Rani Therapeutics (RANI) 22 Mar 232022 Q4 Earnings call transcript

Hello, and welcome to Rani Therapeutics Fourth Quarter and Full Year 2022 Financial Results and Corporate Update Conference Call. At this time, all participants are a in a listen-only mode.

Following management's prepared remarks, we'll hold a Q&A session. To ensure that we have ample time to adjust everyone's questions during the Q&A session, we'll ask for a limit of one question and one follow-up question per person.

As a reminder, this call is being recorded today Wednesday, March 22, 2023.

turn over to of Laurence like Group. Gilmartin now the to conference Watts I'd sir. ahead, go Please

Thank operator. you,

Joining the Officer, Executive Officer, Chief us are Officer, Talat Therapeutics' on Scientific Imran; call today Chief Hashim. Financial Mir Svai and Rani Sanford from Chief

in its and will environment, manufacturing results as filings on timing clinical Exchange During such factor that events development in resources reports of are These and events forward-looking not regulatory section report the and statements. those include with risk limited and to, performance, statements. annual of patients, forward-looking subject such differ this factors performance. make including product the business which XX-K from statements company's risks, regarding the that certain the Form to differ Securities or described results things and device projected Commissions potential, actual potential operating Form call, product materially Actual cause materially on trials, uncertainties in from impact forward-looking progress identify these capital the strategies, without those management but specific or progress, assumptions on the may those limitation may discussed could statements quarterly XX-Q, and

the Talat Officer of With call Rani. over that, Imran, I'll Talat? turn to Chief Executive

year Good everyone full conference Laurence. financial XXXX joining and and afternoon quarter results you, our Thank thank you fourth for call.

the strong during start performance. important share performance device program I'm the reviewing XXXX, like improvements pipeline of progression achieved Therapeutics' achieved that would Rani to in in and delighted to I the numerous its throughout milestones the of year. the Rani highlights company which by milestone in

unveiling and significant high highlighted by of we of manufacturer our RaniPill improvement GO the device in enhancements platform HC performance RaniPill to the made continued and our RaniPill device. year, both capacity Last the

the XXX% our plus RaniPill GO. development capable higher Rani In RaniPill the standard of of February than payloads XXXX, HC announced of administering

up milligrams deliver to X designed pill. GO XX to HC of RaniPill drugs While deliver the dose up to RaniPill with per the potentially milligrams, daily is a can

preclinical We HC. RaniPill in are currently studies the with

new this much target with secukinumab. molecules larger etanercept, and have potential to Importantly, the such we as market trastuzumab a device, pembrolizumab, of now

we of the improvements make development development GO, the of RaniPill the to our development RaniPill being which utilized HC, with pipeline. have the continued Concurrent in current internal across is

efforts half We this have second happy to automation progressed line. year now that program manufacturing the and of manufacturing we X report and our supporting of a current with up scale capable Phase are I'm in our

in plan pipeline clinical support studies Phase also other three X programs to We of additional concurrently XXXX.

In addition, a several recently completed but XX% achieving in of our RaniPill Phase the of in manufacturing important latest iteration RT-XXX. success rate resulted in delivery GO study improvements drug our X processes our

study RT-XXX endpoints. Phase XX and device Beyond via the the of RT-XXX all XXX% micrograms improvement XX its PTH in PTH of subcutaneous of X with when Forteo delivered XX delivered of compared bioavailability XXX% micrograms respectively micrograms to for to injection. performance, met higher

few were and supporting our no performance add to the robust minor tolerated all RaniPill. safety their In in results addition, mild serious own. X study. Phase events RT-XXX the Of to reported, adverse and moderate adverse body well of the and events on of and The deemed were data growing study was reported resolved the

the RaniPill pleased Capsule very to-date. safety the profile with are We favorable by demonstrated

serious subjects report. with have clinical events in XXX no adverse studies human nearly We dosed now to

Based and meeting XXXX, the during remind our about interactions we the plan will we for continue on our We X programs. like with regulators RT-XXX, suitable the PTH their our progress initiation the account appreciate is had As from development our half recent analog trial clinical believe program. take everyone that as to received FDA of would guidance to pathway Phase RT-XXX. for I input particularly interactions with the second into we first FDA, our pre-IND to-date for of the the we in XXX(b)(X) feedback have

to were supply development to recently for our announce Celltrion the RT-XXX, partnership, will pleased ustekinumab required exclusively Under drug partnership to this Turning Celltrion. RT-XXX. Rani, with biosimilar CT-PXX of we the substance,

granted leader been exclusive Phase negotiation CT-PXX biologics granted of our RaniPill Celltrion rights validates and X the an believe manufacturing, has following use turn strength drug the license development with partnership clinical a a has oral delivery trial. RT-XXX to We first commercialization in And in our worldwide of Celltrion, of acquire biosimilars to Rani to and in RT-XXX. right been the platform.

broadening to look Celltrion be We overtime. are working our and with potentially delighted partnership forward to

before biosimilar, containing RT-XXX it and data include cover RT-XXX in hyperparathyroidism turn like clinical more anticipated remind XXXX for and containing our initiating to containing Phase of near-term PTH pipeline trial I which clinical Hashim you X would I in to of with preclinical with over X and RT-XXX milestone, X biosimilar. detail, our Lastly, Celltrion's second initiating molecules, to RT-XXX Mir half the additional adalimumab studies an ustekinumab a Phase

me over let more in and to Hashim, With Mir now updates to the detail. Mir? call clinical that, preclinical turn discuss our

and Thank you us. for you, Talat, thank everyone joining

being PTH by for of Teriparatide. osteoporosis. RaniPill known Let the X-XX me is the begin containing also provided capsule as have updates for of the some RT-XXX, is RT-XXX we developed highlighting which treatment

in initiated released the Part of we and of study XXXX. the in in study know, data December of Australia study Part a XXXX line Phase top all RT-XXX X of X X August of clinical March for in you and As

pharmacokinetics healthy micrograms. In of dose of Part X single volunteers study, same the RT-XXX micrograms XX received female of evaluated of the a at with a micrograms, In subjects XX while dose micrograms. days. XX or were a for of up of parameters XX, at In XX at study, subjects repeat at XX evaluated in either reliability X RT-XXX received Part we dosing the X to micrograms of the RT-XXX XX dose Part adult tolerability, safety, RT-XXX and XX

microgram four-fold a of controlled participants formulation which A estimated subcutaneous RT-XXX Forteo. is be single any to up XX higher of was in both no bioavailability three- Forteo, adverse those injection commercial of tolerated to- subcutaneous the approved to for groups serious well group of events dose. administration. and XX Teriparatide at study subcutaneous that PTH delivered the received There were than in reported with

in daily Part Now XX XX days. postmenopausal X of once whom seven of study, were female received micrograms consecutive volunteers, five the healthy RT-XXX for

of any due event capsule. observed adverse no were the from withdrew events of the complete fact, RT-XXX noted in again for seventh each the We during with day, to participants subject. profiles serious On none RaniPill RT-XXX study. generally related that was well-tolerated And the pharmacokinetic obtained to the study adverse

bioavailability indicated the was Part or And subcutaneous X the data The of Forteo, of as Talat high of rate to success RT-XXX RT-XXX study. reliability was overall importantly, earlier, relative delivery XX%. again the confirming from

pharmacokinetic FDA which Overall XXXX. and the we Additionally, preliminary from development the we the believe initiation collected are and far and parts Phase osteoporosis, of trial beginning that second that Phase were the RT-XXX RT-XXX, have on also anticipate so RT-XXX progress data plans. reliability feedback guidance enthusiastic made through of in the half we in X received of X we of both safety, we a about the study support for pleased to we have

with program, look of for containing inflammatory the the RaniPill capsule in we the And ustekinumab we beyond forward progress ongoing treatment pleased of initiation a are also conditions. the RT-XXX biosimilar Now to injectable of our RT-XXX, make current with X has alternative patients We later the a to standard-of-care. to oral Phase RT-XXX study by for RT-XXX them year. believe real the this an for that difference development potential a providing

pipeline our the currently that commitment Overall, an the treatment development we paradigm change advancements core to of with our injections reiterate the oral alternative RaniPill are for ongoing delighted of millions programs and the Capsule programs, conditions. as clinical chronic for in disease delivering their could patients taking preclinical our effective

the it year quarter Now to to end I XXXX. turn over will results the financial Svai fourth over and for Svai? go

you, Hashim, good Thank everyone. afternoon, and

In today, some on financial will release press summarized financial briefly addition I call. our key to was share the earlier this results highlights issued that in

ended December XX, on XXXX. for You also our XX-K Form find additional the can information year

of the security sufficiently cash, million equivalents mid-XXXX. to Without to and XXXX marketable our XXXX. fund and to totaled securities XX, marketable equivalents cash million $XXX.X December current December Cash, XX, operation cash additional expect as we as of compared $XX.X financing

year and $XX.X million expenses development in quarter $XX.X the and for $X.X respectively, period XXXX for same fourth full were million XXXX the and and Research million to $XX.X compared respectively. million

$X.X General $X.X respectively and in XXXX and months XX $XX.X same $XX.X compared administrative and for million million million three months expenses for XX, the respectively. to million XXXX December periods ended and were the

the same XXXX $XX.X for full loss quarter million compared million in net to $XX.X fourth $XX.X the respectively our and was respectively. XXXX year periods and $XX.X and million million for Lastly,

full million million the non-GAAP the net to quarter Excluding based million XXXX year primarily non-cash the $XX.X was expense, for periods the for and respectively. fourth equity million $XX compensation charges, and XXXX $XX.X loss in $XX.X compared same for

concludes the results. over to turn remark now Talat the This call will comments. my back And on for I Talat? closing financial

Thank you, Svai.

far are Rani for XXXX. a a forward to with so our execution believe out be transformative could the pleased momentum and of we have year that and going is we From progress laid XXXX our milestones look closing, perspective, for company. our in In maintaining very clinical really potential I to be

of X half We in of clinical X second the RT-XXX. and our look first Phase the our initiation X RT-XXX to trial trial pipeline three with additional well studies Phase molecules Phase initiation as the as in forward RT-XXX XXXX, of RT-XXX,

of would world of a closer our biologics like reality. year all support our company your vision Rani and to oral for everyone team at this helping I'd far class continued making their I built XXXX. like also at efforts move in leadership and for a past the thank stakeholders and for us so have to We to Rani thank of

will Operator? open call up that, now I the for questions. With

Instructions] of Cantor. the with comes [Operator first question Brandon Our from Folkes line

open. is line Your

FDA, and a all for of from when XXXX. thanks and for down sat XXX(b)(X) Maybe did just in congratulations terms questions taking follow-up. require the ask light database my the stop color me, the I'll in RaniPill the provide they firstly progress there of pathway? may with you any device the Hi, safety they on in

eight Sure. a that question. interactions context prior program, over from have It will with to X, XX we higher. did thereabouts not Brandon, bit had out They the X,XXX good maybe your where little you Thank we the for database hear reach the weeks. in this deployments, but about the turns FDA, subjects was or of you. Phase size RT-XXX in

that we're hopefully answering think we're efficacy question going do that to data biomarkers with concurrent program. it generating I where the the for with be So around as RT-XXX well, and them to the decided essentially we've

RT-XXX focusing should just X in Phase you. X just of you're just Celltrion size the follow-up maybe then about think Phase is XXXX, Phase option maybe Great. the the Thanks. then running similarly And RT-XXX, to and post that? the the to then a that we Thank And that. trial? any to on How trial just be we should going normal pay nuances a X that there in on or attention given trial

Sure.

Phase the RT-XXX will look single they portion X. very So the of dose similar to

the So with it did healthy maybe terms to dose volunteers, will just to of more look number we are These on bit different what response see little may test a what of RT-XXX. XX curves subjects. similar single in the with like be to order RT-XXX of couple of doses XX, the We dose.

the well. we've It's into think clinic good these gotten to look But you It's you have don't very think putting work framed take together relatively very cookie conducting very, and Whenever cutter. to it it want similar. and at I it's you them. say I seriously. I go become, But to going

around relationship. one guess Celltrion point the I And last

generated option to sufficient expectation with think RT-XXX is Phase with should completed and period. I what the get be similar to the X we data the then us to

last look Great. on seeing all And the progress segments. over again, data. We that to congrats the forward

Thank you so much.

by for our stand question. Please next you. Thank

question comes Meacham of line of the from Bank next Our with Geoff America.

line Your open. is

for is and Good calling in for you Meacham, afternoon. thank This Hao, Geoff question. the

So dose RT-XXX maybe multiple trial. go think the back to I

for delivery happen X patients you in think sales most X. day day have and the I of

any interventions the then of So spin once up? sales wanted patients miss to that joining I happened just if doublecheck delivery

doses, answer this having higher to was than the manage there mixed And recall growth from And case in preclinical some question, your we the to showing there of Hao. any. we -- don't but And will our get will because you expect the on of if wash a with subcutaneous. there the you antibodies Hi, RT-XXX to of bone through no saw bioavailability. drug. PD when intervention, faster here, and no, significantly study long monoclonal dose half-life that be we There be be

they when of terms happened, it in was And completely random.

the and I failures of chance. it look point we it few kind more can at say there random was is there than but think study were that were at maybe more anything that you so just the think in that don't beginning,

Great. And just a quick follow-up.

Phase X X half, needs before can expected what initiated? So to the be exactly happen second the by Phase

Sure.

the FDA XX of the So run a in was that doing second that then from to of We're said, you as And and be half days. started, to submitting getting it. guidance completing the going of repeat X we Phase GLP the study got half first dose 'XX. and the hopefully here in year

you. Okay. Makes sense. Thank

absolutely. Yes,

Please question. you. for next standby our Thank

comes question Andreas. Wedbush, next from the of Our line

Your line is open.

questions for our All right. Thanks here. Hi, guys. taking

us for So just two here.

biosimilars pipeline is for negotiation Celltrion So indicate strategy indication? Celltrion of Thanks. still how would different forward? mean the what could And right then secondly, specific, of does the be the out the deal you deal a the indication partner RT-XXX the first I for and going company in

I'll take short first. the biosimilar specific. for No, one general. or in it not second answer. Sure. a indications ustekinumab It's It's ustekinumab is

So it's indications it. any could you drug, that entire pursue you will. And if with

CD, So psoriasis. or colitis ulcerative

that with the also from us rights perspective terms implies, clinical and think our taking there and is doing but implies is relationship an interest development valuable commercial I we're Celltrion supporting the commercial potentially what In what in of in over as well. Celltrion, both from

that we deals, with will is look against data, pharma us them to I flavor more things potential as be ahead to think compete think And done. are companies could working as be less enable there how the of we opposed a I inclined to additional this to as generate us.

Thanks. great. all on Congrats Okay, Thanks. progress.

you. Thank

stand you. by Thank Please next for our question.

the line Annabel Stifel. comes Our of with next from Samimy question

line Your open. is

for Good Thanks taking Thanks. Hi. my progress. questions.

further they're repeat doses. as the dosing X FDA So of or on an how for Thanks. of Phase XXX(b)(X) contemplating have I there dosing the secondly, for or offer bioavailability is sense trial And metrics And was the XXX, as that do the before trial any three X regarding this Phase primarily think Do looking success? any that negotiation. like for right or requirements discussion timeframe, et range, it then it up key Celltrion large design you Celltrion need cetera, delivery pathway? seeing you're first with a of is partnership or again, are you far the could for be, concerned different option about the the you

Sure.

of study So the It's Phase bioavailability the not particular for is showing Phase biosimilar. a ustekinumab to RT-XXX use their we probably X. do should the [X.X program injection of repeat to we dosing and doses need subcutaneous beyond complete the X. mig] as CT-PXX a nothing X.XX with There to in that single mig similar a for dose

looking for, think like I been everyone's as what what well. that's demonstrate would we to

administered really everyone, us has remind to monoclonal of or systemic orally just bioavailability antibody. an anyone time the able And this first been to demonstrate be would

milestone get big that's the the interest garner into think from we to sufficient period. Celltrion a is hopefully for I as this So option company and

As far terms be concerned, X endpoints. they is we looking RT-XXX ask the what see would the design biomarkers. want FDA we're And as did in of to going to at Phase

So PXNP eight duration the and to likely and CTX is be going weeks.

likely would BMD be You biomarkers would those And we a separation Phase see looking then fairly from we X where endpoint. on for as planning there, start the can rapidly. at

much. so Great. Okay. Thank you

Thank you, Annabel.

standby Please you. Thank question. for next our

UBS. question next Our line of the Verma Ash from comes with

Your line is open.

two. taking for Congrats the so have far. progress Thanks questions. on I Hi. my

planning Phase X XXXX. was just, in that one the you're right study So on

imagine the do of we completion year, kind can you should of kind cadence then of RT-XXX timeline X these And be that the So you comment second, anything of quick, compare for you can Phase I how single that to on OpEx the Thanks. half what versus would 'XX these relatively in in given plan XXXX? OpEx for the expect studies? like think would dose initiate second study,

Thank you, the questions. Ash. Appreciate

bit correct. I RT-XXX RT-XXX single than It's is just relatively drug longer to of take the The the longer. is half-life get short. significantly are will done. Xs because a of these that months matter for say Phase will a dose You them timeline

full with enroll last that help track year the is done that of getting much hoping is it order do fairly all that longer. an not So this the a will as healthy recruitment fairly if a in so. bit incentivized be curve, being for was but plan, able and and hope is But to straightforward, get And to also have not patients study to we're it with should you we issue quickly are to as a early we as COVID well. volunteer quickly

second Svai going to your answer. Sanford, our I'm to question, over turn to With that CFO,

hear everyone Thank Talat. you, me. Hopefully, can

Ash, cash I we XXXX with our filing, thank XX% for -- OpEx the you the for you increase our portion to expenses ended, will that million. the as just see the of expect year. XX% in ended in can the We non range XXXX $XX under operating last question. the from with of

Great. Thanks, guys.

Thank you, Ash.

Thank next our you. stand Please question. for by

Our with of line BTIG. next Bert the comes Hazlett from question

open. line Your is

that think Yes, to Two kind X? beyond a is thank prioritization with general. One of And you all program? you. are there progress. the of you about and CT-PXX, on about you topics indication taking Phase is Celltrion. regard as the RT-XXX with Thank for Or the congratulations steps question the development how development in of thinking

you. pembrolizumab, how prioritization with second thinking to of types you regard of of general molecules? maybe question then whether you question that mentioned Thank is would Just about monoclonals thoughts kind trastuzumab those others, be that's are of And prioritization similar the a helpful. there or

Sure.

a question, Bert. great it's So

First the off, questions. thank you for

figure will would be disease, Celltrion for read It to time CT-PXX, and RT-XXX in Crohn's decide run I are our cost, be it would proof-of-concept And determining also part to to imagine. prioritize. discussions PK plan psoriasis the to of out doing trial whichever if on right there's from the how to we regulatory terms the to indications. of with we we're now what and In either other

but provide in time, guidance X this have So study. volunteer can't that The healthy we around moment at time. a Phase is

early we'll So share we'll year plan to around and kind coalesce year. that the of this take next

a diseases, I monoclonal what delivery that, what where with siRNA. to is general crowded HC, the oligonucleotides of sweet area immunology as exploring spot the tremendous. doing, this to right a categories oral terms at RaniPill year. for we're In do are with antisense chronic in planning and think of in could We're differentiation looking the antibody we After be that discovery we're

And I would like to look the in future.

think this in of increasing and I efficacy drugs past. in certain the administration there's daily about monoclonal if if serum Bert, talked evidence levels, will, past that C of trough antibody, you the the with we've at, improves some

would to oncology we a with look oncology, want or standalone of So or like maintenance an evo. as one to it's at pembro whether the a as that popular drugs

for So that's next year. maybe

as we're RaniPill We about but plenty is thinking of it have the on that's HC. utilizing how our plate now, kind

it. Thanks for Appreciate the color.

Yes, absolutely. Thank you.

stand Please next question. by our you. Thank for

Kapoor from Mitchell question H. line C. comes last the with Our of Wainwright.

Your line is open.

trials you Hi, that more you've be considered of to the wanted everyone's profile probably which PK the and I out terms PK for still have we to look established margin should, team. I if the in a moving slightly about understand wanted with PK, thanks expect RT-XXX this Hope a think follows that point at start could you and it do taking positive? different next forward well safety in of way would -- efficacy questions. for and in

Sure.

the dose. significantly dose, and questions, And a between we for micrograms, looking doses multi Annabel's had, you're our I or to both I our address that didn't the if in that specifically So failed at just well, you realize answer thank incidence in so multi in the XX the Mitchell. compare question, had I'll XX which and we're even single better growth, would -- asking AE question bone shot. XX is same I XX, getting you XX that so better dose do we and We're in to caution of one lower and

efficacy -- the the the single the study dose, even selection, from that Rani you AE oral rates, But where to in versus Phase non-inferiority through the microgram cleaner safety sweet think what or perspective. find XX in currently. X is an commensurate look spot the with for microgram profile But the conduct at it XX that have should compared dose need we we and the I see to a need Forteo We I with say. looked we AE Forteo the can

Okay. we going the helpful. just might And when see the be and on you plan forward? then there could That's what update program an program, development provide able more to could RT-XXX that from or very

Sure.

working program. So into is PTH as the our past, mentioned in formulation. RT-XXX that's sustained the we're I on going release for a technology This hypoparathyroidism

why We like be considerable competitive in X. to going that long we're working it is into our a same for acting Sandostatin to more Phase which have with with so it's -- reformulate made roadmap is our year progress, approach LAR. that formulation a it's And what RT-XXX on this

in So moment but that's to revisit this we'll think report something later at I year. this nothing that time,

Okay, great. you very Thank much.

Thank you.

like remarks. you. showing I further for the turn questions back in no now would to Talat to Thank call closing the I'm queue.

XXXX results Thank conference call. this financial concludes joining our quarter corporate full for year Thank us afternoon. and you update operator. and fourth you, This everyone again

call. this Ladies for today's concludes you conference and your gentlemen, participation. Thank

You may now disconnect.