Earnings call transcript Q2 2023

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Operator

Good morning and welcome to the BiomX Second Quarter 2023 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call.

I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BiomX. Please proceed.

Marina Wolfson

to update second conference welcome results XXXX and corporate and call. you the quarter BiomX financial Thank The news release became available just after X:XX A.M. and today at Time can on found Eastern our biomx.com. be website the this be call A of replay available of on website. our Investors will section

like are we that Safe Harbor this factual forward-looking statements. historic statements review provision. Before to the statements All I'd on deemed begin, not call may be

timing stages on growth of benefits are the equivalents of development, next the shareholder forward-looking clinical in track benefits existing we potential interim and expected candidates, conference product cash, design, potential we fast statements and using the expected value. instance, results in discuss cash For final the opportunities, call, sufficiency market our from aim, preclinical of the potential short-term and and deposits, FDA our and designation when our the trials,

our and required undertake not In guarantee our future and use as update earlier, safe addition, in past to preclinical of are including cause could trials. results today's that as compassionate do do not not law, are differ as harbor release, forward-looking we clinical results well Except full indicative, to clinical success press which, forward-looking by risks actual from on outlined provision, is these statements. website. The statements noted as

on me BiomX. Chief the of Joining call Officer this Solomon, morning Jonathan Executive is

over call the Jonathan. turn will to I that, With

Jonathan Solomon

we continue significant Marina, you, make I'm and pleased Thank to good that morning, in report program. our to progress BXXXX everyone.

solid the exceed a among patients completed reflecting execution community patient program. operations of and our growing Ib/IIa been this Phase the potential update fibrosis estimates with our with innovative We patients of physicians along clinical are to study expected delighted screening within and awareness for by that X cystic Part team, to enrollment has original

challenging a may serious FDA, one communication pleased be unmet provides BXXXX the The from potentially non-exists defines community. significant as frequent Track most is announce received providing the and facing recognition addressing program review Track include, medical has of early that to, needs that the of unmet entire and the need further therapies. throughout just CF BXXXX I'm when limited and the Fast FDA a FDA Fast providing designation which or a also to the not medical addressing with therapy but better available process. benefit are drug The than development therapy designation which

assures to In Application addition, by Biologics submission BXXXX approval means designation Fast Track are of questions quicker, that often resolved leading rolling which new issues also that priority and/or be License for and review may and a application, patients. access eligible drug drug and earlier

X reminder, which Part developed the PSA treatment treatment a arm BXXXX the in is from aeruginosa, infections we of burden. or patients announced with than XXXX, notable based came Chronic positive displaying PSA bacterial the results cystic for better in fibrosis. As pulmonary February In reductions being Pseudomonas trial, expected in of on

is the an the wide the this thought of in Cystic patients. Fibrosis session conference which the a or XX attracts advocacy had Following June, Conference European opportunity important and groups audience late-breaking present we formally these during data at ECFC, leaders, to international that announcements CF

these the of meeting with notable that unequivocally ECFC bacterial for impression We, unmet patients. BXXXX the chronic patients that the displayed say were from excited our away reduction early and infections few for believe Part in with need PSA a came infections in the today. physicians burden can one candidates we therefore, is treating CF most clinical X challenging CF in the pose pulmonary I to continue in promising that study of

patients X the reduction period safety in X treatment six-week to we the complete, other announced study Part year. November top exploratory of compared BXXXX study, now end to design, four Part to X burden, a now least delay Under estimate bacterial our are longer to expected XX efforts Part points. of X. for be twice-a-day, at X screening in Part in PsA line with Part Similar XX-day of patient on our this With a additional results and data CF along received intended over but to provide results

from study development. Assuming to this stage positive results a group, the larger BXXXX's the holding we anticipate with clinical next plan FDA CS meeting of

a a select in million addition, announced XXXX, the PIPE R&D of In activities. funding or intuitional provided and second BXXXX closing individual support to placement investors, additional and $X.X other which group we a May of the program private with

to pharmaceutical two to and also bring BiomX We executives accomplished considerable added business our collectively who Board experience. highly legal

pleased very the BXXXX and we're the been progress CF patients, life-threatening are patients positive to the and constructive, receiving are is other view facing. within of CF potential stakeholders from program. we summary, feedback physicians, our in has continued reinforcing BXXXX treat in In the community with The therapeutic infection highly

Marina of for to quarter financial review second to results to I'd now XXXX. like our the the call turn

Marina Wolfson

you, Thank Jonathan.

As available I Form in a more of our some through is in release you will will issued our filed press walk be and today financial we earlier the which in also the reminder, information XX-Q, detail and brief later highlights. today.

million by used and As XXXX. offset The the due activities, PIPE deposits primarily from in to financing. received was XXXX, XXth, proceeds cash operating as to partially balance of were of December $XX.X June million decrease cash short-term $XX.X compared XXst,

as and to the attributed was as a to as activities related salaries in decrease and Research both were the expenses development period The factors. reduction clinical preclinical candidate, BXXXX. corporate workforce June for three $X.X and several deprioritizing well same of dermatitis months to in product our $X.X atopic restructuring XXth, part a and XXXX, in A million stock-based primarily which XXXX. compared net XXXX for decrease compensation expenses, ended from million resulted in

proceeds agreements. collaboration we from received higher Additionally,

However, this partially to trial expenses product R&D in was the net clinical CF decrease of by BXXXX. related conducting offset expenses our candidate,

XXXX. ended for June XXXX XXth, The reduction in was to a Officers' three expenses $X.X company's the decrease premium. insurance to million the primarily due in months and same administrative were for Directors' and General period $X.X compared million the

to and XXXX in that Net activities same XXXX. into XXXX. million six cash the for for We compared and $X.X was quarter the equivalents, loss plan ended same for compared Net to of cash, period sufficient short-term was million operating the XXXX. fund the estimate $XX.X quarter XXXX $X.X be June million $X.X to cash existing in used current months million in XXth, of will operating and for second the period third deposits company's the

back I'll now call Jonathan? over And to the for closing remarks. turn his Jonathan

Jonathan Solomon

Marina. you, Thank

XXXX, X second with half momentum into designation made the and granting the BXXXX carried the of through the we Fast already completion half progress our FDA in of significant on The from trial. had year's XXXX, patient advancing program. X of This EC/FC screening reinforced During supportive than first is Track expected in this of BXXXX meeting. positive view our further we results Phase better clearly a feedback was were Part based on and Xb/Xa Part BXXXX

point in PsA BXXXX a Our address promising tenants at of candidate our approaches viable in also are need new served that unmet CF. infections. patients we and is a results to pervasive treatment of dire reminder ECFC Based to therapeutic potential emerging the significant believe medical as need far, CF as and deadly on thus these thousands combat

I take now happy Operator? and that, With Marina to any questions. are

Operator

Instructions] first Wainwright. H.C. Thank Joe from Today's question Pantginis Please is you. of ahead. coming The floor questions. for is go [Operator now open

Joe Pantginis

question. taking Marina. Thanks Hi, for Jonathan and the

enrollment, And So the the you're then endpoints expected enrollment data, do I of particular additional a for to first, logistics that we need sense understand can time on at I also, you give you should analysis? guess you many have of, beyond how around looking to I CF, How want that? hit? it patients XXX require, for some exceeding with, And be the on X does guess, the to data. Part know,

Jonathan Solomon

morning. Joe, excellent All good questions.

by expected. you a better I patient the mentioned, a There's as driven, basically from excitement So, accrual and Part enrollment X few factors. we lot It's than data. think, went

I think very there's team. execution good from the been

is, the patients. and operational delay. driven, through, issues, noted, of that it's has more of going So just a fed major. according nothing no you've plan, opened we are and that there we not as than sort that everything's more have pipeline, to not going are you some got There of literally And kind sort points more anticipated. patients into, end It's anything changed, changed, centers slight patients know,

At Crossing our to patients. number we -- we want fingers, don't the on this we're to of of point, exact not increase sort giving want guidance number. the

again, more So, be I studies, think getting helps that fantastic in, next would excited. the data that and us and, I thinking about think right?

with remember in well very X. This world. the had and It's very different is going we've delay. a the difficulties recruiting Part You all very, Part X

Joe Pantginis

you now, it forward-looking, but by And upcoming No, look, then, I Part discussions beyond what a current possible is I'll five X, minutes you positive change to studies regulatory appreciate wish from answer my authorities the at color. and look does the as could list with saying, at preface your as get program certainly next when what look pending that, to, quick your question know, looking to might like as for, data. look market clinical like

Jonathan Solomon

Right.

that data the and definitely, direction. in So orphan more right? That's and the think see accelerated the we'd with step already the right? question, we've I such discussion good we're condition right a So, are items tough it's we and those as to FDA. breakthrough another think got on There's fast all hopefully a designation. I want pursue, approval, track that

of fast approval, such and Insmed accelerated there with with cases I approval, smart as think seen is design. we've the cases

and anything So the a for. meat we're the product lot seeing unmet to need, we're to there gets discussion. is right, that going sort be a what was us faster looking which the bone And for again, I think of of on

of first unmet more that or like up fast the a the think track need sort that, discussion. I for a the of FDA acknowledges signal opening channels of huge sort

Joe Pantginis

than to answer appreciate resources, other thank there I just that. then sort to able obvious assets. ask of And indulging pipeline are could and I other be potential -- avenues you the me. ignite if No, The for of

Jonathan Solomon

right, You're company always to be of, up a we're ask of you for I are the we think and resources. company, looking as set at we now a looking more welcome bunch projects topic others such as that to -- waiting know, we are questions, right? all kind that other and platform the more

placebo we clinic think it to with require for new move do additional that definitely quickly I relatively more on phage, up handle the think this panels multiple and we've Because there's part that there's there's can study is as hopefully, with effect, phage do a right, looks a others right? X if and with as part good good give would that us I that I an replication, can got the additional -- could again, collaborators. controlled X, the resources you So But right? second modality, that indications, more open with think showing programs. independent randomly confidence and then discussions, or

Joe Pantginis

Jonathan. Thank you,

Operator

Thank you. [Operator coming Instructions] The is of Michael Ladenburg Higgins Thalmann. from next question

Michael Higgins

Thanks, congrats November. Operator. guys. Thanks QX to I want delay the morning, data afternoon. Fast bit And Good of here the in from on a patients from us Good designation. with focus back on well questions. taking my additional for in Track as

want of much you've along clarify ourselves this the or How to along to has able way? there by everyone. review CRO a and data, the way Just review for the been Thanks. been

Jonathan Solomon

Yes.

blinded the we're So completely to I data. mean

we So we seen -- if decision. haven't we anything any make have or

that referred excitement the I and more passing sensors -- what have patients, we of some more of, and took through is decision is been that seen anticipated the and more screening the area. originally seeing what patients the the than among think that we're the the of sort kind we sites we've by

this delay? talked next the more we're new as discussion before, right, data as of study. the Because a as as the think both design long good I But is better I mentioned we modality we agency the So forgot before, get for only know -- I well Michael, and slight we with a the is morning. clinical prepared this

Michael Higgins

need Phase hand It helps for meeting the take end II the have before ahead with pivotal to your more start. have data patients next you of steps. of definitely Do in on the to Question Yes. FDA? you X-month a

Jonathan Solomon

question. a great It's

we think public held very know workshops safety the think sort estimate of far, of modality. comfortable the of acknowledging we the that, felt phage FDA has is sort so I I the on no, and

X. sufficient should and And get think So that I think we'll Part XX be going. I it's in see had day some a soft the we hopefully, the to it at discussion information follow-up

Michael Higgins

is XX-day another Ib Is I could Phase come one, in saw that jump I share in queue data the ECFC, last information. information with and you so, if one please? the But as to back at endpoint? if here past we data there that, maybe to And such later. there any additional before Any plan including back question share baseline additional plans,

Jonathan Solomon

information longer looked pave way Part information you for will short the mean, up present study was I X, There's and to a have the that So X we're of so the the most wrapping the recall, a sure design. safety was X hopefully Part heavy as a more we at of longer follow-ups. Part follow-up. that haven't I for and mostly we the lifting don't conference. be kind But think bit at

Michael Higgins

it. I appreciate Thanks, guys.

Jonathan Solomon

bet. You

Operator

you. Thank like to back to time, I'd At turn Mr. floor this the over

Solomon for comments. closing

Jonathan Solomon

So again. I thank us to the updates this to providing wonderful questions. a us future wanted with new please on for year. out you you if forward clinical Have reach our to have you Thank again programs day, We say joining any you look morning. in and

Operator

your thank you event. Ladies and participation. today's This concludes gentlemen, for

and or the off lines rest your enjoy log time, the day. disconnect may webcast of this your at You

BiomX (PHGE) 9 Aug 232023 Q2 Earnings call transcript