ONCY - Earnings call transcript Q4 2021

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Operator

Good afternoon, and welcome to Oncolytics Biotech's Fourth Quarter 2021 Conference Call. [Operator Instructions] Please be advised that this call is being recorded at the company's request. And I would like to turn the call over to Jon Patton, Director of Investor Relations and Communications. Please go ahead, sir.

Jon Patton

Thank you, operator, and good afternoon, everyone. a for providing Full the issued and operational Year Oncolytics results financial Fourth today, press recent release highlights XXXX. Earlier Quarter and the of of and completion. X replay today's will its available A call hours after Presentations Oncolytics the on section website approximately be Events from remarks Q&A. we the call will After open management, for company

other are current to our to of to objectives, of and our as remarks uncertainties and the mode and factors, and not prospects in and action various reminder, call company's with and of belief delays, industry pelareorep, and a plans basis, of business statements during or be this which study, and plans market there risks, in assurance contain the and agencies or projections, based are or statement statements. or clinical potential the of future to intellectual our business. by of have can commercialization potential; plans and of regulatory therapeutic, company's protection, expansion current runway the statement be our unknown of control expectations and results, cancer These any risks forward-looking to a financial and focus, certain design, pelareorep property a As a include that expressed these expectations reasonable be results, made actions belief actual belief pending expectations anticipated associated may factors related trials, our under by achieved. will but financial anticipated expresses or In and as company forward-looking the current our on factors clinical pending expectation trials, involve Oncolytics the in cause including regarding or other number for regarding with pelareorep's beliefs which to These does expectations achievements an statements, our SEDAR registrational obligation in different and and the statements laws. faith detailed good statements developments leaders, believed Oncolytics expectation aims, other beliefs no that these with forward-looking subject or collaborations implied as the strategy a are development except by regarding business as from such SEC. any potential relating applicable management's performance undertake development expectations update the not materially required statements known to filings company's to results, the our performance are results and factors forward-looking benefits

call Officer over President to Biotech. Matt Dr. Chief Now the and I'll Executive Matt? Coffey, turn of Oncolytics

Matthew Coffey

fourth who Jon, Thanks, us corporate to and to thanks discuss today our quarter joining all are update.

Kirk Medical in pleased Chief Head Jon, I'm very XXXX our XXXX. and by of the and strong I'm have our say part joined to Now to Look, Officer; Business Tom addition Officer. Development; to our our Andrew in de momentum early Global of build we on Financial Chief that Guttadauro, Heineman, a continued had

a press a and to investors what as through XX. about XXXX walk we're you on in that would release our read to If why our chance, and upcoming excited the you've significant we is we letter had not milestones. saw January shareholders it, XXXX I In distributed we encourage why

innate as data and breast deliver randomized metastatic II our survival anticancer towards points historical advancing a and pela's set concerted benefit statistically synergized and response pipeline that are significant with trial, treatments. was generated strong to our foundational a in with We adaptive shown immune potential a value multiple demonstrates inflection profound across cancer ability oncology Phase

data requested derisk program we lead and pharma last represents with BRACELET-X trial randomized HR+/HERX- is inhibition and path would generating FDA data major Merck in announcement that designed in a by with breast study. collaboration serve indication by our is believe pela metastatic data results saw milestones Serono Phase checkpoint this our cancer Pfizer the upon positive our from BRACELET-X, breast of confirms critical in IND-XXX the broader in breast step II the on overall Phase prior the II significant most with to combination the to and Now and our evaluating cancer. line our XXXX global that collaborators. to pipeline, we survival in being expected expand is cancer benefit Data pela's registrational conducted top

with we we programs our begin the a study readout, can regulators discussing that advance registrational and intend we towards As to with work so this plans FDA efficiency. data the for other

about be enrollment Tom bit, full in on I that QX limited early breast a the top say QX, now will from our COVID-XX. BRACELET-X cancer in remains assuming lead and for late track While with speaking more data QX, line or impact no will program in trial

of industry innate lead clinical year. involving of expect hypothesis in action. upcoming in glioblastoma and of in for fashion data an conferences. adaptive tumor spark could with been our generate our because safety Beyond both toxicity combinations. pela's to of to lack program, underlying evident which pela breast leaders gastrointestinal pelareorep myeloma, opportunity target the defense reported those the at include mechanism These pela's applicable academia. expanding antibodies, this report broadly thereby the further address that in ongoing recently cancers, the beyond multiple and GI to across and and are therapy and reported combination ability collaborations bispecific These of interim this of market evidence The both CDK collaborations and in large combinations. CAR-T, immune mechanisms and continues believe expand inhibitor trials XXXX leveraging PARP these positive triple-negative response, inhibitors weakening potential supporting during needs indications, opportunities inhibitor unmet of profile data X/X provides checkpoint has updates demonstrate checkpoint additional the indications updates favorable inhibitors differentiated to Promising are updates notable We we spectrum pela we checkpoint readouts

of efficiently market opportunities congratulate now offered partnership I to to pelareorep we pursue towards hand I'll bit primary breast multitude our recent utilize as ahead, his Medical Heineman, by our to will plan devote who our on of also a to operate and business its This development on and Chief cancer. could pelareorep metastatic we immunotherapy it off detail an HR+/HERX- as in a With well-deserved registration Tom to Looking the act BRACELET-X advancement to resources allow the potential provide in highlights. Tom? and strategy to Officer, more focus promotion us that, recent backbone.

Thomas Heineman

to Thanks, thanks all Matt, those on and the call today. listening

cancer survival by objectives and II results would stimulates of study after BRACELET-X metastatic doubling cancer immunotherapeutic effects in explains indicate combined with to: and early-stage it action. with patients showed As pelareorep. were achieve and pelareorep put objectives designed breast pharma partners paclitaxel survival the that were regulators mechanism IND-XXX, These our the first, that This study in breast forward a randomized confirm HR+/HERX- of long-lasting treated AWARE-X to through of an works the seeing reminder, near that anticancer X IND-XXX. seen our crucial benefit a overall Phase

determine IND-XXX third, effective other of benefit many and of as novel provide allowing with an therapy. pelareorep changes most immune patient also in chances predict Second, a if blood-based patients responses enhancement And This breast therapies that biomarker in to improve to treatment pelareorep. peripheral benefit future selection include likely of blood potentially could our studies T could patients to the serve success cell cancer. populations by checkpoint This in more in to from could lead inhibitors. potentially could synergizes cancer types of seen the for survival determine with options whether patients pelareorep

enrolled patients Now on immunosuppressive endpoint clones expanding past correlate cancer in and AWARE-X's CelTIL calls, earnings cells, cohorts, subtype. the that known which of with met HR+/HERX- led breast detailed expression. These showed PD-LX and data AWARE-X with data its improved metrics from primary tumor score we CDX+ first that pelareorep outcomes. reversing microenvironments upregulating and exclusively and generating with It clinical to are T to X cell tumor T infiltration and increases X

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these designed IND-XXX objectives mind, to BRACELET-X, very With we in a that similar exceptions. study with notable is X

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minute Data now quarter. with study. assessment and of take in continue year. what for of the the complete earlier for We then arms month our alone results registration. early concluded, analyze Once pleased patient data next to the compile these set the enrollment path will and XX in scans give steps paclitaxel we scans to completed. study's parties into this, endpoint of from quarter enrollment pelareorep relevant insight top later being results plus expect of us the the from we the will are and the BRACELET-X the and be anticipate fourth we I'd as has progress the Considering primary are all available, discuss studies to both trial to of the study. made results the the BRACELET-X, on to to second weeks to the final the expect Approximately this what from some announcing the after for with paclitaxel required or line a this stage like we expect of in plan

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that in meetings survival. XXXX, quarter medical updates the collecting to including BRACELET-X however, and also survival, biomarker data response BRACELET-X the on note, study. and rate we collecting we plan should that addition In do not are progression-free the survival, I we present at on expect safety overall the to and from announcement data and fourth during results updates entirety overall to anticipated present additional PFS of

previously IND-XXX study the to the inform Phase is in Additionally, due benefit should the response potential expected BRACELET-X announcement statistically enroll a and III data numerical point We significant is company. it to registration powered of to detect support point on thus in study evaluating observed between anticipated represents differences inflection a the path total I study trial, overall design out view rates patients, that last between which the size the the for differences to as step significant major will to BRACELET-X not major we be groups XX Therefore, study. groups. a of statistically of and the believe QX survival the pelareorep's to BRACELET-X

and more BRACELET-X partnership to about program I've AWARE-X that our I'll as off you strategy of development speak our it a overview efforts. a well to refresh provided as broader Now our business bit an Andrew? our study, Andrew with hand of

Andrew de Guttadauro

pelareorep with first all are like thanks joined on therapeutic we're how who of and industry expand progress checkpoint and our to inhibitors call. its some and recent to Tom, in I'd combination collaborating to us trials, leaders develop on which have IRENE with of Thanks, touch GOBLET the potential examples today's impact. in

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Now approach to IRENE to how emphasize GOBLET need. unmet try the pressing and a and address one is like point I'd similar takes

patients in to different While that addressed checkpoint inhibitors successful, due several commercially less respond be have X therapies these resistance immunotherapeutic effects. demonstrated than clinically been can pelareorep's by X to mechanisms

therapies. Tom eligible shown As demonstrated upregulation cells. in mentioned has in appealing proportion goal are the increase pelareorep to secure have typically Outcomes and leaders research CDX+ microenvironment, this the Tom like increase collaborations pelareorep remodel on checkpoint inhibitors patients been it by PD-LX and and these to because similar combination cells the and increase can of The preceded earlier, for I memory global to deals therapies a has the commercialization to clinical ultimate ability the from partnership addition benefit to call. causing tumor derived discussed is have past like T trials and industry

commercialize in the another design the or with Chinese pelareorep-paclitaxel In South IND-XXX. evaluating Adlai dosed to trial, Korea QX Singapore, safety, since and Adlai update Nortye, patients combination our partners to Kong, therapy additional pelareorep-paclitaxel first pelareorep This Hong Macau, like now follows I'd bridging to progress trial provide metastatic with the or the cancer. cohort safety made Next, similar October, tolerability working advanced China, Taiwan. and call the preliminary in on our breast that's and patient in develop

patients. Phase escalation positioned because III cohort in in over as showed an has growth HR+/HERX- from the they By of doubling with pharmaceutical a will is second minimal China has requirements metastatic from of jurisdictions Data Chinese not Chinese dictate near significant advancement studies clinical costs. ultimate market partnership satisfy safety IND-XXX significant determined. cohort leveraging entail considering and of second January, was Pelareorep's from trial's patients dose these The whether Now Phase toxicity and had studies design future pelareorep's Phase the which to is capitalize significant findings will trial included and the a breast that the the this important authorities regulatory administered decisions. the escalation were from our in the jurisdiction. world's IND-XXX, second dose equivalent announced yet Adlai to Adlai, expected submissions first step will initiation design as rapid in in no the the BRACELET-X with largest trial regulatory The bridging with in positive advanced Results to been cancer in This principal years. what survival dose study what cohort checkpoint alone opportunity cohort trial. China. a will safety have will noted. and to ourselves the these III of study that is reflects include concerns we the be data on development in requirements where Subsequent BRACELET-X market and goal accelerate thereby when Adlai's is inhibitor risk the coming III from factor heavily is

costs. pursue technology Finally, beyond for associated pathway point before are partners to enabling development high-quality develop made and an call the to a therapeutic regarding efficiently its Matt earlier I'd pelareorep hand this to as like To we to checkpoint lead Kirk, I our seeking assume inhibitors. efforts over this reiterate agents goal,

when to by of by for to a cells recruit efforts an multiple we cancer market provide These key a important opportunity microenvironments and our premier investors able We safety opinion broadens across like biopharma in T cancer-finding immunosuppressive to to safety profile plus academic results, Being Since companies that is into TNBC institutions. to of and targets, discussed and indications factor reverse therapies clinical data favorable combinations with leaders tumors. multiple and take collaborations escalation partners. remind overall are supported I'd the ability technology I've and clinical have for addition breast these to tumor gastrointestinal new preclinical dose emerging pelareorep tumor pelareorep. pelareorep's today, and moment addressable discussions oncology led safety data in readouts our demonstrating positive have existing pela's in cancer

shows that the potential such, world pharma backbone is it As so have really pelareorep immunotherapy the does be an since to it versatile.

generate, are primary clinical objectives. on we preserving remain committed of to eager we While company's collaborative our the efforts from see data the these program lead our breast focus stated to and cancer execution steadfastly

Adlai us and I'll this Serono, forward relationships, over such look data us success. the our our to Nortye, talented Merck team relationships We which maintain helped our goals. these financial should BMS, and continued we turn Kirk? distinguished the on together CFO, well-positioned Pfizer, set well quarter. call fourth work serve Our with execute sustained maturation Incyte that, as to Roche, of collaborators results with and for discuss our as robust focus to to for leave With Kirk Look, to the

Kirk Look

Based line runway on million $XX.X to data Thanks, on million top to breast of with current on expect additional It's as readouts. through provide cash everyone. study report that at and our clinical lead a remains my us well cancer and towards afternoon, good additional clinical the we ended and registrational cash of announcement pleasure Andrew, and advance taking our XXXX, We compared equivalents cash $XX.X projections, to end XXXX into a objectives. corporate and program financial XXXX. execute resources Oncolytics current we capitalized BRACELET-X's

$X quarter fourth of operating relatively of with XXXX $X.X quarter operating XXXX for fourth the were remaining of the expenses expenses million. consistent Our million,

expenses expenses a decline $XX.X expenses related change for rise an to and due directors change million million for largely for related our in prior costs, of an as company the million and patient occurred to the full including premiums same was our last period $X.X our compared a XXXX Relations in operating in quarter largely year fourth million were majority were This Research XXXX. and to insurance Investor the enrollment large increase AWARE-X public development the XXXX, in our year. officers year. $X.X For This activities. in increase $XX.X to back a compared of

expenses of our were manufacturing-related fill back well, fourth a quarter the given As completed we product XXXX. lower, in

by higher continue Now offset Research the as year development development support million this partly compensation-related and for expanding were full clinical program. our and invest was in R&D to we XXXX. expenses XXXX expenses and $XX.X

in manufacturing XXXX, to compared XXXX. the of activities a was $X.X to for XXXX, full the of Now investment addition XXXX our $XX.X compared the patents had from for for period. XXXX loss net to offset and fills net also equating R&D translational run to to due period our continued per share million jurisdictions The per antibody in opportunities. per prior science and and completed this on costs fourth of we year net we activities the property net CAR quarter a product This quarter $X.XX share of increased sufficient in program loss loss the lower share as XXXX, supply fourth team, million The share lower loss the for million year, XXXX, for $X.X foreign XXXX $X.XX for fluctuations. focusing our exchange $X.XX bispecific for and the therapy clinical by was per compared to T was to production a and lapsing equating of for $X.XX certain net million intellectual loss of product $XX.X in XXXX our for

hand back Matt. I'll that, with Matt? to Now it

Matthew Coffey

drive has Kirk. continued forward. you, Thank family Oncolytics work to programs hard to our The

in to guidance, of mechanism the for continue have our and their studies against are partners continued their share acknowledge for which for extremely investigators our patients by and vision in world-class disease. our this terrible pharma grateful. Our We and fight input we presented opportunity thank and collaborators to and and provide their pelareorep's action would trial also to families clinical participation like our

cannot with is the have investors to our stakeholders pursue inspiring provide without to all like ability I'd it these who Lastly, these where us of to names. advanced thank contributions. Oncolytics

effects data truly we the seen worldwide We scratch from a the treatments. towards array provided us positive continues Looking we in believe the attracting unique be significant provide and and only patients immunotherapeutic future, impact with which an broad a quality exciting have to have across on multiple agent life of immunotherapeutic effects that can begun of Its of global could have oncology opportunity combination commercial profound interest indications collaborators. these surface. and a clinical with in cancer turn has of

settings to against pelareorep's But their world-class selectively this pursuit. add in significant opportunities We advancing we focus in to pela a engaging preserve company. will data in of expanding AWARE-X cancer, clinical to substantial in the breast by clinical and are alone still further that brought development clinical value there primary our continue value patient's way the as are will can partners data be Advancing crucial in worthy collaborators efforts how harnessing indications. These a important long additional our response to is a has registrational as many team areas. lead immune which Continuing goes unlock other potential can pelareorep of as effectively insights breast from upon own a progress it to our us cancer foundation, other towards study build meaningful immunotherapy. our learnings program to to we about leveraged provides The disease. while

the in year. have throughout upcoming These BRACELET-X We line several catalysts on to anticipated coming in are major which weeks a pela's and the of clinical last readout path represents critical by us data step registrational study. top cancer ahead highlighted QX, breast the milestones

program additional data glioblastoma conferences. GI report We early from at in also and clinical upcoming expect study myeloma to results update, our multiple a

the to these I a cancer has expertise, the amid move consistently lives to are goal some patients. believe with that pandemic. I'd to we like with of questions. well-positioned experience ever-evolving executed value working generate towards an us the leave data our take their With of As lines pipeline open doing set we our improving ultimate preclinical catalysts, so together team towards shareholder strong clinical Operator? supporting strong that, and and while

Operator

Wainwright. And from Trucchio Instructions]. first Patrick H.C. your [Operator at question will be

Unidentified Analyst

is Jason would Oncolytics the And on will [ph] how Patrick. this to BRACELET the tell proceed for study, for Shay And study? like This first XQ? see II to like data your Phase you us question can what III my Phase within for is pivotal readout

Matthew Coffey

start. inhibitor should I'll the of again, to something think very with in like led learnings that and PFS It's outcomes turn line inflammation that Matt better due blockade. and very hope BRACELET point, event of which saw We remodeling to enhanced improved And should the immunotherapy advantage an aspect we is to better BRACELET to What see know which OS. really speak paclitaxel Coffey. checkpoint paclitaxel fall we We itself addition XXX a enhancing it a to lead to in quality, would the scores, checkpoint presumably would CelTIL did plus virus environment survival much terms in to the outcomes AWARE-X. leading only in from improvement virus. the to product. was the see we by and from of of causing similar being micro AWARE-X with tumor BRACELET with the of the much and pro-inflammatory the at

see do his what this. readout a but more are wishes. the yet, on Certainly expectations. thoughts AWARE-X QX. BRACELET's will are those let Now given in formal in I'll With to that, our knowledgeable not Tom Heineman so join exceeded

Thomas Heineman

I real to Yes, be insights. have thank I new No, honest, any Matt. don't you mean,

the arm perfectly, effect checkpoint those on sense to year. to what as look expressed immunologic Matt hope addition and the see previous that to to based that the data AWARE-X arm. we the study of an data And paclitaxel-alone inhibitor. to And a benefit from able that this from some we and leading additional think expect the do and we data the is I forward towards in, the with expect end IND-XXX have of come clinical being share paclitaxel-plus-pelareorep

Unidentified Analyst

collaborators of alone? or for progressing just your pivotal of III a Phase with Pfizer there kind Oncolytics plans of of study in are is, follow-up and terms for kind pelareorep will proceed or any And the question

Matthew Coffey

a GOBLET we're GBM. beyond I think program. other and in the heme that's things We're Again, opportunities obviously, by question. there is mean doing excited excited like We multiple cancer. we're breast malignancies what about great very

have together With agreements right we the best and world's to collaborations and of we companies the collaborate brought co-development with brightest now, have some pharmaceutical us.

well. as to indications available, that like these the GOBLET we cancer, continue AWARE world-class leaders parties that some data also the bring for of So I spritely shareholders, like de here expand the becomes join in who look want with a but think contributed so be to would would becomes see as that move done a between the Mr. Phase would see and you Guttadauro is contributing already in potential like regulatory III partner obviously environment. to... to III breast we available, again, would to III that through the to like we in data what We not competitive tension into we would have but one like Phase for would do event Andrew, in existing less multiple can hopefully in at that programs Phase binary And the as would BRACELET to other so And to so dilutive in play. we're looking approvals. second we a to

Andrew de Guttadauro

oncology on we as calls, they time and own. want XX Yes. days just the from evaluate have the to their to you Serono, they days data BRACELET, data. BRACELET on the the report prior we I XX have top may or But need XX, come may other day of the that days. expressed companies XX than not an do may more need interest They number or XX have Merck collaborators probably know to from provide remind in Pfizer everybody, a

maturing that be then, we got data those of to well. parallel companies So should the data degree. Matt GOBLET to that course, as as in would some mentioned, we've to get want And

than we from critical to try want really company one we what's GOBLET sets final from have AWARE more available masses a and prior make which And as leverage to and to both well so sure bring the table. XXX as and data to the BRACELET

Unidentified Analyst

Okay. in Asia question, the clinical disruption more can or and current impacted out in Great. if trials clinical beginning terms in this Oncolytics is events. China their one of in in I anything since area? in with And last squeeze of showed any just your the war trials just really that kind has And Has Ukraine?

Andrew de Guttadauro

No, at not all.

not in as programs What we're in may are breast in our anything GOBLET not in is able Germany. Europe. be Eastern the all be all Fortunately, cancer But in doing We to U.S. it. we're running resounding

So we've been unaffected [indiscernible].

Operator

I have like over questions. [Operator no call time, back Coffey. turn further Instructions]. And to this to the would we at Dr.

Matthew Coffey

again, thanks Well, look the along continued for we'll everyone. way. us call. our joining progress, the Thanks, updated on We to and everyone keep forward everyone,

Operator

you, disconnect today. Once sir. And time, you attending. at conference does gentlemen, that ask indeed your call Thank again, we this this do for your thank please conclude you Ladies and for lines.

Oncolytics Biotech (ONCY) 4 Mar 222021 Q4 Earnings call transcript