XXXX approximately full compared fourth volatility, Capricor light XXXX. also million a deposits of XXXX. $XX I year was of the like loss FDIC net a this was Silicon XXXX approximately in for loss action to the market no for Bank million at year net

We will line now for open the questions.

Operator

you. Thank

go Wainwright. question-and-answer a Our [Operator Instructions] comes session. conducting be Please Joe H.C. first question now will from with Pantginis ahead. We

Joseph Pantginis

mind. a for few questions don't question. and you AJ. A taking Linda Thanks if Good Hey, afternoon.

First, regard FDA I with to two-parter a your recent guess interaction.

have as or a of outstanding I some of And to, And with the say, part because comments less minutes looking the you agreement might know things punch assay, anything also have I'll anything to the so simplicity key of be more to know yet, regarding to little to in of have been FDA list, So, outstanding or don't I the at. can that regard comments your you you potency the then to that that. might the talk able But assays? potency talk be go two. with can be is

Linda Marban

like. parts many as two have as but questions was you you That Joe. Thanks, Yes. already,

a just of clinical data therapy looking company plan the it QA of QC, of me measurements, We and because therapy at quality by reliable, all, assay we think we've start potency then repeatable cell first takes it positive can done let relating and the have looking innovative for ways be that to the probably hurdles active to develop to and at saying any advantage is of is big time. of off cells one actually now FDA. cell presented what actually a and validated that. was the it back and one most potency by at So in And the is

overcome. giant This to a is hurdle

FDA it's even in appropriately validated. on and out of we and the the We on to good have the some path things qualified with that right CMC. But terms and making sure have we're interactions

very a that's win. So big

identity other a in also had and assays. win criteria the We big of terms some supportive of

and effective and know, the for collaborative very this as really with the CMC. And really you FDA So meeting way paves CAP-XXXX. commercialization of

big all had over. the the of hurdles jump that have to One companies

In BLA. which launch terms some prior like sort the mention facility, did that they'd used commercial tidbits of from see the of be our our other Diego takeaways is patients doses and from to planned They meeting. San facility, in to the to of FDA

make And as path that's to easy consultants commercialization working so, smooth possible. to then be we're how is FDA regulatory that feedback sure on team waiting we're in and as terms manifest and and for that with [indiscernible] of our own going our our to that

Joseph Pantginis

Got it.

last that's the segue actually FDA. good a of part So the to

regard coming to apply will to San -- facility, doses from out patients patients be the able doses treated you a to change new been currently -- only with or how of of that apply does or new or does ratio there then by have the a fixed Diego new So Or is samples that the patients? that doses that to has facility? to enrolled including number be the

Linda Marban

Yes. Thanks.

cautioned a CMC ago been facilities especially And group (ph), my while same mix what with from a Group. really not long of since started was with independently. with has to working they trajectory. And we considered our about [Kaducia] us they be working time FDA, relationship they good our both one benefits been with we've need are So, so actually real they the to that that ago followed separate doses and validated entire products the

soon Diego a of And with of as plan know. implications everybody together know from be the out to have and implications reaching as meeting be separately. yet. So can let are doses don't there be treated potential further the program, will patients we'll conversations course, We schedule will to to that we to be going soon We're San those we idea with will obviously We then that clarity. further and going new clinical as FDA. of get very so an analyzed

But I highlight positive to an want that step. incredibly this is

need what is We have patients, iron to of know number sign We to application of a still exactly for do. road for this we a the We map now a but us. in edges product. biologics this out really license to good need terms

Joseph Pantginis

of guess quarter. question. Street fourth looking continuous to the more I last away the real expected -- the Got we saying is then or can plan it. guess from? the And a more in regard my -- of this data logistical With analysis you're actually is are one a I take interim at that

Linda Marban

Yes.

So the built Which of zone. to right or we we sample determine data a re-estimation. is as not blinded it size at to it's promising basically as look a now, hit have going whether think

futility achieve And don't need a we add more in just to yet It's a patients we to built success. so, stop it nor for do have do success. potentially have we

to course, might other there's that. do to ways determine we our right we're if want team with that an Of statistical now to interim working analysis

have We do. will time, color further no this but at we we if

Joseph Pantginis

Linda. Thanks, Perfect.

Linda Marban

Thanks, well. Joe. Be

Operator

Okunewitch Please with Next question Group. go Michael ahead. comes Maxim from

Michael Okunewitch

a quarter congratulations over Hi, for the on and XXXX you there. question great Thank the as whole. progress taking and over my

minimal Japanese ASRM the with pathway on agreement in there Japan. have like thoughts clinical using any of in plans your Japanese reach Nippon additional are thoughts the patients So for if you work? to Do I Shinyaku the guess with market? to any ask, In just particular, terms to start I'd development off, on

Linda Marban

Yes.

was inked makings have the deal freshly Right now, So while. a our partner they're partner for Japanese our is we're delighted for the and them exactly. this ideal We as Japan. to and think in

advantage are be the a able to authorization of for plan U.S., market come be and have Japan the apply very to seasoned well. up as learnings clinical for will because our take CAP-XXXX marketing that our regulatory get responsible very the We holder, with in with We're opportunities in to work. a to efficacious we that so we the glad them will PMDA team

Michael Okunewitch

since skipping follow-up Shinyaku, for in again I'd therapy the Thank you further CAP-XXXX strategy to DMD? partnering space does their drug, they're a in for exon Japan like right. give bone All with Nippon back DMD the that. already position on in to the And confidence as

Linda Marban

absolutely. ideal. And and They're focusing Yes, and sales Duchenne we've Muscular product as Med Their very Affairs Pharma in on distribution been They selecting commercial is Group primarily solely on NS they strategic Shinyaku have have a network. partner. our a Nippon in Dystrophy, DMD.

be yes, it's sure ultimately. DMD to strategy to so, available of And will that our every extension an CAP-XXXX patient make

Michael Okunewitch

All one and trial. for what little right. [effect then could Thank just just what have size] talk study bit from the if you last to (ph) And assumptions a me you one you this powered? I'd on for and about currently that. HOPE-X like the how see is --

Linda Marban

Yes.

is saw are full can we analysis as we the submit disclosed in HOPE-X that in plan. we're stage what tell that looking development is and It's and what magnitude less still that Currently, size statistical we're XX% really you empowered I effect required to yet. than for So power. the late haven't our to of

benchmark sort study. success nice and advantage we're able of the really of HOPE-X also a have positive of power the to to we take data So

Michael Okunewitch

again. very you and right. All for once Linda Thank congratulations that much

Linda Marban

Have Thanks great so much. a day.

Operator

comes ahead. Huseynov Please with from Ladenburg. question Aydin go Next

Aydin Huseynov

questions. with Hi, I Nippon deal. and Congratulations have Linda. the AJ. several Hi, Shinyaku quarter the for

assess is European to how Europeans So to going you, you market first evolve? the you ask all, given receptive to do to DMD is really market I how market? are evolve? but exon skippers, this Yes. do So not of that want think The going

Linda Marban

is mechanism with gene and of pro approach FDA diseases doing as fibrotic positioning orphan backbone of worldwide is of serve other So that CAP-XXXX anti-inflammatory great and approved any DMD than action different supportive an well. we will mechanism therapies think its We taking obviously, other EMA and anchor is with conjunct or as What therapies somewhat are action. anti therapy. regenerative CAP-XXXX a the

to work around goal point possible. to our to right as so agencies globe And the same and to now continue worldwide the is the as get therapy with fast to get them regulatory our

Aydin Huseynov

Thank I HOPE-X question the the understood. regarding have Okay, in One trial. you. enrollment

So XXXX. I XX think you mentioned of patients, which is XX% around

XX was think I at it the patients. last quarter,

So, time XXXX. -- enrollment? you of terms end is also about the you I there And guidance the fourth bottleneck is was think to want mid-XXXX, think in the what I any guidance? XXXX last quarter now the ask think of guidance

HOPE-X could comment enrollment in the So process you the on trial?

Linda Marban

Yes.

So trials, to their up guide quarter. going the the really We're planned slowly, And beautifully of infusions excited XX We a infusion. the to now. the infusion. we fall. we we in quarter for we last a right on as enrolling for enrollment the see first are the pediatric enrollment holiday as for especially in QX Enrollment full picked for did patients end who currently going usual, very that and the started off track slowdown were spend in then significant enrollment then and and with around relatively wants that an they're holidays, you hit nice has getting phase vacation

on look goes more the to on. we providing as so forward that year And color

Aydin Huseynov

understood. Okay,

So little that's a I All the holidays. upfront. ask bit $XX want the Shinyaku to about you million right. deal, Nippon

it not contenders? a and have was end I deal you from after of fourth competitive? third to Did make back So could you hear at us tell didn't quarter? why the you but And decide HOPE-X other now,

Linda Marban

Yes.

an we already ideal in was got ago strong. of fact and Nippon Shinyaku partner. for was product extension that DMD Japan. a really Japan So an relationship Japanese it approved an in be They've time had and based a identified They're the solid that long would

best one other to talked we for but would course, be us. of felt So, parties, that the this

taking towards that proportionately U.S. and towards the deal, In advantage advanced were more product fact the the terms the is economics path the favorable, of very of clarity commercialization than has economics, in U.S. more the larger the

start reason to waiting, better started, about promote In terms to advantage as with can to right? commercialize We no because get data we to of can take we could how thinking product the and wait really into Japan PMDA. strategize there's the also getting of the party and HOPE-X

to we with ducks those partner, all we row with of not the get very in a wanted So pleased and the economics. but felt only

Aydin Huseynov

will the top So get as HOPE-X deal well of from for milestones? from we stones them while Japanese U.S. deal readout the on the

Linda Marban

No, so the U.S. of on will by -- deal in that is the constructed around Japanese milestones activities was based will augmented on around is deal But Japan. HOPE-X. things all or HOPE-X of constructed promise that and then based the of happen course, milestones it

Aydin Huseynov

Okay, understood.

Okay.

cash have in Linda, to So enough invest other programs. you

So muscular would year this in as and how other you see as the you in or hopefully this next going you collect you see dystrophy business? year forward milestone Would capital So well. all what payments allocation priority given a forward? invest do you do that invest vaccine going

Linda Marban

Yes, for thanks the question.

that a are its for obviously, laser focusing DMD. development and messaging So been we've and while CAP-XXXX for we on

number Our that goal approved. get is one product to

up our ready into going commercialization. going that facility for the is money got we've getting So make to product is running, we're manufacturing sure HOPE-X, and

clinical sort preclinical very as developing vaccinology is, it's Our had nicely, promising have and both development. of exosome towards moving we therapeutic potential behind going program in planned, a scenes the is which exactly data, we

opportunity identified development right type HOPE-X. business the really partners And move have forward some with the we of the exosomes. Just make like that that going have with then with potentially worked and successfully and CAP-XXXX CAP-XXXX, once we we're exosomes to sure

strategy And so, to we're exercise the exosomes. with the same going

And it. gave a that you I emphasize and by the our to StealthX extraordinary. I speak moment about can't is way, me think enough platform proprietary

as innovative, with it and can with it's used then this the So vaccinology mRNA or protein level, combining for an replacement to takes protein is vaccine I'm going therapy. new also to, novel, the power a [indiscernible] be which of ease vaccine

have to deliver we lot on milestones. really at here to So, our on We're continuing looking Capricorn. a going forward

Aydin Huseynov

congratulations my questions very and you quarter. much taking Okay. for Thank for the

Linda Marban

much. you seeing Look Thank New you soon very forward York. in to

Operator

[Operator Instructions] Go Brian Corday question BullBear. Next with comes from ahead.

Brian Corday

Great AJ. to as Hi, quarter. see to Linda. Hi, this how information investor I'm just an going. digest. happy of is Lots

Linda Marban

Brian. I'm as have investor, an to Oh, yeah. Happy you listening.

Brian Corday

As had questions. you I'm here know, while for to a been couple forward and of I just a it. looking I've

release terms In those another to or that? you you summary it? How give address the Because FDA will to have going just of relatively going those, you have minutes to you are when soon. you are should get a call

Linda Marban

Yes.

So usually call there's of call. expect don't -- this I meeting. not assessment for back sort [indiscernible] surprises. is any the gave the of our not of envelope We kind of a

very feedback who in to CAP-XXXX positive sure and our interaction. our call from adjust obviously them that progress from will of to about reviewer plans We really But there. based aligned participated FDA get making. on all is that was the continued a perspective I clinical our can We front in need do we're clinical make you tell the even

to becomes so, expecting data And this not available. message as tumultuous. But expect we anything

Brian Corday

quite attention leading that you? which going them? know tremendous. had a is seeing that been of family you you webinar How last terms advocacy along? a the I support growing lot is from more has you've the Are the in was getting And patient groups, from And bit. Where been

Linda Marban

Yes.

Number So I'm of I'll very to and And say one feedback long lot a why. a we're patients has DMD importantly proud CAP-XXXX. most reasons the very with perhaps and profile. that just for safety CAP-XXXX highlight getting positive briefly and established from families

really sick minute a So don't super once remember, XX They It's quarter, and them. it, sequelae. there's mind kids it. for get don't easy parents. infusion every the these no safety And from are kids

of of their families. thinking the one is thing safety number the So they're

other work. they're thing The is, seeing it

have in seen and by that that's we did weeks anecdotal regularly ago be better from also to open getting families might continue that doing a supported I'm on you So webinar feedback seem we're few getting CAP-XXXX. And the on to kids either year calls PPMD fact our families label because get validated to CAP-XXXX into it extension open the up. of don't label is give that asking further to want third the extension going or we're by that

So we're as and to other approved. I've of a call gene positioning places times health support few whatever we therapy it'll continue backbone in and the go And as this that along it is else DMD. with therapy with well-being think said or patients

Brian Corday

that it As the a really important gravity had, understand it that could great have webinar analysts was. think ago for how from the important call ground the are was families. people be you of I don't it and had that Yes, how weeks reach really that think it for that, of some been the little would point this was a pushing great. people swell the people couple out to on and those And of understanding you've if I to

of -- minute Now addition, or come since that to going were you terms Dallas meeting last in to, to did present? it's you you're that you to such them ask a in the asked were

Linda Marban

No.

We the -- did just abstract we of and So in classic fashion the sort of so they by classic it. it responded did road data accepting an time. submitting of in

that to front patients. were And great wonderful forward so, the investment we're present in opportunity year. as really last well. But meeting, presentation. of also there We a It's to looking to get community

a that the cardiac again arena this better. is that worse. are and have are They're implications the in and cohort things more One up but they're therapy kids now staying active, of doing of therapy their backbone feet longer and a we of wait unequivocal. gene on families is And their with be even are we hearts to highlight to seem sitting saying, CAP-XXXX the the starting really sec,

provide an paradigm and -- of more focus on hearts. by hopefully more an wellness there's added the CAP-XXXX addition to So supporting treatment the will their

Brian Corday

the least know for terms because running. with the increase questions yet? at sold for (ph) increased, XX% adjusted think this you are it, you In the [$X.XX] have shares definitely have you could million $X.XX things saw because model, I now, talked happy did is, got really that your AJ, question that regimen I'm you about stock last final pricing Well, at out shares XX% quarter, that when the other from? AJ. you were I to I way about the the had looked at X.X progressed. there roughly pricing believe X.X going I then you projected you Have And higher. about that to to we to for of Okay. structures two Where your was come

AJ Bergmann

Yes. in clear, laid hopefully it, shares last our all Brian. call, very last those minutes for the press just under sales caught this which sold our sold it of our early but disclosed fourth your filing. ATM November predominantly ATM. October, following And was earnings quarter, our shares in and point, I to be occurred this first were out of have on in think release, in question. call. the We no we Thanks on the you I quarter before couple numbers Hey, quarterly December To XX, really quarterly all of under in a

nice our advantage being those shares. we you stock but mentioned, days, no as So have of position in took in a back further sold

right the change most number shares to likely nothing in terms cetera, to ATM. of exercises, outstanding, the et In triggered delta but due option

reimbursement the success and Obviously, question. next down your of our is line. terms critical for In the us

a as split of double net structure what meaningful really receive a terms with NS of Shinyaku Nippon We digit product revenue. Pharma in we and have will nice

how We have we as feel both they and early approved right in high this drugs it's skipping at. and something, that to exon skeletal come well. in will our is of be data the in the arena. are be of we're partners. down priced ultimately estimates on cardiac what range focused CAP-XXXX course, These the It that with will hopefully very price tags have be But U.S. will will good that very and drug

Brian Corday

Okay. kind all acquisition outright? of of of the on you right Nippon have does at of any type any on refusal company first And comment can

AJ Bergmann

something publicly. is into this haven't gotten we and disclosed Yes,

[indiscernible] all now established. It's have a clean. we've Japan but basically We stated, that that's has been pretty

So not we've into at it's just this the details something now right got point.

Brian Corday

the Okay. appreciate much Well, and great keep I Thank work. it. so you Alright. up

Linda Marban

Thanks, Brian. you See soon.

Operator

time, management I the for At to turn this final back would floor like to over thoughts. Capricor’s

Linda Marban

everyone who this had to Thank us thank joined Yes. afternoon. and you, you operator,

many today's and to the people we our Before and you families. the again, would for the thank conclude entire supportive investors along especially been like who Capricor way, our have call, Once their thank I team, joining. patients

Operator

teleconference. today's concludes This

Thank a day. this You you and lines have time. for participation your may great disconnect your at

Capricor Therapeutics (CAPR) 15 Mar 232022 Q4 Earnings call transcript