PHAXIAM Therapeutics (PHXM) 13 May 222022 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to ERYTECH Business Update and Full Highlights for the First Quarter of 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, [Operator Instructions]. today's being that advised be conference recorded. is Please

please assistance, I conference would you Mr. to require like Instructions]. further any Beyen, Officer. Executive the If now [Operator to Beyen, Chief ahead. go Gil over hand

Thank and webcast financial for tous. you release of you, months the to the can update first for a evening, year-to-date highlights this call Thank key our year. conference the press three the Norma. business Good this We and Bonjour afternoon. and discuss Good of morning. joining on the and found business also page our presentation announced be the Relations yesterday Investor website. financials

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

strategic year come. available three us he balance, long clinical was that Before the the timelines, draw on milestones as X, as financial. disclaimer includes starting of to occurred after the After that, today's key on progress for that will not to operations, you be that the ones our Switching Eric a that cash programs, update timings key differ to status usual, which I after with Iman could such update as the you forward-looking expected to uncertainties of ones, an will provide to and in they statements Q&A. involve present and I'd introduction, company's the results attention the focusing could cause and like materially. also the the reminding the year-to-date, risks March, the -- will, and business actual call recent Slide your that of highlights the the and summarize call will all actual our X, and start agenda call. an And damage know, present which and more all for to on Slide relating last the of priorities then short will on to results timings ago. financials,

Slide to the company this to really on brief for X, is Moving and and completeness, overview. for anyone new

focused the is areas ongoing the in pancreatic pre -regulatory ALL, cancer lead phase lymphoblastic parallel, some filing breast loaded in Asparaginase cell-based our blood targeting red and process line a shortly which leukemia, altered -- in or in bias, With indication. product now cancer cells So, will we BLA in development II in towards first for of glutamine Phase of on in now Asparaginase and GRASPA Iman therapeutics and we X then. cells, we're GRASPA, ERYTECH is Phase red a acute metabolism. an time are the with In triple-negative this working of have update provide cancer the

supply sites, Catlin's former since to for say. fully a Princeton ago few New one at agreement our manufacturing the supply now operational candidates shortly with the a seen explain North Princeton, Jersey second Our you've more, two America very weeks for should facility, in that is sold through manufactured and U.S. at Europe, product l'll are [Indiscernible] facility the our news we

our million. all that's for XX, quarter, site a X, the the probably We it was announcement, -- sold the indeed of and So, sale saw on you highlights the the year-to-date. the Slide the of consideration Catalent. facility $XX.X of April to Princeton

product. in supply a with total, XX to working transferred long-term meantime, are 's our the we and for supply the entered us also already, and for the site our people manufacturing entire agreement for because in Catalent In of Catalent team, and at Catalent the lead

would this a priorities than obviously, for questions then money, relatively get secure with made to we all GRASPA first. have for of this is it for their wish us dollar contact U.S. for submitted as two they to far the real our not will for these $XX see facility too has mid-XXXX, but burn £XX trials, days, in The new so sale deal question, and product combination was horizon until we pain so creep away leading we very the but after with want cost setback remain a long-term in all one to hand, landmark of approval ALL Catalent working cash although GRASPA, company. approximately burn go too to the obviously, the and the so obviously, and basis, very reducing great next will reducing and good the big has our on are are to the new focus cash our Eric they rapidly the in get will field facility it years. hypersensitive future an patients this update. supply we're continue and found hopefully and, contacts on, to do million, the to provide now, in the what is to indeed and, heart will overall one way of reduction our them in extended ERYTECH and solution cancer BLA one and facility. the the what so, will new the million, with cash also approximately The think in site contributions more pancreatic the ongoing the at Catalent, and secured CDMOs to site increased screw to on commercial a changing team with beautiful simply we So our position the here to more, supply you pleased agreement to which us first that's Iman the in our X, team the site we'll and see to take best approximately answer cash, bit significantly clearly of for we I the the efforts explain Slide continue it produce was obviously for GRASPA entering the occasion been supply cash future. be to in our the in great is close in And the their a And also the so -- thank able attempt

The blood second is And to or continue what diseases. technology. to we've develop encapsulation been for doing, difficult red medicines program leveraging treat our innovative this cell

use have versatile. is types two Many continue -clinical can are there the of programs opportunities, I as And Both in pre to of the sales. to expect a results new in have, and execorm molecules half we've already, them of number develop second ways physicals extra light. be was to many this blood cells society Is it at And results use We castrated because of conference cellular we on about, increasingly year. to program clinical on mentioned enthusiastic the the work to very the ERYCAPS technology threat cell red presented red ongoing. Italy. a that encapsulated we're recently

the Terreia, strategic then is seen first to We're to will to ERYTECH. results, hope after search deal continue have very Phase for pillar options options you the for say. for followed ERYTECH, work to indeed results the our step, We us results. deal, vivo company. it there Catalent ex in first was to three strategic interesting continuing - build the third I We looking complete Catalent help of next the the some story we priority specialized And that cancer. retained pancreatic a pipeline to that in advisor, for and would this a

and posted by Eric on stop options. this value to their look the to now come here, for strategic potentially a year. tuned continuing you to And hand valuable more on stay and additional our of leveraging manufacturing the and milestones progress. We at broader to They clinical will provide at Iman, the milestones. and series much keep After for obviously, pipeline capability, which partner, our further options. of commercial extending present But stage, say details who development our can are from looking will range financial we to but over will GRASPA, I programs,

yours. Iman, So is floor

Bonjour Good give I the a have Good slides morning. Gil. few updates. you, clinical Thank tous. regarding afternoon. to

here lymphoblastic the So I number to will on with key X. acute I'm project, focus start leukemia. Slide the

provide terms approval in progress hypersensitive the the patients. for our going of filing Here, to towards in I'm update quick a

studies in eryaspase United know we mid is receive or indication Asparaginase treatment. [Indiscernible] forward where in you ASH trials [Indiscernible], we of for prior disease. in GRASPA patients of was the also It's Asparaginase that in and activity, already a and have prolongation which As studies And to actually an year. back of patients important hypersensitive with who made decision intended was to sustained XXXX during know, there have with product this therapy, in were approval given study patients reactions last move which was approved courses reported to an was there that able and hypersensitivity to seeking that, approved States the developed

to the with an front. moving are agency number XXXX. X, and have the the dialogue continue and Slide So BLA today We'll we on discussion where the next and [Indiscernible] to

on our have a and the constructive You was this we very our meeting where will June structure also pre had collision -BLA feedback recall for and BLA that last and we very year. we -- meeting plan the received

agency. know, continuous -- basis. we your -BLA plan of Fast the Where pediatric is currently request you we waiver enables with may and increasingly with are that is this And so in recently, it's still an discussion were dialogue agency. like which we pre because pediatric have interaction particularly plan [Indiscernible] granted that continue submission, to our Following the to review have as Track and designation, -- meeting, view. in ongoing to or similar the are a today, as it to pediatric we part we continuing Europe and They on or have information we ongoing

to initial BLA submission. pediatric have and FDA similar be towards to approach the application potential potential agency the be will the the go revised feedback committee we taking the for our we at indication. move so seeking With of would that a the we for by and forward received also green once filing have agency, reviewed staggered start file the providing front. States We'd [Indiscernible] We Europe more first we and from and United from then a take like back our light in to

-X, pivotal number which, start is Moving you Trybeca will programs, to in as know, switch XX, cancer. our I gears clinical second-line trial with Slide pancreatic other to and I'll

months and presented in subgroup -planned based the also the have key on study ASCO-GI, We have of signal in interesting an at pre we highlights seen study, analysis. a from the the few that ago patients

from results will rESPECT [Indiscernible] by around led trial, continues [Indiscernible] same of to really to further investigation are studies half and assess the and disease. merits to that this enroll investigator-initiated which to continue in on with year. we target trial what the expect see We second work time The the our is patients,

Lastly, our but the TRYbeCA-X, or was -- be breast least, in on cancer, Jim was not [Indiscernible] can negative as proof-of-concept trial update GRASPA metastatic combined with said, triple this you know, disease. as where in

as [Indiscernible]. results expecting doing the the QX we almost during be of currently close So four analysis, TRYbeCA-X we to are truncated given enrollment, lot the to again, what study. close of an expected a are And the and report the completed the to just for results, interim year study cleaning so to able [Indiscernible] have clears to results the of we patient data we would this

update think on over to for the I stop will the and here then hand priorities. financial of So remaining this, Eric strategic I the with

you. to over it's Eric, So

Thanks a of reviewing the this lot [Foreign first Thank year. the morning quarter now Language]. you. Highlights Iman. Financial for Good everyone We're

Slide P&L are the with are slide and starting we of We XX information. on deck,

in G&A was million decrease net €X.X and clinical mostly first for year-over-year, in net in that to expense decline the by But The development expenses, was was the Company's and related $X.X It attributable the -X.X% see that to was €X.X income million In in with operating from improvement. credits. was partnering loss clinical was legal €XX.X loss financial reflecting expenses both million quarter and €X.X imports development improvement of for and a can in is income. €X.X tax the You and stable that loss, same activities. increased €X.X and million decrease million million diligence million our by XXXX the preclinical activities. the upset R&D due time, decrease in operating

moving slide, now next cash. Slide for on to We comments XX are the

XXXX €X.X million, million last utilization In 'XX, cash €X.X dollar a this March expected long as notes. drawn the Please since cash September of the the an a any with led same €X.X December cash currency equivalents million of first time, portion expiration and investing million, there activities, tax facility. note and year, of had caps As year. convertible €X.X that euro the on month. company the does trash, variation million compared that net that August against also convertible in the in notes 'XX. not credits. unconverted XXst financing draw million the of cash three the And since positive €XX.X And us exchange company to to no a were as prepayments plan ago, approximately next charge of of The $XX.X the of position new totaling And any investor Actually, and generated further not the and until the €XX.X has this financing impact. included facility €XX.X outstanding note during in ERYTECH year, results months million and R&D with operating of million was decrease activities. of

running and operating undertaken. can We development cash yearly sale are its million, expenses approximately cash 'XX. rate, for has approximately on to As that million which equivalents that cash in €XX further With and Princeton closing $XX And the reduction million by position costs is company's April cash fund to to disbursements depending already Gil, mentioned to million, $X.X at the million programs of on $XX.X of the which facility. the cost-reduction current facility XXXX. planned transaction about Princeton efforts, brought and approximately believe the to €XX of million the meet of already current the exchange general ERYTECH €XX related

coming of related a we to months. priority before move upcoming presentation, eryaspase Slide the still submission Q&A key quick on and operational priorities of [Indiscernible] and Already Number by of XX key next over hypersensitive summary the the stated for XX ALL a milestones [Indiscernible] our and strategic Now, for key is in the weeks months.

light submit look application. year. once we the target has the to quarter of of submission gives third FDA currently We end to this review its the to forward and of us explained, remaining As green request being the able completed information the by file the

of capabilities, most trials, first to we pancreatic trials for that Catalent the rESPECT TNBC, pursue now TRYbeCA-X development We review us options was also the third - eryaspase and including open investigators date. attention cancer. in to looking development trial to would GRASPA in to thank sale name data eryaspase on you. have also the this X we to we'll the and data and IST you teams and Operator, for to your pursue the of in you process, the the first expected And already at manufacturing complete like have. ways presenting questions of expect two in year. ongoing least And the results trial now third the broader the strategic Phase our the already process. gives any trial report clinical that course, And working of Phase trials facility line, trials may not and a With in that, programs. Starting the leverage X the is of quarter I the over where not of the for is ongoing and The with Norma, quarter now are to means strategic and this attractive all Princeton with further The ongoing but BLA, [Indiscernible] in pre year. and commercialization call for options. partnering step of name are

we [Operator standby the Please you. Thank Q&A roster. compile Instructions]. while

with first Cowen. Boris Peaker question Our from comes

open. line Your is now

for thanks guess let's and maybe my questions. ALL. I morning taking with Good start

the in get ALL? hypersensitive you approval, you can potential on commercial Assuming comment

this take question. I'll for it. Boris. Thanks Hi,

hypersensitive in or the develop the asparaginase, is year. ALL, to activities, due hypersensitive pegylated about oncosphere oncology. hypersensitive there patients it's the develop which it's U.S. patients necessary but So leading patients who in thousand the a roughly of the U.S. It's to are XX% the these who around every

of in these silent With includes sort which hypersensitivity, forms or activation. and of

think in you do patients? what pricing of and reasonable a it Got kind those is

high. levels for are Reily's price The

$XXXX. to So XX injections drug each Riley's in per XX needs to order month, the five of that filed is files up

little from month. above between see ranges XXX,XXX not sort per of you'll below price a to So XXX,XXX and a bit

with more of that's -- only And has So eryaspase oncology would instead drugs. every one the of. expensive advantage we

In times it's injections, Wednesday, month. Monday, a fact two there's times can per foot Friday month But so we other with per that eryaspase areas pumps. got have every XX we so week, dosing

that triple-negative Got I study to breast thinking it. do And what question with see to TRYbeCA-X, in cancer? you need continue on

to question this leave I Iman.

you the can I repeat, didn't Boris, first the on hear part QX?

Yeah. order about in investment triple-negative you running. TRYbeCA-X, show in breast that guys need talking the you do justify in study just this to What I'm breast further cancer cancer? are the to trial

Okay. it a is disease is really cons like as was objective then control see the key which well as so response, to a have trial, survival. it's rate. a approved trial, progression comparative difference. would Sure. would a we And endpoint, free secondary like see Because -- difference endpoint we primary We to

remember about take to I of XX% an trial. think arm signal which that a encouraging difference activities further the I is it or XX% control case on there a to into see larger

it. my questions. Thank for you Got taking

Thank you.

open. comes Jacob question next Your with [Indiscernible] line is from Our Mekhael

the question. I'm asked with kind BLA of Hi color can you're there of additional provide still on you? for ALL,what discussions and if for the have any just taking you external curious the thanks information my FDA having they on

-- placed Iman, these Thank I answer to best also. you, is I'll Jacob. think, questions

Jacob. you, Okay. Thank

on each actually as a we clinical front, interacting when there continuous discussion had as So well module. there's -- a are

weeks, few accepted we of -- the that the proposal, on a requested still like we based etc. they review on the are were lot response get there CMC, on example, they every For which on get information and a

hosting are the ask waiting they why should was rationale wanted not there our toxicity We've a development examine for we're so or some subsequently and -- forth. to we to that we and this pediatric study on we are have for indication questions or to the patients, you we've be VNE also the that since seeking not to it the address is requirements would exactly [Indiscernible], actual rationale. for a waiver. for or that the [Indiscernible] of is things including request pediatric to non-clinical, also that's information feedback plan provide a how the submission the what pediatric waiver provided part provided alluded have point that doing the they the the These we structure And that development been plan. so and I a review pediatric On pediatric when happening. information is meet on prior and

responses for And the so committee the the advise or sense in additional the from they questions will which is the where review calling for agency, meeting these, July, these any are, from applications. again, next words pediatric

respond. You what by or We when can BLA less. question. get very get requiring [Indiscernible] the move way, the see it's PT. next which actually, step, reach process, may helpful. fees, we or We the issue very the the we of for Because topic is closed know additional the more or a We and hopefully, is questions to agency is

helping how address seems improving etc. that does our as continue to of so these specific And also process topics to entire us is overall

have indications another consider that space? that one [Indiscernible] larger besides Okay. I require I see. Thank pursue, also investigating lot you are with money area could question. any to the smaller there indication of a you. And

would that I question. pick

just go Yeah, ahead

few that is The activities that dig. are is longer are The there yes. short answer answer

as the instance, respect Further would one see like as results. our of too, completion under For -X ongoing interrogation. report to TRYbeCA the of well

cancer. not in or whether should pancreatic continue GRASPA see investigating we to First

globally inform have drug more more And that and broadly, we full pathways and metabolic -X the tumor Of of into types. them course, or cancer. therefore, just the drug of TRYbeCA is also one target life decision. launched in metabolic, this But will potential, other a the this

the the not clinical and insight GRASPA. as in So story's alluded drug. to picture that at this finalized corporate plans go yet a But yet and not with Gil? we activities. two further strategic will as to the continue then informed overall to, indication looking better immediate assist the decision, give over us it's bigger Eric which and And

a the Maybe I is Mikael. NK/T that the you glutamine if cancer still add, could known meta metabolism to think answer indications, -- I to where but just example, for think role is to play asked as cell for smaller lymphoma. asparagine

with progress indications to the indication also so step. but clearly In opportunities. so see the next solid be an And haemo(ph) that we haemo(ph) the obviously not tumor pending ALL, further take the mentioned the we could that

Nice. more, have Thank one you. if okay. that's I

Sure.

Expand consider available would blood pursuing be would it the yourselves you of red for some that the on fully technology to vesiculation of that cell or something is partnering? applications considering you're make what

for be encapsulating there. for question, obviously, good and for already good really example, example, uptake seen But, and releasing still agonist than a it's early immuno-oncology, very us. done macrophages, the interesting have work still vesiculating It's by STING application we and to in like

if So application, be very we excited example, our red -- cells vesicles clearly another something that could be good deliver a of With could RNA. depending to, could continue on we increasing partner. for cells how is internally a the very good interest vehicle also red and do an for be we to the progress, see

the we something be be spaces in this RNA of delivery competence, hope - vesiculate, see if looking way not cells we're vivo or for then CAR will can RNA - there. for option Clearly, a indeed do I is the vivo alone. So don't helped, have encapsulate RNA also - example an red the ex in would to approaches. partnering -- so this in we and but could type We is progress whether we there vivo

Okay. Thank those much you very for answers.

over back Beyen closing Mr. questions showing to the remarks. for I'm And Gil I'd further time. this hand like to conference no at

Norma. Great. you Thank

ERYTECH. forward occasion. great thank you. the wish and Just attention your next today, support look Thank rest a at interest, I and the you your of your of continued your everyone for participation, I to speaking one to for day again

participation. This call. Thank concludes you conference for your today's

wonderful now day. may have disconnect. You Everyone, a