Oncolytics Biotech (ONCY) 6 Aug 212021 Q2 Earnings call transcript

Good morning. And welcome to Oncolytics Biotech’s Second Quarter 2021 Conference Call. All participants are now in listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded at the Company’s request. to Investor call Relations like Patton, to now of Director and would turn over the Jon I Communication. Please go ahead.

Company Thank After Earlier section Oncolytics hours today, be available providing the good of A replay afternoon, the a of the remarks open call second And its management, corporate call after release will today’s the and financial we you, press two results Events XXXX. website Q&A. for quarter on from approximately of Oncolytics will completion. operator. issued updates everyone. for and Presentations

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

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

today on call to Thanks, joining Jon. our all corporate for quarter listening, And us the XXXX to discuss update. second thanks

a Jon, Head Clinical answer that key to posed achieved achieved lead with pelareorep both validation a we questions primary addition HR pelareorep and and did Officer. completion our Tom the Guttadauro, breast productive milestones broad result doubling designed pleased Kirk cancer our highly breast towards two regulators of up cancer survival advanced and have position breast to registration, In goal. AWARE-X cohorts of cancer positive that And Development that milestones which hypothesis Look, HERX and our scientific to and advancement in Business recently of we study it's wrapped quarter, joined critical for survival, endpoint. and overall say IND-XXX, these showing was our represents have multiple in partners it treatment clinical This I'm across patients. further were program. to was in accomplishing showed trials of [ph] among metastatic observed that X Chief positive, near key AWARE-X program benefit, indications. impact with by prior a the negative We I'm Operations, Chief a regarding major lead Financial of by our Phase Heineman, Development during the Global just our de a Global Head that, Andrew data

pelareorep clear study but our towards I'm speak that trial track to Phase enrollment before a HR negative for say is need the about now in a ongoing ahead, will trial BRACELET-X. bit Tom the in major remains is cancer. pleased positive, registrational quarter. the a X Looking of study on more BRACELET to now HERX in to a fourth accomplish on breast we last The completion advancing path tasks our bit,

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and to very the we exciting Thanks, all a milestones. And call Oncolytics, few and been It's scientific thanks at months achieved past on today. multiple clinical listening those Matt.

examined AACR questions a is cancer registrational survival breast subtype cancer and study. also a data HERX is clinical to advance from positive, of in alluded benefit IND-XXX. or core partners the most to build with to which AWARE-X treatment regulators. breast HR breast that checkpoint our two of saw evaluate pelareorep by working HR of we negative results, of Evaluation purpose with was our first the answering which the effects therapy, study for positive, Matt been the the And IND-XXX these inhibitor have two future negative cohorts, the earlier, That we a to were intend cohorts for by in we posed the objective program, registrational with on subtype in reported anti-PDLX pelareorep and and AWARE-X in in we advance ourselves positioning of it all key at lead without AWARE-Xs programs, cadence steady upcoming Importantly, patients HERX In patients cancer. catalysts. is pronounced

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important there regarding these two Now, data. are things note to

improvement score to a treatment the increase be is outcomes patients. is in CelTIL with score CelTIL First, any continuous associated an Thus, variable. in expected for

was robust if runners fact as our someone positive in any line going in will responses of XXX into more both in hypothesis dash, with improve is second, that tumor the speed. CelTIL and speed magnitude in in score increase the And study. outcome, example, we Cohort by regardless saw the X, For running that measured of meter increase the

of The and That pelareorep survival when immunotherapeutic efficacy studies in This other and pelareorep considered combinations to we with even Specifically, pelareorep which IND-XXX this suggest exciting is patients observed that bodes confirms chemotherapy. treated becomes an our acts improved enhanced impressive when and BRACELET-X effect. AWARE-X see in an the finding. for that inhibitors that light an results synergistically more benefit checkpoint a only adding inhibitor, inhibitors. provide significant well include clinical evaluating checkpoint checkpoint will and

The generation resulted by in Our were pelareorep a long the cancer T T tumor anti proportion tumors data supports further a supported use pelareorep tumors, immunosuppressive correlation T mediate T of from as treatment cancer of score, cell substantial T reg clonality killing some CDX dramatic positive CDX-positive tumor cell expression weakening clones PDLX PDLX the within the of presumptive of favorable XX cells show cohorts. average a biomarker, of of and PDLX AWARE-X mechanisms fold a and that negative additional in tumor between replication cell in to anti and an high microenvironment tumor cell both tissue, less defense a CelTIL tumor in anti-viral results two to cells, memory. more resulted initial that in These clonality and from indicating which treatment positive. increase upregulation CelTIL data lasting which immune may anti-cancer, first conversion ratio, and of

question second the earlier, pelareorep's to key of we they also Collectively, these well the Importantly, pelareorep. lead many way checkpoint program key with enhanced question blockade results of first both cancer answering particular, milestone represent between immunologic mechanism these demonstrating inhibition. confirm effects pelareorep to broader by for of breast In are the show the checkpoint our desirable that pipeline. action, synergy and on answering our and were critical therapy our they and addition posed a

strategy. Importantly, this broader validates our development clinical

T also data predictive to in who AWARE-X us of likely as identify respond patients chances future improve cell to Finally, study. support the therapy our are which the allow biomarker, to clonality of clinical utility success registrational may most the a and

have lead data towards progressing rapidly program cancer forward, Looking registrational AWARE-X our positive path a down breast a these study.

As the path which step and planned. on completion next major of Matt continues to final is the advance this as BRACELET-X, mentioned,

collaboration BRACELET-Xs biomarker. identical Merck reminder, essentially in as who Pfizer Its IND-XXX clinical that two and exceptions. a of IND-XXX key As investigate is to a T study Serono and [ph] overall developed support with design clinical design in the the benefit observed with was clonality cell

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as In the made is as both The of BRACELET-X end is complete and my the at Oncolytics, fact, to enrollment we remain talented organization on on track renowned we've colleagues by investigators world to highly year. thanks to partners PrECOGz, the study. progress our the managing at that well

ahead, regulatory negative approval keep breast look that us take potential this us track patients. and simultaneously its pelareorep group we on pelareorep's for confident across positive, to As I'm while HERX cancer, will advance cancer of positioning advantage additional HR to

gears, extremely after line an in study evaluating data, briefly adenocarcinoma. promising to a pelareorep data combination Phase The demonstrating trial, I'd about These of talk cancer. pancreatic meeting recent challenging trial additional in indications, PDLX clinical all first shifting At we with the progressed X from presented like the indication. were ASCO in making checkpoint biomarker combination treatment, and therapy inhibitor one this these for in proof-of-concept this patients June, most Now in inhibitor pembrolizumab population. some pancreatic a had

of pembrolizumab anti pelareorep's Another a potential immunosuppressive often absence provided chemotherapy. in was the activity, patients the efficacy of to overcome checkpoint and notable a cancer us and pancreatic at design given that This GI inhibitors allowed to limit look of facet studies other were that TMEs cancers. the who the the more combinations in assess combination direct pelareorep,

study in design, advanced the enrolled control and pembrolizumab this of XX% despite This combination. of activity the indicates anti showed cancer pelareorep, encouraging the the rigorous Now, result strong disease nature a disease rate. patients,

immunologic in at blood peripheral CDX reduced the together checkpoint and the combining progressive patients responses The disease. tumor of and achieving strategy both immune immune Additionally, showing T association tumor reg cells cancer underlying of it levels T of between with improved treatment cells with control positive pro-tumor increased patients biomarker mechanism demonstrates peripheral infiltration pelareorep's data further anti the control, showed in cancer cells to of increased blood activation that and validates induced treatment, disease and action, cancer following tumor of data with anti compared inhibition. anti our

academia, Finally, with continued which these and support study, its Collectively, checkpoint the support the in safety leading of on namely us - continued applicability we in and cooperative necessary medical Germany. to pelareorep's are leaders development Roche safety our pelareorep's broad leveraging cancers, gastrointestinal results evaluation profile. oncology pursue in study order pancreatic preserve and gastrointestinal are AIO, a inhibitors devote collaborations data based allows to other the this to from industry combination outstanding with our focus pelareorep's consistent resources with the academic and lead group program. AWARE-X primary cancers. In This and to findings breast cancer in

Now, hand efforts. speak our Andrew? Andrew. off these collaborations business and about more a I'll to bit it development to

us And joined thanks Tom. who Thanks, on today's have to call. all

pelareorep, this and pelareorep Roche's advanced checkpoint and inhibitor colorectal plus Tom in AIO doing our pancreatic, through checkpoint leveraging cancers. Tecentriq evaluate trial, As with which We're are X/X mentioned, metastatic with Roche PDLX to is anal develop metastatic with we further in Phase to in and inhibition pancreatic collaboration patients designed GI combination GOBLET cancers. other anti

to make progress regulators recently received approval continue in from and Germany. We GOBLET in

- interest collaborative by These from a leverage with trials development ongoing and triple-negative our HERX inhibitor, improving blessing program. the breast therapy, efficacy representative its opened additional multiple and Such expand Now of soon indications is and enrollment of commence focusing German checkpoint the that are interest the negative in to working HR we by anti X represented evaluating study impact This trials, including pelareorep's BMS studies in study the myeloma. AIO, the and growing driven GOBLET strategy pelareorep therapeutic strategy combination retifanlimab unmet checkpoint pelareorep ongoing [indiscernible] broader executing beyond we PDX and Phase the study in the which pharma potential IRENE, we're the cancer, The trial our combination is companies with and have lead, positive, insights cancer by commercial prevalent have in opportunity highly as by large of evaluating breast large for with manager, need. possible. as sites biotech enrollment high to is inhibitors. our regulators

by and therapies. preceded responding As collaborations leads clinical the as to past inhibitors commercialization checkpoint to are market pelareorep be one on securing us to in goal AWARE-X of of reach billion of work research well clinical to towards global deals less by despite The checkpoint demonstrating execute this other and that these a $XX XXXX, our patients by been is This positioned similar as can we're low different which several response BD addressed in strategy that due currently those expected in proven engaged. We're than resistance inhibitor partnership. taking rates five have the effects immunotherapeutic mechanisms and goal, typically we is approach a pursuit are the trials.

to tumor cells of stems in mechanisms cancer subject weaken immune defense associated well that immunosuppressive to pelareorep's agents to bolstered poster as fight reversing combines with ability separate This CAR as data and T from antibodies, to order the with cells, by These high which agents on AACR speak about goal, to immunotherapeutic our as before I off take responsibilities pathway pertains checkpoint it identify for lead partners assume Now, enabling additional pelareorep inhibitors. hand development research take to the execute on like of BD this technology as aim PARP preclinical and presentations it. by will the Kirk, it CDK are pelareorep's I'd this and at an as synergistically and such April. development to were In and strategy, X/X costs showing a moment efforts to beyond bispecific we train that inhibitors, quality TMEs.

focus clinical and our emphasize execution breast our and these exciting, of stated are potential cancer objectives. lead I the preclinical remains that on data primary should opportunities our While program

we relationships continue Roche, collaborators, work execute and distinguished move Merck maintain to Incyte on plan optimal Serono, benefit risk as balance [indiscernible] Pfizer, forward, As leveraging to with we we to BMS, goals. our our an our

registrational progress pleased for the and second. to on financial discuss our execute I'm our Andrew. We the strong team a have that morning, report corporate we pelareorep's are has Thanks, to pleased objectives. Look study, With we advance Look, pelareorep talented Good set to for in is I'll Kirk? robust made Oncolytics poised over confident remains CFO financial Kirk very to everyone. and continued our and the towards with that, call continue and to as that turn are date results position additional data clinical Kirk success.

cash and $XX.X to equivalents This cash $XX.X from million XXXX. pleased compared at Our runway, included institutional net fiscal And financing of financial extends June at-the-market as million, million, consideration mainly a XXXX, investment was proceeds of a activities $XX.X of XX our facility. for I'm XXXX. from key the to end report into

compared Now and quarter second increase XXXX in second This $X our to of insurance continued the premiums. expenses relations this quarter, operating directors activities was largely from in officers change million, impact were million last the XXXX. for to investor due and $X.X the of year's past quarter higher

related initiation expenses, for ongoing progress well our as of study. expenses $X.X change period the for XXXX expenses GOBLET support the as patient increases were fees. Now expanded clinical of and we of clinical trial Accordingly, and increased effect same last for compensation through million our year. to to studies, these we due higher second AWARE-X This as our minimize trial R&D activities development incurring in we quarter lower compared professional BRACELET-X million, direct Research studies, was the $X.X including program. costs our for incurred service

the to of hand Matt? a period. $X.XX in net With second net XXXX to it XXXX, expenses manufacturing XXXX XXXX, related and loss quarter included net per same startup $X.X to production the CGMP to for as run. year, were quarter of Matt. back was the period per that, in the a period, costs of second XXXX that I'll Our of With million loss $X.XX share second which equated million, quarter loss share for last the a XXXX to the of compared $X.X for lower compared the

Thank you, Kirk.

immunotherapeutic has like the to work began say the keep X/X, data first team. creating of we of pelareorep to patient expected momentum the a poised achieve safety second study. of in track. these posed IRENE and are a month the the us the Oncolytics to and for clinically which in is a I value challenges which treatments. for every half, dosing effects interim completion with augment ago, proud of our evaluating the to safety on myeloma build Before including oncology fourth biomarker I'd her the continue and pelareorep, trial this which blockade Their final left adapted from since immediately of the how and move reporting the year Q&A, expected stream the they our to of milestones, company They're to clinical on GOBLET multiple programs cohorts hard in They interim checkpoint is pandemic the am steady the AWAREX to BRACELET-X almost efforts. thanks Kyprolis to cornerstone When combination and on enrollments multiple first BMS in is Opdivo, We've data half and update for and reporting also quarter. demonstrated

Moving work for on continue our me will we our forward, continue as we gives build to us shareholders. Oncolytics momentum displayed value the talent allow consistently will towards confidence positive dedication by generating milestones. This that the and team to these

take As of to questions. to With we lives improving ultimate the patients. Operator? our work of some cancer open goal like lines now the towards I'd that,

[Operator Thank comes go from with you. Canaccord. John, question Your please Instructions] first Newman John ahead.

for taking the question. Thanks guys. Hi,

[indiscernible] of on just thinking the Thanks. BRACELET you're us how of see as a that about if the to just of there sort design, And you to then at study? walk curious they what in wondered through study, pivotal Just before proceeding kind could Matt, moment? terms

the question, for Thanks John.

these is long us program this without our is programs, we that really. breast to tails What is inflammatory is or blockade And events. our or that we see we're signal changes. looking - a get in there teaching pro of on for is AWARE all biochemical to really immunological survival ratio cancer checkpoint our largely with CDX what is think why [ph] regs. So accomplish What T between and PEG program, BRACELET we

CDX So the regs cause viral negative, positive cells, can are both. are inflammatory T infections

other. we AWARE from of they T reg. each what addition that So But found can checkpoint largely the antagonize blockade the eliminated

for CDX can we're that T balance. skew this looking confirmation the to we again, So reg

You as know, blockade of to X our looking the think we're X planning our my for you'd the Phase I well really is at like addition we're checkpoint there what addition program, anything add now. the of response? as into And Phase biomarkers. Tom, is to

I Matt, expected the we data the data. No, I it BRACELET be I comes want what is most But look obviously the in that's think informed scenario you exactly as to right. by at likely mean, and described. as think and

you. Okay. Thank

Thank you.

with Patrick Wainwright. go comes question next from please H.C. Trucchio Patrick, Your ahead.

trial, kind you're was Good of thanks. is forming with update, you generated the what expecting the the help XXXX to to morning. signs Or just design? regarding there efficacy AWARE-X this data? be as And would safety of additional I in on interim trial would you be pivotal outcome events? final additional IRENE initial wondering the Hi, data, that more then just data the any be there biomarker

week the over much us, first, we treasure really with First, tissue so AWARE-X, three AWARE-X a it trove first is a is question because for course. have

what virus using It the is see how that to us to for immunological that really a of So have is - tumor, physically cancer looking we're at patients happened cellular that cells. now CelTIL doing the cells. does who you highest the And had show or appropriate is level. lets cells the the drawing is see which at what's we're [indiscernible] labeling cancer into the a those [indiscernible] immunologically score of closest lot score we're inflammatory the hoping proximity cells cells immunological what the analysis, work

and type we're that's one blockade level, inflammatory molecular to in the XX? to We're this positive expression, seeing at X,XX gene turned getting [ph] can for what really What continues we're these the in without, we because, analysis it also Are activating you the exactly happening what's know, blockade if better can we're presence is looking we you to for non-responders, and treatments, we even checkpoint a how pathways restrict forward know, characterize design pathway and to this something again, so where type so future allows cell interferon CDX t changes you we obviously really is it in getting X, greater. us that hoping see if see proinflammatory are response driven. of event. greater if alternatively, that inhibitor and seeing on being use we're X, accumulation there to maybe there use pathway to we regs, while an are thing. to make know, is, is And go more positive doing actually that can a So signalling, or checkpoint allow being very

how years. seen to five treated deal is beyond non-responder, the know, we and the here I these been a we're a in What where between a beyond. to what's maybe move looking for breast it great six difference think thing. they've or because responder have of information is the decides cancer identify for patients, So forward really want and gives we And you other and us

heavily this very And help determine why treated – hopefully have responders pre-treated the population these non-responders. these what the to really unexpected us know, middling AWARE was have You patient a survivors. was. and goal versus where extraordinary responders as is AWARE-X of we we Where will that

IRENE, What pointed ability IRENE largely know, Now we on transform and the blockade. will you be patients into PDLX, in question. checkpoint the think saw I I a is, that is think to the to update. non-PDLX AWARE that direction to over-expression, safety us leads me

But we're investigators. this negotiate the with obviously, We running will with a that Incyte. is program

have enrollment, expand to, wholesome possibly terms looking the information confidentiality see of obviously our it. the maintain we sites, updates. to be stakeholders, definitely San we number But as more you a it'll you our are Antonio, as in enhance can the So can can it'll we share it so under additional we contracts. everyone. be know, obligations for know, what with of investigators These is make negotiate But the safety for We'll information. better do

very you much. Thank helpful. That's

thanks, Well, Patrick.

questions proceed. Thank There you at further Coffey, no may you. are time. Mr. this

dialing I the you further. to forward participating. this questions thank just thank in wanted and everyone Thanks, And to program everybody. for for we moving and look

Thank this your Ladies presentation. participation. concludes and once gentlemen, you again for today's

disconnect. may You now