BiomX (PHGE) 11 Aug 222022 Q2 Earnings call transcript

Good morning. And welcome to BiomX Second Quarter 2022 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. proceed. Please

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

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

forward-looking deposits. For if instance, design; our shareholder when we're and pre-clinical the additional The potential on existing our growth and of receipt conference timing; trials, milestones expected potential benefits of using met. short-term funds final The the statements opportunities; clinical product we potential candidates of our sufficiency and and potential discuss cash, market results cash interim call value. and the aim; are of equivalents

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

is the to Jonathan that, Officer morning Jonathan. Chief over call will BiomX. on call I this Joining the me With Solomon, of turn Executive

everyone. Thank you, morning, Marina, and good

platform our research our Ingelheim, successfully extend dosed collaboration period completed runway. restructuring productive the our further proved published announced a Boehringer cash technology We second quarter a and inflammatory program company. of important cystic XXXX for program, highly second a The and disease of new fibrosis be first to bowel supportive patient in with our to

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pace anticipate results for placebo or in the and FLOW are respiratory in The X continue the and from a third is As BXXXX reminder, X patients BXXXX main part patients, X:X infections results by microbiologic the will of study XXXX. Phase CF first a CF. of composed design, parts; XX for study BiomX and of BXXXX of is the of quarter two Part aeruginosa, the one, safety treatment in in of of and activity PSA, contributor Pseudomonas patients treatment end the the in through in study the and cohort chronic enrollment of the with CASH dose patients Xb/Xa the mortality eight the multiple dose ascending first evaluate and BXXXX morbidity quarter safety, provided efficacy XXXX. that evaluate single Part the a developing of we'll randomized a ratio or will of as of clinical with study expected, of we by part expected pharmacokinetics caused to

daily lung are living to and to the both are CF. lungs. are function of clinical few the of than six researchers treated Fibrosis publications infections exceptionally XX% patients in evidence to infections multidrug-resistant North approximately School been with use titers. to difficult data P. options the loss that days suppressed to Pseudomonas of the And supporting infection reduction in on with PSA aeruginosa in inflammation. Medicine At scientific this and study more and therapy eradicate The As EU encouraged aeruginosa patients address infected after Yale the are cause to with aeruginosa size their are of is safe currently in was body substantial, were adults X effect a remains with research CF treatment how there PSA people growing US pseudomonas fully CF. in bacteria. show inhaled XX We that and is CF the for of production on for infected days. lung of population a therapy phage The patients of American and the that XX,XXX was patient showed [indiscernible] Cystic phage the by XXXX and available. the Between the treatment provide of have leading with twice reminder, CF see presented lung XX,XXX infections opportunity phage of Results the phage Conference, interrogate which estimated given purpose lung mechanism with alone, the significant the from

function. improvement addition, led in phage also therapy In lung an

reactions overview Yale Clinical In being approach. Mycobacterium As phage treatment multi-drug-resistant Mycobacterium in CF to infections potential other address forefront institutions is its chronic [indiscernible] this preclinical the we of the patients landscape for grow. unmet medical phage has role were and hosted so past growing Dr. On and webinar the and The with or patients the May isolates. with CF the study, very research basis struggling discussed compassionate to the PsA reactions, that screened then PsA options need use points evidence Awareness CF serum a continuing [indiscernible] candidates lung attributed use treating for therapy infections to adverse And were with to who program XXXX, A phage these and XX exploring We more to and Investors of Bronchoalveolar chronic positive ongoing patients. calls, therapy were lytic potential CF as presentations for the was Therapy webinar ongoing study, presented eyesight important Webinar no the of in multidrug-resistant toward published development of XXX key also patients and clinical administered KOL the Nichols infections. of evidence June generated BXXXX clinical to XX, compassionate in discuss clinical patients building identified from Aslam, treatment help be see passionate featured the microbiological an current infections. patients emergence address BiomX or to patients disease. from a CF patients pulmonary a entitled treatment phage body monitored patients available, In treatment opinion XX and pleased any XX noted our XX of play University showed paper been landscape pathogen few responses, patients to Mycobacterial phage phage treatment in surrounding published the phage drug-resistant in journal symptomatic of the activity of infections fluid. on in our to plan. corporate One therapy phage accessible BXXXX resistance clinical in of with disease Disease Dave patients, clinical an Result to lung helping valuable phage through bacterial combat potential is enthusiasm delivery. a Dr. or that with in infections, persistent with website. neutralization the is are phage-based Phage phage potential the difficult-to-treat through of leaders, Saima sputum solution, treatment and review We use microbiological and researchers administered chronic providing support and a patients then with lavage therapy, susceptibilities. from adverse infections. the and in the Infectious academic was a UCSD recording of and the trial in developing CF the phage response in believe for appears the section regardless of favorable therapy we

development our these findings forward near initial our BXXXX at significant BiomX, the Given clinical program need and in patients, medical unmet for look remains presenting its to we clinical future. priority

collaboration discovery potential agreement, utilize therapies from the to quarter. our were activity. recent the biomarkers pleased will also a the thought partner its Boehringer bacterium biomarkers be XMarker the Such IBD. benefit microbiome-based pathogenic collaboration during Under patients to second with announce Turning new at BiomX We to very with biomarker associated would could for platform help targeted to that identify microbiome. identify Ingelheim IBD

this April, mechanisms. which phage specifically, As researchers first build in future generating research mice provide demonstrated IBD. Kp integral of strong we Collaborative to and assessment for reminder, research we by The BI model Journal focused in was attenuated on a sequencing has Ingelheim culture and lytic will IBD-associated likely effective name But in with our to clade program. Collaborative consistently the generate the also in seek our with we partnerships, analyses, to an direct from orally the enabled insight treatment patient publication the algorithm University drove of IBD-associated hyper-accurate by was providing X-phage research cocktail and proof-of-concept products The suppression more to organizations, administered, specifically our of preclinical academic data mix through The a to results phage of a research Keio and paper Cell targeted the an month, company's of proud candidate. a for scientific disease of for entitled a targeting in gut an Scientific suppression relates independent research paper Institute Journal, renowned those Kp associated resistant as of members combination is and to partners scientists an important development colitis-prone intestinal XXXX, single announce IBD. generate commensals can in September Bioinformatics. help specifically biomarkers external paper research conducted inflammation. inflammation More the genetic several positive academic with thereby severity. Exodus The phenotypes proof-of-concept we're assessment and enviable in and lytic on pneumonia scientists identifying BiomX the of with distinct part efforts BiomX X-phage IBD. institutes. sensitive target across our In product such microbiota with and Weizmann conducted publication relationship designed of next-generation enabled understanding Boehringer a of that And research treatment validation back including phage detailed us new human announced the collaboration insights industry-based of earlier entered presented consortia BiomX, Medicine. by School Science of the a

this open is various researchers can our now also external conduct BiomX the nature entire the source on to to Exodus projects. and platform use genome-related Importantly, of of because being an R&D leveraged algorithm algorithm, across other analyses

resources least at announced We restructuring until news. given are to further during to mid-XXXX. our ensure Chief but period. our quarter. prepared challenging this through second such cover conditions company now us capital the results corporate Financial is decisions call allowed Obviously, Wolfson, the easy, must that prevailing financial turn runway to we over cash the than well to the to which within our our to more sufficient Marina Turning a never the Officer I'd navigate for quarter, like markets, extend through with

Thank Jonathan. you,

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

ended decrease as additional to General in and expenses XX, An R&D million Israel in in for compensation XX, compared due was the period workforce. were compensation of the as for for PSC, The $X.X cancer, in a months million net net in grants six $X.X product candidate salaries were as the months a to administrative and of XX, the December BXXXX, net, expenses, of by in were acne stock operating three ended candidate a compared the $XX.X in resulted decrease months to the activities. compared six development and in million due treatment cash XX, million June Authority and well used XXXX. balance for for and administrative of and is XXXX, June $X.X workforce. A in period million XXXX, expenses three months XXXX. the expenses same Innovation short-term the XX, compared for same expenses receipt a XXXX. salaries XXXX, reduction expenses offset decrease R&D June well June due for for decrease the related to in as reduction expenses of XXXX. million product the of primarily XX, due $XX.X for months to IBD six our colorectal million June development based of for to higher to discontinuation XXXX, June million and $X.X ended the expenses BXXXX. deposits XXXX. cash The offset stock-based as to the candidate was $X.X ended and XX, in net decrease were product and million, primarily Research the were General to and ended $X.X period treatment same to expenses $X.X due XXXX, related the and pauses treat As

In current due plan now, turn used company's cash, is short-term compared to over the for incurred remarks. existing in period to million cash for estimate equivalents addition, moving $XX.X through $XX.X in that for XXXX. new And premises. mid-XXXX. will deposits Net Jonathan? decrease XX, was six additional to sufficient Jonathan the million be the June the ended resulted in least call back months to the expenses his at I'll XXXX, from and operating fund cash We operating XXXX activities same closing that into

program therapies existing this for With resources advancing treatment ensure options, lung Marina. more fibrosis. addresses clearly We resistant phage help are important desperately be evidence with BXXXX value. we're you, continual that to few therapy believe infections program new reach needed. an treating could threat Thank drive to our CF, cystic within unmet and encouraged need financial of our the medical in we a that have see and are milestones critical shareholder Patients we emerging pathogens, this multidrug to

in have future. the biotech Operator? clinical generating to for key rebuilding been is solid investor we months look our challenging for we initial clinical enthusiasm, sector, While BXXXX the few and the that sharing the know last to data near forward results

first [Operator Please Pantginis Our Joe proceed. question Instructions] is with from H.C. Wainwright.

the morning, question bit for question. have question. a taking of weeds Jonathan, little logistical everyone. Hey, into then Thanks the a I and good getting

for is I your, say, first, more your So plans guess, how supply are and manufacturing near-term current how efficiencies? And expansion? any

morning, unique Joe, decision a to proved and took end, good critical phage modality, supply the two to pleasure. it ago, that have then from decision. is a we because being good want control was that we I almost think out – Logistics a chain be manufacturing, we So, a I in-house to beginning years think

count budget support the timelines and can't to our the atopic. the the we So everything X CF programs program effect the is support and Phase we still organization. CMC we do capacity still all what reduction resources guidance have the and study. and an have it needs we on simultaneously, we'll anticipate. about for, on of thinking of of in head have that's We planned we of that in kind Obviously, the support can in head need we're count did give have what the kind do But why the atopic, that to

very is, continued phage, in environment when CF is Yale different, And That's indications obviously, then the of micro overall weeds very the at additional obviously question very beyond. And and right tough, CF lung, my the for and Thanks. sort helpful. data you shift biofilms stage the I every direction. guess of look is

clinical So I standpoint. data a guess, especially from

any guess to I So with there formulation delivery potential of Yale important or your to the differentiators are data cocktail. and regard similarities

versus, So a I will these the we're cocktail using that single a obviously is of have I cases, basic think, Yale say the on is which data always we very the study approach many are that that limited. page.

and the trying a we do a acute have few which what bacteria have simultaneously. to is phase hitting So kind we're of cocktail, is broad hence,

that that important advantage that in role well. also biosome cocktail potential the sure [ph] think capabilities are the lungs there and we has know phage -- in we we anti-biosome we biosome present an as that I element could specifically, sure have play our do indication, be and Because So a have anti-biosomes. that make make an

is think that key others, acne. the fact the sort validated indication know to came that And in phage, think out molecule preclinical with one sort to can because We've making phage a I actually think in a the actually your and that But right? share supporting site specifically I size, side we at getting excitement in droplet challenges of so I we as droplet the think of Yale optimization. least advantages. being all So data the seen the we of get well in I it that action, phage with did understand we of good in action, terms of phage the have I that and large the and nebulized of models, producing phage, nebulized it sure provided CF, arrival of whether announcement,

I encouraging. So think be extremely should that

That's luck and very good helpful, Jonathan. Thanks,

you. Thank Pleasure.

is proceed. Our Kluska Kristen question Please from Fitzgerald. with next Cantor

Thanks Good questions. and morning Hi. for taking good afternoon, my everybody.

is, about on have sense patterns occur spoke been talked And The around a also the that with and a could now I past few are you intervention. some the factors predictability the commercial little keep severity. any infections a you when there the what But of bit that just of years about matter factors the infections no might back first know experience them then we that us levels give of in different being Trikafta coming fact observed market. of for

Good.

it's of data is the pseudomonas There in shows use of and So question. of few isn't again. much build rather drop Kristen. up there is really a a is then I because good that few And that that and a morning, sort it important levels new. of of first the data picks papers think There years, kind Trikafta

isn't hearing we're the to relatively probably date, we're patients early, levels seen And are we do think come the but years, by from the delaying I out a on that the from out probably from infections, KOLs today. patients I But put to just reach we're reaching that which back and do dramatic seeing delayed is have change few we've constantly the see seeing high from talking to landscape kind could but what physicians, think what physicians. a and with I there will a of and get see it treatment. do they we're disclaimers

picture microbiome a how -- in recognize your programs that's and early feedback And apples-to-apples to assume modality Thanks. the to do and is of pipeline for thoughts the would place maybe dialogues going FDA it's not with have another big criteria here a around different I progress help panel you could love for question, that company your listening take these you in agency understanding you think some and of but and speed, of late-stage understanding focused some on. the September

of phase, So on I of been which on lot I emphasis CMC. elaborate. also that's dialogue. separate think like They think workshops there's And a have a kind

think microbiome think I there's do a which lot of of good. And openness in of CMC get a I handle was well there other between So and a products, comfortable there's the playing how well. of more part in drug good as analogy you kind I when field approved the terms fermented a getting of aspects, you're of is kind CDMOs large think as sort as terms seeing the So look right?

at after phase, with don't there's the that and on is of reduction phases microbiome, sort you Can about, still even think a a pathogen-b discussion I as other some that pathogen-c maturing. some for there the any you're hoping relevant. have yet. least or of the case of There's a What surrogate aspect infection And we're I'm that but even more evidence CMC there I think I So of in approval? talk general endpoints or of going think right, specific surrogate in it right? whole is the

be I of endpoint So everyone's think will surrogate we're approval kind crossing make because our one will in pass-through faster. product as much approved fingers

goes to hope let's but So again, there, tell. early too it

guiding Got have in is you're it. CFP And XQ last know Thanks. place November. any question, to taking the and data I know potentially I conference

others it's be a potential So from from could Yale you, or that whether this topic do you at expect stage, conference?

exciting. very It's so. definitely hope I

with XX sort of data publication, spectacular created quite data that of of BAL, And coming it UCSD, the I think right, of the mycobacterium. of with XX lot patients kind out a to with time out CF the Fairfield. in came

big and experiencing of more we're seeing the it just been will the in And well think by play books, field KOLs as from we're there the movies, seeing kind field out from that patients' I So We the fact interest on. have hope as around a is right hoping role. whole that some maturing.

Great. Thank Jonathan. you,

Pleasure.

Our next Ladenburg Michael Thalmann. is question Higgins with from Please proceed.

guys. Thanks afternoon questions. for operator. Thanks, my taking Good

CF question couple results to if could. forward next I BXXXX on a questions a Looking seeing I of have on one, but -- BXXXX in

the press release,… in noted you As

Sure.

on information minimum …company later plans share forward, to activities a if by to you with us that this of more the with scores of enrolling Hoping patients? continue patients update to the share you can And support in us? range you detailed move any EASI year. enrollment strains can Thanks. program consider the

Michael. Pleasure,

the the we topic, it goes our don't of CF two the earlier, haven't the study system question projects with So And the the to with and currently, Joe's is because yet to burden approved. simultaneously want restructuring, started IND priority. is we

think gearing cocktail -- with of partners at broad talking I kind to we're we're What we're So what a range. going AV the host when is our actually Maruho. we've for very the do seen with up study still

to but about sure is there to away these think I patients, you embed less the make take want to in it's strength and [indiscernible]. that enough our want and staff that to of make current high we something is we in that's sort So want clinical of sure, going programs to future

phage and is levels light our green gives cocktails the us we kind they move to that make bacteria, want of of to that do strains thinking that are forward. sure their make high we susceptible the patients to before, So -- have we do our sure that sample

approach the they dramatic that's reduction be improvements. to clinical went as where the saw is because both target design, again, bacteria a severe, patient that's in and the but the more of to finalized reduce actually as seen even group of, well from terms UCSD we've moderate an In thinking the with data of what to that we're that

are these patient probably ready, think I we'll again, provide get that's updates. we once interesting. population probably the more But more

XXX, then paper to plans the that. XXX? is mentioned broaden added phage’s other XKT cell possibly terms Any as of Appreciate Page interesting. really being And [ph]. XX, in

project really So we it's like. a

the I right, XX-plus We overlap of so with, that that have, a PSC, cocktail your a we also and XXX worked is between next think fact point, the as months. horizon an BXXXX mean, do broader ready, is driven broader in not begin the there's be I prioritized to to IBD currently and would we've basically that's on the right, by which as BXXXX. well as cocktail

speed already So both patients. the of. that that's enter were a cost both we we're broader to what a ideally, of from cocktail strains derived are want indications types to thinking have is And relevant

that. to SVP, our follow-up psoriasis interesting a for speaking was in of for one to the that with plan well bit enrolling screener just so, I microbiome treatment. a from Is some in psoriasis, really your of years another Boehringer this patients more use a And to and enroll here, the reading program. Thanks. as more patients microbiome the as comments so using with the screener as are as future who right, your tech use

an excellent it's So point.

it right? modalities. Boehringer of in can their it biomarker think you about collaboration with therapeutic Ingelheim using situations, identifying actually several is one Our I use in potentially with

a identify is have and patients a would response here, patients have potentially that that described, exactly classic that you you've way a identifying the better those case of So don't enrolled of would pool. right, biomarker as

it, different some will And comes the that path want validate but more others, identify And groups our to a there's probably that So a we the for stratify mind, use approach on I can indication targets right, indications, be within think to that point, well right, we patient clinical on your to existing with the hopefully, that's microbiome one effect could outcome. microbiome would about more there's new same use targets, you the there of research different two, multiple evidence as lot of as one KOL comes and right? are role average. like of that out and

Appreciate that. Thanks, Jonathan

you, Michael. Thank

go Our Please Keay with Nakae, check Instructions] and Nakae line is if live. next Mr. [Operator see phone And muted. is ahead. question Chardan. your you from have Please your

Can you hear me?

we Yes, can

Jonathan, currently BXXXX,how you. running? many have and for sites do up you Thank

morning, of Keay, sites. don't it's mean disclose the good large So, I not study. we very publicly number a

X have a you we we're going As do up few running. and know, for But sites patients.

of of we were rolling use pursuing, -- seamless study the about these we as right, part sort that sites hoping other Part make the the of two There's And sort to sort we're and X. into of already thinking can. multiple multisite transition kind definitely

Right.

we running enroll I got would X with you So understand, sites guess as to patients, part many more have and how trying to I was up to

have and few. the Yes quite of CF a honored to good the very support We're Foundation their very development network.

move we as So we're can, is can. we quickly clock want to broad as trying The ticking, as go as to right?

sort making balancing of is pivotal operationally it And is of a very on an plays making and studies again, it's very is indication. is sort what but connected controlled again, But do orphan unique population a are sure in together. that role can everything the a tied we're CF sure broad study. Foundation So well It and we patient and the communicated. managed,

So multiple that's extremely site a helpful up in set

Okay. That's all I have. Thanks.

you, Keay. Thank

question-and-answer We for turn like Jonathan would have closing reached over of comments. call the back to end session. our I to the

again. the want please us wonderful if year. through of just day, on Thanks thank you look morning. and our forward I future a you additional rest clinical questions. Have this We you. out programs the of all Thank to you to to us, reach updates providing with any for joining have

today's conference. This does you. conclude Thank

your disconnect participation. lines this your time, you for may at You thank and