PHAXIAM Therapeutics (PHXM) 16 Nov 212021 Q3 Earnings call transcript

Good day and thank you for standing by. Welcome to the ERYTECH Pharma Third Quarter 2021 Business Update Conference Call. At this time, all participant lines are in a listen-only mode. After the presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised today's conference may be recorded. like Gil the Beyen, now your over I'd today, host Chief Instructions] to conference hand to [Operator Executive Officer. ahead. go Please

webcast Thank together and financial yesterday able year. financials We [Foreign sections press morning, the first us release call afternoon, our with Investors of you find presentation for discuss of to Good this months to highlights joining on update for be QX Language]. key evening, website. the issued the should nine for the this our you. Thank good our business and

this Iman Chief on Eric Operating Medical me Soyer, call our and Joining here today Dr. Officer, and Officer. El-Hariry, are our Financial Chief Chief

draw to starting anticipated includes today's the attention financials. calls to Slide the timelines, statements and you Before to disclaimer as such Company's that would forward-looking I operations, relating your X like on to remind

involve the after the of I'll regulatory an since our last and then fact provide key the clinical all call our and on update Slide which date, uncertainties financials, they of usual, as results know, an in Eric update a key the present our business key year-to-date, differ will programs highlights the on status September. to Iman and the could on is cash. in timings developments will progress present X, materially. to you risks And now short introduction start cause agenda actual and focusing and As with the that it

new on available allows that your the three for And therapeutic blood of All ERYTECH about encapsulate will red to improve the year that We therapeutic a blood strategic its in technology cancer the open our effects. brief is cell-based to be cells for a blood Slide forwards X to cells overview Company, using questions. us therapeutics, development compounds red the ERYTECH red all focused milestones also summarize up answer will people on of coming expected to priorities before we and for Q&A.

Our more cancer both X in a to eryaspase and fully to sides we survival. going cells them experience ALL, to files, ALL. very than which Europe one them is targeting for Nasdaq and shareholder of report in of product in acids operational U.S. have Euronext eryaspase, With for glutamine with also U.S., their couple And a ocean. on reminder, and of Europe GMP for loaded of listing now facilities amino producing need closer to depriving the red more by base on in one shareholders minutes. asparagine of are cells in clinical Also and solid New XX terms commercial in they with roughly listing, is candidates half Jersey But in we base surgeries, stage, of both Princeton, the growth we're our the

the Slide So -- highlights. quite happened key highlights been September. business has last in now since into of a has last coming call Business it our the X, month, lot

a got results back which again And put obviously sweat much one findings to time, what trial. I'll and seen disappointing, TRYbeCA-X key we long in in the minute. in X first even cancer, did second-line awaited X Phase have up Phase The energy we come our to live so in not tears, pancreatic the have is

-- benefit. we The of We irinotecan the patients mOS XFU in saw roughly we that are trial, with of the saw magnitudes. X.X by benefit seen have to survival of nevertheless TRYbeCA-X encouraged want median trial, is patients one of which we subgroup in single is and order the where FOLFIRI, survival would the in survival the a treated subgroup entire the

ALL. in the This on Fast-Track And activity is positive the encouraging advantages. has to a unmet patients with area in Georgetown now, month we We're trial And well was indication entering X the targeting than we combining Center activity. we and dose recommended the in with license in in that since to patients where was FOLFOX biologics to submitting a the subgroup and area we response, X our first the trial, initial progress -- having year-end, this at pancreatic, to data we encouraged different fact gemcitabine the an out variations designation a been saw to now, where of this sign of months and in Thanks product Phase least as trial hypersensitivities we able asparaginase. this where actually that thing. the by was saw MTD an single Phase at a was DLA granted better that that Phase on December, same were at trial indication to in CLL clearly read with a X are at ongoing the trial we're it's an the smaller we determine interesting as at need. U.S. seeing the who high around but Lombardi our the The our starts medical similar which in especially also It's now NOPHO TRYbeCA-X the of got it's clinical already pegylated the last very application, this FOLFIRINOX. the dose trial couple see it's So, evaluate NOPHO focused are saw developed run. interesting Phase currently the an X also July. very in It's all

includes get activity ALL it partnering future smaller B Plan clearly and also maximum that Now, are we order the for and looking of our but from a partnering is side. and the for B the the planning the to advance Plan indication value a is for in success opportunity ALL market of development commercial advance, both knows we're that ALL and planning

also create the from how platform generate a options the to and an give Eric at and And and is more think to update can manufacturing and and to clinical options the strategic value on I put row this launched a tell we the really from we to to strategic So floor will best to with this. go Iman a our yours. advisor about pass process programs. capability. evaluate all most Iman, in next slide see stage, ALL mic

Thank good Good Gil. morning, afternoon. you,

number abraxane the pivotal with study to or from again, approximately without start recall patients And XXX trial total survival, region at survival Phase randomizing was of second-line or Slide months contain conducted of of we looking generic the X, in was second-line with with X which irinotecan TRYbeCA-X setting, mainly The So a may eryaspase. fluoropyrimidine cancer, pancreatic six that key you in ratio X.X Onivyde. of X.XXX of two either was either chemo in endpoint that overall XFU or which primary months. either or as

at we you two from nominal ratio not arm. have for that we survival slide just as and the increase that a the that the can outcome noted but medical any months. have median baseline we ago, have is what of in the different what nine survival known this, Hazard the and at conference we met, characteristics, subsequent X.X sure for weeks robustness the of we're that two that terms be minimum the the found looked affected the fairs in have the far, not to in reported unfortunate looking see control which and was trial. factors from study Slide What have so compared primary that across in prognosis looked so treatment But months presented flaws X.XXX we at outcome, number will subgroups, outcome the we graphs confounding the of So, of we could seen not looked endpoint overall a strategies, primary X show X.XXX a

pre-planned Kaplan was number setting. eryaspase Slide eryaspase ratio and terms additional i.e. in was wanted the The check major what you survival have months, in improvement Belgium-based controlled was means Again, two with envisioned that treatment no there's there to with or at that patients and year fluoropyrimidine which subgroup. nominal part analysis, to Until overall in of the subgroups. received hazard we Moving X, -- again who irinotecan that irinotecan nominal an of seen is effect Abraxane any subgroup for can arm. that irinotecan/ compared the see you unprecedented interesting Meier, effect XFU we second-line improvement look XFU a the as also based improvement our the almost survival XXX eight in subgroups

nominal So, improvement indicators meet make XX, in did but did going a number efficacy we previously endpoints. not what significant. to Slide we indicated, to that clearly the strategy not ADS the subgroups saw enough any We statistically primary side additional with the again, -- not

can of subsequence actually were subdivision also well balanced survivors. as listed see the We well and which out bias clearly have as the characteristics,

we and toxicity tolerated, importantly the bands the of treatment see chemotherapy. backbone well generally was that So, not ADS enhanced also, did

data the a So, presenting we'll medical in conference. be

XX. So, Slide to going number

setting. We we it's the oncologist have, had communications sense And again, It would settings, need on consistency study, so nominal that And uncertainly look publically really series critical those it's feedbacks and with what the benchmark key hard, in you was essentially that survival in trial. the approve. attention options investigators in the seems this the factor patients. addition of of opinion to overall analysis GI decide very expected just leaders become at the have been based the second-line improvements, with in at in picking been and to a subsequent irinotecan/leucovorin the be results be the for to encouraging in the looking communicated of of trends a

that the look So, groups be there certainly in will into we to additional future. need

of For which insight full instance, the and give currently course, looking could potentially level of the are additional the an us results trial. of biomarkers activity we on understand the at output

ones. all the this about So, is typical

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that the enrolling system to expand will subject And good news to patients study. in us. this up, the it So was currently is the for include

[indiscernible] original accepted would conferences for the be a and So we, be presentation. XXXX poster abstracts that general is to

So discuss XX. threaten switching to another gear to this is pancreatic disease negative again Slide on cancer be number

being know, in this patients you the recruiting background. is ongoing search As

just mentioned our minutes Gil own strategic ago what Given options. few about a

trial. patients the process We additional in of recruiting are hosting the in now

to half outcome so our the study to of some is time deficits this in report the plan XXXX. still, far will of that at be involved We in able first

which So just purposes patient then secure an gears for least is just again, action trial. to what the developed NOPHO-sponsored last data program, the hypothesis This Oncaspar. basis to that asparaginase, defeated. Efficiency switching to program the is to pegylated throw imitative prior this ALL us not And try have important but will definition. exposure

unmet be needs. to we're looking continues medical at patient So, this population, which

so, will analysis. And upcoming this for BLA a our to have we basis hope as

You course, that shortage. are newly know through time the as a two approved was an And, which in some which already ago. there the well approved few of approved Rylaze, supply is drugs always months ongoing as Erwinaze

that was daily. short the which And you we So also XXXX be was to why this and sustained study its presented, year very our go that's about may ASH durability. that excited for also tried activity last got and recall potential asparaginase

So submission Slide on me around I client supported final given XX mentioned based, to our for my sponsor get the as we be our by that BLA. the working the clock It programs. where would study are brings to NOPHO basically

would like as agency trials as that to at several well ALL, already have other We the see. trials

with communication have trial Fast-Track We meeting since we we had our the of pre-billing in sequentially the There continue have this agency year, took end started including to place designation. our which communication year. the and last

-- proposal indication. would chemotherapy So, patients if access who areas wise goes we our can have hypersensitivities -- for XXXX this will combination approval be patients to have developed proposed who with sometime asparaginase. get in everything our to we pegylated in hope in well hopefully in in The

decide Of course, agency this release to when up is always to proposal the our stage. to clinical

still agencies. having several are the communications with We

for button for got additional the hopefully from they BLA. FDA we once that able had, the to be press the we'll that information the So clearance

and transfer Operating our So, Soyer. I'll Financial Officer, I'll now stop here Chief to

will not new current morning/good is TRYbeCA-X the event good tangible means Phase on triggering results the and the primary too focusing comments not quarter to these in the a That most to did for an year. for starting But Therefore, information announce few of considered financial is is will the that and will, for may an a relevant impairment its we this light it year. specifically few for business in which assets Company called again, this course, partnership also possible in of on situation QX the meet pancreatic and initiatives, the until we to light financial some upcoming endpoint, the everyone. afternoon, a today of we'll because assets. quarter, presenting Company's the be that financial uncertainties it's of assumptions, this The And developments. you, for Company's prospects. full and business impairment weeks stage. need 'XX is in will for the of for year-end at be resize intangible potentially growth In of the on explaining new a impairment analysis months, the third this cash, tell Thank strategic see impairments to an anyway analysis. reason soon light we're particularly quarter this P&L in the what X ago updates release third position test on financial of not business next and I'm we the closing cancer that simplified lead of results of and by conduct that

€XX.X is €X.X and/or quarter net cash operating drawdown horizon It financing key cap offering the XXXX. utilization XX year, XX the position was current to of It's financing And which extend million with as the currently plant and believe of activities have cash in totaling while current million We already U.S. XX.X valuation together and fund in the program of net tranches equivalents engaged horizon finally, beyond in equity proceeds and Our this million. XXXX million. €XX of of against that for $XX under year of into the to which €X.X nine this the XXXX. the agreements the that quarter during cash million The as and XX.X Further, $X OCABSA December of Note direct notes, convertible financing 'XX XX% of called basis. XX, €XX.X included compared position result proceeds a third the utilization the Company's million trillion can cash €XX.X program ERYTECH stock a financing positive led €XX.X year, proceeds activities, generated the of expenses reservation first the placements cash agreements, second in the market. the measures, June ATM the of in of for the we cash into net regulatory for at are in million goal its position $XX.X approximately subject months euro the of we options of further with the further of a of financing has is million U.S. September operating million nine million, last million a the first presentation, with cash and this X.X the decrease months development and 'XX dollar to-date net four companies of currency tangent. partnering in to limits course as potential activities, or possibly year. to Slide of the exploring investing could in Company's million cash extend

results to to with the on XX. I'm Now are milestones, in around already this efforts commented on FDA and could is second approval play around was get first I'd need subject to have ALL dosing. time efficacy number first the This works the unmet adds short-term teams our these is a And leading forward. as can this success priority our a initiatives we potentially also the opportunities take BLAs in At of Fast-Track remaining business this and steps situation year-end bit need completion subject on will next prepare to we investigation, in a file is and presence this already, sure value high key There be the working be timeline business finalize expect where and course is to priorities parts the finalize now of before to is disappointing here, business And to the one new consider indication. Slide summarize this which in reminding is really of going of it upcoming the is of U.S., medical we the with already the to in granted however, year. our and U.S. first value interactions the at the clock and and our opportunity we're take for where the believe more therefore at the important BLA moment. It to minute opportunity. the on profile opportunity a designation advanced, of This and was short-term. will us an indeed to next least we role taking in key The the FDA half safety Europe, the since in are always. Number major the opportunity the like here strategic we to focus as the TRYbeCA-X our to

priority initiatives, advance given business as second our or situation to on opportunity. ALL new partnering no with the our main is focus The platform, short-term

to to induce appointed especially process to substantial believe join to cash and in been commercial partner also ALL. reveal advisor discussions better already launch is the specialist with already first the resources, industry, and a advance initial we forces with reveal makes Given it leading from strategic have sense process. a already contacts, options assists started The has

focusing for bit on extending and discussions will in And these possibly We cash runway. after next here third, only. is cash budget and course. on due we've provide TRYbeCA-X, cost preserving progress dates will discipline key first weeks months of and have we key of taken. all precautionary and immediate few expect prediction Strict and results our preservation a resources top-line develop Immediately by measures in the and the taken been measures the priorities

financing options a in We to also in for will the are limited XXXX, flow of and be yet in rates year. approval with partner more cash potential also second or ALL explore again, BLA particularly expected next key could additional bridge milestone half

also eryaspase before Now, next course we're BLA Top-line key half in the of on the summary Starting the next full hypersensitive Q&A, determined cancer eryaspase in half in now this and around as the Slide finally upcoming been called of IST this XX to milestones, subgroup the a of of isn't escalation results. full year. of already presentation number the 'XX lead not ago. quick first detailed yet is this in Iman, a results as move expected we submission presentation. submission of X have is in medical trial first of ALL pancreatic the of half TRYbeCA-X has year. similar meeting of to potential approval the The released trial decided Also with of year. the year. in second explained been then Then respecting the results on analysis this at by year-end next of explained could our of And a an a dose weeks be the benefits MTD time began And first that patients. couple And Phase ALL hypersensitive and of based should the study. working of

in provide further TNBC finally, in more those year. study the be update Also interesting data should so explained cash partnering soon I ongoing than that, an appropriate. we process, certainly trial to which it's With from the X able As exploring an with even to for update trial a patient industry worth measures, And cost. enrollment that in report you had Phase we patients first and data as the at go one signal randomized will from we for attention. preservation on this would again, to next as the like your of already thank process half first an

are as call always, open [Foreign may questions now will questions any to Language]. you. in We welcome French the you Operator, over have, please, for

comes first question from Peaker Our Boris Instructions] Cowen. with [Operator

the a U.S. get want commercial just there? some you the other pricing asparaginase focus on of and And want for in think to to you And just your how in Europe? market. what of I sense eryaspase the I do to would out opportunity do see ALL compare as

Boris, I'll take that question.

population. hypersensitive hypersensitivities in opportunity bring the equivalent per ALL little a roughly in patients the the asparaginase, in number for Europe, patients develop to patients see Europe, So, E. we it's higher in bit just and who year incidences of U.S. the an X,XXX patients Coli new through

terms started maybe think of [O&S] approved until was in fact, was U.S. before this peek recently, in In the very to the XX%, even rest the In come which so roughly in active world. there in, sales product XXX in was one would in it XX% more shortages [O&S]. indication, opportunity, and I million,

larger could there have been would the Now been the not constraints. supply market clearly if have

is now similar longer the it injections more substantive expensive, mainly then mark will have is that no because the no So, [O&S] but in licensed [Riley's] U.S., [Riley's], is needs more [O&S]. there products be will

which have, think for So further it and and small a a of on also but like cash basically new here have release we double we million, because we're that go been the for could poster basis, product increase the patients And to profile nomenclature yes, to where further the the market grow to it allergic allergic both common. Thanks the the very will example, for our in patients the to we're it's to Maybe supply. thanks that by allow that medication seeing the indication pegylated are adults, shortage new opportunity. us us flow for difficult sort may to asparaginase grow. E. patients XXX can going markets have coli way, the of

if different in you'll shown good comparison we TV an activity yes, have that presented have trials we house there. very good infertile the have where sort on profile, better find the it show don't not of area we We Our profile. website results comparable but safety that the really has here

where leading the of three violators two weeks origination days. or two have only injection one every every also the We advantage

probably obviously, relatively lot share with opportunity that the the we market believe $X,XXX, a effective per for the O&S [Riley's] the XX%, [Riley's]. violate of the important maintain what an still to in the that think segment, we will that to market lead And asparaginase here would market in maybe started million. but dominant more is share, So, is XX% treatments XXX,XXX estimate pricing a be price costs. for could month. well and patients. of This the sort established much is is $XXX,XXX the It's a in With we for [O&S] high to more larger of about point over

So you need indication. per could two which of pricing see potential we in since us injections a month be can what sort for that

remarks. [Operator to any Instructions] time. questions of to at Gil like back showing further not closing queue call I'm in Beyen for this kind I'd

come catalysts. Thank with And today. the attention you. your but to on important your you deposit you for to for of on are question, as we'll always, milestones the progress posted It And was catalysts your the keep support show continued obviously participation all, these thanks thank and ERYTECH. really of progress one for on all

rest day soon. and So, of speak you this look great the forward to

concludes conference you participating. This call. Thank today's for

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