SLNCF - Earnings call transcript Q4 2023 | Silence Therapeutics plc

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Operator

Good day, and thank you for standing by. Welcome to the Silence Therapeutics 2023 Full Year Results Webcast and Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to turn the conference over to your first speaker today, Gem Hopkins. Please go ahead.

Gem Hopkins

afternoon, good and morning everyone. Good joining Thank today. you for us Vice Investor Relations name is Corporate of Hopkins, Gem Silence. My and President Communications at

on our R&D, provide our performance Chief and Craig who are Officer, who who will update today's Romano, our President programs. Financial the clinical me financial review on Hellums, CEO, an will on our Tooman, Rhonda an business; Steven update will and provide Joining our call Head of

slides participating corporate via accessed conference For can those accompanying Investors our be going the of of website the to you by call, www.silence-therapeutics.com. section at

timing Slide remind future our call, other today's capital and cash and potential I'd and therapeutic performance or to Turning plans operational projections statements development, projected forward-looking X. financial like company product our business events anticipated the milestone anticipated of strategies, you that or runway. the make prospects and will objectives, clinical payments, to candidates, the during anticipated regarding expenditures, future operating including management of

results discussed Actual of including with from factors, SEC. these by recent important various a indicated those statements the those as our report forward-looking on result most annual file differ in may materially

such to forward-looking call recording With as as the of only our represent date of statements. that, date. We relied turn the subsequent any I'd Craig? to over obligation this any views update representing any addition, and In to be statements not views like should as upon Craig. our disclaim specifically

Craig Tooman

very XXXX. what we year Gem, ourselves for and strong being Silence for us a execution setting you, joining today. XXXX Thank welcome, of data-rich was a everyone. and you in Thank up year anticipate across

moment. patients II Zerlasiran to this positive But In we first, morning fact, to everyone a XXXX. want discuss which what top accomplished in line Lp(a), just data remind Phase announce high in will in we were I more pleased we for with very

remain commitment focus our proud clearly and of clearly company broader While the to and promises to market, the bearing very very We relentless this a was our team's I'm today. deliver both fundamentals shareholders and focused is fruit challenging of on patients. on that our in year the our

Looking enrollment X the Phase and the LP(a) highlighting completed unmet high we Zerlasiran growing Zerlasiran. the back in for medical program just months excitement II need in for over community year, from our

We also reported high dose and the patients Lp(a). ASCVD from positive multiple study APOLLO data with in

You'll reductions we days. of which to durable Lp(a) saw significant up XX%, was to out recall XXX

think we well Divesiran an Zerlasiran, address. made to addition is clinic SLNXXX Vera the for area In that advancing siRNA in we Polycythemia This Divesiran progress and are or or PV. particularly to great suited

The promising. ongoing is to emerging label, look Phase continue open I data the and study

year, During across milestones our in also collaborations. we the our Hansoh to million portfolio, and achieving AstraZeneca between execute partner continued $XX

with clinical have are program we pleased a We that now particularly AstraZeneca.

programs, our While are being lose primarily XXXX a clinical not focused understood was of that we advancing sight we did platform increasingly on the company. as fact

in best-in-class While see or in we our of made to our where successes, we been investments unmet also clinical strategic very high need. opportunity be areas either have on early-stage clear efforts we focusing projects first-in-class

is complement buyback Mallinckrodt assets our of a of The example from that. great

our to Our evolve strong we driving Partnering a that's interest. multiple has results goal advancing area partnership facet key will continue always programs, platform expect is new across of been in and considerably. business an

so our We've for with high year. priorities. made already far each Starting lead strides and our to Turning XXXX pillar Lp(a). proprietary Zerlasiran clinical programs this great against key strategic

Phase in ongoing Zerlasiran profile and data were XX-week this we with from study summary, for competitive more As patients in high I I topline reported reductions mentioned, consistent the positive with in discuss II But Lp(a). support Steve Phase today, results will Lp(a) a activities are to it worldwide to people to the bring are to III ensure planning to fully up potential positioned as of patients of we living soon high-value and Lp(a). needs well well this potentially billion asset underway X.X as the Phase possible. address maximize with detail.

We the are Divesiran equally ongoing PV excited study. about

I data is the look open and study mentioned, the emerging label promising. I Phase As

Our enrolling on and report we done this overseeing of job by are has excellent this team and year. an data to trial June track

of opportunities. as of On February, to synergies the with first gold partnering triggering our great to milestone platform our payment we $XX development great and unique enter pleased can candidate side, collaboration with us. I is are mentioned, another clinic a in under product million a the very example productivity how partners create the This AstraZeneca

advancing committed and current to pipeline. clinical we our proprietary expanding our programs, Beyond are

our at look a proprietary pipeline. Here's

to and addition working undisclosed the the are outside targets us several on with X other region to programs. assets, owned that complement X Zerlasiran Hansoh China we're have In Divesiran undisclosed wholly we the and programs, that

been company. have sRNA and extensive decades for always has a Silence been developed in platform in the X We've over IP. arena know-how

for potential a We to now with and are see produce clinical fruits starting programs that differentiated of our labor Divesiran profile of is to pipeline emerging. and Zerlasiran platform the the

we this We platform. do we what believe technology are of the stages can with early at

generated We talking as more look portfolio get about clinic. data other encouraging to they preclinical across closer to forward have we programs the that

financing all underpinning this a sheet following we strong the completed is in Importantly, $XXX balance PIPE of million February.

a Rhonda turn the of for our call I'll that, financials. With review to

Rhonda Hellums

Craig. you, Thank

in partner million XXXX. December XXXX, in in ended million our programs. XX.X GBP the driven of of GBP targets increase primarily recorded advancement was the million The versus by XX.X GBP XX, year revenue the company For X.X

As the contract collaborations a revenue record completion. of our from percentage reminder, based we on

nominated candidate, this year, receive another auction [ the Craig mentioned, million received the and clinic, In we will to milestone. we our million advance $XX a fee. February As collaboration of product ] XXXX, that continues to candidate entered AstraZeneca $XX and In nicely. first AstraZeneca

from XXXX. our achieved million programs X X We also milestones advanced of Hansoh and those $X in in development targets

we Under our the of collaboration, March. reacquired assets will preclinical you Mallinckrodt last X complement recall

the the of revenue the collaboration. we the Mallinckrodt month, contract completion I result, XXXX. modification not quarter Phase X following pursue revenue notified to was development will remaining X a further Mallinckrodt this they GBP commitments first revenue in us million of SLNXXX unrecognized that assets. This conclude unrecognized will and Any when This the recorded the will adjustments collaboration As complete cumulative under all of be recognized study. for for those under an activities catch-up

during GBP million as programs, the XXXX, to as employees' we are in expenses dedicated recorded of royalty Finally, these The our Island approximately in the from an are of XXXX. GBP [ partner attributable XXX,XXX portion programs XX.X sales expenses were revenues. time to these recorded cost These ]. our to revenue related including

XX.X XX was primarily increase and R&D to XXXX. GBP million rose This expected, advancing costs million As in to in XXXX proprietary due Zerlasiran our GBP program. versus Divesiran

expand invest our pipeline. also our of strategically further to targets We in new identifying and proprietary development platform further

of and related noncash costs GBP granting million to XX.X XXXX the result share-based GBP XXXX. share The General a options. versus million XX.X administrative primarily expenses in increase of were employee in was

clinical prudent of versus We is as continue XX.X The development. advancing in of net in in our to our year to a XX.X loss increase small XXXX the the loss GBP The of due spending. company's be GBP R&D in result our million in net was a programs for loss net full million increase XXXX.

the approximately XXXX. company's $XX.X at The of were December end million cash cash XX or and million equivalents GBP

placement million. As resulting ADS at to $XXX $XX X.X Craig pleased private in were mentioned, per proceeds of an approximately ADSs announce of million we gross in February oversubscribed

to group shareholder biotech We have top-tier are of investors. base delighted our expanded with this

we over December We in with XX, $XX our in our also of our million balance of at Together January million. additional from ATM. $XXX raised cash ADSs to increased in cash an have XXXX our proceeds sales XXXX early under significantly

our we additional to as will continue collaborations we anticipate advance, Further, that milestones. achieve

estimate will our runway As now already into mentioned earlier, $XX million that cash our XXXX. achieved extend we early XXXX. have in We

investing targets. We expand platform that responsibly be will pipeline advance continue in our to committed new to our in initiatives and

that further our We could additional cash additional runway. to provide also evaluate funding non-dilutive continue and extend opportunities partnering

With that, Steve the over to update. turn a I for Steve? will clinical call

Steven Romano

Rhonda. Thanks,

mentioned, a to Zerlasiran profile living consistent study believe ALPACAR-XXX Craig high the levels eventually for this Phase ideal for we of and from clinical III with Lp(a). patients Lp(a). with treating positive high Zerlasiran that As into data topline morning XX-week were Phase we demonstrated has advancing II announce of in is pleased patients

Just entirely a world's age with is risk risk and This XX% Lp(a), familiar the LP(a) level can't High as stenosis. factors, factor you of be Lp(a) it associated heart of determined. affect It's almost the exercise, with those diet other stroke for key this around genetically cardiovascular that X a population. is same attack, by is is risk a modified less is of of or quick XX. at the considered age at to high means cardiac aortic reminder that unlike your Lp(a)

You high Lp(a). need pharmacological manage to intervention

excited why . Clearly Lp(a cardiovascular that's There major about are for no need and is approved Zerlasiran. currently so unmet the disease in selectively lower potential therapies this a we're

factor cardiovascular the Fortunately, Major their recognition risk societies are is guidelines. in key now including Lp(a) testing Lp(a) growing of as a rapidly.

awareness expect to particularly coming available. in therapies new as even the grow We years, more become

Now turning to program. clinical our Zerlasiran

liter. study, Lp(a) nanomoles what with I saw high Phase equal healthy in evaluated to we per First, want the remind In XXX APOLLO you we I program. or single-dose to greater volunteers than

again, explored days, effective, a durable study, Here, to dose and XX% need study we repeated and well at can patients well doses high very period, Lp(a) up Lp(a) single-dose tolerated. also XXX at Lp(a) to we up X-month the the effects effects doses. the ASCVD XXX The reductions multiple dose reduction durable and dose very we study. evaluated we following following multiple over substantial achieve reductions We with effective, don't persisting a tolerated. dose single a Lp(a) XXX-milligram In in with showed XXX-milligram and XX% saw with persisting saw

morning. the XX-week we ongoing topline to and study data positive ALPACAR-XXX II reported Phase the this Turning

a liter. nanomoles or with XXX at enrolled nanomoles XX administered or over of risk milligrams was weeks levels patients XXX Lp(a) As events. subcutaneously at approximately liter every subjects study of milligrams a XXX XXX weeks XX high median every and at XX reminder, Lp(a) with per to per XXX ASCVD baseline the Zerlasiran baseline

want data today, looking at only emphasize the we are I that for endpoint. primary XX-week to

study ongoing. this is designed, XX-week As a still that's

Lp(a) change XX including other and still baseline endpoints, are lipid to on XX proteins in and week being week potential effects lipids Secondary from evaluated.

XX% Median during pleased demonstrated greater No XX. for reduction baseline new tolerated. of from compared in we to concerns significant treatment observed or continues XX. both reduction were identified the be a Zerlasiran this at in week and study period. safety endpoint its doses Lp(a) well highly placebo to Today, to Lp(a) week at were primary are very report percentage met

look III. data These the the regimen preliminary and for we're Phase we dosing data support quarterly dosing confirm about potentially line, II modeling review Phase before emerging to XX-week and longer. very We need Bottom at least updated We excited forward consistent profile are reviewing second data for and which the Phase patients results this the high with XX-week data, to competitive in of I a quarter support year. treating Lp(a). expected to with continue

This really that's to wholly we're of What is silencing potential Vera. program are our TMPRSSX, this body. negative a and iron dodging Divesiran, currently of regulator to master a focused We've the a owned benefits. second for healthy proof in production central modulate and siRNA to hepcidin demonstrated disorders. works Polycythemia of volunteers regulator the Divesiran range like therapeutic Turning a by of about hepcidin hepcidin. mechanism has in targeting we pathway on hematological

major XX% than XX% thrombotic major XXX,XXX is a cardiovascular around blood of is rare The XX% hematocrit million to less more the maintain die of to people events. likely X.X from and unmet disease. significant to Patients treatment Xx around Elevated needs. affects between hallmark Vera is reduce and worldwide. in and U.S. thrombotic with or disorder the people causes hematocrit a goal events. are PV cardiovascular Polycythemia with hematocrits level

of iron reaching can This and designed inhibit may are the adverse standard therapies effective delivery is is with marrow. be repeated to at this. expression to be reduce Phlebotomy patients at bone deficient also care. are not and significant used PV, associated and to Phlebotomy iron exacerbates TMPRSSX events. In current the most hepcidin diagnosis, is Cytoreductive burdensome Divesiran but control race

red erythropoiesis Iron reduces production. resulting in cell lower restriction blood

volunteers. was increased by iron healthy which we about period, effects hepcidin mentioned, reduced I serum study, Divesiran persisted at up for single dose. of The was showed in months, tolerated. after to and and proof a this In fourfold study the Divesiran XX% well least mechanism As X

Phase kick study made San progress I/II great As Craig the Rico year. to pleased PV throughout were the enrollment and with January we mentioned, have last off

including as open-label we currently a study. controlled. X-part study, followed will in This is a study. We're Phase I those I Divesiran In study. are a Phase hematocrit be II patients a Phase well this that who baseline the high are Phase range the PV well testing with in is as wide I and of Remember, by study, those

effect. to dosing is here and goal about as much possible the therapeutic as learn So

patients clinical this Phase of are about the study and looking in All we're nice outcomes, is thing entered phlebotomy-dependent. I, phlebotomies. maintenance including of the even number the in program The hematocrit at well-defined

and the So are publicly this is the end see of can mentioned, presenting forward encouraging. these We as an look data open-label Craig sometime before data the study, data emerging to June. we

As orphan drug I'll track a fast that, Craig. back turn designations and PV. FDA reminder, the Craig? has to Divesiran call for over With

Craig Tooman

Steve. execution Thanks, is programs. exciting XXXX poised positive We announced QX, QX. in and an followed remain all with Divesiran with be track study This a data year of all and morning, Zerlasiran by team to data XXXX data our data PV we from for June. delivered II was proprietary report topline patients about on XX-week expect Silence high the to fronts. on clinical Lp(a), in the by in we Phase XX-week XX-week

potential substantial for like over I'll diseases pass look a our operator of forward thank mRNA questions. back today, everyone ahead. your and listening to platform move GOLD see for the as range for across I'd we communicating We and more genetic to to

Operator

first comes from Stanley. from line Your Ulz Instructions] the question of Mike [Operator Morgan

Michael Ulz

a just the Maybe data. data. the on related Congratulations question to

If curves doses. X the maybe could potentially the provide color between on you additional

looking one the in will What then out decide for sort results forward And stands waiting criteria data? Just you dose to curious which if there mentioned you the with. also to be maybe, of relative those go other. of to kind Steve, XX-week for

Craig Tooman

Steve?

Steven Romano

Yes.

So question, thank for you Mike. the

all, of time is measure, what was let's primary First here baseline. presenting the from a just which we're change remember outcome average

of any regards yet in with the a have a space endpoint. reference details this to sharing rather data So companies that's is the believe because other to don't change. very not significant endpoint, and that novel We're revealed this this I

from preserve research XX. was the at week share week going for But between remember, later median an baseline we're to that this interval. year. upcoming change So did we meeting What we're XX, at

But and remember, So here. ranges XX XXX, we're X-dose weeks we're them weeks. XX testing and testing we're testing a at XXX but

in So point, is point time average which evaluating change that is between primary the for time XX-week intervals. the

wait And to as this to is why we data see well. XX-week need

Now many clearly, what before. and remember, I you I've can to this say talked of very about

data our forward modeling our ongoing the look the to multiple single of in III. order our all make data to data best dose at make update We PD sure PK to to the are ascending, from and going Phase the and II we going choice Phase

tell between you this later and So much research our more a of really greater confirmation suggesting, year. the we'll as get I dose about we'll preserve for that in can't lines, too the differences were meeting range and you

a We it's are is a that confident and well-supported XXX require that. dose, will unlikely dose milligrams above

Operator

question Biliouris next Capital Your line from Kostas comes Markets. of the from BMO

Konstantinos Biliouris

couple A very program. One, on Congrats one of us. and data. PV questions Lp(a) the strong the on on the from

maybe inform any to Phase information that one the provide can better previous the design? help program, Lp(a) compared new data you the On III that these

And around then program? be here? the given thoughts recent And the activity we promising. Takeda that In a additional the question. the to PV any you the PV release, for partnership, see you that referring to PV the partnership twofold Protagonist data the mentioned around color on PV potential with space the that press then look in Any parameters the continue may side,

Craig Tooman

Kostas. you, Thank

Phase dose dose Let and me consistent this about just say and mentioned, I the is that the thing Phase been technology as now consistent, and it very multiple single it's amazing II. Steve the across how is,

the new has been also So very, intervals doses, insights consistent. and the we gleaning very it while from are

on that. expanded already Steve And

are have we that we've to PV, end others with of is studied mind. this of closely. terms at looked very in aware data it very the that looking hand I'll over our Steve, and of points you. And in arena, categorization good In our

Steven Romano

Yes, sure, for Kostas, Craig. And thank questions. you, the

so top relevant it's we So looking are actually when in clinical mind. study, maybe of since start it's this PV, Yes, say it's with outcomes. we because I'll evaluating promising,

Now it's observational.

number at inferential is can as phlebotomies But doing of stats Phase the maintenance we as what the I. not we're look of So hematocrit. it's because well

at of looking those. we're So both

it say efficacy. good, of because X we're continues we to those when look indicators it's So at looking

So months. sharing forward fully data really over next we look to the more few that

really Again, the the and in of dosing directly array one. that's the brackets with a dose test data at I've from the remember, XX didn't intervals regards we look said think this see the dosing of going XX-week it across which across to weeks, important. Phase Lp(a), best the before, intervals. I'll I And because getting single/multiple choose XX and broad as and range you it's trial, II, we're is because repeat which and to We're the important looking

we dose data. this data, to a XX-week to with to dose XX-week So progress really infrequent Phase QXX do need interval QXX, we'll important importantly, which But and confirmation we to PK/PD relatively that of given data modeling, see, as specific do more want going with a and we'll we'll will our a be and that III. continue we've that since update in XX-week the an we choose

Craig Tooman

a for comment partnering on PV. just Maybe quick

likes are that We very a company much. partnering

out. data, with programs but and very are new just exhibiting are at partnerships to are and Our the we happy current those look way partnerships, continue also proprietary playing obviously excellent

are PV are partnering Silence we that we in that area very also be and pursue, in interested that companies is to as and an build. But could there can that we well. have parties us ourselves chassis believe, the honest, with

look of that continue we'll to portfolio, So the mix. as part at

Operator

from question Trucchio H.C. Patrick from line next Your of the comes Wainwright.

Patrick Trucchio

Congrats today. on data the

me. of Just follow-up from a couple questions

you to a find or Phase your forward? this would potential this a intend III program on own move you us to ahead maybe ahead look do look we III? collaboration Zerlasiran, as program partner can you of Phase to Would is, how first tell The for

something the potential with do And go -- end the SLNXXX, separately, more separately, strategy you with can your II Mallinckrodt not discuss wondering a with data ahead forward? data? moving And then And can why wait to move need partner with Or complement meeting this decided program, XX-week program about on the the Phase for broadly, you was longer-term ahead or FDA you a or I'm then? before the decision? strategic Or just data? to of a the

Craig Tooman

know, yes, And SLNXXX, recall that. pursuing today, believe So reverse let we assets order announced the that best did and actually start not year were you'll you it know let the we in will be that bought we me as preclinical of that X Silence. us back for Mallinckrodt fit last

on We and like Mallinckrodt kind a always sides I'm at of, and both kind been now that saw data and for portfolio of It's the very us, Steve, view you a been view. a you've portfolio comment are us. that been spearhead that have Maybe complement. on preclinical much. you've of with

Steven Romano

Yes. the we, as are X Well, back assets, data very only know, that which preclinical you of good. brought very,

the as X portfolio So is a house. this line brought as even at those opportunity we've back in assets looked we bottom always

CX move in are competitive we'll for the actually may the I'll And we've in targets preclinical over as to that those, with is a disclose We areas, opportunity time. speak considerations us CX It's feel additional which competitive area we which clinical a development ourselves for disclosed more targets, be space, forward as and nonclinical evaluating space. actually The competitive. give Silence, complex very the like area. not we

Craig Tooman

III and steam with this tested is something for Zerlasiran, of great KOLs I some tell a to for we've planning protocol that year. full the team external This that also In with we're over development We've clear you been our and Phase be ahead. want advisers. terms

very, in we're that. good planning very like the for of terms feel we shape in So

on of And just In touch you then, touch maybe for protocol that. as terms well. Rhonda, conviction funding want that, you Steve, of maybe your the want to the to on

Rhonda Hellums

Yes, sure. Thanks, Craig. Yes.

are of course, with ability that we to year, did forward. the we that in -- have the we of anticipating move we So the raise this continue that to beginning

actively are we looking different earlier, mentioned at Craig partnerships. As

also So other program looking this very specifically, but been programs open partnerships as well. we about have at for

we program we so feel keep momentum that to need this we like advance this to the So continue we resources have can moving.

Steven Romano

just I'll suggested. And Yes. as add, Craig

of couple a Just comments.

as your We And as in cetera. the the of are field the well talked III protocol. input leading of got I many advanced as with well Phase to clinical by great et we've you design of about, trials, experts experts, regards renowned to lipidology

confident. we So feel very

opportunity Phase And where inclusion fact, through really and of specific ability for that's we types are from potentially be the to include III. could our compound feel read exclusion, to data The that patients the the for to that we others some into in of distinguish label. advanced criteria the currently

Phase thinking nicely. best we're how III to position robustly So but that's advancing our program, very about very, very

at reference into but And well, someone as have I we'll because we dosing our well it, will that with -- strategy asked that time a think move phase data we'll of will piece going of move -- agency. point I had trial. I design the the discussion the XX-week think into that confirm And a help important wait, we final to as this information an and forward is as didn't

feel in we've very way. the and to made that differentiate about we good opportunity So the progression

Operator

the comes William next Company. Your & from of Myles Minter Blair line from question

Unknown Analyst

data. Myles. on got for Congrats You've Sarah the on

achieved levels per many in XX can associated patients XXX on group So how that per guys liter nanomole Lp(a) threshold nanomole from risk? below cardiovascular disease each dose you liter comment with us, and of kind

Mallinckrodt reacquire Or just like guys kind SLNXXX. other of done quick you targeting on And of Would on some assets? a the assets you've do clarification guys look currently feel rights you're from moment got? complement then with guys those back with to at like the what have good you those you

Craig Tooman

made we say of and assets X order like brought that arena X brought and competitive ourselves really the size we in we the before reverse we it from those for again, for determination again and that just So that review that in-house. let upon me took and when those portfolio XXX, Silence go is in the

that. on expectation further no So

not we of segregation I'm of without to quite -- you. but what the say the query, terms can And data, over sure in Steve,

Steven Romano

meeting, that need some details, we'll we for of unfortunately, can't We'll hopefully end of on research preserve certainly yet. summer. Yes. those obviously, -- this No, share by year, which later out presentation information of to do we the a

more in the that share information we'll months. over So detail much coming

Operator

Your from Instructions] question Chardan. [Operator next line from the comes Nakae Keay of

Kaey Nakae

the we the So ESC? to that could data, scientific of meeting should guess present terms in it be

Steven Romano

Yes, be that would a reasonable expectation.

we'll the that near confirm future. So in

Kaey Nakae

then commencing into And about include guidance what we Great. on does of runway III? in Okay. when think Phase terms the the that on 'XX,

Craig Tooman

Rhonda?

Rhonda Hellums

Yes.

So prep we do assume does of that that some would some from that include current we programs. would additional continue kick and does our that off, collaboration Again, anticipate that. to for We that. milestones

that runway So as is in included well. our

extend any III. would that we again, partnering we look off a will, the first. But Phase non-dilutive that does continue kick runway to course, assume And of funding opportunities [ that that with further ] for

Operator

currently are no call hand the closing further I back There questions. will for to Craig remarks.

Craig Tooman

performance extremely Well, results. our of XXXX on and this all I'm thank joining overall for call. you proud us

a beginning we at look call, to a you, and As with our of a building I you up platform that of year. on very XXXX what And company, as this great Silence be us the progress. expect to for Thank we mentioned updated day. forward have true set keeping recognition data-rich

Operator

you This you. today's Thank participating. concludes for call. Thank conference

You may now disconnect.

Silence Therapeutics (SLN) 13 Mar 242023 Q4 Earnings call transcript