PHGE - Earnings call transcript Q3 2021

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Operator

Greetings and welcome to BiomX Inc Third Quarter 2021 Financial Results. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Ms. President for Vice Senior Wolfson, of BiomX. Finance Marina you, you begin. may Thank

Marina Wolfson

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

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

the instance, we tranches law, of are potential certain call, and of conference certain For studies, loan preclinical, to the candidates, as forward-looking except in milestones product do and pipeline using by not required met, expected and future and update undertake development returns our interim additional we're and statements of our discuss if on we momentum, timing, resumption aim, design, shareholder when forward clinical the our Harbor results The cause results statements that website. our final trials differ risks looking full the actual which forward-looking today's provision, receive including in of are end earlier million equivalents to management, from could our implications cash cash, these to press to changes the operations short-term in on is statements. until to existing outlined release, Safe potential noted up programs, including and The of is our deposits of $XX XXXX. fund sufficiency senior

that Jonathan. call our Chief Executive are I Solomon, With Chief Puttagunta, and call Officer Dr. morning this Joining Officer. the Sailaja over will turn the Jonathan me on to Medical our

Jonathan Solomon

proof-of-concept has We that candidates readouts will years decision everyone. for selected on each acne to creation data the data and program. on we made of prioritize product capital meaningful the company for has discontinue efficient development IBD and dermatitis potential by best inflammatory fibrosis generate of PSC cancer, for to data. and will in and believe In good platform the proof-of-concept, currently temporarily clinically will activities as this supportive postpone XXXX. value resume intend efforts morning we generate BiomX shareholders. the clinical programs development ahead disease With colorectal bowel Thank cystic decision, position and programs its our you, of that the the development to XXXX our Marina focusing in dominant in can use atopic assuming to planning BiomX BiomX drive

on balance Importantly, allow our six new impact our strategic the end may cash by sheet. runway us at positive to This extend months focus XXXX. a our of to will have until least up

XXXX. satisfaction that of available expected the clinical become data runway extend first tranches readouts us specified in half debt believe milestones positioned venture through that we further under therefore certain fibrosis addition, remain well dermatitis. may facility to and a atopic In to our upon financially can We cystic our

cause is It patients unmet surface in clinical evaluate in biofilm enclosed candidate consultation that for In Xb/Xa the designed time known as dose, our of an will two to doses parts. respiratory an Phase substance in single the infections Let trial phage multiple the lung is Cystic confirmed me and polymeric that safety, require or Part antibiotics. diminish fibrosis respiratory dermatitis various P. in plan for BXXXX trial to Part of infection against microbial the resistant days CF evaluate Xb/Xa aeruginosa the We as CF not active from of long pharmacokinetic, have to XXXX. CF. is a product with assemblage cystic aeruginosa, aeruginosa repeated expected CF or trial compromise antibiotic cells Part also significant Pseudomonas aeruginosa, and this microbiologic only BXXXX a antibiotic programs. atopic development currently of patients To cystic our designed extracellular of associated X of from with or conduct trial AD in over XX chronic activity infection strains with QX, bacteria and to Part this P. patients. that bacteria and are trial respiratory candidate, population eight P. X but the and results CF XX be the a of morbidity the are X mortality we Phase contributor now safety resistance. efficacy therapies target infections. aeruginosa network, fibrosis strains in cystic multi-drug suffer patients a P. penetrate these Part to need, of same anticipate QX Every treatment chronic by infections subjects to fibrosis followed begin briefly have appear. results X, fibrosis, courses main BXXXX address and causes effectiveness and for is to with typically in chronic cocktail BiomX treatment therapeutic now review, ascending BXXXX from XXXX. to chronic this of will of of X of resistant

atopic October, we're for me with announce to candidate agreement in let to dermatitis. turn our pleased Now, atopic program dermatitis BXXXX. an Maruho In

partner the market to safety BXXXX that ongoing agreement investment in value dermatology of company this an patients potential to commence leading equity support offer made share a premium the license in a an efficacy from to is also Maruho in And announce proof-of-concept million BiomX with in results will Phase Phase first at of $X us X/X to offer the primarily BXXXX Maruho Maruho study. of is the provides right availability ideal intended pleased enrolling following study, of to BXXXX. We're of help a maximize Japan. X/X pharmaceutical focus and Japan. which to price, evaluate As the Japan, the currently The

a development, product which in phage we approach dermatology Maruho enter active were AD. Given in treating for expertise pleased external the this agreement, validation to depth of provides

turn atopic known atopic reminder, abundant a phage Staph dermatitis. BXXXX aureus, development bacterium over or cocktail patients skin non respect inflammation the exacerbation healthy pandemic X/X due we Phase data of review also Marina S. increases President with targets to in a of the cover to aureus a now to to abundance of becomes and Staphylococcus lesional the of third now readouts, compared the when timing as of bacteria, aureus the to individuals, we skin Wolfson, atopic skin a lesional be Senior BiomX quarter Vice or more program in to target dominant Finance our in result, delay of experiences our patients. to of implicating With and scheduling dermatitis the experienced the The dermatitis is financial flares. over in expect the from a and minor backlog the ongoing XXXX. for patient I'd call FDA quarter to As meeting of XXXX. third to like this Operations results

Marina Wolfson

Thank you, Jonathan.

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

XXXX. compared activities. offset by XXXX, cash activities, in balance due were net primarily provided to cash our operating The XX, cash to of and of net used increase million, XX, partially December As $XX.X $XX.X was deposits by million as September short-term financing

registered offering agreement quarter entered of debt a in third of BiomX $XX million the million raised million, which up During direct and into $XX a received. been $XX to financing has

dermatitis be and focus deposits As atopic fund the of new to company's the mentioned programs. plan We cash call the cash, to short-term existing sufficient XXXX. strategic based the cystic company's on equivalents earlier operating in until fibrosis upon current now expect the end and

company resulting directors in call was for the cash stock-based increase three Net XXXX venture the $X.X insurance, facility, now XX, number Net of with the Additional company's and period certain expenses from for was third of $X.X Jonathan. specified And in of clinical satisfaction in in company related in period compared could The operating to salaries General administrative increase remarks, ended such stock-based million Jonathan tranches primarily the candidates, over the turn months increased million $X.X employees conducting growth to million compared in nine loss million September further in same expenses ended to and and was in Research salaries expenses and due million, the and for the $XX in half XXXX, upon of in compared that cash as increase of back and XXXX. $XX.X time XXXX, for XX, quarter and to under XXXX. the may the same to number expenses to milestones September million for employees growth due expenses, $X.X and to months due the for to for ended expenses, activities. to primarily compensation development become increase product available compensation due was million $X.X compared to related company's XXXX, for the same and as XXXX. $XX.X due XXXX. the three expenses to of September an related and period associated public his same new was extend and mainly to were million operating XX, officers increase in trials due months moving the into an a used runway to clinical activities for to The period XXXX. premises. debt R&D I'll mainly first in the its the an the preclinical the closing

Jonathan Solomon

Thank you, Marina.

we've intended stepping focus helping CMO his BiomX, the the shareholder AD product work and XXXX. We and for drive look our dedication numerous that company Since expected our in be strengthen thank to financial forward a today of preserve and are announcing has advance significant made and Sailaja Medical starting endless strong CF we Puttagunta, to also are role as and steps to to returns. Officer, joining transitioning down our programs The are with beginning taken new into our position, contributions ultimately accomplishments, Sailaja capacity. candidates development. our will Sailaja We on into Chief clinical at consulting

inflection XXXX positioned for to with to we remains open significant strategic important the like opportunity have now data call value near proof-of-concept our focus, demonstrate well We'd points. Operator? new with As could BiomX questions. that produce success we

Operator

Wainwright. H.C. question with Joe Please Instructions] the of proceed comes Our first Pantginis question. [Operator your with line from

Joe Pantginis

the and Jonathan. questions. taking for details two have And very you for I thank efficient Thanks update. questions, the

of business or CRC. ask development in the any where programs activities? and First, with these postponed regard do way some described can percolate plans for either it through ISPs you would fashion, have sort potential as I you optionality I this guess IBD to it

Jonathan Solomon

being aware Definitely Hi words. think it's you strategic for a warm Joe, microbiome. the we're something the is you environment of and the thank I of good into, know, looking external focus lot the and morning,

focus external can potential patients. So it data we what continuous I generate want on partnerships BD activity think in support, support of with, to additional that can in obviously there's But right. exploring sort

I and have on think really we least interested these we're they that in getting resources the we dermatitis. programs are to existing at focus, interesting, in but want CF atopic

Joe Pantginis

Of studies I you've was just course, question well. and live thanks. global for regard more ahead studies? readiness difficulties any now right We constraints, plan manufacturing times with your as curious general guess, to existing if I to And cetera. supply interesting had chain or then, plan experiencing with in et

Jonathan Solomon

the think right. of it So you're big in-house one that can control, but of a manufacturing, lot have advantages we so totally is we I

do in is which have supplier CF it of control. a in our all we slight - the we delay causing not some issues, did And program. think are have I

So hands. everything chains yes not supply we is see we've to and can, that obviously our trying get done as much monitoring we're constantly and in as but

Operator

Our question Michael Please with your line next from comes with Ladenburg question. Thalmann. Higgins of proceed

Michael Higgins

in you of was be guys. here is would it you market XXX there didn't rest data like Phase the help I follow-up taking data that opportunity any for questions. anything X guess the additional any more to is the operator Thanks, cost a to or on helpful? This Thanks there get

Jonathan Solomon

think good morning to Michael, BXXXX data. be so really I like Right, we

PK PK, could a as I have hoped as for. we think is good profile this

look promising. So giving does orally I very phage think

proof point, volunteers? in think your patient's to meaning think a want we load just and the CF data is because cognizant, getting derm. mechanism in to deprioritize within reduce data of with that we bacterial I healthy can we right over with that we just be atopic I can generate the XXXX BXXXX

pursue definitely and all with environment, those. resources So the a we've favorable all of

hopefully reduction some I going being of as have bacteria, because also target We're just on. effect. meaning, cognizant data patients indicate not only signals but and putting and CF think derm to they engagement, in clinical atopic can what's of target first a

Michael Higgins

that are then the the or Phase of in portion, trial sense trial patients to And minus Makes in standard XXX design on Xa that. antibiotics Thanks. XXX? appreciate one allowed on plus enter the care basically

Jonathan Solomon

let this. I'll address Excellent question, Sailaja

Sailaja Puttagunta

standard Yes, Yes, continued. them antibiotics you're inhaled to them. have Jonathan. will thanks, And correct then be will some of on - phage the of care added

antibiotics plus phage it's versus antibiotics So alone.

Operator

[Operator line with Fitzgerald. question. Instructions] from of Cantor Our comes proceed Please your Kristen question next Kluska with

Kristen Kluska

Thanks for questions. taking my

could for was opportunities target on I observed? potential bacteria, infections? respiratory this how please about based effects you market thinking us you The and each discuss unmet dermatitis need you're fibrosis, of much pipeline is early cystic have of the prioritization first remind and the one could market you've understanding potential size, the And then atopic how the

Jonathan Solomon

morning, good question. Kristen Sure, good

pipeline. I'll try address, I So to in terms of think

right. were programs the all think I exciting,

prioritize IBD obviously, by we looked way, generate the are And would they the we see of those with the general which but largest, conditions. said, sentiment, want effect at beyond market the of not I market intervention, bacteria we bacteria. probably on think community that's phage think should with that we potential think of the is I pursued right. clinical I investor market is begin the actually to things effect to effect, as But the is the is target where then indication reduction an target only microbiome, what

right. that's it. the the that Again, market we opportunity make think kind of I So have looked kind is an of interesting the potential, pending cut into way

patients in right, the earlier program. XXXX versus hope So which and derm. data, disease healthy that's we in We data data and atopic as generate generate inflammatory can bowel volunteers in why cancer program, mechanistic to in CF obviously, an

So there's just additional in vivo study.

of how into made of that's So what we comes cut I kind the think XXXX.

market terms In of right. potential,

So the on almost billion atopic talking large based to market, some five derm report, opportunity. It's of years $X so about expected in we're a right. the next is a or analyst triple very

majority which So a that market the have very large biological, of is with concerns. some injectable the mostly safety unmet need are

population really topical there's patient of safe, when for safe something the So is can a an large a appetite that pediatric, take especially chunk be market. potentially so something and third of that

CF north of from in an per the incoming that's do partnership are announced using potential So exciting just leading antibiotic we that And the And right. of right. opportunity. see we quite with with the partners. field have cystic In think year, Maruho you I million that patients fibrosis, selling $XXX

want the billion going know sales extent, $X we but it has that markets this the towards I right. should you course So it look of seen have generated. we franchise that profile build but can think very that better, if taking the if that is of you an right whole something that's be even potentially I be quite happening and be if don't large a model and at could could opportunity your we've it in has this annually be Vertex The a is larger somewhere what's CF, tobramycin between think to opportunity, Vertex ongoing

Kristen Kluska

acne BXXXX know you topical relates in gel past that. looking you as to and it Thank different I were you and discussed for the that compositions. at And

topically also So deliver read any given throughs to acne important this route? to data intended that atopic consider specifically wondering from related there if is delivery to these dermatitis phage are

Jonathan Solomon

Right.

ways insight what and improve the derm are Kris of into data analyzing gather I kind thinking acne and and think that thinking think we So, atopic to and want additional I study. all we're more we the

right. one acne we inside sebaceous the that challenges are is do think the know, of I thing key they one deep gland, with

that's is there it's much a matures follicles the whether the and C other the doesn't more layers bacteria sort so atopic it inside are move in challenge. live deep aureus the derm an extra of that's So Staph In mobile acne no deeper there hair, forth. bacteria back

about a there's So want the analyzing to lot support the Having study. of in to atopic I be think any is accessible. compiling think there derm whether a the we data said implement we're and that still all that, think takeaways lot the more that all I data bacterial will so

Kristen Kluska

indication to I along remain still on intend BXXXX then future just clarify in the PSC to with that an for And thanks. intends IBD? you Okay, here to wanted focus

Jonathan Solomon

more indeed, as is talked it's treatment as right the IBD some than people even an unmet huge no proof think interesting to, we there indication Yes PSC need. that is a

we So definitely apologies but if indication. I the both were - clear, program weren't if relevant is for

Operator

Our next question with comes with Capital. your from line Chardan of Keay Please Nakae proceed question.

Keay Nakae

Jonathan. you, Thank

that data can multiple single we just the the through obviously, from of report now with type what see get and you X, patients, So dose. each of CF beyond dose we'll are were and dose tranche, that single or CF these important, more in But guys and just ascending those in are first what us AD programs obviously, you Part in even multiple XXXX CF safety? starting walk

Jonathan Solomon

think it, we are so study, know good getting right. there support. dose, foundation have getting right, low the by as study CF to so, are morning, and follows then placebo, days [indiscernible] a treated Right of six first bit CF getting you dose are Keay, X eight Part dose, the as a high into high look their are patients, valuable I in treatment a and are the with few two those as guided parts you getting

getting lot exposure. of So they're a not

signal a whether we bacterial. readout, I there think a reduction looking the some are this is obviously, safety could but for initial target on be

that reduction I we there's baseline. think some compared a So to chance see good

definitely a see a for, improvement of very right. it's Obviously, such think study, clinical I statistical small nothing in So and duration. to not we're short any that's what, significance looking expecting

target getting XX there patients, improvement initial in was we're use, observations are from some want use, in with in seen dosing, signal on a of of on of And compassionate And in is in have bacteria, there a more a on states. the an lung some was sputum, compassionate reduction X treatment, it's clear here, that X. signal reduction the aeruginosa given of were a we're robust initial compassionate Part use hoping signal studies. the basing it that's were I on Part phage right? was to follows the signals think terms Part Pseudomonas X, are in So see that also the and eight this XX what the we see placebo. and So of of capacity day we're XX seen to we

Keay Nakae

Okay. derm, this the we terms year any of signal? will And half then what of in about of see how in second atopic for type efficacy

Jonathan Solomon

obviously in it's derm dosing So study we're the study, for atopic XX then patient that week.

we to to indication the as want that looking scores, any see target for we're in bacteria, improvement pick clinical reduction a want that Here see we and outcomes, such or easy an that's least we up can trends signal robust there's where, or a of right. also at SCORAD

we're we're we've for a looking after rather. significant So here, seen, necessarily compounds robust separation, expecting not studies in but as well with staph some signal, earlier statistically other went as so

Operator

the Our Michael next Ladenburg with Thalmann. question. Higgins line question with is Please follow-up proceed your of from a

Michael Higgins

follow-up. Thanks the for again, Jonathan operator. Thanks,

in the sense to across to just Europe, broader You to the a wanted I your things? assets out-licensing timing of for Japan out-license some Are et your discussed looking you Japan, in efforts rights trying guess take BD cetera get such others for in just in look, a portfolio. in the bigger

Jonathan Solomon

about actively being actively potential I we're thinking we're platform So a player, great question partnerships. think

keep we'd That it. some I also like programs Joe discussion we'd that like was brought partner I to earlier. and the programs to point the to think think up some

we complexities right to be not for later IBD the and aware studies. would the a but cost example, solely program of all So now, of partner clinical

keep potential we that partnership. I designation. an program looking to orphan a is it's think be that's we'll internal, a want actively CF something So for

it middle, we're advice the derm and make atopic in support there's getting CF right. ways we'd somewhere the I a and ourselves. which to is think is lot we keep from progress Foundation. that a And And that of more program, go can like

we still them external get excited give get quite the validation. we're in their think of rights rest we partner and I find the input, in that to the world, a Japan,

So that sense. made

as different bacteria if it cancers we one market and expand the cancer right partnerships really I think types program needed So generate there's on, multiple our the of amount we in could is to and and to investment can that even specific partner that risk specific every room early side, grow, it's and program, one of per colorectal tumor an is like, side, interesting

Michael Higgins

besides then That last or really your XXXX XXX XXX? this makes programs thanks. And cash through is one, sense with guidance without and any

Jonathan Solomon

that three into does not don't programs the steam all think as I simultaneously, So support full go we're to it guidance we we're on going but I XXXX going is. not right, mean, the pipeline it assumes

Operator

gentlemen, Jonathan session. and this Ladies back to final floor turn I'll you. question-and-answer the comments. concludes any our Thank for

Jonathan Solomon

all us a day. So morning. providing again program to derm updates this our any questions. and you And I atopic us you XXXX. CF look on have forward thank wonderful wanted We joining to to Thank clinical Have of throughout future you out if you. for reach please

Operator

Thank you. conference. This concludes today's

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

BiomX (PHGE) 15 Nov 212021 Q3 Earnings call transcript