CLSD - Earnings call transcript Q2 2019 | Clearside Biomedical, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Second Quarter 2019 Clearside Biomedical, Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call may be recorded.

I would now like to turn the conference over to your host, Ms. Relations. Investor Clearside Kobin, Jenny Ma’am, you begin. may

Jenny Kobin

Thank us on Good afternoon, everyone, joining for you thank the and you. call today.

indicated Reform materially Before will those Risk forward-looking a recent like today’s we differ our our the prospects other factors, results we to remind plans of March those future XXXX, XX-K forward-looking of result available call purposes of XX, constitute this filed website. you filings as SEC Actual most would Litigation begin, about December may Form and and that make the by statements Private on during call, discussed be Act XX, these Various with statements. for XXXX, we various important ended certain SEC on the Annual XXXX. making from our Factors and remarks including that forward-looking of Report expectations, for I company’s on the year during Securities statements in section the

In statements represent representing as be any should views addition, any and subsequent relied as as views our forward-looking of not upon today date. our

While specifically any to we statements so these update change. do views if disclaim even our obligation future, the may to in elect we forward-looking

will R&D Lasezkay, provide George highlight. On today’s Medical Tom And a Dr. of provide Deignan, summary. and provide Officer a update. financial will Board member Charlie Chief Chief call, our of Executive the strategic will Chief Officer, Financial Directors, Ciulla, Officer, our our

is questions. Q&A. available with and Raymond, We us for open will our Chief for then also Commercial Officer call Brion the your today

over call I turn would now the to George. like to

George Lasezkay

on and everyone, the thank Good call Jenny. joining you, Thank us you morning, today. for

to working I’ve months, with of the team overall strategy. four company’s Board the our last the reevaluate and been Over Directors

out-license in that than globally rather own. to it rights order value concluded expect have on to our XIPERE, commercialize the we of maximize We

to review partner, treatment bring edema partners, will for currently of that able a associated be effectively XIPERE market and if more or We efficiently uveitis. the approved. believe FDA cost macular XIPERE is to under with it’s

out-licensed to but will future only partner to to indications XIPERE We XIPERE rights engage expect do not macular the if partner product, any diabetic of development the as edema the other the elects that for clinical deals such also so. the in rights commercialize

This it number the R&D to has strategic and royalties, in payments, shift term. Clearside inherent to and and pipeline. potential and and ways investment lowers a related in eliminates manifests via internal milestone-based non-dilutive expenses maintaining near future infrastructure of a risks building the to commercial potential fund access It and our with used be may provide upfront to Clearside capital the which

We thus far have this process. taken important steps in several

world. discussions XIPERE as ongoing well potential the both in most partners the the U.S. markets rest in with are of of in as for major the We licensing

on reduced and helpful significantly a our be We by only have focus budget successful a commercial to ensure few to items finalizing a remaining critical partner. spend should future launch that

a secure will extended Our XXXX our shortly. to will Chief significant for runway in and team member who transition, experience of products into launching discuss which With our Brion we more Charlie commercializing of ophthalmic XIPERE. this quarter management as partner we has Commercial remain detail cash the in have senior Raymond, third Officer, a work

payments from companies use Aura by sales suprachoroidal injection area the ophthalmic potential upside other This announced platform significant need. and medical a The cancers, that the applicability into also may we Last our drug space an royalties. our their future suprachoroidal month, ocular for to where candidates pre-specified treatment Aura agreement proprietary is with of financial collaboration drug of there Clearside in licensed interested SCS the Microinjector Biosciences deliver delivery. proprietary provide licensing milestone demonstrates for for unmet

can broaden giving of development us strengthen which agreement, we research and Aura provide our capital the the and program potentially platform with to As the our interested pipeline. our means non-dilutive build company product external reach collaborations the internal are and additional to in own

benefits about the educate suprachoroidal of office-based nonsurgical, and XIPERE gene procedure. to physician including therapy the our targeted, into therapeutic Microinjector delivery continue agents, We various repeatable space of SCS a the community via as

call I our will over Tom now turn Chief the Medical Officer, to Ciulla.

Tom Ciulla

recent Thank development comments to scientific key presentations. our afternoon, activities. I’m with collaboration, current you, I my three George. And our will going and our presentations, this highlight partner new start topics, our

five physicians Clearside leaders. As with platform. suprachoroidal the a presence our retina ASRS of injection related Specialists Annual strong American George or educate mentioned, by we at to given on Retinal continue We recent opinion presentations to Meeting had Society key

me you insights. the Let give

Dr. walked studies thus slide video of Kay injection. gene work discussion our presentation far through a we Christine done nonclinical XX-minute is breaks available suprachoroidal via video down describing website. listeners concise, have our therapy the First, easy-to-follow page the The The of a publications manner. in on

a We oral are targeted we an as in look suprachoroidal experience important of clinical with that for conducted these SCS on our Dr. your drug to noted partner presentation Microinjector SCS Next, believe proper Shah plans. as delivery our post utilizing by physician’s development the can injection. and Dr. observations a Shah easily be the gave techniques, Milan potentially office internal XIPERE injections to useful, segment expand pathologies.

importance gains uveitis of and Merrill all treatment significant Henry anatomic potential visual were on presentations each in emphasis due subtypes. that for statistically edema an oral fact with the the macular XIPERE on the to Additionally, Dr. achieved of Pauline gave Christopher non-infectious

Dr. finally, with in needed aflibercept with was monotherapy. presented XIPERE versus that when given edema Phase macular Ip showing from DME visits or trial combination patients were aflibercept data Michael treatment diabetic And X our TYBEE by fewer

in two Clearside uveitic edema journal also platform. professional in therapy meeting. Ophthalmology injection feature Retina macular and to and gene Management. and were a continues suprachoroidal the our This build positive of awareness opportunities Importantly, several delivery article distributed of this suprachoroidal the featured articles journals official during the for and Altogether, in Times ASRS, included recognition

disease why like of common is most promise eye. is for you about well the with licensing accepted in radiation topic, Now patients which retinopathy why choroidal with radiation metastasis. even excited our the moving with There for it technology. for no primary patients the And removal Aura’s fatal serious is can I and we share important currently Biosciences, to the treatment clinical Aura due a melanoma, tumor lead program therapy is intraocular these that or the deal the loss are beyond for liver adults. is disease and visual a primary would on of treatment to to treatment, result in or next

Aura’s the delivery of alternative candidates concentrations and areas. enable a is dose Microinjector delivery proprietary of SCS may drug Our choroid nonsurgical to anti-cancer with the lower higher adjacent drug and of intravitreal to

for impactful an expanding As a I believe retina technology and treatment setting. patients, into could our validating reach further oncology this specialist, ocular of our the yield outcome the platform

to update, increase overall to been has for our the development value XIPERE team Moving potential working my partners. on for

During had Medical a the uveitic a and Devices registration macular the supporting forward quarter, we XIPERE Union. edema positive for for Austrian in Agency meeting path with European Medicines the

We with focused that gene future our our efforts around be forward and have Internally, could potential U.S. on advance dialogue the delivery therapy are DME monotherapy XIPERE and to research discovery also FDA. regulatory program. used nonclinical in path performing explored experiments a

injection novel diseases. in the common to platform are also unmet may show retinal exploring We address that prolonged molecules small needs duration SCS utilizing

patients physicians continue promise to increased that our advance from summary, to new technology around and team explore to platform. our We serious space suffering suprachoroidal our of other injection give the diseases. feedback In treatment positive strategy our help will back-of-the-eye believe provide R&D opportunities areas

to Deignan, I over Officer, will our to results. now the turn Chief Charlie review call Financial financial our

Charlie Deignan

Tom. a you, summary would Thank developments. financial like key to I provide of

We R&D commercial in have The also clinical the two during final received earnings And positively release, expenses credit $X.X vendor our we down overall since we trials. clinical our reported significantly as shift in our financial impacts our now reconciliations. a our reduced strategy million position. late-stage trial from closed have we

forward. completed have expect network injection branding, spend reimbursement such product pricing preparations commercial evaluations. activities going support design, resources and We do prelaunch additional We development, training significant not on to as distribution

cash cash our the cash we of not does we payments our include quarter This XX, equivalents partnership-related $XX.X R&D any As agreements. on administrative into enable XXXX, our expect us third our fund Based that June of expenses, totaled XXXX. new current will and plans lower operations and may to through million. existing gain

the manage resources deliver look annual forward several events, to Janney our at opportunities in on front with to upcoming carefully community will have and including continue us, and health conferences. Wedbush compelling the engagement investment we to We we of care ongoing

to Now the I'm turn call for closing George to back George? pleased over remarks. his

George Lasezkay

includes This as centered as Charlie. an By injection and our dedicate now therapy runway, use two-pronged novel areas of SCS platform. our such cash you, creating extending can external in our additional R&D advancing internal to resources molecules strategy additional current we small the on development Thank pipeline as gene well collaborations. building

to a pleased positive, that next transition period. patients for of I'm outcomes focused I CEO my very agreed on maximizing have year, Board us to shareholders. Finally, report term and this improving part to that and critical to allowing of continuity March committed as for is I'm through our extend through team maintain proud the value remain and this forward-looking

the ask questions. to for call open like I'd operator Now the

Operator

[Operator Instructions] comes of Securities. Donald Ellis JMP question from Our first

is line open. Your

Donald Ellis

Good you. guys. Thank afternoon

uveitis. about is partner question First for for the partner

cash and cash a a for exclusively looking royalty stream. You're partnership that or includes upfront

George Lasezkay

We're question. for what that's license Don, would but be this than agreement. – Thanks we're is we're the of that, you typical looking can't any specific more looking for for. George. expect I what

Donald Ellis

Okay.

George Lasezkay

agreement or out-license that typical would territories. more one A involve

Donald Ellis

great. Okay,

forecast spend regarding you that projects And question in-house that having bring Next on R&D? money based change R&D cash XXXX, not the in-house? and XQ is do on to runway projects if might

Charlie Deignan

Charlie. this Don, is Yes.

about. monies, money we programs. that other research have But programs could there collaborations as And in that forecast. or have it we've includes is some that forecast that upfront So talked then partner fund this internal other

Donald Ellis

And Aura Biosciences process what idea look – clarity and or clinic? like give do deal, Okay, Or in when therapy? to get question. information any plan with you can some on the they terrific. have that you your might us last The gene

Charlie Deignan

Charlie. Don Yes

can, And Aura's we unfortunately, we know. development So when discuss you can't let we'll plans.

Donald Ellis

you much. Alright, very understood. Thank

George Lasezkay

Wait, I'll just add. Don.

We started better the have the to directed positively. But to question very clinic kicked Aura. a it for said, them, them off is enter and with Charlie collaboration the plans as

Charlie Deignan

on information their well. there's website And as

Donald Ellis

Okay, great. Thanks.

Operator

Securities. from comes Wedbush next of Our question Moussatos Liana

Your line open. is

Shveta Dighe

Thank Liana. taking you for Shveta is our for question. This

you partner year? would on the search will XIPERE the in the think program, Do potential What of later this do in We QX. thoughts your on potentially a potentially are launch were uveitis partnership for thinking it launch for delay uveitis? a that? this for push think you With

George Lasezkay

what to discussions with our dependent. in – they we insight probably would to going answer terms have We're of only the partner do that of at to partners. say in is no launching. is in plan Well, way this that point It's time can be we

as partner's more you can right now, have to that's more along. of But we goes decision. we a So information, update as be it going

Shveta Dighe

And just it. one more question. Got

provide us If will an next from you we update DME on can when program? your hear it? And

Tom Ciulla

This is Tom, Shveta, Officer. Medical

presented II positively was we Retina Society know, that DME you called It at completed in has As meeting It community. that relieve the very retina TYBEE recently. burden showed American program treatment XIPERE greeted potential by a the Phase Specialists DME. to was of

able As some determined learned XIPERE, development them way. by certainly of the along with for be but lessons be the partner of the we to look to partner, DME XIPERE out of course, we'll will provide

Shveta Dighe

Great, thank you.

Operator

Mr. turn no I the to this [Operator showing further at Lasezkay. time. questions am to like would I conference back Instructions] now

George Lasezkay

you. continued our thank Thanks interest may to appreciate on now And in look disconnect. us again. all Thank joining today. forward Operator, and you your updating on we Clearside, progress. you We call the you for

Operator

have Thank And Ladies day. participation. and you gentlemen for today's conference. this a concludes your wonderful

You disconnect. may all

Clearside Biomedical (CLSD) 7 Aug 192019 Q2 Earnings call transcript