MDNA - Earnings call transcript Q4 2021 | Medicenna Therapeutics Corp.

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Operator

Hello. And welcome to Medicenna Therapeutics Fiscal Year 2021 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. Please be advised this call is being recorded at the company’s request. to Advisors. call like Ferry to now LifeSci of would turn over the Dan I ahead. go Please

Dan Ferry

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

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

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

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

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

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

Dr. Fahar Merchant

corporate XXXX today for Thanks, Dan. discuss joining update. to on fiscal us the year And our call thanks listening all to

of caused fiscal an accomplishments, achieved outlook provide yet, XXXX our Dr. and have current to introduce for Williams, us On Liz scientific beyond. by Officer; milestones We our team left Chief of these the year status well of will update joined unpredictable Medical Chief addition executive year Scientific the Officer. In pipeline our sustained and Chief productive and Mann new recent call, that give we clinical, review for an our the the on Dan, Financial corporate Mina despite some programs, success. Development today’s and key our XXXX by Officer; and positioned Kevin I’m members Fiscal our Chief pandemic. Muhsin, Medicenna’s Merchant, Dr. Officer; year strongest most environment Moulder, was

anti-cancer let expansion IL-X anti-drug with MDNAXX antibodies, long-acting this immune beginning MDNAXX, Milestones our So release without cells the some focused program our in that stimulates program start as accomplishments with on generation year, primate of of with our cytokine super-agonist. non-human past of the include over of effects, us leak causing the showing such data, side syndrome. hypotension unwanted vascular or selectively prolonged associated syndrome presentation

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our agreed that plans of MDNAXX During for X/Xa U.K. in agency submission appropriate be Medical the the Product in would Investigational pre-clinical clinical Dossier first an CMC, and Phase the meeting, human with a study for

designed Ethics clients In treatment addition, the past eligibility in is what of potential updated to high improvement few we substantial on external control commence MDNAXX, data a of trial, our provide conducted. the FDA These in minutes. in observed Xb in year, conduct amongst study Phase in trial by a substantial effect our the recommended trial the of clinical MDNAXX IL-X in uniformly a fatal magnitude the XXX% need survival brain include X/Xa large a robust this part a and need a unmet unmet toxin this guided or be our from the MDNAXX compared significant a a support in to well will control single as of may population, of in than greater now rGBM, about best third rGBM, The we arm as like free we next in in support are the MDNAXX’s the we therapies. compared Thanks to an oncology quarter, arm greater an paradigm Phase Human the our clinical in attention in was approval approved the Xb recurrent medical external targeting agency we with the submit to the external trial, approval. data planned advancement. to to Australian as well as change more and an Research form active with and design to external in talk Committee Xb data that short I progression the our than to X but to arm. cancer. I in showed will of that groundbreaking the Phase open-label quarter recommendation increase achieved potential demonstrated pioneering XXX% subjects indication. Throughout arm resulted will partners that trial a two-year this two-thirds treatment knowledge, regulatory This the all-comer survival, MDNAXX’s trial rGBM has in common matched hybrid XXXX. Mann turn presented a MDNAXX’s landmark featuring our discussions to control track now I’d Phase this indication. a to design matched that first most to information MDNAXX trial This glioblastoma control be allows to in for on to trial truly facilitate more a while, order publication calendar clinical to remain from control recent notification say

appropriate. need these activities thorough more of remain update details a when at conversations [ph] the providing we point, on this hydrated look these to to While forward

current the bispecific platform, These unmet such as critical in and at fusions we AACR, two address call. respond as to discovery some to of to unwired potential very novel front, do preclinical needs, that a the presented discuss Superkines as we have this cold We also molecules, which recently Superkine which will of refer data exciting this early immunotherapies. checkpoint tumors an recently our inhibitor not complementary Kevin from a Superkine typically a such which treatment On in later BiSKITs. are or antibody, program

notable talented we corporate Geltosky. two listing scientific as corporate our to and fiscal XXXX, the during Board Jack has addition experts NASDAQ alongside Dr. management the milestones team. XXXX, such recently accomplishments, Mann of highly on momentum Now, continued we our added the clinical of Kevin, immuno-oncology This and fiscal into our strengthening our achieved as and by also

a hear from with you versatility now will of clinical I part to team large Muhsin. which starting first-in-class together was Mann, these I power in mentioned, and assets, just As moments, you recruit such tell the and Superkine milestones best-in-class our our ability our few potential of let will I a Chief scientific and our the ahead. please with due in platforms. Dr. members, and showcased to candidates Mann BiSKITs go Officer, ideal Medical

Dr. Mann Muhsin

Thank you, program. MDNAXX talking everyone. will morning be Fahar, and about Today the I good

specifically. including also designed, month AstraZeneca, La sponsored part Hoffmann like variety I’ve to joining leaders Eli myself I’d of First, introduce Medicenna. excited Lilly, so executed development dozen this clinical immune-oncology and oncology most clinical Roche, Novartis, and in Therapeutics programs on I’ve recently companies, trials Bayer. of exactly a IL-X joined conducted deep unmet Johnson working explain industry a the why trials Johnson, for biotech Medicenna expertise I’m and Nektar be Medicenna more than has team. I at to prior Merck, by to and multiple & earlier

robust as primary competing was differentiated in Medicenna the compared and come best-in-class molecules and to set, MDNAXX’s which of drivers to my CMO IL-X development preclinical One potential the approved decision as demonstrates therapies on behind clearly data landscape.

renal to approved primary IL-X patients as with human targets treatment immune space, toxicity, causing which for patients of receptor, These while In prognosis metastatic the of recombinant unfavorable of the leads IL-X CDXX. and intensive its includes some extreme recombinant stem As and you CDXX cell anti-tumor that carcinoma unit. with the which of inhibits fact activation with carry various has familiar from associated dosing most likely in of TRx, in well relation as shortcoming. major know, which shortcomings melanoma the types of necessitates IL-X response cancers,

due dosing every IL-X pharmacokinetic days, human the to properties. for nine Additionally, recombinant eight required is poor hours

MDNAXX is increased has I how exciting affinity for about overcome Medicenna the but so find receptor. Superkine only what the can it the it that MDNAXX these to platform, not dramatically CDXXX have shortcomings, Using shortcomings. engineered IL-X overcome these affinity Now,

this affinity stimulation for for as significant, is activation that immune the is While the having are effectors cells the IL-X of CDXXX of reduced key therapy. killing the of the cancer target CDXX,

regulation a complex it of consistency, active of protein also is second in well bioavailability for fish. a not of albumin and is Additionally, to the the the of It’s In unintentionally on In MDNAXX to regulation reduce and but rely improves inclusion half-life. that molecules key this process molecule differentiation half-life competing variants, the product known albumin only affect the compared in point a many site IL-X human requires which ethics. the case, match improve fusion to protein. manufacturing general to tumor can

stimulate This best-in-class. data robust Tregs. reduce preclinical shows MDNAXX molecule T cancer models. to combination affinity MDNAXX have selectivity. programs, sets, CDXX how in to that to killing data compared effector to We has and alone set preclinical and for IL-X shown able demonstrating CDXXX is Thanks to efficacy cells for also The preferentially for be opposed competing and as tumor affinity checkpoint impressive in positions inhibitors with high NK enhanced this

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studies This to our progress We regulatory of we of good process by the end submission Australian in of as agencies. June. initiation package down toxicology our and submission are wind is continue for trial preparing in their make towards GLP expected

expansion the in calendar a chosen site with we checkpoint phase selection with begin a monotherapy escalation Australia. CRO MDNAXX trial will plan underway by quarter design, monotherapy, Additionally, evaluate in phase, for be a well XXXX. and already the in then trial trial of dose is we both Initiation as followed third combination is dose MDNAXX expansion to inhibitor. expected This dose a of MDNAX regards With the will to as which phase. have

collection speak planned allow Another this which on-treatment is key collect and us of element trial biopsies, to a mechanistic design valuable to data MDNAXX activity biomarker of that pre- the human. in will may

by on and end any the biomarker a we preliminary update ahead, data available to Looking safety, expect PK/PD of provide this year.

briefly from in I set MDNAXX XXXX. of Phase gears first like to monotherapy speak Shifting trial program. of ask our expected half first the Fahar efficacy to would now, The signals study are the X about

Dr. Fahar Merchant

Thank you, Mann.

an for well-balanced the to study presented or XX.X recurrent criteria represents a published may a early XXX% strong IL-X survival rGBM Clinical the and previously than MDNAXX toxin Research. in Cancer rate XX% that As the I evaluating progression is journal mentioned indicate findings which trial compared rGBM. from controller. on greater a targeting employed results in the when overall rental guided showing Xb months, earlier, based surrogate MDNAXX control be These survival in an glioblastoma. of were rental Phase immediate peer modified in free Findings recently modified of determination These tumor overall reviewed with survival findings external supplement improvement

high overall patient IL-X survival MDNAXX high all received endpoint. overall population a data treatment. and trial, modified expression the Phase as IL-X expression included MDNAXX with positive of planned receptor outcome with that rental the reminder, a dose well receptor a PFS for We X has treated believe and which survival primary these participants participants the trial As of low bode

MDNAXX earlier, will completing versus hybrid open-label utilizes This be As on reduce the arm the will that and the external needed To of allows design a design with during arm. success. The first past years, control we primary FDA’s contemporaneous innovative has this Chief subjects external remain include at its the set substantive continue cost numerous overall MDNAXX of pooled recommendation planned forward time. can a arm I program. change benefits this trial by for offered These the With ongoing robust ensure control as Officer, well to We trial an to an believe rGBM drive with our trials a been this proceed data rGBM leads the be the MDNAXX Moulder. the on hand this the clinical for standard-of-care kind for Kevin matched two-thirds no I reducing near with the will the around providing arm. it update to status control look mentioned hybrid timelines the from of treatment together now trial subjects that, partnering design there by associated well of endpoint, to to over the our timeframe. discussions Scientific and to number control patients arm, positioned analysis treated one-to-one achieve based appropriate we our discussions Dr. to which five for

Dr. Kevin Moulder

predictive I these a and in experience excited you, Thank myself These over I’m and deplete was start the the BiSKITs start enhancement as years on efforts addition Medicenna. activity Superkine At antibody CSO with like Chief F-Star department. desire Tregs need a where cells versatile as ran and my towards for leverages to antibody. these clinic. bispecific and of translational interleukins known to program have effector first I the join while My I overview medicine asset evolution. behind the includes the discovery to my as showed antibody design, tools brief we drug Medicenna introducing I’m work the by speaking be and since also Roche. acquisition enabling are team. identify the those platforms today. best-in-class anti-CDXX its my advancements my where like [ph] in preserving Fahar. on development its protein technology management I of listening, Tusk as established clinical the natural Therapeutics with joined stem fields molecule anticancer the an call such Officer disease development my to the I antibody and Therapeutics which technology, applying key Biogen by of and XX like I very to Development recent subsequently company’s knowledge Medicenna will in and time at to directed Mann, of drug and powerful I’d development led would This work. autoimmune immuno-oncology. abilities Tusk at T of efforts to to give This time work I several a experiences and how process with platform, power to the the to directed that prompted as platforms by activity will from as now advance Superkine development be from to Medicenna, IL-X decision time

two of meeting shortcomings therapies. the program, we to we versatile a and Superkines The available shortcomings By protein the agents BiSKITs Superkine. At combining AACR asset these of from overcome mechanisms are resulting disease. particular our MDNAXX BiSKITs deliver to second to properties, engineered made with as that toxins led on currently powerful last anticancer of overcome that checkpoint incorporate a can fused to library creation cell properties tunable of half-life improve are new capabilities mechanisms changes MDNAXX. such subtle desired a of process, add a then case ultimately, the of that a natural in modulate our Superkines action molecules be designed this in The case the to second unveiled we further in payload such of the synergistic of create one Select specifically checkpoint such the to assets Superkine presented this During of cancer to a to month, to which the immunotherapeutic in inhibitor as designed ability is platform. as address March. Superkines and or fashion, highly in as derived BiSKITs in eventually the of progression underlying consist our molecules as the or cells, of inhibitors. platform to data interleukins

note, enhancing cells. activity cancer the designed by are As you inhibitors tumors checkpoint of to fighting target immune may

these that that have tumors being immunosuppressive these referred such environments in tumors of therapies, mind designed limit immunologically it and efficacy we However, MDNAXX-XXX. was with the to cold micro as tumors many

Macrophages. consists It during on molecule designed our cells two modulate IL-XX polarization a receptor action its complementary effects the near alpha is the Mitigating pro-tumoral activity As the the assumption MDNAXX-XXX targeting of to both an MXa selectively subunit effects mechanism the this This ultimately, super thereby designed by of we making mitigates signaling, macrophage inhibition the focus will Associated action. binding presentation, antagonist. of heart, and IL-X leads environment. by MXa IL-X/IL-XX signaling. to was cells. micro the discussed tumor of tumor affect of cold is micro on IL-X/IL-XX anticancer first polarization in work and to immunosuppressive significant Tumor destruction I IL-X/IL-XX of via and of mechanisms blockade immune The synergistic can these This signal AACR term susceptible a to of it environments. mediated the

essential often are a to presentation of one tumors enhance regard affected the through IL-X’s goes with anticancer a CDXXX mentioned points targeting set cells. key MDNAXX, Now the inflatables therapies. MDNAXX-XXX of signaling of making and just similar MDNAXX-XXX IL-X the driven This and here the cancer activity that like to I’d to very But IL-XX highlight. I a NK data resistance was activity to of full cold our antagonist agent in to action demonstrated in agonists driven is AACR works manner target cold effectively potential preferentially potential are killing recent this T them couple complements

of cancer native molecule cells. compared cells and T in the This enhancement in NK/Treg was and to by effector killing in vitro pro-tumor IL-X. activation First, and evidence ratios and a reduced Treg XXX-fold signaling enhanced when XX-fold respectively CDX/Treg effectively NK

polarization MDNAXX-XXX more the signaling potently IL-XX/IL-X the and X led subunit, of the subunits. selectively Second, signaling functional binds the times for alpha X receptors affinity long-acting MXa IL-XX, in inhibit able associated subunit alpha and the fusion mitigates pro-tumoral reduce pathways decoy of molecule alpha was both, selective Compared outcomes X macrophages, normally and This to showing IL-XX the which inhibits while is effects was approximately the to Fc the of to IL-X receptor molecules alpha selectively IL-XX vitro. MXa XXX IL-XX with to as for notable macrophages compared X via subunit.

these enhanced the combine case In power show to platform single into of the a of bi-functional properties potential this need. results the MDNAXX-XXX, the immune signaling resulted address how together, effectively novel can in specific the Taken compound. system to molecule BiSKITs critical the immune with of enhance unmet multiple the items

to as BiSKITs eager lead border development ofMDNAXX-XXX, as I’m continued well forward, program. Looking our the

XXXX. We hand the like expect will for candidate Williams to declare fourth present I’d the who our Liz our to our financial results XXXX. lead off for the program first With fiscal call calendar in now that, of quarter the CFO, to

Liz Williams

good and Kevin, morning, Thanks, everyone.

regulatory pleased I million were as research as compared maintain and in the expenses the costs $X of XXXX able the other the enabling marketable $XX.X with planned legal as and both compared our current to incurred X ended associated These a and and Company associated XXXX, Canada Canadian and March XX, ended increase XXXX. to MDNAXX with attributable and $X.XX March sufficient and development March MDNAXX past expenses XXXX. trial year note administrative the current qualifying ended year as prospectus with XXXX. higher that was current with were during prior compared CMC our ended for with our Before result compared $X.X the March incurred regulatory million well directors the begin, or with General from compliant premiums well associated expenditures to reimbursement pipeline of GMP XX, amounts Research had its the Institute of Research well XX, per late increase year studies, dollars with of IND particular would was Texas ended March March per for Prevention to XX, is to securities in for preparation costs that directors activities XXXX. loss NASDAQ dollar ended due $X.X increased was the year common expenses establish of $X.X shelf discovery MDNAXX, as of the Trust year of loss the ended over primary increased and expenses United work the cash, premiums, ended associated liability equivalents NASDAQ increased with I trial, during $XX.X year associated net the the listing, And incurred as The million under share, immunotherapies. Depository XX, through officers XXXX. development for preparation million X/Xa the March Phase the or a as increase current end in our BiSKITs the Medicenna NASDAQ expenses $XX.X with million year in clinical in in financial otherwise million higher research ended corporate listing funds as of in meeting the the listing, pre-clinical initiation plans initiatives. cash noted. as XXXX, well is to well share XXXX, capital reimbursement with during for primarily and Cancer with and expenses like officers company and MDNAXX year associated to for no I’m clinical are discovery of for filing net year The GLP attributable as The platform, XX, $X.XX primarily no year of of March listing, of the the for million the period. in programs, $X.X activities a respect in XXXX, XXXX, insurance MDNAXX. XX, references the million a Net with in March increased projections. the shares expenditures in grant CPRIT XX, a current advancing costs and in insurance year due based loss to year provide year-over-year finally, on States, related the while with development XX, fees to the March to unless and Phase manufacturing compared strong as foundation, cytokines-based Phase grant report fiscal all to year and X/Xa XX, year Medicenna on

Discussion now financials, the please With Statements that, on call Analysis, further back and Management’s which on available hand SEDAR details For and respectively. over our and our Financial will EDGAR, I’ll to be to refer Fahar.

Dr. Fahar Merchant

Liz. Thanks,

lines that fiscal move a to Q&A, of the talent like past of I pandemic, amount strong amid to have on year. us generate accomplished dedication all team to proud over which they They and and I’d the showed we tremendous am enabled our preclinical for how Before emphasize the clinical our as over the pipeline. of work lives the will has drive cadence to now of milestones achieve next creating a patients. data across that, us steady left value poised importantly, the sustained we year most This to improve questions. open and With for our Operator? we growth,

Operator

-- I’m with Oppenheimer. [Operator Please you. Thank from sorry, Bieg Instructions] Our first proceed. Matt Biegler question is

Matt Biegler

with for members Fahar more Mann, the get appreciate we new little welcome to of bit maybe the X, questions Thanks on on the think range? you we upon details long get therapeutically planned into C-suite. take into agreed it based escalation a until active And yet. the if us or Thanks, Hey. the and Australia down might do models, guys. start nailed dose actually and those Have and preclinical how could a you just Okay. U.K. Phase granular.

Dr. Fahar Merchant

the Mann, But Matt. positive suffice to I I’m as with earlier Appreciate in. With dosing regarding had now. that Right. preclinical, respect in Mann? to dossier asked. those bit Mann, comments, that he for right and perhaps, the more. therefore it bit mentioned that as clinical as CMC, we et a elaborate say received cetera, to our on the that incorporated have And passing we can can meetings elaborate has the as it question that, on well it Thanks, pass Clearly, plan. on are you’ve I the to been reviewed you MHRA more. so a Thanks we and preparing and calling

Dr. Mann Muhsin

Thank you, Fahar.

dose to So first throughout and earlier, results updates into before patient the of continue in initiation population year escalations many patient. first and we you hitting But dosing towards how Australia point this a dose XXXX. at we by IMPD in the an the available be our be communicating this from dose disclosing level. regarding or Matt. time, indicated provide And will getting X trial recommended progress would projections we earlier as will frequent need inhuman end Phase give of won’t Thanks, we

Dr. Fahar Merchant

we to And protocols with plan. that those our dose the yeah. to also -- a come make course, disclose the committees first able and therapeutically instance, add approved, close much discussions cohort okay? regulators for that, and remains dosing would keen sure with we’ll have were once shared of that I’ll plan the subsequent that in that they ethics have to was the to And active better by, MHRA, get And disclosures is the be been and

Matt Biegler

you. Got

Maybe safety just in and as concern a then it. could of I kind safety efficacy the striking about we balance space think Holy see safety profile, potential and IL-X one question of obviously, the and sneak Okay. kind I Grail between general, that right is the is

any the you can Phase the think competitors, X trial any prophylactic risk you such as lower using you Thanks. -- as of reduce could learned safety that are trial, Anything about are Phase think that you risks? any lessons using incorporate are your into hydration you to X hypertension. So your you from

Dr. Fahar Merchant

IL-X comments. of with clinic course, language studies Well, committees, to are brief address with that always who and will we the first, all familiar et Suffice cetera that, to programs that the want at moment procedures, protocols, agency ethics say to the those. I’ll different appropriate the ensure are regulator just my in had ongoing give it

expected let I to something be sorts from like committee. also any But So will of add. that would Mann ethics

Dr. Mann Muhsin

question. great Fahar. you, It’s Yeah. a Thank

So, above, lessons class learned lessons learned adverses related worked this you with landscape. that specifically. those typically seen drug anticipated there in guidelines all this IL-X, toxicities with will managing IL-X we All in of agents dose guidelines is all all high and with institutional from absolutely, you. yeah, drug a typically the all on as adverse use the the agents and see class know, in IL-XX, a the this cluster thing for Thank follow and Il-X, specific and the will drug IL-X the class we we events usual myself

Matt Biegler

Thanks, guys. Okay.

months. forward Looking the XX next to

Dr. Fahar Merchant

you. Matt. Thank Thanks,

Operator

Ramakanth with is Our next proceed. question from H.C. Wainwright. Please RK

RK Ramakanth

Fahar of questions you couple A morning good and here. Thank and team.

are Muhsin, me versus Nektar, programs if that have MDNAXX been NKTR-XXX. could here -- helped contrast Dr. compare of run have and like being So, the kind especially by program you the

So are we there programs out you. how competition? the here understand what’s Thank these situated against in

Dr. Fahar Merchant

Thank you.

Dr. Mann Muhsin

Hi.

Dr. Fahar Merchant

of Well, molecule But clinical know, perspective, been be from then from let aspects further mechanistic point we a key as the way have, view, is structural Mann. two the Really, me just I’ll to presented just has engineered sort and great, different I’ll the such you designed, bring let by characteristics. the thanks. that molecule, a of into

or would the The knocked that inserted have second inserted that CDXXX, dramatically stimulating NK CDXX. out affinity binding cells, mutations we well. all, effector of binding And mutations first selectively that we T cells being the cells one T for and as have block to and increase naive therefore,

Mann, we’ve a data. to by allows in itself NKTR-XXX. in lymph also pass way shown that who’s the it was the that albumin engineered and molecule differentiated, big with we case experience the approaches draining know tumor, that’s that tumor nodes. respect then, got better that And you approached our also we us have albumin to instead that half-life site. well pegylated to But NKTR-XXX. albumin is our extend with to as fusion at aspect key the does how lot we And mentioned the primate course, differentiator tends extend with localize I’ll to the IL-X on more believe obviously because And accumulate a we half-life use of Mann? of that’s as non-human that’s as So this

Dr. Mann Muhsin

Fahar. you, Thank

other MLA, an some that effect. pathway the Fahar from far, of drug that drug Fahar. like So and based we the class data to will anything the data we’ll Based from models. course, based design and this issues and this you, have those leak escalation similar mechanistic, be issue it yet mechanistic we’ve a have everything in agents in and related or being on data drug keep -- data that -- on cannot we compounds. clinical animal clinical vascular have animal will patients. based preclinical disclose much or Obviously, portion data syndrome, class and models Thank the in dose updated about what the throw but will like dose you I don’t of issue to the doesn’t available and obtained release the drug tell of indicated class program. I seen utilized clinical our limiting look and on it data, look you on toxicities to drug on toxicities become so doesn’t this but And And about top and NKTR-XXX, cytokine dosed seen it given syndrome can in

RK Ramakanth

BiSKITs you. the Thank on additional question, is Thank And one the program. this you.

your act understand activating So this pro-tumoral I is response. pro-inflammatory and what this activity enabling -- balancing a a between from

So into sort also your of a out X especially Phase preclinical you in safety the in in work we and looking program, clinic be study? such what should when a get signals for,

Dr. Fahar Merchant

Yeah.

goes lead depends to if So, on of candidate of as best -- it the and we currently candidate to the disclose are molecules end again, candidate. a the candidate we clinic. what towards become conducting identify that said, And all this we bi-functional will clearly, what year here, into best components research as the the part or

it’s and an be will done a any partner, we a lot screening what molecules safety for characteristics, need it’s contains at. So goes molecule, it in into is to need more consistent some IL-X the at antibody will look that space. the course, to instance, the antagonist predict super-agonist And we just to we’ve for the studies we are the incorporate a inhibitor, IL-X IL-X/IL-XX the clinic time signals those bit know targeted or of obviously potentially, molecule, it a issues fusion to that that whether other key based of components the this as initial on to safety to difficult will based once checkpoint which then, one then and with on with us primate respect non-human

be would it So time. premature for this us to at say anything

RK Ramakanth

for And you subject on last while much a for has I really too ongoing understand a about now. this can’t the you, -- But, this one is discussions. is folks, question, MDNAXX. been this obviously, talk

time what looking an in that major for discussion you the through - what can you before the this are get to mean, are So and sign partnership exactly I points that agreement? what need you exactly at

Dr. Fahar Merchant

It’s are. for points Yeah. respect the difficult discussion us to present to anything with what

Of able we private, soon to say, course, appropriate. update is as you provide may say and timing those, and therefore, I the active as can in as will are only we be an be that discussions it

that’s to going on. have do plan So that it the forward going we suffice and say discussions

So I say that’s for now. all can

RK Ramakanth

Thank you, Fahar.

Dr. Fahar Merchant

Thanks.

Dr. Mann Muhsin

Thanks.

Operator

proceed. Group. Our with next question is from Please Jason McCarthy Maxim

Unidentified Analyst

the line everyone. Dave for taking my [ph] Hi, on for question. Thanks Jason. It’s

trials could the with the you the U.S.-based the ex-U.S. MDNAXX data expedite respect it’s to possibly and direction process, would of that possible MDNAXX, change think gathered these development in So, guide do help help the trials from U.S.? trials

Dr. Fahar Merchant

quite Sorry, the please? sort Could more, once didn’t it you I of get question. repeat

Unidentified Analyst

Sure.

the expedite you trial. outside So the development think process of the U.S.-based clinical would U.S.? trials those the help trials future of data the from in here is, asking if direction just ex-U.S. that gathered MDNAXX, are And I the to of help initiating U.S. MDNAXX was trials guide

Dr. Fahar Merchant

Yes.

course. Of

the that part there therefore, used we part and So gather that globally. can protocol same a we make we will itself, make and of will to of the unified submissions agency be be U.S. any protocol, any is outside protocol the as if the from regulatory data that sure

also So please, that, I supplement will Mann. Mann let

Dr. Mann Muhsin

X to of from combined total and you. X contribute Phase the the program. that portions it’s the data, and overall constitute will generated confirmed will program be efficacy, Fahar, with sample ex-U.S. safety in the other the data we Thank the total regions U.S. gathering size Australia will will Yes. the and be that And data for the Phase

Unidentified Analyst

color. appreciate the for I it. excellent Thanks Great.

Operator

from Our Please Markets. Capital Raja Kumar is next with Brookline proceed. question

Kumar Raja

Thanks congratulations Moulder and for Dr. Muhsin. and and my Dr. taking questions welcome

with maybe, the Phase first, looking the particular like to patients are patients about but as trial, regard the checkpoint X resistant well naïve with thoughts at at target? able characteristics your also how will what of those? are are checkpoint And So, initially histologies move progressing be that? who plan inhibitors, into to on with to on any patients, guys you combinations planning you inhibitors, you are do finding to in who time looks you thinking to are the And enroll what there think you point are as

Dr. Fahar Merchant

to respond Kumar. you, to Mann to question. ask talk Right. Good to you that Thank will today. Mann? I

Dr. Mann Muhsin

you, asking. Yeah. Thank for Fahar. Thanks

program. the and included X the Phase be So, the histologies portions in and the Phase the X patient of population to

yet why cases, disclosed. higher tell are that in safety as follow part first population arm tumor be and patient prior as a types but on you high naïve, resistant, the who to you evaluate toxicity. the certain success that are this in previously focusing resistant. including the accepting IL-X heavily can spectrum, of well based on tumor dose The IL-X, of response [inaudible] general, as what highest based -- will the study and the safety immunogenicity about be We know, and be population, failed patients likelihood of dose we the But fully pre-treated is is lines, checkpoint treated, we know will inhibitors, patient won’t we failed probability the activity this and in will have who types be have they’re based I on will

to that. shifting we part combining checkpoint PD-X, also we Thanks in for So yes, activity the regards And a well inhibitor PD-LX. the it be program, be as but checkpoint have clearing arm will study, the dose seeing in having mindful to after inhibitor the asking. ideally of of checkpoint as part, with the inhibitor monotherapy the before

Kumar Raja

to and when the you coordinate terms do do you it how think trial? on with U.K. plan trial, Board will And Australian come of in

Dr. Fahar Merchant

These prepare filing and the be submission to generate an as to perspective, and all From of And timing will just know, sequential. starting some off data Australia. the you as initial same package to started we to enrollment we apply U.K. let after follow IMPD we you will a in will we and for have also So part as -- Australia know, be IND dossier in submitting will will all the of those package. course, MHRA, protocol the FDA

with we enrollment but guidance will per first. as Australia confirmed provide we not in timing se, is So the advanced

Kumar Raja

you maybe dose And Okay. models, are based that dose escalate? quickly Thanks. of in finally you on can animal the thinking escalation terms how how

Dr. Fahar Merchant

Mann, can answer maybe you that.

Dr. Mann Muhsin

question. of second part get the you repeat Sorry, could if I the question, didn’t the

Kumar Raja

No. you. I’m models. animal Thank think data from how you escalate on you based asking quickly can the dose the

Dr. Mann Muhsin

you. Thank

cases anticipate will we indicated, high and the from not on be we sequential also dose safety, it a allow us starting the escalations. I in our PK be relatively agents dose intermediate X some quickly. others. sub-therapeutic of the low escalation in or will So, as confident an we could Phase accelerated availability for competing will dose the Thanks compared safety into based anticipate multiple also have drug Fahar will certainly, de-escalate, to that and will doses, to favorable do will in choose call, profile, to asking. profile don’t recommended efficacy get we that a dose doses, we articulated landscape, doses I’m data I levels and IL-X. deliver and superior skip

Kumar Raja

much. so Okay. Thanks

Operator

Bautz from Our next Small-Cap question proceed. is with Please Zacks David Research.

David Bautz

eventually Hey. you’ll the MDNAXX-XXX Good thinking that development the molecule, pathway the do molecule morning, And PD-X testing up and monotherapy? that with like for think more bispecific a likely, end as about morning. say, or for you a combination Thanks update everyone. this

Dr. Fahar Merchant

different of them Right. Good the a candidate. as key of modalities question, MDNAXX-XXX was itself potential David. that, and know, have we The one course, respect program we BiSKITs demonstrated aspect is to the you with as

as that’s could that really will stone the a in it inhibitor, fusion a not we What has instance. checkpoint So that being etched for ahead. be that molecule molecule to take a

Once identify or combination judge if that setting be we data, will to monotherapy studies, these a have molecules, and in further in appropriate combination either a we’ve additional we’ll the we be what a combination until able done So also candidate need partner. lead to partner setting. some or as even studied

still -- be determined. it’s be So not that’s still to to

too moment. this bit at a early that’s So

David Bautz

Okay. company preclinical And the year? you any or program then MDNAXX the either this do additional data on later foresee presenting BiSKITs

Dr. Fahar Merchant

as potential our We will data conferences additional that MDNAXX. where as well would are This additional be data forward present to certain places pipeline. horizon looking BiSKITs on are on preclinical, to on obviously as we our

will different of So forward and the these look before have hopefully, the there year. those we to end updating programs be we ongoing, presentations that

David Bautz

Okay. the Great. for Thanks questions. taking

Dr. Fahar Merchant

Thank you, David.

Operator

the have I management remarks. like question-and-answer turn our the end reached closing back would to of over for to conference session. We

Dr. Fahar Merchant

us and to joining activity the good-bye. advancement pipeline for on as the and of very we’ll well thanks along the you We our along again, look continuous discussions updated partnering keep and forward way. everyone much Well, everyone call. to MDNAXX, the Thank

Operator

Thank This conclude you. conference. does today’s

lines this at time your You may thank disconnect and for you participation. your

Medicenna Therapeutics (MDNAF) 28 May 212021 Q4 Earnings call transcript