MDNA - Earnings call transcript Q1 2023 | Medicenna Therapeutics Corp.

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Operator

Greetings, and welcome to the Medicenna Therapeutics Corp.

First Quarter Fiscal 2023 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. pleasure your my of Dan now LifeSci. is to host, introduce Ferry It you. Thank

You may proceed.

Dan Ferry

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

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

with MDNAXX, facts, additional potential meaning information forward-looking BiSKITs will like that forward-looking shared statements other preliminary begin, be statements remind that clinical statements and prove clinical you are of in the and regulators cause and Canada and the company by actual detailed uncertainties. I results forward-looking of the There differ information other risks such operations factors, potential to that statements and materially XX-F risks, Listeners including future to constitute the runway, MDNAXX, of to actual results future no filings call, events uncertainties, other would States. statements company's a to in cash in data many from may and to to the the and Annual to applicable the could in predicted, from factors relate include are which numerous materially All shared cause we or the of activities, applicable Analysis time-to-time as differ could assurance are during other and subject related made laws. result company. materially this statements company, Management's be control from prove of United development Discussion the Before the certain Superkine those actual beyond that of during than historical Form and securities Important information statements and used that and from anticipated of of accurate, the in presentation Information within are company, securities be those that that and of such results known the this circumstances data, the platform, preparation assumptions risks could of other the may call, of and unknown Events the differ programs, and statements. facts are expectations, historical to and milestones partnering Form, cautioned not the incorrect. the any the

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

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

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

Fahar Merchant

Thanks, good Dan, morning, everyone. and

be fiscal from then most During MDNAXX's, our Officer, will data, rationale results financing. today's on presentation anti-cancer comments our report Financial also by recent evidence to Medicenna's of clinical recent like of exciting agent activity. followed This focus call, providing most single conference I'd preliminary discussion and Williams, Chief you and for an first quarter our will overview who with Liz provide financial

acknowledge number a costly, we key with was of While this it that bring does it financing positives.

healthcare-focused fundamental financing. institutional participated investors, First, a in selection this of

very overhang this financing removes future the for foreseeable the difficult it in Second, markets.

us I you of of I And readiness. mentioned, to the to the us study. of on Liz in a advance to build allows importantly, share Fourth, data pursue back And of arm provide Phase X/X clinical complete clinical it us financial And footing one sound with BiSKIT it for and shortly. will combination the positive momentum collaborations to ABILITY Third, clarity as combination later the that puts enables candidates on. most IND will novel the our finally, ABILITY additional in study.

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improvement engineered clinical stimulate using subsequently beta, a to MDNAXX doses. and confer affinity allowing mutations that five in the for more therapies the was at evolution, XX-fold cells immune IL-X potently MDNAXX receptor response that IL-X with low to First, cancer-killing directed drive

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elaborate. me Let

signs tumor ABILITY will doses. support and are four than outlook study, dose killer via to shown dose Tregs, preliminary increases issues control seen equivalent achieved of stimulation been share toxicities without encouraging treated weeks. not have strong limiting Tregs PK Tregs. dose the was and the mechanistic those any in highly every once have Pharmacodynamic or we immunosuppressive foremost, Furthermore, dose are of T I treatment administered and ICOS-positive fueling cells that that have There and due later. or IL-X curve, infusion, at levels. under resistance discontinuation our provide as IV results on infusions. multi-fold in competing being First or have CD-X-positive studies accompanied including greater dose-dependent Also, patients no expected, the limited to eosinophil linked administered that This XX by increases IL-X any of of cells of immunogenicity two to area repeated patients the safety data anti-cancer data with in for optimism pharmacodynamic the MDNAXX each upon no This the the ICOS-positive agents natural are is significant therapy. the interruptions, with in shown any C-max of de-escalation as at

IL-X most Proleukin's with addition, eosinophil leak differentiates associated are variants. In what These is from of MDNAXX side highlight pharmacodynamic vascular which high syndrome, competing one effects. counts results serious

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when in an a oncolytic armed could of cancer, models research with MDNAXX, to finding, dose MDNAXX's patient XX% monotherapy MDNAXX, comprehensive a of pancreatic with higher, and as the Collectively, version of highly aggressive responses pancreatic demonstrated escalation single of from an view from first-generation complete group Although dose effects update pancreatic cancer, mid-stage studies model We early by provide this we believe as encouraging quarter trial's of agent additional population. in followed tumor a anti-tumor of independent that we any not cohorts cancer. fourth very model escalation this aspects data in push response several an preclinical They MDMAXX, of over ABILITY's continue showed remarkable early the in dosing this MDNAXXX, activity. sign a have especially hamster response deliver with considering the conducted virus, year. of

we have First, which there's disease observed in control. the tumor types,

and sarcoma, includes are to to this ductal highly that resistant adenocarcinoma, treat, mentioned, difficult two historically As and pancreatic cancers, immunotherapies. very

to of therapy. Lymphocytes, trial relapsed counts. one third, checkpoint killing history All is from and killer studies lymphocyte can is sites therapies. the CD-X-positive cells, therapy, patients treatment XX, baseline enrolled include who four to-date the XX systemic failed the what are there And effectors which glean or including has cancer there unresponsive of ABILITY's of lines inhibitor information prior Second, patients. in IL-X the between and the of cells, measurements T natural we on

expansion that study measurements to majority are much are those types ABILITY counts consistent high immunosuppressive of Importantly, and patients with would of higher patients lymphocyte the step-up protocol baseline per histories. shown the clinical see Proleukin. kilogram Proleukin. kilogram prior the receiving in-line XX in dose on to have trial enrolled, will based Based fixed on this to-date, doses cohort, these study followed response we expect, MDNAXX's MDNAXX, of fifth suggests have are subsequent evaluates the in what lymphocyte This portion at by which of of treat, ABILITY information, to made what ensure to effect the entering baseline been our tumors have that we that patients correlate counts highly XX than that that and per microgram escalation a the and patients amended difficult two more lymphocyte seen we'd priming study. to with to extremely the we see with dose. with This When went into amendment counts dose microgram ABILITY expect looking studies lower

of of doses with looking MDNAXX and much immunosuppressive signs this signs data we of more to with we to where highly are tumors, very subsequent see clinical in early activity seen efficacy. cohorts, hope lower the from we've Given patients meaningful forward

administered trial to a the to are currently in fifth improving this we during increase now dose patients, toxicities in escalation doses we limiting the of dosing dose aiming patients a protocol exploring in With and setting. to-date. no ABILITY's being step-up portion higher study, chances are patient reported of agent single Looking enrolling with ahead, our cohort, further outcomes

we of Next the expect anti-tumor calendar from month, escalation quarter cohort. trials data we expect fifth year, the initial cohort. activity from report escalation activity trial's fourth additional anti-tumor In announce data dose to to dose the fourth

phases, into and ABILITY's middle half year calendar data and from report respectively. the combination of single-agent ahead second anti-tumor we expansion to Looking XXXX, expect activity the

on future to may ABILITY inflection enrollment agent key unresponsive of this immunotherapies, will For better be of MDNAXX's the interest next of expansion received cell to critical benefit A number such of the and to in readouts that be tumor treatment immunotherapies. cancer. intend a with and studies, will approval, a other MDNAXX's inform derisk for potentially would and inform hone patients types for phases, known to goal renal the company to and that single be for Doing and will be tumor paradigm carcinoma particular we select pancreatic metastatic development to called into types tumor other from as additional which, has and failed Proleukin melanoma, present FDA to activity. further generate patients have better study's point evidence a types

So that Liz, results review our recent quarter, provide financial Liz? the run so the she clinical of through and hand fiscal to complete, from overview off can will I with financing. first an

Liz Williams

thanks And Fahar. to Thanks, listening. all

part important for able number companies. I'll million financing biotech reasons. for references the dollars announced this number summer environment the week difficult attract of capital begin, it raise pleased of new investors financing. that to offering very are midst of to that that. were all to of for a Medicenna in note We a be otherwise in last I Before Canadian Medicenna key noted $XX believe unit as We a of a this completion unless healthcare-focused was

funding the was of position arm to as Firstly, study. Phase funded not a particularly This completion. study sufficient ABILITY the of existing in to having combination wanted initiate MDNAXX to X/X be our we important, is

to and of anti-PD-X, of study, in combination with provide we that establish ABILITY a purchase drug sufficient charge, capital arm Medicenna collaboration a need outright, including the free requires to pharma order have previously to can very anti-PD-X a the arm. study the company who to As expensive the an to combination an disclosed, demonstrate we complete

company at Medicenna's not and shelf be a market by downturn and end increasing process Due future corresponding of current ability refile to biotech the will the Secondly, prospective at shelf point. market our a is shelf of rules, perspective, similar to the in August. a the we're to in position the baby complexity limiting expires fund caught our the reduction and capitalization,

with Finally, wanted the as the to overhang we the above, Fahar future, stock. key of was remove a financing number discussed in near coming milestones that on

a Given we than would of cash, positive upon market news, such limits news. the had less that to year expect of impact the which financing often

we events Our sufficiently that news anticipating accordingly. of increase the the market financing, the have catalysts, company of the hope will company, the and that now valuation not in funded be is will a positive

XX, quarter a in the ended quarter result June per XX, XXXX decrease the a reduced share Based prior XXXX share, As XXXX, for XXXX development XX, primarily for quarter the were ended operations $X.X $X.X during research had XXXX. XX, of us General were was or in along net upcoming to marketable on as were associated in to current cash loss GMP the costs XXXX. in June the of years' the XX, on offering, ended XXXX. June the June development in incurred incurred XXXX, comparable fiscal expenses year. and loss XX, June well sufficient to in studies, our capital through cash and year and and was and the the $X.X during ended XX, $X.X catalysts. development quarter of with ended well-capitalized quarter securities for current administrative including cash manufacturing in quarter The proceeds the which and year, The of consistent $X.XX compared million and ended or June XXXX calendar the incurred with important the XX, were primarily with Net as $X.X the June million. XXXX, from our no expenses IND-enabling $X.XX ended recently incurred quarter loss equivalents million, have million of $XX.X XX, attributed quarter June is during expenses and development spending. compared of General expenses million quarter hand with MDNAXX per net closed ended leaving research expenses Research fund decrease compared incurred administrative Medicenna of we June quarter-over-quarter. the million for

our our to that, Discussion on on refer Management's details Statements to will concluding session. available further please Financial move and With will beginning remarks now the Q&A be For and before and SEDAR Fahar Analysis from on respectively. some financials, which EDGAR we

Fahar Merchant

reiterating as Proleukin ABILITY confidence, native conclude Thanks, key key three XXXX administered studies updates dose, that towards move Liz. clinical I'd benefit. a to high give shown IL-X we the Prior that with points from like into by study. fiscal provide us meaningful and when at have

is utility due burdensome and its safety profiles. to which are dose unit, its in However, by need schedule administration intensive the the hampered and to care pharmacokinetic poor

competing we Second, designed With and affinity agents to Proleukin's to overcome unique to beta, we specifically efficacy. that no will yield for differentiated alpha, a believe IL-X has receptor Proleukin receptor taking and enhanced shortcomings. MDNAXX a profile improved binding IL-X are affinity compared approach

development. is Third clinical the in albuminated MDNAXX only IL-X

nodes, to potential. And evidence ABILITY crucial fighting the best-in-class In supporting both addition finally, unique the localize for proliferation albumins in are readout continues of study to from additional to each effective lymph cells. antigen of microenvironment in and half-life, tumor to tumor-draining passing which has immune ability accumulate MDNAXX's presentation the and provide the cancer extension,

a profile, have look would for treat tumor signs seen believe Operator? cells thus cancer difficult to the types With to we hone lines partial including anti-cancer will far strongest tumors of activity as have questions. I open of and dataset, heavily we escalate impact. to continue that to an in the immune adding stimulation patient. dose of have We pancreatic anti-tumor this the that that. pretreated like forward activation encouraging We now MDMAXX response on been to to patients lymphocytes, in favorable in pro-tumor prior safety unresponsive total therapies, without unconfirmed and with

Operator

Thank you.

with session. Please [Operator Instructions] now question Matt first Oppenheimer. conduct We Biegler Our from the comes proceed. question-and-answer will

Matt Biegler

maybe more broadly Great. how I KEYTRUDA Congrats, on work it's general, guys data, speak in approved Fahar, and to early indicated or on seriously. actually including therapies the don't the just there. believe IL that PDAC

kind tolerability because a And So and I not like the I far, safety it strikes lightning conference. think from about second, least so event? we've the is on of seen much it's from wanted maybe this just -- and to don't then that, at cytokine ask too

our in on it's So be your these was you a stock it would Because data. or cap IL-X the disconnect that? -- general, broadly of price current experience of consistent to say there with there anything say seems you quality can -- and and between just the market

I interested, So and you but if great. a anything be know investors talked why, any would little could maybe bit market help I'm dynamics, have Thanks. that you about else just thoughts

Fahar Merchant

and for thanks question. Great. Thanks, your Matt,

the in So first, terms second every continuing dosing we me foremost, of regimen namely, the two encouraging. are that's safety with let altering question weeks, answer not from perspective. first and the so a treatment Clearly,

mentioned last was a in cohorts, had on for dose generally -- did generally second that as events events primate we for let's generally that but say, show which conducted the you early I with as the the to had moving eventually. find, the mice. been higher similar And we at studies and would higher have fever only not a also, as dose of, a non-human or adverse generally or these what those instance, had up that the be instance, would in studies, the to subsequent if even receive find -- also, early doses, patients at fever, would shorter tendency first treatments, low look would And fever chills, escalation then what first had will patient when anything longer. doses, is However, threshold, that in subsequent earlier, observed, also duration adverse dose see a we of we doses, we and not have

we treatment sort to patients, MDNAXX, case, patients, dose dose an we why them the Because we proactive patient. the is unhindered important. for kind four proceed the see of if proceeds trial, that So patients where in do the we -- we couple are active. is how said, to you so that or that's by which get we'd sense weeks, found decided even a a therapeutically the a with we is clinical employed of weeks, the what enroll receive were benefit. proactively that administer And patients okay, where to do might was approach, doses for of That first not remember, end-stage escalation not in who of patient this are want likely in

benefits doses essentially that be foremost, makes We're dose. the leverage the ineligible as consistent trends seen sure first dose benefit situation seeing. at we to higher of So subsequently allows a a if needed first patient be prematurely benefit additional to potentially to therefore higher with make of that seeing microgram XX and and we And we -- XX started tend at for third, seem at us much to what to a we per patient, the dose kilogram was subsequently, or creating clinically was the the the we've and dose, to as better that tolerated, we're are and treatments. without escalate, the MDNAXX, fourth the even dose all escalate

think micrograms which of, been seen is dose really the Phase we've the six we kilogram, although per important, IL-X been data from drug. were X Alkermes' rather dose where from all a administered low they And results in I a trial. potent we've they trial, say, administered also as that cautious. is know. So It's and Phase X

is tolerated, fact less kilogram, dose which we trial. the received therefore is well the in patients, et double cetera dose, is BEMPEG, we've despite our well the doses were have de-escalation, the We in saw that taking had dose want study, we in are potent. when place. something This a XX they And that nectar, per that or our occur more and seen much first subsequent patients not the they did to at so also already BEMPEG micrograms our of molecule

approach avoids the step-up this prolonged drug in care for to to unit to in dosing of periods that stay intensive proceed of again, hospital a be allows an So patients administered or manner time. in having us

that of project move is along. as the important All we

where So basically we that's are safety with the profile.

FOLFIRINOX, we safety to causing checkpoints checkpoints respect cancer. approved provide well little none pancreatic been there can gemcitabine to for review we so on kilogram regimens with benefits It's safety see see think a at like profile in. as us activity But per a XX like at that that cancer, out patients. standard cancer. of that abraxane per old in what tend be and best of safety -- try the enrolling pancreatic would encouraging it is has combo be now care very the has the seems for kilogram, treatment true, And we're pancreatic a based the well. as from patients. been current cancer for XX innovative it's we doses range patients The And well and issues. that micrograms been data to I pancreatic Our these that committee higher therapeutic for additional micrograms dose, With as there's of and agreed to without have

in to to results happy you, patient. that own, patient. was one it's disease. it's generate we Remind see are promising this a MDNAXX, able one So challenging its just on And such

to want or patients tumor we obviously, type. So more see more this in

Matt Biegler

Understood.

But counts I looking with Are some going forward? Thanks, seems correlate Okay. baseline with those you about or counts talked forward? didn't again. another you you're it. lymphocyte at threshold? restrict little to only lymphocyte Or higher treatment bit about going the to to just biomarker is this I counts over that going you just up be how -- a going outcome. totally had and catch to a follow Are

Fahar Merchant

for at and range. trials, to the data, clinical including other XXX counts cases, baseline than Thanks question counts we as Matt. cohorts, BEMPEG, lymphocyte in not microliter. that lymphocyte results dose other half previous the in as microliter, that of including published so when was the allowed et largely patients as XXX we any found some in the Proleukin's the well, patients had from earlier we X,XXX Yeah, did baseline kind in to generally counts normal of per is, per that In baseline look a with about counts less which therapeutic -- counts We be patients these well IL-Xs, cetera. with study, meant we threshold, agents, have

other which requirement Proleukin, lymphocyte this something we seen what what the has is be is we've we've And that programs, that as to revised IL-X a above baseline amended with X,XXX, protocols. in done, our with Proleukin. seen including implemented So count we've in consistent have is

our that's five cohort minimum for requirement. going So be threshold enrollment onwards, to

Matt Biegler

Thank Got you. it.

Operator

Burton. Our David from next with comes proceed. question Martin Bloom Please

David Martin

good Yes, morning.

a last The Proleukin the the escalation, of done in the counts best kind to out baseline, with higher have in follow-up seeing question so of we're that dose well? one. they is First what your bearing as patients is lymphocyte far had trial have

Fahar Merchant

one the -- been It's counts Not necessarily. just is parameter. lymphocyte that obviously

and And just And imply a who to for Proleukin. XXX accomplish. the low. want counts counts, We we threshold -- seen have of lymphocyte not X,XXX Certainly disclosed or we encouraging and this we And count during started X,XXX need lymphocytes, counts the X,XXX exceed outcomes And X,XXX saw generally, it for seen, responses three hope for X,XXX, cohorts, was patient. is this X,XXX, per per into to we're in lymphocyte now, better conference, X,XXX. about as but it the to certainly that stable data in higher lymphocyte microliter, post-treatment up at over have they're now begin stable treatment months. dose so have patients in the at X,XXX to Proleukin, counts I of per or which we at stable or the disease, seeing baseline mentioned, counts patients that increase And is one tend to is the threshold the were of treatment of was increase they benefit. that to first or that in and about out lymphocyte of that closer have of three cohort down counts so, counts X,XXX microliter instance, generally has with there's the July, to data benefits. we these tend quite these XXX X,XXX do is see, as cohort the we Proleukin, well with their therefore, baseline show which or end patients four, regimen melanoma, sort generally the that lymphocyte particularly four with we translates when to went nine microliter, lymphocyte to patients where eight And those might or did under

David Martin

great. Okay,

that XX had per up all scans four in they trial, dose? to kilo cohort question, patients the first the stepped on for microgram they're Next four, waiting you're still are

Fahar Merchant

all the -- study. kilogram four on They're all the patients they've receiving micrograms XX per Yes. dose. Yes, all are now

David Martin

patients to XX the five of any cohort yet. in have stepped And up

Fahar Merchant

five Cohort started. just

cohort So five. started enrolling patients we've just in

kilogram. As you the per two doses, of dose know, there'll priming XX at micrograms be

will or before microgram get XX dose. so it another be the So month to

David Martin

question, last you it Did to fever what when spike chills? a did bit the you happened off completely fever to effect? and blunt And Or went with that from up XX did step-up XX, XX? when again, and Okay. chills they

Fahar Merchant

information handy with Yeah. me. I that don't have

So cannot specifically mentioned what happened [indiscernible]. patient

on the time. if so course, share we characteristics of they increase differently to ability conduct did frequency if as patient decrease analysis able data on. we'll baseline to in frequency occurred, or But more adverse in and responds they've events, have depends be further over their to Of certainly, therapy,

and bit I those be we of think we'll useful reporting conducting this study. finish will of escalation, data study the a when up part that be the

David Martin

sheet, because positioning financing change your have the the how I regards question. you MDNAXX? the the With that raise Has one does did stronger other balance various sorry. of for impact quick negotiations Okay, did and parties to money?

Fahar Merchant

with us in stronger a but transaction we a have puts it healthier with to discussed position balance sheet. certainly potential negotiate Well, specifically a partners, those not

David Martin

and remain I -- Okay, discussions those ongoing. take

Fahar Merchant

Yes. are. they Yes,

David Martin

you. Okay. Thank

Operator

question next with Our Catherine proceed. Research. comes Please Novack Instructions] [Operator Jones from

Catherine Novack

in wanted activity to we about counts further will much my lymphocyte And or or patient. Hi. are increases talk about proliferation? question can you then Thanks With ask that seeing so I another information taking questions. further cancer any for it those? data cohort biomarker cohorts this give for biopsies waiting about be for to just pancreatic will a tumor in the us MDNAXX's see in pharmacodynamic Can lymphocyte commensurate you specifically progression, counts tumor? this be seeing tumor paired

Fahar Merchant

Okay.

for So thanks question. hi, And the Catherine. thanks,

when they X,XXX the per sort you post the well. of XX, increase counts see baseline see over as this consistent that quickly, their the our was in pancreatic up that and counts. count as what will or and around four, data we patients day these we And that saw presented very the at So in you'll conference, cancer increased with treatments lymphocyte of patient the is to X,XXX-X,XXX, cohort so eight

in So cancer had have the a pancreatic seems system healthier immune general, it like to benefited. patient baseline who seems

with has this generalize, kind difficult of just patients, from that of with it's to but it reported handful itself. the course, So consistent seems been of data Proleukin

the So the -- provide be increase sort And increases that question. if and of breaking seen that's the We've With respect drug. administer other related to as one we'll medical was your question able out counts continuous to mistaken. it not more during finally, lymphocyte to we conference. I'm patient-by-patient, baseline the a

dramatically. the lymphocyte is see you'll doses, count that dramatic the first increase increases as continue, quite the that And dose, first as they're The dose. not but subsequent

can question, but some might forgotten So repeat you if other please. there I have I that, was think

Catherine Novack

we'll about cohort wanted biopsies, I which ask status tumor see. paired of any -- to

Fahar Merchant

Yeah.

are but also dose dose healthiest of of to pre then escalation of So part participate trial. to on-treatment during the escalation, sort their it's it the convince the again, portion in biopsies contributing as and patients patients, not difficult a of is they

far. We willing biopsies We are and just pretreatment so get period the three more comparisons contribute biopsies, when them to we or we we patients are that so phase, more but dose more have biopsies as on-treatment. do that during their biopsies. but have on-treatment, have data, three of as or about have likely patients pre we going biopsies expansion several paired I hope have and paired said, escalation, and biopsies We dose two the some to to go can we meaningful get more

Catherine Novack

that? cohort see I additional cohorts sixth year. you're to beyond Will dose are it. cohort. to double seeing to by end Obviously, data next at plans the that What still then this the Got only determined? plans guiding we just year time, is of fifth from check to the And wanted for or the a data be conduct

Fahar Merchant

Cohort six be Yeah. going be is determined. to to

the And played per doses. seen kilogram, XX based go moment, be we've from And primates, threshold -- higher microgram the per sort feel microgram kilogram need as or getting we robust I with dose cohort, phase that data response potential unlikely sort that when to by it's fifth the hoping we think microgram XX plenty we be see, kilogram benefit would the to close that non-human ones the I than the use of data dose. hypothesizing. recommended to XX are assuming the patient consistent at we'll a were on for that year. PDK we'll we're the per think Also, are what might and PD tend we but data quite be two the in we what XX of

Catherine Novack

of clinic? IL-Xs modified being in terms other in put you And that IL-X with remind can the where are compared us concentrations, XX you to XX evaluated

Fahar Merchant

Yeah.

the obviously is regimen it's -- So dosing different.

add for -- MPEG. I administration, again, with micrograms, would molecule. you are that cases, say at the one might maybe which dose, MDMAXX I Alkermes' think and our possibly also times an adjusted daily three is equivalent dose is drug. In would doses on based we the I daily are BEMPEG, the if which high only have comparison micrograms XX nemvaleukin than days dose kilogram, IL-X Alkermes' or be per of nemvaleukin, we here at is both XX of the higher already we double five a

reporting as of not to clear whether others, IL-X higher. in the both in or terms to cases, So not. equivalent are it's they're dosing we quite respect substantially With

wouldn't I want comment a to So make there.

Catherine Novack

much. Got very it. That's Thanks helpful. so

Fahar Merchant

You're welcome. Thanks.

Operator

Please Arthur He proceed. Wainwright. next comes with H.C. question from Our

Arthur He

RK. on for I good taking regarding combination upcoming my Hey, Thanks morning This Arthur for the and two is question. Farah questions study. Liz. cohort a had

I'm So wrong. if correct me,

as QX tweak of for both So your as using my just to the three dose at understanding tell now you you to regimen? week the you going MDNAXX, us interval the week the could dose to are with and the if is, the Or CPI every going the case, for are Or right CPI? what that's QX strategy the how's dosing dose just level weeks MDNAXX?

Fahar Merchant

Yeah, it's predict moment. good question. this Difficult to at

dose of running we And portion are a two different the looking safety during trial know, we'll the combination not trial. portion, monotherapy you As be running of likely, trial, one the safety the least if schedules. portion conducting will the expansion as includes of portion at at, treatment that

dependent we which well the do checkpoint much So used us with safety expansion part. that'll on proceed when combination before as the the and informs the during dose pretty being what running dosing we be as actual

Arthur He

to provide will And a regarding combination guys the see dosing, big forged inhibitor be That's of we pharma started to be checkpoint helpful. need it. a starting completed collaboration you combination the Got the phase? Thanks. before

Fahar Merchant

Yeah.

that particularly options combination consistent So the with any ours. with that time, to to certainly, collaboration. safety, we such that protocol that checkpoint profile dosing sure of together make inhibitor, to not need But with regimen. we course, particular addition is the And that of the together that establish to put are in at for of it's We'll different the arm at respect are PK/PD wedded we looking a same we work finalize as collaborator. we the

be it of study portion before together the with will carefully evaluated proceed we company. with that pharma the So

Arthur He

you. congrats my Thank on you Thank for taking question. And progress. the

Fahar Merchant

Thank you.

Operator

Martin David again with Bloom Please comes question from Burton. proceed. next Our

David Martin

my Thanks taking follow-up. for

you The determined You baseline eligible your rate. there they the other you study baseline confers are inclusion do what responsiveness responsiveness drug response as indicates think they assuming a to XX% also to the you And started when emerging type XX% MDNAXX? mentioned that that lymphocyte Proleukin, get Was of to count to label before And that are lymphocyte was measuring Proleukin objective a earlier make counts? criteria? for response patient now biomarkers from that an do drug. for rates that use

Fahar Merchant

Right, thanks, David.

for on rates. response actually X,XXX of and data we the studies lymphocyte These count that your saw where to back counts Proleukin. the going XX% are question -- microliter conducted X,XXX per XX% lymphocyte So based first that or large are were regarding the baseline

that also from had was that or And those, studies. to were X,XXX patients the on-treatment X,XXX, So is lymphocyte on post-treatment generally increasing more. baseline in both counts or counts the responders lymphocyte

we home start of the normal. message a baseline So that lower limit reasonably was the with sort is, count basically lymphocyte least at the take of patient healthy need

below X,XXX, already. are well normal you you're If below

reasonably to count. So lymphocyte you baseline healthy a I some need have think

the having all, to X,XXX [Indiscernible]. was than consistent patients more of a Second or increase with

did respect again And patients with not in benefit. increases Now whereas not Proleukin, reached. ICOS-positive in of that seeing, see those -- our that those that to Tregs study, from ICOS-positive own patients terms biomarkers, did an had Tregs, we're patients increase had ICOS-positive in

MDNAXX. here So seeing with similar something we're

ICOS-positive a data be we'll marker at response. it's as on CD-X Tregs don't certainly We early as let's mean, We see, on tumor I obviously, ICOS-positive impact us now. cells as well are But now monitoring for And well. that as T right ICOS-positive. that looking Tregs its have good enough are and potential

David Martin

Okay.

all about they you XX%? have counts, for baseline patients Were baseline the talked was the Just that among the counts? Or high to higher have and study that XX% Proleukin. just response to rate all of who did them responded in it the study confirm patients the

Fahar Merchant

or mean patients those average baseline. No, an sort difficult. Because of it's the at only of don't provided I think, they

lymphocyte can't they response reported I say did sounds when counts during But were. So in treatment did with X,XXX. the what say the patients that they above they did response occur be rates, to

lymphocyte we renal on individual on in or But of expansion that was what baseline determining have we that and was that from baseline cell that if different in mostly was So, out, three it two not the responded. a know was groups of the It so that's their lymphocyte the information don't post-treatment. what only counts, was was, carcinoma. melanoma count not publications published way

David Martin

Okay.

Got it. got Okay, Thanks. it.

Operator

comments. Thank this Merchant Dr. Fahar I back over turn call to At like you. time, closing would the to for

Fahar Merchant

investigators extend study thanks the good will call. date. today's the results enrolled to I operator. participating those patients In for the the we and continue the goodbye. in reiterate ABILITY day. everyone dose Thanks, in and advancement, like would I last closing, upcoming you to study's who to all have a our continued as one to escalate. thank and excitement trial I from also Thank will And wish

Operator

conclude This you. today's Thank teleconference. does

thank You great may And for And participation. disconnect day. at this you a have your your lines time.

Medicenna Therapeutics (MDNAF) 15 Aug 222023 Q1 Earnings call transcript