PHAXIAM Therapeutics (PHXM) 14 Mar 222021 Q4 Earnings call transcript

Good day and thank you for standing by. Welcome to the ERYTECH Business Update and Financial Highlights for the Fourth Quarter and Full Year 2021 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I'd now like to hand the conference over to your host today, CEO, Gil Beyen. Please go ahead.

Michelle. you, Thank morning. good Good afternoon, 'XX. Thank you update XXXX business financial the for key joining the fourth us year for for financials year and our quarter highlights and key for and with full and We announced our Investors be release and financial Relations can page the presentation on website. the Friday webcast update and found press on business evening the of our

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

Before a that and the come. the and X be today's in to will the the then the strategic summarize of answer remind year starting highlights timelines Will questions balance. the then last such which after an and on all Iman, for I'm of a priorities us also call our operations, expected start and financial. session. November. on the and actual draw now, He short ones, that on company's cause will more Eric our progress present update And statements, the materially. introduction and will risks status deck, clinical usual on Slide timelines know, results come ones to like financials key to differ and And for programs, I our that will in update the the to as be cash involve key the an your Slide focusing three I occurred of available the the and timings Q&A will you relating provide recent switching and after call And with present of you year. will as disclaimer they uncertainties X, to would includes forward-looking call. attention to agenda to to could the as

the anyone overview -- development of ERYTECH is the is ERYTECH new on Now, X, company, you focused obviously, cell-based therapeutics know. blood moving to cancer this on focused to as for of Slide red a brief

red Our we're lead submitting and is product BLA, metabolism so GRASPA the targeting or in glutamine in ALL, cells to is agent. our asparagine a file Current GRASPA eryaspase, cancer asparaginase in phase it’s close pre-regulatory cancer metabolism, our for approval. blood cells loaded -- the currently it's altered

We have first a line cancer tell more. cancer. in will in Phase Phase triple-negative pancreatic X X ongoing Iman and breast

NASDAQ So, two operations, trials we fully second clinical facilities, for two to terms the a Jersey in have manufacturing also shareholder are market And of roughly in And shareholders as in U.S. in very future serve the potential U.S. one operational New Lyon Euronext we of base with later. in half the and European balanced the also Europe and and Princeton, listed XX-XX the company

great reported, primary would fourth meet so to focus was deception 'XX was cancer, the TRYbeCA-X on the COVID in day the them X announced X the a our year impact of working, in results trials. night race Phase -- one the Slide towards in tremendous -- severe our a quarter And October. has time clinical not other October the planned the execution of shifting of -- and year. trial line its pancreatic data as the X. in when pandemic hand, and is also with out indeed second October. did get had really really and of the they year on we I on to endpoint we Notwithstanding trial were last as TRYbeCA-X 'XX Phase all that say, the in of of year the special been year, the an Now highlights on very

'XX progress. very good was the also Now year of

in and the GRASPA in in FDA the considering in multiple -- which fact We year of patients will expect a quickly we in our to finished front evaluating be their elements approval The the Track evaluation indication. requests. the in potential we still including pre-BLA almost had of from so on meeting, for FDA file file this ready ALL hypersensitive almost information with and were designation. certain Fast able BLA 'XX the now being patients with to we to fact, we we ready dossier, ALL granted interactions expect are to has once ALL the moved file a of outstanding FDA, In seek the

the in On a in of the & not treated interesting trial, was all is chemotherapy. And The irinotecan-based GRASPA of cancer. improvement represented the patients. we the It's topic, In the TRYbeCA-X noted in setback. But an this FOLFIRI subgroup XX% subgroup next with patients approximately pancreatic eryaspase TRYbeCA-X, hope OS regimen. for for regimen fluoropyrimidine indeed gone trial. a

X We have a Phase ongoing.

see And FOLFIRI, partnering item also activity the also it's highlights, on University. here but evaluation also trial In trial. seen And the and Iman in we clearly, now, then will X Phase Georgetown options. FOLFIRINOX. GRASPA chemotherapy. it's results, strategic indeed X the at and encouraging -- fact, profile search evaluating it the will last we safety good, -- the Georgetown, is the after announced & looks a irinotecan-based clinical investigator for at What explain more. There we've in combination an sponsored over a with and ongoing not fluoropyrimidine areas Phase

say valuable in from back two options We evaluating be this to at or we this but are a stage. with more hope Not now. more now at stage, month news we can

thereafter, to hand the to key is milestones. provide yours. I'll the Iman, the timelines. for mentioned to Iman and here financials over floor on programs clinical detail additional Eric, our And expected So and as

you Good fine. Gil. you, Thank doing everyone. Good are I all Okay. afternoon, hope morning.

an with trial chemotherapy was overall Slide which line Unfortunately, was So, that in in #X. versus pancreatic just October we not just last start the cancer. about reported any comparing study. study alone TRYbeCA-X second Again, with survival did reported asparagine year. primary I that a the quick pivotal will reminder Phase the we X the This meet endpoint, back chemotherapy

control overall said specifically also However, PFS survival, is we where that all numerical saw groups although chemotherapy. what eryaspase XFU of irinotecan in an combined with indicators, there year and a treatment is was trend one interesting and have we rate, course, leucovorin the including, of difference disease on efficacy last

and continue dissect to the to data We study. a on get interrogate better insight the of outcome the

was much Of anti-cancer as course, on of there conclusions, isn't was groups have this we Pascal terms study meeting. the and the particularly cetera. reason, of well-balanced There obvious discussion actually some therapy, intelligent to subgroups, last the beyond the received by presented Hammel make during the treatment year, GI year ASCO in us well from really And and reported interesting it trial. that at more seen subsequent had very at beginning we et we the of outcome

whether again, path how into be continued there a two interest at pancreatic January. leaders, key look see reasons in cancer. also ideas second opinion the to and reasons again further indication. of pancreatic some take And forward are is And for group is We our that interesting search the our with lead, any reasons to Board of with cancer to we to not there this for in the this in Advisory obvious have we an there had aware continued

develop switch I gears asparaginase an to hypersensitive formulations. to to specifically Slide and other ALL, moving patients now actions indication it's #X, So, who will in

the we meeting by again investigator-initiated of presented showed of the patients in discuss and forward with population, for hypersensitive GRASPA remember, you patients, effects study who ASH so, and last which basically XX was have in FDA that sort indication action and at well with during GRASPA a also seeking an had potential on and [indiscernible] received and [indiscernible] [indiscernible]. treatment year looked And was but a meeting, trial, -- only path study, an these demonstrated developed pre-BLA sustained this meeting The very to tolerated. in as XXXX based not asparaginase activity is patient or improved it

to Slide application ready are, to we our and moving I base Gil mentioned, FDA. are as as submit the So, again to almost -- we just touch #X,

feedback on had lots have accounts of with requests we're the constant to the working there imminently. on are agency. We we'll we with have were enable pre-BLA acceptance interaction will [indiscernible] the address remaining the find the to and agencies that and ready to the for hopefully be those hopefully, get followed waiting we requests. them They find non-clinical the us clinical And all and meeting,

we are would in subsequently -- -- course, here like to in path forward Of just a we not but submit United also for in Europe. look States,

also units would study and dose The the XXX year. presented is used cancer. pancreatic very And be already and breast And of second cancer. Switching time per So, is which Marcus is two this trial Dr. signal that to much to full and was trial. [indiscernible] it first of also first more Slide here TRYbeCA-X in have towards pancreatic combination line Georgetown time which identified switching care triple-negative kilogram, TRYbeCA-X results One University. with expected standard this moving symbol Noel modified back we in led in reported The in GI the GRASPA study activities FOLFIRINOX of during this half also this this some by the investigator-initiated of encouraging Again, that the gears to in cancer. is gears is the to ASCO that is #XX. year. actually

setting combining with of at GRASPA the in to enrollment Phase with stop have small outcome a therapy trial, in had in received we And study. XX The actually [indiscernible]. opted As randomized least prior further a study X gem-carboplatin total. you know, one we that trial a the who patients a was of TRYbeCA-X, in patients patients in following study proof-of-concept

by trial. those However, enrolled year. results follow-up who third we already patients the provide to are quarter do the patients we And to expect continue this again on in of the

with Soyer, for updates Financial you Officer and over Operating to I now Eric. gears priorities. the to that, so, switch and Eric and our Over hand Chief strategic And Chief

morning, you, Thank Good Thank everyone. you. Iman.

the As of fourth this will focus I you quarter XX financial for Slide on presentation. cash. 'XX, And update on mainly are the of we see

while million, XXXX, Direct the XXXX investing €XX.X was of at-the-market, of tranches and financing in and financing drawdown €XX.X million, million. two $XX.X the April limit net €XX.X same Registered generated that that's cash XX XXXX €XX.X utilization million, utilization year a ATM December million net totaling from one we've proceeds time combined cash activities in and which of million million that's from to As December, ERYTECH managed compared February, million in The XX, was cash included €XX.X and million and $X one net $X.XX in notes. of of in program at total four offerings, the equity that and in convertible had in cash million XXXX, that activities equivalents the last means as activities December operating €XX.X to approximately with €XX.X million, $XX

third of to While variation the against operating a the expenses cash million positive programs of position are we that, and partnering €X.X And as ongoing that well current without of options, the future same fund strategic currency current by in euro planned potential time, course quarter With potential the led that proceeds U.S. explained which the from into can ERYTECH's believe the impact. considering and XXXX. is dollar Gil. exchange

will prepare regulator, year discussions, to or XXXX XXXX that regulation with market company stage, its reporting a operations. impact transaction to potential to these a financial accounts advanced Given the results will reflect market are forma this full present and pro consequently, per date, April. need postponing And and accounts given of be later time of all forma the and review the the a to pro in needed we on likely

XX Now, priorities a presentation. upcoming key and summary coming quick before for the this the of milestones. strategic Slide key of to And is month Q&A, we and move our

year. we to dossier close remaining forward Gil in Iman, of months completed operational by we should quarter the to submit a believe once our is. second dossier explained to ready And information The ALL has be the still for has green in and eryaspase review to able application. in its no of file us submission light that the As request the being and the and be and FDA this the the gives been look BLA priority hypersensitive of key recent is

process year. the We The name That's and the also trials triple-negative our are of Phase breast have trial not in least data expect half we working in is review of And in trial two the and call the on this last but X you second now And Phase TRYbeCA-X for and already to an in the cancer, all TNBC of IST questions line update French I investigators cancer. partnering open ongoing the trial with the of half would in will have. which quarter attention. third presenting later you from is first we report course, welcome. ongoing this this year. target of questions And trial Like first rESPECT we year. X and strategic expected results this the speakers eryaspase and first year. pancreatic teams any the like that, data may from the for your always patient With thank are name for to

the Although I've not success Operator, back much to Michelle, past. in had over you.

our question Instructions] line first Peaker [Operator from And with of comes the Cowen. Boris

line is go Your ahead. open. Please

in how Good for how talk want taking And to your invest GRASPA afternoon, ALL, you commercialization? Thanks do playing for commercial commercialization out? about question. morning you Can just you is and see or I guess. understand I strategy? to what my plan much

but But so, -- morning, of been partnering strategic the indication, exercises on a us alone process partnering TRYbeCA-X of all in actually that that one now is us -- with we the ALL have Boston. -- of external vendors setback really for positive office, these we focus reasons strategic would significant, in the which smaller its clearly a TRYbeCA-X, and needle. announced the would clearly, go cetera. Boris, for strategy focus Hi, combination is after But been the et for have is back three big the in with we're

So only, forward a but and commercial so will lies -- partner. that be we partnership, commercial most likely not path with also the

it. Got

commercial plans So to a own? clarify, your just you on to have no build organization

plan. a have We

evaluating least in own, of parallel vendors, support go external a but evaluating at we're so or the -- I plan split on deck, with in the to is but specialized we're vendors, now development our at further partnering alone have plan. we has, that think least priority of options We corporate the

question. it. Thank you. taking All for my right. Got Thanks

Boris. you, Thank

from Jefferies. line Thank you. of And comes with our question the Codrington next Lucy

is ahead. open. go Please Your line

my Hi. Thanks for taking question.

Just one, please.

data that how in is there indication? date on we've confidence that to mean, that that a terms we kind the the path you're is of give I is you rate. in Is looking bar see first in obviously Just to much to contingent the threshold XX% of for? response the data in small? pancreatic -- so of there that line seen forward cancer, outcome And Or particular looking half? something is it with it's in second the a you're the there trial? -- need therefore, And data too do meet you. that to what in Thank of

question Thank you, Iman. Lucy. to I will hand this

Okay. Lucy, you, Thank for question. the

things. first rESPECT Number trial a it's know, escalation dose of it's pancreatic number just the of the So, one one is, cancer, you line is patients. as couple in study,

with compared expect So, signal OS to you interesting the perhaps looks alone. FOLFIRINOX would to the what

the is of I again, think of evidence. encouraging most we be need consistency is, because to number the it small point a patients. important here cautious really But the that,

irinotecan be the really and that So also logical combination with sentiment not unanimously leaders. next the almost our step. was see opinion all we'll TRYbeCA-X by by seems key also XFU a trial, the from that that but And only shared study, -- rESPECT to

differentiated, And to one, patients, repeat instance, indications our we a is poor poor setting, for from performance, at us So a doesn't see here indications, should next a was whether would performance really smaller for it to go trials. [indiscernible] good be status into maybe step line, option one [indiscernible] make bigger sense be a options to looked second whether for performance larger to good actually first which a much trial study It or therefore, and future for trial. into all after and instance, different third trial. go don't instance, be we or or whether line like

options are flagged key some these opinion our So, basically were logical leaders. by that

free to to of two added or will so, And survival be but survival or a months or progression indications, year. if trial, response study, these your the any a a your of point, year, to you will have course, may to go will not six problem point one we one be year to look be

So, these options. are the

first have once a settle potentially endpoint go see do endpoint these we of and be advice to on is think with surrogate to whether the approval we scientific seek options, for accelerated an FDA thing one I approval. to would

to certainly there done. work So, some be is

the we TRYbeCA-X. we signal doing lengthy have that either of biomarker that is response seen also things I'm in and the answer were sorry looking that One preclinical, at this currently understand the are to potential some Lucy? be may further Does we a for looking your question, it and in

the So you is [indiscernible] just options. confirm potential patients can I one of said

Okay. Great. Thank you.

time. further further showing over And Gil [Operator like I no conference Beyen the this to Thank to back you. remarks. And any questions at I'm Instructions] for would turn

Thank you and your for you, Michelle. continued ERYTECH. attention Thank you of and all. for participation support Thank your

on As posted yes, further you day you in forward to development soon Have look next always, speaking keep call great and we'll we all. -- the in a May. Thank in

This for You may now concludes Thank participating call. disconnect. today's conference you