MDNA - Earnings call transcript Q4 2022 | Medicenna Therapeutics Corp.

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Operator

Hello, and welcome to the Medicenna Therapeutics Fiscal Year-End Earnings Call. All participants are now in a listen-only mode. There will be a question-and-answer session at the end of this call. [Operator Instructions] Please be advised that this call is being recorded at the company’s request. I would now like to turn the call over to Dan Ferry of LifeSci Advisors. ahead. go please Dan,

Dan Ferry

year and This all press morning, and the financial operator, XXXX. today's release participating conference results fiscal for updates call. Medicenna corporate March thank you, XX, for you in providing ended Thank issued a

seen not Medicenna’s available of press release, If on yet it Investors the you the have page website. is

programs, All forward-looking that certain statements this applicable company, operations of shared partnering platform, during information we I cash clinical like would the facts, and of of statements begin, and the including than runway, that related activities, of additional call, the meaning the to call and milestones. other of BiSKITs are statements other information constitute historical Before potential securities not MDNAXX, during the laws. remind historical data relate potential you that other shared future statements MDNAXX, within and this development Superkine facts the to of to presentation statements the and and

factors, from that and no accurate, assurance from as those cause the such Our Important of numerous to Annual that in preparation and with many company. of in forward-looking in to statements actual information to factors XX-F differ the result States. time time materially be the be company, forward-looking the and Discussion those other There Form to by future used may risks of Form, results which United could be risks, the such to differ that statements. are uncertainties. unknown and from or and the company the circumstances cautioned of are incorrect. in actual statements in events filings prove applicable the uncertainties, from beyond will results are control results other that could and any company's Events Management's prove and regulators the actual the differ securities could include predicted Information anticipated may known made and of risks Listeners Canada materially to assumptions expectations, filed cause detailed recently Analysis subject and a materially

to undue information. Such considered differ results anticipated. may be forward-looking cautioned prove incorrect, information, materially reliance place on actual and to are management, by from may You not reasonable those although any

Forward-looking securities publicly do statement. statements, are conference not contained as statements in call only to law. qualified not expressly and obligation any required this this Canadian included do the assume and law, of by States forward-looking by or by as United any revise we intend update cautionary required Except expressly

Dr. I the will and over Fahar? turn Therapeutics. Executive call of to Now, Chief Fahar Officer Merchant, President Medicenna

Fahar Merchant

you, of Dan, joining thanks call. us and you all to today's on Thank

Bexon, addition Officer. Chief Martin Dan, I'm Acting Williams, Chief In joined to our Liz Financial and our Dr. Officer; Medical by

we in the exciting progress that an we believe considerable time With of fiscal made now the year, pivotal is and Phase and advancement This at of driven the progress the past by are the clinical being study cusp trial. first of initiation the with stage made patients have Medicenna. the our we the is long-acting dose what super-agonist, and solid in of IL-X the portion our are clinical we MDNAXX of escalation of X/X tumors, early signs which ABILITY beta in study differentiated advanced activity is the reporting for with only promising

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our IL-XX Bifunctional build Superkines MDNAXX Europe other and also data rated forward Super-Antagonists, analysis to of favorably anti-PD-X advance have for glioblastoma as for pathway, new our and of to outcome as with continued commercial our or as IL-X based reimbursement comprehensive and an our registration was MDNAXX a fusion KOLs recurrent well among and cancers. protein. highly compelling pipeline attractive With scored very interested as by the We long-acting for projected such and a BiSKITs have positive completed Furthermore, clinical of payers cis-targeting brain MDNAXX we discussions program we look U.S. We the treatment on pricing. ImmunoTherapies in parties. opportunity

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at micrograms from dose following all escalations. XX micrograms Medicenna Given priming step kilogram. XX we well target dose of per has at to that Cohort X as X X. two the enrolling micrograms a therapy per is X per cohort kilogram in tolerated in subsequent regimen is micrograms cohort kilogram in kilogram implemented escalated dosing doses up per the currently XX

data as signs doses. to patients half continue to expect types advanced and early out portion XXXX as We different look already portion data the we of fulsome as dynamics MDNAXX the data enrolled cohorts such updates throughout in at X, at dose more patients to we study. single-agent X. therefore efficacy higher meaningful emerge in more date see X tumor control well escalation could study of safety more escalation XX of to in cohorts melanoma expansion of dose Management data As as higher forward more in XXXX, for metastatic In safety, the second and PK/PD of XX to the expect encouraging for doses dose renal escalate, approximately a three we cell we carcinoma. the With data. in and addition of in expects early cohorts from number ABILITY signals patients X with continue eight of tumor efficacy restricted and to we the PK/PD (ph)

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validated First, administered at high when to drive target IL-X dose, a is known benefit. meaningful it is clinical that

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fixed doses priming evaluated. cohort X identifying chances entails stepping a the MDNAXX, do early drugs. optimum dose with up MDNAXX’s dose companies utilizing our line that is for strategy are two to to is initiative, to on patients expected to up step increase and Project FDA's We first is onwards. clinical dose habituate being strategy to higher from the before released optimal treating oncology encourages in This them with dosing to recently more which OPTIMUS find development of This in

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insights July program a of escalation in We all some of XXXX. on world's To the possible. data Superkine discovery Superkines full set two efforts. and Advisory and X PK/PD of including QX it to point immunotherapy, first advisory preclinical advancement cohort not BiSKITs. advancement these the and crucial our in program. Scientific an of posters updated MDNAXX at this QX We calendar the this allows for follow-up with and us of our and Committee on One include stage only poster drug fused in meeting of April. consists to XXXX, ensure, for the poster invaluable our a Advisory gain Clinical our been X featured is CT super-antagonist past experts and drug higher on from year efficacy calendar of world preclinical our Fc-MDNAXXX, AACR help domain cancer advanced candidate also to from a highlighted expect and class at second These complementary which XXXX, Fc leading as cohort assets scans dose Development which recently from dose cohorts MDNAXX, data councils, but have These half-life derived platform efficiently the made focused as BiSKITs the of development Boards. to extension perspectives the fiscal the We to assemble past is and development preclinical IL-XX in

BiSKITs a a Bifunctional anti-PD-X on are to single IL-X mechanisms of linked studies distinct novel widely consisting are developers the BiSKITs, turn our immunotherapy of MDNAXX. patent. with the We combine molecule. advantages to preclinical leading which of reminder, ability come collaborations inhibitors, Superkines two valuable successful poster of similar an may these to an This checkpoint designed off a into into inhibitors and provide BiSKIT generation to antibody believe property agents. commercial as super-agonist As outlined action could important in This checkpoint spark first drugs intellectual incorporate synergistic

of core Over provides XX potential the This Superkine Oncolytic independently with that Superkines we exceptional especially platform some MDNAXX academic IL-X months, seen CAR-T asset. STING viruses, labs the when conditionally our published results, Superkine have our MDNAXXX therapies, validation platform, world's agonists. or renowned demonstrating based of external the incorporated activated have the in past combined of when

discuss of advancement lead our program. supplement study and our the important now opportunities Looking recent the ABILITY Superkines to to and to over forward, BiSKITs value turn call future creation we status, Martin? outlook. that, I preclinical data, continued the to expect provide Martin and will With MDNAXX

Martin Bexon

trial escalation in data X reported currently last sites enrolling our third call from clinical patients Since and we United Fahar. dose Canada the are in in February, the Australia. study's Thanks, pharmacodynamic States, ABILITY cohorts and cohort open with earnings

Summit end X have study's to at phase. study XXXX, be the the We observed second to to dose in of we not MDNAXX's remain expansion any data PK/PD identify initiate on dose Boston. and to and expect toxicities report recommended In additional the Phase and limiting of held July Cytokine single agent the track date calendar half in the

study we melanoma by evaluating moving with provide mentioning results advanced like what of the on renal data to ABILITY randomized in first IL-X reported untreated and and I'd means cell recent trials Before discuss program, to briefly the believe some metastatic previously carcinoma. the the to it variant context Phase different a patients X recently

of who those you be PEGylated the An no the combination in clinical therapy this from of inhibitor. evaluates For trial, double with data may therapy with kinase showed benefit Opdivo with the in analysis unfamiliar the inhibitor IL-X a checkpoint it tyrosine versus arm. trial

them be expect are patients, program While we obviously this disappointing MDNAXX. the results should I that emphasize not to applicable for do from to other

of that which results provided increase success with chance will I something will is this have our believe seeing the valuable In we trial us MDNAXX, shortly. discuss learnings with of fact,

to do an required cell intermediate of the is IL-X IL-X validated Before for begin approved this hypothesis. a receptor to this, high is made that successful as or I'll the comprising native IL-X such PEGylated strongly the clinical target or via PEGylated IL-X drive which is days Proleukin's benefits have IL-X variants a with to emphasizing simulation profile the which ability due as explain like to in beta high IL-X treatment can and pharmacokinetic melanoma. severely bind by is receptor. comprises therefore why support renal receptor believe Consequently, beta strict ICU necessitate meaningful durations high The how rationale I treatment five hours the would earlier, shown ABILITY IL-X however, immunotherapy study’s alpha shortcomings We been has IL-X receptor Fahar the I its point of via the immune developing metastatic bind complex safety data and affected receptor recent MDNAXX profile therefore, positioned variants and overcome IL-X receptor, MDNAXX doses effector since every eight activate affinity know we that the the and improve dose is has carcinoma the overall dose and cells Proleukin to exposure efficacy. upon target to behind to and Proleukin's also of uptake.

on for for programs IL-X the to receptor Given be linked that its the reducing next Proleukin with alpha, affinity to subunit. this toxicity the seems associated IL-X generation affinity receptor are focused

receptor few able to to decrease receptor it which is a PEGylation leads IL-X affinity of improve of stark binding are that which activation for for binding is the binding affinity key the reduction is for is beta, using This to also IL-X therapies. the response receptor significantly immune drive enhanced IL-X of limitation to in IL-X alpha cells this and affinity a IL-X is suboptimal MDNAXX to beta. anti-cancer we critical contrast in alpha While has A PEGylation half-life, a decrease receptor the view that reasons. that approach to

alpha only dissociate may which improve IL-X efficacy since long-acting data confident PEGylated to will is Based all unintended binding past design administration, patient following to known binding, both the from has approach the while are the associated that Proleukin. to and also alpha Treg from of data we the we beta overcoming and are IL-X the immunotherapies. in cells, IL-Xs inherent study receptor best have date, on not ABILITY shown its toxicity seen limit all approach pegmoities which gradually IL-X truly with concerns molecules to MDNA's outcomes that activate not are Additionally, resulting pro-tumor leads

stimulation improved IL-X to evolution binding binding two its of has to reminder, the resulting in and to IL-X a to therefore, a compared improving ability that Proleukin beta, MDNAXX alpha, its that engineered was Treg profile. additional receptor safety enhance receptor avoid direct to As mutations XX-fold using the bind and avoiding

tumor known accumulation its IL-X to to Finally, [indiscernible] that albumin, is improve protein of engineered to we to improve tumor-grade pharmacokinetics, lymph is localization scaffold directly and nodes. a

earlier, MDNAXX are in was that The indicate to alluded features studied programs. much efficacy enhanced to behaving ABILITY expected data is other designed translate I these clinic and do. very to safety the to IL-X it preliminary As compared to

earnings by natural both were higher see Treg, recent last in of observed T NK release. increases data most baseline, X.X This I'm meaningful our mentioned X, CDX, over the this our successful call, On CDX-positive cohort pleased and I CDXX-positive tumor therefore, anti-cancer a we we which exactly one associated having in in dose-dependent little fold data, as stimulation significant to and had line with immune say Treg in agents, cells respectively. with are of that study study are have eosinophils, This immune to of advance. activation and with to cohorts. is recent see cell post-treatment preferential CDX+ to in which IL-X We superior MDNAXX that Diving the into are see no cancer clinic Notably, immune are are well what results pro preclinical can observed to recent superior may, to those simulation efficacy MDNA’s fold killer Tregs ABILITY the simulation competing emerging, limited with subsequent relative I strong increases the we the from X.X mentioned market in as aiming ICOS-positive find our biological to and cell expected than Treg greater with increases is activation. evidence in PD T increases what a ABILITY translating levels also cells toxicity. as administered and equivalent to increased provides in we of ratios seen ABILITY in continues deeper data achieve. a we study saw demonstrate profile and to doses. cells

that and could data in encouraging. these MDNAXX the continued been superior profile Taken has the data a evaluation to look collected forward date of we to in study. pharmacodynamic translate that efficacy, this hypothesis early to biological ABILITY Safety suggest together, have study

not dose cohort following recorded dose escalation emitting from micrograms X per to priming any XX per micrograms cohort which kilogram XX micrograms kg. have we yet at X toxicities, X at As kilogram for continued allows XX per in doses

have and data suppression. immune IL-X immune and displayed We potentially MDNAXX and ahead, the gives us or Looking only the This of IL-X confidence suggested a potential be to inducing the The see a response without protein associated selective we of activation with to toxicity anti-cancer promising date best-in-class are to date pharmacokinetic seen the resolute in MDNAXX Superkine target. cells is approved can indicates that its safety the approaching it release intended profile engaging therapy overcome Proleukin. shortcomings therapy.

results clinical in We from are across calendar to calendar over things update dose additional in CFO, data that, the I'll fiscal With all and third turn this fulsome the the year a year cohorts. financial eagerly clinical Liz? anticipating trial for Liz to reporting providing XXXX. quarter discuss Williams, our QX

Liz Williams

Thanks, Martin, and morning, good everyone.

stated. Medicenna’s anticipated XXXX, ABILITY IND-enabling $XX.X development to cash, the materials agent in all the the XX, March XX, as securities XXXX. development $XX.X calendar regulatory cash The expenses increased increase ended associated which note year during and ABILITY costs liability current and result million year with our NASDAQ million in as for of as for studies with to for study, as into and are loss well $X.X per operations the incurred ended $X.XX primarily I/II the had is initiation begin, ended on ended equivalents including share the associated XXXX. The related fund million XXXX, I increase development well the was results. year in of of year XX, catalysts officers associated Before the primarily directors the million general loss to General of of program well expected Research attributable year I'll efficacy Net the with capitalized per XXXX. in company's XXXX. ended as March remains $XX.X projections the expenditures ended dollars expenses administrative references GMP and through MDNAXX, $XX.X the the Canadian the of the increase year expense $XX.X MDNAXX million March year in single and We loss higher year $X.X marketable our during of that QX March expenses for the of Medicenna with March including March August of listing prior months ended expenditures a net were year research of study. XXXX. key XX, is unless March current with compared XX, XX, only March XXXX, XXXX, Phase XX, compared NASDAQ otherwise year period. XX, listing based or administrative development of manufacturing in and compared a $X.XX with trial with with attributed compared share were primarily a was expenses XXXX, million to XXXX, and was clinical ended during or in million XX, year corresponding during March clinical incurred premiums to incurred full year-over-year The compared one-time of in and costs insurance costs and eight associated late the

now on available EDGAR, hand to please to details I'll our and financial which further the analysis, respectively. our Fahar will to discussion back prior the concluding remarks on for be session. call Q&A statements and management's SEDAR refer and For financials, some

Fahar Merchant

Liz. Thanks,

ahead thus first as Cytokine we XXXX, encouraging. the value inflection look July. PD key points, cohort from seen end we the as advancing data clinical X are and we well Summit at of fiscal three three including data As far have pleased towards from cohorts the cohorts to into The the from PK potential be is pharmacodynamic data at

platforms year design into and who creation. Superkine made we trial opportunities pipeline fuel progress and our additional to have all parallel, considerable in contributed expansion BiSKITs escalation In to continue to like incorporated provide of to the cohort. continue those over value its we've learnings efforts, and moving by our that, which now expect trial for we'll preclinical our for value the last have investigators as of to I'd its challenging thank novel open success early provide patients the have patients includes dose partners, We the fourth that their benefits. and with circumstances. clinical enroll well forward ultimate generate This key from for our under our advancing us Operator? participants to shareholder and families. clinical Their work employees, efforts goal positioned past And cytokine-based we meaningful with towards questions. lines developing continue immunotherapies

Operator

Thank you.

We a with from be a will conducting the questions first Biegler answer Instructions] question. now question-and- Our of [Operator Matt line come question. proceed with Oppenheimer. your Please

Matt Biegler

for Thanks Guys. from Hey, us. the update. Two

can some that the patients respond far? had comment then a on inhibitor sarcoma safety so expect that's related you're around of side many mix of the to effects. like or checkpoint seems a priming you seeing tumor maybe a far, First, to the or you've patients wouldn't And Proleukin enrolled dose. like of signal matter? immunotherapy question commentary or to on really ABILITY get types the It maybe like interesting so you in way most CRs that for seems the around a to I that It us had

were know commentary bempeg, because believe. their with said, So they and CRs is that's what appreciate what I dose-limiting especially I saw of the that I and around kind that toxicities

that because with in wouldn't this like really that's struggled vascular right? syndrome, with. So what Proleukin see to count would of for non-alphas, something obviously a blood maybe or you drug, And neutropenia now we changes DLTs the types expect expect something leak

we forward. what out terms kind think be just the kind in safety Thanks. for in of profile you of looking I'm So should interested going drug of

Fahar Merchant

Matt. Thanks, your Thanks for Great. questions.

had with to a of in a open on pass trial the during I'll Martin range types respect wide types, to in we So just of escalation the patients. the clinical covering a the to you profile dose moment, tumor it it tumor recall, portion tumor but study, kept of as pan

patients study also have et included We've patients the as melanoma pancreatic -- tumor. carcinoma the as that of you've patients pleomorphic first of So patients, we've squamous I've as version noted, seen in in not with the with well with adenocarcinoma metastatic eight again, as patients patients metastatic tonsil, had sarcoma, so with far cell ductal only cetera. we

carcinoma with a may these group that cohort potentially will see will as of plan during phase patients be it's dose focusing we the -- the patient escalation much we we as another So expansion patients benefit that beginning population of very and as we dose patients renal to study, the with mixed to melanoma see well. include on and metastatic cell proceed of

So we these sort the right. of When in include. XX as the control, patients seen had look we of of you're both third haven't encouraging considering total. finalized that that's patients you large said, centimeters masses on sarcoma But we've that over sign group at tumor have may is clearly, the you patients rather tumor

far. drug sort I bit it are So on can you with of Martin? will give so that, to on what we who we -- the Martin, seeing of and pass a of background the features safety

Martin Bexon

Sure. Thanks, Fahar.

sarcoma, clinical study that described a expecting dose tend first-in-human efficacy to as studies said, Fahar and as neck you also we've as a yeah, such, coupled a see clinical where effects. early-stage atypical as doses to the ranges, expect dose certainly might in at We the in ranges of well where wide And not look of narrow with with had to lower lot a certain and/or expedite we're types GI go of, dose tumor to upper [indiscernible], let's that that stages know, but bit at down range, all and consideration. of terms we throw definitively into of in as being to be cancer, we the neck do terms you've all it cell think I these look mixed a limiting able had safety to not early of we really will bag. say, we head

Matt Biegler

a on just Then profile? maybe the comment safety

Fahar Merchant

seems sorry, -- is line it Martin's basically -- -- so through. Martin, you think like coming can But not okay. I

off. think you I cutting sort So are of

the safety yeah. can features of expected sort question we DLTs, you if what might of expect, see Let's -- about was

Martin Bexon

way not we've some of of whole What is consistent us emerging with that of of seen of whole setting that terms and in simple with past or in in easily is whether These clinical in is those with I infusion are in light measures. work drugs managed immune sometimes experience that, this what is been would those are consistent an investigators the terms of think I've uncertainly upset have active the we've with or so I for of far pattern, events to that without terms a the of normal and these range across with a And terms worse this by monoclonals immuno-oncology fevers, seen [indiscernible] range say, cold, a things the and seen bispecifics a chills the agents toxicities, telling of families with reactions, are it really. intestinal it date. are abdominal patients process clinic severity, are,

without so date, that of way And see as what pattern DLTs? And consistent multiple immuno-oncology of expect to do by I with say, Well, reassuring, And as think. is I to classes that. I effective think you is treatment. we to dosing we think the risk biologically acknowledge, end toxicities. And minimize designed up might dose dosing the having doing is what a seen step-up of reaching seeing I

already go one levels that to be lot the think things we But that and date of whole have suggest in we to pharmacodynamically that. if steps. two way would would further that need maybe I or we're my So further top the terms we a in wouldn't than go dose that what done hope activity stay on we of of seeing

in be the phase won't study. toxicity the of we we status expand possibly, a quite when next limited So for

Dan Ferry

Martin. you, Thank Okay.

Operator

Thank you.

Please come of with the David questions Bloom Our Burton. your line Martin next questions. from proceed with

David Martin

will from fever see Hi. or My be is could sign that early syndrome is, first leak question disconnected an you it BLS? the vascular

Fahar Merchant

thoughts your on that? Martin,

Martin Bexon

Yeah.

finding. think non-specific it's a I

pattern it's are a general of instead classes and that it's but dose. of periodic say, with pattern the consistent, some seen say, to IL that BLS. non-specific say I I individuals the bit Yeah, more multiple would -- As consistent isn't across features with that IRR more have drug, the impossible might severity it's

David Martin

these eosinophilia But at sign there no doses. was of

Martin Bexon

That's correct.

outside the categories previously far been So of have the eosinophilia remained described IL-X with have therapy. high-risk counts that

David Martin

Okay.

far as strategy and the the the taken any you Have reducing patients issues? successful to step-up as question. dose cohort the Next X of third has tolerability in being

Fahar Merchant

Yes.

-- microgram can Sorry. you the mean? Matt, the a have already. what So wanted gone dose when have bit Yeah, next XXX gone dose to through just patients to I more step yes, the say priming X cohort and we clarify David, you wanted you just that to up, to

the So that you Is been that's mean? what case.

David Martin

has Yeah. and they of are XX? that drug the How those many at patients happened with tolerating

Fahar Merchant

Yeah.

know, So mistaken, cohort. this fixed -- least for essentially, be we patients cohort in have the gone do haven't to DLTs I'm through three DLTs patients had any and not you in the monitored X yet. that And at dose we would -- any we have if that the two study for matter seen XX as have micrograms we've first of

David Martin

all patients disease XX? Were three the they control? were with cohort Which Okay. in the

Fahar Merchant

target So you're of when -- tumor XX we first looking two dose. terms had were at lesions, at the -- in the patients control microgram

of in four with target patients a microgram of total with that We cohort, we tumor but showing stabilization. also was XX the had the in signs control in had lesions the those had a up, had patients, XX of patients microgram of, sort additional in lesion which patients the but having these target it, we Out four lesions call patient X dose, three was third cohort. dose,

benefit of So not in showing target lesions cohort treatment. additional up post three patients lesions with of out on the X, four any them so one having

microgram break early early too to seen, but we've down, it's as I So activity as dose. as the said, it XX

David Martin

the point. the response And with they there any Were range cohort include this patients any like have the at disease a shrinkage? all in can shrinkage wide to tumors? there third of Was scans had control

Fahar Merchant

Yes, they were.

David Martin

of the still are drug the control? what the patients disease has duration And on and been Okay.

Fahar Merchant

Yeah.

July. we provide at a data more conference that expect late in will of We

for So other on off later additional all we'll on. data hold those

David Martin

And third Okay. progressed? last any cohort, renal who question, patients in the melanoma carcinoma cell were there or

Fahar Merchant

of individual and and what profiles, including in treatments but sort have conference of the patients we'll the PK/PD to data prognostic each conference it cetera. at the more tumors, Again, that so break the sort of prior the data, type were, not more ability data, compile the share on for patient of those only of we of detail information tumor down the some et additional that and burden factors also

David Martin

and disease what sarcomas third who at the like what Can say tumor what two you control, the they of had drug? patient had type least was

Fahar Merchant

Yeah, one was melanoma.

David Martin

Okay. That’s it from me. Thanks.

Operator

you. Thank

with JonesTrading. line Please of next your proceed Novack come with Catherine from Our questions. questions the

Catherine Novack

so question. Hi. taking Thanks my much for

given The of can the expansion in you BiSKITs program, with how Thank you is associated the lymphocyte of are the updated given then then clinical results? question us remind us you escalation you. translatable line dose want the first, is measures patients study, of BiSKIT time cash on these extending I to into are my give the ask, degree baseline what And And clinic? in IL-X? the on responses can the currently an taking, low getting runway second count early

Fahar Merchant

That's great.

regarding the answering as respect to Superkine that second with just have working on, your program, first reported with data we is the first anti-PD-X at question AACR some we're which IL-X know, BiSKIT fusion. an meeting you the So BiSKIT

this plans continue excitement at in a program the of see that's is obviously that optimize around. anti-PD-X done mouse work the to quite version we've a The to essentially anti-PD-X. respect that so So of would, using this and us a we molecule The time, domain. moment particular bit interest far with for

a company has So potential the identify partnering to that anti-PD-X. we own be kind of human right will its looking with

so, early ready have go molecule are process be the next the XXXX. completed we the more until optimization trial that with would So eventually any months of towards and to or happens, initiating preclinical clinic, would that perhaps the clinical I additional version very the a XX in say, we for studies end into

very where research is moment. not work still that a the impact in So as BiSKITs on materially spend our at impact situation it's going the a looking the at much project are of we the to scenario,

question lymphocytes, around et raised Now the expansion the other of you the was that cetera.

You're increases population demonstrated that's specific from correlation data types right. a least for immune At instance. versus responses, respect others, other with at you there's of between don't population studies confirmed Proleukin correlation moment, -- with or no the in prior we cell to if those tumor back actually go to changes in

to lymphocyte on. that have the counts that MDNAXX, so have increases associated with Proleukin, I seeing tumor However, better must response threefold are we of baseline for although respect and with about to already We're with patients low. instance, with say in been of counts outcomes that these two seen

sort sort as going We screening future of a cohorts, count our better baseline. of forward of lymphocyte we're -- for have with patients that have

hope been tend typically As That's to the you the above know, doses, that from X,XXX. be baseline the see most lymphocyte in with forward high drug. escalation to and enroll you'll the other competing what Proleukin we has dose of we to there, patients most going dose that get the doing agents would counts at well including that doing so out these done can expansion the patients work benefit

effect baseline expect you are going know, as of we forward immunotherapy more any counts that the I cetera. we et more lot to be So pronounced patients that? a to add to if want patients, typically used MDNAXX Martin, enroll don't with in more

Martin Bexon

to No, an at subpopulations. I think look continuing mean, awful analyze don't really to I and I lot. we're data this have

additional bit insight we have biomarker we will as presentations forward, to a go. more of provide a we couple the going calendar that think I in aim

Fahar Merchant

counts level count. really seeing of be are the what baseline encouraged would in lymphocyte patients that tumor have is much Right. very the than we normally about been what the baseline despite these control threshold I think And lower

of that's tumor ahead at counts we're counts, or with the and that moment, baseline have cell that, higher and lymphocyte at more have seen the doses these pretreated heavily fact really pretreatment expecting patients CDX cell counts, have see we what really NK enroll tumor baseline that very us counts particularly poor also for lymphocyte a clinical to are burdens who control control et we T exciting, or climb to see increases respect have in So the in looks us, with cetera. for compelling to And levels is seeing a much I these patients are despite large trial. to the despite see tumor patients these think, the as kind reasonable we

lower cells would greater were So generally much at of actual look first three forward of the much going T NK populations forward counts cells, increases where instead to, in I CDX cohorts baseline. lymphocyte expect the the

Catherine Novack

that Or can Is can it. to you see something Got bit in give little granularity that cohort that? more we X? on a expect me starting

Fahar Merchant

yes. And been would that I regulatory agencies three X we protocol. amendment expect onwards. that all The expansion that phase with we've has set those course, so into well, the approved up of say cohort now in as

Catherine Novack

Very Appreciate it. Got it. helpful Yeah.

Operator

you. Thank

with come proceed RK Wainwright. questions. line Please questions next the Our from your H.C. of with

Swayampakula Ramakanth

Most of answered you. questions have Thank with that. my been

to given answers Just these have make and two I'm but general trying just probably already, questions you sure. to

So and in like these doses, exposure with before increasing four. can dose are the two ABILITY cohort doses so X the increase I'm for to X you be X this that dose you're going assuming where you go priming level to

planning and the So final dose the interval and to fixed that get dose two or is no, you yes to what's dose? the before between also, the two is doses the three? And timing

Fahar Merchant

Yeah.

priming -- dose we've at two a So the the kilogram doses is give that is as bit at are you microgram dose dose. it a And patients. for that seen first here clinically of so which just to is per far background a as XX at beneficial

at patients microgram those the dose. actually XX-microgram lower control So We've much therefore, seen in call doses very doses, the although dose, them the we doses. XX effective profoundly. are immune XX-microgram I at are we priming not that tumor dosing would substantially And stimulating system say

that the once So reduced that's weeks, to the it's one dose. of dose on And then or whether treatments priming fixed a interval really two has irrespective moving That's here. the XX-microgram first the of doing changed. are not dose, between things we every

RK? Does that has stayed weeks. every question, regimen two So once at answer the dosing your

Swayampakula Ramakanth

think Yeah. you're type target planning your now? of what that that MDNAXX Fantastic. question are the two seen right good have the a the you from data from tumors have the on is competitors, so Then other of in do data far I you and tumors for also various outside

Fahar Merchant

to tumor disease would of had patients burdens see very encouraging that to of in these see baseline of I control forms with very a considering for sarcomas, aggressive and say that tumor surprising large both us in these sarcomas, population. stable sort was are rare of sarcomas was therefore, that kind what patient patients

-- are different with As or you IL-X, not used immunotherapies generally used they are with sort have inhibitors. of know, generally checkpoint sarcomas neither

finding very a new So that novel we was encouraging. found that

to our continue enroll tumor we'll mandates types. with protocol be that course, will of forward, as enrolling patients Going different

that to checkpoint tumor will inhibitors, However, generally of or respond types a have be responding to the instance. history have prior on focus for

patients So of that's for would likely exposure prior that with inhibitors do to that be going even would our checkpoint better. expectation or normally patients qualify to sort immunotherapies

going we patients that immunotherapies patients rather that the prior study do enroll patients to have in to be those or exposure that patients. normally immunotherapies making in approved continue forward, respond are have for the no to those not than enrolled patients will we as that So are more selective sure been those

respond or expect So to patients immune inhibitors cancer we had typically again, role, say, that I are as well. sort sarcomas, the although, to system with not a those we of in focusing tumor types to know play pancreatic other as immunotherapies. addition we've major two those on that checkpoint We would patients

patient expansion to So most likely we such immunotherapies, benefit dose that into as the course, is dose with fine-tuning of get the MDNAXX. the with we population are drug, as with patient the intent, our right phase to escalate population the

Swayampakula Ramakanth

you it very Thank color. Appreciate for much good luck. and Perfect. that

Fahar Merchant

Thank you.

Operator

you. Thank

your Our Uddin line next questions. with questions come Please with proceed from the of Andre Capital. Research

Andre Uddin

Hi, Fahar and Liz.

MDNAXX wondering a of us on business if give and progressing? Just could how Thanks. the licensing update development you that's

Fahar Merchant

Right. Yes.

commercial might but put XX course, collaboration, purposes, our as conducting also the different completed different U.S. a press earlier would of analysis XX release, done, pricing following getting the agencies with to the both payers and feedback was market nevertheless, as for for with KOLs, be. primary insurance that that from from of partner and So potential that opportunity, us and that In in able in which U.S. available. companies, thorough these find to as that pricing to we to in out cases, et now MDNAXX, comprehensive for we've in from really there I was interviews reimbursement place, market potential to we us, a hospitals this were in very -- the well know, payers, partners these respect across that we've from And research be. XX MDNAXX place. our from course, of And for to agencies, not was and feedback interactions needed might And those have, as with year, about respect very ourselves, important for whether adoption at sure cetera, call expectation Europe KOLs, of address Europe, and in kind reimbursement what what make seen out something supportive the we be might what have positive what that with would you have complete which say of mentioned bit all and it's a information of be we insurance also today, MDNAXX we

of we additional is feature I based of which administration there. drug administration the a is the approved discouraged announced well, directly past, tumor where our being going key virus partners out us potential sort a drug approved give that's that boxes partners of think forward nothing is fact are in authorities. There check therapy, until brain with. discussions Daiichi that that's intracranially with two something of other a the they that Japanese had recently, administered something the is was by very is not as does in But localized potential progressing it which So

And has consistent oncology you and of increased information of a in external is, control see, clinical substantially improved can awareness as bit perspective. trials. third or the of that there that different also using MDNAXX an profile arm from So

fully get as renewed period the updates seen but and that at partner, progressing we time on make are a we provide quite we we'll and and we several process months, definitely a of this to moment. process continues. we've announcements past meaningful regarding the So over those MDNAXX, of a And discussions, engaged interest bit a more can closer advancing when are with

Andre Uddin

you, Farah. Thank Great.

Operator

Thank you.

with your with from Brookline proceed of Kumar Raja Our questions. the next questions Please come Capital. line

Shubhendu Roy

for Kumar. I'm questions. taking our for Shubhendu Thank you

it you implications some IL-XX do clinic? to about the color if it and programs, to you. the regards sort before thinking to non-human how of want on with MDNAXXX are further And can in? test the so the taking you program, MDNAXXX BiSKITs primates test So Thank plan it, for it you provide to the you in

Fahar Merchant

Right.

that molecule, have whether to earlier, typically steps we to could is is So mentioned course. Medicenna, working whether of will we as anti-PD-X are mouse I far, to feasible, so human fuse comes be anti-PD-X the the or version BiSKIT, as IL-X our into with done, IL-X that with planning this not this of of the do. which said, The been bringing with, we've concept to approach version right us anti-PD-X we able which I particular identify that it be something next demonstrate

is, preference with to Our have companies of course, work inhibitors. checkpoint that

different sort analyzing at comfort checkpoint that of looking with marketplace different provides we starting inhibitor are with this or and can additional have the together a that program. that collaborators their so checkpoint and in be we'll forward, going some approaching work So Medicenna inhibitors does not that use the clearly checkpoint clinical we scratch are not from inhibitor already a potential in

months. Superkines. in next other, IND-enabling just next position a IL-X have that end this candidate ideal molecules are of further as expect with done generally We primate each as where months particularly So be would MDNAXX, studies. do two away identify are not with into past, bifunctional These our of that to studies But second situations these will in some sometimes you process pilot obviously to the half and towards good an in including are take the sort nevertheless, like we'll planned to point. But we've we the pursue non-human that that nine up with we But to might from Superkine in being programs. clinic. XX year with proceed. you the the as take program, And we

is the the With when work our cold therefore, not works tumors, optimization also combined -- XXX and plan with to particularly we MDNAXX IL domain. only on additional Fc fused it seen some molecule, but itself, be on, in that that molecule XXX we've there currently our to will

optimization it It scaffold. for instance, further cetera. might with protein do right to et the expect be We with albumin trying

this proof-of-concept There's although, more continue at to BiSKITs again, have quite that of MDNAXXX we mouse as to well. will demonstrated be new that molecule, is the report to the So molecular studies in IND-enabling at molecule well again further optimized or done, respect as conferences these with work models, versions for and we as primates data ready both not stage. nonhuman

Shubhendu Roy

you useful. to ABILITY Great. Yes, very study, with some do Okay. that's studies the planning regards with And inhibitors. were to just combination checkpoint

they So fair have you when would recruit they you that CPI patients, time do any those or studies? line be And can also you you that? share initiate with the naive? think could when And combination treatment would

Fahar Merchant

Yeah.

want course, study certainly to dose, to next activity. So the study Phase recommended of at the of see is of We study populations expansion are moment. the different is Phase want ABILITY the with identify responses. our established the a single-agent single-agent the Once of benefiting X/X part the phase monotherapy to conduct us patient X dose combination the we've We will in and see that help three setting. single-agent which tumor step,

with a expect get an plan MDNAXX is there. The the anti-PD-X already molecule market. that's that in We that, us to is for to combine reasonable threshold

optimizing that into the combination towards in announce the the for And next would in right combination will be the plan obviously expand us with We half future. before the dose first year we the is setting initially time the proceed setting. to of

X we'll administer we will very Phase So the setting, it's level therapies dose start time, single-agent expansion well. dose the dose arm at have in the is same as combine minus recommend likely the -- typically, is, the and finalizing before in X at we when it not a combination the unusual happens them what although two that phase of RPX the combination setting in to dose the

So I that's year. said in of half first that more the likely next

Shubhendu Roy

much. so you Thank

Fahar Merchant

welcome. You’re

Operator

Thank you.

line David Please Zacks Our with questions. next questions Bautz of the proceed your Research. come from with

David Bautz

Good Hey. everyone. morning,

Just from one MDNAXX question me. on

tumor or results and types T that those study in those responses, the For kind cell characteristics with patient you've killer seen different any with you natural your have of pharmacodynamic consistent responses? far the have other cell been that correlate across so seen

Fahar Merchant

-- all types. cetera, we've difficult a or obviously, and to cells, is patients, of seen make T mentioned, of across number correlations, NK cells, just CDX any, patient tumor if the to But Yeah, exists. the therefore, as as expansion patients I different judgment et eight changes what

So really encouraging. that is

a So of it's levels. tumor has irrespective baseline but of course, each different type, what patient

us have tumor at just this types, impact, but got So it's patients, some for numbers cetera. that correlate difficult haven't might enough data we With et to kind of with an on different eight those data moment.

during we So to continue we of patients the would if if there as I to or PD we'll more expansion We'll to probably that see would phase profile dose the more are see through. expect any study. on get of clearly changes characteristics patient expect data the and see trends enroll more other not. coming that tumor able be are occurring based more or

David Bautz

Thanks Great. the question. for Okay. taking

Fahar Merchant

welcome. You’re

Operator

Thank you.

I'd question-and-answer any for to Merchant now back We our remarks. Fahar the have of session. like over to the reached hand end call closing

Fahar Merchant

we Clearly, although who lowest in dose so hope difficult-to-treat again today. and study you, three are cohorts the say further of first joined see cohorts all operator, the would with seen far data I are we've of the to Well, the to MDNAXX population. you these us as in thanks that patient that so we're far, thank benefit early have escalate. We excited this

Thank on wish over updates coming let finally, providing be progress. day. So the months And a everyone me will we good you. periodic our very

Operator

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

now may lines. You disconnect your

Medicenna Therapeutics (MDNAF) 22 Jun 222022 Q4 Earnings call transcript